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Generic Heart Medicines Found Equal to Brand-Name Counterparts

BMBiology

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We all have known this for a long time but here is it:

Dec. 2 (Bloomberg) -- Generic heart drugs work just as well as the brand-name treatments they mimic at a fraction of the cost, according to a new analysis that challenges why some people still have doubts about generics’ benefits after almost 25 years.

Patients fare no worse when given generics in place of brand-name drugs designed to lower cholesterol, reduce blood pressure or otherwise prevent heart attacks and strokes, researchers at Harvard Medical School say in tomorrow’s Journal of the American Medical Association. The researchers analyzed 47 studies of nine types of drugs.

Generics cost 30 to 80 percent less than their brand-name counterparts and account for 65 percent of U.S. prescriptions. Even though the U.S. law permitting generics was enacted in 1984, helping curb medical spending, some doctors and patients still question whether the cheaper copies can be safely prescribed, the authors said. The review should end that concern, they said.

“Evidence does not support the notion that brand-name drugs used in cardiovascular disease are superior to generic drugs,” said the authors, led by Aaron S. Kesselheim, of the Harvard- affiliated Brigham and Women’s Hospital in Boston. The authors suggested makers of brand-name drugs contributed to negative publicity about generics.

Americans spend more money on heart drugs such as Lipitor, the cholesterol medicine made by Pfizer Inc., and Plavix, the blood thinner from Bristol-Myers Squibb Co. and Sanofi-Aventis SA, than any other type of prescription medicines, according to the research firm IMS Health Inc. Cholesterol drugs alone accounted for $18.4 billion in U.S. sales last year.

Teva Pharmaceutical Industries Ltd., the world’s biggest maker of generic drugs, and Mylan Inc., the biggest U.S.-based generic company, helped propel growth in 2006 and 2007 by introducing copies of heart drugs such as Merck & Co.’s cholesterol pill Zocor and Pfizer’s blood-pressure medicine Norvasc.

Editorials Reviewed

The authors also examined 43 opinion pieces from medical journals and newspapers and found more than half had a negative view of generic drugs. Pharmacists and insurers automatically switch many patients to generics when available to cut costs.

The gap between clinical data and opinion may be because the doctors writing the pieces may rely on anecdotal evidence rather than numbers or may have financial ties to the brand-name drug makers, the authors said.

“Brand-name manufacturers have suggested that generic drugs may be less effective and safe than their brand-name counterparts,” the authors said. “Anecdotes have appeared in the lay press raising doubts about the efficacy and safety of certain generic drugs.”

PhRMA Response

The Pharmaceutical Research and Manufacturers of America, a Washington-based trade group representing brand-name drug companies, supports “patients receiving the medicines that are best for them, including both brand-name medicines and generic drugs,” said Ken Johnson, senior vice president of the Washington-based trade group, in an e-mailed statement.

“Without today’s innovative brand-name drugs to legally copy, there would be no generic drug industry,” Johnson said.

The 47 studies in the new analysis covered the period from 1984 to August of this year. Among the medicines are blood thinners, cholesterol pills, blood-pressure medicines and treatments for irregular heartbeat.

While a handful of studies suggested slight differences between certain brand-name and generic drugs, favoring either side, they weren’t statistically significant when the data were pooled, the researchers found. This was true even among drugs with a so-called narrow therapeutic index, meaning the difference between the recommended and lethal doses was less than twofold.

Twenty-three of the editorials reviewed, or 53 percent, expressed a negative view on the practice of substituting generic drugs. Twelve supported it, and eight didn’t reach a conclusion.

The analysis was supported in part by the Attorney General Prescriber and Consumer Education Grant Program. The program was set up as part of a settlement between Pfizer and state attorneys general over marketing of the epilepsy treatment Neurontin. The researchers have also received awards from federal agencies.

http://www.bloomberg.com/apps/news?pid=20601124&sid=aQPqqyXr2lYU&refer=home
 
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