Monday, December 19, 2005

More gardening

Mark Henderson criticises John Le Carré's plot for The Constant Gardner:

It might at first seem plausible that a company would seek to cut costs by pushing a trial on deprived and ill-educated people who do not not ask questions of free medicine. But if selling in a Western market was the ultimate goal, this would be a stupid way to design a trial. Its aim would be to test safety and efficacy, which means limiting confounding factors that might offer alternative explanations for changes in a subject’s health. Testing on a population with high rates of HIV, malnutrition and other serious medical problems would make it very difficult to achieve useful results.

Nonetheless, Wired reports that there are serious ethical concerns over drug trials being run by Big Pharma in India:

Shantha Biotech failed to obtain proper consent from patients while testing a drug meant to treat heart attacks. Biocon tested a genetically modified form of insulin without the proper approval from the Drug Controller General of India or the Genetic Engineering Approval Committee.

In another incident, Sun Pharmaceuticals convinced doctors to prescribe Letrozole, a breast cancer drug, to more than 400 women as a fertility treatment in a covert clinical trial -- and used the results to promote the drug for the unapproved use.

1 comment:

Hovis said...

Mark Henderson is naive in the extreme to think that drug companies would not look to cut costs by testing drugs in the third world. There is a vast amount of information to be gained from testing a drug on any population, as long as their health status is known and taken into account in the findings. But a drug with the mortality rate portrayed in the film would be pulled after such a trial due to the high cost associated with litigation in the US.

Big Pharma may not be interested in developing drugs for diseases like TB, but they are interested in licencing them, which generally involes them paying for the later phases of clinical trials. TB is a very large market, that will sooner rather than later affect the Western world, and with the appropriate compounds it will prove to be profitable. Plus making drugs for the third world means that the Times science correspondant will write even more cuddly copy for your company.