Well, yes, when people die because dangerous drugs have won approval based on lies medical school professors in the pay of drug companies have told about them, that’s certainly a disservice.
Prominent cardiologist Dr Marvin Konstam (Tufts University Medical Center, Boston, MA) agreed to be lead author on a 2001 Circulation paper about the COX-2 inhibitor rofecoxib (Vioxx, Merck), which was written in-house by Merck scientists, according to claims made in a federal court in Australia last week. The paper was designed to deflect safety criticisms, some experts believe, following the publication of an article in the Journal of the American Medical Association (JAMA) two months previously that first demonstrated an increase in cardiovascular side effects with the drug.
This is very significant, says Dr Steve Nissen (Cleveland Clinic, Cleveland, Ohio), who was an author on the JAMA paper. “During the three years after publication of the Konstam manuscript, millions of patients around the world were prescribed rofecoxib by physicians who believed that the drug was safe. In this case, a ghostwritten article caused great harm to the public health.”
Pretty ugly stuff, huh? Only comes out when there’s a big lawsuit from the injured… or their survivors.
But think of it from Konstam’s perspective. He makes money, gets another publication, and doesn’t have to lift a finger.
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UPDATE: Colin, a reader, adds important information to this post. UD is very grateful. It goes without saying that these are enormously complicated stories, and UD is happy to pass along details, amendments, etc.
Merck pulled the drug the day after an internal study – much like the kind attacked above – found that taking the drug for more than 18 months in a row raised the risk of cardiac problems. This is also true of other drugs in the class – but only Merck reacted, and thus exposed itself to all the lawsuits, most of which, by the way, they have won; the other drugs remain on sale. (As a side note, the FDA asked Merck to sell Vioxx with a new warning label, and the company refused.) I very much take the point about ghost-writing, but in the case of Vioxx the system did work: professional scientists employed by a drug company conducted a scientific study, reported its negative results to management, and action was taken promptly despite the huge financial consequences. None of this, of course, answers the point about academic scientists putting their names to things they did not write, but I still think it’s important to have all the facts of the case.
May 4th, 2009 at 12:13PM
I should begin by declaring a vested interest: my partner works for Merck. Having said that, the Vioxx thing is rarely properly reported. Merck pulled the drug the day after an internal study – much like the kind attacked above – found that taking the drug for more than 18 months in a row raised the risk of cardiac problems. This is also true of other drugs in the class – but only Merck reacted, and thus exposed itself to all the lawsuits, most of which, by the way, they have won; the other drugs remain on sale. (As a side note, the FDA asked Merck to sell Vioxx with a new warning label, and the company refused.) I very much take the point about ghost-writing, but in the case of Vioxx the system did work: professional scientists employed by a drug company conducted a scientific study, reported its negative results to management, and action was taken promptly despte the huge financial consequences. None of this, of course, answers the point about academic scientists putting their names to things they did not write, but I still think it’s important to have all the facts of the case.
May 4th, 2009 at 12:41PM
Many thanks, Colin. You’ll see that I’ve added an excerpt from your comment as an update to the post.
May 4th, 2009 at 3:15PM
FWIW: I was on Vioxx for chronic pain during a 6-8 month period in 2000-2001, right before the risks became known. It was a last-ditch effort to control head, neck and back pain that had just about disabled me and that nothing else would help with. It saved me from having to take disability leave and allowed me to stay at work. I know that doesn’t discount the issues that were later found to be associated with the drug. But it’s true, too, that a great many people had enormous benefits from Vioxx that they could not get anywhere else. I’m forever grateful to Vioxx.
May 4th, 2009 at 5:16PM
I’ve heard a lot of people make Erin’s point: that’s why the FDA wanted to put Vioxx back on the market. For further context, it’s worth listening to Pfizer’s ads for Celebrex, which is of the same class as Vioxx, has the same cardiac risks, and is still for sale. It’s quite extraordinary: to soothing, almost happy music, the narrator warns three or four times that the product can kill you.
On the point about getting credit for ghost-written articles, I’ve been thinking about my scientist friends. They were forever getting their names on papers that they had not written, because they had contributed some lab work, or done a bit of necessary synthesis, or, it seemed to me, had simply been passing by when something good happened. In turn, they were putting others’ names on their papers, often just because Professor X had shared lab resources or loaned out a postdoc for an afternoon. As an historian all this seems strange, but I gather it’s quite normal in the sciences. Is much of this a science/humanities culture gap?