Lee and Harmer have highlighted the achievements of GAVI but they have also cited the criticisms leveled against it (1). Their article however would have gone to press before the recent controversy over WHO and GAVI functioning, started in India.
This week, the Indian Journal of Medical Research published an article entitled: "Incomplete reporting of research in press releases: Et tu, WHO" (2). The article relates to a press release issued by WHO jointly with GAVI, USAID, and Johns Hopkins among others (3,4), after the Bangladesh case-control study on effectiveness of Hib vaccination (5). The press release suggested that the vaccine is useful, whereas the study itself showed no benefit. No statistical difference was seen in the vaccination status of those with pneumonia or meningitis compared to controls. A post-hoc analysis presented without proper multiple testing was used to bolster the erroneous claim. Contrary to the subtle suggestion in the press release, analysis of data from an earlier Indonesian probe study also found no benefit (6).
This misleading press release is seen as the smoking gun.
After the Bangladesh study (2006) the WHO issued a position paper recommending the inclusion of Hib vaccine in all routine immunization programs, regardless of national burden (7) replacing the earlier 1998 position paper which suggested countries should consider Hib burden before introducing the vaccine (8). GAVI (which includes representatives of vaccine manufacturers on its Board,) "encouraged" developing countries in Asia to avail of the vaccine at a highly subsidized rate. The subsidy of course came from money given by donor countries and the Bill and Melinda Gates foundation, for achievement of the MDGs.
Given that the probe studies in Asia had failed to confirm benefit from the vaccine, it would appear that millions of dollars from the MGD Fund were spent wastefully. A possible argument that the vaccine was/is/maybe highly efficacious in other parts of the world hence should be used in Asia, is unscientific because the very basis of the research studies was that the situation in Asia was/is different.
A collective of civil society organizations have written to the Director General of the WHO to investigate how the misleading press release came to be put out and the events surrounding the Bangladesh study. It is hoped that widespread reporting of these events, will bring about changes in the way decisions are taken for/in developing countries.
Jacob M Puliyel MD
References 1. Lee K, Harmer A. Ten years of the Global Alliance for Vaccines and Immunization BMJ 2010;340:c2004.
2. Puliyel JM, Mathew JL, Priya R. Incomplete reporting of research in press releases: Et tu, WHO. Indian J Med Res 2010;131:588-589. http://www.icmr.nic.in/ijmr/2010/april/0418.pdf accessed 23/4/2010.
3. The Hib Initiative. Hib vaccine: A critical ally in Asia's effort to reduce child deaths. (Press release) http://www.hibaction.org/news/2007/20070627.pdf accessed on 23/4/2010.
4. WHO. Hib vaccine: A critical ally in Asia’s effort to reduce child deaths. http://www.who.int/immunization/newsroom/Hib_vaccine/en/ accessed on 23/4/2010.
5. Baqui AH, El Arifeen S, Saha SK, Persson L, Zaman K, Gessner BD, Moulton LH, Black RE, Santosham M. Effectiveness of Haemophilus influenzae type B conjugate vaccine on prevention of pneumonia and meningitis in Bangladesh children: a case control study. Pedaitr Infect Dis J. 2007;26: 565-571.
6. Gessner BD, Sutanto A, Linehan M, Djelantik IG, Fletcher T, Gerudug IK, Ingerani, Mercer D, Moniaga V, Moulton LH, Moulton LH, Mulholland K, Nelson C, Soemohardjo S, Steinhoff M, Widjaya A, Stoeckel P, Maynard J, Arjoso S. Incidences of vaccine-preventable Haemophilus influenzae type b pneumonia and meningitis in Indonesian children: hamlet- randomised vaccine-probe trial. Lancet 2005; 365: 43-52.
7. World Health Organization. WHO Position Paper on Haemophilus influenzae type b conjugate vaccines. Wkly Epidemiol Rec 2006;81: 445-452.
8. [Anonymous] Global programme for vaccines and immunization (GPV). The WHO position paper on Haemophilus influenzae type b conjugate vaccines. Wkly Epidemiol Rec 1998;73: 64-68.