Re: A world of guinea pigs -- Medical experimentation on humans in India

In November I was traveling in India and came across this article in the local newspaper: A world of guinea pigs (Deccan Herald, November 11, 2005). The article starts with all the poor people in India who have a lot of diseases, and points to this as a "plus" to India. It means, the article explains, that the megalopolis drug companies are flocking to India to try their medicines on sick people.

That’s how large pharmaceutical companies see us – as an “excellent potential market” to test new drugs. Testing on humans before a drug is approved as safe calls for human guinea pigs on whom the medicines can be tried out. Developed countries have stringent regulations governing tests. These include guidelines on safeguards, generous payments, obtaining full, informed consent from participating volunteers (so that they know and understand the risks and possible side-effects) as well as the possibility of having to shell out huge compensations to volunteers if the trials cause harm.

India ‘‘scores’’ on each of these points – our medical compensation laws are not as strong as in the West, we have large populations of diseased persons – over 30 million patients with cardio-vascular problems, 25 million with diabetes – and informed consent is often absent because of high illiteracy and lack of awareness among citizens. Even educated urban citizens sign medical consent forms without carefully reading the print. The unlettered rustic puts his faith completely in the medical fraternity, the way he/she would in God.

Reading between the lines -- the attraction to India is that the drug company can come in with any old concoction, and no matter what harm it does to the health of the "guinea pig" they won't see any punishment. This is "outsourcing", in a different vein, of the clinical trials that would normally be performed in the U.S.

The article concerns a report published by the Consumer Education & Research Centre of Ahmedabad India. It discloses several illegal trials, in India, which resulted in deaths or damaged health. The article does say India has some health safeguards, but that the nature of India makes enforcement nigh on impossible.

Wired News has a similar article here: Testing Drugs on India's Poor (By Scott Carney, Wired News, December 19, 2005)

The Wired article points out a possible initiatory cause to the influx of drug research

For decades, pharmaceutical research in India didn't rely on clinical testing. Scientists mostly reverse-engineered drugs already developed in other countries. But in March, everything changed when India submitted to pressure from the World Trade Organization to stop the practice and implement rules that prohibit local companies from creating generic versions of patented drugs.

Namely, now that they've agreed to the intellecutal property protections and WTO oversight, the drug companies now have enough protection that they can do research in India without fear their results will be stolen by the domestic companies.

The problem is couched in "Bio Ethics". This is a field where medical and biology practitioners debate the ethical use of medical or biological technology. In the U.S. bio-ethics is very strong, and is what's caused the strict informed concent regulations. In India it isn't so strong, and the populace generally doesn't understand due to the lack of education and illiteracy. In effect the drug companies are a lot freer in India, but apparently the FDA still requires the same guidelines to be followed regardless of which country the research was performed in. But I can imagine that by the time the results were transported from India to the U.S. and presented to the FDA, that more than a few things could be lost in the several stages of translation involved.