Chicago Tribune (CT) - MONDAY, October 20, 1997 Edition: NORTH SPORTS FINAL Section: EDITORIAL Page: 12 Word Count: 580

Or are they merely doing what grim circumstance requires, sacrificing ethical punctilio in favor of seeking results that conceivably could save thousands, and hundreds of thousands, of lives in Third World countries?

This riddle has roiled the medical research establishment for more than a month now, ever since the New England Journal of Medicine published articles on the disputed AIDS experiment and an editorial decrying it as a "retreat from ethical principles." It is a measure of the issue's potency and sensitivity that feelings have subsided hardly at all since the journal articles first appeared.

And while there are powerful arguments on both sides, it appears, on balance, that the defenders of the experiment have the better of the case.

The experiment involves administration of the drug AZT to pregnant women in Ivory Coast, the Dominican Republic and Thailand, to determine how small a dose will do what scientists have shown in U.S. experiments that the drug can do: prevent transmission of the AIDS virus, HIV, from mother to child.

The experiment is necessary because AZT is extremely expensive and use of the dosage now standard in the U.S. and other developed countries would be financially prohibitive for most undeveloped nations. If smaller doses can achieve the same prophylactic effect, many more children could be spared the disease--and death.

The ethical problem arises from the fact that, besides giving AZT dosages of varying sizes, the researchers give half of the expectant mothers placebos, dummy pills containing no medication at all. Use of such a control group is standard scientific practice, and is considered necessary for researchers to determine exactly the effect of the substance being tested.

Except, say the critics, the researchers already know, on the basis of their experiments in this country, what the effect of using no AZT is. And so the women receiving placebos are being used by the researchers the same way the poor black men in the infamous Tuskegee syphilis experiment were used.

That is a charge of enormous gravity, and the two U.S. government agencies sponsoring the AIDS experiments, the National Institutes of Health and the Centers for Disease Control and Prevention, have responded with commensurate seriousness.

In a statement issued late last month, they noted that, precisely because of the "difficult ethical issues" involved, the experiment was designed in cooperation with health officials of the countries involved as well as with international agencies like the World Health Organization. And they added:

"The use of a placebo control was ultimately chosen by the countries themselves and by the international medical research community because it is the only approach that can be expected to produce a sufficiently clear response, in a reasonable time period, to the questions that must be answered: Is the intervention safe and effective, and is it feasible in the developing world."

To put it another way, human biochemistry may be the same everywhere, but the conditions in which humans live and with which they must contend--diet, culture, environment and others--are sufficiently different that the use of control groups in the Third World experiments is necessary to obtain valid, reliable information.

That conclusion seems not at all unreasonable. Much as we might wish it otherwise, the use of placebos and control groups in this instance looks like an ethically justified scientific necessity. A regrettable necessity, perhaps, but still a necessity.

Copyright 1997/The Chicago Tribune. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Permissions Desk, The Chicago Tribune, 435 North Michigan Avenue, Chicago, IL 60611.
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