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Every new scientific gain in AIDS seems to create more ethical dilemmas. The latest in this constant struggle to release drugs faster than research can introduce them to the market involves several studies in developing countries funded by the National Institutes of Health and the Centers for Disease Control and Prevention. These large clinical trials involve 12,211 women in seven countries and test the effectiveness of several treatments of AZT in preventing transmission of HIV from a pregnant mother to her fetus.
Although these studies have been conducted over the past three years, the ethical questions have only now come to the forefront-just as some researchers publish their results. Last Thursday an editorial in the New England Journal of Medicine by executive editor Marcia Angell harshly condemned some of these trials for including a placebo group. Angell condemned the use of a placebo group because those women given the placebo were deliberately denied treatment for the sake of an experiment, even though the treatment may have helped them.
While Angell's moral outrage is not unique, her reasoning is. Angell loses sight of the issue and compares these AZT trials to the Tuskegee Study of Untreated Syphilis, when poor African-American men were told that they were receiving penicillin treatment, a known cure, but were in reality given a placebo. In the studies of today, there is no such cover-up. The women in the study know they may be receiving placebo or AZT-and they had a voice in designing the experiments and worked with international health officials.
Although some of Angell's concerns are understandable-after all, the Tuskegee experiments were sanctioned-they appear ridiculous when applied to these particular clinical trials. She misleads readers as to the reasons and intentions of these studies. "Research in the Third World looks relatively attractive as it becomes better funded and regulations at home become more restrictive," she writes. She points out a legitimate fear: as guidelines in the United States become more restrictive, more risky research will be carried out in the Third World. But she neglects to mention that the reason these trials are conducted in the developing world is because their goal is to find the most effective treatment that could be used in the developing world. Rather than risking lives by hastily approving new drug therapies, researchers are erring on the side of caution and studying the full effect of treatments.
Even in the United States, where Angell believes this research would be completely unacceptable, there is a strong argument to be advanced for using willing and knowledgeable people in scientific experiments. Across the country, many poor sufferers from HIV have been kicked off treatment programs that can cost the state $12,000 a year per person. This year, Missouri evicted many sufferers from the state program. After public outcry, the program took back 417 patients, but not everyone it had laid off. Thirty-five state-administered AIDS programs across the country have taken emergency moves, cutting their treatment programs in response to financial pressure. People are already not getting access to the drugs they need. If a study could provide a treatment that is affordable and efficient, and the patients understand the risks involved, surely the study could provide a good immediate service to the community while benefiting long-term research about what causes AIDS and what can be done to slow its progression.
With the concern over the spread of AIDS and the pressure to find a treatment, clinical drug trials have changed drastically. In 1989 when drug treatments for HIV were being developed, trials shifted their primary focus from learning as much about toxicity and efficacy by including placebo groups to also trying to give drug treatment to as many participants as possible. The Department of Health and Human Services started offering dideoxynosine as a treatment after it had been used in less than 100 patients and allowed it to be combined with other drugs, even though that increased the concerns about toxicity in these drugs. After use as a treatment, it was pulled because it was less effective than AZT and also did not work as a combined therapy. This information could have been known before widespread distribution as a therapy; in the meantime, patients could have used previously released treatments or waited, which may have been better than ingesting large amounts of toxic products.
After all the hoopla over these trials, it may be that AZT is not the cure-all Angell suggests. Recent studies show that even though HIV may be decreased in the blood, where it is measured as an indication of efficacy of treatment, it may still be harbored in higher concentrations in lymph nodes, where it is equally if not more dangerous to the body's immune system. Already, drug-resistant strains have appeared. A recent study from the National Cancer Institute even shows that AZT causes cancer in the offspring of pregnant mice treated with AZT.
In 1989, then director of the National Institutes of Allergy and Infectious Diseases Anthony S. Fauci explained that the primary focus of a clinical trial should not be shifted away from the basic requirements of cautious scientific exploration-in which placebo is a given. "[The primary focus is] not to deliver therapy. It's to answer a scientific question so that the drug can be available for everybody once you established safety and efficacy."
Three years ago when the trials were being designed, all these questions were addressed and the participating countries and researchers agreed with Fauci: including a placebo group was best. Officials from Uganda have called the recent attacks on the studies ethical imperialism, arguing that their need for a treatment they can use as well as their level of comfort with the study should be the guide for these studies, not the comfort of U.S. officials and editors. Ignoring the political and economic realities of those one claims to help hurts them most in the end.
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