Healthy Skepticism Library item: 701

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Henderson D.
Calls are mounting for revamp of FDA
The Boston Globe 2004 Dec 25

Full text:

Just as the Enron scandal triggered an overhaul of corporate accounting practices, the nation’s prescription drug crisis may prompt a sweeping revamp of the way the Food and Drug Administration ensures drug safety, some say.

The momentum for FDA overhaul is driven by the recent parade of drug problems dominating the nation’s front pages, including antidepressants that heighten suicidal thoughts and behaviors among children, and the painkillers naproxen, Bextra, Celebrex, and Vioxx increasing the risk of heart attacks or strokes.

‘‘Each one of these drugs has affected another large group of Americans and, collectively, the spotlight is now shining on the FDA — more than any other federal agency — as one in need of reform,” said US Representative Edward J. Markey, Democrat of Malden. ‘‘I think Congress will be forced to act in the same way that Enron and MCI Worldcom forced an overhaul of the accounting industry in America.”

On Thursday, the FDA issued a public health advisory cautioning doctors to restrict Bextra and Celebrex prescriptions to fewer patients, including those at high risk for gastrointestinal bleeding. From January through October this year, doctors wrote 30.7 million prescriptions for those drugs, according to IMS Health, a pharmaceutical information company. The agency did not change either drug’s label or remove either drug from the market.

The agency’s action came the same day the New England Journal of Medicine published a letter from Vanderbilt University School of Medicine staffers urging doctors to write fewer Bextra prescriptions because cardiovascular risks linked to the drug ‘‘constitute a potential imminent hazard to public health and thus require action.”

C. Michael Stein, a Vanderbilt clinical pharmacologist and one of three coauthors of the letter, said the FDA’s prescription restrictions pending review of Bextra and Celebrex risks are ‘‘a move in the right direction.”

Fueling calls to reform the FDA, headed for much of the Bush administration by an acting commissioner, is criticism that it is too cozy with the drug industry it regulates and unwilling to act when red flags are raised.

As drug companies absorb the latest body blow — heart safety questions raised by the painkiller naproxen that crippled a government-funded national study — some already plan to transform concerns over drug safety into congressional action.

Specialists inside and outside the FDA say at least three changes are needed before the public can be assured that drugs are safe: naming a permanent FDA commissioner; increasing the agency’s budget to permit meaningful surveillance of the safety of drugs after they are approved for use by consumers; and adding regulatory muscle to require that companies complete promised postmarketing studies. The White House is said to be considering a short list of candidates for a permanent FDA commissioner, and a decision is likely by mid-2005.

And US Senator Charles Grassley, an Iowa Republican, will introduce legislation to create an office of drug safety independent of the FDA. Markey is eyeing ways to speed the slow pace of safety studies that drug companies promise in exchange for swift FDA approval.

US Senator Edward M. Kennedy, a Democrat working with Republican US Senator Michael B. Enzi of Wyoming, is contemplating widespread FDA changes to bolster the safety of drugs once they’re used by millions of Americans. The legislation, still under discussion, would increase the FDA’s budget to conduct stepped-up drug safety surveillance. Epidemiologists would scour massive databases — such as health records kept for 8.2 million members of Kaiser Permanente, the nation’s largest HMO — to track side effects as drugs are used widely. When the epidemiologists spot a worrisome trend, as they did with Vioxx, targeted studies would look to find the drug’s role in causing that side effect. In addition, Kennedy is keen to add the force of law, so the FDA can require postmarketing safety studies that companies promise, but few complete.

‘‘Reform is urgently needed,” Kennedy said. ‘‘It is time for the administration to end its business-as-usual, head-in-the-sand posture toward this healthcare crisis.”

How effective is the FDA’s decision-making on drug safety issues? The question, posed by the Government Accountability Office in dozens of interviews for two congressional committees, cuts to the heart of what millions of patients want to know.

‘‘Much of this can be fixed by strong leadership,” said David A. Kessler, FDA commissioner from 1990 to 1997. ‘‘You don’t need a change in statute to give greater prominence to drug safety review. An FDA commissioner on his or her own could give greater independence to an office of drug safety . . . overnight.”

The current system puts drug companies in charge of monitoring side effects. That system is derided as too crude to pick up subtle increases in common health woes.

But the agency also lacks money for nuts-and-bolts spending. Until recently, new drug applications were logged in a three-ring binder, said Raymond Woosley, vice president for health sciences at the University of Arizona Health Sciences Center. FDA staffers trained by Woosley tell ‘‘horror stories,” he said.

‘‘No one at the agency can sit down at a computer and bring up the data on Celebrex and Vioxx and compare them,” he said. ‘‘Their computer systems are so antiquated, it’s criminal.”

The proposal garnering the most support is Grassley’s plan to create an independent drug safety office to keep drug companies honest.

Absent that, drug safety details trickle out from lawsuits, congressional hearings, and academic meetings.

Curt Furberg’s data linking Bextra to doubled heart risks among patients with heart disease were presented at the American Heart Association annual meeting in early November.

Like Merck & Co. with Vioxx and Bayer AG with Baycol, Pfizer Inc. ‘‘suppressed or ignored” problems with Bextra that it knew about last spring, said Furberg, a Wake Forest University School of Medicine professor and drug safety adviser. Pfizer ‘‘didn’t talk to anyone, until some of us started raising questions about it in October, six months later,” he said.

The firm says it shared information with the FDA in a ‘‘timely manner.” The trial data Pfizer disputed in November were published this month on Bextra’s label, with a warning that the painkiller should not be used immediately after coronary artery bypass graft surgery.

And an independent safety board would have had the teeth to require Merck to conduct more tests when safety issues arose with Vioxx, said David Campen, Kaiser Permanente medical director in pharmacy operations. ‘‘That would put the clear responsibility of the agency back where it truly, truly belongs . . . to serve the safety of the American consumer,” he said.

Critics call withdrawing drug approval an ‘‘atomic bomb” the FDA rarely hurls. And drug label changes are a ‘‘powder puff” solution that does not slow a drug’s use. The push is on for Congress to add more regulatory options.

Dr. Alastair J.J. Wood, a Vanderbilt University Medical Center associate dean, said drug firms should earn the right to corner a market in exchange for safety studies with solid goals. That exclusivity keeps generics at bay, guaranteeing profits to offset research expenses.

‘‘Losing exclusivity doesn’t remove the drug from people who might want to take it,” Wood said. ‘‘It removes the pricing advantage for the company, so they will move heaven and earth to make sure that doesn’t happen.”