August 2006
Thursday, August 31, 2006
Rising health expenses are a good value,
researchers say
FDA warns consumers about counterfeit
prescription drugs from some Canadian websites
FDA forms task force on human tissue safety
DHHS announces bioshield stakeholders workshop
Nicotine levels rose 10 percent in last six
years, report says
How VA hospitals became the best; No longer a
nation's shame, veteran care is acing competitors
Rising health expenses are a good value,
researchers say
Despite dramatic increases in health expenses since 1960, the
return on medical spending is high, according to a new study
by researchers at Harvard University and the University of
Michigan. Studying health and spending trends from 1960 to
2000, the researchers concluded that healthcare in America has
been cost-effective on the whole, although ballooning costs
for the elderly are a cause for concern. In an article
published in the Aug. 31 New England Journal of Medicine,
David M. Cutler, the Otto Eckstein Professor of Applied
Economics in Harvard's Faculty of Arts and Sciences, and
Allison B. Rosen and Sandeep Vijan of the University of
Michigan Health System compared average per-capita spending
and life expectancy of four different age groups from 1960 to
2000, analyzing increases in medical expenses versus
improvements in health. “The rising cost of healthcare has
been the source of a lot of saber-rattling in the media and
the public square, without anyone seriously analyzing and
discussing the benefits gained,” said Cutler. “But the
dramatic increase in life expectancy that we've seen over the
last decades shows that rising medical costs have been largely
justified.” Conservatively adjusting for non-medical factors
in longevity such as lower smoking prevalence and reduced
death rates from accidents, suicide, and homicide, the
researchers attributed 50 percent of the increase in life
expectancy since 1960 to improved healthcare. Following this
methodology, Cutler and colleagues estimated that from birth,
the increased life expectancy since 1960, approximately seven
years, from 69.90 to 76.87 years, has cost $19,900 per added
year of life. Of the portion of this longevity gain attributed
to improvements in healthcare, the researchers estimated that
some 70 percent was due to reductions in deaths from
cardiovascular disease, while reductions in infant mortality
accounted for 19 percent. Comparing this $19,900 against the
value of a year of life as defined by insurance companies and
medical decision-makers, a figure that ranges from $50,000 to
$200,000, according to different statistical estimates, Cutler
and colleagues judged the increase in medical costs to be a
good value. The researchers write, “The increased spending
has, on average, been worth it.” By contrast, persons age 65
and older have increased their longevity by just 3.5 years
since 1960, with a cost of $84,700 for each year of added
life. “The foremost cause of concern posed by rising medical
costs is the tremendous strain coming from increased costs for
the elderly,” Cutler said. “The cost per year of life for
seniors is three times higher today than it was in the 1970s.”
While Cutler, Rosen, and Vijan indicate that rising costs
could lead to diminishing returns as life expectancy reaches a
ceiling, the researchers say greatly increased quality of life
for the elderly, an important factor not considered in the
current study, mitigates in favor of current levels of
healthcare spending among the elderly.
FDA warns consumers about counterfeit
prescription drugs from some Canadian websites
The U.S. Food and Drug Administration (FDA) is advising
consumers not to purchase prescription drugs from websites
that have orders filled by Mediplan Prescription Plus Pharmacy
or Mediplan Global Health in Manitoba, Canada following
reports of counterfeit versions of prescription drug products
being sold by these companies to U.S. consumers. FDA is
investigating these reports and is coordinating with
international law enforcement authorities on this matter.
FDA recommends that consumers who
have purchased drugs from these websites not use the products
because they may be unsafe. Preliminary laboratory results to
date have found counterfeits of the following drug products
from these websites: Lipitor, Diovan, Actonel, Nexium, Hyzaar,
Ezetrol (known as Zetia in the United States), Crestor,
Celebrex, Arimidex, and Propecia. All of these medications
require a prescription from a licensed health care provider to
be legally dispensed. Some of the websites that are operated
by Mediplan or that have order fulfillment through Mediplan
are: www.RxNorth.com; www.Canadiandrugstore.com;
www.Rxbyfax.com; www.Northcountryrx.com;
www.Canada-pharmacy.com; www.My-canada-pharmacy.com;
www.NLRX.com; www.Canampharmacy.com;
www.Canada-Meds-For-Less.net; and www.Canadian-safe.com. As a
general matter, FDA advises consumers to use caution when
buying medical products online. In August of 2005, FDA
conducted an operation at New York, Miami, and Los Angeles
airports which found that nearly half of the imported drugs
FDA intercepted from four selected countries were shipped to
fill orders that consumers believed they were placing with
“Canadian pharmacies.” Of the drugs being promoted as
“Canadian,” based on accompanying documentation, 85 percent
actually came from 27 other countries around the globe. A
number of these products also were found to be counterfeit.
These results demonstrated that some Internet sites that
claimed to be “Canadian” were, in fact, selling drugs of
dubious origin, safety and efficacy. Counterfeit drugs may be
toxic or contain doses that are too small to treat a medical
condition, or so large that they could endanger the health of
the user. For more information
CLICK HERE.
FDA forms task force on human tissue safety
The Food and Drug Administration (FDA) announced the formation
of a multidisciplinary FDA task force on human cell and tissue
safety. The FDA Human Tissue Task Force (HTTF), which will be
led by senior FDA officials from within the Center for
Biologics Evaluation and Research (CBER) and the Office of
Regulatory Affairs (ORA), was established as part of the
agency’s efforts to strengthen its comprehensive, risk-based
system for regulating human cells and tissue.
The main priority of HTTF will be to
assess the effectiveness of the implementation of the new
tissue regulations, which went into effect in 2005. Of
particular interest will be a review of recently reported
findings that some tissue recovery establishments are not
following federal requirements for tissue recovery. “The
primary goal of the new task force is to identify whether any
additional steps are needed to further protect the public
health while assuring the availability of safe products,” said
Jesse Goodman, MD, MPH, director of CBER. While the agency
believes most firms involved in tissue manufacturing comply
with the new regulations, FDA wants to explore where
additional steps could help strengthen its approach to making
sure firms follow required practices to prevent the
transmission of communicable diseases. Within the next three
months, the task force will develop an action plan, and where
necessary, propose changes to existing policies, as well as
generate a set of recommendations, identify what resources are
needed to support these actions and report on how the agency
can immediately implement its action plan.
DHHS announces bioshield stakeholders
workshop
The US
DHHS is hosting a 2-day workshop for bioshield stakeholders,
in Arlington, VA, on Sept 25-26, 2006, beginning at 8 am on
both days. The BioShield Stakeholders Workshop will be an open
meeting for representatives from the pharmaceutical and
biotech industries, professional societies, state and local
public health organizations, academic R&D community, public
interest groups, stakeholder federal agencies and Congress.
The purpose is to accelerate the R&D, acquisition, and
availability of effective medical countermeasures for
chemical, biological, radiological & nuclear (CBRN) threats.
Space at the Workshop is limited. There is no charge to
attend. The workshop will be held on Sept. 25, from 8 am-6 pm
and Sept. 26, from 8 am-5 pm at the Crystal Gateway Marriott,
1700 Jefferson Davis Hwy, Arlington, VA. Goals of the workshop
include: To provide attendees with insight into the current
BioShield interagency governance process; To provide
individual stakeholders with an opportunity to help guide the
future implementation of Project BioShield, by providing input
into the draft Public Health Emergency Medical Countermeasures
(PHEMC) Strategy for Chemical, Biological, Radiological, &
Nuclear (CBRN) Threats. This Strategy will define the
principles guiding DHHS medical countermeasure research,
development and acquisition. For more information contact:
Elizabeth Jarrett, DHHS Office of Public Health Emergency
Medical Countermeasures at 202-260-1200. To register online
CLICK HERE.
Nicotine levels rose 10 percent in last six
years, report says
The level of nicotine that smokers typically consume per
cigarette has risen 10 percent in the past six years, making
it harder to quit and easier to be addicted, said a report
that the Massachusetts Department of Health released on
Tuesday. The study shows a steady increase in the amount of
nicotine delivered to the smokers’ lungs regardless of brand,
with overall yields increasing 10 percent. Massachusetts is
one of three states to require tobacco companies to submit
information on nicotine testing to its specifications and is
the sole state with data as far back as 1998. The study found
that the three most popular brands with young smokers,
Marlboro, Newport and Camel, delivered significantly more
nicotine than they did six years ago. Nicotine consumed in
Kool, a popular menthol brand, rose 20 percent. The study has
always measured nicotine levels based on the way smokers use
cigarettes, health officials said. That includes partly
covering ventilation holes while
smoking
and taking longer puffs. Traditional testing does not take
habits into account and typically reports lower nicotine
contents, researchers said. “The amount of nicotine in a
cigarette has increased steadily over the past six years,” the
department said, indicating in its reports that the smoking
habits simulated had not changed in that period. Of the 179
brands tested in 2004, 93 percent fell into the highest range
for nicotine. In 1998, 84 percent of 116 brands were in the
highest range. “We want health care providers to know that
smokers are getting more nicotine than in the past and may
need additional help in trying to quit,” the public health
commissioner, Paul Cote Jr., said. The report said that for
all brands tested in 1998 and 2004 there was no significant
difference in the total nicotine delivered among full flavor,
medium, light or ultralight cigarettes. The finding means that
agencies trying to help smokers quit may have to adjust the
strength of nicotine replacement therapies like nicotine
patches and gums. (The Associated Press)
How VA hospitals became the best; No longer a
nation's shame, veteran care is acing competitors
Until the
early 1990s, care at VA hospitals was so substandard that
Congress considered shutting down the entire system and giving
ex-G.I.s vouchers for treatment at private facilities. Today
it's a very different story. The VA runs the largest
integrated healthcare system in the country, with more than
1,400 hospitals, clinics and nursing homes employing 14,800
doctors and 61,000 nurses. And by a number of measures, this
government-managed healthcare program, socialized medicine on
a small scale, is beating the marketplace. For the sixth year
in a row, VA hospitals last year scored higher than private
facilities on the University of Michigan's American Customer
Satisfaction Index, based on patient surveys on the quality of
care received. The VA scored 83 out of 100; private
institutions, 71. Males 65 years and older receiving VA care
had about a 40% lower risk of death than those enrolled in
Medicare Advantage, whose care is provided through private
health plans or HMOs, according to a study published in the
April edition of Medical Care. Harvard University just
gave the VA its Innovations in American Government Award for
the agency's work in computerizing patient records. And all
that was achieved at a relatively low cost. In the past 10
years, the number of veterans receiving treatment from the VA
has more than doubled, from 2.5 million to 5.3 million, but
the agency has cared for them with 10,000 fewer employees. The
VA’s cost per patient has remained steady during the past 10
years. The cost of private care has jumped about 40% in that
same period. Vets still gripe about wading through red tape
for treatment. Some 11,000 have been waiting 30 days or more
for their first appointment. The Iraq and Afghanistan wars
could stress the system, although for the moment VA officials
say the agency can accommodate the new patients. That’s
because older vets, especially those from the World War II and
Korean War eras, are dying of natural causes at the rate of
about 600,000 a year, whereas the Iraq and Afghanistan wars
have so far created a little more than 550,000 new vets. On
the other hand, because advances in body armor and field
medicine have enabled soldiers to survive battlefield injuries
that in earlier conflicts meant death, many of the new
patients are arriving at VA hospitals with severe wounds. In
response, the VA has set up four polytrauma centers around the
country. The roots of the VA’s reformation go back to 1994,
when Bill Clinton appointed Kenneth Kizer, a hard-charging
doctor and former Navy diver, as the VA’s under secretary for
health. Kizer decentralized the VA’s cumbersome health
bureaucracy and held regional managers more accountable.
Patient records were transferred to a system-wide computer
network, which has made its way into only 3% of private
hospitals. When a veteran is treated, the doctor has the vet’s
complete medical history on a laptop. In the private sector,
20% of all lab tests are needlessly repeated because the
doctor doesn’t have handy the results of the same test
performed earlier, according to a 2004 report by the
President's information technology advisory committee. Another
innovation at the VA was a bar-code system for prescriptions,
a system used in fewer than 5% of private hospitals. Private
hospitals, which make their money treating people who come to
them sick, don’t profit from heavy investments in preventive
care, which keeps patients healthy. But the VA, which is
funded by tax dollars, “has its patients for life,” notes
Kizer, who served in his post until 1999. So to keep
government spending down, “it makes economic sense to keep
them healthy and out of the hospital.” Kizer eliminated more
than half the system's 52,000 hospital beds and plowed the
money saved into opening 300 new community clinics so vets
could have easier access to family-practice-style doctors. He
set strict performance standards that graded physicians on
health promotion. Hundreds of thousands of veterans abandoned
private physicians and enrolled in the lower-cost and
higher-quality VA care. But that created a new problem. The
VA’s budget from Congress (currently about $30 billion
annually) couldn’t cover the influx. By January 2003, with
hundreds of thousands waiting six months or more for their
first appointment, the VA began limiting access to only vets
with service-related injuries or illness or those with low
income. Veterans’ groups understandably want the healthcare
system expanded to accommodate vets with higher incomes and no
service-related ailments. Tom Bock, commander of the American
Legion, has another idea: allow elderly vets not in the system
who are drawing Medicare payments to spend those benefits at a
VA facility instead of going to a private doctor, as is now
required by Medicare. “It's a win-win-win situation,” he
argues. Medicare, which pays more than $6,500 per patient
annually for care by private doctors, could save with the VA’s
less expensive care, which costs about $5,000 per patient. The
vets would receive better service at the VA’s facilities,
which could treat millions more patients with Medicare’s cash
infusion. But conservatives fear such an arrangement would be
a Trojan horse, setting up an even larger national healthcare
program and taking more business from the private sector.
Congress has no plans to enlarge the scope of veterans’
healthcare, much less consider it a model for, say, a
government-run system serving nonvets. But it’s becoming more
and more “ideologically inconvenient for some to have such a
stellar health-delivery system being run by the government,”
said Margaret O'Kane, president of the National Committee for
Quality Assurance, which rates health plans for businesses and
individuals. If VA health care continues to be the industry
leader, it may become more difficult to argue that the market
can do better. (Time Inc.) To read the full article
CLICK HERE.
Wednesday, August30, 2006
Drug maker will pay fine for promoting
off-label use
Johnson & Johnson wins antitrust suit
Transfusions of blood products might help to cut deaths in a
future flu pandemic, research suggests
Hospital projects $34 million loss; However, bottom line numbers
show that it will still record
a $38 million profit
Waistlines continue to grow in U.S.
Medical errors? Patients may be the last to know
Medline signs five-year, $75 million prime vendor distribution
deal at Daughters of Charity Health System
Drug maker will pay fine for promoting
off-label use
The
Schering-Plough Corporation agreed on Tuesday to
pay $435 million and plead guilty to conspiracy to settle a
federal investigation into marketing of its drugs for
unapproved uses and overcharging Medicaid for certain drugs.
Schering-Plough said it would pay $255 million to resolve
civil aspects of the previously disclosed investigation. A
subsidiary, the Schering Sales Corporation, will pay a
criminal fine of $180 million and plead guilty to one count of
conspiracy to make false statements to the government. The
agreement is subject to court approval. Schering-Plough said
the settlement resolved an investigation by the Justice
Department and the United States attorney’s office in Boston
that began before a new management team took over at the
company in April 2003. “With this agreement, we are putting
issues from the past behind us,” said Brent Saunders, senior
vice president for compliance and business practices. The
agreement comes two years after Schering-Plough agreed to pay
$346 million to settle charges that it paid a kickback to a
health insurer to protect the market for its allergy drug
Claritin. The investigation that led to Tuesday’s settlement
began in 2001. Investigators found evidence that
Schering-Plough marketed drugs for off-label uses. Off-label
uses have not been approved by government regulators, although
doctors can individually choose to prescribe drugs for those
purposes. One such drug was Temodar, which the
Food and
Drug Administration in 1999 approved to treat
anaplastic astrocytoma, a type of brain
tumor,
in patients who had not responded to other drug regimens. A
United States attorney, Michael
Sullivan, who announced Tuesday’s settlement, said Schering
promoted the drug to treat several other types of brain
cancers and
cancer
that had spread to the brain from elsewhere, uses that the FDA
had not approved. Sullivan said that Schering-Plough also
provided misleading information to the government about the
price it was charging a health maintenance organization
for Claritin RediTabs, to avoid having to pay rebates to the
Medicaid program. Medicaid is supposed to obtain the benefit
of low drug prices and drug makers are required to report
their best price on drugs supplied to commercial customers.
(The Associated Press)
Johnson & Johnson wins antitrust suit
Johnson & Johnson
won an antitrust lawsuit yesterday that had accused the company of illegally
using its sutures monopoly to increase sales of other surgical products. A
federal jury in Santa Ana, CA, rejected claims by the Applied
Medical Resources
Corporation that the Ethicon unit of Johnson & Johnson had blocked competition
in the market for trocars, instruments used in so-called keyhole surgery.
Applied Medical, which is closely held, sued in 2003 for $54 million in damages,
which could have been tripled under antitrust laws. Applied Medical, based in
Rancho Santa Margarita, CA, said Ethicon had taken away its sales by offering
discounts on sutures to hospitals that also bought the company’s trocars and
clip appliers. Johnson & Johnson, based in New Brunswick, NJ, argued that the
bundling contracts did not unfairly exclude other suppliers and were requested
by hospitals that sought lower prices. The jury deliberated for 2½ days before
reaching a decision. (Bloomberg News)
Transfusions of blood products might help to cut deaths in a
future flu pandemic, research suggests
US researchers
examined records from the Spanish flu pandemic of 1918-1920 which killed up to
100m worldwide. They found transfusions taken from people who had recovered may
have improved the condition of others hospitalised by the virus. The study, a
joint project by various groups including the US Navy, will appear in Annals
of Internal Medicine. The latest research suggests that blood transfusions
might be an effective addition to the treatment arsenal, alongside vaccines and
anti-viral drugs. The researchers say a single recovering patient could donate
enough blood plasma to treat many others. They examined the Spanish flu outbreak
because the virus behind it is a close cousin of H5N1. However, they admit the
records on which they based their study were limited. The number of patients was
small, the work was not scientifically well controlled, and dosages were not
standardised. Disruption caused by World War 1 probably made record keeping very
difficult, and wartime censorship may have affected publication of research. The
researchers are calling for experts to examine the potential for plasma therapy,
or serotherapy, in greater detail, and to consider the benefits of drawing up
treatment guidelines. Writing in the same journal, Dr John Treanor, an expert in
infectious diseases at the University of Rochester, said a similar approach had
been used to treat other viral diseases. He said plasma therapy might pose
logistical difficulties, such as how to obtain, classify and prepare blood
materials in the midst of an outbreak. In addition, more work was needed to
refine suitable dosages. However, he added: “Although many logistical hurdles
exist, controlled clinical studies done now will probably pay a considerable
dividend when the pandemic begins. We can, should, and must explore these issues
about serotherapy now, in advance of the pandemic.” Dr John Wood, a virology
expert at the National Institute for Biological Standards and Control, said the
research was intriguing, and demanded further investigation. He said: “Our
present armoury against pandemic flu is limited. We can probably make vaccine,
but it will be five months before it is ready, and there are logistical problems
with anti-virals. It is better to have as many strings in your bow as possible.”
However, Dr Andrew Hayward, an immunologist at University College London, said
it might prove difficult to carry out research into the effectiveness of the
treatment before a pandemic strain of flu emerged. He also warned that any
treatment involving blood products carried the potential for transmission of
other infections. He said vaccines, anti-virals were likely to be the front line
defences, along with basic public health measures, such as hand washing and
wearing masks. Dr Iain Stephenson, a consultant in infectious diseases in
Leicester, said any
potential treatment for pandemic flu was worth exploring. However, he said:
“Immunotherapy is likely to work only in the very early stages of infection and
it will be difficult to identify patients that might benefit.” (BBC News)
Hospital projects $34 million loss; However, bottom line
numbers show that it will still record
a $38 million profit
How does a business lose $34 million on its day-to-day operations and still turn
a $38 million profit? Those are the bottom-line figures in Sarasota (FL)
Memorial Hospital’s proposed budget for 2007. Behind them are two trends, a
nationwide rise in bad debt, from patients who can't or don't pay their bills,
and a regional boom in property values. Hospital administrators presented the
budget last week to board members, who will conduct the first of two public
hearings on the proposal Sept. 5. The budget reflects two conflicting goals:
serving the entire community but also maintaining financial soundness. “We exist
for the public good. That's the only reason we're here,” hospital Chief
Executive Officer Gwen MacKenzie said. “We have a fiscal responsibility, too.”
The projected losses stem largely from bad debt. The hospital has seen a surge
in patients who lack insurance and insured patients who do not pay their share
of the bill. National hospital chains, including HCA and Health Management
Associates, both reported that trend in their recent financial statements.
Sarasota Memorial expects bad debt to reach $65.6 million this year, about 75
percent more than 2005's mark. It projects a smaller rise to $75.7 million next
year, still about double the 2005 total. The hospital is seeing more uninsured
patients and more patients, from many insurers, who are not paying copayments.
Bad debt is separate from charity care, which is writeoffs to patients meeting
the hospital’s poverty guidelines. That should reach $26.5 million this year and
$28.1 million next year, according to the budget. The two combine for more than
$100 million in writeoffs, about 7 percent of gross revenue. Sarasota Memorial
also is the only county hospital delivering babies, which loses money, about $4
million through nine months of fiscal 2006. The losses outpace the new
administration’s efforts to boost income and hold down salaries, benefits and
supply costs. Hospitals typically measure their performance in terms of how many
cases they handle. By that standard the hospital is holding the line. The budget
shows salary per discharge will increase less than 1 percent for the second year
in a row, after rising 6.9 percent in 2005. Fringe benefits would increase 2.6
percent in 2007, after 6 percent increases the previous two years. Supplies
would climb 4.2 percent, up from about 1 percent in 2006, but are flat as a
percentage of net revenue. The budget cites the high cost of surgical implants
as a main reason. MacKenzie said the hospital would continue the “checkbook”
approach she instituted to manage labor and supply costs. The hospital also is
holding jobs at the 2006 level and plans to recoup about $6.4 million with
better collections. To boost the revenue side, the hospital plans a 10 percent
price increase, the first in two years. The hospital also foresees the number of
outpatient cases rising 5 percent. It predicts inpatient volume will be flat.
Outpatient cases are more profitable, but generate less cash. It takes about
eight outpatient cases to make up for one inpatient case, MacKenzie said.
Meanwhile, inpatient cases are becoming harder to manage. As more surgeries
become outpatient procedures, the remaining inpatient cases tend to resemble
intensive care cases, said Michael Harrington, chief operating officer. They
tend to become more complex and require more supplies and staff time. To read
the full article,
CLICK HERE. (Sarasota Herald-Tribune)
Waistlines continue to grow in U.S.
Obesity continues to surge in the U.S., with 31 states showing an increase.
Mississippi continued to lead the way. An estimated 29.5 percent of adults there
are considered obese. That's an increase of 1.1 percentage points when compared
with last year's report, which is compiled by Trust for America's Health, an
advocacy group that promotes increased funding for public health programs.
Meanwhile, Colorado remains the leanest state. About 16.9 percent of its adults
are considered obese. That mark was also up slightly from last year's report,
but not enough to be considered statistically significant. The only state that
experienced a decrease in the percentage of obese adults last year was Nevada.
“Quick fixes and limited government programs have failed to stem the tide,” said
Dr. Jeff Levi, executive director of the trust. States have different challenges
to contend with when it comes to obesity, said Dr. Janet Collins of the Centers
for Disease Control and Prevention. “Populations are not equal in terms of
experiencing these health problems,” Collins said. “Low-income populations tend
to experience all the health problems we worry about at greater rates.” Indeed,
the five states with the highest obesity rates, Mississippi, Alabama, West
Virginia, Louisiana and Kentucky, exhibit much higher rates of poverty than the
national norm. Meanwhile, the five states with the lowest obesity have less
poverty. They are Colorado, Hawaii, Massachusetts, Rhode Island and Vermont. The
group's estimate of obesity rates is based on a three-year average, 2003-2005.
The report says health costs related to obesity are in the billions of dollars
annually. Citing a 2004 report, the advocacy group said $5.6 billion could be
saved when it comes to treating heart disease if just one-tenth of Americans
began a regular walking program. For more information
CLICK HERE. (Associated Press)
Obesity leads to more aggressive ovarian cancer, research shows
Whether or not a woman is
obese will likely affect her outcome once she has been diagnosed with ovarian
cancer, according to a new study from Cedars-Sinai Medical Center. The study,
published online on Aug. 28 in the American Cancer Society's journal Cancer,
showed that obesity affected survival rates, shortened the length of time to
recurrence of the disease, and led to earlier death from the cancer than for
women diagnosed at their ideal body weight. “This study is the first to identify
weight as an independent factor in ovarian cancer in disease progression and
overall survival, suggesting that there is an element in the fat tissue itself
that influences the outcome of this disease in obese women,” said Andrew Li,
M.D., the study's principal investigator at Cedars-Sinai's Women's Cancer
Research Institute at the Samuel Oschin Comprehensive Cancer Institute. Ovarian
cancer, one of the most lethal cancers, affects almost one in 60 women. Most
will be diagnosed with advanced disease, and 70 percent will die within five
years. There are several types of ovarian cancer, but tumors that begin with the
surface cells of the ovary (epithelial cells) are the most common type. While
previous studies have shown that obesity is a factor in the development and
prognosis of cancers such as breast, uterine and colorectal, the nature of the
relationship in ovarian cancers has been less well understood. In this study, Li
and his colleagues examined data from 216 patients with epithelial ovarian
cancer to identify relationships between obesity, ovarian cancer, tumor biology
and outcome. Comparison of the obese women to ideal-weight women showed 29
percent of the obese women and 10 percent of normal-weight women had localized
disease. However, obesity was shown to have a significant effect on both the
recurrence and mortality of women with advanced disease. The cellular
characteristics of the tumors found in the two groups also appeared to be
different. “While further molecular studies are warranted, our study suggests
that fat tissue excretes a hormone or protein that causes ovarian cancer cells
to grow more aggressively,” said Li, who is also a physician in the Department
of Obstetrics and Gynecology at Cedars-Sinai Medical Center.
Medical errors? Patients may be the last to know
.
A survey of more than 2,600 surgeons and medical
specialists reveals wide variations in doctors’ willingness to disclose errors
and in the ways they would present the details to patients. The authors of the
survey presented hypothetical but clinically realistic medical errors to the
doctors to determine how they would disclose the mistake, whether disclosure was
different if the error was less apparent to a patient and what factors were
associated with disclosure. The survey results were published Aug. 14 in The
Archives of Internal Medicine. The hypothetical errors were all mistakes
that would cause some degree of serious injury. Some were apparent, like leaving
a sponge in a surgical patient, and some were less so, like misreading chart
data. When the error was obvious, like an improperly written prescription that
led to an overdose, 81 percent of doctors said they would definitely disclose
the error to a patient. But when presented with an error less apparent, only 50
percent thought it was worth mentioning. One example was a blood chemistry
reading that had been overlooked. If it had been noticed, a serious complication
would have been prevented. “It isn’t that doctors routinely make a conscious
decision to conceal errors,” said Dr. Thomas H. Gallagher, the study’s lead
author and an associate professor of medicine at the
University of Washington.
But when an error is less obvious, he continued, “the doctor is thinking about
what the patient really needs to know to understand what happened.” “Doctors
worry about telling patients too much, scaring them unnecessarily,” Dr.
Gallagher said. Surgeons were more likely than other medical specialists to
believe that an error would result in a lawsuit, but they were also more likely
to report that they would definitely disclose an error. At the same time, they
would disclose less information than medical specialists, and they were less
inclined to use the word “error.” Over all, 56 percent of doctors would mention
the problem, but only 42 percent would disclose that the problem had been caused
by an error. Half of the doctors surveyed said they would disclose specific
information about what the error was, while 37 percent would offer only a
partial explanation. The remaining 13 percent would reveal no details at all
unless the patient asked. When presented with just the errors that were less
apparent, almost one-fifth would volunteer no information at all. Only 8 percent
would be silent about more obvious mistakes. Almost all doctors surveyed said
they would apologize, but only about one-third chose an explicit apology (“I am
so sorry that you were harmed by this error”) while two-thirds would offer a
general expression of regret (“I’m sorry about what happened”). According to the
authors, some
malpractice
insurers encourage doctors to apologize in the belief that this may help prevent
lawsuits or encourage smaller settlements when suits are filed. One problem
physicians face, Dr. Gallagher said, is that patients may fail to distinguish
errors from unavoidable medical problems. “I think that often patients assume
that any adverse event is due to error,” he said. “That’s not so. A vast
majority of such events are not errors and not preventable.” (The
New York Times)
Medline
signs five-year, $75 million prime vendor distribution deal at Daughters of
Charity Health System
Medline Industries Inc.
announced that the company recently signed a $75 million Prime Vendor deal to
provide medical supplies to Daughters of Charity Health System, a five-hospital
system in California. The Daughters of Charity Health System (DCHS) is a
regional healthcare system of five hospitals spanning the California coast from
the Bay Area to Los Angeles. The sponsors are the Daughters of Charity of St.
Vincent de Paul who, for more than 370 years, have been serving the sick and the
poor through healing ministries around the world. “We look forward to
implementing and establishing a long-term relationship with Daughters of Charity
Health System. Our prime vendor program will provide high quality Medline brand
products and distribution services with significant quantitative value. The
program will also provide comprehensive logistical, standardization, and
utilizations services through Medline Select,” said Tim Jacobson, vice
president, Medline Corporate Sales. In the first year, Medline estimates it will
save the system more than $900,000. Over the five-year term of the agreement,
Medline estimates it will save the system nearly $5 million.
Tuesday, August 29, 2006
US Marshals seize defective infusion pumps
made by Alaris Products; Pumps can deliver
excess medication
Colonel Marc Sager receives AHRMM’s 2006 Leadership Award
New
test quickly pinpoints the most lethal avian flu;
A 12-hour diagnosis
allows for fast treatment
China: Tests find bird flu vaccine safe
Levels of serious mental illness in Katrina survivors doubled
compared to earlier survey
13 plague cases reported in 4 states, highest in 12 years
Amerinet announces
agreements
US Marshals seize defective infusion pumps
made by Alaris Products; Pumps can deliver
excess medication
At the request of the U.S.
Food and Drug Administration (FDA), the U.S. District Court for the Southern
District of California issued a warrant for seizure of Alaris Signature Edition
Gold infusion pumps, model numbers 7130, 7131, 7230 and 7231. The pumps are
manufactured by Cardinal Health Care 303, Inc. and the seizure occurred August
25. The seized infusion pumps have a design defect called “key bounce” that may
cause potential over-infusion of medications. This seizure was intended to
ensure that infusion pumps located at Alaris’ manufacturing facility are not
distributed unless the problem is corrected. Infusion pumps are electronic
devices intended for controlled delivery of intravenous solutions and
medications to patients. Key bounce occurs when a number pressed on the pump
registers twice although the operator only pressed the key once. If a key bounce
occurs and is not detected during programming verification, it may result in an
infusion rate at least 10 times the intended infusion rate. For example, if an
infusion rate is intended to be entered as 4.8 milliliters per hour and the key
bounce occurs when the 4 is pressed, the actual rate registered will be 44.8
milliliters per hour. If not detected during programming verification, key
bounce events may result in serious patient harm or death. FDA inspections
revealed that Alaris failed to follow FDA's medical device manufacturing
regulations. The infusion pumps were seized by the U.S. Marshals Service at
Alaris' manufacturing facility in San Diego, CA. The seized devices valued at
more than an estimated 1.8 million dollars. Alaris has distributed these
products nationally and internationally. No products were seized from healthcare
facilities or individual users, and there are no plans to do so. Alaris was
issued warning letters by FDA in August 1998 and October 1999 outlining the
violations and was given opportunities to correct the violations, but failed to
take appropriate actions. In an August 15 recall letter, Alaris informed
customers that it will provide a warning label for the pumps and a permanent
correction for the key bounce problem once it is available. In the letter,
Alaris also provided recommendations to pump users on steps they can take to
minimize key entry errors until the problem can be corrected. The steps are as
follows: Proper
Stance - When
programming pumps, stand squarely in front of the keypad (ideally with the pump
at eye level for best visibility) to facilitate proper depth of depressing each
key. Listen
- Focus on listening to the number of beeps while programming IV
pumps; each beep will correspond to a single digit entry. Unexpected double tone
could indicate an unintended entry.
Verify Screen Display
- When programming the pump or changing settings, always compare
the patient's prescribed therapy or the medication administration record,
original order, or bar code device to the displayed pump settings for
verification before starting or re-starting the infusion.
Independent Double Check
- Request an independent double check of pump settings by
another practitioner before starting or changing infusions with
hospital-selected high alert drugs.
Look
- Before leaving the patient's room, observe the IV tubing drip
chamber to see if the observed rate of infusion looks faster or slower than
expected. Adjust accordingly. Healthcare facilities can continue to use pumps in
their possession, guided by these and further instructions. For more
information, CLICK HERE.
Colonel Marc Sager receives AHRMM’s 2006 Leadership Award
The
Association for Healthcare Resource & Materials Management (AHRMM) has named
United States Air Force Colonel Marc Sager as the recipient of the 2006 George
R. Gossett Leadership Award. The Association’s highest honor, presented in
memory of George R. Gossett, an early president of the Association, the
Leadership Award is given to an individual who has demonstrated an extraordinary
level of leadership and professional competence in the supply chain field,
advanced the state-of-the-art in healthcare materials management or made other
significant contributions to AHRMM. Col. Sager, administrator of the 59th
Medical Group of Wilford Medical Center in Lackland, TX, received the award in
recognition of his efforts to advance educational opportunities and experiences
for Air Force medical logisticians. He opened the door for materials and
services personnel to hold government contracting warrants and streamlined
acquisition processes for Air Force Medical Treatment Facilities. He has also
been a strong advocate for providing institutional memberships to AHRMM, and
introduced the Certified Materials & Resource Professional (CMRP) credential to
Air Force Medical Service Corps officers so they may further fulfill their
advancement criteria. With a military career that spans over 20 years, Col.
Sager has served the United States in a variety of U.S.-based healthcare
facility and staff positions, as well as in Korea and the Middle East (many of
these facilities were the Air Force’s front-line operations). Most notably, as
Chief of Air Force Medical Logistics, he was responsible for the development,
construction and deployment of mobile medical assemblages worldwide in support
of ongoing operations in Afghanistan, Iraq and other locations. “Col. Sager is
most deserving of the Association’s highest award. Not only is he a military
hero in every sense of the word, he has also proven that it is possible to
successfully transition from logistics and supply chain management into hospital
administration,” said AHRMM President Robert Perry. “He is living proof that a
logistician's knowledge and skills are ideal for senior leadership positions in
healthcare.”
New test quickly pinpoints the most lethal avian flu;
A 12-hour diagnosis
allows for fast treatment
In an advance that speeds up
diagnosis of the most dangerous avian flu, scientists have developed a detailed
influenza test that takes less than 12 hours, federal health officials said. The
new technology, a microchip covered with bits of genetic material from many
different flu strains, cuts the typical time needed for diagnosis of the Asian
H5N1 flu to less than a day from a week or more. In addition, rather than giving
just a yes-or-no result, it usually reveals which flu a human or an animal has.
That means that public health officials investigating, for example, a flu
outbreak in poultry or in humans in a remote Asian or African village will be
able to decide quickly whether to kill thousands of birds or to treat hundreds
of potentially exposed people with expensive anti-viral drugs. Right now,
ascertaining whether a flu is of the lethal H5N1 strain requires that a sample
be frozen and shipped to a highly secure laboratory, usually in a major city
like Atlanta or Hong Kong, where the virus can be grown in eggs, isolated and
genetically sequenced, a process that takes four to five days plus shipping
time. The new test, called FluChip, can be performed in any laboratory that can
amplify bits of genetic material; many countries have such laboratories in their
national capitals. Samples need not be frozen, and because only bits of genetic
material are multiplied rather than whole viruses, the work can be done in
laboratories with lower biosecurity levels. Dr. Anthony S. Fauci, director of
the National Institute of Allergy and Infectious Diseases, which announced the
creation of the test, called it an “encouraging advance” that could be
“invaluable to international flu surveillance efforts.” A more advanced version
may be ready within two years, said Kathy L. Rowlen, the University of Colorado
chemistry professor who led the team that developed the test. At present, animal
and human health experts trying to fight avian flu in remote areas are forced to
make important decisions based largely on guesses because it is too risky to
wait a week for a laboratory to confirm that a highly dangerous virus is loose.
A dipstick test done on the spot, which a veterinarian working in Indonesia said
was as quick and as simple as a home pregnancy test, can tell only if a flu is
type A. It also has the potential to speed up mass testing because dozens of
samples can be tested on dozens of chips at once. (The New York Times)
China: Tests find bird flu vaccine safe
A Chinese-developed vaccine against the H5N1 strain of bird flu in humans has
been found safe in the first round of tests, a government news agency reported.
Researchers began work on the vaccine last year, and the government said it was
ready to start mass production. But any vaccine would face more tests before it
could be approved for human use. Tests were conducted on six human volunteers at
a Beijing hospital between November and June, the official Xinhua News Agency
said. Researchers said the vaccine “proved initially safe and effective,” the
Xinhua News Agency reported. The tests were conducted by the China Center for
Disease Control and Prevent and a Chinese drug company, Beijing Sinovac Biotech
Co., according to Xinhua. Chinese authorities say the vaccine is meant for
high-risk groups such as poultry workers. The U.S. National Institute of Allergy
and Infectious Diseases is also conducting trials on an H5N1 vaccine for humans.
(The Associated Press)
Levels of serious mental illness in
Katrina survivors doubled compared to earlier survey
According to the most comprehensive survey yet completed of mental health among
Hurricane Katrina survivors from Alabama, Louisiana, and Mississippi, the
proportion of people with a serious mental illness doubled in the months after
the hurricane compared to a survey carried out several years before the
hurricane. The study also found that thoughts of suicide did not increase
despite the dramatic increase in mental illness. The authors suggest that this
low rate of suicide thoughts is due to optimistic beliefs about the success of
future recovery efforts. The research, which was published in a special online
edition of the Bulletin of the World Health Organization, was led by researchers
from Harvard Medical School (HMS). “The increase in mental illness among Katrina
survivors is not surprising, but the low suicidality is a surprise,” said Ronald
Kessler, PhD, professor of health care policy at HMS and lead author of the
study. “Our concern, though, is that this lowering of suicidal tendencies
appears to be strongly associated with expectations for recovery efforts that
might not be realistic.” This report is the first in a planned series based on
the Hurricane Katrina Community Advisory Group, a statistically representative
sample of hurricane survivors participating in ongoing tracking surveys to
monitor the pace and mental health effects of hurricane recovery efforts. The
project is funded by the National Institute of Mental Health and the Office of
the Assistant Secretary of Health and Human Services for Planning and
Evaluation. The team discovered a strong relationship between the comparatively
low rate of suicide thoughts and the existence of positive cognitions among
Katrina survivors, especially with cognitions regarding increased sense of
meaning and purpose in life and increased realization of inner strengths.
Kessler notes that although previous studies have suggested a connection between
positive cognitions and lowered suicidality, this is the first study that offers
quantitative evidence of these psychological processes in a sample of disaster
victims. Kessler and his team believe that their findings suggest a systematic
investigation of positive cognitions might be useful in guiding public health
mass media efforts in the aftermath of future disasters, given that previous
research has shown that public health messages play an important role in
psychological reactions to disasters. “The immediate take-home message for
disaster recovery and policy makers is that communications with survivors can
sometimes build on the temporary reprieve from suicidal tendencies afforded by
these protective cognitions. Efforts on the part of public officials to control
expectations as practical recovery moves forward without destroying the positive
cognitions related to these expectations could prove crucial in the process of
continued psychological recovery,” said Kessler. For more information
CLICK HERE.
13 plague cases reported in 4 states, highest in 12 years
Thirteen cases of plague including two deaths have been reported in the Western
United States this year, the highest number of cases in 12 years, health
officials say. Seven cases were reported in New Mexico, three in Colorado, two
in California and one in Texas, according to the U.S. Centers for Disease
Control and Prevention. Two New Mexicans died, a 54-year-old woman who grew ill
in May and a 43-year-old woman who became sick in July. On average, the plague
is diagnosed in about seven people a year, CDC officials said Friday. Fourteen
cases were reported in 1994. It’s treatable with antibiotics, but health
officials stress the importance of prompt diagnosis to reduce the fatality rate.
Plague is transmitted through the bites of infected fleas, but people also can
get it by direct contact with infected rodents, wildlife and pets. Most people
become ill one to six days after being infected. The increase probably stems
from human encroachment into areas where infected rodents live, said Hannah
Gould, a CDC epidemiologist who investigated some of the cases. Plague takes
three forms: bubonic, septicemic and pneumonic. A common symptom of bubonic
plague is painful swollen lymph nodes in the groin, armpit or neck. Other
symptoms include fever, chills, and sometimes headache, vomiting, and diarrhea.
Septicemic plague can involve fever, chills, nausea, vomiting, diarrhea and
abdominal pain. Eight of the cases this year were bubonic and the other five
were septicemic. Most cases usually occur in May through September, Gould said.
(The Associated Press)
Amerinet announces agreements
Amerinet announces its agreements with First Quality
Products Inc. for adult incontinence products for acute care and non-acute care
facilities. Effective through June 30, 2009 these contracts include adult and
youth incontinence products, briefs, breathable briefs, night-time briefs,
underpads, pants, protective underwear, pant liners, cotton-snap pants,
washcloths and wet wipes.
Amerinet
announces its agreement with Cincinnati Sub-Zero Products Inc. for niche cold
therapy supplies. Effective through July 31, 2009 this contract includes Electri-Cool
II localized cold therapy systems and accessories. The Electri-Cool II is
primarily used postoperatively to deliver controlled cold therapy to the patient
and operates on thermoelectric technology, eliminating the need for a
compressor.
Amerinet announces its agreement with Tyco Healthcare Group for needles and
syringes. Effective through July 31, 2009 this contract includes needles,
syringes, flush syringes, spinal needles, bone marrow and biopsy products,
allergist trays and IV access. Tyco products offer new robust print technology,
wider finger flanges, increased peel headers and many other safety conveniences
for caregivers. This contract was the result of a competitive bidding process.
Monday, August 28, 2006
AHRQ estimates on long-term uninsured,
2001–2004
MRSA linked to nearly 14,000 PA
hospitalizations in 2004
Los Angeles hospital faces possible closure
Center for Hispanic medical students loses all
its U.S. aid
New compound causes cancer
cell suicide
PSA predicts treatment success in advanced
prostate cancer
AHRQ estimates on long-term uninsured,
2001–2004
The Agency for Healthcare Research and Quality (AHRQ) has
released a statistical brief providing detailed estimates for
the U.S. civilian noninstitutionalized non-elderly (under age
65) population that was uninsured for the entire 2001–2004
period and identifies groups most at risk of lacking any
coverage over that four-year period. According to the Medical
Expenditure Panel Survey (MEPS-HC) for 2003 and 2004, 31.2
percent (79.8 million people) of the under-65 population were
uninsured for at least one month during the full two-year
period, and 10.3 percent (26.4 million people) were uninsured
for the entire two-year period. Approximately two-thirds of
those individuals lacking coverage for all of 2003–2004 were
also without coverage for the entire prior 2001–2002 two-year
period. This translates to 6.6 percent (16.9 million people)
of the total population under age 65 being uninsured for the
entire four-year period from 2001 through 2004. The age group
18 to 24 was the most likely to be uninsured for some time
during 2003 to 2004; 55.1 percent were uninsured for at least
one month or more. Conversely, children under 18 were the
least likely to be uninsured for same two-year period as well
as for the entire 2001–2004 four-year period. Only 2.6 percent
of children were uninsured for the entire 2001–2004 four-year
period. Individuals reporting excellent or very good health
status were the least likely to be uninsured for some time
during 2003 to 2004. For those reporting excellent health,
27.1 percent were uninsured at least one month; while for
those reporting very good health, 30.1 percent were uninsured
at least one month over the same time period. Those reporting
good or fair/poor health were the most likely to be uninsured
for the entire two-year period, 12.6 and 12.9 percent,
respectively. Approximately 70 percent of those individuals in
fair or poor health lacking coverage for all of 2003–2004 were
also without coverage for the entire prior two-year period
from 2001 to 2002. This translates to 8.9 percent of the total
population under age 65 in fair or poor health being uninsured
for the entire 2001–2004 four-year period. Among Hispanics or
Latinos under age 65, 49.5 percent were uninsured for at least
one month, while 22.1 percent were uninsured for the entire
2003–2004 two-year period. Approximately three-fourths of
those Hispanic individuals lacking coverage for all of
2003–2004 were also without coverage for the entire prior
two-year period from 2001 to 2002. This translates to 16.3
percent of the total Hispanic population under age 65 being
uninsured for the entire 2001–2004 four-year period. While
Hispanics and Latinos single race represented 15.4 percent of
the population under age 65, they represented 37.9 percent of
the long-term uninsured for the period 2001–2004.
Alternatively, while white non-Hispanics or Latinos single
race represented 65.3 percent of the under 65 population, they
represented only 43.7 percent of the long-term uninsured for
the period 2001–2004. Individuals who were poor (i.e., persons
in families with income equal to the poverty line or less)
were disproportionately represented among the long-term
uninsured. While poor individuals represented 12.9 percent of
the population under age 65, they represented 23.3 percent of
those uninsured for the entire 2001–2004 four-year period.
While individuals with high incomes (i.e., persons in families
with income over 400 percent of the poverty line) represented
37.1 percent of the population under age 65, they accounted
for only 14.8 percent of those uninsured for the entire
2001–2004 four-year period.
MRSA linked to nearly 14,000 PA
hospitalizations in 2004
In 2004, there were 13,722 Pennsylvania hospitalizations in
which patients had a Methicillin-resistant Staphylococcus
aureus (MRSA)- related infection, according to a new research
brief released by the Pennsylvania Health Care Cost
Containment Council (PHC4). MRSA is a more serious form of the
Staphylococcus aureus (often called “staph”) bacteria and is a
major health concern because of its resistance to commonly
used antibiotics such as methicillin. “MRSA, a virulent form
of drug-resistant bacteria, can be community-acquired or
hospital-acquired,” said Marc P. Volavka, Executive Director
of PHC4. “Yet no matter where MRSA is contracted, it can have
significant health and financial consequences, and represents
a titanic public health challenge.” PHC4's latest report does
not distinguish between community and/or hospital-acquired
MRSA infections. Compared to patients without a MRSA
infection, patients with a MRSA infection were four times as
likely to die, had hospital stays more than two and a half
times longer, with hospital charges three times as much for
the hospitalization. Specifically, the mortality rates for
patients with and without a MRSA infection in 2004 were 8.9%
and 2.1%, respectively. On average, patients with a MRSA
infection stayed in the hospital eight days longer than
patients without a MRSA infection. Whereas the average charge
of a hospitalization with a MRSA infection was $87,990, the
average charge for a hospitalization without a MRSA infection
was $28,711. In July of 2005, Pennsylvania (PHC4) became the
first state to publicly report hospital-acquired infection
numbers, and has issued two subsequent infection reports.
Those reports have focused on four types of hospital-acquired
infections (central line-associated bloodstream infections,
ventilator-associated pneumonia, surgical site infections, and
indwelling catheter-associated urinary tract infections). PHC4
is now reporting that of the 1,932 patients identified by
hospitals as having hospital-acquired bloodstream infections
in year 2004, 11.2% (217) had a MRSA infection. Of the 1,335
patients with hospital-acquired pneumonia, 9.2% (123) had a
MRSA infection. Of the 1,317 patients with hospital-acquired
surgical site infections, 6.6% (87) had a MRSA infection. Of
the 6,139 patients with hospital-acquired urinary tract
infections, 3.3% (200) had a MRSA infection. It is not known
if MRSA was the bacteria responsible for these
hospital-acquired infections. Other findings: About half
(50.9%) of all hospitalizations with MRSA infections were
among patients with respiratory diseases, disorders of the
circulatory system, and infectious and parasitic diseases;
More than half (54%) of hospitalizations with MRSA infections
were for patients age 65 and older, followed by those in the
45 to 64 age category (27%) and the 25 to 44 age category
(13%). The 18 to 24 age category and the 0 to 17 age category
each comprised 3% of the MRSA hospitalizations; The MRSA
infection rate was similar for hospitals of all sizes;
Geographic differences in the rate of MRSA-related hospital
discharges were found; The Southeastern Pennsylvania region
had the highest MRSA infection rate; The Southcentral
Pennsylvania region had the lowest MRSA infection rate. Copies
of MRSA in Pennsylvania Hospitals are free and available on
the Council's Web site at
http://www.phc4.org.
Los Angeles hospital faces possible closure
Investigators from the Centers for Medicare and Medicaid
Services descended on the King/Drew Medical Center in South
Central Los Angeles earlier this month and will soon determine
whether the hospital meets standards of care in 23 areas. If
it doesn't, King/Drew will lose $200 million of its $380
million budget and could face closure. Should that happen,
county officials predict a health crisis across this county of
10 million people as emergency rooms from Beverly Hills to the
middle-class San Fernando Valley are flooded with patients.
“It will set off a medical meltdown in terms of emergency
service,” predicted Zev Yaroslavsky, a member of the Los
Angeles County Board of Supervisors, which oversees the
facility. King/Drew has been out of compliance with Medicare
standards since January 2004, said Medicare and Medicaid
Services spokesman Jack Cheevers. It lost its national
accreditation in early 2005. In 2004, the Los Angeles Times
produced a series of articles on the failings of the hospital
and its affiliated medical school, Charles R. Drew University.
A public outcry followed. Between 2004 and earlier this year,
more than one in five of the hospital's 2,300 staff members
were disciplined or fired, Yaroslavsky said. The trauma center
was shut in November 2004. But when the county moved to also
cut the hospital’s obstetrics, neonatal and pediatrics wards,
Rep. Maxine Waters (D-CA) and other leaders pushed back. The
county hired a new chief executive for the hospital,
Antionette Smith Epps, who has been credited with major
improvements at the facility. Still, Epps has acknowledged
that King/Drew continues to have problems recruiting permanent
staff and improving its reputation among potential patients. A
new obstetrics ward averages 60 births a month, small compared
with the 600 born at the nearby St. Francis Medical Center.
Los Angeles police officers, sheriff's deputies and
firefighters all oppose being taken to the hospital if they
are hurt in the line of duty. While the region King/Drew
serves remains poor (It's No. 1 in Los Angeles in coronary
heart disease, diabetes, homicides, poverty, uninsured
children, teen birth rate, unvaccinated elderly and total
death rate), a demographic change has swept the community.
What was once an all-black region being served by a largely
black hospital has morphed into a predominately Hispanic area
being served by an institution that is slowly changing, too.
Thirty years ago, 85 percent of King/Drew's patients were
black. Today, 70 percent are Hispanic. “This change makes the
policies of the past untenable and has emboldened those of us
who are trying to transform King/Drew,” Yaroslavsky said.
“Whether we've done enough, we'll soon find out.” A decision
on Medicare and Medicaid funding is expected in early
September. (The Washington Post) To read the full article
CLICK HERE.
Center for Hispanic medical students
loses all its U.S. aid
As a medical student at the
Albert
Einstein College of Medicine in the Bronx,
25-year-old Noé Romo has turned again and again to the
college’s Hispanic Center of Excellence for financial support,
friendship and guidance. The center was hailed by community
leaders when it opened in 2001 as a crucial way to address
what they saw as a disturbing, little-known trend: the
underrepresentation of Hispanics in the medical field.
According to the
American
Medical Association, only 3.2 percent of physicians
in the United States are Hispanic. The Hispanic Center of
Excellence teaches medical students and doctors of various
backgrounds about Hispanic culture and conducts research on
Latino health issues. Yet its main focus is recruiting and
encouraging Hispanic students to pursue healthcare careers.
The center does this in part by providing academic counseling,
scholarships and professional networking. But budget
cuts in Washington are threatening the future of the federally
financed center. “There’s a very strong need for physicians
who not only speak the language but understand the culture,”
said Romo, who is an American citizen of Mexican descent. The
center, the first such Hispanic center in the state, recently
lost all its financial support from the federal government. In
the fiscal year that began on Aug. 1, the cut was $700,000,
about 80 percent of the center’s operating budget. Dr. A. Hal
Strelnick, the center’s director, said that as a result of the
cut, he was forced to eliminate a two-year fellowship that
helped Hispanic faculty members at Einstein sharpen their
research skills and earn a master of science degree in
clinical research methods, to supplement their other degrees.
He fears what another cut next year will mean to the center,
though he vowed to keep it open somehow, through city, state
or private support. “The metaphor that we use is a pipeline,”
Dr. Strelnick said. “If you choke off the pipeline for
producing Hispanic health professionals, you’re going to have
consequences down the line.” Yesterday at the Albert Einstein
College of Medicine, the largest private medical school in the
state, Dr. Strelnick, Romo and other Hispanic students called
on Congress and the United States
Department
of Health and Human Services to restore the money.
They were joined by Representative Joseph Crowley, a Democrat
whose district includes parts of Queens and the Bronx. The
college in the Bronx is one of 34 institutions across the
country that had received Centers of Excellence grants from
the Department of Health and Human Services. In 2005, Congress
approved $33.6 million in grants to the 34 centers. This year,
$11.8 million was approved for four centers. Crowley has urged
the leadership of the House Appropriations Committee to
include $43 million for Centers of Excellence grants next
fiscal year. David Bowman, a spokesman for the Health
Resources and Services Administration, said the president’s
proposed budget for the 2007 fiscal year included no money for
the Centers of Excellence grants. (The
New York Times)
New compound causes
cancer cell suicide
Suicide is
the regular mode of cell death. When cells reach the end of
their useful life, internal mechanisms kick in and the cell
automatically perishes, a process known as apoptosis. But in
cancer cells this mechanism has often been genetically
disabled or otherwise broken, allowing tumors to proliferate.
Now researchers have found a way to reactivate programmed cell
death and thereby treat cancer. In preparation for apoptosis,
a chain of chemical events takes place in the cell. Near the
end, the chemical procaspase-3 is activated. This chemical
then transforms into caspase-3, an executioner enzyme that
terminates the cell. Chemist Paul Hergenrother of the
University of Illinois and an international team of colleagues
realized that a compound that activated procaspase-3 might be
effective in killing cancer, because many tumors show elevated
levels of procaspase despite their inability to complete
apoptosis. After screening 20,500 related molecules for this
activation ability, the researchers narrowed it down to five
likely candidates. Of these, only one showed an increasingly
strong effect with increased doses: newly named procaspase
activating compound, or PAC-1. “We have identified a small,
synthetic compound that directly activates procaspase-3 and
induces apoptosis,” Hergenrother said. “By bypassing the
broken pathway, we can use the cells’ own machinery to destroy
them.” The researchers tested the efficacy of PAC-1 on colon
cancer cells from 23 patients. The tumors had elevated levels
of procaspase-3 averaging roughly eight times as much as
normal colon cells and proved more sensitive to the compound.
In one case, the cancerous cells were 2,000 times more
sensitive to PAC-1's enforced apoptosis than were surrounding
regular cells due to their increased expression of the enzyme.
Further tests in mice proved effective in treating grafted
human kidney- and lung-cancer cells, and those results also
indicated that PAC-1's strength correlated with procaspase-3
levels in the various cancer cells. “The potential
effectiveness of compounds such as PAC-1 could be predicted in
advance and patients could be selected for treatment based on
the amount of procaspase-3 found in their tumor cells,”
Hergenrother added.
Nature
Chemical Biology published the paper presenting the
finding online. (Scientific American)
PSA predicts treatment success in advanced
prostate cancer
A test
used to detect prostate cancer can also help doctors know when
treatment is working. A man’s prostate specific antigen, or
PSA, level after seven months of hormone therapy for advanced
prostate cancer predicted how long he would survive, according
to a new multicenter study conducted by the Southwest Oncology
Group and led by researchers at the University of Michigan
Comprehensive Cancer Center. The study evaluated 1,345 men
with prostate cancer that had spread to distant parts of the
body. The men were treated with seven months of androgen
deprivation therapy, a treatment designed to block the effects
of hormones on the cancer. PSA levels were monitored
throughout the treatment. The researchers found that men whose
PSA dropped below 4.0 ng/ml had a quarter the risk of dying
compared to those whose PSA was more than 4.0. Results of the
study appear in the Aug. 20 issue of the Journal of Clinical
Oncology. “Our analysis showed that a low or undetectable PSA
after seven months of androgen deprivation therapy is a
powerful predictor of risk of death in patients with new
metastatic prostate cancer. This could allow oncologists to
identify patients who are unlikely to do well with this
treatment long before they develop clinical signs of treatment
resistance,” said lead study author Maha Hussain, M.D.,
professor of internal medicine at the U-M Medical School. The
researchers found 69 percent of the men maintained a PSA level
of less than 4.0 ng/ml after seven months of treatment and 43
percent had an undetectable level of PSA at that time.
Patients whose PSA was higher than 4.0 at the end of seven
months survived 13 months, while patients whose PSA dropped
below 4.0 but above 0.2 lived 44 months and those whose PSA
was undetectable, below 0.2 ng/ml, lived 75 months. “What is
attractive about using PSA to predict survival in metastatic
prostate cancer is that it is an easily measurable factor.
These findings could help patients avoid ineffective treatment
and could help researchers design further trials,” Hussain
said.
Friday, August 25, 2006
2005 medical group data finds financial losses, despite
increases in physician compensation for most specialties
Nurses strike over health plan at hospital in New Jersey
Researchers move biotechnology closer to replacing electronic
pacemakers
Cooling towers may host new pathogens
Group urges disaster planning for pregnant women, babies
Business continuity planning contracts with Tenet to supplement
emergency air response service
Lawson Software passes milestone in mobile supply chain
offerings
2005 medical group data finds financial
losses, despite increases in physician compensation for most
specialties
According to findings in the American Medical Group Association’s 2006
Medical Group Compensation & Financial Survey, most specialties saw modest
increases in compensation in 2005. In 2005, 89% of the specialties experienced
increases in compensation, with the overall average increase around 6%. The
primary care specialties saw about an 8% increase in 2005, while other medical
and surgical specialties averaged around 6% and 5% increases, respectively. The
survey also found that, on average, only organizations in the Western region
were operating on a profit, whereas organizations in the Northern region were
operating at a significant loss. The survey found that during 2005 three
specialties experienced the largest increases in compensation: dermatology
(12.01%), cardiac/thoracic surgery (11.47%), and gastroenterology (11.66%).
Interestingly, gastroenterology had one of the lowest increases in 2004 (1.07%).
In addition to pediatrics and adolescent (7.63%), other primary care specialties
saw increases: family medicine (8.62%) and internal medicine (8.42%). After
years of substantial increases, hematology/oncology saw one of the lowest
increases in compensation in 2005 (3.25%). “The survey indicates that
compensation increases reflect the rise in the cost of living,” said Donald W.
Fisher, Ph.D., president and chief executive officer of the American Medical
Group Association (AMGA). “However, declining reimbursements, competition for
specialists, the cost of new technology, and other factors are having a negative
effect on revenues in most parts of the country, a situation that is clearly
unsustainable.” The section of the survey that examines financial operations
found that medical groups were operating at an average loss of $1,264 per
physician (median performance per physician). It also reports significant
variation by region: groups in the Northern Region continue to operate at a
significant loss, $8,111 per physician. In 2003, these groups were operating at
an average loss of $3,477 per physician, and in 2004 they were operating at an
average loss of $1,365 per physician. Medical groups in the Eastern and Southern
regions continue operating at a loss ($3,494 and $1,539 per physician,
respectively). Groups in the Western Region were performing better, at $7,970
per physician, a significant improvement over last year ($479 per
physician). “One of the components contributing significantly to the trends in
financial performance of medical groups is the current payment model. Most of
the groups represented in the survey are large multispecialty groups that make
substantial investments in technology, operations, and the most innovative care
processes to best serve populations under their care, and are able to achieve
remarkable results for their patients. Our current transaction-based
reimbursement system is indifferent to these results and to the efforts of
medical groups to elevate the standard of care in the U.S. Currently AMGA is
working to address the inequities of the current payment model and develop a
model that incorporates a substantial component reflecting achievement of
quality results,” said Fisher. He was referring to AMGA’s Results-Based Payment
System (RPS) initiative, which seeks to design and implement a reimbursement
system that rewards care quality and results. RPS would align the positive
attributes of the current payment process with a reimbursement system based
on appraisal of quality care and appropriate outcomes.
Nurses strike over health plan at
hospital in New Jersey
Nearly all of the 1,300 nurses at Robert Wood Johnson
University Hospital in New Brunswick, NJ, went on strike yesterday morning in a
contract dispute over what their health insurance plan requires them to pay for
outside medical services. The nurses on Aug. 16 rejected a proposed contract
that would have given them a 3 percent raise in each of the next three years.
But that proposal went to a vote without the backing of union leaders, said
Jeanne Clark, a radiology nurse at the 584-bed hospital and one of the
negotiators for the union. At 7 a.m. yesterday, the nurses began leaving their
jobs at the hospital with many of them joining about 400 workers on a picket
line that began forming outside. John Patella, a hospital spokesman, said that
officials who were notified of the impending strike when the proposed contract
was rejected, had arranged to bring in replacement nurses. “These nurses have
been recruited from all over the country,” he said, adding that the replacement
nurses had met
New Jersey
licensing requirements, and were experienced “in the specialty and subspecialty
services that the hospital offers and have also undergone a thorough hospital
orientation.” Under the hospital-run health insurance plan, nurses or their
family members would have to pay a fixed fee of up to $700 for each hospital
admission and each outpatient procedure performed outside of the network of
doctors and hospitals in the plan. Clark, the union representative, said the
proposed fee was different from a deductible. “This isn’t a deductible as the
hospital wants to call it, but a penalty,” she said, adding that the union had
found other plans that did not include such a feature. “Our members come from
four states in this region and cannot always get to providers that are in the
network and to the hospitals that are covered.” According to the union, nurses
at the hospital make an average annual salary of $78,000, although hospital
officials said that the average was $90,000. Both sides agree that a starting
registered nurse earns about $60,000 a year. Dr. Joshua Beshad, the hospital
medical director, conceded that the basic health plan required paying a fixed
fee outside the network, but he explained that emergency hospitalization or
emergency care outside the network was covered “100 percent.” Patella, the
hospital spokesman, disputed the union negotiators’ assertion that they had not
agreed to recommend approval of the proposed contract when it went to a
membership vote on Aug. 16. He provided a memo that he said accompanied the
proposed agreement which stated that negotiators and union leaders would
recommend its approval. (The
New York Times)
Researchers move biotechnology closer to
replacing electronic pacemakers
UC Davis researchers have
successfully used a custom designed protein and gene delivery system to restore
normal heart rhythms in pigs with electronic pacemakers, reducing their
dependence on implanted devices. This work suggests that scientists are one step
closer to making bioengineering a reality in treating the more than 2.2 million
Americans affected by irregular heartbeats. The UC Davis study, which was
co-authored by an international team that included scientists from the
University of Hong Kong and Johns Hopkins University, is published in the
current issue of the journal Circulation. The same issue also includes a
similar but independent research effort by scientists from Columbia University
and State University of New York at Stony Brook. “Our study offers positive and
direct evidence in living models that bioengineered cells can replace the
electronic pacemaker,” said Ronald Li, who leads the research team and is an
associate professor of cell biology and human anatomy at the UC Davis School of
Medicine. More than 250,000 people in the United States get artificial
pacemakers implanted each year. Researchers believe this biological approach
would provide a more permanent, reliable and less invasive alternative to
implanted electronic devices.
Cooling towers may host new
pathogens
Cooling towers may be hot spots where new forms of disease-causing bacteria
emerge, scientists report. Sharon G. Berk and colleagues set out to determine
whether cooling towers, fixtures that extract waste heat and provide cooled
water for air-conditioning, manufacturing and electric power generation,
encourage a worrisome relationship between amoebae and bacterial pathogens of
amoebae (single-celled organisms that dwell in water). Numerous human pathogens
have been detected in amoebae, and evidence suggests that amoebae act as
incubators in which certain human pathogens multiply profusely. The microbe
responsible for Legionnaires' disease is among the bacteria that reproduce in
amoebae. Infected amoebae swell like a balloon, burst and release bacteria that
then can infect other hosts. In the new study, Berk's group sampled 40 cooling
towers and 40 natural aquatic environments. Infected amoebae were 16 times more
likely to be in cooling towers than in rivers, lakes and ponds. “Such pathogens
of amoebae may spread to the environment via aerosols from the cooling towers,”
the researchers state in a report published online in advance of a special issue
on infectious disease, scheduled to be published in the Jan. 1, 2008, issue of
the ACS journal, Environmental Science & Technology. “Studies of emerging
infectious diseases should strongly consider cooling towers as a source of
amoeba-associated pathogens.” For more information
CLICK HERE.
Group urges disaster planning for pregnant women, babies
In the
days after Hurricane Katrina struck Louisiana, about 125 critically ill newborn
babies and 154 pregnant women were evacuated to Woman's Hospital in Baton Rouge.
Some of the fragile newborns arrived without their mothers, and some of the
women were already in labor. It was at least 10 days before some of the infants
and mothers were reunited. Katrina focused unprecedented attention on pregnant
women and newborns as an acutely vulnerable population during emergencies. A
year later, those concerns are driving a push to add provisions for both groups
to national preparedness guidelines for disasters, epidemics or terrorist
attacks. No accurate data are available on the number of babies born during the
Katrina crisis, but officials at both hospitals in Baton Rouge described vivid
scenes of distraught pregnant women arriving with no records, of desperate
mothers searching for their babies and of women who delivered on their way to
the facility. Heidi Wigley, 26, was three months pregnant when the storm struck.
She lost her home, including her medications, in St. Bernard Parish, and her
doctor was evacuated to Florida. “I was evacuated to another town and could not
contact my doctor, who had all the information about my pregnancy,” Wigley said
from Mandeville, LA, where she now lives. “I was worried I may miscarry. The
relief teams did not have any gynecologist and no prenatal vitamins. I told them
I wanted more food and more money because I was pregnant, and they said no.” Two
months later, Wigley developed high blood pressure, a common complication of
pregnancy, and delivered prematurely in February. At 5 1/2 months, her son is
now healthy. “Pregnant women face greater risks, like premature births,
low-birth-weight babies and infant deaths, during the stressful conditions of a
disaster. This can make delivering a child difficult and potentially
life-threatening,” said Theresa Shaver, executive director of the District-based
White Ribbon Alliance for Safe Motherhood. “International relief agencies have
detailed guidelines for helping pregnant women, infants and new mothers in
disasters around the world,” she said. “But in the United States, it is not yet
integral to our preparedness plans.” The alliance has set up a working group to
develop domestic guidelines in association with groups of pediatricians,
gynecologists, obstetricians, nurses and midwives. Representatives from the
Centers for Disease Control and Prevention and the National Association of
County and City Health Officials are also taking part. Shaver noted that in the
past few years, healthcare providers and officials have worked on disaster
preparedness plans focusing on other vulnerable groups, including children, the
elderly, heart patients, those on dialysis and disabled people. These efforts
were accelerated in response to the Sept. 11, 2001, terrorist attacks and the
anthrax attacks later that year, and concerns about bioterrorism and pandemic
flu. But several public health advocates said it was not until Katrina exposed
the lack of provisions for pregnant women and new mothers and their babies that
those groups were included on the preparedness agenda. “Pregnant women and
newborns are just entering the radar, and that is a post-Katrina development,”
said Georges C. Benjamin, executive director of the American Public Health
Association. The White Ribbon Alliance working group hopes to release by the end
of August proposals to address the needs of newborn babies in disasters and
present those recommendations at emergency planning meetings across the country.
It is also exploring the option of introducing federal legislation. The proposed
guidelines, called the Women and Infants Service Package (WISP), advocate
training first responders in the special needs of pregnant and new mothers and
babies, preparing birth-complication readiness packages, keeping mothers and
infants together during evacuations, and setting up dedicated toll-free numbers
that pregnant women can call for assistance. The guidelines also recommend that
emergency teams include certified midwives and have supplies of baby formula,
bottles, diapers, vaccines, and folate and iron supplements. The alliance
believes that disaster situations call for a shift in the thinking of American
women, who generally expect to give birth in a hospital or clinical setting. In
the early phase of a disaster, officials said, births will often take place
outside a health facility and without the assistance of trained health
personnel. “We will be in situations where there are no healthcare facilities.
In fact, if there is a pandemic flu, a hospital is not where you take a pregnant
woman or an infant to,” said Robbie Prepas, a certified midwife who heads
disaster preparedness at the American College of Nurse-Midwives. During Katrina,
Prepas helped many pregnant women with deliveries in airports and ambulances.
“We will have to retrain care providers to be comfortable with assisting
deliveries outside hospitals,” she said. (The Washington Post)
Business continuity planning contracts with Tenet to
supplement emergency air response service
A Tenet Healthcare
Corporation subsidiary has contracted for a dedicated emergency air response
program as a part of its ongoing, assured response planning efforts, according
to Jeff Young of Frisco-based Business Continuity Planning Inc., whose ALERT
program will provide the services. The agreement is between Business Continuity
Planning, a subsidiary of XGL, and Tenet and supplies Tenet with the ALERT,
Aviation Logistics Emergency Response Team, program. ALERT puts in place
dedicated, pre-positioned assets to fulfill the aviation component of Tenet’s
emergency and disaster planning strategies. ALERT delivers systems necessary to
help maintain business continuity through emergency airlift, expedited cargo,
and related communications infrastructure for the duration of the contract.
Launched in 2006, ALERT evolved from the response provided by its parent company
following major natural or man-made business interruptions. During the massive
2005 hurricane cycle, for example, the company responded quickly to mobilize
rotary-wing (helicopter) assets, fixed-wing (private jet) assets, forward
operating teams, and real-time field based communications. “The ALERT program is
designed to reduce response time for customers,” he said. “The goal is to
accelerate the return to normalcy.” XGL and its subsidiaries are headquartered
in Frisco, TX, and are on the web at
http://www.xgl-air.com/.
Lawson Software passes milestone in mobile supply chain
offerings
Lawson Software says that customers like Boston Medical Center, Jewish Hospital
& St. Mary’s HealthCare, MediCorp Health System and Providence Health and
Services represent a growing number of healthcare providers that have selected
Lawson’s advanced, mobile supply chain offerings, Par and Cycle Counting,
Receiving and Delivery, and Surgical Instrument Management – to control their
supply costs by managing and tracking supplies, packages and surgical
instruments more effectively. Using bar coding, wireless and Internet
technologies, the applications enable employees to increase their productivity
via more efficient and more accurate business processes. The goal is faster
supply replenishment cycles, ensuring the right supplies are available when and
where they are needed. Providence Health and Services, an existing Lawson
Enterprise Financial Management, Human Capital Management and Supply Chain
Management customer, has licensed both Par and Cycle Counting and Receiving and
Delivery. The multi-state
healthcare network will use the mobile applications to increase
supply chain efficiencies and reduce costs by improving the accuracy and speed
with which it processes packages and moves supplies within its facilities.
Specifically, the health system wants to increase staff productivity so
employees have more time to analyze the data they collect. This analysis will
help technicians identify supply usage trends and opportunities for improving
inventory turnover. “Mobile applications were the logical next step as we sought
new ways to drive even greater benefits from our ERP system,” said Kurt Reasoner,
director, ProvConnect, Providence Health and Services. “By adding bar code
scanning and wireless technologies to our supply chain execution, we expect to
reduce both supply and staff costs. For example, the productivity gains driven
by these applications will enable us to manage supplies at growing facilities
without hiring new staff.”
Thursday, August 24, 2006
In new method for stem cells, viable embryos
HHS Secretary calls for brand-new healthcare
system
for New Orleans
Medicare cuts payments for pharmacy-made drugs
U.S. pushing for release of flu data
FDA proposes new rule to automate drug
registration and listing
Getinge acquires telemedicine growth company
Amerinet
announces agreements
In new method for stem cells, viable
embryos
Biologists have developed a technique for establishing
colonies of human embryonic
stem cells
from an early human embryo without destroying it. This method,
if confirmed in other laboratories, would seem to remove the
principal objection to the research. It could also redirect
and intensify the emotional political debate over current
limits on federal financing for research on human embryonic
stem cells, which give rise to the cells and tissues of the
body and which scientists and patient advocate groups see as a
potential source for treatments for diseases like Alzheimer’s,
Parkinson’s and
diabetes.
But the new method, reported by researchers at Advanced Cell
Technology on the Web site of the journal Nature, had
little immediate effect on longstanding objections of the
White House and some Congressional leaders yesterday. It also
brought objections from critics who warned of possible risk to
the embryo and the
in vitro
fertilization procedure itself, in which embryos
are generated from a couple’s egg and sperm. The new technique
would be performed on a two-day-old embryo, after the
fertilized egg has divided into eight cells, known as
blastomeres. In fertility clinics, where the embryo is
available outside the woman in the normal course of in vitro
fertilization, one of these blastomeres can be removed for
diagnostic tests, like for Down syndrome. The embryo, now with
seven cells, can be implanted in the woman if no defect is
found. Many such embryos have grown into apparently healthy
babies over the 10 years or so the diagnostic tests have been
used. Up to now, human embryonic stem cells have been derived
at a later stage of development, when the embryo consists of
about 150 cells. Both this stage, called the blastocyst, and
the earlier eight-cell stage, occur before the embryo implants
in the wall of the womb. Harvesting the blastocyst-stage cells
kills the embryo, a principal objection of those who oppose
the research. Last year, Dr. Robert Lanza, vice president of
Advanced Cell Technology, reported that embryonic stem cell
cultures could be derived from the blastomeres of mice, a
finding others have confirmed. He now says the same can be
done with human blastomeres, and that the colonies of cells
behave in the same way as those derived from blastocysts.
Although he used discarded human embryos, he said that anyone
who wished to derive human embryonic stem cells without
destroying an embryo could use a blastomere removed for the
test, called preimplantation genetic diagnosis. “By growing
the biopsied cell overnight,” he said, “the resulting cells
could be used for both P.G.D. and the generation of stem cells
without affecting the subsequent chances of having a child.”
Ronald M. Green, an ethicist at
Dartmouth
College and an adviser to Advanced Cell Technology,
said he hoped the new method “provides a way of ending the
impasse about federal funding for this research.” Dr. James
Battey, head of the stem cell task force at the
National
Institutes of Health, said that it was not
immediately clear if the new method would be compatible with
the Congressional restriction, since removal of a blastomere
subjected the embryo to some risk, but that embryos on which
the genetic test was performed seemed to be as healthy as
other babies born by in vitro fertilization. The federal
policy does not affect privately financed stem cell research,
like that done by Advanced Cell. Dr. Andrew La Barbera,
scientific director of the American Society for Reproductive
Medicine, said that more than 2,000 babies had been born in
the United States after a preimplantation genetic diagnosis.
There is no sign yet that they have any greater risk of
disease than other in vitro fertilization babies, but the
society needs more data to be sure, Dr. La Barbera said. To
read the entire article
CLICK HERE. (The New York Times)
HHS Secretary calls for brand-new
healthcare system
for New Orleans
In
the wake of Hurricane Katrina's devastation, the country’s top
health official wants a brand-new, top-to-bottom healthcare
system for New Orleans, and he wants it to be built as soon as
possible. “What's clear to us is that there's a green-field
opportunity here,” Health and Human Services Secretary Michael
Leavitt said Wednesday in New Orleans, where Katrina tore
apart the city's healthcare network, destroying hospitals and
clinics, driving some medical personnel into permanent exile,
and forcing people remaining behind to wait hours for
emergency care in hospitals that stayed open. Those facilities
are the last remnants of a two-tier system consisting of
private medical care for people with insurance and the Charity
hospital system for people with no coverage. “The worst thing
we could do is rebuild that system,” Leavitt said. “We intend
to build a new system.” That new system is being designed by a
task force of city, state and private health experts who have
an Oct. 20 deadline to submit their plan to Leavitt, who was
in town to meet with them and encourage them. Because this is
a work in progress, no details are available yet, nor are such
data as the system’s cost or a timetable for putting it into
place. The new system will be built on prevention. “We'll try
to keep people well,” Leavitt said, “not treat them when
they're sick.” With that goal in mind, the plan will include a
network of primary-care clinics throughout the city, where
most problems can be diagnosed and treated before they become
much worse and require more expensive hospital care. “It will
require a certain amount of change,” Leavitt said, “but it'll
meet our objective of everyone having a medical home.” These
clinics will keep electronic medical records of each patient
that can be called up wherever anyone happens to show up for
an appointment. Besides being a logical next step in the
technological advancement of the practice of medicine, the
idea of providing this capability, with privacy protection,
grew out of the Katrina experience, when tens of thousands of
Louisianians lost their medical records because their doctors’
offices were drowned and their files washed away. “I see a
system where, if there's another disaster, people don’t lose
their medical records and we have to start over,” Leavitt
said. At the meeting, Leavitt asked the 40-member group to
determine by Sept. 15 what kind of computer equipment would be
required to maintain records online, and he told participants
to work out the details of the clinic network, including how
to pay for it, said Bob Johannessen, a spokesman for the state
Department of Health and Hospitals. “People need to know the
level of quality they’re receiving,” Leavitt said, “and they
need to know what the price is.” What Leavitt and the
Louisiana group are working on is complicated, he said, and it
will take a long time to realize. “It's not the thing you
build all at once and then flip the switch on,” he said.
“There'll be some bricks and mortar that’ll have to be put
into place, clinics to be built, health records to be
safeguarded, and it won't just be systems. It'll have to be
sociology that'll have to change. People have to change the
way they think. In New Orleans, they had a system for a long
time where most of the money went to institutions to pay for
care for people who were uninsured. Now the goal is to get
them insured.” (The Times-Picayune)
Medicare cuts payments for pharmacy-made
drugs
In a sweeping change, Medicare says it will significantly cut
payments to pharmacies that make their own, non-FDA-approved
versions of drugs used by asthmatics and others with
respiratory ills. The move was disclosed in a letter sent
Tuesday to Sen. Charles Grassley, R-IA. He and some consumer
advocates say patients may unknowingly get such drugs, which
have provided profits for pharmacies, but are made under
less-stringent safety and sterility rules than the government
sets for drug manufacturers. It follows action earlier this
month by the Food and Drug Administration, which warned three
large national medical-supply companies that their pharmacies
may be violating federal law by mass producing “thousands of
doses” of unapproved respiratory drugs. Starting in January,
Medicare will use special payment codes for pharmacy-made
respiratory drugs, allowing it to pay less for those products
than for brand-name formulations. For most drugs, Medicare has
until now paid the same, no matter whether the pharmacy bought
the drugs from manufacturers, or purchased raw ingredients and
made them in-house. The new payments are likely to be
“significantly lower” and will remove “any inappropriately
large financial incentives” encouraging pharmacies to make
drugs for patients, even when there is no medical reason to
switch from products made by drug manufacturers, Medicare
chief Mark McClellan said in a letter to Grassley. At issue
are liquid drugs used to treat lung conditions. The FDA says
patients are unlikely to get such drugs from national chain
pharmacies. Instead, most get them from Internet mail-order
pharmacies or firms that sell the devices used to inhale the
drugs. Pharmacists are allowed to make drugs when they have
specific prescriptions for patients who need specialized
treatments that are not available from brand-name
manufacturers. Pharmacy-made drugs are not generic drugs,
which are produced by commercial manufacturers. Both brand and
generic drugs must receive FDA approval. Pharmacy-made drugs
do not. Medicare says it is not trying to stop legitimate
pharmacy-made drugs. In July, Grassley wrote Medicare and the
FDA, saying former industry employees told his staff that some
pharmacies switch patients to pharmacy-made drugs without
telling them or their doctors. Tests conducted by
pharmaceutical companies on samples of pharmacy-made drugs
found contamination and incorrect dosage amounts, Grassley’s
letter added. Medicare now has a separate payment code for
only one pharmacy-made version of the 37 respiratory drugs it
covers. That code, for a drug called budesonide, cut payment
from $4.40 a dose to 29 cents, according to a recent
Securities and Exchange Commission filing by pharmacy Rotech
health care, one of the three firms recently warned by the
FDA. Rotech said the change could cut its revenue $30 million
this year. (USA Today)
U.S. pushing for release of flu data
In an effort to speed
flu
research and set an example for other nations, the United
States announced this week that it had placed the genetic
sequences of about 650 flu
viruses
in a public database. But the sequences did not include any
highly pathogenic A(H5N1) flu, the strain that has killed 140
people in 10 countries and is threatening to turn into a world
pandemic,
because it has not been found inside the United States.
Instead, the sequences are of seasonal human flus and animal
flus isolated here. The agency is trying to put pressure on
Indonesia, Thailand, Vietnam and China, where the
avian flu
has infected humans and is mutating rapidly, to release
sequences found inside their borders. “We hope these
initiatives will set the stage for other countries to adopt
similar approaches,” said Dr. Nancy Cox, director of the
influenza division at the
Centers for
Disease Control and Prevention. Some scientists
have been accused of slowing flu research by hoarding
sequences until they can publish scientific papers, which can
take months. The
World Health
Organization, which considers all laboratory
samples submitted to it the property of the submitting
governments, has posted all its sequences in a
password-protected archive. In March, an Italian veterinarian
who sequenced genes from birds infected in Africa and Europe
refused to put her data there, released it publicly and urged
others to do the same. Also at issue is the anger of poor
nations like Indonesia and Thailand, which release data
gathered in their countries and then see it used by private
companies to make vaccines for sale in the West at prices they
cannot afford. At the gathering of the world’s health
ministers in Geneva in May, the Thai delegation tried to pass
a resolution preventing any commercial use of member nations’
data, said Edward Hammond, the American director of the
Sunshine Project, an organization based in Texas and Germany
that opposes the creation of biological weapons. After months
of pressure, Indonesia recently agreed to release avian and
human sequences found there. One Indonesian cluster now being
investigated, in Cikelet village in the Garut district of West
Java province, appears to consist of up to 20 suspect cases,
according to Indonesian news reports. Only three have been
confirmed by laboratory tests. A local health official said
Tamiflu antiviral tablets had been given to 2,400 residents of
the district as a preventive measure. (The
New York Times)
FDA proposes new rule to automate drug
registration
and listing
The U.S. Food and Drug Administration (FDA) issued a proposed
rule to make managing drug information more efficient and
effective by automating the process by which drug firms
register themselves and list their products with FDA. The
proposed rule is part of a broader federal effort to modernize
the management of health information. The Electronic Drug
Registration and Listing System would make the complete list
of drug products marketed in the United States readily
accessible electronically. Currently, part of the list is kept
on paper. The new proposal would improve the quality and
completeness of the drug product information that FDA receives
and manages. Users of the list also include other government
agencies, healthcare providers and healthcare payers. The
list, which currently has more than 120,000 drug products,
contains up-to-date information about specific drug
formulations and manufacturers. The data includes ingredients,
dosage forms, strengths, labeling and manufacturer
information. Drug developers and manufacturers would be
required to submit establishment registration and drug listing
information electronically, rather than on paper. “Having drug
makers submit drug information electronically will help to
keep an accurate, up-to-date inventory of drugs on the
market,” said HHS Secretary Mike Leavitt. “This will help us
maintain more accurate information and make it easier for us
to respond to drug emergencies such as recalls and drug
shortages.” The proposed revisions would also reorganize and
clarify current regulations concerning which drug
establishments must register and list their drugs with FDA and
what information they must submit. The proposal would change
the system FDA uses for assigning a drug listing number (the
National Drug Code, or NDC), to marketed drugs, and would
require drugs to display the NDC code on their label.
Getinge acquires telemedicine growth
company
The Getinge Group’s Medical Systems business area has
concluded an agreement regarding the acquisition of 60 percent
of the shares in the German company OTY GmbH. The agreement
also includes an option to acquire the remaining shares at a
future point in time. OTY is a rapidly expanding company
active in the telemedicine area and specializing in products
and solutions for the IT infrastructure of hospitals, with a
focus on the operation theatre. The company has developed
hardware and software that enable the integration of various
electronic data systems in the operation theatre, thus
increasing the efficiency of the communication and visibility
of patient data. The products constitute a natural complement
to the Surgical Workplace division's existing product range.
For some time, Medical Systems has been cooperating with OTY
in several markets. The market for telemedicine products
focusing on the operation theatre has expanded rapidly in
recent years and is expected to show continued favorable
growth. OTY GmbH will be incorporated in the Getinge Group as
of September 2006.
Amerinet announces agreements
Amerinet announces its agreement with CDW Government
Inc. for technology products and services. Effective through
June 30, 2008, this contract includes servers, desktops,
laptops, monitors, printers, digital imaging scanners, network
hardware, cables, telephony and software licensing. This
contract was the result of a competitive bidding process.
Amerinet announces its agreement with Attainia Inc.
for software solutions. Effective through July 31, 2008, this
contract includes capital budgeting and equipment planning
software solutions designed for the healthcare setting.
Attainia systems are secure with firewall, backup and network
redundancies.
Effective through June 30, 2009, Amerinet’s
agreements with First Quality Products Inc. for incontinence
products for acute care and non-acute care facilities includes
adult and youth incontinence products, briefs, breathable
briefs, night-time briefs, underpads, pants, protective
underwear, pant liners, cotton-snap pants, washcloths and wet
wipes.
Wednesday, August 23, 2006
USC seeks sale of hospital by Tenet; lawsuit contends that the
firm has not adequately invested in the facility
HealthSouth to sell its clinics and focus on inpatient care
JCR appoints consulting practice leaders for accreditation
improvement, infection prevention and control
Tissue for transplant is recalled after FDA shuts down North Carolina firm
Study shows how obesity, chronic conditions drive Medicare spending
Two
studies find high weights shorten lives
Making healthcare the engine that drives the economy
Metropolitan Chicago Healthcare Council affiliates with MedAssets Supply Chain Systems
USC seeks sale of hospital by Tenet;
lawsuit contends that the firm has not adequately invested in
the facility
USC filed suit Tuesday in an effort to force Tenet Healthcare Corp. to sell its
ownership and control of USC University Hospital, contending that the troubled
hospital operator had not adequately invested to improve the facility. The
269-bed hospital near downtown Los Angeles is staffed by USC medical personnel
and is also used as a teaching facility. The university owns the land and
Dallas-based Tenet manages the hospital and owns the buildings and equipment.
Some of the hospital's programs, including gynecology, neurology and
neurosurgery, ophthalmology and orthopedics, rank among the top 50 in the
nation, according to U.S. News & World Report magazine’s annual hospital
survey. But The Times recently reported that the hospital's liver
transplant program had the nation’s highest death rate. Marshall B. Grossman,
the attorney representing USC, said Tenet’s investment in the hospital since
2003 was about $100 million short of what was agreed upon. The lawsuit, filed in
Los Angeles Superior Court, does not take issue with Tenet’s management of the
Boyle Heights hospital but with the company's ability to continue investing to
improve the facility. “Tenet simply cannot or will not offer the necessary
support at a level appropriate and befitting a top-tier, teaching hospital of
USC's quality,” Grossman said. Tenet spokesman Steven Campanini disputed that,
saying the company had made “substantial investments,” including a new
$150-million patient building scheduled to open in coming months. Tenet
officials called the lawsuit a negotiation tactic. “There has been ample
opportunity for USC leadership to indicate their concerns to Tenet leadership,
and they chose not to do so,” Campanini said. The lawsuit is the latest in a
string of financial and legal troubles for Tenet, the nation’s second-largest
hospital operator with 68 facilities, including 19 in California. The company
has lost more than $3 billion in the last three years and has been embroiled in
disputes over illegal kickbacks and overcharges. USC attorney Grossman said the
university filed the lawsuit to force a sale of USC University Hospital by
Tenet, whose lease on the land doesn't expire until 2063. The lawsuit, he said,
also is necessary to determine whether Tenet breached its contract by not
investing enough in the hospital, which opened in 1991. The dispute does not
involve the nearby USC/Norris Cancer Hospital, also owned and operated by Tenet.
Grossman said the dispute with Tenet would not disrupt hospital operations and
that USC officials had not yet decided how to replace Tenet’s management if they
forced the company to sell. (Los Angeles Times)
HealthSouth to sell its clinics and
focus on inpatient care
The
HealthSouth Corporation
plans to shed its outpatient rehabilitation clinics and other segments to focus
on intensive care of inpatients, the company said last week as it reported
declining revenue but a lower loss in its second quarter.
HealthSouth, which started as
a chain of rehabilitation clinics and diversified through a growth period that
ended in a huge accounting fraud, said in addition to the outpatient
rehabilitation division, it would sell its surgery centers and its diagnostic
division. The proceeds would be used to pay off debt, and HealthSouth would be
left to focus on its inpatient business, which accounted for about 58 percent of
its operating revenue for the last quarter. The company reported a
second-quarter loss of $51.7 million, or 13 cents a share, compared with a loss
of $62.4 million, or 16 cents a share, a year earlier. Second-quarter revenue
fell 4 percent, to $787.5 million, down from $818.3 million in the period last
year. The company said the narrower loss resulted from cost controls. A decision
by HealthSouth to sell its outpatient clinics is not as radical as it might seem
to some, said Derrick C. Dagnan, an analyst at Avondale Partners in Nashville.
While the clinics are the most visible part of the business to the general
public, he said, the medical community is more focused on HealthSouth’s
post-acute-care centers, which generally specialize in intensive therapy for
older patients, most of them on Medicare. “It seems like you are getting rid of
your bread and butter,’’ Dagnan said. “But that inpatient rehab business to
clinicians and doctors is really the business of HealthSouth.” (The Associated
Press)
JCR appoints consulting practice leaders
for accreditation improvement, infection prevention and control
Joint
Commission Resources (JCR) announced the appointment of two consulting practice
leaders to provide innovative solutions in two critical focus areas for
healthcare organizations: Accreditation improvement and infection prevention and
control. JCR is an affiliate of Joint Commission on Accreditation of Healthcare
Organizations. The consulting practice leaders will partner with healthcare
organizations to improve strategic decision-making and enhance daily operations
in a way that promotes health care quality and safety. Consulting practice
leaders specializing in patient safety, the environment of care and medication
safety will be available later this year. “JCR’s consulting practice leaders
will skillfully guide organizations in transitioning from a culture of simply
achieving standards compliance at a particular point in time to one that uses
innovation to create practical and effective organization-wide solutions and
fosters a continuous emphasis on performance improvement,” said Karen H.
Timmons, chief executive officer, JCR. The JCR consulting practice leaders are:
Stephen C. Anderson, MBA, RN – Accreditation Innovations. Anderson has more than
30 years of executive experience in healthcare, including expertise in clinical
and senior management, clinical applications and information management. He is a
former Joint Commission and Joint Commission International surveyor who has held
leadership positions at not-for-profit, government and investor-owned healthcare
delivery systems (adult and pediatric) in the United States and abroad. Barbara
M. Soule, RN, MPA, CIC – Infection Prevention and Control Services. Soule has
broad experience practicing and teaching infection prevention and control in the
United States and internationally and has published extensively in this area,
serving as editor in chief of the Association for Professionals in Infection
Control’s (APIC) first Curriculum for Infection Control Practice. She is a
member of the HealthCare Infection Control Practices Advisory Committee (HICPAC),
which provides advice to the U.S. Office of the Surgeon General and the Centers
for Disease Control and Prevention (CDC). For more
information about JCR’s consulting practice leaders, please contact Nanne Finis,
executive director, at nfinis@jcrinc.com.
Tissue for transplant is recalled after FDA shuts down North
Carolina firm
A
leading medical firm has recalled hundreds of human-tissue products destined for
transplants around the nation that were supplied by a North Carolina body-parts
broker. On July 6, AlloSource of Centennial, CO, began a recall of about 300
transplant parts supplied by Donor Referral Services of Raleigh, NC, an
AlloSource spokeswoman said. On Friday, the Food and Drug Administration shut
down Donor Referral Services, saying the company, run by Philip Guyett, had
“serious deficiencies” in its processing, donor screening and record-keeping.
The FDA refused to say how many people may have received potentially risky
tissue. It is the second scandal in less than a year in the booming but
little-regulated tissue-transplant industry. Cadaver tissue is used in more than
a million transplants each year in such routine operations as back surgery and
knee repairs. Improperly processed or poorly tested tissue can lead to illnesses
such as hepatitis or AIDS, or even death. Last year, a scandal unfolded around
Biomedical Tissue Services, a New Jersey company accused of using stolen bodies
and of shipping potentially tainted body parts. (Associated Press)
Study shows how obesity, chronic conditions drive Medicare spending
A new
analysis of Medicare costs and patient data by Kenneth E. Thorpe, the Robert W.
Woodruff Professor and chair of the Department of Health Policy and Management,
Rollins School of Public Health, Emory University (Atlanta) and David H. Howard,
an assistant professor in that department,
examines the impact of
the rise in treated disease prevalence on the growth in Medicare beneficiaries’
healthcare spending. According to the analysis, published in the journal
Health Affairs, virtually all of this spending growth is associated with
patients who are under medical management for five or more conditions. This is
traced to both a rise in true disease prevalence and changes in clinical
treatment thresholds. Using metabolic syndrome as a case study, the authors
found that the share of patients treated with medications has increased 11.5
percentage points in less than ten years. This raises important questions about
the “fit” of how Medicare pays for services for complex medical management.
Medicare spending is projected to nearly triple from 3 percent
of U.S. gross domestic product (GDP) in 2006 to 8.8 percent by 2030. The top ten
disease conditions accounted for two-thirds of the growth in spending incurred
by Medicare beneficiaries between 1987 and 2002. The three conditions associated
with metabolic syndrome -- hypertension, diabetes, and hyperlipidemia --
collectively accounted for 16.1 percent of the rise in spending. Virtually all
of the growth in spending from 1987 to 2002 can be traced to the
twenty-percentage-point increase in the share of Medicare patients receiving
medical treatment for five or more conditions during a year. Overall, the
prevalence of obesity among Medicare beneficiaries has doubled since 1987, but
the share of spending incurred by obese beneficiaries has almost tripled, from
9.4 percent to nearly 25 percent of total spending. Efforts to control the
growth in Medicare spending using lifestyle modification strategies and care
coordination will require changes in the way Medicare pays for services and
interacts with providers. Another implication concerns the critical need to
track the future benefits associated with the more-aggressive preventive
treatment of the conditions associated with metabolic syndrome.
For more information
CLICK HERE.
Two studies find high weights shorten
lives
Modestly overweight baby boomers will live shorter lives, two studies will
report in The
New England Journal of
Medicine. That fits with the conventional wisdom of many public
health experts who cite the increased risk of
heart disease and
cancer. But it runs
counter to a study last year by researchers at the
Centers for Disease Control
and Prevention and the
National Cancer Institute
that found slightly overweight people had a somewhat lower risk of death. One of
the two new studies looked at more than 500,000 members of
AARP, an
organization for people 50 and older. Over 10 years, more than 61,000 of them
died. Among women, the risk of death increased for any amount of weight above
the normal range. For men, the risk was not higher for those merely overweight.
The researchers said the more telling analysis arose when they focused on
186,000 healthy men and women who had never smoked. Among men and women, being
overweight raised the risk of death 20 percent to 40 percent compared with
normal-weight people, the researchers said.
Obese people had
a risk two to three times that of normal-weight people. “We found that people
who are overweight had a modestly increased risk of premature death,” said Dr.
Michael F. Leitzmann, an investigator at the National Cancer Institute and the
senior author of the article. Because all the participants were recruited from
AARP, they are not exactly representative of the population as a whole, and the
participants reported their weight themselves, which contributes to some
uncertainty in the results. Dr. Leitzmann said neither factor would probably
skew the results considerably because “it’s a very large sample of people.”
Errors in reporting weights, people sometimes say they weigh less than they
actually do, would also not produce a large effect, he added. Researchers have
almost universally found that obese people have considerable health risks. But
there has been debate over whether someone who is less severely overweight is at
a greater risk of illness. Other factors, especially
smoking, can
complicate analysis of the data. Smoking greatly increases the chances of deadly
lung diseases, but smokers tend to weigh less.
As with
most such studies, the fatness and thinness of the participants was specified by
their body mass index. A second study by researchers at Yonsei University in
Seoul, South Korea, and
Johns Hopkins University
looked at 1.2 million Koreans ages 30 to 95 and followed them for 12 years. The
researchers looked at 82,372 deaths and correlated them with the body mass
index. They found, too, that risk of death and cancer increased in people who
were overweight, but not obese. “It’s the first time an Asian population this
large has been studied,” said Dr. Eliseo Guallar, a professor of epidemiology at
the Johns Hopkins School of Public Health and an author of the paper. The
diet and lifestyle
of Asians differ considerably from those of Americans, as does physiology. An
Asian with the same body mass index as a white typically has a higher percentage
of fat, so doctors recommend that Asians maintain a lower weight. The Koreans in
the study were much thinner than typical Americans, with an average body mass
index of 23.2 compared with 28 for Americans. The overweight category runs from
25.0 to 29.9. Dr. Guallar said the findings suggested to him that keeping weight
in what is regarded as a normal range was a good idea. “That will help control a
whole bunch of other big problems,” he said. As an example, according to the
body mass index, someone who is 5 foot 9 would be considered overweight at 169
pounds; he would be considered obese at 203 pounds. (The
New York Times)
Making healthcare the engine that drives
the economy
After
receiving a hip replacement last year, Angus Deaton,
an economist at
Princeton, wondered
how much it had cost. He found out that his hospital room was $10,000 a day.
“Telephone and television were extra,” he said. As for the
total cost, there
were so many charges associated with one service after another,
anesthesia, pain
management,
physical therapy,
the surgery itself, that he was never able to figure out how much each of them
cost. All he knows for sure is that insurers say they pay, on average, $50,000
for a hip replacement. The United States already spends nearly 16 percent of its
gross domestic product on healthcare, and it is almost impossible to know where
all that money goes. Projections are that healthcare will take up even more of
the G.D.P. as the population ages and as more expensive drugs and medical
devices are developed. But a new economic approach to healthcare expenditures
views costs in a very different light. Economists agree that huge increases are
coming. But some say that may be just fine. By 2030, predicts Robert W. Fogel, a
Nobel laureate at the
University of Chicago
Graduate School of Business, about 25 percent of the G.D.P. will be spent on
healthcare, making it “the driving force in the economy,” just as railroads
drove the economy at the start of the 20th century. Unless the current system is
changed, most healthcare costs will continue to be paid by insurance, especially
Medicare, which means that the taxpayers will foot the bill. But Dr. Fogel says
he is not alarmed. Americans can afford it, he says, because the nation is so
rich. “It takes so little of household income to satisfy expenditures on food,
clothing and shelter,” he explains. “At the end of the 19th century, food,
clothing and shelter accounted for 80 percent of the family budget. Today it’s
about a third.” Other economists agree. “We have to spend our money on
something,” said Robert E. Hall, a
Stanford University
economist. In a
paper published in
The Quarterly Journal of Economics, Dr. Hall and Charles I. Jones of the
University of California,
Berkeley, write: “As we get older and richer, which is more valuable: a third
car, yet another television, more clothing, or an extra year of life?” David
Cutler, an economist at
Harvard, calculated
the value of extra spending on medicine. “Take a typical person aged 45,” he
said. “They will spend $30,000 more over their lifetime caring for
cardiovascular disease than they would have spent in 1950. And they will live
maybe three more years because of it.” He added, “Are you willing to do that?
Yes, it costs a lot, but we’re rich enough where the alternative use of the
money isn’t as valuable.” Still, Victor R. Fuchs, also an economist at Stanford,
notes that buying healthcare is fundamentally different from buying a television
or a car. “Most of it involves transfers from the young to the old,” he said.
“Down the road, most medical care will be for people over age 65, and most of
the payments will be from taxes on younger people.” Dr. Fuchs calls it the
restaurant check problem. “You go out to a restaurant with a bunch of friends
and you sort of understand that you will split the check,” he said. “The waiter
comes along and says, ‘The lobster looks very good, and how about a soufflé for
dessert?’ The restaurant check balloons, but you are not so careful because you
figure everyone is splitting it. “That’s the way medical care gets paid for,” he
said. Dr. Fuchs added, “We want to spend our money on the things that will bring
the most value for the dollar. When we are spending collective money as we are
in health care, then it becomes much more difficult.” The
issue, he says, is
not how much is being spent but whether spending more is the answer. Are those
extra dollars buying marked improvements in health or are they making any
difference? That, Dr. Deaton said, was the point of his exercise in trying to
find out the cost of his hip replacement: “Is it worth spending all this money
on a hip replacement?” In London, he said, a hip replacement costs £5,000, or
about $9,500. “Don’t you think people would prefer to have it for £5,000?” Dr.
Deaton said. “It is probably true that if we spent twice as much money on health
care we’d be better off. But half the money we spend is wasted.” That, Dr. Hall
pointed out, is an important issue. “We all know that especially in Medicare,
where more and more of the spending is going to occur, there isn’t anybody who
has responsibility for making sure the money gets spent well,” he said. “Some
huge improvements will have to be made as the consequences of that waste get
greater.” Still, the wasted money is, in a sense, a separate discussion, he
said. The real questions for the future of medical spending, he said, are: “Does
it make sense in terms of how we value different things? What do people think a
life is worth? And what do you get?” (The New York Times)
Metropolitan Chicago Healthcare Council affiliates with MedAssets Supply Chain Systems
MedAssets Supply Chain Systems announced a new affiliation with Metropolitan
Chicago Healthcare Council (MCHC), a membership and service association
comprised of more than 140 member hospitals and health care organizations. The
affiliate agreement between MedAssets and MCHC to enhance the financial
performance and business processes of MCHC’s member organizations was effective
August 1, 2006. The affiliation with MedAssets will drive supply cost savings to
MCHC members through MedAssets Supply Chain Systems’ group purchasing contracts;
Aspen Healthcare Metrics’ cost management programs for clinical service lines;
and MedAssets Analytical Systems’ best of breed supply chain technology, data
cleansing, and analytics. This affiliation also equips MCHC with the ability to
offer the MedAssets Net Revenue Systems’ suite of revenue cycle management tools
for linking the hospital supply chain item file to the chargemaster, defensible
pricing, chargemaster management, charge capture auditing, and denials
management within the Chicago health care community.
Tuesday, August 22, 2006
Potential J&J-Medtronic deal ‘makes sense’
says analyst
Bush to sign healthcare comparison law
Medicare posts ASC transparency information
Aetna members gain access to care price,
quality data
Bird flu patients need testing before starting
drugs
Medline receives American Red Cross award
for rescue efforts after hurricane Katrina
Medline awarded Premier contract for O.R.
safety products
Potential J&J-Medtronic deal ‘makes sense’
says analyst
Credit Suisse said an acquisition of Medtronic would be a logical move for
healthcare giant Johnson & Johnson, which is facing a growth problem as patent
expiration looms for a handful of key drugs. Shares of Medtronic, which is set
to announce first-quarter results on Aug. 22, were pounded earlier this month
after the company warned that quarterly sales would likely fall short of
expectations due to a slowdown in sales of implantable cardiac defibrillators,
or ICDs. But the stock bounced back somewhat last week amid renewed speculation
Johnson & Johnson would take advantage of recent sharp declines in Medtronic's
share price by making a bid for the Minneapolis-based medical device maker. A
buyout of Medtronic makes “good strategic sense” for Johnson & Johnson, the
analyst said Monday, since the company has long wanted to enter the pacemaker
business as evidenced by its failed bid for Guidant. In order to satisfy
Medtronic investors, however, the analyst said the company would likely need to
offer a lofty 30% to 40% premium to the current stock price. (Forbes)
Bush to sign healthcare comparison law
An executive order being
signed today by President Bush is designed to help people make more informed
decisions about doctors and hospitals. Four federal agencies will be required to
compile information about the quality and price of care they pay for and share
that information with their customers and each other. The order directs the
agencies to: Use, where available, health
information computer systems that can talk to each other. That way, the health
records of a veteran living in Maine can be viewed by a doctor working in
California if the veteran needs emergency care there during a vacation; Enact
programs that measure the quality of care, and develop those measures with the
private sector and other government agencies; Make available to beneficiaries
the prices that agencies pay for common procedures; Develop and identify
practices that promote high-quality healthcare. The
agencies affected by the executive order are the Health and Human Services
Department, which oversees Medicare; the Defense Department, which oversees
health care for the military; the Veterans Affairs Department and the Office of
Personnel Management, which oversees the Federal Employees Health Benefit
Program. (The Associated Press)
Medicare posts ASC transparency information
To
help consumers, providers, and payers make more informed healthcare decisions,
the Centers for Medicare & Medicaid Services (CMS) is making available Medicare
payment information for 61 procedures performed in Ambulatory Surgery Centers (ASCs). President
Bush recently directed that more data be made available to all Americans as part
of the Administration’s commitment to make healthcare more affordable and
accessible. Today’s announcement is the second set of geographically-based
information made available; information on what Medicare pays for 41 procedures
performed in an inpatient hospital setting was posted at the beginning of June.
The new information posted by CMS at
http://www.cms.hhs.gov/HealthCareConInit/ will help patients undergoing
surgical procedures select the most appropriate setting for the delivery of high
quality, efficient care. The information will show “Commonly Performed
Procedures in ASCs”, and will contain charge and Medicare payment data for ASC
facility costs for a limited number of services administered in states and
counties. The data is broken down at the county, state and national level. CMS
is also concurrently releasing data on “Other Commonly Performed Procedures in
ASCs”, which contains similar charge and payment data, but for facility costs
related to services of high utilization. The department is working closely with
a number of national and local organizations toward the goal of developing more
comprehensive and personalized information on quality and cost. Building on
private sector quality measurement efforts, a new Medicare pilot project, to be
conducted initially in six geographic areas, will produce comprehensive quality
data that will help improve the quality of Medicare-covered services, and
provide information to Medicare beneficiaries that will assist them in making
more informed choices among their healthcare options. The quality information
produced under this Medicare pilot project will be based on services provided to
Medicare beneficiaries, Medicaid beneficiaries, and individuals with private
health insurance in Massachusetts, Indiana, Minnesota, Wisconsin, Arizona and
California. In making this information available to Medicare beneficiaries, it
will also be available to providers, other insurers, employers, and the public.
Aetna members gain access to care price, quality data
On Sunday, major insurer
Aetna began allowing its members in the Washington area and several other
markets to access prices for “30 of the most widely accessed services” and
care-quality information via the company's member services site,
http://www.aetna.com/. The company expects pricing information will likely
be most helpful to people who have health savings accounts (HSAs) tied to
high-deductible insurance plans that place more of the burden for containing
health costs on consumers, rather than their employers. The posted prices are
the rates that care providers have agreed to accept as payment for services to
Aetna members; prices for patients who are not Aetna members may be higher. The
service, begun a year ago in Cincinnati, allows the estimated 1 million Aetna
members in the District, Maryland and Virginia to log on to the company's Web
site, pull up a provider’s name and view price and quality information. Another
1.3 million members in other parts of the country also gained access to the new
service. Aetna members in those markets can view, from any computer with
Internet access, how much specific services will cost them at their provider’s
office. An advisory on the site reminds members that posted rates are the
“maximum amount allowed by Aetna. Depending upon your particular plan, your
actual out-of-pocket costs may be less (for example, co-pays, co-insurance
and/or deductibles).” Quality information is drawn from Aetna’s “Aexcel”
network, described on the company’s Web site as a “designation for specialist
physicians . . . who have demonstrated effectiveness in the delivery of care
based on a balance of measures of clinical quality and efficiency.” Quality
ratings are available for providers who specialize in 12 areas: cardiology,
gastroenterology, cardiothoracic surgery, general surgery, obstetrics and
gynecology, neurology, neurosurgery, orthopedics, otolaryngology, plastic
surgery, vascular surgery and urology. The quality information is divided into
three categories: clinical quality, volume and efficiency, according to the
company. (The Washington Post)
Bird
flu patients need testing before starting drugs
Bird flu cases may go
undetected in patients who took antiviral drugs days before being tested because
treating the virus may mask infection, said virologist Menno de Jong, whose team
observed 18 cases in Vietnam. Specimens should be collected from suspected cases
before or soon after medicines such as oseltamivir are administered, said de
Jong, head of virology at an Oxford University clinical research unit in Ho Chi
Minh City. Nasal and throat swabs from Vietnamese patients who responded well to
oseltamivir, marketed by Roche Holding AG as Tamiflu, were unable to detect the
virus 48-to-72 hours after beginning treatment, he said. “If a patient is on
oseltamivir for three days before the first swab is taken for diagnostic
testing, it's possible the result will be negative, but the patient could be
infected” with the H5N1 strain of avian influenza, de Jong said. A delayed or
incorrect diagnosis is a concern for disease trackers as they monitor human
cases for signs H5N1 is becoming contagious to people, not just birds. Early
detection and isolation of suspected cases are important to limit the spread of
the virus should it begin to spread easily between people, the World Health
Organization (WHO) said last year in a recommendation of strategic actions to
fight a pandemic. Oseltamivir is recommended by the WHO as the first choice for
doctors treating human H5N1 cases. In patients with confirmed or strongly
suspected H5N1 infection, doctors should administer the drug as soon as
possible, according to agency guidelines. The efficacy of oseltamivir and other
antiviral drugs that work by preventing the virus from spreading from infected
cells to other cells in the body “depends on their administration within 48
hours of onset of symptoms,” the WHO said. A study of H5N1 cases in Vietnam,
published in the Sept. 29, 2005, edition of the New England Journal of
Medicine, found the virus’s genetic material couldn’t be detected in
throat-swab samples until between two and 15 days after the patient began
feeling ill. The median interval from the onset of illness to the detection of
viral RNA was 5.5 days, a consultative committee to the WHO wrote in the study.
(Bloomberg)
Medline
receives American Red Cross award
for rescue efforts after hurricane Katrina
Medline Industries Inc.
recently received one of the highest honors awarded by the American Red Cross
for its efforts as a first responder to help bring in medical supplies and
rescue victims of hurricane Katrina last year. “We are thankful for, and
applaud, the significant contributions Medline Industries, Inc. has made to help
those affected by recent hurricanes. It is through these types of generous gifts
that the American Red Cross is able to continue the work we do. As we have seen
with Medline Industries and others, employee initiatives, combined with support
from top management, has made a remarkable impact on disaster relief efforts,”
said Judith Ostronic, National Chair, Biomedical Development. In addition to
donating $100,000 to the American Red Cross and an additional $100,000 to help
Medline employees hit by the hurricane, Medline immediately chartered a first
response helicopter rescue team that has been lauded for rescuing and
coordinating the rescue of more than 1700 men, women and children from hospital
and other rooftops in New Orleans. “We are so honored to be recognized by the
Red Cross. We feel very fortunate that we were able to respond immediately with
food, water, medical supplies and hire some of the best rescue professionals
around,” said Medline CEO Charlie Mills. “It was a dangerous mission for them.
There was no air traffic control, fog, downed power lines and thousands of
people that needed to be rescued who were at times desperately rushing the
chopper. These guys are heroes.” Mills also noted the extraordinary efforts of
Medline’s Covington, LA, facility employees who came to work within 24 hours of
the hurricane even though many had lost their own homes. “We were amazed by
their strength of spirit and their willingness to put their own needs aside and
help our customers and others who had suffered. They literally lived in the
warehouse with their families and worked around the clock.”
Medline
awarded Premier contract for O.R. safety products
Medline Industries Inc.
recently signed a national agreement to provide operating room safety products
to members of Premier Purchasing Partners, LP. The contract was developed in
direct response to the Joint Commission's new national Patient Safety Goals. The
multi-source agreement, to be fully implemented September 1 and effective
through July 31, 2009, covers O.R. safety products including sterile standard
and blank label sheets, skin markers (with rulers and labels), transfer trays,
tube/cord holders and scalpel holders, important products to help hospitals with
sharps safety, correct site incision and drug identification.
Monday, August 21, 2006
New treatment, first in years, demonstrated
for dangerous staph infections
Families troubled by healthcare costs
Children slip through cracks of AIDS efforts
Healing
potential discovered in everyday human brain cells
Doctors warn of powerful and resistant tuberculosis strain
Adverse effects and costs of chemotherapy greater than previously thought
FDA, MIT to work on tracking drug side effects
New treatment, first in years, demonstrated
for dangerous staph infections
Duke University Medical
Center (Durham, NC) researchers have demonstrated in an international clinical
trial the effectiveness and safety of a new drug for treating bloodstream and
heart infections caused by Staphylococcus aureus bacteria. Based on the trial,
the Food and Drug Administration already has approved the drug, daptomycin, for
treating heart infections and bacteremia, also known as bloodstream infection or
blood poisoning, caused by S. aureus, according to Vance G. Fowler Jr., M.D., an
associate professor of infectious diseases who participated in the study. “This
is the first new drug the FDA has approved in two decades for treating these
types of potentially life-threatening infections,” Fowler said. “This advance
adds a new weapon to our dwindling arsenal of antibiotics against these
difficult-to-treat infections.” Daptomycin had been approved by the FDA in 2003
for treating skin infections caused by S. aureus. But until now, Fowler said, no
one knew definitively whether the drug would be effective against the more
serious bloodstream and heart infections. The researchers published their
findings in the August 17, 2006, issue of the New England Journal of Medicine.
Cubist Pharmaceuticals, which manufactures daptomycin, funded the study. S.
aureus now causes up to 2 million infections and 90,000 deaths per year
worldwide, most of them in healthcare settings, Fowler said. Treating S. aureus
infections is difficult because many strains have developed resistance to all
penicillin-related antibiotics, according to the researchers. For these highly
resistant strains, called methicillin-resistant S. aureus, or MRSA, the drug
vancomycin has been the only consistently reliable treatment alternative.
Recently, however, MRSA strains with resistance to vancomycin have appeared.
“The rising prevalence of S. aureus infections and the organism's increasing
resistance to drugs make these bacteria a growing threat to medical care
throughout the world,” said Ralph Corey, M.D., a professor of infectious
diseases who participated in the study. In the study, the research team tested
daptomycin's ability to combat two specific types of infection caused by S.
aureus, including MRSA strains. The first type was bacteremia, or bloodstream
infection. The second was infective endocarditis, which is an infection of the
inside lining of the heart. Endocarditis due to S. aureus is a particularly
severe form of the infection. It can involve either the tricuspid, mitral, or
aortic valves and often occurs in patients with pre-existing heart disease. The
results showed daptomycin was as effective as standard therapy, Fowler said.
Daptomycin was more successful at eliminating drug-resistant S. aureus, at 44.4
percent success versus 31.8 percent. However, the standard therapy slightly
outperformed daptomycin for S. aureus without drug resistance, at 48.6 percent
success versus 44.6 percent. Both types of treatment took roughly the same
amount of time, eight or nine days, to clear an MRSA infection. “Having another
drug in our armamentarium against S. aureus not only will give physicians a new
treatment option, but also may help slow the current troubling spread of drug
resistance among these bacteria,” Fowler said.
Families
troubled by healthcare costs
About half of adults in middle-income families reported serious problems in
paying for their healthcare while even those in more affluent circumstances said
they had troubles with medical bills, a new survey found. Forty-eight percent of
individuals in families earnings between $35,000 and $49,999 said they had
either a somewhat serious or very serious problem paying their medical bills in
the last two years, according to a study by The Commonwealth Fund. Meanwhile, 50
percent of adults in that income bracket said they had difficulties affording
their health insurance. Meanwhile, 33 percent of individual in families earning
between $50,000 and $74,999 a year said they had trouble paying for medical
bills while 21 percent of people in families earning $75,000 or more reported
such a dilemma. Fifty percent of individuals in families earnings less than
$35,000 annually reported such a problem. Thirty-five percent of people in
families with an annual income of between $50,000 to $74,999 reported they had
trouble paying for health insurance while 23 percent of those in families
earning $75,000 or more said the same. Forty-eight percent of those in families
with incomes of less than $35,000 said the premium cost represented a problem.
Karen Davis, president of the Commonwealth Fund, said she was surprised that
people earning more than $50,000 were having difficulties affording healthcare,
and that it signals that the high costs are affecting more people. The study
also found that 48 percent of those surveyed worried that wouldn't be able to
pay their medical bills in the event of a serious illness, regardless of their
income. The study also found that while people are having difficulties paying
for their health services, they are also unsatisfied with them. Forty-two
percent of people surveyed said they had experienced poorly coordinated,
inefficient or unsafe care at some points during the past two years. Their
experiences included a medical error, a duplicate test or the failure to provide
important test results to doctors or nurses. Three-quarters of the adults
surveyed said the healthcare system needs fundamental change or a complete
rebuilding. The Commonwealth Fund is a New York-based private foundation that
aims to promote better health care. The study contacted 1,023 adults by phone in
early June. For more information on the Commonwealth Fund,
CLICK HERE. (The Associated Press)
Children slip through cracks of AIDS efforts
Efforts to greatly
expand antiretroviral treatment for
AIDS in poor
countries are not reaching a vast majority of children who need it, a
World Health Organization
official said in Toronto. The official, Dr. Kevin M. De Cock, who directs the
organization’s AIDS program, said that an estimated 2.3 million children 15 and
under around the world are infected with H.I.V., the
virus that causes
AIDS, and that 800,000 of them needed antiretroviral drugs to stay alive. Of the
800,000, only 60,000 to 100,000 are receiving therapy. While the children
account for 14 percent of AIDS deaths, they make up only 6 percent of recipients
of antiretroviral drug therapy. Many of the children are orphans. “We must
conclude that scale-up has so far left children behind,” Dr. De Cock said at the
16th International Conference on AIDS, which has attracted 24,000 participants.
His comments drew on an extensive review of progress in efforts to step up
antiretroviral treatment. At the same time, Dr. De Cock said, fewer than 10
percent of pregnant women with H.I.V. in poor and middle-income countries are
receiving the simple regimen of pills that can prevent the transmission of the
AIDS virus to their newborns. By contrast, rich countries have virtually
eliminated pediatric AIDS. Dr. De Cock also described an inequity in
antiretroviral treatment for injecting drug users, particularly in Eastern
Europe and Central Asia. There, these users account for more than 70 percent of
people infected with H.I.V. but about a quarter of those receiving treatment.
“An urgent priority is improving access to antiretroviral therapy for children,
especially in sub-Saharan Africa, and for injecting drug users everywhere,” Dr.
De Cock said. (The
New York Times)
Healing potential discovered in everyday human brain cells
University of Florida (Gainesville) researchers have shown
ordinary human brain cells may share the prized qualities of self-renewal and
adaptability normally associated with stem cells. Writing online Aug. 16 in
Development, scientists from UF’s McKnight Brain Institute describe how they
used mature human brain cells taken from epilepsy patients to generate new brain
tissue in mice. Furthermore, they can coax these pedestrian human cells to
produce large amounts of new brain cells in culture, with one cell theoretically
able to begin a cycle of cell division that does not stop until the cells number
about 10 to the 16th power. “We can theoretically take a single brain cell out
of a human being and, with just this one cell, generate enough brain cells to
replace every cell of the donor’s brain and conceivably those of 50 million
other people,” said Dennis Steindler, Ph.D., executive director of UF's McKnight
Brain Institute. “This is a completely new source of human brain cells that can
potentially be used to fight Parkinson's disease, Alzheimer's disease, stroke
and a host of other brain disorders. It would probably only take months to get
enough material for a human transplant operation.” The findings document for the
first time the ability of common human brain cells to morph into different cell
types, a previously unknown characteristic, and are the result of the research
team's long-term investigations of adult human stem cells and rodent embryonic
stem cells. Last year, the researchers published details about how they used
stem-like brain cells from rodents to duplicate neurogenesis, the process of
generating new brain cells, in a dish. The latest findings go further, showing
common human brain cells can generate different cell types in cell cultures. In
addition, when researchers transplanted these human cells into mice, the cells
effectively incorporated in a variety of brain regions. The human cells were
acquired from patients who had undergone surgical treatment for epilepsy and
were extracted from support tissue within the gray matter, which is not known
for harboring stem cells. When the donor cells were subjected to a bath of
growth agents within cell cultures, a type of cell emerged that behaves like
something called a neural progenitor, a cell that is a bit further along in
development than a stem cell but shares a stem cell's vaunted ability to divide
and transform into different types of brain cells. Even when the cells from the
epilepsy patients were transplanted into mice, bypassing any growth
enhancements, they were able to take cues from their surroundings and produce
new neurons. Scientists speculate a small amount of existing progenitors may be
emerging from the gray matter of the brain and multiplying in torrents, or
perhaps the aging clock of the mature cells actually turns backward when the
donor cells are in a new environment, returning them to past lives as
progenitors or as stem cells. In addition to using the cells in treatments to
repair or replace damaged brain tissue, the ability to massively expand cell
populations could prove useful in efforts to test the safety and efficacy of new
drugs. It is also possible to genetically modify the cells to produce
neurotrophins, substances that help brain tissue survive, researchers said. The
research was supported by grants from the National Institute of Neurological
Disorders and Stroke and the National Heart, Lung and Blood Institute of the
National Institutes of Health. Steindler and co-senior author Bjorn Scheffler,
M.D., a UF neuroscientist, are involved with RegenMed Inc., a biotechnology
company that seeks to use stem cell technology to develop human therapeutics.
Doctors warn of powerful and resistant tuberculosis
strain
Virulent strains of tuberculosis resistant to all standard drugs have killed 52
of 53 patients in a rural hospital in South Africa in recent months, a team of
researchers reported in Toronto. The patients, who were also infected with the
virus that causes AIDS, were resistant to all first- and second-line drugs for
tuberculosis, Dr. Neel R. Gandhi told the 16th International Conference on AIDS.
“It’s essentially not treatable,” said Dr. Gerald Friedland, an AIDS specialist
at Yale who worked in the South African hospital and was an author of the study.
“There’s quite a lot out there. We don’t know the whole extent.” The illness was
rapidly fatal. About half the patients died within 30 days of the time their
sputum was collected and sent to a laboratory. Officials from South Africa, the
World Health Organization in Geneva and other public health agencies will meet
in South Africa in the next few weeks to come up with a strategy, he said. The
drug-resistant strains killed two healthcare workers and were suspected in the
deaths of four others. Of the 536 patients studied, 221, or 41 percent, had
tuberculosis strains resistant to at least two drugs. In 2004, only 128 such
cases were found in the whole United States. More important, 53 of the residents
of the area had what was called an XDR, for “extremely drug-resistant” strain.
Dr. Friedland estimated that half the patients had picked up their infections at
hospitals or clinics. Most of those who died were in the advanced stages of
AIDS, he said. Many were relatively young, the median age was 35, and had never
been treated for tuberculosis, so they presumably had not developed resistance
slowly in themselves, but had caught the extremely resistant strains from
someone else. Dr. Gandhi, of the Albert Einstein College of Medicine at Yeshiva
University in the Bronx, said 26 of 30 isolates were genetically similar,
suggesting that their infection was acquired shortly before patients developed
cough, fever, weight loss and other problems. Tuberculosis and infection with
the AIDS virus have long been known to be closely intertwined. This year, the
Centers for Disease Control and Prevention in Atlanta reported a total of 347
cases worldwide in which the agency found tuberculosis bacteria resistant to all
first- and second-line drugs, including isoniazid, rifampin, ethambutol,
streptomycin, kanamycin and ciprofloxacin. But there has been little data about
such strains in Africa or among H.I.V. patients, Dr. Gandhi said. About 80
percent of new tuberculosis cases in KwaZulu Natal are also infected with H.I.V.,
Dr. Gandhi said. The annual death rate among such patients was 40 percent before
the introduction of antiretroviral drugs, Dr. Gandhi said. The death rate then
fell to 12 percent. Dr. Gandhi’s report was based on information that became
available after the deadline for submission for the main papers presented at the
conference and was made in what is termed a “late breaker” session. Dr. Gandhi
led a team that included scientists from Yale and the Nelson R. Mandela School
of Medicine in Durban. (The New York Times)
Adverse effects and costs of chemotherapy greater
than previously thought
Researchers at Dana-Farber Cancer Institute and Harvard Medical School have
found that breast cancer patients 63 years of age or younger may experience more
chemotherapy-related serious adverse effects than reported in clinical trials,
according to a study in the August 16 issue of the Journal of the National
Cancer Institute. Led by Michael J. Hassett, MD, MPH, of Dana-Farber,
researchers studied a database of medical claims made by women with newly
diagnosed breast cancer who had employer-provided health insurance between
January 1998 and December 2002. “This is the first study, to our knowledge, of
chemotherapy-related serious adverse effects in a population-based sample of
younger women with breast cancer,” said Hassett, who is also an instructor in
medicine at Harvard Medical School. “We found that eight chemotherapy-related
serious adverse effects may be more common than reported in large clinical
trials, and, therefore, these adverse effects may be responsible for more
patient suffering and higher healthcare expenditures than currently predicted.”
Doctors often prescribe chemotherapy to eliminate residual cancer cells in women
who have undergone surgery for breast cancer. Women who received chemotherapy
were more likely to be hospitalized or visit emergency rooms for problems that
are typically related to chemotherapy, including fever or infection, low white
blood cell or platelet count, nausea, diarrhea, malnutrition, or dehydration.
Researchers studied 7,052 women from a database of claims made to health plans
that contract with large employers in the U.S. The group was equally divided
into two cohorts of 3,526: those who received chemotherapy within 12 months of
their first breast cancer diagnosis, and those who did not. In addition to more
incidents of chemotherapy-related adverse effects, women undergoing chemotherapy
for breast cancer also experienced increased healthcare costs: $1,271 more per
year for hospitalizations and emergency room visits and $17,617 more per year
for ambulatory care than women who did not receive chemotherapy.
FDA, MIT to work on tracking drug side effects
Methods used
to track disease outbreaks also may be used to help spot side effects from
prescription drugs after they hit the market, U.S. health officials said. The
Food and Drug Administration agreed to work with the Massachusetts Institute of
Technology on adapting technology to detect side effects earlier than current
FDA monitoring systems. The project will involve automated scanning of databases
for unusual patterns of health problems that could be drug-related, said Dr.
Scott Gottlieb, FDA deputy commissioner for medical and scientific affairs. It
will build on computerized systems public health officials use to spot
infectious disease outbreaks, follow the spread of influenza or detect a
bioterrorist attack, he said. The partnership with MIT is the latest step to
strengthen post-approval oversight of medicines, Gottlieb said. The efforts
“will also require continued support by Congress,” Gottlieb said. (Reuters)
Friday, August 18, 2006
Heart procedure is off the charts in an Ohio city
FDA approves new medical use for Plavix;
Drug benefits patients with common form of heart attack
New
details in reported secret deal over generic drug
New bird
flu drugs possible, study says
WHO Update:
Avian influenza situation in Indonesia
Nonin
Medical acquires MedAir AB; Adds carbon dioxide monitoring technology to Nonin
product line
Heart
procedure is off the charts in an Ohio city
People with
blocked coronary arteries can typically choose among drugs, bypass surgery and
vessel-clearing procedures like
angioplasty. But in
the small, aging industrial city of Elyria
in northeast Ohio, doctors are much more likely than those anywhere else in the
country to steer patients toward angioplasty. No one has accused the doctors
involved of any wrongdoing. But the statistics are so far off the charts,
Medicare patients in Elyria receive angioplasties at a rate nearly four times
the national average, that Medicare and at least one commercial insurer are
starting to ask questions. And the hospital where most of the procedures take
place says it plans to conduct an independent review.
Dr. Elliott S. Fisher, a
researcher at Dartmouth Medical School, analyzed Medicare data and found Elyria
to be an outlier.
Nearly all the procedures at the Elyria hospital are performed by a
group of cardiologists who dominate coronary care in this city and have an
unabashed enthusiasm for angioplasties, the highly profitable procedure in which
they specialize. The cardiology group’s leader says the high rate of
angioplasties is simply a function of his doctors’ detecting disease more often
in their patients than physicians elsewhere might spot, and being quicker to
intervene. “We do manage very aggressively the patients we care for,” said Dr.
John W. Schaeffer, the founder and president of the group, the North Ohio Heart
Center, which employs 31 cardiologists. But some outside experts say they are
concerned that Elyria is an example, albeit an extreme one, of how medical
decisions in this country can be influenced by financial incentives and
professional training more than by solid evidence of what works best for a
particular patient. Medicare pays Elyria’s community hospital, EMH Regional
Medical Center, about $11,000 for an angioplasty involving use of a drug-coated
stent. The cardiologist might be paid an additional $800 for the work. That is
well above the fees for seeing patients in the office. And with the North Ohio
doctors performing thousands of angioplasties a year, about 3,400 in 2004, for
example, the dollars can quickly add up. Some medical experts say Elyria’s high
rate of angioplasties, three times the rate of Cleveland, just 30 miles away,
raises the question of whether some patients may be getting procedures they do
not need or whether some could have been treated just as effectively and at
lower cost and less risk through heart drugs that may cost only several hundred
dollars a year. Or whether, in some cases, patients might be even better off
with bypass surgery, even though a bypass is a riskier, more invasive and more
expensive procedure. At EMH Regional, Medicare pays the hospital about $25,000
for a bypass operation, and as much as $2,200 to the surgeon. The Elyria
cardiologists do not perform bypasses. Because they are not surgeons, the North
Ohio cardiologists must refer a patient to another doctor if they conclude that
bypass surgery is that patient’s best option. The bypasses are performed at the
Elyria hospital by surgeons from the Cleveland Clinic who have operating
privileges there. But even in cases of extensive disease where other doctors
might typically recommend bypass surgery, the Elyria doctors say they frequently
favor the use of stents. For patients with less serious disease, the doctors say
they do prescribe drug-only treatment. When it comes to treating blocked
arteries, there are no definitive studies showing which approach most benefits
patients in the long term. And some local insurers agree that the Elyria
hospital provides high-quality care. But there is little doubt that hundreds of
Elyria patients each year are getting angioplasties that they might not be
getting if they lived elsewhere, at a cost of millions of dollars a year to
Medicare. Experts know that changing the financial incentives can change the way
medicine is practiced. For example, Kaiser Permanente, which employs its own
doctors, says its patients in Ohio, including some in Elyria, are slightly less
likely than the national average to undergo the type of cardiac procedures the
North Ohio Heart Center doctors perform so prolifically. Kaiser’s cardiologists,
who work on salary instead of being paid by the procedure, typically treat
patients in that region at the Cleveland Clinic, where they have hospital
privileges. And they follow established protocols about when a patient should
undergo an angioplasty, when drugs might suffice and when bypass surgery might
be the best resort. “We believe we’re doing a good job,” said Dr. Donald
Sheldon, the hospital’s vice president for medical affairs. But he conceded that
the high rates raise questions. He said the hospital had decided to ask a
professional society of heart specialists to review the cardiac program and
“give us an honest and objective outside look.” Experts say that cardiac care is
one of the most lucrative areas of medicine. EMH Regional says it generates
nearly half its profit from cardiac services. The high rates do not have “a good
explanation,” said Dr. Eric J. Topol, a nationally known cardiologist at Case
Western Reserve University in Cleveland. He said Elyria did not appear to have
significant differences in risk factors and demographics from Cleveland and the
rest of Ohio that would explain the sharply higher rates. One clear reason for
the high number of angioplasties in Elyria, though, is the way the doctors tend
to perform the procedures. In many other parts of the country, doctors who
perform angioplasties try to unblock all of the blood vessels during a single
session. Or they may elect not to put a stent in another vessel that might
require an additional session because there is only a minor blockage. But in
Elyria, patients are more likely to undergo two or more procedures, sometimes
requiring separate hospital stays and additional bills. As many as 31 percent of
patients there who receive treatment undergo additional procedures, according to
Dr. Scott Sheldon, a North Ohio Heart Center cardiologists, who is not related
to the hospital’s Dr. Sheldon. That would be three times the national average.
No one has accused the North Ohio doctors of inappropriate conduct. But there
have been cases in which unusual patterns of medical activity that also showed
up in the Dartmouth data have prompted federal law enforcement investigators to
look into whether unnecessary procedures have been performed. Experts say it can
be difficult to detect cases in which doctors cross a medical line and are
clearly performing unnecessary treatments. In the absence of any real monitoring
or oversight, doctors in most places have few incentives not to favor the
treatments that provide them the most reimbursement.
Dr. David D. Waters, chief of
cardiology at San Francisco General Hospital, who is currently studying the
effectiveness of different kinds of treatment for heart disease,
said that the way physicians are typically paid, more
money for more procedures, results in too many decisions to give a patient a
stent. “You can’t be paying people large sums of money to do things without
checks and balances,” he said. To read the entire article
CLICK HERE. (The New York Times)
FDA approves new medical use for Plavix;
Drug benefits patients with common form of heart attack
The Food and Drug
Administration (FDA) approved the use of Plavix (clopidogrel bisulfate) for
patients who have had a type of heart attack called acute ST-segment elevation
myocardial infarction (STEMI), who are not going to have coronary artery repair
(angioplasty). A STEMI is a severe heart attack caused by the sudden, total
blockage of an artery. In STEMI patients, Plavix prevents subsequent blockage in
the already-damaged heart vessel, which could lead to more heart attacks,
stroke, and possibly death. FDA approved Plavix in November 1997 to decrease
platelet function in people who suffer from acute coronary syndrome (ACS).
According to the American Heart Association, each year an estimated 500,000
Americans have a STEMI heart attack. “Plavix has demonstrated that it can help
reduce these post-STEMI events for patients who suffer certain kinds of heart
attacks," said Steven Galson, MD, Director of FDA's Center for Drug Evaluation
and Research. Two studies support the effectiveness of Plavix in treating STEMI
heart attack patients. A large trial, the Clopidogrel and Metoprolol in
Myocardial Infarction Trial (COMMIT) study, demonstrated that Plavix, when
combined with other standard treatments including thrombolysis, a procedure to
dissolve clots, reduced mortality and also reduced the combined number of
recurrent heart attacks, strokes and deaths. COMMIT was a randomized,
double-blind, placebo-controlled trial of 46,000 patients conducted in China.
The findings in COMMIT in China are supported by the results of the Clopidogrel
as Adjunctive Reperfusion Therapy (CLARITY) study. CLARITY was a clinical trial
of 3,500 patients undergoing thrombolysis for STEMI heart attacks. CLARITY
showed that the coronary artery blood flow was better with clopidogrel treatment
compared to placebo. Serious side effects of Plavix include bleeding and,
rarely, low white blood cell counts or thrombotic thrombocytopenic purpura (low
platelet counts with spontaneous bleeding and clotting). Plavix is manufactured
by Sanofi Aventis of Bridgewater, NJ.
New details in reported secret deal over generic drug
A federal
court filing provided new details about accusations that a
Bristol-Myers Squibb
executive entered a secret side deal with a generic drug maker in hopes of
preserving the lucrative monopoly over the anticlotting drug Plavix. Those
accusations are thought to be the focus of a Justice Department investigation of
Bristol-Myers and the French company
Sanofi-Aventis, its
marketing partner for Plavix. The filing, made in Federal District Court in
Manhattan by lawyers for the Canadian generic drug maker Apotex, asserts that
Bristol-Myers made the secret agreement as part of a proposed settlement with
Apotex of a patent lawsuit. The secret deal, Apotex asserts, was an effort to
evade the scrutiny of the federal and state regulators who were reviewing the
settlement. Although the
Food and Drug Administration
approved Apotex’s generic version of Plavix earlier this year, the settlement
would have delayed the introduction of the generic drug until 2011, several
months before the Plavix patent is scheduled to expire. Apotex’s filing asserts
that Dr. Andrew G. Bodnar, a top assistant to Bristol-Myers’s chief executive,
Peter R. Dolan, negotiated the secret deal after regulators objected to an
earlier version of the patent settlement because it would have restricted
competition. The side deal, the filing said, contained two provisions that had
been in the original version of the settlement agreement but that were not
included when the companies formally submitted their revised version. One
provision called for Bristol-Myers and Sanofi to give Apotex a six-month head
start to introduce its generic version of Plavix in 2011 before the two big
companies would introduce their own generic, according to today’s court filing.
Under the other provision, Bristol-Myers and Sanofi would secretly give Apotex a
$60 million fee that had been part of the original settlement agreement. After
regulators rejected the revised settlement agreement late last month, Apotex
began shipping its generic version of Plavix, known as clopidogrel bisulfate.
The company has flooded the United States market with millions of pills priced
10 to 20 percent below the $4-a-day price of brand-name Plavix. Plavix, used to
prevent the recurrence of heart attack and stroke, had United States sales last
year of $3.5 billion and is one of Bristol-Myers’s top products. Worldwide, the
Plavix franchise is worth more than $6 billion. Apotex has said that it
negotiated the settlement on the assumption that regulators would reject it, but
conducted the discussions to win concessions from Bristol-Myers and Sanofi that
have made it easier to introduce its generic drug in defiance of the big
companies’ patent claims. It is unclear whether Apotex is a subject of the
Justice Department investigation. Yesterday’s filing was made ahead of a hearing
scheduled for today in Federal District Court in Manhattan. There, Judge Sidney
H. Stein is to consider a request by Bristol-Myers and Sanofi to block further
sales of the generic drug until after a patent trial, now expected to begin in
January. Tony Plohoros, a Bristol-Myers spokesman, said that an internal
investigation by the company’s outside lawyers had found no evidence of unlawful
conduct by Bristol-Myers employees. In a hearing before Judge Stein earlier this
month, a lawyer for Bristol and Sanofi asserted that Apotex’s chief executive,
Bernard C. Sherman, had lied to the federal government about the secret
agreement to sabotage the settlement agreement and clear the way for his
company’s sales of the product. Sherman has denied that accusation. To read the
entire article,
CLICK HERE. (The New York Times)
New bird flu drugs possible, study says
Advanced
X-ray technology has helped scientists spot a new target that drug designers
might use to attack the bird flu virus. Though a new drug would still be years
off, the new research offers hope of a fresh way to fight a disease that health
experts fear could one day evolve into a deadly human flu pandemic. “This gives
us a new target that we didn't know we had before," said Dr. Michael Perdue, a
flu expert at the World Health Organization, who had no role in the study.
Researchers used advanced X-ray technology to provide an “atomic picture” of the
atoms and molecules that comprise one of the two surface proteins in the H5N1
virus. Neuraminidase, the “N” in H5N1, is the protein in bird flu that allows
the virus to spread to other cells in the body. Drugs currently used to treat
bird flu are based on other neuraminidase models that are not specific to H5N1.
By identifying H5N1's unique blueprint, researchers may one day be able to use
drugs that home in on the strain that has killed 139 people in the past three
years. New drugs targeting H5N1 could potentially be used in combination with
the current leading bird flu medication, Tamiflu, to reduce the risk of the
virus mutating into a resistant form, said John Skehel, lead author of the paper
appearing in the journal Nature. Drug combinations can reduce the risk of
a virus becoming resistant to one drug, a lesson learned in the fight against
AIDS, noted Skehel, director of the National Institute for Medical Research in
London. Research into new flu drugs has traditionally focused on the
neuraminidase protein because flu’s other surface protein, hemagglutinin, the
“H” in H5N1, has proven harder to attack. To date, Tamiflu, which was developed
to treat human flu, is the only drug shown in lab studies to be somewhat
effective against H5N1. However, there have been isolated instances of strains
resistant to Tamiflu. Experts agree on the importance of having more drugs in
the arsenal to fight bird flu. “Right now, our options are really quite
limited,” said Dr. Fred Hayden, an antivirals and influenza expert at the WHO.
“We're really down to Tamiflu and Relenza, so there is a need for an
alternative.” Though the timeline for producing a new drug usually takes between
three to five years, it could potentially be shortened as countries accelerate
their pandemic preparedness plans. “Since drug companies have already attacked
neuraminidase before, they should already have a lot of information on how to
build compounds that would work in attacking it,” said Perdue, who cautioned
that the process of conducting clinical trials in humans could still take years.
(The Associated Press)
WHO Update: Avian influenza situation
in Indonesia
In an
update of August 17, 2006, the World Health Organization (WHO) reports that the
Ministry of Health in Indonesia has confirmed the country’s 58th case of human
infection with the H5N1 avian influenza virus. The case occurred in a 9-year-old
girl from a remote village in Garut district, West Java Province. She developed
symptoms on August 1, was hospitalized on August 14, and died on August 15.
Recent chicken deaths were reported in her household. Three hamlets within the
village are currently under investigation. An
additional case
from the village, but from another hamlet, was confirmed by the Ministry of
Health on August 14. This 17-year-old male developed symptoms on July 26 and is
now recovering. Another death from severe respiratory disease occurred on August
5 in a 20-year-old neighbor, who is also now known to be a cousin. As no samples
were taken for testing, the cause of his illness remains uncertain. Based on
epidemiological and clinical findings, however, infection with the H5N1 virus is
strongly suspected. As both young men developed symptoms on the same day (July
26), epidemiologists assume that they acquired their infection from a shared
environmental source. The currently recognized incubation period for H5N1
infection of 2 to 8 days makes human-human transmission between the two highly
improbable. Teams from local health authorities, the Ministry of Health, and WHO
are currently in the three hamlets investigating these cases and assessing the
overall situation. Team members include experts in animal health. Recent
die-offs of poultry are known to have occurred in the village, and all three
cases described above had documented exposure to diseased chickens. Heightened
awareness in the hamlets, supported by the presence of well-equipped teams, has
led to the presentation of additional persons for medical evaluation. Rumors of
additional deaths from respiratory disease in the hamlets in late July and early
August are also being investigated. Although the village is remote and access by
road is difficult, good communications from the field have been established with
the Ministry of Health and WHO. Of the 58 cases confirmed to date in Indonesia,
45 have been fatal.
Nonin Medical acquires MedAir AB; Adds carbon dioxide
monitoring technology to Nonin product line
Nonin
Medical Inc. announced the acquisition of Swedish medical technology company
MedAir AB. With the acquisition, MedAir, which specializes in developing and
manufacturing optical equipment for medical gas analysis, has become a wholly
owned subsidiary of Nonin Medical. Medair AB management and employees are not
affected by the acquisition, the terms of which were undisclosed. The future
plan calls for the expansion of Medair AB. Minneapolis-based Nonin Medical
designs, manufactures and distributes a broad spectrum of physiological
monitoring devices
Thursday, August 17, 2006
Swiss company will compete with J&J in spinal disks
Study finds MRSA most common cause of skin infections in patients presenting in
nation's ER's
Cancer Institute’s new chief talks of cutbacks
Projected
costs of stroke highlight need for increased NIH funding
VHA’s global spend analysis debuts at AHRMM Conference
University of Pittsburgh Medical Center enhances internal controls with
MedAssets’ supply chain technology
Swiss company will compete with J&J in
spinal disks
After nearly a two-year head start,
Johnson & Johnson
is about to face competition in the market for artificial spinal disks. Synthes,
a Swiss orthopedic devices company, told investors after European stock markets
closed Tuesday that it had received regulatory approval to sell its Prodisc
lumbar disk replacement in the United States. For now, only surgeons at the 19
hospitals that participated in the Prodisc’s clinical trials will be implanting
the device in this country. But Synthes plans to start a training program next
month for others who want to do the implants, Peter Fehlmann, a Synthes
spokesman, said. Synthes is just one of several large device companies,
including
Medtronic,
Abbott Laboratories
and Stryker, that expect to compete with Johnson & Johnson’s DePuy Spine
subsidiary for a share of what analysts believe will be a billion-dollar segment
of the orthopedics industry. Implanting the Prodisc, thousands of which have
already been implanted in patients in Europe, could be an alternative to spinal
fusion surgery for as many as 25 percent of the 220,000 Americans who undergo
fusion annually. The companies are also racing to develop cervical disks for the
neck and upper spine. Johnson & Johnson’s disk, known as the Charité, was
approved in October 2004. But sales have been disappointing. Insurers have
continued to classify the disk as experimental, and many refuse to cover the
cost of the implant procedure, which can cost more than $10,000 per disk and
several times that amount in hospital and doctors’ fees. Like the Charité, the
Prodisc consists of metal end plates around a hard plastic core. But backers of
the Prodisc say that differences in the design make it easier to implant the
disk accurately and keep it firmly anchored. That may make it harder to remove
if necessary, but could also make the Prodisc less prone to wear and to
displacements requiring remedial surgery. Unlike the Charité, the Prodisc
demonstrated superior results to spinal fusion in its clinical trials, according
to Dr. Rick B. Delamarter, a spinal surgeon who participated in Prodisc’s trials
and will work for Synthes training other surgeons. “We’ve gotten inundated today
with calls from patients who want to proceed with it,” said Dr. Delamarter, who
practices at the Saint John’s Health Center in Santa Monica, CA. (The New York
Times)
Study finds MRSA most common cause of skin infections in
patients presenting in nation's ER's
UCLA researchers report in
the Aug. 17 issue of The New England Journal of Medicine that Methicillin-resistant
Staphylococcus aureus, or MRSA, is the most common cause of skin and soft-tissue
infections among patients presenting in emergency rooms across the country. MRSA
is resistant to the antibiotics used for years to treat these skin conditions,
such as cephalexin and dicloxacillin. “The study points to the rising prevalence
of this type of MRSA and the need for clinicians to culture infections and make
sure the proper antibiotic is administered to treat MRSA,” said Dr. Gregory J.
Moran, the study's principal investigator and a clinical professor of medicine
in the department of emergency medicine and the Division of Infectious Diseases
at Olive View–UCLA Medical Center. Since the 1960s, MRSA has been found in
healthcare settings, generally among patients who have been hospitalized or are
in nursing homes. In the last few years, however, a new type of MRSA has
emerged, affecting people with no connection to health care settings. Outbreaks
of these new strains of MRSA have been reported among athletes, correctional
facility inmates and military recruits. Still, the UCLA study demonstrates that
the infections appear to be common in people who are not connected to any
particular risk group. “We noticed more patients showing up in our emergency
room with infections that turned out to be community-associated MRSA and wanted
to see if this was the case nationwide,” said Dr. David Talan, an author of the
study and a professor of medicine in the Division of Infectious Diseases and
chief of the department of emergency medicine at Olive View–UCLA Medical Center.
Community-associated MRSA most often manifests itself on the skin as a boil or
pimple that can be swollen, red and painful, and have discharge. Researchers
cultured the acute skin or soft-tissue infections of 422 patients seen at 11
metropolitan emergency rooms in the United States during August 2004. Out of
those patients, 249, or 59 percent, were found to have MRSA. The proportion of
infections caused by MRSA in various cities ranged from 15 to 74 percent.
Further characterization of the MRSA samples, performed at the Centers for
Disease Control and Prevention, revealed that one genetic type accounted for 97
percent of the samples. “This one genetic type of MRSA is appearing in
metropolitan areas across the country,” Moran said. “More research will
determine how prevalent it is in other parts of the nation.” Researchers tested
the antibiotic resistance of the isolated MRSA samples and found that in 57
percent of cases, doctors had prescribed an antibiotic to which the bacteria
were resistant. “Doctors need to change what they've done for decades, since
traditional antibiotics don't work against MRSA,” Talan said. “We encourage
physicians to reconsider antibiotic choices for skin and soft-tissue infections
in areas where MRSA is prevalent in the community.” Talan notes that most MRSA
cases are mild, and having the infection drained and keeping it clean resolves
the problem. But when antibiotics are needed, it's important to prescribe an
effective medication. Sometimes these infections may require hospitalization
and, in rare cases, may even be life-threatening. Researchers tested the
effectiveness of different types of antibiotics on the MRSA samples and found
that 95 percent were susceptible to clindamycin, 6 percent to erythromycin, 60
percent to fluoroquinolones, 100 percent to rifampin and
trimethoprim-sulfamethoxazole, and 92 percent to tetracycline. The next step,
according to Moran, is to compare these different antibiotics in real patients
in order to identify an optimal treatment. The study revealed several potential
risk factors for community-associated MRSA. Patients with MRSA were more likely
to report a spider bite as the reason for the skin lesion, perhaps thinking it
was a bite in absence of other skin problems. Those with MRSA also were more
likely to have close contact with a person with a similar infection. “However,
none of these risk factors were consistent enough to help doctors identify cases
of MRSA; it appears now that everyone is at risk,” Moran said. Dr. Rachel J.
Gorwitz, an author of the study and a medical epidemiologist at the Centers for
Disease Control and Prevention, noted the importance of educating patients in
order to avoid transmission. She offered the following guidance: Wash hands
often with soap and water to keep them clean, or use an alcohol-based hand
sanitizer (if hands are not visibly soiled); Don't share towels, razors or other
personal items; Avoid contact with other people's wounds or bandages; Keep
breaks in your skin clean and covered and watch for signs of infection, such as
redness, warmth and swelling; See your doctor if you notice signs of infection;
don't try to drain a boil yourself at home; If you have a skin infection, keep
the infected area covered with a clean, dry bandage until it is healed; wash
your hands thoroughly after changing the bandage and put used bandages in the
trash. For more information,
CLICK HERE.
Cancer Institute’s new chief
talks of cutbacks
A surgeon who was appointed by President Bush
this week to lead the
National Cancer Institute
said Wednesday that he had great hopes for finding new nontoxic
cancer drugs but
that given a shrinking of resources, some of the institute’s programs would
probably have to be phased out. The appointee, Dr. John E. Niederhuber, also
said that Bush’s limits on federal financing of embryonic
stem cell research
were acceptable for now but that they might someday slow cancer discoveries. Dr.
Niederhuber, in an expected appointment, was named by Bush on Tuesday to become
the 13th director in the history of the cancer institute. He has been running
the institute since last fall, however, when his predecessor, Dr. Andrew C. von
Eschenbach, was appointed acting commissioner of the
Food and Drug Administration.
He requires no Senate confirmation for his new post. “I think the research
questions that we have before us are quite doable under the current constraints.
However, I anticipate that these constraints could be limiting as our knowledge
increases,” concluded Dr. Niederhuber The more pressing question is how the
institute will adjust to a changed fiscal outlook. From 1998 through 2003,
spending at the
National Institutes of Health
doubled. In recent years, however, budgets have flattened. And since expenses
have risen, cuts are needed. Dr. Niederhuber said he hoped to invest more in
high-tech drug discovery machines, and made clear that he intended to continue
supporting cancer centers at universities across the country. He declined to
specify cuts but said that through a collaborative process, he would identify
programs “to phase out.” (The
New York Times)
Projected costs of stroke highlight need for increased NIH
funding
With projected costs of ischemic stroke in the United States expected to top
$2.2 trillion dollars by 2050, the American Academy of Neurology (AAN) is urging
Congress to further increase funding for the National Institutes of Health (NIH).
A study published August 16, 2006 in the online edition of Neurology, the
scientific journal of the AAN, found the total cost of stroke from 2005-2050, in
2005 dollars, is projected to be $1.52 trillion for non-Hispanic whites, $379
billion for African Americans and $313 billion for Hispanics. The estimated per
capita cost of stroke is highest in African Americans ($25,782), followed by
Hispanics ($17,201) and non-Hispanic whites ($15,597).
The
study's lead author Devin Brown, MD, of the Stroke Program at the University of
Michigan Medical School in Ann Arbor, said the ethnic disparities in stroke
related healthcare are a critical issue since Hispanics and African Americans
are less likely to be insured, have limited access to quality healthcare and
have a higher incidence of ischemic stroke than non-Hispanic whites. In
determining cost estimates, researchers considered ambulance services, initial
hospitalization, nursing home costs, rehabilitation, outpatient clinic visits,
drugs, informal care giving, and potential lost earnings. “With the cost of
stroke reaching $2.2 trillion, it is essential the NIH have the resources to
halt this impending epidemic,” said Catherine M. Rydell, CEO and Executive
Director of the AAN. “The NIH has the ability to perform the research that can
save countless lives and billions of dollars in healthcare costs if Congress
would adequately fund its mission. The AAN will continue to work with our
partners at the American Stroke Association, a division of the American Heart
Association, and others to stress to Congress the importance of funding NIH.”
The AAN is strongly supporting a budget increase of five percent, or $1.4
billion, to bring overall funding for the NIH FY-07 budget appropriation to $30
billion. Congress has postponed action on the Labor-HHS-Educations
appropriations bill, which includes NIH funding. Under the Senate's bill, NIH
would receive $28.5 billion in fiscal year 2007, which is $200 million more than
the House Appropriations Committee has approved. The Neurology study projecting
the costs of stroke was supported by the National Institute of Neurological
Disease and Stroke at the National Institutes of Health.
VHA’s global spend analysis debuts at AHRMM Conference
VHA
Inc. introduced a new supply chain information tool at the Association for
Healthcare Resource & Materials Management (AHRMM) conference in Orlando, FL,
this week. The global spend analysis tool leverages advanced analytical
capabilities to provide members with unprecedented visibility into their supply
purchases and new insights regarding specific cost savings opportunities. Dan
DeLay, senior vice president of Supply Chain Analytics at VHA, says hospitals
would typically have to engage in lengthy and expensive consulting relationships
to uncover the information that’s available through the global spend analysis
tool. VHA members are using VHA’s Global Spend Analysis to gain detailed insight
into their purchasing behavior and history, identify opportunities for cost
savings and position themselves for greater supply chain efficiency and improved
economic performance. Specifically, VHA members using the global spend analysis
tool are able to: Analyze their current expenditures by product category,
vendor, department, contract and/or item using its robust drill-down and
reporting capabilities; Improve their Item File content and integrity by
leveraging the UNSPSC categorization and standardized product and vendor
information provided by VHA; Identify savings opportunities resulting from one
or more of the following: 1.) Product pricing analysis 2.) Contract matching and
product conversion analysis 3.) Product and/or vendor standardization analysis;
and Identify price leveling opportunities to ensure consistent pricing among
departments across their systems and delivery networks. VHA worked with some of
its largest members to develop the global spend analysis tool, and those members
found an average savings opportunity of between 1 percent and 2 percent on their
total spend, and as much as 10 percent in some specific product categories.
University of Pittsburgh Medical Center enhances internal controls with
MedAssets’ supply chain technology
The
University of Pittsburgh Medical Center based in Pittsburgh, PA, announced its
success to further drive corporate transparency and internal controls process
enhancements using supply chain management technology offered by MedAssets
Analytical Systems. Although not required by law, UPMC, a not-for-profit
organization, initiated a project in June 2004 to comply with regulations set
forth by the Sarbanes-Oxley Act of 2002. Subsequently, UPMC’s supply chain
function, a department managing an approximately $1 billion supply spend, was
identified as an area of focus for improving data integrity, streamlining
business processes, and enhancing internal controls in financial reporting.
MedAssets Analytical Systems’ Client Item File Services standardizes and
normalizes the supply chain data in 19 facilities across the UPMC enterprise. By
continuously cleansing the supply item file, a database housing items routinely
purchased by UPMC, the foundation for accurate purchasing and analytics is
established. MedAssets’ Strategic Information service and technology allows UPMC
to aggregate the normalized purchasing data across multiple facilities, analyze
purchasing activities, and make informed and accurate decisions to reduce costs,
streamline business processes, and report on total supply procurement across the
enterprise. A customized, Web-based contract catalog warehouses UPMC’s entire
contract portfolio, including all local, regional and national agreements. An
executive dashboard provides key performance metrics to consistently and
accurately measure supply chain performance.
Wednesday, August 16, 2006
Rotech won't make copies of drugs after FDA warning
Experts cite distribution as key in fighting H.I.V.
Treatments for cancer are linked to heart ills
FDA forms internal nanotechnology task force
Ekahau and St. Croix Systems team up to integrate RTLS and asset
management
Rotech won't make copies of drugs after FDA
warning
One of the nation's largest respiratory therapy companies on Monday said it
would stop making unapproved copies of drugs and distributing them to patients,
days after receiving a warning from the FDA. Rotech health care, while saying it
disagreed with the Food and Drug Administration's stance, said in a release that
it will no longer accept new prescriptions for some of its pharmacy-made drugs
and begin switching 30,000 patients to brand-name formulations. At issue are
drugs used by asthmatics and others with respiratory conditions. The drugs are
inhaled using a table-top device called a nebulizer. The company was one of
three targeted by the FDA for scrutiny last week, with the agency saying the
pharmacies were mass-producing respiratory drugs in violation of federal law.
The FDA says some pharmacies are making large amounts of unapproved copies of
brand -name drugs. Drugs made in pharmacies are held to less-stringent safety
and sterility rules than the agency sets for drugmakers. The FDA allows
pharmacies to make drugs for patients, a process called compounding, but only if
they have valid individual prescriptions from doctors saying their patients need
treatments, dosages or formulations that aren't made by commercial
manufacturers. Last week, the FDA said the three, Rotech, CCS Medical and
Reliant Pharmacy Services, owned by home oxygen company Lincare, had crossed
into mass-producing their own versions of the drugs. "There is no demonstrated
medical need for your compounding of these products that are essentially copies
of commercially available drugs," the FDA said in a warning Wednesday to
Orlando-based Rotech. Generally, states oversee the practice of pharmacies, but
the FDA steps in when problems arise, such as product contamination or when
pharmacies cross into manufacturing. Rotech's statement Monday that it supplies
30,000 patients with compounded respiratory drugs is a rare look at the size of
some drugma k ing pharmacies. Generally, the number of customers or doses
supplied is kept secret by the FDA and the companies. A Rotech subsidiary, Pulmo-Dose,
makes the drugs for asthma and other respiratory conditions. Rotech is of the
nation's largest respiratory therapy and home medical equipment firms, with $533
million in revenue last year. But it is struggling, particularly after Medicare
lowered payments in the past two years for oxygen and some inhalation drugs. For
just one product, a pharmacy-made drug called budesonide, the company said in a
recent Securities & Exchange Commission filing, the lower payments may result in
a $30 million drop in revenue this year. Medicare now pays abou t $4.40 a 0.5
milligram dose for the commercially prepared drug, the SEC filing says, but
dropped payment to 29 cents for a pharmacy-made product. Ro tech on Monday said
its decision to switch patients back to commercially prepared products, which it
said would take several months, woul d increase its annual revenue by about $60
million and its projected annual pretax profit to about $10 million. (USA
Today)
Experts cite distribution as key in fighting H.I.V.
Large studies of an array of promising new ways to prevent H.I.V. are nearing
completion, but the world is unprepared to make them widely available to the
hundreds of millions of people at risk of becoming infected, an international
panel of experts reported in Toronto. Findings from some studies, like those
assessing the effectiveness of microbicides and male circumcision, are expected
within the next five years, some possibly in about a year, the panel said at the
16th International Conference on AIDS. The studies are vastly complex, there
will be no magic bullet to prevent the disease, and whatever new methods work
will have to be combined with existing preventions, the panel of 50
international experts said. It urged the world to address a significa nt number
of practical and ethical challenges that it said threaten to slow or derail
critical research projects concerning many prevention measures. In addition to
microbicides, male circumcision and vaccines, the report focused on three other
H.I.V. prevention methods: Diaphragms and other cervical barriers that could
help protect women from H.I.V. and other sexually transmitted diseases; A drug
to suppress herpes, which infects up to 70 percent of people in some parts of
Africa, microbicides, and vaccines;&nbs p;Antiretroviral pills like tenofovir to
prevent infection among prostitutes, drug injectors and other people at high
risk of becoming infected before and after exposures. The need is urgent to make
prevention measures of proved effectiveness widely available because four
million people are becoming infected each year and fewer than one in five people
at high risk for H.I.V. have access to such preventions. As treatments have
proved effective, “the harsh reality is we are quickly falling behind in H.I.V.
prevention,” Dr. Helene Gayle, the president of the International AIDS Society,
which is the main organizer of the conference, said. No new prevention method
under study is likely to be 100 percent effective, which will increase the
difficulty of putting them into practice, the panel said, adding that
educational campaigns will be needed to integrate the new met h ods with
effective older ones. The panel cautioned against the complacency about risk
behavior that could follow bro ader use of effective preventions. More donor
funding will be needed to introduce and deliver the new preventions, said the
panel, known as the Global H.I.V. Prevention Working Group. It made a number of
recommendations, including one to find ways to help poor countries train enough
health workers to carry out male circumcision safely. Last year, a study in
South Africa found that circumcised men were 60 percent less likely than
noncircumcised men to become infected with H.I.V. by female sex partners. (The
New York Times) For more info,
CLICK HERE.
Treatments for cancer are linked to heart ills
Two widely used treatments for breast cancer, radiation and the drug Herceptin,
can cause heart problems, researchers are reporting. But the problems can
usually be treated or prevented, and they should not scare women away from
needed cancer therapies, the doctors say. The findings, from two studies being
published in The J ournal of Clinical Oncology, expand on earlier research
linking the treatments to heart trouble. The first study involved 961 women
with early-stage breast cancer who were treated from 1977 to 1994 at the
University of Pennsylvania; 477 had cancer in the right breast, and 484 in the
left. Those who had radiation to the left breast had an increased risk of heart
disease up to 20 years later, apparently bec ause the radiation hit parts of the
heart and coronary arteries. The women’s risk of coronary artery disease was 25
percent, compared with 10 percent in the women who had radiation on the right.
Similarly, 15 percent of the women treated on the left side had heart attacks,
compared with only 5 percent treated on the right. The problems did not usually
show up until 10 or more years after the radiation. Women who already had heart
disease, hypertension or high cholesterol before starting cancer treatment had
the greatest risk. Despite th e problems, the women did not have higher death
rates from heart disease. Dr. Eleanor E. R. Harris, the lead author of the
study, said that in one sense, the findings reflected good news: many women with
breast cancer are now living long enough to be concerned about the long-term
effects of treatment. Dr. Harris, who has moved from Pennsylvania to the H. Lee
Moffitt Cancer and Research Institute in Tampa, said her study was more
important for women who had radiation in the past than for those being treated
today. Those treated five or more years ago need to be especially careful about
treating high blood pressure and cholesterol, she said. Nationwide, researchers
estimate that there are about 370,000 women who had radiation to the left side
of the chest for breast cancer more than 10 years ago. Women today have less
risk, Dr. Harris said, because improved radiation techniques and equipment have
made it possible to avoid exposing the heart in nearly every case. But she said
it was i m portant for women to be treated at centers with the most advanced
techniques. Some women who have the breast removed completely do not need
radiation. Those who have lumpectomies, removing just the tumor, almost always
need it. But Dr. Harris said she would not recommend that women choose
mastectomy just to avoid radiation and its risks. The operation has
complications of its own, and patients sometimes need radiation anyway. She said
the first priority should be picking the most effective treatment for the
cancer. Dr. Larry Norton, a breast cancer expert at Memorial Sloan-Kettering
Cancer Center in New York, who was not involved in the study, said the effects
of radiation on the coronary arteries were relatively small but of concern to
cancer doctors. He said more data and recommendations about the problem would
become available later this year. The second study, at the M. D. Anderson Cancer
Center in Houston, involved 173 women with cancer that had spread beyond the
breast. The women had tumors that were sensitive to the drug Herceptin, which
can help 20 percent to 25 percent of patients but is known to cause heart
problems in some. The patients took the drug for at least a year; in 49 women,
or 28 percent, the heart lost some of its pumping ability, usually while they
were still taking the drug. More than half had no symptoms, but some felt short
of b rea th. But the pr oblem co u l d usually be reversed with medicines like
beta blockers and ACE inhibitors. Most of the women recovered fully, but a few
had lingering problems, and one died from heart failure. The director of the
study, Dr. Francisco J. Esteva, said that over all, the findings were
encouraging because the heart problems were reversible and women could even take
the drug again once their hearts recovered. But women who have already had heart
failure may need to avoid Herceptin. Dr. Esteva said: “Patients need a baseline
cardiac evaluation, and need to be seen by a cardiologist if they develop a
decline in cardiac function or cardiac symptoms. And they need a cardiologist
who is familiar and has experience with this problem.” (The New York Times) For
the entire article,
CLICK HERE.
FDA forms internal nanotechnology task force
Acting Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D., announced
the formation of an internal FDA Nanotechnology Task Force. The new task force
is charged with determining regulatory approaches that encourage the continued
development of innovative, safe and effective FDA-regulated products that use
nanotechnology materials. The task force will identify and recommend ways to
address any knowledge or policy gaps that exist so as to better enable the
agency to evaluate possible adverse health effects from FDA-regulated products
that use nanotechnology materials. FDA will continue to address product-specific
nanotechnology-related issues on an ongoing basis. Specifically, the task force
will: Chair a public meeting to help FDA further its understanding of
developments in nanotechnology materials that pertain to FDA-regulated products,
including new and emerging scientific issues such as those pertaining to
biological interactions that may lead to eith er beneficial or adverse health
effects. This public meeting is scheduled for October 10; Assess the current
state of scientific knowledge pertaining to nanotechnology materials for
purposes of carrying out FDA's mission; Evaluate the effectiveness of the
agency's regulatory approaches and authorities to meet any unique challenge that
may be presented by the use of nanotechnology materials in FDA-regulated
products; Explore opportunities to foster innovation using nanotechnology
materials to develop safe and effective drugs, biologics and devices, and to
develop safe foods, feeds, and cosmetics; Continue to strengthen FDA's
collaborative relationships with other federal agencies, including the agencies
participating in the National Nanotechnology Initiative such as the National
Institutes of Health (NIH), the Environmental Protection Agency (EPA), and the
United States Department of Agriculture (USDA), as well as with foreign
government regulatory bodies, international organizatio n s, healthcare
professionals, industry, consumers, and other stakeholders to gather information
regarding nanotechnology materials used or that could be used in FDA-regulated
products; Consider appropriate vehicles for communicating with the public about
the use of nanotechnology materials in FDA-regulated products; Submit its
initial findings and recommendations to the Acting Commissioner within nine
months of the public meeting. The National Nanotechnology Initiative (a United
States government research and development coordinating program,) refers to
nanotechnology as "the understanding and control of matter at dimensions of
roughly 1 to 100 nanometers, where unique phenomena enable novel applications."
A nanometer is a billionth of a meter. A human hair is about 80,000 nanometers
in width. Materials made in the nanoscale size range can often have chemical or
physical properties that are different from those of their larger counterparts.
Such differences include altered magnet i c properties, altered electrical or
optical activity, increased structural integrity, and increased chemical and
biological activity. Because of these properties, nanotechnology materials have
great potential for use in a vast array of products. Also because of some of
their special properties, they may pose different safety issues than their
larger counterparts. For additional information about FDA's Public Meeting
scheduled for October 10,
CLICK HERE.
Ekahau and St. Croix Systems team up to integrate RTLS and
asset management
Ekahau Inc., a provider of Wi-Fi-based Real Time Location Systems (RTLS),
announced that it is collaborating with St. Croix Systems Corp. to deliver a
combined asset management, maintenance and real-time location solution for the
health care industry. The Ekahau RTLS now integrates with St. Croix Systems’
Capital Asset Lifecycle Management software. The combined solution enables
health care facilities to use their existing campus-wide wireless
infrastructures to track historical and real-time locations of their assets and
equipment. The addition of location tracking capabilities adds value to existing
asset management solutions by providing documentation of maintenance status,
condition, and availability for use, as well as exact life-to-date usage and
costs patterns of critical assets. Effective asset management in a health care
organization depends on the interplay of people and t echnology. The combined
management and tracking solution will enhance coordination and communication
between care givers and hospital support services leading to a safer more
efficient environment of care.
Tuesday, August 15, 2006
USDA says Michigan bird flu case no risk to humans
Why the
U.S. has not stemmed HIV
Cardinal Health & Mecmesin develop new syringe pump calibrator
Omnicell launches ProServ 1 Services Program, announces OptiFlex
system enhancements at AHRMM
Aeroscout enhances its Wi-Fi based active RFID
tag
USDA says Michigan bird flu case no risk
to humans
The bird flu virus has been found in a pair of wild swans in
Michigan, but U.S. officials said on Monday the birds have not
contracted the deadly H5N1 strain that has spread through
birds in Asia, Europe and Africa, killing more than 135
people. Routine tests conducted in a Michigan gaming area
found two of 20 swans have what government officials believe
is likely a low-pathogenic strain of H5N1. Confirmatory test
results are underway and will be available in about two weeks,
but officials stressed there is no threat to human health. "We
can definitely say this is not the H5N1 highly pathogenic
virus that's been found in Asia and other parts of the world,"
said the U.S. Agriculture Department's Ron DeHaven, head of
the Animal and Plant Health Inspection Service. "It's not the
introduction of that virus into North America." The swans had
shown no sign of sickness and test results indicate this is
low pathogenicity avian influenza. Pathogenicity refers to the
ability of the virus to produce a disease. A low-pathogenic
strain produces less disease and mortality in birds than does
a high-pathogenic version. Health officials and industry
analysts said they do not believe the infected swans came in
contact with U..S. commercial poultry. The low-pathogenic
strain of H5N1 has been found before in wild birds in the
United States, in 1975 and 1986. A similar low-pathogenic
strain was found in Canada last year. It is common for mild
and low pathogenic strains of bird flu to appear in the United
States and other countries. The infected swans were found as
part of an increased surveillance program put in place after
Congress approved a $29 million request by the Bush
administration in December. So far, more than 10,000 wild
birds have been tested. Just last week, the program was
expanded beyond Alaska, targeted because of its close
proximity to the Pacific Flyway with Asia, to the rest of the
country. "We see no cause for public hea lth and medical
authorities to take any special actions as a result of this
information," said Bill Raub, science advisor to the
Department of Health and Human Services. (Reuters)
Why the U.S. has not stemmed HIV
The number of new HIV infections in the United States has been about 40,000 a
year for the past decade and a half. It has not budged, not with new drugs, new
prevention strategies or new administrations. Five years ago, the Centers for
Disease Control and Prevention launched an effort to cut it in half. It did not
move. The intransigence of the AIDS epidemic in the place where it emerged, and
where many of the strategies against it have been developed, will be on the
minds of many this week as 20,000 people gather in Toronto for the 16th
International AIDS Conference. There is little question that, for public health
experts and AIDS activists, the fact that the HIV infection rate has not changed
since 1990 is an embarrassment. At the same time, it is a testament to a
victory, albeit one that happened long ago. AIDS was first recognized in June
1981. I ncidence of the disease, the number of new cases in a period, generally
a year, peaked at 160,000 in the mid-1980s. With intensive effort to reduce
risky behavior in gay men and, to a lesser extent in injecting drug users, it
fell to 40,000 by 1990. It has remained there since. The number of new HIV cases
each year has not changed despite a dramatic increase in HIV prevalence, the
number of Americans infected at a given time. That number stands at 1.1 million
and is growing as people on combination antiretroviral therapy live
far longer than AIDS patients used to. Deaths from AIDS in the United States
dropped from 52,000 in 1995 to 15,800 in 2004. Normally, a rising number of
infected people would lead to a rising number of new infections each year, as
more people are able to transmit the virus. But that is not happening. One of
the main reasons is that HIV-positive people today are more likely to know they
are infected, and t o know to take precautions, than was the case in the past.
Consequently, a stable rate of 40,000 new cases a year is a "very, very
significant finding," Ronald O. Valdiserri, deputy director of the CDC's HIV and
AIDS activities, said last week.. "We think it represents some level of success
in HIV prevention. We will not deny that we have a ways to go." Holtgrave, who
worked at the CDC and at Emory University before moving to Johns Hopkins, tried
to answer that in 2002 and recently updated his calculations. He estimates that
the number of new infections could be cut in half if the 5 million Americans at
highest risk of HIV, 4 million because of sexual activity and 1 million because
of drug use, received the full battery of proven interventions. Those include
HIV counseling and testing, free condoms, one-on-one or small-group counseling
sessions, and
needle exchange. The CDC now spends $720 million a year on HIV prevention. It
would need to spend $415 million more to reduce new cases by 50 percent,
according to Holtgrave's calculations. He and his collaborators further
estimated that the country would need to prevent 12,000 infections each year
to save money in the long run. HIV infection is expensive to treat, and newly
infected people will need to be treated for decades, a huge cost to the
health-care system. "I think it's fair and certainly honest to say that over the
past several years we've gotten more stringent with our funding," Valdiserri, of
the CDC, said last week. The CDC estimates that 17 percent of new infections
each year come from contaminated needles. Evidence suggests that 65 percent of
those could be prevented if every addict had access to a clean needle. However,
federal law prohibits using federal money for that purpose. (The Washington
Post)
Cardinal Health & Mecmesin develop new syringe pump
calibrator
Mecmesin, global supplier of force and torque testing systems, have recently
worked with Cardinal Health in joint development of an instrument to calibrate
the occlusion monitoring function of their syringe pump infusion systems. The
automatic detection of a blockage, or ‘occlusion’, which may halt infusion of a
drug to the patient, is a critical safety feature of a syringe pump. The
occlusion will present itself as a build-up of excess pressure behind the
syringe plunger, detectable by an integrated pressure sensor. An alarm is
triggered if the pressure exceeds a pre-defined safety level. The accuracy of
this sensor is therefore vital to ensure early occlusion detection, and
guarantee consistent drug dosage; hence regular calibration of the sensor is a
necessity. Working closely together, Cardinal Health and Mecmesin developed a
custom-engineered ‘occlusion tester’, comprised of a CFG 100N digital force
gauge with a special fixture designed to fit comfortably into the syringe seat.
Omnicell launches ProServ 1 Services Program, announces
OptiFlex system enhancements at AHRMM
At the AHRMM 44th Annual Conference & Exhibition at the Gaylord Palms Resort &
Convention Center in Orlando this week, Omnicell Inc. introduced its new
Omnicell ProServ 1 program of professional services to help customers maximize
their investment in Omnicell automation solutions. Omnicell ProServ 1 offerings
include the following categories of support: Omnicell OnSite consulting services
- Three levels of on-premises support provide day-to-day operational management,
periodic review, and custom engagement assistance; Reporting services - A series
of flexible reporting packages and services, available at various frequencies
(one-time, monthly or quarterly) and with summary and detailed data options
leverage the information generated from the use of Omnicell automation systems.
In addition, a comprehensive executive dashboard, capturing critical operational
and financial metrics, is offered; Benchmarking services - Available on a
quarterly basis, Omn icell ProServ 1 benchmarking services enable healthcare
facilities to compare themselves against other similar Omnicell customers on a
variety of key operational and financial metrics; Database services - Assistance
in diagnosing and/or cleansing databases is offered to help healthcare
facilities manage their systems; Operational services - Secure hosted
operational services, such as OmniBuyer, Omnicell's Web-based requisitioning and
purchasing system, are available.Omnicell also. introduced new management,
security and tracking enhancements to its OptiFlex SS supply management system
for hospital surgical services units. OptiFlex SS is a physician preference card
system as well as a perpetual inventory management system for all supply
management requirements of the surgical services department. New enhancements to
OptiFlex SS include: The ability to globally manage items across pre ference
cards and physicians, ensurin g accuracy and eliminating manual work; Security
improvements, including bolstered system password and user timeout features a s
required by HIPAA; Track expiration date, lot number, and serial numbers easily
via bar code scanning, eliminating manual tracking.Omnicell introduced new
inventory management, cost tracking and usability enhancements to its OptiFlex
MS supply management system for hospital medical-surgical units. OptiFlex MS is
a complete, integrated system for managing supplies in closed cabinets and open
shelves in medical-surgical nursing units. New enhancements to OptiFlex MS
include: Expansion of inventory control reporting capability, allowing inclusion
of multiple departments/pars; Security improvements, including bolstered system
password and user timeout feature s as required by HIPAA; central management of
user credential authentication; and expanded availability of the magnetic card
reader feature for improved system access control; Inventory management and cost
tracking for temporary patients; Improved cost tracking and inventory management
features, including the ability to store purchase unit of measure information at
the item level and the true cost of item at time of issue to patients, improving
accuracy of cost analysis; Additional user-friendly features, including improved
guiding light functionality, making it easier for users to locate needed
inventory items. Omnicell introduced new case, product and patient tracking
enhancements to its OptiFlex CL supply management system for hospital cath labs,
endoscopy and other special procedure units. OptiFlex CL is a specialty area
management system with real-time point-of-use data collection that tracks
supplies and procedures to the physician for cost management and automated
charge capture. New enhancements to OptiFlex CL include: Track case costs via
user defined case types (e.g., diagnostic and interventional radiology,
endoscopy, electrophysiology) back to the case, physician, patient and
technician, ensuring accuracy and cost control; Track expiration date, lot
number, and serial numbers easily via bar code scanning, eliminating manual
tracking; Inventory management and cost tracking for temporary patients. The
enhanced versions of the OptiFlex systems were successfully beta tested at St.
Patrick Hospital and Health Sciences Center in Missoula, MT.
Aeroscout enhances its Wi-Fi based active RFID tag
AeroScout Inc., a provider of Wi-Fi-based Active RFID visibility
solutions, announced several enhanced features and capabilities for its
AeroScout T2 Tag. The T2 tag is the industry's leading Wi-Fi-based Active RFID
tag for asset tracking and management, with tens of thousands of units being
shipped each month to customers around the globe.
New
features on the AeroScout T2 Tag include a built-in temperature monitor and
motion sensor, for unmatched asset management capabilities. The motion sensor
provides transmission control based on movement of the tag, improving real-time
location accuracy and enabling a 4+ year battery life in most customer
environments. The temperature sensor provides an additional stream of asset
management data for environment-sensitive assets, enabling the tag to wirelessly
trigger a remote alert if the temperature goes above or below a certain
threshold. In addition, advanced call button and LED functions, intrinsically
safe and electromagnetic certifications on the tag, and extendable battery life
(up to 8 years) all enable customers to further enhance their asset management
capabilities.
Built-in motion sensor gives greater efficiency to the tag's performance and
advanced real-time visibility. The tag can be configured for different
transmission rates when static or in motion. For example, an infusion pump in a
hospital can be set to transmit every ten seconds while in motion, updating its
location in real-time, but will transmit only once an hour while stationary to
conserve energy and reduce network overhead. Using the AeroScout MobileView
software application, users can confirm whether an asset is in motion or
stationary. Optional built-in temperature sensor is a valuable tool which can be
programmed to wirelessly report its temperature, enabling customers to view both
the asset's location and its temperature from the Web-based MobileView
interface. In addition, customers can enable automated temperature-based alerts.
For example, a refrigerated trailer in a shipping yard can trigger an alert to
the yard manager's pager, if the internal temperature in the trailer is too high
and threatens spoilage. Advanced call button functionality enables the tag's
call button to be used for multiple business purposes simultaneously. Customers
can configure different patterns, such as multiple clicks or long-versus-short
clicks, to represent different assets statuses or alerts. Electromagnetic
compatibility certification ensures that the T2 tag is safe for use within
environments with other critical electronic devices, such as hospitals. This
certification ,
IEC
60601-1-2,
is recognized by the FDA in the United States, as well as all EU nations and
several other countries worldwide. Optional intrinsically safe tags ensure
safety for customers in explosion-prone environments such as mining and oil
refineries. The Intrinsically Safe T2 Tag follows the same dimensions as the
standard tag, and is available with or without the call button. Expanded LED
functionality adds the option for up to three different colored LED lights on
the tag when unique visual identification is needed for large inventory
settings. Optional extended battery life configuration enables to extend tag
battery life for up to 8 years. The T2 tags are a key component of the AeroScout
Visibility System, a complete suite of products utilizing Wi-Fi standards for
asset visibility and process improvement. The system can employ existing
wireless access points to act as Active RFID readers, without needing additional
networking equipment or disrupting voice and data communications.
Monday, August 14, 2006
Study: 4-Drug AIDS cocktail no advantage
Abbott expands its AIDS program; 45 countries to get drug at
lower price
GOJO hand cleaners EcoLogo and Green Seal certified
Kelsey-Seybold Clinic chooses MedAsets Supply Chain Systems for
Pharmacy Purchasing Solutions
Aethon redefines hospital asset tracking with HOMER
Study: 4-Drug AIDS cocktail no advantage
A four-drug cocktail isn't any better for treating newly diagnosed HIV infection
than the standard three-drug regimen, according to a study that followed 765
patients for three years. The finding is welcome news to patient advocates,
despite the lack of a step forward in treatment. Adding a fourth drug would have
raised costs in an already overburdened system in which some states report
waiting lists of uninsured patients who need help paying for their HIV drugs.
The annual cost per person for antiretroviral drug therapy in 2001 was about
$11,000 a year, according to a previous study. Murray Penner of the National
Alliance of State and Territorial AIDS Directors estimated that adding more
drugs to already complex regimens could cost health systems millions of dollars
more. Adding a drug to the cocktail also could increase side effects and the
potential for dangerous drug interactions, said Jim Pickett of the AIDS
Foundation of Chicago. The new study clears up a ling ering question posed by
the conflicting results of prior studies. Some smaller studies had found a
quicker effect at beating back the virus when more drugs were added to the
cocktail, while others found no added benefit. "Triple drug therapy has been the
standard approach to treatment of HIV infection for a decade or so, but there's
always been a question about whether we could do better with more drugs," said
study co-author Dr. Dan Kuritzkes of Harvard's Brigham and Women's Hospital.
"This reaffirms the potency of the current standard of care," Kuritzkes said.
Researchers made the two drug cocktails equally easy for patients to take,
delivering both in five pills taken daily. Patients and their doctors didn't
know which cocktail they were getting. The study will appear in Wednesday's
Journal of the American Medical Association and was released Sunday to coincide
with the opening of the 16th International AIDS Conference. Researchers found
that the four-drug cocktail, which a dded the HIV drug abacavir, had no
advantage in reducing the amount of virus in patients' blood. Compared with
standard therapy, it also didn't increase levels of CD4 cells that fight
infection. "Over the entire course of the study, at no point did there seem to
be an advantage of the four-drug regimen," Kuritzkes said. Supported by grants
from the National Institutes of Health, the research was conducted at more than
40 U.S. sites. Several pharmaceutical companies provided drugs. Some of the
researchers, including Kuritzkes, reported financial ties with the makers of HIV
drugs. More than half the patients in the study were black or Hispanic and
almost 20 percent were female. "It was a pretty diverse population that reflects
the epidemic today," Kuritzkes said. Black patients who took the drugs as
directed did as well as white patients, but blacks who did not adhere precisely
to the drug routine returned to high virus levels quicker than whites who didn't
take the drugs as prescr ib ed. The reason for the difference wasn't clear,
Kuritzkes said. For more on the International AIDS Conference CLICK
HERE. (The Associated Press)
Abbott expands its AIDS program; 45 countries to get drug at
lower price
Under criticism for pricing of its AIDS drugs, Abbott Laboratories has added 45
countries to its preferential pricing program, reaching beyond just the poorest
of nations in the world to the "low- to low-middle income." The Chicago-based
drug giant already makes its blockbuster AIDS pill Kaletra available for $500
per patient per year in 69 of the poorest countries, including all of Africa. In
the United States, Kaletra costs more than $7,500 a year per patient. In
expanding the program Abbott said it would add countries considered "low
income," such as India, Vietnam and Pakistan, as well as "lower middle income"
economies, including China, Syria, Jordan and several countries in South America
and Asia. These additional 45 countries will pay $2,200 a year per patient,
reduced from the $3,300 or $5,000 a year they had been paying, an Abbott
spokeswoman said. (Chicago Tribune)
GOJO hand cleaners EcoLogo and Green Seal certified
GOJO is proud to be the first to provide a family of environmentally preferable
products that meet the new EcoLogo (Environmental Choice) and Green Seal
certifications (CCD-104/GS-41) for Hand Cleaners and Hand Soaps. The family of
products, which will be available in early Fall 2006, includes GOJO’s Green
Certified Foam Hand Cleaner and Green Certified Lotion Hand Cleaner. Once a
manufacturer attains certification from one of these organizations, the company
may place the widely recognized EcoLogo and/or Green Seal logo on the product.
This helps buyers, both consumer and corporate, select sustainable products that
help protect the environment. EcoLogo categorizes hand cleaners as “those
products designed to remove both organic and inorganic soil from skin”. They
usually fall into two specific categories: industrial and institutional.
Industrial hand cleaners are usually found in such places as auto manufacturing
and repair facilities, factories, print shops, and similar industrial settings.
Institutional hand cleaners are most often found in the public washrooms of
airports, restaurants, retail stores, educational facilities, and office
buildings. “Hand soaps and similar cleaners can negatively impact indoor air
quality and often contain ingredients that irritate the skin and eyes,” said
Scott McDougall, President of EcoLogo. “And when the active ingredients in these
products are washed down drains, they have the potential to harm waterways and
aquatic ecosystems. We commend GOJO on their products and ongoing efforts to
help protect our environment.”
In order to attain EcoLogo’s CCD-104 certification for hand cleaners, the
manufacturer must
demonstrate
environmental leadership throughout the product’s life cycle. Additionally,
they
must
meet requirements such as: Perform as well as or better than conventional hand
cleaners; Have limited toxicity, helping protect waterways, aquatic life, and
other organisms; Are biodegradable, producing minimal waste; Have eliminated or
reduced ingredients considered likely to negatively impact h ealth a nd th e
environment; Are derived from sustainable sources. For more information, contact
EcoLogo toll-free at 1-800-478-0399 or visit
www.ecologo.org.
Kelsey-Seybold Clinic chooses MedAsets Supply Chain
Systems for Pharmacy Purchasing Solutions
MedAssets announced that Kelsey-Seybold Clinic, based in Houston, TX, has
selected MedAssets Supply Chain Systems to implement supply chain solutions for
pharmacy. The multi-year relationship was effective February 2006.
Kelsey-Seybold Clinic was previously affiliated with Premier for pharmacy
purchasing services. Through the agreement, Kelsey-Seybold Clinic will be
utilizing MedAssets’ contract portfolio and CDQuick on-line catalog. Access to
the MedAssets’ contracts and supply chain technology will provide cost savings
and improved operational efficiencies for the organization’s 18 clinics and
ambulatory surgery center. Kelsey-Seybold Clinic will be taking part in
MedAssets’ Clinical Pharmacy Consulting Program which includes the Pharmacy
Audit tool, a disease state management program which supports Kelsey-Seybold’s
own physician-drive n programs via clinical information; a comprehensive
professional educational program; and other decision support tools.
Aethon redefines hospital asset tracking with HOMER
At AHRMM's Annual Conference & Exhibition - August 13, 2006, in Orlando, FL, Aethon
Inc., a provider of practical robotics, introduced HOMER, an asset management
solution designed to locate and recover hospital equipment. HOMER, a fast
growing Radio Frequency Identification (RFID)-based asset tracking
system, also allows hospitals to avoid major infrastructure investments. In the
fast-paced hospital environment, equipment is constantly moving and often hard
to find. By tracking the location of assets, hospitals can improve staff
efficiency and satisfaction, increase asset utilization, decrease equipment
rentals, and improve regulatory compliance. "HOMER increases confidence that
equipment will be in the right place at the right time," said Aldo Zini, Chief
Executive Officer, Aethon. "It is a complete solution, which improves workflow
dynamics in hospitals, because it's the only asset tracking system capable of
automated transportation." HOMER's unique asset tracking capabilities are an
outgrowth of technology made possible by TUGTM, a robotic hospital delivery
system. Leveraging the TUG platform and employing a single mobile antenna
eliminates the typical infrastructure hurdles of competitors' systems. This
translates into more efficient organization and location of pumps, wheelchairs,
monitors, respirators, beds and virtually any other assets hospitals are
interested in tracking. A cost-effective and nimble solution, HOMER can
seamlessly merge with existing hospital systems and requires minimal
installation. HOMER works with active RFID tags (unique identifiers). Because it
can use any third-party tag, HOMER is tag independent. Furthermore, HOMER can be
integrated into existing asset management software. Aethon provides
installation, tag selection and setup, software integration, training and
support.
Friday, August 11, 2006
GlaxoSmithKline settles claim of inflating prices on cancer
drugs
FDA statement on JAMA article on recalls and safety alerts
affecting AEDs
FDA warns three pharmacies to stop
mass-producing unapproved inhalation drugs
Study finds that a type of cancer in dogs
is contagious
Battling breast cancer with The Pink Glove
GlaxoSmithKline settles claim of inflating
prices on cancer drugs
GlaxoSmithKline Inc. has agreed to pay more than $41 million in restitution to
end claims by more than 40 states that it inflated the prices of drugs used by
cancer patients and others. The settlement announced Thursday with the U.S.
Justice Department, National Association of Medicaid Fraud Control Units and New
York Attorney General Eliot Spitzer will include more than $1.5 million in
restitution to New York state's Medicaid program for cancer drugs and $940,000
in connection with pricing of an antibiotic, Spitzer said. With some state
lawsuits still pending on behalf of consumers and government health plans, the
company expects eventually to pay a total of $70 million, said Mary Anne Rhyne,
spokeswoman for the British company. They include civil actions by the attorneys
general of New York, California, Connecticut, Nevada, Montana and Arizona. The
cost will be covered by the company's existing legal reserve, she said. She said
testimony showed states and health plans chose to use the company’s drugs at the
set prices “although it has been widely known for years that (average wholesale
price) exceeds the prices actually paid by physicians, pharmacies and others,”
according to the company's prepared statement. “Nevertheless, GSK has agreed to
settle the cases, without admitting wrongdoing, to put this historical matter
behind it,” the company stated. Connecticut Attorney General Richard Bluementhal
called it a “brazen scheme.” “The fraud is especially shameful because the
company sought to increase sales by manipulating prices instead of competing
honestly,” he said. In a separate settlement of a private class action lawsuit,
the drug company will also fund a $40 million restitution fund for the poor and
needy who use the Medicaid health care system nationwide and New York's Elderly
Pharmaceutical Insurance Coverage plan, Spitzer said. That suit was settled in
federal court in Boston. “Our lawsuit helped stop a long-standing practice that
inflated the cost of drugs for people suffering from cancer and cheated the
Medicaid system” Spitzer said. “Today's settlement provides significant
restitution for consumers and the Medicaid program.” Spitzer had accused the
company of inflating average wholesale prices of drugs in the class
“anti-emetics” that help patients overcome the nausea and other effects of
chemotherapy to fight cancer. In turn, health plans and consumers overpaid and
government health plans reimbursed drug stores and physicians based on the
inflated prices. People on Medicare, the health plan for the elderly, also
overpaid because they allegedly paid a percentage of the inflated prices,
Spitzer said. An inflated average wholesale price also allowed the company to
market the drugs to health care providers as coming with a “spread” between the
wholesale price and actual price that could be pocketed by doctors and others to
choose the GlaxoSmithKline product, Spitzer said. The company also paid the New
York Attorney General's Office $750,000 for the cost of the investigation.
(Associated Press, Newsday Inc.)
FDA statement on JAMA article on recalls and safety alerts
affecting AEDs
Automatic external defibrillators (AEDs) are important medical devices. Numerous
studies have shown that thousands of lives are saved each year using these
devices to treat patients in sudden cardiac arrest. In the past decade, these
devices have become simpler to use and have been placed in more public places
like airports and schools. A recent article in the Journal of American Medical
Association (JAMA) titled Recalls and Safety Alerts Affecting Automated External
Defibrillators helps inform the public about the safety of AEDs. FDA supports
the kind of research and most of the conclusions reached in the JAMA article are
consistent with FDA's own findings. However, there are a few points on which the
agency differs. First, the authors assert that manufacturers are unable to track
AED units, making it impossible to know how many AED units were actually fixed
or taken out of service. However, under FDA regulations, manufacturers are
required to track AEDs and are doing so with processes in place to identify the
location of a device in the event of a recall. Our records show that these
devices are being tracked with a high level of accuracy. In fact, more than 95
percent of the AEDs affected by Class I recalls in 2005 were returned to the
manufacturers or taken out of service. Fewer than three percent were lost or
stolen. Second, the authors state that there has been an increase in the number
of AEDs affected by advisories during the study period. This is true, however,
FDA believes that improvements in the devices' ability to self-diagnose hardware
and software problems may contribute to this trend. This capability may result
in users reporting problems before a device is ever used on a patient. Also,
while more than 21 percent of AEDs were affected by an advisory, it does not
necessarily mean that they malfunctioned. A device advisory is issued when a
medical device has the potential
to exhibit a certain failure mode, not only when a device has, in fact, failed.
We continue to depend on our ability to work with owners of AEDs when these
devices are subject to a recall and have taken steps in recent months to improve
our communication and collaboration with the broader community. AED users should
continue to report device malfunctions to the manufacturer and to FDA. In
addition, users should heed device error messages and warnings during regular
device self-checks and respond appropriately to recall notices and safety
alerts. For more information, visit
www.fda.gov.
FDA warns three pharmacies to stop mass-producing unapproved
inhalation drugs
The Food
and Drug Administration (FDA) has warned three firms, RoTech Healthcare, Inc.,
CCS Medical, and Reliant Pharmacy Services, to stop manufacturing and
distributing thousands of doses of compounded, unapproved inhalation drugs
nation-wide. Responsible officials at firms that do not properly address
violations identified in FDA warning letters risk further enforcement, including
injunctions that prevent further violations and seizure of their products that
violate the law. The three firms warned by FDA say that they produce inhalation
drugs as part of the practice of pharmacy compounding. Traditional pharmacy
compounding typically involves pharmacies preparing drugs that are not
commercially available, such as a unique medicine for a patient who is allergic
to an ingredient in a FDA-approved drug. This kind of compounding follows a
physician's decision that his or her patient has a special medical need that
cannot be met by FDA-approved drugs. FDA normally permits traditional pharmacy
compounding and the agency's action is not targeting this practice. Inhalation
drugs are used to treat diseases including asthma, emphysema, bronchitis, and
cystic fibrosis. Compounded inhalation drugs may be distributed to patients in
multiple states, and patients and their doctors may not know that they are
receiving compounded products. FDA urges consumers using inhalation drugs to
discuss their medications with their physicians and verify with their
pharmacists that the medications they received are what their physicians
ordered. “Compounded inhalation drugs are not reviewed by the FDA for safety and
effectiveness, often are not produced according to good drug manufacturing
practice, and typically are not sterile. This may expose patients to unnecessary
risk,” said Dr. Steven Galson, Director of FDA's Center for Drug Evaluation and
Research. “To avoid these risks, we encourage patients to use FDA-approved drugs
whenever possible.” FDA believes that, in compounding mass amounts of inhalation
drugs, a number of pharmacies go well beyond traditional compounding. FDA is
aware of certain pharmacies compounding millions of doses of inhalation drugs
per year. These compounded drugs often simply copy FDA-approved, commercially
available drugs, and any differences from FDA-approved drugs do not appear to be
related to patients' medical needs. Consumers and health care professionals
should notify FDA of any complaints or problems associated with compounded
drugs. These reports may be made to MedWatch, FDA's voluntary reporting program,
by phone at 1-800-FDA-1088 or online at
www.fda.gov/medwatch/report.htm.
Study finds that a type of cancer in
dogs is contagious
Scientists in England
have gathered definitive evidence that a kind of cancer in dogs is contagious, a
peculiar exception to the age-old medical wisdom that you can't “catch” cancer.
Although no human cancer is known to spread naturally from person to person, the
finding of such a disease in dogs, and emerging evidence that a different
contagious cancer is spreading among marsupials in Tasmania, is a reminder,
scientists said, that under the rules of evolution, DNA will try anything to
perpetuate itself. Cancer-causing viruses may spread from person to person, but
the cancer does not. But the dog cancer, known as Sticker's sarcoma, is spread
by tumor cells getting passed from dog to dog through sex or from animals biting
or licking each other. Because Sticker's sarcoma is usually not fatal, and
because some of the tumor cells reside in the dogs' genital tracts, today's
worldwide distribution of Sticker's tumors represents a single colony of cancer
cells, the new research concludes. Indeed, scientists suspect that the colony,
distributed among countless dogs, may be the longest in the world. Scientists
have suspected for decades that Sticker’s was being passed directly from dog to
dog, but doubts persisted because no other naturally transmitted cancers were
known. Rarely, recipients of human organ transplants have “caught” cancer from
tumor cells hiding in the organs they received. Weiss and his colleagues did
genetic studies on the tumor cells from 40 dogs with Sticker's sarcoma,
collected from five continents. The researchers showed that the cells are not
genetically related to the dogs they are in, proof that they did not arise from
the dogs’ own cells. Further genetic studies by Weiss's team suggested that the
parent cell probably arose in a domesticated dog of Asian origin, perhaps a
husky, hundreds of years ago, and perhaps more than 1,000 years ago. Since then,
the cancer has perpetuated itself by jumping from one dog to another. For
the whole story
CLICK HERE (The
Washington Post)
Battling breast cancer with The Pink Glove
International spa products distributor Universal Companies has joined
hands with Intrinsics single-use essentials, and ERGO styling tools
to fight breast cancer with The Pink Glove project. Available beginning in
September, $5.50 from the sale of each box of pink vinyl gloves will be donated
to City of Hope, a leading Southern California biomedical research and treatment
center and hospital for cancer and other life-threatening diseases. “We are very
hopeful that people will want to partner with us in this effort to increase
funding to battle breast cancer,” said Universal Founder and CEO Marti Morenings.
“All of us have been touched either personally or by a friend or loved one
suffering from breast cancer. City of
Hope is doing amazing research on fighting breast cancer, and
we’re privileged to be a part of that work.”
When spas, salons, and
healthcare providers purchase and use the pink vinyl gloves while performing
services, they are not only donating to City of Hope, but also demonstrating
their support and building awareness of breast cancer research, treatment, and
education among their clients. The Pink Glove is lightly powdered and available
in small and medium sizes. A box of 100 latex-free gloves may be purchased for
$9.99. To order, please visit
http://www.thepinkglove.com/.
Thursday, August 10, 2006
FDA seeking comments on use of Identifier System for medical
devices
Reaction mixed to latest round of CMS Regs
Bird flu monitoring expands nationally
Genetic
test aids lung cancer fight
High-dose
statins following a stroke can prevent a second
SCCM to
host new conference on quality and safety; pre-course to highlight rapid
response teams
U.K.-based
Radal Technology introduces risk management products to the U.S.
FDA seeking comments on use of Identifier
System for medical devices
The Food and Drug
Administration (FDA) is seeking information for the next 90 days, on how the use
of a unique identifier system for medical devices may reduce medical errors,
facilitate device recalls and improve medical device adverse event reporting.
The comments will be used to help the agency determine what next steps the
agency should take related to a unique device identifier (UDI) system for
medical devices. "Much like the bar code rule for drugs and biological products,
unique identifiers for medical devices could have many potential benefits for
improving the quality of care for patients," said Daniel Schultz, M.D.,
Director, Center for Devices and Radiological Health, FDA. "A unique device
identifier system could have broad applications in reducing medical errors,
facilitating device recalls, improving medical device adverse event reporting
and encouraging cost effectiveness by improving delivery and supply chain
efficiency." The number and complexity of medical devices is growing. It is
important for FDA to quickly identify new risks and work with industry and
device users to manage these risks appropriately. A UDI system may be used to
identify a device and the information associated with that device throughout its
lifetime. For example, a UDI could identify which devices are compatible, such
as implanted devices being used safely with magnetic resonance imaging (MRI)
systems.FDA also commissioned two reports from outside experts on automatic and
unique identification of medical devices. The reports identified several
potential benefits of a UDI system, including identifying incompatibility with
devices or potential allergic reactions. In addition, FDA has been working with
the Agency for Healthcare Research and Quality (AHRQ) in the U.S. Department of
Health and Human Services (HHS) and with other federal partners to better
understand the issues with the development, implementation and use of a UDI
system. During the comment period, FDA wants to learn about the feasibility,
utility, benefits and costs associated with developing and implementing a UDI
system for medical devices. In addition, the agency wants to hear about various
automatic identification technologies, such as bar code and radiofrequency,
which could be used with a UDI system. A list of questions as well as what a UDI
could look like, are included in the Federal Register notice. To submit
electronic comments, visit
www.fda.gov/dockets/ecomments. For more information, visit
www.fda.gov/cdrh/ocd/udi/index.html.
Reaction mixed to latest round of CMS Regs
Critics
of doctor-owned specialty hospitals reacted favorably to aspects of a plan
issued late Tuesday by the Medicare program to tighten oversight of the
facilities, but they stuck to their view that the facilities should be banned.
The plan “is important,” said Senate Finance Chairman Charles E. Grassley,
R-Iowa, but “these steps alone won’t unravel the web of conflicts that have been
created by these limited-service hospitals, which cherry-pick patients based on
dollars rather than diagnosis and put the well-being of both individual patients
and the health care delivery system at risk.” Doctor-owned specialty hospitals
limit themselves to
certain procedures — cardiovascular surgery, for example — that according to
critics are highly lucrative and siphon off patients from traditional hospitals
they need to be able to offer services with low or no profit margins. Similarly,
the American Hospital Association, which depicts doctor-owned specialty
hospitals as a threat to the survival of the traditional hospital, praised the
plan’s requirement that physician-owners disclose to patients their financial
interest in the facilities. “Patients have a right to know whether a conflict of
interest may affect their care,” said Thomas Nickels, AHA senior vice president.
Nickels also praised the Centers for Medicare and Medicaid Services plan for
requiring the facilities to disclose what percentage each physician-investor
owns and how much he or she is being paid. In cases where the percentage of
profits received by a physician exceeds the percentage representing his or her
ownership stake, CMS could prosecute the specialty hospital for violating laws
barring kickbacks for referrals. But “given the growing evidence that financial
interest may be overtaking patient interest, the AHA continues to believe
physician self-referral to limited-service hospitals they own should be banned,”
he said. Grassley and top Finance Committee Democrat Max Baucus of Montana had
urged CMS to delay issuance of the regulatory plan, citing flaws in a survey on
which the plan was based. Delaying the plan would have extended a CMS
administrative moratorium on enrolling new doctor-owned specialty hospitals as
Medicare providers. But CMS Administrator Mark B. McClellan defended the survey
in a letter Tuesday to the two senators, blaming problems in the survey in part
on a low response rate by hospitals. CMS declined to extend the moratorium. (CQ
Healthbeat)
Bird flu monitoring expands nationally
Monitoring of wild migratory birds to prevent a deadly
bird flu
virus is expanding
to cover the entire nation and U.S. territories in the Pacific. The stepped-up
testing will be done by scientists in the lower 48 states, Hawaii and other
Pacific islands. They will begin keeping an eye out for the deadly H5N1 strain
of the avian flu that has killed more than 100 people, mostly in Asia. In
Alaska, where the first migratory birds began arriving, monitoring started just
before summer. “This move to test thousands more wild birds throughout the
country will help us to quickly identify, respond and control the virus if it
arrives in the United States,” Agriculture Secretary Mike Johanns said. “Because
we cannot control wild birds, our best protection is an early warning system.”
Interior Secretary Dirk Kempthorne said more coordinated monitoring by federal
agencies, states and universities “will be important this fall as birds now
nesting in Alaska and Canada begin their migration south through the continental
United States.” The Agriculture and Interior departments are providing $4
million to state agencies to collect samples from specific species of migratory
birds winging along four major U.S. migratory bird flyways. Congress budgeted
$29 million for monitoring for the highly pathogenic strain of bird flu. Feces
or tissue samples from 75,000 to 100,000 wild birds will be collected, along
with 50,000 samples of the water and ground that birds come into contact with.
Locations where the samples will be collected will vary depending on weather and
habitat conditions. Likely sites include national and state wildlife refuges and
parks, city ponds and parks, and private lands where owners have given approval.
(The Associated Press)
Genetic test aids lung cancer fight
Scientists have developed
a powerful new genetic test to determine which lung cancer patients should get
chemotherapy, saying the advance could save thousands of lives every year and
heralds the growing importance of genetic profiling in cancer care. Patients
whose lung cancer is caught at the earliest stage typically do not get
chemotherapy, because the benefits outweigh the toxic side effects of the drugs
only for a subset of patients likely to suffer a recurrence. The new test allows
doctors for the first time to identify which patients are at greatest risk for a
recurrence, an almost certain death sentence, and then give them chemotherapy.
The results, described in the New England Journal of Medicine, are so
promising that researchers are launching a broad, government-funded clinical
trial of the test within the next six months, including some 1,200 patients at
about 60 sites in the United States and Canada. Using new genetic tools, doctors
are learning how to measure the characteristics of a particular patient’s tumor
and use this information to mount a more effective counterattack. This
“personalized medicine” is already saving lives of patients with breast cancer
and leukemia, and the list of diseases is now expected to grow. Similar tests
are being developed for colon, prostate, and other cancers. One of the great
frustrations of cancer medicine is that tumors that look the same do not always
act the same, leaving doctors unsure how to treat patients. Now, scientists are
learning to distinguish cancers by the genetic machinery at work in the tumors.
Some tumors may have distinctive mutations in their DNA. Tumors may also have
telltale patterns of genes that are active. At any given moment, some genes in a
tumor are turned on, making proteins, and others are turned off. Identifying the
“on” genes is known as measuring “gene expression,” and this is the method used
in the lung cancer study, which was led by scientists at Duke University. The
scientists at Duke identified patterns of active genes typical of more lethal
tumors. The work could provide pharmaceutical companies clues that will help
develop drugs and help scientists understand the disease's inner workings,
according to Tyler Jacks, a lung cancer researcher who is also director of the
MIT Center for Cancer Research. The test could also have broad clinical
applications, according to Dr. Anil Potti, who led the study and is an assistant
professor at Duke. Initially, it will be used to identify patients with stage 1
non-small cell lung cancer, a common form of the disease, who would benefit from
chemotherapy. The team also hopes to identify patients with later stages of the
disease who are unlikely to benefit from chemotherapy, saving them the rigors of
the drugs. And, Potti said, the team has early data that suggest the same
genetic tools can identify which chemotherapy drug will work best on which
patient's tumors. This could also have applications in the treatment of breast
cancer, where doctors use some of the same chemotherapy drugs, he said. Between
40,000 and 45,000 patients are diagnosed with stage 1 non-small cell lung cancer
every year in North America, Potti said. Typically, a surgeon will remove the
tumor, but the patient is not given chemotherapy. Between 40 percent and 50
percent of patients will have a recurrence, and virtually all of these patients
die. Preventing even some of these deaths would mean thousands of lives saved
every year, Potti said. (Boston Globe)
High-dose statins following a stroke can prevent a second
Loading up on a statin
within six months of a stroke or transient ischemic attack reduced the risk of
recurrent stroke or TIA, according to results of a major trial. Lipitor (atorvastatin)
at 80 mg/day begun during that period was associated with 2.2% five-year
absolute reduction in risk of stroke and a 16% relative reduction in risk of
fatal or nonfatal stroke, found the SPARCL (Stroke Prevention by Aggressive
Reduction in Cholesterol Levels) trial, reported K. Michael Welch, M.B., Ch.B.,
of Rosalind Franklin University of Medicine and Science, and colleagues, in the
Aug. 10 issue of the New England Journal of Medicine. It's not news that
patients with established cardiovascular disease are less likely to have a
stroke if they are taking statins, but Dr. Welch and colleagues wrote that it
was unknown whether statins could reduce stroke risk in the absence of
established heart disease. SPARCL, they contend, answered that lingering
question. In an accompanying editorial, David M. Kent, M.D., of the Institute
for Clinical Research and Health Policy Studies at Tufts-New England Medical
Center in Boston wrote that the case for a change in recommendations is not so
clear cut. He pointed out that “the relative risk of hemorrhagic stroke was
increased by 66% among patients in the [Lipitor arm], an effect that is likely
to be of some import among patients presenting with a hemorrhagic stroke.”
Although Dr. Kent was not persuaded that high dose Lipitor should be recommended
for all stroke or TIA survivors, he predicted that the SPARCL trial results are
likely to add to the “gathering momentum favoring the promotion of ischemic
stroke to a ‘coronary heart disease risk equivalent,’ the adoption of statin
therapy on discharge as a ‘quality indicator,’ and the inclusion of statins in
preprinted stroke orders to improve adherence by physicians.” The SPARCL trial
was supported by Pfizer, maker of Lipitor. Dr. Welch reported having received
consulting fees from Eisai, GlaxoSmithKline, Medpointe, AstraZeneca, NMT
Medical, and Ortho-McNeil; lecture fees from GlaxoSmithKline; and grant support
from Pfizer. Dr. Kent reported having received grant support from Pfizer. (MedPage
Today)
SCCM to host new conference on quality and safety; pre-course
to highlight rapid response teams
Initiating a rapid response team (RRT) in the hospital setting can decrease
patient deaths, according to the Institute for Healthcare Improvement’s 100,000
Lives Campaign. Hospitals that participated in the Campaign implemented up to
six evidence-based and lifesaving interventions, including initiating an RRT, to
prevent an estimated 122,300 avoidable deaths. The Society of Critical Care
Medicine (SCCM) is a Scientific Partner to the Campaign and recognizes the
importance of RRTs in the hospital setting. As a result, SCCM developed the
Rapid Response System Training for First Responders course, to be held on
September 21, 2006, in Baltimore, MD. The Rapid Response System Training for
First Responders course will offer an international perspective on how to train
team members while affording smaller group discussions to analyze real-world
case studies. Participants will receive the paper, “Findings of the First
Consensus Conference on Medical Emergency Teams,” by Michael A. DeVita, MD, from
the University of Pittsburgh. This paper addresses questions regarding benefit,
design elements, and advisability of implementing an RRT system. The paper will
be published in the September issue of Critical Care Medicine. Rapid
Response System Training for First Responders is a pre-course to SCCM’s new
conference Excellence in Quality and Safety in Critical Care, to be held
September 22 and 23, 2006, in Baltimore, MD. Clinical shortages, coupled with
diminishing resources and rising medical costs, are straining healthcare
organizations as well as personnel. This multifaceted dilemma can impede the
practitioners’ ability to deliver high-quality patient care. To assist
healthcare professionals, SCCM developed the progressive conference,
Excellence in Quality and Safety in Critical Care. The conference will
address administrative and clinical problem areas to identify everyday solutions
that critical care professionals can use in their practices. For more
information, CLICK HERE.
U.K.-based Radal Technology introduces risk management products to the U.S.
Radal Technology Limited, a U.K.- based company specializing in the design,
manufacture and distribution of risk management products, announced its
expansion into the North American market. Radal Technology provides sensor
technology specifically aimed at reducing facility risks associated with
cigarette smoking, slip-and-fall accidents and hygiene. The company’s speech
messaging unit can be programmed to verbally alert occupants of wet or slippery
floors or remind employees to wash their hands, for example. For more
information CLICK HERE.
Wednesday, August 9, 2006
ARAMARK announces signing of merger agreement
CMS
announces payment revisions
Appropriateness criteria issued for cardiac computed tomography,
cardiac magnetic resonance imaging
Doubt is raised on defibrillators;
Devices do save lives
but can sometimes fail
Number of uninsured children declines as
enrollees
in state health insurance programs increase
ARAMARK announces signing of merger
agreement
ARAMARK
Corporation announced Tuesday, that it has signed a definitive merger agreement
under which Joseph Neubauer and investment funds managed by GS Capital Partners,
CCMP Capital Advisors and J.P. Morgan Partners, Thomas H. Lee Partners and
Warburg Pincus LLC will acquire ARAMARK in a transaction valued at approximately
$8.3 billion, including the assumption or repayment of approximately $2.0
billion of debt. ARAMARK is a leader in professional services, providing food
services, facilities management, and uniform and career apparel to health care
institutions, universities and school districts, stadiums and arenas, and
businesses around the world. The Board of Directors of ARAMARK, on the unanimous
recommendation of a special committee comprised entirely of independent
directors, has approved the agreement and will recommend that ARAMARK’s
stockholders approve the merger. The transaction is expected to be completed by
late 2006 or early 2007, subject to receipt of stockholder approval and
regulatory approvals, as well as satisfaction of other customary closing
conditions. Joseph Neubauer, ARAMARK Chairman and Chief Executive Officer, said,
“We are proud to partner with this distinguished group of private equity firms,
all of which have outstanding reputations and proven records of success. They
are committed to working with us in building long-term solutions that deliver
the most value for our clients and customers. They understand our business,
share our mindset, and will be strong partners moving forward.”
www.aramark.com
CMS announces payment revisions
Centers for Medicare
and Medicaid Services has released proposed major payment revisions for
physician, hospital outpatient, imaging, specialty hospital and ambulatory
surgery center services. Among the surprises: a proposal for quality measures
for hospital outpatient care that would lessen payment increases next year if
data on quality isn’t reported. Under a proposed regulation for Medicare
physician payments in 2007, doctors are scheduled to take a 5.1 percent cut on
Jan. 1, rather than the original CMS estimate of 4.6 percent. The
higher-than-expected payment cut to physicians means that the cost of
legislation to block that reduction, widely expected at the end of this year,
will be more than $1 billion more expensive than expected. That puts other types
of providers in line to see cuts to come up with that extra money. CMS
Administrator Mark B. McClellan emphasized new coverage of preventive services
in the payment rule. For example, the proposal would implement a statutory
requirement that Medicare’s colorectal screening benefit is no longer subject to
the Part B deductible in Medicare. McClellan also highlighted the fact that
doctors would receive payment incentives to spend more time with their patients.
The proposed rule would continue to impose a 25 percent reduction in payment for
preparing additional medical images of contiguous body parts. CMS said last year
that it would slice payments by half in 2007, not 25 percent, for the added
images, but the latest proposal retreats on that prediction. The proposed rule
also would implement a statutory requirement that payments for certain types of
medical imaging in the doctor’s office be capped at the same amount paid to
hospital outpatient departments. By applying those caps after making the
reductions for multiple images, imaging payments will be higher, McClellan said.
McClellan said that
because of fast-rising spending on hospital outpatient care, the status quo must
not continue. “Doing nothing is not sustainable from the standpoint of Medicare
costs and beneficiary premiums, and we want public input on the best approaches
to promoting high-quality, affordable care,” he said. Citing what he called
Medicare’s “equitable adjustment authority,” McClellan said the proposal would
require hospitals to report data on quality performance measures starting in
2007. If hospitals next year failed to report the inpatient quality-of-care data
necessary to receive a full payment increase, the update they receive for
outpatient care would be two percentage points lower, CMS said. Thus instead of
receiving an increase next year of about three percent for outpatient care,
facilities would get an increase of about one percent. CMS said that pending the
development of quality measures specific to outpatient care, something CMS plans
to do, it’s fair to tie payments to reporting of data on inpatient measures
because they cover many of the same activities as in outpatient care. The
outpatient rule also expands the set of quality measures on which hospitals must
report data to receive a full payment update for inpatient care in fiscal 2008.
Added measures assess the satisfaction of patients with the care they get at a
facility, post-surgical complications, and death rates at a facility for heart
attack, heart failure and pneumonia patients within 30 days of receiving
treatment.
CMS also is proposing a new payment system for ambulatory surgery centers that
would take effect in 2008. CMS said the proposed rule would “allow payment to an
ASC for any surgical procedure that does not pose a significant safety risk,
greatly expanding the list of surgical procedures for which Medicare pays an ASC
facility fee.” But payments to the surgery centers would be tied for the first
time to the “Ambulatory Payment Classifications” (APCs) used for payment of
hospital outpatient departments. The proposal calls for ambulatory surgery
centers to receive 62 percent of the APC level, a relatively low percentage,
analysts said. McClellan also announced the release of a regulatory plan for
doctor-owned specialty hospitals. Release of the plan effectively lifts a CMS
administrative moratorium on the enrollment of new specialty hospitals as
Medicare providers. But CMS will require facilities to disclose the percentage
that individual doctors own of a facility and the terms of their compensation.
Specialty hospitals also will be required to inform patients before they receive
care that staff physicians have an investment interest in the hospital.
Hospitals may be found in violation of anti-kickback regulations if the
compensation of doctors is out of proportion to the percentage of the facility
they own. And hospitals that fail to report physician investment and
compensation arrangements will face fines of up to $10,000 a day. That
enforcement effort will begin with specialty hospitals that did not fully
respond to a recent CMS survey to determine their investment and compensation
arrangements. The hospitals that responded reported compensation proportional to
investment percentages, but 53 percent of the specialty hospitals polled did not
provide the requested data. CMS noted that traditional hospitals have complained
that specialty hospitals can better coordinate the delivery of care with staff
doctors because of the opportunity for physician ownership. To “level the
playing field,” CMS said it will do a pilot test easing hospital-doctor
collaboration on more efficient care, including a “gain-sharing” demonstration
in which traditional hospitals can share profits with doctors from increased
efficiency. (Congressional Quarterly)
Appropriateness criteria issued for cardiac computed tomography,
cardiac magnetic resonance imaging
The American College of
Cardiology Foundation (ACCF) along with key specialty and subspecialty societies
have released Appropriateness Criteria for two relatively new clinical cardiac
imaging modalities, cardiac computed tomography (CCT) and cardiac magnetic
resonance imaging (CMR). These Criteria were developed in order to address the
growth in biomedical imaging to ensure that it is appropriate to patient needs.
“In response to the need for guidance in ordering and performing advance cardiac
imaging procedures, such as CT and CMR, the ACCF has focused a great deal of
resources in helping to determine if it is ‘reasonable’ or appropriate to
perform a test for a specific indication. We aim to assist patients, clinicians,
and payers when determining how best to use cardiac tests and procedures. It is
now widely apparent that these imaging studies should be used only when the
information provided will have a direct impact on patient care, as medical
imaging has undergone tremendous growth in recent years,” said Robert Hendel,
M.D., F.A.C.C., chair of the writing group for the Appropriateness Criteria for
CCT and CMR. “It is also our hope that the criteria will generate discussion
between physicians and payers regarding reimbursement,” added Dr. Hendel. An
appropriate imaging study is defined as one in which the expected incremental
information combined with clinical judgment, exceeds the expected negative
consequences by a sufficiently wide margin for a specific indication that the
procedure is generally considered acceptable care and a reasonable approach for
the indication. Negative consequences include the risks of the procedure (i.e.,
radiation or contrast exposure) and the downstream impact of poor test
performance such as the delay in diagnosis (false negatives) or inappropriate
diagnosis (false positives). The 39 CCT and 33 CMR indications rated by a
technical panel of experts encompassed the majority of clinical scenarios
referred for CCT and CMR, respectively. These appropriateness reviews assessed
the risks and benefits of the imaging tests for several indications or clinical
scenarios and scored them based on a scale of 1-9, where the upper range (7-9)
implies that the test is generally acceptable and is a reasonable approach, and
the lower range (1-3) implies that the test is generally not acceptable and is
not a reasonable approach. The mid range (4-6) indicates an uncertain clinical
scenario. “We recommend that cardiovascular professionals use the CCT and CMR
Appropriateness Criteria to avoid ordering tests deemed inappropriate in the
clinical setting unless there are very unusual circumstances. In addition,
clinical scenarios rated uncertain require more research before we understand
whether a given test is appropriate or inappropriate for that particular
scenario,” said Michael Poon, M.D., F.A.C.C., a member of the writing group for
the Appropriateness Criteria for CCT and CMR.
www.acc.org.
Doubt is raised on defibrillators; Devices do save lives
but can sometimes fail
A
review of safety data raises questions about the reliability of the automated
external defibrillators (AEDs) that hang on the walls of airports, shopping
malls and health clubs. Harvard Medical School researchers found that over the
past decade, 1 in 5 automated external defibrillators were recalled because of
the potential for malfunction, and devices that failed were associated with 370
deaths. Nonetheless, the devices have saved tens of thousands of lives, and the
benefits outweigh the risk of malfunctions, said study author Dr. William Maisel.
“The number of malfunctions may be alarming to some, but you have to take it in
the context of the large number of patients saved by these devices,” he said. He
said the study, the first comprehensive look at safety data on the devices,
underscores the importance of properly maintaining the defibrillators. The study
appears in Wednesday's Journal of the American Medical Association. The
American Heart Association estimates that 900 Americans die each day from sudden
cardiac arrest. Combined with cardiopulmonary resuscitation, AEDs can keep
victims alive until emergency crews arrive. In a 2004 study, the devices helped
raise the cardiac arrest survival rate to 23 percent, compared with 14 percent
with CPR alone. Some states have passed laws requiring defibrillators in public
buildings, and Congress has approved money for rural communities to buy them.
The devices cost around $700 to $1,200; nearly 200,000 are distributed a year.
The study found that most of the recalls were for electrical or software
problems. The findings were based on reports to the Food and Drug Administration
from 1996 through 2005. The FDA issued 52 advisories about automated external
defibrillators or crucial components during that period. (Associated Press)
Number of uninsured children declines as enrollees
in state health insurance programs increase
Even though
the total number of Americans without health insurance is on the rise, a new
study analyzing government data suggests good news for the nation’s children.
The percentage of uninsured kids in America has decreased by 20 percent since
the government-funded State Children’s Health Insurance Program (SCHIP) was
approved by Congress in 1997. The State of Kids’ Coverage was released by
the Robert Wood Johnson Foundation (RWJF) to kick off the Covering Kids &
Families’ Back-to-School Campaign, a nationwide effort to enroll
eligible children in public health coverage programs during the back-to-school
season. The report shows that the number of uninsured children has decreased by
2 million since the creation of SCHIP and recent expansions in public programs.
In the same period, the number of uninsured Americans has increased by nearly 5
million people. States with the biggest decline in the percentage of uninsured
kids are Arkansas (-60 percent), Maine (-50 percent), Alabama (-47 percent),
South Carolina (-46 percent) and North Dakota (-44 percent). The report also
shows that fewer children are receiving private health insurance, which is
supplied mostly through their parents’ employer-sponsored health plans. The
percentage of children who have private health insurance has fallen by five
percent since 1997-98. That means 1.4 million fewer kids have private health
insurance. States with the biggest decline in percentage of children having
private health insurance include New Mexico (-23 percent), Mississippi (-23
percent), Alaska, (-23 percent), Oklahoma (-19 percent) and Wyoming (-17
percent). The reports shows that even though the number of kids with private
insurance is declining, public coverage programs have expanded, resulting in
more kids being insured. The percentage of kids enrolled in public health
coverage programs has increased by 31 percent since SCHIP programs began,
meaning at least 5 million more kids now have public coverage. States with the
greatest increase in percentage of kids enrolled in public coverage (e.g., SCHIP
or Medicaid) since 1997-98 are Alaska (+139 percent), Maryland (+139 percent),
Indiana (+132 percent), Wyoming (+114 percent) and Arkansas (+109 percent).
Despite the success of public programs, millions of children remain uninsured.
The latest Census data show that nearly 8.3 million children remain uninsured
nationwide. Experts say that more than 70 percent of these children are likely
eligible for low-cost or free health care coverage through SCHIP or Medicaid,
but have not yet enrolled.
Tuesday, August 8, 2006
Deaths spur debate about drugs made in pharmacies;
Experts seek stricter
oversight
WHO: Fuel shortages in Lebanon a grave threat to health
WHO: Avian influenza
update
Docs: 5%
Medicare cut would hurt patient care
Journal won't bar authors on drug makers payrolls;
Fear of
antitrust lawsuits cited by JAMA editor
FCC begins
rulemaking to establish a new “MedRadio”
service for medical radio communication
devices
Amerinet announces agreement with Nonin Medical Inc.
Deaths spur debate about drugs made in
pharmacies; Experts seek stricter oversight
In eight days last summer, the same dangerous inflammation
struck three cardiac surgery patients at Mary Washington
Hospital within hours of their operations. On Sept. 2, one man
died. The unusual cluster of cases alarmed chief cardiac
surgeon John Armitage, who feared a contaminant was in the
surgery center. Tests confirmed it: Bacteria were found in a
solution injected into patients’ hearts during surgery. The
Fredericksburg, VA, hospital shut down its cardiac surgery
program the next day and called state health officials, who
brought in the Food and Drug Administration and the Centers
for Disease Control and Prevention. Within days, the FDA and
the CDC confirmed the presence of several types of bacteria in
opened and unopened bags of the cardiac surgery solution, a
state report later showed. The hospital later determined that
at least 11 cardiac surgery patients were stricken during a
10-month period from the end of December 2004 to September
2005, and three died. The illnesses and deaths drew attention
to a practice few patients know about: Some drugs, including
high-risk sterile preparations, are made in pharmacies under
less-restrictive rules than those that drug companies follow.
The troubles at Mary Washington raise questions about the
oversight of such pharmacies by hospitals, state regulators
and the FDA. Almost all hospital pharmacies do some type of
drug making, called compounding, ranging from low-risk
procedures, such as adding medications to intravenous
solutions, to high-risk work, such as making sterile
treatments from scratch. In most states, hospitals are not
required to test the sterility or potency of products made in
their own pharmacies or purchased from outside pharmacies. The
frequency and thoroughness of state inspections of the
pharmacies vary widely, and the FDA's role in oversight is
sometimes hampered by questions over whether it has
jurisdiction over what generally is a state matter. Scrutiny
of the pharmacy that served Mary Washington and 45 other
mid-Atlantic medical facilities set off a cascade of actions:
Virginia health officials pegged the contaminated solution as
the likely culprit in the cluster of patient illnesses. All
injectable medications made by the pharmacy during a six-week
period were recalled, the pharmacy lost its Maryland license
temporarily, and its parent company received an eight-page
letter from the FDA outlining problems in five of its
facilities nationwide. The hospital was cleared to reopen its
surgery program two weeks after the testing. The pharmacy,
owned by one of the nation's largest such firms, regained its
state license in January. Before the rise of large drug
companies, most prescriptions were made in pharmacies. Now,
the National Association of Boards of Pharmacy estimates that
pharmacy-made compounds account for 1% to 5% of all
prescriptions. Time pressure, or the cost of having the staff
and equipment to mix drugs, leads some hospitals to hire
outside pharmacies to make compounded products, including
difficult-to-prepare sterile drugs. In 2003, Mary Washington
hired Central Admixture Pharmacy Services (CAPS) in Lanham,
MD, to produce a blended cardiac surgery drug called
cardioplegia, the hospital said. The solution stops the heart
from beating during bypass surgery and must be sterile because
it is infused directly into the heart. CAPS, owned by B. Braun
Medical, has 20 locations across the country and supplies 400
medical facilities, according to its website. Because of its
size, it is one of a few pharmacies that fall under regular
FDA oversight, with routine inspections scheduled about every
two years. Most pharmacies, even those that make sterile
products, are smaller and are overseen by state inspectors,
not the FDA. Rules governing such pharmacies vary by state. In
Maryland, where CAPS has one pharmacy, regulators are updating
rules governing preparation of sterile drugs in pharmacies,
said John Balch, president of the Maryland Board of Pharmacy.
Despite efforts to beef up oversight of sterile-drug making by
pharmacies, only 12 states have adopted new standards set in
2004 by U.S. Pharmacopeia, a non-profit drug-safety
organization. Some hospitals have updated their pharmacies to
meet the standards, which can mean buying expensive equipment,
but many others have not.
The
standards were created partly in response to two separate incidents a few years
earlier, when contaminated, pharmacy-made medicines killed three people in
California and one in South Carolina. Pharmacy board attorney Louis Ling says
the new rules will require any pharmacy making compounded batches of drugs to
test them for sterility and potency. Special “clean rooms” and equipment will be
required, and employees will have to don protective clothing to make sterile
drugs. CAPS' website advertises that it meets the new standards, and the company
runs programs that teach other pharmacies how to comply with the rules. But FDA
investigators found some of CAPS' facilities falling short of good manufacturing
practices. “Sterility is an area that we're very concerned about,” said Steve
Silverman, acting assistant director at an FDA compliance office. “So we closely
monitor firms like CAPS, which train their personnel and have procedures
designed to minimize risk. If these firms were to disappear, then sterile
compounding likely would return to hospital and local pharmacies that may be
less-well-equipped.” (USA TODAY) To read the entire article,
CLICK HERE.
WHO: Fuel shortages in Lebanon a grave threat to health
WHO warns that if
fuel is not delivered this week, 60% of all hospitals in Lebanon, in addition to
other health facilities will simply cease to function. WHO urges all parties to
ensure the safe passage of fuel, as a matter of priority. Due to the damage to
infrastructure in the conflict-affected areas of Lebanon, hospitals and other
health centres are relying on fuel to run generators. Power is essential to run
operating theatres, life-saving equipment including incubators for newborns,
refrigeration for vaccines and treatments including insulin. It is also
essential for safe water provision and hygiene. WHO has received reports that
fuel supplies are running dangerously low. One hospital in Marjayoun, for
example, reports that it will run out of fuel by Wednesday. “Based on available
information, if there is no fuel delivered in the next few days, more than half
of the hospitals will not be able to operate by the end of this week and the
situation will be much worse next week,” warned Dr. Ala Alwan, Representative of
the WHO Director-General for Health Action in Crises. Lebanon has 12 000
hospital beds. A reasonable estimate is that, in order to function, each
hospital bed needs 80 litres of fuel per week for electric power. Up until now,
fuel deliveries have been severely hampered because of the ongoing military
operations. “Fuel is key in any basic infrastructure. The provision of fuel is a
matter of life or death in a hospital setting. We urge all parties to ensure
safe passage of fuel supplies to hospitals,” said Dr. Alwan. Fuel shipments are
ready to be sent to Lebanon as soon as the security situation allows. Fuel tanks
are also ready to be sent from Beirut to other areas in Lebanon in convoys,
provided security is ensured.
WHO: Avian influenza update
The Ministry of
Public Health in Thailand has confirmed the country’s 24th case of human
infection with the H5N1 avian influenza virus. The case, which was fatal,
occurred in a 27-year-old man from the central province of Uthai Thani. He
developed symptoms on 24 July, was hospitalized on 30 July, and died on 3
August. Investigation of his source of infection revealed contact with household
chickens, which began dying around one week prior to symptom onset. This is the
country’s second case of H5N1 infection, and second fatality, within the past
two weeks. Confirmation of these cases follows an 8-month period in which no
human cases were reported in the country. Recent outbreaks in poultry have been
officially reported in two provinces, Phichit and Nakhon Phanom, located in the
northern and north-eastern parts of the country. The World Health Organization
(WHO) has issued an update on the cumulative number of Avian Influenza
A/(H5N1) reported to WHO. As of August 7, 2006, there have
been a total of 233 cases of Avian Influenza A/(H5N1) and a total of 136 deaths.
Vietnam and Indonesia have both reported 42 deaths due to Avian Influenza. To
view the table,
CLICK HERE.
Docs: 5% Medicare cut would hurt patient care
Medicare
reimbursements to doctors are set to drop by nearly 5 percent next year, an
amount that physicians say could make it harder for elderly patients to see a
doctor. Mark McClellan, administrator for the Centers for Medicare and Medicaid
Services, said Monday that the agency would soon issue new regulations updating
reimbursement rates for physicians. He did not provide an exact amount the rates
would change in 2007, but trustees for the Medicare program projected in May
that the cut would be 4.7 percent. The reimbursement rates are established by
formula, which sets annual and cumulative spending targets for physician
reimbursements. When spending increases exceed economic growth, payments to
doctors are supposed to be cut. McClellan attributed proposed payment reductions
to a “vicious cycle” in health care. Doctors provide more and more services per
patient, which drives up Medicare spending faster than the overall economy.
However, Congress in the past has headed off similar reductions called for by
federal regulation, and it's expected to step in again this year once lawmakers
return from their August recess. Already, 80 senators wrote their respective
leaders in that chamber last month to say they believe the Senate should
increase the reimbursement rates for doctors before Congress adjourns in
October. McClellan said he was optimistic that the federal government could also
make some structural changes as soon as this year in the way doctors are
reimbursed. Those changes would focus more on paying doctors when they provide
services proven to improve patient outcomes rather than just reimbursing doctors
for more care. He said he is seeing more leadership from physician groups this
year when it comes to providing guidance on how the government could undertake
such a transformation. (The Associated Press)
Journal won't bar authors on drug makers
payrolls; Fear of antitrust lawsuits cited by JAMA editor
The Journal of the American Medical Association said it and other
periodicals would be sued by the pharmaceutical industry if they banned authors
who fail to reveal financial ties to drug makers. “There's a risk for antitrust
suits,” said Catherine DeAngelis, editor in chief of Chicago-based JAMA. “I've
talked to lawyers, and so have other journals.” Last month, JAMA said doctors
failed to disclose their ties to drug makers in two separate studies, including
one that linked migraines to heart attacks in women. The journal, which has the
largest circulation of any medical periodical, published corrections in both
cases. Researchers who flout disclosure rules can expect “appropriate corrective
actions” from their universities, DeAngelis said in an editorial published
yesterday. DeAngelis rejected suggestions that JAMA ban authors who are revealed
to have undisclosed financial ties to drug makers. That “would only encourage
that author to send his or her articles to another journal; it cleans our house
by messing others,” DeAngelis wrote. If all medical journals agreed to ban such
authors, antitrust issues would arise, she said. While a collective agreement
might be unlawful, there's nothing stopping JAMA and other journals from sharing
the names of authors who've broken the rules, said Stephen Ross, a former lawyer
for the Federal Trade Commission and a law professor at Pennsylvania State
University. “They could even jointly observe that particular journals published
a certain researcher” despite past problems with disclosure, said Ross. In the
study linking migraines and heart disease, the study's six authors had all
worked as consultants or paid speakers for companies that make drugs to treat
headaches or heart disease. Last month, JAMA also corrected a February study on
depression, noting that more than half the authors were paid speakers or
consultants for antidepressant makers. (Bloomberg News)
Amerinet announces agreement with Nonin Medical Inc.
Amerinet announces that it has entered into an agreement with Nonin Medical Inc,
a U.S. health care manufacturer of physiological monitoring devices, to make
Nonin's line of wrist, fingertip, and MRI compatible pulse oximeters and
applicable sensors available to Amerinet's members, including a wireless
oximeter based on Bluetooth technology. Under the three-year agreement
Amerinet's members will have access to these pulse oximeters and applicable
sensors.
Monday, August 7, 2006
Administration aims to set health care standards
Blue Cross
and Blue Shield plans unveil Blue Health Intelligence
TB diagnosis sometimes delayed by unfamiliarity in the U.S.
Diabetic blacks, hispanics face more hospitalizations
US Surgical takes measures to acquire Confluent Surgical for $245 million
Fuji
receives FDA clearance for Obliquus 3D Software
Thailand alert for bird flu is expanded
A 27-year-old Thai man has died of
bird flu, the
country’s second death from the disease this year, officials said Saturday, as
they put eight more provinces, including the Bangkok area, on a watch list. The
man died on Thursday after the A(H5N1)
virus killed
chickens on his backyard farm in Uthai Thani Province, 135 miles north of
Bangkok, and the third province to have an outbreak since the virus re-emerged
in July after an eight-month lull. “He buried them without any protection, and
that’s why he caught bird flu,” Thawat Suntrajarn, chief of the Department of
Disease Control, said of
Thailand’s 16th
victim since the disease swept through parts of Asia in late 2003. Bird flu
killed at least 134 people worldwide before this latest death, according to the
World Health Organization.
Since the death of a Thai teenager in late July, Thailand has rushed to plug
gaps in its bird flu defenses. The area around the sprawling Thai capital was
among eight provinces declared bird flu risk zones on Saturday, increasing the
total to 29 of Thailand’s 76 provinces. Agriculture Minister Sudarat Keyuraphan
said local officials would go on a door-to-door campaign to educate villagers on
how to handle sick or dead poultry. A new call center will take reports of
suspicious poultry deaths and answer questions about the disease. The government
has threatened fines of up to about $100 or two months in jail for failing to
report sick or dead birds. The outbreaks in Thailand and neighboring Laos, where
bird flu was found on a farm last month, renewed fears that the disease is
flaring up again in Asia. In Vietnam, where no cases have been confirmed in
poultry or humans this year, the authorities are taking no chances. Animal
health workers slaughtered 53 wild storks at a theme park in Ho Chi Minh City on
Saturday after random tests showed H5, part of the A (H5N1) virus, in two birds.
In Indonesia, tests confirmed six suspected human cases were not bird flu, an
official said. (Reuters)
Administration aims to set health care standards
The Bush
administration will soon launch an ambitious effort to require that all
providers of federally financed health care adopt quality-measurement tools and
uniform standards for their information technology, Health and Human Services
Secretary Mike Leavitt said Sunday. Leavitt told a session of the National
Governors Association's annual meeting that “in a matter of weeks,” President
Bush will sign an executive order setting the new requirements. He promised that
by year's end, a majority of the 100 largest private employers will sign similar
contracts with the hospitals and doctors they use to care for their workers. He
urged the governors to follow suit by signing up the groups that take care of
state employees and Medicaid recipients. The goal of the initiative, Leavitt
said, is to reduce health-care cost inflation while increasing the quality of
medical services individuals receive. The executive order would affect doctors
and hospitals serving the Medicare population of elderly Americans and people
served by any other federally financed service. It would require those health
providers to join with the government to standardize the requirements for
information technology systems coming into their facilities; set standards for
care of specific health problems; and develop uniform methods of measuring and
reporting the outcomes of treatments. Leavitt cautioned that the first standards
in all three areas would be “pretty basic,” but said they would provide a
foundation for a future system in which patients could make “much more informed
decisions” about where to go for treatment and what it is likely to cost.
Leavitt said that the demand for such information is large and that tools are
becoming available to supply it. He said he had contacted executives of 21 of
the 100 largest private employers and “21 of 21” are ready to sign such
contracts with their own suppliers. That number will grow rapidly in coming
weeks, he said. Governors expressed interest in using Leavitt's model in their
states but voiced some skepticism about the readiness of doctors to have their
work evaluated. Leavitt insisted that the physicians with whom he has met “want
the standards” set for care in their specialties, in part because they want to
evaluate their own performance against that of their peers, and in part because
rewards for quality, which Leavitt said these measurements would make possible,
might offset the loss of income threatened as budget pressures reduce their
reimbursements for Medicare patients. Leavitt conceded that many of the doctors
are “skeptical we can create a system that measures quality accurately,” but he
said some specialties are already developing such standards and more can be
nudged into doing so. As for the standardization of information technology, now
moving in rather haphazard fashion into hospitals and doctors' practices,
Leavitt said HHS teams have finished drafting recommended standards for four
basic functions: registering patients, reporting lab results, writing
prescriptions, and providing secure communication channels between patients and
doctors and among health-care providers. Those standards will also be written
into the proposed executive order, he said. (The Washington Post)
Blue Cross and Blue Shield plans unveil
Blue Health Intelligence
Blue
Cross and Blue Shield Plans announced the creation of Blue Health Intelligence (BHI),
a resource designed to help improve healthcare quality through opportunities to
share critical health information initially with employers, and in the future,
with consumers and providers. BHI as a health intelligence resource will
strengthen the movement to greater healthcare transparency by ultimately
providing unmatched detail about healthcare trends and best practices. The
secure, HIPAA-compliant database is comprised of claims information (with no
personal identifiers) from 79 million lives, significantly larger than existing
healthcare databases. Twenty Blue Cross and Blue Shield Plans currently are
participating in BHI. Access to the aggregate data will be available only to the
participating Plans. The development of BHI over the last several years responds
to the demands of employers, consumers, and providers who are calling for
credible and actionable data to drive informed, evidence-based decision making.
BHI is currently being pilot-tested and will be operational by 2007. As BHI
evolves, the resource will provide a number of benefits to employers, consumers,
providers and other stakeholders, such as: Sharper insight into healthcare
trends and best clinical practices; information about the efficacy of certain
treatments and new medical technologies as well as emerging trends in healthcare
practice and delivery; benchmarking data to assist in conducting comparative
analyses across a number of healthcare components; and opportunities for health
services research. For more information
CLICK HERE.
TB diagnosis sometimes delayed by
unfamiliarity in the U.S.
Many doctors in the United States no longer recognize tuberculosis (TB), one of
the most dreaded diseases of the 19th and early 20th centuries. “It's the
biggest thing that bothers me in my entire career,” said Dr. Lee Reichman,
executive director of the Global Tuberculosis Institute at the New Jersey
Medical School. Though relatively rare in the United States today, tuberculosis
remains among the most common infectious diseases in the world, having killed
1.7 million in 2004, according to the World Health Organization. And it remains
a danger in the United States, especially in states such as California, with
large numbers of immigrants from countries where the disease is endemic. Last
year 2,903 of the 14,093 cases in the U.S. were reported in this state, more
than three-quarters of them among foreign natives. Tuberculosis bacteria can
remain dormant for years, then begin multiplying, particularly if the host's
immune system is weakened. The disease still is generally treatable if caught
early. But if diagnosis is delayed, it can permanently harm or kill its victims
and spread to others. “Delayed diagnosis is a concern that obsesses people in TB
control,” said Dr. Kenneth Castro, director of the division of tuberculosis
elimination at the U.S. Centers for Disease Control and Prevention. “There are
many outstanding physicians who don't see it anymore and therefore lose
proficiency to promptly diagnose and treat it.” Though government officials do
not track how often TB is missed or misdiagnosed, some research and high-profile
cases have fueled experts' concerns. A study of 158 patients in Maryland,
published last year in the International Journal of Tuberculosis and Lung
Disease, showed 45% to be undiagnosed 30 days after they first contacted a
doctor, with 16% remaining so 90 days after. Some health agencies have
mobilized: The National Heart, Lung and Blood Institute has been helping to fund
a TB curriculum in medical and professional schools. The CDC has sponsored four
national centers for doctors to call to request diagnostic help when TB is
suspected. And the California Department of Health Services is participating in
a national study of delays in diagnosis of foreign-born TB patients. Two
initially misdiagnosed cases recently grabbed the attention of top health
officials because of who was infected: the spouses of CDC researchers. In 2004,
Dr. Claudia Lacson, who was pregnant with her first child, fell into a coma 10
days after she was admitted to an Atlanta hospital complaining of severe
headaches and a persistent fever. Lacson, a physician married to a CDC
behavioral scientist, initially went to the emergency room a week before she was
admitted; doctors sent her home with sinus medication. Days before she fell into
the coma, doctors had been treating her for bacterial meningitis, even though
they were reminded that Lacson had tested positive for exposure to tuberculosis
in the past, said her husband, Romel. Lacson was a native of Bogota, Colombia,
and had treated many TB patients while she trained as a physician there. And
Lacson herself suspected TB was causing her illness, underlining “tuberculosis
meningitis” in an internal medicine textbook from her hospital bed, her husband
said. But by the time doctors began TB treatment, it was too late. She died July
31, 2004, at 38, several weeks after she gave birth to a daughter, who also did
not survive. “If they treated her…from the beginning with TB medication, I do
believe she would be alive today,” said Romel Lacson, who worked in the CDC's
Division of HIV/AIDS Prevention at the time and now promotes TB awareness at the
University of South Carolina. Diagnosing TB can be an involved process. The
familiar skin test, required by schools and some employers, determines only
whether a patient has a latent TB infection, not whether there is active,
infectious disease. The results are not foolproof. A follow-up chest X-ray and a
laboratory culture can help pin down the diagnosis, and the doctor can try TB
drug therapy to see if the patient responds. TB isn't necessarily restricted to
the lungs, nor does it always result in the coughing that is widely considered a
telltale sign. The bacteria can be harbored in the gastrointestinal tract, the
nervous system and other places in the body. (Los
Angeles Times)
Diabetic blacks, hispanics face more hospitalizations
Blacks and Hispanics are four to five times
more likely than non-Hispanic whites to be hospitalized for uncontrolled
diabetes and at least three times more likely to have diabetes-related,
lower-extremity amputations, a federal study finds. Such hospitalizations are
“potentially preventable,” and similarly large racial/ethnic disparities exist
in terms of “preventable” hospitalizations for other chronic conditions, such as
high blood pressure, said the U.S. Agency for Healthcare Research and Quality
report. It concludes that many people who comprise those two minority
populations are not getting adequate primary and preventive care. “The magnitude
of these disparities was so high it surprised me,” said Roxanne Andrews, an AHRQ
researcher and an author of the report. Excess hospitalizations deemed
preventable “many times can result from a lack of access to good patient care,”
she said. “A lot of treatment can be provided in the outpatient setting.” No
evidence exists of such a deficiency for Asians, given that the report showed
their hospitalizations for poor diabetes control and resulting amputations, as
well as high blood pressure, are lower than those of non-Hispanic whites. In
fact, hospitalization of elderly patients for asthma was the only indicator
where rates were higher for Asians than for whites, the study found. Data on
hospitalization disparities come from analyses of the 2003 State Inpatient
Databases, the most recent year such information is available. The database uses
records from a sample of hospitals from 23 states. In terms of hospitalizations
for diabetes with long-term complications, the rate was 306.5 per 100,000
population among blacks and 245.6 per 100,000 among Hispanics. Those rates
compared with 89.1 per 100,000 for non-Hispanic whites and 84.1 per 100,000 for
Asians. Hospitalization rates for diabetes-related foot amputations were 98.7
per 100,000 for blacks, 81.8 per 100,000 for Hispanics, 28.4 per 100,000 for
whites and 19.2 per 100,000 for Asians. Another racial/ethnic gap was found in
hospitalizations for high blood pressure. In 2003, the rate for blacks was 98.7
per 100,000; for Hispanics, it was 81.8 per 100,000. In contrast,
hospitalization rates of whites and Asians for that same condition were 31.8 per
100,000 and 29.1 per 100,000, respectively. Preventable hospital admissions were
highest for blacks for other conditions, including congestive heart failure,
adult and pediatric asthma, perforated appendixes and dehydration. Hispanics
have the highest hospitalization rates for conditions such as asthma in the
elderly, pediatric gastroenteritis and urinary tract infections. “This is the
first report that focuses on hospitalization disparities at the national level,”
Andrews said. “We want to get a better handle on why these disparities occur
and…see how states are responding.” (The Washington Times)
US Surgical takes measures to acquire Confluent Surgical for $245 million
Research and Markets announces the addition of a new report from Espicom
Business Intelligence Ltd “US Surgical Medical Device Company Intelligence
Report” to their offering. United States Surgical (US Surgical), based in
Norwalk, CT, is a manufacturer of wound closure products and advanced surgical
devices. US Surgical has recently undertaken measures to enhance its product
line, having entered into a definitive agreement to acquire Confluent Surgical,
a developer and supplier of polymer-based technology used in sprayable surgical
sealants and anti-adhesion products. The transaction is priced at $245 million
and is expected to close by the end of August 2006.
Fuji receives FDA clearance for Obliquus 3D Software
FUJIFILM Medical Systems
USA has received FDA 510(k) clearance of Obliquus, an integrated 3D software
package providing diagnostic MIP (Maximum Intensity Projection) and MPR (Multiplanar
Reconstruction) functionality that is important to the radiologist’s diagnostic
process. A software option for Fuji PACS facilities using Synapse version 3.1.1
and higher, Obliquus was designed to reduce facilities’ requirements to
integrate a third party 3D solution for basic, commonly-used functions. Because
the Obliquus software was written and developed by Fuji and is a direct
component of Fuji’s Synapse PACS, it offers a number of advantages to both
radiologists and their facilities over the use of a third party 3D solution.
Radiologists benefit from the availability of Obliquus anywhere on the network
that Synapse is available, even from remote locations since it works with
compressed studies. It also allows users to maintain productivity by seamlessly
displaying any cross-sectional study while within the Synapse application; there
is no need to exit to a new application. Facilities benefit from the ability to
leverage the use of existing Synapse workstations, as well as from the ease of
deployment.
Friday, August 4, 2006
CMS isn’t planning to extend moratorium on
specialty hospitals
Underperforming transplant centers are hearing from federal
regulators
Capacity cripples U.S. health system
Settlement
reached in Sutter lawsuit; Hospital group will
give refunds, discounts to former
patients
Blood
clot fiber study may aid treatment
Newly
published guidelines for treatment of heart valve disease
lower recommended age
for tissue valve recipients
Five nationally renowned speakers at ASHES 21st
Annual Conference
CMS isn’t planning to extend moratorium on
specialty hospitals
Despite a request by the
leaders of the Senate Finance Committee, the Centers for Medicare and Medicaid
Services has no plans to extend by two months an administrative
moratorium on approving new specialty hospitals to
receive Medicare payments. The agency will issue a regulatory plan for
overseeing the facilities by the deadline set in the budget savings law (PL 109-171),
CMS spokesman Peter Ashkenaz said on Thursday. That measure requires that
the plan be released by Aug. 8 and provides that the moratorium be lifted by
then. It also allows CMS to extend the administrative moratorium for two months
if the agency misses the deadline for preparing a plan. Finance Committee
leaders said CMS should take the extra time to ensure that the plan is sound,
asserting that there are flaws in a survey used by CMS in preparing the
document. But Ashkenaz said CMS sees no evidence that an extension of the
moratorium is merited. (Source: CQ HealthBeat News)
Underperforming transplant centers are hearing from federal regulators
Federal regulators began sending out letters Thursday to
about 35 underperforming organ transplant centers, giving them one last chance
to prove their quality before taking enforcement actions against them, possibly
including pulling federal funding. The move by the U.S. Centers for Medicare and
Medicaid Services follows reports in The Times highlighting the agency's
failure to enforce its own standards for heart, liver and lung transplant
centers. The Medicare agency, which funds most of the nation's transplant
centers, requires programs to achieve a specific survival rate to be certified
for funding. Medicare also requires transplant programs to perform a minimum
number of operations per year to ensure competency. The benchmarks vary by
organ, and neither applies to kidney transplants. Last month, The Times
reported that nearly 50 federally funded transplant centers, about one in five,
did not meet at least one of those standards. After questions from The Times
earlier this year, the Medicare agency sent letters to every certified
transplant center requesting information on performance, staffing and changes
that could affect patients. After reviewing results, Medicare is asking
underperforming centers to verify their data and “let us know of any other
information we ought to know about,” said Dr. Barry Straube, the agency's chief
medical officer. “We want to make sure that there's due process here,” he said.
“We'll be taking action soon.” Medicare would not identify the centers receiving
the letters, but Straube said his agency would release their names if they are
hit with sanctions. The federal government plans to take other steps to improve
its transplant center oversight, officials said. Updated standards, which will
heighten supervision of federally funded programs, will be issued before the end
of the year, Straube said. They had not been expected until 2007, but the date
was moved up in light of concerns. (Los
Angeles Times)
Capacity
cripples U.S. health system
Demand for emergency
department (ED) services at U.S. hospitals is surging. As a result of this
upsurge, EDs are confronting a crisis. They do not have the capacity to deal
with rising demand. Due to federal regulations that require EDs to treat any
patient who enters, hospitals have struggled to manage such overcrowding.
Overcrowding is most often attributed to the inability of emergency departments
to transfer admitted patients to inpatient beds, according to a report by the
Government Accountability Office. Therefore, hospitalwide capacity problems are
driving overcrowding in EDs. There are two causes of this phenomenon: 1.
Supply-side factors have exacerbated overcrowding: In response to the pressures
of managed care and lower reimbursement from Medicare and private payers over
the past 15 years, hospitals have reduced their number of beds to improve
efficiency. Hospitals have also closed less profitable units or converted them
to specialized units, leaving less overall inpatient capacity to absorb ER
admissions. Even hospitals that have enough beds often suffer from staffing
shortages. Skilled nursing facilities and home health services have seen a
decrease in investment and are facing financial problems, resulting in fewer
discharge options. This puts further strain on inpatient capacity. 2. Factors on
the demand side are also fueling the overcrowding problem: A political backlash
against health maintenance organizations (HMOs) in the late 1990s led to a
relaxation of their policies on emergency care, which stimulated more ED use by
HMO patients. The Emergency Medical Treatment and Active Labor Act (EMTALA)
requires ambulance services and hospitals that receive Medicare reimbursement to
provide emergency care to anyone. As baby boomers grow older and sicker, demand
for emergency care is increasing. Less than half of all emergency visits are
classified as “emergent” or “urgent.” Many policymakers assume that the rising
number of uninsured people is primarily responsible for driving the crisis.
However, a recent study by the Center for Studying Health System Change
concludes that most of the increase in ED use is due to more visits by insured
patients. Overcrowded EDs have several deleterious effects on patients and
hospitals: Higher waiting times for examination and admission leave patients
less satisfied with treatment. EDs are primarily designed for emergency care and
non-emergent visits detract from this task. ED treatment is expensive, relative
to other ambulatory services. Increases in non-emergent visits to the ED raise
costs that may spill over to all patients. Capacity constraints highlight
other related challenges facing the U.S. health care system, including:
unchecked demand and overconsumption of health services among the insured; and
inadequate access to primary care for the uninsured. Individual hospitals are
attempting to address issues of overcrowding by expanding EDs and raising
efficiency. This should help in the short term. However, in the long run, more
fundamental reform will be needed. The ED experience shows that the alternative
of universal insurance coverage will not solve problems of demand.
Market-oriented approaches, in combination with government-led reforms, may
offer a more comprehensive solution. The pressure for a more concerted
legislative attempt to reform the system will grow during the 2007-2008
Congressional term. (Source:
Oxford Analytica)
For more information CLICK HERE.
Settlement
reached in Sutter lawsuit; Hospital group will give refunds, discounts to former
patients
A
Sacramento judge approved an agreement Thursday that requires Northern
California hospital operator Sutter Health to pay refunds and offer discounts to
thousands of former patients to settle accusations that it overcharged uninsured
individuals for services. An attorney representing plaintiffs said the payments
could exceed $275 million. But a Sutter spokesman said that estimate appeared
high. The settlement resolves a class-action lawsuit filed in 2004 that accused
Sacramento's Sutter of charging uninsured patients at its high rates for
services, while offering deep discounts to insurance companies and other big
payers. Sutter operates 27 hospitals in the Bay Area and other Northern
California locations. Sutter officials said costs could be lower than the
plaintiffs’ attorneys estimate because most uninsured patients never paid their
bills and therefore wouldn't be entitled to refunds. A wave of lawsuits has been
filed in recent years, accusing hospitals nationwide of gouging uninsured
patients by charging prices far above the rates they negotiate with insurers and
other big institutions. Under the terms of the settlement, plaintiffs will
receive discounts or refunds from their bills ranging from 25 to 45 percent,
depending on which hospital treated them. To be eligible, claimants must have
been treated at a Sutter-affiliated hospital between Sept. 3, 2000, and Aug. 3,
2006. Sutter officials said the settlement won’t change current practices.
Sutter changed its billing policies in 2004 to extend discounts to all uninsured
patients, regardless of income, spokesman Bill Gleeson said. Settlement claim
forms must be postmarked by Jan. 17. (San Francisco Chronicle)
Blood clot fiber study may aid treatment
The fibers that make up blood clots are more elastic than rubber bands and
stretchier than spider webs. They're even tougher than doctors suspected, a
discovery that could lead to improved treatment of heart attacks and strokes.
Understanding how much these fibers can be stretched before they break should
point to better ways to bust up blood clots on demand. Made of a protein called
fibrin, the fibers are stretchier than any other naturally occurring ones, even
super-stretchy spider silk, concluded researchers who rigged up a
double-microscope to measure how tough the tiny strands, 1,000 times smaller
than a human hair, really are. The discovery, published in Friday's edition of
the journal Science, goes a long way toward explaining the dual nature of blood
clots: You need clots to seal up wounds, prevent hemorrhaging and start the
healing process. But abnormal clots can kill, blocking critical arteries to
cause strokes, heart attacks or lung-clogging pulmonary emboli. “It can be good
and bad that they're so stretchable,” noted Wake Forest University physicist
Martin Guthold, one of the lead researchers. “When they do form in the bad
places, it's kind of difficult to get rid of them. ... You can rip on them, and
they will just stretch out.” Already, he's talking with the maker of a device
that uses ultrasound to attack clots, with hopes of improving its effect. It's
an important finding, said Dr. Richard Becker, a cardiologist and hematologist
at Duke University Medical Center and a spokesman for the American Heart
Association. Aside from better clot-busting treatments, the work could lead to
better ways to prevent dangerous blood clots in the first place, and, on the
flip side, to help blood clot better in people with hemophilia and other
bleeding disorders, he said. Blood clots are a mesh of fibrin fibers bonded to
platelets, a sticky substance in blood. To heal a wound, those clots have to be
both strong and flexible, to withstand the pounding of regular blood flow,
explained study co-author Dr. Susan Lord, a pathology professor at the
University of North Carolina, Chapel Hill. But until now, the fibers’ small size
had prevented pinpointing just how strong they really are. UNC and Wake Forest
scientists came up with a solution. They dyed fibrin fibers to appear
fluorescent, and suspended them over one microscope. Then they balanced an
atomic force microscope, which senses tiny surfaces using a special tip, over
the first microscope. The second microscope's tip stretched the fibers while the
scientists measured from below, and watched as the toughest fibers stretched to
over six times their original length before breaking. On average, the fibers
stretched to about four times their length. They also contracted back to their
original size after stretching, elastic like a rubber band. But natural fibers
are far stronger than manmade rubber bands, Guthold said. (The Associated Press)
Newly published guidelines for
treatment of heart valve disease lower recommended age for tissue valve
recipients
Newly published guidelines for the diagnosis and treatment of heart valve
disease, developed by the American College of Cardiology (ACC) and the American
Heart Association (AHA) are available. A summary of the guidelines was published
in the Aug. 1, 2006, issue of the Journal of the American College of Cardiology
and Circulation. The new recommendations offer the first comprehensive update to
physician practice guidelines in this area since 1998. New data have led to more
specific guidelines for physicians to manage the complexity of heart valve
disease, including determining the severity of the disease and the appropriate
timing for heart valve surgery. An ACC-AHA joint committee revised the
guidelines for tissue valve replacement, lowering the recommended minimum age
for tissue mitral valve patients from 70 to 65 years. In changing the age
recommendations, the committee acknowledged that today's tissue valves are
demonstrating increased durability. The committee also concluded that
current-generation porcine valves have the same durability as pericardial tissue
valves.
Five
nationally renowned speakers at ASHES 21st Annual Conference
The 21st Annual Conference and Healthcare Marketplace of the
American Society for Healthcare Environmental Services (ASHES), September 24 –
28, 2006 in Nashville, TN, features well-known best selling authors, a famous
broadcaster and nationally-renowned motivational speakers.
Dr. Jerry Punch,
Physician and Broadcaster, ABC's Wide World of Sports and ESPN is the opening
keynote speaker of the conference. His session is titled, “eXceeding
eXpectations Through Teamwork!”
Mac Fulfer
Author, Amazing Face Reading, shows how this art/science of face reading
can be a means to a deeper communication with every person you meet.
Greg Blake,
Chief Encouragement Officer (CEO), PepWorks International, presents a
best-in-class, high-energy motivational session entitled “How to THRIVE and Not
Just Survive in Turbulent Times! An eXtreme Personal & Professional
Environmental Makeover”.
Ron Rosenberg,
President, Quality Talk, will hold an interactive and entertaining session
entitled, “The Hidden Secrets to Double Your Memory”.
Fred Lee,
President of Fred Lee and Associates Inc., and author of If Disney Ran Your
Hospital – 9 ½ Things You Would Do Differently, is the closing keynote
speaker. For more information about the ASHES Conference,
CLICK HERE.
Thursday, August 3, 2006
Thompson tackles Medicaid
FDA announces medical device user fee rates for
2007
FDA approves influenza vaccines to be
manufactured for upcoming flu season
Washington
Redskins take multiple precautions against dangerous MRSA
Incorrect treatment provided
to one in three patients with methicillin-resistant
staphinfections
2006 Health Connect Partners Supply and
Pharmacy Expo
Kimberly-Clark launches femoral angiography
drape for high-fluid diagnostic and interventional procedures
Thompson tackles Medicaid
Tommy G.
Thompson left the Bush Cabinet nearly two years ago, but the
former secretary of health and human services is trying to
keep a hand in the policy mix in Washington. The former
Wisconsin governor, who garnered national attention in the
1990s for his state's welfare-to-work efforts, has his eye on
Medicaid. Thompson, who now works for two law and consulting
firms, is set to release a white paper Friday in which he
calls for overhauling Medicaid by shifting responsibility for
long-term care of the burgeoning elderly population to the
federal government, while leaving states to focus on acute
care for those under 65, particularly children. “The federal
government is the only one large enough to handle this growing
problem,” said Thompson, who will address the National
Governors Association on Saturday in Charleston, SC. “The
states are going broke right now under the Medicaid system.
Who else is going to be able to handle the elderly?” Thompson
also calls for helping Medicaid recipients take a more active
role in their care through new health literacy and
disease-prevention efforts. As the program becomes more
efficient, he argues, states could use the savings to help
cover the nation's 45.8 million uninsured people, in some
cases by subsidizing access to commercial health insurance.
Medicaid also should adopt technology such as electronic
medical records to help manage cases and improve public health
information-gathering. Jeff Nelligan, a spokesman for the
Centers for Medicare and Medicaid Services, said agency
officials were reviewing Thompson's ideas. Thompson said that
his proposals would probably increase spending initially
because of start-up costs but that overall spending would be
likely to decrease over time as officials learned to operate
more efficiently. The federal government would not be called
upon to shoulder a greater share of total Medicaid spending,
he said, and states should not expect to see a decrease in
their share. Rather, for both sides, savings would derive from
operating more efficiently in the new system, he said.
Thompson acknowledged that Medicaid funding formulas would
have to be tweaked to prevent some states from reaping
financial windfalls. “You want to set up almost a competitive
environment where the states will strive to improve upon the
healthfulness of their populations, and that will result in
less costs for the states at the acute level,” he said. “And
as these people get older and they move over into the federal
responsibility, they will be less expensive for the federal
side as well, because you're inheriting a healthier
population.” (The Washington Post)
FDA announces medical device user fee
rates for 2007
The Food and Drug Administration (FDA) is publishing the fee
rates and payment procedures for medical device user fees for
fiscal year (FY) 2007. The Federal Food, Drug, and Cosmetic
Act (the act), as amended by the Medical Device User Fee and
Modernization Act of 2002 (MDUFMA) and the Medical Device User
Fee Stabilization Act of 2005 (MDUFSA), authorizes FDA to
collect user fees for certain medical device applications. For
all applications submitted on or after October 1, 2006, and
through September 30, 2007, fees must be paid at the FY 2007
rates at the time the applications are submitted to FDA. This
notice provides details on how fees for FY 2007 were
determined and payment procedures for medical device
applications subject to user fees. Under the act, all fees are
set as a percent of the full fee for a premarket application,
and the act sets the standard fee for a premarket application
at $281,600 for FY 2007; this is referred to as the “base
fee.”' A 180-day supplement is set at 21.5 percent of the base
fee; the fee for a real-time supplement is set at 7.2 percent
of the base fee. For all applications other than premarket
notification submissions (510(k)s), the small business rate is
38 percent of the standard (full fee) rate. For 510(k)
premarket notification submissions, the fees are to be set so
that fees from all 510(k)s would produce revenue as if all
were assessed a fee of 1.42 percent of the base fee, but these
fee rates are to be adjusted so that the fee paid by a
qualifying small business is 80 percent of the full rate for a
510(k) premarket notification submission. Based on FDA's
estimates, about 19 percent of 510(k) premarket notifications
will qualify for the small business fee, and about 81 percent
will pay the standard (full) fee. The FY 2007 fee rates for
all application categories are set out in table 1 of the
following document.
http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-12394.htm
For more information
CLICK HERE.
FDA approves influenza vaccines to be
manufactured for upcoming flu season
The Food and Drug Administration (FDA) announced that it has
approved this year's seasonal influenza (flu) vaccines that
include the new strains of virus judged likely to cause flu in
the Northern Hemisphere in 2006-2007. Each year influenza
vaccine manufacturers submit information and samples to FDA of
their virus strains being manufactured for the upcoming
seasonal influenza season for review and testing in FDA
laboratories. Because different influenza virus strains may
appear each year, one or more of the strains in the vaccine
may need to be changed to protect against what public health
experts think are the strains most likely to infect people
that year. This season's approved formulation for the U.S.
vaccine is identical to that recommended by both the World
Health Organization and FDA's Advisory Committee. The
formulation includes one strain that was used in last year's
vaccine and two new strains. Seasonal flu vaccines do not
protect against avian flu, which is caused by different viral
strains. The best way to prevent influenza is by getting
vaccinated. Although it is best to be immunized in the fall,
getting the vaccine in the winter months when flu season often
peaks is also recommended. According to the Centers for
Disease Control and Prevention, every year in the United
States, on average five to 20 percent of the population gets
the flu, more than 200,000 people are hospitalized from its
complications and approximately 36,000 people die from it.
There are four vaccine manufacturers approved to market their
vaccines in the United States: Chiron Vaccines, Ltd.;
GlaxoSmithKline Biologicals; MedImmune Vaccines, Inc.; and
Sanofi Pasteur, Inc. The manufacturers have projected making a
total of about 100 million doses of influenza vaccine for the
2006–2007 season, but these projections could change as
manufacturing continues.
Washington
Redskins take multiple precautions against dangerous MRSA
The Washington Redskins took steps during the offseason to
combat one of their tiniest and toughest foes, a microscopic
organism that is becoming increasingly dangerous and
potentially lethal. The microbe, methicillin-resistant
Staphylococcus aureus (MRSA), is a bacteria once relegated to
hospitals and prisons but now, because athletes are in such
close contact with one another and share Jacuzzis, whirlpools
and athletic equipment, is proliferating in locker rooms at
all levels of sports. Over the past two years, the Redskins
have had five cases of MRSA, team physician Tony Casolaro said
last year. “We're concerned about it,” aid Bubba Tyer, the
Redskins’ director of sports medicine. “We don't want to lose
any player. We don't want anything to affect their career and
we want to do all we can do. It's a terrible infection that
can cripple your team.” In addition to spending $17,000 on a
new Jacuzzi system that is equipped with an ultraviolet light
filtering system designed to kill germs, the Redskins hired
SportsCoatings Inc. to treat the training room, locker rooms
and weight rooms with an anti-microbial coating the company
claims will help kill various strains of the bacteria. Tyer
did not divulge the amount the Redskins spent, but
SportsCoatings spokeswoman Wendy Orthman said the treatment
cost roughly $1.50 per square foot. The Redskins aren’t the
first NFL team to take preventative measures where MRSA is
concerned. Some teams are doing so with different products
this year and others, such as the St. Louis Rams, have done so
in the past, using bleach. Players must also be retrained. To
Tyer, who has taken a personal interest in the prevention of
MRSA, especially at the high school and college levels, the
Redskins’ high-tech approach has little value if the team and
players do not adopt basic, low-tech methods, such as washing
hands with an alcohol-based sanitizer, avoiding sharing towels
and daily athletic gear. Last season, the Redskins’ locker
room was filled with benches. This year, each locker has its
own stool. There are signs throughout the training room,
reminding players to avoid entering the whirlpools or Jacuzzis
without first having showered. At each entrance to the
training room are oversized dispensers of antibacterial liquid
soap. In the locker room’s bathroom area is a sign adjacent to
the sink, reminding players not to share razors.
Representatives from the Centers for Disease Control and
Prevention also inspected the Redskins’ facilities, Tyer said.
Last week, the Toronto Blue Jays confirmed that the staph
infection that has kept right fielder Alex Rios on the
disabled list for the past month is a version of MRSA, which
can enter the body through a tiny opening in the skin and
spread rapidly. Blue Jays pitcher Ty Taubenheim, who is
suffering from an infection on his foot, also is on the
disabled list, but it is unclear whether the infection is MRSA.
In 2003, Jeffrey Hageman, an epidemiologist with the CDC and
expert in sports-related MRSA cases, investigated the St.
Louis Rams and found that five of 58 players developed MRSA
infections, likely from turf abrasions. In his research on the
Rams, Hageman found linebackers, linemen and players of high
body mass to be particularly susceptible. To health experts
and sports physicians alike, the reason for MRSA's growing
prevalence is confounding. According to CDC spokeswoman Nicole
Coffin, disease experts believe that MRSA has not grown in
virulence because of environmental forces, meaning that the
Redskins’ locker room is perhaps no more naturally predisposed
to MRSA today than it might have been 20 years ago. The
difference, she said, is in the need to increase prevention
methods. Staph infections have been part of the sports world
for years, but in recent years, medical experts say, the MRSA
bacteria have become highly resistant to common antibiotics,
such as penicillin. In turn, the potential for its spread,
some experts believe, has been heightened by the inappropriate
use of antibiotics, such as using antibiotics to treat viruses
and not bacteria. These misuses can increase the resistance of
bacteria. Orthman said the application of anti-microbial spray
protected a surface for life without the possibility of the
bacteria becoming resistant. Orthman also said that the
chemicals that comprise the treatment do not weaken over time.
According to Coffin, the CDC does not evaluate the efficacy of
products, nor do they test the methodology behind products.
(The Washington Post)
Incorrect treatment provided
to one in three patients with methicillin-resistant
staphinfections
Drug-resistant, hospital-acquired infections often are treated
initially with ineffective antibiotics, which increases the
risk of death, according to an article in the August issue of
Critical Care Medicine, the journal of the Society of
Critical Care Medicine.
The
researchers conducted a three-year retrospective study of 549
Barnes-Jewish Hospital patients with MRSA sterile-site
infection to determine the rate of appropriate initial
antimicrobial administration and to evaluate the influence of
this treatment on outcome. They found that nearly one in three
MRSA-infected patients initially received inappropriate
treatment for MRSA infection, nearly doubling their risk of
death. “Physicians should deliver early appropriate antibiotic
therapy,” said senior author Marin H. Kollef, M.D., professor
of medicine at Washington University School of Medicine in St.
Louis. “For methicillin-resistant Staphylococcus aureus
(MRSA) that means treating acutely ill hospitalized patients
with antibiotics that are active against MRSA instead of less
effective antibiotics. The occurrence of MRSA has skyrocketed
in the last five to 10 years and is now the most common
hospital pathogen.” Hospital-acquired MRSA infections have
serious consequences including increases in the risk of death
and in healthcare costs. Patients in intensive care units are
particularly vulnerable. Hospital mortality associated with
MRSA sterile-site infections is reported to be greater than 20
percent. Lead author Garrett E. Schramm, PharmD, said that it
is crucial for physicians to aggressively identify and treat
patients at risk for sterile-site MRSA infections and for
physicians to be aware of local susceptibilities for both
hospital and community-acquired MRSA isolates. “In our ICUs,
we automatically treat for MRSA along with other bacteria when
we have a patient with hospital-acquired infection,” said Dr.
Kollef. “Obviously, not everyone will have MRSA infection, but
it is so common and the consequences of not treating it
upfront are so high that we treat for MRSA before its presence
is confirmed.” Dr. Kollef said there are no drawbacks to
including MRSA treatment in initial therapy, as long as
clinicians monitor the patient. If the culture results show no
evidence of MRSA infection, then MRSA-related antibiotics can
be stopped. In most patients, this is done within 48 hours.
Dr. Schramm says that there are a variety of antibiotics that
can treat MRSA infections. Many are given intravenously and
are appropriate for hospital use, while some, including
sulfamethoxazole-trimethoprim (Bactrim: Roche Laboratories
Inc., Nutley, NJ,
can be administered orally and may be used to treat
community-acquired MRSA infections. Dr. Schramm is a clinical
pharmacist at Mayo Clinic in Rochester, MN, and a former
critical care specialty resident at Barnes-Jewish Hospital in
St. Louis. “We have the antibiotics, and now we should develop
optimal treatment algorithms,” concluded Dr. Kollef. “This
will provide early appropriate therapy, while minimizing
emergence of further resistance in MRSA and other bacteria.”
In an accompanying editorial in the August issue of
Critical Care Medicine, lead author Andrew F. Shorr, M.D.,
M.P.H., from Washington Hospital Center in Washington, DC,
expands on the research of Dr. Schramm and his coauthors. “As
newer tools for rapid diagnostics and organism identification
become commercially available we will need to update our
approach to antimicrobial prescribing generally and for MRSA
specifically,” concludes Dr. Shorr. “However, in the absence
of some marker that allows for accurate and reliable
determination of resistant isolates, few options exist. If
clinicians fail to acknowledge and adapt to the current
situation surrounding infection management, patients will
continue to be unnecessarily and inexcusably exposed to the
risk of inadequate therapy. This simply becomes a question of
ownership. If we do not act, who will?” “MRSA infection is
becoming more common while remaining equally deadly,” said
Joseph E. Parrillo, M.D., editor-in-chief of Critical Care
Medicine. “MRSA is a changing organism and a changing type
of infection. We need more clinical research in this area to
optimize treatment and to better understand the epidemiology
of MRSA infection.” For an audio companion to this article,
CLICK HERE.
2006 Health Connect Partners Supply and
Pharmacy Expo
Time is running out to register for the 2006 HCP Supply and
Pharmacy Expo to be held at the Tampa Marriott Waterside
Resort and Marina on September 6-9, 2006. The event will
feature a “Reverse Expo” where there will be over 100 Hospital
Systems represented by VP's of Purchasing and Directors of
Pharmacy so that all vendors will have the opportunity to meet
each of the hospital executives. This will be a two and a half
day educational and networking event that you will not want to
miss. Register now before the event sells out or call Nelson
Hendry at 727-432-6931
for more Conference information
CLICK HERE.
Kimberly-Clark launches femoral angiography
drape for high-fluid diagnostic and interventional procedures
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