What the Environmental Protection Agency has done to American mines and manufacturing, the Food and Drug Administration threatens to do to American medicine. These agencies provide truly effective foreign aid: not handouts to despots, but the export-actually the banishment-of American technology and jobs.

Politicians say over and over again that ``American medicine is the best in the world.'' Is it still true, or is it becoming a mantra for the has-been?

America ascended to the position of leadership in medicine after Germany fell. In the second half of the 19th century, predominance in German medicine was conferred by political appointment. Kings and barons could appoint a ``secret advisor'' (Geheim Rath), whose political power enabled him to attract the lion's share of resources. Additionally, Germany was the birthplace of corporate socialism in medicine. America seems determined to emulate both examples.

The tools of the American physician's trade-drugs and medical devices-are under the control of the FDA. The FDA received authority to regulate medical devices under the Federal Food, Drug, and Cosmetic Act of 1938. At first, its authority was limited to seizing ``adulterated'' or ``misbranded'' devices involved in interstate commerce. Through a process of ``punctuated politics,'' its power expanded whenever there was news of a catastrophe from which Americans needed to be saved (deformed babies, faulty mechanical heart valves, less-than-perfectly reliable defibrillators, etc.)

Under the regime of chief Geheim Rath David Kessler, FDA power has taken a quantum leap. Now, the FDA is the gatekeeper through which all new or old-but-slightly-modified devices must pass before entering the market.

The FDA excels at the primary function of a bureaucracy: to delay, to obstruct, and to amass paper. Meanwhile, patients suffer or die, and companies with products that could help them wait, and wait, and wait, as their strength is sapped and their capital devoured.

Companies are ill advised to fight the bureaucrats. About two years ago, the Health Industry Manufacturers Association discovered the existence of a secret FDA computer ``blacklist,'' known as the ``reference list.'' If a company lands on the blacklist, all work on its applications stops. Companies are not informed when their name is placed on the list and cannot find out how to have it removed (BNA's Health Care Policy Report 9/18/95).

The FDA is a ``full-service'' bureaucracy: ``within broad and often vague statutory limits, it makes the rules; monitors compliance without inconveniences such as search warrants; and, with wide discretion, punishes those it finds guilty. It is promulgator, police, judge, jury, and executioner all rolled into one'' (Robert Higgs, Wrecking Ball: FDA Regulation of Medical Devices, Cato Institute Policy Analysis No. 235, 8/7/95, 1000 Massachusetts Ave, NW, Washington, DC 20001, $4).

Not surprisingly, 84% of companies polled in 1991 reported declining to file a complaint against the FDA for fear of retaliation. Yet according to a survey reported in the March, 1994, issue of Medical Device and Diagnostic Industry, 67% of respondents had experienced a problem with the FDA during the preceding 12 months (``A Blueprint for Reform of the FDA's Center for Devices and Radiological Health,'' presented by the National Medical Device Coalition, Spring, 1995).

One response is to move to the United Kingdom, Japan, Germany, Belgium, or the Netherlands. Capital outflow from the domestic medical technology industry increased threefold, from $321 million to $993 million, in this decade alone (Common Sense, National Policy Forum, Winter 1995). The US share of the global market for medical devices declined from 60% in the early 1980s to 46% in 1994 (Insight 11/6/95).

Another response is to cut back on innovation. An official of Siemens Ultrasound stated that the company ``could easily develop new generations of equipment...with the amount of money we are spending on regulatory activity'' (Diagnostic Imaging, May, 1995).

The FDA's zeal means that women have to undergo unnecessary breast biopsies, and Parkinsonian patients are deprived of a device that controls tremors (Insight 11/6/95). The inventor of a new shoulder implant will have to go to England to get one himself (USA Today 5/10/95).

There is also a cost in lives: scores of premature babies died when the FDA ordered hospitals to stop using specialized new ventilators (ABC News, 20/20, 8/12/94). Uncounted lives were lost when the FDA shut down Physio-Control, the leading producer of defibrillators. Orders for the life-saving product went unfilled while the company spent two years bringing its procedures and paperwork into compliance with an oppressive consent decree. The death toll from impeding better devices adds to the already large toll from drug lag-tens of thousands died from delays in approval of beta blockers and streptokinase (CEI UpDate, Feb. 1995).

An additional, usually forgotten cost is the acceptance of the idea that there is such a thing as a truly ``safe'' drug or device, and that the FDA can protect us from unsafe ones. This myth has hindered the development of an informed and skeptical public (James Ostrowski, ``The Most Lethal Agency,'' Free Market, 12/91).

In the guise of protecting the public against quackery and profiteering, the ``FDA has shifted from regulating medical devices to centrally managing virtually all significant aspects of a highly diversified industry. There is no historical precedent in the US for this degree of control of any economic or technical sector, except in wartime,'' stated Joel Nobel, President of ECRI (5/22/95).

Starting with the regulation of the physician's tools, the FDA has through ``regulatory creep'' effectively become the regulator of the practice of medicine itself. Through censorship of information (under the pretext of controlling ``promotion''), the FDA exercises control over what physicians may learn. The FDA has pursued criminal prosecution of drug company personnel for disseminating information about off-label uses of drugs. The number of casualties cannot be precisely known, but possibly 10,000 Americans died prematurely because the FDA forbade publicizing the finding that an aspirin a day can decrease the risk of heart attacks by half.

Physicians' judgments are also influenced by fear of criminal prosecution. Hospitals were subpoenaed under the False Claims Act 10 years after Medicare paid for devices not FDA-approved for a specific application (AAPS News, August, 1994).

Republican attempts to reform the agency are likely to result in prescription of a placebo. Criticism of the agency by those in the best position to know (i.e. those under its heel) tends to be muted, as in the report of an incognito survey summarized by an adjunct of the University of California at San Diego.

``A cynic might suppose that UC San Diego wasn't eager to endanger its significant financial relationship to the feds by resorting to appropriately harsh words (``Fighting the FDA with Feathers,'' Wall St J 5/26/95).

One modest suggestion for FDA reform: turn the agency into one that provides voluntary certification for drugs and medical devices, supported by user fees. Strip it of all enforcement powers relating to the practice of medicine. Expand the agency's mission to subject other federal agencies to the same standards for safety and efficacy that now apply to manufacturers of pharmaceuticals. This includes agencies that promote condoms as the means to control HIV, departments that prescribe standards for education-and above all, the EPA.

Why not turn Czar Kessler into the king of kings?