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From 'Poison Squad' to pharma watchdog, the ever-changing and controversial role of the FDA makes for fascinating history

By John Russell

 Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation 
Philip J. Hilts
Alfred A. Knopf/$26.95
Sept 15, 2003 | Life has never been simple for the Food & Drug Administration. Frequently attacked by business, intermittently stabbed at (front and back) by politicians, rocked by at least one internal scandal, and sometimes criticized by consumers, the FDA embodies America's uneasy relationship with regulation. We don't like it, but sometimes need it. Debate over just how much regulation to tolerate started with the Bill of Rights and hasn't stopped since.

So what is the proper role for the FDA? This question permeates Philip J. Hilts' fascinating retelling of the history of the FDA in Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation. 

From its contentious start with the Pure Food and Drug Act of 1906 to commissioner David Kessler's renovation of the agency in the 1990s, Hilts takes readers behind the scenes of the FDA's great dramas: Harvey Wiley's "Poison Squad"; Teddy Roosevelt's conversion from critic to advocate and back to wary supporter; Frances Kelsey's success in preventing a U.S. thalidomide disaster; the kickback scandal of 1959 in the FDA's antibiotics division; Nixon appointee Ted Malek's "manual" for crushing FDA personnel, and more.

Imagine being one of Wiley's "Poison Squad" in 1903, when as chief chemist for the Department of Agriculture he fed all manner of noxious stuff to a group of volunteers to see what would happen. For five years, chef Wiley doled out doses of "adulterants" and preservatives mixed into the group's meals. Much was learned, but many never fully recovered. (Now, there's a project that could have used a good IRB!) Wiley eventually led the "new" FDA from his position as chief of the bureau of chemistry.

It is both amazing and frightening to realize how far we have come. The 1906 law had few real teeth — it required only that ingredients be accurately labeled for interstate commerce. Its overhaul in 1938 added proof of safety as a requirement for new drugs. Not until 1962 was proof of drug effectiveness mandated (Kefauver-Harris Drug Amendments). This last law required testing 4,000 drugs already on the market — an effort regarded as useless by many at the time. Medical devices weren't covered until 1976. Viewed from the present, it's tempting to think all the flagrant problems have been solved, but Hilts lobbies hard against this notion. For example, he describes in some detail the battle in the early 1980s to suppress data indicating that children who took aspirin when they had flu or chicken pox were far more likely to develop Reye's syndrome. Aspirin manufacturers feared any cautionary labeling would reduce sales needlessly. While the total number of Reye's cases was small, many were fatal, and the increased likelihood of getting the disease was large.

After nearly five years of wrangling over the data, including pressure from U.S. Health and Human Services chief Margaret Heckler not to label, the FDA was finally able to require cautionary labeling on aspirin in 1986. A federal court suit mounted by a private group helped break the logjam.

Select Milestones in U.S. Food and Drug Law (1880-1949) 
Selected milestones from the FDA.

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Clearly, the story of the FDA is complex. The agency is subject to manifold internal and external forces. Begun as the Food, Drug, and Insecticide Administration and shortened to the familiar FDA in 1930, the agency has been shuffled about from the Department of Agriculture (1906) to the Federal Security Agency (1940) to the Department of Health, Education and Welfare (1953) to the Public Health Service (1968) and finally to the Department of Health and Human Services (1988). The courts have given, taken, and shifted its authority several times.

Which brings us back to the question: What is the FDA's correct role? Hilts' answer can be roughly summarized as follows: Left unchecked, businesses — drug- and food-related included — worry more about profits than health. Enough companies have left a trail of damage to public health to warrant close watching and control by an independent agency. The FDA's rightful role is to challenge claims in a vigorous scientific effort to safeguard public health.

He's even included an epilogue, "Greed and Goodness," to illustrate the dark side of human nature. In it, he cites Wharton School (University of Pennsylvania) Professor J. Scott Armstrong's experiments showing students consistently making unethical decisions.

Don't be put off by the obvious slant. This is a wonderful book, and even though Hilts' politics occasionally gets in the way, it raises important questions. Is the FDA's best role to protect health or to facilitate the introduction of new therapeutics? Should the FDA be a vigorous watchdog, as Hilts suggests, or the lapdog many staunch free-marketers prefer? In the end, this may be the wrong question.

The truth is that most pharmaceutical companies recognize that a strong FDA is a bit like the goose that laid the golden egg. The confidence it has created among consumers has led directly to huge markets. People buy and use drugs far more eagerly because they know the FDA has vetted them. Kill the goose and lose the egg. Read this book. * 

For reprints and/or copyright permission, please contact Angela Parsons, 781.972.5467.