January 2006
Tuesday, January 31, 2006
Preliminary findings: 2004
national sample
survey of registered nurses
HMOs earn $7 billion in first
half of 2005
Doctors: Primary care system
on verge of collapse
SMI ramps up initiative
activity
Tronex Healthcare announces
contract with Consorta
Tally of human bird flu cases rises to 160
The U.N. health agency on Tuesday raised to 160 its official tally
of people worldwide who have been infected with the deadly H5N1
strain of bird flu virus after laboratory tests in London confirmed
that at least 12 people in Turkey have been infected with the
disease. The death toll from the disease has risen to 85, including
four in Turkey, the World Health Organization said. Nine further
samples, from individuals confirmed by Turkish health officials as
H5N1 positive, are still being examined in Britain to verify that
they carried the disease, said WHO spokesman Iain Simpson. The
agency does not officially update its tally of confirmed cases until
the disease has been verified in a laboratory outside the country of
the outbreak, meaning that WHO's figures often lag behind national
counts. All human cases had been restricted to eastern Asia until
the first positive test results for the virus in Turkey earlier this
year. On Monday, Iraqi officials announced that a 15-year-old girl
who died Jan. 17 had contracted bird flu, the first human case in
that country. Simpson said WHO was sending a team to northern Iraq
to investigate possible bird flu cases. (The Associated Press)
Preliminary findings: 2004 national sample
survey of registered nurses
The
National Sample Survey of Registered Nurses (NSSRN) is the Nation’s most
extensive and comprehensive source of statistics on registered nurses (RNs) with
current licenses to practice in the United States whether or not they are
employed in nursing. The Department of Health and Human Services, Health
Resources and Services Administration, Bureau of Health Professions previously
conducted seven sample surveys. The eighth NSSRN began data collection in March
2004 and responses were received through November 2005. The resulting database
for the 2004 NSSRN is comprised of 35,724 individual licensed RNs from all 50
States and the District of Columbia. After applying weights to each response,
the total number of licensed RNs living and working in the U.S. was estimated to
be 2,909,467 as of March 2004, an increase of 7.9 percent or 212,927 above the
2,696,540 licensed RNs estimated in 2000. This increase is higher than the 5.2
percent increase reported between 1996 and 2000 when the RN population increased
by 137,666, but lower than the estimated 14.2 percent or 319,058 increase
between 1992 and 1996, which was the highest rate of growth since 1980. Of the
total licensed RN population in March 2004, 83.2 percent (an estimated
2,421,461) were employed in nursing in 2004 and 16.8 percent were not employed
in nursing in 2004. This estimate of the number employed in nursing represents
an increase of 219,647 RNs (10 percent) over the projected 2,201,813 RNs
employed in nursing in 2000. Of the total estimated population of nurses in
2004, 58.3 percent (1,696,916) were working full-time, and almost 25 percent
(724,544) were working part-time in 2004. In 2004, the most common initial
preparation for nursing was an associate’s degree. There has been a downward
trend in the number of nurses whose initial preparation for nursing was a
diploma program. An estimated 0.5 percent of RNs in 2004 (15,511) had received
their initial nursing education through a master’s or doctoral degree program.
The highest level of preparation for an estimated 17.5 percent of RNs is a
diploma; for an estimated 33.7 percent the highest preparation is an associate
degree; for 34.2 percent it is a baccalaureate degree; and for 13.0 percent it
is a master’s or doctoral degree. The highest increase from 2000 to 2004 was for
the number of RNs receiving their master’s or doctorate degrees (37 percent)
compared to a decrease of 15.2 percent in the number of RNs whose highest degree
was a diploma. Over the entire period from 1980 to 2004, there was a 43.5
percent decrease in the number whose highest level of preparation was a diploma,
while the number whose highest level was a masters or doctorate increased by 339
percent. The estimated number of RNs whose highest preparation was a
baccalaureate increased by 170 percent and the estimated number whose highest
preparation was an associate’s degree increased by 232 percent. The trend toward
more RNs in older age groups continued. The average age in each survey since
1980 has increased. In March 2004, the average age of the RN population was
estimated to be 46.8 years of age, more than a year older than the average age
of 45.2 years estimated in 2000; and more than 4 years greater than in 1996 when
the average age was 42.3 years. In 2000, an estimated 31.7 percent of all RNs
were under the age of 40; in 2004 only 26.6 percent of all RNs were estimated to
be under the age of 40. Continuing the history of nursing, relatively few men
are licensed as RNs, with a slight, insignificant increase estimated for 2004
from 5.4 percent in 2000 to 5.7 percent in 2004. However, it appears that the
initial nursing preparation for more male RNs was an associate’s degree rather
than a diploma (53.5 percent for men compared to 42.2 percent for women).
HMOs earn $7 billion in first half of 2005
The nation's HMOs1 reported a $6.98 billion profit for the first six months of
2005, representing a $1.2 billion, or 21.2 percent, increase over the $5.76
billion earned during the same period in 2004, according to Weiss Ratings Inc.,
an independent provider of ratings and analyses of financial services companies,
mutual funds, and stocks. HMOs reporting the largest year-over-year dollar
increases in net income include: Horizon Healthcare Services Inc. (Newark, NJ),
262.7% change, Oxford Health Insurance Inc. (New York, NY), 120.6% change,
Capital Advantage Insurance Co. (Harrisburg, PA), 348.3% change, Blue Cross Blue
Shield of Michigan (Detroit, MI), 27.6% change, Aetna Health Inc. (Uniondale,
NY), 83.8% change. “Despite a slowdown in earnings growth, industry
profitability remains strong," said Melissa Gannon, vice president of Weiss
Ratings Inc. “With premium rate increases leveling off, insurers will look for
more innovative cost control measures to remain competitive and financially
secure.” Of the 503 HMOs reviewed by Weiss using second quarter 2005 data, 76
were upgraded, while 12 were downgraded. Notable upgrades were: Community
Insurance Co. (Mason, OH), from B+ to A-; Mercy Health Plans of
Missouri Inc. (Chesterfield, MO), from B+ to A-; Total Health Care Inc.
(Detroit, MI), from C+ to B-. Notable downgrades include: Health First Health
Plans (Rockledge, FL), from C+ to C-; UPMC Health Plan Inc. (Pittsburgh, PA)
from B- to C; SHA LLC (Austin, TX), from C- to D+.
http://www.weissratings.com/
Doctors: Primary care system on verge of collapse
Primary care, the basic
medical care that people get when they visit their doctors for routine physicals
and minor problems, could fall apart in the United States without immediate
reforms, the American College of Physicians said. “Primary care is on the verge
of collapse,” said the organization, a professional group which certifies
internists, in a statement. “Very few young physicians are going into primary
care and those already in practice are under such stress that they are looking
for an exit strategy.” Dropping incomes coupled with difficulties in juggling
patients, soaring bills and policies from insurers that encourage rushed office
visits all mean that more primary care doctors are retiring than are graduating
from medical school, the ACP said in its report. The group has proposed a
solution, calling on federal policymakers to approve new ways of paying doctors
that would put primary care doctors in charge of organizing a patient's care and
giving patients more responsibility for monitoring their own health and
scheduling regular visits. U.S. doctors have long complained that reimbursement
policies of both Medicare and private insurers reward a “just-in-time” approach,
instead of preventive care that would save money and keep patients healthier.
“Medicare will pay tens of thousands of dollars ... for a limb amputation on a
diabetic patient, but virtually nothing to the primary care physician for
keeping the patient's diabetes under control,” said Bob Doherty, senior vice
president for the ACP. The ACP plan called for innovations such as using e-mail
to consult on minor and routine matters, freeing up expensive office visit time
for when it is needed. Doctors would be compensated for an e-mail consultation.
The proposals include incentives for doctors to work more efficiently and to
provide better care, ACP President Dr. C. Anderson Hedberg said. “ACP proposals
would provide patients with access to care that is coordinated by their own
personal physician,” Hedberg said. The ACP cited an American Medical Association
survey that found 35 percent of all physicians nationwide are over the age of 55
and will soon retire. In 2003, only 27 percent of third year internal medicine
residents actually planned to practice internal medicine, the group said, with
others planning to go into more lucrative specialty jobs. “Primary care
physicians, the bedrock of medical care for today and the future, are at the
bottom of the list of all medical specialties in median income compensation,”
the ACP said. “If these reforms do not take place, within a few years there will
not be enough primary care physicians to take care of an aging population with
increasing incidences of chronic diseases,” said Dr. Vineet Arora, chair of the
College's Council of Associates. (Reuters News Service)
SMI ramps up initiative activity
Strategic Marketplace
Initiative (SMI) recently announced the appointment of Dennis P. Orthman as SMI
Initiative Project Manager. Reporting to Tom Hughes the Executive Director of
SMI, Orthman will be responsible for the ongoing support and coordination of SMI
member-led initiatives. His role includes research, analysis, and coordination
of SMI initiative team activities. Orthman has served as a consultant to the
healthcare supply chain marketplace for over ten years, and brings over 25 years
of industry experience. Prior to joining SMI, Dennis served as Principal
Consultant with BD Healthcare Consulting and Services. There are currently six
different SMI teams working on industry initiatives supported by Orthman: 1).
Contract Synchronization: Working to create a new business model of
collaborative data management processes aligned to reduce waste and overall
expenses within the healthcare supply chain. The Team is examining the contract
data loading process, with the goal of establishing a standardized process for
correct contract data loading by all necessary parties by the appropriate
designated effective date. 2). Perfect Order: This team is working to develop
and implement a new management tool and metric for the healthcare supply chain …
“Percentage of Perfect Orders.” With the creation of this tool, the team hopes
to reduce operational expenses associated with today’s inefficient and
time-consuming order-to-payment process. They have defined appropriate
measurable elements within the supply chain that constitute a “perfect order.”
3). HIN or GLN? That is the question that this team is working to answer so that
healthcare can achieve a standardized identifier for providers, manufacturers
and distributors in the efforts to increase efficiencies and drive down supply
chain expenses. 4). Access Guidelines: Addressing the inconsistency of practices
among healthcare facilities and suppliers regarding vendor access that can lead
to potential liability concerns and health and safety issues. The goals of this
team are to examine regulatory requirements, search for best practices, and to
establish a standardized partner access guideline, outlining minimum
requirements that will ensure the health and safety of patients, partners and
healthcare facility employees. 5). Measuring Effective Relationships:
Organizations across the country have separately developed programs that measure
the value and effectiveness of their business relationships. This initiative
team is reviewing existing programs with the goal of creating a best practice
that can be used by all supply chain stakeholders to measure and improve their
collaborative effectiveness. The SMI team seeks to develop a flexible approach
that can be used by all trading partners based on a common platform to define
and measure the tangible and intangible benefits to the healthcare supply chain.
6). Supply Chain Opportunity Review: Working to identify key components,
strategies, and values of the supply chain to guide and recommend future SMI
initiatives, allowing all SMI Initiatives to be addressed and discussed in a
unifying context and the value of the individual initiatives to be collectively
defined. The team is mapping where providers and suppliers intersect,
identifying significant cost drivers at each key intersection, and evaluating
the value and opportunities that are present for future efforts. For more
information on SMI contact Tom Hughes, Executive Director for SMI, at
thughes@smisupplychain.com or
info@smisupplychain.com.
Tronex Healthcare announces contract with Consorta
Tronex Healthcare Industries announces the awarding of a supply contract with
Consorta Inc.’s Pharmacy Services, as the supplier of choice for Cleanroom
Apparel. This contract covers a full range of head-to-toe disposable apparel
including bouffant caps, beard covers, sleeve covers, face masks, shoe covers,
lab coats, and jump suits. These products are available in both Cleanroom 10,000
and 100 versions and are manufactured to meet or exceed USP 797 regulations.
Monday, January 30, 2006
Iraq girl ‘died of bird flu’
First pre-birth stent implant
AAMI survey:
Salaries increase 3 percent
CHD Meridian Healthcare offers
resources to help
employers prepare for avian flu pandemic
Kimberly-Clark
Health Care joins national initiative
to reduce surgical
complications
Company-wide RFID technology
installation
is completed
by SRI/Surgical Express
FDA approves inhaled insulin for diabetics
The first
inhalable version of insulin won federal approval Friday, giving
millions of adult diabetics an alternative to some of the regular
injections they now endure. The Food and Drug Administration said
the Pfizer Inc. insulin, to be marketed as “Exubera,” is the first
new way of delivering insulin since the discovery of the hormone in
the 1920s. Pfizer jointly developed the drug and dispenser with
Sanofi-Aventis and Nektar Therapeutics. Use of rapid-acting inhaled
insulin will not replace the need to occasionally inject the
hormone, according to the FDA. And diabetics will have to continue
pricking their fingers to test blood sugar levels. The FDA delayed
its decision by three months so it could review chemistry data on
the diabetes treatment. The European Commission approved Exubera for
use in adults on Thursday. Analysts have said the inhaled insulin
could eventually become a $1 billion-a-year seller for Pfizer, which
recently agreed to pay Sanofi-Aventis $1.3 billion to obtain full
worldwide rights to the drug for use by both Type 1 and 2 adult
diabetics. Clinical trials found that Exubera managed blood sugar
levels just as well as injected insulin, but an independent FDA
panel in September stressed that use of inhaled insulin will not
mean diabetics can toss out the needles, pens or pumps used to
inject the hormone. Inhalable insulin is a welcome advance, said Dr.
Nathaniel Clark, the national vice president for clinical affairs
for the American Diabetes Association. But he added that needles
still will allow a patient to better control dosage. “Injecting
insulin is far more precise in the sense of, what you want to
deliver you deliver. You don't have to deal with any questions of
how much is delivered through the lungs,” Clark said. The FDA review
panel also expressed concern about the bulkiness of the Exubera
dispenser and about some patients who experienced coughing or a
slight decrease in lung capacity when using the drug. Pfizer will
conduct studies on the long-term effects of Exubera on the lungs, as
well as the safety and effectiveness of the drug on patients with
lung disease, the FDA said. Diabetics with either type of the
disease could use the rapid-acting inhaled insulin before or after
meals to manage their blood sugar levels. However, the drug would
not replace the longer-acting insulin injections that some
diabetics, particularly those with Type 1 diabetes, need to take in
the morning or before bed. “You're not going to eliminate the
needles in Type 1. For Type 2, it really depends on the stage,” said
Dr. Will Cefalu, a clinical investigator for both Pfizer and Eli
Lilly and Co., which is developing its inhalable insulin system with
Alkermes Inc. About 15 percent of diagnosed diabetics do not take
the insulin or pills they should, according to American Diabetes
Association estimates. The Exubera device is about the size of an
eyeglass case. It delivers insulin, as a dry powder packaged in one-
or three-milligram inhalable capsules, to the lungs through the
mouth, according to Pfizer. Diabetics with poorly controlled or
unstable lung disease, or who smoke or recently quit, shouldn't use
Exubera, the FDA said. And patients should have their lungs checked
before using the drug, as well as at six to 12 month intervals after
that. Eli Lilly and Co., Kos Pharmaceuticals Inc., MannKind Corp.
and Novo Nordisk A/S all are developing their own versions. (The
Associated
Press)
Iraq girl ‘died of bird flu’
Iraqi and
U.N. health officials said Monday that a 15-year-old girl who died
this month was a victim of the deadly H5N1 strain of the bird flu
virus, the first confirmed case of the disease in the Middle East.
Tests were under way to determine if the girl's uncle, who lived in
the same house, also died of the H5N1 virus. The uncle died a few
days later after suffering the same symptoms, officials said. Iraqi
health authorities began culling domestic birds in northern Iraq, which
borders Turkey, where at least 21 cases of the deadly virus have
been detected. Turkey and Iraq also lie on a migratory path for
numerous species of birds. The girl died after contracting a severe
lung infection in her village
of
Raniya,
about 60 miles south of the Turkish border and just 15 miles west of
Iran. The prospect of a bird flu
outbreak in Iraq is especially alarming because the country is
gripped by armed insurgency and lacks the resources of other
governments in the region. Government institutions, however, are
most effective in the Kurdish-run area of the north where the girl
lived. Kurdistan's health minister said authorities started culling
domestic birds in the village where the girl lived and nearby areas.
(The
Associated
Press)
First pre-birth stent implant
The parents of Grace VanDerwerken faced a grim choice last year when
doctors in
Virginia discovered a potentially fatal heart defect before she was
born. Angela and Jay VanDerwerken were told they could either
terminate the pregnancy or subject the newborn to immediate
open-heart surgery that had only a 20 percent survival rate. Rather
than accept the long odds, the couple went to Children's Hospital
Boston and Brigham and Women's Hospital for a first-ever operation
last November. Sunday, 17-day-old Grace went home as the only
patient in the world to receive a stent before birth. She will have
to return for more surgery in four to six months, but so far,
doctors say her recovery has been “extraordinarily smooth.” Grace
was diagnosed in September with hypoplastic left heart syndrome, a
condition in which the left ventricle fails to fully develop. Making
her condition particularly serious, the wall between the two sides
of her heart had no opening to let blood out, which meant it would
back up into her lungs and make it hard to draw her first breath.
After the VanDerwerkens were given the prognosis, they researched
prenatal heart surgery centers and came upon the Boston team, which
has done 60 fetal surgeries to correct defects in the left
ventricle. The team from Children's and Brigham and Women's decided
it could greatly improve the child's survival chances by making a
small opening in the wall that divides the pumping chambers and then
prop it open with a mesh stent. On Nov. 7, a team of 16 specialists
operated on the 30-week-old fetus at Brigham and Women's, using a
fine needle at the end of a wire to penetrate the tiny heart wall
and implant the stent. When Grace was born, she still had a heart
defect, but she was no longer at risk of immediate death. Three days
after birth, she had the first of three operations to correct the
underdeveloped pumping chamber, operations that doctors at
Children's say have a mortality rate of less than 15 percent. (The
Boston Globe)
AAMI survey:
Salaries increase 3 percent
Salaries for
professionals who service medical technology increased by 3.2% over
the last year, according to the results of a new survey commissioned
by the Association for the Advancement of Medical Instrumentation (AAMI).
For the nine specific job title categories surveyed, the median base
salary increased from $60,000 in 2004 to $62,000 in 2005, with
salaries ranging from $29,700 for entry level positions to $78,000
for a department director or manager. AAMI’s 2005 Employment Survey
also found that: Fewer employers today are paying the full cost of
their employees’ health insurance. Only 11% of those surveyed say
that their employers pay 100% of their health insurance, compared to
23% who received full healthcare insurance in AAMI’s 2003 Employment
Survey; Manufacturers generally pay significantly more than
hospitals or independent service organizations (ISOs), although
hospitals are more apt to offer employees overtime, call-back pay,
life insurance, and employer-provided pensions. On average,
respondents who are certified reported earning 5.7% more than those
who hold similar positions but are not certified. Biomedical
equipment technicians and clinical engineers living in the western
part of the United States earn more than their counterparts in other
regions of the country. “Manufacturers have been increasing salaries
and benefits to try to stop losing talent to the field, and to try
to bring back some of the employees who left for a less-traveled
lifestyle,” said Larry Hertzler, PE, CCE, vice president of program
management at ARAMARK Clinical Technology Services. The median 2005
salary for certified medical technology professionals was $62,350
compared to $59,000 for someone who was not certified. The survey
also found that about 78% of respondents said they receive
subsidized healthcare as a fringe benefit. “Employers in all
industries are asking employees to carry more of this financial load
for health insurance,” said Carol Davis-Smith, CCE, senior
consultant, Capital Lifecycle Solutions at Premier Inc. “Having
worked in the hospital and moved outside to a consulting position, I
would suspect that the actual costs paid by hospital employees are
still less than those of us paying retail.” The survey results are
featured in the Nov/Dec 2005 issue of AAMI’s journal, Biomedical
Instrumentation & Technology, and are also available online to
AAMI members at
http://www.aami.org/publications/BIT. To order the survey, call
(800) 332-2264, ext. 217 or visit
http://marketplace.aami.org. The order code is SAL and the
source code is PBFE.
CHD Meridian Healthcare offers resources to help
employers prepare for avian flu pandemic
I-trax Inc.,
a provider of integrated health and productivity management,
announced that CHD Meridian Healthcare, an I-trax company, is
offering its Avian Flu (Bird Flu) White Paper, Version 6, “Preparing
for the Possibility of a Pandemic”, to the general public free of
charge for the next 30 days in an effort to better prepare employers
and help protect their employees in the event of such a pandemic. CHD
Meridian launched its avian flu program last fall to its over 180
on-site, employer-sponsored health centers and has been helping
these employers prepare for a potential avian influenza
pandemic. Now, CHD Meridian is offering the White Paper with online
registration through its website at: www.chdmeridian.com.
The White Paper focuses on managing the avian flu in a corporate
setting and provides frequently asked questions for both management
and employees to assist in the education process. The paper also
offers information for traveling employees, health center staffs and
pharmacies in addition to providing an emergency action guide. The
CHD Meridian avian flu program is led by Raymond Fabius, MD, CPE,
FACPE, the company’s president and chief medical officer. Formerly,
Dr. Fabius was the global medical leader for General Electric (GE)
and senior medical director for Aetna’s
national accounts. Dr. Fabius defines six key protective measures
every company should take to ensure they are prepared for the avian
flu: 1). Understand the potential risk and ways to mitigate the
risk. 2). Communicate this understanding to employees reducing
anxiety and channeling energies appropriately 3). Create a tie to
local public health resources and local hospitals and doctors 4).
Develop a business contingency plan identifying responsible people
and an action plan 5). Assign a champion responsible for managing
the plan dynamically 6). Practice the plan by engaging in exercises
to test the organization’s preparedness.
Kimberly-Clark
Health Care joins national initiative
to reduce surgical
complications
Kimberly-Clark
Corporation’s Health Care business announced its participation in
the Surgical Care Improvement Project (SCIP), a national initiative
designed to improve surgical care in hospitals. Kimberly-Clark
Health Care’s involvement with SCIP continues the business’
commitment of reducing the number of healthcare associated
infections in acute care and alternate site surgical settings. A
partnership of leading public and private health care organizations,
SCIP was created to provide hospitals, physicians, nurses and other
caregivers with effective strategies to reduce four common surgical
complications: surgical site infection, adverse cardiac events, deep
vein thrombosis and postoperative pneumonia. SCIP is one of the
first national quality improvement initiatives to unite national
hospital, physician and nursing organizations; the federal
government; JCAHO; and private sector experts. Under SCIP, this
initiative brings together the best available science and technology
to improve patient safety and well-being.
www.medqic.org/scip
Company-wide RFID technology installation
is
completed
by SRI/Surgical Express
SRI/Surgical Express Inc. (SRI), a provider of products and services
supporting the healthcare industry, announced the successful
implementation of Radio Frequency Identification (RFID) Technology
in all ten of its processing facilities across the United States.
SRI will install RFID chips in over one million of its reusable
surgical gowns and drapes in this implementation. SRI believes that
this is the first full integration of RFID Technology into Class II
Medical Devices and among the largest uses to date of “Multi-Read”
applications of RFID technology. SRI incorporated “multi-read” RFID
tags into its surgical gowns and drapes, replacing its use of labor
intensive bar code scanning to track product usage. “The immediate
benefit for SRI is improved inventory control, better monitoring of
quality and a productivity enhancement of 5% over our results with
bar code scanning. As we further integrate RFID Technology into our
processes, SRI expects to virtually eliminate inaccurate shipments
of customer orders from our plants,” said Joseph A. Largey, chief
executive officer, SRI/Surgical Express.
Friday, January 27, 2006
Bird flu viruses carry unique
genes, study finds
New cancer drug approved
Statins may prevent sepsis in
heart patients
Two studies find defect in
gene for Parkinson's
Rubbermaid’s Bill Slezak
appointed to ASHES Board
of Directors
PAR Excellence and Consorta
extend their partnership
FDA sends Boston Scientific Corporate Warning
Letter
On January 25, the Food
and Drug Administration sent James Tobin, president and CEO, and Peter M.
Nicholas, chairman of Boston Scientific Corporation, a corporate warning letter.
The FDA recently performed inspections of Boston Scientific Corporation (BSC) at
three separate facilities. The inspections were performed at Natick, MA on July
27 through August 26, 2005; at Maple Grove, MN on July 22 through August 25,
2005; and at Spencer, IN on August 25 through September 12, 2005. These
inspections covered Vaxcel, Enteryx, and Taxus Paclitaxel drug eluting stent
products and Leveen Needle Electrode product. These three FDA inspections each
revealed serious regulatory problems involving the medical devices. FDA recently
issued BSC three Warning Letters relating to serious deficiencies identified
during inspections at three other BSC facilities. The first Warning Letter was
issued on May 18, 2005, regarding Boston Scientific’s Watertown, MA facility.
This Warning Letter discussed, among other items, the failure of the
organization to have an adequate quality management system. The second Warning
Letter was issued on August 1, 2005, for the Company’s Glens Falls, NY facility,
and the third Warning Letter was issued on August 10, 2005, regarding the
Quincy, MA facility. Each of these Warning Letters identified serious, systemic
problems with overall corporate quality management systems. The purpose of this
letter is to apprise top management of inadequate corporate-wide corrective
action plan as evidenced by the continuing serious deficiencies identified at
each of these facilities and to remind BSC of its responsibility to ensure that
all facilities continuously comply with the Act and all pertinent regulations.
The FDA requested a prompt meeting with BSC. The three most recent inspections
at the Natick, MA, Maple Grove, MN and Spencer, IN facilities revealed that the
devices manufactured at these sites are adulterated under section 501(h) of the
Act, in that the methods used in, or the facilities or controls used for, the
manufacture, packing, storage or installation are not in conformance with the
Current Good Manufacturing Practice (CGMP) requirements for medical devices. FDA
has found ongoing systemic violations in the quality management system employed
to ensure the safety and effectiveness of the medical devices BSC distributes.
FDA warned BSC that these serious violations of the law may result in FDA taking
regulatory action without further notice. These actions include, but are not
limited to, seizing product inventory, obtaining a court injunction against
further marketing of the product, or assessing civil money penalties.
Bird
flu viruses carry unique genes, study finds
Scientists may have found out what makes the H5N1 influenza virus so deadly:
bird flu viruses have a gene that may make them especially destructive to cells,
U.S. researchers reported on Thursday. All the bird flu viruses studied by the
team at St. Jude Children's Research Hospital in Memphis had the gene and none
of the human influenza viruses did, they said. People infected with the H5N1
bird flu virus in Vietnam and Thailand had the “avian” version of the flu virus,
as did the victims of the 1918 influenza pandemic, which killed tens of millions
of people globally, the researchers said. But the influenza viruses that cause
the normal seasonal flu, and those that caused the less deadly 1957 and 1968
human flu pandemics, do not carry the avian genes. The finding, published in the
journal Science, may provide a way to identify the more dangerous viruses and
may also help companies trying to make better flu drugs, said St. Jude's Clayton
Naeve. “We documented a clear difference between bird viruses and human viruses.
You need much more work to demonstrate this actually contributes to virulence in
nature,” Naeve said. Naeve and his colleagues have been working to sequence the
genomes of all known influenza viruses. No one has done this, even though flu
viruses have just eight genes and are relatively simple organisms, the
researchers said. “This is information we expect will be very important in
understanding the attributes of this virus, how it will cross from birds to
humans. We are releasing this data so that other investigators worldwide can
mine it for information,” he said. The researchers used a collection of samples
of 11,000 influenza viruses, including 7,000 avian influenza viruses, assembled
by St. Jude's Dr. Robert Webster over 30 years. Naeve's team may have identified
a protein to watch. It is called NS, for non-structural protein, and is only
made once the virus has infected a cell. The avian versions seem to allow the
virus to do much more damage to a cell than the human versions of NS, Naeve
said. It is possible that a mutation that would allow a flu virus to more easily
infect people will weaken the NS protein, Naeve said. (Reuters)
New
cancer drug approved
For
the first time, the Food and Drug Administration has approved a new cancer drug
for use in two different diseases, advanced kidney tumors and rare abdominal
malignancies. Sutent, made by Pfizer, is the second drug in only about a month
to treat advanced kidney cancer, a disease for which there were no new therapies
for more a decade, according to the FDA, which approved a Bayer drug called
Nexavar in December. Although studies have not yet shown that Sutent improves
survival, the agency granted Sutent accelerated approval because kidney cancer
is so deadly. Sutent shrank tumors in 26% to 37% of patients, according to the
FDA. That makes it far safer and more effective than older drugs for the
disease, which are so risky that they are often given in an intensive care unit.
About 36,000 cases of kidney cancer are diagnosed each year and 12,600 die of
it, according to the American Cancer Society. Pfizer plans to continue studying
Sutent, and is testing it in cancers of the breast, colon, lung and other
organs, says Joseph Feczko, the company's chief medical officer. Sutent belongs
to a new wave of “smart drugs,” said George Demetri, who helped develop Sutent
and directs the Center for Sarcoma and Bone Oncology at the Dana-Farber Cancer
Institute in Boston. Sutent is able to combat two types of tumors because both
cancers are fueled by the same defective proteins, Demetri said. Unlike
chemotherapy, which poisons all growing cells, drugs such as Sutent are designed
to block the spread of tumors but largely spare healthy tissue, said Demetri.
Sutent also combines two powerful strategies to fight cancer, Demetri said. It
silences growth signals inside cancer cells and also also cuts off their blood
supply. In addition to kidney cancer, the FDA approved Sutent for patients with
gastrointestinal stromal tumors, or GIST, whose disease is no longer controlled
by a drug called Gleevec, or who had rare but severe reactions to it. Sutent
works by blocking the proteins that make tumor cells immune to Gleevec, Demetri
said. In a carefully designed trial of more than 300 patients, in which some got
Sutent and some took placebos, Sutent cut the risk of death by more than half,
according to Demetri's study. Researchers at the medical conference in San
Francisco also presented promising news about esophageal cancer, a disease that
kills 85% of patients within five years. Patients with early-stage disease who
underwent surgery, chemotherapy and radiation lived more than twice as long as
those treated with surgery alone, said Mark Krasna, a professor at the
University of Maryland. Those who got the triple therapy lived about 4.5 years,
while other patients survived only 1.8 years. Only about one-third of esophageal
cancer patients today receive the combination. Another third of patients today
are treated with surgery alone, Krasna said. (USA Today)
Statins
may prevent sepsis in heart patients
The cholesterol-lowering drugs, statins may lower the risk of developing sepsis,
a potentially fatal reaction to infection, by 19 percent in patients with heart
disease, a new Canadian study suggests. “Patients
who are treated with statins enjoy not only a reduction in their risk of heart
attack and strokes, but a reduced risk of sepsis,” said lead researcher by Dr.
Donald Redelmeier, from Sunnybrook and Women's Hospital, in Ontario.
The findings appear in the Jan. 25 early online edition of The Lancet.
More than two people die every minute from severe sepsis in the United States.
It is the leading cause of death among patients in intensive care units, and is
responsible for more deaths than breast, colorectal, pancreatic and prostate
cancer combined, according to the Society of Critical Care Medicine.
For the new study, Redelmeier's group collected data on 69,168 patients over age
65 with heart disease. All had been hospitalized for acute coronary syndrome,
stroke or a revascularization procedure. Half of the patients had been
prescribed statins after discharge, and half had not.
The researchers found that after two years, 551 patients taking statins were
hospitalized for sepsis, compared with 667 patients not taking these drugs. That
represented a 19 percent reduction in the risk of sepsis among those taking
statins, Redelmeier's team noted.
If the finding is
replicated in other trials, Redelmeier believes the use of statins may be
important in reducing the risk of sepsis in any patient undergoing complex
surgery. “Patients who are at risk for sepsis should not have their statin
discontinued, contrary to standard therapy in intensive-care units,” he said.
In addition, patients undergoing high-risk surgery should consider taking
statins to prevent sepsis, Redelmeier said. “Patients with high degree of
immunocompromise may want to consider statins for primary prevention,” he noted.
Some experts thinks additional studies are needed to prove whether statins
really do reduce the risk of sepsis.
(HealthDay News)
Two
studies find defect in gene for Parkinson's
An
error in a single gene might cause many cases of Parkinson's disease in certain
groups, including Ashkenazi Jews and Arabs, two studies report. Previously,
genes for Parkinson's disease have been identified only in rare cases. But
findings from the scientific papers, both of which were published in the New
England Journal of Medicine, suggest that for certain ethnic groups, the
disease could carry a substantial genetic component. Identification of the
genetic mutation might help scientists better understand how Parkinson's damages
the brain and causes symptoms of the disease, says J. William Langston of the
Parkinson's Institute in Sunnyvale, CA. The discovery also might lead to better
therapies for Parkinson's, he said. Susan Bressman, a neurologist at New York's
Beth Israel Medical Center, Laurie Ozelius, a molecular geneticist at the Albert
Einstein College of Medicine in New York, and their colleagues studied 120
Parkinson's patients and 317 healthy people. All were Ashkenazi, or Eastern
European, Jews. The team zeroed in on a gene called LRRK2 that previously has
been shown to have mutations that cause Parkinson's in some families. When the
team looked for one of the more common mutations, they found it in 18% of the
Jewish patients. When they looked only at patients who had a family history of
the disease, they got a more dramatic result: The mutation was found in nearly
30% of such cases. The researchers also found the mutation in 1% of controls:
Ashkenazi Jews in their 70s who remained healthy. The team estimates that about
70,000 Ashkenazi Jews in the USA could be carriers of the mutation; they might
escape the disease, or they could develop symptoms late in life, Bressman says.
She and other experts believe people with an inherited vulnerability also might
need exposure to an environmental factor to get the disease. The second study
suggests the same mutation frequently can be found in Parkinson's patients of
Arab descent. The studies might change the way people of Jewish or Arab descent
are diagnosed, Bressman says. But she doesn't recommend widespread testing just
yet. “We don't have a cure for Parkinson's right now,” she said, and there also
is no known way to prevent it. A positive test in family members might simply
raise worries about developing the disease in the future, says Robin Elliott of
the Parkinson Disease Foundation. (USA Today)
Rubbermaid’s Bill Slezak appointed to ASHES Board
of Directors
Following the
annual ASHES conference and exposition, Bill Slezak, Healthcare Industry Manager
at Rubbermaid Commercial Products, was appointed to a three year term on the
American Society for Healthcare Environmental Services (ASHES) Board of
Directors. Slezak brings over 20 years of healthcare, business and IT
experience, including his current responsibilities with Rubbermaid Commercial
Products, located in Winchester, VA. Slezak will contribute the perspective of
the supplier and manufacturing community and their constituents to ASHES
strategic, procedural and policy-making decisions.
PAR Excellence and Consorta extend their partnership
PAR Excellence Systems, Cincinnati, OH, which provides innovative and affordable
products and services to automate the health care supply chain, and Consorta,
Schaumburg, IL, announced they had extended their original agreement for open,
point-of use systems for an additional two years. Recently, PAR Excellence added
PAR Vision, a browser-based data analysis tool. All of these are now available
to the Consorta shareholders and individual hospitals. “Because PAR Excellence
offers such a wide variety of solutions, we are a good fit for the Consorta
membership with their many different budgetary, inventory, and supply billing
requirements,” said Dick Felger, VP of Sales for PAR Excellence.
Thursday, January 26, 2006
CDC considers flu vaccine
for millions more children
Joint Commission issues alert
to improve medication safety
National evaluation of the
effect of trauma-center care
on mortality
Clotting drug linked to kidney
damage
Medline adds
antimicrobial lab coat to its Omega line
Glaxo to begin bird flu clinical trials
Drug maker
GlaxoSmithKline PLC hopes to start clinical trials in early April for its
vaccine against the deadly H5N1 bird flu strain, a company executive said. The
London-based company would test the vaccine with two different boosters and the
first results should come about three months later, said David Stout, president
of the company's pharmaceutical operations. Production is slated to start by
year's end, he said. GlaxoSmithKline has submitted a mock-up dossier to the
European Agency for the Evaluation of Medicinal Products, or EMEA, seeking an
outline approval to market a vaccine against pandemic flu. The mock-up process
requires companies to conduct clinical trials for safety and to establish the
dosage and schedule for core compounds to obtain quick authorization for
pandemic vaccines. The company submitted an adjuvant tested in the mock-up file
the company has submitted to the European regulator, Stout said. An adjuvant
stimulates a person's immune response to an infection to help make a vaccine
work. “We know one adjuvant works, and we have a second adjuvant,” Stout said.
“We are going to take both formulations in the clinic in early April, so that we
will know we'll be able to pick between the two, and should be able to start
production by the end of the year,” Stout added. The company is starting
production of its traditional flu vaccine in the next couple of weeks for the
next influenza season, Stout said. “If a pandemic breaks out, we would be able
to stop production of the traditional flu vaccine and start production of the
pandemic vaccine,” he said. “We could start production on a risk basis (without
regulatory approval) if that was necessary.” (The Associated Press)
CDC considers flu vaccine for millions more children
Federal disease
specialists are considering whether to routinely vaccinate millions more
children against the flu, a measure designed to protect children and the adults
they might expose to the virus. A decision on whether to give flu shots to
children 2 to 6 years old is expected by the end of the year, disease trackers
from the US Centers for Disease Control and Prevention said at a flu vaccine
summit. Already, federal guidelines advise flu immunizations for children 6
months to 23 months old because they are especially prone to complications from
the respiratory illness. Doctors and public health authorities also discussed
making shots an annual ritual for all Americans. “'But if we were to say we want
universal vaccination, that doesn't happen overnight,” said Nicole Smith, an
epidemiologist in the CDC's flu branch. US health guidelines strongly urge that
senior citizens, the very young, and the chronically ill be vaccinated against
seasonal flu. (The flu vaccine is not considered safe for infants under 6
months.) Although that policy does not recommend shots for healthy adults under
65 and children over 2, there's no medical reason in most cases that they can't
receive vaccine. Instead, the current recommendations reflect a desire to get a
limited supply of vaccine to patients who need it most. This year, about 86
million doses of vaccine are expected to be produced, but the CDC estimates that
180 million Americans are either at serious risk of complications from the flu,
or have contact with those high-risk patients. But with vaccine manufacturers
promising to substantially increase the number of shots they make for future flu
seasons, disease specialists are reviewing research to determine whether
vaccinating children ages 2 to 6 makes sense. Among the studies the federal
specialists said they will review: a Harvard Medical School report that suggests
3- and 4-year-olds often spur flu outbreaks, showing respiratory symptoms weeks
earlier than other children. The Harvard and Children's Hospital Boston
researchers have said they believe 3- and 4-year-olds should be routinely
vaccinated to prevent spreading flu to older children and adults. If federal
specialists go along with that recommendation, the new policy would not go into
effect until the 2007-2008 flu season. (The Boston Globe)
Joint Commission issues alert to improve medication safety
The Joint Commission on
Accreditation of Healthcare Organizations issued a new
Sentinel Event Alert
that urges
intensified attention to the accuracy of medications given to patients as they
transition from one care setting to another, or one practitioner to another. The
failure to reconcile medications during these transitions can cause serious
patient injuries and even death. According to the
Alert,
medication reconciliation should occur whenever a patient moves from one
location to another location in a health care facility (for example, from a
critical care unit to a general medical unit); or from one health care facility
to another or to home; and/or when there is a change in the caregivers
responsible for the patient. When effective medication reconciliation does not
occur, patients may receive duplicative medications, incompatible drugs, wrong
dosages, or wrong dosage forms among the array of potential errors. The
medication reconciliation process also provides an important opportunity to
assure that the patient is receiving all medications necessary to his or her
care and to eliminate any medications that are no longer needed by the patient.
Last year, United States Pharmacopeia received more than 2,000 voluntary reports
of medication reconciliation errors, and a 1999 Institute of Medicine report
estimated that more than 7,000 deaths occur each year in hospitals alone due to
medication errors. The Joint Commission's Sentinel Event Database also
identifies medication errors as one of the most frequently occurring threats to
patient safety. This Database reveals that 63 percent of the reported medication
errors resulting in death or serious injury were due to breakdowns in
communication, and approximately half of those would have been avoided through
effective medication reconciliation. The fact that medication reconciliation
errors continue to occur, despite repeated warnings and rigorous standards,
prompted the Joint Commission to issue the
Sentinel
Event Alert on
medication reconciliation to the more than 15,000 health care organizations it
accredits. “A systematic approach to reconciling medications must be the
foundation for all efforts to prevent drug errors,” said Dennis S. O'Leary,
M.D., president, Joint Commission. To reduce the risk of errors related to
medication reconciliation, the
Alert
recommends that health care organizations: Put the list of medications in a
highly visible place in the patient's chart and include essential information
about dosages, drug schedules, immunizations, and drug allergies.
Reconcile
medications at each interface of care, specifically including admission,
transfer and discharge. The patient and responsible physicians, nurses and
pharmacists should be involved in this process. Provide each patient with a
complete list of medications that he or she will take after being discharged
from the facility, as well as instructions on how and how long to take any new
medications. The patient should be encouraged to carry this list and share it
with any caregivers who provide any follow-up care. In addition, as part of its
current National Patient Safety Goals, the Joint Commission also specifically
requires that each accredited health care organization: Implement a process for
obtaining and documenting a complete list of the patient's current medications
upon admission. This includes a comparison of the medications the organization
provides to those on the list. The patient should be asked to describe or
confirm any prescription medications, over-the-counter medications, vitamins,
herbs or other supplements that he or she takes. Communicate a complete list of
the patient's medications to the next service provider when the patient is
referred or transferred to another setting, service, practitioner or level of
care within or outside the organization.
www.jcaho.org.
National evaluation of the effect of trauma-center care
on mortality
Hospitals have difficulty justifying the expense of maintaining trauma centers
without strong evidence of their effectiveness. To address this gap, researchers
examined differences in mortality between level 1 trauma centers and hospitals
without a trauma center. Mortality outcomes were compared among patients treated
in 18 hospitals with a level 1 trauma center and 51 hospitals non–trauma centers
located in 14 states. Patients 18 to 84 years old with a moderate-to-severe
injury were eligible. Complete data were obtained for 1104 patients who died in
the hospital and 4087 patients who were discharged alive. After adjustment for
differences in the case mix, the in-hospital mortality rate was significantly
lower at trauma centers than at non–trauma centers (7.6 percent vs. 9.5
percent), as was the one-year mortality rate (10.4 percent vs. 13.8 percent).
The effects of treatment at a trauma center varied according to the severity of
injury, with evidence to suggest that differences in mortality rates were
primarily confined to patients with more severe injuries. The findings show that
the risk of death is significantly lower when care is provided in a trauma
center than in a non–trauma center and argue for continued efforts at
regionalization. This research was conducted by the Johns Hopkins Bloomberg
School of Public Health, Center for Injury Research and Policy, Baltimore; and
the University of Washington School of Medicine, Harborview Injury Prevention
and Research Center, Seattle. The Centers for Disease Control and Prevention
helped fund the study, published in the New England Journal of Medicine.
Clotting drug linked to kidney damage
A
drug widely used during heart surgery to control bleeding doubles the risk of
kidney damage, forcing an estimated 10,000 patients onto dialysis each year,
according to a new study from a group that is calling for surgeons to abandon
its use. Known as aprotinin, the drug also increases the risk of heart attack by
48 percent, heart failure by 109 percent, and stroke by 181 percent, according
to a study among nearly 4,400 patients reported in The New England Journal of
Medicine. The researchers added that the drug is not even needed in most cases
because there are two generic drugs that cost a tenth as much and are nearly as
good at stopping bleeding without increasing risks. “I wonder how we can
ethically prescribe aprotinin when there are alternatives that are safer,” said
Dr. Dennis T. Mangano of the Ischemia Research and Education Foundation, who led
the study. The drug, which is derived from the lung tissue of cows, was approved
by Food and Drug Administration in 1993. It is now used in a significant number
of the 1 million heart surgeries performed worldwide each year, largely because
it is slightly more effective and has been well marketed by its manufacturer,
Bayer. Surgeons and anesthesiologists had suspected potential problems with the
drug for many years, but the number of adverse side effects was lost among the
huge number of patients given the drug. “We didn't have good, hard data to prove
it,” said Dr. O. Wayne Isom, chair of the Department of Cardiac and Thoracic
Surgery at New York Presbyterian Hospital/Weil Cornell Medical College. A
spokesman for the FDA said the agency is reviewing the data. (Los Angeles Times)
Medline
adds antimicrobial lab coat to its Omega line
Medline Industries Inc.
added an antimicrobial lab coat to its Omega line of infection control products.
The new antimicrobial lab coat will help prevent cross-contamination. The lab
coat's HaloShield technology harnesses residual chlorine molecules from the
normal laundry process and kills even the most dangerous bacteria within
minutes. “Research shows that lab coats can be a major contributor to
cross-contamination problems as physicians go from room to room in the
hospital,” said President of Medline's Textiles Division Ron Barth. “Lab tests
show that when bacteria comes into contact with chlorine bleach anchored to a
HaloShield-treated fabric, 99.9 percent of the microbes are killed within
minutes, including MRSA, VRE, and Klebsiella pneumoniae.” A 2005 study by
Minnesota-based Ecolab found that bacteria such as MRSA could live on a bed
linen for as long as five days. A study published in 2000 demonstrated that lab
coats are a potential source for cross-contamination of bacteria including
Staphylococcus aureus. The Omega line lab coats are infused with the same
treatment introduced in Medline's HaloShield sheets and underpads. The patented
technology in HaloShield is a durable coating that binds chlorine molecules,
used during a regular wash cycle, to nearly any textile. The coating is
rechargeable meaning the antimicrobial properties of the chlorine are renewed
each time the fabric is laundered in an EPA-registered chlorine-based sanitizer.
The HaloShield treatment maintains its ability to bind chlorine to the product
throughout its life cycle. While chlorine is known as one of the best
antimicrobial agents in the world, its power before HaloShield had been limited
because it evaporates from untreated fabric soon after laundering.
Wednesday, January 25, 2006
Flu vaccine distribution
flawed, CDC contends
Doctors write article backing
ban on gifts from drug makers
Bush considering tax breaks
for health care;
workers who must buy coverage may be aided
DMAA launches project to
develop standards for measuring,
evaluating disease management outcomes
Thermo Asset Management Services and
Vanderbilt University
Hospital announce partnership
Guidant goes with Boston Scientific
Guidant Corp. formally
ended its merger agreement with Johnson & Johnson and entered into a $27 billion
accord with Boston Scientific, the medical device maker announced early
Wednesday.
J&J had until
midnight ET Tuesday to raise its offer for
Guidant, which
it had agreed to buy in December 2004. Boston Scientific was offering $27
billion for Guidant, in a cash and stock deal worth $80 a share. The midnight
deadline passed without any new bid from J&J, which had offered $24.2 billion
for the company. Guidant said Wednesday it will pay a termination fee of $705
million to J&J. Shares of Boston Scientific rose 70 cents, or almost 3 percent,
to $24.70 in pre-market trading on Inet following the announcement, while shares
of Guidant slipped 68 cents to $76.10 as the potential for another round of
bidding ended. Shares of Dow component J&J were not trading on Inet, but were up
slightly in Frankfurt trading. J&J issued a statement early Wednesday saying
simply that increasing its latest offer “would not have been in the best
interest of its shareholders.” The Boston Scientific-Guidant deal still needs
the approval of antitrust regulators in the United States and Europe, who had
already cleared the potential deal between J&J and Guidant. (CNN)
Flu
vaccine distribution flawed, CDC contends
The nation's top disease tracker Tuesday acknowledged that there are significant
flaws in the flu vaccine-distribution system in the United States and pledged to
consider expanding the federal government's role in buying and tracking shots.
For the current flu season, the U.S. Centers for Disease Control and Prevention
bought about 11.5 million doses, out of 86 million produced by private
manufacturers, with much of it then resold to state health departments. “Since
we don't own the supply, it's very difficult for us to put our weight behind
supporting appropriate distribution,” said Julie Gerberding, CDC director,
speaking at a major summit on the flu vaccine supply and its distribution.
“Certainly,” she said, “government could purchase more vaccine.” Next year,
manufacturers are likely to produce as many as 120 million shots, company
representatives disclosed at the Atlanta summit. But doctors and public health
authorities voiced continued concern about the patchwork system of public
agencies and private doctors, pharmacies, and big-box retailers that now provide
flu vaccine. Health authorities said they are particularly dismayed by the
failure to establish a network that would follow every shot from the time it
left a manufacturer to the time it was administered. A detailed tracking system,
public health officials and doctors said, has the potential to ease a persistent
supply-demand mismatch that results most years in millions of vaccine doses
being squandered. The CDC is studying such a tracking system, and summit
participants are expected to offer recommendations on how a network could be
structured. But Dr. Raymond Strikas, a leading flu vaccine specialist at the
agency, acknowledged that further discussions with vaccine makers and
distributors are necessary before a registry could be implemented.
Pharmaceutical industry executives have long expressed fears that providing the
CDC with too much information might jeopardize their competitive edge. Jennifer
Alfisi, an executive with the Health Industry Distributors Association, said her
industry is concerned that providing information to the CDC could breach
confidentiality agreements with doctors, who may not want details of their
practice disclosed to the government. But association members are discussing how
they can be more helpful. (The
Boston
Globe)
Doctors write article backing ban on
gifts from drug makers
The gifts, drugs and
classes that makers of
pharmaceuticals
and medical devices routinely give doctors undermine medical care, hurt patients
and should be banned, a group of influential doctors say in The Journal of the
American Medical Association. Medical schools and teaching hospitals should be
the first to establish a comprehensive ban, the group writes. But the authors
argue that all doctors should eventually follow suit. Broadly adopted, the
recommendations would transform doctors’ day-to-day lives and shut off the focus
of drug makers’ biggest expenditures. But Dr. David Blumenthal, an author of the
article, said it was “not very likely” that many in medicine would listen to the
group. Federal law forbids companies from paying doctors to prescribe drugs or
devices, but gifts and consulting arrangements are almost entirely unregulated.
Voluntary professional guidelines suggest that doctors refuse gifts of greater
than “modest” value. Sanctions against doctors who accept gifts of great value
are extremely rare. The drug industry spends tens of billions of dollars a year
to woo doctors, far more than it spends on research or consumer advertising.
Some doctors receive a significant part of their income from consulting
arrangements with drug and device makers. Others take regular vacations and
golfing trips that are paid for by companies. While such rich arrangements are
often restricted to specialists, most physicians routinely accept small gifts
from drug salespeople. Surveys show that most doctors do not believe that these
gifts influence their medical decisions, although most believe that they do
affect their colleagues’ medical judgment. But even small gifts can lead to
profound changes in doctors’ prescribing behavior, with “negative results on
clinical care,” the article states. As a result, all gifts should be banned, the
authors conclude. Ken Johnson, a spokesman for the Pharmaceutical Research and
Manufacturers of America, said the drug industry had a voluntary code of
marketing conduct. “Only practices that do not compromise independent judgments
of health providers, such as modest working meals, gifts of minimal value that
support the medical practice, and distribution of free samples, are permitted,”
Johnson said in a statement. Dr. Duane M. Cady, board chairman of the American
Medical Association, said in a statement that “drug and medical device makers
can play a role in educating physicians about new products.” He said the
organization was “in the process of examining and updating its policy on gifts
to physicians from industry.” (The New York Times)
Bush considering tax breaks for health care;
workers who must buy coverage may be aided
President Bush is
weighing proposals for new tax breaks for health care costs, which will be a
major topic of next week's State of the Union address, a top economic adviser to
the president said Tuesday. “People are very, very frustrated about the cost of
health care,” said Allan Hubbard, director of the National Economic Council.
Hubbard told reporters at USA TODAY and Gannett News Service that the tax code
offers advantages when a company buys health coverage for its employees but
doesn't do the same for employees who have to buy coverage on their own. “The
president's very concerned about the unfairness of the tax code,” Hubbard said.
Bush himself has discussed some other health care ideas, including expansion of
health savings accounts. Bush has also talked about providing consumers with
more information about medical costs, to enable them to be better shoppers.
Hubbard said Bush will discuss that topic, but he declined to say whether Bush
would propose that the government require doctors to post their fees, or simply
encourage patients to ask. Hubbard said Bush will also devote part of Tuesday's
speech to higher energy prices and the rising costs of entitlement programs such
as Medicare and Social Security. Sen. Edward Kennedy, D-MA, said the
administration's health care approach does not address the increasing numbers of
uninsured Americans, or problems with Medicare's new prescription-drug plan. In
recent appearances, Bush has indicated he will revive past health care
proposals. They include allowing businesses to pool their health insurance costs
across state boundaries and restricting what Bush calls “junk lawsuits” that
drive up medical costs. The president and aides will also promote health
insurance “portability” in an increasingly mobile society. “People should be
able to leave their jobs and keep their insurance,” Hubbard said. (USA Today)
DMAA launches project to develop standards for measuring,
evaluating disease management outcomes
The Disease Management Association of America (DMAA) announced the launch of an
ambitious project to develop by year’s end a uniform method for measuring and
evaluating outcomes in disease and care management programs. Don Fetterolf, MD,
chair of the DMAA Quality and Research Committee will lead the DMAA Outcomes
Steering Committee’s stewardship of the standards development project. The
committee expects to present a final, uniform evaluation methodology during the
DMAA’s 2006 Disease Management Leadership Forum, Dec. 3 to 5, in Denver.
Underscoring the importance of this effort is agreement among the companies and
individuals involved to support the final methodology and to put on hold
independent standards development projects already underway. Initial work on the
project will involve a survey of the disease management community to collect
data on how disease management organizations and others now measure outcomes.
The steering committee established sound criteria for a survey instrument, using
a process that examined questions of scope, statistical and actuarial
considerations, collection methods and other issues. “The DMAA recognized that a
gap exists in our understanding of best practices for evaluating disease and
care management programs,” DMAA Executive Director Tracey Moorhead said. “Our
experience shows disease management works, but lack of agreement on how to
measure that success has hampered our ability to convince skeptics. Through the
leadership of the DMAA and its members, we will develop the tools we need to
erase any doubt that disease management benefits patients and payers alike.” The
DMAA will reach out to a broad coalition of public and private quality and
standards-setting entities to enlist their assistance and support as the project
moves forward. Relationships already established include those with URAC, the
National Association of Manufacturers and third-party evaluators and
researchers.
Thermo Asset Management Services and
Vanderbilt University
Hospital announce partnership
Thermo Asset Management Services, Brookfield, WI, and Vanderbilt University
Hospital, Nashville, TN, have announced an agreement for the hospital to
implement Thermo AMS’ LIFECYCLE Program. The program creates effective
management and operational tools designed specifically for Vanderbilt University
Hospital.
Tuesday, January 24, 2006
FDA announces new program to
transform
and strengthen medical device safety
APIC, IDSA, SHEA develop model
legislation
on public reporting of healthcare-associated infections
China reports 10th bird flu
case
MedAssets Net Revenue Systems
enhances Crosswalk,
offering improved data integrity
Whistle-blower suit says device maker
generously rewards doctors
A prominent surgeon in
Wisconsin was paid $400,000 a year by
Medtronic for
a consulting contract requiring him to work just eight days. Another doctor in
Virginia received nearly $700,000 in consulting fees from Medtronic for the
first nine months of 2005. These doctors work in a growing field, complex back
surgery, and this makes them particularly valuable to the spinal-implant
division of Medtronic. In recent years, the company has spent tens of millions
of dollars on consulting contracts and other types of payments to them and
numerous other prominent surgeons, according to papers filed as part of a
whistle-blower lawsuit. The suit contends that some of these payments were made
to attract or retain the doctors’ business. Medtronic, based in Minneapolis, is
one of the country's largest medical device makers, with $10 billion in annual
sales. The documents shed new light on a matter that has troubled the medical
device industry for years: the assertion that companies employ a variety of
financial ruses to pay doctors who use their devices, a practice that medical
and legal experts say is unethical and possibly illegal. But despite industry
efforts to clean up such practices, the documents and accusations made by former
Medtronic employees suggest that the problem persists and may have gotten worse.
The lawsuit, filed in United States District Court in Memphis two years ago and
since amended, was brought by the whistle-blower, a former Medtronic employee.
The Justice Department, which has the right to intervene in the case but has not
yet done so, is seeking to recover Medicare funds. According to legal filings,
it proposes that Medtronic settle the matter by paying $40 million. The suit
accuses Medtronic of giving spine surgeons “excessive remuneration, unlawful
perquisites and bribes in other forms for purchasing goods and medical devices.”
The plaintiff, Jacqueline Kay Poteet, a senior manager of travel services for
Medtronic until 2003, has also accused the company in a supplemental complaint
of continuing these improper payments in 2004 and 2005. Her lawyer has objected
to the proposed settlement offer as too low. All the doctors involved in the
lawsuit who were reached for comment said that the payments to them were
appropriate and fair compensation for work done for Medtronic. The company,
which said it continues to cooperate fully with the government to resolve the
case, declined to comment directly on the accusations, saying they remained the
subject of litigation. In a written response, a spokesman, Rob Clark, said, “We
take these allegations very seriously and we do not tolerate conduct that is
illegal or unethical.” Consulting arrangements with doctors to improve devices,
he said, “are critical, in our view, to the delivery of state-of-the-art health
care and are perfectly legal.” The internal Medtronic documents filed as part of
the suit show that Medtronic spent at least $50 million on payments to doctors
over some four years, through June or later in 2005. Such payments can become
illegal when they are linked to a doctor's use of a particular device and
violate the federal law against kickbacks, which says that payments and other
benefits cannot be provided to doctors if the payments are intended to induce
them to use the company's products. In addition to consulting fees and other
payments, the lawsuit said, Medtronic played host at medical conferences where
the “principal objective” was to “induce the physician, through any financial
means necessary” to use its devices. According to the Medtronic documents, the
company closely tracked the use of its devices by the doctors who attended the
conferences, choosing some for “special attention.” Poteet, the whistle-blower,
worked for Medtronic until an injury forced her to leave in 2003. At Medtronic,
she arranged trips for doctors to the company’s conferences and became familiar
with attempts to win the doctors’ favor. Medtronic is also the target of another
whistle-blower lawsuit in Memphis, where its spine division is based; that suit
also accuses it of making improper payments to doctors. Medtronic’s “bribery
program,” as it was described in the suit, “has not only failed to cease, but
continues unabated with increased payments made to many physicians,” the suit
said. A doctor in Virginia, for example, made $300,000 in consulting fees in
2003 but only $75,000 in 2004. Last year, the company paid him nearly $700,000
for his consulting work through September. The doctor, who was not named as a
defendant in the suit, said the spike in payments was a result of a change in
how he was paid, requiring him to document his work before he received any money
and therefore increasing the amount he received last year. The company commonly
paid for doctors to attend any of 200 professional meetings a year. If the
doctors wanted to go snorkeling or play golf, the sales representatives or
Medtronic employees almost invariably paid for the expense, she said. When the
doctors visited Memphis, she said, Medtronic employees would take them to a
local strip club, disguising the expenses as an evening at the ballet. A
Medtronic lawyer raised concerns in 2003 about whether the company should pay to
take doctors sailing or fishing, or ask for contributions, according to a
company e-mail message that is part of the legal filings. “When we are sending
scores of doctors to a nice resort like this under the guise of training and
education on our products,” he said, “I think we need to be more careful and
stick to the limits of our rules as best we can.” A spreadsheet compiled by
Medtronic for a June 2003 meeting indicated what Medtronic hoped to accomplish
with each doctor attending an event, Poteet said. This list of 230 or so doctors
included an estimate of the dollar value of the devices each doctor used in
surgery, including the value of the devices made by Medtronic. One doctor is
described as “a 100 percent compliant M.S.D. customer,” while others were cited
for “special attention.” M.S.D. referred to Medtronic Sofamor Danek, the largest
competitor in the spinal device market. The notes for one doctor suggested an
expectation that those offered an arrangement where they helped design a device
would become loyal users. (The New York Times)
http://www.nytimes.com/2006/01/24/business/24device.html?emc=eta1
FDA announces new program to transform
and strengthen medical device safety
The U.S. Food and Drug Administration (FDA) is launching a new program to
transform and strengthen the way it currently monitors the safety of medical
devices after they reach the market, both new technology and existing products.
The FDA Center for Devices and Radiological Health's (CDRH) Postmarket
Transformation Initiative will better protect the public health by allowing the
FDA to identify, analyze and act on problems more quickly, including alerting
the public sooner of potential medical device issues. “Over the next decade,
medical technology innovations will fundamentally transform the health care and
delivery system, providing new solutions with medical devices that will
challenge existing paradigms and revolutionize the way treatments are
administered,” said Dr. Scott Gottlieb, FDA's Deputy Commissioner for Medical
and Scientific Affairs. “Under the leadership of our device center's expert
staff, we are working to develop even better ways to evaluate new technologies
to maximize benefits and minimize risk, including more efficient ways to develop
more effective post-market systems that can support safer medical practices as
well as continued innovation.” Areas in which this initiative will focus
include: Working toward an electronic reporting system for adverse medical
device events;
Unique ways
to identify medical devices including standardized and globally accepted names;
ways to improve device information in patient records; improved internal
collaboration on post market safety issues; and identifying opportunities to
improve the safety of medical devices through collaborative efforts with
professional organizations and the medical device industry. The FDA undertook
this initiative after a comprehensive, year-long internal inventory of the tools
used to monitor the safety of medical devices after they are approved. This
inventory identified many areas that are working well; however, it also
identified challenges associated with medical devices after they reach the
market. To obtain a copy of CDRH's Medical Device Postmarket Safety Program or
Medical Device Postmarket Safety Program – Synopsis and Recommendations, see:
www.fda.gov/cdrh/postmarket/mdpi.html
APIC, IDSA, SHEA develop model legislation
on public reporting of healthcare-associated infections
The
Association for Professionals in Infection Control and Epidemiology (APIC), the
Infectious Diseases Society of America (IDSA), and the Society for Healthcare
Epidemiology of America (SHEA) has released model legislation to assist patient
safety initiatives by giving state legislatures a template to use when adopting
legislation for the collection and reporting of healthcare-associated infection
rates. “Our organizations recognize the challenges to the states of public
reporting,” said Michael L. Tapper, MD, chair of SHEA’s Public Policy and
Governmental Affairs Committee. “Sound science and appropriate methodologies are
integral to states’ successful institution of reporting requirements. APIC, IDSA,
and SHEA have worked together to provide a comprehensive document based on these
principles.” “Currently, there is no uniform national standard for surveillance
of healthcare-associated infections or standardized systems for collecting and
reporting these infections when they occur,” said APIC President Kathleen Meehan
Arias, MS, MT, SM, CIC. “For the first time, states are armed with a tool to
help craft legislation that will result in useful data by which facilities can
benchmark their performance.” Healthcare-associated infections (HAIs) are a
major public health problem in the United States, and are thought to be
responsible for increasing mortality and morbidity, adding millions of dollars
in healthcare expenditures by states and their taxpayers. “It has been estimated
that in the United States, HAIs account for 2 million infections and $4.5
billion dollars in excess healthcare costs each year,” added Arias. The new
model legislation was developed in response to a growing trend. At least six
states (FL, IL, MO, NY, PA, and VA) now have laws mandating public reporting of
infection rates, and one state (NV) mandates reporting infection rates to the
state government. Similar proposals have been introduced in about 20 other
states. “States need a good model on which to base their systems,” said IDSA
President Martin J. Blaser, MD. “It’s important that public reporting be done in
a way that allows people to discern what the data actually mean, and—just as
importantly—how the data can be used to prevent infections and improve patient
care.” The model legislation aims to ensure that state reporting systems adhere
to recommended practices that have been shown to reduce the risk of HAIs,
protect the confidentiality of medical records, and reflect the fact that some
institutions treat more seriously ill patients. “People should be able to use
this information to measure how well institutions perform. The model legislation
makes certain that state reporting systems are based on reliable data,” said
SHEA President Trish M. Perl, MD, MSc. Click on the following link to access a
copy of the model legislation:
http://www.apic.org/Content/NavigationMenu/GovernmentAdvocacy/MandatoryReporting/mr_resources/Model
_Legislation_-_APIC__IDSA__SHEA.pdf
China
reports 10th bird flu case
A 29-year-old woman in
southwestern China has tested positive for bird flu and been hospitalized in
critical condition, the official Xinhua News Agency said. The woman was the 10th
human case of bird flu in China. There have been six human fatalities in
mainland China. The woman showed symptoms for a fever and pneumonia on January
12 and has been hospitalized in a critical condition, Xinhua said Monday. It
said she tested positive for the H5N1 strain of bird flu on January 17. (The
Associated Press)
MedAssets Net Revenue Systems enhances Crosswalk,
offering improved data integrity
MedAssets Net Revenue Systems announced the release of the latest version of
CrossWalk, a technology that automatically and continuously links a healthcare
provider’s supply cost data to charge data to ensure charges cover costs with a
reasonable, payer-compliant mark up. CrossWalk version 2.0 provides greater
functionality that will improve hospitals’ data integrity and will result in
more consistent and controlled billing practices. CrossWalk now offers seamless
integration of updated supply charges into each hospital’s patient accounting
system. This enhancement will facilitate accurate charge capture of high cost
medical devices for which prices change frequently. CrossWalk also addresses
compliance issues related to over-charging for supplies. Other enhancements
included in CrossWalk version 2.0: Non-file purchase tracking allows linking to
all items including special order, high cost items not included in a hospital’s
Master Item File; Trending reports allow important data trends to be sorted
daily, weekly or monthly; and E-mail summary reports provide key action items
via e-mail on items that may require immediate attention.
To
learn more about the steps and benefits to linking supply chain and revenue
cycle, visit
http://www.hfma.org/education/Audio_Webcast/january24_2006.htm to register
for the Healthcare Financial Management Association’s Audio Webcast “Linking
Supply Chain and Revenue Cycle: The Time Has Come.” The date and time for this
event is January
24, 2006 from 2:00- 3:45 p.m. Central Standard Time.
Monday, January 23, 2006
French woman free from bird
flu: health ministry
Patients needing care overwhelm New Orleans
hospital system
Sweeping changes sought in New
Orleans health care system
Second medical journal
investigates research fraud
Medline awarded Premier
contract valued at $325 million
Arabs' bird-flu fears spur new caution
Bird flu has killed in Turkey on the northern fringe of the Middle
East, and residents in the Arab lands to the south fear migrating
birds have already spread the virus to their countries.
No cases have been confirmed despite
scares in
Lebanon and Iraq, but many Arabs have stopped eating chicken, health
officials are stockpiling medicine, poultry flocks have been culled
and citizens have been warned to be alert for dead birds and people
with symptoms of the disease. Fears that the virus is already among
them deepened when Turkey's agriculture minister on Friday accused
unnamed countries among its neighbors of concealing outbreaks.
Turkey has confirmed the deadly strain in 21 people, including four
children who died. A team of U.S. government flu experts on Sunday
visited a hospital in Van, the eastern Turkish city where the
children died. The team was hoping to assess what help the United
States could provide. (The Associated Press)
French woman free from bird flu: health ministry
A
French woman who was hospitalized on Saturday tested negative for bird flu, the
French health ministry said on Sunday. Earlier on Sunday, France said it was
investigating a possible case of bird flu in the woman who had returned from a
two-week stay in the Tarsus region in Turkey. The woman, who had seen dead birds
while traveling in Turkey, showed symptoms of flu combined with breathing
difficulties and was hospitalized in Montpellier. Several tests were done to
establish if she was affected by the virus but all the results were negative,
the ministry said in a statement. Tarsus, in Turkey's East Mediterranean part,
is not known to have been affected by the disease, the ministry said. The French
government earlier this month tightened its own protection measures against a
possible outbreak of the virus. It has raised the number of departments where
poultry must be kept inside to 58, almost two-thirds of the country, from 26.
(Reuters)
Patients needing care overwhelm New Orleans
hospital system
As thousands of
residents have begun returning to New Orleans in the weeks since New Year's,
there are far more sick people than there are doctors, nurses, beds and
equipment to take care of them. The slow repopulation of the city picked up
speed after the holidays as more schools reopened and, in the words of one
emergency room doctor, the sicker people began to return. But only seven of what
had been 15 adult acute-care facilities in the city and three surrounding
parishes are open, and only one-third of the acute-care beds. Hundreds or
perhaps thousands of doctors and nurses never returned to New Orleans after the
flood; long-term and psychiatric hospitals, not to mention hospices and
rehabilitation centers, are now almost nonexistent in and around the city. As a
result, the returning residents have filled the functioning hospitals in and
immediately around the city to capacity and beyond. Waiting times in emergency
rooms have extended to as much as six hours, medical personnel at three
hospitals reported. The city's sickest residents were among the first to leave
New Orleans after Hurricane Katrina and should be the last to return, but that
is not happening, said Dr. John Wales, chairman of the department of emergency
medicine at East Jefferson, which for days has had more patients than it has
beds. The Touro Infirmary is the only full-service hospital now functioning
within the New Orleans city limits, and the lack of beds in the city has pushed
patients to suburban hospitals like East Jefferson and filled them up.
(Children's Hospital is also open in the city.) The situation is likely to get
worse as
flu season,
which usually begins around late January here, hits its stride. The thought of
next month's Mardi Gras festivities has local doctors so worried they have
formed a committee just to plan for care during the first large-scale, signature
event in the distorted post-hurricane world. Dr. Jullette Saussy, who runs the
911 emergency medical service for the City of New Orleans, said that during
Mardi Gras, the number of ambulance calls typically tripled, from an average of
120 a day to 360. “There's a resource problem right now,” said Dr. Peter
DeBlieux, who heads the emergency department of Charity Hospital, a venerable
institution for the city's poor, which no longer has a building and is operating
out of Air Force tents in a far corner of the convention center. Five hospitals
in the city, severely damaged by the storm, have been unable to reopen,
including the Medical Center of Louisiana, the only Level 1 trauma center on the
Gulf Coast, which is a combination of Charity and nearby University Hospital.
Some hospitals have opened neighborhood clinics or parking-lot tents for walk-in
care, but some may never reopen, or may take up to a year to find the money to
rebuild. The state wants to replace Charity, and its planned renovations to
University Hospital could take several months or up to a year. The city's
rebuilding commission said in a report this week that if 65 percent of the
region's prestorm population returns by July 1, as many experts have predicted,
the city will need to triple the number of hospital beds available, which would
require hiring 2,550 medical staff members in less than six months and an
“extraordinary expense” in housing them and paying them enough to return.
Cynthia Matherne, the designated regional coordinator for emergency management
in an area that includes New Orleans and the parishes of Jefferson, St. Bernard
and Plaquemines, said the problem of limited medical resources put pressure on
emergency rooms from all directions. Ordinarily, patients who have been
stabilized after an emergency episode are gradually moved out to long-term acute
care, rehabilitation or psychiatric facilities. “But these have not reopened,”
Matherne said. “So all the psych patients end up being held in the E.R.'s. And
when you're trying to discharge patients, there's no long-term care to discharge
them to. There's no discharge to hospice care because there's none available.”
Home health aides are virtually nonexistent, she added. Dr. Saussy, of the New
Orleans medical emergency response office, described a parallel problem among
the ambulance units in the city. Because only Touro, with 273 beds, and
Children's Hospital, with 125 beds, are open, city ambulances must often go to
the three hospitals in nearby Jefferson Parish: East Jefferson General (444
beds), West Jefferson Medical Center (330 beds) and Ochsner Clinic Foundation
(350 beds, expanding soon to 484). Matherne said the number of acute-care beds
in the four parishes before the storm was 5,063, with an average of 4,083 filled
each day. “Right now we're right at about 1,750 beds,” she added. Charity
Hospital, once a magnet for some of the most severe medical emergencies, and for
patients least likely to have insurance, is shuttered, leaving a jury-rigged
emergency room under tents within the convention center. Dr. DeBlieux said 100
to 200 patients a day arrived with complaints ranging from major trauma or
strokes to breaks and sprains. Psychiatric patients are now being sent to
emergency rooms unused to them. Charity's lease at the convention center runs
out in a few weeks, and the hospital is making plans to move its emergency room
to another hospital building in Jefferson Parish. In the early weeks after
Hurricane Katrina, military medical units from the Army, Navy and Air Force set
up temporary medical facilities around the city and helped with everything from
diabetes to
births to
immunizations,
but most of these units are gone. Dr. Wales at East Jefferson, like other
emergency room directors, is trying to get more staff members to come back,
particularly nurses and technicians and orderlies. (The New York Times)
Sweeping changes sought in New Orleans health care system
Vowing to never again
allow the conditions that contributed to the deaths of at least 140 hospital and
nursing home patients during and after Hurricane Katrina, the health care
committee of Mayor Ray Nagin's Bring New Orleans Back Commission on Wednesday
proposed immediate changes to the way medical centers plan for and deal with
natural disasters, and unveiled a 64-page plan. In a sweeping proposal, the
group called for hospitals to do a better job evacuating patients before a storm
hits, to elevate generators and other requirement needed to survive a flood, and
to acquire communications equipment that will link hospitals to emergency
officials even after catastrophic damage. More broadly, the plan would raise
from the ruins of the region's wrecked hospitals a health care system better
able to care for the poor and uninsured, to deliver services at the neighborhood
level and to generate enough revenue to keep hospitals healthy financially.
Katrina created an opportunity to dismantle and rebuild the region's
dysfunctional health care system, which for decades left the city's most
vulnerable residents with little choice other than going to the state's
antiquated and overwhelmed Charity Hospital System, said Kim Boyle, a New
Orleans lawyer who was chairwoman of the committee. The report is among seven
being released this month by the mayor's commission. More than 200 people,
including leading doctors, hospital managers and public health officials, took
part in a series of public meetings between Nov. 1 and Dec. 20 to flesh out the
biggest problems facing the health care industry in the wake of the storm. The
health care committee's report relied heavily on a recovery plan developed a few
weeks after Katrina by government health care agencies, local medical schools
and community health care organizations. Funding for a new communications
system, likely a big-ticket item, should be sought from the federal government,
and the Federal Emergency Management Agency should be asked to cover the cost of
moving critical equipment at local hospitals to flood-proof elevations, Boyle
said. The committee also wants hospitals to work more closely with social
service agencies and organizations to identify and track people with medical
conditions or disabilities that might make evacuation from their homes
difficult, if not impossible. Many evacuees who sought medical care in other
cities faced another problem: They didn't have access to their medical records.
The committee said the problem could be solved by a federal initiative to
convert paper medical records to uniform computerized records. But that move
will take years to complete and certainly will not be in place in time for the
next hurricane season. So doctors, under the direction of the New Orleans Health
Department, should provide patients with a printed card containing a summary of
their medical history that can easily be carried during an evacuation, the
committee said. The committee called on the Legislature to consider replacing
some or all of the state's Charity Hospital System with a program that would
provide insurance for the poor and uninsured, who then could seek care at the
hospitals of their choice. Boyle noted that the state's uninsured population
grew from 900,000 people before Katrina to 1.2 million after the storm. “One of
the primary objectives is to eliminate what we deem to be a two-tier system,”
she said. “We are attempting to create a model health care system in Louisiana.”
(New Orleans Times Picayune)
Second medical journal investigates research fraud
A second medical
journal is reporting it published false information from a Norwegian scientist
who has done research on oral cancer. Last weekend, Norwegian officials said the
researcher admitted falsifying data for a study published in The Lancet, a
British medical journal. On Friday, the New England Journal of Medicine reported
that a paper published on April 26, 2001, contained two photographs claiming to
represent two patients with different stages of oral cancer, but actually showed
the same patient. A second article, published April 1, 2004, was believed to
involve the same set of “patients.” The journal has not retracted the studied
but sent a “letter of concern” to the researcher's hospital. The researcher, Dr.
Jon Sudbo of the Norwegian Radium Hospital in Oslo, has been on leave and
unavailable for comment, his clinic has said. An independent commission is
investigating the faked research. The two New England Journal studies were about
apparent connections between various genetic characteristics and oral cancer.
The study in The Lancet claimed to show that common pain relievers such as
Motrin, Advil and Aleve lower the risk of oral cancer but raise the risk of
heart problems. Sudbo is alleged to have made up roughly 1,000 patients. (The
Associated Press)
Medline awarded
Premier contract valued at $325 million
Medline Industries Inc. recently won a new three-year national agreement to
provide custom procedure trays, packs and gowns to members of Premier Purchasing
Partners, LP. The multi-source agreement, valued at approximately $325 million
is effective through December 31, 2008. The agreement covers a multitude of
custom procedure trays, packs and gowns used in surgical procedures. The deal
will also provide Medline’s advanced protection Proxima surgical drapes and
gowns.
Friday, January 20, 2006
Report: Japan to halt U.S.
beef imports
Doctor says autistic boy died
from drug mixup
Webinar: Breathing filters can
help safeguard patients and
healthcare workers in event of influenza pandemic
VA care is rated superior to
that in private hospitals
Studies look to sea for
cystic fibrosis treatment
Premier awards contract to
BELIMED Infection Control
Documents suggest Guidant debated device peril
Six
months before the Guidant Corporation publicly disclosed short circuits in its
heart devices, a debate may have been going on within the company over whether
to alert doctors about such failures, internal company documents released
Thursday suggest. The documents appear to indicate that some Guidant executives
recommended in January 2005 that the company find a way to tell doctors about
the failures posed by a device known as the Contak Renewal, an advanced heart
defibrillator. The records, which were disclosed Thursday as part of a court
proceeding in Texas, include handwritten notes said to have been composed by a
top Guidant executive. Guidant started receiving a small but growing number of
reports of short circuits in Contak Renewals in late 2004, more than two years
after it discovered a similar problem in another defibrillator, the Prizm 2 DR.
The Guidant records suggest that company executives came close to alerting
doctors about the Contak Renewal last January, but that some officers opposed
the idea. The company also conducted tests on the device. One executive later
reported that the unit's failure rate was not as bad as first feared, the
documents show. Because the records are handwritten notes, it is not clear
whether the “recommendation” in them refers directly to the Contak Renewal,
though that appears to be the case. Asked specifically about the issue, Guidant
declined to comment or explain. In a statement, the company said, “As the
documents reflect, the company took responsible action during an ongoing
investigation of Renewal and Renewal 2.” It also noted it had “aggressively
evaluated product performance and communication thresholds.” Guidant publicly
disclosed problems with the Prizm 2 DR and the Contak Renewal last spring after
it came under scrutiny. Seven people are known to have died in connection with
short circuits in the devices; five deaths have involved a Contak Renewal or a
related model known as the Contak Renewal 2. But the number of deaths is
probably higher because physicians only recently became aware of the problem,
reported The New York Times. Guidant has said the number of reports it
received did not warrant an earlier physician alert. At a minimum, the
disclosure of the new Guidant documents is likely to fuel efforts to develop
industrywide standards about when and how doctors and patients should be
informed by heart device makers about malfunctions, said The Times. A
report by a committee formed by Guidant is due out in March, and a medical
group, the Heart Rhythm Association, plans to issue recommendations in May. (The
New York Times)
Report: Japan to halt U.S. beef imports
Japan will
halt U.S. beef imports following the discovery of material considered at risk of
mad cow disease in a shipment from the United States, Kyodo News agency reported
Friday. Yumiko Sakurai, an official with the Japanese Agriculture Ministry, said
she could not immediately confirm the report, but that the ministry was
preparing a statement. Prime Minister Junichiro Koizumi's office said
Agriculture Minister Shoichi Nakagawa has recommended a total halt to U.S. beef
imports. Nakagawa said earlier Friday it was possible that material from cattle
backbones was included in beef recently imported from the United States,
according to Yumiko Sakurai, a ministry official. Japan in December partially
lifted a two-year-old ban on American beef imports imposed in 2003 following the
discovery of the first case of mad cow disease in U.S. herds. (The Associated
Press)
Doctor says autistic boy died from drug mixup
PITTSBURGH -- A 5-year-old autistic boy died from a drug mixup, not the
lead-poisoning treatment that was attempted to ease his disorder, a federal
health official who reviewed the boy's autopsy results said. Instead of a
synthetic amino acid that treats lead poisoning, Abubakar Tariq Nadama was given
a medication that removes calcium, said Dr. Mary Jean Brown, chief of the
Centers for Disease Control and Prevention's lead poisoning prevention branch.
“It's a case of look-alike/sound-alike medications,” Brown said Tuesday. The
drug “acted as a claw” that pulled too much calcium from his blood, causing an
emergency event. She said the child was given Disodium EDTA instead of Calcium
Disodium EDTA. “They sound alike. They're clear and colorless and odorless. They
were mixed up,” Brown said. The treatment Abubakar was receiving, called
chelation therapy, is FDA-approved for lead poisoning. The therapy has not been
proven to help autistic patients, though some parents and doctors advocate it
because they believe autism is caused by heavy metals. Abubakar of Monroeville
died Aug. 23 in his doctor's office after his third chelation treatment, the
coroner has said. Brown reviewed the autopsy report for the CDC.
Butler County Coroner William Young has said he plans
to meet soon with District Attorney Randa Clark and the state police to
determine if an inquest is warranted. For now, Young is classifying the death as
an accident. (The Associated Press)
Webinar: Breathing filters can help safeguard patients and
healthcare workers in event of influenza pandemic
In the spring of 2003, the
respiratory virus SARS traveled to five countries within 24 hours. Many of those
who died were first responders, principally Canadian and Taiwanese healthcare
workers. SARS patients on ventilators infected the equipment, inadvertently
exposing hospital staff and subsequent patients to the deadly virus. The same
scenario looms for avian flu. Presenting with respiratory illness, many may
require ventilators, already in short supply, to help them breathe. Even with
sufficient ventilators and respiratory equipment, a threat remains. Traditional
disinfection methods do not destroy the SARS or influenza viruses. The SARS
virus was found to live on surfaces for prolonged periods of time, up to 72
hours on plastic and stainless steel and 96 hours on glass slides, thus the
threat of nosocomial (hospital-acquired) infection remains significant. Based on
key observations from the SARS outbreak, the public health community recognizes
that there are a number of measures hospitals can take now to help safeguard
patients and staff from avian flu and other infectious viruses that could
threaten global health. One such measure is the use of breathing system filters
as a barrier between viral and bacterial transmission to patients, hospital
staff and respiratory equipment. To prevent further SARS contamination, health
officials in Canada and Taiwan issued directives to hospitals to use
high-efficiency breathing circuit filters that effectively capture and retain
the offending virus to prevent cross-contamination. They also recognized that
only filters that meet stringent criteria, specifically being hydrophobic
(ability to repel liquids) and also demonstrating high levels of viral
retention, would be effective. These criteria are even more critical with
influenza, due to its likely modes of transmission, through droplets in the air
and contaminated fluids, such as saliva and bronchial secretions. Pall
Corporation's breathing system filters for anesthesia and respiratory care
combine these stringent requirements to provide an effective barrier against
viral and bacterial contaminants, and were specifically recommended by
international health authorities. Studies have shown that Pall Breathing System
Filters provide an effective barrier to contaminated liquids and have an
airborne bacterial and viral removal efficiency of at least 99.999 percent. The
filters have been challenged with bacterial (Brevundimonas diminuta) and viral
(MS-2 bacteriophage) organisms that represent the gold standard for pathogen
exclusion on the basis of size.
To help prepare for an
influenza outbreak, international experts including representatives from the
U.S. Centers for Disease Control and Prevention (CDC) and the Canadian Critical
Care Pandemic Provincial Committee discussed influenza risks and protective
measures in a global web-based interactive teleconference, sponsored by Pall
Corporation, on January 18, 2006. The webinar entitled “Pandemic Preparedness:
Transmission of Influenza and Other Infectious Disease and the Role of Breathing
Filters in the Clinical Setting” is designed for healthcare systems and
disciplines likely to be affected by infectious diseases, such as avian flu. It
is especially relevant to first responders, emergency room physicians, infection
control officers, anesthesiology practitioners, surgeons, respiratory and
pulmonary specialists, nurses and public health officials. To download a
transcript of the webinar go to http://invite.mshow.com/findshow.aspx?usertype=1&cobrand=100&shownumber=266838
VA care is rated superior to that in private hospitals
The Department
of Veterans Affairs medical system once epitomized poor-quality care. But after
a series of changes, the system has been hailed in recent years as a model for
health care reform. Now, survey results released this week indicate that those
improvements have translated into a high level of satisfaction among veterans
getting treated by the rehabilitated VA. The telephone survey, conducted in
October, found inpatient care received a rating of 83 on a 100-point scale;
outpatient care got a rating of 80. In comparison, a similar survey of patients
receiving private care found they rated their satisfaction at 73 for inpatient
care and 75 for outpatient care. The survey involved more than 200 veterans who
received care at one of the VA's 154 hospitals or 875 clinics. The findings mark
the sixth consecutive year the VA health care system has outranked the private
sector for customer satisfaction. Veterans Affairs Secretary Jim Nicholson
attributed the high ratings to the changes in the system, such as implementation
of electronic records to reduce the risk of errors. The survey, known as the
American Customer Satisfaction Index, has been conducted since 1994 by the
National Quality Research Center at the University of Michigan business school
and two consultants, the CFI Group and the Federal Consulting Group. Peter S.
Gaytan, director of veterans affairs and rehabilitation for the American Legion,
said he was not surprised by the findings because the quality of VA care has
been steadily improving. But Gaytan said many veterans have to wait months or
travel long distances to get care because tight budgets have forced many
facilities to cut back on service. “The problem that the American Legion has is
the accessibility to care. There are veterans waiting in line to receive care,”
Gaytan said. Nicholson acknowledged that some veterans do have to wait for care,
but he said the waiting time has been improving and continues to improve. (The
Washington Post)
Studies look to sea for cystic fibrosis treatment
Two studies
published Wednesday in the New England Journal of Medicine report that cystic
fibrosis patients who inhaled a specially mixed saltwater solution at least
twice a day had half as many hospitalizations for lung problems and
significantly improved their ability to clear mucus from the lungs. The patients
in the studies also had marked improvement in lung function, said Dr. Scott
Donaldson of the University of North Carolina at Chapel Hill. Cystic fibrosis
causes thick, sticky mucus to build up in the lungs. Lung airway surfaces in CF
patients are dry, which makes the mucus both harder and stickier, Donaldson
said. “Surfers with cystic fibrosis had fewer lung exacerbations,” Donaldson
said. That led him and other scientists working in North Carolina and at the
Royal Prince Alfred Hospital in Sydney, Australia, to theorize that there might
be something about saltwater that could explain improved lung function in the
surfers. When the patients inhaled the saltwater, it caused their lungs to
“re-hydrate by adding a layer of water to the airway surface,” Donaldson said.
“That acts as a lubricant, which makes it easier to clear the mucus.” Donaldson
and colleagues conducted a pilot study on 24 patients, and those results were
shared with the Australian doctors, who tested the treatment in 164 patients for
48 weeks. Donaldson said he was surprised by the results because he doubted that
saltwater, or more precisely a 7 percent sodium chloride solution called
“hypertonic saline”, could work by itself. “We found exactly the opposite,”
Donaldson said. “The patients who received just the hypertonic saline got all
the benefit, while the patients who underwent pre-treatment with amiloride (a
diuretic drug used to boost the hydration effect of the saltwater) had no
improvement. “We were blown away by this finding, and it sent us scurrying back
to the lab where we discovered a novel property of amiloride: It blocked water
transport from the blood.” In the Australian study, patients getting the
saltwater through a nebulizer had significant improvement in lung function and,
perhaps most significantly, they had 56 percent fewer lung exacerbations. Dr.
Gail Weinmann, director of the Airway Biology and Disease Program at the
National Heart, Lung and Blood Institute, said the enthusiasm for the finding
needs to be tempered because “more clinical trials are needed to determine how
well this treatment is tolerated.” Both studies received funding from the Cystic
Fibrosis Foundation, and the North Carolina study received additional support
from the National Institutes of Health, while the study in Sydney was also
funded by the Australian Cystic Fibrosis Research Trust and the National Health
& Medical Research Council of Australia. (MedPage Today)
Premier awards contract to BELIMED Infection Control
Premier has selected BELIMED Infection Control (Miami, FL) as a contracted
supplier for Steam Sterilizers, Washer/Disinfectors and Cart Washers for all
their 1400+ members. The new agreement will take effect March 1, 2006 and will
continue through February 28, 2009. BELIMED focuses on maximizing reprocessing
productivity while minimizing consumption of resources, including, personnel,
water, steam, electricity and chemicals, resulting in new standards for
efficiency and environmental consciousness.
Thursday, January 19, 2006
Medicare won't repay states
for emergency purchases
Once-a-day AIDS pill could be
ready soon
GPO ethics initiative holds
its first Best Practices Forum
States fear FDA rule would
risk liability
Lawson signs new
contracts
China reports sixth bird flu death
China has recorded its sixth death from the avian flu virus, according to a
report on the Chinese Health Ministry's Web site. The victim was a 35-year old
woman from Jianyang in Sichuan province who slaughtered poultry. She was the
ninth person in the country to contract bird flu. The woman fell ill on January
3, the report said, was hospitalized on January 10 and died the next day. The
woman lived in a residential compound of eight families where chickens began
dying in late December, according to Roy Wadia, a WHO spokesman in Beijing. He
said she was asked to kill dying birds. “She was definitely in close contact
with sick or dead chickens that did have H5N1,” said Wadia. He said tests after
her death confirmed she had the virus. Experts say the deadly H5N1 virus poses
the biggest threat in the colder months in affected regions, and could also
spread in east Asia as people celebrate the Lunar New Year. Then, hundreds of
millions of Chinese will be on the move, potentially spreading bird flu in a
country where the disease has spread rapidly among birds since late last year.
(CNN,
Associated Press)
Medicare won't repay states for
emergency purchases
The federal government will not repay states that are making emergency purchases
for hundreds of thousands of poor, sick people whose new Medicare
prescription-drug coverage is not yet working, Medicare officials say.
Instead, those states must recoup the money from the
private plans that began providing drug coverage Jan. 1 on behalf of Medicare.
Medicare administrator Mark McClellan said the new Medicare legislation was
clear: “Under this program, we don't have the authority to pay states directly.
People are in Medicare drug plans, and it's the Medicare plans that are supposed
to pay for the medications.” That could create an administrative nightmare for
states such as California that stepped up to safeguard the health of low-income
elderly and disabled people whose Medicare coverage has not materialized because
of administrative problems and poor planning by Medicare officials. In
California on Tuesday, lawmakers said they will pass stopgap legislation this
week authorizing the state to pay for medications for those denied coverage by
Medicare. Over the weekend, the Bush administration told insurers to provide a
temporary supply of any prescription that a person was previously taking, and it
said that co-payments for low-income people must not exceed $5 for a covered
drug.
(Knight Ridder, The
Associated Press, The New York Times)
Once-a-day AIDS pill could be ready soon
Two
drug companies say they've put aside commercial rivalry to achieve a goal that
seemed out of reach for 20 years: a single-pill, once-a-day AIDS treatment. The
pill is to contain a regimen of three drugs already available on pharmacy
shelves and shown to be effective in multiple studies, including one coming out
today in the New England Journal of Medicine. Barring last-minute problems in
formulating the pill, doctors expect it to be approved by the end of the year.
If that happened, it would be a milestone in the development of treatments for
the human immunodeficiency virus, which causes AIDS. Under heavy pressure to
simplify treatment regimens, companies have been combining medicines and
reducing pill counts for several years. Yet for commercial, rather than
scientific, reasons, no company has yet managed to create a single once-a-day
pill containing an effective combination of AIDS drugs. As it happened, no
single company owned the rights to all the drugs necessary for an optimal
combination, and the companies were wary of working together. Now two companies
say they have combined into one pill the three licensed AIDS drugs that already
make up the most-prescribed drug regimen for newly diagnosed HIV patients. The
companies recently announced data showing the pill can achieve adequate blood
levels of all three drugs, and the study in the New England Journal of Medicine
adds to a large body of evidence showing the drug combination is effective with
relatively few side effects. The companies are already producing test lots of
the pill at a plant in Ontario. The Food and Drug Administration readily blesses
new, more convenient formulations of previously licensed drugs, and approval of
the new pill, though it will take several more months, is expected to be
routine. The biggest hurdle at this point is making sure the pills have an
adequate shelf life, a problem the companies say they are confident they can
solve. The companies involved, Gilead Sciences Inc. and Bristol-Myers Squibb
Co., say they are indeed committed to providing the treatment to poor people
overseas. But their immediate goal is to get it on the U.S. and European markets
by the end of this year. (The Washington Post)
GPO ethics initiative holds its first Best Practices Forum
Leaders of the nation’s largest healthcare group purchasing organizations
convened in Nashville, TN, January 12-13 for the first Best Practices Forum of
the Healthcare Group Purchasing Industry Initiative (HGPII). The HGPII was
created in May of last year to promote a high level of ethical business
practices in this industry. HGPII signatories must complete an Annual Public
Accountability Questionnaire and participate in a Best Practices Forum. There
are nine founding participants: Amerinet, Broadlane, Child Health Corporation of
America, Consorta, GNYHA Ventures, Healthtrust Purchasing Group, MedAssets,
Novation and Premier. Other smaller GPOs are in the process of considering
participation and are welcome as part of the effort. Approximately 100 people
attended the Best Practices Forum, which began with remarks by Richard Norling,
the Chairman of the HGPII’s Steering Committee and CEO of Premier. There was
then a roundtable discussion of the entire Steering Committee or designees:
Susan Devore, leader of the Premier GPO; Rand Ballard, president of MedAssets’
Supply Chain and Business Services Group; Don Black, president and CEO of Child
Health Corporation of America; Bud Bowen, CEO of Amerinet; Jim Fitzgerald, CEO
of HealthTrust Purchasing Group; Lee Perlman, president and CEO of GNYHA
Ventures; Charles Saunders, M.D., CEO of Broadlane; John Strong, president and
CEO of Consorta; and Mark McKenna, president and CEO of Novation. There were
also outside speakers, including newly appointed HGPII Coordinator Richard J.
Bednar, currently senior counsel at Crowell & Moring LLP; Kirk Hanson, the
Director of the Markula Center for Applied Ethics at Santa Clara University;
and Pat Harned, the President of the Ethics Resource Center. “HGPII’s extensive
disclosure requirements go beyond those of any other segment of the health care
supply chain, including those of device manufacturers, pharmaceutical companies
and other suppliers,” said Richard A. Norling, president and CEO of
Premier Inc., a founding member of HGPII. Prior to the Best Practices Forum,
each of the nine founding GPOs completed an HGPII accountability questionnaire
about its business practices. HGPII posted these questionnaires on its website,
www.healthcaregpoii.com.
States fear FDA rule would risk liability
Federal regulators are proposing to insert language in a prescription drug rule
that officials in some states believe would help pharmaceutical companies fight
off lawsuits. The National Conference of State Legislatures revealed the
proposal last week in a press release and letter sent by its president to Health
and Human Services Secretary Mike Leavitt. The new language reportedly appears
in the preamble to a proposed rule that guides the labeling of prescription
drugs, first proposed by the Food and Drug Administration more than five years
ago. The inserted language claims that the revamped and federally approved
labels on prescription drugs would pre-empt state law. “This attempt to insert
pre-emption language is a thinly veiled attempt on the part of FDA to confer
upon itself authority it does not have by statute and does not have by way of
judicial ruling,” National Conference of State Legislatures President Steve
Rauschenberger wrote in his letter to Leavitt. The group wants either the
language to be withdrawn or the FDA to reopen the public comment period for the
proposed rule, first announced in December 2000. The group said it initially
agreed that the proposal didn't contain provisions that would trump state or
local laws. The FDA declined to comment Tuesday. The FDA wants to overhaul the
fine-print warnings on prescription drugs intended for doctors and patients. The
revised drug warnings, as originally proposed, would lead off with a
user-friendly “highlights” section that includes the most important warnings for
each drug.
http://www.fda.gov (The Associated Press)
Lawson
signs new contracts
Lawson Software
signed a multi-suite contract with Presbyterian Healthcare Services in Lawson's
second quarter. The New Mexico healthcare provider licensed Lawson's Financials,
Human Resources, Supply Chain Management for Healthcare and Business
Intelligence suites to reduce costs and equip decision makers with timely,
actionable information. As the state's largest healthcare provider, Presbyterian
operates seven hospitals, the state's largest health plan, a growing medical
group, as well as home healthcare, outpatient centers and ground ambulance
services. Presbyterian will replace its legacy business applications with the
Lawson products to create a unified ERP system. The transition to Lawson is part
of a larger organization-wide effort to redesign core business support
processes. The consolidated Lawson system will help Presbyterian improve
business processes by automating administrative tasks and giving staff the
information they need to make strategic business decisions. Specifically, the
Lawson products will enable Presbyterian to focus on financial strategy and
analysis, expedite its hiring processes and increase the percentage of supply
chain purchases made on contract.
Lawson Software also signed a contract with Newton Memorial Hospital Services in
Northwestern New Jersey. The hospital licensed Lawson’s Supply Chain Management
for Healthcare and Business Intelligence suites as well as Lawson Budgeting and
Planning to help in efforts to reduce supply costs and deliver actionable
information to decision makers. An existing Lawson Financials customer since
1999, Newton Memorial licensed the Supply Chain Management for Healthcare suite
to create a unified system that supports greater data sharing between its
financial and materials management departments. In addition, Lawson's Business
Intelligence suite will supplement the Financials and Supply Chain Management
for Healthcare suites, providing Newton Memorial with quicker access to
enterprise-wide data and greater visibility into its operations. Using Lawson
will help Newton Memorial staff to more efficiently and accurately make
purchasing decisions using a list of predetermined vendors. The system also will
help them automatically match invoices with purchase orders.
Wednesday, January 18, 2006
Error rate greatest in
hospital radiology;
study cites communication failures
Hospitals say meth cases are
rising, and hurt care
Web Seminar: ‘EHR
Case Study: Delivering Patient Data Today’
MedAssets acquires decision
support solution provider
Avega Health Systems
Priorities of Beijing declaration on bird flu
Participants in the
international donor conference on bird flu on Wednesday signed the Beijing
Declaration, vowing to step up efforts to prevent avian influenza from sparking
a human pandemic. International donors pledged $1.9 billion at the conference,
sponsored by the World Bank, the European Union and host China, to improve
health and veterinary services in poor countries and boost global surveillance
systems.
The United
States pledged about $334 million, saying in a statement the money would be
mainly in the form of grants and technical assistance.
In the declaration,
participants pledged to act on the following priorities:
-- Developing national
action plans within the framework of the strategies of key U.N. agencies and
drawing upon government, civil society and the private sector. Helping
countries contain, control and eliminate the bird flu virus in poultry and
prepare for a possible pandemic.
-- Aiding in response and containment to outbreaks and mitigating social,
psychological and economic impacts.
-- Improving surveillance and detection and increasing public awareness.
-- Timely sharing of information and relevant biological materials related to
bird flu strains.
-- Increasing cooperation in global research and development of safe and
effective animal and human vaccines and anti-viral medicines for humans and
promoting affordable access for all.
-- Promoting vaccine research and development and building stockpiles of human
anti-viral agents.
-- Developing capacity and infrastructure in and reforming countries' human and
animal health sectors. (Reuters)
Error
rate greatest in hospital radiology;
study cites communication failures
One of the most dangerous
times in the hospital for patients is when they are wheeled out of their rooms
and taken to the radiology department for a test or a procedure, according to
report being released today. Medication errors that harm patients are seven
times more frequent in the course of radiological services than in other
hospital settings, according to the analysis by the United States Pharmacopeia,
a nonprofit group that sets standards for the drug industry. “Whenever a patient
is moved from one location to another, the patient should ask where they are
going and why,” said John P. Santell of the organization's Center for the
Advancement of Patient Safety, who helped prepare the study. “Our report shows
this is when the risk is particularly great.” The researchers said they hope the
findings will prompt hospitals to examine the problem, find ways to minimize
errors and let patients and their loved ones know they should be alert to
mistakes at such times. “We hope that this report is a call to action,” Santell
said. There are a variety of reasons that harmful errors are much more likely in
the radiology suite. These include the fact that patients often receive
potentially dangerous drugs such as dyes, sedatives and blood thinners, and
their care is being handed off from one department to another, creating the
opportunity for communication failures, the researchers said. “The errors often
occur in the transfer of information,” Santell said. The findings are especially
significant because the number of radiological procedures being performed is
increasing, Santell said. Other experts said the findings were surprising and
important, because this area has not received a lot of attention in recent
efforts to minimize medical errors. “I don't think anyone really recognized how
much of a problem this really is,” said Michael Cohen, president of the
Institute for Safe Medication Practices in Huntingdon Valley, PA, which studies
drug errors. Others, however, said the report created the false impression that
such tests and procedures are particularly dangerous by lumping together all
errors that occurred in the radiology department, even if the errors had nothing
to do with a radiological exam. Even including those, the risk is “minuscule,”
said James P. Borgstede of the American College of Radiology, noting that more
than 570 million procedures are performed each year. “We certainly are concerned
about any kind of patient errors, and we don't want any errors at all,”
Borgstede said. “The big concern that I have is this may cause unnecessary fear
in patients, and patients may therefore avoid needed examinations.” For the
report, Santell and his colleagues reviewed 823,268 medication errors that were
voluntarily reported by 315 hospitals between 2000 and 2004. The researchers
identified 2,032 errors that occurred in radiology departments. Of those, 12
percent resulted in some kind of harm to patients, which is seven times higher
than the percentage of hospital medication errors that caused harm overall, or
1.67 percent, Santell said. “So even though the volume of errors is low, the
risk of harm is high,” he said. Many of the errors resulted from communication
breakdowns, the researchers found, such as passing on incorrectly the dose or
name of the drug being administered, or one worker failing to inform another
about other drugs a patient was taking. The most common errors were patients
getting the wrong dose or drug, failing to get the drug they should have had or
having the drug administered incorrectly, Santell said.
(The
Washington Post)
Hospitals say meth cases are rising, and hurt care
A sharp increase in the number of people arriving in emergency rooms with
methamphetamine-related problems is straining local hospital budgets and
treatment facilities across the country, particularly in the Midwest, according
to two surveys to be released in Washington. The studies, conducted late last
year by the National Association of Counties, are another indicator of the toll
the drug has taken on local communities, particularly in rural areas where
social service networks are ill-equipped to deal with the consequences. In July,
the association reported that an overwhelming number of sheriffs polled
nationwide declared methamphetamine their No. 1 law enforcement problem. In the
most recent survey, conducted late last year, 73 percent of the 200 county and
regional hospitals polled said they had seen an increase in the number of people
visiting emergency rooms for methamphetamine-related problems over the last five
years; 68 percent reported a continued increase in the last three years, and 45
percent in the last year. The problem was particularly intense in the middle of
the country: 70 percent of hospitals in the Midwest and 80 percent in the Upper
Midwest said methamphetamine accounted for 10 percent of their patients.
Nationwide, 14 percent of the hospitals said such cases made up 20 percent of
their emergency room visits. Methamphetamine users are often unable to hold down
jobs because of the highly addictive nature of the drug, meaning they are often
uninsured, the hospitals say. Yet many hospitals are required to treat them
under state laws. “These are labor-intensive cases, and the money that's put out
is money that the hospitals won't recover,” said Jeri Reese, an emergency room
nurse manager in Greene County, Iowa, who is scheduled to speak at a news
conference explaining the survey results. Fifty-six percent of hospitals said
their costs had risen because of the growing abuse of the drug. In Arkansas,
where the problem has increased in severity recently, 78 percent of the
hospitals said costs had increased. Methamphetamine is often made in small home
laboratories using toxic household chemicals. Many of the people who arrive at
emergency rooms because of methamphetamine have been burned making it or are
children who have been exposed to the chemicals. Users frequently develop rapid
heartbeat, increased
blood pressure
and
fevers that
can reach 105 degrees. And because the drug's neurological side effects
frequently include aggressive behavior and paranoia, the hospitals say they deal
with many victims of fights or beatings. In the second survey, 69 percent of the
hospitals reported an increased demand for treatment for methamphetamine abuse,
which tends to be long and intensive. And 63 percent of the hospitals said they
did not have enough capacity to meet demand. Though a relatively small number of
total emergency room visits are for illicit drugs, the hospitals said
methamphetamine was by far the leading drug problem. Forty-seven percent of
hospitals, and 57 percent in the Northwest, said methamphetamine caused more
emergency room visits than any other drug, while 16 percent cited marijuana, 15
percent cocaine and 1 percent heroin. The White House Office of National Drug
Control Policy said it wanted more federal money for compensation for hospitals
tending to the uninsured, as well as for treatment care, programs to help
affected children and continued law enforcement grants for regional drug task
forces. (The New York Times)
Web
Seminar: ‘EHR
Case Study: Delivering Patient Data Today’
HIMSS is
offering a Web seminar: “EHR
Case Study: Delivering Patient Data Today” for members
and nonmembers.
Hear the real
life experience of a dominant provider network and a dominant payer working to
establish the information transfer that helps to achieve better patient care.
Ed
Ewen, M.D.,
Director of Clinical Informatics for
Christiana Care Health
System and
David St.Clair, Founder and CEO,MEDecision
Inc. will present the seminar on
Thursday,
January 19, 2006 from 2:00 – 3:00 pm Eastern time.
This case study
will: Demonstrate how payers can gather the patient data that can serve as a
foundation for electronic health records; reveal what data the payer has that
can support patient care; and demonstrate the impact payers’ patient data can
have on the physicians' efforts at the point of care.
To register for this
event, go to
http://www.himss.org/asp/ContentRedirector.asp?ContentId=65510&cetID=20
MedAssets acquires decision support solution provider
Avega Health Systems
MedAssets Inc.
announced it has acquired Avega Health Systems, a provider of business decision
support solutions for acute care hospitals. Based in Los Angeles, CA, Avega
provides Alliance, a suite of proprietary business decision support software
tools and consulting services to assist healthcare organizations with budget
management, managed care contract management, cost management, and strategic
service line management. The Avega Alliance Suite recently achieved “Best in
KLAS” for the KLAS market segment of Business Decision Support for 2005. “The
integration of the Avega services with MedAssets’ solutions will expand our
capabilities to help providers more effectively implement business process
changes to increase cash flow and operating margin,” said John Bardis, chairman,
president and CEO of MedAssets. “Avega will continue to provide its industry
leading products and service solutions and will gain the operating resources of
MedAssets to accelerate innovation.” As a subsidiary of MedAssets, Avega will be
a sister company to MedAssets Supply Chain Systems, MedAssets Analytical
Systems, MedAssets Net Revenue Systems and Aspen Healthcare Metrics.
Tuesday, January 17, 2006
Amerinet announces CEO Robert
“Bud” Bowen to retire
after 20 years of service
CDC: Progress made in estimating frequency of
birth defects
CompView Medical completes premier
installation
of NuBoom at Oregon Health and Science University
Nexera Consulting signs
agreement with
Columbia-St. Mary’s
Posey Co. awarded contract
with Amerinet for fall management,
restraint, restraint alternative products
Boston Scientific offers $27 billion for Guidant;
bidding
war continues
Medical device maker
Boston Scientific Corp.
raised its offer for heart device maker
Guidant Corp.
to about $27 billion Tuesday, its latest salvo in the bidding war between it and
Johnson & Johnson.
The new offer comes in response to Guidant's acceptance of J&J's $24.2 billion
offer Friday, which the Indianapolis company chose over Boston Scientific's
previous $25 billion bid. Guidant has said the J&J deal has a better chance of
closing sooner. Boston Scientfic's latest $80 per-share offer for Guidant is
composed of $42 in cash and $38 in stock. Boston Scientific said that under the
deal Guidant shareholders will own about 36 percent in the combined company.
J&J's latest offer, worth about $71 per share, is made up of $40.52 in cash and
0.493 shares of stock. Guidant shares rose $5.16, or 7.3 percent, to $76, and
shares of Boston Scientific fell 70 cents, or 2.8 percent to $24.50 in premarket
activity. (The Associated Press)
Amerinet announces CEO Robert “Bud” Bowen to retire
after 20 years of service
The
Amerinet Board of Directors announces the retirement of industry leader Robert
“Bud” Bowen from his long-standing position as the innovator and leader of group
purchasing organization Amerinet, effective March 31, 2006. “The board accepted
Bud's decision to retire with tremendous pride and appreciation for his record
of accomplishment, and impact to both the organization and the industry,” said
Stephen Saucier, chairman of the Amerinet board of directors. “His leadership
style embodies the ethics, wisdom and fair business dealings that have come to
be hallmarks of the Amerinet organization.” Saucier also affirmed that Amerinet
will continue under the leadership of Todd Ebert, president of Amerinet. Ebert
carries extensive experience in health care management and leadership and has
been responsible for directing all Amerinet operations and support divisions. “I
am honored to have worked with so many fine individuals who have made such a
profound contribution to the delivery of health care in our industry,” stated
Bowen. “Working at Amerinet has been a wonderful and rewarding experience. I
leave Amerinet with positive memories of our success and our accomplishments,
and am confident that the organization will continue to set the standards for
ethics, integrity and excellence within our industry.” During the GPO Senate
hearings in 2002, Bowen provided a positive voice for the group purchasing
industry. His emphasis on open and inclusive contracting policies and higher
customer service standards are reasons Amerinet was heralded as a prime industry
example of ethics and integrity during those hearings. Bowen joined Amerinet at
its formation in 1986 as senior vice president, responsible for all contracting
activities. Promoted to executive vice president in 1988, Bowen served as the
company's chief operations officer until the Amerinet Board of Directors
appointed him president in January 1998. The Board named Bowen chief executive
officer in July 2004. Bowen has served as a chairman of the Health Industry
Group Purchasing Association (HIGPA) and as the HIGPA board representative to
the Health Industry Business Communication Council (HIBCC). His credentials also
include terms as chairman and board member of the Health Care E-business
Collaborative (HCeC).
CDC: Progress made in estimating frequency of
birth defects
Among the 18
major birth defects studied, orofacial clefts (cleft lip and cleft palate) were
the most common birth defect in the United States, affecting an estimated 6,800
infants annually, according to the Centers for Disease Control and Prevention
(CDC) estimates released in its journal Morbidity and Mortality Weekly Report (MMWR).
The condition with the second highest prevalence was Down syndrome, which
affects about 5,500 infants a year. Among the 18 major birth defects selected
for this study, each of 10 different types of birth defects affected more than
1,000 babies per year. Although federal, state and local surveillance data
suggest that approximately 3 percent of babies born in the United States are
affected by a major birth defect of some type, this is the first effort to
develop population-based national prevalence estimates for these 18 specific
birth defects. The data used to develop the national estimates came from
1999-2001 National Birth Defects Prevention Network (NBDPN) information for 11
states: Alabama, Arkansas, California, Georgia, Hawaii, Iowa, Massachusetts,
North Carolina, Oklahoma, Texas and Utah. These states are the only ones that
send staff to hospitals to review records and identify babies with the 18 major
birth defects for which the national prevalence was estimated. The report
represents important progress toward estimating national prevalence for 18 major
birth defects using population-based data. The population-based national
estimates are important to help plan for children’s health care and educational
needs, and to help determine resource needs for basic and public heath research.
January is Birth Defects Prevention Month, designed to highlight steps women can
take to help achieve a healthy birth. In addition, January 9-16 is Folic Acid
Awareness Week, highlighting the importance of folic acid in preventing neural
tube defects. For more information please visit
www.cdc.gov/ncbddd/bd/abc.htm.
CompView Medical completes premier installation of NuBoom
at Oregon
Health and Science University
CompView Medical, a wholly
owned subsidiary of CompView Inc. that provides integrated audio-visual systems
for medical environments, announced the premier installation of NuBoom, the next
generation Operating Room (O.R.) equipment management
solution, at Oregon Health and Science University (OHSU).
Designed as
an all inclusive equipment management, boom and visualization system,
NuBoom efficiently houses medical and video equipment, thereby
enabling precise monitor positioning so that surgeons can comfortably
view monitors from anywhere around the patient. In addition, the shelves and
connections within the NuBoom cabinet hold all the necessary surgical equipment
so there are no longer multiple carts and equipment cords in the operating
field. NuBoom also incorporates an integrated O.R. control system that enables
the staff and surgeons to intuitively select the input device or image they want
to appear on each monitor based on the type of procedure they are conducting,
which has helped improve the staff’s workflow efficiency. NuBoom was installed
over the weekend at OHSU, in contrast to the months it typically takes to
install traditional ceiling-mounted alternatives. In addition to installing
NuBoom at OHSU, CompView Medical also installed its Digital Operating Control
System (DOCS), which provides nurses with a touch panel interface to
control video and computer sources to the monitors.
Nexera Consulting signs agreement with
Columbia-St. Mary’s
Nexera Inc., a national health care consulting company, has signed an agreement
with Columbia-St. Mary’s, a three-facility teaching hospital in Milwaukee, WI.
The agreement features contracts for two different areas. Under the first
contract, Nexera Consulting will conduct an assessment of central sterile supply
on all three campuses, as it relates to operating room materials management and
instrument reprocessing for a period of 90 days. The project will focus on
improving processes and identifying system or industry best practices to
implement throughout. In addition, as part of Columbia-St. Mary’s building plans
for a new hospital campus, Nexera Consulting will advise in the design of the
new central sterile area. Under the second contract, Nexera Consulting will
offer interim management services, managing the central sterile departments at
the three Columbia-St. Mary’s facilities for a minimum of six months.
Posey Co. awarded contract with Amerinet for fall management,
restraint, restraint alternative products
The Posey Company signed a three-year agreement with Amerinet Inc. for its
Restraint, Restraint Alternative and Fall Management health care products. The
agreement expands Posey’s longstanding relationship with Amerinet and its
members across the United States. In addition, it opens up new marketing
opportunities for Posey to promote and sell its full line of products, including
Fall Prevention Monitors, Fall Protection Aids, the Posey Bed Canopy System and
Seating and Positioning products.
Monday, January 16, 2006
Turkey
steps up bird flu fight, Indonesian girl dies
Scientists find gene that
increases diabetes risk
Cancer researcher admits to faking data
President tells insurers to
aid ailing Medicare drug plan
More than 900 hospitals sign with
U.S.
Surgical
under Novation supply agreements
CDC: Clinicians should not prescribe two
common antivirals
The Centers for Disease Control and Prevention (CDC) announced that clinicians
should not prescribe two common antivirals (amantadine and rimantadine) to treat
or prevent influenza during the 2005-2006 influenza season. Laboratory testing
by CDC on the predominant strain of influenza (H3N2) currently circulating in
the United States
shows that it is resistant to these drugs. CDC has tested 120 influenza A (H3N2)
virus isolates and found that 109 (or 91 percent) were resistant to amantadine
and rimantadine. This represents a sharp increase from last year when only 11
percent of isolates tested were resistant and 1.9 percent were resistant the
year before that. However, all H3 and H1 influenza viruses tested to date are
susceptible to the other commonly used antivirals (oseltamivir and zanamivir).
“This is certainly unexpected news as we now have to remove
a few tools from our tool box that we use to combat influenza,” said CDC
Director Dr. Julie Gerberding. “Thankfully we still have antivirals available
that work but this new development serves as a reminder of the importance of
getting people vaccinated to prevent them from getting influenza in the first
place.” During this period CDC recommends oseltamivir (Tamiflu) and zanamivir (Relenza)
be prescribed if an antiviral medication is needed for the treatment or
prevention of influenza. Influenza activity is starting to pick up across the
country as eighteen states are reporting either widespread or regional activity.
Individuals who have not been vaccinated against influenza can still get
vaccinated especially since influenza will continue to circulate for several
more months. This year over 80 million doses of vaccine have been distributed
but remaining supplies vary from state to state so individuals may have to check
with more than one provider to receive vaccine. Also, CDC will have available
3.5 million doses from its stockpile to sell through manufacturers as soon as
possible. In addition there are doses of vaccine presently available for sale by
manufacturers and distributors. Testing of influenza isolates for resistance to
antivirals will continue throughout the 2005-2006 influenza season and
recommendations will be updated as needed. In addition, CDC is working with
state and local health departments and clinicians across the country to monitor
drug resistance in influenza viruses.
For more information please visit
www.cdc.gov/flu.
To listen to the briefing, call 1-866-498-3480.
Turkey
steps up bird flu fight, Indonesian girl dies
Turkey stepped up the culling
of poultry across the country on Monday as it battles to stamp out bird flu and
Indonesia said a 13-year-old girl died of the virus at the weekend.
Turkey still
has a chance of preventing bird flu from becoming a permanent feature among its
poultry, the United Nations’ Food and Agriculture Organization (FAO) said on
Monday. The FAO expressed fears that the virus could take hold in neighboring
countries such as Georgia, Iran, Syria and Armenia. The World Bank aims to raise
$1.2 billion to fight bird flu, Vice President Jim Adams said on Monday, the eve
of a global donor conference in Beijing tasked with securing the resources
needed to combat the deadly virus. Indonesia said local tests showed a
13-year-old girl died of bird flu at the weekend while two of her siblings have
tested positive for the H5N1 virus. Turkey’s Health Ministry said initial tests
on teenager Fatma Ozcan, who may have died of bird flu on Sunday, were negative
but doctors suspect she did contract the disease. Her brother Muhammet was in
critical condition in Van, the province worst hit by the outbreak that has swept
Turkey since late December. If Fatma is confirmed to have died from the virus,
it would bring the number of human cases in Turkey to 20. (Reuters)
Scientists find gene that increases diabetes risk
Scientists have discovered a variant gene that leads to a sizable extra risk of
Type 2
diabetes and
is carried by more than a third of the American population. The finding is being
reported in the journal Nature Genetics by researchers at Decode
Genetics, a company in
Reykjavik,
Iceland,
that specializes in finding the genetic roots of human diseases. Decode Genetics
first found the variant gene, one of many different versions that exist in the
human population, in Icelanders and has now confirmed the finding in a Danish
and an American population. An immediate practical consequence of the discovery,
said Decode's chief executive, Kari Stefansson, would be to develop a diagnostic
test to identify people who carry the variant gene. If people knew of their
extra risk, they would have an incentive to stay thin and exercise, he said.
Diabetes affects 20.8 million Americans, according to the Centers for Disease
Control and Prevention. Type 2 diabetes accounts for up to 95 percent of all
diagnosed cases, according to the centers. Because people carry two copies of
every gene, one inherited from each parent, the risk conferred by the new gene
depends on whether one or two copies of it have been inherited. The estimated 38
percent of Americans who have inherited a single copy have a 45 percent greater
risk of Type 2 than do unaffected members of the population. The estimated 7
percent who carry two copies are 141 percent more likely to develop the disease,
according to the Decode researchers, who were led by Struan F. A. Grant. What
scientists call the “population-attributable risk” of the new variant is 21
percent, which means that if all the variant genes in the population were
erased, so would be 21 percent of diabetes cases. Diabetes is thought to be
caused by a variety of different genes, each conferring a risk for the disease.
Because most of the variants exert a minor effect, they are hard to detect, and
many claims to have found diabetes-causing genes have turned out to be
unfounded. The new variant identified by Decode was of a somewhat obscure gene
that had not been suspected of having any involvement in diabetes. The gene,
designated TCF7L2, is one that controls the activity of other genes. Its role
may include setting the level of a hormone that acts along with insulin to
control blood sugar levels. Discovery of the TCF7L2 gene could be
therapeutically helpful, Dr. Stefansson said, because it identified a major
biochemical chain reaction or pathway through which the disease developed.
Several different genes, and their protein products, are involved in the pathway
that sets the level of the companion hormone. Any of these genes and proteins
are potential targets for new drugs. (The New York Times)
Cancer researcher admits to faking data
A Norwegian cancer researcher has admitted fabricating data
published in a renowned international medical journal, officials in
Norway said Saturday. The
researcher at Norway's Comprehensive Cancer Center, who was not identified, used
faked patient data in an article on oral cancer published in the October 2005
issue of The Lancet, Britain's leading medical journal, said Stein Vaaler,
strategy director for the cancer center. The article claimed that a certain kind
of drug decreased the risk of getting oral cancer and referred to results seen
in patients in two national databases, Vaaler said in an interview. A colleague
raised questions about the article when it was published, and when the
researcher was confronted this week about the data, he acknowledged the
fabrication, Vaaler said. “All of it was fabricated,” Vaaler said. “It was not
manipulation of real data; it was just complete fabrication.” The
Washington-based journal Science announced Thursday that it was
unconditionally retracting two papers by South Korean stem cell researcher Hwang
Woo-suk, who publicly apologized for faking data that purported to show the
creation of stem cells from the world's first cloned human embryos. Vaaler said
the center has informed The Lancet about the fabrication, and an external review
committee will examine the researcher's methods and his previous publications. A
decision about whether the researcher should be fired will be made after the
review committee issues its report, Vaaler said. “This is a very serious
situation for the hospital,” the center's director, Aage Danielsson, said in a
letter to colleagues that was posted on the Web site of The Norwegian
broadcaster TV2. (The Associated Press)
President tells insurers to aid ailing Medicare drug plan
More than 900 hospitals sign with
U.S.
Surgical
under Novation supply agreements
U.S.
Surgical, a business unit of Tyco Healthcare, announced that more than 900 of
Novation’s VHA and University HealthSystem Consortium (UHC) hospitals have
signed agreements for U.S. Surgical’s wound closure, surgical stapling and
endomechanical products during the first eight months of the new agreement with
Novation. U.S. Surgical was the only supplier selected to participate in all
eight wound closure, surgical stapling and endomechanical categories on the
multi-year Novation agreement. Under these awards, the Autosuture and Syneture
divisions of U.S. Surgical offer unbundled purchasing options to Novation’s VHA
and UHC hospitals. Customers are provided unrestricted, open choice among
Syneture’s sutures and topical adhesive, and Autosuture’s surgical stapling and
laparoscopic instrumentation. “The response to the agreement has been gratifying
and, as a result, we have expanded our sales force by 25% to support our new
customers,” said Mark Roby, vice president of marketing, U.S. Surgical.
Friday, January 13, 2006
Bid raised in battle for
Guidant
Tenet to settle investor suits
over billing
HHS announces $100 million for
state and local pandemic influenza preparedness efforts
WSJ: Pandemic flu could cause breakdown of
drug-supply chain
All-digital heart
hospital is one-of-a-kind in Southeast U.S.
Tyco gains, plan to split company
Tyco
International Ltd.'s board may decide to spin off its electronics and health
care units during a Thursday meeting at its headquarters in Pembroke, Bermuda, a
person familiar with the meeting said. Chief executive Edward Breen would stay
on to run the industrial valve, fire and security units. Breen said on Nov. 16
that he was considering a split to help realize Tyco's value after its stock had
fallen 23 percent in the year to that date. A share of Tyco, the world's biggest
maker of electronic connectors, security systems and industrial valves, has
rebounded 13 percent since, although investors debated the worth of dividing the
$62-billion market-value company. Tyco's capital structure has improved and
management is more competent than Kozlowski was when he tried to split the
company in 2002, said Omega Advisors Inc. chairman Leon Cooperman in an
interview. Imprisoned former chief executive L. Dennis Kozlowski Kozlowski used
more than $60 billion to expand from a valve maker into businesses such as
health care and security before being convicted of looting the company last
year. The breakup would create tax-free spin-offs of the electronics and health
care businesses, according to The Wall Street Journal. Breen would run the
remaining Tyco components, consisting of security, fire-protection and
valve-making operations. Tyco has agreed to sell its plastics and adhesives
business to Apollo Management, a private equity investment firm, for $975
million. Electronics is Tyco's largest division based on revenue, but the health
care unit, whose products include sutures and surgical staplers, ventilators,
needles and syringes and home-use portable liquid oxygen systems, is more
profitable with much higher margins. (Bloomberg News)
Bid raised in battle for Guidant
Raising the stakes in an increasingly hostile takeover battle for Guidant,
Boston Scientific increased its bid by $332 million Thursday night, to $25
billion. It also said it would assume all regulatory risk to completing the deal
in an effort to wrestle Guidant away from Johnson & Johnson. Boston's
Scientific's offer also came with an ultimatum: If Guidant does not declare the
bid superior to Johnson & Johnson's $23.2 billion by 4 p.m. today, it will be
withdrawn. The higher offer came one day after Guidant spurned Boston Scientific
in favor of Johnson & Johnson, which had agreed to raise its bid to $68.06 a
share from $63.08. Guidant said it accepted the Johnson & Johnson offer despite
its being lower than Boston Scientific's original bid of $72 a share because the
deal had already been approved by regulators. In a statement, Boston
Scientific's chairman, Peter M. Nicholas, called on Guidant's board to accept
the bid and suggested it would not be fulfilling its fiduciary duty if it did
not do so. “We strongly encourage the Guidant board to act in the best interests
of Guidant shareholders by declaring our $73 per share offer superior to the
revised $67.92 per share transaction with Johnson & Johnson,” Nicholas said.
Boston Scientific's new offer includes $36.50 in cash and $36.50 in Boston
Scientific stock for each outstanding share of Guidant stock. To placate members
of Guidant's board who worried that a deal with Boston Scientific could be held
up by regulators, Boston Scientific agreed that it would shed any assets
required to complete the deal and it added another unusual carrot: it promised
to pay Guidant's shareholders an additional 1.2 cents a share for each day from
April 1 to the closing if there were delays. “Our amended offer addresses all of
the outstanding issues raised by Guidant's board,” Nicholas said. If Guidant's
board determines that Boston Scientific's bid is superior, Johnson & Johnson
would have five days to make a new bid. (The New York Times)
Tenet to settle investor suits over billing
Tenet
Healthcare Corp. said Thursday that it had agreed to pay $215 million to settle
a swarm of shareholder lawsuits triggered by a 2002 Medicare billing scandal.
Former Chief Executive Jeffrey C. Barbakow and former Chief Operating Officer
Thomas B. Mackey together would pay $1.5 million of the settlement cost out of
their own pockets. Investors applauded the news, sending Tenet stock up 1.5% to
$7.64 on Thursday, but the nation’s second-largest hospital chain still faces
challenges. Although the company abandoned the Medicare billing scheme that gave
rise to the suits, a federal investigation into the matter continues. Also, a
jury in San Diego is weighing kickback charges against the company, and Tenet’s
five New Orleans-area hospitals, including two that are closed indefinitely, are
recovering from hurricane damage. Disclosure of the Medicare billing scheme in
2002 was accompanied by news that authorities were investigating whether
physicians at a Redding hospital then owned by Tenet had performed unnecessary
heart surgeries. Since the scandals broke, the company’s stock has dropped by
more than 85% and it has reported losses for 11 quarters in a row. To resolve
the disputed surgeries in Redding, the company and the physicians involved made
a series of deals to pay patients and the government more than $500 million. The
company also has sold 27 hospitals as part of a turnaround plan, leaving it with
69 facilities, including 18 in California. And several top executives, including
Barbakow and Mackey, resigned under pressure. The settlement announced Thursday
would end a class-action lawsuit in U.S. District Court in Los Angeles that
consolidated a series of suits filed in late 2002 by shareholders, who accused
the company of misleading investors about Medicare revenues. It also would
resolve related litigation in state court in Santa Barbara. Both courts must
approve the deal. After insurance, the net cost to the company would be $140
million, Tenet officials said. Analysts said shareholders were anxious for Tenet
to negotiate a broad settlement of all the outstanding government probes, and
have estimated that the price could run as high as $2 billion. But Tenet has
said that its efforts to make such a deal have been hampered by the long-running
prosecution of the company and administrators of its Alvarado Hospital Medical
Center in San Diego. Prosecutors led by U.S. Atty. Carol Lam have charged that
Alvarado bribed doctors to refer patients. If convicted, Tenet would face fines,
and the San Diego hospital could be expelled from Medicaid and Medicare
programs. (The Los Angeles Times)
HHS announces $100 million for state and local pandemic
influenza preparedness efforts
As
part of President Bush’s plan to mobilize the nation to prepare for an influenza
pandemic, HHS Secretary Mike Leavitt announced $100 million in funding for state
and local preparedness. “Pandemics happen globally but must be managed at the
state and local level, and these funds will help communities meet that
responsibility,” Secretary Leavitt said. “Preparation works and it can save
lives. We have the opportunity to become the first generation in history to
prepare for a pandemic.” This funding is part of $350 million included in the
recent emergency appropriation for combating pandemic influenza passed by
Congress in December. These initial grants will be awarded to all 50 states, 7
territories, the Commonwealth of Puerto Rico, and the District of Columbia. Each
state will receive a minimum of $500,000, with additional allocation of funds by
population. In addition to the state grants, funds are being awarded to New York
City, Chicago and Los Angeles County. The remaining $250 million from the
appropriation will be awarded later this year in accord with guidance that will
require progress and performance. States and municipalities will use these funds
to accelerate and intensify current planning efforts for pandemic influenza and
to exercise their plans. The focus is on practical, community-based procedures
that could prevent or delay the spread of pandemic influenza, and help to reduce
the burden of illness communities would contend with during an outbreak.
Secretary Leavitt made the announcement at Pandemic Planning Summits in Vermont
and West Virginia with state officials and community leaders. These summits are
the latest in a series of forums that will be convened in each state over the
next few months. In addition to this new funding and the state summits, HHS has
sought to foster planning by developing checklists for individuals and families,
businesses and state and local health departments to aid their pandemic
preparedness efforts. More information on pandemic preparedness efforts is
available at www.pandemicflu.gov.
WSJ: Pandemic flu could cause breakdown
of drug-supply chain
The
Wall Street Journal on Thursday examined how the drug-supply chain is “almost
certain to break” in the event of a flu pandemic, which could cause the closing
of drug factories and truck routes and lead to shortages of important medicines,
“quite apart from any shortages of medicine to treat the flu itself.” The “very
rules of capitalism that make the U.S. an ultra-efficient marketplace also make
it exceptionally vulnerable in a pandemic,” the Journal reports. For example,
many drugs are manufactured outside of the U.S. because of lower costs, while
warehouses in the U.S. are generally kept nearly empty for efficiency reasons.
In addition, the federal government does not intervene as a guaranteed buyer of
vaccines, meaning that such products are not attractive for drug companies, and
antitrust rules prevent private companies from collaborating their efforts to
hasten new drug development. Many large hospitals stock only 30-day supplies of
drugs because of costs and waste associated with stockpiling more, as well as
drug manufacturing delays. According to the Journal, a supply-chain breakdown
could cause the economy to “go into a tailspin” in the event of a pandemic flu,
since “at the first sign of panic, all supplies disappear from shelves.” To
assist states and hospitals in bolstering medical preparedness, the federal
government allocated $5 billion in grants over three years, but the money has
been used toward priorities other than surge capacity at hospitals as well.
Michael Osterholm, director of the Center for Infectious Disease Research and
Policy at the University of Minnesota, said, “Most if not all of the medical
products or protective-device companies in this country are operating almost at
full capacity.” He added, “That's the reality of today's economy, just-in-time
delivery with no surge capacity.” Indiana-based emergency physician Michael
Bishop said, “You can't plan for a surge capacity in an emergency room of 500 or
1,000 patients from the 20 you see in a day. Nobody could afford to do that. You
can't have 10 doctors and 100 nurses sitting around waiting for something to
happen”. (Wall Street Journal, Kaiser Daily Health Report)
For
another report on the state of the nation’s emergency systems from the American
College of Emergency Physicians, visit the January 2006 Daily Update Archive at
http://www.hpnonline.com/daily
updates/January_06.html#10-3
All-digital heart hospital is one-of-a-kind in Southeast U.S.
GE
Healthcare, a division of General Electric Company, announced the preview and
the public announcement of the Capital Campaign of Pepin Heart Hospital & Dr.
Kiran C. Patel Research Institute in Tampa, FL, the next generation all-digital,
state-of-the-art facility developed around GE's cardiovascular and integrated
information technologies (IT). By combining clinical healthcare information
solutions with cutting-edge diagnostics, cardiovascular and patient monitoring
systems, the $50-million, 125,000 square-foot digital hospital will provide
physicians with quick and comprehensive diagnostic tools to treat cardiovascular
disease in a paper-light, filmless and wireless environment where information
flows seamlessly from patient admission through discharge. “With computers at
every bedside, patient medical records available online, and technology to
review cases, the physicians at Pepin are uniquely positioned within the
healthcare industry,” said Vishal Wanchoo, president and CEO of GE Healthcare
Information Technologies. In addition, the new Pepin Heart Hospital & Dr. Kiran
C. Patel Research Institute will ultimately include a 52-bed pre/post cardiac
unit, 16 cardiovascular critical care beds, a 20-bed cardiac surgery recovery
unit, 48 progressive care beds, five surgical suites, ten cardiac
catheterization/invasive procedure labs with additional diagnostic equipment,
and a dedicated auditorium to be used for education and training presentations.
GE will also supply its advanced Cardiac Cath Lab suite of technology, including
the Innova(R) 2100 and Innova 4100 and Mac-Lab(R) hemodynamic monitoring
technology. GE is also working on studies with the Pepin Heart Hospital & Dr.
Kiran C. Patel Research Institute to focus on patient, nurse and physician
satisfaction, as well as cost and quality metrics.
Thursday, January 12, 2006
Drug makers scrutinized over
grants
Turkish bird flu 'may be
endemic'
Florida doctors threaten to
quit due to dispute
over indigent care
Medline launches new
respiratory division
Johnson raises bid for control of Guidant
The battle for control
of the
Guidant Corporation
took a new turn Wednesday as
Johnson & Johnson
raised its bid to $23.2 billion and reached a new agreement with Guidant,
pre-empting an offer from
Boston Scientific.
But the outcome was quickly thrown into question when Boston Scientific
dismissed Guidant's agreement with Johnson & Johnson, saying: “Our discussions
with Guidant are ongoing. We intend to vigorously pursue this transaction to its
completion.” Several people close to Boston Scientific suggested Wednesday night
that the company was planning to make an offer higher than its original $25
billion. But it is unclear how much higher Boston Scientific may go. The company
“could pull off a $76 offer, but in doing so it would be pushing itself towards
junk credit status,” Matthew J. Dodds, a
Citigroup
analyst, wrote in a note to investors. Over the last 48 hours, Johnson & Johnson
and Boston Scientific have played cat and mouse as they sparred for control of
Guidant and a share of the market for implantable heart devices, one that is
worth $10 billion a year. Guidant said Wednesday that its board had accepted a
lower offer from Johnson & Johnson, worth $68.06 a share compared with Boston
Scientific's $72 - because the deal could be completed more quickly. But people
involved in the negotiations suggested that Guidant's agreement with Johnson &
Johnson was more of a tactical maneuver, intended to elicit even higher bids.
The premium involved in the new plan includes a $4 increase in cash over Johnson
& Johnson's offer in November. In announcing the new deal, executives of both
Guidant and Johnson & Johnson addressed the higher standing offer from Boston
Scientific. “This agreement with Johnson & Johnson provides significant
financial value and certainty for our shareholders,” the chairman and chief
executive of Guidant, James M. Cornelius, said. It is expected that the new
Johnson & Johnson plan will be voted on at a meeting of Guidant shareholders
scheduled for Jan. 31. But any new offer from Boston Scientific could complicate
those plans or derail them. While the Johnson & Johnson offer is lower, the
apparent argument is that it is better because it already has regulatory
approval and can close quickly. (The New York Times)
Drug
makers scrutinized over grants
A Congressional
investigation of the money that drug companies give as supposed educational
grants has found that the payments are growing rapidly and are sometimes steered
by marketing executives to doctors and groups who push unapproved uses of drugs.
Twenty-three drug makers spent a total of $1.47 billion in 2004 on educational
grants, or an average of $64 million per company, according to the Senate
Finance Committee. That number was a 20 percent increase from the total in 2003,
which was $1.23 billion. The committee did not estimate what percentage of those
grants were instead used for marketing purposes. But in a letter sent Monday to
Johnson & Johnson,
the committee suggested that the use of educational grants to further marketing
aims was widespread in the industry. The committee also sent letters to most
other major drug makers this week, seeking more information about their use of
educational grants. The investigation is being directed by Senator
Charles E. Grassley,
Republican of Iowa, and Senator Max Baucus, Democrat from Montana, who are the
chairman and ranking minority member, respectively, of the committee. “It's hard
to see how you could call some of these grants ‘educational,’” Grassley said in
an interview. The investigation is part of a growing reassessment by federal
legislators and prosecutors of the ways that drug makers are said to encourage
doctors to prescribe medicines for uses not approved by federal drug regulators.
In one example cited in the committee's letter, Johnson & Johnson in 1999
provided an “educational” grant to pay for an alumni reception at the annual
meeting of a medical specialty society. That grant was provided at the request
of a physician who had previously received grant money for research and
educational activities related to Propulsid, a Johnson & Johnson drug that was
withdrawn in 2000 after it was found to cause potentially fatal heart
arrhythmias. Although Propulsid was approved only to treat severe heartburn in
adults, it ended up being widely prescribed for off-label use by children. The
committee's letter seeks information beyond what Johnson & Johnson has already
provided investigators. Some companies have said that they have revamped their
grant-making procedures recently, taking the power to bestow grants out of the
hands of marketing executives and giving it instead to executives in the
companies' medical divisions. But the committee found that these changes had not
been universally adopted. “It appears that many manufacturers’ sales and/or
marketing personnel still have a role in originating or evaluating grant
requests,” the committee's letter to Johnson & Johnson said. The letter noted
that from 1996 through 1999 Johnson & Johnson provided more than $1.3 million to
a patient advocacy organization that had almost no financing from any other
source. The group folded in 2000 after Propulsid was withdrawn. (The New York
Times)
Turkish
bird flu 'may be endemic'
The bird flu virus
could become endemic in Turkey and poses a serious risk to neighboring
countries, the United Nations' Food and Agriculture Organization (FAO) said.
“The virus may be spreading despite the control measures already taken,” Juan
Lubroth, senior FAO animal health office, said Wednesday. The FAO statement came
as Turkey set up a bird flu crisis center in its capital Ankara and the World
Health Organization said two more people had died from bird flu in China.
Meanwhile Germany's Agricultural Minister Horst Seehofer said Wednesday that
Germany “very likely” will require all birds be kept indoors to prevent bird flu
in the country. “Far more human and animal exposure to the virus will occur if
strict containment does not isolate all known and unknown locations where the
bird flu virus is currently present,” Lubroth said. He called upon neighboring
countries such as Armenia, Azerbaijan, Georgia, Iraq, Iran and Syria to be on
high alert, to apply surveillance and control measures and to ensure that the
public was fully informed about the avian influenza risk. The FAO added it had
sent a team of experts to Turkey to support the authorities in their bird flu
control efforts. “Turkey needs to apply a centrally coordinated and country-wide
control campaign based on efficient local actions carried out in a transparent
manner. Infected poultry should be reported immediately and all internationally
recommended control measures should be used in outbreak areas, including humane
culling, strict isolation and, if and when appropriate, vaccination,” Lubroth
said. Turkey confirmed a 15th human case of the deadly virus in that country on
Tuesday. However, a World Health Organization official told Turkey there was “no
reason to panic.” The WHO's Roy Wadia in Beijing said on Wednesday the deadly
H5N1 strain killed a 10-year-old girl from Guangxi province in the south of the
country, while a 35-year-old man died in eastern Jiangxi province. The latest
deaths brings the country's total bird flu death to five. Bulgaria has
veterinarians and border officials on notice, and Greece is stepping up checks
and disinfections at its main border crossing. The European Union decided
Wednesday to extend its monitoring of wild birds and poultry until the end of
2006 in an effort to prevent the further spread of bird flu. The EU program was
to have run out at the end of January. The EU's executive office also freed up
$2.4 million to increase laboratory testing for bird flu. (CNN, Associated
Press)
Florida doctors threaten to quit due to dispute
over indigent care
At least 15 surgeons have threatened to resign from Manatee Memorial Hospital's
staff over what they see as unfair burdens in caring for patients who can't
afford it. The warning shots escalate a long-running dispute involving doctors,
the hospital and Manatee County, FL, over indigent care. And they come as a
county task force meets Thursday to try to find both a short-term fix and a
long-term solution. Doctors and hospital officials say the rising number of
uninsured patients is the core of the problem. By law, emergency rooms must
provide care for anyone who requests it, even those who cannot pay. Doctors on
Manatee Memorial's staff are required to take turns handling emergency room
patients and must provide follow-up care. The county repays them from the
interest on a trust fund, but the amount of interest has been insufficient for
at least two years. The task force hopes to issue recommendations in several
months but will look for interim solutions to some of the problems that the
doctors raised. One issue the group is likely to tackle is the shortfall in
money for doctors. Now, the cash set aside to directly reimburse physicians
generally is spent in the first eight months of the year, said Cheri Coryea, a
community services manager with Manatee County. “Their requests sit idle until
the following budget year,” Coryea said. Manatee Memorial lost about $6 million
in direct costs for indigent care last year, not including overhead. The task
force also might address the entire funding structure. No other county in
Southwest Florida, and possibly none in the state, pays for indigent care from a
trust fund. The durability of the fund, created from the 1984 sale of Manatee
Memorial, also is an issue. Doctors required to take emergency room shifts end
up carrying over indigent patients into their regular practice. In the long run,
that may create shortages in care for Manatee County. (Sarasota Herald-Tribune)
Medline launches new respiratory division
Medline announced the launch of a new respiratory division dedicated to meeting
the growing demand for respiratory products and services. “Over the past 10
years we’ve experienced tremendous growth in respiratory sales, averaging close
to 30 percent per year,” said Medline Respiratory Division President Dennis
Cook. Medline’s respiratory group will include a team of engineers working on
the development of a series of new products. The new division will offer
continuing education, and its staff will include several clinicians serving as
product managers. The clinical expertise will help both Medline engineers and
customers to better understand this complex product area.
Medline chose Cook, a licensed respiratory therapist
for more than seventeen years from
Cary, IL, to
head up the new division. Cook joined Medline in 1999 as vice president of the
Durable Medical Equipment division and served in that position until now.
Wednesday, January 11, 2006
NY Times: In treatment of
diabetes, good care means
bad business
Study: Mid-life obesity a
threat by itself
AmerisourceBergen to acquire
oncology service provider,
NMCR LLC
Setra Systems launches e-commerce site for
sale of
laboratory balances and accessories
Stricter nanotechnology laws are urged;
report warns of risk to public
An independent report being released Wednesday concludes that current U.S. laws
and regulations cannot adequately protect the public against the risks of
nanotechnology, the rapidly growing science of making invisibly small particles
and molecular devices. Unless existing laws are modified or a new one is
crafted, the report warns, the immense promise of the field, predicted to be a
trillion-dollar industry by 2015, may be short-circuited by either a disaster or
an economically damaging crisis of public confidence. J. Clarence Davies Davies
researched and wrote the report for the Project on Emerging Nanotechnologies at
the Woodrow Wilson International Center for Scholars, a research and policy arm
of the Smithsonian Institution. Several government officials and industry
representatives disputed the findings Tuesday. Among them was E. Clayton Teague,
director of the National Nanotechnology Coordinating Office, which oversees the
federal government's approximately $1 billion annual investment in
nanotechnology. “We still have so much to learn,” he said. “All the agencies we
talk with . . . have generally said to us that with the information that's
currently available, their regulatory authorities should be adequate.”
Nanotechnology involves manipulating atoms to make things that are smaller than
one one-thousandth the diameter of a human hair. At that size, even conventional
materials exhibit unconventional physical and chemical properties, making them
valuable for a wide variety of products. But nanoparticles’ peculiar
characteristics are potentially hazardous. Animal studies have shown that at
least some can cause deadly airway blockages or can migrate from nasal passages
into the brain and other organs, where they may cause metabolic problems. Other
studies suggest they can trigger environmental damage that would be difficult to
reverse once the minuscule particles disperse into soil and water. The report
outlines the range of laws and regulations in place to protect people and the
environment from such risks, and finds each one wanting when it comes to
nanotechnology. Moreover, the report notes, the agencies in charge of
implementing the nation's protective laws are understaffed. The Occupational
Safety and Health Administration has 25 percent fewer employees than it did in
1980, even though it must oversee more workplaces than ever, Davies said. (The
Washington Post)
NY Times: In treatment of diabetes, good care means
bad business
In an
ongoing series in the New York Times, the business side of providing care
was examined. Beth Israel Medical Center in Manhattan opened a new
diabetes
center in March 1999. At four hospitals across the city, they set up centers
that featured a new model of treatment. They would be boot camps for diabetics,
who struggle daily to reduce the sugar levels in their blood. The centers would
teach them to check those levels, count calories and exercise with discipline,
while undergoing prolonged monitoring by teams of specialists. But seven years
later, even as the number of New Yorkers with Type 2 diabetes has nearly
doubled, three of the four centers, including Beth Israel's, have closed. They
did not shut down because they had failed their patients. They closed because
they had failed to make money. They were victims of the byzantine world of
American health care, in which the real profit is made not by controlling
chronic diseases like diabetes but by treating their many complications.
Insurers, for example, will often refuse to pay $150 for a diabetic to see a
podiatrist, who can help prevent foot ailments associated with the disease.
Nearly all of them, though, cover amputations, which typically cost more than
$30,000. Patients have trouble securing a reimbursement for a $75 visit to the
nutritionist who counsels them on controlling their diabetes. Insurers do not
balk, however, at paying $315 for a single session of dialysis, which treats one
of the disease's serious complications. Not surprising, as the
epidemic of
Type 2 diabetes has grown, more than 100 dialysis centers have opened in the
city. The center's demise, its founders and other experts say, is evidence of a
medical system so focused on acute illnesses that it is struggling to respond to
diabetes, a chronic disease that looms as the largest health crisis facing the
city. America's high-tech, pharmaceutical-driven system may excel at treating
serious short-term illnesses like coronary blockages, experts say, but it is
flailing when it comes to Type 2 diabetes, a condition that builds over time and
cannot be solved by surgery or a few weeks of taking pills. Patients with the
disease do not test their blood as often as they should because they cannot
afford the equipment. Patients wait months to see endocrinologists because lower
pay has drawn too few doctors to the specialty. And insurers limit diabetes
benefits for fear they will draw the sickest, most expensive patients to their
rolls. Dr. Diana K. Berger, who directs the diabetes prevention program for the
City Department of Health and Mental Hygiene, said the bias against effective
care for chronic illnesses could be seen in the new popularity of another
high-profit quick fix: bariatric surgery, which shrinks stomach size and has
been shown to be effective at helping to control diabetes. “If a hospital
charges, and can get reimbursed by insurance, $50,000 for a bariatric surgery
that takes just 40 minutes,” she said, “or it can get reimbursed $20 for the
same amount of time spent with a nutritionist, where do you think priorities
will be?” For the complete article, visit
http://www.nytimes.com/2006/01/11
/nyregion/nyregionspecial5/11diabetes.
html?pagewanted=1&th&emc=th
Study:
Mid-life obesity a threat by itself
Northwestern University researchers tracked 17,643 patients for three decades
and found that being overweight in mid-life substantially increased the risk of
dying of heart disease later in life, even in people who began the study with
healthy blood pressure and cholesterol levels. High blood pressure and
cholesterol are strong risk factors for heart disease. Both are common in people
who are too fat, and often are thought to explain why overweight people are more
prone to heart disease. But there is a growing body of science suggesting that
excess weight alone is an independent risk factor for heart attacks, strokes and
diabetes. The new study fits with that evolving school of thought and contrasts
with a controversial government study published last year that suggested excess
weight might not be as deadly as previously thought. “The take-home message
would be pay more attention to your weight even if you don't have an unhealthy
risk factor profile yet,” said lead author Lijing Yan, a researcher at
Northwestern and Peking University. The study appears in Wednesday's Journal
of the American Medical Association. Participants were Chicago-area men and
women in their mid-40s, on average, who had no heart disease or diabetes when
the study began. They were followed for an average of 32 years. The researchers
tracked deaths from cardiovascular disease and diabetes, and hospitalizations
for those conditions, starting at age 65. A total of 1,594 heart disease deaths
occurred, 31 of them in people who started the study with normal blood pressure
and cholesterol. Among participants with normal blood pressure and cholesterol
at the start, those who were obese, or grossly overweight, were 43 percent more
likely than normal-weight participants to die of heart disease later on. They
were also four times as likely to be hospitalized for heart disease.
Participants who were modestly overweight but had normal blood pressure and
cholesterol still ran a higher risk than the normal-weight people. (The
Associated Press)
AmerisourceBergen to acquire oncology service provider,
NMCR LLC
AmerisourceBergen Corporation announced that it has signed a definitive
agreement to purchase Network for Medical Communications & Research LLC. (NMCR),
a privately held provider of physician accredited continuing medical education (CME)
and analytical research for the oncology market that is headquartered in
Atlanta, GA, for the purchase price of approximately $90 million including
assumed debt. The acquisition is expected to close during the quarter ending
March 31, 2006, subject to regulatory approvals. NMCR’s analytics business uses
physician panels and case studies to research and analyze cancer treatment
regimes, resulting in practical data. The CME business will complement
AmerisourceBergen Specialty Group’s Imedex accredited CME
unit. AmerisourceBergen will operate NMCR as part of the Specialty Group’s
manufacturer services business, which includes physician education, analytics,
reimbursement consulting, third party logistics and other support services.
Setra
Systems launches e-commerce site for sale of
laboratory balances and accessories
Setra
Systems Inc., a designer and manufacturer of pressure
measurement devices and weighing systems, has launched an e-commerce site for
the sale of
Himalaya and
Sierra laboratory balances and accessories. By accessing
http://www.setrascalesonline.com customers can download product
specification and other information, as well as place an order using a major
credit card. The Himalaya Series of single range laboratory balances offers
extremely high readability (0.001g). The six button keyboard allows a choice of
several weighing modes. The Sierra Series of precision balances includes four
single range models, as well as two dual range models. The dual range laboratory
balances automatically display the maximum resolution whenever the balance is
tared, regardless of how much weight is zeroed out.
Tuesday, January 10, 2006
GAO to probe reprocessing of
single-use medical devices
Growth of national health
spending slows
along with drug sales
Emergency systems ailing; most
states
not prepared for medical crises
16th Annual AAMI/FDA
International Conference
on Medical Device Standards and Regulation
Healthcare industry to
celebrate decade of environmental
successes at CleanMed 2006
Patient advocates rip CDC for
failing to do enough
to stop hospital infection
GAO to probe reprocessing of single-use medical
devices
Congress's
investigative arm said Monday that it will investigate the safety of using
reconditioned medical devices designated for one-time use and the government's
oversight of the practice. In a meeting Monday, top officials of the Government
Accountability Office agreed to open the probe in response to a request from
Reps. Thomas M. Davis III (R-VA), the chairman of the House Committee on
Government Reform, and Henry A. Waxman (D-CA), the ranking minority member on
the committee. The lawmakers' request followed a series of articles in The
Washington
Post examining
the reuse of single-use medical devices, a growing practice called reprocessing.
“It's clearly an important safety and health issue that needs attention,” said
Robert White, a spokesman for Davis. Device manufacturers say they cannot vouch
for the safety of their reconditioned single-use devices, but reprocessors say
there is no credible evidence that their refurbished devices are riskier than
new ones. The reprocessors also say no surgery is without risk, and many
hospitals cite cost savings and consider the practice safe. The GAO's
investigation will build on a report issued in 2000, when reprocessing was a
nascent industry. Then, the agency “found little available evidence of harm from
reuse,” but also said “reprocessing is not invariably safe, and relatively
little is known about the practice.” Reprocessing has grown substantially since
then, and it is believed to be practiced in all 50 states and many of the
nation's hospitals, including several in the Washington region. GAO spokesman
Paul L. Anderson said the watchdog agency will look into the adequacy of the
Food and Drug Administration's oversight of reprocessing. He said the
investigation will be conducted by the GAO's health care team, although he said
it has yet to define the scope of its work, including how many staffers will be
involved and what their timetable will be. Dan Vukelich, deputy executive
director of the Association of Medical Device Reprocessors, said in a statement,
“We're confident that the GAO will again take a thorough look at reprocessing
and issue a report confirming that the industry is stringently regulated and
reprocessed devices are safe.” FDA spokeswoman Julie Zawisza defended the
agency's oversight of the reprocessing industry, saying it strictly enforces
regulations over it. The FDA “does not have evidence that device reuse
represents a danger to health,” she said in a statement. “Reusing single-use
medical devices is a legal, widespread and common practice in hospitals and
healthcare facilities driven by the need to control and reduce costs.” (The
Washington Post)
Growth
of national health spending slows
along with drug sales
The growth of national
health spending slowed in 2004, mainly because insurers reined in drug costs so
that spending on
pharmaceuticals
increased at the slowest rate in a decade, the Bush administration said Monday.
Total healthcare spending rose 7.9 percent in 2004, to $1.9 trillion, or an
average of $6,280 a person, the administration said. That represents 16 percent
of the nation's economy, the highest share on record. Spending on prescription
drugs rose 8.2 percent, to $188.5 billion in 2004, the government said. This was
the first year of single-digit growth in retail drug sales since 1994. But
spending on hospitals and doctors' services surged in 2004, and the nation spent
far more on them than on prescription drugs. The 8.6 percent increase in
spending for hospital care and the 9 percent increase in payments to doctors
were the highest recorded since 1991. The new figures do not reflect the cost of
the Medicare prescription drug benefit, which took effect this month. The
government's annual report on health spending, issued Monday, includes these
highlights: Spending for hospital care totaled $570.8 billion. Hospital spending
by private insurers rose 9.5 percent, while Medicaid spending on hospitals
increased 9.9 percent. Spending for doctors' services climbed to $399.9 billion
in 2004. Medicare spending on doctors rose 11.1 percent, up from an increase of
8.8 percent in 2003. Doctors are performing more services and more complex
services, for which they receive higher fees from Medicare. Payments to
independent home health agencies have been rising more rapidly than any other
category of health spending. They increased 11.1 percent in 2003 and 13.3
percent in 2004, to $43.2 billion. Medicare spending for home care shot up 19.3
percent in 2004, partly because of rapid growth in home-based hospice services.
Spending on care provided by skilled nursing homes rose 4.3 percent in 2004, to
$115 billion. Medicaid accounts for 44 percent of that spending. (The New York
Times)
Emergency systems ailing; most states
not prepared for medical crises
Few states are equipped to handle emergency medical crises such as a terrorist
attack, a natural disaster or an influenza outbreak, according to an analysis by
the American College of Emergency Physicians. The organization gave an overall
grade of C-minus to emergency care in the 50 states and the District of
Columbia, with more than half earning below-average scores in areas dealing with
the availability of hospital beds and emergency specialists, immunization rates,
injury-prevention programs, malpractice laws and sophistication of 911 telephone
systems.
Emergency care specialists
such as Angela Gardner, chair of the task force that prepared the first-ever
analysis of emergency medical systems, said they expected to find some
deficiencies in a field that has seen budget cuts and rising demand. But the
panel was startled at how poorly prepared the nation is as a whole to manage
trauma, whether in individual patients or in the event of a large-scale
disaster. “We have no capacity to handle a Hurricane Katrina or an avian flu
outbreak,” Gardner said. “We can barely handle a regular flu outbreak.”
Analyzing publicly available data, the task force gave each state and the
District an overall letter grade and ratings in four categories: access to
emergency care, quality and patient safety, medical liability environment and
public health and injury prevention. No state received an A overall. California,
Massachusetts, Connecticut and the District scored the highest, with overall
ratings of B. “More than 80 percent of the states earned poor or near-failing
grades,” the report concluded. At the bottom, earning D grades, were Arkansas,
Idaho and Utah, while Virginia scored a D-plus and Maryland got a B-minus. The
report supported what many Americans have experienced directly -- long waits in
overcrowded emergency rooms, loss of health insurance, and specialist shortages
in areas such as neurosurgery and obstetrics. Many patients are facing higher
bills and traveling longer distances to receive needed care, the authors found.
“What we need are beds, doctors and nurses,” especially doctors and nurses with
special training in trauma care, Gardner said. From 1990 to 1999, hospitals
nationwide eliminated 107,000 beds, 7,800 of which were critical-care beds,
according to the report. At the same time, more and more people have sought
care. Emergency department visits have increased by 5 million a year, hitting
114 million patient visits in 2003, the last year for which data were available.
In many instances, states with wealthier residents fared better than
lower-income states. But the task force found exceptions as well. South Carolina
and West Virginia, two of the poorest states in the nation, received
above-average grades.
16th Annual AAMI/FDA International Conference
on Medical Device Standards and Regulation
Join
your colleagues and other industry professionals from around the world at the
16th Annual AAMI/FDA International Conference on Medical Device Standards and
Regulation, March 22–23, 2006, at the Hyatt Regency in Reston, VA. The
conference, which is sponsored jointly by the Association for the Advancement of
Medical Instrumentation (AAMI) and the U.S. Food and Drug Administration (FDA),
will provide up-to-date, detailed information about some of the latest standards
and regulatory initiatives that affect manufacturers of medical devices, both in
the U.S. and overseas. Hear directly from representatives of the FDA about
recent changes in the law, and about the actions your company will need to take
to comply with those changes. Deadline for hotel reservations is February 28,
2006, but rooms may sell out sooner: Call 703-709-1234. Additional information
and program updates can be found online at www.aami.org/meetings/isc. Should you
have any questions, please contact Chris Dinegar at 703-525-4890, ext. 210.
Healthcare industry to
celebrate decade of environmental
successes at CleanMed 2006
The largest healthcare conference on environmentally preferable medical
products and practices is to be held in Seattle, WA, April 18-20. Healthcare
decision makers from across the United States will meet at CleanMed 2006 to
discuss trends and celebrate successes in the growing movement to protect health
by reducing pollution in the healthcare industry. Event partners and sponsors
include Catholic Health Initiatives, Consorta, Kaiser Permanente, Premier Inc.,
Consorta, Hospitals for a Healthy Environment and Health Care Without Harm.
Leaders along the entire healthcare supply chain attend CleanMed, including
major healthcare systems, top Group Purchasing Organizations and product
vendors, along with hospital executives, health and safety managers, nursing
leaders, architects, designers, food service professionals and many others. The
conference will feature a day-long seminar on green building, and the annual
awards presentation and workshop for Hospitals for a Healthy Environment (H2E).
To register for CleanMed and for more information see http://www.cleanmed.org
Patient advocates rip CDC for failing to do enough
to stop hospital infection
The federal Centers
for Disease Control and Prevention (CDC) and local public health officials
should make hospital infection prevention a New Year's resolution, according to
Betsy McCaughey, Ph.D., a health policy expert and Chairman of the Committee to
Reduce Infection Deaths (RID). RID released a report, “Unnecessary Deaths”,
calling on the CDC and local health officials to do more to stop hospital
infection deaths. The report, co-sponsored by the National Center for Policy
Analysis, alerts the public to the grave financial and human consequences of
poor infection control in American hospitals and demonstrates that these
infections are almost all preventable through improvements in hospital
procedures and hygiene. “Infections that have been nearly eradicated in some
countries-such as MRSA (methicillin-resistant Staphylococcus aureus)-are raging
through hospitals in the United States.” “Unnecessary Deaths” documents the
success of U.S. hospitals that have reduced infections by 85% or more in pilot
programs. “Hospitals that lack the discipline and training to stop ordinary
bacterial infections from spreading from patient to patient are unprepared for
the larger challenge of stopping avian flu or bioterrorism pathogens from
sweeping through their institutions,” McCaughey added.
To download this report,
visit
http://www.hospitalinfection.org/
Monday, January 9, 2006
Boston Scientific bids for
Guidant; plans to sell Guidant’s
vascular intervention, endovascular business to Abbott
Johnson & Johnson reaffirms
commitment
to Guidant acquisition
Bird flu appears to spread West
WHO Update: Figures for bird
flu cases in humans
Intel chairman urges U.S. to
address healthcare
for aging society through technology innovation
Novation awards
SPSmedical Supply Corp. contract
for SporView PA Culture Set
Boston Scientific bids for Guidant; plans to sell Guidant’s
vascular intervention, endovascular business to Abbott
Boston Scientific Corporation announced Sunday that it has submitted to Guidant
Corporation a definitive offer to acquire all the outstanding shares of Guidant
for a combination of cash and stock worth $72 per Guidant share, or $25 billion
in the aggregate. This offer is set forth in a merger agreement that was
executed by Boston Scientific and delivered to Guidant Sunday. Boston
Scientific's offer price represents a premium of approximately 12 percent over
the purchase price proposed to be paid by Johnson & Johnson under the revised
merger agreement between Guidant and Johnson & Johnson, based on the closing
price of Johnson & Johnson common stock on Friday, January 6, 2006. In a
separate announcement today, Boston Scientific said that it has executed a
binding definitive agreement with Abbott under which Abbott will purchase
Guidant's vascular intervention and endovascular businesses, assuming completion
of Boston Scientific's proposed acquisition of Guidant. As part of this
agreement, Boston Scientific will share rights to Guidant's drug-eluting stent
portfolio with Abbott, providing Boston Scientific a second DES platform. Boston
Scientific announced last month that it would divest Guidant's vascular
intervention and endovascular businesses to enable it to rapidly secure
antitrust approval for the acquisition of Guidant. The combined company will
have significant scale, accelerated top- and bottom-line growth and strong cash
generation. In 2007, the first full year of the combined operations, Boston
Scientific expects $10 billion in pro forma sales. The combined company's sales
are expected to grow at a double-digit rate achieving $16 billion in sales in
2011. Over the past month, a team from Boston Scientific, together with its
legal and financial advisors, has conducted due diligence on Guidant's
businesses and operations around the world. Boston Scientific is satisfied with
the results of this due diligence review. “Our due diligence confirmed our
belief in the underlying value of the company and the significant long-term
potential we see in a Boston Scientific/Guidant combination,” said Jim Tobin,
President and Chief Executive Officer of Boston Scientific. Boston Scientific's
definitive offer is outlined in a letter from Boston Scientific Chairman Pete
Nicholas and President and Chief Executive Officer Jim Tobin to Guidant Chairman
James M. Cornelius.
Johnson & Johnson reaffirms commitment to Guidant acquisition
Johnson & Johnson reaffirmed Sunday that it expects to consummate the
acquisition of Guidant Corporation immediately following a favorable shareholder
vote by Guidant shareholders on January 31. All other conditions to close have
been satisfied. “We continue to believe that the agreed upon Johnson & Johnson
deal represents a better offer for Guidant Corporation, its shareholders and its
employees than the recently announced Boston Scientific proposal,” said William
C. Weldon, Johnson & Johnson chairman and chief executive officer. “Johnson &
Johnson has the capacity to invest in Guidant's future. We intend to dedicate
the resources necessary to enable Guidant to achieve a full and complete
recovery in the cardiac rhythm management market, and to achieve and sustain
leadership in interventional cardiology.” Johnson & Johnson has secured Federal
Trade Commission, European Commission and other regulatory bodies’ clearance of
the acquisition and is satisfied that no other issues such as rights to
intellectual property will impede the close of the Johnson & Johnson/Guidant
merger.
Bird flu appears to spread West
Two
children and an adult from a town near the Turkish capital tested positive
Sunday for a lethal strain of bird flu as the virus continued to spread west
from its source in East Asia toward Europe. The preliminary test results, which
must still be confirmed by the World Health Organization, came days after a
teenage brother and sister from a village in the far east of Turkey died from
the H5N1 strain of bird flu in the first confirmed human cases of the disease
outside Southeast Asia and China. Bird flu was also suspected in the death of a
third sibling, but test results remain inconclusive. Turkish medical authorities
reported Sunday that as many as 10 Turks have been infected. Some of these cases
have appeared in family clusters, raising concern that the disease might have
begun spreading more easily among people. But international health experts said
they find it more likely that the human cases in Turkey were caused by contact
with infected birds. Influenza experts have said they suspect that in Thailand,
Indonesia and Vietnam, the virus has already demonstrated the ability to be
transmitted among humans. In each of these instances, however, the disease only
infected members of an immediate family and did not spread further. That would
indicate that the ability of the virus to spread among people remains limited.
Turkish officials said they have ordered a mass slaughter of birds in the
capital region to stem the further spread of the disease. Turkey's Anatolia news
agency reported Sunday that the epidemic in birds had already reached the west
of the country, where infected chickens had been found in the area of Bursa,
about 200 miles from Ankara. Scientists are eager to see the outcome of detailed
genetic sequencing that could show how the highly changeable bird flu virus has
evolved since it spread from East Asia, where it has infected more than 140
people since 2003. WHO has dispatched two teams to investigative the Turkish
outbreak, Cheng said. Russia's chief state epidemiologist, Gennady Onishchenko,
was quoted by the Interfax news agency as urging Russians to refrain from
traveling to Turkey, especially the eastern region hardest hit by the outbreak.
(The Washington Post)
WHO Update: Figures for bird flu cases in humans
The
World Health Organization (WHO) has confirmed 76 deaths from the deadly H5N1
strain of bird flu since late 2003. The figures include two deaths in Turkey
over the past week. The WHO reports only laboratory-confirmed cases. A third
death in Turkey is still subject to further WHO tests. Following is a list of
confirmed human cases of H5N1 bird flu from the WHO in Geneva. Total cases
includes survivors. The following list shows the number of deaths, followed by
number of total cases: Cambodia: 4, 4; China: 3, 7; Indonesia: 11, 16; Thailand:
14, 22; Vietnam: 42, 93; Turkey: 2, 4; TOTAL: 76, 146 (Reuters)
Intel chairman urges U.S. to address healthcare for
aging society through technology innovation
Speaking at the White House Conference on Aging, held only once a decade, Intel
Corporation Chairman Craig Barrett urged U.S. government leaders to seize the
opportunity to apply technology to help solve the economic and social challenges
faced by the country due to skyrocketing healthcare costs and a growing wave of
aging citizens. With nearly 35 million senior citizens in the United States, the
country already spends 16 percent of its gross domestic product (GDP) on
healthcare. Forecasters estimate that 25 percent of the nation’s GDP will go
toward healthcare as the number of senior citizens doubles during the next 20 to
30 years. Barrett said the country’s economy cannot keep pace with the soaring
costs of caring for an aging society. “We can make the healthcare system more
cost-efficient while simultaneously improving the quality of care and life for
our nation’s aging population,” said Barrett. “No company, no industry, no
country can afford to ignore the economic and social impact this wave of aging
people will create.” Developing technologies to keep people well and moving care
from the hospital to the home are central to transforming the healthcare system,
according to Barrett. He pointed to new computer-based technologies and
innovations in sensors, software and wireless technologies that can allow such
vital information as heart rate, respiratory rate, blood pressure and sleep
patterns to be tracked remotely. Broadband Internet connectivity allows the data
to be shared real-time between seniors and healthcare professionals, as well as
amongst family members and friends who deliver the majority of care to seniors.
Novation awards SPSmedical Supply Corp. contract
for SporView PA Culture Set
Novation has awarded a new agreement to SPSmedical Supply Corporation (Rush, NY)
for the SporView PA Culture Set, a 24-hour biological indicator for the STERIS
SYSTEM 1 sterilizer. This agreement was not competitively bid. It was awarded
based on a review by the Novation Perioperative Council, which determined the
company offered innovative technology that offered improved clinical
advantages. Novation's innovative technology program speeds opportunities for
suppliers with new products to gain contracts without waiting for scheduled
competitive bids. This product does not require refrigeration and provides the
fastest BI results on the market, for the SYSTEM 1 sterilizer. For more
information about the SporView PA Culture Set or to request a free sample kit,
go to www.spsmedical.com or call 800-722-1529.
Friday, January 6, 2006
Desperate measures for stroke
push
the edge of medical knowledge
Bird flu claims 3rd Turkish
child
U.S. chicken producers
to test flocks for bird flu
Report shows cost a prohibiting
factor for adoption of
medication safety technology in small rural hospitals
CBSPD relocates offices; moves
forward with computerized testing
Desperate measures for stroke push
the edge of medical knowledge
In an extraordinary
attempt to save the life of Prime Minister
Ariel Sharon
of
Israel,
doctors in Jerusalem operated twice on his brain for a total of nearly nine
hours, then put him into an
anesthesia-induced
coma and connected him to a mechanical respirator, his medical team said
Thursday. The measures were desperate and, experts agreed, unlikely to succeed,
but they were about all that remained in the effort to save Sharon's life and to
retain as much of his motor functions and intellectual skills as possible after
the horrific hemorrhagic stroke he suffered Wednesday. It was Sharon's second
stroke in less than three weeks. On Dec. 18, a small stroke temporarily impaired
his speech but caused no apparent permanent damage. His doctors said he would
need at least 48 hours in a coma, from the time the surgery had ended, before
they could gradually awaken him to begin to determine the degree of brain
damage. They said they did not plan to try to reverse his coma for several days.
Stroke experts not involved in
Sharon's
care said in interviews that, based on the induced coma, the stroke most likely
had produced significant swelling of his brain, threatening to impair the
centers that control his heart, breathing and other vital functions. A number of
factors play critical roles in whether patients like Sharon survive strokes and
how much function they lose. These include the amount of bleeding, its location
in the brain, the pressure in the brain and the age of the patient. However, Ron
Krumer, the chief spokesman for Hadassah Ein Kerem Hospital in Jerusalem, where
Sharon is being treated, said that the goal of the extraordinary and largely
uncharted treatment course was to reduce the pressure inside his skull “to let
the various systems of his body - especially his mind - get a real rest.” While
some experts supported the extraordinary treatments that were used to try to
save Sharon's life, and others opposed them, all agreed that
Sharon's
Israeli doctors were working at the very edges of medicine's lifesaving
capacities, with little experience and few studies to guide them. “We are now
beyond areas of standard practice, with things like repeated surgery to relieve
pressure and inducing a deep coma,” said Dr. Lalit Kalra, professor of stroke
medicine at Kings College London. “There are no studies on this. We are very
much in gray areas here and we are talking about desperate measures.” (The New
York Times)
Bird flu
claims 3rd Turkish child
An
11-year-old girl died of bird flu in Turkey on Friday, the country's third death
from the virus, officials said. Hulya Kocyigit is the sister of two teenagers
who died earlier this week of the virus. The 14-year-old brother died of a
strain of avian influenza on Sunday, and the 15-year old sister died Thursday.
The children lived in a remote rural district of eastern Turkey near the
Armenian border. Their six-year-old brother is also being treated for the same
disease in the hospital. Huseyin Avni Sahin, the head doctor at Van hospital
where the children died, told CNN Turk 23 people were now being treated at his
hospital for suspected bird flu. World Health Organization (WHO) spokeswoman
Maria Cheng told CNN the group has confirmed that the two teenagers had an H5
variety of the avian influenza, but said it is not yet known if it was the
deadly H5N1 strain. The hospital said Friday that they believe the latest death
is also from the H5N1 strain, and samples have been sent to Britain for testing.
(CNN, Associated Press)
U.S. chicken producers to test flocks for bird flu
U.S. chicken producers including Tyson Foods Inc. and
Pilgrim's Pride Inc. will begin testing all their flocks to make sure they are
free from hazardous forms of avian influenza, after the disease decimated the
industry in Asia.
Samples will be taken on the farm before the birds are moved to processing
plants under a program announced by the National Chicken Council, a trade group.
Tests will be conducted under procedures approved by the National Poultry
Improvement Plan, an existing federal-state cooperative program, the Washington,
D.C.-based chicken council said. The
U.S.,
the world's largest producer and exporter of poultry, is preparing for the
possibility that the lethal H5N1 strain of bird flu may reach domestic flocks,
threatening an industry valued at $29 billion. The virus, which has never been
found in the U.S., led to the destruction of millions of birds in
Asia and parts of eastern Europe and resulted in at least 74
human deaths since 2003. Testing
U.S. flocks “will add another
layer to the multiple barriers that already exist to protect American consumers
and continue to ensure safety and quality of the food supply,” Stephen Pretanik,
the council's director of science and technology, said. Flocks found with the H5
or H7 form of bird flu will be humanely destroyed, the council said. Poultry
producers accounting for more than 90 percent of chicken production in the U.S.
have enrolled in program, and most will have it in place by Jan. 16, council
spokesman Richard Lobb said. Consumers should also make sure poultry meat is
properly cooked before it is consumed, the council said. The avian flu virus
can't withstand high temperatures, so cooking poultry to a temperature of 160
degrees Fahrenheit (71 Celsius) ensures the meat is safe to eat, according to
the U.S. Department of Agriculture. (Bloomberg)
Report
shows cost a prohibiting factor for adoption of
medication safety technology in small rural hospitals
A December 2005
report from the University of Minnesota Rural Health Research Center and the
University of North Dakota Center for Rural Health, “Pharmacist Staffing and the
Use of Technology in Small Rural Hospitals: Implications for Medication Safety”
reveals the results of a national study that assessed the capacity of rural
hospitals to implement medication safety practices, with particular focus on
pharmacist staffing and the availability of technology. The primary data for the
project was collected through a telephone survey of a national random sample of
small rural hospitals conducted from March to May 2005. A total of 387 hospitals
responded out of 409 eligible hospitals, for a response rate of 94.6%. The
survey respondents included pharmacists (89%) and Directors of Nursing (11%).
The results of this study indicate that many small rural hospitals have limited
hours of on site pharmacist coverage. In hospitals with limited pharmacist
coverage, pharmacists may not be able to take an active leadership role or spend
significant time on medication safety activities. Technology use varies by type
of technology and hospital characteristics, with 77% of the hospitals reporting
use of a pharmacy computer for one or more clinical purposes, but only 3% of
hospitals using bar code technology for bedside medication administration. Cost
is a major reason given by survey respondents for not implementing specific
medication safety-related technologies. Other reasons for not using technology
include computer system and software problems; limited pharmacy hours/pharmacist
time; and belief that the hospital is too small and technology is not needed or
not a priority. The majority of hospitals have implemented key medication safety
practices including a do-not-use-abbreviations list, a policy of using two
patient identifiers for administering medications, a policy of having two health
professionals independently check doses of high alert medications, and a high
alert drug list. However, only half of the hospitals have implemented all four
practices. While achieving full compliance with medication safety practices is
challenging, all hospitals should be working towards implementation, and
multiple resources are available on the Internet to help hospitals assess and
improve their medication use systems. Of particular interest to policymakers,
two factors, JCAHO accreditation and hospital financial status, are
significantly related to pharmacist staffing, use of a pharmacy computer, and
implementation of four key medication safety activities. Improving
implementation of key medication safety practices among non-accredited hospitals
will likely require a comprehensive approach that includes increasing awareness
of the importance of implementing the practices, as well as targeted provision
of technical assistance and financial incentives. The finding of significant
relationships between financial status and pharmacist staffing, use of
technology, and implementation of medication safety practices supports a
continuation of Medicare policies to help ensure financial stability for small
rural hospitals through cost-based reimbursement as a means of helping to
support quality and patient safety activities.
CBSPD relocates offices; moves forward with computerized
testing
The
Board of Directors of The Certification Board for Sterile Processing &
Distribution, Inc. announce the relocation of their offices to: 2 Industrial
Park Road, Suite # 3, Alpha, NJ 08865. The toll free number will remain the same
(800-555-9765). The toll number is now 908-454-9555. The new FAX# is
908-454-9554. The email address remains the same. With the dramatic expansion of
the CBSPD, it was essential to obtain larger quarters. According to Nancy Chobin,
RN, CSPDM, Executive Director, “this new space is twice the size of the
Flemington office and will serve the CBSPD for many years to come.” The CBSPD is
the only sterile processing certification program that is accredited by the
National Commission for Certifying Agencies. The CBSPD offers five levels of
certification; technician, supervisor, manager, surgical instrument processor
and now Ambulatory Surgery. The Ambulatory Surgery Sterile Processing
Technician exam was implemented in April 2005 after a Job Analysis Survey was
performed indicating significant variances in practice from hospital sterile
processors.
The
CBSPD Board has also announced that it plans to move forward with computerized
testing in 2006. According to Nancy Chobin, “this was not an easy decision to
make due to sterile processing personnels’ lack of ease with computers. In
addition, there are issues with security with internet testing so it is
imperative that the testing agency delivering the exams has many safety nets in
place.” The CBSPD is currently evaluating several testing agencies that offer
computer based testing. It is anticipated that the first administration will be
in October. However, this will depend on many factors and until all systems are
in place, we will not set a firm date. According to Chobin, “we will be able to
offer more availability to the exam. The exams will be offered during “windows”
or specified time periods. The exact times are still being considered.” Look for
more information on the CBSPD website at:
www.sterileprocessing.org. as this process moves forward.
Thursday, January 5, 2006
Hospitals' profit margin hits
6-year high in 2004
Bird flu claims second Turkish
child
Gain reported in combating
ovary cancer
Roche boosts Tamiflu shipments
to states
Healthcare Supply Chain Metrics
conference available on CD
Hospitals' profit margin hits 6-year high in 2004
The
nation's hospitals, boosted by a slowdown in expense growth and continued
ability to drive a hard bargain with insurers, posted profit margins that
reached a six-year high in 2004, and indications are that 2005 was just as good.
The hospital industry is in the midst of its biggest construction boom in 50
years, spending nearly $100 billion in inflation-adjusted dollars in the past
five years for new and expanded facilities nationwide, often in rapidly growing
suburban areas. That spending comes as conditions have been good for both
borrowing and spending. Hospitals reported an average 5.2% profit margin in
2004, the last full year of data available from the American Hospital
Association. In addition to strong bargaining power and slowing expenses,
profits were also driven by investment income from an improving stock market,
said the association's Rick Wade. Even so, Wade says the good times are not
shared by all. “About 25% of hospitals are in the red,” Wade said, down from
about a third in the past few years. The ongoing construction boom has not
affected profits, Wade said, though once new facilities come on line, overall
revenue might increase for the industry. Similar results were reported by
credit-tracking agency Moody's Investors Service, which follows more than 500
hospital systems. Median operating margins, which don't include investment
income, were 2% in 2004, according to Lisa Goldstein, a senior vice president at
Moody's in New York. The median overall margin for the same year was 4.5%. Those
margins were the best she has seen since hospital profits stumbled after
Congress passed the Balanced Budget Act of 1997, which reduced Medicare payment
rates. Some of those Medicare cuts have since been restored. Goldstein says
hospital profits remained strong in 2005. “We have about 100 audits in house for
fiscal 2005,” said Goldstein, “and the numbers are looking better: Margins are
above 2004 levels.” Goldstein said profit margins were helped by: Favorable
Medicare reimbursements and hospitals' success in negotiating higher rates with
private insurers; performing more high-dollar services, such as cardiac surgery,
orthopedics and neurosurgery; strong outpatient revenue; and costs for pension,
malpractice insurance and other expenses coming under control. The American
Hospital Association reported that expenses increased 6.9% in 2004, compared
with 8.1% in 2003. Wade agreed that Medicare and private insurer payments were
healthy during the past couple of years. But he has a less rosy outlook for 2005
and 2006. State Medicaid payments are being cut, he said. That, coupled with
natural disasters affecting hospitals in the South, “will have a dramatic effect
on national margins.” Wade fears that Medicare payments in future years will
also be affected as Congress faces growing deficits related to the war in Iraq,
Hurricane Katrina and other issues. “There will have to be a move for some kind
of deficit reduction,” says Wade. “We've been telling members that Balanced
Budget Act 2 could be just around the corner.” (USA Today)
Bird flu
claims second Turkish child
A 15-year-old
girl has died of bird flu in Turkey, becoming the country's second person to
succumb to the virus, health officials said Thursday. The girl’s 14-year-old
brother died of the H5N1 strain of avian influenza Sunday. Test results
confirming the lethal strain came back late Wednesday from a facility in
Istanbul, Health Minister Recep Akdag said. The siblings are the first known
human deaths from the illness outside of China and Southeast Asia. Nine other
people, most of them members of the teenagers' family, are in hospital with
flu-like symptoms in the city of Van in eastern Turkey. The head doctor of the
facility said he is in urgent need of more respirators to treat the patients.
Five additional patients, also with flu-like symptoms, have been hospitalized in
Erzurum. On Thursday, health officials also announced 11 additional patients,
also with flu-like symptoms, have been hospitalized in two eastern cities,
Erzurum and Aralik, bringing the national total of suspected cases to 20. All 14
patients are from the Dogu Beyazit area, an agricultural town in eastern Turkey.
Dr. Huseyin Avni Sahin, head of the hospital in Van, said the children's family
reported that some of their chickens began dying late last year, and that the
family cooked the remaining chickens for dinner. Shortly after that, he said,
four children in the family began feeling ill and were brought to the hospital
with flu-like symptoms. Then, a parent and another child from the same family
were also admitted to the hospital, Sahin said. Another three people from a
family in the same area and one person from Van were also hospitalized around
that time with flu-like symptoms. The patients have all been isolated from other
patients in the hospital, according to Sahin. Of the nine remaining patients,
all are in serious condition, two of them more seriously ill than the others,
according to Sahin. (CNN)
Gain
reported in combating ovary cancer
A
rarely used treatment that pumps
cancer drugs
directly into the abdominal cavity can add 16 months or more to the lives of
many women with advanced cases of ovarian cancer, doctors are reporting. Medical
practice should change immediately to reflect the findings from the study, being
published today, as well as those from several earlier studies, cancer experts
say. In the United States there are more than 22,000 new cases each year, and
16,000 deaths. Currently, most women receive
chemotherapy
intravenously. They should still do so, but many should get the drugs
abdominally as well. The combined treatment should be offered to every woman who
meets the medical criteria for it, the cancer experts say, and doctors who
cannot provide it should refer women to clinics that can. They advise that
patients ask their doctors about the treatment. The technique employs two
generic drugs already in wide use for ovarian cancer, paclitaxel and cisplatin,
and involves high doses that can have severe side effects. The National Cancer
Institute is taking the unusual step of issuing a clinical announcement to
encourage doctors to use the abdominal treatment. Such alerts are uncommon. The
last one was in 1999, to publicize a major advance in cervical cancer. “We want
to use the bully pulpit of the National Cancer Institute to say that patients
and doctors need to be aware of this information,” said Dr. Edward Trimble of
the cancer institute. He and other cancer experts said that a survival increase
of more than a year was extraordinary for any type of cancer, and that new drugs
were often approved on the basis of much smaller gains. The institute is posting
information at
http://ctep.cancer.gov/highlights/ovarian.html, along with a list of medical
centers that can provide the abdominal treatment. Information can also be
obtained from the institute's Cancer Information Service by telephone: (800)
4-CANCER. The new recommendations are based in part on a study being published
in The New England Journal of Medicine. But that study is the third major
one in a decade to show benefits from abdominal chemotherapy. The new study had
the clearest and most definitive results, researchers said. The cancer institute
said five other smaller studies had also supported IP treatment. The new study,
led by Dr. Deborah K. Armstrong of the Johns Hopkins Kimmel Cancer Center,
included 415 patients treated at 40 hospitals in the United States. Most were 41
to 70 years old, and all had had surgery to remove the cancer. About half the
women, 210, were chosen at random to get intravenous therapy, and 205 received
both intravenous and IP treatment. Patients getting IP treatment had devices and
tubing implanted in the abdomen to pipe in the chemotherapy. In the intravenous
group, the median survival was 49.7 months, but it was 65.6 months in the IP
group, a difference of 15.9 months. (The New York Times)
Roche boosts Tamiflu shipments to states
The maker of
influenza drug Tamiflu is stepping up shipments to parts of several Western and
Midwestern states recently hard hit by the flu. Roche Pharmaceuticals, the
manufacturer of the prescription antiviral medicine, on Wednesday began
increasing shipments to wholesalers in affected areas. The company will continue
to do so according to demand for the drug, U.S. subsidiary Hoffmann-La Roche
said late Wednesday. Tamiflu is not approved to treat avian flu, but has shown
effectiveness in some people infected with the H5N1 bird flu strain because it
is a type A flu virus, Hoffmann-La Roche spokesman Terrence Hurley said. Tamiflu
targets the most common strains of influenza types A and B. Some healthy people
were asking doctors to provide Tamiflu prescriptions for stockpiling in case of
a problem, so Roche tightened its inventory management to ensure Tamiflu
availability where needed. Tamiflu is approved for both treatment and prevention
of the flu in adults and children aged 1 year or older. It limits the ability of
the virus to reproduce, and can reduce the severity and duration of symptoms
when taken within two days of onset. (The Associated Press)
Healthcare Supply Chain Metrics conference
available on CD
Originally broadcast in
April 2005, Healthcare Supply Chain Metrics conference is now available for
purchase on CD. Each CD is self contained, easily referenced, and requires no
special software to use. A great resource to share with your peers, you will
watch the slide presentations as you listen to the presenters' commentaries.
This conference focuses on applying performance metrics to identify and combat
supply chain inadequacies: overstocking, antiquated sourcing options, poor
interdepartmental communication, doctor brand sensitivity, etc. The 4
presentations emphasize tracking underlying performance data to arrive at
organizational, technological and resource management based solutions.
Presentations focus on case studies and results based solutions rather than top
down perspectives of societal and organizational causes of supply chain
inefficiency. “Optimizing the Healthcare Supply Chain”; Part I: Healthcare
Supply Chain Metrics and Part II: Strategic Sourcing for Healthcare are now
available on CD with full speaker slide presentations and commentary Purchase
one for $245 or both at a $100 discount! For ordering information go to:
www.thesbc.org/SC.htm
Wednesday, January 4, 2006
Hospital building booms in suburbs
Stomach bug mutates into medical mystery;
antibiotics, heartburn drugs suspected
Widespread flu outbreaks
in western U.S.
U.S. not told of two deaths during
study of heart drug
U.S. to monitor medical school in New
Jersey
Novation and InnerSpace Corp. ink
three-year agreement
Hospital building booms in suburbs
The United States is in the middle of the biggest
hospital-construction boom in a half-century, a development expected
to increase the use of high-tech medicine and add fuel to rising
healthcare costs. The hospital industry has spent nearly $100
billion in inflation-adjusted dollars in the past five years on new
facilities, up 47% from the previous five years, according to the
Census Bureau. Spending was likely to reach a record $23.7 billion
in 2005. “We are replacing a generation of hospitals that are
obsolete,” said Kirk Hamilton, a hospital architect who teaches at
Texas A&M University. New hospitals don't mean more beds: Capacity
fell to 808,000 beds in 2004, down 18,000 from 2001. The money is
being spent on more luxurious buildings packed with advanced
equipment. The hospitals focus on profitable treatments such as
heart surgery and neonatal care that are reimbursed at higher rates
by private insurance and Medicare. The nation's hospital system is
moving from semiprivate to private rooms. Today's new hospitals have
single rooms measuring 300-450 square feet, many with sleeper sofas
for family members. Older hospitals — even those built a decade ago
— have semiprivate rooms of 250-280 square feet. Today's hospitals
have bedside Internet connections and expensive air-conditioning and
filtration systems to keep infection from spreading. Hospital beds
are being shifted from inner cities to growing suburbs, where the
most-affluent and best-insured people live. Some researchers fear
the new hospitals will drive up costs without improving patient
survival rates and widen the gap between the medical care provided
to the rich and that available to the poor. “These hospitals are
loaded with technology to intensively treat chronically ill patients
right up to death,” said physician John Wennberg, director of the
Center for the Evaluative Clinical Sciences at Dartmouth Medical
School. “We know from research that does not improve outcomes, but
it does drive up costs.” Others say the new hospitals will provide
an affluent, aging society the top-notch medical care it expects and
may restrain health care costs through increased competition.
Expensive hospitals are under construction or planned in nearly
every major city and many small towns. The St. Louis area is getting
three new suburban hospitals that will cost nearly $1 billion.
Indianapolis has gained four heart-surgery centers, two general
hospitals and an orthopedic hospital since 2004 — and an additional
$1 billion in hospital construction is underway. Similar booms are
occurring in Austin, Cincinnati, Denver, Charleston, SC, and other
cities. (USA Today)
Stomach bug
mutates into medical mystery;
antibiotics, heartburn drugs suspected
A growing number of young,
otherwise healthy Americans are being stricken by the bacterial
infection known as Clostridium difficile, or C. diff,
which appears to be spreading rapidly around the country and causing
unusually severe, sometimes fatal illness. That is raising alarm
among health officials, who are concerned that many cases may be
misdiagnosed and are puzzled as to what is causing the microbe to
become so much more common and dangerous. It may, however, be the
latest example of a common, relatively benign bug that has mutated
because of the overuse of antibiotics. In addition, new evidence
released last week suggests that new heartburn drugs may also be
playing a role. The antibiotics Flagyl (metronidazole) and
vancomycin still cure many patients, but others develop stubborn
infections that take over their lives. Some resort to having their
colon removed to end the debilitating diarrhea. A small but
disturbingly high number have died, including an otherwise healthy
pregnant woman who succumbed earlier this year in Pennsylvania after
miscarrying twins. The infection usually hits people who are taking
antibiotics for other reasons, but a handful of cases have been
reported among people who were taking nothing. There are no national
statistics, but the number of infections in hospitals appears to
have doubled from 2000 to 2003 and there may be as many as 500,000
cases each year. Other estimates put the number in the millions. The
emerging problem first gained attention when unusually large and
serious outbreaks began turning up in other countries. After the CDC
began receiving reports of severe cases among hospital patients in
the United States, and in people who had never, or just briefly,
been hospitalized, it launched an investigation. In the Dec. 8 issue
of the New England Journal of Medicine, the CDC reported that
an analysis of 187 C. diff samples found that the unusually
dangerous strain that caused cases in Quebec was also involved in
outbreaks at eight healthcare facilities in Georgia, Illinois,
Maine, New Jersey, Oregon and Pennsylvania. The dangerous strain has
mutated to become resistant to a class of frequently used
antibiotics known as fluoroquinolones. That means anyone taking
those antibiotics for other reasons would be particularly prone to
contract C. diff. Experts said the resistant germ's
proliferation offers the latest reason why people should use
antibiotics only when necessary, to reduce both their risk for C.
diff and the chances that other microbes will mutate into more
dangerous forms. In addition to being resistant, the dangerous C.
diff strain also produces far higher levels of two toxins than
do other strains, as well as a third, previously unknown toxin. That
would explain why it makes people so much sicker and is more likely
to kill. Adding to the alarm is evidence that the infection is
occurring outside of hospitals. When the CDC began looking for such
cases earlier this year, investigators quickly identified 33 cases
in New Hampshire, New Jersey, Ohio and Pennsylvania, including 23
people who had never been in the hospital and 10 women who had been
hospitalized only briefly to deliver a baby, the agency reported
this month. Eight of the patients had never taken antibiotics. It
remains unclear whether the cases occurring outside the hospital are
being caused by the same dangerous strain. Canadian researchers,
however, have found one possible culprit: popular new heartburn
drugs. Patients taking proton pump inhibitors, such as Prilosec and
Prevacid, are almost three times as likely to be diagnosed with
C-diff, the McGill University researchers reported in the Dec. 21 issue of the Journal of the
American Medical Association. And those taking another type
called H2-receptor antagonists, such as Pepcid and Zantac, are twice
as likely. By suppressing stomach acid, the drugs may inadvertently
help the bug, the researchers said. Whatever the cause, the
infection often resists standard treatment. Because the bacterium
can hibernate in protective spores, patients can be prone to
recurrences. It can take multiple rounds of antibiotics, or
sometimes infusions of antibodies or ingesting competing organisms
such as yeast or the bacteria found in yogurt, to finally cure them.
(The Washington Post)
Widespread flu outbreaks in western U.S.
Four western states are the nation's hotspots for flu, and an
epidemiologist predicts infections will grow after the holidays as
children return to school and adults go back to work. Arizona, Utah,
California and New Mexico report widespread flu infections,
according to the Centers for Disease Control and Prevention's weekly
flu report. “Widespread” is the CDC's highest designation for flu
activity. “We think the worst is still yet to come,” said David
Engelthaler, epidemiologist for the Arizona Department of Health
Services. The nation's flu season typically peaks in January,
February or March. The number of flu cases is not known. Wait times
at some emergency rooms in metropolitan Phoenix are getting longer
as flu patients seek treatment, leading some hospitals to rearrange
their staffing plans. Deborah Busemeyer, spokeswoman for the New
Mexico Department of Health, said her state is on par with a typical
flu season. Susan Mottice, a state epidemiologist in Utah, said
recent reports indicate the rate of flu activity there is rising.
Dr. Art Mollen, who operates two medical offices in Phoenix, said
this flu season is far busier than in the past, but most illnesses
are mild to moderate. (The Associated Press)
U.S. not told of two deaths during
study of heart drug
The Scios unit of
Johnson & Johnson
Tuesday added to the questions already clouding its heart failure
medication Natrecor, saying the company had failed to tell federal
regulators about the deaths of two patients in a clinical trial of
the drug.
The two deaths were also omitted from a report of the trial
published in October in The Journal of Emergency Medicine, the
company said. That article reported 6 deaths within 30 days among
237 patients given Natrecor or other treatment in hospital emergency
rooms in 2001 and early 2002. Five of those deaths were of people
who had taken Natrecor. The two additional deaths raised the total
to seven among Natrecor patients, although Scios said Tuesday that
the difference did not change the safety assumptions about the drug.
Neither Scios nor Dr. W. Franklin Peacock 4th of the Cleveland
Clinic, the principal investigator in the study, disclosed Tuesday
how the deaths had been omitted from the results, but said they had
learned only recently that the deaths occurred within the 30-day
study period. A final analysis of the results is under way and will
be submitted to the Food and Drug Administration, said Mark Wolfe, a
Scios spokesman. He said he did not yet know the causes of the two
additional deaths. But a spokeswoman for the Cleveland Clinic,
Eileen Sheil, said that Dr. Peacock strongly believed that the
deaths had been accidental and not related to problems with Natrecor.
The Justice Department is also investigating whether Scios promoted
the drug for unapproved uses. And the government recently announced
that Medicare and Medicaid would no longer cover the drug's
outpatient use. Scios consistently defended Natrecor's safety. (The
New York Times)
U.S.
to monitor medical school in New Jersey
One of the nation's largest healthcare universities, the University
of Medicine and Dentistry of New Jersey, agreed on Thursday to give a federal
monitor sweeping oversight of its finances and management to avoid
criminal prosecution for fraud. The United States attorney for New
Jersey, Christopher J. Christie, said his investigation found that
the university had defrauded the federal and state governments of at
least $4.9 million in a scheme that involved the “purposeful
overbilling of Medicaid.” Senior administrators at the university
were aware of the fraudulent billing for years, he said, yet allowed
it to continue until November 2004. The university's trustees voted
to accept the federal monitor on Thursday after Christie warned them
last week that he had enough evidence to prosecute the university.
Such a move would have made it ineligible to receive federal money
and would have effectively shut it down. Patients made more than two
million visits to the New Jersey university's healthcare facilities
and faculty members' practices around the state last year, according
to the university. The agreement, which Justice Department officials
say is the first instance of a federal monitor's being installed to
oversee a public university, does not prevent Christie from
prosecuting university officials responsible for the double-billing
or other misdeeds, and he warned the trustees last week that
indictments were expected, people who were in the meeting said. The
university's action comes as Christie continues to investigate
allegations of widespread cronyism and insider deals that have
exposed the institution's political underside. Federal prosecutors
are investigating allegations that university officials padded the
payroll with patronage employees, curried favor by making
contributions to elected officials and politically connected
charities, doled out hundreds of millions of dollars in no-bid
contracts, some for which no work appears to have been done, and
awarded huge salaries and bonuses to top officials. The agreement,
which went into effect immediately on Thursday, is likely to cause
little disruption to the patients treated at the university's
hospitals, or to its 4,500 students or 11,000 full-time faculty and
staff members. In a meeting with more than 100 faculty members and
managers on Wednesday, Christie assured them that the monitor would
oversee only the institution's finances and leave the academic and
medical decisions in the hands of educators and doctors. Last week,
the university's chief counsel and two compliance officers were
pressured to resign. When he begins his duties as monitor next week,
Herbert J. Stern, a former United States attorney, will have access
to financial documents, background information about vendors and
companies that bid for university contracts, and the power to make
recommendations to the board regarding the hiring or firing of
senior management. One crucial appointment will be to fill a new
position of chief compliance officer, which the university agreed to
create as part of its agreement with prosecutors. The terms of the
agreement call for the monitor to oversee the university for two
years, and allow the United States attorney the option of extending
it an additional year if necessary. (The New York Times)
Novation and
InnerSpace Corp. ink
three-year agreement
InnerSpace Corp has signed a
three-year national purchasing agreement with
Novation,
the contracting services company of VHA Inc.
and the University HealthSystem Consortium
(UHC), effective immediately.
InnerSpace’s cabinetry, casework, specialty carts, and wire shelving
products are designed to meet space and storage needs in hospitals’
clinical areas, such as the cardiac cath lab, interventional
radiology, endoscopy/GI, surgery and emergency room. InnerSpace will
serve as one of two contracted vendors for VHA and UHC members for
these products.
Monday, January 2, 2006
Stomach bug mutates into medical mystery;
antibiotics, heartburn drugs suspected
Widespread flu outbreaks in western U.S.
U.S. to monitor medical school in New
Jersey
MDCT angiography guides cardiac
vein procedures
Novation and InnerSpace Corp. ink
three-year agreement
Stomach bug
mutates into medical mystery;
antibiotics, heartburn drugs suspected
A growing number of young,
otherwise healthy Americans are being stricken by the bacterial
infection known as Clostridium difficile, or C. diff,
which appears to be spreading rapidly around the country and causing
unusually severe, sometimes fatal illness. That is raising alarm
among health officials, who are concerned that many cases may be
misdiagnosed and are puzzled as to what is causing the microbe to
become so much more common and dangerous. It may, however, be the
latest example of a common, relatively benign bug that has mutated
because of the overuse of antibiotics. In addition, new evidence
released last week suggests that new heartburn drugs may also be
playing a role. The antibiotics Flagyl (metronidazole) and
vancomycin still cure many patients, but others develop stubborn
infections that take over their lives. Some resort to having their
colon removed to end the debilitating diarrhea. A small but
disturbingly high number have died, including an otherwise healthy
pregnant woman who succumbed earlier this year in Pennsylvania after
miscarrying twins. The infection usually hits people who are taking
antibiotics for other reasons, but a handful of cases have been
reported among people who were taking nothing. There are no national
statistics, but the number of infections in hospitals appears to
have doubled from 2000 to 2003 and there may be as many as 500,000
cases each year. Other estimates put the number in the millions. The
emerging problem first gained attention when unusually large and
serious outbreaks began turning up in other countries. After the CDC
began receiving reports of severe cases among hospital patients in
the United States, and in people who had never, or just briefly,
been hospitalized, it launched an investigation. In the Dec. 8 issue
of the New England Journal of Medicine, the CDC reported that
an analysis of 187 C. diff samples found that the unusually
dangerous strain that caused cases in Quebec was also involved in
outbreaks at eight healthcare facilities in Georgia, Illinois,
Maine, New Jersey, Oregon and Pennsylvania. The dangerous strain has
mutated to become resistant to a class of frequently used
antibiotics known as fluoroquinolones. That means anyone taking
those antibiotics for other reasons would be particularly prone to
contract C. diff. Experts said the resistant germ's
proliferation offers the latest reason why people should use
antibiotics only when necessary, to reduce both their risk for C.
diff and the chances that other microbes will mutate into more
dangerous forms. In addition to being resistant, the dangerous C.
diff strain also produces far higher levels of two toxins than
do other strains, as well as a third, previously unknown toxin. That
would explain why it makes people so much sicker and is more likely
to kill. Adding to the alarm is evidence that the infection is
occurring outside of hospitals. When the CDC began looking for such
cases earlier this year, investigators quickly identified 33 cases
in New Hampshire, New Jersey, Ohio and Pennsylvania, including 23
people who had never been in the hospital and 10 women who had been
hospitalized only briefly to deliver a baby, the agency reported
this month. Eight of the patients had never taken antibiotics. It
remains unclear whether the cases occurring outside the hospital are
being caused by the same dangerous strain. Canadian researchers,
however, have found one possible culprit: popular new heartburn
drugs. Patients taking proton pump inhibitors, such as Prilosec and
Prevacid, are almost three times as likely to be diagnosed with
C-diff, the McGill University researchers reported in the Dec. 21 issue of the Journal of the
American Medical Association. And those taking another type
called H2-receptor antagonists, such as Pepcid and Zantac, are twice
as likely. By suppressing stomach acid, the drugs may inadvertently
help the bug, the researchers said. Whatever the cause, the
infection often resists standard treatment. Because the bacterium
can hibernate in protective spores, patients can be prone to
recurrences. It can take multiple rounds of antibiotics, or
sometimes infusions of antibodies or ingesting competing organisms
such as yeast or the bacteria found in yogurt, to finally cure them.
(The Washington Post)
Widespread flu outbreaks in western U.S.
Four western states are the nation's hotspots for flu, and an
epidemiologist predicts infections will grow after the holidays as
children return to school and adults go back to work. Arizona, Utah,
California and New Mexico report widespread flu infections,
according to the Centers for Disease Control and Prevention's weekly
flu report. “Widespread” is the CDC's highest designation for flu
activity. “We think the worst is still yet to come,” said David
Engelthaler, epidemiologist for the Arizona Department of Health
Services. The nation's flu season typically peaks in January,
February or March. The number of flu cases is not known. Wait times
at some emergency rooms in metropolitan Phoenix are getting longer
as flu patients seek treatment, leading some hospitals to rearrange
their staffing plans. Deborah Busemeyer, spokeswoman for the New
Mexico Department of Health, said her state is on par with a typical
flu season. Susan Mottice, a state epidemiologist in Utah, said
recent reports indicate the rate of flu activity there is rising.
Dr. Art Mollen, who operates two medical offices in Phoenix, said
this flu season is far busier than in the past, but most illnesses
are mild to moderate. (The Associated Press)
U.S.
to monitor medical school in New Jersey
One of the nation's largest healthcare universities, the University
of Medicine and Dentistry of New Jersey, agreed on Thursday to give a federal
monitor sweeping oversight of its finances and management to avoid
criminal prosecution for fraud. The United States attorney for New
Jersey, Christopher J. Christie, said his investigation found that
the university had defrauded the federal and state governments of at
least $4.9 million in a scheme that involved the “purposeful
overbilling of Medicaid.” Senior administrators at the university
were aware of the fraudulent billing for years, he said, yet allowed
it to continue until November 2004. The university's trustees voted
to accept the federal monitor on Thursday after Christie warned them
last week that he had enough evidence to prosecute the university.
Such a move would have made it ineligible to receive federal money
and would have effectively shut it down. Patients made more than two
million visits to the New Jersey university's healthcare facilities
and faculty members' practices around the state last year, according
to the university. The agreement, which Justice Department officials
say is the first instance of a federal monitor's being installed to
oversee a public university, does not prevent Christie from
prosecuting university officials responsible for the double-billing
or other misdeeds, and he warned the trustees last week that
indictments were expected, people who were in the meeting said. The
university's action comes as Christie continues to investigate
allegations of widespread cronyism and insider deals that have
exposed the institution's political underside. Federal prosecutors
are investigating allegations that university officials padded the
payroll with patronage employees, curried favor by making
contributions to elected officials and politically connected
charities, doled out hundreds of millions of dollars in no-bid
contracts, some for which no work appears to have been done, and
awarded huge salaries and bonuses to top officials. The agreement,
which went into effect immediately on Thursday, is likely to cause
little disruption to the patients treated at the university's
hospitals, or to its 4,500 students or 11,000 full-time faculty and
staff members. In a meeting with more than 100 faculty members and
managers on Wednesday, Christie assured them that the monitor would
oversee only the institution's finances and leave the academic and
medical decisions in the hands of educators and doctors. Last week,
the university's chief counsel and two compliance officers were
pressured to resign. When he begins his duties as monitor next week,
Herbert J. Stern, a former United States attorney, will have access
to financial documents, background information about vendors and
companies that bid for university contracts, and the power to make
recommendations to the board regarding the hiring or firing of
senior management. One crucial appointment will be to fill a new
position of chief compliance officer, which the university agreed to
create as part of its agreement with prosecutors. The terms of the
agreement call for the monitor to oversee the university for two
years, and allow the United States attorney the option of extending
it an additional year if necessary. (The New York Times)
MDCT angiography
guides cardiac
vein procedures
Angiography using multi-detector
computed tomography (MDCT) may be a good alternative to conventional
angiography for imaging cardiac veins to guide procedures,
researchers reported. Although the newer three-dimensional technique
sometimes suffered from motion artifacts, it proved equal to
traditional two-dimensional angiography by all measures and provided
better visualization of small cardiac veins, said Goerg Mühlenbruch,
M.D., and colleagues at the Aachen University Hospital.
Although MDCT angiography has already proved valuable in guiding
procedures involving coronary arteries, no previous studies have
compared MDCT and conventional angiography in procedures involving
coronary veins, the authors reported in the November issue of the
American Journal of Roentgenology. The study included seven patients
undergoing interventional cardiac procedures involving the coronary
venous system. Two patients underwent radiofrequency ablation
procedures and five had left ventricular leads implanted for
biventricular pacing. All patients underwent conventional
angiography and MDCT angiography. Both techniques were able to
visualize the major coronary veins, such as the coronary sinus,
great cardiac, and left ventricular veins equally well in all
patients. When it came to the small cardiac veins, MDCT was able to
adequately visualize these in three patients, compared with two for
conventional angiography. “Especially for visualization of the small
cardiac veins draining directly into the right atrium, MDCT
angiography was superior to conventional angiography,” the authors
said. On a visibility grade ranging from 0 (worst) to 3 (best), both
techniques rated a solid 2. MDCT angiography scored a mean of 2.38,
while conventional angiography scored a mean of 2.33. “Compared with
conventional angiography, MDCT angiography is less invasive and has
a lower rate of complications,” the authors wrote. “Besides
increased acceptance of the procedure by the patient population,
reduced hospital stays and cost-reduction may be expected.” They
concluded, “Cardiac MDCT angiography provides additional information
on cardiac function and thoracic abnormalities and may replace other
invasive procedures, in some cases even catheter-based coronary
angiography.” (MedPage Today)
Novation and
InnerSpace Corp. ink
three-year agreement
InnerSpace Corp has signed a
three-year national purchasing agreement with
Novation,
the contracting services company of VHA Inc.
and the University HealthSystem Consortium
(UHC), effective immediately.
InnerSpace’s cabinetry, casework, specialty carts, and wire shelving
products are designed to meet space and storage needs in hospitals’
clinical areas, such as the cardiac cath lab, interventional
radiology, endoscopy/GI, surgery and emergency room. InnerSpace will
serve as one of two contracted vendors for VHA and UHC members for
these products.
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