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Researchers Call for Caution on US Drug Trials Abroad

Researchers say major U.S. pharmaceutical companies are increasingly conducting drug trials in developing countries, a pattern that raises questions about government oversight, quality control and the value of the findings.

Researchers at Duke University in North Carolina looked at recruitment records for some of the largest drug trials as of late 2007 conducted for the top U.S.-based companies and found that about one-third of those trials were conducted overseas. Many of the trials took place in developing countries in Eastern Europe and Asia.

The researchers also found that the number of foreign countries used as trial sites rose sharply between 1995 and 2005, while the number of trials conducted in the United States and Western Europe declined.

Duke University's Kevin Schulman led the research review. He says drug trials required for U.S. regulatory approval cost pharmaceutical companies much less when performed overseas. But Dr. Schulman says caution is needed.

"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," he said.

He says some drugs, for example allergy medicines, are tested in areas where they probably will not be sold.

The Pharmaceutical Research and Manufacturers of America said in response to the study that American companies are developing drugs for a worldwide audience.

Dr. Schulman say large clinical trials might benefit local populations, bringing needed health care and wealth to poor communities. But he says these benefits need to be weighed against the risks of testing new drugs.

The U.S. Food and Drug Administration, which oversees drug studies in the United States, has increased the number of its investigators abroad to monitor foreign drug trials by American companies. But the Duke University researchers warn that the FDA is not equipped to adequately monitor the studies.

And Dr. Schulman says there are concerns about whether foreign drug study participants are fully informed of the potential risks involved in pharmaceutical testing before agreeing to participate.

"We don't have a huge ability to go monitor for ethical violations, although there have been documentation in the literature where people haven't been offered informed consent. I think this is the challenge with the work at this point," he said.

Dr. Schulman says he knows of no instance when clinical trial participants have been harmed.

The Duke University researchers are urging more international collaboration and openness among the pharmaceutical industry, academic institutions conducting clinical trials and regulatory bodies in developing nations to ensure the safety of clinical trials.

The study looking at overseas clinical drug trials was published this week in The New England Journal of Medicine.