.comment-link {margin-left:.6em;}


reports and thoughts on legal issues, music, Orthodox Christianity and/or whatever else strikes my interest

My Photo
Location: Houston, Texas, United States

My name is David Stone. I live in Houston, Texas. I am a 30-something single white male. I am an Orthodox Christian and am a member of an English-language parish of the Russian Orthodox Church Outside of Russia (ROCOR).

Wednesday, September 28, 2005

Merck Executive testifies

Here is an interesting article from Newsday.com on the ongoing Vioxx trial in New Jersey.

The article begins by noting:

"Fearing a warning about Vioxx's cardiac risks would hurt the painkiller's sales, Merck & Co. battled with federal regulators for two years to keep the information out of the "warnings" section of the package insert, the company's top marketing official testified Monday.

Under questioning by plaintiff's attorney Chris Seeger, David W. Anstice acknowledged Merck forecast a $500 million drop in sales for the $2.5 billion-a-year blockbuster drug if Merck lost its bid to instead put information about heart attack risks in the insert's less-urgent "precautions" section. "

The article then continues:

"A patient study in 2000 showed Vioxx users suffered five times as many heart attacks as those taking the older, cheaper painkiller naproxen. Anstice testified that Merck asked the FDA to put that risk information in the "clinical studies" and "precautions" sections of the detailed package insert, or label, not in the more-serious "warnings" section. In the meantime, Merck stuck to its policy of not letting its sales representatives talk to physicians about any potential risks not yet listed on the Vioxx label, Anstice said. "

The article also offers some details on the seemingly damning internal Merck emails which were also used in the first Vioxx trial in Texas:

"Seeger again showed jurors e-mail messages written by Edward Scolnick, Merck's former head research scientist, in which Scolnick ripped the FDA's proposed label as "ugly" and called FDA officials "bastards." Scolnick, who testified earlier in the trial that he had lingering fears about Vioxx's safety, told Merck colleagues in a Feb. 25, 2002, e-mail it would be a miracle if FDA agreed to put the warning in the "precautions" section. "To all: If you get this label, it will be an Al Michaels quote: Do you believe in miracles?" Scolnick wrote, alluding to the sportscaster's call when the U.S. hockey team defeated the Soviet Union in the 1980 Olympics. "


Post a Comment

<< Home