Examining Antidepressant Generic Drugs
JOHN YDSTIE, host:
This is WEEKEND EDITION from NPR News. I'm John Ydstie.
Coming up, a high school's lesson in foretelling genocide. But first, is a drug by any other name still the same? Some doctors and patients don't think so. After a generic form of the antidepressant drug Wellbutrin was approved, patients started complaining about its negative effects and they were disappointed by the Food and Drug Administration's response.
Joining us from our New York bureau is Melinda Beck. She wrote about how generics differ from brand name drugs in the Wall Street Journal this week. Welcome to the program.
Ms. MELINDA BECK (Columnist, The Wall Street Journal): Thank you, John.
YDSTIE: So tell us what was happening to these patients who were switched from Wellbutrin to a generic form?
Ms. BECK: Well, first of all it's just a fraction of the patients who were switched. And many of them were saying that they were experiencing side effects that they never had on Wellbutrin: nausea, trembling, anxiety, irritability. In some cases, even Wellbutrin was known to have seizures if people were not accustomed to it. So a couple mentioned those.
And then many of them said that they no longer had the antidepressant effect that they had become used to on Wellbutrin. It seemed like their depression had returned, and some people were complaining about feeling even suicidal.
YDSTIE: And which generic form of Wellbutrin was this?
Ms. BECK: A generic form called Budeprion, distributed by Teva Pharmaceuticals, the largest generic maker in the world. And it was approved by the FDA in December 2006.
YDSTIE: But the FDA did look into this and then wrote a report on it.
Ms. BECK: Yes they did, and it came out last week. And it went back and reviewed the bioequivalence data, because by law a generic has to be what's called bioequivalent to the original drug.
YDSTIE: Bioequivalence means it has to act the same in your body as the original drug, right?
Ms. BECK: Yes, and what's behind that is that it's the original drug that goes through all these very lengthy and costly trials. It takes years and millions and millions of dollars. So when a generic comes out it does not have to repeat all of this costly testing. It just has to demonstrate that it is the exact same thing as the drug that has gone through all these testing.
YDSTIE: Let me ask you, can we generalize from this experience to other generics that at least for some people the generic drug may not work as well as the brand name drug?
Ms. BECK: If one can generalize about what is at base individual experiences, yes, because there is this range of how quickly generics can be absorbed in the body and still be considered bioequivalent. It seems to me there's wiggle room on both sides.
YDSTIE: What does this episode tell us about the FDA's approach to the generic drugs in general? I, for one, would've thought the FDA would have done a little bit more study on the generic version of the drug.
Ms. BECK: For a lot of economic and public health reasons, it really wants to get generic versions of medications out there because it helps keep healthcare costs down and spread the benefit of medications to many more people. I was surprised to learn in reporting this that 65 percent of the prescriptions written in the U.S. are for generics, even though they only represent 20 percent of all spending on drugs. But I was surprised to learn that it has never withdrawn an approval for a generic once it's been approved. I was told that it has never had caused to do so.
YDSTIE: Are there other drugs that have prompted the same kind of complaints from patients as Budeprion?
Ms. BECK: There are several other ones. One is Toprol, which is a beta blocker. It's used to keep blood pressure down. And some patients are reporting fairly significant spikes on the generic version.
YDSTIE: Melinda Beck is the health journal columnist for the Wall Street Journal. She joins us from our New York bureau. Thanks so much for talking to us.
Ms. BECK: Thank you, John.
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