The Hundred Years' War at the FDA

By John Carey PROTECTING AMERICA'S HEALTH

The FDA, Business, and

One Hundred Years of Regulation

By Philip J. Hilts

Knopf -- 394pp -- $26.95

When new drugs to treat life-threatening heart rhythms came on the market in the 1980s, the medical community made a logical leap. If the medicine worked in serious cases, doctors reasoned, then it must also work in cases of mild irregular rhythms, which are far more common. The drugs quickly became the standard of care for these milder cases -- even though they had never been tested for those conditions.

Scientists finally performed a rigorous clinical trial later that decade, despite the protests of physicians. Doctors argued that denying the drugs to some patients, by giving them placebos, would be unethical and immoral. However, the results showed that, far from saving lives, the treatment was killing thousands of people every year. It was "arguably the worst drug disaster in American history," writes veteran New York Times science and health reporter Philip J. Hilts in his often fascinating new history of the Food & Drug Administration, Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation. The lesson: to look after the public and advance medicine, there's no substitute for scientific testing. And to get the proper tests done requires a strong regulatory agency.

That may seem like a no-brainer. But as Hilts documents, Washington only gradually instituted the food and drug safeguards we now take for granted -- and it did so only after deaths and other tragedies forced its hand. Moreover, industry executives and conservative politicians screamed in protest every step of the way and tried regularly to strip the agency of its hard-won powers. Even now, the FDA is largely forced to sit idly by while dietary-supplement makers sell dubious or potentially dangerous nostrums, such as the herb ephedra, because the agency lacks the authority to regulate the industry. Hilts tells the sad tale of Jennifer Bilger, who, in the mid-1990s, lost her unborn baby after drinking tea made from pennyroyal that she got from her Boston food co-op. Even ancient Greeks knew the herb induced abortions, so "it is difficult to understand why potent drugs such as pennyroyal...should be permitted to be sold without even the hint of a warning to consumers," Hilts writes.

But it was once far worse. At the end of the 19th century, Americans were regularly being poisoned by food and what passed for drugs. "The corruption in the food and drug trade was unlike anything seen at any time in history," Hilts observes. Chemicals were poured on food to make faded vegetables appear green and to cover the evidence of rot. Brown sugar was cut with ground-up lice (which looked just like sugar), and flour with chalk or plaster of paris. Medicines contained everything from arsenic to cocaine, with no hint of what the ingredients were. When Harvey Washington Wiley, an Agriculture Dept. chemist and a pivotal figure in the FDA's creation, fed commonly used preservatives and other chemicals to volunteers (and himself) at fairly low doses, everyone got violently ill.

Pushed by Wiley and other reformers, in the early 1900s the House of Representatives passed bills to make food and drugs a little safer. But the bills were killed by Republican Senate leaders, who argued -- in a foreshadowing of a century of right-wing attacks on regulation -- that government had no business meddling in business. Not until journalists exposed how infants were being killed by cocaine-containing "soothing syrups" -- and after Upton Sinclair vividly described sausages made from rotting, rat-feces-covered meat in his novel The Jungle -- did Washington act. In 1906, Congress created the agency that would become the Food & Drug Administration. Its regulatory and enforcement powers were limited. Still, this was a fundamental change in policy, Hilts argues, "an assertion that it was the job of the government to protect citizens from some kinds of commerce rather than just to protect commerce."

Thus began the agency's tumultuous history, marked by a constant struggle between the foes and advocates of government oversight. It took 107 deaths from a liquid antibiotic preparation using highly toxic diethylene glycol (a common ingredient in today's antifreeze) to get Congress to pass a landmark 1938 law. At last, before a product could be sold, a company would have to submit data proving that it was safe. Similarly, the thalidomide tragedy of the early 1960s resurrected an attempt by Senator Estes Kefauver (D-Tenn.) to add more consumer protections. After terrible birth defects became known, Kefauver and the Kennedy Administration were able to push through the then-startling idea -- bitterly opposed by the American Medical Assn. as well as conservatives -- that drugs should be tested to see if they actually work before they can be sold.

In addition to these events, Hilts chronicles the tension at the agency as it struggled to find a balance between tougher and looser rules. Indeed, the FDA is often simultaneously accused of moving too quickly and too slowly. In early July, for instance, it won both plaudits and criticism from consumer groups for requiring new data about fat on food labels -- at the same time that it allowed more health claims by food producers. I wish Hilts had more explicitly analyzed how and why the pendulum has swung between more and less FDA regulation. But his story is compelling, and it comes with a powerful message: that Americans are hugely in debt to the reformers who gave the agency its powers -- and to the usually unappreciated bureaucrats toiling away in the trenches. Senior Correspondent Carey covers the FDA from Washington.