Despite annual revenues approaching $1 trillion, the global pharmaceutical industry has lately experienced a critical decline in the rate of profit, for which it lays most of the blame on regulatory requirements. A US think tank has estimated the cost of new drug development at $5.8 billion per drug, of which 90 per cent is incurred in Phase III clinical trials mandated by the US Food and Drug Administration and similar agencies in Europe.41 (These are tests administered to large groups of human subjects in order to confirm the effectiveness and monitor the side effects of new vaccines and other medicines.) The international business consulting firm McKinsey & Company called the situation “dramatic” and urged Big Pharma executives to “envision responses that go well beyond simply tinkering with the cost base” — primarily the relocation of clinical trials to emerging markets, where drug safety testing is seen as relatively cheap, speedy, and lax.42
It is in this specific context that BMGF’s intervention in the distribution of certain vaccines and contraceptives must be seen. Heavily invested in Big Pharma,43 the Foundation is well positioned to facilitate pharmaceutical R&D strategies tailored to the realities of the developing world, where “[t]o speed the translation of scientific discovery into implementable solutions, we seek better ways to evaluate and refine potential interventions–such as vaccine candidates–before they enter costly and time-consuming clinical trials.”44 In plain language, BMGF promises to assist Big Pharma in its efforts to circumvent Western regulatory regimes by sponsoring cut-rate drug trials in the periphery.
The instruments of this assistance are Gates-controlled institutions like the GAVI Alliance, the Global Health Innovative Technology Fund, and the Program for Appropriate Technology in Health (PATH) — public-private partnerships purportedly devoted to saving Third World lives. Notionally independent but so heavily funded by Gates as to function as virtual arms of the Foundation, these organizations began to conduct large-scale clinical trials in Africa and South Asia in the mid-2000s.45
Africa soon experienced an “unprecedented increase in health research involving humans” who were typically “poverty-stricken and poorly educated”46; the results were predictably lethal. In 2010 the Gates Foundation funded a Phase III trial of a malaria vaccine developed by GlaxoSmithKline (GSK), administering the experimental treatment to thousands of infants across seven African countries. Eager to secure the WHO approval necessary to license the vaccine for global distribution, GSK and BMGF declared the trials a smashing success, and the popular press uncritically reproduced the publicity.47 Few bothered to look closely at the study’s fine print, which revealed that the trials resulted in 151 deaths and caused “serious adverse effects” (e.g., paralysis, seizures, febrile convulsions) in 1048 of 5949 children aged 5-17 months.48 Similar stories emerged in the wake of the Gates-funded MenAfriVac campaign in Chad, where unconfirmed reports alleged that 50 of 500 children forcibly vaccinated for meningitis later developed paralysis.49 Citing additional abuses, a South African newspaper declared: “We are guinea pigs for the drugmakers.”50
Read more: http://www.rupe-india.org/57/pharma.html