Global Trials Attracting Attention
This is my site Written by Alex on December 3, 2008 – 10:50 pm   

Clinical trials in third world and other foreign countries are facing closer examination following several deaths, according to the Wall Street Journal. The article by Shirley S. Wang, Geeta Anand, and Jeanne Whalen, describes the unfortunate and wrenching death of an infant in India who was enrolled in a trial. The story says more scrutiny is being paid to overseas trials conducted by western drug companies in particular because those companies are running many more trials than before. They point out, as I did in a more in-depth examination of the globalization of clinical trials in Chasing Medical Miracles, that the cost of a trial in a developing country can cost half as much as running it in the United States.

In order for trial results to be valid for approving a drug, procedure, or device for sale in the U.S., the FDA stipulates that the overseas trial meets either the standards of the country where they are taking place or lives up to the Helsinki Declaration, whichever is more stringent. Many host countries, such as China, India, Russia, and others, have lax regulations. Frequently under-developed countries, find it’s in their interest to avoid imposing tough laws. The countries are so poor that they want to attract clinical trials because they provide people with medicine and other “treatment” that the government cannot provide.

When I went to Uganda to research my book I found that the government, universities, independent doctors, and the health ministry were working hard to impose tougher regulations to govern clinical trials. Other countries, however, didn’t even appear to be trying, as I discovered and wrote about in Chasing Medical Miracles:

One man, Ilian Ivanov, for instance, oversees the regulations governing clinical trials in Bulgaria. He is simultaneously the regulator and recruiter of companies to come and conduct trials in Bulgaria and he openly aspires to someday be employed by a pharmaceutical company, just like the man who occupied his post before him. Part of his $100 monthly paycheck goes toward a bottle of whiskey he keeps at the ready for visitors to his office. Ivanov insists he’s no pushover for allowing sponsors of clinical trials to cut corners. Two Bulgarian researchers felt his regulatory wrath once when he caught them conducting trials without government permission. He slapped them with a $10 fine.

To read the full Wall Street Journal article, click here. (A subscription is required but a free trial subscription is available.) 

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