Thu 16 Dec, 2004 01:36 pm
Some FDA Staff Had Drug Safety Concerns-Survey
Thu Dec 16, 2004
By Lisa Richwine
WASHINGTON (Reuters) - Nearly 20 percent of U.S. Food and Drug Administration scientists surveyed in late 2002 said they were pressured to approve or recommend approval of a medicine despite their reservations about the drug's risks or effectiveness, according to documents made public on Thursday.
Also, two-thirds of the scientists questioned by the Department of Health and Human Services' inspector general said they lacked full confidence in the FDA's ability to monitor side effects of prescription drugs after they hit the market.
The survey shows at least some government scientists backed accusations last month by FDA safety officer Dr. David Graham, who told a Senate hearing he was pressed to water down safety concerns about Merck & Co. Inc.'s painkiller Vioxx. The drug was pulled from the market Sept. 30 over links to heart attacks and strokes.
Graham, associate director for science in the FDA's Office of Drug Safety, also told Congress he felt the FDA was incapable of protecting the public from other dangerous drugs.
The survey of nearly 400 FDA scientists was obtained through the Freedom of Information Act by the Union of Concerned Scientists and Public Employees for Environmental Responsibility, two environmental activist groups.
"The scientists' concerns warrant further investigation as Congress reviews drug approval practices at FDA," said Kathleen Rest, executive director of the Union of Concerned Scientists, which has Nobel-prize winning researchers as well as activists as members.
An FDA spokesman did not immediately return a call seeking comment.
Among other findings, 36 percent of the FDA scientists said the were "not at all" or only "somewhat" confident that "final decisions adequately assess the safety of a drug."
Portions of the survey were published in a March 2003 inspector general's report about the FDA's review process. But the negative opinions often were downplayed in favor of a focus on positive findings, Rest said.
A main conclusion in the 2003 report was that "both FDA reviewers and (drug company) sponsors have confidence in the decisions FDA makes," noting 78 percent of FDA scientists felt comfortable with decisions regarding drug effectiveness.
The inspector general's report did note that many reviewers felt time-pressured, and 58 percent said the six months allotted for a priority drug review was inadequate.
This doesn't surprise me at all, considering I had a friend who recently died of a heart attack after being on Vioxx 50mg for two and a half years. Single father, early 40's loving man. Now where does his 14 year old son begin to pick up the pieces?
On October 5, 2004, Kenneth B. Moll & Associates, Ltd. filed the first worldwide class action lawsuit against Merck, on behalf of all persons who were prescribed the potentially deadly arthritis drug rofecoxib, also known as Vioxx (Ceoxx outside the United States).
Thank you, husker! I will find a way to pass this info on. I was on 50mg Vioxx myself for close to a year before my doc and I switched anti-inflammatory meds. I don't have any claim, but my friend's son, Scotty I know does. Your information is wonderful....thank you!!
I can understand that conflict. Drug development is a long and expensive process. One one hand, being too severe about dangerous side effects stunts innovation and does people who could have used the drug a disservice. On the other hand, being too lenient can mean sickness and death, and distrust of the organization.
It is inevitable that a few people will die from just about any new drug. I wonder what their standards are for drawing the line between "safe" and "not safe?"
I really like that warning labels are required on everything, even commercials.
Did any of the scientists say where they felt the pressure was coming from?
Over 50% of the lobbyists (a very lucrative racket) for the Pharmaceutical industry used to be employed as Congressmen or on Capitol Hill.
The "revolving door" for gummint officials, and the inherent "conflicts of interest" issues definitely require further inspection.
We must get the foxes out of the henhouse.