Anemic Drug Oversight
Congress has passed two bills since 1996 that accelerated the Food and Drug Administration’s approval of drugs and medical devices. The bills have cut red tape that can delay the release and development of promising new drugs, sometimes lifesaving ones, but they have also eroded consumer protection. A Times series last week on the FDA’s hasty and careless approval of the diabetes drug Rezulin underscores the need for Congress to restore proper oversight.
In 1995, Rezulin’s manufacturer, the consumer products company Warner-Lambert, pleaded guilty to a felony in connection with concealing quality-control problems in its drug manufacturing from the FDA and agreed to pay a $10-million fine. At that point, the FDA should have put the New Jersey-based company under microscopic scrutiny. Instead, when Warner-Lambert pushed for fast approval of Rezulin, the agency dismissed concerns raised by two of its veteran medical officers about the drug’s association with liver injury, failed to prevent Warner-Lambert from advertising seriously misleading safety claims and failed to require physicians to conduct liver tests on patients receiving the drug. The result? At least 33 deaths are attributed to Rezulin use, and there may be many more. Other lives were greatly impaired by organ damage.
Those FDA medical officers are only the most vocal of an increasing number of agency scientists who believe the FDA has grown cavalier about approving and lax about monitoring new drugs. For example, Dr. Sidney Wolfe, medical director of the consumer group Public Citizen, recently asked 53 FDA scientists whether the agency had inappropriately approved two dozen new drugs; 19 said yes.
This is a problem that can be solved without harming fast-track approval of important new drugs. Here’s where the FDA should start:
* Beef up oversight of drugs already on the market. A central but shaky tenet of Congress’ FDA reforms has been that scrutiny of new drugs would be intensified by doctors and drug companies. But HMO doctors don’t have the time to play scientist, and the evidence that drug companies are biased in their oversight grows daily. The cure is for Congress to provide the FDA the funding it needs to keep up with the drug industry’s phenomenal growth. A scant 52 FDA employees monitor the safety of 5,000 approved drugs. “Post-market drug surveillance” is more crucial now than ever, because drug companies are now allowed to contact doctors directly to promote the use of drugs for purposes the FDA has not yet approved: prescribing an antidepressant, for example, for the prevention of migraine headaches.
* Root out the appearance of compromising ties between researchers and drug companies. FDA Administrator Michael Friedman needs to explain why so many of his own scientists say his agency is approving drugs recklessly, and National Institutes of Health Director Harold Varmus needs to explain why his agency put a Warner-Lambert consultant in charge of studying Rezulin’s efficacy. More fundamentally, Congress should establish a separate office of drug safety shielded from drug company lobbying pressure.
* Require doctors, hospitals and pharmacists to report adverse drug effects promptly to the FDA. The agency now tends to wait until reports of patient injuries and deaths come ambling in voluntarily; only about 1% of adverse side effects are reported at all.
Each year, 100,000 Americans die of adverse drug reactions and 1.5 million are hospitalized. That figure, like virtually everything associated with pharmaceutical drugs in America, is a rough estimate. And therein lies the problem: a laxness that chiefly benefits the pharmaceutical industry, with its $100 billion in annual sales. But what’s at stake are consumers’ lives, and that’s where the FDA’s first responsibility should rest.
