Thursday, September 22, 2005

Vioxx Trial #2: Ex Merck Researcher says FDA employees get a "D"

This is from various sources including the web and people sitting in the courtroom @ the Humeston trial:

Videotape testimony played: This week, a former Merck researcher Edward Scolnick, had his testimony played to the jury. He was questioned about emails he wrote raising concerns about the safety of Vioxx. "My worry quotient is high," was written in an April 2000 e-mail. He actually wrote: "I am actually in minor agony."

Scolnick also had concerns about the safety of Vioxx. He admitted that he wanted to work with a larger trial than had previously been done, but later concluded that the drug was safe.

One trial with 8,000 people in it, and whose results were published in March 2003 revealed 20/4,000 patients taking Vioxx suffered MIs, compared with 4 out of 4,000 who were taking naproxen.

Scolnick also admitted he was not happy when the FDA pushed to warn Vioxx users that the drug had a risk of MI's. Scolnick's opinion of FDA personnel wasn't very positive, to say the least. His internal email on FDA employees that evaluated the safety of drugs was the equal to "grade D high school students." (Ouch)

Not surprisingly, he suggested that Merck take an adversarial approach to the FDA.
"I have never seen being nice to the FDA, except on rare occasions, pay off," he wrote in an e-mail.

My comment: I think the term that describes this gentleman may be "bully?" Who coached this guy before his deposition?