Insider: FDA Won't Protect Public

Employee Therese Finizia of Miller's Drug Store in Pepper Pike, Ohio will be removing the drug Vioxx from the pharmacy's inventory with the news that manufacturer Merck & Co. is haulting worldwide sales of the arthritis medication on Thursday, Sept. 30, 2004. AP

At least five medications now sold to consumers pose such risks that their sale should be limited or stopped, said a government drug reviewer who raised safety questions earlier about the arthritis drug Vioxx.

In testimony Thursday before a Senate committee, Food and Drug Administration reviewer Dr. David Graham cited Meridia, Crestor, Accutane, Bextra and Serevent. Drug makers defended the use and safety of their products.

"I would argue that the FDA as currently configured is incapable of protecting America against another Vioxx," Graham, a 20-year FDA doctor, said before the Senate Finance Committee.

In October, the FDA ordered that all antidepressants carry warnings that they "increase the risk of suicidal thinking and behavior" in children who take them. Vioxx's maker, Merck & Co. pulled the drug from the market on Sept. 30 after a study indicated the popular painkiller doubled the risk of heart attacks and stroke when taken for longer than 18 months.

The committee chairman, Sen. Charles Grassley, suggested an independent board of drug safety might 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 An "awful lot of red flags" were raised before Vioxx was withdrawn, said Grassley, R-Iowa., and the agency disdained, rather than listened to, its own reviewers.

Graham contended that FDA has an inherent conflict of interest that triggers "denial, rejection and heat" when safety questions emerge about products it has approved.

CBS News correspondent that Graham blames a FDA culture where supervisors intimidate scientists who uncover drug dangers, and pressure them to change their conclusions. When he determined Vioxx was a danger, he says his FDA bosses frowned on the results and refused to act. FDA was still defending Vioxx when Merck finally pulled the drug.

The FDA's statement disturbed lawyer Andy Birchfield, who is evaluating thousands of potential cases against Merck on behalf of injured patients.

"How can they see that type of problem and look back and say 'We did everything right'?" Birchfield said. "When they're not willing to recognize mistakes, we have no hope for them voluntarily taking measures to correct the situation."

Graham is an experienced doctor, who was lead author on a research project that studied the records of almost 1.4 million Kaiser Permanente patients, including 40,405 treated with Pfizer's Celebrex and 26,748 treated with Vioxx. The study found that high doses of Vioxx tripled risks of heart attacks and sudden cardiac death.

Vioxx was responsible for an additional 27,785 deaths from heart ailments from 1999 to 2003, Graham concluded.

In his view, the five most worrisome drugs that demand speedy action:

  • Meridia, a weight-loss drug. He said the agency should consider whether its benefits outweigh the risks of higher blood pressure and stroke among people taking it. "I don't think Meridia passes that test," Graham said.

  • Crestor, an anti-cholesterol drug. He said the government should evaluate the occurrence of renal failure and other serious side effects among people taking Crestor. Two of three other statin competitors prevent heart attack and stroke and do not cause renal failure, he said.

  • Accutane, an acne drug linked to birth defects. Graham said the drug represents a 20-year "regulatory failure" by the FDA and sales should be restricted immediately.

  • Bextra, a painkiller. Graham said the drug poses the same heart attack and stroke risk as Vioxx. He recommended designing studies to look at the drug's cardiovascular risks.

  • Serevent, an asthma treatment. He said the drug was shown, with 90 percent certainty in a long-term trial in England, to cause deaths due to asthma. GlaxoSmithKline, told by the FDA to do a large, clinical trial, begged off. "We've got case reports of people dying, clutching their Serevent inhaler," Graham said. "But Serevent is still on the market."

    But an FDA colleague, when asked about Graham's short list, said, "That is clearly Dr. Graham's opinion." Dr. Sandra Kweder, deputy director of the FDA's Office of New Drugs, said there is no "magic formula" to determine which marketed drugs are most worrisome.

    "I do not have reason to believe that the set of five drugs is specifically more concerning than any other drugs that we review," Kweder said, according to Attkisson's CBS Evening News report.

    Tim Lindberg, a spokesman for Abbott Laboratories, said "science continues to support the safe use of Meridia to treat obesity."

    AstraZeneca PLC, maker of Crestor, has confidence in the drug, spokeswoman Emily Denney said. "To date, the FDA has not given us any indication of a major concern regarding Crestor," she said.

    Carolyn Glynn, spokeswoman for Roche Holdings AG, a maker of Accutane, acknowledged that the drug carries risk and said it is reserved for serious cases. "This drug is extremely beneficial as long as it's used safely and appropriately," she said.

    Susan Bro, a Pfizer spokeswoman, said Bextra did not increase the risk of serious cardiovascular events in a recent analysis of nearly 8,000 arthritis patients who took the drug from six weeks to 52 weeks. She said Bextra has been found to be safe and effective when used as indicated.

    GlaxoSmithKline, maker of Serevent, issued a similar statement about its product.

    In his testimony, Graham said Kweder's office at the FDA unrealistically maintains a drug is safe unless reviewers establish with 95 percent certainty that it is not.

    That rule does not protect consumers, Graham told the Senate committee. "What it does is it protects the drug," he said.

    Grassley accused the FDA of attempting to intimidate Graham. Sen. Jeff Bingaman, D-N.M., urged President Bush to name a new leader at the FDA, where Lester Crawford is the acting commissioner.

    Graham said he fears continued intimidation.

    "I was frightened before," he told reporters after the hearing. "Senior management at the FDA did everything in their power to intimidate me prior to my testimony," he said.
    • Dan Collins

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