Drug companies are finding many willing test participants in India and other countries stricken with extreme poverty.
Given the rising cost of drug research in the United States and Europe, more and more drug companies are conducting clinical trials in developing countries where government oversight is more lax and research can be done for a fraction of the cost. According to a 2004 study by Rabo India Finance, a subsidiary of the Netherlands-based Rabo Bank, clinical trials account for more than 40 percent of drug-development costs. The study also found that performing the studies in India can bring the price down by about 60 percent.
By 2010, total spending on outsourcing clinical trials to India could top $2 billion, according to Ashish Singh, vice president of Bain & Co., a consulting firm that reports on the health-care industry.
Regardless of where clinical trials are performed, the FDA requires the same evidence showing that a drug is safe and effective before it will approve any drug, according to a written comment from Ken Johnson, senior vice president of The Pharmaceutical Research and Manufacturers of America Foundation.
And it’s the responsibility of the institutional review boards at the medical institutions where the studies take place to “actively pursue issues of informed consent,” according to another written comment from Jeff Trewhitt, a spokesman for the pharmaceutical industry trade group.
One of the best films of this year was The Constant Gardener. It tackled this subject if a very compelling way. See it if you can.