Will the FDA die of AIDS?

Will the FDA Die o AIDS?

FEW FEDERAL agencies have resisted thetrend toward deregulation as stolidly as the Food and Drug Administration (FDA), but then few are subjected to so irrational a set of political pressures. Most drugs with therapeutic value also cause side effects in some users, but the agency comes under more attack if one person dies from the side effects of a drug it has approved than if three people die because it has not yet approved a new drug that might have helped them. So don't just blame the agency for creating a "drug lag"; blame the liberal politicos and Nader groups who attack it when it tries to behave differently.

The arrival of the AIDS crisis is making it impossible for the agency to continue business as usual. With the number of cases doubling yearly and two million Americans already exposed to the virus, the leisurely six-to-eight-year pace of drug approval puts hundreds of thousands of lives at risk. And with thousands of articulate, well-educated patients scanning the medical literature in search of therapeutic advances, the agency cannot hope to keep them in the dark.

Several drugs that the agency is holding up have shown promise against the disease. Isoprinosine is legal in 89 countries for various use, and has been specifically approved by New Zealand for treating AIDS-related complex (ARC), a condition that often leads to AIDS itself. The substance stimulated immune response in more than two-thirds of ARC patients tested in a recent study. Ribavirin is a widely used antiviral that is legal in about thirty countries. Other promising compounds are HPA-23, the drug Rock Hudson flew to Paris to obtain, and the related drug Suramin, which reportedly has fewer side effects.

"With absolutely nothing to lose," reports Washington writer David Lampo, "some AIDS victims aren't willing to wait." They are shuttling to Mexico and smuggling back isoprinosine and ribavirin (both of which are available over the counter there) inside hollow souvenirs. There is also a growing underground network of American doctors who are risking their licenses to get bootlegged supplies for their patients.

The rationales for paternalistic safety regulation have always been weak, but here they are at their weakest:

"Let the experts decide." Isn't the government better equipped than ordinary parents to decide how far apart crib slats should be?--so the argument goes. But FDA control of prescription drugs is mostly a way of second-guessing doctors, not consumers. The brilliant doctor at the front line of AIDS therapy in New York, working with hundreds of actual cases, cannot follow his best judgment; the Washington civil servant, studying two-year-old data and perhaps never having known an actual victim, gets to choose. Even if we want rule by experts, this isn't it.

"Unapproved remedies can harm patients, or at least enrich quacks." Isoprinosine seems to be nontoxic to users, and it is expensive only because of its illegality: A tablet that sells for 12 cents in Mexico can bring $25 on the San Francisco black market. All four of the drugs used to treat ARC are manufactured by established firms, some of which (like Germany's Bayer, which produces Suramin) are among the world's most respected.

"Unproven therapies distract patients from proven ones." There are no legal proven therapies for AIDS. Patients with ARC seem to do better if they get plenty of rest and are under a doctor's supervision, which is a good reason not to force them to fly regularly to Juarez and take charge of their own therapy.

The clock of FDA approval ticks very slowly, but the clock of public patience with the FDA may be about to run out.