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Policy & Practice


 

Counterfeit Lipitor

The Food and Drug Administration is alerting U.S. physicians and patients to a recent recall of a batch of counterfeit “Lipitor” (atorvastatin) that was sold in the United Kingdom. U.S. consumers who purchased FDA-approved Lipitor through legitimate U.S. pharmacies should not have received the counterfeit medicine, according to the FDA. However, consumers may have received counterfeit pills if they obtained drugs from the United Kingdom via online or storefront operations that do not supply FDA-approved products, or through state-run drug importation programs that facilitate the purchase of foreign drugs. Initial testing of the counterfeit drug by U.K. health officials showed that the product does not pose an immediate risk to patients. However, the FDA is advising patients that there is no guarantee of quality or effectiveness. Patients who have the counterfeit Lipitor should stop using it and consult their physician or pharmacist if they have questions or concerns. The counterfeit tablets are 20 mg and are sold in packages of 28 tablets. The batch number is 004405K1 with an expiration date of “11 2007.” Legitimate doses of Lipitor sold in Britain also have the same batch number, the FDA reported.

Chronic Care Pilots

Medicare is launching chronic care pilot projects this year aimed at improving care for people with heart failure and diabetes. The program, called Medicare Health Support, will provide free, voluntary services to about 160,000 Medicare fee-for-service beneficiaries for 3 years. Participating patients will get access to nurse coaches, reminders about preventive care needs, prescription drug counseling, home visits and intensive care management when needed, and home monitoring equipment to track health status. At press time, eight areas had been selected for the program: Maryland, Oklahoma, Western Pennsylvania, Mississippi, Northwest Georgia, Chicago, Central Florida, and Washington, D.C. “We are providing beneficiaries additional tools to help them manage their health more effectively and avoid preventable complications,” Health and Human Services Secretary Mike Leavitt said in a statement.

Heart Trials and Women

More women should be recruited to participate in clinical trials of heart disease to have “statistically sufficient power” to identify whether women respond differently to treatment than men, according to a study published in August in the European Heart Journal (2005;26:1585–95). The study analyzed the existing literature on female-specific aspects in the pharmacotherapy of chronic cardiovascular diseases. The authors recommended that researchers analyze data on hormonal aspects, such as concomitant hormone therapy; gender differences in pharmacodynamics and in complication rates should be incorporated as well. “It is essential that trials are designed to provide the necessary data so that researchers know from the outset that they will be able to analyze factors that could contribute to different outcomes for men and women,” Verena Stangl, M.D., a cardiologist in Berlin and senior author of the study, said in a statement.

Taking Obesity Seriously

Most Americans are still taking obesity seriously as a public health problem, despite recent studies indicating that health risks may have been overstated, according to a survey designed by the Harvard School of Public Health in Boston. Only 15% of Americans surveyed said they believed that the health risks of obesity were being overestimated by scientific experts. In fact, 58% said that they thought the experts were portraying the risks accurately, and 22% thought the risks of obesity were being underestimated. And despite the conflicting research results, Americans are continuing to track calories, fat content, and carbohydrates at about the same rate as last year, Robert J. Blendon, M.D., and his colleagues reported. Julie Gerberding, M.D., director of the Centers for Disease Control and Prevention, said in a statement she was encouraged by the results of the poll.

Clinician's Guide to Alcoholism

Physicians have a new tool to help them identify and care for patients with heavy drinking and alcohol use disorders. About 3 in 10 U.S. adults drink at levels that increase their risk for physical, mental health, and social problems. Of these heavy drinkers, about one in four currently has alcohol dependence problems that often go undetected in medical and mental health care settings. The National Institute on Alcohol Abuse and Alcoholism recently released a new guide called “Helping Patients Who Drink Too Much: A Clinician's Guide,” which offers guidance for conducting brief interventions and managing patient care. The guide shows physicians how to look for symptoms of alcohol abuse or dependence. The guide is at

www.niaaa.nih.gov

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