Amar Jesani
Indian Journal of Medical Ethics (www.ijme.in)
Centre for Studies in Ethics and Rights (www.cser.in)
Mumbai, India
Bioethics as health activism
I have taken public position on the case around
which this presentation is structured
 I was also a member of the advisory committee of
the project for a brief while – after the data of the
formative research came in, and participated in
the committee to discuss draft report. However,
soon after I resigned from the committee.
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Framework
About India
A case study of HPV vaccine demonstration project
Learning from the case
 (a) Science and evidence
 (b) Coming together of global policy makers
 (c) Promotion of techno-managerial solutions in public health
 (d) Nation state: What is the right balance between facilitation and
regulation?
 (e) Global health governance: Is there a balance between
facilitation and regulations?
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To conclude
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The global health policies are increasingly shaped by
 (a) global trade relations giving priority to the interests
of global Corporate business,
 (b) World bank’s involvement in the field of health and
 (c) Private philanthropic foundations
The inter-governmental agency, the WHO, has
considerably ceded its powers in the global governance to
the above players
Global health policies are paying only lip service to
strengthening of the national public health system
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Dominant disease centric vertical approach is often found
to weaken the existing health systems in many
developing countries
The non-state players dominate in setting the agenda and
priorities, and they often co-opt the national elites in the
process
The international community must learn from the
experiences of the global health policies in the field
Policies without robust global and national governance
systems would not provide expected results
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High economic growth of last two decades
 Booming business – including private for- profit
pharmaceutical and hospital service sectors
 Massive export of drugs, and country opened to Medical
tourism and Clinical trials to sustain health care
business
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At the same time
 Increased inequities - Substantial proportion of
population below poverty line, illiterate or semiliterate, and discrimination in accessing health care
 Government spends only ONE percent of GDP on health
care, which is one fifth or sixth of total health care
expenditure
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No universal access to health care
 80% of health services in for-profit private sector
 10-20% covered under voluntary health insurance
 High cost of health care & over two third of health care
financed by out of pocket expenditure by patients
 Cost of health care a major cause of poverty
 Recent report for universal access system
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Health care regulations:
 Dominant for-profit private health sector covered under
grossly inadequate regulations .
 Existing weak regulations hardly implemented
Instead of putting together evidence from the
review of scientific literature, this presentation
takes up a case and tries to unravel the effect of
the global health policies at the ground level in
India.
 It argues that the complexities should not deter
us from understanding something very simple
that emerges from the analysis of practice
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Cervical cancer - a major cause of deaths of women due to
cancer. Also has a history of unethical research in India
Screening program
 1976 to 1990: A long term observational study of 1163
women with cervical dysplasia to understand causative
factors and biological behaviour of dysplasia.
 Rationale – scarce resources could be saved if dysplasias
that need intervention are identified
 This research was completely supported from Indian
sources and Indian medical scientists and institutions were
involved
 The end point of the study was carcinoma in situ (CIS) when
appropriate treatment was offered.
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In 1986, the results of the study were extensively used in
planning National Cancer Control Program for control of
cervical cancer.
 However, the screening program could never be
universalised due to low investment and weak public
health system
 So the very purpose with which over a thousand women
were exposed to risks without offering treatment was
never achieved
 Controversy in 1997
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HPV vaccine
• 2006-07: Phase IIIb marketing approval clinical trials of the
HPV vaccines to test its immunogenicity in 100 to 200 subjects
• 2008: Marketing approval by Indian drugs regulator
• 2009: Market launch of vaccine
HPV vaccine demonstration project
• 2007: PATH, in collaboration with Indian Council of Medical
Research (ICMR) and two state governments (Andhra Pradesh
and Gujarat) launched the project – funded by the Gates
Foundation
• Objective: “generating evidence the would enable policy
makers to decide on possible public sector introduction of the
HPV vaccine” in the country’s immunisation program
HPV vaccine demonstration project
2008: Completion of formative research in one district each of
two states
• 2009: Launch of demonstration project with two components:
• (a) An observational study of post-licensure HPV vaccination
(a Phase IV clinical research on a vaccine)
• (b) Evaluation of Implementation of HPV vaccination though
operational research in terms of coverage, acceptability,
feasibility and costs.
• Of the five primary outcome measures, four were assessment
of serious and non-serious adverse events and the timeliness of
their reporting
• The Companies, the producers of the vaccines, provided
vaccine free for the study (costing over $5 million)
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2010: After 23,428 girls in the age group 10 to 14 years
were vaccinated, in March it was suspended following an
investigation report by women’s health organisation,
Sama, Delhi, on the death of seven girls (5 in AP, and 2 in
Gujarat)
 2010, April: Govt appointed an Investigation Committee
 Committee submitted its final report on February 15, 2011
 The report is still not in public domain, but its interim
report released on Nov 10, 2010 is in public domain
 The report points to several concerns which are important
for their human rights and public health dimensions – so
also for the Global Health Policies
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Some of the findings of the committee:
The project, though used the national immunisation
services, was never put up for appraisal by the National
Technical Advisory Group on Immunisation
A quarter of participants were drawn from tribal
communities
 In the predominantly tribal blocks it was known that the
immunisation system was not in robust shape, with extremely
inadequate reporting and management of the Adverse Event
Following Immunisation (AEFI)
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And yet the project relied on it without enhancing its
capacity, or creating additional support structure from the
project.
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As a consequence, non-serious adverse events hardly got
recorded (0.29% to 1.37%), and there were long delays in
reporting of serious adverse events
In AP, the deaths of girls who died in July, Sept and Oct
2009, were not taken cognizance until Jan 29, 2010.
In the process, the project also blurred the distinction
between regular work of the national immunisation
program and the research project
Gave a wrong impression to people that the HPV vaccine
was a part of the national program
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Deficiencies in Informed consent:
• (a) In AP, 20% parents gave thumb impression,
• (b) In Gujarat, 37% parents gave thumb impression
• (c) The AP tribal department issued an administrative
order giving authority to hostel warden/head masters of
schools to provide consent on behalf of girls - nearly
one-third of forms were signed by them
• (d) a sample study of the forms found most of the forms
deficient in information, many names not matching
with the signatures,
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▪ (e) assent of girls not documented, though as per the
ICMR guidelines, it is mandatory to do so
• (f) at no time the participants were provided
information that the HPV is a sexually transmitted
infection; and not told about other preventive measures
available
No insurance for participants obtained, though insurance
for PATH and its researchers was purchased.
Since project did not have its own follow up mechanism,
no appropriate data on causality of girls’ death were
available, but indirect evidence suggested that deaths
were not related to the vaccine. No compensation paid.
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What do we learn from this case?
Prima facie, the researchers involved in the project
believed that once a good tool is developed by the
science, the only thing remaining for its use is to show
that it can be delivered – nothing else mattered
 Evidence is not evidence without a proof from experiment
– a wholesale application of the natural science paradigm
to the social reality
 Under development of developing societies converted
into disease emergencies
 In the “war on terror”, the doubters are unpatriotic; in the
“war on disease”, they are “against science”!
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Societies and communities are emerging as a vast terrain
for experimentation – the experiments are getting
converted into “experimentality”.
Social experiments are good when they are needed, if
 Undertaken with some credible consent of communities and
individuals involved, and protection of their safety
 And there is economic feasibility and political will to implement their
findings.
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At present, social and public health experiments are global
trends, involving researchers from all types of nations
And yet, we do not have ethical framework and guidelines
in place for protection of participants’ human rights
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The project brought together most of the key players of
the global health:
 An international foundation set up for philanthropy
 An international NGO established to do research on technologies -
an NGO that acted more like a Contract Research Organisation
 The pharmaceutical companies that donated over $5 million dollar
worth vaccines with an eye on a massive captive market
 A willing national scientific establishment that was more
interested in experiment than the feasibility of providing universal
access to the benefits of its findings to the people
 And interestingly, the WHO Bulletin was the first to publish the
findings of operation research without any mention of what
happened in that research in India
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This, indeed, was a big global collaborative research taken
with an obvious objective of impacting a nation’s public
health system.
Yet, the investigation committee or the research ethics
committees that reviewed the project, were not provided
any information on:
 Total cost involved
 Terms of agreements and contracts signed by all participating
parties
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All parties invoked “trade secret” clause of India’s Right to
Information Law when they were formally requested by
the civil society organisation to reveal those agreements
and research protocol used
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Thus, the operation of the international and national health
policy makers is shrouded in complete secrecy
The formal release and public discussion of the investigation
committee report are stalled, as government has taken no
action on its findings
Not just hard-core biomedical research for commercial
product development, but also the social research with
potential to affect lives of millions of people, is a part of the
trade policies, and secrets that surround them
A section of scientific, bureaucratic, corporate and political
elite at national level is always implicated to ensure that if
anything went wrong, there will be the least repercussion
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Lastly, something about the involvement of philanthropic
organisations in international and national health policies
What should be the role of such foundations?
 Should their dominant actions be such that consistently
and progressively the health moves from the realm of
market and philanthropy to human rights?
 Should they narrowly concentrate on the task of
plugging the market failures so that the rest of business
and trade could go on unhindered?
There is a need to engage with private players, but the
engagement ought to be for pulling them in towards the
right to health
There is no doubt that the public health systems of many
developing countries are deprived of basic technologies and
suffer from inefficient and sometimes corrupt management
practices
 The building of universal access public health system with
adequate technology and strong, transparent and accountable
management system ought to be a top priority on the agenda
of the global health policies
 Social and public health research, therefore, need to be
evaluated from the perspective of whether it would build a
good health system or break the existing one, howsoever
deficient it may be – the responsiveness requirement of ethics
thus has a massive added dimension in such research
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For this project, from the health system building
perspective, there were two important questions:
 It is known that HPV vaccine will not provide protection to a
significant number of people (over two fifth of them).
 Would the research be done in communities where the screening
and treatment program is in place?
 Would the introduction of universal screening and treatment
program go hand-in-hand with the introduction of universal
vaccination of girls?
 How would the weak public health system accommodate the
task of universal immunisation with one more vaccine?
 And above all, how cost-effective would that be as compared
to universal screening program that would build basic
laboratory and medical services?
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Social and public health experiments are often done with
an intention to keep multiple solutions ready for the
system as and when it is able to absorb their findings or, if
the system cannot absorb them in foreseeable future,
then at least some can avail of it from the market
When system is not ready, the use of its infra-structure for
experimentation, more so if that would disrupt its normal
functioning, must be critically examined
There is some lack of ethical responsiveness when
experiments are done on the poor who are unlikely to
afford when their findings are scaled up in the market
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The clinical trials outsourced in developing countries, with
research participants drawn from the poor communities
lacking access to health care, have shown phenomenal
lack of ethical responsiveness
The social and public health intervention research going in
the same direction ought to worry all of us
Lastly, the international polio eradication program –
another techno-managerial solution that disrupted
regular health services for long - and with India declared
free of polio cases, has raised concerns about the disease
eradication strategies, and about the Non Polio Flaccid
Paralysis cases getting neglected in the health system
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The HPV vaccine project would not have been possible
within the public health system without the helping hand
of the state
The reach of the global health players was such that they
could obtain from the state an administrative order
compromising rights of the participants
On May 8, 2012 the Parliament Standing Committee in its
report noted that the stated mission of the Indian drugs
regulator is “to meet the aspirations... demands and
requirements of the pharmaceutical industry”, without
any reference to protection of consumers and research
participants.
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Report provides numerous instances of drugs approved
for marketing without adequate research and the industry
drafting and obtaining support from doctors on identical
letters of recommendation to get drugs approved
Regulatory agencies are grossly under-staffed, poorly
trained in inspection and monitoring and lack competence
to scientifically evaluate research findings
If a similar investigation is done of research ethics
committees - the frontline regulators of clinical health
research going on in over 4000 hospitals and research
institutions in India – its findings would be similar
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Capture of regulators by the regulated is not new – but
the concern is that the national and international health
policies are the least committed to change the situation
There is inadequate material and human investment and
capacity building for regulations
Good governance is not possible without independent,
transparent and accountable regulators
The physical independence of regulators may have to go
hand-in-hand with the political and ideological liberation
from the deep rooted convictions of theirs that limit their
actions to facilitation without effective protection of users
of services and research participants
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The situation in the global health governance in some
ways mirror the situation at the national level in
some developing countries
The dominant players in the global policies on trade,
services and research in health are effectively allowed
to decide the system of governance themselves.
The inter-governmental agency, the WHO as a UN
body is reduced to a technical organisation without
power in the global governance
A huge proportion (nearly 80%) of funding of the WHO
comes from the partnerships it forges with the global
health players – aid funds of member states, corporate
sector, philanthropic foundations and the banking
institutions
 Such funding is conditional, short-term extra-budgetary
funds
 This compromises its constitutional mandate as against
the specific interests and priorities of individual donors
 Unlike the WTO, the WHO has no mandate to work for
compulsory dispute settlement and enforcement
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We may get carried away by the complexities of global
health policies, and conclude that there are no easy
solutions
Or we may take a view that complexities should not deter
us from finding the basic political trends that become
easily visible when the complex policies are seen from
what is happening at the ground level
To make global health policies useful for developing
countries and to establish and strengthen universal access
health care systems, we need to evolve independent,
transparent and accountable governance, globally as well
as nationally.
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Marchal Bruno et al, “Global health actors claim to support
health system strengthening: Is this reality or rhetoric?” PLoS,
2009, 6(4)
Sarojini NB et al, “HPV vaccine: science, ethics & regulation”,
2010, EPW, 45(27): 27-34. Sarojini NB et al, “Undeniable
violations, unidentifiable violators”, 2011, EPW, 46(24): 17-19)
Amit Sengupta, “Global governance of health: a minefield of
contradictions and sectional interests, Ind Jn of Med Ethics,
8(2): 86-90 (www.ijme.in)
Reports of Global Health Watch, 2005, 2008, 2011
Report of the High Level Committee on Universal Health
Coverage, Planning Commission, India, 2011
Final report of the committee appointed by Govt of India to
enquire into “alleged irregularities in the conduct of studies
using HPV vaccine” by PATH in India, Feb 15, 2011
 59th Report of the department related Parliamentary Standing
Committee on functioning of the Central Drugs Standard
Control Organisation, Government of India, May 2012
 Neetu Vashisth, Jacob Puliyel, “Polio program: Let us declare
victory and move on”, Indian Journal of Medical Ethics, Vol IX,
No. 2; April-June 2012, pages 114-117
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