Generic Heart Drugs as Good as Brand-Name Counterparts
TUESDAY Dec. 2, 2008 -- Brand-name drugs used to treat cardiovascular disease are no better than generics, a new review of available evidence shows.
Yet a number of editorials in medical journals, written by specialists, have urged against substituting the less expensive generics for their designer counterparts.
"We found no evidence that brand-name drugs are any better in terms of clinical outcomes than generic drugs," said Dr. Aaron S. Kesselheim, lead author of a study appearing in the Dec. 3 issue of the Journal of the American Medical Association and an instructor in medicine at Brigham and Women's Hospital in Boston. "The FDA [U.S. Food and Drug Administration] has approved all generic drugs and certifies that they are bioequivalent, meaning equivalent in all biological and chemical characteristics of the drug."
The challenge then becomes one of perception, Kesselheim said, with this new paper itself representing "hopefully another step in helping combat the misperception that brand-name drugs are clinically superior," he said.
The findings come closely on the heels of another study which found that there is often little evidence that off-label prescribing (prescribing a drug to treat a disease or condition different from the one it was approved for) is effective or safe.
Generic drugs have the same active ingredient as their brand-name counterparts, but may differ in terms of the color or shape of the pill and some of the inert binders (which are not clinically active).
The advantage to generic medications, of course, is that they cost substantially less.
The developers of drugs are permitted to exclusively market the drug for a finite period of time after its approval, at least partly to recoup the costs of developing the medication. After that time, however, other manufacturers may produce the same drug as a generic.
"There are a number of studies out there saying that generic drugs should be an important part of a physicians prescribing treatment, that they're able to reduce costs and improve patient adherence which can lead to better patient outcomes," Kesselheim said. "Generic drugs are available for nearly every condition but generally are underused in the marketplace, and one of the reasons they're underused is that there is a perception out there among physicians and patients that brand-name drugs are better than generic drugs."
Kesselheim and his colleagues decided to investigate the data to see if brand-name drugs really were superior.
They searched for articles comparing the clinical efficacy of brand-name and generic cardiovascular drugs published between January 1984 and August 2008.
All of the studies involving beta blockers, antiplatelet agents, statins, ACE inhibitors and alpha-blockers showed clinical equivalence, while 91 percent of randomized controlled trials showed clinical equivalence for diuretics, and 71 percent showed the same for calcium-channel blockers.
Yet 53 percent of 43 editorials had a negative take on substituting generic drugs.
"We found no evidence that a brand-name drug is clinically superior," Kesselheim said.
Almost half of the trials and nearly all of the editorial and commentaries failed to identify funding sources.
"The key is, are the drugs therapeutically equivalent. In other words, do you get the same result," said Robert Stanberry, an assistant professor of pharmacy practice at Texas A&M Health Science Center Irma Lerma Rangel College of Pharmacy at Kingsville. "I would tend to agree, that's mostly true."
The U.S. Food and Drug Administration has more on generic drugs.
Posted: December 2008
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