Healthy Skepticism Library item: 707

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

Editoral .
FDA warnings
The Boston Globe 2004 Dec 26

Full text:

WHEN THE departing secretary of health and human services, Tommy Thompson, endorsed creation of a new independent agency to review prescription drugs after they are on the market, he helped save the proposal from getting buried under pharmaceutical industry opposition. The Senate should press Thompson’s proposed successor,Mike Leavitt, on the issue in his confirmation hearings.

Still, creation of such an office is just one of many steps needed to protect the public from dangers like the cardiovascular problems linked to long-term use of two popular painkillers.

The scandal involving Vioxx and Celebrex and the suppression of evidence by drug companies and the Food and Drug Administration that antidepressants could increase suicidal thinking among adolescents have highlighted serious shortcomings in the way drugs are approved by the FDA, presented to doctors and the public, and monitored once they are on the market.

That monitoring is now done by an office within the FDA that lacks sufficient funding.

Its staffers also know that any decision they take to demand tougher label warnings or even suspend drugs is an implied criticism of colleagues who approved them.Whether a new, strengthened drug review office is set up inside or outside of the FDA, adequate funding from Congress will be crucial.

Over the years, the review office has seen its staffing actually decrease even as more and more drugs came on the market. This is the result both of Congress’s stinginess and a 1992 agreement with drug companies that shifted more government and industry money into speeding approvals of new drugs for diseases like AIDS and cancer.

By all means, life-saving drugs should not be kept off the market because the FDA’s new drugs office lacks staffers. But even that of- fice, which is well funded, should reexamine procedures that let a non-life-saving drug like Vioxx on the market after safety testing that was not rigorous enough to reveal its longerterm effects on the cardiovascular system.

The slowness with which the FDA addressed the issue of antidepressants demonstrates another problem. Studies that pointed to problems with the drugs were often suppressed by the drug companies that sponsored them.
More-positive results, of course, quickly found their way to the pages of the leading medical journals, a chief source of information for doctors, and into the hands of drug company sales people, another major source of doctors’ information.

Between drug makers and patients are phalanxes of professionals who should ensure the safety and effectiveness of medications: researchers, FDA reviewers, medical journal editors, and doctors. All of them depend on impartial, fully transparent information to do their jobs right. In any changes Congress makes, that goal should be foremost.