FDA Scientists Felt Pressure to Approve Drugs

Reply 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.

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Lady J
Reply Thu 16 Dec, 2004 01:42 pm
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? Sad
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Reply Thu 16 Dec, 2004 01:49 pm
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).

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Lady J
Reply Thu 16 Dec, 2004 01:55 pm
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!!
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Portal Star
Reply Thu 16 Dec, 2004 03:04 pm
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.
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Reply Thu 16 Dec, 2004 03:14 pm
Did any of the scientists say where they felt the pressure was coming from?
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Reply Fri 17 Dec, 2004 11:08 am
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.
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Walter Hinteler
Reply Tue 25 Jan, 2005 01:51 am
husker wrote:
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).


Painkiller linked to 140,000 heart attacks in patients
By Jeremy Laurance, Health Editor
25 January 2005

A blockbuster drug launched five years ago as a revolutionary treatment for arthritis may have caused up to 140,000 heart attacks in US patients of whom 44 per cent died, scientists said yesterday, making it the world's worst drug disaster.

Vioxx, a new type of painkiller launched in 1999, was one of the most heavily promoted drugs in history, with sales in 80 countries and a global market of 80 million patients.

More than 400,000 patients were taking it in Britain, where it could have caused up to 1,000 heart attacks and deaths.

Last September, the manufacturer, Merck & Co, withdrew the drug from the market after evidence emerged linking it with heart problems.

Now, a study of 1.4 million people in California shows that those taking Vioxx had a one-third higher chance of having a heart attack than those taking other painkillers.

David Graham, of the US Food and Drug Administration, and colleagues concluded: "An estimated 88,000 to 140,000 excess cases of serious coronary heart disease probably occurred in the USA over the market life of rofecoxib [Vioxx]. The US national estimate of the case-fatality rate was 44 per cent, which suggests that many of the excess cases attributable to rofecoxib use were fatal." The results, published online by The Lancet, will be seized on by critics of the pharmaceutical industry as evidence of the failure of the drug regulatory system to protect the public. Dr Graham had earlier estimated that Vioxx may have caused up to 27,000 heart attacks but the new study caused him to upgrade the estimate by five times.

Doctors on both sides of the Atlantic have warned of a public health emergency over other painkillers in the same class, known as Cox-2 inhibitors, which could also pose a risk.

A report in The New England Journal of Medicine last October said studies since 1999 had repeatedly indicated a danger with Vioxx. Drug regulators made Merck include a warning in the drug package but never ordered a definitive trial.

Professor David Webb, of the clinical pharmacology unit at the University of Edinburgh, says in The Lancet: "It falls to the manufacturers, under the careful review of the regulatory authorities, to provide evidence that this class of drugs is safe."

Asked if this was the worst drugs disaster in history, Professor Webb said: "Quite possibly because these drugs were very widely used."

The previous worst disaster involved the drug Tambocor (flecainide) prescribed to patients with irregular heartbeats. It was estimated to have killed 50,000 patients in the Seventies and Eighties.

The European Drug Safety Agency is conducting an urgent safety review of all the Cox-2 inhibitors, which have a combined global sale of $10bn (£6bn). Last month, the UK Medicines and Health Care Products Regulatory Agency advised all patients still taking Vioxx, estimated at 750,000, to review their treatment with their doctor.
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