BMJ, May 2008; 336: 974 - 975
Unmasking GAVI and Big Pharma: Rethinking Vaccine Access 9 April 2008
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Jacob M. Puliyel,
Consultant Pediatrician and Head of Department
St Stephens Hospital, Tis Hazari, Delhi 110054 India.,
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Re: Unmasking GAVI and Big Pharma: Rethinking Vaccine Access
We are dismayed that the article �Rethinking global access to vaccines� has been published as an �Analysis� article in the BMJ (1). The article has the hallmarks and specious logic of a story planted by the vaccine industry and we hope that in fairness to developing countries, you will provide comparable space to present the counter point and dispute the implications of the paper.
The authors write, �Our difficulty in disseminating well established vaccines cast doubts on our ability to promote wide spread use of new ones such as for diarrhea associated with rotavirus infection and for human papillomavirus (HPV). Currently - -93% of 260,000 annual deaths from cervical cancer occur outside the 60 wealthiest countries�
For a start, we would like to put these figures in its perspective. For the analysis let us assume that Gardasil, the vaccine against HPV related cervical cancer, covers all strains causing the cancer. (Actually Gardasil protects against 4 of the over-100 different strains of HPV and it protects against 70% of the strains presently associated with cervical cancer. It is not known if the infective strains will shift with time, with widespread use of the vaccine.) What will it cost to buy vaccines to avoid these 260,000 deaths? 21 million girls will have to be vaccinated each year, as they approach the age of 10 (2). The vaccine costs $400 per person. The total cost will be $8400 million. This program has to be sustained for over 20 years. Even if it prevents all cervical cancers, this would result in a mere 2% reduction of the mortality related to infective diseases. (The total deaths due to infective diseases is 10.9 million (2))
Let us assume that through very innovative pricing mechanisms, the cost of the vaccine comes down to $1 per dose. It will still cost $63 million for the vaccine alone, without including the cost of implementing the program and for injecting all these children.
The case for Gardasil has always been a little insecure because cervical cancers are not so common and the vaccine is exorbitantly expensive. Let us therefore examine the case for rotavirus vaccine � the other vaccine that the authors discuss in their introductory paragraph.
The authors lament the fact that it causes 440,000 deaths each year. Let us assume that we have a vaccine that covers all the human strains (A CDC sponsored study by Ramani and Kang has shown bovine-human strain reassortment and emergence of several new strains (not covered by vaccines) in India (3)). 126 million children around 2 months of age will need to be vaccinated three times (378 million doses) (2). At the present public sector cost of $7/dose (4) the cost of the vaccine will be $7938 million. This expenditure will bring down the deaths due to infections by 4%.
Vaccines and Market Forces:
Clearly, vaccines are not invariably a public good. We need to lay to rest, the concept that immunizations are always cost-effective (5). In an ideal market with perfect information, if a vaccine is not cost-effective and not capable of yielding better returns than other uses of the resource (6), there will be no demand for that vaccine. The compulsion to increase demand for these vaccines is felt by the manufacturers not the consumer. That is why organizations like GAVI have to enter the picture and give grants-in-aid to poor countries to offload those vaccines. It is hoped that poor countries can be persuaded to continue to use the vaccine after the aid is withdrawn. Willy-nilly poor nations are lured into a debt trap by such schemes. All the time, these organizations (like GAVI) masquerade as philanthropic organizations.
Drug trials among vulnerable populations:
Traditionally vaccines are tested by multinational manufacturers in the USA and Europe and only later in developing countries, as supplies and competition increase, and the cost of vaccine come down. This is in accordance with the Helsinki Declaration that trials be done in populations who are directly to use the drug.
Vaccine manufacturers want the rules changed. Chokshi and Kesselheim point out that Gardasil (the vaccine that costs over $400 for three doses needed to immunize one person) produced in the USA and Australia was tested in Brazil, India and Costa Rica (1). The cost of research is halved by conducting it in developing countries (7). The compensation needed to pay for adverse events is much lower. In an upside down world where profits are paramount, the authors write that this arrangement �could help meet international demand for low cost products� (1). The fates of human guinea pigs in developing countries don�t count for much.
�Competing interests: None declared�:
A casual reader of the article will notice it is written by a medical student and his teacher. However the BMJ demands to know more than just the names of the authors and it is published in small print. The article was written as the result of a �dialogue� with the former President of Merck Vaccines (1,8) and a few others. To some of us, that explains a lot.
1. Chokshi DA, Kesselheim AS. Rethinking global access to vaccines BMJ 2008;336:750-3
2. WHO Revised global burden of disease 2002 estimates http://www.who.int/healthinfo/bodgbd2002revised/en/index.html accessed on 8/4/08
3. Ramani S, Kang G. Burden of disease of group A rotavirus infection in India. Indian J of Med Res 2007;125:619-32
4. PATH Rotavirus. http://www.rotavirusvaccine.org/documents/RotaQA_Jan06.pdf accessed 8/4/07.
5. Jean-Pierre Le Clavez. GAVI funding and assessment of vaccine cost -effectiveness. Lancet 2007;369:189.
6. Dhanasiri SK, Puliyel JM. Regulating vaccines: Can health- economics tools be used profitably? Indian Pediatrics 2007;44:11-14
7. Sharma D. India pressed to relax rules on clinical trials. Lancet 2004;363:1528-9.
8. Global HIV Vaccine Enterprise. Adel Mahmoud http://www.hivvaccineenterprise.org/_dwn/news/mahmoud_bio.pdf accessed 8/4/08
Competing interests: None, except that we live in a developing country � India.