In 1997, Public Citizen's Health Research Group brought widespread international attention to unethical clinical trials. The trials were testing new methods for preventing the spread of HIV infection from pregnant women to their babies before or after giving birth in developing countries in Africa, Asia and the Caribbean. In each of these trials, most of which were funded by the U.S. government, some women were randomly assigned to receive placebos or other treatments known to be ineffective, rather than a drug proven effective in preventing the spread of HIV infection from mother to baby.
Unfortunately, nearly 20 years later, similarly unethical trials continue to be conducted. One recent such trial in India, reported in The Lancet in June, evaluated an experimental vaccine for preventing a very common, potentially life-threatening viral infection called rotavirus. Two rotavirus vaccines have been available for the past decade: RotaTeq, marketed by Merck & Co., and Rotarix, marketed by GlaxoSmithKline. Large clinical trials of both vaccines demonstrated that they were highly effective in preventing rotavirus-induced gastroenteritis -- including the most severe cases -- and the need for hospitalization. Despite the availability of these vaccines, more than 2,000 children in the India trial received placebo injections of salt water rather than one of the available effective vaccines.
Prior to the introduction of effective rotavirus vaccines, nearly every child in the world developed a rotavirus infection by ages 3 to 5, and 2 million children were hospitalized annually. In 2013, the World Health Organization (WHO) issued a report estimating that in 2008, approximately 450,000 children died from rotavirus infection globally, accounting for about 5 percent of all child deaths. Not surprisingly, 90 percent of these deaths occurred in countries in Africa and Asia.
The clinical trial in India -- funded by multiple private and government sources, including the Bill & Melinda Gates Foundation and the National Institutes of Health -- enrolled approximately 6,800 infants between March 11, 2011, and Nov. 5, 2012, in rural and urban areas of the country. The experimental vaccine was given by injection in three doses at 6 to 7 weeks, 10 weeks or older, and 14 weeks or older. Two thirds of the infants received the vaccine, and one third received saltwater placebo injections. The trial results showed that, as with the two available oral rotavirus vaccines, the new vaccine was effective in preventing severe rotavirus-induced gastroenteritis and hospitalizations. Given the availability of two highly effective rotavirus vaccines at the time the India study was initiated, the failure to provide infants with one of these two vaccines instead of a placebo violated international ethical standards for conducting human research.
A rotavirus vaccine study in which infants received a placebo would never have been permitted in the U.S., and it should not have been permitted in India. The continued conduct of such trials reflects a persistent, troubling disregard for international ethical principles for human subjects research, particularly research involving disadvantaged subjects in the developing world. Allowing such research creates a double standard that allows research using unacceptable designs to proceed in developing countries. In 1997, Public Citizen's Drs. Sidney Wolfe and Peter Lurie argued for the need to implement a single international standard of ethical research. As Wolfe and Lurie predicted, the number of clinical studies taking place in developing countries has increased dramatically. Unfortunately, the troubling rotavirus vaccine trial in India indicates that we still have a long way to go to achieve implementation of a single international ethical standard for human subjects research.
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