Expert Rev. Pharmacoeconomics Outcomes Res.2005;5:515-6
“Suppose it were ascertained that every child in the world could be rendered absolutely immune from all disease during its entire life by taking half an ounce of radium to every pint of its milk. The world would be none the healthier, because not even a Crown Prince - no, not even the son of a Chicago Meat King, could afford the treatment. Yet it is doubtful whether doctors would refrain from prescribing it on that ground. The recklessness with which they now recommend wintering in Egypt or at Davos to people who cannot afford to go to Cornwall, and the orders given for champagne jelly and old port in households where such luxuries must obviously be acquired at the cost of stinting necessaries, often make one wonder whether it is possible for a man to go through a medical training and retain a spark of common sense.”
George Bernard Shaw1
This issue of ‘Expert Review’ carries a review of the economic evaluations of Rotavirus vaccines2. Common sense suggests that if a vaccine is safe and efficacious and it has been shown to be cost-beneficial (saves lives and saves money), it should be included in the program for universal immunization. The authors of the Rotavirus review note that this does not happen routinely – that the experience with introducing Hepatitis B and Hib vaccines in developing countries (countries that have the largest markets) has not been encouraging2. The twin issues of biased cost-effectiveness evaluations and the question of affordability are discussed in this annotation.
Rotavirus vaccine was withdrawn in 1999 due to unacceptable side effects – one intusussception in 5000 vaccine recipients3. Given this background, reintroducing Rotavirus vaccine in resource poor countries is going to be particularly difficult. Economic evaluation, need to include costs of side effects, to be comprehensive. However the reviewers point out that none of the papers studied by them computed the cost of vaccine side effects2. As the data is not available, it is impossible to draw conclusions about cost-benefits of the vaccine.
Cost-benefit equations can be biased in other ways . Underplaying the costs and enlarging the perspective in which the benefits are evaluated can justify any vaccine, no matter how expensive. Economic evaluations done on chicken pox and Hepatitis B vaccines illustrate various aspects of this problem. The recent call for the retraction of an economic evaluation that exaggerated the number of deaths from Hepatitis B in India from 5000 to 250,000 per year shows how data is manipulated4. A national vaccination program would have been difficult to justify preventing only 5000 deaths and so the mortality was inflated to 250,000. The authors could not provide the model used to project the figure of 250,000 deaths5.
Chicken pox is a relatively mild disease in childhood. When chicken pox vaccine was first introduced in the USA the cost of vaccination worked out at US$ 98 million. The cost of Chickenpox disease, if no vaccine was used, is US$ 90 million. The vaccine was not cost-effective. The perspective was therefore enlarged, to add loss in wages of a parent staying at home with the child with chicken pox, to show the vaccine as cost effective6. Loss in wages was estimated at US$ 390 million6, allowing for justifying a considerable hike in the price of chicken pox vaccine
The saga of Hib research in India demonstrates how international research funding is used to promote the interest of vaccine manufacturers - to demonstrate a need that does not in fact exist. The incidence of Hib disease in Asia is very low - 6/100.000 compared to 109/100,000 in the Western Pacific7. The thrust of Hib research was to convince health planners that Hib was a major problem that had gone unrecognized because of poor microbiological facilities and the technical inability to culture the organism. IBIS study done over 4 years, in 6 large referral hospitals in India, employed sophisticated culture techniques to isolate the organism, also found a remarkably low incidence of Hib disease 8, 9. Not convinced, the WHO undertook a large population based study following this. The study found the incidence of Hib disease of 9 per 100 00010. It merely confirmed the low incidence of Hib being similar to 1998 figures of Levine et al7. The WHO study was completed in 2002 and presented at a conference but it is yet to be published a paper. Research designed to promote the interest of vaccine manufacturers, and its selective publication, make health planners look at health economic evaluations with skepticism
Even if a vaccine is cost effective there is the question of affordability. The reviewers of the Rotavirus evaluation point out that many countries cannot afford more than US $ 8 per child for vaccination2. One method to judge if an intervention is affordable is to look at costs against the GNP of the country. It can be assumed that interventions that cost more than the per-capita-GNP of the country, per QALY saved, are not affordable11.. It is up to vaccine manufacturers to lower prices and comply with the affordability criteria in developing countries.
Public funding for vaccine research has all but dried up. In a market economy, it is open to vaccine manufacturers to produce biased cost-effectiveness evaluations and even determine what vaccines are produced to boost dividends for shareholders. Yet, in the market economy, it is for the consumer (health care provider) to decide whether the vaccine needs to be used at all for the benefit of the target population. Decreased demand will drive prices down. National health planners, and those advising vaccination need to play their part as consumer advocates. Unbiased critical reviews of economic analyses, as done by the authors of the review of Rotavirus can help2.
Rajiv Arora MD
Jacob M Puliyel MD MRCP M Phil
St Stephens Hospital
Delhi 110054 India