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Senators told fda too cozy with drug industry { November 18 2004 }

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Scientist: FDA Incapable of Protecting Safety

Says Vioxx 'Tragedy' Proves Agency Is Poorly Organized; Cites Five Other Drugs as Potentially Unsafe

By Todd Zwillich
WebMD Medical News Reviewed By Michael Smith, MD
on Thursday, November 18, 2004

Nov. 18, 2004 -- An FDA scientist who says he was pressured by superiors not to warn the public about the cardiovascular risk of Vioxx urged lawmakers Thursday to create an independent safety office free of influence from regulators who approve new pharmaceuticals.

David J. Graham told senators that the FDA's ability to police the safety of drugs already on the market is being compromised because the agency is "too cozy" with the drug industry.

He also warned that besides Vioxx, which was pulled from the market by its maker, Merck & Co., on Sept. 30, there are five more available drugs that should be closely reviewed for safety.

Graham, an associate science director in the FDA's Office of Drug Safety, has accused FDA officials of trying to discourage him from sharing the results of a California study showing that high doses of Vioxx increased the risk of heart attacks and stroke by up to 500%. The drug was later removed from the market when a Merck study showed that the cardiovascular risk was real.

An estimated 20 million people took Vioxx between its approval in 1999 and its withdrawal in September, and Graham calculated that the drug caused up to 139,000 heart attacks, 30% to 40% of which could be expected to result in death.

Graham told members of the Senate Finance Committee that scientists reviewing the safety of drugs already on the market are frequently overruled by those in the Office of New Drugs, which clears medications for initial marketing. That also happened when he raised questions about the ill-fated Vioxx, he said.

He also accused the agency of resisting pleas from safety officers in 2001 to place strong warnings on the Vioxx label warning of heart risks.

"In these situations, the new drug reviewing division that approved the drug in the first place and regards it as its own child typically proves to be the single greatest obstacle to effectively dealing with serious safety issues," he said.

Graham continued, "Vioxx is a terrible tragedy and a profound regulatory failure. I would argue that the FDA, as currently configured, is incapable of protecting America against another Vioxx. We are virtually defenseless."

Sandra L. Kweder, MD, acting director of the FDA's Office of New Drugs, said that no one knows how many -- if any -- patients were actually harmed by Vioxx and that Graham's estimates of 139,000 heart attacks were theoretical. "These are not real deaths. They're a mathematical model that is put together with a number of assumptions along the way."

Call for Independent Safety Office

Several researchers, including Graham, urged lawmakers to create a new independent FDA drug safety office free from the influence of officers who review drugs for approval. "The same group that approved the drug is also responsible for taking regulatory action against it. This is an inherent conflict of interest," Graham said.

"An independent office of drug safety which does not report to the FDA new drug approval section should be established," said Gurkirpal Singh, MD, chief science officer at the Institute of Clinical Outcomes Research and Education at Stanford University in Woodside, Calif.

Kweder said that she has not seen the problems within the FDA that Graham described.

"That is not the FDA that I know," she said.

Next: 5 Drugs Questioned

Kweder said the FDA's current system "works very well" in assessing the risks and benefits of drugs both before and after they are put on the market. But asked by Sen. Max Baucus (D-Mont.), the committee's senior Democrat, if she would support restructuring the agency, Kweder said that concerns about it may be founded.

"I don't have any objection, sir, to an independent Office of Drug Safety."

Shuffling the agency could have an important impact on the way the FDA approves and polices drugs. Safety officers would for the first time be able to disclose study data directly to the public separately from the drug approval process. The new office could also be able to independently conduct safety reviews with teams of outside experts.

5 Drugs Questioned

Graham told lawmakers that the same problems he encountered with Vioxx also slowed other FDA scientists from warning the public about the potential for increased suicide risk in children who take antidepressant medications. The agency in September demanded strict warnings for those drugs after more than a decade of sales in some cases.

Graham then stunned the hearing audience and some committee members when he said that several other popular prescription drugs also have significant safety concerns.

"There are at least five other drugs on the market today that need to be looked at," he said.

Asked by Sen. Jeff Bingaman (D-N.M.) to list the five drugs, Graham said the weight loss drug Meridia may not work as well as expected because side effects cause many patients to stop taking it before it can have an effect. The side effects, including elevated blood pressure, may not be worth the limited benefit, he said.

Graham also questioned the use of the acne drug Accutane and the cholesterol-lowering drug Crestor. Accutane is known to cause birth defects if pregnant women use the drug, but Graham said the FDA has not done enough to ensure that women of child-bearing age follow safety measures. Crestor increases the risk of kidney failure and a muscle disorder called rhabdomyolysis but may offer little advantage over other cholesterol drugs on the market, he said.

Graham also listed Bextra, a drug from the same class as Vioxx, and the asthma drug Serevent, saying that data suggest that it could increase the risk of death from asthma.

Lawmakers then asked Kweder for her response to Graham's list of potentially dangerous drugs.

"It's important not to get so focused on the risks that one forgets about the benefits," she said.

SOURCES: David. J. Graham, MPh, associate director for science, FDA Office of Drug Safety. Gurkirpal Singh, MD, chief science officer, Institute of Clinical Outcomes Research and Education, Stanford University. Sandra Kweder, MD, acting director, FDA Office of New Drugs. Sen. Max Baucus (D-Mont.). Sen. Jeff Bingaman (D-N.M.).

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