Conflicts of interest

A board to discuss the newly-released drug Tysabri, (formerly known as Antegren) as a treatment for Multiple Sclerosis

Conflicts of interest

Postby bromley » Mon Mar 06, 2006 3:59 pm

This one is from the BCP site.


Five of the eleven scientists so far selected to judge the safety of the new multiple sclerosis drug Tysabri have financial ties to either the drug's sponsors, Biogen and Elan Pharmaceuticals, or their competitors. The Food and Drug Administration's Peripheral and Central Nervous System Drugs Advisory Committee will meet March 7 to reconsider Tysabri, which was pulled from the market last year after a handful of patients developed a rare brain disorder. Permanent committee member Lily Jung and Karl Kieburtz, special appointee, disclosed they earned between $10,000 and $50,000 from either Biogen and Elan by serving on their speakers bureaus or consulting. In addition, committee members Steven DeKosky, Larry Goldstein and Ralph Sacco consulted for or sat on the speaker bureaus of direct competitors.

The FDA claims it cannot find experts without conflicts of interest to serve on advisory panels, whose advice it usually follows".

The BCP site provides a link to an article.
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Conflicts of Interest

Postby Chicano » Mon Mar 06, 2006 5:11 pm

Each of the FDA committee members are intelligent, qualified people. The discloure was appropriate and required. In my experience, it is indeed difficult to find a committee that is 100% comprised of people without some percieved conflict of interest. It's the disclosure that's important.
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Postby Brainteaser » Mon Mar 06, 2006 5:37 pm

Why not simply have the remaining 6 scientists who have no conflict, do the judging?
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Postby Brownsfan » Wed Mar 08, 2006 8:08 am

Of course T will be re-approved, and I would probably agree with that decision. I might even consider taking it if I were declining rapidly. However, nobody should mistakenly think that the FDA is actually looking out for public health or protecting the public from dangerous drugs.

FDA officer says conflicts of interest compromise agency
Marc Kaufman, Washington Post

Friday, November 19, 2004

Washington -- A veteran Food and Drug Administration safety officer Thursday told a Senate hearing inquiring into the abrupt recall of the arthritis drug Vioxx that five other widely used drugs should be either withdrawn or sharply restricted because they have dangerous side effects.

Describing the agency that he works for as incapable of stopping dangerous drugs from coming to and staying on the market, David Graham, associate director of the Office of Drug Safety, told the senators that the FDA's role in reviewing and approving new drugs sometimes conflicted with its duty to address safety issues.

Asked by Sen. Jeff Bingaman, D-N.M., to identify the five drugs, Graham hesitated and then listed them to the startled hearing room: the popular cholesterol-lowering drug Crestor, the weight-loss drug Meridia, the painkiller Bextra, the acne medication Accutane and the asthma medication Serevent.

Each poses different issues, Graham said in answer to questions from senators, but all require more aggressive action by the FDA.

AstraZeneca's Crestor, he said, poses risks of kidney failure and a rare muscle disease; Abbott Laboratories Inc.'s Meridia is of little use and has cardiovascular side effects; Roche's Accutane can cause birth defects if used by pregnant women; Pfizer's Bextra carries cardiovascular risks similar to those linked to Vioxx; and GlaxoSmithKline's Serevent increases the risk of dying of asthma. The makers of all five drugs later defended their products vigorously.

Dr. Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research, said the agency already had taken steps to alert consumers to those drugs' safety concerns. That includes heightened warnings for Serevent; a tougher risk-management plan to ensure pregnant women don't use Accutane, and an upcoming advisory committee hearing regarding Bextra.

A 20-year veteran of the FDA, Graham has played a significant role in the withdrawal of nine drugs over the past decade, and his highly unusual attack on his own agency astonished many in the room. He called the FDA's handling of Merck & Co.'s Vioxx -- which he said should have been pulled from the market years ago -- the most distressing episode of all and a "profound regulatory failure."

"I would argue that the FDA as currently configured is incapable of protecting America against another Vioxx," Graham said in his scathing assessment. "The scientific standards (the FDA) applies to drug safety guarantee that unsafe and deadly drugs will remain on the U.S. market."

Citing estimates he said were based on the results of Merck's own clinical trials, Graham said between 88,000 and 139,000 Americans had probably had heart attacks or strokes as a result of taking Vioxx, and that 30 to 40 percent had probably died.

Graham also contended that FDA had an inherent conflict of interest that triggered "denial, rejection and heat" when safety questions emerged about products it had approved.

Graham's sentiments were endorsed at the hearing by two other drug safety experts, but they were disputed by a ranking FDA official as "not the FDA that I know."

Sandra Kweder, deputy director of the Office of New Drugs, said the agency was dedicated to protecting consumers and that drug safety was at the heart of its activities. She acknowledged, however, that "clearly, there's concern by the public and this committee that the system isn't working as well as it should, and we need to address that."

Asked about the five drugs that Graham identified as needing immediate action, Kweder said, "I don't have reason to believe that set of five drugs gives more reason for concern than any other set."

Graham's revelations and criticisms were the centerpiece of the hearing called by Sen. Charles Grassley, R-Iowa, chairman of the Senate Finance Committee and an increasingly sharp critic of the FDA. Following Graham's comments, Grassley pointedly warned agency officials against disciplining Graham in any way.

Grassley also suggested that an independent board of drug safety may be needed to ensure the safety of medications after FDA approval. An "awful lot of red flags" were raised before Vioxx was withdrawn, said Grassley, and the agency disdained, rather than listened to, its own reviewers.

Merck CEO Raymond Gilmartin came to the defense of the FDA and his company's actions in dealing with the issues around Vioxx, a heavily advertised and hugely profitable drug until it was abruptly recalled in September. He said the company had no scientific reason to withdraw the drug until it heard clear negative results reported by the safety monitoring committee of a clinical trial. At the time, Gilmartin said, his own wife was regularly taking the drug.

"Throughout Merck's history, it has been our rigorous adherence to scientific investigation, openness and integrity that has enabled us to bring new medicines to people who need them," Gilmartin said. "I am proud that we followed that same rigorous scientific process at every step of the way with Vioxx."

One of a class of painkillers known as COX-2 inhibitors that are widely used by arthritis sufferers, Vioxx was introduced in 1999. It was withdrawn after researchers halted a clinical trial because patients taking Vioxx were experiencing twice as many heart attacks and strokes as patients taking a placebo, but witnesses testified there had been suggestions of possible cardiovascular risks going back the mid-1990s.

Officials of the companies whose drugs were cited by Graham all said they were surprised by his testimony.

Carolyn Glynn, a spokeswoman for Roche, said it had long recognized that Accutane required special handling because of its known connection to birth defects.

AstraZeneca, the maker of Crestor, said in a statement that "to date, the FDA has not given the company any indication of a major concern regarding Crestor, and the comments today are inconsistent with past public statements from the FDA."

Abbott Laboratories issued a statement defending its weight-loss drug Meridia. "Obesity remains one of the leading health epidemics in the U.S., and Meridia is one of the few effective drugs that are currently available," it said.

GlaxoSmithKline stood by its asthma drug Serevent, saying it was "safe and effective when used appropriately."

Pfizer spokeswoman Susan Bro said its Cox-2 drug, Bextra, "has been found safe and effective when used as indicated." She noted that the company had already "committed to conducting further studies to confirm the longer-term cardiovascular safety profile."
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Postby amelia » Wed Mar 08, 2006 8:17 am

As far as the FDA and drug companies go, this review, etc.., it's all a dog and pony show. If something goes wrong, they have covered their butts in public for law suits. And you are misinformed if you think otherwise. When Biogen and Elan pulled Tysabri, at first it was a concern for loss of life. But I am sure that was quickly replace with "what if they sue us". And they are NO DIFFERENT than any other pharmacutical company out there with any drug.
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