GMP Tips - FDA Whistle Blower Speaks Out Again - Sept 13, 2006

In an editorial published Sept 12, 2006 on the Journal of the American Medical Association's (JAMA) website, Dr. David J. Graham is once again is speaking out about new arthritis drugs. He says, "The FDA, academia, and the medical research enterprise are once again faced with the opportunity to forsake common sense by willfully accepting misdirection and disinformation presented in the guise of science.”

Graham, a physician in the FDA's Office of Drug Safety, made news nearly two years ago when he told a Senate panel that the agency was "virtually defenseless" in preventing a "tragedy and profound regulatory failure" such as Vioxx. Vioxx was withdrawn by manufacturer Merck in 2004.

Graham is a high ranking employee of the FDA, and the FDA allowed Graham to write the editorial as a private citizen, not as an agency employee. (Interesting.) The editorial and the two studies it accompanies will run in the Oct. 4 JAMA, but they were posted online early "because of the public health implications," a JAMA press release says.

Read more about this development in an article appearing in USA Today, Sept 12. You can also find Dr. Graham’s editorial listed. Go to:
http://gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles and scroll down to find these two documents.

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