Western drug companies are coming under increased scrutiny in the wake of overseas drug tests -- mostly in poor developing countries -- in which test subjects died and allegations of unethical behaviour.
Critics of using people in developing countries as test subjects have long considered the practice exploitive, saying poverty drives people to be guinea pigs for untested medicines. As well, such people are used to test the efficacy of medicines -- such as AIDS drugs in Africa and a hepatitis E vaccine in Nepal -- that they can't afford once they come to market.
The Wall Street Journal reported today that recent deaths have sparked the increased scrutiny.
In November, regulatory authorities in India halted a 350-participant study of a new Wyeth vaccine after a baby died. The Drugs Controller General of India is now investigating whether the infant was screened properly and whether the rules were bent to get babies into the study. A conclusion is expected shortly, according to A.B. Ramteke, deputy drugs controller general for India.
Last year, two elderly patients died after Polish investigators enrolled them in a study of a bird-flu vaccine being developed by Novartis AG even though they should have been excluded based on age. The deaths and other problems with participants in Poland, one of 10 countries involved in the 3,000-patient study, have led to a delay of at least a year in approval of the vaccine by European authorities, according to Novartis.
"There are standard ways of conducting clinical trials," said Sonal Singh, an assistant professor of medicine at Wake Forest University who studies clinical-trial regulation. "The question is: Are they being adhered to?"
Questions have also been raised about the integrity of developing country drug trials, as local researchers cut corners to save on costs and recruit test subjects who do not meet project standards. One Novartis project in Poland was found to have recruited test subjects in old age homes and homeless shelters.
Testing in developing countries is far cheaper than in western countries, and test subjects easier to recruit. Researchers also report that the people used in the tests are less likely to be taking other medications that might influence results.
The drug companies say they do not treat developing country test subjects any differently.