April 2007
April 30,
2007
Amerinet leadership changes hands as Ebert takes the helm
SterilMed and The Scope Exchange merge
Ray Taurasi joins Healthmark Industries
CMS
proposes payment changes for Medicare home health services
CMS issues guidance on hospital emergency
services requirements
Joint update: FDA/USDA update on tainted animal feed
Alzheimer’s memory loss may one day be
reversible
Major manufacturer of unapproved and adulterated drugs
agrees to stop illegal practices
Amerinet leadership changes hands as
Ebert takes the helm
Todd Ebert, president and chief
operating officer of Amerinet Inc., saw his leadership role
within the national group purchasing organization expanded
even more following the announced resignation today of CEO
Victor Samolovitch. Though Ebert takes the chief executive
reins of Amerinet, responsible for overall leadership of the
organization, his professional elevation does not include the
CEO title, which has been shelved. As president, Ebert “will
focus on continued implementation of the Amerinet strategic
business plan adopted in June 2006,” he told Healthcare
Purchasing News in a prepared statement. “The plan calls for
continued organizational growth, investment into program
development and differentiating Amerinet in the
marketplace. Key areas include programs and services such as
clinical consulting, clinical preference products and data
analysis and management tools.” For now the CEO position will
not exist, according to Lisa DiMuccio-Conway, Amerinet’s vice
president of marketing, and “there is not to be a CEO search
at this time.”
Samolovitch was promoted to
Amerinet CEO last June as the GPO celebrated its 20th
anniversary and was embarking on a new business model that
unified its three shareholder organizations under a single
national platform. He succeeded the retiring Robert P. “Bud”
Bowen. Samolovitch was president of Warrendale, PA-based
Amerinet Central, one of the GPO’s key shareholder companies.
Samolovitch also had been part of Amerinet since 1986. When
Bowen retired, Amerinet tapped Samolovitch to be CEO and
created a new position for Ebert, who had served as president.
As president and newly named chief operating officer, Ebert
would oversee “customer-facing operations,” such as
contracting, marketing and sales. He originally hailed from
Salt Lake City-based Intermountain Health Care, another key
Amerinet shareholder.
Bert Zimmerli, Amerinet’s
chairman of the board, praised Samolovitch for his leadership
role in the GPO’s move to a single organization from the
shareholder-based structure it operated under since its
inception in 1986. “Over the past year, Vic has been
instrumental in leading Amerinet through its organizational
transition to one national group purchasing organization,”
Zimmerli stated in a press release distributed to the media
this morning. “Thanks to Vic’s vision and perseverance,
Amerinet developed a restructuring plan that solidly positions
the organization for future success and growth.”
AmeriNet, (its original
designation in 1986), comprised four multi-state regional
purchasing groups during its debut: Haricomp (which became
Vector Healthsystem), Health Services Corporation of America
(which left the GPO four years later and now is part of
MedAssets), Hospital Shared Services of Western Pennsylvania
(which became Amerinet Central) and Intermountain Health Care.
Based in St. Louis, with offices in Salt Lake City,
Providence, RI, and Warrendale, PA, Amerinet serves more than
22,000 acute and non-acute healthcare providers nationwide.

SterilMed and The Scope Exchange merge
SterilMed and The Scope Exchange have reached an agreement to
merge. The merger is part of SterilMed and The Scope
Exchange’s strategy to help healthcare providers conserve
their resources by extending the life of medical devices,
instruments, and equipment. Combining the two companies’
expertise in the repair and reprocessing of medical devices
will provide customers with a comprehensive single-source
supplier. The merged expertise
combined with SterilMed’s broad market presence will further
strengthen the breadth of services provided, including
industry leading technical capabilities and showcase repair
facilities. The newly formed company can now offer the
benefits of an integrated reprocessing and repair service
approach.

Ray Taurasi joins Healthmark Industries
Healthmark
Industries Company, Inc. (St. Clair Shores, MI) is pleased to
announce the appointment of Ray Taurasi as the new Director
Clinical Sales & Services - Eastern Region. “Ray is an
excellent addition to our Sales and Marketing team. His long
time experience both in managing of and in marketing to
sterile processing departments means he has unique insight
into our customers and their needs,” explained Steven Basile,
Vice President Sales. “Ray will be responsible for working
with our Eastern Region sales representatives, providing them
with training, direction and sales support. He will also be a
vital asset to our customers as they seek clinical support and
education.”
Stephen Kovach, Healthmark’s Director of Clinical Education,
said “I have worked with Ray for years, as a counterpart
managing CS Departments, as a colleague on various ASHCSP and
IAHCSMM boards and activities and most recently on various
AAMI Sterilization Standards committees. I look forward to
drawing upon Ray’s vast experience as we continue to expand
our efforts in customer education and support.”
Taurasi’s
healthcare career spans over three decades as an
administrator, educator, technologist and consultant. Taurasi
has been a member of ASHCSP since 1969 and holds advanced
membership status. He is also a past president of IAHCSMM. For
19 years, he was the Director of CPD at Boston’s Beth Israel
Deaconess Medical Center and prior to that he was the Director
of SPD and Faulkner Hospital. He has been a faculty member of
numerous colleges teaching in the divisions of business
administration and health sciences. For the past five years he
has authored a monthly column in Healthcare Purchasing News
entitled “CS Solutions”. In addition to professional
credentials in the field of Central Service Technology and
Education, he holds a BS degree in management and counseling
and an MBA. His dedication to the healthcare field and
community service has won him international recognition and
several prestigious awards, including IAHCSMM Presidential
Citation Subject Matter Expert.
Healthmark
Industries Company provides solutions for the sterile
processing profession including products designed to address
the needs and challenges related to the sterilization,
decontamination, storage and distribution of medical equipment
and supplies. For more information see
THIS LINK.
CMS proposes payment changes for Medicare
home health services
The Centers
for Medicare & Medicaid Services (CMS) proposed a rule
designed to ensure more appropriate payment for services
provided by Medicare home health agencies, while establishing
incentives for more efficient care for Medicare
beneficiaries. This proposed rule contains the first
refinements to the Medicare home health prospective payment
system (HH PPS) since 2000 and also contains the annual update
to the Medicare HH PPS payment rates. The net impact of all of
the proposed refinements and updates in the HH PPS proposed
rule is an estimated additional $140 million in payments to
home health agencies in CY 2008.
The
proposed home health market basket increase for CY 2008 is
2.9%. Home health agencies (HHAs) collect and report Outcome
and Assessment Information Set (OASIS) data. For CY 2008, CMS
proposes to evaluate home health care quality by continuing to
rely on the submission of OASIS assessments. Continuing to use
the current OASIS instrument ensures that providers would
avoid any additional burden of reporting through a separate
mechanism and any related costs associated with the
development and testing of a new reporting mechanism. The
proposed rule includes a provision to continue to adjust
payment for reporting of quality data. HHAs that submit the
required quality data would receive payments based on the
proposed full home health market basket update of 2.9 percent
for CY 2008. If a HHA does not submit quality data, the home
health market basket percentage increase would be reduced by 2
percentage points to 0.9 percent for CY 2008. The proposed
rule adds two National Quality Forum-endorsed measures to the
10 that are currently reported: emergent care for wound
infections - deteriorating wound status; and improvement in
status of surgical wound.
CMS analysis of the latest available home health claims data
indicates a significant increase in the observed case-mix
since 2000 and that the case-mix increase is due to changes in
coding practices and documentation rather than to treatment of
more resource-intensive patients. To account for the changes
in case-mix that are not related to a home health patient’s
actual clinical condition, this rule proposes to reduce the
national standardized 60-day episode payment rate by 2.75
percent per year for three years beginning in CY 2008. This
rule proposes ways to improve the comprehensiveness of the
case-mix model and thus improve the accuracy of Medicare’s
payments. The proposed case-mix model includes a proposal to
replace the current therapy threshold at 10 visits per episode
with three new therapy thresholds at six, 14, and 20 therapy
visits. The new levels would have graduated payment levels
between the proposed therapy thresholds to reduce incentives
to inappropriately target higher thresholds.
This rule
also proposes to modify the low utilization payment adjustment
(LUPA) and to eliminate the significant change in condition
payment adjustment. The rule proposes to increase payment for
LUPA episodes that occur as the only episode or the first
episode during a series of home health episodes to account for
the initial greater costs in such episodes. CMS is also
proposing to revise the way to account for non-routine medical
supplies (NRS) in the standardized 60-day episode payment
rate. This rule proposes to pay for NRS based on 5 severity
groups, similar to the proposed clinical case-mix model, to
more accurately reflect home health agency costs for NRS. The
comment period closes on Tuesday, June 26.The proposed rule is
available at
THIS LINK.
For a fact sheet summary see
THIS LINK.
CMS issues guidance on hospital emergency
services requirements
The Centers
for Medicare & Medicaid Services (CMS) issued guidance
clarifying the responsibility of hospitals provide emergency
services if they participate in the Medicare program. The
guidance makes it clear that nearly all hospitals, including
specialty hospitals and others without emergency departments,
must be able to evaluate persons with emergencies, provide
initial treatment, and refer or transfer these individuals
when appropriate. The guidance does not apply to critical
access hospitals (CAHs), which are small, rural hospitals that
are subject to separate regulation.
Today’s
letter reiterates Medicare’s long-standing requirement that
hospitals have appropriate policies and procedures in place to
address individuals’ emergency care needs 24 hours per day, 7
days per week. “Any hospital participating in Medicare,
regardless of the type of hospital and apart from whether the
hospital has an emergency department must have the capability
to provide basic emergency care interventions.” said Leslie V.
Norwalk, Esq., Acting Administrator of the Centers for
Medicare & Medicaid Services. “The guidance we are issuing
today is part of an overall strategy to ensure quality care by
assuring the rapid response to emergencies for all people with
Medicare.”
Three key
requirements are (a) the capability to appraise the emergency
situation, (b) providing initial treatment, and (c) referral
when appropriate. The letter clarifies that the Medicare
Conditions of Participation (CoPs) do not permit a hospital to
rely upon 9-1-1 services as a substitute for the hospital’s
own ability to provide these services. In a separate
development, CMS issued a proposed rule on April 13, 2007 that
would increase transparency and public disclosure concerning
emergency services. The FY 2008 acute care hospital inpatient
prospective payment system (IPPS) proposed rule would require
a hospital to notify all patients in writing if a doctor of
medicine or doctor of osteopathy is not present in the
hospital 24 hours a day, seven days per week. The hospital
would be required to disclose how it would meet the medical
needs of a patient who develops an emergency condition while
no doctor is on site.
CMS also
invited comments on whether current requirements for emergency
service capabilities in hospitals with and without emergency
departments should be strengthened in certain areas, such as
the types of clinical personnel that should be present at all
times and their competencies; the type of emergency response
equipment that should be available; and whether hospital
emergency departments should be required to operate 24 hours
per day, 7 days per week. Although the survey guidance issued
today applies to all hospitals, it also implements one element
of the Strategic and Implementing Plan for Specialty
Hospitals that CMS reported to Congress in August of 2006,
in accordance with the provisions of section 5006 of the
Deficit Reduction Act of 2005. For more information see
THIS LINK.
Joint update: FDA/USDA update on tainted animal feed
The U.S.
Department of Agriculture (USDA) and the U.S. Food and Drug
Administration (FDA) continue their investigation of imported
rice protein concentrate which has been found to contain
melamine and melamine-related compounds. Based on information
currently available, FDA and USDA believe the likelihood of
illness after eating pork from swine fed the contaminated
product would be very low. The agencies are taking certain
actions out of an abundance of caution. As announced on April
26, swine known to have been fed adulterated (contaminated)
product will not be approved to enter the food supply.
(Because the animal feed in question was adulterated, USDA
cannot rule out the possibility that food produced from
animals fed this product could also be adulterated.)
As reported on April 22 by FDA, the Agency determined that
rice protein concentrate imported from China was contaminated
with melamine and melamine-related compounds. The product was
imported by Wilbur-Ellis, an importer and distributor of
agricultural products. Although the company began importing
product from China in August 2006, the company did not become
aware of the contamination until April 2007. As part of the
ongoing investigation, FDA has determined the rice protein was
used in the production of pet food and a portion of the pet
food was used to produce animal feed. The ongoing
investigation is tracing products distributed since August
2006 by Wilbur-Ellis throughout the distribution chain.
At this time, the agencies have no evidence of harm to humans
associated with the processed pork product, and therefore no
recall of meat products processed from these animals is being
issued. If any evidence surfaces to indicate there is harm to
humans, the appropriate action will be taken. The assessment
that, if there were to be harm to human health, it would be
very low, is based on a number of factors, including the
dilution of the contaminating melamine and melamine-related
compounds from the original rice protein concentrate as it
moves through the food system. First it is a partial
ingredient in the pet food; second, it is only part of the
total feed given to the hogs; third, it is not known to
accumulate in the hogs and the hogs excrete melamine in their
urine; fourth, even if present in pork, pork is only a small
part of the average American diet. Neither FDA nor USDA has
uncovered any evidence of harm to the swine from the
contaminated feed.
In
addition, the agencies are not aware of any human illness that
has occurred from exposure to melamine or its by-products. To
further evaluate any potential harm to humans, the FDA is
developing and implementing further tests and risk assessments
based on the toxicity of the compounds and how much of the
compounds consumers could be expected to actually consume.
The ongoing investigation and product reconciliation and testing have
led to certain farms. The agencies expect the investigation
will continue to find more places where product may have been
distributed. As of April 26, sites in the following states are
believed to have received and used contaminated product:
California, Kansas, New York, North Carolina, South Carolina
and Utah.

Alzheimer’s memory loss may one day be
reversible
A new US study suggests it may one day be possible to reverse
the memory loss associated with Alzheimer’s and similar
degenerative brain diseases. The study is published in
Nature. Scientists at MIT’s Picower Institute for Learning
and Memory in Cambridge, MA, put mice with induced brain
atrophy in an enriched environment; a “playground” where they
had the company of other mice, were given new colorful toys to
play with every day, and were able to exercise on wheels. The
enriched environment mice recovered long term memories while
mice kept in a bare cage on their own did not. Li-Huei Tsai,
Picower Professor of Neuroscience in the Department of Brain
and Cognitive Sciences and her colleagues got the same results
when they gave the brain atrophied mice a new type of
experimental drug called histone deacetylase (HDAC)
inhibitors.
Neurodegenerative diseases of the central nervous system are
frequently accompanied by impaired learning and memory, and
eventually dementia. Scientists have been trying to find ways
to reverse the process and re-establish the ability to learn
and remember. In this study, Prof Tsai showed it was possible
to “re-established access to long-term memories after
significant brain atrophy and neuronal loss had already
occurred”. The stimulated mice’s brain cells had sprouted new
dendrites and produced new synapses, in effect reversing the
degeneration. Prof Tsai, who is also a Howard Hughes Medical
Institute investigator, said: “This is exciting because our
results show that learning ability can be improved and ‘lost’
long-term memories can be recovered even after a significant
number of neurons have already been lost in the brain.” “This
hints at the possibility that cognitive function can be
improved even in advanced stages of dementia,” she added.
HDACs help genes that have been too tightly packed in the
nucleus of cells to express themselves and make proteins.
HDACs have been increasingly used by researchers in other
fields, for instance in clinical trials with Huntington’s
disease patients. Some HDACs are already available to help
chemotherapy drugs target DNA by opening up the chromatin
structure. However, as Prof Tsai said: “To our knowledge,
HDACs have not been used to treat Alzheimer’s disease or
dementia. Future research should address whether HDAC
inhibitors will be effective for treating neurodegenerative
diseases.” Speculating on their findings, Prof Tsai and her
colleagues suggested that perhaps degenerative brain diseases
like Alzheimer’s do not wipe out memories, but make them
inaccessible in some way. Many treatments for Alzheimer’s and
other brain degenerative diseases target the early stages,
while this study suggests memory and learning may be
restorable even when the brain is already quite damaged. A new
report from the Alzheimer’s Association says there are now
more than 5 million Americans living with the disease. At
present one American develops Alzheimer’s every 72 seconds.
This is estimated to become every 33 seconds by 2050 as 78
million baby boomers began turning 60 last year. (Medical News
Today) For the abstract, see
THIS LINK.
Major manufacturer of unapproved and
adulterated drugs agrees to stop illegal practices
The U.S. Food and Drug Administration (FDA) announced the
entry of a Consent Decree of Permanent Injunction against
PharmaFab Inc., its subsidiary, PFab LP, and two company
officials, Mark Tengler, PharmaFab’s president, and Russ
McMahen, PFab’s vice president of scientific affairs, to stop
the illegal manufacture and distribution of prescription and
over-the-counter drug products. The products are illegal
because they are not produced according to the required
current good manufacturing practice (CGMP) and many also lack
required FDA approval. The case was filed in the United States
District Court for the Northern District of Texas. PharmaFab
is a major contract manufacturer and distributor of more than
100 different prescription and over-the-counter drug products,
including cough and cold products, ulcer treatments, and
postpartum hemorrhage products. Consumers who have products
manufactured by PharmaFab should consult with their physician.
The unapproved drugs manufactured by PharmaFab include, but
are not limited to: De-Congestine Sustained Release Capsules;
GFN 1200/DM 60/PSE 60 Extended-Release Tablets; Rhinacon A
Tablets; Sudal 12 Chewable Tablets; Histex PD 12 Suspension;
Atuss HX CIII; Ergotrate Tablets; and Hyoscyamine Sulfate
Time-Release Capsules. Because these drugs have not undergone
FDA approval, their safety and effectiveness have not been
established, and FDA has not reviewed the adequacy and
accuracy of the directions and warnings in their labeling.
According to the complaint filed with the court, PharmaFab did
not comply with CGMP by not investigating manufacturing
failures and not recording and justifying why it deviated from
written manufacturing procedures. Further, the company lacked
an effective quality control unit and failed to establish
reliable expiration dates for products. Compliance with CGMP
is necessary to ensure that drugs have the requisite safety,
identity, strength, quality, and purity.
The consent decree requires the defendants to destroy certain
illegal drugs, and bars them from distributing all drugs until
they obtain required FDA approval and fully comply with CGMP.
If they resume distributing drugs, the defendants are required
to retain an auditor to conduct inspections of their
facilities for a period of five years and to provide reports
to FDA analyzing compliance with CGMP and labeling
requirements. The decree also allows FDA to require recall or
shutdown in the event of future violations and provides for
damages of $5,000 per day and $1,000 per violation, up to a
maximum of $5 million per year, if the defendants fail to
comply with its terms.

April 27,
2007
AmerisourceBergen receives DEA order to temporarily halt
distribution
of controlled substances from Orlando
facility
Over time, more women are developing MS than men
New prostate cancer test may detect more
tumors
New Clorox Anywhere hand sanitizing spray
helps
industry professionals
prevent spread of infection
DuPont
introduces engineered elastic nonwoven technology
to
offer stretch capability in a nonwoven fabric
Novation introduces first product catalog for
private label brand, NOVAPLUS
AmerisourceBergen receives DEA order to
temporarily halt distribution
of controlled substances
from Orlando facility
AmerisourceBergen Corporation announced that the U.S. Drug
Enforcement Administration (DEA) has temporarily suspended the
Orlando, FL Distribution Center’s (DC), license to distribute
DEA controlled substances and listed chemicals. The temporary
suspension affects only the Orlando DC and only DEA controlled
items. The action may impact approximately 1,400 pharmacy
customers in Florida. In the event this temporary suspension
is not quickly resolved, alternative arrangements will be made
for customers served by the Orlando Distribution Center, so
they will not be inconvenienced. The DEA asserts that
AmerisourceBergen did not maintain effective controls against
diversion of controlled substances, specifically hydrocodone,
to four internet pharmacies from January 1, 2006 through
January 31, 2007. Historically, AmerisourceBergen has
proactively cooperated with the DEA in preventing diversion of
hydrocodone and other controlled substances, and will fully
cooperate with the agency in resolving the temporary
suspension. The Company has a diversion program and a DEA-approved
suspicious-order monitoring program in place to identify
customers who are suspected of inappropriately selling
products sold to them by AmerisourceBergen. All of the Orlando
Distribution Center’s DEA audits, the most recent within the
last year, were passed with no deficiencies found.
AmerisourceBergen is not doing business with any of the four
customers cited by the DEA, and all of the pharmacies
mentioned by the agency held active DEA licenses to sell
controlled substances at the time AmerisourceBergen sold
product to them.

Landmark
study shows at least 10 genetic variants are associated
with
adult onset diabetes
In the most comprehensive look at genetic risk factors for
type 2 diabetes to date, a U.S.-Finnish team, working in close
collaboration with two other groups, has identified at least
four new genetic variants associated with increased risk of
diabetes and confirmed existence of another six. The findings
of the three groups, published simultaneously today in the
online edition of the journal Science, boost to at
least 10 the number of genetic variants confidently associated
with increased susceptibility to type 2 diabetes, a disease
that affects more than 200 million people worldwide. “This
achievement represents a major milestone in our battle against
diabetes. It will accelerate efforts to understand the genetic
risk factors for this disease, as well as explore how these
genetic factors interact with each other and with lifestyle
factors,” said National Institutes of Health (NIH) Director
Elias A. Zerhouni, M.D. “Such research is opening the door to
the era of personalized medicine. Our current
one-size-fits-all approach will soon give way to more
individualized strategies based on each person's unique
genetic make-up.”
To make their discoveries, researchers used a relatively new,
comprehensive strategy known as a genome-wide association
study. “Genome-wide association studies offer a powerful way
to uncover the genetic variations that contribute to diabetes,
as well as other common conditions, such as asthma, arthritis,
heart disease, cancer and mental illnesses,” said lead study
author, Michael Boehnke, Ph.D., of the University of
Michigan's School of Public Health, Ann Arbor. “Once
susceptibility genes are identified, researchers then can use
this information to develop better approaches to detecting,
treating and preventing disease.” To conduct a genome-wide
association study, researchers use two groups of participants:
a large group of people with the disease being studied and a
large group of otherwise similar people without the disease.
Utilizing DNA purified from blood or cells, researchers
quickly survey each participant’s complete set of DNA, or
genome, for strategically selected markers of genetic
variation. If certain genetic variations are found more
frequently in people with the disease compared to healthy
people, the variations are said to be associated with the
disease. The associated genetic variations can serve as a
strong pointer to the region of the genome where the genetic
risk factor resides. However, the first variants detected may
not themselves directly influence disease susceptibility, and
the actual causative variant may lie nearby. This means
researchers often need to take additional steps, such as
sequencing every DNA base pair in that particular region of
the genome, to identify the exact genetic variant that affects
disease risk.
In the latest work, researchers began by scanning the genomes
of more than 2,300 Finnish people who took part in the
Finland-United States Investigation Of NIDDM Genetics (FUSION)
and Finrisk 2002 studies. About half of the participants had
type 2 diabetes and the other half had normal blood glucose
levels. To validate their findings, the researchers compared
their initial results with results from genome scans of 3,000
Swedish and Finnish participants in the Diabetes Genetics
Initiative and 5,000 British participants in the Wellcome
Trust Case Control Consortium, led by Peter Donnelly, D.Phil.,
Oxford University. After identifying promising leads through
this approach, the three research teams jointly replicated
their findings using smaller, more focused sets of genetic
markers in additional groups totaling more than 22,000 people
from Finland, Poland, Sweden, the United Kingdom and the
United States. All told, the genomes of 32,554 people were
tested for the study, making it one of the largest genome-wide
association efforts conducted to date. Ultimately, the
researchers identified four new diabetes-associated
variations, as well as confirmed previous findings that
associated six other genetic variants with increased diabetes
risk.
When the genomes of the Finnish participants were scanned for
all 10 diabetes-associated genetic variants, researchers could
identify individuals whose genetic profiles placed them at
increased risk for type 2 diabetes, including one subset of
people who faced a risk four times higher than those at the
lowest genetic risk. This “could potentially have value in a
personalized preventive medicine program,” the researchers
wrote. However, the researchers emphasized that their
predictions of disease risk need to be interpreted with
caution because the diabetes group in their sample was
“enriched” with people who had affected siblings and because
the healthy group excluded people who had impaired glucose
tolerance or impaired fasting glucose. For more information
about genome-wide association studies, see
THIS LINK.

Over time, more women are developing MS
than men
Over time, more women are developing multiple sclerosis (MS)
than men, according to research that will be presented at the
American Academy of Neurology’s 59th Annual Meeting in Boston,
April 28 – May 5, 2007. In 1940, the ratio of women to men
with MS in the United States was approximately two to one. By
2000, that ratio had grown to approximately four to one.
“That’s an increase in the ratio of women to men of nearly 50
percent per decade,” said study author Gary Cutter, PhD, of
the University of Alabama at Birmingham School of Public
Health. “We don’t yet know why more women are developing MS
than men, and more research is needed.”
Cutter said researchers will need to explore multiple
changes that have occurred for women over the last several
decades, including the use of oral contraceptives, earlier
menstruation, obesity rates, changes in smoking rates, and
later age of first births. “We also need to ask the general
questions about what women do differently than men, such as
use of hair dye and use of cosmetics that may block vitamin D
absorption,” he said. “At this point we’re just speculating on
avenues of research that could be pursued.” Cutter said the
largest increase in the ratio has been for those whose MS
started at younger ages. For the study, researchers examined a
database (the North American Research Committee On Multiple
Sclerosis, or NARCOMS, hosted at Barrow Neurological Institute
in Phoenix, Ariz.) of 30,336 people with MS and determined the
male/female ratio according to the year the disease was
diagnosed and the age of the person when the disease started.

New prostate cancer test may detect more
tumors
An
experimental blood test for prostate cancer may help eliminate
tens of thousands of unnecessary biopsies at the same time
that it detects many tumors that are now missed by the test
commonly used, its developers said. PSA, the current test,
measures a protein normally produced by the prostate, while
the experimental one, called EPCA-2, detects a chemical made
principally in cancerous tissue. Prostate cancer, the most
common malignancy in men, is one of the more perplexing areas
of medicine. Physicians are unsure how to find it and when to
treat it. Today, about 80 percent of prostate biopsies find no
tumor, a percentage that is rising as physicians become more
aggressive in searching for the disease. “We hope this will
minimize the number of unnecessary biopsies,” said Robert H.
Getzenberg, a molecular biologist at Johns Hopkins Hospital
who developed the new test, which is still under study and not
yet commercially available. A description of it appears in the
journal Urology.
”It’s an exciting new marker,” said Martin G. Sanda, a
urologist at Harvard Medical School. “There certainly is a
need for a better test than PSA. Everyone accepts that.” His
view was echoed by Gerald L. Andriole Jr., chief of urologic
surgery at Washington University School of Medicine, who said
that “if the data hold up, this marker will be a substantial
improvement over PSA.” The PSA test casts a net that is too
big and too full of holes. Finding a replacement that catches
fewer healthy men, but more of those who do have cancer, would
help settle at least one of the clinical conundrums concerning
prostate cancer. The new test is being developed by
researchers at Johns Hopkins Hospital and Onconome Inc., a
Seattle-based biomedical company. It could become commercially
available in 2008.
EPCA-2 is a
protein that is part of the “nuclear matrix,” the scaffolding
inside a cell’s nucleus that helps it copy its genes. The
Hopkins researchers measured it in different groups of men
whose cancer status was known. They tried the new test on 30
men with PSA readings above 2.5 and in whom biopsies found no
cancer. All had normal EPCA-2 readings (below 30 ng per ml.).
This suggested that the test may eliminate many of the
“false-positive” PSA results, readings that are abnormal but
apparently do not denote cancer. On the other hand, the EPCA-2
test appears able to detect cancer even when the tumor is
small. It identified 36 out of 40 men who had cancer confined
to the prostate gland, and 39 out of 40 men in whom the tumor
had spread. It also identified many men, 14 out of 18, who had
cancer but whose PSAs were normal. This last group is
especially worrisome to physicians. A study published three
years ago found that about 12 percent of men with normal PSA
readings have cancer.
The new
test is not perfect, though. Getzenberg and his colleagues
tried it on 35 men with severe “benign prostatic hypertrophy”,
enlargement of the prostate that sometimes makes the PSA go up
but is not cancer. In eight of them, the EPCA-2 was high,
suggesting that the EPCA-2 test would flag some men who turn
out not to have cancer, although probably not as many as the
PSA test does. The new test will not help solve the other
major clinical uncertainty in prostate cancer. It is unclear
who will clearly benefit from aggressive treatment and who are
likely to be able to live a normal life if the tumors are
simply followed and removed only if they begin to cause
symptoms. (Washington Post)
New Clorox Anywhere hand sanitizing spray
helps
industry professionals prevent spread of infection
Clorox’s
Professional Products Division extends the Clorox brand’s
health and wellness efforts beyond surfaces to hand hygiene
with the launch of Clorox Anywhere Hand Sanitizing Spray,
representing the company’s first entry into the personal care
category. The new bleach-free, alcohol-based spray is
formulated to kill 99.999 percent of germs on contact and does
not dry out hands or leave a sticky, greasy residue. Available
in an easy-to-use spray, this delivery mechanism also helps
target places in the hand that can often be missed by
traditional sanitizers, such as fingernails, knuckles and
spaces between fingers. Clorox Anywhere Hand Sanitizing Spray
is formulated to help kill microorganisms that can cause
illnesses including adenovirus; Hepatitis A, B and C; MRSA;
norovirus and rotavirus. The hand sanitizing spray contains
glycerin, a naturally-occurring moisturizer, to help
professionals who wash and sanitize their hands frequently.
For more information see
THIS LINK.
DuPont introduces engineered elastic
nonwoven technology
to
offer stretch capability in a nonwoven fabric
DuPont
announces the introduction of Engineered Elastic Nonwoven
Technology, a new offering that enables designers to provide
unique elastic functionality and deliver soft-stretch comfort.
Available now, this innovative technology is latex-free and
contains no elastomeric polymers or chemical additives,
resulting in a versatile fabric that can meet a variety of
industry needs. “DuPont Engineered Elastic Nonwoven Technology
is a breakthrough development that enhances our traditional
nonwoven media portfolio and provides a cost-effective
substrate for high-power elastic sheeting applications,” said
Matt Trerotola, vice president and general manager, DuPont
Nonwovens. Fabrics produced from DuPont Engineered Elastic
Nonwoven Technology can be high stretch or high stretch with
varying degrees of elastic recovery power, depending on end
user needs.
Potential
applications and benefits include: wound dressings that are
soft and have comfortable stretch; knit-like stretchable gown
sleeves and cuffs for use in protective and clean room
apparel; hygiene side panels for diapers and adult
incontinence garments that are less irritating and fit better;
elastic bandages and low power wound care sleeves that may be
less irritating than conventional materials; elastic
protective covers that fit better, reducing the number of
sizes needed; elastic interlinings that are resistant to
deformation; and elastic composites that are versatile and
stretchable. Those interested in fabric samples or additional
information may contact DuPont by calling 1‑888-476-6827 or by
e-mail to
zelasticnonwovens@dupont.com
Novation introduces first product
catalog for private label brand, NOVAPLUS
Novation,
the health care contracting services company of VHA Inc. and
the University HealthSystem Consortium (UHC), recently
introduced the first product catalog for its private label
brand, NOVAPLUS. The catalog offers information on more than
1,300 products from the industry’s leading manufacturers and
features an easy-to-use format with a quick reference
glossary. Products are organized by category and include color
images, information about product features and benefits.
NOVAPLUS products are identical to their brand-name
equivalents and offer hospitals quality products for the best
price and the benefits of standardization. NOVAPLUS products
include a wide range of products, including anesthesia,
medical, pharmaceutical, radiology, respiratory and surgical
products. NOVAPLUS was first introduced in 1985 and provides
alliance members with a unique competitive advantage in the
supply chain marketplace. In 2006, NOVAPLUS’ portfolio of
products helped members realize substantial supply cost
savings through NOVAPLUS purchases. The NOVAPLUS catalog will
be produced annually. Alliance members can request catalogs
through their Novation portfolio executive or access an
electronic copy of the catalog through the member portal on
Marketplace@Novation.

April 26,
2007
NEJM: Physician ties to drug industry stronger than ever
IOM report: The future of disability in America
Prognosis: Predicting heart disease among
the 20-somethings
Cheaper,
easier virtual colonoscopy could boost detection
Emergency medicine to benefit from the HL7’s
first registered clinical profile
MedAssets Supply Chain Systems and M Cubed
Medical join forces
to help decrease costs for physician
practices
Amerinet
announces agreements
NEJM: Physician ties to drug industry
stronger than ever
Despite
the potential for conflict of interest, virtually all
practicing physicians in the U.S. have some form of
relationship with pharmaceutical manufacturers but the nature
and extent of those relationships vary, depending on the kind
of practice, medical specialty, patient mix, and professional
activities, reports a study in the April 26 issue of the
New England Journal of Medicine. In the first national
survey to gauge the predictors and depth of relationships
between industry and practicing physicians, 94 percent of
doctors report that they have at least one type of
relationship with the drug industry, mostly in the form of
receiving food in the workplace or prescription samples.
However, more than one third are reimbursed for costs
associated with professional meetings or continuing medical
education (CME), and more than a quarter receive honoraria for
consulting, lecturing or enrolling patients in clinical
trials, say researchers.
The
findings, from a survey of 1,662 practicing physicians
conducted in late 2003 and 2004, also show that drug and
device manufacturers pick and choose which doctors to form the
strongest ties with. For example, cardiologists are more than
twice as likely as family practitioners to receive direct
payments from drug companies for consulting and other services
and are also significantly more likely to be paid honoraria
than pediatricians, anesthesiologists, or surgeons.
“Cardiology is a highly influential specialty within the
medical profession. If the drug and device industry can
influence cardiologists, they can likely influence the
prescribing practices of other doctors,” said lead researcher
and co-author Eric Campbell, Ph.D., an associate professor of
medicine at the Institute for Health Policy at Massachusetts
General Hospital and Harvard Medical School.
Campbell
and his co-authors, including Institute for Health Policy
Director David Blumenthal, MD, report that the idea that
companies target opinion leaders for marketing is further
suggested by the higher frequency of industry payments to
physicians who have developed clinical guidelines and who
serve as mentors for doctors in training. Researchers surveyed
physicians in six specialties (anesthesiology, cardiology,
family practice, general surgery, internal medicine, and
pediatrics) to measure the extent of their financial
associations with industry and the factors that predict those
ties. The study found striking differences in the nature of
physician-industry relationships depending on the primary
practice location of the physician. Compared to physicians
practicing in hospitals, those in group practices were three
times as likely to receive gifts and nearly four times more
likely to be paid for professional services. Group practice
physicians along with solo or two-person practices also met
more frequently with industry representatives such as drug
detailers than did physicians practicing in hospitals or
clinics or staff model HMOs. The authors suggest that the
primary reason for these differences is that hospitals may be
more likely to have policies and practices in place that limit
physician contact with industry representatives. It may also
be that hospitals are more likely to provide physician
education through grand rounds and CME events, rendering
physicians in these facilities less dependent on industry
representatives as the source of medical education and
information.
The
survey also found that: Pediatricians and anesthesiologists
were significantly less likely than family practitioners to
receive samples, reimbursements and payments for professional
services. Family practitioners reported the highest average
number of meetings with industry representatives (16 meetings
a month), followed by internists and cardiologists (9-10 per
month, respectively). Anesthesiologists had only 2 meetings a
month. All specialties except anesthesiology appear to be
meeting more frequently with industry today as compared to
2000, when the average was about 4.4 meetings per month. Women
physicians are less likely to receive payment than their male
counterparts. Physicians were more likely to receive payments
if less than 25 percent of their patients were uninsured or
covered by Medicaid.

IOM report: The future of disability in
America
Today
more than 40 million Americans live with a disability. If we
consider people who now have disabilities, people who are
likely to develop disabilities, and people who are or will be
affected by the disabilities of family members and others
close to them, then disability will affect the lives of most
Americans. Members of the baby boom generation, people born
between 1946 and 1964, face an especially uncertain future as
they grow older, as their risk of disability increases, and as
programs such as Social Security and Medicare face serious
funding challenges. Disability in the form of limited
activities and restricted participation in social life is not
an unavoidable result of injury and chronic disease. It
results, in part, from choices society makes about working
conditions, health care, transportation, housing, and other
aspects of our environment. The United States faces important
decisions that could reduce, or increase, the extent to which
people can live independently and be involved in their
communities. Inaction may lead to diminished quality of life,
increased stress on individuals and families, and lost
productivity.
The
Institute of Medicine (IOM) was asked to assess the current
situation and provide recommendations for improvement, which
culminated in the report “The Future of Disability in
America”. The committee reviewed developments since two
previous IOM reports on disability (1991, “Disability in
America” and 1997, “Enabling America”), analyzed a number of
shortcomings in the nation’s disability policies and programs,
and raised serious questions about how individuals and society
will cope with the challenges of disability. Some progress has
been made since the release of the two previous reports: The
growth of assistive and “mainstream” electronic technologies
allows many people to interact more easily with their
environments; and advances in public health and medicine have
contributed to reduced incidences of certain injuries,
developmental disorders, and other potentially disabling
health conditions. However, too little progress has been made
in adopting the major public policy and practice
recommendations made in the 1991 and 1997 IOM reports. Due in
part to inadequate implementation and enforcement, the 1991
Americans with Disability Act (ADA) has not lived up to its
promise. Physical and other barriers still exist in many
places, even hospitals and medical offices. Research spending
on disability is inadequate. Medicare, Medicaid, and private
health plans employ outdated policies for covering assistive
technologies and services.
The new
report encourages agencies involved in disability monitoring
to adopt the World Health Organization’s International
Classification of Functioning, Disability and Health (ICF) as
their conceptual framework. Using the ICF would help
standardize how agencies describe and measure different
aspects of disability, which would improve the clarity and
comparability of research findings and strengthen the base of
scientific knowledge that guides public policies and health
practices. This report reiterates the absence of a
comprehensive disability monitoring system and recommends
creating one. The current report recommends increasing public
funding to support a program for research. Federal funding
agencies should invest more in the development, testing, and
dissemination of promising interventions that will help people
maintain their independence and ability to function in
community life. The report recommends that policymakers
eliminate or modify the “in-home-use” requirement in the
Medicare statute and regulations. This provision keeps many
from obtaining scooters and wheelchairs that would allow them
to navigate reliably and safely outside the home. For more
information see THIS LINK.
Prognosis: Predicting heart disease among
the 20-somethings
It’s never
too soon to think about the risk of cardiac disease. A study
published today has found that mildly elevated levels of
cholesterol
or slightly above normal
blood
pressure from ages 18 to 30 are strong predictors
of having coronary artery calcium at ages 30 to 35. Coronary
artery calcium, a form of arterial plaque, is a predictor of
later
heart
disease. Researchers recruited 5,115 people from 18
to 30 in 1985 and 1986 and followed them with physical
examinations 2, 5, 7, 10 and 15 years later. The scientists
tested blood pressure, cholesterol and serum glucose levels
and recorded body mass index. The study appears in The
Journal of the American College of Cardiology. At the
year-15 examination, 10 percent had coronary artery calcium
detectable on a CT scan. Compared with young adults who had
below-optimal levels of the risk factors at the start of the
study, those with above-optimal levels were one and a half to
three times as likely to have coronary artery calcium 15 years
later. Catherine Loria, the lead author and an epidemiologist
at the National Heart, Lung and Blood Institute, said even
young people should be screened. “If they do have
above-optimal levels, even slightly,” she added, “they might
want to make lifestyle changes to reduce their risk.” At the
start of the study, 20 percent had high levels of LDL, the
so-called bad cholesterol, and a third were overweight.
Twenty-five percent smoked cigarettes. By the 15th year, fewer
smoked, but 30 percent had above-normal LDL, 35 percent had
elevated blood pressure, and more than two-thirds were
overweight or obese.
(The
New York Times)

Cheaper,
easier virtual colonoscopy could boost detection
A cutting-edge technology called “virtual colonoscopy”
promises fewer complications and better cost-effectiveness
than traditional colonoscopy, researchers report. These
technologies have been compared before, but the current
analysis relies on the notion that identifying and removing
polyps smaller than 6 millimeters won’t do much to reduce
colorectal cancer cases. “Because there’s virtually no risk
associated with having such small polyps, 90 percent of folks
don’t need an invasive and expensive colonoscopy to screen for
colon cancer,” explained lead researcher Dr. Perry J.
Pickhardt, an associate professor in the school of medicine
and public health and radiologist at the University of
Wisconsin in Madison. “So, here it was easy to show that
virtual colonoscopy is a very effective way to filter out
these people and hone in on those who really need the more
invasive procedure,” he said. Pickhardt is not suggesting that
virtual colonoscopies replace traditional optical screening.
But non-invasive screening might up the number of people who
decide to undergo screening, he said. “We need to encourage
more folks to get screened, period,” he said. “We’re not
trying to take away from the screening already in place. It’s
a personal choice. Some people prefer the colonoscopy route
compared to virtual colonoscopy, and that’s fine.”
Pickhardt
and his colleagues discussed their findings in the June 1
issue of the journal Cancer. Virtual colonoscopy
involves a combination of sophisticated X-rays and CT scans of
the abdomen after it has been pumped with air. A two- and
three-dimensional computer model of the gastrointestinal tract
is then generated, potentially revealing cancerous and
precancerous lesions. If dangerous lesions are spotted, a
second, more invasive procedure is required. Unlike
traditional colonoscopy, the virtual method is faster,
involves no sedation, no post-procedure recovery, and no risk
of invasive complications such as abdominal bleeding or
life-threatening bowel perforation. However, the American
Cancer Society (ACS) has not yet backed this option as a
proven screening method, citing the need for further research.
Instead, the group suggests other screening methods, including
blood stool tests; a barium enema combined with X-rays; a
flexible sigmoidoscopy and traditional optical colonoscopy.
All people over 50 are encouraged to undergo a regular
colonoscopy once every 10 years, or either a barium enema or a
flexible sigmoidoscopy (with or without a yearly blood test)
once every five years. The ACS does not deem a digital
rectal exam to be a sufficient means of screening.
To compare
some of these options, Pickhardt and his colleagues developed
a mathematical model involving 100,000 patients with an
average risk for colorectal cancer. In the computer
simulation, all of these “patients” (over the age of 50) were
screened for colon cancer once every decade for three decades,
using either a standard colonoscopy, a flexible sigmoidoscopy,
a virtual colonoscopy, or a combination thereof. Polyp
searches were based on one of two thresholds: those measuring
6 millimeters in diameter and up, and lesions of any size. The
model indicated that 2,940 patients would ultimately go on to
develop colorectal cancer. The simulation also revealed that
flexible sigmoidoscopy screenings reduced the rate of cancer
by just over 31 percent, while traditional colonoscopy reduced
the rate by just over 40 percent. Virtual colonoscopies were
only slightly less efficient than the traditional method,
achieving an almost 38 percent reduction when polyps of all
sizes were considered. The prevention rate dropped slightly,
to 36.5 percent, when screenings focused only on polyps 6
millimeters and up. Virtual colonoscopy also had the added
benefit of dramatically reducing the need for unnecessary
polyp removal. Nearly 78 percent fewer patients went on to
have an invasive polyp removal after a virtual screening
compared with patients who underwent a regular colonoscopy.
And when virtual screenings focused solely on lesions 6
millimeters and up nearly 12,900 additional unwarranted polyp
removals were avoided.
In terms of
both preventing cancer and minimizing cost, the use of any
screening method was better than no screening at all, the
study found. However, virtual colonoscopy with a 6-millimeter
polyp diameter threshold was by far the most cost-effective
approach: Costs were less than half that of traditional
colonoscopy when broken down by year of life saved. Even with
no polyp size threshold, virtual colonoscopy still came in at
more than 20 percent cheaper. However, Pickhardt noted that
the high-tech procedure is not yet widely available. (HealthDay
News)
Emergency medicine to benefit from the
HL7’s
first registered
clinical profile
Health
Level Seven (HL7), a healthcare IT standards development
organization, announced the Emergency Care Functional Profile
(EC FM) as the first registered profile based upon HL7’s EHR
System Functional Model (EHR-S FM) standard. In late February,
the EHR System Functional Model standard became the healthcare
industry’s first ANSI-approved standard to specify the
functional requirements for an electronic health record
system. HL7’s Emergency Care Special Interest Group (SIG)
developed the Emergency Care Functional Profile for Emergency
Department Information Systems to develop an open and
objective standard for the development, refinement, and
evaluation of information systems employed in the ED. As a
registered profile, it becomes a standard that may be
referenced by the Certification Commission for Health
Information Technology (CCHIT) as a foundation for
certification of EHR systems in the emergency department
setting.
Adopting registered profiles is one way that CCHIT ensures a
consistent methodology for assessing EHR systems across all
healthcare domains.
Registering
profiles that conform to the EHR System Functional Model is an
important step in the widespread adoption of this standard
because technically EHR systems conform to profiles rather
than the model itself. The Functional Model is structured to
allow vendors to implement a specific profile for real-world
settings, such as the Emergency Department, and users to
purchase a system that conforms to the profile. Registering a
profile with HL7 gives the profile credibility and approval
that it has met a minimum set of guidelines of what a profile
should contain.
The Emergency Care Functional Profile is not only critical for
the integration of Emergency Departments (ED) into the
developing national health information network, but is also
needed for handling regional disasters such as Hurricane
Katrina. The EHR-S Functional Model and the Emergency Care
Function Profile will facilitate solutions to underlying ED
operational problems such as overcrowding, ambulance diversion
and shortage of services. Systems conforming to the EC FP will
facilitate vital care to the over 110 million patients seen
each year in US emergency departments. The EHR System
Functional Model is versatile, adaptable, and applicable
across the continuum of care. There are several profiles under
development in addition to Emergency Care. For more
information see
THIS LINK.
MedAssets Supply Chain Systems and M Cubed
Medical join forces
to help decrease costs for physician
practices
MedAssets Supply Chain Systems announced an exclusive
affiliate agreement with M Cubed Medical, a newly formed
specialty group purchasing organization headquartered in
Webster City, IA. M Cubed Medical serves the non-acute care
market including physician practices, clinics and ambulatory
surgery centers. The multi-year agreement was effective April
1, 2007. M Cubed Medical has developed a strategy that
congregates the collective economic power of physicians across
the country to bring the same improved cost and efficiencies
already seen in physician-owned ambulatory surgery centers to
the supply side of the business while maintaining a fair
profit margin for manufacturers. The affiliation with
MedAssets will provide additional savings opportunities and
access to MedAssets’ CDQuick, a best-of-breed contract
catalog. “By utilizing MedAssets’ group purchasing contracts
and technology, physicians and other non-acute care providers
will save money on purchases for common medical supplies,
office supplies, business services, pharmaceuticals, and
capital equipment,” said Gary Green, senior vice president,
MedAssets Supply Chain Systems.

Amerinet announces agreements
Amerinet
Inc. announces its agreement for baby products with Johnson &
Johnson Consumer Products Company, a division of Johnson &
Johnson Consumer Companies. Effective
May 1, 2007, through April 30, 2010,
this agreement provides cost-saving opportunities to Amerinet
members on infant hygiene products that include baby
wash, powders, lotions, oils and shampoos.
Amerinet Inc. announces its agreement with Vendormate for
vendor credentialing and compliance monitoring services.
Effective April 1, 2007, through February 28, 2010, this
agreement includes patent-pending Vendormate VISION service
which delivers supplier registration, automated policy
acceptance, screening, rating, cataloging and physical access
control. Vendormate’s services are uniquely suited to satisfy
both internal policies and government mandates including HIPAA,
Stark Law and Deficit Reduction Act.

April 25,
2007
FDA causes
unnecessary scare about common painkillers
FDA to test
imported additives for melamine
New virus discovered; 3 organ transplant recipients
in
Australia succumb to infection
Medicare Trustees release annual report
Only 1 week left to take advantage of special AAMI membership
offering
FDA causes
unnecessary scare about common painkillers
The U.S. Food and Drug Administration (FDA) has caused an
unnecessary scare about some pain relievers by adding a
warning to drugs that are safe, said Curt Furberg, M.D.,
Ph.D., from Wake Forest University School of Medicine. At the
same time, he says the agency has failed to recognize the harm
of a pain reliever that should be taken off the market. “The
FDA is adding ‘black box’ warnings to all prescription and
over-the-counter pain relievers, even to naproxen, which the
evidence shows is safe,” said Furberg, who serves on the FDA
Drug Safety and Risk Management Advisory Committee. “This is
based on the false assumption that all nonsteroidal
anti-inflammatory drugs increase the risk of heart attacks. In
fact, there are major differences between these agents.”
In a commentary published by Trials, an online journal of
BioMed Central, Furberg says the FDA has failed to recognize
current scientific evidence when it made decisions on the
safety of nonsteroidal anti-inflammatory drugs (NSAIDs) that
are often used to treat the pain or inflammation from
arthritis. The most commonly used NSAIDs are ibuprofen
(Advil), naproxen (Aleve), and diclofenac (Voltaren). There
are more than a dozen others, including drugs such as
celecoxib (Celebrex) that are in a special class known as
selective COX-2 inhibitors because of the hormone they target.
The other NSAIDs are known as “non-selective.” Furberg said
while the evidence for the non-selective NSAIDs is somewhat
limited, an analysis combining several small studies found
that high doses (500 mg twice daily) of Aleve were not
associated with an increased risk of heart attacks compared to
a placebo, or an inactive pill. On the other hand, high doses
of Advil (800 mg three times a day) and Voltaren (75 mg twice
daily) were associated with rates of heart attack that were 51
percent and 63 percent higher, respectively, than placebo.
An analysis of a large number of trials comparing COX-2
inhibitors to other NSAIDs found similar results, that
Voltaren was estimated to increase vascular risk by about 70
percent over Aleve. “Naproxen does not increase the risk of
heart attacks and ought to be a painkiller of choice,” said
Furberg. “On the other hand, Voltaren carries the same risk as
the harmful COX-2 inhibitors Bextra and Vioxx, which have been
taken off the market. The FDA has failed to recognize the
evidence that the risk of heart attack varies substantially
among this group of drugs and that Voltaren has the highest
risk of all. Since it is the most commonly used NSAID, the
unrecognized harm it has caused worldwide could be enormous.”
The European Regulatory Agency has reviewed the same evidence
that the FDA considered and reached entirely different
conclusions, said Furberg. He said this suggests that the
decisions are not based on scientific evidence. With Celebrex,
the FDA didn’t follow the recommendations of its Advisory
Committee to substantially restrict the drug’s use. Instead,
it required only a “vaguely worded” black box warning, said
Furberg. European countries require clear warnings for
patients at high risk of heart attacks and have said COX-2
inhibitors should not be taken by patients with heart disease.
With the non-selective NSAIDs, Europe has given a “clean bill
of health” to the agents and the FDA has judged them to have
similar risks to Celebrex and is adding “black box” warnings.
“Decisions by regulatory agencies are expected to follow
explicit regulations and should be evidence-based,” said
Furberg. “Scientific studies point to clinically important
differences among the non-selective NSAIDs, which the FDA has
not recognized. It’s time for the FDA to set the record
straight.” For more information see
THIS LINK.
U.S. wonders if drug data was accurate
The
Food and
Drug Administration is examining whether
Eli Lilly &
Company provided it with accurate data about the
side effects of the antipsychotic drug Zyprexa, a potent
medicine that has been linked to weight gain and
diabetes.
The F.D.A. has questions about a Lilly document from February
2000 in which the company found that patients taking Zyprexa
in clinical trials were three and a half times as likely to
develop high blood sugar as those who did not take the drug.
That document was not submitted to the agency. But a few
months later, Lilly provided data to the F.D.A. that showed
almost no difference in blood sugar between patients who took
Zyprexa and those who did not. The F.D.A. confirmed its
inquiry in response to questions from The New York Times. The
agency said it had not yet decided whether to take any action
against Lilly. “The F.D.A. continues to explore the concerns
raised recently regarding information provided to the F.D.A.
on Zyprexa’s safety,” Dr. Mitchell Mathis, a deputy director
in the psychiatry division of the agency’s center for drug
evaluation and research, said. A Lilly spokesman, Phil Belt,
said the company had rechecked its database and found errors
in the original statistics. The data submitted later was
accurate, Belt said. But the 2000 document said that its
figures had already been checked for error. The Times
disclosed the existence of the document in an article last
December.
The discrepancy between Lilly’s initial data and what it later
submitted came at a time when Zyprexa’s sales were soaring,
even as some doctors and foreign regulatory agencies were
questioning the drug’s safety. The F.D.A. has never concluded
that Zyprexa causes diabetes more than other widely used
psychiatric drugs, although the American Diabetes Association
has. Zyprexa remains Lilly’s top-selling drug, with $4 billion
in worldwide annual sales. But prescriptions in the United
States have fallen nearly 50 percent since 2003 amid the
safety concerns. Besides the F.D.A. inquiry, Lilly is facing
federal and state investigations into the way it marketed and
promoted Zyprexa. The company has already agreed to pay $1.2
billion to settle 28,500 lawsuits from people who contend that
they developed diabetes or other diseases after taking the
drug. At least 1,200 more lawsuits are pending. Belt, the
Lilly spokesman, said in a statement that the company properly
marketed Zyprexa and disclosed its side effects to the F.D.A.
and doctors. “Lilly always cooperates fully with requests for
information from the F.D.A.,” he said, “and that includes any
requests regarding information on Zyprexa. Lilly is
forthcoming with all relevant clinical data on all of our
products.”
Lawyers who represent drug companies said the F.D.A. largely
depended on the companies to be honest about the side effects
of their drugs. With a staff of fewer than 3,000, including
support personnel, the agency’s drug division oversees more
than 12,000 prescription medicines and 400 nonprescription
drugs. In most cases, said William W. Vodra, senior counsel at
the law firm of Arnold & Porter and a former F.D.A. associate
chief counsel, it does not perform detailed audits of clinical
trials or independently check the integrity of the data that
companies send to it. “There’s no way they could police the
system with the resources they have,” Vodra said. Robert A.
Dormer, a partner in the law firm of Hyman, Phelps & McNamara,
who represents drug companies, said that the companies did not
have to provide every analysis they performed to the F.D.A.
(The New York Times) To read the original article see
THIS
LINK.
FDA to test
imported additives for melamine
Concerned that a wide variety of Chinese vegetable protein
products may be contaminated with the harmful compound
melamine, the
Food and
Drug Administration said yesterday that it will
begin testing batches of six imported ingredients used in pet
foods and livestock feed, as well as additives to human food.
Officials have not found the substance in food products for
people but detected it in two imported ingredients widely used
in pet food: wheat gluten and rice protein. The agency said
that imported corn gluten, corn meal, soy protein and rice
bran will also be tested. The vegetable proteins are used in
bread, pizza, baby food and many vegetarian dishes. “This is a
proactive step,” said David Acheson, chief medical officer of
the FDA Center for Food Safety and Applied Nutrition. “We will
test a variety of foods and feeds because we need to know all
there is to know” about the melamine contamination.
Melamine, a nitrogen-based compound used in products such as
countertops, glues and fertilizers, was identified this month
as the cause of fatal kidney failure in an unknown number of
dogs and cats, leading to the recall of more than 100 brands
of pet food. Officials traced the melamine to two Chinese
plants, which have been supplying American distributors since
last summer. Agency officials said that some contaminated
products, sold by pet food manufacturers as scraps, were fed
to hogs in the Carolinas,
New York,
California
and
Utah,
and that some of those animals tested positive for melamine.
They said that a contaminated shipment of feed had been sent
to a
Missouri
chicken farm as well. Stephen Sundlof, director of the FDA’s
Center for Veterinary Medicine, said a second chemical called
cyanuric acid, which is related to melamine, has also been
found in samples of rice protein concentrate. FDA officials
said that they are in discussions with Chinese officials about
inspecting the plants where the contaminated pet food
originated, but that no agreement has been reached. Julia Ho,
of the agency’s Office of International Programs, said Chinese
authorities also are investigating.
Steve Miller, chief executive of ChemNutra, a
Las Vegas-based
importer of nutritional and pharmaceutical chemicals, said he
suspects that the contamination was intentional. “We are
concerned that we may have been the victim of deliberate and
mercenary contamination for the purpose of making the wheat
gluten we purchased appear to have a higher protein content
than it did, because melamine causes a false high result on
protein tests,” Miller wrote in an open letter posted on
ChemNutra’s Web site. Michael Payne, outreach coordinator for
the Western Institute of Food Safety at the University of
California at Davis's School of Veterinary Medicine, said he
thinks that there is little risk of people becoming ill by
eating pork from pigs that ate melamine-laced feed. Toxicology
studies on laboratory rodents have long suggested that it
takes high
doses of the chemical to cause health problems, typically in
the bladder and kidneys, Payne said. And the modest doses
found in pet food would be diluted even further in the body of
a pig that ate it. (Washington Post) To read the original
article see
THIS LINK.
New virus discovered;
3 organ transplant recipients in
Australia succumb to infection
The unfortunate deaths of three organ transplant recipients in
Australia this past January has led to the discovery of a new
virus. All three had received organs from the same deceased
donor in December, and their closely spaced deaths suggested
their transplants might have exposed them to a deadly
infectious agent. When investigators at the Victorian
Infectious Diseases Reference Laboratory in Melbourne applied
all the standard tests, however, they could not identify any
known pathogen. So the Australian team turned to scientists at
the Greene Infectious Disease Laboratory of the Mailman School
of Public Health of Columbia University, who have been
developing new techniques for diagnosing infectious diseases
with funds from the National Institute of Allergy and
Infectious Diseases (NIAID), part of the National Institutes
of Health.
Partnering with the company 454 Life Sciences, the Columbia
University team applied a high-throughput technology that can
sequence hundreds of thousands of bits of DNA simultaneously.
Then, using bioinformatics algorithms they had created, the
team sorted through the data and identified a new infectious
agent, a virus that was sufficiently different from any known
virus that it could not have been detected using existing
diagnostic methods. By assembling additional genetic
sequences, the researchers determined that the new virus is
related to, but distinct from, known strains of lymphocytic
choreomeningitis virus (LCMV), which has been implicated in a
small number of cases of disease transmission by organ
transplantation. The knowledge of the genetic sequence of this
new virus will enable improvements in screening that may
enhance the future safety of organ transplantation. For more
information, see
THIS LINK
or
THIS LINK.
Study links faulty DNA repair to Huntington’s disease onset
Huntington’s disease, an inherited neurodegenerative disorder
that affects roughly 30,000 Americans, is incurable and fatal.
But a new discovery about how cells repair their DNA points to
a possible way to stop or slow the onset of the disease. The
research was funded by the National Institutes of Health
(NIH). “As so often happens, basic research on a fundamental
biological process, in this case, enzymes involved in DNA
repair, leads to new insights about how diseases arise and new
approaches for treating or preventing them,” said NIH Director
Elias A. Zerhouni, M.D. The study was published April 22 as an
Advanced Online Publication in Nature and led by
Cynthia T. McMurray, Ph.D., a professor of pharmacology at the
Mayo Clinic in Rochester, MN.
Unlike most inherited diseases, Huntington’s disease symptoms
usually don’t appear until middle age, leading scientists to
wonder what triggers the disease onset and whether it can be
halted, or at least slowed down. People with the disease have
a version of a gene called huntingtin that carries an extra
segment with a particular sequence of repeated subunits. If
the segment is too large, the gene produces a faulty protein
that has a destructive effect in the brain. “Huntington’s
disease is a progressive disease, but nobody knows exactly
why,” said McMurray. “Our work supports the idea that the
disease progresses when the extra segment expands over time in
non-dividing cells such as nerve cells.”
McMurray’s study shows that the inserted segment grows when
cells try to remove oxidative lesions, which are caused by
byproducts of the oxygen we breathe. DNA repair enzymes
initially keep oxidative lesions in check, but over time,
increasing numbers of lesions overwhelm the repair systems.
Oxidative lesions also accumulate in people who do not have
Huntington’s disease, but because their huntingtin gene lacks
the extra segment it is not prone to expansion. While
scientists have long suspected that oxidative lesions play a
role in Huntington’s disease, the specific role of the lesions
has remained elusive until now.
To show that the extra segment enlarges with age, the
researchers engineered mice to carry a version of the human
huntingtin gene with an inserted segment, one large enough to
cause Huntington’s disease in humans. After a few months, when
the mice had aged, the scientists analyzed the gene and found
that the segment had expanded. They also observed an increase
in oxidative lesions in the mouse DNA. To see if the oxidative
lesions played a role in expansion of the extra DNA segment,
the researchers next deleted OGG1, a key enzyme in oxidative
lesion repair. Without OGG1, the bulk of the DNA’s oxidative
lesions remained untouched, and the inserted segment did not
grow at all or it grew far less than in mice carrying a
working version of OGG1.
These findings show that while doing its part in removing
oxidative lesions, OGG1 triggers a far more damaging effect,
the DNA expansion associated with Huntington’s disease. “The
effect is much like what might happen if a technician came to
repair a minor defect in your computer but was called away by
a more urgent problem midway through the process. Now your
computer is lying in pieces and you’re unable to use it,” said
McMurray. The study suggests that OGG1 might offer a target
for the development of new Huntington’s disease treatments.
McMurray’s team is already pursuing this path and is screening
for small molecules that block OGG1 function. This work may
also be relevant to research on other diseases, such as
Alzheimer’s and Parkinson’s, in which oxidative lesions are
believed to play a role.

Medicare Trustees release annual report
The new
Medicare Trustees Report shows that while Medicare’s financial
outlook remains troubling, the program’s outlook has improved
slightly compared to last year’s estimate. The Trustees note
that Medicare expenditures were $408 billion in 2006, or 3.1
percent of gross domestic product (GDP), and are projected to
increase to over 11 percent of GDP in 75 years. HHS Secretary
Mike Leavitt said the report points to the need to act quickly
and efficiently to strengthen and improve Medicare, including
enactment of the steps proposed in the President’s budget to
address Medicare’s fiscal health.
“We are
already beginning to implement steps to protect Medicare for
future generations,” said Centers for Medicare & Medicaid
Services Acting Administrator Leslie V. Norwalk. “Medicare is
now providing up-to-date preventive benefits and comprehensive
drug coverage and is developing better information on quality
and costs of healthcare to ensure that we pay appropriately
for the healthcare of our beneficiaries. A critical element of
this process is the movement we have underway for Medicare to
change from being a passive payer of services to becoming an
active purchaser of high-quality, efficient care. Until those
steps are fully implemented, today’s report starkly
demonstrates the need to act to change Medicare’s current
growth trajectory.”
In the
estimate, Medicare’s Hospital Insurance Trust Fund is
projected to be exhausted in 2019, one year later than
estimated in last year's report. This change results from
slightly higher projected income and slightly lower projected
expenditures than shown in last year’s report. HI expenditure
growth is estimated to average 7.2 percent per year over the
next 10 years. Because of continued rapid growth in
expenditures for the program as a whole, program costs
financed by general revenues, rather than by “dedicated
revenues,” are projected to exceed 45 percent in 2013. Because
this result falls within the first seven years of the
projection period (2007-2013), the Trustees have issued a
determination of “excess general revenue Medicare
funding.” This determination has now been made in two
consecutive years, triggering a “Medicare funding warning.”
An element
of good news in this year’s Trustees Report involves the new
prescription drug benefit under Medicare Part D. The latest
cost projections for Part D through 2015 are 13 percent lower
than estimated in last year’s report (and substantially lower
than the original estimates from 2003). Plan bids for 2007
were 10 percent lower than in 2006, as a result of intense
competition among plans to attract and retain enrollees and
plans’ expectations to further increase use of inexpensive
generic drugs, rather than more costly brand-name
equivalents. In addition, overall prescription drug costs have
increased much more slowly during 2004-2006 than in prior
years. 
Only 1 week left to take advantage of special AAMI membership
offering
Until
April 30, hospitals that join AAMI will receive a complimentary
registration to attend AAMI’s Annual Conference & Expo in
Boston, MA from June 16-18 (a $750 value.) Your facility can
become an institutional member for as low as $540 per year,
which would provide you and your colleagues with: A
subscription to AAMI’s award-winning journal, BI&T,
which includes practical articles of interest for CEs, BMETs,
and other medical technology professionals; A subscription to
the monthly newsletter, AAMI News, to stay on top of
breaking industry news; Full access to AAMI's new online journal,
a comprehensive library of searchable and archived articles;
Significant discounts on all educational program registration, AAMI standards and other publications, which is available to
all members of your facility; Access to salary benchmarking
information, Joint Commission guidance, career resources,
networking opportunities, and much more. To become an
institutional member, simply submit this online form,
www.aami.org/advertising/membership/institution.html, and
AAMI will contact you. Make sure to select the dues level that
best fits your department or facility’s needs. If you have
questions, contact Susan DeCourcey, Vice President of IT and
Membership Services, AAMI, at
sdecourcey@aami.org or 703-525-4890, ext. 232. 
Hospitals to utilize Diagnostix’s industry-driven pharmacy
technology
Diagnostix, a subsidiary of Amerinet Inc., announced that 10
healthcare providers, representing a unique range of
healthcare services from across the county, have chosen
AccuPrice, to monitor and resolve pricing discrepancies in
their pharmacy programs. AccuPrice, a pharmacy-auditing tool,
takes unique provider contract price files and audits the
distribution invoice file to identify price variances. The
provider receives a daily e-mail report outlining
discrepancies between wholesaler and contract prices. Amerinet
applies the resources necessary to resolve variances and works
with the distributor to issue the necessary credits.
The latest
members to sign up to utilize AccuPrice include: Columbia
Memorial Hospital, Astoria, OR; Highlands Hospital,
Connellsville, PA; Medina General Hospital, Medina, OH; Moses,
Ludington Hospital, Ticonderoga, NY; North Philadelphia Health
System, Philadelphia, PA; Platte Valley Medical Center,
Brighton, CO; Samaritan Health Services, Corvallis, OR; St.
Barnabas Hospital, Bronx, NY; St. Joseph’s Community Health,
Hillsboro, WI; and Virginia Mason Medical Center,
Seattle, WA.

April 24,
2007
Human bird
flu deaths reported in Egypt, Cambodia;
China, Indonesia still not sharing
virus samples with WHO
Drug company sales visits influenced doctors, study finds
Neither abortion nor miscarriage associated with breast cancer
risk
One in four hospital patients is admitted with a mental
health
or substance abuse disorder
Scrushy settles SEC civil claims
GHX develops collaborative contract commitment tool
for the
healthcare supply chain
Human bird
flu deaths reported in Egypt, Cambodia;
China, Indonesia still not sharing
virus samples with WHO
The World Health Organization (WHO) has confirmed two new
human cases of the highly pathogenic H5N1 strain of avian
influenza in Egypt and another case in Cambodia, the first to
be confirmed in that country in 2007. The Cambodian Ministry
of Health said the 13-year-old girl, from Ponhea Kreak
district in Kampong Cham province, developed symptoms April 2,
was hospitalized the next day and died April 5. Samples from
the girl tested positive for H5N1 at the Pasteur Institute in
Phnom Penh. Sick and dead poultry were reported in the village
in recent weeks, according to WHO, and the girl reportedly had
eaten part of a sick chicken before she became ill. A team
from the Ministry of Health, WHO and the Pasteur Institute
there are following up with the girl’s contacts and conducting
awareness-raising activities in the area. Of seven cases
confirmed in Cambodia, all have been fatal. In Egypt, the
Ministry of Health and Population announced two new human H5N1
cases that were confirmed by the Egyptian Central Public
Health Laboratory and U.S. Naval Medical Research Unit No.3 in
Cairo. A 2-year-old female from Menia Governorate developed
symptoms April 3 and the next day was admitted to a hospital
where she is in stable condition. Investigations show that she
had contact with backyard poultry. Another girl, a 15-year-old
female from Cairo Governorate, developed symptoms March 30,
was admitted to the hospital April 5 and died April 10. Of 34
cases confirmed in Egypt, 13 have been fatal.
The announcement brings to 291 the total number of human cases
confirmed by WHO since 2003, with 172 deaths. These totals
include all countries except Indonesia, which since January
has not shared virus samples from infected people with WHO
collaborating centers and does not have a public health
laboratory that WHO has certified to confirm human cases of
the H5N1 strain of avian flu. On March 27, after a two-day
meeting in Jakarta, Indonesia, among officials from WHO and 20
nations that have had animal and human H5N1 outbreaks, WHO
agreed not to share virus samples with vaccine makers without
approval from the virus-collecting country, and the government
of Indonesia agreed to resume sharing H5N1 virus samples. The
meeting endorsed WHO’s efforts to link vaccine manufacturers
in developed and developing countries to speed the transfer of
technology to manufacture influenza vaccine. Individual
countries will negotiate how vaccine is made available to
them. So far, WHO has not yet received samples from Indonesia.
WHO can confirm that Indonesia has had 81 avian flu cases
since 2003 and 63 deaths, but news reports put the total at
94, with 74 deaths. China also has been withholding virus
samples from infected people since April 2006 for unknown
reasons, but its H5N1 case count is up to date at WHO. “We
have confirmed China’s cases,” said WHO spokesman Gregory
Hartl, “because if the national laboratory has been certified
as being able to do H5N1 testing and it undergoes periodic
review, then we will accept their national certification or
report.” On April 25, WHO is scheduled to hold another meeting
in Geneva to focus on ways to increase developing-country
access to potential pandemic vaccines. The gathering will
bring together representatives from WHO, countries affected by
H5N1, vaccine manufacturers and donors to discuss strategies
for vaccine production and access. According to WHO, potential
outcomes include an agreement on ways to increase access to
vaccines, including options for stockpiling vaccines. (USINFO)
For WHO’s timeline of events for avian influenza see
THIS LINK.
For a summary of a WHO consultation on clinical aspects of
human infection with avian influenza see
THIS LINK.
Overcrowded hospitals may risk adverse events on busiest
days
Hospitals that operate at or over their capacity may be at
increased risk of adverse events that injure patients,
according to a study led by investigators from Massachusetts
General Hospital (MGH) and Brigham and Woman’s Hospital (BWH).
The report in the May issue of the journal Medical Care
suggests that efforts to meet two primary challenges facing
hospitals today, reducing costs and improving patient safety,
may work against each other. “While financial and political
pressures to make health care more efficient are leading to
increased hospital occupancy and greater patient turnover,
patients and policymakers are quite rightly demanding that
health delivery systems be made safer,” said Joel Weissman,
PhD, of the MGH Institute of Health Policy, the report’s lead
author. “Our study suggests that pushing efficiency efforts to
their limits could be a double-edged sword that may jeopardize
patient safety.”
In order to examine their hypothesis that increased
workload could raise the likelihood of adverse events, the
investigators examined data from four hospitals in two states,
two large urban teaching hospitals and two suburban teaching
hospitals, over the 12 months from October 2000 through
September 2001. To compile patient care information they
reviewed patient charts and billing records on almost 25,000
patients, selecting 6,841 for comprehensive review, and
analyzed that data against information on hospital workloads
and staffing patterns, with a focus on variations within each
hospital. From the nearly 7,000 records receiving detailed
review, 1,530 adverse events, defined as preventable injuries
not resulting from patients’ underlying medical condition,
were identified. The most common such events were wound
infections and adverse drug events. At three of the four
hospitals, the rate of adverse events did not appear to
increase at times of peak workload. But at the fourth, a major
urban teaching hospital with consistently high occupancy
rates, exceeding 100 percent for more than three months,
workload increases and higher patient-to-nurse ratios were
associated with more adverse events.
“While we looked at only four hospitals, which limits the
ability to generalize these findings, the hospital where we
found a relationship between working conditions and adverse
events was disproportionately crowded for much of the study
period,” said study co-author Eran Bendavid, MD. “That
suggests hospitals operating at the high end of their capacity
may need to examine safety systems with an eye towards coping
with periods of high stress.” Formerly with the MGH Institute
of Health Policy, Bendavid is now at the Center for Health
Policy at Stanford University. “This study helps quantify the
impression that many clinicians have and confirms that systems
perform poorly when they are overloaded,” said study co-author
David Bates, MD, MSc, of the BWH Division of General Medicine
and Primary Care. “Future research should address approaches
for distributing workload and examine the effectiveness of
strategies to improve safety in high-workload situations.”
Drug company sales visits influenced doctors, study finds
Almost half of sales visits by pharmaceutical company
representatives advocating the use of the drug gabapentin led
to doctors stating that they intended to increase their
prescription of the drug or recommend it to colleagues,
according to an analysis of a survey completed by the doctors
shortly after the visits. Nearly 40 percent of the visits
involved discussion of so-called “off-label” uses of the drug
not approved by the Food and Drug Administration, say the
authors of the study. At the time of the visits, gabapentin
was approved only for secondary treatment of a certain form of
epilepsy. Off-label uses included treatment of pain, migraine,
and psychiatric conditions.
“The increased intention to prescribe after these sales visits
is remarkable, and is in fact greater than has been observed
in other studies,” said lead author Michael A. Steinman, MD, a
staff physician at the San Francisco VA Medical Center
(SFVAMC). The senior author is Lisa Bero, PhD, professor of
clinical pharmacy and health policy studies at the University
of California, San Francisco (UCSF) and an expert on
pharmaceutical industry marketing practices. The study appears
in the April 24, 2007 issue of PLoS Medicine. The
authors analyzed a survey form that chronicled 116 visits to
97 physicians by pharmaceutical sales representatives from
1995 to 1999. The forms were collected by a market research
firm and became available to the researchers as the result of
a lawsuit against Parke-Davis, the maker of gabapentin. The
lawsuit was brought by a former employee who alleged that the
company promoted gabapentin, which it sold under the name
Neurontin, for uses not officially approved by the FDA.
“To me, the remarkable thing is how effective a very brief
visit by a drug representative, most often less than five
minutes, can be in influencing physicians’ choices to use a
drug for an unapproved indication,” Bero said. After 46
percent of the visits, the doctors expressed the intention to
increase either their prescribing of gabapentin or their
recommendations that their colleagues prescribe the drug.
During 39 percent of visits, the sales representative either
gave or promised free drug samples to the doctor, said
Steinman, who is also an assistant professor of medicine at
UCSF. During 38 percent of the visits, the “main message”
involved discussion of at least one use of gabapentin that was
not approved by the FDA at the time, he says. “We can’t say
for sure whether these off-label uses were brought up by the
sales representatives or the physicians,” cautions Steinman,
“but it’s clear there was extensive discussion of uses that
were not approved by the FDA, which, in general, sales
representatives are prohibited from discussing in an
unsolicited manner.”
Steinman notes that physicians were just as likely to say they
intended to increase prescription of gabapentin whether or not
visits included mention of off-label use. Neither the duration
of visit nor the visit’s perceived educational value made any
detectable difference in intention to prescribe, he said.
There was no indication of whether the physicians followed up
on their stated intention to prescribe more gabapentin, he
said. Steinman speculates that the real effectiveness of
pharmaceutical sales visits lies primarily in the
“relationship-building” that occurs during those visits.
“Aside from free drug samples, the representative will often
bring a gift, lunch for the doctor and his or her staff, new
pens and coffee mugs, offers to attend an educational
conference. As a result, the doctor feels subtly, even
subconsciously, indebted to the representative. This can lead
to higher prescribing.”

Neither abortion nor miscarriage associated with breast cancer
risk
Neither
induced abortion nor spontaneous abortion (miscarriage)
appears to be associated with breast cancer risk in
premenopausal women, according to a report in the April 23
issue of Archives of Internal Medicine. Women younger
than age 35 who carry a pregnancy to term appear to have a
reduced lifetime risk of breast cancer, according to
background information in the article. Pregnancy may
accelerate breast cell differentiation, the process by which
cells take on specialized roles. “An incomplete pregnancy may
not result in sufficient differentiation to counter the high
levels of pregnancy hormones that may foster proliferation,”
the rapid growth and division typical of cancer cells, the
authors write. “However, these biological mechanisms are
uncertain, and a prematurely terminated pregnancy may not
affect breast cancer risk at all.”
Karin B.
Michels, Sc.D., Ph.D., and colleagues at Brigham and Women’s
Hospital, Harvard Medical School and Harvard School of Public
Health, Boston, examined the association between abortion and
breast cancer in 105,716 women who were part of the Nurses’
Health Study II (NHSII). A total of 16,118 participants (15
percent) reported having a history of induced abortion and
21,753 (21 percent) had a history of spontaneous abortion.
Between 1993 and 2003, 1,458 new cases of breast cancer
occurred among the women. “In this cohort study of young
women, we found no association between induced abortion and
breast cancer incidence and a suggestion of an inverse
association between spontaneous abortion and breast cancer
incidence during 10 years of follow-up,” the authors write.
“We observed associations in two subgroups, an association
between induced abortion and progesterone receptor–negative
breast cancer [cancer that does not respond to the hormone
progesterone] and an inverse association between spontaneous
abortion before the age of 20 years and breast cancer
incidence,” they continue.
However,
they caution that these secondary analyses are based on small
numbers of women. “No obvious mechanisms can be provided for
these subgroup findings; thus, chance has to be considered as
a possible explanation.” A 2003 international expert panel
convened by the National Cancer Institute reviewed and
assessed research regarding reproductive events and the risk
of breast cancer, and concluded that based on existing
evidence, induced abortion is not associated with an increased
risk of breast cancer. “The data from the NHSII provide
further evidence of a lack of an important overall association
between induced or spontaneous abortions and risk of breast
cancer,” the authors conclude. “Among this predominantly
pre-menopausal population, neither induced nor spontaneous
abortion was associated with the incidence of breast cancer.”
One in four hospital patients is admitted with a mental
health or substance abuse disorder
Almost
one-fourth of all stays in U.S. community hospitals for
patients age 18 and older, 7.6 million of nearly 32 million
stays, involved depressive, bipolar, schizophrenia and other
mental health disorders or substance use related disorders in
2004, according to a new report by HHS’ Agency for Healthcare
Research and Quality. This study presents the first
documentation of the full impact of mental health and
substance abuse disorders on U.S. community hospitals.
According to the report, about 1.9 million of the 7.6 million
stays were for patients who were hospitalized primarily
because of a mental health or substance abuse problem. In the
other 5.7 million stays, patients were admitted for another
condition but they also were diagnosed as having a mental
health or substance abuse disorder. Nearly two-thirds of costs
were billed to the government: Medicare covered nearly half of
the stays, and 18 percent were billed to Medicaid. Roughly 8
percent of the patients were uninsured. Private insurers were
billed for the balance. The study also found that one of every
three stays of uninsured patients was related to a mental
health or substance abuse disorder.
“Community hospitals play an important role in the treatment
of people with mental health and substance abuse disorders,”
said AHRQ Director Carolyn M. Clancy, M.D. “This report gives
healthcare policymakers an in-depth look at the impact of
mental health and substance abuse care on the healthcare
system.” Substance Abuse and Mental Health Services
Administration Administrator Terry Cline, Ph.D., said, “The
significant number of hospital stays related to mental health
and substance use disorders signals the need for an increased
national effort to identify and intervene early before the
conditions require a hospital stay. Too often because of
social stigma or lack of understanding, individuals and health
care providers don't recognize the signs or treat mental
health or substance use disorders with the same urgency as
other medical conditions.”
AHRQ
found that most patients with mental health and substance
abuse disorders were older. For example, although people age
80 and older comprised only 5 percent of the U.S. population
in 2004, they accounted for nearly 21 percent of all hospital
stays for these conditions, principally for dementia. There
were also gender differences. The most frequent admitting
diagnosis for women was mood disorders, while that for men was
substance abuse. AHRQ also found that patients who have been
diagnosed with both a mental health condition and a substance
abuse disorder, those with “dual diagnoses”, accounted for 1
million of the nearly 8 million stays. Nearly half of these
cases with dual diagnoses involved drug abuse, a third
involved alcohol abuse, and one in five involved both drug and
alcohol abuse.
In
addition, 240,000 women hospitalized for childbirth or
pregnancy also had mental health or substance abuse problems.
Four of every 10 of these patients were between 18 and 24
years of age. Suicide attempts accounted for nearly 179,000
hospital stays. Of these, 93 percent involved a mental health
condition, most commonly mood disorders, and/or substance
abuse. Nearly three-quarters of these patients were between
ages 18 and 44 and more than half were women. Poisoning, by
overdosing prescription medicines or ingesting a toxic
substance was the most common way patients attempted suicide.
The report is based on 2004 data, the latest currently
available, from AHRQ’s Healthcare Cost and Utilization Project
Nationwide Inpatient Sample, a database of hospital inpatient
stays that is nationally representative of all short-term,
non-federal hospitals. The data are drawn from hospitals that
comprise 90 percent of all discharges in the United States and
include all patients, regardless of insurance type, as well as
the uninsured. For more information see
THIS LINK.
Scrushy settles SEC civil claims
HealthSouth Corp. founder Richard M. Scrushy reached an $81
million deal with the Securities and Exchange Commission to
settle claims against him related to the massive accounting
fraud at the healthcare rehabilitation company, according to
The Wall Street Journal. Under terms of the agreement,
filed in U.S. District Court in Birmingham, AL, Scrushy agreed
to give up $77.5 million in gains and pay a $3.5 million
penalty. Scrushy neither admitted or denied the SEC’s
allegations, and will receive credit for $71.5 million he has
already paid or forfeited in related cases, cutting the
remaining bill to $9.5 million. Scrushy was charged by the
Justice Department and the SEC in 2003 with accounting fraud
and insider trading. At the time, the SEC sought more than
$200 million in penalties, and Scrushy faced the possibility
of years in prison. (The Wall Street Journal)

GHX develops collaborative contract commitment tool for the
healthcare supply chain
GHX has extended the functionality of its Contract Center to
include a collaborative contract commitment module that can be
utilized by all providers, manufacturers, distributors, and
group purchasing organizations (GPOs) in the healthcare supply
chain. More than sixty hospitals have already successfully
used the tool to activate hundreds of contracts negotiated by
HealthTrust Purchasing Group with Medtronic, Boston Scientific
Corporation, and St. Jude Medical. Johnson and Johnson
Healthcare Systems Inc. will begin utilizing the contract
commitment module later this year. Cardinal Health has also
expressed support for a single industry solution for contract
commitment.
Effective contract management requires that all authorized
parties to a contract share accurate information related to
factors such as tier pricing and commitments, customer
eligibility, and effective contract dates in a timely manner.
When that information is inconsistent or delayed, errors can
occur that not only create rework and higher labor costs but
also may result in financial losses for the various parties as
the result of inaccurate pricing, rebates and chargebacks. The
GHX Contract Commitment Module addresses these issues by
automating what has traditionally been a highly manual process
and by enabling manufacturers, distributors, GPOs, and
healthcare providers to agree on key contract terms and
conditions up front.
These process improvements help ensure greater accuracy in
both transactions and reporting related to contract purchases,
whether they are through a GPO or direct with a manufacturer.
GPOs can provide manufacturers with data on contract terms and
conditions, including tier pricing, definitions, and
requirements, as well as which customers are eligible for
various contracts. Hospitals and other healthcare providers
can then utilize the tool to activate contracts, with
manufacturer approval and agreement on effective dates
occurring in a collaborative online environment.
For more
information, see THIS LINK.

April 23,
2007
In turnabout, infant deaths climb in South
FDA was aware of dangers to food;
outbreaks were not preventable, officials say
MedAssets’
2007 Healthcare Business Summit celebrates successes
in healthcare
Antibiotics not necessary to treat most
abscesses,
even in the presence of MRSA
Medicaid programs ‘severely
challenged,’ report says
State Medicaid programs vary wildly in their eligibility
criteria, the scope and quality of their care, and the amount
they reimburse physicians providing it, according to an
independent assessment published last week. Overall, the
programs are “severely challenged,” with the best scoring the
equivalent of a low D and the worst way below an F. “This
evaluation demonstrates a bleak picture for millions of people
in many states,” wrote the authors of the 143-page evaluation,
produced by Public Citizen’s Health Research Group. The top
five programs, in order of rank, were in Massachusetts,
Nebraska, Vermont, Alaska and Wisconsin. The bottom five, with
lowest-ranked last, were in South Dakota, Oklahoma, Texas,
Idaho and Mississippi. Maryland ranked 15, the District 27,
and Virginia 37. Beyond the minimum specified services that
the federal government mandates state Medicaid programs to
provide, states may choose to expand coverage for other
services. For example, all states and the District also choose
to cover uninsured poor women needing care for breast or
cervical cancer. Thirteen states and the District also cover
uninsured people with tuberculosis.
The anecdotal differences between states can be dramatic. For
example, a pregnant woman in a family of three must have a
household income of less than $22,128 to qualify for Medicaid
in Wyoming. In Minnesota, she could qualify with an income of
$45,650, according to the report. “We know that the
differences between programs reflect both differences in
priorities and resources, but nobody knows the extent of them.
The programs haven’t been subjected to a uniform scoring
scheme,” said Annette B. Ramirez de Arellano, a health-policy
expert who headed the project. The authors used published data
to measure Medicaid performance in 55 areas. In calculating a
final score out of a possible 1,000 points, they weighted
issues of eligibility and reimbursement more heavily than
breadth of services and quality of care. The highest- and
lowest-ranked states differed in their scores by a factor of
two, 646 for Massachusetts vs. 318 for Mississippi. There was
even more variation in the components that went into the total
scores. For example, the top-ranked state for the breadth of
its eligibility criteria (Rhode Island) scored 3.3 times
higher than the lowest-ranked state (Indiana) in that
category. In the reimbursement component of the score, there
was a 20-fold difference between Alaska, which had the most
generous reimbursement, and New Jersey, which had the least.
“Most of the states are failing in one or more areas, and some
of them are failing in most areas,” Ramirez de Arellano said.
Public Citizen’s Health Research Group did a similar analysis
and ranking 20 years ago. Four states in the top 10 now were
in the top 10 then. Five states in the bottom 10 now were in
the bottom 10 then. The authors admitted they were operating
off incomplete information on many subjects, which made their
task difficult. For example, the quality assessment was
largely based on nursing home performance and the success of
childhood immunizations, although Medicaid pays for the entire
range of medical care. The reimbursement comparisons were
based only on Medicaid programs using a fee-for-service
payment scheme. However, 60 percent of Medicaid patients are
in managed-care schemes in which physicians or clinics get a
flat fee to provide all medical services to a client. Alan
Weil, executive director of the National Academy for State
Health Policy, said the report fails to capture Medicaid’s
cutting edge, experimental coverage programs, managed-care
reimbursement schemes and home-based care, because there are
no data collected in all states that can serve as grounds for
comparing those components. (Washington Post)

In turnabout, infant deaths climb in South
For decades,
Mississippi
and neighboring states with large black populations and
expanses of enduring poverty made steady progress in reducing
infant death. But, in what health experts call an ominous
portent, progress has stalled and in recent years the death
rate has risen in Mississippi and several other states. The
setbacks have raised questions about the impact of cuts in
welfare and Medicaid and of poor access to doctors, and, many
doctors say, the growing epidemics of
obesity,
diabetes
and
hypertension
among potential mothers, some of whom tip the scales here at
300 to 400 pounds. “I don’t think the rise is a fluke, and
it’s a disturbing trend, not only in Mississippi but
throughout the Southeast,” said Dr. Christina Glick, a
neonatologist in Jackson, MI, and past president of the
National Perinatal Association. To the shock of Mississippi
officials, who in 2004 had seen the infant mortality rate,
defined as deaths by the age of 1 year per thousand live
births, fall to 9.7, the rate jumped sharply in 2005, to 11.4.
The national average in 2003, the last year for which data
have been compiled, was 6.9.
Smaller
rises also occurred in 2005 in
Alabama,
North
Carolina and
Tennessee.
Louisiana
and
South
Carolina saw rises in 2004 and have not yet
reported on 2005. Whether the rises continue or not, federal
officials say, rates have stagnated in the Deep South at
levels well above the national average. Most striking, here
and throughout the country, is the large racial disparity. In
Mississippi, infant deaths among blacks rose to 17 per
thousand births in 2005 from 14.2 per thousand in 2004, while
those among whites rose to 6.6 per thousand from 6.1. (The
national average in 2003 was 5.7 for whites and 14.0 for
blacks.) The overall jump in Mississippi meant that 65 more
babies died in 2005 than in the previous year, for a total of
481. The main causes of infant death in poor Southern regions
included premature and low-weight births; Sudden Infant Death
Syndrome, which is linked to parental
smoking
and unsafe sleeping positions as well as unknown causes;
congenital defects; and, among poor black teenage mothers in
particular, deaths from accidents and disease. Dr. William
Langston, an obstetrician at the Mississippi Department of
Health, said that officials could not yet explain the sudden
increase and were investigating. Dr. Langston said the state
was working to extend prenatal care and was experimenting with
new outreach programs. But, he added, “programs take money,
and Mississippi is the poorest state in the nation.”
In the past
10 years, the infant mortality rate for blacks in most of the
Delta has averaged about 14 per thousand in some counties and
more than 20 per thousand in others. But Sharkey County, one
of the poorest, has had a startlingly different record. From
1991 through 2005, the rate for blacks hovered at around 5 per
thousand. State officials say the county’s population is too
small, it registers only 100 births a year, to be
statistically significant. But many experts feel it is no
coincidence that a steep drop in infant deaths followed the
start of an intensive home-visiting system run by the Cary
Christian Center, using local mothers as counselors. The
program, which is paid for with private money, buses nearly
all pregnant blacks in Sharkey and a small neighboring county
to pre- and postnatal classes. (The
New York Times)

FDA was aware of dangers to food;
outbreaks were not preventable, officials say
The
Food
and Drug Administration has known for years about
contamination problems at a
Georgia
peanut butter plant and on
California spinach farms that led to disease
outbreaks that killed three people, sickened hundreds, and
forced one of the biggest product recalls in
U.S.
history, documents and interviews show. Overwhelmed by huge
growth in the number of food processors and imports, however,
the agency took only limited steps to address the problems and
relied on producers to police themselves, according to agency
documents. Congressional critics and consumer advocates said
both episodes show that the agency is incapable of adequately
protecting the safety of the food supply. FDA officials
conceded that the agency’s system needs to be overhauled to
meet today’s demands, but contended that the agency could not
have done anything to prevent either contamination episode.
Last week, the FDA notified California state health officials
that hogs on a farm in the state had likely eaten feed laced
with melamine, an industrial chemical blamed for the deaths of
dozens of pets in recent weeks. Officials are trying to
determine whether the chemical’s presence in the hogs
represents a threat to humans. Pork from animals raised on the
farm has been recalled. The FDA has said its inspectors
probably would not have found the contaminated food before
problems arose. The tainted additive caused a recall of more
than 100 different brands of pet food. The outbreaks point to
a need to change the way the agency does business, said Robert
E. Brackett, director of the FDA’s food-safety arm, which is
responsible for safeguarding 80 percent of the nation’s food
supply. “We have 60,000 to 80,000 facilities that we’re
responsible for in any given year,” Brackett said. Explosive
growth in the number of processors and the amount of imported
foods means that manufacturers “have to build safety into
their products rather than us chasing after them,” Brackett
said.
Tomorrow, a
House Energy and Commerce subcommittee will hold a hearing on
the unprecedented spate of recalls.
Rep.
John D. Dingell (D-MI), chairman of the full House
committee is considering introducing legislation to boost the
agency’s accountability, regulatory authority and budget.
According to Caroline Smith DeWaal, who heads the Center for
Science in the Public Interest, a consumer-advocacy group,
“When budgets are tight... the food program at FDA gets hit
the hardest.” In next year’s budget, passed amid discovery of
contamination problems in spinach, tomatoes and lettuce,
Congress has voted the FDA a $10 million increase to improve
food safety, DeWaal said. The
Agriculture Department, which monitors meat,
poultry and eggs and keeps inspectors in every processing
plant, got an increase 10 times that amount to help pay for
its inspection programs. The FDA visits problem food plants
about once a year and the rest far less frequently, Brackett
said. (Washington Post) To read the original article see
THIS LINK.
FDA to consider approval of
first CCR5 antagonist against HIV/AIDS
An advisory panel of the U.S. Food and Drug Administration
(FDA) is meeting this week to decide whether to recommend
approval of Pfizer’s HIV/AIDS drug Maraviroc for patients
already taking other drugs. If approved, it will be the first
drug available in the class called CCR5 antagonists. Many HIV
drugs fight the virus from inside infected white blood cells.
CCR5 antagonists stop the virus from getting into cells by
blocking the main entry point common to most people who have
the infection. CCR5 stands for chemokine (C-C motif) receptor
5. HIV uses it as a co-receptor to get into target cells: the
CD4 T-cells or helper cells, the main coordinators of the
immune system. When the co-receptor “sees” the HIV virus it
signals to the main CD4 cell receptor to allow the HIV antigen
into the target T-cell.
By blocking the CCR5 co-receptor, CCR5 antagonists stop
strains of HIV known as “R5-tropic”, an HIV variant that is
common in earlier infection. However, as the disease
progresses, the virus adapts to use an alternative entry
point, the CXR4 receptor. In February, Pfizer announced that
marketing authorization applications for Maraviroc were
receiving accelerated review in both the US and Europe. The
marketing applications for Maraviroc are supported by efficacy
and safety data from two phase 3 trials. Named MOTIVATE-1 and
2 (Maraviroc plus Optimized Therapy In Viremic Antiretroviral
Treatment-Experienced patients), the trials show 24 weeks of
data comparing Optimized Background Therapy, with or without
Maraviroc, in over 1,000 highly treatment-experienced patients
with CCR5-tropic HIV-1. The HIV virus was suppressed in 45
percent of the patients, compared with 23 percent who took a
placebo. Maraviroc and the placebos were taken in combination
with other drugs. According to Pfizer, these trial results
have been accepted for presentation at a forthcoming HIV
conference.
CCR5 antagonists have raised safety concerns in the past.
Earlier drugs under development were linked to lymphoma and
liver damage. These risks did not appear to be significant in
the Pfizer studies, but according to media reports, the FDA
reviewers are concerned about modest increases in liver
damage. Other drug companies are also working on CCR5
antagonists. Nobody knows what the long term effect of using
CCR5 antagonists will be. Some have speculated that it will
accelerate the development of new strains of HIV that use
other entry points. Early trials have suggested not, but it
highlights the importance of keeping an eye on the impact of
the drug over the coming years should it pass the FDA and
European approval. According to researchers on the Pfizer
trials, the priority now is to get the drug to the people who
are running out of options. The longer term effects will not
be known until the drug has been used for 5 to 10 years.
(Medical News Today)
MedAssets’ 2007 Healthcare Business Summit
celebrates successes
in healthcare
At its
Healthcare Business Summit in Las Vegas, April 9-13, MedAssets
announced its commitment to further expand its technologies
and services to help healthcare providers improve their
overall financial and operational performance. In his address
to the more than 2,700 healthcare professionals attending the
MedAssets Healthcare Business Summit, MedAssets’ Chairman,
President and CEO John Bardis shared the company’s plans to
expand its revenue cycle management suite through acquisition
of Xactimed and emphasized that the company’s diligent and
deliberate growth is driven by the need to solve the
challenges healthcare providers are facing as they work to
improve the quality of care and efficiency in our nation’s
healthcare system.
During the
event, MedAssets recognized customers who had achieved
substantial financial and operational success through the use
of the company’s technologies and services. MedAssets Supply
Chain Systems also presented awards to GPO suppliers who work
with healthcare providers to help them realize greater cost
efficiency. This year marked the initial presentation of The
Lifetime Financial Improvement Award as well as awards
recognizing high-performing customers of MedAssets’
subsidiaries Avega Health Systems, MedAssets Net Revenue
Systems and MedAssets Analytical Systems. The Lifetime
Financial Improvement Award, which recognizes the healthcare
provider that has documented and signed off on the greatest
financial savings over a multi-year relationship with
MedAssets, was presented to St. Joseph Health System for
saving $98 million. Norton Healthcare received MedAssets Net
Revenue Systems Customer of the Year Award, and Maricopa
Integrated Health System was recognized as MedAssets Net
Revenue Systems Best Practice Leader.
A total of
16 customers received the MedAssets Net Revenue Systems Best
Practice Award. The Avega Best Practice Leader Award was
presented to three customers: Legacy Health System, Vanguard
Health System and Mercy Hospital in Iowa. Four MedAssets
Analytical Systems customers received Utilization Excellence
Awards: Erlanger Health System, MedCath, Wellmont Health
System and Atlantic Health System. The 2007 Outstanding
Humanitarian Award went to Chris Van Gorder, chief executive
officer of Scripps Health in San Diego, CA. The MedAssets
President’s Award was presented to Trae Roby of OfficeMax for
his strong leadership and delivery of superior value to
MedAssets’ customers. OfficeMax was also recognized as this
year’s Strategic Sponsor of the Healthcare Business Summit.
The second annual Enterprise President’s Award was presented
to Atlantic Health for its improved financial performance
achieved through the complete MedAssets enterprise solution
platform including supply chain innovation and other
technology solutions. Other award presentations included 260
supplier awards, as well as The Supply Chain Savings Award,
which was presented to OfficeMax and ICU Medical. For more
information see
THIS LINK.

Physicians should be able to review
performance rates before release
A policy paper and principles assuring that physicians are
given the opportunity to comment on performance ratings that
they believe are inaccurate were adopted this week by the
American College of Physicians (ACP) at its annual meeting
April 19-21 in San Diego. The principles, part of the paper
“Developing a Fair Process Through Which Physicians
Participating in Performance Measurement Programs Can Request
a Reconsideration of Their Ratings”, also address performance
ratings that do not take into account the characteristics of
the practice or patient population being treated prior to the
release of ratings to the public.
Accurate reports of physician performance will allow
physicians to effectively assess and improve their
performance, and enable consumers and purchasers to make
informed decisions concerning treatments, coverage and the
quality of care. The principles, ACP says, should be
considered in tandem with other organizational principles on
developing measures; sharing, aggregating, and reporting data;
and the ethics of physician performance measurement.
Performance data should be used for public reporting or to
determine physician payment only after data are fully adjusted
for case-mix composition, including age, severity of illness,
co-morbidities, and other features of a physician’s practice
and patient population that may influence the results. “A fair
and accurate reconsideration process is yet another way to
minimize unintended consequences that may compromise the care
of the patient,” said ACP President Lynne M. Kirk, MD, FACP.
“These principles reflect the importance of balancing
stakeholders’ urgent need for useful information with the need
for due diligence to ensure that the information provided is
valid, reliable, and useful.”

Antibiotics not necessary to treat most
abscesses,
even in the presence of MRSA
A 30-year review of the medical literature concerning a common
skin infection reveals that abscesses treated by simple
incision and drainage heal just as well as those treated with
incision, drainage and antibiotics. An article appearing
online in the Annals of
Emergency Medicine finds that, except in cases
where cellulitis is present, abscesses can be treated
successfully without antibiotics, even in an environment
heavily contaminated with methicillin-resistant Staphylococcus
aureus (MRSA) (“Are Antibiotics Necessary After Incision and
Drainage of a Cutaneous Abscess?”). “The typical treatment for
an emergency patient with a skin abscess is incision, drainage
and antibiotics, but it looks like incision and drainage alone
are enough,” said study author Worth W. Everett, MD, of the
University of Pennsylvania Department of Emergency
Medicine. “Given widespread concerns about antibiotic misuse
and antibiotic resistance, this could change how we treat this
very common emergency department complaint for both adults and
children.”
MRSA, a
powerful Staph infection sometimes referred to as a “superbug,”
has proliferated recently in many public settings, including
hospitals and healthcare facilities. MRSA’s resistance to many
antibiotics and potential to cause harm to people with both
normal and compromised immune systems have raised alarm among
many healthcare workers. “Patients tend to clamor for
antibiotics, even in situations where the evidence is clear
that they are ineffective, such as with the common cold or the
flu,” said Dr. Everett. “The body has a tremendous ability to
heal itself over time, and we can now see that this includes
skin abscesses, at least those that do not include cellulitis. The
current research simply does not support the routine practice
of prescribing antibiotics following incision and drainage of
simple abscesses.”
The National Institutes of Health (NIH) has solicited
proposals to study on a broader scale how to treat skin and
soft tissue infections, including abscesses, and whether
antibiotics are necessary. “Every study we looked at came to
the same conclusion: abscesses treated with incision and
drainage alone healed at the same rate as abscesses treated
with incision, drainage and antibiotics,” said Dr.
Everett. “If the anticipated NIH study supports the findings
of the last 30 years, this may help stem the tide of
antibiotic overuse. The next step, of course, will be to
reinforce to the public the message that they don't need
antibiotics to treat every ailment.”

April 20, 2007
John
Hopkins begins aggressive screening for ‘superbugs’ in
children
OSHA, NIOSH publish bulletin to help protect
surgical personnel
from needle stick injuries
VHA Rapid Response Team network saves lives in
Central Atlantic Region
Premier, Cardinal Health team up to help
hospitals identify safer products
through use of standardized
terminology
Misusing vitamin to foil drug test may be
toxic
‘Bird Flu’ genome study shows new
strains, Western spread
In a paper in the May issue of
Emerging Infectious Diseases, an international team of researchers report the first
ever large-scale sequencing of western genomes of the deadly
avian influenza virus, H5N1. Their study of 36 genomes of the
virus collected from wild birds in Europe, the Middle East and
Africa (EMA), and Vietnam confirms not only that the virus has
very recently spread west from Asia, but that two of the new
western strains have already independently combined, or
reassorted, to create a new strain. Several samples also
contained the mutation associated with the form of the “bird
flu” that caused several human deaths in 2006. It is the
virus’s ability to rapidly mutate into a pathogen that may
eventually be passed between humans that concerns health
officials about a worldwide pandemic of H5N1 influenza. The
study also produced some evidence that strengthens the case
that humans have had an impact on the movement of the flu out
of Asia. “This is the first time anyone’s looked at all of the
H5N1 genomes in the west,” said Steven Salzberg, the study’s
lead author and director of the
University
of Maryland Center for Bioinformatics and Computational
Biology. “Until now, the studies have been
primarily on samples from the Far East. Our study shows that
the virus is spreading west, and that there have been three
separate introductions of H5N1 in Europe, the Middle East and
Africa.”
The study shows that the new Euro-African lineage, which was
the cause of fatal human infections in Egypt and Iraq in 2006,
has been introduced at least three times into the EMA region
and has split into three distinct, independently evolving
lineages. Two of those sublineages have recently reassorted.
The broad dispersal of the different forms of the virus
throughout the different countries over a relatively short
period of time points to the possibility of human movement,
rather than wild birds as the reason for the quick spread of
the H5N1. “The migratory pathways of wild birds don’t
correspond with the movement of the genomes that we
sequenced,” said Salzberg. “Humans carry chickens between many
of the countries in our study, often transporting them across
great distances. That and the weak biosecurity standards in
most rural areas point to human-related movement of live
poultry as the source of the introduction of H5N1 in some
countries.” While the study “dramatically increased the number
of genomes that have been sequenced, we have to do more
surveys,” Salzberg said. “It’s surprising that we found what
we did with such a small sample.” To read the paper see
THIS
LINK.
Baby boomers appear to be less healthy
than parents
As the
first wave of baby boomers edges toward retirement, a growing
body of evidence suggests that they may be the first
generation to enter their golden years in worse health than
their parents. While not definitive, the data sketch a
startlingly different picture than the popular image of
health-obsessed workout fanatics who know their antioxidants
from their trans fats and look 10 years younger than their
age. Boomers are healthier in some important ways, they are
much less likely to smoke, for example, but large surveys are
consistently finding that they tend to describe themselves as
less hale and hearty than their forebears did at the same age.
They are more likely to report difficulty climbing stairs,
getting up from a chair and doing other routine activities, as
well as more chronic problems such as high cholesterol, blood
pressure and diabetes. “We’re seeing some very powerful
evidence all pointing to parallel findings,” said Mark D.
Hayward, a sociologist at the University of Texas at Austin.
“The trend seems to be that people are not as healthy as they
approach retirement as they were in older generations. It’s
very disturbing.”
While
cautioning that the data are just starting to emerge,
researchers say the findings track with several unhealthy
trends, notably the obesity epidemic. Two-thirds of Americans
are overweight, and those extra pounds make joints wear out
more quickly, boost cholesterol and blood pressure, and raise
the risk of a host of debilitating health problems. And
despite all those gym memberships, baby boomers tend to be
less physically active than their parents and grandparents,
their daily routines often dominated by desk jobs and the
drive to and from work. Boomers tend to report more stress
than earlier generations, from their jobs, their commutes,
taking care of their parents and their kids, all of which can
take a physical toll, which is compounded by having less
support from extended families and communities, experts say.
When
researchers examined the first wave of baby boomers (5,030
adults born between 1948 and 1953)to enter a federally funded
Health and Retirement Study which is tracking more than 20,000
U.S. adults as they move through middle age toward retirement,
they were shocked to discover that they appeared to report
poorer health than groups born between 1936 and 1941, and
between 1942 and 1947. The baby boomers were much less likely
than their predecessors to describe their health as
“excellent” or “very good,” and were more likely to report
having difficulty with routine activities, such as walking
several blocks or lifting 10 pounds. They were also more
likely to report pain, drinking and psychiatric problems, and
chronic problems such as high blood pressure, high cholesterol
and diabetes. It is unclear whether boomers are really sicker
or are simply more health-conscious by dint of being better
educated and having better access to information. They may
also have higher expectations, making them more likely to
notice and complain about aches and pains that earlier
generations would have accepted as just part of getting older.
The
findings are consistent with a number of studies, including
one last year that found American adults have poorer health
than their British counterparts, and a preliminary analysis of
data collected between 1972 and 2003 for the National Health
Interview Survey, a nationally representative survey of more
than 100,000 Americans. If the findings are confirmed by
further analysis, the trend could force policymakers to
rethink a host of expectations and projections about the
nation’s overall medical bill and the future of Social
Security and other retirement programs. (Washington Post)
To read the original article see
THIS LINK.
John Hopkins
begins aggressive screening for ‘superbugs’ in children
Infection control and critical care experts at The Johns Hopkins
Hospital have ordered testing for the two most common hospital
superbugs for every child admitted to its pediatric intensive
care unit. The more stringent admission screening methods for
methicillin-resistant Staphylococcus aureus (MRSA) and
vancomycin-resistant Enterococcus (VRE) go well beyond
standard hospital practices, where tests are only ordered
after symptoms or early signs of infection appear. The new
hospital practice was introduced March 1 after a study
conducted at Hopkins last year showed that more frequent
screening detected many more carriers of the germs before
their presence led to infection or the germs spread to others.
Admission screening is already standard at Hopkins for adults
admitted to intensive care units. Health experts fear spread
of these particular bacteria because they have developed
resistance to the antibiotic drugs most commonly used to
combat them. Though infections caused by these bacteria are
rarely fatal, carriers of either bug are at greater risk for
more dangerous infections.
Results from the study, presented April 16 at the annual meeting of
the Society of Health Care Epidemiology of America (SHEA) in
Baltimore, are believed among the first to make a case for
better screening in efforts to slow spread of the germs in
hospitalized children. The study compared the effectiveness of
weekly screening to current practices for ordering tests and
found the weekly model to be many times more effective than
standard risk monitoring, in which the highly contagious
bacteria are looked for after patients develop skin rash,
fever or pain. Weekly swab testing and bacterial growth
cultures were done on nearly 330 patients in the hospital’s
pediatric intensive care unit for four months. Results were
compared to findings of cultures obtained from patients
showing possible signs or symptoms of infection. All patients
were under age 18. The weekly testing for MRSA, the most
common superbug, detected more than half of young patients who
were carrying the germ (54 percent, or one and a half times as
many) than were detected through routine testing, which
missed 35 percent of those with MRSA. Results for detecting
VRE, a lesser known but still common superbug, were six times
higher with weekly testing than with routine testing, which
missed 82 percent of those with VRE.
Like most bacteria, hospital superbugs are picked up through
direct contact, by touching someone or a surface with it. “The
results were quite clear to us: Aggressive patient safety
programs should consider testing on admission as standard
practice,” said study senior author and hospital
epidemiologist Trish Perl, M.D. Perl and her team, however,
will wait for evidence of improved patient safety before
making any national recommendations to government agencies and
other hospitals. Perl is past president of SHEA. “We need to
find patients who have these bacteria on them and who, as
such, are not only at risk of personal infection, but also
pose a serious threat of infection to other patients and
hospital staff,” she said. According to Perl, a professor of
medicine and pathology at The Johns Hopkins University School
of Medicine, patients found to be infected or to be a carrier
before infection has set in are placed in isolation for the
remainder of their stay. Wound care is done only in
designated, confined treatment spaces or separate rooms, and
hospital staff must take special precautions between
treatments, such as cleaning equipment and furniture with
strong disinfectants and wearing disposable gloves, masks and
gowns.
“Children are more vulnerable to the problem of antibiotic
resistance because their bodies are not fully developed to
fight off illness and because fewer drugs are FDA approved for
use in children,” said Aaron Milstone, M.D., a pediatric
infectious diseases research fellow at Hopkins who led the
tudy. Vancomycin (Vancocin) is currently the only FDA-approved
drug for MRSA in children, and only one drug, linezolid (Zyvox),
is approved in pediatrics for VRE. Milstone says children
admitted to Hopkins are increasingly identified as harboring
MRSA or VRE, with recent reports from the intensive care unit
showing four times as many children with MRSA and twice as
many with VRE than five years ago. 
OSHA, NIOSH publish bulletin to help
protect surgical personnel from needle stick injuries
The U.S.
Department of Labor’s Occupational Safety and Health
Administration (OSHA) and the National Institute for
Occupational Safety and Health (NIOSH) in the U.S. Centers for
Disease Control and Prevention have jointly published a Safety
and Health Information Bulletin (SHIB) designed to help
protect surgical personnel from needle stick injuries while
using suture needles. “Surgical personnel are at risk of
occupational exposure to bloodborne pathogens from injuries
caused by sharp surgical instruments,” said Assistant
Secretary of Labor for OSHA Edwin G. Foulke, Jr. “We strongly
encourage the use of blunt-tip suture needles when feasible
and appropriate to reduce this risk.” “The effectiveness of
blunt-tip suture needles for preventing needle stick injuries
has been widely reported,” said NIOSH Director John Howard,
M.D.
The SHIB, available on the OSHA Web site at
http://www.osha.gov/dts/shib/shib032307.html
and on the NIOSH Web site at
http://www.cdc.gov/niosh/docs/2007-132/, describes the
hazards of sharp-tip suture needles and presents evidence of
the effectiveness of blunt-tip needles in decreasing injuries.
It also emphasizes OSHA’s requirement to use appropriate,
available and effective safer medical devices. Sharp-tip
suture needles are the leading source of penetrating injuries
to surgical personnel, causing 51-to-71 percent of these
incidents. These injuries potentially expose staff and
patients to bloodborne pathogens. The American College of
Surgeons (ACS) issued a statement in 2005 supporting the use
of blunt-tip suture needles where clinically appropriate. This
statement has been endorsed by the six organizations that,
along with the ACS, make up the Council on Surgical and
Perioperative Safety.

VHA Rapid Response Team network saves
lives in Central Atlantic Region
In May 2005, VHA Inc., a national health care alliance,
launched a national effort to help its members implement Rapid
Response Teams, hospital teams that can be called upon to help
when it looks like patients in medical-surgical units are
slowly spiraling toward a crisis such as cardiac arrest or
shock, with the purpose of preventing that event. Thirty-one
hospitals from Maryland, North Carolina, South Carolina,
Tennessee, Virginia, West Virginia and Washington D.C., joined
the VHA initiative through its Central Atlantic office. By
learning as a network through VHA and participating in VHA-sponsored
educational meetings, using standard data collection tools and
sharing their results, 68 percent of the hospitals decreased
their mortality rates and experienced 256 fewer code blue
episodes (incidents when the patient stops breathing) outside
of the intensive care unit (ICU). “Rapid response teams help
nurses provide better patient care, reduce costs and improve
hospital culture,” said Crystal Mullis, RN, BSN, MBA, MHA,
director of performance improvement at VHA. “More than half of
the organizations that participated in the VHA rapid response
team network in the region saw improvements in mortalities,
percent of codes outside of the ICU and percent of patients
that coded and survived.”
Moses Cone Health System in Greensboro, NC, was so impressed
with the results of their program that the system hired a
dedicated team that is not assigned from ICU staff. Convincing
administration about hiring the team was relatively easy as
both the finance committee and chief financial officer
understood the value of the rapid response team concept. Rapid
response team composition varies by hospital, but all teams
contain a nurse trained in critical care. Teams can include a
variety of other hospital staff members, physicians,
residents, respiratory therapists and pharmacists. When
patients show signs of clinical deterioration, distress or
changes in vital signs, the team is called within minutes to
the bedside for rapid assessment and treatment. Their response
is crucial because patient survival rates are directly
impacted by how quickly the patient is assessed and treated;
swift clinical intervention decreases patient mortality rates
significantly. The rapid response team is especially helpful
when new staff needs help, hospital resources are limited or
physicians are unavailable. VHA members participating in the
rapid response team network have seen dramatic results from
their adoption of the concept.
Mary Washington Hospital in Fredericksburg, VA, calls its team
the Medical-Surgical Emergency Team (MSET). Prior to launch,
they experienced up to 25 codes a month. Within the first
three months, their code calls dropped by 10 to13 calls. NorthEast
Medical Center in Concord, N.C., launched its program, called
the Stabilization Teaching Administration and Transport (STAT)
team, in March 2004. The program’s success spurred the launch
of a secondary group called the Code Care team in June 2006.
By dialing a special number, patients and family members can
activate the Code Care team to evaluate a patient's condition.
The STAT team is called if the patient’s condition is serious
or potentially life-threatening, and it has helped the
hospital achieve a 65 percent decrease in cardiac arrests
outside of the critical care unit and emergency department.
Parkwest Medical Center in Knoxville, TN, launched its program
in January 2006. In one year, the hospital achieved a 40
percent reduction for in-patient non-critical care codes. In
addition, the hospital has reduced the number of days that
patients spend in the critical care unit and estimates it has
avoided $520,000 in costs. For more information see
THIS LINK.
Premier,
Cardinal Health team up to help hospitals identify safer
products
through use of standardized terminology
Hospitals
will have an easier time selecting safer products through an
“industry first” effort by the Premier healthcare alliance and
Cardinal Health to standardize medical product terminology in
online catalogs. Historically, industry information describing
the contents of a specific medical product has been
inconsistent or non-existent, posing possible safety concerns.
Through Premier’s Supply Chain Advisor electronic product
catalog and Cardinal Health SupplyLine, a large product
comparison and purchasing database, Premier members will have
a standard set of nomenclature for product attributes to make
it easier to search for products that won’t cause allergic
reactions or those that are potentially toxic. For example,
products that are made without latex, mercury, PVC and DEHP
will have the new standardized nomenclature to include
attributes such as: LATEX-FREE for products without latex;
DEHP-FREE for products without the plasticizer, DEHP (Di(2–ethylhexyl)
phthalate); MERCURY-FREE for products without mercury; and
PVC-FREE for products without polyvinyl chloride.
Unlike pharmaceuticals, medical and surgical products do not
have a standard coding system, and functionally equivalent
healthcare products are often difficult and time consuming to
identify for cost saving opportunities. SupplyLine is a core
component in Cardinal Health’s rapidly growing Supply
Technologies business that enables healthcare providers and
companies to evaluate more than 800,000 healthcare products
and research alternatives from thousands of manufacturers. In
addition to cost savings, the benefits of SupplyLine include
reduced waste and excess, improved inventory controls,
improved utilization management and outcome analysis.
The Premier
Safety Institute Web site has extensive resources on latex
allergies and environmentally preferable purchasing at
www.premierinc.com/safety. Premier Data Management
Services has already processed several million new and updated
product descriptions received in the past few months from
SupplyLine. As the Supply Chain Advisor (SCA) database becomes
populated by these new attributes, SCA users will be trained
so they can begin to use the new search capabilities.
Misusing vitamin to foil drug test may be
toxic
Taking
excessive doses of a common vitamin in an attempt to defeat
drug screening tests may send the user to the hospital, or
worse. Researchers from The Children’s Hospital of
Philadelphia and The University of Pennsylvania reported on
two adults and two adolescents who suffered toxic side effects
from taking large amounts of niacin, also known as vitamin B3,
in mistaken attempts to foil urine drug tests.
Both adult
patients suffered skin irritation, while both adolescents had
potentially life-threatening reactions, including liver
toxicity and hypoglycemia (low blood sugar), as well as
nausea, vomiting and dizziness. One of the teens also had
disrupted heart rhythms. All four patients recovered after
treatment in hospital emergency rooms for the adverse effects.
The report appeared online in the Annals of Emergency
Medicine.
“Because
niacin is known to affect metabolic processes, there is a
completely unfounded claim that it can rapidly clear the body
of drugs such as cannabis and cocaine. However, niacin is
toxic when taken in large amounts.” said study leader Manoj K.
Mittal, M.D., a fellow in Emergency Medicine at The Children’s
Hospital of Philadelphia. Niacin is easily available as an
over-the-counter vitamin supplement. As a vitamin, the daily
recommended intake is 15 milligrams, but niacin is used in
much larger doses to treat vitamin deficiencies and other
conditions. “People often assume niacin is completely safe,”
said Dr. Mittal. “As a water-soluble vitamin, it is easily
excreted from the body. However, the body has its limits, and
some of these patients took 300 times the daily recommended
dose of niacin.” Dr. Mittal added that there is a report in
the medical literature of a patient who suffered liver
failure, requiring a liver transplant, after taking excessive
doses of niacin. “We hope that our study will alert emergency
medicine physicians and other healthcare providers to this
hazardous practice,” said Dr. Mittal.
CDC launches new home page and other Web
site improvements
The Centers for Disease Control and Prevention (CDC) unveiled
a new look for the home page and major topic pages of its Web
site. The changes are designed to make it easier for people to
find health information and resources quickly. The CDC Web
site address is
www.cdc.gov. The redesigned site has an improved layout, a
more powerful search engine, and other features to help people
locate needed health and science information more efficiently.
Among new features on the home page: Health and safety
information is now grouped in broad, easy-to-browse topic
areas. Additional new features provide better access to data
and statistics, recent news, tools and resources, and new
publications. A new Google-based search engine provides more
relevant search results. An interactive features area at the
top of the new home page highlights a number of current
issues, events and health topics with relevant photographs or
videos. This feature enables CDC to better display health
recommendations, guidelines and upcoming events. A “Top 20 at
CDC.gov” section allows visitors to quickly view a list of the
most popular health topics, and access each directly from the
home page. For a virtual tour see
THIS
LINK.

April 19, 2007
Republicans block Medicare drug price bill
WSJ: Pediatric ICUs make headway against
infection
Difficult births in obese women due to uterus failure
Consorta Inc. finalizes agreement to
become sixth equity owner
of HealthTrust Purchasing Group
Consorta
Inc. and HealthTrust Purchasing Group LP, two of the nation’s
leading healthcare group purchasing organizations, today
finalized the agreement that establishes Consorta as the sixth
equity owner in HealthTrust.
The
combination of the two companies creates the nation’s fourth
largest group purchasing organization (GPO), with more
than $13 billion in combined volume. According to John W.
Strong, Consorta’s president and chief executive officer,
during the first five years of the partnership, Consorta
forecasts that the combination will provide shareholders and
members with $535 million in cost savings, via price
reductions and broader coverage afforded by HealthTrust’s
portfolio. All 12 Consorta shareholders are participating in
the combination, along with Consorta affiliates.
“We are
very pleased to have these outstanding Consorta shareholders
and affiliates as new members of HealthTrust,” said Jim
Fitzgerald, president of HealthTrust. “While it validates our
unique model and value-proposition, I'm even more excited
about the potential to strengthen our competitive
position. We’ll refresh all of our contracts over the next 18
months, delivering added value to all HealthTrust members.”
HealthTrust will be responsible for all GPO Operations,
including contracting. Consorta will remain an independent
organization, serving as its shareholders’ voice on the
HealthTrust Board of Advisors, and on HealthTrust clinical
advisory boards to guide product selection. Consorta will also
provide educational and analytical programs and manage member
compliance for its shareholders.
Decrease in breast cancer incidence
linked to drop in hormone replacement
A special report in the April 19, 2007 edition of The New
England Journal of Medicine concludes that the sharp
decline in breast-cancer incidence in 2003, followed by a
relative stabilization at a lower rater in 2004, is most
likely related to the first report of the Women’s Health
Initiative (WHI) (JAMA 2002; 288:321-333. Risks and benefits
of estrogen plus progestin in healthy postmenopausal women…)
and the ensuing drop in hormone-replacement therapy among
postmenopausal women. The report shows that the age adjusted
incidence rate of breast cancer in women in the United States
fell sharply by 6.7% in 2003, as compared with the rate in
2002. Data from 2004 showed a leveling-off relative to the
2003 rate with little additional decrease. The decrease was
evident only in women who were 50 years of age or older and
was more evident in cancers that were estrogen-receptor
(ER)-positive than in those that were ER-negative. The
reports’ lead author is Peter Ravdin, M.D., of the Anderson
Cancer Center, and included investigators from the National
Cancer Institute and the Los Angeles Biomedical Research
Institute at Harbor-UCLA Medical Center (LA BioMed). Rowan
Chlebowski, MD, PhD, a principal investigator/oncologist at LA
BioMed, and the only researcher to participate in the 2002
reports of the trial evaluating estrogen plus progestin (which
led to the decrease in menopausal hormone therapy use in 2003)
and the 2006-07 studies outlining the subsequent decrease in
breast cancer, states: “While the cause of the reduction is
not definitive, the sustained decrease in new breast cancer
diagnosed in the U.S. is a remarkable event. We estimate
44,000 fewer breast cancers over those two years (2003-04) and
thousands more in the coming decades.”
Researchers looked at several variables that could be
responsible for such a decline. They looked for flaws in the
data itself, changes in reproductive factors, changes in
mammographic screening, changes in environmental exposures,
changes in diet, and changes in use of hormone-replacement
therapy. Only the use of hormone-replacement therapy changed
substantially, with the total number of prescriptions for the
two most commonly prescribed forms of hormone-replacement
therapy in the U.S., Premarin and Prempro, having their
steepest declines starting in 2002 and particularly in 2003
(62 million scripts in 2000, 61 million in 2001, 47 million in
2002, 24 million in 2003, 21 million in 2004, and 18 million
in 2005). The reduction of hormone-replacement therapy could
have caused a decreased incidence of breast cancer by direct
hormonal effects on the growth of occult breast cancers, a
change that would have affected predominantly ER-positive
tumors. The rapidity of the change suggests that clinically
occult breast cancers stopped progressing or even regressed
soon after the discontinuation of the therapy. The hypotheses
is that hormone withdrawal can rapidly influence the growth of
breast cancer is supported by anecdotal reports of regression
of breast cancer after discontinuation of hormone replacement
therapy.

1,000 extra ovarian cancer deaths due to
HRT in UK since 1991
A suspected 1,000 extra women in the UK have died from ovarian
cancer between 1991 and 2005 because they were using Hormone
Replacement Therapy (HRT), according to an article published
online and in an upcoming edition of The Lancet. There
were also around 1,300 extra cases of ovarian cancer diagnosed
in the same period. The figures are reported in the “Million
Women Study” by Professor Valerie Beral and colleagues, of the
Cancer Research UK Epidemiology Unit, Oxford, UK. Ovarian
cancer is the fourth most common cancer in UK women, with
about 6,700 developing the condition and 4,600 dying from it
every year. The researchers assessed data from 948,576
postmenopausal women who did not have previous cancer or
bilateral oophorectomy (removal of the ovaries) for five
years. Around 30% were current HRT users and 20% had
previously received HRT. 2,273 women developed ovarian cancer
and 1,591 died from it. They found that current HRT users were
on average 20% more likely to develop and die from ovarian
cancer than those who had never received HRT. For every 1,000
women using HRT, 2.6 developed ovarian cancer over five years,
compared to 2.2 per 1,000 in women who did not use HRT, one
extra ovarian cancer diagnosed in every 2,500 HRT users, and
one extra death from ovarian cancer in every 3,300 users. But
risk did not differ significantly by type of HRT preparation
used, its constituents, or mode of administration.
The women’s
socioeconomic status, reproductive history, previous use of
oral contraceptives, body-mass index, alcohol and tobacco
consumption did not appreciably alter the effect of HRT on
their risk of developing ovarian cancer. The researchers also
reported that after women stop taking HRT, their risk of
ovarian cancer returns to that found in never-users of HRT. In
total, ovarian, endometrial and breast cancer account for
around 40% of all cancers diagnosed in UK women. The authors
conclude: “The effect of HRT on ovarian cancer should not be
viewed in isolation, especially since use of HRT also affects
the risk of breast and endometrial cancer.” They add: “The
total incidence of these three cancers in the study population
is 63% higher in current users of HRT than never users. Thus
when ovarian, endometrial and breast cancer are taken
together, use of HRT results in a material increase in these
common cancers.” In an accompanying comment, Dr. Steven Narod,
of the Women’s College Research Institute, University of
Toronto, Canada, said: “Use of hormone replacement has
declined dramatically in the UK and elsewhere since the report
of the Women’s Health Initiative, and is thought to be
responsible for a recent reduction in breast cancer rates
recorded in the US. “With these new data on ovarian cancer, we
expect the use of HRT to fall further. We hope that the number
of women dying of ovarian cancer will decline as well.”

Republicans block Medicare drug price bill
Senate Republicans blocked legislation yesterday that would have
allowed the federal government to negotiate Medicare drug
prices, denying Democrats a victory on their 2006 election vow
to lower prescription costs for senior citizens. “We’ll have
plenty of additional chances,” said Sen.
Ron Wyden
(D-OR), a supporter of the bill. “This is not the end of the
debate.” Democrats needed a 60-vote majority to start debate
on the measure, but lost 55 to 42. Democratic leaders had low
expectations for victory. For one, they faced formidable
opposition from the pharmaceutical and health insurance
industries, two of the most powerful lobbying forces on
Capitol Hill.
But the benefit also has gained wide popularity, costing
consumers and the government far less than initially
projected. Republicans in particular who had been skeptical
about the benefit now acknowledge its success and are
reluctant to tamper with it. Currently, more than 22 million
seniors
and disabled people receive drug coverage under Medicare. The
Senate legislation would have allowed the government to
directly negotiate with drug companies to secure lower prices
for medications. But an independent Congressional Budget
Office analysis found that the proposal would not result in
cheaper drugs unless Congress modified the program, possibly
restricting access and choice for beneficiaries. (Washington
Post)

WSJ: Pediatric ICUs make headway against
infection
For the sickest infants and children, pediatric intensive-care
units provide the highest level of medical care, treating
children after complicated surgeries, severe illness or
accidents. But the very catheters, intravenous lines and
invasive medical procedures used to keep children alive are
also putting them at higher risk of bacterial infection. Now,
with mounting alarm about the high rate of hospital-acquired
infections, critical-care specialists are taking new steps to
protect the smallest and most vulnerable patients, challenging
the prevailing wisdom that infections are simply inevitable in
a busy and stressful intensive-care environment. The nonprofit
National Association of Children’s Hospitals and Related
Institutions, with 208 member hospitals in the U.S. and
overseas, is leading an ambitious effort to eradicate
bloodstream infections, the most severe infectious threat in
pediatric ICUs. In the first six months of the three-year
project, 29 participating hospital units have slashed
infection rates by close to 70% by adhering to a rigid set of
measures shown to prevent infection in children, including far
more rigorous care of catheters, higher sterile precautions,
and constant assessment of the need for keeping catheters in
place. Pediatric intensive-care units also are adopting new
programs to sharply reduce or eliminate urinary-tract
infections for children with bladder catheters, and pneumonia
for children on ventilators, the two most prevalent
complications after bloodstream infections.
While
infections have always been a risk for hospital patients of
every age, experts say that children may be at even higher
risk than adults. Until now, though, prevention efforts have
focused largely on adults, and measures that are known to
prevent infection in children aren’t always consistently used,
experts say. Over the past few years, hospital bugs have
become increasingly resistant to common antibiotics, striking
two million patients and claiming 100,000 lives annually.
There are no precise statistics on how many of those deaths
are infants and children. But a review of published literature
last month in the journal Pediatric Critical Care by
Jana Stockwell, a pediatric critical-care physician at
hospital operator Children’s Healthcare of Atlanta, concluded
that infections can strike as many as 16% of children in
pediatric units, a higher rate than in many adult ICUs, and
increase the risk of death by up to 20%. Studies also show
that treating an infection can add nearly $40,000 in
additional hospital costs. “These kids are at incredible risk
for infection, with thin skins that provide a poor barrier to
infection and immature or severely compromised immune
systems,” said Paul Sharek, chief clinical patient-safety
officer for Lucille Packard Children’s Hospital at Stanford
University, which has made reducing catheter-related
infections its No. 1 goal for the past two years. Even though
the steps for preventing infections are fairly routine, he
adds, “it’s easier said than done, and involves massive
cultural shifts” for medical staff who are used to handling
medical procedures their own way.
Catheters
are a big focus of such efforts because they require an
invasive procedure that could allow bacteria to enter the
body. Nachri’s bloodstream-infection prevention effort is
relying on so-called “bundles” of catheter insertion and
maintenance protocols that have already been shown to save
lives and costs. Children’s Healthcare Corp. of America, a
supply-purchasing cooperative of 42 children’s hospitals,
pilot-tested the bundles in 2005. The goal was to cut
bloodstream infections by 50%, to 1.5 infections per 1,000
catheter days. About two-thirds of the 28 participating
hospitals were able to reduce infections by an average of 57%,
which Barbara Spreadbury, a vice president at CHCA, estimates
saved 112 children’s lives, and nearly $1 million in potential
treatment costs. The aim now is to test a more comprehensive
set of measures over a longer period and get them adopted as
standard procedure, according to Mary Gorman, a vice president
overseeing the project at Nachri. (Source: The Wall Street
Journal) To read the original article see
THIS LINK.
US critical care delivery system in
critical condition
The demand for critical care services in the United States
will soon outpace the supply of specialists trained in
intensive care, a situation that, if not remedied, may prove
fatal for critically ill patients. The solution to this
problem lies not in recruiting and training more personnel,
but in reorganizing the critical care system nationwide,
according to a report from a group of critical care
stakeholders, led by University of Pittsburgh School of
Medicine researchers and published in the April issue of the
journal Critical Care Medicine. “The number of
Americans over the age of 65 is expected to double by 2030. In
addition to non-elective medical admissions for critical
illness among chronically ill elders, the growth rate in
elective surgical procedures requiring intensive care unit
admission, such as bypass surgery, is growing fastest among
this age group,” said Amber E. Barnato, M.D., M.P.H., M.Sc.,
assistant professor, department of medicine, University of
Pittsburgh School of Medicine. “All of this means more and
more people will demand already strained intensive care
services. This anticipated mismatch between supply and demand
is perhaps no different for critical care services than for
other medical care disproportionately serving elders, ranging
from emergency services to long-term care services, but the
opportunities for improving the efficiency of the existing
system to meet demand are probably greater.”
The report, developed following a meeting of critical care
stakeholders called the Prioritizing the Organization and
Management of Intensive care Services (PrOMIS) Conference held
in September 2005, calls for creation of a tiered,
regionalized system for critical care services in an effort to
centralize expertise, equipment and facilities. This would
make the necessary critical care services readily available to
the patients who are most in need. “Prior conferences aimed at
addressing this problem sought input only from critical care
professionals, who are a fraction of all the stakeholders,”
said Dr. Barnato, lead author of the report. “These groups
often stated the need for more trained providers. Surveying a
wider group of interested parties, we found that this isn’t
necessarily the best or only solution.”
For the PrOMIS Conference, organizers attempted to identify
problems in the current U.S. critical care system as seen by
all stakeholders, including those from professional
organizations, critical care and non-critical care physicians,
federal and private health insurers, federal and private
funding organizations, and the general public. In the paper,
researchers say the primary concern voiced by participants was
that the “utilization, organization and management of
intensive care services in the United States was not optimal.”
They broadly agreed that there was a need to regionalize and
tier the critical care system, similar to what previously had
been done by the U.S. trauma system. Such a system would
require the most critically ill patients to be seen in
top-level critical care centers. Lower-level centers would not
provide ongoing critical care services, but would need to
transfer critically ill patients to higher-level centers.
Participants also cited the need to acknowledge that some
critical care services should be provided by physicians, such
as hospitalists and emergency physicians, who currently are
not certified by the existing critical care boards. Conference
organizers hope that critical care societies will support a
second stakeholder meeting, PrOMIS II, charged with developing
concrete accreditation criteria for the proposed regionalized
tiered system, defining explicit triage and quality
surveillance criteria for each tier, developing a
comprehensive set of core competencies for critical care
providers and endorsing a method to train and certify critical
care providers in these competencies.

Women weighed down by health care costs,
new study finds
As Cover
the Uninsured Week approaches, a new Commonwealth Fund report
by researchers at the National Women’s Law Center finds that
even women with health insurance coverage are more likely than
insured men to go without needed healthcare because of costs.
Also, a higher percentage of women than men struggle with
medical bills. The report, “Women and Health Coverage: The
Affordability Gap,” by Elizabeth M. Patchias and Judith G.
Waxman of the National Women’s Law Center finds that women are
at a disadvantage because they have greater healthcare needs
and lower incomes than men. More specifically, the report
finds that 38% of women are struggling with medical bills
compared with 29% of men. And, the high cost of healthcare
services and premiums is forcing many women, even women with
health insurance, to go without needed care. In fact, 33% of
insured women and 68% of uninsured women don’t get the
healthcare they need because they can’t afford it. In
contrast, 23% of insured and 49% of uninsured men are avoiding
care because of cost. Further, 16% of women are underinsured,
meaning they have high out-of-pocket costs compared to their
income, while only 9% of men are underinsured.
“Women are more likely than men to go without needed
healthcare services because of costs, yet they still have
higher out-of-pocket expenses. This disparity exists for both
insured and uninsured women,” said Waxman, vice president for
Health and Reproductive Rights at the National Women’s Law
Center. “As policymakers and advocates explore how to expand
and improve health coverage, they should ensure that any
proposal provides comprehensive benefits and low
cost-sharing.” Other factors contribute to this gender gap in
healthcare coverage and access: women are slightly more likely
than men to purchase coverage in the individual insurance
market which is often more expensive and less comprehensive
than employer coverage. Women are also more likely than men to
take prescription drugs. “These findings show that
comprehensive healthcare coverage that doesn’t require high
out-of-pocket costs is vital to ensuring that women get the
care they need to be healthy,” said Sara Collins, assistant
vice president for the Program on the Future of Health
Insurance at The Commonwealth Fund.
To view the report see THIS
LINK.
Difficult births in obese women due to uterus
failure
In a study of 4,000 pregnant women, researchers found that
almost 1 in 5 overweight women had to undergo an emergency
Caesarean Section birth because the muscles in their uterus
failed. The research suggests obesity impairs the ability of
the uterus to contract sufficiently in order to dilate the
cervix and deliver the baby. The team from the University of
Liverpool’s Physiology department found that obese women were
3.5 times more likely to require a Caesarean for slow labor
than normal weight women. Obese women who gave birth vaginally
were also found to encounter other problems in child birth,
more than twice as many (6%) experienced excessive bleeding
following delivery compared with normal weight women (3%).
This blood loss was also attributed to poor uterine activity
in the obese group.
Professor Sue Wray, said, “Our research shows overweight women
are at considerably higher risk of having to undergo an
emergency Caesarean Section birth and find labor a more
difficult experience than normal weight women. Interestingly,
when we took uterus muscle samples from the overweight women
and studied them in the lab they also performed poorly and
contracted less well than matched samples from normal weight
women.” The research team found that less calcium was able to
enter the uterine cells of the obese women to support uterus
muscles in contracting during labor. Professor Wray explained:
“We suspect one reason preventing sufficient levels of calcium
entering the uterus muscles is the high levels of cholesterol
in an obese woman’s bloodstream. This could disrupt cell
membranes and signaling pathways, including calcium entry. We
will be investigating this further in future studies.” Dr.
Siobhan Quenby from the University of Liverpool’s Obstetrics
department commented: “In the meantime it is vital
pre-pregnancy advice and counseling is available to women
about the implications of weight on childbirth. Pregnancies
among overweight women must be classified as high risk
pregnancies and appropriate antenatal care should be provided
so they receive the optimum care during maternity.”

April 18, 2007
FDA approves first U.S. vaccine for humans
against
the avian influenza virus H5N1
UGA study suggests that lowering blood
pressure following stroke
may reduce damage
New research shows that flu is a trigger of
heart attacks
For-profit dialysis centres may be
over-treating anemia
Long Island Chapter for Central Service honors
Parseghian
as “Kathi O’Shaughnessy Tech of the Year”
FDA seizes all medical products from NJ
device manufacturer
for significant manufacturing violations
U.S. Food and Drug Administration (FDA) investigators and U.S.
Marshals today seized all implantable medical devices from
Shelhigh Inc., Union, NJ, after finding significant
deficiencies in the company’s manufacturing processes. The
deficiencies may compromise the safety and effectiveness of
the products, particularly their sterility. The products
include pediatric heart valves and conduits, surgical patches,
dural patches, annuloplasty rings and arterial grafts. The
tissue-based devices are used in many surgical settings,
including open heart surgery in adults, children and infants,
and to repair soft tissue during neurosurgery and abdominal,
pelvic and thoracic surgery. Critically ill patients,
pediatric patients and immuno-compromised patients may be at
greatest risk from the use of these devices.
Shelhigh’s violations include: manufacturing products in a
facility with a poorly constructed and poorly maintained clean
room where sterilized devices are further processed; failing
to adequately monitor critical manufacturing environments for
possible microbial contamination; failing to properly test
products for sterility and fever-causing contaminants; and
failing to scientifically support product expiration dates.
Physicians should consider using alternative devices.
Physicians should also monitor patients with a Shelhigh
implant for infections and proper device functioning over the
expected lifetime of the device. Patients who think they may
have received a Shelhigh device during surgery should contact
their physician for more information. FDA will issue a
Preliminary Public Health Notification to physicians and other
health care professionals and a Preliminary Advice for
Patients shortly with more information; those documents will
be posted to FDA’s Web site. The seizure follows an FDA
inspection of the Shelhigh manufacturing facility last fall,
as well as meetings with the company at which FDA warned
Shelhigh that failure to correct its violations could result
in an enforcement action. FDA also alerted the company to its
manufacturing deficiencies and other violations in two warning
letters.
Medical
devices manufactured by Shelhigh include: Shelhigh Pericardial Patch;
Shelhigh No-React Pericardial Patch; Shelhigh No-React PneumoPledgets;
Shelhigh No-React VascuPatch; Shelhigh No-React Tissue Repair Patch/UroPatch;
Shelhigh Pulmonic Valve Conduit No-React Treated; Shelhigh No-React Dura
Shield; Shelhigh BioRing (annuloplasty ring); Shelhigh No-React EnCuff
Patch; Shelhigh No-React Stentless Valve Conduit; Shelhigh Internal Mammary
Artery; Shelhigh Gold perforated patches; Shelhigh Pre Curved Aortic Patch
(Open); Shelhigh NR2000 SemiStented aortic tricuspid valve; Shelhigh
BioConduit stentless valve; Shelhigh NR900A tricuspid valve; Shelhigh
MitroFast Mitral Valve Repair System; Shelhigh BioMitral tricuspid valve;
and Shelhigh Injectable Pulmonic Valve System.

FDA approves first U.S. vaccine for humans against the
avian influenza virus H5N1
The U.S. Food and
Drug Administration (FDA) announced the first approval in the United States
of a vaccine for humans against the H5N1 influenza virus, commonly known as
avian or bird flu. The vaccine could be used in the event the current H5N1
avian virus were to develop the capability to efficiently spread from human
to human, resulting in the rapid spread of the disease across the globe.
Should such an influenza pandemic emerge, the vaccine may provide early
limited protection in the months before a vaccine tailored to the pandemic
strain of the virus could be developed and produced.
The vaccine was
obtained from a human strain and is intended for immunizing people 18
through 64 years of age who could be at increased risk of exposure to the
H5N1 influenza virus contained in the vaccine. H5N1 influenza vaccine
immunization consists of two intramuscular injections, given approximately
one month apart. The manufacturer, sanofi pasteur Inc., will not sell the
vaccine commercially. Instead, the vaccine has been purchased by the federal
government for inclusion within the U.S. Strategic National Stockpile for
distribution by public health officials if needed. The vaccine will be
manufactured at sanofi pasteur's Swiftwater, PA, facility.
A clinical study
was conducted to collect safety information and information on recipient’s
immune responses and to determine the appropriate vaccine dose. The vaccine
was generally well tolerated, with the most common side effects reported as
pain at the injection site, headache, general ill feeling and muscle pain.
The study showed that 45 percent of individuals who received a 90 microgram,
two-dose regimen developed antibodies at a level that is expected to reduce
the risk of getting influenza. Although the level of antibodies seen in the
remaining individuals did not reach that level, current scientific
information on other influenza vaccines suggests that less than optimal
antibody levels may still have the potential to help reduce disease severity
and influenza-related hospitalizations and deaths.
With the support of
FDA, the U.S. National Institutes of Health and other government agencies,
sanofi pasteur and other manufacturers are working to develop a next
generation of influenza vaccines for enhanced immune responses at lower
doses, using technologies intended to boost the immune response. Meanwhile,
the approval and availability of this vaccine will enhance national
readiness and the nation’s ability to protect those at increased risk of
exposure. For more information see
www.pandemicflu.gov.

UGA
study suggests that lowering blood pressure following stroke
may reduce damage
A new University of
Georgia study suggests that commonly prescribed drugs used to lower blood
pressure may help reduce brain damage when given within 24 hours of a
stroke. The finding, based on a study using rats and published in the April
issue of the Journal of Hypertension, may ultimately revolutionize
emergency stroke care by putting blood pressure-lowering medications
alongside clot-busting drugs and blood thinners as front-line medications.
“There is a long-standing controversy about whether you should even treat
elevated blood pressure in stroke victims,” said lead author Susan Fagan,
professor of clinical and administrative pharmacy at the UGA College of
Pharmacy and the Medical College of Georgia. “We were able to show that
lowering blood pressure in the 24 hours following a stroke can reduce brain
damage.”
Fagan and her team
induced strokes in rats by occluding a major artery in the brain. After
three hours, the suture was removed to simulate the effect of thrombolytic,
or clot-busting, drugs. The rats were then given one of two common blood
pressure lowering drugs or, for the control group, a saline solution. When
the researchers measured the amount of brain damage, they found that the
rats that had received the blood pressure lowering drugs fared significantly
better. While the control group showed damage in 50 percent of the brain,
those receiving the drugs hydralazine and enalapril showed 30 percent
damage.
The finding
complements a study Fagan and her colleagues published last year in the same
journal that found similar reductions in brain damage using the common blood
pressure drug, candesartan, a popular drug in the class known as angiotensin
receptor blockers (ARBs). The rats given candesartan, however, showed the
additional benefit of improved function while the rats receiving the other
blood pressure medications had less benefit. Fagan said that in addition to
protecting the brain and blood vessels through lowering blood pressure, ARBs
appear to provide additional benefits by blocking the damaging effects of
angiotensin II, a molecule released from the brain and probably other
tissues following stroke.
Many physicians
believe that elevated blood pressure following a stroke is necessary to keep
oxygenated blood at the site of the blockage. Now that there is convincing
evidence that lowering blood pressure can be beneficial after stroke, Fagan
is working on a protocol for a human clinical trial that would identify what
patient characteristics predict a good response to blood pressure lowering.
“There are probably some patients that can benefit a great deal by having
their blood pressure lowered within that first 24 hours after a stroke,”
Fagan said. “Our challenge now is identifying those patients.”

New research shows that flu is a trigger of heart attacks
Doctors need to take
concerted action to ensure that people who are at risk of heart disease
receive the influenza vaccine every autumn, according to the authors of a
new report published in the European Heart Journal. Their research
shows that influenza epidemics are associated with a rise in deaths from
heart disease and that flu can actually trigger the heart attacks that
result in death. However, only about 60% of people in the US who ought to
have a flu shot actually have one and this percentage is even smaller in
Europe, said Professor Mohammad Madjid, the lead author of the report. “Our
research has shown that influenza epidemics are associated with a rise in
coronary deaths. This calls for more intensive efforts to increase the
vaccination rate in people at risk of coronary heart disease. This may be
especially important in an influenza pandemic when we would expect to see
high mortality amongst the elderly and those suffering from heart problems
or who have multiple coronary risk factors,” he said. “Between 10 and 20% of
people catch flu every year, and I have estimated that we can prevent up to
90,000 coronary deaths a year in the US if every high risk patient received
an annual flu vaccination.”
Madjid, who is
assistant professor of medicine at the University of Texas-Houston, and a
senior research scientist at the Texas Heart Institute in Houston, worked
with colleagues in the US and in St. Petersburg in the Russian Federation to
investigate deaths between 1993 and 2000 in St. Petersburg that had been
shown by autopsy reports to be due to coronary heart disease. “This was a
population where only a small minority were receiving flu vaccines or statin
drugs, so this enabled us to see what happened naturally in the absence of
these medicines,” said Madjid. “Relying on autopsy reports rather than death
certificates enabled us to be much more accurate about the cause of death,
because doctors often neglect to list flu on a death certificate if their
patients have died from a heart attack and, conversely, heart attack
symptoms can be missed in patients suffering from flu and pneumonia.”
They found that 11,892
people died from acute myocardial infarction (AMI) (47.8% men and 52.2%
women), and 23,000 died from chronic ischaemic heart disease (IHD) (40.1%
men and 59.9% women). The peaks in deaths from both AMI and IHD coincided
with the times when influenza epidemics and acute respiratory disease (ARD),
which often accompanies flu, were at their height. They found that the
chances of dying from AMI increased by a third in epidemic weeks, compared
to non-epidemic weeks, and the chances of dying from IHD increased by a
tenth. This was the same for both men and women and in different age groups.
Researchers believe that flu causes an acute and severe inflammation in the
body, which, in some patients, can destabilize atherosclerotic plaques in
coronary arteries and cause heart attacks.
Madjid said: “Most
people develop atherosclerotic lesions in their coronary arteries in early
childhood and these lesions grow over time. Inflammation plays a pivotal
role in development and growth of these lesions. Most people in Western
countries live with different stages of atherosclerosis and many will never
show any clinical manifestations of the atherosclerosis. However, in some
patients the quiescent, stable atherosclerotic plaques undergo sudden
changes, mainly due to exaggerated inflammation, leading to rupture of these
vulnerable plaques and subsequent formation of clots resulting in heart
attacks. This study shows that flu is an important trigger of heart attacks
because flu is a severe infection, with high incidence rates and is readily
preventable.” Madjid pointed out that the implications of the research were
even more important with a looming flu pandemic when a much higher
percentage of the population could be expected to catch the illness.


For-profit dialysis centres may be over-treating
anemia
In a new US study, scientists suggest that large for-profit kidney dialysis
chains in the US give patients more anti-anemia drugs and aim for higher
hemoglobin levels than nonprofit centres. Giving patients too much
anti-anemia drugs can put their lives at risk. The study is published in the
Journal of the American Medical Association (JAMA). Epoetin (marketed
as Epogen and Procrit) is prescribed to kidney patients as part of their
dialysis treatment, depending on how anemic they are and the level of
hemoglobin their doctor is aiming to get them to. In the US as well as
hospital-based dialysis facilities there are independently owned profit
based facilities that claim back expenses for patient treatment, including
anti-anemia epoetin, from Medicare. Epoetin therapy is the single largest
Medicare drug expenditure for dialysis-related anemia, accounting for 1.8
billion dollars of expenditure in 2004, said the study authors. The
researchers used data from the US Renal Data System and found 159,522 adult
Medicare-eligible, end-stage renal disease patients who were receiving
hemodialysis at various centres during November and December 2004. They
analyzed the data using statistical regression models to examine the mean
epoetin dose and dose adjustment by profit, chain, and affiliation status of
the centres that patients attended.
The researchers found that: Dosing of epoetin varied significantly depending
on organizational status and ownership of the kidney dialysis centre. The
106,116 patients who attended large for-profit dialysis centres were
consistently administered the highest doses of epoetin compared with 28,199
patients who attended nonprofit centres, regardless of how anemic they were.
A typical hospital-based centre administered an average dose of 16,188 units
per week of epoetin, while for-profit chain centres administered an average
dose of 20,838 units a week. On average, for-profit centres gave patients an
average dose of 3,306 units a week more than non-profit dialysis centres.
The greatest difference in dosing practice patterns between centres was
found among patients with hematocrit levels of less than 33 percent. On
average, compared with nonprofit centres, for-profit centres increased
epoetin doses 3-fold for patients with hematocrit levels of less than 33
percent. Among the 6 large chain facilities with a similar patient case-mix,
the average dose of epoetin ranged from 17,832 units per week at chain 5
(nonprofit facilities with a mean hematocrit level of 34.6 percent) to
24,986 units per week at chain 2 (for-profit facilities with a mean
hematocrit level of 36.5 percent).
The researchers concluded that: “Dialysis facility organizational status and
ownership are associated with variation in epoetin dosing in the United
States. Different epoetin dosing patterns suggest that large for-profit
chain facilities used larger dose adjustments and targeted higher hematocrit
levels.” The authors expressed concern that overprescription of epoetin was
taking place in the for-profit centres. In an accompanying editorial (Use of
Epoetin in Chronic Renal Failure), Dr Daniel Coyne, professor of medicine at
Washington University School of Medicine, in St. Louis, said that the
authorities disagree on what the optimal level of hemoglobin in the blood
should be. For example, the US Food and Drug Administration (FDA), recommend
the maximum level of blood hemoglobin should be under 12 grams per decilitre
(12 g/dl). But, this compares with 13 g/dl, the maximum level recommended by
the National Kidney Foundation, which Dr. Coyne says is about to revise its
guidelines. In his view, because of recent clinical trials, Dr. Coyne thinks
the 12 g/dl limit is safer.
Experts reacting to this study suggest that changing the way for-profit
dialysis centres are reimbursed by Medicare (currently they are paid for
doing dialysis and giving the anemia drugs separately) to a composite system
would be a better way to do it and would remove the incentive that is tied
to the drug on its own. Administrators of for-profit dialysis centres say
that the decision on which dose and guideline to follow is under the control
of the patient’s doctor. The FDA has recently issued warnings for epoetin
and another similar drug darbepoetin which is used to treat cancer patients
with anemia. Too much hemoglobin is dangerous because it increases the risk
of heart attacks, strokes and blood clots. (Medical News Today)

Long Island Chapter for Central Service honors Parseghian as “Kathi
O’Shaughnessy Tech of the Year”
The Long Island Chapter for Central Service is honored to recognize Charles
Parseghian as the recipient of the prestigious “Kathi O’Shaughnessy Tech of
the Year Award”, sponsored by Healthmark Industries Company Inc.
O’Shaughnessy was one of the leaders of this Chapter for many years and held
most all positions on the Board of Directors. Her commitment to education in
the field of Central Service was paramount. She knew that our profession was
getting more technical with all the advancements in Medicine and that we
would as technicians have to step up to the plate or be left out. She
traveled all over the country with this mission. O’Shaughnessy lost her
battle to cancer last October but never gave up her fight. It’s with this
spirit that The Long Island Chapter for Central Service recognizes and
applauds Parseghian on his career goals.

HHS
issues report to Congress on e-prescribing
In a report to Congress, HHS Secretary Michael Leavitt announced the results
of an electronic prescribing pilot project that support the adoption of new
electronic prescribing standards. These standards, required by the Medicare
Modernization Act of 2003, would help cut both medication errors and health
care costs. “Electronic prescribing improves efficiencies while helping to
eliminate potentially harmful drug interactions and other medication
problems,” Secretary Leavitt said. “It also solves the problem of
hard-to-read handwritten prescriptions. Additionally, such health
information technologies promote affordability by allowing physicians to
know which medications are covered by their patients’ Part D plans.”
The pilot project demonstrated that three initial standards are already
capable of supporting e-prescribing transactions in Medicare Part D. These
are standard transactions that provide physicians with patients’ formulary
and benefit information, medication history, and the fill status of their
medications. The report also found that, with some adjustments,
e-prescribing can work successfully in long-term care settings. Some of the
initial e-prescribing standards tested by the pilot project were found to
have potential but still need further development if they are to be adopted
as e-prescribing standards. These include standards used to convey
structured patient instructions, a terminology to describe clinical drugs,
and messages that convey prior authorization information. Five pilot sites
operating in eight states tested initial standards to determine if they were
ready for widespread adoption. Those pilot sites were Achieve Healthcare
Information Technologies, LLP, Eden Prairie, MN; Brigham and Women’s
Hospital, Boston, MA; Rand Corporation, Santa Monica, CA; SureScripts, LLC,
Alexandria, VA; and University Hospitals Health System, Cleveland, OH. For
more information see THIS LINK.
April 17, 2007
MedAssets to expand revenue cycle suite
offering
with agreement to acquire XactiMed
FDA announces recommendations to reauthorize
medical device
user fee program
Geisinger launches extensive study on obesity and related
liver problem
Study shows hope for early diagnosis of
Alzheimer's
FDA urgently warns consumers about health
risks
of potentially contaminated olives
SPSmedical introduces new catalog
Rampage strains area hospitals
BLACKSBURG, VA, April 17 -- Four hospitals in this rural area
of southwestern Virginia were swamped Monday after the
Virginia Tech shooting rampage sent more than two dozen
victims to emergency rooms, with the first arriving here at a
regional medical center about 7:30 a.m. “I don’t know if you
can ever be prepared for this type of violence,” Scott Hill,
chief executive officer of Montgomery Regional Hospital, said
Monday night. Hill said that extra nurses and an additional
surgeon were called in to help treat more than a dozen
patients sent to the 146-bed hospital. “We certainly had a lot
of patients and extra help to deal with the situation,” Hill
said. “We were in constant communication with police, so we
knew what was coming.”
Hospital officials kept friends and family members sequestered
away from the news media. William Brady, an emergency medicine
professor at the University of Virginia, said that the total
number of gunshot wounds would swamp any hospital, especially
those in rural areas with limited resources. “If it’s a single
hospital or two hospitals, it could certainly paralyze the
hospital,” he said. “It can really slow a hospital down.” He
said gunshot wounds pose special challenges. (Washington Post)

MedAssets to expand revenue cycle suite offering with
agreement to acquire XactiMed
MedAssets Inc. and XactiMed Inc. announced today, they entered into an
agreement whereby MedAssets will acquire XactiMed, a provider of web-based
revenue cycle technologies and services to the healthcare industry. The
agreement, which is expected to be finalized in May, will expand the
offering of MedAssets Net Revenue Services to include claims management,
remittance management, denial management solutions, and an array of revenue
cycle services and consulting.
Based in Richardson, TX, XactiMed is ranked number one in KLAS for Claims
Management in 2006. The company also offers Medicare direct claims
processing, accounts receivable collections and denials management with more
than 350 hospitals and provider organizations as clients. The addition of
XactiMed’s solutions with the MedAssets Net Revenue Systems’ portfolio will
offer healthcare providers an integrated suite of technologies and services
to improve accuracy in their revenue cycle processes, improve accounts
receivable days outstanding, increase charge capture, speed collections and
improve compliance. MedAssets’ current revenue cycle offerings include
chargemaster management, charge capture auditing, defensible pricing,
denials management, as well as supply item file and chargemaster linkage.
“This agreement will provide us with more resources to solve our customer’s
revenue cycle issues,” said Neil Hunn, president of MedAssets Net Revenue
Systems. “XactiMed’s solutions and services will complement as well as
expand MedAssets’ revenue cycle suite, allowing us to provide an integrated,
comprehensive offering to help healthcare providers improve their net
revenue by improving business processes around billing and collections.
MedAssets continues to remain fully committed to the development of an
integrated, end-to-end revenue cycle solution”.

FDA announces recommendations to reauthorize medical
device user fee program
The U.S. Food and Drug
Administration (FDA) proposed recommendations to Congress for reauthorizing
the Medical Device User Fee and Modernization Act (MDUFMA II), which, if
adopted, would help to ensure that safe and effective medical devices get to
patients in a timely manner. FDA is accepting public comments on the
proposal for the next 30 days and is holding a public meeting on April 30.
Under the medical device user fee program, industry covers a portion of the
costs of FDA’s pre-market review program through a variety of fees. The fees
are used in concert with the agency’s annual appropriations to help FDA meet
its review performance goals, which would speed more promising products to
market than before. The industry user fees represent less than a quarter of
the overall device budget for MDUFMA II. MDUFMA II would provide industry
with predictable and more stable fees because the amount for each type of
fee for each year of the program would be prescribed in the statute.
Manufacturers would continue to pay fees when they submit applications for
some types of medical device applications, but at a lower rate than under
the current program. The proposal would also provide for additional fees. A
fee would be assessed on facilities that register with FDA as a medical
device manufacturer. In addition, annual report filing fees would be
collected for pre-market approvals.
Small businesses, a significant portion of device manufacturers, would see
additional benefits under the proposal. The fees currently paid by
businesses with $100 million or less in annual sales or receipts would be
reduced from 80 percent of the full fee in the first device user fee program
to 50 percent for 510(k) applications, and from 38 percent to 25 percent for
pre-market approvals and related supplement fees. FDA would continue to
waive the fee for all first-time pre-market approval applications for
businesses with $30 million or less in annual sales or receipts. In
addition, the proposal would allow a mechanism for foreign businesses to
qualify as small businesses.
To achieve greater transparency, FDA would continue to foster interactive
review by encouraging informal communication with companies; facilitate the
timely scheduling of informal and formal meetings; expand the kinds of
performance information FDA makes available to the public; enhance
opportunities for stakeholders to provide input into guidance document
development; facilitate the development of guidance to streamline the
processes and to clarify the data requirements for the approval or clearance
of imaging devices that use contrast agents or radiopharmaceuticals. The
proposal would streamline the third party inspection program, which allows
for the use of accredited private sector auditors for routine inspections,
by making it easier for manufacturers to participate in the program. MDUFMA
II would foster the development of innovative in vitro diagnostic tests by
issuing new industry guidance on important emerging issues and reviewing
some low-risk devices to determine whether any of them could be exempted
from the need for product review. In addition, FDA would conduct a pilot
program under which the agency would review simultaneously a company's
510(k) and waiver applications under the Clinical Laboratory Improvement
Amendments, the law that governs quality standards for all laboratory
testing.
To view the notice
CLICK
HERE. To submit electronic comments on the proposal, visit
www.regulations.gov or
www.fda.gov/dockets/ecomments. For more information see
THIS LINK.

Geisinger launches extensive study on obesity and related
liver problem
Relying on one of the largest collections of liver tissue samples ever
acquired by a single organization, Geisinger Health System researchers have
embarked on a massive study of one of the fastest growing liver problems.
Nonalcoholic fatty liver disease starts with the accumulation of fat on the
liver, which leads to inflammation and scarring. It can progress to the
point of permanent liver damage and lead to the potentially fatal cirrhosis.
If the damage becomes too great, a liver transplant may be needed. Linked to
America’s increasing obesity problem, doctors have predicted a steep
increase in the coming years. The disease is asymptomatic in its early
stages and many people don’t know they have it initially.
Geisinger Health
System is leveraging several key system resources in an effort to develop a
simple blood test to diagnose the disease. Early detection would likely help
patients better manage the disease and could even save lives. Yet a major
obstacle needs to be cleared first. Right now, the only way to definitely
diagnose the disease is through a liver biopsy. However, biopsies can pose
health risks because of the potential for bleeding from the liver or for
infection. The goal is to develop a noninvasive blood test for the disease
and then bring it to market so other physicians can use it, said Geisinger
staff scientist Glenn S. Gerhard, MD. To that end, Geisinger is uniquely
positioned to develop such a test because of the array of resources the
system has at its disposal. Geisinger has collected more than 600 liver
tissue and blood samples donated from patients who have undergone bariatric
weight loss surgery. “Nonalcoholic fatty liver disease hasn’t really been
studied, in part, because investigators can’t get access to samples,”
Gerhard said.
The federal government
estimates that the disease affects 2 to 5 percent of Americans, while
another 10 to 20 percent of the population has fat in their liver, but no
inflammation or liver damage. As part of the project, investigators from the
Weis Center for Research, the Center for Health Research, the Center for
Nutrition and Weight Management, and the Department of Surgery are combing
through Geisinger’s $80 million Electronic Health Record to learn why some
obese and overweight people develop nonalcoholic fatty liver disease and
similar problems.
“We need to look at
what causes this disease and how we can treat it,” Gerhard said. A liver
transplant costs about $370,000 on average, while bariatric surgery costs
$40,000 in Pennsylvania, depending on the negotiated rate with the person’s
health plan. (These costs are not what the patient pays, but the average
costs for the provider.)

Study shows hope for early diagnosis of Alzheimer's
Research by faculty
and staff at Rowan University, Glassboro, NJ; the University of Pennsylvania
School of Medicine; and Drexel University may lead to better diagnosis of
early-stage Alzheimer’s disease. In a $1.1-million National Institutes of
Health’s National Institute on Aging study that team members conducted
during the last three years, they determined early Alzheimer’s could be
diagnosed with a high rate of accuracy evaluating electroencephalogram (EEG)
signals. The study may lead to an earlier diagnosis, and therefore earlier
treatment and improved quality of life, for people at the earliest stages of
the disease. Rowan University electrical and computer engineering associate
professor Dr. Robi Polikar conducted the research with Dr. Christopher
Clark, associate professor of neurology, associate director of the NIH-sponsored
Alzheimer's Disease Center at Penn and director of the Penn Memory Center,
and with Dr. John Kounios, a Drexel psychology professor. “Individuals in
the earliest stage of Alzheimer’s disease are often not aware of their
progressing memory loss, and family members often believe the changes are
simply due to aging,” Clark said. “Even the patient’s personal physician may
be reluctant to initiate an evaluation until a considerable degree of brain
failure has occurred. The advantage of using a modified EEG to detect these
early changes is that it is non-invasive, simple to do, can be repeated when
necessary and can be done in a physician’s office. This makes it an ideal
method to screen elderly individuals for the earliest indication of this
common scourge of late life.”
The teams conducted
several experiments, ultimately evaluating the parietal and occipital
regions of the brains of 71 patients, some already diagnosed with
Alzheimer’s and some without Alzheimer’s. Their diagnostic accuracy rate was
82 to 85 percent using the EEGs (e.g., it matched evaluations conducted at
Penn 82 to 85 percent of the time). Alzheimer’s disease cannot be confirmed
until a patient has died and his or her brain has been examined. Gold
standard tests administered at world-class research facilities, such as
Penn, have a 90-percent accuracy rate. However, most people are evaluated at
community hospitals and clinics, where the diagnostic accuracy is estimated
to be around 75 percent. Though the study’s accuracy rate is under that
90-percent figure, it still means the test potentially could have great
value to physicians and patients and their families, and the results are
particularly significant for patients who have limited access to teaching
hospitals, where they may undergo six to 12 months of evaluation for a
diagnosis. The team members hope that eventually they or other researchers
will develop a hand-held device that can be used to conduct similar
evaluations as those done by the Rowan/Penn//Drexel group. “We don’t
envision this replacing a neurologist,” Polikar said. “We hope it can serve
as a first test for those folks who don’t have access to research
facilities.” If the initial test indicates a possible problem, physicians
could refer the patient to a research hospital for further evaluation.

‘Live’ Web Cast Opportunity to see computer-assisted knee replacement
surgery
On Wednesday, April 18 at 4:00 PM EDT (20:00 UTC/GMT) web viewers will have
a unique opportunity to witness a “live” total knee replacement surgical
procedure that employs a state-of-the-art Computer-Assisted Surgery (CAS)
system from ORTHOsoft Inc. ORTHOsoft is an international company that
develops and markets software applications, instruments and computerized
medical systems that help improve the accuracy of knee, hip and spine
procedures. The “live” Web cast will originate from Tampa General Hospital
(Tampa, FL). Kenneth Gustke, M.D., founding member of the American
Association of Hip and Knee Surgeons, will perform the total knee
replacement surgery. The procedure will be narrated by Steven Lyons, M.D.,
surgeon at the Florida Orthopaedic Institute. CAS, such as with ORTHOsoft
Navitrack(R) Navigation Systems, provides surgeons immediate instrument
alignment and implant placement feedback. With CAS, hip, knee, and ankle
replacement adjustments surgeons can have a perfect alignment rate up to 98
percent. The prime benefit for patients when surgeons use CAS is shorter
post-surgery recovery time. To see the “live” procedure on the Internet
visit
http://www.gettingbackontrack.com and click on the Web cast link on the
right side of the home page. For more information about ORTHOsoft's
Navitrack Navigation System see THIS LINK.

FDA urgently warns consumers about health risks
of potentially contaminated olives
The U.S. Food and Drug Administration (FDA) is alerting consumers to
possible serious health risks from eating olives that may be contaminated
with a deadly bacterium, Clostridium
botulinum. C. botulinum
can cause botulism, a potentially fatal illness. The olives are made by
Charlie Brown di Rutigliano & Figli S.r.l, of Bari, Italy and are being
recalled by the manufacturer. No illnesses have been reported to date in
connection with this recall. The olives should not be eaten alone or in
other foods, even if they do not appear to be spoiled. Consumers should
discard these products or return them to the point of purchase. If in doubt,
consumers should contact the retailer and inquire whether its olives are
part of the recall.
The olives are sold under the following brands: Borrelli, Bonta di Puglia,
Cento, Corrado's, Dal Raccolto, Flora, Roland and Vantia, and have codes
that start with the letter “G” and are followed by 3 or 4 digits. All sizes
of cans, glass jars and pouches of Cerignola, Nocerella and Castelvetrano
type olives are affected. Symptoms of botulism include general weakness,
dizziness, double vision, trouble with speaking or swallowing, difficulty in
breathing, weakness of other muscles, abdominal distension and constipation.
People experiencing these symptoms should seek immediate medical attention.
Consumers may also report illnesses associated with consumption of these
olives to the nearest FDA district offices. Charlie Brown di Rutigliano &
Figli S.r.l, initiated a recall of these olives on March 27, 2007. The
recalled olives had been distributed to wholesalers, who have marketed them
nationally to restaurants and retail stores. FDA concluded that additional
warnings are needed because, to date, the company has not contacted
importers with specific instructions on the recall. Consumers with questions
may contact Charlie Brown Company at 011-039-080-7839073 or
charliebrownbari@yahoo.com.

SPSmedical introduces new catalog
SPSmedical introduces a redesigned 2007 catalog featuring sterilization
products, services and educational programs. This new catalog segments
sterilization products & services by sterilization process (Steam, EO Gas,
Gas Plasma, Peracetic Acid, Dry Heat and Chemical Vapor). SPSmedical is the
largest sterilizer testing laboratory in N. America and sells a
comprehensive line of sterility assurance products including biological
indicators, chemical indicators, integrators, bowie-dick test packs,
packaging and recordkeeping products. GPO’s and the Federal Government have
contracted for SPSmedical products, which are available through authorized
distributors worldwide. Contact SPSmedical at 1-800-722-1529 or
info@spsmedical.com for a FREE catalog and more information.
April 16, 2007
Staph
aureus infection rates on the rise in
U.S.
hospitals
Rhode Island
Hospital
study identifies high-risk patient populations for MRSA
carriage
Rare case of dental patient-to-patient
hepatitis B virus transmission recorded
Jani-King approves healthcare cleaning system
Independent healthcare research leader
announces new name:
ECRI Institute
Healthcare providers to benefit from Amerinet’s
agreement with Med1Online
CMS proposes payment reforms for
inpatient hospital services in 2008
The
Centers for Medicare & Medicaid Services (CMS) issued a
proposed rule that takes steps to improve the accuracy of
Medicare’s payment under the acute care hospital inpatient
prospective payment system (IPPS), while providing additional
incentives for hospitals to engage in quality improvement
efforts. The payment reforms include a proposal to restructure
the inpatient diagnosis related groups (DRGs) to account more
fully for the severity of the patient’s condition. In
addition, the proposed rule includes provisions to ensure that
Medicare no longer pays hospitals for their additional costs
of hospital-acquired conditions (including infections), and
includes an expanded list of publicly reported quality
measures. The proposed rule would also reduce payment for a
DRG involving the implantation of a device, when a hospital
replaces a device and the replacement is supplied to the
hospital at no or reduced cost. Medicare’s inpatient rates for
operating expenses will increase by 3.3 percent in FY 2008 for
those hospitals that report quality data to CMS. Overall, the
proposed rule is estimated to increase payments to more than
3,500 acute care hospitals by $3.3 billion.
The
proposed rule would create 745 new severity-adjusted diagnosis
related groups (DRGs) (Medicare Severity DRGs or MS-DRGs) to
replace the current 538 DRGs. Projected aggregate spending
from the reforms will not change. However, payments would
increase for hospitals serving more severely ill patients and
decrease for serving patients who are less severely ill. CMS
is proposing to revise the current DRGs so that the system
will continue to be based upon a non-proprietary case mix
system making it available to the public. By more accurately
recognizing the costs of caring for a patient, the new MS-DRGs
will further reduce incentives for hospitals to “cherry pick,”
the practice of treating only the healthiest and most
profitable patients. They also address concerns that specialty
hospitals may selectively provide such profitable services.
For FY
2008, CMS is proposing to adopt a high cost outlier threshold
of $23,015, down from $24,475 in FY 2007. By better
recognizing severity of illness in the DRGs, fewer cases would
be paid as outliers. However, CMS proposed to lower the
outlier threshold to meet the legal requirement to continue
paying between 5 and 6 percent of payments as outliers. The
proposed rule recommends changes to the way Medicare pays for
hospital capital-related costs based on an analysis that
showed substantial positive margins experienced by some
hospitals.
The proposed rule would add five new quality measures, which
would bring to 32 the number of measures hospitals would need
to report in FY 2008 in order to qualify for the full market
basket update in FY 2009.
The proposed
rule would require physician-owned hospitals to disclose such
ownership to patients and provide the names of the physician
owners upon request. The proposed rule would also
require physician-owned hospitals to require physician owners
who are members of the hospital’s medical staff to disclose
their ownership to the patients they refer to the
hospital. Disclosure would be required at the time of
referral. The proposed rule would require a hospital to notify
all patients in writing if a doctor of medicine or doctor of
osteopathy is not present in the hospital 24 hours a day,
seven days per week, and describe how the hospital will meet
the medical needs of a patient who develops an emergency
condition while no doctor is on site.
Under
the proposed rule, hospitals would be paid during 2008 based
on a blend of one-third list charge-based weights and
two-thirds hospital cost-based weights for the DRGs. In 2009,
hospitals would be paid 100 percent based on cost-based DRG
weights. Comments on the proposed rule will be accepted until
June 12, 2007 and a final rule, to be effective for discharges
on or after October 1, 2007, will be published later in the
summer. To read the press release see
THIS LINK.
For fact sheets on the
proposed rule see
THIS LINK or
THIS LINK

Staph aureus infection rates on the rise in
U.S.
hospitals
Findings presented at the Society of Healthcare Epidemiology
of America annual meeting further demonstrate that there has
been a significant increase in Staphylococcus aureus
(commonly referred to as Staph aureus) infection rates
among patients in U.S. hospitals, resulting in longer
hospitalizations and millions of dollars of excess healthcare
costs. Researchers analyzed more than 45 million hospital
discharge records and found that from 1998 to 2003 the
prevalence of Staph aureus infection among all patients
increased at an annual rate of 7.1 percent. The problem grew
even faster among surgical patients; the rate of Staph aureus
infection rose 7.9 percent each year for all
surgical stays and 9.3 percent each year for orthopedic
patients.
The
studies, which were funded by 3M Health Care, were conducted
by lead investigator Dr. Gary Noskin, Associate Professor of
Medicine at the Feinberg School of Medicine, Northwestern
University and Associate Chief Medical Officer at Northwestern
Memorial Hospital. “Staph aureus causes a wide range of
infections, from mild skin infections to life-threatening
blood stream infections,” said Angela Dillow, PhD, Global
Business Manager, 3M Medical Diagnostics. “Identifying the
bacteria and reducing its spread in hospitals is crucial to
improving patient outcomes, and these findings underscore the
need to control these infections.” Prior to surgery, about
one-third of patients carry Staph aureus in the nose,
but do not have an infection. It is only if the bacteria enter
other parts of the body, through a surgical incision, for
example, that they can result in a serious infection.
The
researchers also presented findings on the economic impact of
Staph aureus infections in hospitals and found that
from 1998 to 2003 the economic burden among all Staph aureus-related
inpatient stays increased from $8.7 billion to $14.5 billion,
an annual increase of 11.9 percent. The costs of Staph aureus
for invasive cardiovascular stays and invasive neurological
stays rose at 12.4 percent a year and 13.5 percent a year,
respectively. “These findings clearly demonstrate the
considerable economic implications of Staph aureus
infections for hospitals nationwide,” said Dr. Gary Noskin.
“It suggests that there could be large cost savings associated
with aggressive efforts to prevent patients from becoming
infected with these bacteria.”
Another abstract submitted by Dr. Noskin and colleagues at the
meeting examined the economic benefit of screening for Staph
aureus from nasal samples. The study showed rapid
pre-admission testing for nasal Staph aureus and subsequent
colonization suppression of carriers resulted in an average
annual cost savings of approximately $519 million for U.S.
hospitals. Researchers analyzed data from the 2003 Nationwide
Inpatient Sample and published literature. Primary input
variables included the marginal effect of Staph aureus
infection on expenditures, prevalence of nasal Staph aureus
carriage, sensitivity and specificity of the rapid Staph
aureus screening device, efficacy of nasal Staph aureus
colonization suppression and cost data. “Rapid, pre-admission
testing of patients could help hospitals better identify
patients that are colonized with Staph aureus and in the
appropriate setting attempt to decolonize them to help reduce
the risk of infection and control costs,” said Dillow.

Rhode Island
Hospital
study identifies high-risk patient populations for MRSA
carriage
A study
presented Saturday at the Society for Healthcare Epidemiology
of America (SHEA) annual meeting found that patients in
long-term elder care and HIV-infected outpatients appear to be
high-risk groups for carriage of methicillin-resistant
Staphylococcus aureus (MRSA), a common cause for
healthcare associated infections. “MRSA can be spread in the
healthcare environment and community and can cause serious
infections,” said lead investigator Leonard Mermel, MD, medical director, department of epidemiology & infection
control,
Rhode
Island Hospital.
“Identifying patient populations that have a high risk of MRSA
carriage is important in our efforts to control the spread of
this microbe among patients.”
In the prospective, multi-center trial, which was funded by 3M
Health Care, clinical nasal swabs were collected from various
patient groups at 11 U.S. sites, including inpatients screened
for MRSA through active surveillance, inpatients and
outpatients requiring hemodialysis, inpatients and outpatients
with HIV-infection, pre-op cardiac surgery patients and
patients admitted from long-term elder care. Among patients at
facilities that did not regularly screen for MRSA, prevalence
of MRSA was highest in patients admitted from long-term care
(18 percent) and HIV-infected outpatients (17 percent),
suggesting these patient populations are at especially high
risk of MRSA carriage. In addition, this trial is the first to
look at the quantity of MRSA in the nares of different patient
populations. Currently, the standard method to detect carriage
of MRSA is by routine culture whereby results can take several
days.
Delayed results can lead to MRSA transmission since potential
MRSA carriers are often not isolated from patients without
MRSA until these results are available.

Rare case of dental patient-to-patient
hepatitis B virus transmission recorded
Researchers have documented a case of hepatitis B virus (HBV)
transmission between two patients at a dentist’s office in the
United States. While this kind of infection is exceedingly
rare, universal vaccination against the virus would likely
have prevented both cases, according to the authors of the
report and an accompanying commentary. Both appear in the May
1 issue of The Journal of Infectious Diseases, now
available online. The case report, by John T. Redd, MD, MPH,
and colleagues from the Centers for Disease Control and
Prevention (CDC) and the New Mexico Department of Health,
describes the index patient as a sexually inactive 60-year-old
woman with no history of intravenous drug use or other
potential exposures to HBV who had undergone multiple tooth
extractions on a single office visit. A cross-match of the
state’s Hepatitis B Registry identified the source patient: a
36-year-old woman who had had teeth extracted hours earlier on
the same day in the same office by the same surgeon and
assistants, and receiving the same medications as the index
patient. No evidence of HBV infection was found in any member
of the office staff. Blood tests indicated that the source
patient had had chronic HBV infection with a high viral load
at the time of oral surgery.
Genetic analysis showed that virus of the same genotype and
subtype was isolated from both patients, and that the isolates
had identical DNA sequences in a sampled region. Medical
records and blood tests of 25 patients operated on after the
source patient showed that 16 (64 percent) were vaccinated and
immune to HBV. “I was pleasantly surprised by the high
prevalence of immunity,” commented Dr. Redd. “It may have
helped to limit spread of the virus.” When investigators
visited the office and monitored its operation they found all
staff members followed standard infection control practices.
The investigators could only speculate that there might have
been a lapse in clean-up procedures after the source patient,
leaving an area contaminated with her blood. HBV infection has
long been a concern in dental infection control. The
blood-borne pathogen is hardy, persisting in dried blood on
surfaces for a week or more. It can be present even in the
absence of visible blood. With routine vaccination against the
virus in
U.S. dental
healthcare personnel over the last two decades, the incidence
of HBV infection in this high-risk group has dramatically
fallen, and no cases of dentist-to-patient HBV transmission
have been reported in the U.S. since 1987. This is the only
known case of patient-to-patient transmission in a dental
setting.
The authors
concluded that the case underscored the need for meticulous
maintenance of blood-borne pathogen infection control for all
patients in dental settings. They also said that it reinforced
the value of universal childhood HBV vaccination, which has
been recommended in the U.S. since 1991. In an accompanying
editorial, Ban Mishu Allos, MD, and William Schaffner, MD, of
Vanderbilt University School of Medicine, noted that adults
account for most new cases of HBV infection in the United
States, and that current recommendations based on such risk
factors as sexual activity and intravenous drug use have
resulted in meager vaccination rates. “Fewer than 10 percent
of young adults with high-risk behaviors have received HBV
vaccine,” they said. In contrast, the incidence of HBV
infection in children has been dramatically reduced by
universal vaccination policies, and surgeon- and
dentist-to-patient transmissions of the infection were
essentially eliminated with routine vaccination of healthcare
workers.

Premier healthcare alliance launches
‘green’ best-practices Web site
To help
more hospitals share best practices for developing “green”, or
environmentally sound, programs, the Premier Safety Institute
recently launched a new public Web site, “Green Corner.”
Located at
www.premierinc.com/greencorner, the site showcases
hospital and supplier success stories about “green”
initiatives that contribute to a safer, healthier community
environment. Stories are categorized under major topics, such
as energy savings and waste reduction, making it easy for
hospitals to find specific information on programs of
interest. “Going green” not only is a smart way for hospitals
to protect the environment, it also allows them to reduce
operational costs, gain a competitive advantage and keep staff
and patients satisfied.
“‘Green Corner’ provides a valuable resource for healthcare
professionals seeking anecdotes about how their peers in the
hospital industry are tackling important community
environmental issues, both simple and complex,” said Gina
Pugliese, RN, vice president of the Premier Safety Institute.
Pugliese noted that such information can provide an important
starting point for projects whose ultimate goal is to reduce
waste, save money and protect a community's quality of life
both now and for future generations.
The new site also complements the Safety Institute’s free,
electronic newsletter, “Green
Link,” that highlights the latest news on “green”
healthcare practices and purchasing. In addition, “Green
Corner” expands the
Premier Environmentally Preferable
Purchasing (EPP) program’s public suite of
offerings, which currently includes electronic tools to
support critical environmental efforts such as mercury
pollution prevention and computer recycling. Premier’s EPP
program, a collaboration of the Safety Institute and Premier's
group purchasing program, supports the efforts of members and
the industry-at-large to enhance the safety and health of
patients, healthcare workers and the environment. For example,
on behalf of hundreds of hospitals and the communities they
serve, the EPP program recently secured purchasing agreements
with Dell and Gateway for computers and electronic devices
that address significant environmental concerns regarding the
manufacturing, use and end-of-life disposal and/or recycling
of electronics.

Jani-King approves healthcare cleaning
system
After more
than one year of research and testing, Jani-King International
has partnered with Rubbermaid to officially implement a
color-coded microfiber cleaning and disinfecting system into
its standard environmental services program. Jani-King, a
commercial cleaning franchise company, worked with Rubbermaid,
a provider of high efficiency environmental services
equipment, in order to adapt best practices, procedures and
techniques for cleaning and disinfecting in a healthcare
environment.
“For patients with weakened or susceptible immune systems,
there is nothing more dangerous than increased bio load on
healthcare surfaces,” said Mark Regna, Director of Healthcare
at Jani-King International. “We labored for over a year
testing and analyzing the Rubbermaid equipment and recommended
procedures. What we have proven is that microfiber technology
is highly effective in disinfecting surfaces while the use of
a color-coded cleaning system greatly reduces the risk of
cross transmission.” Jani-King has already implemented this
new cleaning and disinfecting standard into its healthcare
certificate program. According to Regna, every Jani-King
franchise owner and all environmental service staff must
receive a healthcare certificate of completion by Jani-King
prior to servicing a healthcare account. For more information
see THIS LINK

Independent healthcare research leader
announces new name: ECRI Institute
Renewing
its mission to research best approaches to improve patient
care, nonprofit healthcare research organization today
announces its new name: ECRI Institute. The independent
organization, formerly known as ECRI, unveils its new logo,
with the tagline “The Discipline of Science. The Integrity of
Independence.” The organization’s redesigned public Web site
offers improved navigation and enhanced content. This
rebranding process is the first for the independent nonprofit
founded in 1968. For more information see
THIS LINK

Healthcare providers to benefit from
Amerinet’s agreement with Med1Online
Amerinet Inc. announces
its agreement with Med1Online for customized medical equipment
management services. Effective April 1, 2007, through March
30, 2010, this contract provides cost-saving opportunities to
Amerinet members on asset recovery, new and used equipment
sales, repair/service/extended warranties, internal exchange
program (through a customized Extra-Net system), inventory and
appraisal services, and equipment planning. Med1Online, LLC
(Med1Online), is a re-seller of capital medical equipment.
Incorporated in 2002, Med1Online has become a worldwide
distributor of both new and used medical equipment. For more
information, see THIS
LINK
April 13, 2007
CDC report highlights growing foodborne
illness challenges;
E. coli O157, Salmonella, Vibrio cause concern
CDC changes recommendations for gonorrhea
treatment due to
drug resistance; Few treatment options remain
Major genetic study identifies clearest link
yet to obesity risk
Materials managers invited to attend
Healthcare Supplier & Provider
Institute meeting for free; New Provider Only
session
Needle guidance now available for Siemens’ new
high-density transducer
RF Technologies offers free Sensatec bed and
chair alarms
as part of trade-in program
Hire
Heroes program launched to place veterans with
disabilities
in healthcare jobs
Hire Heroes, a program designed to help veterans with
disabilities find careers in the healthcare industry, was
launched today by Health Careers Foundation, a non-profit
healthcare education organization. The announcement was
made during the general session of the MedAssets’
Healthcare Business Summit in Las Vegas, NV. MedAssets is
one of a number of healthcare companies providing funding
to Health Careers Foundation. As part of the Health
Careers Foundation, Hire Heroes will help veterans
returning from Operation Iraqi Freedom and Operation
Enduring Freedom with any level of disability as
determined by the United States Department of Veterans
Affairs. “Through Health Careers Foundations’ connections
within the healthcare industry, the Hire Heroes program
will help thousands of our veterans with disabilities
throughout our nation,” said Clayton Shepherd, chief
executive officer, Health Careers Foundation. “By adding
these honorable veterans to the healthcare industry, they
will be able to continue to serve and to make a
difference.”
Hire
Heroes will identify veterans with disabilities who are seeking career
placement services by working with transition centers and VA rehabilitation
centers. Each applicant will be qualified and screened to determine career
interests, job skills and location preferences. Additionally, Hire Heroes
will work with potential employers by contacting interested healthcare
companies to identify suitable positions for the veterans. Companies hiring
veterans are eligible for a tax credit of $4,800 per hired
hero and
are entitled to a tax deduction for donations made to the program. The cost
of ongoing operations will be covered by employer donations of $6,000 for
each hired hero. Hire Heroes’ goal is to place more than 8,000 heroes in
jobs within the healthcare industry in the first three years of operation.
The program start date is June 1. Efforts are underway to raise the
necessary operating funds to make this program a success.
“Our
mission is to be the bridge to the right healthcare career fit for our
returning heroes,” said Bayne Tippins, director, Hire Heroes. “Currently,
there is a shortage of employees in the healthcare field. Hire Heroes will
help to ease this shortage as well as ease the transition from military to
civilian life.” The Hire Heroes program was inspired by the experiences of
Justin Callahan, who served as a Sergeant in the U.S. Army during Operation
Iraqi Freedom and is now a corporate event planner for MedAssets. While
undergoing treatment at Walter Reed Army Medical Center, Callahan met John
Bardis, chairman, president and CEO of MedAssets, by chance in a hotel
lobby. Bardis extended a job offer to Callahan that day, and Justin has been
a MedAssets’ employee since he officially retired from the military three
years ago. Callahan’s experiences raised awareness and understanding of the
challenges veterans with disabilities may face when re-entering and
adjusting to the workplace, which led to the creation of Hire Heroes. “This
program gives guys a chance to start a new life and really opens paths for
them,” Callahan said. “It is more than helping them out with a job. It’s
about helping them grow stronger mentally and emotionally to have a more
normal life.” To learn more about the Hire Heroes organization, please visit
www.hireheroesusa.org,
or contact Bayne Tippins, Director, Hire Heroes, 1-866-915-HERO.

CDC report highlights growing foodborne illness
challenges; E. coli O157, Salmonella, Vibrio cause concern
A report released Thursday by the Centers for Disease Control and Prevention
(CDC) shows a leveling of cases for some foodborne infections after a period
of decline. For others, incidences of infection which had declined appear to
be returning to earlier levels. The findings are from 2006 data reported to
the CDC as part of the agency’s Foodborne Diseases Active Surveillance
Network (also known as FoodNet). FoodNet monitors foodborne disease and
related epidemiologic studies to help health officials better understand the
epidemiology of foodborne diseases in the United States.
Camplylobacter, Listeria, Shigella and Yersinia show a sustained decline in
incidence compared to baseline data from 1996-1998, but most of the decrease
occurred between 1999 and 2002. The FoodNet data showed there continues to
be little change in the incidence of Salmonella cases, and progress made in
2003 and 2004 in reducing the number of cases of with E. coli O157
infections has been lost. Vibrio infections, which are often related to the
consumption of raw shellfish like oysters, have increased to the highest
level since FoodNet began conducting surveillance. The 2006 FoodNet data
indicated that the incidence of infections caused by E. coli O157 and
Salmonella was similar to 1996-1998 baseline years.
The reasons
for the lack of decrease in the incidence of infections caused by E. coli
O157 and Salmonella are not fully understood. One possible explanation is
the development of cases of disease in foods that previously were not
associated with these diseases, such as spinach and peanut butter. Previous
efforts to decrease the incidence of E. coli O157 in ground beef and
Salmonella in eggs have been successful, but contamination of other foods
may be the problem now, according to Dr. Robert Tauxe, deputy director of
CDC’s Division of Foodborne, Bacterial and Mycotic Diseases.
Consumers can reduce their risk for foodborne illness by following safe
food-handling recommendations and by avoiding the consumption of
unpasteurized milk, raw or undercooked oysters, raw or undercooked eggs, raw
or undercooked ground beef, and undercooked poultry. The risk for foodborne
illness can also be decreased by choosing in-shell pasteurized eggs,
irradiated ground meat, and high pressure-treated oysters. The report
appears in the April 13 Morbidity and Mortality Weekly Report at THIS LINK
http://www.cdc.gov/mmwr/. To learn more about FoodNet, see THIS LINK
http://www.cdc.gov/foodnet/.

CDC changes recommendations for gonorrhea treatment due
to drug resistance; Few treatment options remain
The Centers for Disease Control and Prevention (CDC) no longer recommends
antibiotics known as fluoroquinolones (ciprofloxacin, ofloxacin, and
levofloxacin) as a treatment for gonorrhea in the United States. This limits
the options available to treat gonorrhea, one of the most common sexually
transmitted diseases in the U.S. The recommendation was prompted by new data
released today in CDC’s Morbidity and Mortality Weekly Report (MMWR) showing
that fluoroquinolone-resistant gonorrhea is now widespread in the United
States among heterosexuals and men who have sex with men (MSM). The data
showed the proportion of drug-resistant cases among heterosexuals rising
above the recognized threshold of 5 percent for changing treatment
recommendations. CDC had recommended fluoroquinolones no longer be used to
treat gonorrhea in MSM when this threshold was crossed in earlier years.
The new data, from CDC’s Gonococcal Isolate Surveillance Project (GISP) in
26 U.S. cities, showed that among heterosexual men, the proportion of
gonorrhea cases that were fluoroquinolone-resistant Neisseria gonorrhoeae (QRNG)
reached 6.7 percent in the first half of 2006, an 11-fold increase from 0.6
percent in 2001. Recommended options for treating gonorrhea are now limited
to a single class of antibiotics known as cephalosporins. Public health
officials believe the lack of treatment options underscores the need for
accelerated research into new drugs, as well as increased efforts to monitor
for emerging drug resistance, especially to cephalosporins. While
significant resistance to cephalosporins has not been observed to date, CDC
is working with state and local health departments to monitor emerging
cephalosporin resistance. CDC is urging health departments to maintain or
develop capacity to perform cultures for Neisseria gonorrhoeae and to assess
any gonorrhea treatment failures for possible resistance. In addition, CDC
is working with the World Health Organization to strengthen international
efforts to monitor for the emergence of cephalosporin resistance and with
government and industry partners to identify and evaluate promising new drug
regimens.
The new CDC analysis shows an increase in the past five years in the overall
proportion of gonorrhea cases that are fluoroquinolone-resistant, from less
than 1 percent in 2001 to 13.3 percent in the first half of 2006. The
analysis also indicated that fluoroquinolone resistance is widespread
geographically. Resistant cases were seen across the U.S. in the first half
of 2006 (in 25 of the 26 cities in the analysis), and sharp increases
occurred from 2004 to 2006 in several cities, including Philadelphia (from
1.2 percent to 26.6 percent of gonorrhea cases) and Miami (from 2.1 percent
to 15.3 percent). The analysis showed QRNG continued to rise among MSM; 38
percent of MSM gonorrhea cases were QRNG in the first half of 2006, compared
to 1.6 percent in 2001. Within the class of cephalosporins, CDC now
recommends ceftriaxone, available as an injection, the preferred treatment
for all types of gonorrhea infection. For more information CLICK HERE
http://www.cdc.gov/std/gonorrhea/arg/

Major genetic study identifies clearest link yet to
obesity risk
Scientists have
identified the most clear genetic link yet to obesity in the general
population as part of a major study of diseases funded by the Wellcome
Trust, the UK’s largest medical research charity. People with two copies of
a particular gene variant have a 70% higher risk of being obese than those
with no copies. Scientists from the Peninsula Medical School, Exeter, and
the University of Oxford first identified a genetic link to obesity through
a genome-wide study of 2,000 people with type 2 diabetes and 3,000 controls.
This study was part of the Wellcome Trust Case Control Consortium, one of
the biggest projects ever undertaken to identify the genetic variations that
may predispose people to or protect them from major diseases. Through this
genome-wide study, the researchers identified a strong association between
an increase in BMI and a variation, or “allele”, of the gene FTO. Their
findings are published online in the journal Science. The researchers
then tested a further 37,000 samples for this gene from Bristol, Dundee and
Exeter as well as a number of other regions in the UK and Finland. The study
found that people carrying one copy of the FTO allele have a 30% increased
risk of being obese compared to a person with no copies. However, a person
carrying two copies of the allele has a 70% increased risk of being obese,
being on average 3kg heavier than a similar person with no copies. Amongst
white Europeans, approximately one in six people carry both copies of the
allele.
“As a nation, we are
eating more but doing less exercise, and so the average weight is
increasing, but within the population some people seem to put on more weight
than others,” explains Professor Andrew Hattersley from the Peninsula
Medical School. “Our findings suggest a possible answer to someone who might
ask ‘I eat the same and do as much exercise as my friend next door, so why
am I fatter?’ There is clearly a component to obesity that is genetic.” The
researchers currently do not know why people with copies of the FTO allele
have an increased BMI and rates of obesity. “Even though we have yet to
fully understand the role played by the FTO gene in obesity, our findings
are a source of great excitement,” said Professor Mark McCarthy from the
University of Oxford. “By identifying this genetic link, it should be
possible to improve our understanding of why some people are more obese,
with all the associated implications such as increased risk of diabetes and
heart disease. New scientific insights will hopefully pave the way for us to
explore novel ways of treating this condition.”
“This is an exciting
piece of work that illustrates why it was so important to sequence the human
genome,” said Dr. Mark Walport, Director of the Wellcome Trust. “Obesity is
one of the most challenging problems for public health in the UK. The
discovery of a gene that influences the development of obesity in the
general population provides a new tool for understanding how some people
appear to gain weight more easily than others. This discovery, along with
further results expected from the Wellcome Trust Case Control Consortium
later this year, will open up a wealth of new avenues to understand and
treat common diseases.”

F.D.A. rejects Merck’s new pain medication
A panel of federal drug advisers voted 20 to 1 Thursday to reject an
application by Merck to sell its pain pill Arcoxia because of concerns that
the drug could cause as many as 30,000 heart attacks annually if widely
used.
Food and Drug
Administration officials were unusually harsh in their criticism
of the medicine. “What you’re talking about is a potential public health
disaster” if Arcoxia is approved for sale, Dr. David Graham, an F.D.A.
safety officer, told the panel. Arcoxia is a sister to Vioxx, which Merck
withdrew in 2004 after a study showed that it also increased the risks of
heart attacks and strokes. Merck sells Arcoxia in 63 countries, and the
company underwrote an extensive safety testing program that involved 34,000
arthritis
patients. The studies showed that Arcoxia caused nearly three times as many
heart attacks, strokes and deaths as naproxen, a popular pain pill sold as
Aleve, but was no more effective in curing pain. Patients taking Arcoxia
suffered worrisome increases in
blood pressure.
A Merck spokeswoman, Kyra Lindemann, said the company was “disappointed in
today’s outcome.” “We continue to believe that Arcoxia has the potential to
become a valuable treatment option,” Lindemann said, adding that Merck would
continue to sell the drug outside the United States. (The New York Times)

Materials managers invited to attend Healthcare Supplier
& Provider Institute meeting for free; New Provider Only session
Materials managers are invited to attend the Third Annual Healthcare
Supplier & Provider Institute meeting, to be held April 23-24 in Dallas, TX,
at the Gaylord Texan Resort and Hotel.
The meeting is free to all providers.
New this year is the “Healthcare Provider Only” meeting taking place on the
first day, April 23 at 1:00 p.m. This professionally moderated session, with
material managers only, will address current strategies, results and lessons
learned from each of the participants. Nationally recognized Dr. Gene
Schneller, Professor and Director of the Health Sector Supply Chain
Initiatives at the W. P. Carey School of Business at Arizona State
University, will also participate, presenting and accepting questions
regarding his current research. There is limited space available for this
free provider only offering, so those interested in participating should
contact Harla Adams at 817-842-2331 or
hadams@nihcl.com.
By
attending the meeting you will have the opportunity to hear from provider
executives from Baylor Healthcare System, Community Health Network, Excela
Health, Sentara Healthcare, St. David’s, Iowa Health System, North
Mississippi Health Services, Northwestern Memorial Hospital and Universal
Health Services Inc. You will also hear from executives from Ascent
Healthcare Solutions, KCI, GE Healthcare, Owens & Minor, Consorta,
MedAssets, Novation and Premier. For more information CLICK HERE
http://www.healthcaresupplierinstitute.com/.To register CLICK HERE
http://www.healthcaresupplierinstitute.com/html/registration.html.

Needle guidance now available for Siemens’ new high-density transducer
CIVCO
Medical Solutions announces the release of its newest needle guidance system
for Siemens, the 17L5 HD. The ergonomic 17L5 HD multi-angle needle guidance
system is designed to work in conjunction with biopsy software on Siemens
ACUSON Sequoia ultrasound platform to provide detailed imaging of small
parts, breast, and subtle pathologies. CIVCO’s needle guidance systems
utilize a two-part system consisting of a custom reusable biopsy bracket and
a disposable snap-on needle guide. Together, these tools offer physicians
reduced technique variability, providing a shorter learning curve and
reduced procedure time. This needle guidance system is designed to increase
the productivity of ultrasound-guided procedures including tissue biopsy,
fluid aspirations and catheter placement. In addition, the single-use design
of the Ultra-Pro II needle guide reduces the risk of cross-contamination and
increases patient throughput.
The Ultra-Pro II
needle guide now incorporates more flexibility and advanced features to
increase productivity during ultrasound-guided procedures. The needle guide
directs instruments according to on-screen software guidelines and features
a larger tab for improved quick-release function, allowing easy detachment
of the needle from the transducer. Easy-to-read gauge sizes on the inserts
make it simple to identify and alter gauge sizes in a darkened ultrasound
suite. The guide now features a larger funnel for instrument insertion and
will accept a full range of needle sizes including: 8.5FR, 14-23GA.
Multi-angle brackets offer professionals different angles for needle
placement. Once the desired angle has been selected, a stainless steel pin
locks the angle securely into position. For more information see THIS LINK
http://www.civco.com/index.

RF Technologies offers free Sensatec bed and chair alarms
as part of trade-in program
Healthcare facilities
can trade in outdated, unreliable bed and chair alarms and receive a free
upgrade to RF Technologies’ Sensatec Fall Management alarms. The offer
allows facilities to trade in competitors’ systems for the latest technology
in bed and chair alarms. There is no limit to the number of alarm units that
may be traded. Whether a facility wants to upgrade one alarm unit for a
single bed or 300 new alarm units for an entire facility, the RF
Technologies trade-in program can be tailored to meet specific needs.
Sensatec Fall
Management Solution features: Free Bed & Chair Alarms; Convenient & Flexible
Program; Easy-to-Operate Alarms; Simple “Plug & Play” Setup; Volume/Delay
Control; Auto-On/Auto-Reset Feature; Low Battery Indication; Nurse Call
Integration; and Protective Silicon Enclosure. To receive Sensatec control
units at no charge, facilities simply send their current alarms to RF
Technologies. The facility will receive new control units at no cost by
agreeing to purchase a minimum number of sensor pads over the next 24-month
or 36-month period. Facilities interested in the trade-in program should
call Dan Mueller, Sensatec Representative, at toll free 1-800-669-9946 ext.
5174 for a no-obligation quote. For more
information see THIS LINK
http://www.rft.com/
April 12, 2007
Rheumatoid arthritis drug may help treat type 2 diabetes
Medicare provides funding for health insurance counseling
in all 50 states
Centers for
Medicare and Medicaid Services launches DOQ-IT University
MaineGeneral Health automates business processes with Oracle
More states adopt apology
shield to protect doctors
Lawmakers
in Rhode Island and eight other states are now considering
bills that would allow physicians to apologize and tell their
patients, “I’m sorry” when things go wrong without having to
fear that their words will be used against them in court. At
least 27 other states have already passed similar laws, nearly
all of them in the past four years, according to the American
Medical Association. The wave of “I’m sorry” laws is part of a
movement in the medical industry to encourage doctors to
promptly and fully inform patients of errors and, when
warranted, to apologize.
Some hospitals say apologies help defuse patient anger and
stave off lawsuits. At the same time, many doctors are trained
or warned never to admit errors in case a patient sues.
Apology laws vary by state. In Arizona, Connecticut, Idaho,
Maine and 11 other states, doctors can safely apologize to or
commiserate with patients or their families about an
undesirable or unexpected outcome, according to the AMA. A law
in Vermont exempts only oral statements of regret or apology,
not written ones. Illinois gives doctors a 72-hour window to
safely apologize after they learn about the cause of a medical
mishap. Providence lawyer
Steven Minicucci, who handles malpractice suits, said displays
of compassion are rarely useful in building such cases. But an
apology and an admission of error could be key evidence. He
opposes the Rhode Island legislation. “I like to call it the
‘I’m-sorry-I-killed-your-mother’ bill,” Minicucci said. “If a
doctor comes out and says something like that, he shouldn’t be
able to immunize himself against statements like that by
couching it in an apology.” Boston-based ProMutual Group,
which insures 18,000 healthcare clients in the Northeast,
warns against apologies that admit guilt. “We encourage
physicians to apologize about the outcome, not necessarily for
any error that may have occurred,” ProMutual spokeswoman Nina
Akerley said. “Apology is not about confession.” (The
Associated Press)

Rheumatoid arthritis drug may help treat type 2 diabetes
A drug
designed to treat juvenile rheumatoid arthritis may also be
helpful for managing type 2 diabetes, new research suggests.
The study found that daily injections of anakinra led to a
drop in long-term levels of glucose in the blood, while they
increased in people given a placebo. “We (showed) that a
13-week treatment with anakinra improves glucose regulation
and insulin production in people with type 2 diabetes,” said
one of the study’s authors, Dr. Marc Donath, an attending
physician and a professor of endocrinology and diabetes at
University Hospital Zurich in Switzerland. The study is
published in the April 12 issue of the New England Journal
of Medicine.
Sometimes,
beta cells, insulin-producing cells, in the pancreas are
destroyed in type 2 diabetes as they are in type 1 diabetes.
Through previous research, Donath and his colleagues learned
that a substance called interleukin-1 beta was a factor in the
demise of these cells in people with type 2 diabetes. The drug
anakinra is an interleukin-1-receptor antagonist, which means
it can block the action of interleukin-1 beta. To assess
whether or not this could have an effect on people with type 2
diabetes, the researchers randomly assigned 36 people to
receive a once-daily placebo injection and 34 people to
receive once-daily injections of 100 milligrams of anakinra
for 13 weeks. After 13 weeks, the glycated hemoglobin levels
were 0.46 percent lower in the group that received anakinra.
Glycated hemoglobin, also referred to as glycosylated
hemoglobin or A1C, is a test that measures the average amount
of glucose in the blood for about three months. People without
diabetes generally have levels around 5 percent. The higher
the level, the greater the risk of diabetes complications,
which can include heart disease, nerve damage, kidney failure
and loss of vision. “Our study is proof of concept for a
mechanism underlying the disease and (may possibly) block its
progression,” said Donath, who added, “Interleukin-1 beta may
be involved in other complications of the disease, such as
arteriosclerosis. Therefore, this therapy may also prevent
cardiovascular events. However, this remains to be shown.”
Anakinra
was well tolerated by the study participants, and Donath and
his colleagues plan on conducting larger, follow-up studies of
the medication. “This study points to inflammation as
definitely having a role in the (diabetes) story,” said Dr.
Stuart Weiss, an endocrinologist at New York University
Medical Center, and a clinical assistant professor of medicine
at the New York University School of Medicine. But, Weiss said
that while this avenue of research is “worth pursuing, I
wouldn’t get my hopes up for a clinical application,
especially since the drug appears to lose its effectiveness
over time.” Additionally, Weiss pointed out that it appeared
the drug was more effective in thinner people. “The authors
don’t really discuss this, but it’s an interesting finding;
it’s not what we’d expect.” (HealthDay News)
Massachusetts offers details on health coverage
Massachusetts is poised to become the first state
to make it possible for 99 percent of its adults to be covered
by health insurance, with an ambitious plan that sets limits
for the premiums people would be expected to pay. State
officials said that under the plan, they expected that all but
about 65,000 of the 328,000 adults who are currently uninsured
would be able to get affordable coverage. The proposal sets a
sliding scale of affordability standards in which, for
example, a single person earning $40,001 a year would be
expected to pay no more than 9 percent of income, or about
$300 a month, for health insurance; a single person earning
$25,000 a year would be expected to pay a much smaller
percentage, about 3.3 percent of income, or $70 a month.
The plan is
expected to be approved by the Commonwealth Health Insurance
Connector Authority on Thursday. Jon Kingsdale, the executive
director of the authority, the agency set up to administer the
plan, said setting the affordability standards “was always the
most difficult and innovative element” of the state’s
groundbreaking healthcare law, passed a year ago. The law
required all residents to get health insurance or face a fine
or tax penalty. But from the beginning, there was concern that
available health plans might be too expensive for some people,
or, that some affordable plans might provide skimpy coverage.
Last month, the authority voted to require all plans to have
substantial coverage, including prescription drug benefits,
which raised further questions about how expensive the
insurance would be. “To do this right means we’re walking a
tight rope,” Kingsdale said. “We don’t want to be too
punitive, we don’t want to put too high a standard of
affordability, but we don’t want to let too many people out of
a universal requirement. We’ve been putting a lot of stakes in
the ground, but this is the center pole that will allow us to
put up the tent and get everybody covered.”
The plan,
if approved Thursday, would still need to be presented at
public hearings across the state and face a final vote in
June. The proposal would cost the state $13 million more than
the $200 million it was planning to spend. This proposal
changes premiums and subsidy rates that were established
earlier. It would allow about 52,000 more low-income people to
qualify for free or cheaper coverage. A person earning up to
$15,315, one and half times the federal poverty level, would
not have to pay anything under this proposal. Individuals
earning $30,630 to $50,001 would not be eligible for state
subsidies, but they would not be penalized if they could not
find health insurance priced at $150 to $300 a month. People
who earn more than $50,001 would not be given a cap on
insurance costs. People who claim they cannot afford coverage
under the new system could apply for a waiver.
The
proposal represents a carefully hammered-out compromise.
Business groups wanted to make sure that premiums for
state-sponsored insurance would not be too much less than the
employee contributions to an employer’s plan because they fear
that people would flock to the government-sponsored plans,
driving up the cost to the state. Advocates for poor people
had wanted lower costs for more residents. “It doesn’t go the
whole way, but it’s good enough for today,” said John
McDonough, executive director of Health Care for All, an
advocacy group. Leslie A. Kirwan, the Massachusetts secretary
of administration and finance, who is chairwoman of the
authority’s board, said the support of advocates like
McDonough was earned in part by action by Gov. Deval L.
Patrick, who agreed to waive fees that more than 10,000 poor
families were paying for their children to be covered by
Medicaid. (The
New York Times)
Medicare provides funding for health insurance counseling
in all 50 states
Medicare will provide funding for health insurance counseling
in every state to help beneficiaries get the most from the
health program for elderly and disabled persons, the Centers
for Medicare & Medicaid Services (CMS) announced. Each state
will receive a share of $30 million in grant funds so state
agencies can bring personalized assistance to people with
Medicare at the local level. Under the State Health Insurance
Assistance Programs (SHIPs), CMS provides funding to 54 SHIPs,
including all 50 states, and the District of Columbia, Puerto
Rico, Guam and the Virgin Islands. SHIPs are a key part of
Medicare’s education and outreach efforts to educate
beneficiaries about health insurance coverage, including
Medigap, Medicare Advantage options, Medicare prescription
drug coverage, and long-term care financing. In recent months,
they assisted millions of beneficiaries with finding drug
plans suited to their individual needs.
SHIP counselors will continue to provide enrollment assistance
to Medicare beneficiaries and offer personalized counseling
regarding all of their Medicare benefits, including new
preventive health screenings and services. Through counseling,
education and outreach, networks of local programs are helping
beneficiaries understand and utilize their Medicare benefits.
SHIPs are intended to serve beneficiaries who want
information, counseling, and assistance beyond what is
available through other CMS channels, including 1-800-MEDICARE
and www.medicare.gov.
To help them succeed, CMS will continue to provide training
for SHIP counselors and full access to computer programs and
other support tools, such as the Plan Finder tool and Tip
Sheets, developed by CMS to help SHIPs with outreach and other
functions. SHIP grants are calculated in two parts. The
initial grant is distributed as a fixed award of $75,000
($25,000 to Guam and the Virgin Islands) to each of the
applicants. The second portion is a variable sum based on the
percentage of nationwide Medicare beneficiaries who live in
the state, the proportion of the state’s Medicare
beneficiaries to the total state population, and the
proportion of the state’s Medicare beneficiary population who
live in rural areas. For a complete list of state health
insurance counseling programs, see
THIS LINK.
Scientists stop genes that help breast cancer to spread
U.S. scientists have demonstrated a way to stop breast cancer
spreading to other parts of the body by either switching off
the genes involved or blocking them with drugs. The study is
published in the journal Nature. Tumours formed from
cancer that has spread or metastased from the primary site to
other parts of the body cause 90 percent of cancer deaths. The
process of metastasis or cancer spread is still much of a
mystery to scientists. They can’t tell the difference between
a tumour that won't spread and one that will. And why, when
hundreds of tumour cells get into the bloodstream every day,
do only a small number of them take up residence in a new site
and start multiplying?
Dr. Joan Massagué from the Memorial Sloan-Kettering Cancer
Center in New York, has been working in this field for some
time. He and his team have been looking at cell regulation and
how it helps cancer cells to spread to specific tissues. In
2005, they found a number of genes that help breast cancer to
metastase to the lungs. In this new study, they have
identified four genes in particular that work together to help
cells from the primary site to settle at a new site and grow.
The four genes are: EREG, MMP1, MMP2 and COX2. Dr Massagué and
his team performed two types of experiments. In one they
switched off the genes, and in another they targeted them with
drugs. In the first experiment they took human breast cancer
cells and switched off all four genes before inserting them
into mice. The tumours did not grow, and metastasis to the
lungs was greatly reduced. However, when they only silenced
the genes individually, the effect was nowhere near as
dramatic.
In the second experiment they used a combination of three
drugs to inhibit the action of the genes. Two of the drugs
have already been approved for clinical use: cetuximab and
celecoxib, while the third, GM6001, is still experimental. The
drugs had a similar effect to switching the genes off. And the
two approved drugs without the experimental one also stopped
the cancer from spreading. In speculating on the results, the
team suggested the four genes have to work together to help
both tumour growth and spread. They said the genes probably
hijack blood vessels and make them feed the tumour instead of
healthy cells. Then they help tumour cells get into the
bloodstream, penetrate capillary walls in the lungs, become
established, and start multiplying. So far Dr. Massagué and
his team have been working with mice; they hope to set up
trials with humans very soon. Since two of the drugs are
already approved for clinical use, this should speed things
up. However, other scientists would prefer to wait for the
results of human trials before getting too excited. The next
stage, said Dr. Massagué, is to find women whose breast cancer
relies on these four genes. Then they can test whether the
drugs they used with the mice will stop the metastasis to the
lungs in humans.
Many scientists believe that cancer spread starts after the
primary tumour has reached maturity. But this research
challenges that and suggests that cancer cells start migrating
to other sites from the start. And the same genes that drive
the growth of the primary tumour also help the cells to move
and settle somewhere else. Another potential contribution this
study makes is the possibility that these same genes are
involved in fuelling metastasis of other cancers, or at least
that similar rules are involved. That is the hope expressed by
Christoph Klein, who studies metastasis at the University of
Regensburg in Germany. While this study sheds valuable light
on the mystery of metastasis, there are still areas that
puzzle experts. For instance, some patients are diagnosed with
metastased tumours without the primary tumour every being
found. And nobody knows why different cancers spread to
particular tissues, such as why breast cancer travels to lung
and bone in particular. (Medical News Today)

Centers for
Medicare and Medicaid Services launches DOQ-IT University
The Centers
for Medicare & Medicaid Services (CMS) announced the national
launch of DOQ-IT (Doctor’s Office Quality Information
Technology) University, or DOQ-IT U, to support health
information technology (HIT) in physicians’ offices. DOQ-IT U
is an interactive, Web-based tool designed to provide solo and
small-to-medium sized physician practices with the education
for successful HIT adoption, including lessons on culture
change, vendor selection and operational redesign, along with
clinical processes. The nationally available e-learning system
is available at no charge.
DOQ-IT U
will provide lessons in assessment, planning and
implementation methodologies that will be disease and
population specific, incorporating clinical decision support
and evidence-based medicine guidelines. This e-learning
platform will be utilized to provide physicians with a
self-paced curriculum and associated tools, based on adult
learning principles, available at their convenience.
Additional features, such as surveys, utilization tracking,
and Continuing Medical Education/Continuing Education Unit (CME/CEU)
offering/issuing capabilities will also be included in the
near future.
The first
learning sessions (modules), available now, focus on physician
office workflow redesign, culture change, and communication
necessary for successful Electronic Health Record (EHR)
adoption, implementation of care management, and the
incorporation of a strong patient self-management component to
clinical care. Disease specific modules, starting with
diabetes, will include a patient self-management component,
which is critical to successfully managing patients with
chronic disease. For more information, see
THIS LINK.
MaineGeneral Health automates business processes with Oracle
Oracle
announced that
MaineGeneral Health, the
parent
corporation of a network of an acute care hospital, physician
practices, long-term nursing care, homecare, behavioral
health, and assisted living and retirement communities, has
recently deployed Oracle’s
PeopleSoft Enterprise Financial
Management 8.9 to automate and manage business processes, as
well as enhance operational efficiency.
MaineGeneral Health wanted to automate and consolidate key financial
management functions across its three hospitals and eight
business units, seeking a stable platform that would expand
visibility of critical enterprise data, automate approval
workflow, improve reporting functionality and enable
e-commerce. The organization selected and implemented
PeopleSoft applications for financial management, accounts
payable, asset management, project costing, purchasing,
inventory management and eprocurement. The system will help
the organization improve financial positioning visibility;
reduce administrative costs, including payment-processing
costs; and improve employee productivity by providing an
integrated solution with broad functionality.
Leveraging PeopleSoft’s cross-module
validation capabilities, MaineGeneral Health can integrate and
validate data from its materials and accounts payable systems
and general ledger and asset systems to improve process
efficiency and ensure data accuracy. Further, the solution
allows the organization to automate inter-company purchases
and allocate expenses to each business, as appropriate.
Oracle’s PeopleSoft applications provide MaineGeneral Health
with enterprise-wide visibility into financial data and
expanded reporting capabilities that will help the
organization close financial books much faster. MaineGeneral
Health expects to decrease the time needed to close its books
from 21 days to 10 days. In addition, by accelerating the
payment process, the institution can take advantage of rapid
pay discounts, which were difficult to take advantage of with
the organization’s legacy system.

April 11, 2007
Medicare proposes revised clinical trial policy
Diabetes may be associated with increased risk of mild
cognitive impairment
Diabetes can lead to host of consequences
ACS Report: Progress against cancer at risk; early
detection, prevention need more attention
VHA introduces a new tool to improve capital budgeting
efficiency for hospitals
Amerinet signs exclusive agreement with St. Theresa Medical
Complex
Egyptian girl dies of bird flu
A
15-year-old Egyptian girl who tested positive for the H5N1 bird flu virus
has died in hospital, bringing the number of deaths from the disease in
Egypt to 14, the health ministry said on Wednesday. A ministry statement
said Marianna Kameel Mikhail, who was admitted to hospital in Cairo on
Thursday, died of respiratory failure on Tuesday evening despite being
treated with the antiviral Tamiflu and being placed on a respirator. None of
her family was found to have bird flu, it added. “This case is the 14th
death from 34 cases of bird flu infection since the disease appeared in
Egypt in February 2006,” the statement said. Egypt has the highest number of
confirmed human bird flu cases outside Asia. (Reuters)
Medicare proposes revised clinical trial policy
The Centers for Medicare & Medicaid Services (CMS) announced its proposed
revisions to the Clinical Trial Policy national coverage determination (NCD). Under
the Clinical Trial Policy, first developed in September 2000, Medicare pays
for certain items and services for Medicare beneficiaries involved in
clinical trials. “This new decision will signal our continued support to
provide access to services for beneficiaries by facilitating participation
in the full range of qualified, scientifically sound research projects,”
said CMS Acting Administrator Leslie V. Norwalk, Esq. In developing the
revised clinical trial policy, CMS convened the Medicare Evidence
Development and Coverage Advisory Committee (MedCAC) on December 13, 2006.
The MedCAC proposed several recommendations, subsequently reviewed by a
federal panel led by the Agency for Healthcare Research and Quality (AHRQ).
In addition to AHRQ, the federal panel included representatives from CMS,
FDA, CDC, HRSA and the NIH. Based on the recommendations from the MedCAC and
the federal panel, CMS is proposing to revise its Clinical Trial Policy.
Highlights of the proposed changes include: Renaming the policy as the
Clinical Research Policy; Adding FDA post-approval studies and coverage with
evidence development (CED) to studies that would qualify under this policy;
Requiring all studies to be registered on the NIH ClinicalTrials.gov website
before enrollment begins; Requiring studies to publish their results; Paying
for investigational clinical services if they are covered by Medicare
outside the trial or required under an CED through the NCD process; and
Expanding the “deeming” agencies to all DHHS Agencies, the Veterans
Administration, or the Department of Defense. Deeming agencies are agencies
that can “deem” whether a trial has met the general standards outlined in
the policy.
The proposed NCD opens a 30-day comment period. CMS will review all the
public comments and suggestions received and incorporate them into a final
NCD. CMS will publish the final NCD no later than sixty days after the end
of the comment period. The revised policy will be effective with the
publication of the final NCD. For details see
THIS
LINK.
Diabetes may be associated with increased risk of mild
cognitive impairment
Individuals with diabetes may have a higher risk of developing mild
cognitive impairment, a condition that involves difficulties with thinking
and learning and may be an intermediate step toward Alzheimer’s disease,
according to a report in the April issue of Archives of Neurology,
one of the JAMA/Archives journals. “Among cardiovascular risk
factors, type 2 diabetes mellitus has been consistently related to a higher
risk of Alzheimer’s disease,” the authors write. Mild cognitive
impairment-particularly a type known as amnestic mild cognitive impairment,
which affects memory more significantly than non-amnestic mild cognitive
impairment-is increasingly recognized as a transitional state between normal
functioning and Alzheimer's disease. José A. Luchsinger, M.D., and
colleagues at Columbia University Medical Center, NY, studied 918
individuals older than 65 years (average age 75.9) who did not have mild
cognitive disorder or dementia when they enrolled between 1992 and 1994.
At
the beginning of the study and again every 18 months through 2003, each
participant underwent an in-person interview and standard assessment, which
included a medical history, physical and neurological examination, and a
battery of neurological tests that measured learning, memory, reason and
language skills, among others. Of the participants, 23.9 percent had
diabetes, 68.2 percent had hypertension, 33.9 percent had heart disease and
15 percent had had a stroke. During an average of 6.1 years of follow-up,
334 individuals developed mild cognitive impairment, including 160 amnestic
cases and 174 non-amnestic cases. Diabetes was related to a significantly
higher risk of mild cognitive impairment overall and of amnestic mild
cognitive impairment specifically after controlling for other factors that
may affect risk, including age, ethnic group, years of education and heart
and blood vessel disease.
“The
risk of mild cognitive impairment attributable to diabetes was 8.8 percent
for the whole sample, 8.4 percent for African-American persons, 11 percent
for Hispanic persons and 4.6 percent for non-Hispanic white persons,
reflecting the differences in diabetes prevalence by ethnic group,” the
authors write. Diabetes could be related to a higher risk for amnestic mild
cognitive impairment by directly affecting the build-up of plaques in the
brain, a hallmark characteristic of Alzheimer's disease, the authors
note. In addition, cerebrovascular disease-diseases such as stroke that
affect the vessels supplying blood to the brain-is related to both diabetes
and Alzheimer's disease. “Our results provide further support to the
potentially important independent role of diabetes in the pathogenesis of
Alzheimer’s disease,” the authors conclude. “Diabetes may also be a risk
factor for non-amnestic forms of mild cognitive impairment and cognitive
impairment, but our analyses need to be repeated in a larger sample.” 
Diabetes can lead to host of consequences
The rate of complications from diabetes is high, says a report, The State of
Diabetes Complications in America, being released today by the American
Association of Clinical Endocrinologists. It shows that nearly 60% of people
with diabetes have at least one of the complications caused by long-term
failure to control the high blood-sugar levels tied to the disease. Most of
the complications could have been avoided with early diagnosis and
aggressive treatment, said Daniel Einhorn of La Jolla, CA, an
endocrinologists association board member. High levels of sugar in the blood
can damage veins, causing vision loss, kidney disease and loss of
circulation to the legs and feet that can result in amputation. Diabetes
contributes to stroke and heart disease. Einhorn says studies show that
intense, early treatment with improved diet, daily exercise and medications
when needed can lower blood-sugar levels and prevent or at least delay
complications. But “the report shows we are failing in the primary mission
of preventing complications,” he said. “The problem is that people don’t
recognize diabetes early enough, so by the time of diagnosis, about half of
people with diabetes already have a complication that took years to
develop.”
Based on data from national surveys, the report is the first to combine
economic and health data on type 2 diabetes complications, says the
endocrinologists association, which prepared it with the Amputee Coalition
of America, Mended Hearts, the National Federation of the Blind and the
National Kidney Foundation. It estimates the cost of treating complications
at $22.9 billion in 2006, said University of Chicago health economist
Willard Manning, who contributed to the analysis. He says people with
diabetic complications face health costs three times those of non-diabetics
and can expect to spend an average $1,600 per year in out-of-pocket expenses
for care that averages nearly $10,000 a year, most of it paid by insurance.
The report, which was paid for by drug manufacturer GlaxoSmithKline, notes
that the prevalence of complications is greater in blacks (about 59%) than
whites (about 55%), and highest in Hispanics (about 68%). Einhorn says
diabetes, like high blood pressure or high cholesterol, is painless and easy
to ignore until it has already caused damage. “There is a huge cost to
denial of this disease,” he said. (USA Today)

ACS Report: Progress against cancer at risk; early
detection, prevention need more attention
The
United States has made great strides against cancer recently, with overall
deaths from the disease declining for 2 years in a row. But a new report
from the American Cancer Society warns that this progress is threatened by
disturbing trends in cancer prevention and early detection efforts. Tobacco
control and cancer screening are of particular concern, according to Cancer
Prevention and Early Detection Facts & Figures 2007 (CPED), the annual ACS
report examining the factors that influence cancer cases and deaths. The
ever-expanding waistlines of both adults and children in America are also a
serious problem. “Much of the suffering and death from cancer could be
prevented by more systematic efforts to reduce tobacco use, improve diet,
increase activity levels, and expand the use of established screening
tests,” said John R. Seffrin, PhD, national chief executive officer of the
American Cancer Society. “But this report shows we may be losing momentum in
some key areas that have been critical to our success.”
Tobacco use is expected to cause some 168,000 cancer deaths this year alone,
and overall it’s the single largest preventable cause of disease and death
in the US. Smoking causes cancers of the lung, larynx, mouth and throat,
esophagus, and bladder, and contributes to several other types of cancer.
About 40% of the recent decline in cancer deaths among men is due to
declines in their smoking rates over the past 50 years, the report says.
Although smoking rates among both youth and adults began dropping in 1997,
that decline appears to have stalled. Smoking rates among high school
students did not change significantly between 2003 and 2005, the report
says. Likewise, adult smoking rates were also basically unchanged from 2004
to 2005. Higher tobacco taxes, restrictions on smoking in public places,
counter-advertising, and coverage for quit-smoking programs and services are
all effective means of curbing tobacco use. Funding for such programs falls
far short of what is needed, the report says. For every $1 spent on tobacco
control in the US in 2003, the tobacco industry spent $23 promoting
products.
More
money is also needed for cancer screening programs that help people with low
incomes or no insurance. Cancer screening tests can find the disease at its
earliest stage, when treatments are more likely to be successful. ACS is
pressing Congress to boost funding for the National Breast and Cervical
Cancer Early Detection Program, run by the US Centers for Disease Control
and Prevention. Although this program helps more than 400,000 women get the
mammograms and Pap tests they need every year, that’s just 13% of the
uninsured and low income women eligible for this lifesaving program. Even
women with health insurance are falling behind in their mammograms. The
American Cancer Society recommends annual tests for women 40 and older. Yet
in 2003, just 55% of women in this group said they’d had a mammogram in the
previous year.
Only
around 42% of adults 50 and older have been screened for colorectal cancer
in the appropriate time frame. Insurance coverage is a major issue: only 17%
of uninsured people have been tested, compared to 44% of those with health
insurance. Low colorectal cancer screening rates are a concern because
unlike screening for many other cancers, colorectal cancer screening can
find colon growths called polyps before they ever become cancerous,
preventing the disease entirely.
About two-thirds of Americans are overweight or obese, and only a fraction
get the exercise needed to help stave off weight gain or lose weight. About
one-third of US cancer deaths are related to excess weight, poor nutrition,
and lack of physical activity, the report notes. Being too heavy is clearly
linked with many cancers, including cancer of the breast, colon, endometrium,
esophagus, and kidney. The CPED report says community efforts are needed to
make our environment more conducive to good food and exercise choices. It
calls for limits on junk food marketing in schools, encouraging more
nutrition information in restaurants, stronger physical education
requirements in schools, and more investment in parks, bike lanes, and
sidewalks.
The
report also calls for greater efforts to educate the public about sun
safety, staying out of the sun during peak hours, using sunscreen and
protective clothing, and keeping to the shade. Getting sunburned can
increase the risk of both melanoma and non-melanoma skin cancers.
VHA introduces a new tool to improve capital budgeting
efficiency for hospitals
The
hospital capital budgeting process is often a time-consuming venture that
requires department managers to conduct their own research, estimate costs
and manually place data into Excel spreadsheets to submit to the hospital’s
chief financial officer. To solve this problem, VHA Inc., the national
health care alliance, and Attainia Inc., a provider of capital equipment
planning systems in healthcare, have co-developed a new Web-based software
product to simplify and streamline the capital budgeting process. Budget
BuilderSM, developed exclusively for VHA members, automates the budgeting
process and helps hospitals identify cost-saving opportunities that
previously may have gone unnoticed. “The annual capital budgeting effort is
painful for hospitals, which have been forced to develop budgets with
inaccurate or out-of-date information using labor-intensive processes,” said
Nik Fincher, senior director of capital asset services for VHA. “With Budget
Builder, hospitals have fast access to real cost information that will
ensure that budgets are more accurate. For example, a hospital with a $10
million overall capital budget can save between $3 million and $3.5 million
by using the cost-cutting information contained in Budget Builder.”
Budget Builder provides members with list pricing information for more than
17,000 equipment items and over 1,500 suppliers. It also includes up-to-date
pricing that factor in the contract discounts and tiered pricing structures
offered through Novation, VHA’s contracting services company. It also links
seamlessly with other Attainia’s software products that VHA members may have
purchased. VHA member Carolinas Healthcare System, Charlotte, NC, helped
pilot the Budget Builder software tool. Michael Rush, director of materials
resource management for Carolinas, said the health system wanted to improve
the capital budgeting process and fix the current flawed process. “The
problem we were facing was buying equipment sporadically and not knowing who
and where and when they were being bought. We saw the need to purchase
capital equipment in bulk. This is where the reports generated by Budget
Builder come into play,” said Rush. Because Budget Builder is Web-based,
hospitals do not need to purchase new hardware or install new software.

Amerinet signs exclusive agreement with St. Theresa
Medical Complex
Amerinet Inc., a national healthcare purchasing organization, announced that
St. Theresa Medical Complex, Kenner, LA has chosen Amerinet to serve as its
sole-source purchasing organization. Amerinet will negotiate contracts on
behalf of St. Theresa Medical Complex, and make available an array of
competitively priced, quality products and services provided by industry
leaders. This new three-year agreement creates a partnership of shared
responsibility to control costs and discover new revenue streams.
The
new partnership will focus on total supply spend management and margin
enhancement services, including cost reduction, contract evaluation,
contract implementation and program coordination at all of the St. Theresa
facilities. St. Theresa is a “new” locally owned and operated medical
facility currently under construction. When complete, the medical complex
will consist of a 42-bed, long-term acute care hospital, a 55-bed rehab
hospital, an ambulatory surgery center and a diagnostic radiology center.
The care to be delivered is designed specifically for patients who need
functional restoration/rehabilitation and medical management services.

April 10, 2007
VA takes
the lead in paperless care
Statin drugs lower respiratory death risk
Proportion of Americans who are severely obese
rising faster than those who are moderately obese
Women under-treated for ovarian cancer
Ovarian cancer is one of the most lethal cancers women can get, yet one out
of three U.S. patients diagnosed with the disease doesn’t get the full,
recommended surgical treatment, a new study finds. “It’s very concerning
that we see such a large proportion of women with ovarian cancer not being
treated up to what we would consider a minimal standard for surgery,” said
the study’s lead author, Dr. Barbara A. Goff, director of the division of
gynecologic oncology at the University of Washington, Seattle. Her team
published the findings online April 9 in the journal Cancer.
According to the American Cancer Society, ovarian cancer is diagnosed in
about 24,000 women in the United States each year, and 14,300 die annually
from the disease. The cancer typically shows few symptoms until it is
diagnosed in its advanced stages. The new study builds on previous research,
Goff said. “People [in previous studies] have looked at this on a
state-by-state basis. What this study really did was look across a broad
geographic area of the U.S. It gave us a good sense of what is happening in
our country,” she said. “Minorities, women who live in low-income areas,
elderly women [over 70] and those who live in rural areas are significantly
less likely to get comprehensive care compared to those women who don’t meet
those [criteria],” according to Goff.
The
Seattle team analyzed hospital data from up to nine states for the period
between 1999 to 2002, looking at factors associated with comprehensive
surgical care. Only 67 percent of the 10,432 women whose cases were reviewed
got the recommended comprehensive surgical procedures. A third of women were
treated at a hospital that performed fewer than 10 ovarian cancer surgeries
a year, not at the high-volume facilities that are considered superior.
Almost half received treatment from a surgeon who performed fewer than 10
such procedures a year, not the best scenario for a good outcome. One-fourth
got care from a doctor who did only one ovarian cancer surgery annually.
Much previous research has found that women who are treated by specialists,
in this case gynecologic oncologists, have better survival, and that those
who have complete removal of the tumor (which is more often done by a
specialist) have better survival.
An
opinion issued by the American College of Obstetricians and Gynecologists in
2002 stressed the importance of referral to a gynecologic oncologist if
ovarian cancer is suspected. A U.S. National Institutes of Health consensus
panel issued similar recommendations on comprehensive surgery for ovarian
cancer more than a decade ago. Another expert said the study confirms the
importance of seeing a gynecologic oncologist, as the ACOG opinion
recommends. “It matters who does the surgery,” said Dr. Ilana Cass, director
of the gynecologic oncology fellowship program at Cedars-Sinai Medical
Center, Los Angeles, and a gynecologic oncologist. The new study, she added,
has more complete numbers than previous research. The experts’ prime advice
for women diagnosed with ovarian cancer or suspected ovarian cancer: Seek
out a specialist. The problem, Goff said, is that the diagnosis is usually
made at the time of surgery. If ovarian cancer is even suspected, she said,
women should seek a referral to a center with a high volume of ovarian
cancer surgeries, performed by a specialist. She defines “high volume” as 10
or more such surgeries per year. If a woman cannot find a center that does
10-plus procedures, finding a center and a physician that does at least more
than one a year is next-best option. “Those doctors who did 2 to 10 ovarian
cancer surgeries were significantly better than those who did only one,”
Goff noted. Cass agreed that asking to be referred to a high-volume center
and to be seen by a physician who is a gynecologic oncologist are both good
steps. (HealthDay News)
VA
takes the lead in paperless care
Since 1999, the Department of Veterans Affairs’ 155 hospitals, 881 clinics,
135 nursing homes and 45 rehabilitation centers have been linked by a
universal medical records network. It allows any authorized person to look
at 5.3 million patients’ records, everything from a nurse’s note written
during a hospital stay, to the result of a blood test drawn at a clinic
visit, to the moving-picture film of a coronary angiogram done in a
cardiology lab. The Department of Veterans Affairs is today one of the few
health systems, and by far the largest, that is virtually paperless. A study
commissioned by the Department of Health and Human Services last fall
reported that one-quarter of American physicians use some sort of electronic
record-keeping in their practices. But less than 10 percent have systems
that store all necessary data, allow electronic ordering of tests and
provide clinical reminders. Only 5 percent of the country’s 6,000 hospitals
have computerized ordering of drugs and tests, and even fewer have a fully
integrated system like the VA’s. Although some people believe making medical
records widely available to many practitioners is a threat to privacy, VA
officials believe strongly that patient privacy is more secure now than in
the era of paper charts. In the past 2 1/2 years, the VA has investigated 20
complaints of security breaches. Seventeen were for patient records accessed
by unauthorized people, and three were for release of medical data to third
parties without patient consent, VA spokeswoman Jo Schuda said.
In
the popular mind, the chief deficit in medical records is legible
handwriting. But that doesn’t begin to describe the problem. Many hospitals
have multiple paper charts for each patient, one for hospital stays, another
for clinic visits and others for specialty services such as physical
therapy. Information is passed via carbons, faxes and letters. (Before the
VA got its electronic system, only 60 percent of patients’ charts could be
found on any given visit.) Looking at X-rays and imaging scans is equally
inconvenient and unpredictable, requiring trips to a film library and luck
that the right folder can be retrieved. Electronic medical records eliminate
those headaches. Searchable computerized databases also allow physicians to
examine information collected across time and space. (In the case of the VA,
a doctor in Washington can easily find a blood test from a patient treated
five years ago at the San Francisco veterans hospital.)
The
ability to detect trends in physiological variables such as serum chemistry,
cell counts, blood pressure and even weight is important to good
decision-making. But it is often hard to do. Electronic medical records make
it easier. Electronic record systems also bridge one of the more perilous
chasms in medicine: the transfer of care when patients leave the hospital.
Two years ago, a study of 2,600 patients discharged from university
hospitals found that 41 percent had test results pending when they left. One
in 10 of those tests eventually proved abnormal enough to warrant action,
more testing, a new diagnosis or a change in treatment. However, other
research has shown that up to 85 percent of patients visit their primary
care doctors, who these days are likely to have had little if any role in
their hospital care, before a summary of their last hospitalization
arrives. A 2003 study showed that 49 percent of patients suffered at least
one medical error in the two months after leaving the hospital, often
because the outside doctors didn’t know what was done in the hospital, or
what was left to do.
Electronic records are especially helpful in managing prescription drugs. The VA software flags questionable doses and
potential interactions. Hospitalized patients have bar codes on their
wristbands that are scanned for an identity check each time a pill is
dispensed or an injection given. The computer system tells practitioners not only what
a patient has been prescribed but what he has actually picked up from the
pharmacy.
The VA is now rolling out “My Health e Vet,” a feature that allows
patients to create a portal to their own charts, where they can record
measurements they take at home; list over-the-counter medicines they use;
and offer comments about their health. Electronic records can also improve
physician performance. They can warn of things that shouldn’t be done,
provide reminders of what should be done and monitor what is done. A
study published in 2004 compared the care of VA and non-VA patients in 12
communities, using 348 quality indicators as the yardstick. VA patients
scored higher on overall quality, chronic disease care and preventive care.
Electronic records appear to be money-saving devices, at least in some
hands. By one estimate, they could save American medical care $162 billion a
year. Many hospital systems, however, balk at the upfront investment, which
can range from “a few million to 50 to 60 million dollars,” said Pat Wise,
an executive with Healthcare Information and Management Systems Society. The
cost of the VA’s electronic medical record, called VistA (for Veterans
Information Systems and Technology Architecture), is hard to measure. It was
developed over many years by many people, including hundreds of clinicians.
However, the software is now free to anyone who wants to get it through the
Freedom of Information Act. (Washington Post) To read the original article
see
THIS LINK.
Statin drugs lower respiratory death risk
People who use statin drugs are less likely to die of influenza and chronic
bronchitis, according to a study that shows yet another unexpected benefit
of the cholesterol-lowering medications. Their study of more than 76,000
people showed that those who had taken statins for at least 90 days had a
much lower risk of dying from chronic obstructive pulmonary disease or COPD,
the technical name for emphysema and chronic bronchitis. Patients on statins
also had a lower risk of dying from influenza or pneumonia, the researchers
reported Monday. Statins, which include Pfizer Inc.’s $10 billion-a-year
Lipitor, Bristol-Myers Squibb Co.’s Pravachol and Merck and Co. Inc.’s Zocor,
are the world’s best-selling drugs, taken by millions to reduce the risk of
heart attack.
The new study supports
a theory proposed last year that statin drugs might help patients with H5N1
avian influenza, which some studies suggest kills by causing an immune
system overreaction called a cytokine storm. Floyd Frost of the Lovelace
Respiratory Research Institute in Albuquerque, New Mexico, and colleagues
analyzed their institute’s database of medical records from several health
maintenance organizations. They looked at incidence of influenza and
pneumonia and of COPD, and then cross-checked to see which patients were
also taking statins. “This study found a dramatically reduced risk of death
from COPD among statin users and a significantly reduced risk of death from
influenza/pneumonia,” the researchers wrote in their report, published in
the journal Chest.
“These findings
suggest that moderate-dose statin use reduces the risk of
influenza/pneumonia death and strongly suggest that statins reduce the risk
of COPD death.” In 2006, researchers in Canada reported that statins act
against sepsis, a dangerous blood infection, and a 2005 study found the
death rate was 64 percent lower in pneumonia patients who had been taking
statins. “Even if
statins are not able to significantly reduce the risk of death from avian
influenza, their use could significantly extend the time between disease
onset and death,” they wrote. “This additional survival time could increase
the effectiveness of anti-influenza drugs, providing a longer time to reduce
mortality risks.” (Reuters)
Proportion of Americans who are severely obese
rising faster than those who are moderately obese
The proportion of
Americans who are severely obese, about 100 pounds or more overweight,
increased by 50 percent from 2000 to 2005, twice as fast as the growth seen
in moderate obesity, according to a RAND Corporation study issued today.
“The proportion of people at the high end of the weight scale continues to
increase at a brisk rate despite increased public attention on the risks of
obesity and the increased use of drastic weight loss strategies such as
bariatric surgery,” said Roland Sturm, author of the report and an economist
at RAND, a nonprofit research organization. The findings will be published
later this year in the journal Public Health. To be classified as
severely obese, a person must have a body mass index of 40 or higher,
roughly 100 pounds or more overweight for an average adult man. People with
a BMI of 25 to 29 are considered overweight, while a BMI of 30 or more
classifies a person as being obese. Sturm found that from 2000 to 2005, the
proportion of Americans with a BMI of 30 or more increased by 24 percent,
the proportion of people with a BMI of 40 or more increased by 50 percent
and the proportion of Americans with a BMI of 50 or more increased by 75
percent. The heaviest groups have been increasing at the fastest rates for
the past 20 years.
The RAND Health study
found that based on self-reported height and weight, which tends to
understate actual BMI, 3 percent of Americans are already severely obese.
Since that is the fastest growing group of obese Americans, widely published
trends for obesity underestimate the consequences of the obesity epidemic
because illness and service use are much higher among severely obese
individuals. Among middle-aged adults, people with a BMI over 40 are
expected to have health costs that are double those experienced by normal
weight peers, while moderate obesity (a BMI of 30-35) is associated with
only a 25 percent increase.
The prevalence of
severe obesity continues to surge despite a rapid increase in the use of
bariatric procedures. The number of bariatric surgeries increased from an
estimated 13,000 in 1998 to more than 100,000 in 2003. Experts estimate that
as many as 200,000 of the procedures were performed in 2006. “The explosion
in the use of bariatric surgery has made no noticeable dent in the trend of
morbid obesity,” Sturm said. Sturm said the latest findings challenge a
common belief held by physicians that people who are obese are a fixed
proportion of the population and are not affected by changes in eating and
physical activity patterns in the general population. The study suggests
that clinically severe obesity, instead of being a rare pathological
condition among genetically vulnerable individuals, is an integral part of
the population’s weight distribution. As the whole population becomes
heavier, the extreme category, the severely obese, increases the fastest. 
New Canadian guidelines to address growing obesity
epidemic
The first-ever
Canadian Clinical Practice Guidelines (CPG) on the Management and Prevention
of Obesity in Adults and Children, published April 10, 2007 in the
Canadian Medical Association Journal (CMAJ), recommend that waist
circumference be measured in all Canadian adults, and that a national
surveillance system be developed that incorporates this measurement along
with height and weight. Canada is the first country in the world to produce
comprehensive evidence-based guidelines to address the management and
prevention of overweight and obesity in adults and children. These are also
important guidelines for health professionals and policy-makers to help them
address Canada’s increasing prevalence rates. The guidelines were developed
by a panel of experts from across Canada, who identified a need for a
comprehensive set of clinical guidelines to provide healthcare practitioners
with a toolkit to manage and treat overweight and obese patients, as well as
those who have a high waist circumference. Furthermore, the panel identified
gaps in existing knowledge, and new research requirements needed to help
develop a greater understanding of weight and body shape and their link to
chronic diseases such as cardiovascular disease and diabetes.
The recommendation for
measuring the waist circumference of all adults is the result of the latest
research indicating that fat in the abdominal area is linked to an increased
risk of cardiovascular disease and diabetes. The guidelines reference the
International Diabetes Federation (IDF) cut-off points for waist
circumference, given that these measures better reflect the ethnic diversity
of Canada. Using IDF criteria, over 50% of Canadians are considered
abdominally obese. The guidelines also recommend that: First-line treatment
for overweight and obese adults should consist of diet changes and regular
exercise, supported by behavior change; if unsuccessful, treatment with
medications or bariatric surgery should be considered; Starting at 10 years
of age, overweight or obese Canadians should undergo screening that would
include tests measuring levels of fasting glucose, HDL (the good) and LDL
(the bad) cholesterol, and triglycerides (a form of fat in the blood)
levels. Furthermore, they should be monitored at regular intervals; Patients
participating in weight management programs should be provided with
education and support in behavior modification techniques as an add-on to
other lifestyle modifications; Programs to promote healthy, active living
and to prevent overweight and obesity should be implemented in schools to
reduce the risk of childhood obesity; these include interventions to
increase daily physical activity through physical education class-time and
opportunities for active recreation; “Screen time” (e.g. television
watching, and video or computer games) should be limited to less than two
hours per day to encourage increased activity and less food consumption, and
to limit exposure to food advertising.

The Council of Supply Chain Executives
announces new member
The Council of
Supply Chain Executives is pleased to announce the participation of Bill
Mosser. Mosser serves the Temple University Health System, as Managing
Director Supply Chain Services. In this role Mosser serves as the senior
executive responsible for the health system’s supply chain strategies and
operations. He is the primary architect of the strategies for strategic
sourcing, product formulary management, technology assessment and demand
pull inventory, all programs being implemented at TUHS. In addition, Mosser
oversees the management teams responsible for procurement services,
contracting and supplier management, product management, technology
management and planning, inventory management and supply distribution
services at all health system campuses. Prior to joining Temple, Mosser was
President and Lead Consultant for KTM Consulting, LLC a Supply Chain and
Information Systems Project Management consulting firm in Bethlehem, PA.
To learn more about the Council’s members see
THIS LINK.
The third annual meeting of The Council will be held on November 7-8, 2007
in Nashville, TN. Limited slots are available for suppliers to participate.
For more information please contact
Hays Waldrop,
President and CEO, via email at
hays@ihesllc.com or call (615) 794-2501. For more information see
THIS LINK.

April 9, 2007
Small steps lead to healthier hearts for women
China
alters organ transplant laws
Lehigh Valley Hospital and Health Network
selects Patient Care Technology Systems’ automatic OR tracking software
FDA provides Web access to information
on post-approval device studies
The U.S. Food and Drug
Administration (FDA) unveiled a new Web page that will keep the public
informed about the status of post-approval patient studies for certain
recently approved medical devices. “Electronic access will give the public
an opportunity to see progress being made on a company’s post-market
commitments,” said Daniel Schultz, M.D., director of FDA’s Center for
Devices and Radiological Health. Modern devices provide significant health
benefits, but experience has shown that the full magnitude of some potential
risks doesn’t always emerge during the mandatory clinical trials that are
required for approval. FDA sometimes orders post-approval studies to address
remaining issues such as the product's performance once it becomes more
widely available or is used over a longer period of time. Generally,
companies must submit interim post-approval study status reports every six
months for the first two years of the study and annually thereafter until
the final report has been submitted.
FDA’s new Web page
includes information on all post-approval device studies ordered by FDA
since Jan. 1, 2005. Each listing includes the company’s name, the product’s
name, the approval number and date, and describes the study and whether it
is meeting its reporting deadlines. No information on clinical data is
available because the studies may be ongoing and include personal and
confidential information. There are currently more than 40 listings on the
Web page. The Institute of Medicine called for public reporting of
post-market studies in a 2005 study on pediatric devices. That same year,
FDA initiated an internal review of its ability to monitor post-approval
studies. As a result, the agency shifted responsibility for tracking these
studies from its pre-market staff to its post-market staff and set up a new
electronic system for them to do so.
FDA is currently
implementing an ambitious action plan drawn up last year by a Post-market
Device Transformation Leadership Team, a group of experts drawn from both
inside and outside of FDA. Their action items included: pursuing the
development of a unique identifier system to identify a device and the
information associated with that device throughout its lifetime, mandatory
use of electronic reporting for required adverse event reports and revising
the Center for Devices and Radiological Health's current system of adverse
event reporting. The new Web page is available at
THIS LINK. For more information on FDA’s post-market action plan consult
see THIS LINK.

Cairo’s first human bird flu infection confirmed
Authorities in Egypt have confirmed that a girl, 15, is the first human to
become infected with the bird flu virus in the capital, Cairo, the 34th
human to become infected in the country so far. The patient, Marianna Kameel
Mikhail, is from the Shubra district, Cairo. She was hospitalized on April
5th. Doctors say she is in a ‘stable’ condition. According to the Egyptian
news agency,
MENA, she is
being treated with the antiviral medication, Tamiflu. Authorities say she
had been in contact with sick birds prior to becoming ill. 13 people have so
far died of bird flu in Egypt. (Medical News Today)

Small steps lead to healthier hearts for women
For
years, doctors have been fighting the perception that heart disease is a
mainly male affliction. But, in fact, cardiovascular disease is the number
one killer of both men and women in the United States, according to the
National Institutes of Health. Two of every five women who die are taken by
heart disease or stroke, more than from all forms of cancer combined. Now,
health officials are broadening their push to educate more women about their
heart risks. The renewed campaign follows an American Heart Association
study, initially done in 1997, that found that only 30 percent of women were
aware that heart disease and stroke were their greatest health threats. A
follow-up survey released last year found that number had climbed to 55
percent. “The problem I see is that, yes, women are much more knowledgeable,
but they aren’t translating that knowledge into action,” said Dr. Jennifer
Mieres, director of nuclear cardiology and associate professor of clinical
medicine at New York University School of Medicine, and a national
spokeswoman for the American Heart Association.
The
heart association continues to push its “Go Red for Women” campaign, which
includes an online self-survey to evaluate an individual woman’s specific
risk factors. “That way, women can increase their thought process about
their risk factors,” said Dr. Nieca Goldberg, a cardiologist and associate
professor of medicine at New York University, and medical director of the
university’s Women's Heart Program. A big part of the problem is that women
often don’t experience a heart attack the same way men do. “Women’s symptoms
can be more subtle,” Goldberg said. “It can be shortness of breath without
any chest pain. Some suddenly feel very exhausted with minimal activity.
Pain often is felt lower in the chest and mistaken for a stomach problem.”
Because the symptoms are less obvious, women often wait too long to get
treatment. “If you look at statistics of women who’ve died suddenly of heart
attack, two-thirds died before they could reach the hospital,” Goldberg
said.
Heart disease also often takes place in women differently than it does in
men, Goldberg added. In men, plaque forms on the walls of blood vessels in
specific places, eventually causing a “kink” in the vessel that stops blood
flow. To treat it, doctors implant a stent at the point of blockage, which
reopens the blood vessel. But as many as 30 percent of women suffer from
micro-vascular coronary disease, Goldberg said. The plaque distributes more
evenly throughout the blood vessels, slowing blood flow without creating a
flow-stopping kink. In those cases, arteries have difficulty dilating during
exercise or exertion, causing extreme fatigue in women. “When women go to
have an angiogram, there have been situations where doctors don’t see any
blockages, even though the patient has symptoms and a bad stress test,” she
said. Since there’s no specific blockage, treating micro-vascular coronary
disease is much harder. “When doctors go in to look, there are no kinks, so
they can’t be stented,” Goldberg said. “Women are given drugs to thin the
blood and take care of symptoms, as well as reduce cholesterol levels.”
Since heart disease is often harder to detect and harder to treat in women,
prevention is the key to saving most women's lives. Women need to take a
hard look at their risk factors, Mieres and Goldberg said. “If they can’t
recite their cholesterol levels or blood pressure, they need to schedule a
visit with their doctor because that shows those probably haven’t been
checked in a while,” Goldberg said. Women also should consider whether or
not a relative has had heart disease. There is a genetic risk involved, and
family members often share the same lifestyle risks, such as drinking,
smoking or eating unhealthy foods. Once that risk is known, women can take
steps to improve their health, Mieres said. Mieres recommends taking small
steps that lead to big ones, walking 10 minutes a day and increasing that to
30 minutes, or eating an apple for a snack instead of a candy bar. “Doctors
want women to realize that simple steps can make a world of difference in
terms of your heart health,” said Mieres. (HealthDay News) For more
information on the “Go Red for Women” campaign, see
THIS LINK.
China
alters organ transplant laws
China published new
rules governing human organ transplants in its latest effort to clean up a
business critics say has little regard for medical ethics. But the
regulations were packed with shortcomings, a human rights group said
Saturday, including a failure to address what it called the “crucial issue”
of the procurement of organs from executed prisoners. The rules issued
Friday by China’s State Council, or Cabinet, include a ban on the sale of
human organs for profit and on donations by people under 18, according to
the text of the regulations published by the Communist Party newspaper
People’s Daily. The regulations, which take effect May 1, are also meant to
standardize transplant procedures at the limited number of hospitals
licensed to perform them.
Little information
about China’s lucrative transplant business is publicly available. Human
rights groups have said many organs, including those transplanted into
wealthy foreigners, come from executed prisoners who may not have given
their permission. Human Rights Watch urged Beijing for full transparency on
the removal of body organs from executed prisoners.
Health officials say
China faces a severe shortage of human organs, estimating that out of 1.5
million people who need transplants in China each year, only about 10,000
operations are carried out. Voluntary donations remain far below demand in
China, partly due to cultural biases against organ removal before burial.
(The
Associated Press)
FDA announces that companies must stop marketing
suppository products containing trimethobenzamide
As part of the Food and Drug Administration’s (FDA) on-going initiative to
ensure that all marketed U.S. drugs have required marketing approval, the
agency announced that companies must stop manufacturing and distributing
unapproved suppository drug products containing trimethobenzamide
hydrochloride. These products are used to treat nausea and vomiting in
adults and children. Drugs containing trimethobenzamide in suppository form
lack evidence of effectiveness. These products have been marketed under
various names, including Tigan, Tebamide, T-Gen, Trimazide, and Trimethobenz.
FDA urges consumers who are using suppositories containing trimethobenzamide,
and who have questions or concerns, to contact their healthcare provider.
There are many alternative products approved to effectively treat nausea and
vomiting, and that are available in a variety of forms, including tablets,
capsules, solutions, injectables and suppositories. Several oral capsules
and injectable products containing trimethobenzamide have been approved by
FDA and are not affected by today’s action.
The
Federal Register notice which outlines the agency’s order to
manufacturers and distributors, also concludes all outstanding issues for
drugs containing trimethobenzamide, under the Drug Efficacy Study
Implementation program (DESI). Under DESI, FDA evaluated the evidence of
effectiveness for thousands of drug products previously approved for safety
only, including those products marketed under the name of Tigan containing
trimethobenzamide. Because DESI findings apply to any unapproved products
that are identical, related, or similar to DESI-reviewed drugs, today’s
notice makes the marketing of any unapproved trimethobenzamide hydrochloride
suppository products unlawful. Companies manufacturing or marketing
trimethobenzamide hydrochloride suppository products must cease shipping
them in interstate commerce by May 9, 2007. Any company wishing to market a
product containing trimethobenzamide in suppository form must now obtain an
approved new drug application prior to marketing. For more information see
THIS LINK.

FDA licenses first biologic product to prevent Hepatitis B
reinfection in liver transplant patients
The U.S. Food and Drug Administration (FDA) announced the approval of
HepaGam B for the prevention of hepatitis B reinfection in certain liver
transplant patients. HepaGam B is the first product of its kind (an immune
globulin product) approved for this purpose. Hepatitis B is a serious
disease caused by a virus that attacks the liver and can cause lifelong
infection, liver cancer, liver failure and death. Liver transplant patients
who have already been exposed to the hepatitis B virus (HBV) are at an
increased risk of reinfection because they have weakened immune systems.
“This approval provides a new treatment option for the reduction of
hepatitis B recurrence in liver transplant patients with a prior history of
this serious disease,” said Jesse Goodman, M.D., M.P.H., director of FDA’s
Center for Biologics Evaluation and Research. “It is the first immune
globulin product, one of several classes of proteins derived from human
plasma, approved for this use.”
HepaGam B works by providing an immediate immune response to the virus. This
immunity protects patients previously exposed to HBV. Patients must receive
injections at the time of their liver transplant and throughout their lives.
This product is manufactured from human plasma collected at U.S. licensed
plasma centers from healthy donors. FDA based its approval on the company's
clinical data in a study of HBV-infected persons undergoing full liver
transplants, which showed a reduction in the virus recurrence rate from 86
percent to about 13 percent. Adverse reactions were similar to other immune
globulin products for other indications and included headache and
hypertension. In January 2006, FDA licensed HepaGam B to prevent infection
with HBV for the following other purposes: after acute exposure to blood or
certain body fluids containing HBV; perinatal exposure of infants to mothers
previously exposed to HBV; sexual exposure to persons previously exposed to
HBV; and household exposure to persons with acute HBV infection. HepaGam B
is manufactured by Cangene Corp. of Winnipeg, Canada.
Lehigh Valley Hospital and Health Network selects Patient
Care Technology Systems’ automatic OR tracking software
Patient Care Technology Systems (PCTS) announced that
Lehigh Valley Hospital and
Health Network (LVHHN) has selected
Amelior
ORTracker
automatic tracking software to improve the efficiency of surgical care
throughout its perioperative departments in all three hospitals within LVHHN.
The tracking system will encompass patient flow throughout the Surgical
Staging Units, the Operating Rooms and Post Anesthesia Care Units. The
automatic tracking software provides real-time tracking of patients and
mobile medical devices using
wireless ultra-wideband badges worn by patients and attached to
equipment.
In
addition to locating and tracking Operating Room resources, the software
translates interactions between patients, medical staff and equipment into
time-stamped stages of a patient’s course of treatment. This information is
continuously updated on an electronic tracking map to inform caregivers of
anticipated demand as patients are prepared for surgery and later for
recovery. The software organizes and enhances communications between
caregivers regarding the status of patients, rooms, and the availability of
clinical staff. As a result, phone calls and other manual interventions to
manage care progression are reduced resulting in more timely care and a
quieter patient environment. Extensive data on patient flow and resource
utilization is generated through the software’s reporting engine to assist
perioperative departments to further analyze department utilization.

April 6, 2007
Statins linked to lower risk of infection; Markedly lower
frequency of sepsis in dialysis patients observed
Touro Infirmary
selects Broadlane for supply chain services
Criteria for depression are too broad,
researchers say
Research shows Masimo Acoustic Respiratory Monitoring
technology provides “significantly more reliable monitoring of
respiration rate”
Bird flu kills Indonesian teen, toll at
73
An
Indonesian teenager died of bird flu in the bustling capital of Jakarta,
bringing the toll in the country hardest hit by the virus to 73, a health
ministry official and doctor said Friday. The 15-year-old girl was admitted
to the Sulianti Saroso Hospital for Infectious Diseases on Monday and died
late Thursday, said Sandakan Giriputro, a doctor at the facility. “By
the time she arrived, it was too late,” he said. “She died after
experiencing multi-organ failure.” Health Ministry official Muhammad Nadirin
confirmed that the girl’s lab tests showed she had contracted the H5N1
virus, apparently after coming into contact with infected pet birds at her
home in central Jakarta. Bird flu has killed at least 170 people since it
began ravaging Asian poultry stocks in 2003, hitting Indonesia the hardest,
according to the World Health Organization. (The Associated Press)
New urgency in debating healthcare
Since
Hillary Rodham Clinton’s
effort to overhaul the nation’s medical system was rejected in 1994, most
big employers have stayed out of the debate on healthcare reform. But with
their medical costs ballooning, top executives of large companies are
starting to speak up again, and many are calling for a national approach to
fixing healthcare. Few advocate a wholesale shift to government-directed
medicine, but most are seeking broad changes in the employer-subsidized
health system, which they regard as unsustainable in its current form.
Business executives are motivated in large part by health insurance premiums
that are rising much faster than inflation, adding to their costs at a time
when many are facing more intense competition from abroad, where companies
rely on government-supported healthcare systems largely financed by taxes.
A 2006 study by
the Kaiser Family Foundation and
Hewitt Associates
found that premiums in the United States had risen about 87 percent since
2000. “Five years from now this problem will have to be cured, or the
competitiveness of the United States will be dramatically affected,” said J.
Randall MacDonald, senior vice president for human resources at
I.B.M. But
companies are by no means speaking with one voice. Everybody’s problem, the
growing cost of health coverage, can be felt differently depending on the
size of a company and whether it has promised health benefits to retirees.
Older companies, for example, are more likely to welcome government help on
coverage for workers who leave before they are eligible for Medicare and may
find they cannot afford insurance. But Silicon Valley technology companies
that do not have or need retiree coverage are wary of new taxpayer-financed
subsidies.
The healthcare debate is
heating up as candidates polish their positions for next year’s presidential
primaries, and as Democrats in Congress assert their newfound power. In
general, employers “are more interested in reform today than at any time
since the Clinton effort” in the early 1990s, said Robert S. Galvin, global
healthcare and policy director at
General Electric,
which provides health benefits for 460,000 employees and dependents and
240,000 retirees and dependents. The surge of interest, Galvin said, “is
driven by compounding health cost increases at three times the general
inflation rate, plus the entrance of
Wal-Mart and
other retailers” that are beginning to feel the pain of out-of-control
increases in costs. Many retailers, with large staffs of low-paid, temporary
and part-time workers, would welcome a larger government role. (The New York
Times) To read the full article see
THIS LINK. 
Statins linked to lower risk of infection; Markedly lower
frequency of sepsis in dialysis patients observed
Researchers at Johns Hopkins may have discovered an
unintended benefit in the drugs millions of Americans take to lower their
cholesterol: The medications, all statins, seem to lower the risk of a
potentially lethal blood infection known as sepsis in patients on kidney
dialysis. The study is published in the current issue of the Journal of
the American Medical Association (JAMA). Sepsis is the leading cause of
death in non-coronary intensive care units in the United States, according
to the U.S. Centers for Disease Control. It also poses serious risk for
kidney patients undergoing regular dialysis treatments. The Hopkins
researchers cautioned that kidney dialysis patients should not necessarily
ask their doctors to put them on statins until more studies are done to
verify their findings.
Building on earlier, limited studies that suggested risk
reduction in animals and some people, Professor of Medicine, Director of the
Welch Center and senior author Neil R. Powe, M.D., and his Johns Hopkins
team followed 1041 dialysis patients for 10 years, dividing the subjects
into those taking statins and those not. “Those taking statins had a 41 in a
1,000 chance of being hospitalized for sepsis, while the other group not
taking statins had a 110 out of 1,000 risk. Although the overall absolute
risk is relatively small, the statin group’s risk is dramatically lower,”
says Rajesh Gupta M.D., the study’s lead author, who was a senior medical
resident at Hopkins when the study was conducted.
Gupta says it remains unclear why or how statins work this
way, “but the consistency of the findings with laboratory studies adds a lot
of credence to the idea that statins are doing something substantial to
reduce risk.” “Statins are known to have an effect on the body’s immune
system, but what that is exactly, and how many statin users it affects, is
still not widely understood.” Statins may regulate the immune response to
infection or fight microbes directly, Powe suspects. The study’s authors
also suppose that statins may work like penicillin, since the first statin
was originally derived from a fungus which, it is theorized, secretes a
statin as a way to starve other competing microorganisms that require
cholesterol to survive. The study included patients from 81 dialysis clinics
across 19 states. Only those enrollees who were admitted to the hospital
with sepsis were counted, in order to rule out any subjects who became
septic during an unrelated hospital stay. Only 14 percent of those initially
enrolled in the study were on statins. Out of the 1,041 patients, there were
a total of 303 hospitalizations for sepsis.
Touro Infirmary selects Broadlane for supply chain
services
Broadlane announced that Touro Infirmary, New Orleans’ only
community based, not-for-profit, faith-based hospital, has selected
Broadlane to provide an array of supply chain services under an exclusive
agreement. Financial terms were not announced. Under the agreement,
Broadlane will provide Touro Infirmary with national and local strategic
supply chain services for consumable supplies and equipment, pharmaceuticals
and purchased services. Touro Infirmary will gain access to Broadlane’s
existing portfolio of contracts and, in addition, Broadlane will assist
Touro Infirmary in developing custom contracts and in managing various high
physician preference item standardization and utilization efforts. Touro
Infirmary subsidiaries include Woldenberg Village, Crescent City Physicians,
Touro at Home and Metro Lab and the combined annual supply spend is in
excess of $50 million. Additionally, Touro Infirmary will fully integrate
into Broadlane's technology and e-commerce exchange, BroadLink. BroadLink is
for Broadlane clients only and is not owned by suppliers.

Criteria for depression are too broad, researchers say
Up to 25 percent of people in whom psychiatrists would currently diagnose
depression may only be reacting normally to stressful events such as a
divorce or losing a job, according to a new analysis that reexamined how the
standard diagnostic criteria are used. The finding could have far-reaching
consequences for the diagnosis of depression, the growing use of symptom
checklists to identify those who may be depressed, and the $12
billion-a-year U.S. market for antidepressant drugs. Diagnoses are currently
made on the basis of a constellation of symptoms that include sadness,
fatigue, insomnia and suicidal thoughts. The diagnostic manual used by
doctors says that anyone who has at least five such symptoms for as little
as two weeks may be clinically depressed. Only in the case of someone
grieving over the death of a loved one is it normal for symptoms to last as
long as two months, the manual says. The new study, however, found that
extended periods of depression-like symptoms are common in people who have
been through other life stresses such as a divorce or a natural disaster and
that they do not necessarily constitute illness.
The
study also suggested that drug treatment may often be inappropriate for
people who are experiencing painful, but normal, responses to life’s
stresses. Supportive therapy, on the other hand, may be useful, and may keep
someone who has been through a divorce or has lost a job from going on to
develop full-blown depression. The researchers, including Michael B. First
of Columbia University, the editor of the authoritative diagnostic manual,
based their findings on a national survey of 8,098 people. They found that
those who had experienced a variety of stressful events frequently had
prolonged periods in which they reported many symptoms of depression. Only a
fraction, however, had severe symptoms that could be classified as clinical
depression, the researchers said. An estimated one in six Americans suffer
depression at some point in their lives. Under the more limited criteria the
researchers urged, that number would be 25 percent lower. “The cost of not
looking at context is you think anyone who comes under this diagnosis has a
biological disorder, so should more or less automatically get antidepressant
medication, and everything else is superfluous,” said lead author Jerome
Wakefield, a New York University researcher. (Washington Post)

Total
shoulder replacements as safe as swapping out hips and knees
Contrary to widespread belief, total surgical replacement of arthritic
shoulder joints carries no greater risk of complications than replacement of
other major joints, a Johns Hopkins study suggests. In fact, the Johns
Hopkins researchers say, their study shows that patients who undergo
shoulder arthroplasty to relieve chronic and significant pain can expect
significantly fewer complications, much shorter hospital stays and less
costs than patients undergoing hip or knee replacement.
The Hopkins research team, led by Edward McFarland, M.D.,
director of the Division of Adult Orthopedics at The Johns Hopkins Hospital,
analyzed anonymous patient information provided by the Maryland Health
Services Cost Review Commission, the state’s hospital rate-regulator. They
looked at all arthroplasties performed in Maryland to alleviate
osteoarthritis pain between 1994 and 2001, including details of 15, 414 hip
surgeries, 34, 471 knee operations and 625 shoulder procedures. “After
looking at how all these patients fared, we concluded that, comparatively,
total shoulder surgery is just as safe and effective as other types of
arthroplasties,” said McFarland. “Lower numbers of shoulder procedures done
both regionally and nationally may indicate that many people live with
shoulder pain because they fear that the corrective surgery is too risky or
costs more than similar procedures. But we have found that this is just not
true.” The findings appeared in an online version of the journal Clinical
Orthopedics. According to nationwide 2003 Medicare figures, 6,700 people
had shoulder joints replaced that year, compared to 106,887 hip replacements
and 199,195 total knee replacements.
Patients in the study who had shoulder surgery had far less
in-hospital post-surgical complications (7.5 percent) compared with those
patients who had their hips and knees replaced (15.5 percent and 14.7
percent, respectively). McFarland's team also determined that the average
time a person remained hospitalized after the surgery was lowest for those
recovering from shoulder procedures (just 2.42 days for shoulder patients,
versus more than four days for both the hip and knee equivalents). Shoulder
arthroplasty is also less expensive, according to McFarland. A shoulder
replacement's total costs, on average, are $10, 351; whereas hip replacement
surgery averages $15, 442, and knee arthroplasty, $14, 674. McFarland says
most patients who are candidates for total shoulder replacement surgery are
“at the end of their rope” trying to manage chronic pain and disability with
drugs. “Ninety-nine percent of the people who have a shoulder replacement
for arthritis get pain relief and say that they wish they had done it
sooner,” said McFarland. “This study indicates there may be little reason to
wait.”
Research shows Masimo Acoustic Respiratory Monitoring technology provides
“significantly more reliable monitoring of respiration rate”
Masimo reported that three new independent studies, including one presented
the recent International Anesthesiology Research Society (IARS) Clinical &
Scientific Congress in Orlando, concluded that Masimo Acoustic Respiratory
Monitoring technology (ARM) is “at least as accurate as capnometry” and
“significantly more reliable” for monitoring respiration in spontaneously
breathing patients. Respiration is one of the five vital signs, but
clinicians have long looked for a continuous and noninvasive method of
monitoring respiration that is both clinically accurate, easy to use, and
well tolerated by patients. Current methods of respiration monitoring,
including impedance pneumography with ECG and end-tidal CO2 with
capnometry, each have limitations that make them unreliable in certain
clinical situations.
In the study released at the recent IARS, conducted by M. R. Macknet, MD and
a team of researchers at Loma Linda University's Department of
Anesthesiology, fifteen pediatric PACU patients were monitored with Masimo's
ARM technology consisting of an adhesive bioacoustic sensor applied to the
patient’s neck and connected to a breathing frequency monitor prototype. In
addition, a nasal cannula was placed, secured with tape, and connected to a
capnometer. The study showed that “premature cannula dislodgement occurred
in 14 patients” in less that 20 minutes, while “in no patient was the
bioacoustic sensor dislodged before the end of the stay in the PACU.” “This
data shows the relative ease and high incidence of capnometer cannula
dislodgement compared to the new bioacoustic sensor,” the researchers
commented. “In clinical settings where continuous and reliable monitoring of
spontaneous respiration is important, the new bioacoustic sensor provides
significantly greater patient connection time, which should lead to
significantly more reliable monitoring of respiration rate.”
In two studies released in January at the 2007 Society for Technology in
Anesthesiology annual meeting, researchers monitored ten postoperative adult
ICU and six pediatric PACU patients in separate studies with Masimo’s ARM
technology as well as a nasal cannula connected to a capnometer. They
concluded that Masimo’s new bioacoustic respiratory sensor “demonstrates
accuracy for respiratory rate monitoring as good as capnometry” and that the
device “offers multiple benefits over existing devices and has a potential
to improve monitoring in a general care setting.”
Masimo expects to combine its Masimo Rainbow SET Read-Through Motion and Low
Perfusion pulse oximetry with Masimo ARM technology as part of a general
floor monitoring solution designed to increase patient safety and heed the
growing call to find ways reduce unnecessary deaths on general care floors.
The combination of these two technologies will give hospitals a continuous
and noninvasive way to accurately monitor a patient’s oxygenation and
ventilation during patient-controlled analgesia, consistent with the new
recommendations from the Anesthesia Patient Safety Foundation (APSF). In
addition, the combination of Masimo Rainbow SET pulse oximetry and Masimo
ARM should assist hospitals in being compliant with new American Society of
Anesthesia (ASA) guidelines for management of patients at risk of
obstructive sleep apnea (OSA) by providing an accurate and reliable
combination of oxygen saturation and respiration rate monitoring. The
technology is currently undergoing additional clinical and engineering
testing and is expected to be introduced at Alpha Sites in late 2007.

April 5, 2007
Scientists spot mutation linked to birth
defects
Medicare announces measure
specifications for the Physician Quality Reporting Initiative
Health system to receive a license from state of Florida to
operate a pharmaceutical repackaging facility
Four numbers on a piece of
paper may not mean much to you, but for LeeSar the Supply Chain Company for Lee
Memorial Health System and Sarasota Memorial Health System (FL) it means a lot.
For the past two years LeeSar has been trying to receive a license from the
State of Florida Department of Public Health to operate a pharmaceutical
repackaging facility. Although the health system would save money repackaging
this product from direct bulk shipments, that was not the total reason this
license was so important. So when LeeSar received notice that its new
repackaging facility had passed inspection and then received its license with
its four figured license number the excitement was that we could now free up our
pharmacists to work on the patient floors with the doctors and nurses on
medication management and by doing so insure the highest quality of patient care
to our community. The repackaging operation is now moving into its operational
phase and registering all medications it will repackage with the state. For
further information you can contact; Bob Simpson, President of LeeSar @
239-303-3402.

Study questions exam to detect breast cancer
A highly promoted and widely used computerized system for examining
mammograms is
leading to less accuracy, not more, a new study finds. The system, known as
computer-aided detection, or CAD, did not find more
breast cancer,
researchers are reporting today. But it did lead to many more false alarms that
resulted in additional testing and biopsies for spots on mammograms that turned
out to be harmless. Such detection systems, approved by the
Food and Drug Administration
in 1998, are sold by several companies, including Hologic of Bedford, MA; iCAD
of Nashua, NH; and Kodak. According to the
National Cancer Institute,
the systems are now being used in about 30 percent of mammography centers. The
equipment is expensive, costing $50,000 to $175,000, but Medicare, assuming it
would improve the outcome, pays an extra $20 for each mammogram read with it.
That made it profitable for large centers to use it. Doctors also worried about
lawsuits if they were not using it and missed a
cancer. But all
along, as more and more mammography centers bought the software, the assumption
was that the computer would find cancers that radiologists would miss, saving
women’s lives.
The new findings are likely to surprise radiologists, said
Dr. Ferris M. Hall, a radiology professor at Harvard Medical School. Dr. Hall
wrote an editorial accompanying the paper, which was published today in The
New England Journal of
Medicine. But executives at the company whose equipment was used
in the study, Hologic, said they interpreted the results differently. If there
is a suspicious spot on a mammogram, women will want to have a biopsy to rule
out invasive cancer, said Robert A. Cascella, the company’s president and chief
operating officer. And the study showed that computer-aided detection was
finding proportionately more very early precancerous growths. “That’s a valuable
finding,” he said. The company has improved its software since the study was
conducted, Cascella added.
The study’s lead author, Dr. Joshua J. Fenton of the
University of California,
Davis, emphasized that women should continue to have mammograms. But, Dr. Fenton
said, they may want to ask if their mammography center uses computer-aided
detection. His study, he said, “does raise concerns that technology is causing
harm without clear benefit.” New technology, like computer-aided detection,
digital mammography, magnetic resonance imaging and ultrasound, can be so
sensitive that doctors have trouble deciding which findings are worrisome. The
only screening method that has been rigorously evaluated is old-fashioned X-ray
film mammograms, but it is likely to be replaced by something, or some
combination of things, whose benefits and risks are largely unknown. “We are
getting ourselves out on thinner and thinner ice,” said Dr. Suzanne W. Fletcher,
an emerita professor of ambulatory care and prevention at Harvard Medical
School. “With mammography, we have multiple studies showing what happens to
mortality rates if you get this versus if you don’t,” Dr. Fletcher said. “With
these newer technologies, we don’t.”
The new study of computer-aided detection was an analysis
of 429,345 mammograms obtained from 1998 to 2002 at 43 mammography centers.
During that time, seven of the centers switched to computer-aided detection.
That enabled the investigators to compare results with and without computer
software to help radiologists find suspicious spots. Computer-aided detection,
the researchers wrote, “was associated with significantly higher false positive
rates, recall rates, and biopsy rates and with significantly lower overall
accuracy.” With computer-aided detection, 31 percent more women were called in
for additional tests and 20 percent more had biopsies. (The New York Times) To
read the full article see
THIS LINK.

Ibuprofen may boost chance of heart problems in high risk patients with
osteoarthritis
The common painkiller,
ibuprofen, may boost the likelihood of heart problems in high risk patients who
have osteoarthritis, suggests research published ahead of print in the Annals
of the Rheumatic Diseases. Previous studies have suggested that ibuprofen
interferes with the effects of aspirin. The research team compared the
cardiovascular health over one year of more than 18,000 patients aged over 50
with osteoarthritis. The patients were taking part in the Therapeutic Arthritis
Research and Gastrointestinal Event Trial (TARGET). They were taking either high
dose (400 mg a day) lumiracoxib, a type of drug known as a cyclo-oxygenase
(COX-2) inhibitor, or ibuprofen (800 mg three times a day), or naproxen (500 mg
twice daily), both of which are traditional non-steroidal anti-inflammatory
drugs (NSAIDs). One in 10 were considered to be at high risk of a heart attack
or stroke, some of whom also took low dose aspirin (70 to 100 mg a day). Some
623 patients were taking ibuprofen, just over half of whom (57%) were also
taking low dose aspirin.
The results showed that
there was no difference in the total number of heart attacks and strokes among
participants at low risk of cardiovascular disease, irrespective of their drug
treatment. But this was not true of those at high risk. High risk patients
taking aspirin and ibuprofen were around nine times as likely to have heart
attacks and strokes over one year as those on lumiracoxib. This is the first
analysis of trial data to show an increased risk for ibuprofen, say the authors.
Among high risk patients not taking aspirin, the rate of heart attacks or
strokes was higher for those on the COX -2 inhibitor than it was for those on
naproxen, but no higher than for those on ibuprofen. Participants taking
ibuprofen also developed congestive heart failure more often than those on the
COX inhibitor. Most patients given COX-2 inhibitors and NSAIDs are elderly, and
evidence to date suggests that both drug types boost the chances of heart attack
and stroke. But the authors say that their findings suggest that ibuprofen
interferes with the blood thinning properties of aspirin in patients at high
risk of cardiovascular disease.
Scientists spot mutation linked to birth
defects
Canadian researchers say they have found the first genetic
mutation clearly linked to neural tube birth defects such as spina bifida in
humans. “We have identified the mutations in a few patients with neural tube
defects,” said Philippe Gros, professor of biochemistry at McGill University in
Montreal. “There are a total of 10 patients where we found the mutations. It is
a very small number, but this is the first time that it has been pinned down.”
The gene, designated VANGL1, codes for a protein that enables cells to orient
themselves properly during development, Gros explained. A mutation causes cells
to lose their orientation, so the tissue in which it is expressed fails to
develop properly, causing gaps that leave nerve tissue exposed. Gros’s group
first identified the mutation in mice. Now, reporting in the April 5 issue of
the New England Journal of Medicine, they say they have found three
VANGL1 mutations linked to neural tube defects in children treated at birth
defect centers in Italy and France.
”There have been many association studies, some risk
factors identified in certain genes, alterations in some genes associated with
neural tube defects, but there hasn’t been any clearly causative mutation,” Gros
said. “There hasn’t been any situation like this, where you knock out the gene
and find a neural defect in the mouse and then find the same thing in humans.”
Yet VANGL1 is just one part of a large picture of neural tube defect causation,
he said. “It is clearly a multigene situation, where alterations in more than
one gene are responsible for the effect,” Gros said. “This is a very important
finding that associates defects in this gene with neural tube defects in these
specific families,” said Marcy C. Speer, director of the Duke University Center
for Human Genetics in Durham, NC.
As far as medical practice is concerned, “for therapy, we
are not sure that it will have a great impact at this time,” Gros said.
Scientifically, the discovery is fascinating, because the gene is found
throughout the animal world, conserved all the way from flies to humans,” he
said. The next step in the McGill research will be to investigate other proteins
in which VANGL1 plays a role, to further pin down its mode of action, Gros said.
(HealthDay News)
Effect
of hormone therapy on risk of heart disease may vary by age and years since
menopause
Secondary analyses of
findings from the Women’s Health Initiative (WHI) suggest that women who begin
hormone therapy within 10 years of menopause may have less risk of coronary
heart disease (CHD) due to hormone therapy than women farther from menopause.
Overall, hormone therapy did not reduce the risk of CHD. However, the farther a
woman was from the onset of menopause when she began hormone therapy, the
greater her risk of CHD due to hormone therapy appeared to be. Although these
findings did not meet statistical significance, they suggest that the health
consequences of hormone therapy may vary by time from menopause.
These findings are
consistent with the primary publications from the WHI trials of estrogen plus
progestin and estrogen-alone (total of 27,347 participants) in showing no
overall benefit for CHD, and in suggesting that risk due to hormones may differ
depending on age or years since menopause. “Postmenopausal Hormone Therapy and
Risk of Cardiovascular Disease by Age and Years Since Menopause,” will be
published in the April 4 issue of the Journal of the American Medical
Association. In a secondary analysis, scientists reanalyze previously
collected data and findings in an effort to clarify or ask new questions. In the
case of this latest WHI analysis, the authors combined the data from the two
trials to explore in more detail the previously observed trends in hormone
effects by distance from the menopause. Differences in hormone therapy effects
were examined in three age categories (50 to 59, 60 to 69, and 70 to 79) or in
years since the onset of menopause (less than 10, 10 to 19, and 20 or more). The
Women’s Health Initiative and the newly published analyses are funded by the
National Heart, Lung, and Blood Institute of the National Institutes of Health.
The analyses also suggest
that the increased risk in heart disease due to hormone therapy in older women
is primarily in those who also have hot flashes and night sweats. Study
participants who had these symptoms were more likely to have risk factors for
CHD such as high blood pressure or high blood cholesterol, but it was not clear
whether this explained their higher risk on hormone therapy. Other results from
the analyses of the combined trials include: Confirmation that hormone therapy
increases the risk of stroke and this risk does not appear to be influenced by
age or time since menopause; Even in women within 10 years of menopause, there
appears to be an increased risk of breast cancer in women taking estrogen with a
progestin; There was a trend (not statistically significant) towards reduced
risk for death associated with hormone use in younger compared to older women.

Medicare announces measure specifications for the Physician Quality
Reporting Initiative
The Centers for Medicare and
Medicaid Services (CMS) announced the posting of detailed specifications for the
74 measures included in the 2007 Physician Quality Reporting Initiative (PQRI).
PQRI establishes a financial incentive for physicians and other health
practitioners to participate in a voluntary quality reporting program. Eligible
professionals who successfully report data for a designated set of quality
measures may earn a bonus payment, subject to a cap, of 1.5 percent of total
allowed charges for covered Medicare physician fee schedule services provided
during the reporting period of July 1, 2007 to December 31, 2007.
The 2007 PQRI quality
measures relate to important processes of care that are linked to improved
healthcare quality outcomes. They are evidence- and consensus-based measures
that reflect the work of national organizations involved in quality measure
development, consensus endorsement, and adoption. The specifications have been
posted well in advance of the statutory deadline of July 1, 2007. This is to
help eligible professionals to identify measures applicable to their practices
and to prepare for submission of quality data in advance of the July 1, 2007
start date of the program. CMS anticipates a small number of additional
specification changes, which may expand the applicability of the measures to
additional eligible professionals. The PQRI measures apply to services that
eligible professionals provide to Medicare beneficiaries in their offices and
other settings. CMS is implementing an extensive outreach and education plan to
assist eligible professionals to understand the program and the measures and to
implement processes to efficiently capture the quality data that is to be
reported under the PQRI program. The measure specifications document and other
programmatic information are available at
THIS LINK.

Vaccine
helps prevent ear infections
A
new study found that the pneumococcal conjugate vaccine (PCV7) moderately
lowered the incidence of middle ear infections and reduced the need for
pressure-equalizing ear tubes, a common surgical treatment for recurrent
infections. “Children prone to recurrent ear infections benefit from the
vaccine,” said lead study author Katherine A. Poehling, an assistant professor
of pediatrics at Monroe Carrell Jr. Children’s Hospital at Vanderbilt University
in Nashville, TN. But do not expect this scourge of childhood, which affects
more than 80 percent of children under age three and costs $5 billion to treat
each year, to go the way of whooping cough anytime soon. The reason: PCV7
prevents only a fraction of the infections that cause it.
According to the Centers for Disease Control and Prevention (CDC), the vaccine
combats the seven most common strains of pneumococcal bacteria behind otitis
media (middle ear infection). But pneumococcal bacteria cause only 30 to 55
percent of such infections; other classes of bacteria cause the rest. The PCV7
vaccine has been part of the routine immunization schedule for infants in the
U.S. since 2000. It was developed to prevent meningitis, invasive pneumonia and
other potentially deadly diseases. It is given to infants in four doses: at two,
four, six and 12 to 15 months. The findings, published in the April issue of
Pediatrics are the first to document the long-term effects of the vaccine on
middle ear infections. Study co-author J. Pekka Nuorti, a medical epidemiologist
at the CDC’s National Center for Immunization and Respiratory Diseases,
estimates that the PCV7 vaccine prevents two million cases of otitis media in
children under two years of age in the U.S. annually.
”Studies show that the number of middle ear infections caused by the
pneumococcus serotypes in the vaccine have declined dramatically, but others
have increased by 30 percent,” Nuorti said. Bacteria on the rise may be filling
the ecological void left by the decline in the vaccine’s seven pneumococcus
strains. But, he adds, two vaccines in the pipeline would cover more
pneumococcal strains, including those whose rates of occurrence are escalating.
“Parents shouldn’t think that just because their kids are getting vaccinated
that they won’t get otitis media,” said Richard Rosenfeld, director of
otolaryngology at Long Island College Hospital in New York City. “Seventy
percent to 80 percent of the tendency to get otitis media is genetic. Beyond
that are a host of factors, including smoking in the household, attending day
care and breast-feeding for the first three months of life…. The vaccine alters
that equation, but the effect isn’t dramatic.” (Scientific American)

April 4, 2007
States revising organ-donation law; critics fear measure may
not go far enough to protect donors
$500 million pledged to fight childhood obesity
RFID
Resource Center launched; Service provides knowledgebase for
healthcare supply chain
HIBCC & Partners HealthCare collaborate on patient safety
standard
10 charged in $5 million Medicare fraud
Study
suggests some drug resistance to influenza B medications
Amerinet announces agreement with Skytron for medical
supplies
WHO proposes global agenda on transplantation
This week, at the second Global Consultation on
Transplantation the World Health Organization (WHO) presented
countries and other stakeholders with a blueprint for updated
global guiding principles on cell, tissue and organ donation
and transplantation. Those principles aim to address a number
of problems: the global shortage of human materials,
particularly organs, for transplantation; the growing
phenomenon of ‘transplant tourism’ partly caused by that
shortage; quality, safety and efficacy issues related to
transplantation procedures; traceability and accountability of
human materials crossing borders. Stakeholders agreed to the
creation of a Global Forum on Transplantation to be
spearheaded by WHO, to assist and support developing countries
initiating transplantation programs and to work towards a
unified global coding system for cells, tissues and organs.
A central theme of the discussions was WHO’s concern over
increasing cases of commercial exploitation of human
materials. “Non-existent or lax laws on organ donation and
transplantation encourage commercialism and transplant
tourism,” said Dr. Luc Noel, in charge of transplantation at
WHO. “If all countries agree on a common approach, and stop
commercial exploitation, then access will be more equitable
and we will have fewer health tragedies.” Recent estimates
communicated to WHO by 98 countries show that the most sought
after organ is the kidney. Sixty-six thousand kidneys were
transplanted in 2005 representing a mere 10% of the estimated
need. In the same year, 21,000 livers and 6,000 hearts were
transplanted. Both kidney and liver transplants are on the
rise but demand is also increasing and remains unmatched.
Reports on ‘transplant tourism’ show that it makes up an
estimated 10% of global transplantation practices. The
phenomenon has been increasing since the mid-1990's,
coinciding with greater acceptance of the therapeutic benefits
of transplantation and with progress in the efficacy of the
medicines, immuno-suppressants, used to prevent the body’s
rejection of a transplanted organ.
The principles put forward by WHO underscore that the person,
whether recipient of an organ or a donor, must be the main
concern both as patient and as human being; that commercial
exploitation of organs denies equitable access and can be
harmful to both donors and recipients; that organ donation
from live donors poses numerous health risks which can be
avoided by promoting donation from deceased donors; and that
quality, safety, efficacy and transparency are essential if
society is to reap the benefits transplantation can offer as a
therapy. “Live donations are not without risk, whether the
organ is paid for or not. The donor must receive proper
medical follow-up but this is often lacking when he or she is
seen as a means to making a profit,” added Dr. Noel.
“Donations from deceased persons eliminate the problem of
donor safety and can help reduce organ trafficking.” WHO
action on transplantation will be aided by a global
observatory set up in Madrid under the auspices of the
Government of Spain. The observatory, which is linked to the
WHO Global Knowledge Base, will provide an interface for
health authorities and the general public to access data on
donation and transplantation practices, legal frameworks and
obstacles to equitable access.
States revising organ-donation law; critics fear measure may
not go far enough to protect donors
State legislatures are rewriting legislation governing organ
donations in one of the most ambitious initiatives in at least
20 years to alleviate the chronic shortage of kidneys, livers
and other body parts, an effort that some doctors and
ethicists fear tilts too far toward allowing organs to be
taken. Virginia, Idaho, Utah and South Dakota have already
adopted a model law designed to make organ donation easier by
clarifying a host of sensitive questions. An especially tricky
one is how to handle unconscious patients who signed donor
cards but also specified that they did not want to kept alive
on life-support. Another one is what doctors should do when
the family of a dying person who agreed to be a donor objects
to surgeons taking their loved one’s organs.
The measure awaits the signatures of the governors of
Arkansas, Indiana, Iowa and New Mexico. At least 17 other
states, plus the District and the U.S. Virgin Islands, are
considering the legislation. Supporters hope it is adopted
nationwide. While praised by transplant advocates, the model
law has stirred concern among some doctors and bioethicists.
Critics say it could result in people becoming donors or kept
on life support against their or their family’s wishes. And
some worry that the measure could make doctors more hesitant
about administering morphine and other drugs to make dying
patients comfortable, for fear of rendering their organs
useless for transplantation. The revised model law is the
latest in a series of initiatives by transplant advocates to
boost the number of organs available for the more than 95,000
Americans on waiting lists. Organ banks have also been
aggressively promoting a controversial practice that allows
surgeons to take organs from patients who are not brain dead,
more than doubling the number of such donations in the past
three years. “There are lots of efforts to bridge the growing
gap between demand and supply,” said Arthur L. Caplan, a
University of Pennsylvania bioethicist. “We have to be very
careful that we don’t make people think that we don’t have
their best interests in mind and are just going to use them to
get their body parts.”
The model
law, the Revised Uniform Anatomical Gift Act, updates 1968
legislation adopted by every state to make organ donation
procedures uniform nationwide. Among many changes, the measure
expands the list of people who can consent to an unconscious
patient becoming a donor, and makes it clear that a person’s
decision to be an organ donor cannot be revoked by anyone
else. The most controversial section deals with unconscious
patients who have signed donor cards but also “living wills”
or other documents that state that they do not want a
ventilator or other medical care to keep them alive, which is
sometimes necessary to maintain organ viability until a
transplant can take place. Under the act, the donor card
trumps the living will, which triggered objections from some
bioethicists and doctors who care for critically ill patients.
In response, the commission sent states substitute language
that calls for family members or others to be consulted in
such situations to try to determine what the donor would have
wanted. Those states that have approved the law already,
however, will have to wait until next year to amend it.
The measure
aims to establish more computerized registries of people who
have agreed to be donors but makes no similar provision for
those who do not want to be donors. It also gives organ
procurement organizations the power to keep potential donors
on life-support while they evaluate their organs’ suitability
for transplantation. “If there’s a patient requiring
palliative or comfort care, you treat them first. That’s
clear. This doesn’t change that balance,” said Christina W.
Strong, who represented the Association of Organ Procurement
Organizations. “What it does is make sure that to free up an
ICU bed a hospital doesn’t forget the patient may have wanted
to be a donor or their family may want them to be a donor.”
(Washington Post)

$500 million pledged to fight childhood obesity
The Robert Wood Johnson Foundation plans to spend more than
$500 million over the next five years to reverse the increase
in childhood
obesity.
It is one of the largest public health initiatives ever tried
by a private philanthropy. “This is an epidemic that is going
to cost the country in terms of morbidity and mortality and
economically,” said Dr. Risa Lavizzo-Mourey, the foundation’s
president and chief executive. “The younger generation is
going to live sicker and die younger than their parents
because of obesity.” The foundation estimates that roughly 25
million children 17 and under are obese or overweight, nearly
a third of the 74 million in that age group, according to
Census
Bureau data and a 2006 study published in The
Journal of the
American
Medical Association. Many of those children are
poor and live in neighborhoods where outdoor play is unsafe
and access to fresh fruits and vegetables is limited. “In many
cases, the environment makes it almost impossible for them to
choose healthy lifestyles,” Dr. Lavizzo-Mourey said. “We’re
going to try to change that.”
The foundation plans to invest in programs to improve access to
healthy food, encourage the development of safe play spaces,
increase research to enhance understanding of obesity and prod
governments into adopting policies to address the problem,
among other things. Experts on childhood obesity welcomed the
foundation’s plans. “Government grants for biomedical research
in general, including obesity research, are being funded at
the lowest levels I’ve seen in my career,” said Dr. David
Ludwig, director of the Optimal Weight for Life Clinic at
Children’s Hospital Boston and author of a new book, “Ending
the Food Fight.” “So we are especially dependent on
philanthropic support.” Philanthropy has long fueled
improvements in health, from John D. Rockefeller, whose money
produced a yellow fever vaccine, to Bill and Melinda Gates,
who are underwriting new health technologies and vaccines to
address a variety of global problems.
Robert Wood Johnson, who built Johnson & Johnson into one of the
world’s largest health and medical care products companies,
established his foundation at his death in 1968 with
10,204,377 shares of the company’s stock. He committed it to
improving the health of Americans. Over the last few years,
the foundation has pledged $80 million to childhood obesity
programs, like grants to the Food Trust to persuade
supermarket operators to return to poor neighborhoods. Its new
effort intends to capitalize on and enhance efforts by the
food industry and school districts and governments to address
the problem, Dr. Lavizzo-Mourey said. Several snack food
producers are making changes in their packaging and
ingredients, and three soft-drink companies said they would no
longer supply sweetened drinks to school cafeterias and
vending machines. Several states have mandated changes in
school menus, increased physical education requirements and
begun reporting students’ body mass index scores to parents.
(The New York Times)
RFID
Resource Center launched; Service provides knowledgebase for
healthcare supply chain
The Health Industry Business Communications Council (HIBCC)
has announced the launch of its new RFID Resource Center. The
Center provides information for the healthcare industry as it
considers the emerging role of radio frequency identification
technology, and is accessible to the public from the
organization’s web site. Included in the RFID Resource Center:
“RFID & HIBC: A Guideline to Implementation,” detailing the
requirements for utilizing the HIBC Supplier Labeling Standard
with RFID technology; “Understanding RFID in Healthcare:
Benefits, Limitations and Recommendations”, a comprehensive
and practical guide to RFID technology, its potential in
healthcare and the cost implications of implementation;
articles and announcements from other industries regarding
trends in RFID. The RFID Resource Center can be accessed from
the home page of the HIBCC Web site at
THIS LINK.

HIBCC & Partners HealthCare collaborate on patient safety
standard
The Health Industry Business Communications Council (HIBCC)
and Partners HealthCare System have announced their joint
development of a data standard to enhance providers’ patient
safety systems. The standard, entitled, “Positive
Identification for Patient Safety; Part 1: Medication
Delivery” defines the processes and technologies involved with
safe medication administration and management. The new
standard is being developed from work initiated by
Massachusetts General Hospital (MGH), a hospital within the
Partners HealthCare System. In 2004 MGH embarked on a project
to define and develop a safer system for the administration of
medication to its patients. The success of their efforts led
the organization to seek formal standardization of their
processes, in order that they could be easily and uniformly
implemented by other providers. HIBCC, an ANSI-accredited
standards development organization (SDO), will administer the
process to formally develop an approved data standard.

10 charged in $5 million Medicare fraud
Ten persons were indicted in federal court Tuesday, accused of
bilking Medicare out of more than $5 million for fraudulent
claims for durable medical equipment and treatments in
expensive infusion therapies intended for AIDS and HIV
patients. Raul Rodriguez and Armando Arias were accused of
committing fraud using Coral Way Professional Services and
Sunshine Health Center of Miami, as well as R&J Medical
Services and N.R. Medical Services, both located in Miami-Dade
County. The infusion therapy schemes have been widespread.
According to a governor’s office report, Florida has far fewer
AIDS/HIV cases than California or New York, but Florida
providers submitted claims for AIDS/HIV cases that were more
than three times the claims from California and five times
more than from New York, according to the report. The clinics
and their operators have been difficult for investigators to
track down because they often switch names, owners and
locations, closing quickly as investigators approach.
Tuesday’s indictment showed what investigators call a typical
pattern, in which Medicare patients were given kickbacks to
indicate they were given treatment at the clinics. Besides
Rodriguez and Arias, those indicted were Carlos Enrique
Monteagudo, Alain Rhaf Vega, Marisol Gonzalez Torres, Edith
Balog, Leonel Galdos Jr., William Balladares, Yulen Arderi and
Jannette Morales. Balog was accused of being the owner of
record of R&J from November 2002 to August 2004. Torres was
office manager and patient recruiter at Coral Way from October
2004 through March 2005, when the clinic closed. The
indictment charges that the accused received about $2.5
million in fraudulent durable medical equipment claims and
$3.2 million for false billing of infusion therapies.
Prosecutors alleged that a medical assistant was told to
tamper with blood samples to justify the HIV/AIDS therapies
and to inject patients with a salt solution rather than
medications. Rodriguez, Arias, Monteagudo, Vega, Galdos and
Balladares were also accused of money laundering in alleged
attempts to hide the money from federal authorities. Rodriguez
and Arias were also charged with witness tampering in alleged
attempts to bribe persons to get them to lie to investigators
and a grand jury. (Miami Herald)

Study
suggests some drug resistance to influenza B medications
Use of
certain common antiviral drugs during a recent influenza B
epidemic in Japan showed the development of viruses with
partial resistance to the drugs, according to a study in the
April 4 issue of JAMA. Two antiviral drugs, zanamivir
and oseltamivir, which are a type of drugs known as
neuraminidase inhibitors, have been effective against
influenza and are used extensively. There has been documented
evidence of the emergence of oseltamivir-resistant type A
viruses, but similar information on influenza B viruses has
been limited. Influenza B viruses are associated with annual
outbreaks of illness and increased death rates worldwide,
according to the article.
Shuji
Hatakeyama, M.D., Ph.D., of the University of Tokyo, Japan,
and colleagues examined the prevalence and transmissibility of
influenza B viruses with reduced sensitivity to neuraminidase
inhibitors in Japan, where zanamivir and oseltamivir are now
used more extensively than anywhere else in the world. In the
winter of 2004-2005, an influenza B virus caused a widespread
epidemic in Japan, creating an opportunity to assess the
effectiveness of neuraminidase inhibitors. The researchers
identified a variant with reduced drug sensitivity in one (1.4
percent) of the 74 children who had received oseltamivir, and
seven (1.7 percent) of the 422 influenza B viruses isolated
from untreated patients were found to have reduced sensitivity
to zanamivir, oseltamivir, or both. Review of the clinical and
viral genetic information available on these seven patients
indicated that four were likely infected in a community
setting, while the remaining three were probably infected
through contact with siblings shedding the mutant viruses.
“Continued surveillance for the emergence or spread of
neuraminidase inhibitor–resistant influenza viruses is
critically important,” the authors write. “Further evaluation
of the biological properties of neuraminidase
inhibitor–resistant influenza viruses is needed to fully
assess their pathogenicity in humans.”
In an
accompanying editorial, Anne Moscona, M.D., of Weill Medical
College of Cornell University, New York, and Jennifer
McKimm-Breschkin, Ph.D., of Molecular and Health Technologies,
Parkville, South Victoria, Australia, comment, “The report by
Hatakeyama et al raises more questions than it answers,
including questions about viral evolution, biological fitness,
and transmissibility. But some facts are strikingly clear.
Influenza B mutants with reduced sensitivity to neuraminidase
inhibitors are circulating, and these viruses can cause
infections with no difference in duration of symptoms, level
of viral shedding, or clinical outcome. Contrary to what had
been hoped until now, some resistant variants are vigorous
pathogens. Whether these viruses arise by spontaneous mutation
or through drug selection, or whether they are transmitted
within families or acquired from the community, the resistant
variants may be here to stay. In light of the recent
observation that oseltamivir may be less effective against
influenza B than against influenza A, an important concern is
whether suboptimal dosing for these viruses will lead to
increased selection of viruses with high-level resistance.”
“Influenza viruses evolve rapidly and nimbly, which compels
ongoing investigation of antiviral therapies that use
alternative mechanisms of action and target different points
in the viral life cycle. The emergence of drug-resistant
influenza B should draw attention to the importance of
continual monitoring of strains over time and to the need for
frequent rethinking of policies for use of antiviral drugs.
While the news about resistance is not good and certainly
calls into question some of the current assumptions about
drug-resistant viruses, an effective response to this news can
help contend with the new challenges of influenza.”
Amerinet announces agreement with Skytron for medical
supplies
Amerinet
announces its agreement with Skytron, Division of the KMW
Group for medical supplies. Effective through March 31, 2010,
this agreement includes Skytron’s patient examination and
procedure lighting. Skytron products include: portable, fixed
and recessed lighting that is ideal for any size and type of
health care facility. This contract was a result of a
competitive bidding process. For more information see
THIS LINK.

April 3, 2007
Mammograms for women in their 40s should be
based on individual
AHRMM &
Arizona State University Partner on Healthcare Supply Chain
Benchmarking Initiative
Is it the flu? Get the fast flu test
Medicare announces competitive acquisition
program for certain DME, prosthetics, orthotics, and supplies
NIAID expands capability for
influenza research and surveillance
HealthGrades patient-safety study shows
hospital errors rise 3 percent
Patient safety incidents at the nation’s hospitals rose three percent over the
years 2003 to 2005, but the nation’s top-performing hospitals had a 40 percent
lower rate of medical errors when compared with the poorest-performing
hospitals, according to the largest annual study of patient-safety issued by
HealthGrades, the leading independent healthcare ratings company.
The HealthGrades study of 40.56 million Medicare
hospitalization records over the years 2003 to 2005 found: Patient-safety
incidents continue to rise in American hospitals, with 1.16 million preventable
patient-safety incidents occurring over the three years studied among Medicare
patients in the nation’s hospitals, an incidence rate of 2.86 percent; 247,662
deaths were potentially preventable over the three years, and Medicare patients
who had one or more patient-safety incidents had a one-in-four chance of dying;
The excess cost to hospitals was $8.6 billion over three years, with some of the
most common incidents proving to be the most costly; Ten of the 16
patient-safety incidents tracked worsened from 2003 to 2005, by an average of
almost 12 percent, while seven incidents improved, on average, by six percent.
Patient-safety incidents with the greatest increase in incident rates were post
operative sepsis (34.28 percent), post-operative respiratory failure (18.70
percent) and selected infections due to medical care (12.23 percent); and
Patient-safety incidents with the highest incidence rates were decubitus ulcer,
failure to rescue and post-operative respiratory failure.
Of the nearly 5,000
hospitals studied, the HealthGrades study identified 242 hospitals, those in the
top five percent of all hospitals, to serve as a benchmark against which other
hospitals can be evaluated, naming them Distinguished Hospitals for Patient
Safety. On average, these hospitals had a 40 percent lower rate of
patient-safety incidents when compared with the poorest-performing hospitals. If
all hospitals performed at the level of the Distinguished Hospitals for Patient
Safety, the study found: Approximately 206,286 patient-safety incidents and
34,393 Medicare deaths could have been avoided; and $1.74 billion could have
been saved.
To be ranked in overall patient-safety performance,
hospitals had to be rated in at least 19 of the 28 procedures and diagnoses
rated by HealthGrades and have a current overall HealthGrades star rating of at
least 2.5 out of 5.0. The final ranking set included 752 teaching hospitals and
857 non-teaching hospitals. The top 15 percent, or 242 hospitals, were
identified as Distinguished Hospitals for Patient Safety, and represent less
than five percent of all U.S. hospitals examined in the study. The study says,
“Despite the flurry of research, publications and process improvement activity
that has occurred since the IOM report there is a growing consensus that not
much progress has been made leading to a visible national impact. Our findings
support this consensus. However, our findings also support that progress
continues to be made at the top. Distinguished Hospitals for Patient Safety
continue to lead the nation in providing safer care…resulting in much lower
costs to society. We believe that Distinguished Hospitals have deliberately
chosen and maintained patient safety as a top priority.” For more information
CLICK HERE.

Mammograms for women in their 40s should be based on
individual
Should all women in their 40s be routinely screened for breast cancer? Not
necessarily, according to the American College of Physicians. In a new set of
guidelines for clinicians of 40-something patients, the group recommends that
mammography screening decisions be made on a case-by-case basis. It advises
clinicians to discuss the benefits and harms of screening with the patient, as
well as each woman’s individual cancer risk and preference about screening. The
organization based its recommendations, which will be published in the April 3
issue of Annals of Internal Medicine, on a rigorous review of evidence
showing there is variation in the benefits and harms associated with mammography
among women in their 40s. The American College of Physicians is the leading
professional organization for internal medicine specialists, with a membership
of 120,000.
“There are important
benefits to screening mammography, but we believe the decision to be screened
should be based on an informed conversation between a patient and her
physician,” said health policy expert Douglas K. Owens, MD, MS, a researcher
with the Veterans Affairs Palo Alto Health Care System and a professor of
medicine at the Stanford University School of Medicine, who chaired the
committee that developed the guidelines. “In our view, the evidence doesn’t
support a blanket recommendation for women in this age group.”
Breast cancer is the
second-leading cause of cancer related death among women in the United States;
according to the American Cancer Society, 25 percent of all diagnosed cases are
among women younger than age 50. Among these younger women, the risk of breast
cancer varies greatly, from less than 1 percent for a 40-year-old woman with no
risk factors to 6 percent for a 49-year-old woman with multiple risk factors,
which include family history of breast cancer, older age at the birth of her
first child and younger age at the onset of menstruation. While it is
well-established that mammography reduces mortality from breast cancer in 50- to
70-year-old women, and that women in this age-group should be routinely
screened, the evidence isn’t as clear-cut for younger women.
Because of the ongoing
controversy, the American College of Physicians’ Clinical Efficacy Assessment
Subcommittee decided to take its own look at the evidence related to screening
in women in their 40s. After their review, the group concluded that screening
mammography for women in this age group likely provides a modest reduction in
breast cancer mortality, but, as with any screening intervention, it also comes
with the risk of potential harms. Based on this, it recommended that clinicians:
Periodically perform individualized assessment of risk for breast cancer to help
guide decisions about screening mammography; Inform women ages 40 to 49 of the
potential benefits and harms of screening mammography; Base screening
mammography decisions on benefits and harms of screening as well as a woman's
preferences and breast cancer risk profile. In the new guidelines, the
organization emphasizes the importance of using a woman’s concerns about breast
cancer and screening to help guide decision-making about mammography. Women’s
thoughts about mammography or their risks of developing breast cancer will
likely vary greatly, the group notes, but it expects the potential reduction in
breast cancer mortality associated with screening to outweigh other
considerations for many women. “We still think many women will choose to get
mammography, and we're supportive of that,” said Owens. “The most important
thing is that women be well-informed about the decision they're making.”
AHRMM & Arizona State University Partner on Healthcare Supply
Chain Benchmarking Initiative
The
Association for Healthcare Resource & Materials Management (AHRMM) has partnered
with the W. P. Carey School of Business at Arizona State University (ASU) to
establish the
Healthcare
Supply Chain Benchmarking and Performance Improvements Metrics,
an initiative that aims to advance and improve healthcare supply chain
performance analysis over the next two years. Through the partnership, AHRMM and
ASU will develop an online benchmarking and performance improvement tool using
well established research method techniques that have been successfully applied
to improving supply chain performance in other industries. This tool will allow
hospitals and providers to compare their performance with organizations of
similar size and operation. The
Healthcare
Supply Chain Benchmarking and Performance Improvements Metrics
is in the
first phase of development.
“Despite
past success with benchmarking, healthcare organizations still need a
consistent, actionable, and credible measure to ensure accurate comparisons and
reporting of financial and other supply chain measures,” said Deborah
Sprindzunas, AHRMM’s executive director. “By identifying and developing
effective indicators of supply chain performance as well as metrics for
evaluating partner performance, AHRMM and ASU’s new tool will lead the way
toward consistent, transferable performance analysis.”
During the
first phase the research team plans to engage industry experts in the
identification, evaluation, and selection of target metrics for the healthcare
field. The second phase involves development of a data capture and online
benchmarking tool for use by practicing supply chain managers. The third phase
moves this project to initial data collection and model validation activities
where a sample of targeted organizations will provide data for validating the
metric definitions and testing the use of the benchmarking and analysis tool.
During the final phase, full scale data collection commences.
“The
Healthcare Supply Chain Benchmarking and Performance Improvements Metrics
will not
only enable organizations to determine the best performer, it will also
determine best known practices and capabilities that have yet to be adopted by
the majority of the industry,” explained Vicki Smith-Daniels, Professor of
Supply Chain Management, W.P. Carey School of Business, Arizona State
University. Associations representing various healthcare professions will be
invited to participate in benchmarking and performance improvement analysis on a
frequent basis, allowing for longitudinal analysis of supply chain performance
improvement in the field of healthcare.
For more information
CLICK HERE.
Is it the flu? Get the fast flu test
Fast flu tests, which drastically cut the time to diagnose a patient with
influenza or not, are helping doctors better treat the illness, according to a
recent study and medical experts. Timing is key in treating the flu, said Dr.
Greg Poland of the Mayo Clinic in Rochester, MN. If diagnosed early enough, from
24 to 48 hours after a patient first shows symptoms, a treatment of antiviral
drugs can alleviate the severity of symptoms, cut down on the number of days
sick and decrease potential complications, Poland said. “I think all through my
career, what the medical system tried to teach people is that when you have a
virus or influenza, don’t come in because there is nothing we can do,” Poland
said. “Now, what we are saying is that medical science has advanced.”
The rapid diagnostic tests
can take anywhere from five to 30 minutes to come up with a diagnosis. In
contrast, results for a traditional viral culture test can take several days to
a week. The rapid tests generally involve a nasal or throat swab and can be
examined in the doctor’s office. A viral culture also usually collects a fluid
sample that is sent to a laboratory. The use of these rapid tests has been
growing during the past few years and more than 10 variations of the tests have
been approved by the Food and Drug Administration, the CDC said. Depending on
the test used and if conducted properly, they register about a 70 percent
accuracy rate in diagnosing whether a patient has the flu and are about 90
percent specific in figuring out what type of flu it is, the CDC said. “Done
improperly, and I think a lot get done improperly, the sensitivity falls
dramatically,” Poland said. The traditional culture tests are more consistently
accurate and they can distinguish between flu subtypes with more specificity.
“The gold standard is still a culture, but the gold standard is not timely,
hence its usefulness in diagnosis and treatment is limited,” Poland said.
Research shows the tests are having an effect on treatment.
Rapid testing has led to a decreased use of antibiotics in the treatment of
children with the flu, according to a recent study conducted by Rochester
General Hospital and the University of Rochester School of Medicine and
Dentistry. The tests also have helped lead to shorter hospital stays for kids
and lessened the amount of extra laboratory testing, the study said. The
diagnostic tests also could be a benefit for the public health sector because
they make it easier to keep track of test results. In some cases, especially
with longer laboratory testing periods, different doctors and nurses may handle
the testing process and reporting the results to public health agencies gets
lost in the shuffle, Poland said. However, with a rapid test, where results are
in-house and the process is shorter, the reporting is more accurate.
Consequently, surveillance of possible outbreaks across the country is enhanced,
doctors said.
Context plays an important role in deciding when to use the
test, said Dr. Henry Bernstein of the Children’s Hospital at Dartmouth in New
Hampshire and also a member of the American Academy of Pediatrics’ committee on
infectious diseases. For example, early in the season, the U.S. flu season can
last from late December through March, the rapid tests are useful because many
patients mistake symptoms of other illnesses for the flu, he said. However, in
the midst of the flu season when a specific community might be overrun by the
illness, the tests might be impractical or a waste of money. The reasons for
being judicious in using the tests, especially if done improperly, increasing
the chances of an inaccurate diagnosis, are twofold, doctors say. Antiviral
doses are limited each flu season and prescribing them indiscriminately could
build a resistance to the drugs in the community, doctors say. The rapid
diagnostic tests have been around for several years and are widely used, with
some insurance plans covering them. Yet only now are people growing more aware
of them, said Poland. (CNN)
Medicare announces competitive acquisition program for
certain DME, prosthetics, orthotics, and supplies
The
Centers for Medicare & Medicaid Services (CMS) issued a final rule that will
reduce beneficiary out-of-pocket costs, improve the accuracy of Medicare’s
payments for certain durable medical equipment, prosthetics, orthotics, and
supplies (DMEPOS), help combat supplier fraud, and ensure beneficiary access to
high quality DMEPOS items and services through a new competitive bidding
program. In 2008, the competitive bidding program will operate in competitive
bidding areas (CBAs) within 10 of the largest Metropolitan Statistical Areas (MSAs),
excluding the New York, Los Angeles, and Chicago MSAs and will apply to 10 of
the top DMEPOS product categories based on criteria outlined in the final
rule. The program will be expanded into 70 additional MSAs in 2009. After 2009,
CMS will expand the program to additional areas and items.
The new
competitive bidding program, which is required by the Medicare Prescription
Drug, Improvement & Modernization Act of 2003, will replace the current payment
amounts, for the items being bid, under Medicare’s DMEPOS fee schedule with
payment rates derived from the bidding process. Suppliers that wish to furnish
competitively bid items in a CBA will be required to submit bids to furnish
those items. Contracts will be awarded to a sufficient number of winning bidders
in each CBA to ensure access and service to high quality DMEPOS items. The
winning bids will be used to establish a single Medicare payment amount for each
item. For beneficiaries in the selected CBAs, this program will reduce
out-of-pocket expenses while ensuring that they receive high quality items and
services. This is because the rule requires all contracting suppliers to be
accredited by an approved accreditation organization as meeting CMS’ quality
standards. CMS has designated 10 entities as qualified to accredit DME
suppliers, based on quality standards that were posted on the CMS website in
August 2006.
The single payment amounts established through competitive bidding will be lower
than the current fee schedule amounts for the items. In addition, contract
suppliers must accept the single payment amount established through competitive
bidding as payment in full. The beneficiary’s liability is limited to 20 percent
of the payment amount and any unmet Part B deductible. For taxpayers, the
competitive bidding program means potentially significant savings for
Medicare. When fully implemented in 2010, it is projected that these savings
will amount to $1 billion annually.
CMS is
creating a limited exception to the competitive bidding requirement that will
allow certain treating professionals to furnish items on the competitive bidding
list to their own patients without having to participate in bidding and without
becoming a contract supplier. This exception would apply to certain specified
items furnished by physicians, physician assistants, clinical nurse specialists,
nurse practitioners, occupational therapists in private practice, and physical
therapists in private practice. The item must be furnished as part of their
professional services.
CMS has
included in the final rule a number of provisions that will modify the rule’s
impact on small suppliers. CMS worked closely with the Small Business
Administration to establish a new definition of small suppliers that is
reflective of this area of the health care industry. The use of this new
definition, in conjunction with policies established in the final regulation,
will enhance the ability of small suppliers to participate in the competitive
bidding program. The final rule will be published in
the Federal Register on April 10. For more information
CLICK HERE.
NIAID expands capability for influenza research and
surveillance
The
National Institute of Allergy and Infectious Diseases (NIAID), part of the
National Institutes of Health (NIH), announced it is awarding $23 million per
year for seven years to establish six Centers of Excellence for Influenza
Research and Surveillance. Collectively, the centers will expand NIAID’s
influenza surveillance program internationally and in the United States, and
will bolster influenza research in key areas, including understanding how the
virus causes disease and how the human immune system responds to infection with
the virus. The goal of the newly created centers is to provide the federal
government with important information to inform public health strategies for
controlling and lessening the impact of seasonal influenza as well as an
influenza pandemic.
The new
awards build upon an ongoing program led by St. Jude Children’s Research
Hospital in Memphis, TN, initiated by NIAID after the 1997 Hong Kong outbreak of
highly pathogenic avian influenza in humans. NIAID is expanding the surveillance
and research program to now include six Centers of Excellence for Influenza
Research and Surveillance, residing at St. Jude Children’s Research Hospital,
Memphis, University of California at Los Angeles, University of Minnesota,
Minneapolis, Emory University, Atlanta, Mount Sinai School of Medicine, New York
City and University of Rochester, Rochester, NY.
Their
work will include determining the prevalence of avian influenza in animals that
routinely come into close contact with people; understanding how flu viruses
evolve, adapt and transmit infection; and identifying immunological factors that
can determine whether a flu virus causes only mild illness or death.
Additionally, some centers will monitor for international and domestic cases of
animal and human influenza to rapidly detect and characterize viruses that may
have pandemic potential and to create vaccine candidates targeted to those
viruses. Ultimately, these studies will lay the groundwork for developing new
and improved control measures for emerging and reemerging flu viruses. For more
information CLICK HERE or
CLICK HERE.

Family members most often source of
whooping cough in young infants
Infants with whooping cough were most likely infected by the people they live
with, according to a multi-country study led by researchers from the University
of North Carolina at Chapel Hill School of Public Health. The study found that
parents were the source of pertussis, commonly known as whooping cough, in 55
percent of infants. In all, household members including siblings, aunts and
uncles, cousins and grandparents were responsible for 75 percent of pertussis
cases among infants for whom a source could be identified. The results appear in
the April 2007 issue of the Pediatric Infectious Disease Journal.
Although pertussis vaccination has reduced the number of
reported cases in industrialized countries by more than 95 percent from what it
was in the 1950s, the number of reported pertussis cases in the United States
has tripled in the past two decades. “It is important to understand how the
disease is spread, particularly to infants who are too young to be vaccinated
themselves, so that steps can be taken to prevent infections in these vulnerable
infants and potentially save lives,” said Dr. Annelies Van Rie, assistant
professor of epidemiology in the UNC School of Public Health and the study’s
senior author. “It is troubling to learn that infants are often infected with
pertussis by their own family members, who are often unaware of having pertussis
themselves, and in whom pertussis could have been prevented if they had received
a pertussis booster vaccination,” she said.
The study, funded by grants from the Institut Pasteur
Foundation, Sanofi Pasteur and Sanofi Pasteur-MSD, was conducted over a 20-month
period in four countries, Canada, France, Germany and the United States. The
researchers found that among infants with pertussis for whom the source case
could be identified, parents were the primary source of pertussis in infants,
followed by siblings (16 percent), aunts/uncles (10 percent), friends/cousins
(10 percent), grandparents (6 percent) and part-time caregivers (2 percent).
“Ongoing research, such as this study, demonstrates that adolescents and adults
can transmit pertussis to infants,” Van Rie said. “Pertussis immunization of
adolescents and adults, especially those in contact with young infants would not
only protect themselves form pertussis, but would also protect young infants
from pertussis and could save lives.”
Newborns who are too young to be fully vaccinated against
the disease are more vulnerable to severe pertussis and face the possibility of
serious complications and even death. Infants account for more than 90 percent
of pertussis deaths in the U.S. The disease is spread though airborne droplets
that are transmitted when an infected person coughs or sneezes. The infected
person may look and feel healthy between episodes of coughing. If left
untreated, people infected with pertussis can spread the disease for several
weeks.
Reports
of pertussis have increased most dramatically among adolescents and adults. This
is partly because pertussis immunity from early childhood vaccinations wears
off, leaving adults and adolescents susceptible to the disease. Most adolescents
and adults are not diagnosed with pertussis because they frequently have milder
cases of the disease and physicians still perceive pertussis as a childhood
disease. The U.S. Centers for Disease Control and Prevention now recommends that
adults and adolescents be given a tetanus-diphtheria-pertussis booster (Tdap) in
place of the tetanus-diphtheria (Td) booster to reduce the burden of pertussis
in the United States.

April 2, 2007
Dengue surging in Mexico,
Latin America
Universal red blood cells
could relieve blood bank shortages
Conflict-of-interest inquiry
may be reopening at NIH
Russia sees
ill effects of ‘General Winter’s’ retreat
CHeS Webinar series
focuses on benefits of synchronized product data across the health care industry
Amerinet signs exclusive agreement with Ohio Valley Hospital
Consortium
Premier acquires CareScience,
strengthening ability of hospitals to improve quality
while safely reducing cost
On Friday, March 30, 2007,
Quovadx, Inc. and Premier Inc. simultaneously signed a definitive agreement and
closed the related transaction wherein Premier purchased all outstanding shares
of CareScience stock for $34.9 million, or a multiple of approximately 2.3 times
CareScience's 2006 revenue. The transaction was approved by the Boards of
Directors of both Quovadx and Premier. The final purchase price is subject to
certain post-closing adjustments, including the final calculation of working
capital for CareScience as of March 31, 2007. The sale is not expected to result
in any income taxes due from Quovadx.
"CareScience's robust
clinical analytics, research capabilities and dedicated employees enhance
Premier's industry-leading capabilities for improving healthcare quality while
safely reducing the cost of care," said Stephanie Alexander, Premier senior vice
president. "We look forward to creating new and enhanced solutions that will
provide hospitals and health systems greater access to the expertise, clinical
research and knowledge-sharing they need to meet the critical challenges facing
healthcare today."
Together, Premier and
CareScience serve more than 900 hospitals. CareScience's physician-accepted,
clinical expertise complements Premier's process improvement focus and
unparalleled database of hospital comparative data. Premier’s Performance Suite
is a single source for integrating quality and safety, labor management, and
supply chain efficiency. It provides Web-based performance measurement and
benchmarking, real-time surveillance and best practices to help improve quality
and reduce costs. CareScience works with hospitals to use comparative data as
the basis for implementing clinical quality improvement plans that optimize
patient outcomes and operational performance, increase staff efficiency and
reduce costs.
“The acquisition of
CareScience further demonstrates Premier’s commitment to its long-term goal of
reshaping American healthcare in ways that make it the safest, most effective
and efficient system in the world,” said Susan DeVore, Premier’s chief operating
officer. “The greatest challenge for hospitals today is improving quality of
care while safely reducing costs. Today’s agreement will help hospitals across
the nation meet that challenge.”
In a second transaction
Sunday, April 1, 2007, Quovadx Inc. and Battery Ventures entered into an
agreement wherein Battery Ventures will acquire 100 percent of the outstanding
shares of the common stock of Quovadx, Inc. for $136.7 million payable to
Quovadx stockholders. Stockholders are therefore expected to receive $3.15 per
share, subject to certain post-closing adjustments. The estimated per share
price includes the net proceeds from the March 30, 2007 sale of the Company's
CareScience division.
New York
Times: Some
hospitals call 911 to save their patients
Should a hospital be able to handle a medical emergency? Patients at some
hospitals may find the staff resorting to what someone might do at home in a
crisis: call 911 for an ambulance. That happened recently in Texas, where a
44-year-old man named Steve Spivey developed breathing problems after spine
surgery. No physician was working there when the staff first recognized he was
in trouble. They phoned 911, and he was taken to a nearby full-service hospital,
where he was pronounced dead a short time later. The episode occurred at a small
hospital that is owned and run by doctors, one of roughly 140 such hospitals
around the country, with nearly two dozen more under development, that are set
up to specialize in certain types of procedures like heart surgery, back
operations and hip replacements. These hospitals have been assailed for
cherry-picking the most profitable procedures from the nation’s 4,500 or so
full-service hospitals. Critics have argued that the doctors have a financial
incentive in sending patients to their own facilities, even when those patients
might be better off having their surgery in regular hospitals. But the Texas
case, and others like it, have invited new scrutiny from regulators and members
of Congress about these hospitals’ ability to care for patients who suffer
complications after their operations.
While some of these hospitals are large sophisticated operations, like those
hospitals specializing in cardiac care, others are much more modest. Small
surgical hospitals may not have separate emergency facilities or, as in the
Texas case, a doctor on site at all times during a patient’s recovery. As the
number of doctor-owned surgical hospitals grows, federal and state officials now
acknowledge that the government rules may be too vague about the emergency
abilities a hospital must have in place. Regulators are particularly concerned
about the very small hospitals that focus on only a few kinds of surgery but
perform operations that frequently require an overnight stay. While Medicare’s
rules currently say a hospital must “meet the emergency needs of patients in
accordance with acceptable standards of practice,” the details are left largely
to the hospital’s discretion. Federal and state officials say they are now
reviewing the guidelines to toughen the rules and make them more specific.
Medicare recently terminated its agreement with the facility involved in the
Texas case, West Texas Hospital, a 14-bed hospital in Abilene that performed
procedures ranging from plastic surgery to complex spine operations.
Although the chief executive
of West Texas Hospital defended its practices, he said it would not appeal the
government’s decision. The hospital has since closed.
The doctors who set up the specialized hospitals defend them by saying that by
running the centers themselves and concentrating only on certain procedures,
they can provide the best results for patients. Proponents of the specialty
hospitals say the Abilene and such cases are aberrations that critics are
exploiting to defend the turf of full-service hospitals. They say they are able
to handle their patients’ medical emergencies, whether or not they have
emergency departments. But some members of Congress are now pushing Medicare to
take a closer look at how such hospitals are regulated. “The problem with
physician-owned specialty hospitals is that decision-making is more likely to be
driven by financial interest rather than patient interest,” said Senator Charles
E. Grassley, (R-IA). “You see it in the cherry-picking of patients, and with
policies that instruct hospital staff to call 911 for the local community
hospital if emergency care is needed,” said Grassley, a ranking member of the
Senate Committee on Finance, which oversees Medicare. Congress has asked for
various reports on the issue, including a comprehensive analysis last year by
the federal Department of Health and Human Services. (The New York Times) To
read the full article
CLICK HERE.

Dengue
surging in Mexico, Latin America
The deadly hemorrhagic
form of dengue fever is increasing dramatically in Mexico, and experts predict a
surge throughout Latin America fueled by climate change, migration and faltering
mosquito eradication efforts. Overall dengue cases have increased by more than
600 percent in Mexico since 2001, and worried officials are sending special
teams to tourist resorts to spray pesticides and remove garbage and standing
water where mosquitoes breed ahead of the peak Easter Week vacation season. Even
classic dengue, known as “bonebreak fever”, can cause severe flu-like symptoms,
excruciating joint pain, high fever, nausea and rashes. More alarming is that a
deadly hemorrhagic form of the disease, which adds internal and external
bleeding to the symptoms, is becoming more common. It accounts for one in four
cases in Mexico, compared with one in 50 seven years ago, according to Mexico’s
Public Health Department.
While hemorrhagic dengue
is increasing around the developing world, the problem is most dramatic in the
Americas, according to the Centers for Disease Control and Prevention. Dengue is
driven by longer rainy seasons some blame on climate change, as well as
disposable plastic packaging and other trash that collects water. Migrants and
tourists, including the many thousands of Americans expected for spring break
this year, carry new strains of the virus across national borders, where
mosquitoes can spread the disease. The CDC says there’s no drug to treat
hemorrhagic dengue, but proper treatment, including rest, fluids and pain
relief, can reduce death rates to about 1 percent. Latin America’s hospitals are
ill-equipped to handle major outbreaks, and officials say the virus is likely to
grow deadlier, in part because tourism and migration are circulating four
different strains across the region. A person exposed to one strain may develop
immunity to that strain, but subsequent exposure to another strain makes it more
likely the person will develop the hemorrhagic form. This dengue spread “is one
of the primordial public health problems the country faces,” said Mexico’s
Public Health Department, which has sent hundreds of workers to the resorts of
Puerto Vallarta, Cancun and Acapulco to try to avert outbreaks ahead of the
Easter week vacation. “We are working intensively, both the federal and state
governments, on (these) three sites that we want to keep under control, so that
it doesn’t become a risk for tourists,” said Pablo Kuri, head of Mexico’s
National Center for Epidemiology and Disease Control.
The Canadian Embassy in
Mexico City issued an alert about dengue after five Canadians were sickened in
Puerto Vallarta earlier this year. Acapulco, a city of 700,000, has documented
549 cases of classic and hemorrhagic dengue in the first two months of 2007, up
from just 86 for the same period last year. In January and February, Mexico’s
dry season, there were 1,589 cases of both types of dengue nationwide, up 380
percent from the same period in 2006, Kuri said. And last year was also bad for
dengue: Mexico documented 27,000 infections overall, including 4,477 hemorrhagic
cases and 20 deaths, compared with 1,781 cases overall in 2001. Dengue has been
found along the U.S.-Mexico border, where 151 classic and 46 hemorrhagic cases
were recorded last year in the Gulf state of Tamaulipas, south of Texas. The
Intergovernmental Panel on Climate Change, made up of the world’s leading
climate scientists, predicted in March that global warming and climate change
would cause an upsurge in dengue. The global solution to dengue outbreaks is
mosquito control, and faltering eradication efforts, together with climate
change, probably share blame for dengue’s rise in the Americas, Kuri said.
(Associated Press)
Severe dengue infections may go
unrecognized in international travelers
Severe cases of a common travelers’ infection may not be recognized if doctors
rely on the World Health Organization’s (WHO) guidelines for identifying it,
according to a new study published in the April 15 issue of The Journal of
Infectious Diseases, now available online. Dengue is the most important
emerging disease among international travelers, with a 30-fold increase in
incidence over the past 50 years worldwide. Like malaria, dengue is transmitted
to humans by mosquitoes. Most cases are mild. Symptoms include fever, rash,
headache, pain behind the eyes, and muscle and joint pain.
According to the WHO, dengue hemorrhagic fever (DHF) is
characterized by fever, low platelet count, clinical evidence of leaking
capillaries, and spontaneous bleeding or fragile blood vessels. The most serious
cases can lead to shock and death. There is no cure for dengue infection, but
management of the disease’s effects can prevent the worst outcomes. The study,
conducted by Ole Wichmann, MD, MCTM, DTM&H, at the Robert Koch Institute in
Berlin, Germany, and colleagues throughout Europe, collected data through the
European Network on Surveillance of Imported Diseases at 14 sites in 8 European
countries.
Out of more than 200 patients treated for dengue infection
at these sites over two years, less than 1 percent fit all four criteria
necessary to meet the WHO definition of DHF. However, 11 percent had at least
one manifestation of severe dengue disease, and a total of 23 percent required
hospitalization due to dengue-related symptoms. “Dengue exists more as a
continuous spectrum,” Dr. Wichmann said. “Severe disease can be present in
patients who do not fulfill all four DHF criteria.” “The term ‘dengue
hemorrhagic fever’ puts undue emphasis on bleeding,” he added, noting that
plasma leakage and shock can occur without it. “Clinicians who mainly focus on
bleeding...may miss the most important conditions that require hospitalization
and treatment.”
Their findings also showed that travelers who acquire a
second dengue infection are more at risk for severe cases of dengue, although
some patients had severe symptoms when infected during their first trip to a
dengue-endemic country. It is becoming more and more crucial that health care
providers understand the clinical spectrum of dengue and its diagnosis. “Given
the increase in business travel and other travel, and the global spread of
dengue fever, these findings have important implications for the future burden
of severe imported dengue infections,” Wichmann said. As a next step to their
study Wichmann highlighted the need for more inquiry into a clinical definition
of dengue. “In order to perform more uniform surveillance and research,
including vaccine trials, studies are urgently needed to establish new and more
robust definitions for severe dengue.”

Universal red blood cells could relieve blood bank shortages
An
international team of academic and industry scientists has come up with a
feasible way of making universal red blood cells that are stripped of their
blood type. The hope is that it can be developed into a viable way of relieving
blood bank shortages. The study is published in the early online edition of the
journal Nature Biotechnology. The idea of “universal red blood cells” has
been around for some time and its feasibility has been demonstrated in clinical
trials. For example, scientists in the US about 25 years ago managed to use a
coffee bean glycosidase enzyme to strip the B antigen from red blood cells. But
the process proved to be impractical.
In the new
study, a team of scientists led by Professor Henrik Clausen from the University
of Copenhagen in Denmark, found a more abundant source of glycosidase enzymes in
bacteria. They found two bacterial glycosidase gene families with enzymes that
efficiently remove A and B antigens from red blood cells (RBCs). Prof Clausen
and colleagues conclude that “The enzymatic conversion processes we describe
hold promise for achieving the goal of producing universal RBCs, which would
improve the blood supply while enhancing the safety of clinical transfusions”.
The university scientists worked with US industry scientists from ZymeQuest in
Beverly, MA. The next step is to start clinical trials to test the method’s
treatment safety and efficiency. (Medical News Today)

Conflict-of-interest inquiry may be reopening at NIH
Federal
investigators are reviewing the activities of 103 scientists who may have had
improper links to pharmaceutical companies while they were employed at the
National Institutes of Health, apparently resurrecting a conflict-of-interest
inquiry that many in the agency thought was closed. In a letter sent to several
members of Congress on March 23, Daniel R. Levinson, inspector general for the
Department of Health and Human Services, said his office is looking into the
cases “to determine whether investigation is warranted.” Levinson also wrote
that his office is reviewing whether NIH is adequately
monitoring potential conflicts of interest among its thousands of grant
recipients, typically university researchers. Members of Congress and watchdog
groups have long called for such a review, noting that conflict-of-interest
policies at universities are generally more lenient than those at NIH. The
concern, critics say, is that federal grant money not go to scientists who may
be predisposed to get results that favor their drug company sponsors.
Scientific and academic organizations counter that adequate
safeguards are already in place and fear that many of the nation’s best
scientists would leave the federally funded research enterprise if options for
outside income were lost. NIH officials had already looked into the 103 cases of
possible conflict of interest in 2004, after a congressional inquiry suggested
that scores of researchers may have taken drug industry money without approval.
As a result of that investigation, NIH Director Elias A. Zerhouni in 2005 banned
all such consulting by NIH employees. Agency investigators concluded that about
half of those who were suspected of wrongdoing and who were still employed at
NIH (and thus available for questioning) had indeed violated policies, including
10 who the agency concluded may have violated federal law. NIH referred only
those 10 cases to the HHS Office of Inspector General (OIG), which referred two
to the Justice Department for possible prosecution. One resulted in a conviction
for criminal conflict of interest; the other is still pending. With new ethics
policies in place and the 2008 budget fight starting, many in the agency had
hoped that the worst was behind them. But the Levinson letter suggests not.
A spokesman for Levinson said he was not at liberty to say why the
OIG had renewed its interest in the cases. But the letter, made public by the
House Energy and Commerce Committee, which has spearheaded inquiries into NIH
for years, said the review began about six months ago. That is about when
committee members complained loudly that too many of those who were found to
have violated NIH rules had gotten off with only modest disciplinary action. In
a joint statement released yesterday, Energy and Commerce Chairman
John D. Dingell
(D-MI) asserted that “NIH bungled the investigation the first time around,” and
ranking Republican
Joe L. Barton (TX)
expressed hope that the inquiry “will finally sort things out so everyone can
have confidence that the public's interest is being fully served.” NIH spokesman
John Burklow said: “We welcome the additional
review; however, we are confident in the rigor of our process.” (Washington
Post)
Russia sees ill effects of ‘General Winter’s’ retreat
Experts
have long feared that Earth’s warming climate would cause tropical diseases such
as malaria to spread into more temperate zones, but a dramatic example of an
apparently climate-related disease outbreak cropped up this winter in a cold
place, Russia. More than 3,000 cases of infections caused by hantaviruses have
been reported so far in Russian cities and towns, including many that are within
a few hundred miles of Moscow, such as Voronezh and Lipetsk. The viruses can
cause a serious, and sometimes deadly, disease known as hemorrhagic fever with
renal syndrome, or HFRS. During Russia’s more typically frigid winters,
scientists believe, HFRS-causing viruses die off in the consistently below-zero
temperatures. But this winter has been anything but cold. On Dec. 7 Moscow hit a
record 46 degrees Fahrenheit. HFRS was last on a rampage in Russia in 1997,
coinciding with another very warm winter. By mid-spring that year, the number of
cases reached more than 20,000. The viruses are transmitted to humans when
infected mice set up housekeeping in the nooks and crannies of homes, barns,
sheds and other buildings. If droppings left by the mice are disturbed, the
viruses waft up and out of the excretions like a miasma, infecting people who
breathe the air.
Biologists estimate that the current population of rodents in Russia is 10 times
as high as in previous years, and that one in three mice is infected with an
HFRS-causing virus. Most researchers attribute the spike to the unusually warm
weather, although some think a natural cycle in mouse populations may play a
role. “Global warming has tipped a balance,” said Irina Gavrilovskaya, a
scientist and physician at the State University of New York at Stony Brook who
has conducted research on HFRS at the Russian Academy of Medical Sciences in
Moscow. “Because of the lack of snow cover on Russian fields, the country has
had an explosion in numbers of virus-carrying mice.” With the coming of spring,
Lyudmial Kirillov, the regional epidemiologist in Lipetsk, is predicting a new
outbreak as the little snow that fell this winter melts and hibernating, and
virus-carrying, mice awaken.
Over the
past decade, unusually warm winters and large populations of mice have also been
responsible for outbreaks in New Mexico and nearby states of a related illness,
hantavirus pulmonary syndrome. As of last year, some 10 states had reported 30
or more cases of the syndrome since 1993, when the virus was identified. More
than 20 other hantaviruses threaten people in China, Korea, Northern and Western
Europe, Argentina, Chile, Brazil, Panama, and Canada. Some of those outbreaks
have also been linked to climate change, higher temperatures or altered patterns
of rainfall, and its effect on rodents. “Climate change is about more than a
warming Earth,” said David Blockstein, senior scientist at the National Council
for Science and the Environment, a scientific advocacy group in Washington.
“Climate change is turning environmental issues into public health issues.”
(Washington Post)

CHeS Webinar
series focuses on benefits of synchronized product data across the health care
industry
The Coalition for
Healthcare eStandards (CHeS) is launching an educational Webinar series focusing
on the need for supply chain data synchronization to reduce costs and increase
efficiencies in the U.S. health care industry. The series brings together
industry experts who are championing efforts to launch a health care product
data utility (PDU), similar to systems already successfully streamlining the
exchange of supply chain information in other large industries. Join CHeS and
industry participants in an engaging Webinar series about how a PDU can benefit
hospitals and suppliers, as well as the industry as a whole, and learn how to
participate in efforts to accelerate adoption of a PDU for health care. Register
online at
http://chestandards.org/pduwebinars.htm.
The schedule is as follows:
Wednesday, April 4, 2 pm - 3 pm Eastern, “PDU: What's in it for
Hospitals?”
Hospitals have the most to
gain from an efficient supply chain, reduced rework, fewer errors, reduced costs
and improved patient safety, to name a few advantages. Find out more about the
specific benefits a fully implemented PDU would bring to America's health care
providers. This Webinar is lead by Robert Perry, senior consultant, MTS, Inc,
2006 President of the Association for Health care Resource & Materials
Management (AHRMM), chair,
CHeS Product Data Utility Provider / IDN Working Group and Frank Fernandez,
assistant vice president and corporate director of materials management, Baptist
Health South Florida, AHRMM member representative, CHeS Board of Directors.
Wednesday, April 11, 2pm - 3pm Eastern, “PDU: What’s in it for Suppliers?”
Suppliers have the
opportunity to reduce business costs and introduce new products to hospitals,
faster, with a PDU in place. Learn what one health care supplier, BD, is doing
to lead efforts for the industry to adopt a PDU and how other suppliers can
participate. This Webinar is led by Joe Pleasant, CIO, Premier, Inc., chair,
CHeS Product Data Utility Organizing Committee and Dennis Black, director of
e-Business at BD (Becton, Dickinson and Company)
Thursday, April 26, 1pm - 2pm Eastern, “PDU: How Hospitals Can Take the Lead”
Hospital materials
managers and financial executives are taking ownership of their supply chain,
and adopting best practices to rein in costs. Learn about efforts to control
supply chain costs and processes in the industry, and how one hospital is
already seeing results. This Webinar is led by Robert Perry, senior consultant,
MTS, Inc., 2006 President of the Association for Health care Resource &
Materials Management (AHRMM), chair, CHeS Product Data Utility Provider/IDN
Working Group and Mike Brown, director of purchasing, University Health Care
System. For more information call Peggy Brody of CHeS at 734-677-3300 or email
Peggy@CHeStandards.org or
CLICK HERE.

Amerinet signs exclusive agreement with
Ohio Valley Hospital Consortium
Amerinet
Inc., a national health care purchasing organization, recently renewed its
agreement to serve as the sole-source purchasing agent of the Ohio Valley
Hospital Consortium (OVHC), an alliance of regional health care providers in
South East Ohio, following a competitive bidding process. Since the initial
agreement in 2001, the consortium has achieved nearly $6 million in cost savings
through Amerinet’s comprehensive portfolio of contracts and solution-based
programs. Amerinet will continue to negotiate custom contracts on behalf of OVHC,
and make available an array of competitively priced, quality products and
services provided by industry leaders.
This new
five-year agreement creates a partnership of shared responsibility to reduce
costs and discover new revenue streams. The partnership will also focus on total
supply spend management, and margin improvement tools, including cost reduction,
contract evaluation and implementation, and education and program coordination
at all of the consortium’s facilities. The Ohio Valley Hospital Consortium is an
independent organization of community healthcare providers, working
collaboratively to improve the health care delivery system in their communities.
The OVHC member organizations include Adena Health System, Chillicothe;
Fairfield Medical Center, Lancaster; Holzer Health Systems, Gallipolis; and
Marietta Memorial Hospital, Marietta.

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