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The other drug war.


The struggle over the FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 is our latest culture war.

Jennifer Cox could barely breathe. Bronchial asthma bronchial asthma
n.
A condition of the lungs characterized by widespread narrowing of the airways due to spasm of the smooth muscle, edema of the mucosa, and the presence of mucus in the lumen of the bronchi and bronchioles.
 and a seizure disorder Seizure Disorder Definition

A seizure is a sudden disruption of the brain's normal electrical activity accompanied by altered consciousness and/or other neurological and behavioral manifestations.
 had not only driven her home from college but left her so weak she couldn't cross the room. Asthma medicine exacerbated the seizures, and the only drugs approved to treat the seizures themselves had terrible complications: One made her chest and respiratory muscles cramp constantly. Another destroyed her bone marrow. The remaining alternative, a three-drug cocktail, gave her tremors, double vision, and balance problems.

After nine years of fighting the seizures, and nearly a lifetime with asthma, Cox was getting worse and worse. At 20, all she had to look forward to was terrible pain and imminent death.

Which apparently would have been just fine with Dr. David Kessler David Kessler may refer to:
  • David Kessler (actor) (1860-1920), Yiddish theater
  • David Aaron Kessler (born 1951), FDA Commissioner, university medical dean
  • David Kessler, Pennsylvania state representative, elected 2006
 and his good friends at The New York New York, state, United States
New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of
 Times, Public Citizen, the Center for Science in the Public interest, the Women's Health Women's Health Definition

Women's health is the effect of gender on disease and health that encompasses a broad range of biological and psychosocial issues.
 Network, and various other bastions of paternalism paternalism (p·terˑ·n . All rallied this summer to defend the power of the Food and Drug Administration to keep medicine out of the hands of people like Jennifer Cox. In articles, press conferences, and TV appearances, they waged an all-out campaign to protect the agency's ever-expanding authority from congressional curbs. They scornfully dismissed critics as "industry-inspired." A two-page puff piece, concluding that "the FDA has become a prime example of government that works," even made it into the fashion-laden pages of George. Public Citizen's Sidney Wolfe, writing in the Los Angeles Times Los Angeles Times

Morning daily newspaper. Established in 1881, it was purchased and incorporated in 1884 by Harrison Gray Otis (1837–1917) under The Times-Mirror Co. (the hyphen was later dropped from the name).
, declared that when critics "complain of the U.S. lagging behind other countries in terms of new products approvals, they are really talking about arthritis or headache pills, not drugs that would have a more important impact."

Fortunately, Cox had a doctor who refused to accept the FDA's answers - or Wolfe's sense of what's important. Allergist al·ler·gist
n.
A physician specializing in the diagnosis and treatment of allergies.


allergist Immunology A physician, who is often trained in both internal medicine and clinical immunology and who manages Pts with
 Stuart Rusnak took his search for a cure abroad, cruising the World Wide Web. In less than an hour, he discovered a drug that has been used in Europe and Canada for a whopping 10 years but is still officially denied to Americans. By contacting the doctor heading an international study on the drug, Rusnak found a pharmacy in the Bahamas that would take a phone order and ship the medicine overnight. Thanks largely to cantankerous can·tan·ker·ous  
adj.
1. Ill-tempered and quarrelsome; disagreeable: disliked her cantankerous landlord.

2.
 AIDS activists, a regulatory loophole allows Americans to legally import small quantities of otherwise unapproved un·ap·proved  
adj.
Not approved or sanctioned: an unapproved vaccine; an unapproved protest march. 
 drugs. And thanks to the unapproved drug, called Sabril, Cox got her life back.

"I've noticed that I can laugh. And it's all right," she told the Honolulu Advertiser's Mike Gordon For other persons named Mike Gordon, see Mike Gordon (disambiguation).

Mike Gordon (born June 3, 1965 in Sudbury, Massachusetts) is a bass player and vocalist most noted for his work with the rock band Phish.
. "It's a little thing, but simple pleasures can mean a lot. I can go out and sit on the beach. I can eat at a deli. I can go to a movie." Nothing important, Dr. Wolfe. Just life.

I read Cox's story not in a think tank document designed to sway Washington opinion, but in a newspaper I picked up on vacation On Vacation was The Robot Ate Me's third album, released in 2004 by the band's frontman, Ryland Bouchard's label Swim Slowly Records, then reissued in 2005 by 5 Rue Christine. . It was a front-page article, true, yet utterly without political context just a well-told human-interest feature about a local doctor who'd solved a patient's problem using a cool new communications technology Noun 1. communications technology - the activity of designing and constructing and maintaining communication systems
engineering, technology - the practical application of science to commerce or industry
.

The assumptions of the story were radical, however; the kind that upset people like Wolfe and Kessler, that rock the world according to George and The New York Times. Doctor, patient, and reporter all took for granted that Cox and Rusnak had the right to choose what was best for her; that a woman dying at 20 shouldn't have borders and regulations standing between her and a chance to live; that medical information should flow freely; and that practicing good medicine may mean looking in non-obvious places. Doctor, patient, and reporter also figured that if Europeans and Canadians had been using a drug for half Cox's lifetime, those patients and their doctors probably had discovered whether the drug worked, or had dangerous side effects Side effects

Effects of a proposed project on other parts of the firm.
, even without the help of American bureaucrats.

As the Internet grows, we will hear more such stories. Not all will have such happy endings: The easy flow of information in cyberspace can also promote quackery Quackery


barber-surgeon

inferior doctor; formerly a barber performing dentistry and surgery. [Medicine: Misc.]

Dulcamara, Dr.
 and innocent-but-ineffective treatments. But enough doctors will find answers, and enough patients relief, to create a serious challenge to the FDA's monopoly powers. We are in the early stages of another culture war - one of those political clashes driven not by interest-group jockeying, socioeconomic association, or party alignment but by fundamentally different values and world views. Paternalistic pa·ter·nal·ism  
n.
A policy or practice of treating or governing people in a fatherly manner, especially by providing for their needs without giving them rights or responsibilities.
 technocrats are rushing to defend an agency whose powers cannot, over the long run, withstand the free flow of information. In the short run, however, the fighting will be vicious.

In a cover story published in early August, Jeffrey Goldberg Jeffrey Mark Goldberg (born September, 1965) is an American journalist. He is an author and a staff writer for The Atlantic Monthly, having previously worked for The New Yorker.  of The New York Times Magazine strove mightily to portray this new drug war as a struggle between science and barbarism bar·ba·rism  
n.
1. An act, trait, or custom characterized by ignorance or crudity.

2.
a. The use of words, forms, or expressions considered incorrect or unacceptable.

b.
, sophisticates and hicks - or, when really desperate, good government and lying tobacco companies. Interviewing none of the economists who study "drug lag," he caught some Washington types unable to name unapproved drugs that could save lives. And, echoing FDA propaganda, he confused bureaucratic delay - the time it takes the agency to process a completed application, a lag the FDA has reduced - with the real issue, which is the 12 years and $350 million in expenses that U.S. regulations soak up before a new drug makes it to a final application.

By his own admission, Goldberg not only dined at the Kesslers' home but routinely worries about the dangers of eating salad dressing. He is on one side of a cultural chasm - and he senses it. "It doesn't take long," he writes, "in fact, for some of the F.D.A.'s detractors to veer away (Naut.) to let out; to slacken and let run; to pay out; as, to veer away the cable; to veer out a rope s>.
- Totten.

See also: Veer
 from specific, policy-based criticisms to a sort of amorphous, class-based attack rooted in the cultural divide between Eastern, Government-friendly elites and everybody else." Neither class nor education has much to do with the issue, of course. And it's hard to take seriously a plea for policy-based arguments from a man whose research not only avoided all economists but included not so much as a friendly medical school professor. If the reporting begins and ends in Washington, the subject is politics, not policy: government-friendly elites vs. everybody else.

And that is, in fact, the issue. This dispute cannot be resolved by addressing a few "specific, policy-based criticisms." There is no technocratic fix, because there can be no risk-free drug-delivery system. Denying people medicine has risks. So does allowing people medicine. The real question, then, is who decides: a question of political philosophy, not neat-and-tidy policy. And on that question, stories like Cox's will, over time, make an enormous difference. There is a reason abortion-rights activists adopted the phrase "pro-choice," and why school-voucher advocates use similar language. Americans don't like being bossed around. Yet when it comes to drags, even the bureaucracy-loving French have more choices.

The FDA's concentrated power breeds public suspicion - suspicion that won't go away simply by yammering about tobacco. Long before the agency began making noises about regulating cigarettes, even before David Kessler arrived on the scene, the FDA had become a bete noire bête noire  
n.
One that is particularly disliked or that is to be avoided: "Tax shelters had long been the bête noire of reformers" Irwin Ross.
 to many very different sorts of people. Devotees of herbal medicines and natural foods believe it conspires with the big pharmaceutical companies to hurt unpatentable "alternative" remedies and stifle information about vitamins. (I suspect the rage for alternative medicine is itself driven at least in part by the fact that such treatments are available without a prescription; the desire for self-reliance precedes the anti-technology ideology.) Science lovers dislike the way it squeezes out small-scale research on ideas like combinatorial chemistry - ideas that could address such problems as drug-resistant strains of tuberculosis. Medical device makers hate its delays, as do the pharmaceutical companies. And libertarians just don't think the government should tell people what to do with their bodies.

When it comes to medicine, that's in fact a widely shared sentiment - at least among the sick. Yet the same politicians and journalists who supposedly extol ex·tol also ex·toll  
tr.v. ex·tolled also ex·tolled, ex·tol·ling also ex·toll·ing, ex·tols also ex·tolls
To praise highly; exalt. See Synonyms at praise.
 "a woman's right to choose" behave as though regulatory caution obviously justifies forcing people like Jennifer Cox to endure years of unchosen, and unnecessary, physical torture. "Pro-choice," they imagine, doesn't apply to medicines available in Europe - except, of course, RU-486. "Freedom of expression" has nothing to do with publishing information on "off-label" uses of drugs. Those liberal ideals are much too grand for mere "headache pills," vitamins, "me-too" antibiotics, or treatments for diseases nobody famous has heard of.

Such inconsistencies cannot stand forever, especially against an increasingly informed - and rapidly aging - public. This summer's nearly hysterical campaign to defend the FDA suggests they may already be weakening. We can, however, expect counterattacks, attacks unlikely to stay contained within the fringe territory of tobacco: The agency and its allies are already marshalling their forces to overthrow the law protecting dietary supplements. Having largely co-opted the once-radical AIDS community, they are positioned to begin restricting access to foreign drug supplies. Time and technology are on the side of choice. But it's going to be one hell of a fight.
COPYRIGHT 1996 Reason Foundation
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1996, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Article Details
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Title Annotation:FDA's growing powers
Author:Postrel, Virginia I.
Publication:Reason
Article Type:Editorial
Date:Nov 1, 1996
Words:1499
Previous Article:Hill and Billy. (Hillary and Bill Clinton's unethical acts)(Column)
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