Is it ethical to conduct medical studies in the developing world that would not be permitted in the United States?
For an answer to that question, one might look to the National Institutes of Health (NIH), which runs programs to train people in developing countries about making ethical medical decisions.
But not everyone agrees that the NIH is teaching the right lessons.
"The U.S. National Institutes of Health is the largest funder of research ethics training in the developing world," said Udo Schuklenk, a German bioethicist and philosophy professor at Queen's University in Canada. "But it is essentially ideological transfer dressed as ethical capacity building."
Critics of the NIH and the Food and Drug Administration (FDA) say that the federal agencies have changed the way they do things to make it easier for the pharmaceutical industry to operate while scaling back human research protections.
The big shift came in 2008 when the FDA made it so that drug companies doing clinical trials abroad no longer had to adhere to ethical standards contained in the Declaration of Helsinki – the long-held international gold standard for medical ethics. Instead, researchers would have to conform to a largely technical document issued by the International Conference on Harmonization, a committee tasked with harmonizing international research methods. The ICH's document (called Good Clinical Practices, or GCP) is more permissive on some critical points of international research, including placebo-controlled studies.
Drug companies like to use placebo-controlled trials for several reasons. One is that it is less expensive. Another is that it is easier to show that a new drug is effective when compared against a placebo as opposed to comparisons with another drug.
The problem, say experts, is that the use of placebos can be unethical. The central question is whether it is ethical to take clinical research to a country where patients do not have access to an existing medication and then deny them that medication for purposes of the study—something that is not allowed in the U.S.
During my reporting, I came across an example of precisely this in an odd clinical trial conducted in the Dominican Republic. This one involved a U.S.-government funded study on "touch therapy" conducted a few years ago on HIV-positive children in the Dominican Republic who were not taking any medication. A University of Miami professor went to the impoverished island to test a theory that touch therapy might boost immune systems in infected children. One group of children was given massage therapy, while the other group was sent to "play therapy" involving play in small groups. The findings, as reported in an alternative medicine journal, were that the massages did cause some increase in immune system activity, a claim disputed by several experts who criticized much about the study, including its protocol.
The study indicates that at no point were the children given anti-retroviral drugs that are provided to patients in the U.S. Elizabeth Woeckner, president of CIRCARE, a group that monitors human research, told me that because the study was funded by the U.S. government (the NIH), it should have been conducted using the same ethical standards the apply in the United States, standards that would not have allowed this study go forward.