FDA: Researcher Alleges Clinical Trials Problem
A Food and Drug Administration researcher claims "he has been asked by a supervisor to resign following his criticism of the agency's drug-testing system in a letter that ran in yesterday's Washington Post," Newsday reports (Talan, 8/25). In his letter to the Post, Dr. Robert Misbin, an agency employee charged with reviewing diabetes drugs, alleges that the FDA sanctions clinical trials that sacrifice the health of unwary patients and compromise medical ethics. Misbin cites an FDA-approved study detailed in the February edition of the Annals of Internal Medicine. In this study, a control group of diabetes patients was deprived of standard diabetes treatment for six months to enhance the comparison between the placebo and a new drug given to another group. "Not surprisingly," Misbin writes, the control group's "blood sugars rose to levels that could be expected to jeopardize their well-being." He writes that "with recent examples of unsafe drugs that had to be pulled from the market soon after approval, an observer might conclude that the pharmaceutical industry is conspiring with university-based medical researchers to bring new drugs to market as quickly as possible, and that the FDA is failing in its duty to protect the public."
A Call For Change
In his letter, Misbin says one trend driving the problem is the decrease in federal funding for medical research, which drives scientists to either work for drug companies or generate funds by arranging a company's drug trials. As a result, Misbin says "it is difficult to find an 'expert' who does not have some vested interest in one drug product or another." In addition, Misbin contends that the FDA program that requires drugmakers to "pay fees for review of their new drug applications" has resulted in "an unfortunate consequence" -- "a linking of the productivity of FDA reviewers with the approval of new products. The more new drugs approved, the more productive the FDA appears, even if the new drugs are not as good as what is available already." He concludes: "FDA policy should encourage the pharmaceutical industry to use its resources to find better drugs, not just more drugs. Further expansion of the FDA would not be needed, and the money saved from dealing with 'adverse effects' could be used to fund medical research" (Washington Post, 8/24).
The FDA yesterday denied that Misbin was asked to resign. But Newsday reports that "the charge prompted Dr. Sidney Wolfe of the Washington-based watchdog group Public Citizen to seek congressional hearings on the issues." Misbin said he will refuse to resign, claiming, "It would defeat my purpose of writing the article. We need things to change. If we (the FDA) don't do it, who will?" (8/25).