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End the FDA's monopoly.


The Food and Drug Administration's (FDA FDA - Food & Drug Administration (USA)
FDA - Failure-Data Analysis
FDA - Fatigue Damage Accumulation
FDA - Fault Detection Accommodation
FDA - Fault Detection and Accommodation
FDA - Fault Detection and Annunciation
FDA - Federal Disaster Area
FDA - Final Delivered Article
FDA - Final Drawing Approval
FDA - Financial Disclosure Agreement
FDA - First Division Association
FDA - Flexor Digitorum Accessorius
FDA - Flight Data Assistant
's) recent bah on dietary supplements containing ephedra
1. Any of various mostly shrubby gymnosperms of the genus Ephedra, some of which (especially E. sinica) are used as a source of ephedrine ephedrine /ephed·rine/ (e-fed´rin) (ef´e-drin) an adrenergic extracted from several species of Ephedra or produced synthetically; used in the form of the hydrochloride, sulfate, or tannate salt as a bronchodilator, antiallergic, central nervous system stimulant, and antihypotensive..
2. A stimulant derived from a plant of this genus.
 shows just how dysfunctional government regulation of drugs and dietary supplements is. Ephedra, according to the FDA, is a naturally occurring substance derived from a Chinese herb. Ephedrine, the main active ingredient of ephedra, has been used for centuries to treat respiratory symptoms and is also used to aid weight loss, enhance sports performance, and increase energy.

Why the ban? The FDA claims that dietary supplements containing ephedra pose "an unreasonable risk" for the consumer. The FDA states in its press release that it reviewed "a seminal report by the RAND Corporation Rand Corporation, research institution in Santa Monica, Calif.; founded 1948 and supported by federal, state, and local governments, as well as by foundations and corporations. Its principal fields of research are national security and public welfare. Research in national security affairs includes studies in planning, procurement, support and operations of military forces, studies of strategic and tactical forces, command and control, logistics management, and." But in the fine print, you read that, of 16,000 adverse events RAND studied, there were two deaths, four heart attacks, nine strokes, one seizure, and tire psychiatric cases. RAND said these events "may indicate a safety problem but do not prove that ephedra caused the adverse event" (emphasis added). Even Naderite Sidney Wolfe, a self-proclaimed consumer advocate, claims only 155 ephedra-related deaths over a decade.

Interestingly, many users of such dietary supplements rushed to stock up on their supplies before the bah begins. They judged, apparently, that the benefits were worth the risks. To the FDA, though, their judgment does not count. And therein lies the problem.

The same problem arises with the FDA's requirement that drug companies test for safety and efficacy before being allowed to sell a drug. This FDA monopoly power on new drugs slows new drug development by years. In December 1988, for example, the FDA approved Misoprostol misoprostol /mi·so·pro·stol/ (mi?so-pros´tol) a synthetic prostaglandin E analogue used to treat gastric irritation resulting from long-term therapy with nonsteroidal antiinflammatory drugs; also used in conjunction with mifepristone (q.v.) for termination of pregnancy., a drug that prevents gastric ulcers caused by aspirin. In some other countries, Misoprostol was available as early as 1985. Using the FDA's own estimates, Sam Kazman, an FDA expert at the Competitive Enterprise Institute, calculated that the FDA-caused delay cost more than 20,000 lives--and that's just for one delayed drug.

The tragedy is that these regulations are unnecessary. The FDA may have expertise on drug safety and efficacy, but on the main issue that matters--our trade-off among various risks, costs, and benefits--the FDA is a rank amateur. No one would advocate that the government plan the same vacation for everyone. Why, then, should the government be able to decide what drugs we ingest?

There is a simple solution: Pare back the FDA's powers to that of an information agency. Require that any drug marketed without FDA approval tout that fact in big letters. And let us make our own trade-offs. Then those who want to avoid all drugs not certified by the FDA can do so; the rest of us can rely on the American Hospital Formulary Service or other private certifiers and thus have wider choices. Those who stuck with FDA certification would be no worse off. Those who tried non-FDA-approved drugs would be, by their standards, better off.
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Copyright 2004, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Title Annotation:ephedra
Author:Henderson, David R.
Publication:Reason
Geographic Code:1USA
Date:Apr 1, 2004
Words:471
Previous Article:Text lit.(Artifact)(text messaging; literature of the future)(Brief Article)
Next Article:Express yourself.(Editor's Note)
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