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The national vaccine policy draft, submitted by the government in the Delhi High Court recently, strongly favours inclusion of new vaccines in the Universal Immunisation Programme of the country.
The court had sought the draft from the Centre last year in a petition against introduction of new vaccines in the immunisation programme. The court has scheduled the next hearing for May 11. The petitioners, comprising public health activists and paediatricians, have called the draft misguided and industry-friendly.
The policy draft favours introducing new vaccines in the universal immunisation programme (UIP) without doing a cost-benefit analysis and substantiating it with proper scientific evidence to suggest the prevalence of the diseases, says N Raghuram, former secretary, Society for Scientific Values, an association of scientists in Delhi. “Half-truths are being deployed to convince policymakers to include pentavalent vaccine in UIP,” says Gopal Dabade of Drug Action Forum, a non-profit in Karnataka. Dabade had filed the petition in 2009.
The new pentavalent vaccine is being promoted to protect children against hepatitis B and haemophilus influenza type B (Hib) apart from diphtheria, pertussis and tetanus (DPT), which are already covered under the UIP.
In March, the petitioners met the Planning Commission and communicated the concerns relating to the pentavalent vaccine. They presented a paper—a copy of which is with Down To Earth—that highlights the misguided information given by the government to suggest the importance of inclusion of the five-in-one vaccine in UIP. “We have asked the Planning Commission to intervene in the matter,” says Jacob Puliyel, head of the department of Paediatrics and Neonatology at St Stephen’s Hospital in Delhi.
Sayeda Hameed, member of Planning Commission of India, agrees with the petitioners’ concern and says, “The government should first concentrate improving the penetration of basic vaccines like DPT before thinking of introducing new vaccines whose efficacy and need is disputed.” Only 50 per cent children get DPT.
The dispute
The government says the pentavalent vaccine must be introduced for its pragmatic convenience as only three shots of injections would be needed instead of nine which are currently given to a child to fight DPT, Hib and hepatitis B.
However, several health experts say the combination is not effective. “The spacing of DPT injections is different from that of Hepatitis B. If given in combination, the ultimate antibody titres (the required amount of antibodies) will not form and their efficacy will be compromised,” says S K Mittal, head of paediatrics department, Pushpanjali Crosslay Hospital in Delhi. While DPT cannot be given at child birth, Hepatitis B should be given at birth to avoid mother-to-child transmission, Mittal adds.
Cost is another factor. The pentavalent vaccine costs Rs 525 per child as against the total cost of vaccines for six basic diseases included in the UIP which costs around Rs 30 per child. “The pentavalent vaccine not only increases the price of DPT by 20-fold, it adds other vaccines like Hepatitis B and Hib that have little utility in India,” Puliyel says. Global Alliance for Vaccines and Immunisation (GAVI), a global health partnership of public and private sectors, has committed US$ 165 million grant for the phased introduction of pentavalent vaccine in India and provides a subsidy of Rs 145 per injection for five years. But after that the government will have to pay the total cost for a vaccine whose efficacy and cost effectiveness is still to be proven, says Y Madhavi, scientist at the National Institute of Science, Technology and developmental Studies (NISTADS) in Delhi.
The Indian Council of Medical Research (ICMR), the apex body in the country for the formulation, coordination and promotion of biomedical research, however, favours pentavalent vaccine. V M Katoch, director general of ICMR, says his committees constituted to look into the matter have concluded that the vaccine is needed in the country. “Cost is a factor, but it should not be above lives,” he adds. If the vaccine is found effective in pilot studies, public sector units will be asked to manufacture it, eventually reducing the government’s dependence on private companies. One of the studies by ICMR, published on the website of The Cochrane Collaboration, says DPT with Hib and Hepatitis B are less effective if the components are given separately and their side effects are more. Cochrane collaboration is an international network of healthcare specialists.
The government says investment in the manpower and infrastructure for new vaccines will in fact improve the uptake of basic vaccines. “The same lie was told when the government chose to invest heavily on polio eradication programme thinking that it will automatically improve overall immunisation rates. But in reality universal immunisation fell from over 60-70 per cent to less than 50 per cent in the last 10 years,” says Dabade. “No one is talking about increasing the reach of basic vaccines like DPT which still eludes 50 per cent of the population. We are not against Hepatitis B and Hib vaccine. We are against their introduction in UIP,” Dabade says. It should be left to the discretion of the doctor to give these vaccines when necessary, he adds.
Public health experts say every dubious new vaccine whose efficacy is not proven needs DPT, measles or some other essential vaccine for back-door entry into UIP. “The sustainability of global vaccine industry depends on adoption of new vaccines in immunisation programmes of large countries like India, because the present prices make them unaffordable even in relatively affluent country markets,” Madhavi says.
A report titled “Giving developing countries the best shot: An overview of vaccine access and R&D” by Oxfam and Medicines Sans Frontiers, international non-profits, states that aid, donations and loans cannot induce financial sustainability of healthcare system of a country. In fact all the money needed for UIP must be found indigenously and even the poorest countries are generally able to purchase the six basic UIP vaccines from their own health budgets. Countries like China and Japan that have an independent method to evaluate costs and benefits of vaccines have all rejected introduction of Hib and Hepatitis B vaccines in their countries.
Poor scientific proof
The public health activists also say that the models and studies that the government used to show that Hepatitis B and Hib are prevalent in the country are flawed. For example, in case of Hepatitis B, the minutes of the ICMR’s core committee meeting on the introduction of new vaccines states that “Even though efficacious and cheap Hepatitis B vaccine is available and in spite of four per cent carrier rate in the country, the vaccine is still not part of UIP.”
Puliyel says the four per cent carrier rate is not useful to estimate NNT (Numbers Needed to Treat is a statistical measure to find out how many children need to be vaccinated to save one life) because most carriers are asymptomatic. Without these basic rational calculations, you cannot identify if the vaccine is needed or not, he adds.
The ICMR committee referred to an unpublished study by S K Acharya, professor Gastroenterology at the All India Institute of Medical Sciences (AIIMS), which analysed biopsy reports of all Hepatitis B carriers who visited Acharya between January 2008 and June 2009. Hepatitis has also been linked to cause Hepatocellular carcinoma (HCC), a type of liver cancer. Based on his study, Acharya put the total number of HCC patients in the country as 21,000 and their treatment cost at Rs 12-14 billion. ICMR used this huge cost to justify immunisation with Heatitis B vaccine.
Public health activists question the figures cited in Acharya’s study. In reality, according to ICMR, total number of people suffering from HCC caused by Hepatitis B in the country is just 10,000, Dabade says. Liver biopsies may have been done on patients who visited the gastroenterology department of AIIMS, but data from such a select group of patients cannot be generalised to the whole population of India. This is like doing a study in the psychiatry unit in AIIMS and finding that half the patients coming there have Schizophrenia and so saying that half the population in India is mad, he adds.
Similarly, the ICMR core committee recommends including Hib vaccine in the UIP, saying it can prevent 52,000 cases of Hib meningitis across the country. Puliyel says such projection should be looked into carefully, because the figure is based on just nine cases of “presumed Hib meningitis” seen in one district in Kerela in 1999; the district had three cases of “presumed Hib” in the following year. “The committee gives no justification for the selective use of data which is against the basic principle of evidence based medicine,” Puliyel adds.
According to T Jacob John, former head of the virology department, Christian Medical College Vellore all the children in India are infected with Hib. However, how many of them get the disease is not known. “In such a condition, when there is lack of data and no alternative to vaccine is present, all children should be vaccinated against Hib,” he suggests. Katoch adds, “The absence of evidence should not be confused with evidence of absence.”
Health activists feel that instead of pushing for vaccine, the government must investigate how these misleading errors have crept into the recommendations of the ICMR core committee.
According to Sujatha Rao, former secretary, Ministry of Health and Family Welfare, the problem is the government has no surveillance system in place to find out which are the relevant childhood diseases, and which are not.
Why push for expensive vaccines?
According to media reports, a major push for introducing pentavalent vaccines in India comes from the Bill and Melinda Gates Foundation (BMGF), one of the major donors in the healthcare sector in India. During his visit in March, Bill Gates is learnt to have again discussed with the Union ministry of health and family welfare about the importance of introducing the vaccine in the country.
The reason seems obvious. Some of the pharmaceutical companies BMGF has affiliation with manufacture the vaccine. For instance, BMGF has US $0.12 billion shares in Sanofi-Aventis, which owns Shantha Biotech, a pentavalent vaccine manufacturer in Hyderabad. BMGF also has links with Merck, another pentavalent vaccine manufacturer. Several such details of BMGF’s investments in pharma companies and other corporations are revealed in a study by David Stuckler of Harvard University in the US. The study titled “Global Health Philanthropy and Institutional Relationships: How should conflicts of Interest be addressed” was published in Public Library of Sciences in April. It is a clear case of conflict of interest because Gates is promoting vaccines manufactured by pharmaceutical companies in which he hold shares, Stuckler says.
It makes a good business sense for him to promote new vaccines like pentavalent vaccine in emerging markets like India, says Meera Shiva, founder coordinator of the All India Drug Action Network.
BMGF is also a major funder of GAVI. The global health partnership promotes new vaccines. It decides which diseases to target and prepares criteria for effectiveness, price and long-term availability in advance. “GAVI and its partners have played a key role in shaping the market conditions that have led to growing demand for the pentavalent vaccine,” Madhavi adds.
Shiva says philanthropic organisations like BMGF have budgets often larger than national budgets. They use it to influence national politics, for their own vested interests. Their influence in policy making constitutes conflict of interest.
“The foundation is committed to high levels of integrity and stays away from any conflict of interest situation,” Gates replied instead of answering specific queries mailed to him.