Study Questions Ethics, Efficacy of Clinical Trials Conducted OverseasFeb 20, 2009 | Parker Waichman LLP
A study has concluded that clinical drug trials, many of which are taking place outside of the United States, beg questions regarding efficacy and ethics. HealthDay News reported that senior study author, Dr. Kevin A. Schulman, noted that the growing trend of conducting such trials on nonU.S. patients might present questionable situations.
"At the end of the day," said Schulman, "would [the potential drug] work the same way here? We may not know the answer to that question." Schulman is a professor of medicine and business administration at Duke University, in Durham, North Carolina, reported HealthDay News. Dr. Robert M. Califf, also a Duke University medical professor, co-authored the research, which appears in the February 19 issue of the New England Journal of Medicine. Califf is rumored to be one of President Barack Obama's candidates to head the U.S. Food and Drug Administration (FDA), said HealthDay; the FDA oversees U.S. clinical trials.
The researchers looked at a U.S. government clinical trials registry as well as at 300 published reports in major medical journals and found one-third—157 of 509—of all Phase 3 trials, considered the largest, most significant phase in a drug’s development, and which were conducted by major U.S. pharmaceutical companies, took place offshore, said HealthDay. Also, half—13,521 of 24,206—of all study locations were overseas with most in developing areas in Eastern Europe and Asia, said HealthDay. And, FDA-regulated investigators who conduct such overseas trials increased 15 percent annually while U.S.-based investigators declined 5.5 percent.
The researchers found that finances, regulatory issues, and timing are forcing trials to be conducted offshore, such as in India where a trial at a top-tier center would cost one-tenth for the same testing at second-tier U.S. location, explained HealthDay. "One reason the industry is going abroad is the fact that there are complicated regulations [in the U.S.], discouraging pharmaceutical companies, although the main driving force is cost," said Adil Shamoo, a biochemistry and bioethics professor at the University of Maryland at Baltimore and editor-in-chief of Accountability in Research, said HealthDay.
Part of the problem, explains Schulman, is that when trials are conducted outside the U.S. for U.S. patients, it becomes unclear what is occurring not only with the developing drugs, but to the participants. "Are their rights being protected? Are they being given unfair financial inducements to participate? That's very hard to govern and regulate and even to understand," he told HealthDay. "The public and potential volunteers in the U.S. are more aware of their rights in the U.S. than in populations elsewhere," added Shamoo. "If we have a hard time reporting adverse events in this country, can you imagine how that would be in poor countries?"
"This is outsourcing not only of jobs but of the way we test drugs to make sure they are safe and effective," said Charles Cairns, M.D., chairman of emergency medicine at UNC and a study co-author of the study, quoted Medical News Today. "Across the globe there are different standards and no uniform approach to conducting clinical trials."
Medical News Today pointed out that many trials conducted overseas are for conditions that are not priorities in those areas, for example, allergies and overactive bladder, while tuberculosis and malaria remain huge problems. Also, how a drug metabolizes in the body is often dependent on the genes, culture, and social influences of that body. Asians, for instance, metabolize drugs like nitroglycerin differently than nonAsians. "It is conceivable that use of the same drug in both populations would produce markedly different results," Seth Glickman, M.D., the study's lead author and an assistant professor of emergency medicine at the University of North Carolina at Chapel Hill School of Medicine, told Medical News Today.
"We don't want there to be a lower ethical standard; we don't want to put people at risk around the world; we don't want people to be exploited to participate in clinical research. And clearly, we need the answers to these questions to be appropriate to the markets where these products are going to be available," said Shulman, according to Voices of America.