In the News for the Week of 5-8-07
- Heart failure, mortality declining in cardiac patients, study finds
- Medicare limits carotid stent coverage
- Single annual drug infusion may prevent fractures in some women
- ACP Journal Club: Influenza vaccination for nursing home staff reduces mortality in residents
Business of medicine
- Call for strengthened suicide warning on antidepressant labels
- Recall issued for Shelhigh devices, injectable colchicine
- Counterfeit weight loss drugs sold on Internet
- ACP releases “Post Mortem” book on famous medical mysteries
Recent improvements in treatment of acute coronary syndromes (ACS) have succeeded in reducing rates of heart failure, mortality, stroke and myocardial infarction, according to a new study. Researchers embarked on the study to determine whether new evidence for treatments of ACS would result in changes in clinical practice and outcomes.
Between 1999 and 2006, the observational study tracked 44,372 patients with ACS at 113 hospitals in 14 countries for an average follow-up of six months. The study found substantial changes in the management of ACS patients over the six-year study period, including increased use of interventional therapy and pharmacological therapy, such as beta blockers, statins, ACE inhibitors, thienopyridines and Gp IIb/IIIa inhibitors. For example, statin use climbed from 37% to 85% between 1999 and 2005 while the rate of angioplasty increased from 16% to 53%.
Researchers also found that patient outcomes significantly improved during the study. At the start, there was an 8.4% in-hospital mortality rate among heart attack patients, which decreased to 4.6% by 2005. Heart failure rates went down from 20% to 11%, and the rate of subsequent heart attacks was more than halved in the six years. The study was published in the May 2 Journal of the American Medical Association.
The results were much more dramatic than expected, study authors told the May 2 New York Times. The findings represent the first demonstration of reductions in hospital rates of new heart failure and mortality in ACS patients. Study authors attributed the improvements to physicians’ adherence, in both the U.S. and Europe, to updated guidelines for ACS. Drug manufacturer Sanofi-Aventis funded the study.
The Journal of the American Medical Association is online.
The New York Times is online.
Medicare said last week it would limit coverage of carotid stents to those patients who are symptomatic and have blockages of 70% or more. The policy is at odds with CMS' previously announced plans as well as current FDA policy.
Based on earlier statements from CMS, it had been expected that Medicare’s stent coverage would be expanded to match FDA approvals, the May 2 New York Times said. The FDA has approved carotid stents for high-surgical-risk symptomatic patients with blockages of 50% or more and patients without symptoms who have carotid restriction of 80% or more.
The announcement from CMS noted strong opposition to expanding coverage from physicians who perform endarterectomy as well as clinical trials which raised safety concerns about the stents, the New York Times said. The agency’s decision also will likely have an impact on private insurers’ coverage of stents. Abbott Laboratories, manufacturer of the first FDA-approved stent, initiated the coverage review last year with a request for expanded reimbursement.
Medicare patients who meet the FDA standards, but do not qualify for stents under CMS criteria, will have to enroll in clinical trials to receive stents. Only about 10% of U.S. patients who currently undergo surgery to clear blockages would fit CMS requirements, the New York Times noted. The agency’s decision could make it easier for physicians to recruit patients to stent trials, experts said.
The New York Times is online.
A single, annual infusion of intravenous zoledronic acid during a three-year period reduces the risk of fractures in postmenopausal women with osteoporosis, but raises the risk of serious atrial fibrillation, a new study found.
The trial assigned 7,765 postmenopausal women to receive either placebo or a single 15-minute infusion of 5 mg zoledronic acid at baseline, 12 months and 24 months. All patients were followed for 36 months. Treatment with zoledronic acid reduced the risk of morphometric vertebral fracture by 70% compared with placebo (3.3% in treatment group vs. 10.9% in placebo group; RR, .30; 95% CI, .24 to .38) and reduced the risk of hip fracture by 41% (1.4% in the zoledronic acid group vs. 2.5% in placebo; HR, .59; 95% CI, .42 to .83). The study was published in the May 3 New England Journal of Medicine.
Nonvertebral fractures, clinical fractures, and clinical vertebral fractures were reduced by 25%, 33% and 77% in the treatment group, respectively. Zoledronic acid also was associated with significant improvement in bone mineral density and bone metabolism markers. While change in renal function was similar in both groups, serious atrial fibrillation was more frequent in the zoledronic acid group (50 patients in treatment group vs. 20 in placebo, p<0.001)
Long-term adherence to oral bisphosphonates is poor, so having another treatment option is positive, though the acceptability and practicality of IV therapy remains to be seen, an accompanying editorial said. The increase in atrial fibrillation for treatment subjects didn’t translate into an excess death rate from cardiovascular causes, but is still cause for concern and should be monitored in similar clinical trials, the editorial added.
The New England Journal of Medicine is online.
A new study found that encouraging nursing home staff to get influenza vaccinations reduces mortality and influenza-like illness in nursing home residents.
In the randomized, controlled trial conducted at 50 private nursing homes in England, staff members in the intervention homes were actively encouraged by the lead nurse to get vaccinated and three vaccination sessions were offered each October in the two-year study. Staffers in the control group were informed about the study and Department of Health recommendations for influenza vaccination.
During the first season of the trial (2003-2004), 35% of staff in the intervention group was vaccinated compared with 5% of the control group. The next year, the vaccination rates were 31% and 3.8%. In 2003-2004, a year of moderate influenza, the intervention homes had 5% lower mortality from all causes (number needed to treat [NNT] = 9) and 9% less influenza-like illness (NNT = 5) than controls. Outcomes did not differ between the groups in 2004-2005, a low influenza year. The study is abstracted in the May/June ACP Journal Club.
The study convincingly showed that vaccinating health care workers reduced influenza-like illness and deaths in nursing home residents, said Journal Club reviewer Henry S. Sacks, FACP, of the Mount Sinai School of Medicine. Vaccination is also cost-effective, since the intervention cost no more than US $793 per life-year gained, Dr. Sacks noted. However, because health care workers are no more likely than the general public to follow vaccination recommendations, measures such as educational campaigns, special vaccination clinics and gift incentives may be needed to improve uptake.
Peer ratings for this review: Infectious Disease: 6/7 stars. Primary Care, Geriatrics: 5/7 stars.
ACP Journal Club is online.
Business of medicine
Pharmaceutical companies can continue to collect and use data on physicians’ prescribing habits, a federal judge ruled last week. The ruling struck down a year-old New Hampshire law that prohibited purchase and resale of such data.
New Hampshire was the first state to pass legislation restricting pharmaceutical companies’ access to information about individual physicians and their prescriptions, said the May 1 New York Times. Shortly after passage of the law, IMS Health and Verispan, two companies which collect, analyze and sell medical data, sued the state, charging that the law was unconstitutional.
A U.S. District Court judge agreed with the companies, finding that the New Hampshire law restricted speech and violated the First Amendment. The New Hampshire attorney general has not announced whether the ruling will be appealed. The decision could have an impact on other states, the New York Times noted. According to the National Conference of State Legislatures, several states were considering similar proposals this year.
In December 2003, ACP sponsored a resolution in the American Medical Association's House of Delegates urging the AMA to prohibit the release or sale of doctors’ prescribing information. Last year, the AMA established an opt-out list for physicians who do not want their data shared with pharmaceutical representatives. About 7,000 doctors have registered on the opt-out list, the New York Times said.
The New York Times is online.
Efforts to steer patients to specialists who score well on quality and efficiency measures are off to a slow start, a new study found.
The study examined “high-performance networks,” which assess physicians on measures like costs per episode of care and screening regularity. While companies like Boeing and Nordstrom have helped institute high-performance networks in Boston, Milwaukee and Seattle, the networks haven’t expanded much beyond the initiating employers, according to the study by the Center for Studying Health System Change.
"Employers pushing high-performance networks reported feeling as if they are out there alone and everyone else is 'window shopping,' until there are more results on service use, costs and quality," said study co-author Debra A. Draper, Ph.D, a senior researcher at the center.
The study also found physicians tend to respond with skepticism to the networks, whose stated goal is to improve the efficiency and quality of care of all doctors. Common complaints from doctors centered on lack of communication from health plans, methodologies used to determine high-performance designations, data quality and sufficiency of sample sizes used.
The study, Performance Health Plan Networks: Early Experiences, was based on interviews with about 20 organizations conducted between May and September 2006.
The CHS report is online.
The black box label on antidepressants should be updated to warn about a heightened risk of suicidal behavior and thinking for adults age 18 to 24 during the first couple months of treatment, the FDA said last week.
Labels should also reflect that this risk doesn’t exist for adults older than 24, and that adults aged 65 and older have a decreased risk of suicidality, the FDA said. People who are currently taking antidepressants shouldn’t stop taking them, the agency said, adding that mental disorders themselves are the most important cause of suicidality.
The label change applies to all classes of antidepressants, which have carried a similar warning for children and adolescents since 2005. In that year, the FDA began a review of 295 antidepressant trials, including 77,000 adult patients, to examine suicide risks. The analysis found twice the risk of suicide attempt in adults age 19-24 who took antidepressants instead of placebo, the May 3 New York Times reported.
The FDA is online.
The New York Times is online.
The FDA last week formally requested that Shelhigh, Inc. recall all of its medical devices—including hospital inventories—due to sterility concerns, but the company refused to comply.
On May 2, the FDA sent a letter to Shelhigh asking it to recall implantable devices including pediatric heart valves, conduits, annuloplasty rings, arterial grafts, dural patches and surgical patches. The action came roughly two weeks after the U.S. Marshals, at the FDA’s request, seized all devices at the company’s Union, N.J. facility upon finding “significant deficiencies in the company’s manufacturing process” that it fears may compromise the products’ safety and effectiveness. Shelhigh declined to do a voluntary recall at that time, and doctors and hospitals should consider using alternative products, the FDA said.
Shelhigh responded on its Web site May 3 that the FDA’s claims were unfounded and that the agency should prove its allegations before making a request for recall.
Separately, the FDA also announced that Apothécure has issued a recall for all strengths, sizes and lots of compounded, injectable colchicine sold in the last year. The recall follows reports of death with .5mg/ml, 4ml vials, lot number 20070122@26, the FDA said. For information, call 800-969-6601.
The FDA MedWatch safety alert is online.
More information from the FDA on Shelhigh devices is online.
The FDA release is online.
The Shelhigh, Inc. release is online.
The FDA warned consumers last week about recent instances of counterfeit weight loss drugs being sold over the Internet. According to the agency, counterfeit versions of Xenical (orlistat) have been purchased online by three patients in recent months.
The 120 mg capsules were bought through two different Web sites, and none of the pills contained orlistat. Laboratory analysis by drug manufacturer Hoffman-La Roche found that one capsule contained sibutramine, a different prescription weight loss drug. Although both drugs are FDA-approved for weight loss, they are used in different patient populations, and have different drug interaction profiles and dosing frequencies, the agency noted.
The other counterfeit samples contained only talc and starch. The drugs displayed a valid Roche lot number of B2306 and were labeled with an expiration date of April 2007. The counterfeits were purchased from brandpills.com and pillspharm.com.
These Web sites are two of 24 listed on the home page of the pharmacycall365.com Web site, noted the FDA. The agency has previously connected sites listed on the page with distribution of counterfeit Tamiflu and Cialis. Consumers should be wary of Web pharmacies that have no phone number, offer dramatically low prices or do not require a prescription, the agency cautioned.
The FDA news release is online.
FDA information about internet prescription buying is online.
ACP has published and released “Post Mortem: Solving History’s Great Medical Mysteries,” by Philip A. Mackowiak, MACP. “Post Mortem” re-examines the medical history and diseases of 12 historically significant figures.
Each chapter details a case organized according to the standard format used by physicians in clinical practice today. To heighten reader suspense, the identity of the patients, including Beethoven, King Tut and Alexander the Great, are not revealed until the end of the chapter. Although “Post Mortem” is written by a clinician and medical educator, the book is intended for both the general public and the medical community. It covers a novel area in history, and was inspired by the annual Historical Clinicopathological Conference that Dr. Mackowiak has hosted since 1995.
The book is currently available at bookstores everywhere, through ACP Customer Service at 800-523-1546 ext. 2600, or online.
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A 42-year-old woman is evaluated for an 8-month history of crampy abdominal pain and three loose bowel movements per day. The pain is relieved by a bowel movement. There are no nocturnal bowel movements, and there is no blood or dark tarry material in the stool. She has not had fever, night sweats, or weight loss. She has a history of Hashimoto disease and is treated with levothyroxine. Following a physical exam, rectal exam, and lab tests, what is the most appropriate next step in management?
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