In the News for the Week of 11-14-06
- FDA looks to strengthen safety monitoring of medical devices
- Recall of store-brand acetaminophen
- States lag on Medicaid coverage for smoking cessation
- ACP Journal Club: Aspirin plus dipyridamole more effective than aspirin alone after minor cerebral ischemia
- Low-carb diet does not increase women’s risk of coronary heart disease
- MRI can help ER doctors determine stroke treatment
- Diabetes drug may help slow thickening of artery walls
- ACP offers suggestions to CMS to improve quality of care
- College names nominees for ACP officers and regents—Clarification
- ADA’s research goals focus on managing oral diseases
The FDA announced an action plan last week for monitoring the safety of medical devices aimed at speeding the government's response to problems that arise after devices reach the marketplace.
The action plan includes:
- developing a system for marking all medical devices with a unique number so they can be tracked;
- reorganizing the Center for Devices and Radiological Health so safety information can be more easily shared; and
- developing internal performance measurements to track how recalls are handled.
Also under discussion is the mandatory use of electronic reporting of adverse events. The FDA is considering expanding a pilot program that collects safety reports from hospitals in real time, as well as gaining access to medical device data gathered by the Department of Veteran Affairs, the Department of Defense and the CMS, according to the Nov. 11 Washington Post.
The FDA is online.
The Washington Post is online.
The FDA last week announced a recall of 11 million bottles of store-brand acetaminophen caplets because they may contain small metal fragments, according to manufacturer Perrigo.
The problem was discovered by the manufacturer after an internal quality control inspection revealed that their tableting equipment was wearing down prematurely, the Nov. 9 Washington Post reported. The manufacturer put 70 million tablets through a metal detector and found 200 caplets containing metal up to 8 mm in length.
No illnesses or injuries have been reported and the risk of serious injury is remote, according to the FDA. The affected 500 mg caplets are sold under store brands at a number of retail outlets, including CVS and Walmart. Consumers who have purchased the product should contact Perrigo at 877-546-0454 and anyone who suspects they have been injured by the caplets is advised to see a physician and contact the FDA’s Med Watch Program at 800-FDA-1088.
The FDA release is online.
The Washington Post is online.
Coinciding with the National Cancer Institute's (NCI) annual Great National Smokeout on Nov. 16, the CDC released a report last week showing that many state Medicaid programs have failed to increase funding for smoking cessation.
Only 38 states fund smoking cessation treatment for Medicaid recipients, according to the CDC's Nov. 10 Morbidity and Mortality Weekly Report, which evaluated Medicare programs at the end of 2005. Only one state—Oregon—offers coverage for all medication and counseling treatments recommended by Public Health Service (PHS) guidelines. Seven states cover all recommended medications and at least one form of counseling, while four states offer coverage only for pregnant women.
The most frequently covered medications are bupropion hydrochloride (Zyban), nicotine patches and nicotine gum. An estimated 29% of adult Medicaid recipients were current smokers in 2004, a significantly higher percentage than that of the overall U.S. adult population and far from the PHS goal of reducing smoking rates to 12% by 2010.
The NCI's Great American Smokeout encourages smokers to reduce their smoking or quit at least for a day. Events to be held across the country include health fairs, lobbying efforts and individual support for smokers who quit.
The MMWR is online.
Information about the Great American Smokeout is online.
A recent trial found that the combination of aspirin and dipyridamole was more effective than aspirin alone for preventing vascular events in patients with recent minor cerebral ischemia of arterial origin.
In a randomized controlled trial, researchers followed more than 2,000 patients who had experienced a minor ischemic stroke, transient ischemic attack or transient monocular blindness of presumed arterial origin in the previous six months. Half the patients received 30 to 325 mg of aspirin daily plus 200 mg of dipyridamole twice daily while the other half received aspirin alone.
The combination therapy was more effective in reducing the composite endpoint of death from all vascular causes or nonfatal stroke, and lowering the number of all vascular events (number needed to treat = 35 for both outcomes). The results did not differ for death from all causes, death from all vascular causes or all major ischemic events. The study is abstracted in the November/December ACP Journal Club.
The results should lead to greater confidence in the effectiveness of aspirin plus dipyridamole, said Journal Club reviewer David L. Tirschwell, MD, of the Harborview Medical Center in Seattle. However because of the small absolute benefit found, cost effectiveness will be a factor and aspirin alone or in combination with generic dipyridamole remains a reasonable alternative, he noted.
The nonblinding of patients and clinicians could undermine the validity of the main study findings, Dr. Tirschwell said. In addition, patients with a possible cardiac source of embolism, significant carotid disease or disabling stroke were excluded from the study, so the results cannot be generalized to them.
Peer ratings for this review: Cardiologists, General internal medicine/ family practitioners/ general practitioners: 6/7 stars.
ACP Journal Club is online.
A new study suggests that low-carbohydrate diets high in protein and fat do not increase women's risk of coronary heart disease. The research, based on data from the Nurses’ Health Study, also found that diets that include a significant portion of fat and protein from vegetable sources may moderately reduce the risk of coronary heart disease.
Researchers evaluated food-frequency questionnaires completed by 82,802 participants in the Nurses’ Health Study and calculated a low-carbohydrate score for each. During 20 years of the study, they also documented 1,994 new cases of coronary heart disease. The study found that women with higher glycemic loads had strongly increased risk of coronary heart disease, with a relative risk of 1.90, while women who got the most calories from vegetable fats and proteins had a relative risk of .70.
Researchers did not find any relationship between low-carb diets and weight loss. Body-mass index increased an average of 2.5 for all participants, regardless of the percentage of carbohydrates in the diet. The study was published in the Nov. 9 New England Journal of Medicine.
The most surprising finding of the study was that the risk of coronary disease was not increased for participants who ate the lowest-carb, highest-fat diet, the lead author told the Nov. 9 New York Times. The findings could be explained by the fact that the lowest-carb diets were compared to the highest-carb diets, while the ideal lies somewhere in between, he said. Critics also noted that the study is not a randomized controlled trial and relies on nurses’ self-reporting of their dietary habits, which could be inaccurate.
The New England Journal of Medicine is online.
The New York Times is online.
MRI scans can help emergency room doctors decide how best to treat a person who has just had a stroke, a new study found. The scans help discriminate those patients who might be helped by medication to open a blocked blood vessel—even when administered after the currently-approved three-hour time window— and those whom drug treatment is unlikely to help or may harm.
Unlike a CT scan, which can indicate whether a stroke is caused by a ruptured or blocked blood vessel, an MRI can also immediately indicate the location and extent of brain injury— which helps determine whether opening a blood vessel is likely to work, the study found. Stroke patients with a large area of severely damaged tissue can die from clot-busting treatment.
The prospective, three-year study examined 74 consecutive stroke patients admitted to stroke centers in North America and Europe, all of whom had MRI scans immediately before treatment, and then again after treatment with intravenous tissue plasminogen activator (tPA). The treatment came 3 to 6 hours after symptom onset.
Sixty-seven percent of patients with a pre-treatment MRI pattern indicating a likely favorable response to tPA had a major improvement in neurological function upon three-month follow-up. Three patients, all of whom had a unique MRI pattern prior to treatment and successful opening of the blocked blood vessel after treatment, developed fatal cerebral hemorrhage. The latter finding helped investigators define a profile that predicts high risk of dangerous bleeding after tPA therapy.
MRI results weren’t used to make treatment decisions, but were analyzed later at Stanford University. The study was published online in the Annals of Neurology and was funded by the National Institutes of Health.
The abstract is online.
The Stanford University Medical Center press release is online.
The New York Times is online.
Pioglitazone, a medication currently used to improve diabetics’ sensitivity to insulin, may also slow the thickening of their artery walls, a new study found. Diabetics have a higher risk of myocardial infarction than non-diabetics, and new approaches are needed to lower cardiovascular risk.
Study participants were 289 men and 173 women from the Chicago area with type 2 diabetes and an average age of 60. Participants were randomly assigned to receive a daily dose of 15 to 45 milligrams of pioglitazone or 1 to 4 milligrams of glimepiride. An ultrasound measured the thickness of the middle layers of the carotid arteries at the beginning of the study, and then 24, 48 and 72 weeks later. Glycosalated hemoglobin levels, blood pressure, blood cholesterol and adverse events were also monitored.
After 72 weeks, the carotid artery intima-media thickness (CIMT) of patients taking pioglitazone had decreased by .001 millimeters, while the CIMT of patients in the glimepiride group increased an average of .012 millimeters. Blood pressure changes weren’t significantly different, but the pioglitazone group had significantly lower glycosolated hemoglobin at week 48 than the glimepiride group. High-density lipoprotein cholesterol levels also increased by week 24 and remained higher for those taking pioglitazone compared to the glimepiride group.
Results could indicate either that pioglitazone lowered patients’ glycosated hemoglobin and increased their cholesterol levels, thus slowing the thickening of the artery wall; or that the drug had a direct effect on the vessel wall, the authors said in a news release. Further research is needed as to whether pioglitazone instead of glimepiride can substantially reduce major cardiovascular events, they said.
The study occurred between 2003 and 2006. Results will be published in the Dec. 6 issue of the Journal of the American Medical Association.
The Journal of the American Medical Association release is online.
In a Nov. 1 letter to the CMS, Joseph W. Stubbs, FACP, chair of ACP’s Medical Service Committee, offered suggestions for developing the Quality Improvement Organization (QIO) 9th Statement of Work (SOW).
QIOs are local organizations that, by law, contract with CMS to provide quality improvement assistance to health care providers, such as physicians, hospitals, nursing homes and home health agencies, and to health plans that contract with Medicare. They are private groups that receive Medicare funds to foster quality health care services, including review of complaints and appeals.
In the letter to Jacqueline Harley, in the Office of Clinical Standards and Quality, Dr. Stubbs said that the QIO program plays a significant role in ensuring high quality services for our Medicare beneficiaries. QIO assistance to our members and other primary care providers is most critical, he said, because providers are under pressure to make major changes in the way they deliver care in order to meet the needs of an aging population with a high prevalence of chronic illness.
ACP’s suggestions included expanding the Doctor’s Office Quality-Information Technology (DOQ-IT) initiative to facilitate the adoption and use of health information technology. The letter also suggested that the QIOs need to offer technical support to primary care providers to help them provide patient-centered, coordinated care. Dr. Stubbs noted that high-priority areas include access to office-based care, enhanced communication between patient and provider, and increased use of evidence-based treatment approaches.
Dr. Stubbs concluded that the QIOs are seen as a critical partner with providers in delivering quality care to Medicare beneficiaries.
The full text of the letter is online.
Please note: Last week two candidates were incorrectly listed under the Board of Governors instead of the Board of Regents. They are listed correctly below.
The election process for College Officers and Regents is currently underway. The voting body consists of the Board of Regents and the Board of Governors, who are elected by popular vote in their respective jurisdictions. Officers and Regents will take office at the conclusion of the Annual Business Meeting on Saturday, April 21, in San Diego. Members are encouraged to review candidate qualifications and share their views with their Governors before Jan. 2.
At their October meeting, the Regents elected William B. Applegate, FACP, Winston-Salem, N.C. as Chair-elect. Dr. Applegate will assume the Chair at the conclusion of the 2008 Annual Business meeting in Washington, DC. Joel E. Levine, FACP, Denver, Chair-elect of the Board of Regents and David C. Dale, FACP, Seattle, President-elect, will assume office as Chair and President of the Board of Regents, respectively, at the conclusion of the 2007 Annual Business Meeting in San Diego.
The ACP Nominations Committee also made the following nominations:
Board of Regents
President-elect - Jeffrey P. Harris, FACP, Millwood, Va.,
Treasurer - W. James Stackhouse, MACP, Goldsboro, N.C.,
Virginia U. Collier, FACP, Newark, Del.
Robert G. Luke, MACP, Cincinnati, Ohio
Lawrence G. Smith, FACP, Great Neck, N.Y.
J. Fred Ralston Jr., FACP, Fayetteville, Tenn.
Allan H. Goroll, FACP, Boston
JosÚ A. Rodriguez-Portales, FACP, Santiago, Chile.
Non governor pool:
Talmadge E. King, Jr., FACP, San Francisco
Barbara J. Turner, FACP, Philadelphia.
Board of Governors
Donald W. Hatton, FACP, Lawrence, Kansas, was recently elected by the Board of Governors to serve as their next Chair-elect. He will serve as Chair-elect from May 2007 to May 2008 and take office 2008-09.
Biographical sketches of the candidates will be posted online in the November ACP Observer.
The American Dental Association (ADA) recently released its 2006-2007 Research Agenda. The agenda identifies priority treatment-oriented areas in need of further research and emerging issues in the management of oral diseases.
The research agenda is organized into four broad goals, which will be ongoing priorities for two to three years. Each goal has corresponding objectives which will change annually.
The new agenda goals are:
- To understand the social, behavioral and biological determinants of oral and dental diseases and their impact on the provision of dental care.
- To understand the outcomes of elective dental procedures provided at different ages.
- To understand the scientific basis of emerging issues of interest to the practice of dentistry.
- To conduct research in support of the application of evidence-based dentistry.
The research agenda is online.
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