By Ingrid Burger
Arizona Daily Wildcat
November 17, 1997

AIDS researchers crossed borders, leaving ethics behind

Arizona Daily Wildcat Ingrid Burger

Taken any medications lately? Tylenol, NyQuil, Vivarin? How about zidovudine? Probably not.

This drug is part of a new treatment designed to prevent the transmission of HIV from pregnant mothers to their babies. In the United States, it has reduced the incidence of HIV infection in newborns by two-thirds. Cool.

We all know that AIDS is a growing, worldwide epidemic. Fueling the fire are more than 1,000 babies born each day with HIV in developing countries. So, Western researchers are looking for inexpensive ways to extend zidovudine's use to those outside the U.S. Sounds like a noble goal. But according to some scientists and ethicists, the research intended to save lives in areas of Africa and Asia has actually done more harm than good.

The idea of Third World governments paying for a full zidovudine treatment for each pregnant woman with HIV is unrealistic. So is the idea of the U.S. footing the bill indefinitely. The most sensible solution is to find a shorter zidovudine treatment which is as effective as possible at a fraction of the cost. Finding such a treatment involves clinical trials, which were initiated by the National Institutes of Health (NIH) and the Center for Disease Control and Prevention (CDCP) with patients in Tanzania, Ethiopia, Kenya, Thailand and the Dominican Republic.

Here's where the controversy comes in. There are two styles of clinical trials. The "placebo-controlled" style involves giving one group of patients the shorter zidovudine treatment, while giving the other group dummy pills. The "equivalency" style involves giving some patients the shorter zidovudine treatment, while administering the full zidovudine treatment (the one used in the U.S.) to others. Put simply, the placebo-controlled trials will reveal whether the shorter treatment is better than no treatment at all; the equivalency studies will show how much the full treatment can be reduced and still be effective. Placebo-controlled trials are generally cheaper and give faster results.

At first, I couldn't really see a big ethical difference between these two trial types. Still, many medical researchers screamed bloody murder when they heard that the NIH and CDCP were allowing multiple placebo-controlled tests to continue. Here's why.

Third World countries are often places of desperately ill people and loose government regulation. It's tempting for rich Western science to waltz in and perform medical trials (which wouldn't be allowed in the U.S.) on foreigners without a lot of ethical restrictions or accountability. In 1993, the World Health Organization (WHO) set strict guidelines for research in the Third World. They require that human subjects receive treatment at least equivalent to that in the country sponsoring the research.

In the United States, placebo trials may not be used when there is a known treatment for a disease. Zidovudine is a known treatment for a disease. Therefore, according to the international WHO standards, only the equivalency studies are ethical. Up until last week when they were finally discontinued, a majority of trials being performed were placebo-controlled and violated the WHO restrictions. Uncool.

The placebo-controlled experiments would never have been allowed in the United States. The zidovudine trials broke an international ethical agreement from the beginning and should never have been initiated.

Unfortunately, this isn't the first time the U.S. has performed inhumane clinical research. Some scientists are likening the zidovudine placebo trials to the notorious Tuskeegee experiments in the United States a few decades back. These experiments involved studying the development of syphilis in poor African American men in Tuskeegee, Ala. Before effective treatment for syphilis was known, the men were divided into an experimental treatment group and a placebo group. A few years into these clinical trials, penicillin was discovered as an effective drug against syphilis. But the men of the placebo group were kept in the dark. Researches stood by with the life-saving cure in their hands and observed dozens die a slow and painful death. Their excuse for such gross behavior was that the men probably wouldn't have been treated anyway; the researchers were simply observing what would have happened if there were no study and no penicillin. The Tuskeegee study only stopped when a reporter discovered what was going on and plastered it across newspapers. That was during the Nixon administration.

You'd think that in 30 years, we'd have learned from our mistakes and morally evolved to the point where this unethical stuff didn't happen anymore. But it just did again. We've made some progress; it took only months to see the fault in the zidovudine trials compared to decades before we stopped the Tuskeegee experiments. Makes you wonder if we'll ever reach some sort of research-ethics nirvana.

The United States can't turn the rest of the world into its own fantasy lab just because it has the money and power to do so. Citizens in all countries need to be protected from potential exploitation in research. The spread of HIV is an urgent problem. The U.S. has the resources to search for cheap, effective treatments. But in our rush for a cure, the health of individuals and the integrity of ethical guidelines must not be compromised.

Babies in the zidovudine placebo group died unnecessarily; they could and should have been treated with either the full or shortened zidovudine treatment. International ethical agreements are useless if researchers don't honor them. Such disregard raises the death count, leaving the United States with blood on its hands.

Ingrid Burger is a senior majoring in molecular and cellular biology.