Without consent: how drugs companies exploit Indian 'guinea pigs'


Western pharmaceutical companies have seized on India over the past five years as a testing ground for drugs – making the most of a huge population and loose regulations which help dramatically cut research costs for lucrative products to be sold in the West. The relationship is so exploitative that some believe it represents a new colonialism.

Since restrictions on drug trials were relaxed in 2005, the industry in India has swollen to the point where today more than 150,000 people are involved in at least 1,600 clinical trials, conducted on behalf of British, American and European firms including AstraZeneca, Pfizer, and Merck. There may be more.

While there is no official figure, some estimates suggest the industry may be worth as much as £189m. Regulators have struggled to keep pace with the explosion. Between 2007 and 2010, at least 1,730 people died in India while, or after, participating in such trials. Many of those people, often only eligible for the studies because they were ill, might have died anyway. Yet when there are complications, even those resulting in deaths, there is often a failure properly to investigate..

Among some of the incidents confirmed by aninvestigation carried out by The Independent in the states of Madhya Pradesh, Andhra Pradesh, as well as in Delhi and London, were:

* The recruitment of hundreds of tribal girls without parental consent for an immunisation study sponsored by the Bill and Melinda Gates Foundation on the nod of the warden of their government hostel. Several girls subsequently died. The study was halted by the federal authorities.

* The use by drug companies of survivors of the world's worst poisonous gas disaster in Bhopal as "guinea pigs" in at least 11 trials without proper informed consent.

* The completion by doctors at a government hospital in Indore, in central India, of dozens of private trials that a police investigation found "violated the ethical guidelines". The doctors who conducted the trials decided that not one of 81 cases in which a participant suffered an adverse effect was linked to the treatment. New trials were stopped while the state government investigated. A whistle-blower was fired..

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