Thursday, August 11, 2005

Company doc testifies at Merck trial - is the FDA wrong?

Dr. Alise Reicin, Merck's V.P. clinical trials, testified in the pending Texas Vioxx trial that the drug was tested on almost 10,000 people in many studies before it was submitted to the Food and Drug Administration for approval in 1998.


She was involved in a study that compared Vioxx to naproxen, the ingredient in Aleve, and showed higher cardiovascular incidents, including blood clots, than with naproxen, she said.

''There was a lower rate of thrombotic events with people taking naproxen than with people taking Vioxx," Reicin testified this week in the case. ''I still believe the difference was because of the heart-protectiveness" of naproxen. The FDA addressed this, and doubted its conclusion in a 2001 warning letter to Merck about its Vioxx marketing tactics.

My comment:

I've read the letter. The FDA Government regulators said the argument that naproxen influenced the number of heart attack incidents was ''hypothetical" and that ''another reasonable explanation" was that the drug caused the incidents.

After analyzing the kind doctor's testimony my first thought was: Does the sun rise in the west in your world, doctor?