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The view from here:

“The duration of an eradication program should not be too long, perhaps in the range of 10–15 years…it is difficult to sustain a high level of enthusiasm throughout the period”
-Isao Arita, in The Eradication of Infectious Diseases, W. R.Dowdle, D. R. Hopkins, Eds. (Wiley, New York, 1998)..                                                         

War with polio:

Is it time to bring down the curtain on Eradication efforts?

Initially, I was bit reluctant to discuss polio eradication related matters in this issue as the bulletin has already had many lead articles on the subject in recent past. Furthermore, most practicing clinicians do gloss over this issue with certain amount of indifference and droopiness. But, ultimately, I gave in. To the temptation of displaying my cynical prowess, once again! Yet, it was quite spontaneous and natural. How unrealistic would it be for a New Yorker to remain unperturbed by the happening of 9/11? Or back home for a Mumbaikar to the 7/11? Similarly, it was unavoidable for me to remain unmoved to the ‘crisis’ erupting in my own backyard!
Being associated with Polio Eradication Committee of IAP, it is my utmost duty to support whatever IAP decides and recommends. There are no second thoughts on this account. At the same time, ‘Pediascene’ is the forum to give vent to my feelings in a most earnest and candid way.

 

“The men in control? David Heymann (left) and Bruce Aylward heading the global campaign.
(Acknowledgement : Science Vol. 312, 12th May 2006)

The crisis
The ‘crisis’ was generated by an epidemic of wild poliovirus, mainly type 1, in the Moradabad division of western UP. It is indeed strange that even after a decade of intensive pulsing, the ‘4-year jinx’ of poliovirus resurgence could not be broken. Right now, we are witnessing almost monthly SIA rounds in western UP and still not able to achieve a target of 90% coverage. The option of m-OPV has already been exercised with some success in Bihar. But the elusive goal of cessation of wild virus transmission still seems distant. The situation has reached to a state where mere continuation of the eradication initiative has come under severe threat. The voices of dissent are getting louder, and becoming increasingly public. And some from the most unexpected quarters. I was bit surprised when National Polio Surveillance Project (NPSP) finally accepted the long pending demand of using IPV somewhere in the ongoing program. It shows their frustration. Nowhere in the world IPV is used to halt intense wild virus transmission. More so, in a campaign mode and in a developing tropical country setting. The enforcing agencies are now under tremendous pressure with their back pushed to the wall. They now need more support from al
quarters. The recently organized National Consultative Meet of IMA strongly criticized the eradication strategy and openly attacked the policies of NPSP-WHO. Now, afraid of losing support of other academic bodies, they conceded the demand of using IPV in troubled, highly infected districts of western UP. Probably, they have run out of the options particularly for western UP.

Will IPV deliver?
Eyebrows will be raised on the decision of ‘target use’ of IPV in highly endemic districts of western UP. To get any impact on the wild virus transmission and subsequent effect on its epidemiology, the require coverage should be at least >85 % (preferably over 90% to get desired response). So far, even after 10 years of intensive efforts, it was not possible to reach even 90% children with as innocuous and simple intervention as slipping just two drops of a liquid palatable vaccine into the guts of under-five children in these districts. How will it be possible to achieve the higher coverage with a vaccine, which is not going to be so ‘child friendly’ and having significant reactogenecity? Any coverage below 80% would be meaningless. And this has to be achieved over a very short span of time. The issues of injection safety, stringent cold chain maintenance, training of personnel and logistics involved are other major concerns. Further, to use two different vaccines in a highly charged atmosphere especially in Muslim community where every move of the government and partners is perceived with certain amount of suspicion and skepticism would further complicate the matter.

We are competent, elite scientific body. We can provide advocacy and expert technical advice on the issues dogging child health in the country. We must stop begging these agencies. We are not equipped to implement any national program but we can provide advocacy and unbiased scientific inputs based on indigenous needs that serve the interest of our children in the best possible way. This quest of the Academy for finances for programs which we are not competent to implement is responsible for eruption of certain controversies in recent times. The demand at the just concluded Delhi Pedicon of having a separate office of IAP at the national capital must be viewed in this context.

The ‘role reversal’!
But given the circumstances, the agencies probably do not have many options left. IPV, in a tropical developing country setting with a very high force of wild virus transmission will not have a measurable impact, this is what WHO reiterated several times in the past. If we analyze the reasons of failure to achieve success in last two remaining states, the programmatic issues (mainly inability to reach 100% children) and poor efficacy of OPV in endemic districts, are the two prime reasons. The former facilitating the latter and further reducing the ‘overall’ efficacy of OPV. Though IPV provides better individual protection after 3 doses, it is not an ideal vaccine to use for mass protection, particularly in a densely populated, poor, endemic coun
try having tropical climate. IPV is the vaccine meant for use only in routine immunization to gradually accord immune protection to a vaccinee. OPV, on the other hand, is the tool to achieve ‘rapid protection’ in a warm, highly endemic country having high force of wild virus transmission. However, both of them are far from being an ideal vaccine- OPV has several inherent weaknesses as VAPP, cVDPV and iVDPV where as IPV is without any herd effect. We should have used these tools intelligently-taking the best out of them.

T. Jacob John: The lone Indian expert!
(Acknowledgement : IAP PEC Bulletin)

The major flaw
Once, we get done with IPV, people will ask, what next? The major flaw of the eradication strategy as exposed now is the failure to invest in research, which should be of high priority to augment the effectiveness of program in terms of vaccines, epidemiological surveillance, and maintenance of pathogen free status in humans. It is indeed a sort of mystery why all the work on development of new vaccine products, which was going smoothly till early 2000, got stalled suddenly after that when it was abundantly clear that target would not be achieved. The only reason could be the absence of any presumed market for a new product against an eradicated disease. Hence, probably, it was concluded at that time that investment in a new product would not make marketing sense.
Had the current imbroglio happened in China or in Japan, they would have definitely come up with a new product irrespective of WHO directives. The poliovirus consists of a
simple viral genome which is not difficult to synthesize in laboratory. Experts fear that this attribute of poliovirus can be exploited by terrorists to use it in a future biological warfare. It seems quite bizarre that terrorists can easily reconstruct the whole new poliovirus in their labs but not the highly sophisticated WHO accredited research laboratories. At a time when the world awaits the next ‘Flu Pandemic’ with some confidence armed with the capability of developing a new vaccine within six months of invasion by a new virus thanks to the new improved vaccine development techniques like ‘reverse genetics’, no attempt was made by WHO to use these new techniques to devise a new, better product for polio eradication initiative in time of crisis and adversity. WHO acknowledges this as one of the options but rejects it as only “a theoretical possibility”. After the Namibia episode, no country will ever even think of stopping all vaccination against polio. As continuous use of OPV is incompatible with the concept of eradication, there will be no other option for most nations but to use IPV in their national immunization schedules for an indefinite period. Given the high cost of production and possible bio-safety concerns, even IPV use will not be permitted for a long-term basis. Ultimately, the world will need to look for better, safer, and cheaper alternatives.

The progress so far
If we forget about the distinction of endemic-imported countries, and genetic diversity of polioviruses, and take account of one attribute of the program, i.e. the absolute number of wild poliovirus cases a mere glance will reveal that since 2001 (when the world reported the least number of cases-483), we are drifting away and losing control. The number of cases is piling up gradually. The task of making last few endemic countries ‘polio-free’ is almost getting unattainable. The similar problem appeared with smallpox eradication when the program was failing to meet the target from 1958 to 1966. However, at that time, continuous research and inputs were provided to improve vaccine quality. Here, with polio, we have not envisaged such options. Mind you, the countries offering fiercest challenge to polio eradication now are the same, which reported the last few cases of smallpox then. But, the world has drifted a lot since the days of smallpox eradication. Circumstances unfavorable to global eradication are part of the circumstances of the changing world. There is increasing global inequality: the rich are becoming richer, poor getting poorer. Nations with a per capita GNP of $ 30,000 constitute less than approximately 10% of global population. The situation appears to be most unfavorable for a globally coordinated program of disease eradication. Hence, until the gross inequality in the economic standards of the different continents of the world is not addressed, any attempt of enforcing global eradication program will be futile and will prove counterproductive to global health.

The brighter side
Despite all the hiccups and setbacks, there are some positive aspects of the eradication initiative. There is extra-ordinary reduction in the number of wild polio cases over last decade. This is quite obvious to all and I am not going to harp on this aspect. To me, the biggest achievement of the decade-old program is that it showed us and to the whole world- we are capable of doing it! Despite having all the shortcomings, and limitations, this very same public health system we abuse often, delivered the program to target population. Barring few pockets in few states, we could reach, and ‘map’ almost every child aged less than five. Not once, not twice but several times. It shows we have the capability to undertake any mammoth exercise but probably, lacking in maturity, competence and versatility to handle many health issues at a same time without adversely affecting the other.

For the first time we came across the concept of ‘real-time’ disease surveillance with its novel components like the molecular genetic surveillance. This was the second gain. Our laboratories and personnel stood firm and responded magnificently to the onslaught of polio epidemics. Thanks mainly to genetic surveillance; we could also ‘map’ every wild poliovirus causing paralysis. At the end of this long drawn out exercise, whatever may be the outcome; we at leasthave an infrastructure of a competent and effective surveillance system in the country. Onus is now on the Union and State health departments to exploit this newfound proficiency to control many other VPDs.
Lastly, we saw an unprecedented coordination amongst various government departments, agencies, NGOs, industry, media celebrities community, religious outlets, academic bodies and many other sections of society joining the program to convert it in a mass movement.


Is polio eradication realistic?
Before discussing this issue, let’s first analyze the concept of eradication. A true eradication of a pathogen has three components- absence of causative pathogen in human population, extinction of pathogen from environment, and lastly, the control measures needed to prevent re-introduction of the disease in human are no longer required. If one closely scrutinizes the WHO Global Polio Eradication Initiative (GPEI), Strategic Plan 2004-2008, it has already abandoned the last two components. There is no provision of environmental surveillance, nor it is feasible, and we are already discussing the vaccination strategy for the post-eradication era. On the other hand, if we examine the smallpox eradication, the program successfully satisfied all the three pre-requisites. Hence, if we could ever achieve polio eradication, its face would be completely different from smallpox eradication. The propagators of eradication initiative have already started talking of a new concept of eradication of infectious diseases where only first component would be taken care of.
There are many contradictions in the GPEI. According to WHO, use of OPV after cessation of wild poliovirus is incompatible with eradication. However, at the same time, they advocate keeping a stockpile of mOPV and using it extensively to combat any future polio outbreak! There is no uniformity on whether vaccination against polio would be stopped after achieving certification. No one knows the extent of threat posed by future outbreaks of VDPVs, particularly in developing countries.

Is ‘effective control’ of polio feasible?
If we dispassionately analyze the progress of polio eradication in the country over last 10 years without applying any statistical method, it is abundantly clear that as the things stand today it will take another 10 years to reach the ‘zero polio status’ and another 10 years to maintain it for three consecutive years! Unless something dramatic happens. Even if we could achieve eradication in the country, what impact will it have on the child health indices of the nation? Almost negligible! Given the current abysmal state of public health services in the endemic states, the sooner we bid adieu to this program the better for other interventions of child survival to take off. The overemphasis on polio eradication has almost incapacitated the entire health machinery of these states. However, after investing so heavily both in terms of money and the human effort, it will be quite illogical to abandon the program mid way. Let’s try our best to finish the job in quickest possible time. Already, voices of converting the initiative in to ‘effective control program’ have started emanating from different quarters. Those who are advocating this approach have also suggested certain parameters to be fulfilled to claim ‘effective control’. But even to attain that we need to achieve a coverage of at least 90%, a figure if we could attain now will almost ensure elimination of wild virus transmission. Right now, in the endemic states of the country, the status of wild poliomyelitis is far from a controlled disease. And see how much effort it needed to achieve even this status! Thus, it would be quite unrealistic to think that ‘effective control’ of polio is possible especially in our circumstances and with the tools we now have at our disposable. Considering the epidemiology of poliovirus and socio-environmental milieu of western UP and Bihar, the disease will remain either in a ‘hyper-endemic’ state or in an ‘eliminated’ form, at least in these two states.


What do we do now?
Considering the entire scenario, the need of the hour is to urgently set a new deadline-may be the next couple of years from now. At present, no one knows the target. This mind-boggling pace cannot be sustained for an indefinite period. WHO needs to be realistic in its approach. We are simply fed up with the oft-repeated cliché, “ necessary tools to eradicate polio are in place… Stopping polio transmission can be completed within next 12 months”. Months after months! Years after years! Let’s concentrate on to the two ‘hot spots’ regions, almost on a ‘war foot’ basis. Speed is the crux of matter. Let’s exercise all the available options; I wonder if we do have many left. OPV is going to be the best bet and the most potent tool as far as halting the intense wild virus transmission in the country is concerned. Let there be no doubt. The issues are mainly programmatic, managerial and related to poor administration. I am sure the target can still be achieved. If we are not able to achieve the breakthrough within stipulated time, let’s be realistic, accept the reality, and decide next course of action. Let’s live and let others also live!


-Vipin M. Vashishtha

Bottom Line .......

  “……what will happen, will happen!”
 -T. Jacob John expressing his views on current polio scenario in the country.

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