Generic Heart Drugs Just as Good as Brand-Name Drugs

Buying prescription drugs under their generic names can save a substantial amount of money, but the perception lingers—among doctors and consumers alike—that brand-name drugs are superior. To determine the accuracy of this prevailing view, a team of reviewers assessed all the studies that compared generic and brand-name heart drugs and found a major contradictory force at work. Although the studies produced no evidence that generic drugs are inferior, many of the medical journal editorials that accompanied these studies urged against their use.

First, it must be said that the FDA requires all generic drugs to be proven bioequivalent to their brand-name counterparts before they are allowed on the market. This means that they must be chemically equivalent in terms of the active ingredients of the brand-name drugs. However, generic drugs may differ in terms of their inactive ingredients like color and shape of the pill, fillers and inert binders. Generic drug manufacturers are not required to replicate the original effectiveness trials. Brand-name drugs are expensive until their patents run out. Once that occurs, other companies are free to produce lower cost generic versions of the same product.

38 Trials in the Review
For their new review, Aaron S. Kesselheim, MD, and colleagues at Harvard Medical School, assessed 38 trials that had randomly assigned people to take either a brand-name heart drug or its generic equivalent. Nine different classes of cardiovascular drugs were studied, including drugs to lower cholesterol and blood pressure and drugs that stabilize heart rate.

Most of the studies (6) involved warfarin, the blood thinner that doctors identify as having a narrow therapeutic index, which describes the difficulty of calibrating the correct dose—too high can cause internal bleeding and too low can result in fatal blood clots.

The reviewers’ conclusion: “Whereas evidence does not support the notion that brand-name drugs used in cardiovascular disease are superior to generic drugs, a substantial number of editorials counsel against the interchangeability of generic drugs.”

Kesselheim and colleagues came up with two educated guesses about the contradictory advice from the doctors who wrote negative editorials. 1) “Physicians’ concerns are based on anecdotal experience;” 2) “The conclusions may be skewed by financial relationships of editorialists with brand-name pharmaceutical companies, which are not always disclosed. Approximately half of the trials in our sample and nearly all of the editorials and commentaries did not identify sources of funding.”

Dr. Kesselheim was asked by e-mail whether his results say anything about generic versions of other drugs. “Well, our study only looked at drugs used in cardiovascular disease, so anything I’d say about other fields of medicine would be outside of the bounds of what we specifically looked at.,” he responded. “Still, for nearly every other field of medicine, I would not expect the results to be substantially different, given the positive experience of millions and millions of patients over the years who take generic drugs for psychiatric, rheumatologic, endocrine, etc. reasons.”

This review was published in the December 3, 2008 issue of the Journal of the American Medical Association and was funded in part by the Attorney General Prescriber and Consumer Education Grant.

Maryann Napoli, Center for Medical Consumers©

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