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Drug antics.

IN A NATION WHERE MOST people worship business--and where business controls politics--it often takes a tragedy to convince lawmakers to protect the public from predatory corporate practices. It took a Great Depression and revelations about Sam Insull's utility stock holding company schemes before investors got a Securities and Exchange Commission. America's cities choked on smog, and one of its rivers burst into flame, before President Richard Nixon signed the law creating the Environmental Protection Agency.

Nowhere has this connection between horrific events and "regulatory creep"--the deliberately obfuscating phrase favored by conservative deregulators--been more apparent than in the evolution of the nation's food and drug laws. Only after Upton Sinclair's The Jungle alerted average Americans to the human butchery taking place inside meatpacking plants did Congress, in 1906, create an agency to test for food safety. "Every new social relation begets a new type of wrong-doing--of sin, to use an old fashioned word," trust-busting President Theo-dore Roosevelt said as he signed the bill into law. "And many years always elapse before society is able to turn this sin into a crime which can be effectively punished by law."

That original legislation also required drug labeling, but not much else in the way of regulating the pharmaceutical industry. It wasn't until 1938, a year after the nation was traumatized when 100 children died from taking an anti-infective suspended in antifreeze, that the government finally required that new drugs be safe before being put on the market. But the law, which still didn't require companies to submit test data to the FDA--it was up to the agency to prove drug wasn't safe--was grossly inadequate to its task.

Over the next three decades, the drug industry introduced thousands of new medicines. Americans could pop pills to fight infections and pain, relieve high blood pressure and excess stomach acid, curb depression and sleeplessness, control diabetes and a few cancers.

Sen. Estes Kefauver, a latter-day trust-buster from Tennessee, was not overly concerned with drug safety when he set out to investigate the drug industry and its "antibiotic cartel." He wanted to know why drugs cost so much when they cost so little to produce. In wide-ranging hearings in the early 1960s, he exposed virtually every practice of the modern drug industry: its penchant for developing drugs that mimic the actions of those already on the market (so-called "me-too" drugs); its cartel pricing behavior; its overbearing and health-agnostic marketing practices; and its willingness to play the research card as a justification for outrageously high prices. Yet legislation designed to curb the economic power of the drug cartel languished in committee, and no bill would have emerged if it weren't for thalidomide. A subsidiary of the conglomerate that made Vicks cough drops wanted to introduce the mild sedative to the United States. Fortunately, an eagle eyed pharmacologist on the FDA staff named Frances Kelsey halted the drug's distribution after learning that European women had begun delivering babies with frightening birth defects. In response to public fears, President John F. Kennedy pushed through a bill that finally forced drug companies to submit safety data before it began marketing drugs. The drugs also had to work.

The law required companies to demonstrate drug safety and efficacy by conducting well-controlled and properly recorded scientific experiments. Over the next few years, the FDA reviewed thousands of drugs already on the market. Hundreds were withdrawn because they were no more effective than the elixirs sold at a 19th-century circus sideshow.

How the government used science-backed regulation to force the drug industry to modernize and innovate--with the industry fighting it every step of the way--is one of the two major themes running through Philip J. Hilts's lively history of the FDA. A former New York Times reporter who covered the agency, Hilts not only believes in the agency's mission, but by and large thinks it's done a pretty good job over the years. In keeping up with the latest scientific advancements, regulators have even taught the industry how to do its job better, and thus steadily elevated the quality of the food we eat and the drugs we consume. In any academic journal, one finds study after study whose parameters reflect the rules and regulations set at the FDA. "The scientific facts and social understandings needed for progress are not created in industry, or in universities, or in government," Hilts writes near the end of his survey, "but in all of them together."

His second major theme is that you can trust the drug companies about as far as you can throw them. It you want sate pharmaceuticals, you'd better keep a well-staffed, well-trained, and aggressive cop on the beat. A large part of the book is taken up with sordid tales of corporate malfeasance, most often cases where companies deliberately ignored warnings their drugs caused harm to an unacceptable number of patients. The worst cases invariably came to light at times when the industry had succeeded in temporarily curbing the agency's power. One thinks immediately of the drug class of 1997--a year that marked the most recent highpoint in anti-FDA furor in corporate and conservative circles. Five drugs ap-proved that year were subsequently withdrawn from the market for safety reasons.

But most drug safety hazards today are not caused by unsafe drugs. They stem from inappropriate prescribing and from unanticipated drug interactions in people taking multiple prescriptions, problems caused largely by hypermarketing.

In recent years, a new generation of muckrakers has taken on the economic side of the industry, relying largely on critiques formulated by citizen activists and insurance companies upset by skyrocketing prices and the drug industry's willingness to subordinate public health in the name of higher sales and profits. Katharine Greider's The Big Fix is a breezily written survey that takes on every aspect of the modern medicine marketing machine.

Hoping to buy cheaper generics? The drug companies abuse the patent system to delay their introduction. Want to import cheaper drugs? Big Pharma gets the FDA to crack down in the name of safety. Are you buying one of those new and improved medicines coming out of drug industry labs? It's probably no better than the older, coming-off-patent medicine you used to take. Find yourself clamoring for the latest pain pill, even though over-the-counter ibuprofen works just fine? Guess what. Advertising works.

Hoping your doctor will sort out the mess for you? His tan is probably from the drug-company run seminar he just attended in Cancun; oh, and by the way, here's a free sample.

The drug industry's willingness to debase science is perhaps the most disturbing aspect of its growing economic clout. Drug companies increasingly dictate not only the terms of research, but also its dissemination. They determine the shape of clinical trials and who gets to conduct them. They increasingly control what gets published and how doctors learn about drugs. The result is an information marketplace skewed toward sales, not health.

Greider doesn't spend many pages on this information problem. Near the end of the book, she opines that "practicing good sense requires a very sophisticated analysis of the good we're getting for the money we're spending." But who can objectively compare drugs? Who should tell doctors whether the latest drug On the market is truly new and improved?

She provides no answer. Hilts does not even grapple with the question. But his history suggests it will take prudent regulation that relies on objective science to curb the current era of drug industry excess. One can only hope it won't take a tragedy to bring the issue into sharper focus.

MERRILL GOOZNER is a former reporter for the Chicago Tribune and author of The $800 Million Pill, which will be published by the University of California Press in 2004.
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Author:Goozner, Merrill
Publication:Washington Monthly
Date:Jun 1, 2003
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