Friday, June 30, 2006

Merck - Vioxx: Scolnick "not aware" of negative trial results

Merck did not inform the FDA about two clinical trials in which users of the painkiller Vioxx were more likely to die than people given a placebo, jurors in the first Vioxx liability case to go to trial in California were told Wednesday.

Dr. Edward Scolnick, the former head of Merck's research laboratories, said in a videotaped deposition that he did not believe the numbers were coincidental.

''It's not likely due to chance,'' he said.

Scolnick testified that people who took Vioxx died at a rate four times higher than those who didn't receive the drug in one of the clinical trials, and 2 times higher in the other.

Both trials were done in 2001 in Alzheimer's patients.

Merck, however, did not turn over trial results to the FDA when company officials met with agency representatives in April of that year.

Scolnick said he was not aware of the clinical trial results at the time.

Why was he unaware? Was he not doing his job as head of research properly?
Insider wonders if there is an email out there that might help Ed refresh his memory?

link

Also see this very helpful NPR Vioxx timeline.

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