WUNRN
The Hindu
"The trials were stopped only after the matter received media attention following the death of seven girls."
INDIA - US PHARMACEUTICAL COMPANIES CITED FOR IRREGULAR TRIALS OF HPV CERVICAL CANCER VACCINES & TRIBAL GIRLS' DEATHS
September 2, 2013 - Accusing the international
organisation PATH (Programme for Appropriate Technology in Health) of
exploiting with impunity the loopholes in the system during a trial of Human
Papillomavirus (HPV) vaccines, a parliamentary panel has also questioned the
roles of the Indian Council of Medical Research and the Drug Controller-General
of India in the entire episode.
The issue pertains to trials conducted by two U.S.-based pharmaceutical companies through PATH on tribal school girls in Khammam district in Andhra Pradesh and Vadodara in Gujarat in 2010.
The trials were stopped only after the matter received media attention following the death of seven girls.
In
its report on “Alleged Irregularities in the Conduct of Studies using HPV
Vaccines by PATH in India” presented to Parliament, the committee has said ICMR
representatives apparently acted at the behest of PATH in promoting the
interests of the vaccine manufacturers, and recommended that the Health
Ministry review the activities of the functionaries of the Council involved in
the PATH project
As
for the DCGI, the approvals of clinical trials, marketing approval and import
licences by the agency “appear to be irregular” and its role “in this entire
matter should also be inquired into.”
The
Department of Health Research/ICMR “have completely failed to perform their
mandated role and responsibility as the apex body for medical research in the
country. Rather, in their over-enthusiasm to act as a willing facilitator of
the machinations of PATH, they have even transgressed into the domain of other
agencies which deserves the strongest condemnation and strictest action against
them.”
The
committee failed to understand why the ICMR “took so much interest and
initiative in this project when the safety, efficacy and introduction of
vaccines in India are handled by the National Technical Advisory Group on
Immunisation.”
How
could the ICMR commit itself to supporting “the use of the HPV vaccine” in an
MoU signed in 2007, even before it was approved for use in the country, which
actually happened in 2008? The committee also questioned the ICMR’s decision to
commit itself to promoting the drug for inclusion in the Universal Immunisation
Programme before any independent study on its utility and rationale of
inclusion in the UIP was undertaken.
Describing
the entire matter as “very intriguing and fishy,” the committee said the choice
of countries and population groups (India, Vietnam, Uganda and Peru); the
monopolistic nature, at that point of time, of the product being pushed; the
unlimited market potential and opportunities in the universal immunisation
programmes of the respective countries “are all pointers to a well-planned
scheme to commercially exploit a situation.”
Had
PATH been successful in getting the HPV vaccine included in the universal
immunisation programme of the countries concerned, windfall profits would have
been generated for the manufacturer(s) by way of automatic sale, the committee
said. It asked the government to take up the matter with these countries
through diplomatic channels.
Flouting
ethics
Drawing
attention to gross violation of ethics during the conduct of trials, the
committee members said that in Andhra Pradesh out of 9,543 consent forms, 1,948
had thumb impressions, while hostel wardens signed 2,763 others. In Gujarat,
out of 6,217 forms, 3,944 had thumb impressions. The data revealed that a very
large number of parents/guardians were illiterate and could not even write in
their local language, Telugu or Gujarati.
It
was shocking to find from one of the reports that out of 100 consent forms for
Andhra Pradesh, project signatures of witnesses were missing in 69 forms. In
many forms there were no dates. One particular person had signed seven forms.
In fact, the legality of the State government directing headmasters of all
private/government/ashram/schools to sign the consent forms on behalf of
parents/guardians was highly questionable. The absence of photographs of
parents/guardians/wardens on consent forms and of signatures of investigators,
the fact that signatures of parents/guardians did not match with their names;
and the date of vaccination being much earlier than the date of signature of
parents/guardian in the consent forms spoke of grave irregularities, the report
said.
The
committee said PATH should be made accountable and the government should take
appropriate steps in the matter, including legal action against it for breach
of laws of the land and possible violations of laws of the country of its
origin.
Describing
this act of the PATH as a clear-cut violation of human rights and case of child
abuse, the Committee has recommended that the National Human Rights Commission
and the National Commission for Protection of Children Rights take up this
matter. The National Commission for Women should also take suo motu cognisance
of this case as all the poor and hapless subjects were female.
The
Health Ministry should report the violations indulged in by PATH to the World
Health Organisation and the United Nations Children’s Fund so as to ensure that
appropriate remedial action was initiated worldwide, the committee said.
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LINK
TO FULL ARTICLE
http://www.global-sisterhood-network.org/content/view/2771/59/
Via Global Sisterhood Network
Dr. Lynette Dumble
The Supreme Court of India admitted
the writ petition against licensing and trials with Cervical Cancer vaccines
and ordered the Government of India to immediately respond.
In what is a superb victory for the
women's movement, and for the incredibly astute research and action of Kalpana,
Nalini, and Rukmini, a research panel from the Ministry of Health & Family
Welfare has indeed responded with a 44 page report which accuses the
Gates Foundation-funded international organisation PATH (Programme for
Appropriate Technology in Health) of exploiting with impunity the loopholes in
the system during a trial of Human Papillomavirus (HPV) vaccines, and has also
questioned the roles of the Indian Council of Medical Research and the Drug
Controller-General of India in the entire episode......
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