http://www.hindu.com/mag/2006/11/19/stories/2006111900100400.htm The Hindu Magazine 19/11/06 Page 4
IT is now being acknowledged that the National Polio Eradication Programme did not work according to plan. The failure of this magic bullet approach (repeated doses of oral polio vaccine) to solve what is essentially a water and sanitation problem was predictable. Yet, that did not mitigate the sadness its failure caused among many of us who have worked tirelessly to make it succeed. The Indian Medical Association (IMA) Sub-Committee on Immunisation debated on whether to go public with its findings about the failure of this initiative. In August 2006, it concluded that it was its duty to do so.
The need to publicise dissent
Dr. Pushpa Bhargava, who is presently the Vice-Chairperson of the National Knowledge Commission, had written an article, "Fighting the polio virus", published on December 12, 1999 in The Hindu. In 1988, he had attended a meeting where it was decided to use injectable polio vaccine (IPV) in India because of the poor efficacy of the alternate vaccine, oral polio vaccine (OPV). A factory to manufacture IPV was set up in Gurgaon. Four years later, in 1992, on advice from the WHO, these plans were shelved and it was decided to use OPV. Dr. Bhargava wrote letters to the then Prime Minister (Mr. Narasimha Rao), the Health Minister and to the Health Secretary at different stages. Having been party to the earlier meeting that suggested the OPV was unsuitable for India, he asked for the evidence on which the government decided to switch in favour of OPV. He also demanded to know how the Rs. 50 crores spent by Indian Vaccine Corporation Ltd. to produce IPV would be justified. His letters were not answered. In the end he wrote this article to the press. He concluded the article saying, "No one will be more delighted and satisfied than me if it can be shown indisputably that OPV has worked in this country. Unfortunately all the evidence available today goes against that view. It is therefore not unlikely that polio will meet the same fate as BCG with valuable time and money lost." Events have proved the prophetic nature of that statement.
Thanks to this publication, we now have some form of a paper trail. There is a need for public accountability and this applies to faceless mandarins in the WHO as also to officials of the Government of India who have been named in the article. Decisions based on judgment can go wrong but unless this is acknowledged, we are bound to repeat these mistakes over and over again.
The IMA Sub-Committee was also placed in a somewhat similar predicament as Dr. Bhargava. It was alarmed by the number of vaccine induced polio cases (1,600 last year) that repeated doses of OPV were producing. More alarming were the 27,000 cases of polio-like paralysis in children in whom the polio virus was not cultured in the stools. The government was not willing to even enquire how many were left with residual paralysis in this group. There was also clear evidence that many who were already vaccinated, were getting polio paralysis, suggesting the vaccine was not efficacious. In the face of a bureaucracy that would not even acknowledge the problem, the IMA Sub-Committee was left with the unpleasant task of exposing this farce.
It is to the credit of the maturity of this Government that they have not set out to castigate the messenger and discredit the IMA. Unfortunately the knee-jerk reaction of the government has been to start another programme which will aggravate rather than remedy this situation. This essay will conclude with suggesting a mechanism to avoid these innumerable cycles of folly.
Before we go into the bigger issues, readers need to understand the disease which started all this fuss. Polio is a virus that can cause paralysis. The virus multiplies in the gut and is spread by contaminated water. Improvements in water and sanitation can control the disease. Routine immunisation would help hasten the eradication of polio. The polio control programme was working well with routine immunisation before the stepped up polio eradication programme was started. The incidence of polio fell from 24,000 in 1988 to 4,800 in 1994, well before pulse-polio started.
However in 1998, the WHO and other international bodies started this grand plan to eliminate the disease worldwide through repeated use of vaccines. Initial funding, to the tune of Rs. 400 crores a year, came from international agencies (including Rotary International). Inevitably, a couple of years after the programme started, these agencies claimed donor fatigue and withdrew funding. The Government of India spent Rs. 1,000 crores on this programme last year. Expenditure on all other immunisation (five diseases) was Rs. 300 crores.
A pattern with external funding — countries are lured into a debt trap.
With international funding initiatives the government is made to look foolish, refusing to accept a donation made for the benefit of its people. Once the programme is introduced on the basis of the external funding, overseas support is withdrawn. Poor countries fall for this ploy and vaccines are introduced without the mandatory cost-effectiveness study.
We have no way of knowing what influence the offer of overseas funding had on this decision, but the fact is that, in the end, the GOI was landed with unprecedented bills for a programme that was destined to fail .
No lessons learnt
But unfortunately we haven't learnt from our mistakes. In the aftermath of the failure of OPV polio eradication programme, the government has accepted an overseas offer of "free" injectable polio vaccine (IPV) to be given in the high endemic areas.
The imported injectable vaccine is 25 times more costly than the oral vaccine. One lot of near-expiry injectable vaccines is being provided free, but we cannot base a national immunisation programme on this. Furthermore, the costs of delivery of this injectable vaccine from door to door will be staggering. If this money were spent on improving water and sanitation in these areas, we will have a permanent solution to the problem. Injectable vaccine must be given to every child, and if we have not succeeded in getting OPV to 100 per cent of the population, the uptake will be much less with the injectable vaccine. So failure is guaranteed once again!
The IMA Sub-Committee had in fact suggested that that the government cool down this entire campaign and get back to strengthening routine immunisation along with concerted efforts to improve the water and sanitation in affected areas. We need a permanent mechanism to make such intricate decisions related to introduction of vaccines. A solution could be the setting up of an independent body similar to the "National Institute of Clinical Excellence" (NICE) in the U.K., to decide these matters. A professional body of health professionals, technical experts, health economists and public representatives should be formed. The government must publicise the vaccine under consideration. All stake holders, such as patient groups, health professionals, academic institutions, industry producing the vaccine, trade unions and international organisations like the WHO and GAVI must register their interest.
The body should assess the clinical evidence and the economic data of benefits. They should put up draft guidelines, to be assessed by the registered stakeholders, and a citizen's council (which provide the social values that underpin the work of group). Based on their input, the panel should then revise the guidelines. Finally an independent panel should review the guidelines, to decide if all stakeholder comments have been taken into account. The final guidelines should then be issued so that the government has clear and unbiased advice on which to base decisions.
The writer is Vice Chairman, the IMA Sub-Committee on Immunisation. The opinions expressed here are his own. Email: email@example.com