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Allow Patients to Take Informed Risks

FDA: It needs more than cosmetic reform; it needs to be cut down to size.

May 28, 1996|ROBERT HIGGS | Robert Higgs is research director of the Independent Institute in Oakland. His 1995 book on the FDA is "Hazardous to Our Health."

The headline read, "Cancer Drugs to Get Quicker OK; FDA Reform Will Put 100 Therapies on Fast Track." The photo showed Bill Clinton reaching out to touch a 6-year-old leukemia patient. The story explained that the Food and Drug Administration would take steps to allow earlier use of new cancer drugs. Said Clinton, "I am happy today to say to those patients and to their families, the waiting is over," because "dozens [of new cancer drugs] will get to the market sooner."

The president did not say, "I beg the forgiveness of all of you whose friends and family members died because my administration, like those before it, allowed the FDA to suppress the use of potentially life-saving medicines and medical devices, often while those same products were being used successfully in other countries."

The highly publicized loosening of FDA restrictions on the use of new cancer drugs in March is not the only change in the agency. Suddenly it has discovered that it has been too slow in approving new products and too overbearing in regulating manufacturers, causing some to flee the country. So, ostensibly to promote the public health, reforms are being made. But appearances and realities differ.

"We will be making initial decisions based on less information," said FDA Commissioner David Kessler, and hence patients using new drugs will bear more risk, but many of them "are willing to take those risks." If Kessler understood the full import of his statement, he would see that it undercuts the rationale of his agency. If patients are willing to take an informed risk, how can anyone justify a bureaucrat's telling them that, under pain of criminal sanctions, they may not do so?

The changes have been made by administrative decree. The FDA's legislative authority remains unchanged. To fend off real reform--that is, amendment of the law that authorizes FDA actions--the bureaucrats have hastened to "reinvent" their bureau. Some of the recent changes have been genuine improvements; some have been more form than substance; some are just empty promises. But all are subject to future reversal unless Congress rewrites the Food, Drug and Cosmetic Act.

Congressional Republicans have spent 16 months holding hearings and negotiating with Democrats and interest groups without passing a single FDA reform bill. Once Clinton is defeated, they promise, reform will come swiftly. But Clinton may win reelection. And even if Bob Dole becomes president, Congress may decide that, given all the apparent improvement the agency has achieved on its own, little is to be gained by taking the trouble to amend the complex statute.

One must appreciate what is at stake. If the FDA is not reined in, thousands of people will die prematurely, and many more will suffer unnecessarily. The FDA's history is a succession of horribly wrong decisions, like its long delay in approving new beta blockers in the 1970s that, according to Dr. Louis Lasagna, dean of biomedical sciences at Tufts University, caused some 119,000 premature deaths of heart-disease sufferers.

From 1992 to 1994, says Dr. Richard Cummins of the University of Washington School of Medicine, the FDA's limitations on Physio Control Corp., the leading manufacturer of external defibrillators, meant that as many as 1,000 victims of cardiac arrest were not restored to life.

Many more examples might be cited. One is the FDA's continuing lethal suppression of advertising that aspirin can help prevent first heart attacks, documented by Dr. Paul Rubin.

Any good that the agency might have done is far outweighed by its devastating mistakes. Continuously proclaiming that we dare not risk "another thalidomide" has propped up the agency far too long. After all, in the rest of the world, where the FDA's deadly overcaution did not apply, there have been no new thalidomides, but many people have been better able to extend their lives and alleviate their suffering through more rapid access to new products.

Americans deserve no less freedom to make their own choices about their own health care. As James O. Page, editor of the Journal of Emergency Medical Services, said, "We will surely live to regret the day we gave the FDA the kind of arbitrary power it is now exercising."

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