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Editor—We would like to dissociate ourselves from the views reported in Fleck's news item about the global initiative that seeks to save millions of children's lives by immunisation.1 We were involved in the design and analysis of a study that was facilitated, funded, and published jointly with Save the Children UK. The report looked at four countries' experience with the application process to the Global Alliance on Vaccines and Immunizations (GAVI) and their perceptions about funding for systems support. Save the Children UK had several concerns about the alliance that went much further than the report but unfortunately gave the impression that these stemmed from the report.
Specifically, we wish to draw attention to four points.
Firstly, the study did not criticise the global alliance “for including managers from pharmaceutical companies on its governing board”; it made no comment on “a potential conflict of interest,” or on the “the risk of commercial, product-oriented pressure.”
Secondly, the reference to the initiative having failed to “ensure that additional resources were provided to countries” is an error. An innovative feature of the global alliance is that it did provide additional resources.
Thirdly, the study made no suggestion that such schemes could create “markets for costly new vaccines while doing little to tackle the biggest killer diseases.” Diseases that are prevented by vaccination are among the big killers in poor countries.
Fourthly, the report did not say that “Ghana was given only 10 days to decide whether to accept a new hi tech vaccine for hepatitis B without any evidence that this was actually needed.” All four countries welcomed the opportunity to introduce hepatitis B vaccine. Some respondents in Ghana expressed concern about the introduction of Haemophilus influenzae type B vaccine.
After the initial press release in Geneva on 15 January 2002, Save the Children UK issued the following statement: “The report is based on country-specific research conducted by the London School of Hygiene and Tropical Medicine and facilitated, funded and published jointly with Save the Children UK. . . . The media documents and statements of Save the Children UK therefore represent the considered views of that organisation alone and not those of the London School of Hygiene and Tropical Medicine. Save the Children UK regrets any confusion it may have inadvertently created between its critique of GAVI and the analysis produced by the London School of Hygiene and Tropical Medicine.”
Editor—Save the Children UK has noted the paradox of having vaccine manufacturers recommend the use of vaccines in developing countries—the paradox of the seller dictating demand.
In a market economy buyers evaluate the cost against benefit. If buyers refuse to buy then prices come down. The case of vaccine manufacturers is unique—they have broken loose from these market imperatives, using a subtle form of blackmail. They have convinced organisations such as the World Health Organization that new vaccine research can be expected only if good returns are ensured. The onus of showing cost benefit has shifted from the manufacturer to the consumer—organisations such as the WHO. Two things that support the charity's findings are, firstly, exaggerating benefits and, secondly, promoting vaccines that are not needed.
As an example of exaggerating benefits Miller (of the WHO's children's vaccine initiative) and Kane suggest that a quarter of carriers of hepatitis B in India die at age 45.1-1 For this they rely on the incidence of hepatocellular carcinoma in Taiwanese males (495 cases per 100 000 carrier years).1-2 This ignores the statement in the report that this incidence is three or four times that in women. The real incidence in Taiwan works out at around 320. In Montreal no cases of hepatocellular carcinoma occurred, although 17 would have been expected.1-3 Selectively using figures for Taiwanese males to project the dangers of hepatitis B on to the world's population grossly exaggerates those dangers.
Then there is the promotion of vaccines that are not needed. Nossal recommended giving four doses of Haemophilus influenzae type b vaccine to each year's birth cohort so that the price comes down.1-4 India is home to a quarter of that birth cohort. We have shown the existence of natural immunity to H influenzae type b in Indian infants.1-5 The vaccine is not routinely used here at present, and thus Nossal is suggesting that we use the vaccine so that its price can come down in the West.
Doctors think that because of vaccines' societal benefits vaccine manufacturers must be considered differently from other pharmaceutical manufacturers. That, though, is to prejudge the issue. Not all vaccines will have the same societal benefits. Vaccine manufacturers cannot be defence and jury in arbitrating the issue. Organisations like the WHO must avoid the blandishments of vaccine manufacturers if they are to retain their credibility.
References
1-1.Miller MA, Kane M. Routine hepatitis B immunisation in India: cost-effectiveness assessment. Indian J Pediatr. 2000;67:299–300. doi: 10.1007/BF02758178. [DOI] [PubMed] [Google Scholar]
1-2.Beasley RP. Hepatitis B virus. The major aetiology of hepatocellular carcinoma. Cancer. 1988;61:1942–1956. doi: 10.1002/1097-0142(19880515)61:10<1942::aid-cncr2820611003>3.0.co;2-j. [DOI] [PubMed] [Google Scholar]
1-3.Villeneuve J-P, Desrochers M, Infante-Rivard C, Willems B, Raymond G, Bourcier M, et al. A follow up study of asymptomatic hepatitis B surface antigen-positive carriers in Montreal. Gastroenterology. 1994;106:1000–1005. doi: 10.1016/0016-5085(94)90760-9. [DOI] [PubMed] [Google Scholar]
1-4.Nossal G. Living up to the legacy. Nature Med. 1998;5:475–476. doi: 10.1038/nm0598supp-475. [DOI] [PubMed] [Google Scholar]
1-5.Puliyel JM, Agarwal KS, Abass FA. Natural immunity to haemophilus b in infancy in Indian children. Vaccine. 2001;19:4592–4594. doi: 10.1016/s0264-410x(01)00222-5. [DOI] [PubMed] [Google Scholar]