March 2008
March 7, 2008 Download print version
GAO: Issues and challenges related to how
hospitals submit quality data and how CMS ensures data
reliability
Vaccine could offer protection against high
blood pressure
Cause of
typhoid outbreak still a puzzle as cases rise
New test for joint infection could spare some
patients an unnecessary procedure
Criminal charges filed over poisonous
toothpaste
Gettin' Jiggy with StyleView
German authorities report problems with blood thinner
Concerns
about the safety of the blood thinner heparin spread to
Germany on Thursday after drug authorities there received
reports of patients being sickened after taking the drug.
Meanwhile, Food and Drug Administration officials announced
that they were asking all companies in the United States that
produce heparin to test it with two new procedures. The
complex tests, nuclear magnetic resonance spectroscopy and
capillary electrophoresis, are the only ones that can uncover
whether the drug contains a possibly counterfeit ingredient.
Dr. Janet Woodcock, deputy F.D.A. commissioner, said that the
agency would post instructions online for the tests.
Food and Drug officials said Wednesday that a possibly counterfeit
ingredient had been found in certain batches of heparin linked to at least
19 deaths in the United States and more than 700 severe allergic reactions.
Federal officials said they could not yet say that the contaminant, which
mimics real heparin, caused the reactions. Until Thursday, federal
investigators had been focusing on heparin manufactured by Baxter
International. But Dr. Woodcock said that German health authorities told the
F.D.A. that Baxter did not make the heparin linked to two separate outbreaks
of allergic reactions in that country. Germany has reported fewer than 100
cases of patients suffering severe allergic reactions and shock, and no
deaths.
F.D.A. officials declined to say whether the raw ingredients for the suspect
German heparin came from China, the source of the starting materials used to
make the contaminated heparin in the United States. Most of the world’s
heparin supply is from China. In the last six months, more than 30 Chinese
companies could be found selling heparin products on major
business-to-business Web sites. “We are working as quickly as possible to
analyze any potential impact on the U.S. market and worldwide,” said Deborah
Autor, the director of compliance for the agency’s Center for Drug
Evaluation and Research.
In the first half of last year, China exported heparin products to 42
countries and regions, according to a September 2007 report by the China
Chamber of Commerce for Import and Export of Medicines and Health Products.
China exported the most heparin products, about 13 tons, to Germany. It also
sent 11 tons to France and about 10 tons to the United States, the report
said.
Erin Gardiner, a spokeswoman for Baxter, said reports that her
company was not responsible for making the suspect heparin in Germany would
most likely point to a problem with the suppliers of crude heparin. “The
news today indicates that the issue could be further back in the supply
chain,” Gardiner said. Last week, Baxter withdrew from the market nearly all
of its heparin products. Most supplies of heparin in the United States are
now from APP Pharmaceuticals, of Schaumburg, IL. APP’s supplies have
undergone the new tests. German authorities have identified Rotexmedica as a
manufacturer of at least some of the suspect heparin there, F.D.A. officials
said. F.D.A. officials said they were told that the German authorities had
recalled an unspecified amount of heparin. (The New York Times) See
THIS LINK
Drugs like aspirin could reduce breast cancer and help existing
sufferers
Anti-inflammatory drugs like aspirin may reduce breast cancer by up to 20
percent, according to an extensive review carried out by experts at London’s
Guy’s Hospital and published in the March issue of IJCP, the
International Journal of Clinical Practice. But they stress that further
research is needed to determine the best type, dose and duration and whether
the benefits of regularly using non-steroidal anti-inflammatory drugs (NSAIDs)
outweigh the side effects, especially for high-risk groups.
“Our review of research published over the last 27 years suggests that, in
addition to possible prevention, there may also be a role for NSAIDs in the
treatment of women with established breast cancer” said Professor Ian
Fentiman from the Hedley Atkins Breast Unit at the hospital, part of Guy's
and St Thomas' NHS Foundation Trust. “NSAID use could be combined with
hormone therapy or used to relieve symptoms in the commonest cause of
cancer-related deaths in women.”
Professor Fentiman and Avi Agrawal reviewed 21 studies covering more than
37,000 women published between 1980 and 2007. Their review included 11
studies of women with breast cancer and ten studies that compared women who
did and did not have the disease. “Having weighed up the findings from over
20 studies, we have concluded that NSAIDs may well offer significant
protection against developing breast cancer in the first place and may
provide a useful addition to the treatment currently available to women who
already have the disease,” said Professor Fentiman. “Recent studies of
NSAIDs use have shown about a 20 percent risk reduction in the incidence of
breast cancer, but this benefit may be confined to aspirin use alone and not
other NSAIDs.”
Previous studies have suggested that NSAIDs like aspirin and ibuprofen,
which have traditionally been used as mainstream non-prescription
analgesics, may provide protection against coronary heart disease and some
malignancies, such as colorectal cancer. But Professor Fentiman is urging
caution until further research fully weighs up the pros and cons of using
NSAIDs to prevent and treat breast cancer.
“Our review did not look at the potential side effects of using NSAIDs on a
regular basis” stresses Professor Fentiman “These can include
gastrointestinal bleeding and perforation which can carry a significant risk
of ill health and death. “It would be essential to take these negative
effects into account before we could justify routinely using NSAIDs like
aspirin to prevent breast cancer. More research is clearly needed and we are
not advocating that women take these non prescription drugs routinely until
the benefits and risks are clearer. But our findings clearly indicate that
these popular over-the-counter drugs could, if used correctly, play an
important role in preventing and treating breast cancer.”
GAO:
Issues and challenges related to how hospitals submit quality data and how
CMS ensures data reliability
Hospitals submit data on a series of quality measures to the Centers for
Medicare & Medicaid Services (CMS) and receive scores on their performance.
CMS instituted the Reporting Hospital Quality Data for Annual Payment Update
Program (APU program) to collect the quality data from hospitals and report
their rates on the measures on its Hospital Compare Web site. For hospital
quality data to be useful to patients and other users, they need to be
reliable, that is, accurate and complete. The Deficit Reduction Act of 2005
directed CMS to implement a value-based purchasing program for Medicare that
beginning in fiscal year 2009 would adjust payments to hospitals based on
factors related to the quality of care they provide.
This statement provides information on (1) how hospitals collect and submit
quality data to CMS and (2) how CMS works to ensure the reliability of the
quality data submitted. This statement is based primarily on Hospital
Quality Data: HHS Should Specify Steps and Time Frame for Using Information
Technology to Collect and Submit Data (GAO-07-320, Apr. 25, 2007) and
Hospital Quality Data: CMS Needs More Rigorous Methods to Ensure Reliability
of Publicly Released Data (GAO-06-54, Jan. 31, 2006). In preparing these
reports, GAO conducted case studies of eight hospitals, and reviewed
documents of, and interviewed officials at CMS.
What GAO found: GAO reported in April 2007 that the eight
case study hospitals visited used six steps to collect and submit
quality data, two of which (steps 2 and 3) involved complex
abstraction—the process of reviewing and assessing all relevant
pieces of information in a patient’s medical record to determine
the appropriate value for each data element. The six steps were
(1) identify patients for whom the quality data should be
submitted, (2) locate needed information in the medical records,
(3) determine the appropriate value for each data element, (4)
transmit the data to CMS, (5) review reports to ensure acceptance
of the data by CMS, and (6) supply copies of selected medical
records to CMS for data validation.
Several factors account for the complexity of the abstraction
process (steps 2 and 3), including the content and organization of
the medical record, the scope of information and clinical judgment
required for certain data elements, and frequent changes by CMS in
its data specifications. GAO’s case studies also showed that
existing information technology (IT) systems help hospitals gather
some quality data but are far from enabling hospitals to automate
the abstraction process. For more information see
THIS LINK.
Vaccine could offer protection against high
blood pressure
A
vaccine that protects against high blood pressure by mopping up a hormone
that makes blood vessels constrict has been developed by a team of
scientists. A trial of the jab showed it significantly reduced blood
pressure in 72 people with mild to moderate hypertension, and was
particularly effective in the early hours of the morning, when people are
most at risk of strokes and heart attacks.
Dr. Martin Bachmann and colleagues from University hospital, Lausanne,
developed the vaccine to target a hormone, angiotensin 2, which causes blood
vessels to tighten and so raise the pressure of blood flowing through them.
Angiotensin-blocking drugs are the most common hypertension treatments
today. To make the vaccine, the researchers attached molecules of
angiotensin 2 to artificial viruses, harmless bundles of protein created in
the lab which look like viruses but cannot replicate or cause damage. The
researchers have formed a company, Cytos Biotechnology.
In the trial, volunteers were injected with either a placebo, 100 micrograms
or 300 micrograms of the vaccine. Each person received three jabs, one on
the first day of the trial, with the others following one and three months
later. The blood pressure of each volunteer was taken one day before the
trial and two week after the last injection.
According to a report in the Lancet, systolic blood and diastolic
blood pressure fell by 9mm and 4mm respectively in patients given 300
micrograms of the vaccine. Those given a placebo showed no change in blood
pressure. "What was quite remarkable and unexpected was the biggest falls in
blood pressure were between 5am and 8am, when most strokes and heart attacks
happen," said Bachmann. "This time is particularly risky because blood
pressure surges in the morning as the body wakens, before patients have
taken their medication ... With a vaccine, we hope they would only need an
injection every six months." (The Guardian)
Cause of typhoid outbreak still a puzzle as
cases rise
As cases of typhoid fever continued to escalate and an already crowded
government hospital had started putting patients under a tent, government
and health officials in Calamba City, Philippines, were still uncertain of
the cause of the outbreak. As of Thursday, the number of persons afflicted
with typhoid fever in the community had increased from 1,041 to 1,149 and
the confinement in six hospitals had risen from 426 to 522, Dr. Dennis Labro,
city health office's spokesperson, told the Philippine Daily Inquirer,
parent company of INQUIRER.net.
Labro said the CHO, with the help of sanitary inspectors in the provincial
level, was conducting an investigation and water sampling. He added that the
test would take some time because their staff members were going from house
to house in every village, including unaffected areas. The team also probed
the possibility that there were leaks in the water facilities of the Calamba
Water District (CDW). CDW earlier denied the allegations that the water it
supplied to villages was contaminated. CDW general manager Alberto M.
Cervancia said they had met the Department of Health's bacteriology
standards for drinking water. CDW had also sought the assistance of the Aqua
Laboratory Center, an accredited agency of DoH for water testing, he added.
The Aqua Lab reported through physiochemical test on February 27 that the
water sample from CWD passed the DOH standards and was negative for
Salmonella typhi, the bacteria which causes typhoid fever. "There could be
other causes aside from water," Cervancia said.
From 155 people, the hospital was accommodating 170 typhoid
patients as of Thursday. Dr. Gonzalo Lavarias Jr., chief of hospital, said
they would be setting up another makeshift tent to shelter the other
patients as the hallways had become even more congested. An open makeshift
tent near the hospital's chapel, which set up Sunday, is housing around 58
patients. Labro however clarified that typhoid cases might not really be
increasing because some of the patients might have just sought
hospitalization recently but had been enduring the disease for days. "There
were also days with lower hospital admission but last Wednesday was one of
the peak days," he said, adding: "This is because of the long incubation
period of the disease." "The city government is both alarmed and concerned
in what is happening. In declaring state of calamity, it would be easy to
disburse calamity funds for medical supplies," Labro said. He said city
residents were also alarmed and facing difficulties in terms of the water
source. "Some residents are already thinking to move out of Calamba
temporarily until the outbreak subsides," he said. (Inquirer.net) See
THIS LINK
New
test for joint infection could spare some patients an unnecessary procedure
A
potential diagnostic test that could help surgeons confirm or rule out the
presence of infection-causing bacteria in prosthetic joints that require
surgical revision has been developed by researchers at the National
Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), a part
of the National Institutes of Health (NIH). Such a test could spare a
subgroup of people who need the surgery a time-consuming and costly
treatment for infection, while helping to ensure that people who need the
procedure get it. The test is described in the March issue of the Journal
of Bone and Joint Surgery.
Each year, hundreds of thousands of joint replacement surgeries are
performed in this country. And each year, thousands of them must be revised
(the prosthetic joint must be removed and replaced) due to severe pain and
swelling. These symptoms are often due to infection, said Rocky S. Tuan,
Ph.D., chief of NIAMS' Cartilage Biology and Orthopaedics Branch.
The standard treatment for suspected infection is to remove the joint
prosthesis and replace it with a spacer that has been impregnated with
antibiotics. After about six weeks, patients must undergo another surgery to
remove the spacer. Only then can the surgeon implant the new prosthesis. The
problem with this approach is that confirming the presence of
infection-causing bacteria is an inexact science. Currently, doctors check
for infection by culturing a sample of the joint fluid. A positive culture
confirms live bacteria, making spacer surgery a certainty. A negative
culture, however, does not necessarily mean there is no infection. In fact,
Tuan says that estimates of the false negative rate for joint cultures in
revision surgeries range from 27 percent to 50 percent. But because failure
to treat an infected joint could lead to severe infection and limb
amputation, spacer surgery is sometimes performed for safety's sake even
when infection test results are inconclusive.
To get around the false-negative problem, Tuan and his colleagues developed
a way to test for joint infections using polymerase chain reaction (PCR),
which detects the presence of bacterial DNA. However, this approach proved
to have pitfalls, too. It picked up all bacteria, even dead or dying
bacteria that cannot perpetuate infection, thereby giving false positives.
Tuan says this new problem led them to expand their PCR approach by testing
for bacterial messenger ribonucleic acid (mRNA). "When bacteria are dying,
their mRNA is one of the first things to go," he said. As a result, the
researchers hypothesized that a good mRNA test would not only detect
bacteria, but would likely tell them if any bacteria they detected were
still viable. Unlike DNA, mRNA is not directly quantifiable by known
techniques, so the mRNA test that Tuan's group developed employs a process
called reverse transcription PCR (RT-PCR) to convert the mRNA into DNA for
measurement.
Now Tuan's team is recruiting 50 people who need joint revision for a
clinical trial that will involve testing patients' joint fluid for bacteria
and then following them for 6 months to a year after surgery. They hope that
the results from this study will validate the protocol to identify or rule
out infections before a person begins a surgical revision. Tuan would like
to be able to tell patients who need infection treatment, "There is a really
bad infection and we know what to do." "But we also want to tell the person
without infection that it's O.K. to put in a revision joint. That saves the
spacer, the additional surgery and its associated risk, and 6 weeks of being
laid up," Tuan said.
Criminal charges filed over poisonous toothpaste
Criminal charges have been filed against a company that prosecutors say
imported and distributed nearly 90,000 tubes of Chinese toothpaste
containing a poisonous substance, Los Angeles City Attorney Rocky Delgadillo
announced Thursday. A wholesaler that supplied local stores with the tubes
was also charged. Selective Imports sold the toothpaste containing
diethylene glycol to distributors nationwide between December 2005 and May
2007, prosecutors said. Vernon Sales is accused of buying some of the tubes
and reselling them to Los Angeles stores. Diethylene glycol is a chemical
used in antifreeze and as a solvent. Chinese manufacturers have used the
chemical, known as DEG, as a cheaper alternative to glycerin, which thickens
toothpaste. Exposure to DEG, however, can cause kidney and liver damage over
time.
Vernon Sales President Kamyab Toofer and Vice President Pejman Mossay were
charged with 14 criminal counts each of receiving, selling and delivering an
adulterated drug. Selective Imports President Frahad Nazarian and Vice
President Yones Ghermezi were charged with two criminal counts each of
receiving, selling and delivering products containing DEG. Each count
carries a maximum penalty of one year in jail and a $1,000 fine. The
companies are liable for distributing the tainted product even if they had
no direct knowledge of the risk because they were negligent in not ensuring
the toothpaste was safe, Supervising Deputy City Attorney Jerry Baik said.
Ghermezi said he had not seen the charges but was shocked by the filing. All
the adulterated toothpaste was voluntarily pulled from shelves and from his
Vernon, CA, company's inventory eight months ago and destroyed by the U.S.
Food and Drug Administration last month, he said. "Everything we had was
destroyed by the FDA," Ghermezi said. "I thought the file had been closed."
Ghermezi said he supplied the toothpaste to Vernon Sales, also based in
Vernon. He said his company never knowingly sold adulterated toothpaste and
thought the product had FDA approval.
"We didn't know of the ingredients of the toothpaste," he said.
"We don't [have] any intention of hurting people." The charges stem from an
inquiry after the FDA confiscated some 70,000 tubes of toothpaste delivered
to the Port of Long Beach in May, Baik said. (Washington Post) See
THIS LINK
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March 6, 2008 Download print version
HPN’s Critical Care Supply Innovator Award
Mystery substance in Baxter's heparin; FDA:
Tampering possible in China
AARP report finds brand name drug prices continue
to soar
Medline and
3M agree to strategic partnership in electrosurgery
Two tests added to recommended list to prevent or
detect colorectal cancer
Type 2 diabetes may be caused by intestinal
dysfunction
VHA Inc. helps hospitals in Central Atlantic Region
improve MRSA treatment
HPN’s Critical Care Supply Innovator Award
Please submit your nomination of no more than 750 words for
HPN's Critical Care Supply Innovator Award.
Highlight the problem, the solution, and who developed the solution.
Deadline: Friday, March 14th.
HPN will feature the winning facility in the May 2008 edition, as well as at
the 2008 AACN/NTI in Chicago, May 3-8.
Email
your nomination to
editor@hpnonline.com with “Critical Care Supply Innovator” in the
subject line.
Mystery substance in Baxter's heparin; FDA: Tampering possible in China
A significant amount of an unidentified foreign substance contaminated
Baxter International Inc.'s
blood-thinning drug heparin, the U.S. Food and Drug Administration said
Wednesday, raising the possibility of intentional tampering in a supply
chain that begins with pig farms in China. The mysterious substance, which
has a chemical makeup similar to heparin, comprises as much as 20 percent of
the active ingredient in nine suspect lots produced by Baxter since
September, the FDA said Wednesday. The suspect lots are connected to at
least four deaths reported nationwide since Baxter noted a spike in adverse
reactions to the drug in late December.
The FDA on Wednesday said heparin is connected to as many as 19 deaths and
785 serious illnesses since Jan. 1, 2007. But the FDA timeline extends well
beyond the period from September to November, when Baxter's
Cherry Hill,
NJ, plant produced the heparin connected to the recent rash of serious
allergic reactions. The suspect active ingredient in heparin originated at a
Changzhou, China, plant owned by Scientific Protein Laboratories, a Baxter
supplier based in Waunakee, WI.
"We don't know whether the introduction of the contaminant was accidental,
as part of the biological process, or if it was deliberate," said Dr. Janet
Woodcock, acting director of the FDA's center for drug evaluation and
research. At least one former top FDA official who helped lead the fight
against counterfeit drugs indicated that some Chinese suppliers in the past
have introduced foreign substances to boost production when supplies are
tight. "The obvious question is, 'Are these plants back-dooring their supply
in order to supplement their capacity?' " asked Benjamin England, who
chaired the FDA's Counterfeit Drug Working Group before leaving for a
private law practice in Washington, DC, in 2003.
Heparin is produced from an enzyme in the mucous lining of pig intestines.
The suspect lots of heparin were made beginning in September, just after the
peak in an epidemic of an often-fatal disease known as "blue ear" that
afflicted more than 250,000 pigs throughout China. An FDA official at the
press conference said it is possible supplies of the adulterated ingredient
came from pig intestines. But FDA officials emphasized they have not
pinpointed the source. Conventional quality and safety testing typically
does not discover a foreign substance, England added, because the tests are
not designed for that purpose. Scientific Protein's plant obtains heparin
from bulk providers of raw material. From its plant in Changzhou, Scientific
Protein ships raw heparin to the company's headquarters outside Madison, WI,
then on to Baxter's Cherry Hill plant for final processing, packaging and
shipping.
Baxter, in its own press conference, sought to point the investigative
spotlight back to China. Baxter executives said the active pharmaceutical
ingredient sourced from its China-based supplier is the focus of the
company's investigation. "Either the problem lies further back in the supply
chain, somewhere before the material gets to the processing plant, or
there's something in the processing before it comes to Baxter," said Peter
Arduini, president of Baxter's medication delivery business. Arduini said
the company's Cherry Hill manufacturing plant, where multidose vials of
heparin are finished and filled before shipment to hospitals and dialysis
centers, recently passed an FDA inspection. Arduini said Baxter's
investigation centers further into the "supply stream" in China. There could
be "process issues" associated with Scientific Protein's Chinese
manufacturing plant, he said. (Chicago Tribune) See
THIS LINK
AARP report finds brand name drug prices continue to soar
According to a report released by AARP, pharmaceutical companies have
substantially raised prices on 220 brand name prescription drugs most
commonly used by people in Medicare Part D since the implementation of the
drug benefit in 2006. AARP has studied drug prices since 2002 and reported
the findings in a series of Watchdog reports. The report expands on the
series by focusing its analysis on those brand prescription drugs most
widely used by people enrolled in Medicare Part D.
The Watchdog report, which was produced by AARP’s Public Policy Institute (PPI),
found that prices of brand name drugs most commonly used by people in
Medicare Part D rose by an average of 7.4 percent in 2007, nearly two and a
half times the rate of general inflation. The report concludes that rising
prices threaten consumers by increasing the likelihood of higher insurance
premiums and the chance that people will fall into the Medicare coverage
gap, and increasing the out-of-pocket expenses of those who find themselves
in this “donut hole.”
The average treatment cost exploded from $80 per year per prescription in
2002, to $151 in 2007. A person who took three brand name prescriptions to
treat a chronic condition over this period saw an increase in their yearly
costs of more than $1,600 between 2002 and 2007. The study found brand name
drug prices increased far greater than general inflation since 2002, with
dramatic spikes since 2006, the period when Medicare Part D was implemented.
For the complete Watchdog report see
THIS LINK
Medline and 3M
agree to strategic partnership in electrosurgery
Medline Industries Inc. and 3M Health Care announce an exclusive license and
supply agreement for 3M's electrosurgical patient plates in the United
States. Under this agreement, Medline has acquired the exclusive license and
sales rights in the United States for 3M's electrosurgical patient plates
and accessories. Included are the 1100 series electrosurgical patient plates
and the 9100 series universal patient plates with proprietary safety
ring. This product line will be sold under the Medline brand. 3M brand
patient plates are featured in national group purchasing contracts and are
currently sold through several distribution channels. Medline will continue
to support all sales channels and build upon the relationships 3M has
established with healthcare customers to ensure optimal supply costs and
allow these customers to maintain their focus on patient safety. For more
information, see
THIS LINK.
Two
tests added to recommended list to prevent or detect colorectal cancer
The
American Cancer Society and other health groups are
recommending two tests they had not previously endorsed to prevent or detect
colorectal cancer, the groups said Wednesday. The new
policy is based on evidence that the tests work well enough to recommend and
applies to all adults 50 and older and to some younger people with symptoms
or risk factors for
colon cancer.
One test
is virtual
colonoscopy, which uses a
CT scan to look for abnormal growths and, unlike the
standard colonoscopy, does not require inserting a camera-tipped tube
rectally. The other test examines stool to find abnormal DNA associated with
cancer and requires an entire bowel movement be packed in
a kit and sent to a laboratory. The tests are now part of a list of seven
testing options from which people can choose. The medical groups are
providing as many options as possible, they say, hoping patients find one
acceptable.
Many
people are so squeamish about tests for the disease that they skip them
entirely. It is one of the very few cancers that can be entirely prevented
by removing polyps or other precancerous growths or can be cured if detected
early. “Fifty percent of the population gets no screening,” said Dr. Grace
H. Elta, a gastroenterologist and professor at the
University of Michigan who is president of the American
Society for Gastrointestinal
Endoscopy. “Any screening is better than that.”
The new guidelines organize the tests in two groups and specify the
intervals to perform them. The first group consists of tests that can detect
cancer or prevent it by finding precancerous growths. It includes
colonoscopy, which examines the entire colon; flexible sigmoidoscopy, which
examines part of the colon; barium enemas; and virtual colonoscopy. The
second group primarily detects cancer, rather than preventing it. Two tests
look for blood in the stool, and the third is the stool DNA test. Blood in
the stool does not necessarily indicate cancer but requires follow-up.
“Prevention should be the primary goal,” said Dr. Robert Smith, director of
screening for the cancer society. That would mean that the first group of
tests is preferable. But Dr. Smith said some people were unwilling to have
them or unable to afford them.
Right
now, Dr. Elta said, insurers do not cover virtual colonoscopy, which she
said costs $1,200 to $1,500. It is uncertain whether the new guidelines will
lead to coverage changes. None of the tests are perfect. Doctors who perform
colonoscopy, for instance, may fail to see precancerous lesions. Virtual
colonoscopy will probably fail to detect lesions that are flat, a type that
is especially risky and more common in the United States than previously
realized, researchers reported Tuesday in The Journal of the
American Medical Association.
Tests
for blood in the stool generally miss polyps and detect just half of
tumors. Sigmoidoscopy does not reach the upper stretches
of the colon. As for the stool DNA test, Dr. Elta said, “It’s really not
ready for prime time.” The test is not accurate enough, she said, and in
many instances not reimbursed by insurers. “Most people are not using it
right now,” she said. “The biggest hope of all is if it ever gets good
enough to pick up polyps. It’s the test with the most promise, but right now
it has no efficacy at picking up polyps.” (The New York Times) See
THIS LINK
Type 2 diabetes may be caused by intestinal dysfunction
Growing evidence shows that surgery may effectively cure Type 2 diabetes, an
approach that not only may change the way the disease is treated, but that
introduces a new way of thinking about diabetes. A new article, published in
a special supplement to the February issue of Diabetes Care by a
leading expert in the emerging field of diabetes surgery, points to the
small bowel as the possible site of critical mechanisms for the development
of diabetes.
The
study's author, Dr. Francesco Rubino of NewYork-Presbyterian Hospital/Weill
Cornell Medical Center, presents scientific evidence on the mechanisms of
diabetes control after surgery. Clinical studies have shown that procedures
that simply restrict the stomach's size (i.e., gastric banding) improve
diabetes only by inducing massive weight loss. By studying diabetes in
animals, Dr. Rubino was the first to provide scientific evidence that
gastrointestinal bypass operations involving rerouting the gastrointestinal
tract (i.e., gastric bypass) can cause diabetes remission independently of
any weight loss, and even in subjects that are not obese.
"By
answering the question of how diabetes surgery works, we may be answering
the question of how diabetes itself works," said Dr. Rubino, who is a
professor in the Department of Surgery at Weill Cornell Medical College and
chief of gastrointestinal metabolic surgery at NewYork-Presbyterian/Weill
Cornell. Dr. Rubino's prior research has shown that the primary mechanisms
by which gastrointestinal bypass procedures control diabetes specifically
rely on the bypass of the upper small intestine, the duodenum and jejunum.
This is a key finding that may point to the origins of diabetes.
"When we
bypass the duodenum and jejunum, we are bypassing what may be the source of
the problem," says Dr. Rubino, who is heading up NewYork-Presbyterian/Weill
Cornell's Diabetes Surgery Center. In fact, it has become increasingly
evident that the gastrointestinal tract plays an important role in energy
regulation, and that many gut hormones are involved in the regulation of
sugar metabolism. "It should not surprise anyone that surgically altering
the bowel's anatomy affects the mechanisms that regulate blood sugar levels,
eventually influencing diabetes," Dr. Rubino said.
While other gastrointestinal operations may cure diabetes as an
effect of changes that improve blood sugar levels, Dr. Rubino's research
findings in animals show that procedures based on a bypass of the upper
intestine may work instead by reversing abnormalities of blood glucose
regulation.
In fact, bypass of the upper small intestine does not improve the
ability of the body to regulate blood sugar levels. "When performed in
subjects who are not diabetic, the bypass of the upper intestine may even
impair the mechanisms that regulate blood levels of glucose," said Dr.
Rubino. In striking contrast, when nutrients' passage is diverted from the
upper intestine of diabetic patients, diabetes resolves. This, he explains,
implies that the upper intestine of diabetic patients may be the site where
an abnormal signal is produced, causing, or at least favoring, the
development of the disease.
Dr. Rubino proposes an original explanation known in the
scientific community as the "anti-incretin theory." Incretins are
gastrointestinal hormones, produced in response to the transit of nutrients,
that boost insulin production. Because an excess of insulin can determine
hypoglycemia, a life-threatening condition, Dr. Rubino speculates that the
body has a counter-regulatory mechanism, activated by the same passage of
nutrients through the upper intestine. The latter mechanism would act to
decrease both the secretion and the action of insulin.
"Further research on the exact molecular mechanisms of diabetes,
surgical control of diabetes and the role played by the bowel in the disease
may bring us closer to the cause of diabetes,” said Dr. Rubino. Today, most
patients with diabetes are not offered a surgical option, and bariatric
surgery is recommended only for those with severe obesity (a body mass
index, or BMI, of greater than 35kg). "It has become clear, however, that
BMI cut-offs can no longer be used to determine who is an ideal candidate
for surgical treatment of diabetes," said Dr. Rubino.
VHA Inc. helps hospitals in Central Atlantic Region improve MRSA treatment
VHA Inc., the national
health care alliance, launched a national MRSA initiative in 2006 to help
hospitals rapidly implement methods to detect and treat methicillin-resistant
Staphyloccus aureus (MRSA) and to prevent the spread of MRSA to other
patients. Sixteen member hospitals from VHA’s Central Atlantic region have
been working together to address MRSA, and after 12 months, they have seen a
27 percent improvement in hand hygiene and 24 percent improvement in barrier
precaution protocol compliance, both of which are key to managing the spread
of this infection.
By establishing a “secret observer” program, Nash Health Care
Systems in Rocky Mount, NC, was able to identify opportunities to increase
hand hygiene compliance. “We identified areas for improvement and
implemented measures to help remind staff about the importance of hand
hygiene,” said Wanda Lamm, RN, BSN, CIC, infection control coordinator at
Nash General Hospital. Measures included providing a button for staff to
wear with a picture of a hand on it to remind staff to wash hands, as well
as fostering a healthy competition between units to identify most compliant
performers. Patients and family members are encouraged through dialogue,
brochures and hospital TV programming to ask caregivers to wash hands before
and after touching the patient. “Hand washing before touching the patient is
up 77 percent and washing after touching the patient is up 80 percent, which
is higher than the national average,” said Lamm. “Active surveillance
efforts, combined with new barrier protection policies and isolation
practice changes (carts are no longer shared between patients and isolation
equipment is mounted directly on each patients door), and new lab media has
allowed us to realize a 38 percent decrease in MRSA infection cases at our
hospital.”
Wheeling Hospital in Wheeling, WV, joined the VHA program to help bolster
staff and community education about MRSA. The hospitals active surveillance
program includes: Frequent culturing of patients; An anonymous observer of
the month for hand hygiene and barrier precaution compliance; Developing a
clinical alert tag that flags high-risk patients through the hospital’s
computer system; New housekeeping policies that require decontamination of
high-touch surfaces in high-risk patient rooms two-to-three times a day; and
developing and awarding a quarterly Golden Hand Award to units with
exceptional compliance. “We have increased our hand hygiene and barrier
precaution compliance levels to 96 percent and are planning to expand our
MRSA control efforts to include those patients coming into our facility from
the local nursing home communities,” said Laura E. Rafa, RN, BSN, infection
control director at Wheeling Hospital. To learn more about VHA’s other
clinical improvement programs, see
THIS
LINK.
March 5, 2008 Download print version
Costly placebo works better
than cheap one
Non-polypoid (flat) colon lesions relatively common and associated with
colorectal cancer
Cathedral Healthcare System to pay $5.3 million to resolve
allegations involving inflated charges
Hospitals: No charge for mistakes
Broadlane’s Live Group buy saves client
more than 30 percent on capital equipment purchase
Amerinet Workforce Solutions fill positions to
meet critical need
Cardinal Health agrees to
acquire ChloraPrep manufacturer for $490 million
Cardinal Health announced a definitive agreement to acquire the assets of
privately held Enturia for $490 million. The cash transaction includes
Enturia’s line of infection prevention products sold under the ChloraPrep
brand name and is expected to close within 60 days, subject to customary
regulatory approvals and other conditions.
ChloraPrep brand products are used widely in U.S. hospitals and surgery
centers to disinfect the skin before surgical and vascular procedures to
help prevent blood stream and surgical site infections, two of the most
common types of health care-associated infections (HAIs) among patients. The
acquisition will complement Cardinal Health’s infection prevention offerings
by adding a differentiated and proven product line to the company’s Medical
Products and Technologies segment. Numerous organizations that focus on
improving hospital safety have cited the active ingredient in ChloraPrep
products as the clinically preferred antiseptic for preoperative skin
preparation.
Cardinal Health plans to accelerate sales of ChloraPrep products to both
hospital and alternate-care customers through its U.S. and international
sales networks. Enturia’s rich product pipeline is expected to help expand
the base of applications for ChloraPrep products.
Enturia (www.enturia.com) was founded as Medi-Flex Hospital Products in
1985. Over the past two years, the company’s revenue has grown more than 70
percent to approximately $140 million in 2007.
Separately, and as part of the company’s ongoing strategy to optimize its
portfolio of products and services, Cardinal Health has decided to pursue
the sale of several smaller, non-core offerings within its Medical Products
and Technologies segment. Details will be announced as there are significant
developments in these transactions. For more information see
THIS LINK.
Researcher says 'unexpected' increase in cancer risk found in follow-up to
women's health initiative
An increased cancer risk in post-menopausal women after they
stopped taking combined hormone therapy was an “unexpected
finding” in a study that will be reported in the March 5 edition
of the Journal of the American Medical Association (JAMA),
said Rowan T. Chlebowski, M.D., Ph.D., a Los Angeles Biomedical
Research Institute (LA BioMed) lead investigator who contributed
to the study.
“This latest
study reinforces the original finding that combined hormone
therapy of estrogen plus progestin should not be taken for the
purpose of reducing disease in post-menopausal women,” Chlebowski
said. “These findings also reinforce the need for monitoring for
cancer in women who have taken the combination of estrogen plus
progestin.”
Dr. Chlebowski is
a medical oncologist who has led several prior reports focusing on
hormone effects on malignancies, including breast and colorectal
cancer. He was a member of the team of researchers, led by Gerardo
Heiss, M.D., of the University of North Carolina, Chapel Hill, who
authored the March 5 JAMA report on a follow-up study of
post-menopausal women enrolled in the Women’s Health Initiative.
Dr. Chlebowski is available for comment for reporters seeking
further insight into the study’s findings.
The Women’s Health
Initiative (WHI) trial began in 1993 to measure the effect of estrogen plus
progestin on reducing disease in post-menopausal women. It included 16,608
postmenopausal women and assessed whether conjugated equine estrogens (CEE)
plus medroxyprogesterone acetate (MPA) prevents heart disease and hip
fractures and increases the risk of breast cancer. The trial was stopped in
2002 when data indicated an increased risk of breast cancer and a failure to
demonstrate an overall health benefit of the therapy. Further analysis
showed that women taking the two hormones had higher risks of cardiovascular
disease, coronary heart disease, stroke and venous thromboembolism and lower
risks of fracture and colorectal cancer.
After stopping
intervention, WHI followed the trial participants using the same study
protocol of semi-annual monitoring to identify and classify study outcomes,
in order to evaluate the effects of stopping hormone therapy. Post
intervention information for the period July 8, 2002 to March 31, 2005 was
available on 95% of the women. In the three years after stopping hormone
therapy women who previously used estrogen plus progestin no longer had an
increased risk of cardiovascular disease (heart disease, stroke, and blood
clots) compared with women on placebo.
The lower risk of
colorectal cancer and fractures seen during the trial in women who
previously used estrogen plus progestin disappeared after stopping the
combined hormone therapy. But the risk of all cancers combined in women who
previously used estrogen plus progestin increased after stopping the
intervention compared to those previously on placebo. This was due to
increases in a variety of cancers, including lung cancer.
After stopping the hormone
therapy, mortality from all causes was somewhat higher in women who
previously used estrogen plus progestin compared with those taking a
placebo.
Costly placebo works better than cheap one
A 10-cent pill doesn't kill pain as well as a $2.50 pill, even
when they are identical placebos, according to a provocative study
by Dan Ariely, a behavioral economist at Duke University.
"Physicians want to think it's the medicine and not their
enthusiasm about a particular drug that makes a drug more
therapeutically effective, but now we really have to worry about
the nuances of interaction between patients and physicians," said
Ariely, whose findings appear as a letter in the March 5 edition
of the Journal of the American Medical Association.
Ariely and a team of
collaborators at the Massachusetts Institute of Technology used a standard
protocol for administering light electric shock to participants’ wrists to
measure their subjective rating of pain. The 82 study subjects were tested
before getting the placebo and after. Half the participants were given a
brochure describing the pill as a newly-approved pain-killer which cost
$2.50 per dose and half were given a brochure describing it as marked down
to 10 cents, without saying why.
In the full-price
group, 85 percent of subjects experienced a reduction in pain
after taking the placebo. In the low-price group, 61 percent said
the pain was less.
The finding, from a relatively small and simplified experiment, points to a
host of larger questions, Ariely said. The results fit with existing data
about how people perceive quality and how they anticipate therapeutic
effects, he said. But what's interesting is the combination of the
price-sensitive consumer expectation with the well-known placebo effect of
being told a pill works. "The placebo effect is one of the most fascinating,
least harnessed forces in the universe," Ariely said.
Ariely wonders if prescription medications should offer cues from packaging,
rather than coming in indistinguishable brown bottles. "And how do we give
people cheaper medication, or a generic, without them thinking it won't
work"" he asks.
At the very
least, doctors should be able to use their enthusiasm for a
medication as part of the therapy, Ariely said. "They have a
huge potential to use these quality cues to be more
effective." The study was funded by MIT.
Non-polypoid (flat) colon lesions relatively
common and associated with colorectal cancer
Flat, non-polypoid colorectal neoplasms (NP-CRNs), which may be
difficult to detect, appear to be relatively common and may have a
greater association with cancer compared with the more routinely
diagnosed type of colorectal polyps, according to a study in the
March 5 issue of JAMA. Colorectal cancer is the second
leading cause of cancer death in the United States. Prevention has
focused on the detection and removal of polypoid (resembling a
polyp) neoplasms (a new and abnormal growth). Recent studies,
however, have demonstrated that colorectal cancer can also arise
from NP-CRNs.
“Nonpolypoid colorectal neoplasms are more difficult to detect by
colonoscopy or computed tomography colonography because the subtle
findings can be difficult to distinguish from those of normal
mucosa [membrane]. As compared with surrounding normal mucosa, NP-CRNs
appear to be slightly elevated, completely flat, or slightly
depressed,” the authors write.
Roy M. Soetikno, M.D., M.S., and colleagues with the Veterans
Affairs Palo Alto Health Care System, Palo Alto, CA, examined data
from a group of 1,819 patients undergoing elective colonoscopy to
estimate the prevalence of NP-CRNs and to characterize the
association of NP-CRNs with colorectal cancer. The overall
prevalence of NP-CRNs was 9.35 percent. The prevalence of NP-CRNs
in the subpopulations for screening, surveillance, and symptoms
was 5.84 percent, 15.44 percent, and 6.01 percent, respectively.
The overall prevalence of NP-CRNs with cancer that had not spread
or had spread in tissue beneath the mucous membrane was 0.82
percent; in the screening population, the prevalence was 0.32
percent. Overall, NP-CRNs were nearly 10 times more likely to
contain cancerous tissue than polypoid lesions, irrespective of
the size.
The positive
size-adjusted association of NP-CRNs with cancer that had not
spread or had spread in tissue beneath the mucous membrane was
also observed in subpopulations for screening and surveillance.
The depressed type of NP-CRNs had the highest risk (33 percent).
Nonpolypoid colorectal neoplasms containing cancer were smaller in
diameter as compared with the polypoid ones.
“In conclusion, in this
population of patients at a single Veterans Affairs hospital, NP-CRNs were a
relatively common finding during colonoscopy. They were more likely to
contain carcinoma compared with polypoid neoplasms, independent of lesion
size. Recent studies have pointed out differences in the genetic mechanisms
underlying nonpolypoid and polypoid colorectal neoplasms. Future studies on
NP-CRNs should further evaluate whether the diagnosis and removal of NP-CRNs
has any effect on the prevention and mortality of colorectal cancer and
particularly focus on their genetic and protein abnormalities,” the authors
write.
In an accompanying editorial,
David Lieberman, M.D., of Oregon Health & Science University,
Portland VA Medical Center, Portland, OR, comments on the findings
of Soetikno and colleagues. “[Nonpolypoid colorectal neoplasms]
may be biologically distinct from polypoid lesions and appear to
be more likely to harbor malignant features. Detection and
complete removal at colonoscopy may be challenging. The current
study emphasizes the importance of quality in the performance of
colonoscopy,” he writes.
Cathedral Healthcare System to pay $5.3 million to
resolve allegations involving inflated charges
Cathedral Healthcare System Inc. has agreed to pay the US $5.3 mln, plus
interest, to settle allegations that it defrauded the federal Medicare
program, the Justice Dept announced earlier today. The settlement resolves
allegations that the Newark NJ-based hospital system improperly increased
charges to Medicare patients in order to obtain enhanced reimbursement from
the federal health care program.
In addition to its standard payment system, Medicare pays supplemental
reimbursement to hospitals, called outlier payments, in cases where the cost
of care is unusually high. Congress enacted the supplemental outlier payment
system to ensure that hospitals have the incentive to treat inpatients whose
care requires unusually high costs. The government alleged that for Jan
1998-Aug 2003, Cathedral improperly inflated charges for inpatient and
outpatient care to make these cases appear more costly than they actually
were, and thereby obtained outlier payments from Medicare that it was not
entitled to receive.
The civil settlement agreement resolves allegations against Cathedral that
were filed in 3 separate federal lawsuits brought by whistleblowers under
the federal False Claims Act. The False Claims Act permits private citizens
to bring lawsuits on behalf of the US. Under the settlement, Peter Salvatori
and Sara Iveson, the relators in the first of the 3 lawsuits, will receive
$848,000.
Cathedral has also entered into a Corporate Integrity Agreement with the US
DHHS Office of Inspector General. The Corporate Integrity Agreement contains
measures to ensure compliance with Medicare regulations and policies in the
future.
Hospitals: No charge for mistakes
The board of trustees for the
Oregon Association of Hospitals and Health Systems
has unanimously adopted guidelines to ensure that no patient
or payer foots the bill for hospital care related to adverse
medical events. The leadership board for the statewide trade
association in February pledged that all 57 Oregon hospitals would
not seek payment for costs associated with the occurrence of
serious adverse events if an investigation by the hospital
determines that the event was preventable and was in the control
of the hospital. The hospital association's list of qualifying
adverse events were adapted from the list published by the
Oregon Patient Safety Commission.
The list includes mistakes like operating on the wrong body part,
performing the wrong surgical operation on a patient,
inadvertently leaving a foreign object inside a surgery patient
and administering the wrong blood type to a patient. "With these
guidelines widely adopted, our patients are the real winners,"
said Norm Gruber, chair of the hospital association Board of
Trustees, and CEO of Salem Health, in a statement.
The move follows similar actions by some of the nation's largest
payers and healthcare purchaser groups. Medicare announced in
August 2007 it would no longer pay for certain serious medical
errors. The Leapfrog Group in 2006 convened a group of large
employers who also pledged not to pay for such errors.
Washington's hospitals joined the list in February 2008, joining
Pennsylvania, Minnesota and Massachusetts. A variety of
large-scale studies have shown that between 3.7 percent and 16.6
percent of total hospital admissions are associated with adverse
medical events. (Portland Business Journal) See
THIS LINK.
Broadlane’s Live Group buy saves client more than 30 percent on capital
equipment purchase
Broadlane’s Live
Group Buy recently saved Randolph Medical Center in Roanoke, AL,
more than 30 percent on a new Computed Tomography (CT) scanner
compared to best price quote they received.
Broadlane’s Live Group Buys are unique because
they are conducted in-person as a client-driven process designed
to help providers acquire the best technology at the best possible
value.
Chief
executive officer Timothy Harlin and chief financial officer Jeff
Kirkpatrick of Randolph Medical Center faced the challenge of buying a new
CT scanner. They needed to determine and acquire the best technology to meet
the current and future needs of their community, while remaining fiscally
responsible. They attended Broadlane’s Live Group Buy after hearing about it
through peers. “The savings exceeded our expectations,” said Harlin. “We
paid 30 percent less than what was offered through the best quote we
obtained on our own. Not only did we get state-of-the-art technology, but
savings of this magnitude allowed us to fund other needed capital
equipment.”
Broadlane has invited ECRI Institute as an unbiased expert for two upcoming
Live Group Buys: Computed Tomography (CT) Live Group Buy – March 26-28 and
Magnetic Resonance Imaging (MRI) Live Group Buy – May 28-30. ECRI Institute,
an independent, nonprofit organization that researches the best approaches
to improving patient care, will serve as an unbiased expert, offering
equipment purchasing clients the inside track on the latest medical
equipment.
For
more information see
THIS LINK.
To view the
Randolph Medical Center case study, see
THIS LINK.
Amerinet Workforce
Solutions fill positions to meet critical need
With
labor shortages looming nationwide in all healthcare disciplines, Amerinet’s
Workforce Solutions and its supplier partners are successfully filling
critical workforce needs in the healthcare industry. Challenged to find
physicians in specialty areas like pulmonology, nephrology or neurology,
Wyoming Medical Center (WMC), a 200-bed hospital in Casper, WY, turned to
Amerinet for help. Within just a few weeks, CareerStaff Unlimited, an
Amerinet partner, presented a locum tenens physician to meet the request.
In
another instance, Adirondack Medical Center (AMC), a hospital of more than
650 unionized employees, had recently acquired two nursing homes with 250
non-union employees. The challenge was to integrate all of the employees
within a few weeks; however, the vice president of human resources had
resigned. The medical center needed to fill this crucial position
immediately and provide a smooth transition for all of its new employees.
For more information, email
info@amerinet-gpo.com.
March 4, 2008 Download print version
Related Nevada
clinics closed amid safety fears
Ban on gifts to doctors sought
As drug ads surge, more get Rx's filled
Immune systems increasingly on attack
Antipsychotic Abilify cleared for use in youths
New detection tool saves medical industry money
Premier extends partnership with SterilMed
Related
Nevada clinics closed amid safety fears
With public fear and outrage growing, Clark County, NV, health
officials on Monday shut down three clinics owned by the same
medical group that exposed patients to incurable diseases at
its Las Vegas clinic. County agents hand-delivered orders
suspending the licenses of the Desert Shadow Endoscopy Center,
the Gastroenterology Center of Nevada and the Spanish Hills
Surgical Center hours after city administrators upheld the
suspension of the Endoscopy Center of Southern Nevada.
In
written statements, county leaders indicated that no evidence
points to patients being exposed to deadly diseases at the
three clinics they closed Monday. Suspending the business
licenses was a precaution, they said. "The practices at their
sister facility requires us to take action to protect the
public," Commissioner Rory Reid said, referring to the Las
Vegas clinic. "When dealing with such serious matters, it is
best to treat each situation with an abundance of caution to
minimize the risk to the public."
County commissioners will review the clinics' suspended
licenses at their March 18 meeting.
The endoscopy and gastroenterology clinics are
at 4275 Burnham Ave., near Flamingo Road, and the surgical center is at 5915
S. Rainbow Blvd., near Russell Road.
The city of Las Vegas shut
down the endoscopy clinic at 700 Shadow Lane
on Friday after investigators found that staff reused
syringes, contaminating vials of medication and infecting six
people with hepatitis C. The Southern Nevada Health District
last week sent out 40,000 letters to that clinic's patients,
urging them to get tested for hepatitis C and B and HIV, the
virus that causes AIDS.
The Burnham center
improperly allowed vials to be used multiple times but did not reuse
syringes, so there was no proof of contamination, state health officials
said last week. Still, county leaders insisted that the reported medical
practices were alarming enough to shut down the clinics in their
jurisdiction. "These are serious accusations and call for an equally serious
response," Commissioner Lawrence Weekly said. "We are dealing with deadly
diseases and so, to put it simply, it is better to be safe than sorry."
In a Monday
afternoon meeting with city officials, attorneys and doctors representing
the Shadow Lane clinic failed to persuade the city to reinstate its business
license. "It is the decision of the undersigned ... that the appeal is
denied," said Mayor Oscar Goodman, who announced the results of the hearing
but did not attend. "Now it's suspended. For the time being, we have their
license and the license will remain with us."
The clinic has the
option of taking the license suspension to court. "We haven't made any
decisions at this point," said Abe Vigil, a lawyer representing the clinic.
"We have to assess how to proceed." He declined to discuss the hearing
itself, saying only, "We definitely tried to put our best foot forward. We
were grateful for the opportunity." A city statement issued Monday noted
that although the center has agreed to no longer engage in the practice of
reusing syringes on vials, "city business license officials are not
confident the practice will stop."
Doctors Dipak Desai
and Clifford Carrol attended the meeting, along with three attorneys
representing them. The other doctors listed on the license are Eladio
Carrera and Vishvinder Sharma. Both Desai and Carrol have hospital
privileges at Sunrise Hospital and Medical Center as well Valley Hospital
Medical Center. Officials from both medical facilities said the two
physicians are still on staff and continue to see patients. "We cannot speak
to the practice inside other facilities,'' said Ashlee Seymour, a
spokeswoman for Sunrise. "We can however speak to the practices at Sunrise.
We do not reuse syringes." ( Las
Vegas Review-Journal) See
THIS
LINK
Editor’s Note:
For a related article from the Associated Press: “ CDC
warns of safety problems at clinics” see
THIS LINK
Ban on gifts to doctors sought
Senate President Therese Murray proposed a total ban on all gifts and
freebies to doctors from pharmaceutical companies, a move that would make
Massachusetts the first state in the country to ban such gifts outright. The
measure is part of a set of healthcare reform measures Murray filed in a
bill yesterday that also includes requiring all doctors statewide to adopt
electronic medical records by 2015, allowing patients to choose nurse
practitioners as primary care providers, and forcing public reviews of any
insurance company efforts to boost annual premiums by more than 7 percent.
"There's going to be a climate change, and there has to be a climate change;
otherwise our healthcare reform will implode, just under the costs," Murray
said at a press conference at the University of Massachusetts Medical School
yesterday.
The
ban forbids the pharmaceutical industry from giving - and doctors, their
families or employees from receiving - gifts from drug companies. Gifts
include payments, entertainment, meals, travel, honorariums, subscriptions,
even a pen with a drug company logo. The legislation would continue to
permit distribution of drug samples to doctors for the exclusive use of
their patients. Anyone who violates the ban could be fined $5,000, face two
years imprisonment, or both, under the proposal.
Massachusetts law already prohibits gifts to legislators and other public
officials of "anything of substantial value," or anything worth more than
$50. The ban on drug and device company gifts to physicians was first
proposed in 2005 by state Senator Mark C. Montigny, a New Bedford Democrat.
Montigny said he grew concerned about the cost of drugs bought through
state-sponsored healthcare programs as chairman of the Senate's Healthcare
Committee. He said he was disturbed to see drug companies hire salespeople
including "former beauty queens and cheerleaders" who wine and dine doctors
and encourage them to prescribe drugs that may not be the most
cost-effective. "You would not believe the conflict of interest here,"
Montigny said. "Of all the nasty manipulation that's gone on, there's no
more effective group at getting more than they deserve at the expense of the
taxpayer than the pharmaceutical industry." He said the state continues to
overpay for drugs.
Julie
Corcoran, deputy vice president of the Pharmaceutical Research and
Manufacturers of America, a trade organization based in Washington D.C.,
said the industry's sales people are "highly educated and trained by their
companies." The group opposes any ban, saying the pharmaceutical industry is
already heavily regulated by the Food and Drug Administration. "I'm not
aware of any kind of evidence or studies that link promotional or marketing
materials with the cost of healthcare," she said.
Mike
Webb, chairman of the Massachusetts Biotechnology Council, said in a
statement that he applauded the scope of Murray's healthcare proposal, but
was "concerned about any measures, such as bans on interactions with
physicians, which could negatively impact information flow to practitioners
and ultimately hurt patient care." The proposed ban is also more strict than
the current policy proposed by the American Medical Association. That policy
bans cash gifts, but allows doctors to receive textbooks, modest meals, and
"other gifts that serve a genuine educational function." The association
also allows doctors to receive drug samples for personal or family use.
Money
for Murray's proposal to spend $25 million annually to implement electronic
health records reform would come from a House-proposed $1 cigarette tax
hike. Murray estimated the new tax would produce up to $175 million in new
revenue. (Boston Globe) See
THIS LINK
As drug ads surge, more get Rx's filled
Prescription-drug ads prompt nearly one-third of Americans to ask their
doctors about an advertised medicine, and 82% of those who ask say their
physicians recommended a prescription. The findings in a national survey by
USA TODAY, the Kaiser Family Foundation and the Harvard School of Public
Health come as drug advertising hit a record $4.8 billion in 2006, up from
$2.6 billion in 2002. "Our survey shows why the drug companies run all these
ads: They work," says Drew Altman, president of the Kaiser Foundation. "Many
people get drugs they otherwise wouldn't. While there's a debate about
whether that's a good thing for patients, it does cost the country more."
Among
people who requested a drug, 44% said physicians gave the one they asked
about, while slightly more than half said doctors prescribed a different
drug. Sometimes, doctors did both. When duplicate answers were removed, the
poll found 82% of patients got some type of prescription. The percentage of
people getting a drug after asking about an ad shows an uptick from 2005,
when Kaiser found that 75% said the doctors recommended some type of drug.
The USA began allowing drug ads in 1997.
Americans are nearly evenly divided in their views of the industry: 47% have
a favorable impression, and 44% have an unfavorable view, frequently citing
high prices, large profits or company greed as the reason. Billy Tauzin,
president of the Pharmaceutical Research and Manufacturers of America, the
industry's lobbying group, says many of those surveyed were likely reacting
to increasing co-payments from insurers rather than escalating drug prices.
Drug costs rose an average of 3.5% in 2006 over 2005, government data show.
The poll
also found that cost pressures have led 29% of Americans not to fill a
prescription in the past two years and 23% to cut pills in half or skip
doses to make their medications last longer. Buying drugs is sometimes a
problem for 41% of families because of cost. (USA Today) See
THIS LINK
Immune systems increasingly on attack
First,
asthma cases shot up, along with hay fever and other common allergic
reactions, such as eczema. Then, pediatricians started seeing more children
with food allergies. Now, experts are increasingly convinced that a
suspected jump in lupus, multiple sclerosis and other afflictions caused by
misfiring immune systems is real. Though the data are stronger for some
diseases than others, and part of the increase may reflect better diagnoses,
experts estimate that many allergies and immune-system diseases have
doubled, tripled or even quadrupled in the last few decades, depending on
the ailment and country. Some studies now indicate that more than half of
the U.S. population has at least one allergy.
The
cause remains the focus of intense debate and study, but some researchers
suspect the concurrent trends all may have a common explanation rooted in
aspects of modern living, including the "hygiene hypothesis" that blames
growing up in increasingly sterile homes, changes in diet, air pollution,
and possibly even obesity and increasingly sedentary lifestyles. "We have
dramatically changed our lives in the last 50 years," said Fernando
Martinez, who studies allergies at the
University of Arizona. "We are exposed to
more products. We have people with different backgrounds being exposed to
different environments. We have made our lives more antiseptic, especially
early in life. Our immune systems may grow differently as a result. And we
may be paying a price for that."
Along with a flurry of research to confirm and explain the trends,
scientists have also begun testing possible remedies. Some are feeding
high-risk children gradually larger amounts of allergy-inducing foods,
hoping to train the immune system not to overreact. Others are testing
benign bacteria or parts of bacteria. Still others have patients with MS,
colitis and related ailments swallow harmless parasitic worms to try to calm
their bodies' misdirected defenses.
"If you look at the incidence of these diseases, a lot of them
began to emerge and become much more common after parasitic worm diseases
were eliminated from our environment," said Robert Summers of the
University of Iowa, who is experimenting
with whipworms. "We believe they have a profound symbiotic effect on
developing and maintaining the immune system."
Although hay fever, eczema, asthma and food allergies seem quite
different, they are all "allergic diseases" because they are caused by the
immune system responding to substances that are ordinarily benign, such as
pollen or peanuts. Autoimmune diseases also result from the body's defense
mechanisms malfunctioning. But in these diseases, which include lupus, MS,
Type 1 diabetes and inflammatory bowel disease, the immune system attacks
parts of the body such as nerves, the pancreas or digestive tract.
"Overall, there is very little doubt that we have seen significant
increases," said Syed Hasan Arshad of the David Hide Asthma and Allergy
Centre in
England, who focuses on food allergies.
"You can call it an epidemic. We're talking about millions of people and
huge implications, both for health costs and quality of life. People miss
work. Severe asthma can kill. Peanut allergies can kill. It does have huge
implications all around. If it keeps increasing, where will it end?"
One reason that many researchers suspect something about modern
living is to blame is that the increases show up largely in highly developed
countries in
Europe,
North America and elsewhere, and have only
started to rise in other countries as they have become more developed. The
leading theory to explain the phenomenon holds that as modern medicine beats
back bacterial, viral and parasitic diseases that have long plagued
humanity, immune systems may fail to learn how to differentiate between real
threats and benign invaders, such as ragweed pollen or food. Or perhaps
because they are not busy fighting real threats, they overreact or even turn
on the body's own tissues. "Our immune systems are much less busy," said
Jean-Francois Bach of the French Academy of Sciences, "and so have much more
strong responses to much weaker stimuli, triggering allergies and autoimmune
diseases."
Several lines of evidence support the theory. Children raised with pets or
older siblings are less likely to develop allergies, possibly because they
are exposed to more microbes. But perhaps the strongest evidence comes from
studies comparing thousands of people who grew up on farms in Europe to
those who lived in less rural settings. Those reared on farms were one-tenth
as likely to develop diseases such as asthma and hay fever. (Washington
Post) See
THIS LINK
CHeS sponsors new Web Series on Healthcare Data
Synchronization
Product
information in the healthcare supply chain is inconsistent and inaccurate.
Currently, the industry suffers from the lack of a systematic way to
consistently identify distinct medical/surgical products, which negatively
impacts the rest of the supply chain. With e-commerce now defining the
day-to-day business processes in the healthcare setting, the healthcare
industry must leverage technology advances to create a more efficient and
effective supply chain, to reduce unnecessary costs and to improve patient
safety.
Unlike other multi-billion industries, the healthcare industry has
not yet enjoyed the benefits of widespread synchronization efforts or
adoption of a Product Data Utility (“PDU”). Healthcare standards advocacy
groups are driving the effort to educate professionals from provider and
supplier organizations, and the industry is seeing great momentum in
adopting the standards necessary to streamline business processes and reduce
costs.
AHRMM, the Coalition for Healthcare eStandards (CHeS), and the
Healthcare Supply Chain Standards Coalition (HSCSC), which have endorsed GS1
standards for healthcare, are co-sponsoring a five-part webinar series this
spring on product data and synchronization in healthcare. Each session will
focus its attention on GS1 standards and the GDSN for healthcare.
Registration is free for all five webinars. AHRMM members will receive 0.1
CEU credits (1 contact hour) for attending each session. Register now at
www.regonline.com/AHRMM_CHeS_HSCSC.
Session
I: Defining a Healthcare Product Data Utility (PDU)
Thursday, March 20 • 1:00 – 2:00 pm (Central)
Kathleen
Garvin, Program Manager for Data Synchronization, DoD GDSN Pilot, Department
of Defense and Joe Pleasant, CIO, Premier, Inc., Chair, Coalition for
Healthcare eStandards (CHeS)
Session II: What is the Global Data Synchronization Network for Healthcare?
Thursday, March 27 • 1:00 – 2:00 pm (Central)
Peter J.
Alvarez, Senior Director, GDSN Healthcare, GS1 GDSN, Inc.
Session III: Retail Success Story – A Case of GDSN Leadership for the
Healthcare Industry
Thursday, April 17 • 1:00 – 2:00 pm (Central)
Marianne
Timmons, VP Supply Chain and Global Business to Business, Wegmans and
Michael Gross, Director of Data Synchronization, Wegmans
Session IV: PDU – How Hospitals Are Taking the Lead
Thursday, April 24 • 1:00 – 2:00 pm (Central)
Curtis
Dudley, Resource Optimization & Innovation, an Operating Division of the
Sisters of Mercy Health System and Joe Dudas, Director of Accounting and
Supply Chain Informatics, Mayo Clinic, Chair, Healthcare Supply Chain
Standards Coalition (HSCSC)
Session V: Healthcare PDU Success Story in
Australia
Wednesday, April 30 • 3:00 – 4:00 pm (Central)
Tracey
McAlister, Customer Solutions Manager, BD (Becton, Dickinson and Company);
Ken Nobbs, National E-Health Transition Authority (NEHTA), Australia and
Marcel Sierra, Manager Business Development & Professional Services, GS1
Australia
For more
detailed descriptions of the Webinars see
THIS LINK
and click on Virtual Event Details.
Antipsychotic Abilify cleared for use in youths
Otsuka Pharmaceutical Co. and
Bristol-Myers
Squibb Co. said the Food and Drug Administration
approved the supplemental new-drug application for Abilify to treat manic
and mixed episodes associated with Bipolar I Disorder in patients 10 to 17
years old. The antipsychotic drug already has been approved to treat bipolar
disease in adults. Japan-based Otsuka discovered Abilify; the companies have
an agreement to co-promote the drug in the U.S. until 2012. Bristol records
65% of U.S. sales. For the fourth quarter, Bristol-Myers said sales of
Abilify rose 28% from a year earlier to $462 million. (The Wall Street
Journal) See
THIS LINK
New detection tool
saves medical industry money
Medical Cost Containment Systems, LLC has announced the release of the
GuardianOR Surgical Instrument Detector. By greatly reducing the cost of
replacing accidentally discarded medical instruments, the GuardianOR
Surgical Instrument Detector can save the medical industry money.
The GuardianOR Surgical Instrument Detector is a loop type metal detector
imbedded in the lid of a standard sized hamper stand that is designed to
alert medical staff whenever a metal object such as surgical instruments and
tools are accidentally discarded into medical waste receptacles or linen
bags. By sounding an immediate alert, the staff is able to quickly retrieve
the discarded instruments at the point of loss.
A digital numeric counter tracks the number of detection events
that pass through the detector, thereby allowing staff to easily determine
the effectiveness of the detector, and the alertness and performance of
personnel in the OR suite. The use of the GuardianOR enables staff to have
their awareness raised, and good habits reinforced in order to help prevent
loss of costly surgical instruments. The GuardianOR even functions as a
theft deterrent since it provides measurable accountability standards of
surgical instruments to a specific OR suite.
The
GuardianOR Surgical Instrument Detector is key-operated, preventing staff
from circumventing the detector. Only those holding the keys can turn the
detector on or off in order to ensure monitoring of the digital counter. The
detector fits snugly onto a 15” X 15” PVC hamper stand which is the most
commonly used stand in operating rooms. The relatively low cost of the
GuardianOR Surgical Instrument Detector means that it can pay for itself in
a very short time. For more information see
THIS LINK
Premier extends partnership with SterilMed
Premier Inc., the largest healthcare alliance in the United States, has
renewed its reprocessing agreement with SterilMed, Inc., a leading
third-party reprocessor of single-use medical devices (SUDs), for its
facilities nationwide. SterilMed's experience has determined that a typical
200-bed hospital could save more than $650,000 and eliminate nearly 20,000
pounds of medical waste under the three-year contract extension.
SterilMed uses proprietary cleaning, testing and sterilization processes to
convert single-use medical devices into reusable devices so hospitals can
reduce device purchasing costs up to 50 percent. State-of-the-art
reprocessing technologies enable SterilMed to supply over 8,000 different
single-use devices in all OR departments as well as for the GI and EP/Cath
labs. SterilMed is
ISO
13485 certified and compliant with the FDA’s Quality System Requirements.
March 3, 2008 Download print version
HealthSpring's Pay for Quality
pilot results show increased prevention, healthier members
Florida emergency rooms can't
find enough doctors
Customized treatments for
sepsis lower treatment time and reduce length of ICU stays
FDA to increase warnings, advisories on side
effects
CDC study reveals adults may not
get enough rest or sleep
HealthSpring's Pay for Quality pilot results
show increased prevention, healthier members
HealthSpring Inc. has released preliminary results from its
Pay for Quality pilot program showing significant improvements
in quality of care and reductions in emergency room and
hospital admissions and healthcare costs. “While these are
preliminary results, we feel very encouraged that the numbers
show our Pay for Quality pilot has made a significant impact
on care and quality of life for our members,” HealthSpring
Chairman, President and CEO Herb Fritch said.
The pilot covered
three states and nine practices with 87 physicians and 7,468 members in
2007. Duration for the pilot is three years for one practice and one year
for all others. Preliminary results show improvement in every preventative
screening area measured: Mammography - 68% increase in use by physicians;
Pneumonia - 65% increase; Influenza - 192% increase; Colon CA - 27%
increase; Diabetic Eye Exam - 93% increase; Diabetic Foot Exam - 378%
increase.
Healthcare
Utilization by Members: ER visits per 1,000 - 7% reduction; Hospital
admissions per 1,000 - 11% reduction; Health plan's medical cost ratio - 8%
reduction.
HealthSpring’s Pay
for Quality pilot structures reimbursements for physicians to encourage more
extensive preventive care, rewarding physicians for performing key
preventive screenings and check-ups. “The focus is on preventing
complications and catching problems before they become serious,”
HealthSpring Medical Director of Quality William Anderson, M.D., said. “This
is a win for everyone involved. Providers are rewarded for delivering the
highest quality care, members are healthier and enjoy a better quality of
life, and healthcare costs are reduced because the member doesn’t need
treatment for serious complications.”
“The success of this pilot also demonstrates the importance of building
relationships with physicians and other providers,” Anderson said. “With our
Pay for Quality program, we’re working together with our providers rather
than forcing something on the physicians that doesn’t work for them. “We
help provide resources the providers need, such as support for electronic
medical record technology or additional nursing resources to help with more
extensive preventive care.”
HealthSpring continues to expand its Pay for Quality
pilot. The program currently includes 27 sites, 348 physicians and 25,000
members with plans to further expand to a total of 35-40 practices, more
than 400 physicians and more than 40,000 members by the end of the year.
Based in Nashville, TN, HealthSpring is one of the country’s largest
coordinated care plans whose primary focus is the Medicare Advantage market.
For more information, see
https://www.healthspring.com/.
Florida emergency rooms
can't find enough doctors
When Bayfront
Medical Center (St. Petersburg, FL) had to turn away trauma patients last
week because the hospital didn't have enough neurosurgeons, it exposed an
emergency system in crisis. That crisis goes far beyond one hospital.
Regional Medical Center Bayonet Point also has told state regulators it
doesn't have neurosurgeons on call full time. Orlando and Palm Beach
hospitals have had shortages. And it isn't just brain surgery. Across
Florida, hospitals lack enough specialists to cover emergencies. If you
sever your fingers in Florida, Tampa may be the only place to get them sewn
back on. If you're pregnant in Polk County, don't count on delivering in
Bartow. The hospital had to close its obstetrics service.
"What we have here
in Florida is a critical shortage of specialists who are willing to take
call in emergency rooms," said Dr. Larry Hobbs, president of the Florida
College of Emergency Physicians and emergency medical director of Southwest
Florida Regional Medical Center. Emergency doctors say the problem will only
get worse. Hospitals are shipping patients across the state, paying more to
specialists to get them to work, lobbying for more legal protections, and
desperately trying to hire more doctors.
Dr. Al Hess is a
senior hand surgeon on call at Tampa General Hospital. Some of Hess'
patients come from so far away that their severed fingers or hands can't be
saved. Dr. Hess and three of his colleagues are among the only Florida
surgeons willing and able to perform such delicate microsurgery in
emergencies. Hess is on call every third night. As one of only seven Level I
trauma centers in the state, Tampa General expects to see the most
disastrous injuries from west-central Florida. But Hess and his colleagues
see cases from all over the state, once even from Georgia. Hess and Dr. Roy
Sanders, president of the Florida Orthopaedic Institute and orthopedics
chief at Tampa General, say the hand surgeons reattach fingers about once a
week. Every few days, they get calls about hand injuries, and Sanders sorts
through whether they should take the patient.
As the crisis gets
worse, Sanders said local hospitals are trying to send cases with less
severe injuries to Tampa General. "It's difficult to understand why a
patient needs to come from a completely different region of the state by
helicopter," Sanders said. The crush of cases isn't because there aren't
enough surgeons, the doctors said. "If every hand surgeon in Florida took
call, there wouldn't be a problem," Hess said. Once, most doctors were
willing to be on call for emergencies, for free. It was part of a code:
Doctors got the "privilege" of being on staff at the hospital. In return,
they gave their time in the emergency room. Often, they benefited by gaining
new patients.
But the code has
broken. Fewer doctors want to work 100 hours a week. They don't want to
practice in the ER, where they say they're less likely to be paid by
uninsured patients and more likely to be sued by strangers. Working
emergencies often means they actually lose money, because they have to
cancel paying patients. Even doctors who do work emergencies have become
more specialized and often are more reluctant than they used to be to
perform an operation on a child, or out of their subspecialty.
In Tampa Bay,
hospitals have resorted to paying doctors to be on call. The money adds up.
It costs All Children's Hospital in St. Petersburg about $6-million a year
to be a trauma center, said Gary Carnes, the hospital's president and CEO.
But money isn't enough. For some specialties no amount of pay is worth it to
them, including eye and plastic surgeons, said Mark Vaaler, vice president
of medical affairs for St. Joseph's Baptist Healthcare. "It's a huge
headache, but we've been able to Band-Aid it. I am very, very concerned
about what's going to happen in the next several years." State medical
leaders are asking legislators to give doctors more protection from
malpractice lawsuits when they're treating emergency patients.
What specialties are the worst? "Any pediatric specialty at all. Ob-gyns.
Most surgical subspecialties: orthopedics, thoracic, gastroenterology,
urology,” said Dr. Vidor Friedman, director of emergency services for
Florida Hospital Celebration. “There aren't enough interventional
cardiologists." Really, he says, there's not enough of anybody. Friedman has
no orthopedists to work on hip injuries.
Update: Bayfront Medical
Center began accepting trauma patients again Thursday. But until the
hospital signs up more neurosurgeons, it will likely have to divert trauma
patients again. Two of the hospital's neurosurgeons recently stopped taking
emergency calls, dropping its on-call staff to two. The hospital has had to
suspend its status as a trauma center three times this month. During that
time, it has remained open for regular emergencies. (St. Pete Times) See
THIS LINK.
Customized treatments for sepsis lower
treatment time and reduce length of ICU stays
Using
a blood test and a decision algorithm, rather than standard hospital
protocols, to determine the appropriate length of antibiotic therapy in
patients with severe sepsis or septic shock can reduce duration of
treatments, shorten ICU stays, and lower hospital costs, all without adverse
effects on patients, according to new research.
“We
have shown that it is possible to customize antibiotic treatment duration in
patients with septicemia based on a reliable and robust blood test,” says
Jérôme Pugin, M.D., of the Intensive Care Unit at the University Hospital in
Geneva, Switzerland.
The
findings appear in the first issue for March of the American Journal of
Respiratory and Clinical Care Medicine, published by the American
Thoracic Society. The researchers randomized 79 patients to receive a
treatment course of antibiotics either according standard treatment
protocols administered by the treating physicians, or according to the
decision algorithm based on measured blood levels of procalcitonin (PCT), a
marker for severe bacterial infection in patients with suspected sepsis.
For patients randomized to the PCT-based treatment there were predetermined
“stopping rules” based on circulating PCT levels at which point
investigators encouraged treating physicians to discontinue antibiotic
therapy, although the treating physician retained the ultimate
decision-making power.
In the
analysis that included all 79 patients, the median treatment time for the
PCT group was 3.5 fewer days than that of the control group, although the
difference was not significant. However, once the investigators controlled
for early drop-outs, previously undiagnosed infections, and patients whose
physicians declined to stop antibiotic treatment when the algorithm would
have dictated it, they found that patients treated by the PCT algorithm had
a significantly shorter treatment time at 6 days, than patients treated
according to standard protocols, who averaged 12.5 days on antibiotics.
“Our
study is the first randomized clinical trial in which a surrogate
biochemical parameter was used to reduce the duration of antibiotic therapy
in a population of critically ill patients admitted to the ICU for severe
sepsis and septic shock,” wrote Dr. Pugin. “Despite the relatively short
duration of treatment in bacteremic patients assigned to the PCT group, no
case of recurrence of infection was observed in these patients.”
Following the PCT algorithm had another benefit: patients randomized to the
PCT treatment had significantly shorter stays in the ICU than control
patients, an average of three days versus five. Customizing treatment does
more than simply save hospitals money and patients precious days in the ICU,
said Dr. Pugin. Overuse of antibiotics can result in antibiotic resistance.
“Given the diversity of the types of infections, bacterial strains and
levels of host immune defense, every infected patient should benefit from a
personalized treatment, and particularly, a personalized treatment
duration,” he said.
The investigators hope that customized treatments will
continue to improve care for sepsis patients around the world. “We have now
implemented this new algorithm based on procalcitonin guidance in our ICU
for patients presenting with severe sepsis and septic shock, and are
following the outcome of those patients,” said Dr. Pugin. “Currently, three
large multi-center trials are ongoing in France, Denmark and Germany, with a
design similar to that of our study. Results from these studies will be
important to determine whether such a protocol of procalcitonin guidance is
definitely safe and can be generalized worldwide.”
FDA to
increase warnings, advisories on side effects
Top Food and Drug
Administration officials said last week consumers should expect to see more
advisories and warnings from the agency about drug-side effects. For years,
the agency has issued dozens of so-called Medwatch safety alerts reports
each year, aimed at healthcare professionals, to inform them of changes to
drug labels, and that practice still continues. But since
Merck
& Co.'s Vioxx was pulled off the market more than three years ago, the
agency has stepped up the number of public-health advisories aimed at
consumers and more recently has started issuing so called "early
communications," informing the public that the agency is looking at a
possible problem. Previously, the agency wouldn't inform doctors or
consumers about a problem until it was fairly certain it was linked to a
particular product.
"I feel strongly it's important for us to
communicate early, but in communicating early we are acting with a much
smaller degree of certainty," FDA Commissioner Andrew von Eschenbach told
the agency's new risk-communication advisory committee Thursday, which
wrapped up its first two-day meeting Friday. But, "we are trying to get
people to understand that we haven't said there's a problem, only that we
are concerned there's a problem."
The advisory panel, which is made up of
outside academic and industry experts, has been established to help the FDA
better communicate risks and benefits to the products the agency regulates;
chiefly drugs, medical devices and certain foods.
"It's a time in which, quite frankly, if
you look at external data there has been an erosion of trust," von
Eschenbach said. "Perhaps because they need to better understand and
appreciate what we are doing people's confidence has been eroded."
Indeed, Janet Woodcock, an FDA deputy commissioner and acting head of the
agency's drug center, told reporters that the agency is finding more drug
side effects, mostly because the agency is looking for them after drugs are
put on the market. Until Congress approved new legislation last year giving
the FDA additional money and authority, much of FDA's drug-center budget was
aimed at reviewing drugs to get them on the market rather than continuing to
monitor drugs once they are on the market.
"Consumers will know we are on the case,"
she said. However, she explained that the agency's goal is to find out which
consumers benefit the most from a particular drug and which ones should
avoid it, rather than pulling drugs off the market, a notion that's becoming
more of a reality with increased use of genetic testing.
Woodcock said the agency is continuing work on a public-private network that
will allow the agency to more quickly track drug-side effects by tapping
into medical databases as well as updating the computer software that runs
the agency's own adverse-event reporting system to make it easier for FDA
staff to track problems.
So far this year the FDA has issued four public-health advisories, which are
aimed at warning the public about a particular health problem, and at least
three so-called "early communications" after issuing 11 public health
advisories involving drugs for all of 2007. The agency also highlighted a
warning about suicides associated with epilepsy drugs that was aimed at
doctors. According to agency's Web site, 16 drug-related public health
advisories were issued in both 2006 and 2005 compared to five in 2004, two
in 2003 and one in 2002.
One of the advisories,
issued Feb. 1, involved
Pfizer
Inc.'s smoking-cessation drug Chantix and warned about severe changes in
mood and behavior in patients taking the drug. It followed a previous "early
communication" issued in November that said the agency evaluating reports of
suicidal thoughts and aggressive and erratic behavior in patients who had
taken Chantix.
On the flip side the FDA
has cleared drugs after previously stating it was looking at a problem. In
January the agency said a review of clinical studies involving
AstraZeneca
PLC's reflux drugs Nexium and Prilosec don't show an increase in heart
attacks and sudden death. (Wall Street Journal) See
THIS LINK.
FDA approves Nexium for use in children
ages 1-11 years
The U.S. Food and Drug Administration approved Nexium (esomeprazole
magnesium) for short-term use in children ages 1-11 years for
the treatment of gastroesophageal reflux disease (GERD). The
agency approved Nexium in two forms, a delayed-release capsule
and liquid form. Nexium is approved in 10 milligrams (mg) or
20 mg daily for children 1-11 years old compared to 20 mg or
40 mg recommended for pediatric patients 12 to 17 years of
age.
"This approval provides
important information for appropriate dosing for children ages 1-11 years
with GERD," said Julie Beitz, M.D., director of the FDA's Office of Drug
Evaluation III in the Center for Drug Evaluation and Research. "Children
prescribed this drug should be monitored by their physicians for any adverse
drug reactions."
Nexium is part of a class
of drugs known as proton pump inhibitors (PPIs). PPIs decrease the amount of
acid produced in the stomach and help heal erosions in the lining of the
esophagus known as erosive esophagitis. FDA approved the use of Nexium in
patients 1 to 11 years for short-term treatment of GERD based upon the
extrapolation of data from previous study results in adults to the pediatric
population, as well as safety and pharmacokinetic studies performed in
pediatric patients. In one study, 109 patients 1-11 in age, diagnosed with
GERD, were treated with Nexium once-a-day for up to eight weeks to evaluate
its safety and tolerability. Most of these patients demonstrated healing of
their esophageal erosions after eight weeks of treatment.
The most
common adverse reactions in children treated with Nexium were
headache, diarrhea, abdominal pain, nausea, gas, constipation,
dry mouth and sleepiness. The safety and efficacy of Nexium
has not been established in children less than one year of
age. Nexium is manufactured by AstraZeneca of Wilmington, DE.
CDC study reveals adults may not get enough rest or sleep
About 10 percent of adults report not getting enough rest or
sleep every day in the past month, according to a new
four-state study released by the Centers for Disease Control
and Prevention′s (CDC) Morbidity and Mortality Weekly Report.
The data from the four states–Delaware, Hawaii, New York, and
Rhode Island–may not reflect national trends. But an
additional study conducted by CDC utilizing data from the
National Health Interview Study indicated that across all age
groups the percentage of adults who, on average, report
sleeping six hours or less has increased from 1985 to 2006.
Nationwide, an estimated 50 to 70 million people suffer from
chronic sleep loss and sleep disorders. Sleep loss is
associated with health problems, including obesity,
depression, and certain risk behaviors, including cigarette
smoking, physical inactivity, and heavy drinking.
“It′s important
to better understand how sleep impacts people′s overall health and the need
to take steps to improve the sufficiency of their sleep,” said Lela R.
McKnight-Eily, Ph.D., the study′s lead author and a behavioral scientist in
CDC′s Division of Adult and Community Health. “There are very few studies to
assess and address sleep insufficiencies; therefore, more needs to done to
better understand the problem and to develop effective sleep interventions.”
The study,
“Perceived Insufficient Rest or Sleep--Four States, 2006,” analyzed data
from CDC′s Behavioral Risk Factor Surveillance System (BRFSS) survey. Among
the four states, the percentage of adults who reported not getting enough
rest or sleep every day in the past 30 days ranged from 14 percent in
Delaware to 8 percent in Hawaii.
People concerned
about chronic sleep loss should consult a physician for an assessment and
possible treatment, such as behavioral or medical interventions, McKnight-Eily
said. They can also try setting a regular sleep schedule and avoiding
caffeine or other stimulants before bed, she said. Variation for
insufficient rest and sleep may be due to occupational or lifestyle factors.
The causes of sleep loss could include busy schedules or shift work;
irregular sleep schedules; or lifestyle factors such as heavy family
demands, late–night television watching and Internet use, or the use of
caffeine and alcohol, according to a 2006 Institute of Medicine report. The
National Sleep Foundation reports that most adults need 7-9 hours of sleep
each night to feel fully rested while school children aged 5-12 years
require 9-11 hours, and adolescents aged 11-17 years require 8.5–9.5 hours
each night.
The MMWR report
said the definitions of “enough” (sufficient) sleep and “rest,” and
responses to the survey question were subjective and were not measured or
equated to reports of hours of sleep per night. The report said the analysis
cannot be compared directly with studies measuring hours of sleep. The
survey question also did not define or distinguish between “rest” and
“sleep.” The study comes just before National Sleep Awareness Week, an
annual campaign held in conjunction with Daylight Saving Time.
For more
information on National Sleep Awareness Week, held March 3-9, see
THIS LINK.
For more
information on CDC′s Sleep and Sleep Disorders Program, see
http://www.cdc.gov/sleep/.
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