Generics: Just as good?

Officials of the Food and Drug Administration insist this feat of economics comes without any compromise to a medicine's effectiveness. To be marketed in the United States, these low-cost medicines must be approved by the FDA, which ensures they are "bioequivalent" to their brand-name counterparts -- the same dose of the same active ingredient, delivered in the same way, and manufactured according to the same standards of quality.

The Generic Pharmaceutical Assn. touts them with a slightly catchier slogan: "Same Medicine. Same Results." But sometimes, patients and their doctors beg to differ.

A switch from a long-used brand-name drug to its generic equivalent can, on occasion, bring a shifting profile of side effects. In a number of cases documented in medical journals and recounted in interviews with physicians, a generic version of what is often called a "pioneer" drug simply doesn't appear to work as well for many patients.

"Everybody thinks generics are swell: To suggest otherwise is like saying you don't love your mother," said Dr. Peter R. Kowey, chief of cardiovascular diseases at the Philadelphia area's Main Line Health System, who reviewed the issue of generic substitution of certain heart drugs for the American Heart Assn. But between some pioneer drugs and their generic imitators, Kowey said, "we are concerned that the margin of difference is large enough" to risk patients' health.

Last December, the American Epilepsy Society called on the FDA to approve a large clinical trial to determine "once and for all" whether the substitution of brand-name drugs with generics increases the risk of "breakthrough" seizures or toxicity among patients with epilepsy. This type of research would probably take years. But until such a study is completed, the society declared, it would oppose measures by state, federal or private insurance programs that would limit physicians' choices in prescribing anti-seizure medicines.