The Public Citizen's Health Research Group (PCHRG) issued a statement on April 22, 1997 that made worldwide headlines. PCHRG charged that 1000 children in several developing countries would die unnecessarily as a result of clinical trials on maternal-fetal transmission of HIV because such placebo-controlled trials are unethical. Since the trials are funded by US and global agencies, PCHRG director Dr. Sidney Wolfe labeled the trials "Tuskegee, part two," a reference to a notorious US government study that denied effective treatment to a group of African-Americans with syphilis because of the trial design.
It is risky to compare trials involving men with trials involving women. In designing protocols for maternal-fetal HIV transmission studies, society often considers mothers as laboratory animals rather than human beings. In the trials attacked by the PCHRG women are given ZDV monotherapy, which by any current clinical guidelines is substandard treatment. After the trial concludes, the substandard treatment generally stops and the mother's health further deteriorates. Scientists measure their success in such trials by preventing vertical HIV transmission to children who subsequently become orphans because their mothers are a disposable commodity. There are also feminocentric questions being raised about the possible long-term risks of ZDV in maternal-fetal studies.
One might also question whether the data obtained from trials in developing countries will benefit the population of each country in which the trials are conducted. Finally, some might argue that, while the ethical values that undergird clinical trials are immutable, the application of such values often involves situational ethics.
We must also realize that clinical trials are not only scientific inquiries but are often the only option for healthcare for the poor, not only in developing countries, but also here in the US. Because clinical trials are also a form of healthcare, the situational ethics of healthcare (which are often different from the situational ethics of clinical trials) must also be addressed in the questions and conclusions. For example, if a clinical trial is the only option for access to effective treatment for an individual, what are the obligations of the trial's sponsors to offer or continue such care after the trial ends when other options for healthcare do not exist? Also, what are the human rights issues applicable to the situation? Human rights are sometimes confused with ethical values, and these are often separate considerations.
It is commendable that the PCHRG serves as an advocate to protect the lives of the 1000 children in question. But where are the advocates for these children's mothers? There are millions of children dying unnecessarily each year from a wide spectrum of infectious diseases for which we have effective and inexpensive vaccines and treatments. Where are the advocates for these children? It's problematic to direct our efforts to treating a symptom of, rather than the real causes of global infant mortality. In the US this year, we celebrate May 11 as Mother's Day. Considering how many mothers are dying as a result of these maternal-fetal HIV transmission trials, why don't we just celebrate May 11 as Matricide Day?