As overseas trials boom, questions about safety arise

In 1990, just 271 clinical trials were conducted overseas. As of 2008, that number has skyrocketed to 6,485 as drugmakers turn to less-developed nations for cheaper trials, fewer regulations and a better pool of patients. Noted investigative reporters Donald Barlett and James Steele question the ethics and safety of this drug testing tend in a Vanity Fair article attacking the entire drug approval process.

One of the major issues raised by the authors is the lack of trial oversight of often far-flung clinical trial locations. In 2008, the FDA inspected only 1.9 percent of U.S. trials; the same year, the agency was able to visit just 45 of the 6,485 overseas trial sites. It's an impossibly huge task for which the agency is underfunded and understaffed. Additionally, companies aren't required to report foreign testing data until they submit an NDA or BLA to the agency. That means if a trial harms patients or is conducted unethically, it will be too late for the FDA to intervene. It also allows drugmakers to quietly drop any trials that may have gone awry, without ever having to report that the trial took place.

The authors also call into question the safety of having CROs conduct clinical trials on drugmakers' behalf. The $20-billion-a-year industry, they feel, is given too much independence when setting up the guidelines and conducting trials. "It used to be that clinical trials were done mostly by academic researchers in universities and teaching hospitals...Today it is mainly independent contractors who recruit potential patients both in the U.S. and--increasingly--overseas. They devise the rules for the clinical trials, conduct the trials themselves, prepare reports on the results, ghostwrite technical articles for medical journals and create promotional campaigns," they note in the Vanity Fair piece.

Barlett and Steele clearly come into the article with an agenda, making sweeping accusations about unethical behavior, conflicts of interest and what they view as an overall corrupt clinical trial process. However, they raise important questions about how well-regulated trials can be when they are tucked into all corners of the world and involve people who have little or no medical resources and no agency ensuring they're being treated ethically. The FDA does what it can with the resources it has to monitor sites. But the overseas clinical trial industry has grown so rapidly that regulators are woefully unprepared to prevent and address potential abuse of the system.

- here's the Vanity Fair article
- read the summary from The New York Times