Merck hid data on deaths from Vioxx

You would expect that a drug company existed not just for shareholders and the FDA but also for patients. Well, apparently Merck exists only for its stockholders and the FDA. When patients during a trial on Alzheimer’s patients started to die, Merck told the FDA so that it would complete its legal obligation but did not tell the doctors, patients who were participating in the trial (or the family members whose loved ones died).

Merck was clearly enjoying the sales/profits of Vioxx to an extent that it did not want to jeopardize that comfortable situation even if it meant that some folks were dying for no fault of theirs. Since the recall of Vioxx a year ago, Merck has never admitted this on its own. Only during cross-examination of Ed Scolnick (a top Merck scientist and architect of Vioxx strategy) in the ongoing trial of Humeston versus Merck, did it come out yesterday. He also admitted that the doctors should have been told of that as early as 2001 when the company first learned about it. (Related article: Merck knew about the deaths from Vioxx but chose to ignore them)

In another startling finding of company data by noted biostatistician Richard Kronmal, he has found that not only are Vioxx patients are more likely to suffer from heart attacks and strokes, they also have a higher probability of getting Alzheimer’s Disease.

According to US law, when patients die during a drug trial, the FDA has to be notified. The guidelines on what information should be provided to patients and doctors is somewhat confusing since when doctors and patients agree to participate in a drug trial they are often required to sign paperwork that takes away a lot of their rights to know. However, most business ethics expert believe that the worst thing a drug company can do is to let patients die and not do anything about it.

It is interesting though that Scolnick who was involved very closely in defending Vioxx from all its critics did not actually see this specific piece of data. His emails that have ridiculed the FDA and all other scientists show how little regard the company had for the rest of the world. In another email that was presented in court, Scolnick wanted a “boil in oil” a Wall Street analyst who wanted to criticize Vioxx.

We also saw early this week that Merck did not want the Vioxx label to change to show the risk of death and injury from taking the drug.

Related articles: Merck lied to doctors about risks of Vioxx, according to Mark Lanier

Merck admits that Vioxx is dangerous for short-term users too

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