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Ignored Outcomes of Polio Eradication

Much of the so-called problems in the polio eradication programme in India pointed out by Rajib Dasgupta (EPW, 20 June 2009) have been known for years. At the same time, the article is silent about several critical issues. It is necessary to take cognisance of the larger political economy of immunisation instead of deluding ourselves that polio eradication is simply a matter of the "right" vaccine, the "correct" number of doses, etc.

DISCUSSION

Ignored Outcomes of Polio Eradication

Indira Chakravarthi

Much of the so-called problems in the polio eradication programme in India pointed out by Rajib Dasgupta (EPW, 20 June 2009) have been known for years. At the same time, the article is silent about several critical issues. It is necessary to take cognisance of the larger political economy of immunisation instead of deluding ourselves that polio eradication is simply a matter of the “right” vaccine, the “correct” number of doses, etc.

Indira Chakravarthi (indira.chakravarthi@ yahoo.co.in) is a public health researcher based in Delhi.

Economic & Political Weekly

EPW
august 29, 2009

A
ny discussion of the deficiencies of India’s polio eradication pro

gramme implies that we are miss

ing deadlines due to reasons internal to

the functioning of the programme in the

country – such as poor implementation,

inadequate routine immunisation (RI),

poor seroconversion, lack of public coop

eration, poor hygiene, etc.

The limitations of the trivalent oral po

lio vaccine (tOPV) have been documented

and well known for long. Monovalent oral

polio vaccine (mOPV) was claimed to be

more potent than the trivalent vaccine,

and “untested” mOPV was, therefore, in

troduced in 2005. Issues relating to imple

mentation, “fatigue”, etc, have been raised

by government officials themselves from

time to time.1 Hence much of the so-called

problems pointed out in the article by

Rajib Dasgupta in “Eradicating Polio: Making

a Short Story Long” (EPW, 20 June 2009)

have been in the public domain for several

years now. Issues critical to the eradica

tion, and which the article is silent about,

need to be placed on record here.

Critical Issues

First, “there has been an alarming increase in the number of children afflicted by paralysis since the beginning of this ‘eradication’ programme” (Table 1), and there is obfuscation of the numbers actually afflicted by polio by a shift in the criterion for diagnosis as polio, and use of multiple terms such as confirmed wild poliovirus (WPV) cases, compatible cases, discarded cases, vaccine derived poliovirus cases, and so on (Sathyamala et al 2005). In their obsession with “polio” in Uttar Pradesh (UP) and Bihar, World Health Organisation (WHO) and the government are turning a blind eye to the “increase in paralysis rate across the country, as well as to the incidenc-e of paralytic polio in vaccinated children”.

vol xliv no 35

This increase in acute flaccid paralysis (AFP) cases is spread across several states, and is not concentrated in just UP and Bihar. However, instead of undertaking a comprehensive epidemiologic investigation into this steady increase, such an epidemic of paralysis – while there is an ongoing “elimination programme” – is being “explained away” by the WHO (that provides technical support to the programme) to be due to “excellent surveillance”.

Reports that most instances of AFP were not being followed up unless the WPV was detected in the stools, cast a shadow over this claim of excellent surveillance. For instance, in 2005 of the 10,264 cases of AFP, 209 were confirmed or compatible with polio. Of the remaining 10,055 cases only 2,553 were followed up; among these 898 had residual paralysis (that would qualify them to be diagnosed as polio using the conventional definition) and 217 died. Projecting these figures on those not followed up shows that approximately 4,800 cases either had residual paralysis (polio) or had died in UP after acquiring non-polio AFP in 2005 (Puliyel et al 2007). In 2006, out of the 10,879 cases of AFP only 2,043 were followed up, of which 48.4% had residual paralysis and 11.9% had died. By the same calculations in all there were 5,265 cases of polio and 1,294 had died, indicating that the problem had worsened between 2005 and 2006 (Sathyamala 2007). The National Polio Surveillance Project (NPSP)-WHO has not given any explanations

Table 1: Children Afflicted by Paralysis

Year Total Cases of AFP Non-Polio AFP
(Acute Flaccid Paralysis) Rate*
1997 3,047
1998 9,461
1999 9,587
2000 8,103 1.99
2001 7,470 1.76
2002 9,705 1.87
2003 8,505 1.97
2004 13,274 3.11
2005 27,050 6.43
2006 32,194 7.35
2007 41,401 9.40
2008 45,582 10.24
2009 (up to11 July) 21,338 7.44

(From www.npspindia.org)

* AFP rate is the annualised rate of AFP cases per 1,00,000 children under 15 years of age. Non-polio AFP rate is the discarded non-polio AFP cases per 1,00,000 children under 15 years of age.

DISCUSSION

for these increases, nor for the lack of f ollow-up of such a large number of AFP cases, or for the high death rates among the “non-polio” AFP children.

Second, many of the scientific assumptions of the “eradication” programme,2 regarding the persistence of wild type polioviruses in the environment and their ability to mutate, the ability of the attenuated vaccine viruses to revert, were all inadequate to begin with, and have since been shown to be incorrect by a host of findings. It is beyond the scope of this response to discuss the findings of all these surveillance and genetic studies in detail. Polioviruses (PV) are considered to be among the most rapidly evolving viruses. And it is amply clear now that OPV-derived polio viruses can acquire highly modified genomes by mutation and by genetic exchanges with vaccine viruses or WPV or even with non-polio enteric viruses (NPEV) (Guillot et al 2000).

These PV vaccine-derived strains can survive for long periods of time, by prolonged excretion, and/or by natural transmission, and may cause paralysis in h umans (Nomoto and Arita 2002; Bassioni et al 2003; Karakasiliotis et al 2005). They may make their way through narrow breaches and evolve into transmissible pathogens “even in adequately immunised populations” (Cherkasova et al 2002). Now that transmission and the capacity of circulating vaccine derived polioviruses (cVDPVs) to cause paralytic disease has also been established, “a vaccine programme might inadvertently initiate an outbreak of poliomyelitis, similar to natural outbreaks”. Low coverage and poor hygiene are conducive to such an occurrence (Nathanson and Fine 2002). Based on such findings, the very idea of “eradication” of polio by wiping out the PV has been questioned (Arita et al 2006; Roberts 2006), and experts have argued for a shift to “control” of poliomyelitis.

In fact, as early as 1997 virologists had expressed serious concerns and argued against marketing polio vaccination to poor countries as an “eradication” campaign; they pointed out that to succeed, the eradication effort should take a balanced approach as part of a larger campaign to improve health and sanitation (Dove and Racaniello 1997). WHO was warned of these problems several years ago but it dismissed these concerns (Hull and Aylward 1997).

Third, since 2005 sections of the public health community in the country too have raised serious concerns regarding the conceptualisation of the pulse polio programme in India, which was also brought to the attention of the WHO. The flawed scientific basis as well as the pernicious impact of the pulse polio programme on the functioning of the public health infrastructure have all been repeatedly brought to the attention of the Indian health ministry and WHO, and even with the National Human Rights Commission (NHRC), by concerned public health professionals and civil society organisations (between October 2006 and March 2007), making several recommendations and asking for a comprehensive review of the entire programme as well.3 The Indian Medical Association had also raised similar concerns. In March 2007 the government of India asked the Public Health Foundation of India (PHFI) to conduct a review of the programme, the outcome of which is not in the public domain till date.

Epidemiologic Investigation

What we thus see is that even though all the problems were known, yet WHO and the government persist with the programme, and vast amounts of resources, financial and human, continue to be used up solely for this programme (Chakravarthi 2008). The “pulse polio” dose continues to be administered repeatedly (at least 10-12 times a year since 2007). The issues of malnutrition, suboptimal sanitation, concomitant

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DISCUSSION

diarrhoeal infections, and along with these routine immunisation, which would constitute the scientific public health approach, continue to be neglected in favour of a vaccine technology as the sole strategy.

It is imperative that a public health programme looks beyond paralytic “polio” and undertakes a complete epidemiologic investigation into the rising paralysis rates, and ascertains their cause. Studies from some other countries indicate that paralysis cases classified under categories other than polio – such as Guillain Barre syndrome, facial paralysis – might be caused or triggered by OPV derived PV strains. Several PV strains were derived from fecal samples of such paralysis cases in Brazil, and their characterisation confirmed the polio vaccine origin of these strains and the presence of mutations known to increase neuro-virulence (Friedrich 1997). A temporal association has also been reported from Finland between PV infection and an episode of increased occurrence of paralytic Guillain Barre syndrome (Kinnunen et al 1998). In India we see that there is no follow-up or study of all children affected by paralysis, nor is there environmental surveillance. So nobody has any idea of the etiology of the increasing paralysis in the children here. Given these facts regarding evolution and mutation of the PV, and the epidemiology of paralysis, there is the possibility of an iatrogenic basis for paralysis. The possibility of “overdose” of the OPV, and variants of WPV and not just WPV causing paralysis need to be considered.

At best, the pulse polio programme in India is proving to be a classic example of a purely technical approach to public health, and a faulty one at that, which, therefore, is a failure. At worst, the programme is an illustration of how WHO-UNICEF, international donors, and philanthropic agencies have all allied in the name of public health and are largely promoting commercial interests (such as vaccine producers and the Global Alliance for Vaccines and Immunisation (GAVI) and the International Finance Facility for Immunisation (IFFIm)), with little concern for the epidemiological impact of the programme.

It is time we stopped deluding ourselves that the polio eradication in India is simply a matter of the “right” vaccine, the

Economic & Political Weekly

EPW
august 29, 2009

“correct” number of doses, a proper cold chain, adequate motivation of health workers and the uneducated poor, etc, and took cognisance of the larger political economy of immunisation that is gaining primacy in public health matters. In addition, a critical review of role of the WHO in these matters is urgently needed (Chakravarthi 2008). After all, if “global deadlines have minds of their own”, surely they are not nameless, faceless entities! The thousands of children getting paralysed too have faces and names, and should not be treated as mere statistics and case studies in this flawed eradication project.

Notes

1 See note 4 in Chakravarthi 2008. 2 Assumptions such as: (i) There are no natural reservoirs of the WPV, that there is no viable circulation and transmission of WPV in environment;

(ii) that only WPV is causing paralytic polio;

(iii) that Sabin strains (live, attenuated PV) do not easily revert to fully neuro-virulent strains;

(iv) that in case of India, where the OPV does not seem to be working, giving more and more doses of mOPV to children under five years of age, and achieve 100% coverage of the population, should achieve immunity and end WPV transmission; and (v) WHO ignores the earlier practice of postpolio residual paralysis as a marker of WPV transmission, and presently stool analysis is the sole basis for diagnosis. However, findings indicate that the stool isolate might not always be representative of the causative agent of paralysis.

3 Memorandum by concerned public health professionals and other documentation on the problems of the polio eradication programme are available on www.phm-india.org (as of 21 July 2009).

References

Arita, I, M Nakane and F Fenner (2006): “Is Polio Eradication Realistic?”, Science, Vol 312 (5775), 12 May, pp 852-54.

REVIEW OF WOMEN’S STUDIES

Bassioni, L-E, I Barakat, E Nasr et al (2003): “Prolonged Detection of Indigenous Wild Polioviruses in Sewage from Communities in Egypt”, American Journal of Epidemiology, Vol 158, pp 807-15.

Chakravarthi, I (2008): “Role of the World Health Organisation”, Economic & Political Weekly, Vol 43(47), 22 November, pp 41-46.

Cherkasova, E A, E A Korotkova et al (2002): “Longterm Circulation of Vaccine-Derived Poliovirus that Causes Paralytic Disease”, Journal of Virology, Vol 76(13): 6791-99.

Dove, A W and V R Racaniello (1997): “The Polio Eradication Effort: Should Vaccine Eradication Be Next?”, Science, Vol 277(5327): 779-80.

Friedrich, F (1997): “Rare Adverse Events Associated with Oral Poliovirus Vaccine in Brazil”, Brazilian Journal of Medical and Biological Research, Vol 30: 695-703.

Guillot, S, V Caro, N Cuervo et al (2000): “Natural Genetic Exchanges between Vaccine and Wild Poliovirus Strains in Humans”, Journal of Virology, Vol 74(18): 8434-43.

Hull, H F and B R Aylward (1997): “Ending Polio Immunisation”, Science, Vol 277(5327): 780.

Karakasiliotis, I, E Paximadi and P Markoulatos (2005): “Evolution of a Rare Vaccine-Derived Multi-Recombinant Poliovirus”, Journal of General Virology, Vol 86, pp 3137-42.

Kinnunen, E, O Junttila, J Haukka and T H Ovi (1998): “Nation-wide Oral Poliovirus Vaccination Campaign and the Incidence of Guillain Barre Symdrome”, American Journal of Epidemiology, Vol 147:69-73.

Nathanson, N and P Fine (2002): “Poliomyelitis Eradication: Dangerous Endgame”, Science, Vol 296 (5566): 279-70.

Nomoto, A and I Arita (2002): “Eradication of Poliomyelitis”, Nature Immunology, Vol 3(3): 205-08.

Puliyel, J M, M A Gupta and J L Mathew (2007): “Polio Eradication and the Future for Other Programmes: Situation Analysis for Strategic Planning in India”, Indian Journal of Medical Research, January, pp 1-4.

Roberts, L (2006): “Polio Eradication: Is It Time to Give Up?”, Science, Vol 312 (5775), 12 May, pp 832-35.

Sathyamala, C (2007): “Polio Eradication Programme in India: Response”, Indian Journal of Medical Research, 125: 695-96.

Sathyamala, C, O Mittal, R Dasgupta and Ritu Priya (2005): “Polio Eradication Initiative in India: Deconstructing the GPEI”, International Journal of Health Services, Vol 35(2): 361-83.

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