Cleaning Up Rezulin Mess
On Friday the Food and Drug Administration is scheduled to hold a public hearing to decide whether to restrict or prohibit doctors from prescribing Rezulin, a diabetes drug the agency “associates” with at least 33 deaths involving liver damage over the last two years. The Times’ own analysis shows that the toll could be much higher--that doctors and others have reported 155 deaths in which Rezulin was cited as a suspect drug.
Rezulin’s manufacturer, Warner-Lambert, argues that the deaths do not in themselves indict Rezulin. Diabetes is a serious disease. Given that Rezulin is used by 1 million people suffering from adult-onset, or Type 2, diabetes, a certain number of serious adverse effects is not surprising.
What is astonishing is that the FDA would fail to require liver testing when it knew from Warner-Lambert’s own clinical trials that 2.2% of Rezulin users showed liver damage. The agency could have released Rezulin with rigorous testing requirements, then eased up if doctors did not report liver damage. Instead, the agency approved the drug with no testing requirements at all in January 1997, then hurriedly beefed up testing as reports of deaths streamed in.
The FDA’s reasoning for this and other seemingly misguided judgments is a mystery because, as Times reporter David Willman has detailed in recent months, the agency has stonewalled reporters and public health advocates seeking that information.
Last month, for example, the FDA insisted to Rep. Henry A. Waxman (D-Los Angeles) that its medical officer’s recommendations regarding Rezulin’s safety were confidential. Warner-Lambert argues that disclosing its drug trials would compromise its competitive market advantage.
Both arguments are groundless. The federal Freedom of Information Act states that information about drug safety and efficacy must be public, and Warner-Lambert’s key trade secret--Rezulin’s molecular design--is protected under patent law.
FDA officials have a lot of explaining to do at their Friday hearing. Ultimately, however, Congress will have to take the lead in fixing the regulatory loopholes that are largely to blame for the Rezulin deaths.
Currently, there are no federal laws requiring hospitals or other health care providers to report suspected adverse drug reactions to the FDA or even to drug manufacturers once a drug is approved for marketing. Even the FDA admits it doesn’t know how many people have actually been seriously harmed by Rezulin. The FDA also would need more staff to enforce after-market drug surveillance.
In voting next month, Congress can help some by approving the FDA’s modest $15.3-million proposal to increase drug monitoring. But the agency must also respond by allowing more public scrutiny of how it looks after public safety.
