… Many of these [outsourced] trials are conducted for the benefit of international drug companies, at unacceptable cost to the local population; … trial subjects could be put at risk; … subjects often have not given their informed consent to participate; … they might be provided care that is of lower quality than if they had been recruited for a trial in the West; … injuries during a trial might not be investigated thoroughly, and … those injured may not receive treatment of the highest standard, or even compensation; and … drugs that are tested are often too expensive for people who need them in India.
The kidney minyan has already alerted us to desperate people around the world induced to sell this or that organ; this journalist from Himal South Asian describes The India Advantage.
India is now prominently on the radar screen of the international pharmaceutical industry in terms of clinical trials, given its vast population of potential trial subjects…
An increasing number of reports are coming to light of unethical and illegal practices that exploit people’s social and economic vulnerability, subject them to serious risks without their knowledge and consent, and do not even assure them of access to the drugs developed from the trials. Certain types of trials depend on paid volunteers who desperately need money. In Gujarat, unemployed diamond workers and migrants from Uttar Pradesh and Bihar get paid between INR 5000 and INR 20,000 to take part in bioequivalence trials – sums large enough for them to put money over personal safety. Indeed, trial participants may be both financially and socially vulnerable.
… The pharmaceutical industry depends on constantly getting new drugs into the market. New drugs include new uses for old drugs (a cancer drug that can also be used for infertility?) or ‘improved’ or ‘me-too’ versions of older drugs (all those antacids, blood-pressure and cholesterol-lowering drugs, anti-depressants or antibiotics). These drugs must be tested on human beings before they can go into the market. Permission has to be obtained, patients have to be recruited, trials carried out and the results filed – all at top speed, because time is money.
… Clinical trials in developing countries depend not only on physical infrastructure – hospitals and laboratories – and trained human power. They also depend on drug companies getting access to bodies on which they can test their drugs. So, [Contract Research Organizations] in India market Indian bodies. In a 2006 advertisement on their website (which has since been removed), a CRO named Igate advertised the ‘India advantage’ as “40 million asthmatics, about 34 million diabetics, 8-10 million people HIV positive, 8 million epileptic patients, 3 million cancer patients.”
… The reports of people dying in trials are likely to be merely the tip of the proverbial iceberg…