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Last Updated

18 Aug 2003

Source: New York Times, June 3, 2002.


In Search of Antiterror Drugs

In an effort to come up with drugs and vaccines to protect people against biological, chemical or nuclear attacks, the Food and Drug Administration adopted new rules last week that will allow it to approve some medicines without requiring clinical trials to determine their efficacy in humans. The agency will rely instead on animal tests and other measures to determine if the substance is likely to be effective.

That could leave the American public in an uncomfortable position. Should a devastating attack occur or be imminent, people could be betting their lives on unproven remedies, with no assurance that they will really work in humans. Even so, the new policy seems the best way to proceed in an age of terrorism. There is simply no ethical way to conduct the clinical trials that are traditionally required to prove a drug's efficacy.

The problem is not that the drugs or vaccines themselves cannot be taken. They can be and will be given to human volunteers in the traditional tests that are designed to demonstrate that a substance is safe for human consumption. Rather, the problem arises at the next step, when the effectiveness of the medicines would have to be tested by exposing human volunteers to lethal agents like smallpox, nerve gas or intense radiation.

In a practical sense, it would be hard to find many volunteers eager to test an experimental vaccine against, say, the Ebola virus, by potentially subjecting themselves to a gruesome death should the vaccine fail. But practicalities aside, the F.D.A. has concluded that it would be unethical and unsafe to conduct such trials. The risks to the volunteer would be very high, and the possible benefit, in the absence of a terrorist attack, would be nonexistent.

The agency will rely instead on animal testing buttressed by whatever supporting data is available. The agency expects that potential drugs and vaccines would be tested in more than one animal species unless there is a single species deemed especially good for predicting human effectiveness.

The agency's carefully drawn rules also require that the pathways by which a drug and a germ operate in the body are understood well enough that reasonable predictions can be made. But none of this is foolproof. As the F.D.A. acknowledges, "There are countless examples of treatments with favorable effects in animals that did not prove effective in humans."

Even consumer advocates who serve as watchdogs over the F.D.A. agree that the new rules make sense. They simply urged that the rules be sparingly applied and not become a loophole to weaken the drug approval process. The F.D.A. swears it will move cautiously and estimates that the new rules might be invoked only once every three years. If that proves the case, the real problem might not be too many approvals, but too few new medicines to cope with terrorist attacks.