The Independent today reports on the story that SOYMB previously reported upon in June of how the pharmaceutical industry preys on the poor to trial new drugs.
Clinical trials for new pharmaceutical drugs are a sensitive business. But tests can be expensive. If they go wrong, companies are liable for compensation. No surprise, then, that in a globalised economy this business – like many others – is being outsourced to countries such as India where costs are far lower. In a country of 1.2 billion people, where more than half the population lives in chronic poverty according to a recent UN report, the supply of people willing to take part in tests for very modest fees is inexhaustible. Compensation payouts are a fraction of what they would be in the West.
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. Some estimates suggest the industry may be worth as much as £189m. The
relationship is so exploitative that some believe it represents a new colonialism. India is just one of many developing countries used by leading Western pharmaceutical companies, which spent £40bn in 2010 on research and development. Globally, it is estimated around 120,000 trials are taking place in 178 countries.
Companies can reduce their research costs by an estimated 60 per cent by outsourcing the work. China, Indonesia and Thailand are among the countries which have also seen the incidence of trials soar in recent years. A quarter of all clinical data submitted to European drug regulators to secure market approval for a new drug has been obtained from trials in low- and middle-income countries. Confidential data from drug companies suggests this has recently increased to closer to 50 per cent.
* 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.
India's Health Minister, Ghulam Nabi Azad, told parliament that a total of 10 foreign drug companies had made payments to the relatives of 22 individuals who had died during or following trials in 2010. The payments came to an average of just 238,000 rupees, or £3,000, for each individual. "Indians are being used by companies to make money selling expensive medicines in the West," claimed Dr Gulhati. "[They are] using illiterate and poor Indians who will never be able to afford these kinds of medicines."