Generics - page 2

The FDA, says Buehler, is meticulous in studying the effect of different time-release formulas. If clinicians observe a significant difference between the two, they will not permit pharmacists to substitute the generic for the brand-name drug. Patients on Coumadin, for example, are not advised to alternate between the brand-name blood thinner and the generic warfarin. Torprol XL does not fall into this category.

But Lever's concerns go beyond patient experiences. He has counted 150 recalls of both generic and brand-name drugs in the past several years, a figure that makes him wonder if the manufacturing process needs further regulatory scrutiny.

Indeed, in late June the FDA ordered U.S. Marshals to seize 33 generic drugs manufactured in Michigan by Caraco Pharmaceutical Laboratories. The company had been warned last October that it had violated manufacturing standards by, among other things, failing to investigate inconsistent batches and distributing products whose ingredients may have been compromised.

Buehler characterizes this incident as an exception instead of the rule and proof that the FDA is closely regulating the production process. Manufacturing problems, he says, aren't exclusive to generic-drug makers either. Brand-name producers, for example, have been forced to recall several asthma drugs, including Advair and Pulmicort. In one case, Schering-Plough shipped asthma inhalers without any medicines in them.

Patients, of course, should discuss complications related to generic or brand-name prescriptions with a physician or pharmacist. If a generic drug seems less effective and is meant to control a condition that can be measured, such as high blood pressure or cholesterol, Graedon recommends keeping a diary of laboratory tests to evaluate the results.

What the Research Shows

Patients do themselves a disservice, however, when they correlate an emergent symptom with a new drug regimen without further investigation. The connection could be coincidence, or it could stem from the perception that generics are inferior.

Researchers have compared generic and brand-name drugs in one conclusive study published last December in the Journal of the American Medical Association and found no difference between such drugs used to treat cardiovascular conditions. The study reviewed 47 previously published articles in which researchers compared several drugs, including statins and beta-blockers.

Despite the lack of convincing evidence to show that generics are harmful, the study's co-author Dr. William Shrank wrote that among the 43 editorials he reviewed, more than half "expressed a negative view of generic-drug substitution."

Shrank can't explain why some physicians discourage generic drugs, but the American Medical Association has discredited this position, noting that the scientific evidence is too weak to support such concerns.

Buehler agrees. "If there was a problem with generics," he says, "we'd be hearing much more than we hear now."