Jewish World Review June 14, 2002 /4 Tamuz, 5762

Drs. Michael A. Glueck & Robert J. Cihak

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The FDA, drug companies and life-saving drugs: Who's the fox and who's the hen now?


http://www.NewsAndOpinion.com | The Food and Drug Administration, one of those gray little government agencies that holds enormous power over our lives, is in the news again. The Public Health Security and Bioterrorism Response Act of 2001 HR 3448, just signed by President Bush on Wednesday, June 12, extends the Prescription Drug User Fee Act of 1992. This law allows drug companies to pay higher user fees so the agency can hire more staff to speed up review of new drug applications.

Since FDA reviews can take more than a decade, accelerated review can potentially prevent much suffering and foster innovation, while saving hundreds of millions of dollars. On the other hand, opponents of the bill point out that expediting the FDA review process this way seems a little like allowing the fox to guard the henhouse.

But let's look at who's really guarding the henhouse now. Most people assume that the FDA approval process ensures that a drug is safe and effective - but it's not that simple. For one thing, about half of all drug complications are discovered only after the FDA has approved a drug as safe and effective. Further, a drug that is lifesaving for some people may be downright dangerous for others. And all drugs produce complications in some people under some circumstances.

Under current federal law, drug approval is an FDA monopoly. Yet medically, it's presumptuous to expect that a single "approval" judgment about any drug - safe or unsafe, effective or ineffective - can be true for every single American.

Further, drug approval in this country usually lags years behind other countries. For example, Propranolol, a beta-blocker heart medicine, was approved and in use in Europe more than six years before it was approved in the US. Propranolol now saves about 10,000 American lives every year. Do the math. The FDA's delay cost 60,000 lives during the six-year wait for approval.

Or take an example possibly costing lives today. An experimental and revolutionary new vaccine has been shown to wipe out all cancer cells in most patients afflicted with follicular lymphoma cancer. Despite this apparent breakthrough, the FDA is now involved in the planning of a five-year randomized clinical trial of the vaccine. During these five years, about 282 patients with follicular lymphoma will receive the new vaccine while 20,000 other cancer patients will be expected to die, deprived of the freedom to even consider this new experimental treatment.

We propose a tested alternative that goes beyond current thinking in Congress. It's time to reconsider the presumption that a monopolistic, centralized agency, such as the FDA, is the only way to evaluate new drugs. The countries in the European Union allow new drugs on the market by reciprocity, that is if they're approved by another EU country's equivalent of the FDA. The EU countries also allow approval by the European Agency for the Evaluation of Medicinal Products (EMEA). For drug applications received in 1997, EMEA completed one part of the approval process, drug marketing applications, in an average of 207 days, less than half the time required by the FDA. Competition causes government agencies as well as private companies to perform more efficiently.

Dr. Henry I. Miller, author of To America's Health: A Proposal to Reform the Food and Drug Administration (Hoover Institution Press), proposes several reforms, including creating new nongovernmental "drug certifying bodies" under FDA supervision. These drug certifying bodies would perform some of the tasks in evaluating new drugs and would compete with the European agencies. In Miller's reform, the FDA would become "primarily a certifier of certifiers, rather than a certifier of products."

We also question whether a government monopoly is needed at all. Or, for that matter, the current "cartel" of the FDA, drug companies, and organized medicine. The FDA could function as an advisory service only, leaving final drug decisions to doctors and their patients. The FDA could continue to review the results of drug testing and issue advisory notices but would have no control over a doctor prescribing a new drug for a patient.

In sum, we think that the "governmental-industrial-medical cartel" drug solution makes no sense. It's time to get the fox out of the henhouse entirely and build a safer, more effective drug approval process. The real decisions to approve any drug or device should be made by the patient and physician with advice from reviewers independent of both industry and government. Why? Because that's where the ultimate medical reality is, not in the labs or bureaucracies.

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Michael Arnold Glueck, M.D., of Newport Beach, Calif., writes on medical, legal, disability and mental health reform. Robert J. Cihak, M.D., of Aberdeen, Wash., is president of the Association of American Physicians and Surgeons. Both JWR contributors are Harvard trained diagnostic radiologists who write numerous commentaries and articles for newspapers, newsletters, magazines and journals nationally and internationally. Comment by clicking here.

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