Globalizing Clinical Research (Page 2)

Government bureaucracy overwhelms clinical research in the United States, scientists complain, but in developing countries "there is tremendous government cooperation," says Kaitin. "The governments of China, India and Taiwan are bending over backward to get these companies to conduct research and manufacture there. They are giving tax breaks, building facilities. In Taiwan, many hospitals have switched overall record-keeping to English, so if Western companies want to do a clinical trial there, they will have no problem."

Conveniently, many of the FDA's ponderous regulations stop at the border. For example, the FDA's requirement that companies prove that their experimental drugs are safe on animals before starting tests on humans doesn't apply for tests conducted outside the United States. And experiments on Americans must undergo painstaking, lengthy reviews by government-regulated "institutional review boards" (IRBs). But "if you go to some countries and say you want the IRB to review this, they say, 'What is an IRB?'" comments Dennis DeRosia, chair of the Association of Clinical Research Professionals. The FDA simply requires that foreign trials conform to the World Medical Association's Declaration of Helsinki, a series of ethical recommendations that critics call rudimentary, nonbinding and ambiguous. Scientists routinely ignore Helsinki directives to publish negative results and make study designs public, and they liken Helsinki-required ethics committees in developing countries to rubber stamps. "No ethical questions are raised at all," one investigator admitted to the National Bioethics Advisory Commission (NBAC).

What results is one set of acceptable risks for patients at home and quite another for patients abroad, a double standard that has left hundreds of preventable deaths in its wake. Most notoriously, in the mid- and late 1990s, the National Institutes of Health and the Centers for Disease Control funded and defended studies in which Western scientists withheld treatment from HIV-infected pregnant women in developing countries, even though they knew antiretroviral drugs would reduce the rate of HIV infection in their infants by two-thirds. Hundreds of infants "needlessly contracted HIV infection" while Western doctors presided over their care, according to an incendiary New England Journal of Medicine paper by Public Citizen's Dr. Peter Lurie and Dr. Sidney Wolfe.

It wasn't that the lifesaving antiretroviral drugs weren't available to the scientists--the manufacturer offered them free to clinical researchers. Rather, the demands of scientific rigor required that some sick patients go untreated, as NIH and CDC officials explained in a later NEJM issue. Only by observing how these untreated patients fared and comparing their outcomes with those of experimental treatments could scientists quickly and decisively determine whether the experimental treatments worked, they wrote. Comparing experimental treatments to antiretroviral therapy--standard in the West but deemed too expensive, risky and difficult to administer in poor countries--could only prove whether new treatments equaled or improved upon antiretroviral therapy. But in some cases, "the really relevant question is whether this quick, cheap, easy thing works. You don't really care if the thing works better," explains international-health ethicist Nancy Kass. "What you care about is, does it work, period." Plus, since none of the study subjects could have afforded antiretroviral drugs at the time, NIH's Dr. Harold Varmus and CDC's Dr. David Satcher argued, "the assignment to a placebo group does not carry a risk beyond that associated with standard practice."

Such justifications, retorted former New England Journal of Medicine editor Marcia Angell, "are reminiscent of those for the Tuskegee study"--a kind of ethical relativism that results in "widespread exploitation of vulnerable Third World populations for research programs that could not be carried out in the sponsoring country."

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