Smugglers' Blues

Acceptable Risks, by Jonathan Kwitny, New York: Poseidon Press, 466 pages, $24.00

A gray-haired couple in a Winnebago approaches the customs checkpoint outside Tijuana, hoping their illegal drug stash will not be detected. After a nerve-wracking delay, they are waved through by a trusting border guard. The smugglers are the grandparents of an AIDS patient, and the illegal drug they carry is a medicine awaiting approval from the Food and Drug Administration.

This disturbing scene is repeated, with variations, throughout Acceptable Risks. If Jonathan Kwitny's book does nothing else, it humanizes the suffering wrought by misguided FDA regulations. The reader is outraged as patients struggle against not only a deadly disease but the deadly illogic of a federal bureaucracy.

Kwitny, a former investigative reporter for The Wall Street Journal, tells the story of Jim Corti and Martin Delaney, two gay men who have lost loved ones to the disease, and their efforts to make potentially beneficial drugs available to AIDS patients. They are forced to fight the FDA, which adheres to its standard drug-approval protocol, entailing years of tests, while patients measure their life expectancies in months.

This is not Delaney's first encounter with the FDA's overly cautious approach to potential cures for life-threatening illnesses. In 1980 he was diagnosed with chronic hepatitis, and doctors advised him that he probably had just two years to live. Desperate, he enrolled in a Stanford University test involving a combination of two drugs (interferon and ARA-A), which cured his hepatitis. Soon after, the FDA discontinued the study because it deemed the drugs too risky and their benefits too uncertain. Delaney had survived his illness because of a fluke exposure to experimental drugs that other patients would never get the opportunity to try. He remembered the lesson of this experience when his lover was diagnosed with AIDS in 1984.

A cure for AIDS has yet to be discovered. But starting in the mid-'80s, several drugs, such as isoprisonine and ribavirin, showed evidence of slowing the disease's progression. In December 1985 the respected British medical journal The Lancet published a study by six prominent physicians showing that isoprisonine impeded the progress of the AIDS virus in attacking healthy cells. By that time, isoprisonine had been approved for use in 89 countries. Four years later, despite Delaney's best efforts, it was still awaiting FDA approval. There are similar stories about a veritable alphabet soup of drugs that show indications of working against AIDS and AIDS-related illnesses: ddI, ddC, AZT, Compound Q.

Many of the drugs in question are highly toxic or have harmful side effects, and the FDA jealously defends its prerogative to determine whether such risks are acceptable. FDA Commissioner David Kessler dismisses those who wish to decide for themselves. "To argue that people ought to be able to choose their own risks, that government should not intervene, even in the face of inadequate information," he wrote in a letter to The New England Journal of Medicine, "is to impose an unrealistic burden on people when they are most vulnerable to manufacturers' assertions." What of the risks run by patients as the FDA gathers "adequate information"? "A lot of people are going to die before the government does anything," Corti predicts early in the book.

Part of the problem is the FDA's strict requirements for proof of efficacy. The agency discounts laboratory tests and secondary indications of improved health, such as weight gain or a rise in antibody count. "In order to get a drug approved you had to kill the virus in the body—cure AIDS—or at least prove over many years that patients who took your drug outlived patients who didn't," notes Kwitny. The absurdity of requiring such exacting proof for a fatal disease is apparent to everyone but FDA officials. Asks Delaney, "What does the government want to protect us from if we're dying?"

While the suffering caused by the FDA's bureaucratic bumbling is maddening, the courage and strength of Corti and Delaney in opposing this misuse of power is inspiring. Corti focuses on the illegal importation of the medicine, while Delaney spearheads the effort to change FDA policy. Delaney's task is more frustrating, Corti's more dangerous.

Kwitny gives readers firsthand accounts of Corti's smuggling runs to Tijuana, Japan, China, and Germany. His writing is crisp, conveying the tension of the situation without overdramatizing it. The images of smuggling—bribing officials in China and stuffing pills into teapots in Bangkok—unfold against a somber backdrop of dying young men and women desperate for medicine. A network of "buyers' clubs" quickly developed to distribute AIDS medicine outside the law. These distribution networks often operate quite openly, since the FDA seems to have adopted an unofficial policy of looking the other way.

Though enforcement actions are rare, the illegality of the drugs discourages doctors from prescribing them and severely hampers efforts to gather data on their effectiveness. The extralegal nature of the buyers' clubs has spurred a proliferation of quack cures and tainted drugs, and obstructed the flow of information on the risks and benefits of various treatments. Corti and Delaney have worked with sympathetic doctors to gather and disseminate information that could persuade the FDA to approve drugs that have shown merit.

How did the FDA get this power? Though Kwitny does not discuss the agency's early history, it's interesting to note that the FDA's authority has expanded through a series of "crises." Established in 1906 amid the furor caused by The Jungle, Upton Sinclair's sensational exposé of the meat-packing industry, the FDA was initially charged with the inspection of food and the labeling of patent medicines. The first major expansion of FDA authority came in 1938, a year after an elixir form of sulfanilamide killed 107 patients. The Food, Drug and Cosmetic Act of 1938 required that all new drugs be reviewed for safety, with approval or rejection required within 180 days.

Kwitny does discuss the thalidomide tragedy of the early 1960s, which prompted the most dramatic growth in the FDA's powers. Given to mothers to relieve nausea during pregnancy, thalidomide caused serious birth defects. The dramatic nature of this sad episode provided strong public sentiment to do something. The 1962 Kefauver Amendments eliminated the 180-day time limit for approval and added a proof-of-efficacy requirement—this in spite of the fact that the problem with thalidomide had been safety, not efficacy, and the drug had never been approved for use in the United States.

The FDA's broadened mandate radically altered the American pharmaceutical industry. The number of new drugs introduced fell by more than half. The average cost of getting a drug approved skyrocketed to $250 million. The typical time needed for approval increased to eight to ten years. The cost of drugs rose sharply, as small drug companies virtually disappeared from the market. Meanwhile, the FDA's budget and power grew.

Late in the book, Delaney describes to the President's Council on Competitiveness the skewed incentives that FDA regulators face: "The only time the FDA staff gets recognition is when it's punitive—when a bad drug is suspected of getting through….These guys are always browbeaten by Congress when a drug causes harm, but they're never criticized when new drugs move too slowly. The system rewards caution and discourages innovation."

Unfortunately, Delaney misses the deeper lesson of his ordeal—that excessive caution is inherent in government oversight. He just wants the FDA to do its job right. He calls for an accelerated approval process that would consider the nature of the illness a drug is intended to treat.

In an afterword, Kwitny presents his own views on the FDA. Although he calls for a "strong, unbiased agency, empowered to compel disclosure" about the risks of available remedies, he wants to strip the FDA of its crucial power to prevent drugs from reaching the market. He asks, "[Do] we have to tolerate a government agency that tells us what we can and cannot take to save our own lives?" Sadly, we have granted the federal government the authority to do just that.

John O'Leary is an associate policy analyst with the Reason Foundation.