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Kai Ryssdal: We don’t read too many medical journals around here. But an item in one of them caught our eye today. There’s a report in the current edition of the Annals of Internal Medicine about Merck and its discredited painkiller, Vioxx. By way of refresher here for a second, Merck pulled Vioxx off the market almost four years ago after it was linked to a series of fatal heart attacks. Today’s report is about a 1999 study that Merck did to test the side effects of Vioxx. It shows that that study — the 1999 one — was actually what’s known in the pharmaceutical business as a seed study, research used primarily for marketing; a way for Merck to get its drug into as many doctor’s hands as it could.
Dr. Ross McKinney runs the Center for BioEthics at the Duke University Medical School. Dr. McKinney, good to have you with us.
Ross McKinney: It’s nice to be here.
Ryssdale: How widespread is this practice of these seed studies?
McKinney: Seeding studies are, we believe, quite common practice. There’s not good documentation, but they’ve been recognized since the early ’90s to be a common means for the pharmaceutical industry to get practitioners to use new drugs.
Ryssdale: If they don’t do them, do pharmaceutical companies risk of leaving money on the table?
McKinney: Oh, I don’t think so. I think these are something that’s, really there are lots of marketing strategies available without having to do these sort of seeding studies.
Ryssdale: So why do them, then? I mean, obviously, it brings up the question of transparency and some ethical concerns.
McKinney: Well, if they’re done correctly, they actually get valuable information. So say, for example, the study that, in fact, was cited, their trial was good enough that it was able to be published in the Annals of Internal Medicine back in 2003. It was a real study. You can say the intent wasn’t good, that it was marketing. But in fact, they learned important information about their drug. My bias is that if it’s a good scientific study, it’s probably not unethical to do a seeding study.
Ryssdale: Is there a rule, though, from the FDA or anybody else that says these companies have to reveal their true motives in conducting these studies?
McKinney: There is not a rule that says they have to reveal their true motives. And in fact, the reality is that every drug company study is ultimately intended to get more widespread use of their drugs. So the seeding studies are done as marketing, but all drug company studies are really done to advance the sales of their products.
Ryssdal: Why does this news today, then, leave us saying, eeeuu, somehow?
McKinney: Because the intent was so clearly focused on marketing in this. And actually, this is really just an indicator that tells us that there’s a problem. Because seeding studies are the kind of studies that are going to get people who would otherwise participate in research, volunteer to help us with clinical trials to advance knowledge. Those people may not want to participate, because they’ll be suspecting the motives of the pharmaceutical industry sponsorship.
Ryssdal: What is the FDA’s role in this? Do they have a job here to police these kinds of seeding studies?
McKinney: The FDA should be policing seeding studies. But, in fact, they don’t have jurisdiction if the drug is already licensed. So the FDA only has a role if it’s a drug that’s not yet approved or the information’s going to be submitted to the FDA for changing the indications of the drug.
Ryssdale: So, if Merck had wanted to, they could have kept this whole thing under wraps and we would never have known about it?
McKinney: Exactly. And that’s a real problem, because all these people would have been put at risk and nobody would ever be the wiser.
Ryssdale: Expand on the risk factor here for these participants in the clinical trial for a second. They were given medications, which later has been shown to be not entirely beneficial and which, in fact, Merck is going to pay out $4 billion to settle claims over.
Ryssdale: All so that Merck could get marketing data.
McKinney: The fact that Merck did this study was, at the time, they thought they were getting people to use what was a real advance. And had it been that there was no cardiac toxicity, it would have been a therapeutic advance. And it’s through studies that you learn about these toxicities. But there’s always a risk whenever you do any kind of investigation of a new pharmacologic agent.
Ryssdale: Dr. Ross McKinney is the Director of the Trent BioEthics Center at Duke University Medical School. Dr. McKinney, thanks a lot for your time.
McKinney: Thank you, Kai.
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