Tuesday, December 23, 2008

Potent Expose of Outsourced Research in India

Kris Hundley of the St. Petersburg (FL) Times has written an impressive series of articles on research conducted in India for U.S. pharmaceutical firms:


It's pretty hard to tell from the articles exactly how widespread are the abuses described, as U.S. drug firms, seeking both cheaper and quicker trials of their new drugs to submit for FDA approval, abandon the US for countries like India--despite the fact that most Indians will never be able to afford the drugs that finally complete the trials. The impression given is that the problem is quite severe, because the system is largely unregulated and unsupervised. The FDA is only just now opening an office in India to allow it to do audits of ongoing trials. According to Hundley, bribery and corruption are so widespread at all levels of the Indian health care system, with doctors and hospitals so overextended that patients routinely feel obligated to pay bribes just to get the most basic care, that it is impossible to imagine that so-called ethics review is legitimate. There are numerous accounts of subjects being asked to sign consent forms in languages they cannot read.

One of Hundley's most interesting interviews is with Kamlesh Solanki, a Dalit (untouchable or lowest caste) who previously worked as a human guinea pig for drug trials. The best of these paid him $150, equal to nearly half a year's wages for a farmer in that region of India. He enjoyed luxurious quarters as a guinea pig with air conditioning, TV, and cushy mattresses on the bed. Despite these benefits he gave up the trial business when he came to realize how much more subjects were paid in the US, and after a subject died in a 2002 Phase I trial of an antidepressant. "Do they think we are worth less [than US citizens]?" he asked Hundley.

The obvious answer is, yes, isn't that the whole idea?

1 comment:

Jim Sabin said...

Hi Howard -

Thank you for this post and the link to Kris Hundley's terrific articles. The medical ethics community in India recognizes clinical trials as a MAJOR problem. I'll be in India for much of January, and hope to learn more about how the problem is seen from the Indian perspective. Readers of your blog may be interested in "Drug Promotional Practices in Mumbai: A Qualitative Study" in the Indian Journal of Medical Ethics (http://www.issuesinmedicalethics.org/152oa57.html).