Generic Not Same as Brand Antidepressant?
STEVE INSKEEP, host:
Let's try to answer some questions about a generic form of a popular antidepressant drug. A study suggests that it does not act in the same way that the brand name product does. As you might expect, the manufacturer of the generic drug is disputing these findings, so we'll try to sort the story out with NPR's Joanne Silberner.
JOANNE SILBERNER: Years ago, Sheryl, a Midwestern woman who asked us not to use her last name, went onto a drug for depression. She says Wellbutrin worked where other drugs hadn't, with no side effects. Last winter, a generic form went on the market
SHERYL: I asked to go on generic because I have always believed that generic medications are as good as the brand name.
SILBERNER: The Food and Drug Administration and the Generic Pharmaceutical Association have been saying the same thing for years, but Sheryl found herself becoming increasingly emotional.
SHERYL: And then one morning I was driving to work and I just burst into tears, out of the blue with no particular reason that I could think of.
SILBERNER: In North Carolina, meanwhile, pharmacologist Joe Graedon was noticing something. He and his wife run a Web site that offers drug information and discussion. They'd always liked generic drugs but they began hearing complaints about them, including the generic form of Wellbutrin XL 300. So they asked for comments
Mr. JOE GRAEDON (Pharmacologist): I'd say over the last several months we've probably gotten a total of 250 reports of generic drug problems in total, and over a hundred of those have been associated with the generic XL 300 for Wellbutrin.
SILBERNER: The Graedons contacted the FDA and also physician Todd Cooperman. Cooperman runs a subscription Web site called ConsumerLabs.com that usually posts test of nutritional supplements. Cooperman sent samples of brand name Wellbutrin and Teva Pharmaceutical's generic Bupropion to two labs for a basic comparison - how fast the drugs dissolve.
Dr. TODD COOPERMAN (ConsumerLabs.com): And we were shocked to find that the Teva product dissolved much more rapidly than the Wellbutrin product. In fact, at just two hours after being taken, you had 34 percent of this once-a-day product already released into solution while only eight percent of the original Wellbutrin was released
SILBERNER: Suggesting people taking the generic got higher doses in the first of few hours. Brand name Wellbutrin uses a patented time-release system that generic Bupropion can't copy. But Mark Goshko, head of legal affairs for Teva, says the drugs are equivalent. He says the company's studies, done a different way from Copperman's, show the drugs dissolve at the same rate in lab tests and in a test of several dozen people.
Mr. MARC GOSHKO (Executive Director, Legal Affairs, Teva Pharmaceuticals USA): We found that upon the completion of the study that the drug indeed did meet FDA's requirements for bio-equivalents
SILBERNER: Meaning the drugs are biologically equal. But the FDA doesn't release data from these types of studies. So sorting this all out is going to take a while. The FDA is reviewing reports on Bupropion. Meanwhile, Todd Cooperman is planning to test other generic drugs, and Sheryl, who had problems with Bupropion, says she's not giving up on all generics, just this one.
Joanne Silberner, NPR News.
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