PHA-Exch> critique of polio erdaication strategy (2)

[Claudio Schuftan]

From: Anant Phadke <anant.phadke at gmail.com>

A more detailed critique is available  in the PHM-India website.
Below a shorter version of our critique focussed only on the ethical aspects
of polio eradication.



*Some Ethical Issues in Vaccine Use in India: -*

*Two Case Studies *

*Anant Phadke******

  There are many ethical issues in designing and implementation of vaccine
policy. In this short piece I would limit myself to two recent examples in
the improper use of vaccines in the Public Health Services in India. These
examples indicate the violation by the concerned decision makers of basic
ethical principles and reflect a deeper malaise in our health care system.

Vaccines are no doubt one of the most cost effective technologies that
modern medicine has to offer. However, thanks to the lack of concern for the
people; lack of competence amongst the concerned health bureaucrats, and due
to pressure from the concerned vested interests, in recent years the policy
decisions about use of vaccines in the Public Health System in India have
not only been unscientific, but have even violated basic human rights of
thousands of people, including children. In India we can see this clearly in
case of the use of two vaccines being used in the Public Health System. –

1.       The Polio Eradication Initiative launched since 1998 is fraught
with many ethical problems, the most significant being - continued use of
additional doses of Oral  Polio Vaccine(OPV) despite a clear evidence that
this has been associated with a massive rise in the no. of paralysed
children!

2.       The policy of using the Anti Rabies Vaccine in India is marred by
the non-utilization of the Intra Dermal (ID) route of administration (thanks
to the double standards of the MNCs and the complicity of the Drugs
Controller and hence denial of this vaccine to thousands of needy people who
have sustained rabid dog bite.

 Let us briefly deliberate on these two examples.



*I*

*(Un)ethics of Excessive Use of OPV in Polio Eradication Programme*



The polio-eradication programme launched in India since 1998 is
fundamentally flawed and different public health experts have made a
detailed, fundamental critique of this policy.*[i]* This is not the place to
go into these scientific arguments. Here we would address only the ethical
implications of this policy.



*Huge Rise in limb-paralysis in children after the Polio Eradication
Initiative!*

The justification for polio-eradication or control programme is that it
would substantially reduce the incidence of lameness in children because
polio constitutes the most important cause of preventable lameness in
children. But in reality the incidence of limb-paralysis in children has
increased after the Polio Eradication Initiative. The number of cases of
Acute Flaccid Paralysis (AFP) in children increased from 3047 to 31973
during 1997 to 2006! *[ii]* When this rising trend of limb paralysis in
children was pointed out, it was argued by officials that this apparent rise
was due to better and more thorough documentation and AFP cases and due to
increase in the sensitivity of the surveillance system for recording AFPs.
It was claimed that instructions have been given to initially record any
child having any sign of any limpness as AFP, so that not single case of
polio would be missed. It was further claimed that subsequent follow-up of
these AFP cases would reveal that more and more of these AFP cases as being
non-polio cases or without any residual paralysis and finally when we reach
the stage of polio-elimination, all AFP cases would turn out to be either as
'false – positive' cases or as non-polio cases. So, it was argued, there is
nothing alarming in the steep rise in AFP cases after the polio-eradication
programme. But this argument is fallacious. If the sensitivity of the
surveillance system is increased in say in the year 2000, we would see a
steep rise in AFP cases in only 2001 and may be 2002. The continuous steep
rise in AFP cases seen every year from 1998 till today clearly shows that
the heightened sensitivity of the surveillance system is not the cause of
this galloping of the AFP cases.

The most damaging evidence against this 'heightened surveillance sensitivity
theory' has come from the detailed break up of the data on follow-up of AFP
cases in UP. This detailed break up was not being shared by the authorities
and was obtained by Dr.Jacob Puliyel invoking the Right to Information! *These
UP data revealed that* –

- *In 2005*, of the 10,055 AFP cases, only 2,553 were followed up

- Of these 217 died and 898 (39%) out of the remaining 2326, had residual
paralysis.*[iii]** *

If we were to believe in the 'heightened surveillance sensitivity' theory,
an overwhelming majority of AFP cases would not have any residual paralysis,
would have turned out to be 'false positive'. But in reality Dr. Jacob
Puliyel and others found that a follow-up of the AFP cases in UP revealed
that a whopping 39% of them turned out to have paralysis even 60 days after
the onset of paralysis. They were thus not 'false positive cases' but were
in fact cases of paralysis. These findings were confirmed again for the year
2006 also by again invoking the RTI –

*In 2006*, of a total of 10,879 cases of AFP, only 2,043 were followed up.

Of these, 989 (48.4%) had residual paralysis!*[iv]** *

That most of these cases of residual paralysis do not have polio virus in
their stools is no consolation. The point is - after the Polio Eradication
Initiative there has been a steep rise in the number of incidence of AFP and
also of residual paralysis in children. One is forced to conclude that
increased number of polio doses in this Polio Eradication Initiative has led
to this increase since such increase is not known to occur in the
polio-control programme in which a child gets 5 doses of Oral Polio Vaccine
in 18 months after birth. The mechanism for this huge increase is not clear.
But this rise should make any policy maker stand up and do something to
reverse this rise. Not only that no action was taken to reverse this trend,
even the relevant data are being suppressed. This suppression of data of
break up of follow-up of AFP cases is unethical. It is an attempt to conceal
the fact that thousands of children are getting paralysed when repeated
additional doses of Oral Polio Vaccine are being given. A rational and
humane response to this stupendous rise in paralysed children after the
Polio Eradication Initiative should be to immediately suspend the additional
doses of OPV and investigate the matter in detail. If any other scientific
explanation is found, the PIE can be exonerated. But till then to continue
with these additional doses of OPV is downright unethical; nay criminal!

It is necessary that all these children who have lost their limbs be fully
rehabilitated and their parents adequately compensated. Criminal liability
should be ascertained for those officials who have suppressed this
information of breakup of follow-up of AFP cases and those officials and
policy makers who are responsible for continuing this policy of PEI.



*No compensation for VAPP cases*

It is well known that OPV inevitably causes Vaccine Associated Paralytic
Polio (VAPP) in a miniscule proportion of OPV receivers – an average 1 case
of VAPP per 4 million doses polio. In India due to the PEI, it is expected
that annually there would be about 200 cases of VAPP till PEI continues.
These children have to sacrifice their limbs involuntarily or the altar of
'Public Good'.

The injectable Polio Vaccine (IPV) does not cause VAPP. But it was decided
that it's too costly for a developing country like India. Assuming that
there was no way to reduce its cost of production or to allocate more funds
for its use in India, it has to be accepted that VAPP is the unavoidable
cost that about 200 children have to pay annually to save the limbs of
30,000 children in India. But then at least these 200 or so children should
be fully rehabilitated and compensated.

Thanks to the technological advancements, each VAPP case can be individually
identified and distinguished from cases of 'natural polio' and paralytic
cases of non-polio origin. All such children struck with VAPP should be
fully rehabilitated and compensated. This demand was made by the Jan
Swasthya Abhiyan to the Health Minister and the National Human Rights
Commission (NHRC) during the National Hearing on 6th March 07. As a result
the NHRC thereafter has recommended such a measure but the govt. has ignored
it.

The National Polio Surveillance Project (NPSP) which publishes some other
details of the AFP cases on its website has not revealed the number of VAPP
cases on its website. Those children struck with AFP and also have the
Vaccine Virus in their stool-culture are categorized as Vaccine Virus cases
in the NPSP website data. These Vaccine Virus cases which would continue to
have paralysis after 60 days of follow-up are VAPP cases and they should be
counted separately. But NPSP has suppressed these figures. This is
unethical.

The India Expert Advisory Group (IEAG), (incidentally 40% of its members are
non-Indians and they dominate this group) which gives technical guidance to
the PEI has argued that polio caused by Polio Virus II and III has been
eradicated and the upsurge of cases of polio in 2002, 2006 was due to Polio
Virus I (P1). Hence to eradicate PI, it advised the use of monovalent OPV
consisting of five times more potent variant of only the attenuated PI
virus. This monovalent vaccine -m1OPV- was administered in UP over a large
scale. Such large scale use has not been done earlier anywhere in the world
and hence has been experimental. It has been pointed out that the vaccine
that was being used was "a new vaccine that was five times more potent than
previous vaccines, presumably also with increased likelihood of adverse
effects. No informed consent was taken, nor was the public told that the
vaccine was experimental. Efforts were made to give the impression that the
monovalent vaccine was not new but was just the monovalent vaccine used in
the 1960s, before the introduction of the trivalent vaccine." *[v]* Would
such large scale experiment have been carried out in the West from where
many of the international advisors come?

So long as polio is not eradicated world wide developed countries have to
continue polio-vaccination even if there have been no cases of polio in
these countries. Hence it is in their interest that PEI is pushed, even if
it may not be the priority of the developing countries. One way of doing
this was to push up the estimated number of cases of polio. It has been
pointed out by C. Sathyamala, "In 1988, when the WHO launched the global
eradication program, the total number of paralytic poliomyelitis cases
reported worldwide was 32,419. However, the WHO increased the figure 10-fold
to justify the claim that paralytic poliomyelitis was a major problem of
public health importance. Thus, post facto, the number of polio cases
worldwide artificially rose from about 35,000 to 350,000 for 1988. The WHO's
argument was that the reported cases were an underestimate and that they
were at least ten times more. While this may or may not be true, in 2004 we
see that the "Geneva Declaration for the Eradication of Poliomyelitis" has
converted the estimated cases (a hypothetical number) into reported cases
(real number) by a magical stroke of the keyboard. In the latest WHO
document presented to the fifty-seventh World Health Assembly in May 2004,
even the word "reported" has been deleted and the statement. Now reads,
"paralysing more than 350,000 children."*[vi]** *

This manipulation to overestimate the incidence of polio is unethical. One
would also point out that polio is only one cause of lameness in children.
In fact overwhelming majority of AFP cases are due to non-polio
entero-viruses. Hence even if polio is eradicated, it will reduce lameness
in children by only about 20%. We should certainly try to prevent polio even
if we can not prevent other causes of children. But to create an impression
that we are eliminating lameness in children through polio-vaccination is
misleading and hence unethical.



*To summarize,* the PEI has been quite problematic on ethical grounds. –

§      The incidence of polio has been highly overestimated by manipulation;


§      The number of VAPP cases has been suppressed and there is no plan for
rehabilitation and compensation to VAPP cases.

§      The PEI relentlessly continues with additional doses of OPV despite
the fact there is steep rise in incidence of AFP resulting into loss of
limbs of tens of thousands of children as there is residual paralysis in
about 40% of these AFP cases.

§      Monovalent polio-vaccine is being pushed on a large scale without
following the ethical norms for this large – scale trial.

***************

* *Co-ordinator, **SATHI-CEHAT, 3&4, Aman Terrace, Plot No. 140, Dahanukar
Colony, Kothrud, Pune – 411029 Tel: 020-25451413; phone fax 020 – 25452325,
cehatpun at vsnl.com*
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