Friday, March 13, 2009

Generic Cardiovascular Drugs Are Just as Effective As Brand Name Varieties


Brand name or generic? That is the question frequently asked by consumers, doctor, and insurers alike. Which is better? Is there really a difference? At least in the case of drugs used for the treatment of heart disease, there is apparently no difference. According to researchers, all brand name and FDA-approved generic cardiovascular drugs are created equal.

Aaron Kesselheim, MD, JD, MPH, of Brigham and Women's Hospital in Boston is the lead author of the new study, which has just been published in The Journal of the American Medical Association. Kesselheim and colleagues analyzed combined data from 47 studies of generic and brand name cardiovascular drugs published between January 1984 and August 2008. Regarding the results of the analysis, Kesselheim stated, “We found no evidence that brand-name drugs are any better in terms of clinical outcomes than generic drugs.”


The study covered beta-blockers, diuretics, calcium-channel blockers, statins, antiplatelet agents, ACE inhibitors, alpha-blockers, anti-arrhythmic agents, and warfarin. The analysis performed by the researchers focused on clinical outcomes for patients in the collection of study data regarding heart rate, blood pressure illness, and death. Brand-name drugs were not found to offer any advantage for patients' clinical outcomes in those studies.

Ironically, the research team also reviewed 43 editorials and commentaries published during the same period of time as the studies and discovered that 53 percent of them voiced negative views on substituting generic drugs. The reasons for the lack of support of generic drugs were not clear although the researchers noted that concerns may rose from subjective experiences as well as from financial connections to drug companies. The authors wrote, “To limit unfounded distrust of generic medications, popular media and scientific journals could choose to be more selective about publishing perspective pieces based on anecdotal evidence of diminished clinical efficacy or greater risk of adverse effects with generic medications.”

Regarding the study, in a statement issued by The Pharmaceutical Research and Manufacturers of America (PhRMA), an industry group for U.S. pharmaceutical and biotechnology companies, Senior Vice President Ken Johnson said, “PhRMA has always supported patients receiving the medicines that are best for them, including both brand-name medicines and generic drugs.” He also acknowledged, “Without today's brand-name drugs to legally copy, there would be no generic drug industry. Worse yet, there would be little hope of finding new treatments and cures for a wide range of debilitating, and often deadly, diseases.”

Pharmaceutical companies retain exclusive rights to market a drug they develop for a certain number of years after approval by the FDA. After this time, other drug developers may sell chemically equivalent generic versions. The active ingredient always remains the same, however the inert binders and fillers as well as color and shape may vary from manufacturer to manufacturer.

The greatest advantage in the use of generic medications is that they have substantially less cost. According to Kesselheim, “Brand-name drugs for cardiovascular disease can be as much as a few dollars a pill, whereas generic drugs might be as little as a few cents a pill.”

About 66 percent of the total prescriptions in the United States are for generic drugs, yet they account for less than 15 percent of the money spent on prescription drugs, as indicated by the Generic Pharmaceutical Association industry group.

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