Wednesday, October 1, 2008
Q: Who is conducting human drug experiments in the developing world?
A: Major drug companies, small biotech firms, universities and the U.S. government.
Why do drug companies go to developing countries to do experiments?
Drug companies can find large numbers of sick people on whom to test unproven medicines. Experiments can be done cheaper and faster, and with less red tape. People in developing countries sign up more readily because they need access to health care. Altogether, that means less promising drugs can be abandoned and profitable ones pursued sooner.
Does that violate any U.S. law or regulation?
No. The authority of U.S. regulators stops at the border. Regulators may, however, question the test results if they are submitted as evidence a drug is safe and effective enough to market to Americans. By that time, however, the experiment may have been concluded for years and the test subjects unavailable for interviews.
How many human experiments do U.S. companies do in the developing world?
Many drug companies refuse to say. While the percentage of experiments done in the developing world remains small compared to that in the U.S. and Europe, available statistics suggest that the number is increasing at a much faster rate.
How reliable are the results brought back to the United States?
U.S. regulators say inspections in developing countries uncover more problems with data integrity and informed consent than inspections in the United States.