by J.D. Tuccille
December 2, 1996

Out, Evil Spirit!

So, who performed the exorcism?

I mean, that’s what must have driven David Kessler from the Food and Drug Administration like a vampire from a garlic-infused Sunday School brunch.

Of course, it’s not that David Kessler was ever really a soul-less creature of the night; he just chose to act that way once he was appointed to the immensely over-powerful position of FDA commissioner. The FDA has long suffered from that international bureaucratic disease known as “jurisdiction creep,” finding new and interesting areas of human life into which to introduce its dubious protective powers. Under Kessler, this process seemed to accelerate.

Notoriously, Kessler’s FDA decided that vitamin supplements were a threat to the nation’s health, and that natural foods stores should be treated with roughly the same consideration as the Iraqi army along the Kuwait border. For the great crime of claiming healthful benefits from the consumption of vitamins, minerals, herbs, and other substances that are generally assumed to … well … have healthful benefits, many dietary supplement vendors were visited by the FDA with the same techniques and display of force to be expected from a raid against a crack den. Unless Kessler truly believed that ex-hippy sellers of herbal remedies were suddenly about to dredge up a hitherto unnoticed violent streak, the armed raids were intended to have two effects:

And there’s little dispute that people died because of the FDA’s crusade against medical device manufacturers. Minor paperwork violations of annoying bureaucratic busywork rules resulted in a ban on a lifesaving ventilator for infants and a leading brand of defibrillators — the electric-shock paddles used to restart the ticker after heart attacks. Hospitals were actually told not to use the offending devices, even though there were no effective alternatives at hand.

Also falling in the kill-’em-with-regulations category is the ban on telling consumers that aspirin can reduce the risk of keeling over from a heart attack. In fact, manufacturers of many medications are forbidden from revealing even widely recognized benefits — and the FDA doesn’t quickly get around to approving new uses for old drugs.

(There seems to be a running trend here of “Better a dirt nap than to relax our rules.”)

Businesses and doctors who’ve found themselves on the receiving end of the FDA’s wrath complain that agency pencil-pushers are vindictive: Stories abound of leaked information, retaliatory raids, lost paperwork and delayed approvals in retaliation for even the smallest sign of resistance to the FDA’s tender ministrations. This has the natural tendency of spurring participants in the regulated medical injury to simply submit to rules, no matter how arbitrary, in order to avoid future difficulties.

Even in its core function of screening and approving new drugs the FDA fell down on the job. The time required to guide new medications through the byzantine corridors of the FDA approval process more than doubled on Kessler's watch, from 6.5 years to 14.8 years — and that’s not to mention the sheer monetary cost of abiding by the rules.

And then there’s Kessler’s self-serving decision to salvage his agency’s (and his own) reputation by joining the anti-tobacco witchhunt — an effort that required the agency to assert jurisdiction over products that had never before fallen under its purview. While Kessler was hardly the first government thug to threaten the civil liberties of tobacco users and sellers, he was one of the smarmiest and most dangerous because of the sheer, unmoderated power available to the FDA (hmmm, there’s another column in here about the tendency of elected officials to assign vast powers to unaccountable bureaucrats.)

So I’ll repeat again my pleasure in seeing David Kessler well on his way back to the private sector, where coercing your neighbor is grounds for legal action, not submission.

But after all that Kessler has done, an exorcism isn’t enough — we may need a stake through his heart.

Ah well, and so much for the power of argument. So back you go to Full Automatic or to my home page.

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Copyright (c) 1996 Jerome D. (Il Tooch) Tuccille. All rights reserved. Reproduction in whole or in part in any form or medium without express written permission of Il Tooch is prohibited. Mess with me and I’ll use your polished skull as a beer mug.