Drug antics.

• Author: Goozner, Merrill

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...