Yesterday I noted the report in the new JAMA on Merck writing research reports about Vioxx and paying prominent academics to pretend to be the authors and investigators. That got a fair amount of coverage in the corporate media. Today I finally had a chance to read this piece by Bruce Psaty and Richard Kronmal, also free to the public. I thought I'd seen it all. I hadn't.
Maybe the reason this hasn't gotten a lot of coverage is because reporters find it slightly harder to understand; or maybe they're just too chickenshit to actually write down what this article says because they're afraid Merck will threaten to sue them or something. So sue me.
What this article says is that Merck murdered people. Here's the story in a nutshell. They wanted to prove that rofecoxib (Vioxx) could delay the onset of Alzheimer's disease or slow its progress. I don't know why they thought it might do that, but whatever, they tried it. So first they did a trial of almost 1,500 elderly people with mild cognitive impairment, half of whom got rofecoxib. It turned out that the people who got the drug had a significantly higher probability of developing Alzheimer's disease.
At about the same time they started a trial of 692 patients who actually had a diagnosis of Alzheimer's. Rofecoxib didn't work to delay progression. They started a third trial, but when it turned out the second one wasn't working, they stopped it. It isn't clear if they followed up with the patients.
Okay, too bad, it didn't work. But here's what it also did. It killed people. They're published report of the second trial said "there were no drug-related deaths during the study." For the first study, their report said "rofecoxib was generally well-tolerate. . . " But the truth is, according to internal company documents, they knew that the risk of death was more than 4 times as high for patients taking the drug in the second trial, and 2 1/2 times as high in the first trial, and combining all three, it was about 2 1/2 times as high -- including patients followed up after they stopped taking it. The main reason was heart disease, which is exactly the risk we now know to be associated with rofecoxib/Vioxx.
They knew this before the conclusion of the trials, yet they allowed the trials to continue, for two years. They even got new informed consent from people to allow the first trial to continue beyond its originally planned conclusion, during which time there were 8 exces deths among those receiving the drug. They did not inform the Instutional Review Boards overseeing the study of these events, and they did not even have a so-called Data Safety Monitoring Board, which is supposed to order trials terminated when such indications of risk emerge.
Psaty and Kronmal write, "Sponsors have a direct financial interest in their products and a fiduciary duty to shareholders to provide a return on investment. These interests disqualify sponsors from other important duties, including those normally accorded to DSMBs and IRBs." Gee, do you think so?
On the other hand, while they do have a duty to provide a return on investment, I had always thought there was also a duty not to commit homicide. But I guess that smacks of creeping socialism.
Friday, April 18, 2008
I am actually finding this hard to believe
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