Scientist At FDA Alleges Job `Reprisal'

[ShotgunSteven]

Makes you all warm and fuzzy inside to know that the people that are supposed to decide if the new drugs are harmful or not might get moved to another job if they DO their job.


SOURCE

By Ricardo Alonso-Zaldivar Tribune Newspapers: Los Angeles Times

Dr. David Graham, the Food and Drug Administration scientist who publicly criticized the agency's approach to drug safety at a congressional hearing last week, said Wednesday that he was facing pressure to transfer to a different job in the FDA.


"What they want to do is move me out of drug safety into the office of the commissioner, where I will basically be exiled and won't be able to do drug research," Graham said in an interview. "It's a reprisal."


Graham, who has worked at the FDA for 20 years, testified at a Nov. 18 Senate hearing into the prescription painkiller Vioxx. Its manufacturer, Merck & Co., pulled the drug from the market after research findings confirmed an increased risk of heart attack among patients taking the medication. Graham testified that the FDA ignored his warnings about the drug and tried to suppress the results of his investigations.


He also identified five drugs that are on the market despite potentially severe side effects: Crestor, a cholesterol-lowering drug; Meridia, used for weight loss; Accutane, prescribed for acne; Bextra, a pain reliever, and Serevent, an asthma drug.


FDA officials have strongly disputed Graham's assertions.

Graham is represented by lawyers from the Government Accountability Project, a non-profit public interest group.


"We are hoping to prevent Dr. Graham's exile before it becomes a fait accompli," said Tom Devine, the group's legal director. "It is an inexcusable abuse of power that the FDA would sideline [this] scientist."


Devine said his organization had received anonymous calls, from FDA phone numbers, accusing Graham of scientific misconduct. On Wednesday, Sen. Charles Grassley (R-Iowa) asked the Health and Human Services inspector general's office to investigate whether the agency was misusing government resources by trying to tarnish an in-house critic.


An FDA statement said the agency "does not condone any form of employee retaliation."


Graham, 50, is the associate director for science and medicine in the FDA's Office of Drug Safety.

 

[Freejack2]

This belongs in P&N.
That aside, All I can say is, think about things like this next time you go to vote.

 

[aplefka]

This doesn't belong in P&N.

That being said, FDA is teh ghey if they follow through with this.

 

[OS]

I've read allegations that many people in FDA enter sort of revolving door between public/private work and often hold stock in the companies they review products for.

 

[Ornery]

I heard the FDA is an agency has become a bureaucracy that "protects" people from the drugs that can save their lives.

FDA Needs a Dose of Reform

• ...In June 2000, the FDA had two drugs in the pipeline for approval within six months under its fast track program. But although 15 countries in Europe had already approved the drug, the FDA then had a crisis of confidence and put it on hold for more data. In the meantime, 15 people with Fabry's have died waiting for the medicine.

Is the FDA necessary?

• ...the FDA routinely denies approval to successful products already used in Europe, holding up use in the U.S. of items ranging from injectable antibiotics for resistant pathogens to a vaccine against meningitis. Economists calculate that the number of people who have died or suffered while waiting for useful drugs to be approved by the FDA may outnumber those saved by keeping bad drugs off the market.

Increasing Access to Pharmaceuticals

• Today the Food and Drug Administration (FDA) both discourages the development of new pharmaceuticals and medical products and increases their cost. Simply relaxing Washington's bureaucratic stranglehold over the drug and device marketplace would be a useful first step. Even more advantageous would be reconsidering the role of the FDA itself; Congress could turn the agency into a certification rather than an enforcement body, for instance. The result would likely be improved medical treatment, less patient suffering, and lower health-care costs.
  
  Everyone, except, perhaps, a couple thousand federal bureaucrats, would gain.