In recommending that Accutane - a powerful acne-fighting drug - be kept on the market despite evidence that it causes birth defects when used by pregnant women, an advisory pannel of doctors is taking a gamble.
The drug, first marketed in 1982, has been used by an estimated 1 million persons. The FDA has received reports of 66 birth defects associated with the drug use; some experts say the actual number may be larger.
Studies show that women who take even small doses during pregnancy have a 25 percent chance of having a baby with severe birth defects, including mental retartdation.
So why did the advisory panel of dermatologists recommend last week that Accutane be kept on the market?
First, it is the only drug available to treat severe cystic acne, the kind that can leave serious scars; there is no substitute. Second, the drug is available in 40 other countries and would probably find its way into a U.S. black market if made illegal. Third, because Accutane is a prescription drug, an education program for doctors could reduce problems. There is some controversy over whether doctors are over-prescribing the drug, using it for less serious acne problems. Fourth, new, unmistakable packaging with piuctures would strengthen existing warnings on the label. Fifth, all kinds of drugs can cause problems during pregnancy and are routinely warned against.
Up to a point, those are persuasive arguments. After all, Accutane is not like the infamous thalidomide of the 1960s, the birth-defect causing drug that was meant to be taken by pregnant women. But still, the reasons somehow fail to remove the uneasy feeling associated with Accutane.
The medication already has tough warning labels and there have been previous education efforts aimed at doctors. Neither has ensured that the drug is used properly all the time. That may be an impossible goal. Female patients with a serious acne problem may not pay any attention to the warnings, particularly if they already have been using the medicine before they become pregnant.
The fact that the drug is licensed abroad does not mean it is carelessly prescribed or available for black market sale to Americans. The U.S. was the first to license Accutane and other countries followed. In many cases, restrictions on the drug by other nations are more stringent than in the U.S.
In Britain, for example, women accepting the drug must sign a form in which they agree to avoid pregnancy while using the medication. They must also agree to an immediate abortion if they become pregnant.
Ultimately, two questions must be resolved:
(1) Is a treatment for acne worth the risk of birth defects? They are not even on the same scale in the field of medical treatment, though serious acne admittedly can leave lifelong emotional as well as facial scars. But a birth defect is a much worse lifelong handicap.
(2) How big is the real risk and can it be reduced enough to make any trade-off acceptable?
All things considered, the FDA would be wise to ignore its advisory panel and pull this drug for the market. If there is a mistake to be made, let's make it on the side of too much rather than too little safety.