Wednesday, March 26, 2014

Polio battle won, war far from over for India! A tale of two assassinations and lessons from past mistakes

If only the Indian government had heeded advice given by seasoned Indian polio researchers, it is foreseeable that the country’s war against polio could have been won long ago, and more significantly, astounding as it may sound, but 3 million children could have been saved from being crippled for life. A walk down memory lane also reveals that the twin assassinations of Indira Gandhi and Rajiv Gandhi pushed polio eradication back by decades. Even as we celebrate the success of the possible elimination of polio from India, a quick reality check: did the country fail its own people by not heeding to sound Indian advice, relying instead on overseas advisors unfamiliar with the ground realities of India? The hard-fought battle against polio has almost been won by India and on March 27, 2014 the World Health Organisation (WHO) finally `certified’ India and the South-East Asian region to be `polio free’. Indeed a great landmark since after small pox and Guinea worm this would be the third human disease whose end is near in India. The disease burden was astounding, studies in India in the 1980s suggests that in 1978 every day some 500 children or almost 200,000 children were being infected with polio annually and soon when the world is free from polio every year some $ 2 billion could be saved. Participating in the celebration on India’s victory over polio Prime Minister Manmohan Singh on February 11, 2014 rightfully said `this is indeed a historic day, it is a day that we have worked for tirelessly … as we celebrate three years without polio’. The road ahead is still bumpy. Experts like Dr Nata Menabde, WHO Representative in India warn `this progress in polio eradication cannot afford to pause and we cannot rest on our laurels’. Also, unbelievable as it may sound, but the main weapon against polio in India, the Oral Polio Vaccine (OPV), itself poses one of the biggest hurdles in the `end game’. There are also many lessons to be learnt from the past, from the burden of delayed implementation of effective strategies to how the sound advice given by Indian experts was consistently disregarded by the Indian government. These are painful lessons, for they led to the unfortunate and needless paralysis of some 3 million children due to polio. All this led to over a decade’s setback in polio elimination. Interestingly the twin assassinations of Prime Minister Indira Gandhi and a few years later of Rajiv Gandhi also became a severe impediment in tackling this crippling disease. The immediate battle against polio has been won but the war is far from over as the `endgame’ against polio is going to be tough. India’s neighbours like Pakistan and Afghanistan still harbour the wild polio virus and this deadly `tiny terrorist’ could well sneak in across the heavily armed borders. Ill-advised plans On advice from global experts in 1978 Indian government chose to use OPV as the preferred weapon to tackle polio, choosing it over the more effective but relatively more expensive Injectable Polio Vaccine (IPV). Pushpa Mitra Bhargava, founder director of the Centre for Cellular and Molecular Biology, Hyderabad recalls that ` developing countries were taken for a ride as there was clear serological evidence to suggest OPV was not as effective as IPV’, but then as he says at that time WHO advised `poor’ developing countries to use the cheaper OPV while it advised the developed nations to pursue the IPV route to try and eliminate polio from their soils. Even as recently as the 1980s Indian vaccine experts like T. Jacob John at the Christian Medical College, Vellore had raised the red flag against the use of OPV as a preferred weapon: although much easier to administer, OPV has a serious flaw, it is manufactured using a form of the `live polio virus’ whose potency to cause polio has been blunted, nevertheless there are rare cases in which the virus regains its virulence and starts paralysing children. Such cases are not counted since they are taken as adverse reaction to the vaccine. The vaccine virus can also regain its infectivity and virulence and even cause polio outbreaks. In effect the cure becomes the cause for the disease burden. WHO statistics reveal that in the last 14 years 20 outbreaks of polio associated directly with the polio vaccine regaining infectivity have occurred in 20 countries and some 655 individuals have contracted polio through this route. If this doesn’t erode the credibility of the vaccine in the eyes of mothers, it would be a surprise. Experts say this was an `acceptable’ risk since in all 10 billion doses of the vaccine were given in this same 14 year period. But the situation would get very complicated soon when the OPV is to be withdrawn as part of WHO’s `end game’ strategy at that point experts fear there could be hordes of children who may once again become infected with the vaccine derived viruses and be vulnerable to paralysis. In this last lap the use of the OPV is like having the tiger by its tail. Writing an anguished editorial in the highly regarded Current Science journal recently John said `for three decades policy-makers ignored Indian science on polio – allowing over 3 million children paralysed unnecessarily and delaying polio elimination by 11 years.’ The problem arose as `decisions were made on the basis of opinion fit for western nations’ explains John suggesting that `in case of polio they [the government] made bad mistakes’ since Indian research studies in the 1970s had established `why western tactics would fail’. The Indian government instead relied on foreign advisors which compounded the problem. In the early part of this decade India faced a peculiar problem of children having been administered more than 10 doses of the oral polio vaccine still coming down with polio. It was soon deciphered that the OPV itself was the problem as it was not as effective since this three in one combination called a trivalent vaccine was trying to tackle simultaneously three strains of the polio virus Type 1, 2, & 3. In 2005 based on old Indian research a more potent monovalent OPV that targets only type 1 and 3 was introduced and it immediately started yielding the desired results and the last wild polio case was detected on January 13, 2011 in West Bengal. Unfortunately the problem of polio is not going away anytime soon even after India is `certified polio free’ since clinically paralysis caused by the wild polio virus and the disease caused because of OPV regaining virulence in the environment are virtually indistinguishable and in 2013 four such cases occurred in India, where the vaccine had gone rogue. While polio occurring due to the vaccine virus in vaccinated children could be easily solved once OPV is withdrawn but the problem of the vaccine virus that becomes virulent in the transmission chains among children could become a huge problem since in the future when OPV is totally withdrawn children would not have the immunity against the virus, but hopefully by then the more expensive IPV would have made sufficient in-roads to provide immunity to the children of the future. Menabde does not hide her trepidation when she says `the polio end game strategy involves a switch from trivalent oral polio vaccine to bivalent oral polio vaccine and phased withdrawal of the oral polio vaccines from the program with the POSSIBLE introduction of inactivated [injectable] polio vaccine (IPV) in routine immunisation schedule’. By 2015 it is hoped the more potent IPV would have become part of routine immunisation but here again lies a tale of missed Indian opportunities, and a lot of irony: India will now have to follow WHO directives and by force have to import the required IPV, since the country’s own indigenous capacity was forcefully shut down. Tale of two assassinations In 1983 the man who invented IPV, Jonas Salk, visited India and advised then Prime Minister Indira Gandhi to introduce IPV, and by 1986 a combination of 4 vaccines (Diphtheria-Pertussis-Tetanus plus IPV) was readied but it was suddenly withdrawn by the government the same year. It was in 1984 that Mrs Indira Gandhi was assassinated and John says ‘if she were alive in 1986, India would have routinely been using the combination vaccine’. It may be pertinent to note that three decades later as part of the `endgame strategy for polio’ the combination vaccine is again being dusted up! Another mishap occurred a few years later when Sam Pitroda was heading up the famous `technology missions’ in Prime Minister Rajiv Gandhi’s tenure. After a great deal of effort by Pitroda, the Indian Vaccine Company Limited (IVICOL) was set up on the outskirts of New Delhi in 1988, costing some Rs 900 million. But then, in 1991, Rajiv Gandhi was assassinated and in 1992 for reasons not so scientific the unit was hurriedly closed down. John says had Rajiv Gandhi `been alive we would have been using IPV on a large scale, but that was not to be … damage had been done’. Meanwhile the country celebrates a much-needed and long overdue success story of nearly vanquishing the dreaded polio virus -- in times when scandals are tumbling out dime a dozen. This success rests on the shoulders of nearly 2.3 million vaccinators (the Indian army is only a little over one million strong) who battled tremendous odds to vaccinate in every Pulse Polio round almost 170 million children (equivalent to about half the population of USA) in more than 240 million households spending some $ 3 billion in funding. But as John laments `while global experts are lauding India for its success and goading India towards the end game, we know that India could and should have led the developing world, since we had all the right evidence and ideas to go precisely through this route towards a world in which no child ever gets polio’. It seems global health politics triumphed over cold hard facts put forward by top class Indian researchers in the last century. So in the current election season will Rahul Gandhi and Narendra Modi learn some lessons from history on how to fight diseases the Indian way, especially as the country now begins its efforts to eradicate another big killer, measles that kills some 66,000 children annually? Missed opportunities, misplaced advice, overt reliance on global directives and several wrong decisions – chances are all will be forgotten as the battle to end this scourge is celebrated across the world. Pallava Bagla (Pallava Bagla is Science Editor for New Delhi Television and correspondent for SCIENCE. Views expressed are personal. He can be reached at Pallava.bagla@gmail.com)