People's Democracy
(Weekly Organ of the Communist Party of India (Marxist)
No.
20
May 15, 2011
|
Vol. XXXV
No.
20 May 15, 2011 |
BRINDA
WRITES TO HEALTH MINISTER
HPV Vaccine
Project Marred by
Companies’ Narrow Agendas
Brinda
Karat, MP and member of the CPI(M) Polit Bureau, wrote on May 9 the
following
letter to Ghulam Nabi Azad, union minister for health and family
affairs,
regarding the HPV vaccine project.
THIS
is further to my correspondence with you regarding the HPV vaccine
project. In
my letter dated February 17, 2011, I had raised certain issues arising
out of
the interim report of the enquiry committee and requested you to take
action.
Since then, the final report has been submitted, which I have been able
to
recently access and study, along with the thousands of pages of
documents
placed before the committee. These include the reports submitted by the
three
doctors who were consulted as experts by the committee, namely Dr Rani
Kumar
(Dean, AIIMS), Dr A K Gupta (head of paediatrics,
DISTURBING
ISSUES
The
final report as well as the annexures substantiate not only all the
issues I
had raised but also raise new and disturbing issues. There has been a
serious
dereliction of duty by many of the institutions involved. In particular
the
role of the ICMR has been extremely questionable. It may be stated on
the basis
of the evidence available in the documents that the ICMR representative
and
some of its officials acted as partisans of the NGO and the interests
of the
manufacturing companies instead of as representatives of an institution
mandated to maintain as well as ensure the implementation of the
highest levels
of ethical standards in research studies. The experience of this study
clearly
shows that it is most unwise to allow an institution like the ICMR to
go in the
PPP mode, as was done for this project as this gives rise to a grave
conflict
of interest.
For
example, a perusal of the documents make it apparent that the Ministry
was mistaken
in appointing the very same ICMR official to assist the enquiry
committee who
was representing the ICMR in the Project Advisory Board (PAB) and more
importantly
as a partner (ICMR) in the project. As a partner, the said official was
responsible
for the design and implementation of the project and therefore was
accountable
for the violations. However, as an assistant to the committee he was
able to
listen in to and participate in the discussions to identify the lapses
and help
formulate the final report. The objectivity, impartiality of any
individual in
such a role is bound to be questioned. In this particular case, the
ICMR
representative played a proactive role as a partner in pushing for the
project
including persuading various committees to accept the project swiftly
on the
plea of “time constraints.” Thus, there was a clear conflict of
interest.
Indeed it may even be legitimately asked whether it was because of any
such
biases in the “assistance” given to the committee that the final
recommendations
of the committee appear as a dilution in comparison to the detailed
comments
made by the committee members as well as the reports of the experts
which are
available in the annexures and even in the main report.
A
crucial aspect raised in the discussions of the enquiry committee and
partially
reflected in the final report is the serious ethical question of
whether the
entire project itself was designed to promote the interests of the
companies.
In its meeting on September 27, 2010 (Appendix 20.5) it is noted: “…Besides
the factual information about the terms of reference the
committee was greatly concerned with the aspect of commercial
interests of manufacturers influencing the Government policy on this
expensive
vaccine. The committee observed that the study was initiated by
PATH on its
own having obtained funds from the Bill and Melinda Gates Foundation
and supply
of vaccine from the manufacturers – without any reference from the
NTAGI, the
official body of the GOI on vaccines..…It
is not clear whether the State expenses were funded by PATH or came
from their
own resources. The monetary contributions of ICMR are also not clear.
The
committee therefore felt that it would be in the fitness of the inquiry
to
document the sources and magnitude of funding of the study”
Although
the committee decided that collection of information on the above
issues would
be followed up by the ICMR scientist who functioned as the secretary of
the
committee, unfortunately it appears from the papers available that this
crucial
information was not provided to the committee and the questions
remained unanswered.
In
this connection it is relevant to also mention that one of the roles
assigned
to ICMR in the MOU signed by the director of the ICMR is “Advising on
plans for
results dissemination to support decision making for use of the HPV
vaccine.”
How could the ICMR have committed itself to support “the use of the HPV
vaccine” in an MOU signed in the year 2007 even before the vaccine was
licensed
for sale in
I
request you to ensure that the necessary information is collected so
that the
issue of funds as well as whether it was wise to accept such a project
by the
ICMR in the first instance may be better addressed.
NATURE
OF
PROJECT
A
related issue is the very nature of the project. This is not an issue
of
semantics but one which deeply concerns the rights and interests of the
subjects of such a vast vaccination project, particularly when the
subjects are
minor girls. There are conflicting statements by the parties concerned
namely
the DCGI, the ICMR, the AP authorities and the NGO. The committee has
unfortunately overlooked these conflicting statements, which are on
record.
In
Appendix 20.4 it is recorded that the DCGI representative appearing
before the committee
stated, “ DCGI considers PATH’s demonstration projects as Phase IV
trials.
It had defined objectives, a plan of study, and dealt with
administration of a
drug. As such approval for carrying out the study was provided by the
DCGI. It obligates
the PI to report any SAE to DCGI within 15 days” (Dr Somani, office
of the
DCGI,
The
expert opinion of Dr Y K Gupta, given in his report dated September 11,
2010 and
quoted in the final report of the enquiry committee (page 38) on this
issue, is
illuminating. He questions the PATH description of the project and
quotes
Schedule Y and Indian GCP guidelines. He says that since “the
demonstration
project is a study of a pharmaceutical product carried out on humans
and since
the primary objectives include the study of serious adverse effects and
since
the study has been carried out on “vulnerable populations,” “it is not
clear”
why the clinical trial protocol should not apply.
Moreover,
the Committee in the Section 7 of its findings (page 73) has explicitly
stated
that it “is of the opinion that by
whatever name you call it, the project proposal has been carried out as
research on human participants. And as such it had to follow all the
guidelines
and statutory requirements applicable for research on human
participants.
Monitoring and management of AE/SAE should have been more vigorously
pursued.”
Thus
in the name of demonstration project and in spite of the directions of
the
DCGI, the said NGO got away with a flagrant violation of the norms,
which
should have been applied. The role of the ICMR as well as the AP Ethics
Committee and the PAG is extremely questionable on this issue. It is
also
necessary to question why the DCGI remained a silent spectator when its
own
instructions were ignored.
ADVERSE
EVENTS
REPORTING
Dr
Y K Gupta in his report has been scathing in his criticism of the lack
of
rigour in the design regarding adverse events reporting. He has asked
the most
pertinent questions regarding the absence of preparedness in the event
of any
such occurrence. From his report it is clear that the side effects
mentioned by
the manufacturers themselves have been revised several times and now
include
serious health issues. He also asks the question that since there are
contraindications for the use of the vaccine, why were there no
checkups for
contraindications before the girls were vaccinated. He also concludes
that the
design neither took the issue of SAE seriously nor was there adequate
attention
paid to the need for an independent monitoring agency. Precisely
because of the
lack of independent monitoring by the project, the reports of the
deaths had an
unacceptably long time gap. Dr Y K Gupta also points to the many
discrepancies
and gaps in the investigations of the deaths as shown in the documents
available.
Expert
Dr A K Gupta, in his detailed report of the deaths of the girls, while
concluding that “there is no common pattern to the deaths that would
suggest
that they were caused by the vaccine,” is sharply critical of the
delays in the
reporting of the deaths in violation of the guidelines, both in AP and
Gujarat,
and comments that it is most unusual that there was no diary card based
reporting of adverse events for assessing minor or major adverse events
in the
study protocol in such a large observational study. He has shown that
the
design of the project resulted in gross under reporting of adverse
events and
questioned the figures of the reported non-serious adverse events. He
also
comments that the insurance cover for the girls should have been
ensured, which
was not done.
Thus
the opinions of the experts point not only to flaws within the design
of the project,
but also to its implementation calling into question the role of the AP
authorities,
the ICMR as well as the NGO.
INFORMED
CONSENT
Expert
Dr Rani Kumar has gone into the question of informed consent in great
detail in
her two reports. She has shown the glaring discrepancies in the consent
forms,
for example, the fact that out of 100 forms from the AP project she was
asked
to study, she found the signatures of witnesses missing in 69 of the
forms, in
many forms there were no dates, in others the signature of one person
was
apparent in several forms and so on. She comments, “All the consent
forms have
been very carelessly filled and are incomplete and probably
inaccurate.”
Further, she states, “The team involved in conduct of the study on HPV
had been
very casual in its approach and has ignored many ethical issues.” She
questions
the legality of the AP circular directing all headmasters/wardens in
all private/government/ashram
schools to sign the consent forms on behalf of the children and their
guardians. Finally, she concludes with a strong indictment, “From the
above
facts it is not clear how correct is it ethically to have vaccinated
such girl
participants.”
Thus
on all counts, the serious issues I had raised about the process of
gross violation
of the concept and legal requirement of consent have not only been
substantiated
but further evidence has been marshalled by the experts which point to
the
extent of the violations. On this basis alone, the NGO has to be made
accountable
and suitable action taken.
ROLE
OF ETHICS
COMMITTEES
Dr
Kumar also raises the very important issue of the role of the Ethics
Committees, their composition as well as the issue of registration.
Neither of
the two committees were registered She finds shockingly that, “Although
the IEC
is supposed to meet periodically to evaluate the progress of a project
and
review SAE reports, no such meetings were held by either of the
committees in
Gujarat or in AP. It was only after the reports which appeared in the
media in
AP, that IEC meeting was held.”
It
would appear that these committees exist only as a formality and have
not
played the role they are designated for. This is a clear dereliction of
duty.
The Ministry should consider whether there should be a mechanism to
take action
against such irresponsibility, more so when the Ethics Committee knew
that the
subjects were children.
WRONG
PRESENTATION
IEC
material approved at various levels asserted that the government had
started a vaccination
programme. Thus the credibility established by the public immunization
programme
was used to promote private interest. It is reported in the documents
that the
funds from the NRHM was used for monitoring and transportation of the
vaccines
to the field for use in the projects (April 15th 2010, PAG meeting). Is
this
permitted under the rules of the NRHM? It is conveniently stated that
the untied
funds may be used by the State Government according to its
requirements. But
would this include a project of this nature involving the interests of
private vaccine
companies? The wrongful use of the NRHM logo for a project implemented
by a
private agency as well as the identification of this project with the
public immunization
programme does damage to the credibility of the UIP programme as well
as the
NRHM and should be disallowed in the future. Those responsible should
be taken
to task.
CONCLUSION
I
have flagged only some of the additional evidences available in the
related documents.
I had already stated on the floor of the Parliament and I reiterate my
position
that my complaint is not against the HPV vaccines per se but against
the gross
violations in the design and implementation of the project, which have
been substantiated
by the reports cited above and which compromised the safety as well as
the
rights of the children vaccinated. I have also raised issues about the
procedures
followed by DCGI for giving licenses for import and sale of the
products by the
companies concerned, in violation of the regulations of Schedule Y of
the Drugs
and Cosmetics Act of India. I give details of these violations in a
separate
note based on the statements of DCGI officials before the enquiry
committee.
I
request you not to delay action on the report as well as the shocking
findings
of the experts about the violations in the project and the questionable
lack of
ethical standards. Those responsible must be held accountable. Strong
action is
required against officials at various levels starting with the ICMR.
The project
itself must be scrapped and in future no NGO should be allowed to take
up such
a project involving a large number of children. At the same time the
children
must be compensated for the grave violations of their rights, as
suggested by
one of the committee members, through the required insurance mechanism.
This
project was proudly proclaimed as “the first of its kind project” by an
ICMR official.
Unfortunately, it turns out that the first of its kind project should
also be
the last of its kind project, if the narrow agendas of the companies
pushing
for the sale of their vaccines in the Indian market through access to
the
public immunization system, are not to be the driving force behind our
research
studies.
Your
step to set up a committee was welcomed across the board in Parliament.
I hope
you will take the next logical step of taking action against those
responsible
for violations. It is only such action that will ensure accountability
in
institutions like the ICMR and the DCGI.
