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FDA 1 ... this Page

FDA 2 ... link


 

Comments by FDA Insider Dr. David Graham, MD

on

Drug Approvals

and

Removing Unsafe Drugs from the Marketplace

Comments attributed to David Graham, by DIEDRA HENDERSON of the Associated Press. This page is a synopsis of an AP article written by Diedra Henderson, published on the internet 11/18/04. Use of the referenced information & quotes is done without permission, for educational and informative purposes only. NOTE: Diedra Henderson fails in her presentation of this information to give Dr. Graham credit for either his educational achievements or his formal position within the FDA.

Dr. David Graham, associate director for science in the FDA Drug Center's Office of Drug Safety  was the lead author on a research project that studied the records of almost 1.4 million Kaiser Permanente patients, including 40,405 treated with Pfizer's Celebrex and 26,748 treated with Vioxx. The study found that high doses of Vioxx tripled risks of heart attacks and sudden cardiac death. Graham also concluded that Vioxx was responsible for an additional 27,785 deaths from heart ailments from 1999 to 2003.

Dr. Graham, associate director for science in the FDA Drug Center's Office of Drug Safety, has told congressional investigators that superiors pressured him to soften his conclusions. [link] to fda "in house" document

Dr. David Graham on November 18, 2004, when testifying before The Senate Finance committee reputedly made the following observations:

The American public is "virtually defenseless" if another medication such as Vioxx proves to be unsafe after it is approved for sale.

"I would argue that the FDA as currently configured is incapable of protecting America against another Vioxx,".

Dr. Graham alleges research indicates that Vioxx caused up to 160,000 heart attacks and strokes., (The research team's original conclusion said high doses of Vioxx should not be prescribed or used.)

Dr. Graham mentioned five other drugs currently on the market that he feels merit re-evaluation. They include:

Dr. Graham questioned the agency's commitment to removing unsafe drugs from the market, since it would call into question their earlier approval.

To the FDA"s credit, according to Dr. Graham, "During my career I have recommended the market withdrawal of 12 drugs,"  "Only two of these remain on the market today."

Sen. Jeff Bingaman, D-New Mexico, said "The culture within the FDA, being one where the pharmaceutical industry, which the FDA is supposed to regulate, is seen by the FDA as its client instead"..

Sen. Charles Grassley, R-Iowa said "Consumers should not have to second-guess the safety of what's in their medicine cabinet."

Sen. Jeff Bingaman, D-New Mexico called on President Bush to appoint a new head for the agency.

 

FDA "Approvals" & You

 

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