Overseas drug tests probed

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.

Genetic screening for children, for sports or disorders

For $149 (US), a company in Boulder, Colo., will tell you whether you child is best suited for soccer or the high jump.

Atlas Sports Genetics says it can help parents figure out if they have a gifted athlete on their hands -- one that might be able to one day go pro or get an athletic scholarship to a US university. It offers several "products" for sale from its website, each using genetic tests to screen for a child's athletic abilities, with enticing sales pitches.

"Finding any great Olympic champion normally takes years to determine. What if we knew a part of the answer when we were born?"

While parents might like the idea, scientists like Theodore Friedmann of the University of California-San Diego Medical Center’s interdepartmental gene therapy program warned it could be a modern version of snake oi.

“This may or may not be quite that venal, but I would like to see a lot more research done before it is offered to the general public. ... I don’t deny that these genes have a role in athletic success, but it’s not that black and white.”

Atlas president Kevin Reilly, a former weight-lifting coach, said his company's products are one tool of parents can use to figure out where their children's' strengths lie.

"We need to identify these kids from 1 and up, so we can give the parents some guidelines on where to go from there.”

Meanwhile, researchers in Texas say they have a way to genetically screen fetuses to more accurately predict an array of disorders. Arthur Beaudet, who led the study and heads Baylor University's Department of Molecular and Human Genetics, says some parents want an early diagnosis so they can decide whether to end a pregnancy. Others simply want to better prepare for a child's special needs.