US science’s cruelty overseas

By Robert Kuttner, Boston Globe, 27 April 1997, e7

Thanks to the Public Citizen Health Research Group, it recently came to light that US medical researchers are still using Third World populations as human guinea pigs, with ethical standards that are unacceptable in the United States.

The studies, on some 12,000 HIV-positive pregnant women in the Ivory Coast, Uganda, Tanzania, Zimbabwe, and other African countries, are financed by the Centers for Disease Control and the National Institutes of Health.

Since 1994, the standard US treatment to reduce mother-child HIV transmission has been the drug AZT during the final weeks of pregnancy. This reduces by about two-thirds the number of infants who contract HIV from their mothers.

But in the Third World experiments, conducted under the auspices of US researchers, target populations are divided into several groups. Some receive variations on the effective AZT treatment. Others get a dummy placebo. This allows scientists to measure the efficacy of the different treatment strategies against a "control group" that gets no medication.

The Health Research Group does not object to the variations in the treatment, only to the fact that some subjects receive placebos.

According to Dr. Peter Lurie, who amassed the data for the Health Research Group, this unnecessary "double-blind" study will result in about 1,000 more HIV-positive children, virtually all of whom will die gruesome deaths. But the Centers for Disease Control takes the position that this approach is ethically defensible because in the absence of the research, none of the target group would benefit.

Still, the fact remains that this study violates ethical standards that are strictly enforced at home: Treatments known to be effective are not to be denied human subjects for the sake of "research." Nobody contends that these research protocols would have been approved had the subjects been Americans. That’s why they had to be conducted on Africans.

In a letter to Secretary of Health and Human Services Donna Shalala, Dr. Sidney Wolfe, who directs the Health Research Group, suggested that these experiments also violate the 1995 Helsinki Declaration of the World Medical Association, which requires that the best available therapy be given human subjects, including those in control groups, as well as the Nuremberg Code of Research Conduct, which was adopted after World War II in response to practices of Nazi doctors.

Among other provisions, the Nuremberg Code requires that all research should be "so conducted as to avoid all unnecessary physical and mental suffering and injury." Shalala’s office has not yet replied.

The evident double standard for medical research on human subjects raises a much larger question - the proper relation between standards that the US values at home and those we demand in relations between Americans and the rest of the world. This issue becomes more pressing as commerce becomes more globalized.

In general, the US government seeks to impose US standards on the rest of the world where the interests of American property owners are at stake but takes a far more relaxed position where other people’s interests are involved.

For example, in our relations with China, American diplomats are extremely upset that China does not honor US laws regarding intellectual property. If trade negotiations break down, it could well be over Chinese piracy of US patents and copyrights. But China’s treatment of workers who produce for export to the US market, including those employed by subsidiaries or partners of US companies, is not an issue in the trade negotiations, nor is the use of child labor or prison labor, nor is the displacement of US workers because of substandard Chinese labor practices.

By the same token, protecting the patent interests of US pharmaceutical companies was key to the diplomatic breakthrough that set up the World Trade Organization.

The property rights of drug companies are protected overseas, but the products of those same companies are routinely exported for uses not approved in the United States. And they are sometimes tested on human subjects in ways that violate US standards.

So there is really a double double standard at work here. It’s bad enough that there is one standard for US-sponsored research on Americans and another where the subjects are desperately poor Africans. But the broader double standard is the enforcement by the US government of one set of global rules for powerful American corporations, wherever they operate, and far weaker rules for ordinary citizens of the planet, foreign and domestic.