No. 57, May 2014
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No. 57, May 2014 |
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No. 57 The Real Agenda of the Gates Foundation I. The World’s Largest Private Foundation The Gates Foundation in India: A Primer
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The Gates Foundation in India: A Primer — Sandhya Srinivasan*
How much money does the Bill and Melinda Gates Foundation (BMGF) spend in India? What are BMGF’s objectives? Key elements of the BMGF strategy5 – as described on the Foundation website – are as follows:(i) using partnerships to leverage public and private resources to influence policy;
In other words, BMGF’s objective is to influence Government policy. The foundation’s memorandum of understanding with the Bihar government (Bihar and Uttar Pradesh are the two states where the foundation’s work is concentrated, according to the foundation website) elaborates on this strategy: to use the foundation’s resources to “leverage public and private resources” for its objectives, and use “the state as an incubator of innovation” to influence national-level programmes and policy. What are Product Development Partnerships (PDPs), and how does BMGF employ them to pursue its objectives? The Gates Foundation has played a key role in promoting ‘Product Development Partnerships’ (PDP), a form of public-private partnership. PDPs bring industry and government together through what is described as a non-profit venture to develop technologies for health. According to the website of the International AIDS Vaccine Initiative7 (a Gates grantee), the PDP is meant to “accelerate product development”, working in collaboration with “academia, large pharmaceutical companies, the biotechnology industry and governments in developing countries”. The products are vaccines, drugs, diagnostics, pesticides etc. For example, the PDP Innovative Vector Control Consortium (also a Gates grantee) is a “not for profit company and registered charity to overcome the barriers to innovation in the development of new insecticides for public health vector control … .”8The last job of its chief executive officer was at Bayer CropScience. The PDP’s job includes taking the product through clinical trials and regulatory approval – and getting country governments to introduce it into their programmes. While the proponents of PDPs justify them on the ground that they focus on disease areas without viable commercial markets, in fact an examination of PDPs indicates that one of its jobs is to identify the market. A study by the Boston Consulting Group9 commissioned by PATH’s Malaria Vaccine Initiative (with funding from USAID and BMGF) looks at the public and private markets for a malaria vaccine at various prices, what donors would fund, the US military as a market, and so on.PDPs are essentially ways for industry to influence the decision-making process and get entry into the large and relatively untapped markets of public health programmes in developing countries. A presentation10 by representatives of the Global Alliance for TB Drug Development and PATH’s Malaria Vaccine Initiative describes what it calls “country decision making”. Globally, PDPs work with multilateral agencies. Locally, “PDPs, WHO, pharma and other actors can assist in the generation of a public health case for and against adoption.” They may also need to assist in the “definition of disease burden; establishment of new decision-making bodies; support for local advocacy; and Phase IV studies.”Not only does the product have to be developed and brought to market; the demand for this vaccine or drug needs to be created; organisations – including advocacy groups and the media – need to lobby for its inclusion in the country’s programmes. Phase IV studies, sometimes described as demonstration projects are conducted to establish the product can be introduced into a government programme. The PDP is also advised to assist in the establishment of “new decision-making bodies”. It is not clear what these new decision-making bodies could be, who they would represent, and how they would be established. What role do contract research organisations (CROs) play in BMGF’s activities? The Gates Foundation’s strategy of blurring of the distinction between public and private is also apparent in its support of private as well as ‘non-profit’ contract research organisations to carry out trials of the products developed by PDPs. Family Health International (FHI)11 describes itself as a “non-profit human development organization dedicated to improving lives in lasting ways by advancing integrated, locally driven solutions.”12 It provides “technical assistance”, partly through contract research, to corporate, governments and NGOs, and its donor base13 includes BMGF, USAID, Centers for Disease Control and Prevention (CDC, US), and Department for International Development (DFID, UK) – and Bayer Pharmaceuticals, GlaxoSmithKline (GSK) and Pfizer. In 2011, FHI,14 Quintiles,15 Pharmaceutical Product Development,16 and GVK Biosciences17 were named ‘preferred providers’ for contract research to a consortium of 14 ‘global health product development partnerships funded by BMGF, government agencies, private companies and “other sources”, that is expected to run 12818 clinical trials of vaccines and drugs in 2011-13. All four CROs run trials in India for pharmaceutical companies – in essence, they are commercial entities working (in this case) for what is described as a kind of non-profit sector.To give another example, Aeras is a “global non-profit biotech” developing TB vaccines. The Aeras Global TB Vaccine Foundation is a PDP testing TB vaccines. Most of its board of directors19 were drawn from the pharmaceutical industry, and at least one is currently the president of a privately held biotech company. Its funding20 includes grants, “investments from industry partners”, and co-investments with other organisations, governments and institutions. The industry partners include Sanofi Pasteur, GSK and the biopharmaceutical companies, Okairos in Switzerland, and Crucell in the Netherlands. In March 2011,21 Aeras and Crucell conducted a Phase 1 trial of a TB vaccine in Bangalore (it had already started Phase 2b trials in Kenya and South Africa) supported by the Research Council of Norway and the Indian government’s department of biotechnology. In 2012, the company announced plans to conduct, in India, the trial of another TB vaccine, being developed with GSK.22 What projects does BMGF fund in India? In an Addendum we have compiled a partial list of BMGF-funded projects in India. From this list it can be seen that BMGF funding travels across a vast web of connections, including international institutions, Central and state governments, NGOs, educational and research institutions, public sector establishments, private corporate sector firms, and so on. This vast web provides it virtually unmatched reach, which can be translated into influence. What are the implications of BMGF collaborations with the Government? We can get an idea of BMGF’s method of operation, and its influence, through some examples. One example of BMGF’s influence with the government is Grand Challenges India launched in April 2013.23 This is a collaboration between BMGF, India’s Department of Biotechnology (DBT) and its Biotechnology Industry Research Assistance Council. According to a BMGF press release,
Among the ‘grand challenges’ are: to create new vaccines and improve existing ones; to develop genetic and chemical strategies to control vector-borne diseases; and to improve nutrition by creating a “nutrient-rich staple plant species”. A director at DBT is quoted24 as saying that the collaboration would ensure that India has access to the medicines developed from this funding. The very fact that a Government department has felt it appropriate to take funds from a private institution indicates the extent of influence BMGF wields. It is not that the Government needs $50 million to run a grant programme of this kind. Nor does the Government need such collaborations to get access to the patents to manufacture the medicines – it is legally entitled to issue compulsory licensing for the manufacture of essential drugs.For BMGF, however, the Grand Challenges India collaboration, with foundation board members on the advisory board, is a way to gain access to decision making in public health research in India – to choose the subjects and focus of research. Of course there is no reason to believe that any drugs and vaccines – and even ‘nutrient-rich’ staple plant species – developed through the Grand Challenges will improve people’s health. Another instance of BMGF influence is its substantial funding25 with the government, of the Public Health Foundation of India (PHFI). BMGF’s funding includes $15 million to set up public health schools across the country. This gives Gates a say in the functioning and direction of these institutions – the type of research they conduct, and the academic programmes they run.What is BMGF’s impact on India’s vaccination programme? India’s public health priorities, including which diseases to focus on tackling, need to be determined independently of pressure from foreign and private interests. These priorities need to be addressed in a comprehensive way, with nutrition, sanitation, drinking water, and preventive measures and curative care. However, in fact the priorities are influenced to a large extent by international and private pressures, which also try to dictate the methods of tackling those priorities. An important example of this is the polio eradication campaign, which has been heavily promoted by the Gates Foundation, Rotary International, the World Health Organisation, and others. In fact, Bill Gates treats it as a test case to prove the efficacy of interventions of this nature in public health.26 Under external pressure, the Government of India ignored the fact that polio eradication is not a public health priority for India. It gave polio, in effect, precedence over all other questions of public health, mobilising vast numbers of its employees (including 2.3 million vaccinators) to vaccinate 170 million children.27 In this it showed a zeal, urgency, and liberality of funding woefully lacking in its overall public health efforts, or indeed its efforts to improve the living conditions which breed disease. (Bill Gates mentions proudly how polio vaccinators “found children in the poorest areas of Uttar Pradesh and in the remote Kosi River area of Bihar—an area with no electricity that is often flooded and unreachable by roads.28) By focusing on one disease and ignoring all others – the polio vaccine is the only vaccine recognised by people all over India – as well as the conditions which breed disease, the polio campaign diverts human and material resources from other pressing needs, and in fact contributes to weakening even the existing universal immunisation programme. Further, the repeated doses of live attenuated vaccine are responsible for cases of vaccine-derived polio paralysis – something the campaign initially denied but finally admitted. This also raises questions of the harm it causes to children who contract polio in spite of vaccination – children who are forced into the programme and not even compensated for the harm caused to them.29Finally, this focus on polio eradication ignores other water-borne infections which would be prevented if people had access to clean water and sanitation. One critic points out that India received a token donation of just $0.02 billion for its polio programme, but wound up spending $2.5 billion on it: “It is tempting to speculate what could have been achieved if the $2.5 billion spent on attempting to eradicate polio were spent on water and sanitation and routine immunisation. Perhaps control of polio, to the level of elimination, may well have been achieved as it has been in more developed countries.”30 The Gates view is that other infections will be addressed by other vaccines. Thus, for example, BMGF has been pressurising the Government to introduce the hepatitis B vaccine and a pentavalent vaccine (against diptheria, pertussis, tetanus, hepatitis B, and haemophilus influenza b). It has funded trials of human papilloma virus (HPV) vaccines. And it is funding the development of, and actively promoting, a rotavirus vaccine. In all these efforts, BMGF has consistently disregarded serious concerns raised by senior public health professionals regarding these vaccines’ relevance, public health value, safety, and cost/affordability for India, as well as the ethics related to their trials.31 In none of these cases have BMGF and its partners been able to convincingly refute the criticisms made. Despite this, the Government seems to be moving along the lines indicated by BMGF. What is the overall impact of BMGF in India? Are there no benefits? No one would claim that everything BMGF funds is bad. Many things are unexceptionable. But these could as well be funded by the public sector. The fact is, BMGF’s funding of useful activities provides it credibility and influence to promote a broader agenda. As we said at the outset, BMGF’s funds are not large in relation to India’s total public health expenditure. The real impact of BMGF is to further a major shift in health policy which has taken place during the last two decades. Earlier, there was at least formal adherence to a comprehensive approach to public health including nutrition, sanitation, drinking water, preventive health care, and an appropriate and universal system of curative care. Since the 1990s, this was progressively replaced with a World Bank-promoted model, which plays down the public sector and tries to involve the private sector in delivery of health care; imposes user fees for public services; and focusses on specific interventions rather than a comprehensive approach. This approach has reached its zenith with the entry of Gates and his foundation. Their aim is to install a public health model driven by private corporations, and revolving around the use of privately-owned technological interventions, a ‘magic bullet’ for each disease. While such a model is incapable of delivering public health, it is geared to deliver a private profit. [For a detailed discussion on BMGF’s role in influencing India’s vaccine policy, please see: Srinivasan S. Shift in directions of medical research. Social Development Report 2014. Forthcoming.]
Addendum: BMGF-funded projects in India – a partial list The following partial list of Gates-funded projects in India gives a sense of BMGF’s reach and influence. BMGF’s first directly funded work in India was Avahan, a massive $338 million project in HIV prevention. Avahan, which was launched in 2003,was to cover 5.3 million people in six states, through over 100 non-governmental organisations. BMGF later withdrew from the project, “to facilitate the transfer of control to the Indian government and other partners”. Interestingly, while the Avahan project has been criticised for the high salaries paid to consultants and project staff, and the problems that the government would face when taking it over, there seems to be relatively little analysis of the targeted intervention itself. There is, naturally, no comment on whether the project had any impact on people’s well-being. Since the Avahan project, Gates funding has expanded to include research and projects on vaccines, maternal and child health and nutrition.32 One of the two Gates-sponsored state-level projects is in Uttar Pradesh, where it has given at least $75 million to at least five organisations and dozens of sub-contracted ones. While the project descriptions are vague, these projects seem to involve giving the poor, and especially mothers, health advice; offering community based health insurance as way to pay for their medical expenses; developing contraceptive programmes and systems for safe delivery practices. The other state-level project is in Bihar, where Gates has funded projects totaling at least $84 million. Its collaboration with the state government, Ananya, is funded via the NGO CARE (CARE’s partners, incidentally, include Merck and Proctor & Gamble). Gates projects here are meant to promote various innovations in the fields of nutrition, contraception, and treatments for pneumonia, diarrhea, tuberculosis and leishmaniasis. A collaboration between Gates, the Indian government, WHO, USAID, the World Bank and the private sector is to research TB diagnosis, treatment and research, and Imperial College, London for mathematical modelling and analysis tools to “catalyse” the establishment of in-country expertise for their use. Gates’ contraceptive projects in India include: through the Urban Reproductive Health Initiative in Uttar Pradesh, with a focus on implants and injectables; Future Generations for contraceptives in Arunachal Pradesh; Management Sciences for Health and Deepam Education for Health for family planning programmes; Pathfinder International for awareness and service capacity; Family Planning Associaton of India to support the Small Family by Choice programme; and Jhpiego (an affiliate of Johns Hopkins University) to support government family planning divisions in UP, Bihar, Jharkhand, Rajasthan, MP and Chhattisgarh, and to “integrate” postpartum IUD devices into FP programmes. Gates has funded CARE to develop ways of ‘scaling up coverage of essential family health interventions within the National Rural Health Mission; WHO to promote research on essential medicines for children, particularly for diarrhea and malaria; WHO and Yale to develop and evaluate the role of face-to-face social networks in the use of ‘skin care practices’ and the impact on neonatal mortality; University of Manitoba to increase the use of newborn and maternal interventions; Seattle Children’s hospital to improve maternal and child health and reduce under five mortality and the Baylor College of Medicine to study whether healthy women produce less of the amino acid arginine than pregnant Jamaican and American women to find interventions to reduce the number of low birth weight babies in India. BMGF is promoting vaccines for cholera and rotavirus, among others. Through PATH, it has supported Serum Institute of India (SII) and Bharat Biotech to develop and conduct phase 3 trials of rotavirus vaccines on 10,000 infants (phase 1 and 2 trials were done on 200 children and adults at KEM Hospital, Pune), evaluated the rotavirus vaccine’s impact for its introduction and rollout; and conducted research for future enteric vaccine development. It funded the International Vaccine Institute to develop a cholera vaccine, got it licensed it to Shantha Biotech, and obtained WHO prequalification so that it can be included in health programes. It also funded research on the rotavirus vaccine through the Society for Applied Studies and has established a reference laboratory for the development of rotavirus vaccines at Christian Medical College (CMC), Vellore. It has funded CDC Foundation to produce a journal supplement on the rotavirus vaccine for India; and Imperial College, London, to improve immune response to oral poliovirus vaccine by treating enteric infections before vaccination. BMGF has worked with the GAVI Alliance to implement the Advance Market Commitment for Pneumococcal Vaccines, and funded PATH and SII develop and introduce additional pneumococcal conjugate vaccines to the market; Johns Hopkins to support the development of a comprehensive approach to the disease burden of pneumonia and diarrhea in children and develop research to study the impact of the pneumococcal conjugate vaccine in India. BMGF has also funded INCLEN for studies on burden, health, social and economic consequences, and development of innovations on pneumonia; King George Medical University to improve household decision-making for the management of pediatric pneumonia in Uttar Pradesh and Bihar; the Clinton Health Access Initiative for “developing and scaling effective product presentation and delivery models to rapidly and cost-efficiently increase coverage of oral rehydration salts (ORS) and zinc”; and PATH for a market research study to identify target product profiles for improved oral rehydration salts and zinc. Gates supported a partnership between PATH, WHO, SII , and African governments to develop an affordable vaccine against meningitis A; International Vaccine Institute for a “policy makers’ meeting on the introduction of cholera vaccination using new-generation oral vaccines in India” and to identify how to accelerate introduction and uptake of cholera vaccines; Emory U on a knowledge, attitudes and practices (KAP) survey of vaccine providers to identify barriers to achieving high immunization rates; CMC Vellore, INCLEN and Child Health Foundation to organize courses in vaccinology and build an “expanded cadre of experts” in vaccines; WHO to “accelerate and sustain access to affordable vaccines of assured quality in China and India”; Centre for Research, Montreal, to “leverage” two literacy programmes by incorporating immunization messages; PHFI to improve the quality and coverage of the routine immunization program in India and by creating a vaccine delivery system; PATH to provide technical and managerial support to expand the adoption of live attenuated SA 14-14-2 Japanese Encephalitis (JE) vaccine and scale up the Expanded Program for Immunization in JE-endemic districts; INCLEN to understand the cold chain upgrade requirements for inclusion of new vaccines into the universal immunisation programme and develop the “analysis framework” to inform Government of India policy and programme decisions; SII to develop and license a quadrivalent HPV vaccine; PATH to develop a Phase 3 clinical trial training programme; and CDRF Global to identify populations for future TB vaccine trials (among the funders of this organization are the US department of defence, the national nuclear security agency and the department of homeland security).
NEXT: Suniti Kumar Ghosh, 1918-2014 *Consulting editor, Indian Journal of Medical Ethics. (back) Notes: 1. http://www.huffingtonpost.com/bill-gates/why-our-foundation-invest_b_1269014.html (back) 2. “...the Bill & Melinda Gates Foundation has invested more than $1 billion in programs to fight disease and poverty in India, I am pleased with the results of those investments, and we are going to continue to invest more in the future.” – Bill Gates, February 10, 2012. http://www.huffingtonpost.com/bill-gates/why-our-foundation-invest_b_1269014.html (back) 3. McCoy David, Kembhavi Gayatri, Patel Jignesh, Luintel Akish. The Bill & Melinda Gates Foundation’s grant-making programme for global health. Lancet 2009; 373: 1645–53 (back) 4. Choudhary M, Amar Nath HK. An Estimate of Public Expenditure on Health in India. National Institute of Public Finance and Policy (NIPFP), May 2012, http://www.nipfp.org.in/media/medialibrary/2013/08/health_estimates_report.pdf, puts public expenditure on health at Rs 83,348 crore in 2010-11. The average exchange rate in 2010-11 was Rs 45.58/US $. (back) 5. How we develop strategy https://docs.gatesfoundation.org/Documents/global-health-strategy-overview.pdf; the Ananya Partnership http://www.ananya.org.in/about-ananya/71-partnership-for-better-health (back) 6. http://archive-org.com/page/3175096/2013-11-17/http://www.gatesfoundation.org/How-We-Work/General-Information/How-We-Develop-Strategy (back) 7. http://www.iavi.org/Information-Center/Publications/Documents/IAVI_Innovative_Product_Development_Partnerships_2010_ENG.pdf (back) 8. http://www.ivcc.com/legacy/index-2.html (back) 9. http://www.malariavaccine.org/files/Market-Assessment-18Jan05-LB-BOS.pdf (back) 10. http://www.conceptfoundation.org/files/meeting/8.%20Wells%20-%20Country%20Dmaking%20PDP%20Mtg.pdf (back) 11. http://www.fhi360.org/countries/india (back) 12. http://www.fhi360.org/about-us (back) 13. http://2013annualreport.fhi360.org/downloads/Funders.pdf (back) 14. http://www.fhi360.org/fhi-selected-preferred-provider-consortium-product-development-partnerships-march-30-2011 (back) 15. http://www.telegraphindia.com/external/display.jsp?mode=details&id=26316 (back) 16. https://www.ppdi.com/Services/Industry-Expertise/Government-and-Public-Health/~/link.aspx?_id=9DBA28A91E004431AF173A6273636248&_z=z (back) 17. http://www.gvkbio.com/news-room/press-releases/2011/gvk-biosciences-is-the-preferred-provider-to-global-health-product-development-partners-consortium-to-focus-on-drugs-and-vaccines-for-neglected-infectious-diseases/ (back) 18. http://www.businesswire.com/news/home/20110325005376/en/Quintiles-Named-Preferred-Provider-Global-Health-Product#.UvT1yWKSzN0 (back) 19. http://www.aeras.org/pages/board-advisors (back) 20. http://www.aeras.org/pages/funders (back) 21. http://www.aeras.org/pressreleases/clinical-trial-of-tb-vaccine-candidate-starts-in-india#.Uvd5ImKSzN0 (back) 22. http://www.aeras.org/pressreleases/aeras-signs-agreement-with-gsk-to-jointly-advance-tb-vaccine (back) 23. http://www.gatesfoundation.org/Media-Center/Press-Releases/2013/04/Grand-Challenges-India-a-new-Partnership (back) 24. http://www.downtoearth.org.in/content/bill-gates-grand-challenges-and-indian-science-congress (back) 25. http://www.phfi.org/about-us/financial-information As of 2013, PHFI received Rs 219 crore. Of this, Rs 65 crore was from the government and Rs 69.22 crore from BMGF. (back) 26. Gates Bill. “What I learned in the fight against polio”, Wall Street Journal, November 10, 2013. http://online.wsj.com/news/articles/SB10001424052702303309504579181753580988412 (back) 27. http://ijme.in/~ijmein/index.php/ijme/article/view/1456/3177 (back) 28. Gates B, Wall Street Journal, 2013, op cit. . (back) 29. John T J. Ethics, human rights and polio eradication. Indian Journal of Medical Ethics 1999. http://ijme.in/~ijmein/index.php/ijme/article/view/1456/3178 (back) 30. Vashisht N, Puliyel J, Polio eradication: Let us declare victory and move on. Indian Journal of Medical Ethics, 2012 April-June 9(2): 114-7. http://ijme.in/~ijmein/index.php/ijme/issue/view/9 . (back) 31. See: Phadke A, Kale A. Epidemiology and ethics in the Hepatitis B vaccine. Indian Journal of Medical Ethics. 2000; 8(1): 8-9. http://ijme.in/~ijmein/index.php/ijme/article/view/1341/2968; Puliyel J AEFI and the pentavalent vaccine: Looking for a composite picture. Indian Journal of Medical Ethics 2013 July-September. 10(3): 142-6; Kumar S, Puliyel J. Minimal risk reduction makes $1 rotavirus vaccine uneconomical in India. http://jacob.puliyel.com/paper.php?id=318 (back) 32. http://www.huffingtonpost.com/bill-gates/why-our-foundation-invest_b_1269014.html (back)
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