Sunday, March 05, 2006

big pharma does india

What is the German pharmaceutical company Boehringer Ingelheim doing in the small town of Sevagram, India?

The answer is in this month's Wired magazine, which covered a (now familiar) story on the outsourcing of clinical drug trials. This particular story is about the stroke-prevention drug Aggrenox. Boehringer has set up 28 trial sites in India; they are offering participants 2 physicals per year for 3 years (the length of the trial) and 30,000 rupees (about $665) to participating hospitals. The drug has been described as having "possible side effects and limited efficacy."

But why India? Well, with a population hovering around the 1 billion mark, India offers a resource America is running out of: willing research subjects. What's more, many of the people signing up for the trials are poor, illiterate and "treatment" naive (which limits the possibility of adverse interactions between drugs). Where American doctors have become suspicious of big pharma and their tickets to Hawaii, many Indian doctors see participation in the trials as a great opportunity for them, their patients, and their hospitals. The benefits to both sides seem apparent.

Perhaps one of the most controversial elements of this story, however, is the issue of informed consent. The article focuses on the experiences of Dr. Kalantri, who describes his patients as passive recipients of their health care. Indian consumers are not "educated" about drugs or health issues like Americans. Medications are not household names in India, but foreign bodies with miraculous mechanisms. Similarly, doctors are revered in many parts of India. Kalantri writes,

"Nine out of 10 times, the patients will just ask me to make the decision for him. So what role do I play? Am I a physician, concentrating on what's best for the patient? Or am I a researcher interested in recruiting patients? I try to balance the two sides's a dichotomy."

The doctor is clearly in a bind, asked to make difficult decisions on his patients' behalf, who don't even know the basic science required to make educated decisions.

Another issue is that the drugs being tested are irrelevant to the true health concerns of a country like India. As Kalantri explains, "finding better treatments for osteoporosis and high cholesterol is important...but these are diseases that will cause problems at 40 or 50. Infectious disease like malaria and filariasis kill at 20 and they're much more common here." Health care in India just isn't ready for large-scale preventative measures. Before they are ready to work towards creating a health country, they need to tackle diseases that we just don't see much of here.

Maybe it's my deep love for India or maybe it's my deep (cough) hate (cough) of drug companies, but something about this makes me very uncomfortable...

Treatment naive, huh? Sounds like biomedical colonialism.

What makes me wonder is, what will it take for Indian research subjects to lose their so-called naivete? A wave of deaths and complications from drugs whose clinical trials would never get approved in the U.S.?

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