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[e-drug] PATH: Collusive Nexus with State Agencies in India

E-DRUG: PATH: Collusive Nexus with State Agencies in India
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[In the interests of fairness we are posting the August 30 and September 3, 
2013 press releases in response to this report, from PATH, beneath the Report. 

We also remind e-druggers of the 2010 discussions on our list.
Post relating to TV report on the issue
http://www.essentialdrugs.org/edrug/archive/201005/msg00036.php
PATH's response at the time
http://www.essentialdrugs.org/edrug/archive/201005/msg00053.php
Response to PATH's response
http://www.essentialdrugs.org/edrug/archive/201005/msg00059.php
Moderator]

The following editorial on the Report of the Indian Parliamentary Committee on 
Health has appeared in September 2013 issue of MIMS (Monthly Index of Medical 
Specialities), New Delhi.

The Program for Appropriate Technology in Health (PATH), an American
charity, came to light in the beginning of 2010 when the media reported deaths
of several hapless, tribal female children after being administered Gardasil,
the vaccine against human papilloma virus (HPV) during a clinical trial in
India. The multi-party Parliamentary Committee on Health decided to
investigate the matter. Its Report was tabled in both houses of parliament on
August 30. The major findings are extremely worrying, namely:
- PATH set up an office in New Delhi in 1999 without mandatory approval from
the Ministry of External Affairs and Home Ministry. It paid no heed to the "sane
advice" of the Reserve Bank of India to take permission from relevant agencies.
Instead, the American agency claimed that it had obtained a "PAN card from
the Income Tax Department."

- In its published financial statements for the year 2008, PATH had claimed
that it received contribution "in excess of US$ 1,000" from the Indian Ministry
of Health and Family Welfare. This claim was found to be false.
- PATH started discussions with the Indian Council of Medical Research (ICMR)
in October 2006 to start the Phase IV trial when Gardasil (HPV vaccine) had
not received approval from the Drugs Controller General, India (DCGI). As per
Indian laws, Phase IV trials can only begin when a vaccine has received
marketing permission. How did PATH and ICMR know in advance that Gardasil
will be approved? Besides all matters connected with vaccines are handled
by National Technical Advisory Group on Immunisations (NTAGI), not ICMR.
But for the involvement of ICMR, the state governments of Andhra Pradesh
and Gujarat would not have agreed to be a party in a program sponsored by
an American entity.
- Thus as early as October-November 2006, it was clear that the main objective
of PATH project was to generate evidence that would facilitate the introduction
of HPV vaccine Gardasil into government-funded immunization program in
India. This was nothing but a promotional activity for the benefit of Merck
because at that time only one HPV vaccine, Gardasil had been approved
abroad, though not in India.
- DCGI approved both Gardasil and subsequently Cervarix of GlaxoSmithKline
in violation of laws.
- Informed consent was not obtained in respect of a very large number of
children from their parents/guardians as per Indian rules.
- No arrangements were made at the sites of vaccination to deal with known,
expected side effects of HPV vaccines including anaphylaxis, syncope,
convulsions, asthma, central demyelinating diseases, acute disseminated
encephalomyelitis, idiopathic thrombopenia purpura etc.
- Deaths that occurred after vaccinations were not properly investigated. DCGI
failed to discharge its statutory duty of protecting the interest of girls who 
were
enrolled in the trial.

The Parliamentary Committee also castigated the Health Ministry for having
appointed an Enquiry Committee to investigate the PATH trial with at least one
member, Dr. Sunita Mittal of the Department of Obstetrics and Gynaecology at
the All India Institute of Medical Sciences, with clear Conflict of Interest. 
She
had visited Seoul to participate in the First Symposium on HPV Vaccination
that was fully funded by manufacturers of the vaccine. How could she be
entrusted with the task of enquiring into the deeds and misdeeds of her
benefactors? Besides as a government employee she was not
even allowed to accept any funding from foreign sources.

Dr. Pankaj Talwar, MD.
"Dr. Pankaj Talwar" <drptalwar@yahoo.co.uk>
.............................................................................................................................................

http://www.path.org/news/press-room/642/
Statement from PATH: cervical cancer demonstration project in India
Contact: Amy MacIver, 206.302.4522, amaciver@path.org.
Updated September 3, 2013.

As media coverage and discussions unfold regarding the recently released report 
from the Indian Parliament�s Standing Committee on Health and Family Welfare, 
PATH reaffirms its position on the report. While PATH welcomes the transparency 
and discussion of our work, we strongly disagree with the findings, 
conclusions, and tone of the released report and its disregard of the evidence 
and facts.

In particular, the report ignores the now voluminous evidence on the safety 
(225 KB PDF) [Go to website for links. Moderator]  and efficacy (176 KB PDF) of 
HPV vaccines and falsely suggests that deaths may be causally linked to the 
vaccines. This is not only inaccurate, but may have tragic consequences for 
delivering these and other lifesaving vaccines to those who need them most.

As with all public health projects that work to save lives through 
immunizations, the vaccines must be procured from a manufacturer. The vaccines 
used in this study were donated by the respective manufacturers, Merck & Co. 
Inc. (Merck) and GlaxoSmithKline (GSK). No pharmaceutical company was involved 
in the design, implementation, or evaluation of the project, nor did they fund 
any part of this work. PATH is a not-for-profit organization that has no 
financial stake in the vaccine and received no funding from the manufacturers 
for this work.  The study was fully funded by the Bill & Melinda Gates 
Foundation.

PATH works with hundreds of diverse partners, mobilizing the expertise and 
resources of in-country and public, private, and nonprofit entities. Any 
suggestion that inappropriate collusion existed in this project is baseless, 
wholly inaccurate, and defies the very spirit of our cross-sector partnerships, 
which are essential in India and around the world.

PATH has been a leader for the past 20 years in the effort to reduce the toll 
of cervical cancer, through screening and more recently through HPV vaccines. 
As India bears one-quarter of the world�s burden of cervical cancer, which 
kills an estimated 72,825 Indian women annually, we believe that poor and 
low-income girls in India should not be denied the right or access to this 
proven, lifesaving, and safe vaccine that wealthy and middle-class girls in 
India and around the world have access to through the private market and other 
public immunization programs. We are committed to our institutional legacy of 
ethical, evidence-based work on transformative innovations that save lives.
........

Posted August 30, 2013.

Today, the Indian Parliament�s Standing Committee on Health and Family Welfare 
released a report critical of a cervical cancer vaccine demonstration project 
conducted in India from 2009 to 2010 through a collaboration among PATH, the 
Indian Council of Medical Research (ICMR), and the state governments of Andhra 
Pradesh and Gujarat.

PATH welcomes public discussion about the role of vaccines in preventing 
life-threatening diseases such as cervical cancer, and we thank the committee 
members for their time and effort in reviewing this matter. We support the 
adoption of reasonable measures to further strengthen and clarify protections 
for individuals participating in research projects. However, we are troubled by 
the report�s inaccurate characterization of this important work.

PATH, an international nonprofit organization, is committed to meeting the 
highest scientific, ethical, and legal standards in our work and to 
contributing our experience and expertise to address the burden of cervical 
cancer through transformative innovations such as vaccines. The demonstration 
project in India was part of a four-country project to explore suitable vaccine 
delivery strategies and help provide evidence for national health authorities 
to make informed decisions about the potential benefits and challenges of 
introducing vaccines against human papillomavirus (HPV), the primary cause of 
cervical cancer.    

Cervical cancer is a preventable disease, yet it kills 275,000 women every 
year, nearly all of them in low-resource countries. India bears one-quarter of 
the world�s burden of cervical cancer, which kills an estimated 72,825 Indian 
women annually.

The ICMR, India�s highest medical research authority, reviewed and approved the 
protocol for this project, including its design and methodology. At the time of 
its review, the ICMR determined the project was a post-licensure observational 
study and not a clinical trial. The project did not seek to evaluate the 
efficacy or long-term safety of the vaccines, which had already undergone 
clinical evaluation in India and had been licensed and approved by the Drugs 
Controller General of India.

The ICMR�s view was crucial, as it established the approval processes and 
protocols for the work that followed. PATH designed the project protocols in 
compliance with the ICMR�s instructions and fully complied with the ICMR�s 
requirements regarding the necessary approval processes and the requirements of 
state governments regarding consent processes.

We believe that by following the guidance provided by the ICMR, as well as two 
state governments and three ethical review committees, we designed a project 
that met or exceeded the country�s existing regulatory standards for 
demonstration projects while providing the greatest health benefit to Indian 
women.

It is important to note that the safety of HPV vaccines had already been 
scientifically established through clinical trials in India and other countries 
before any use of the vaccines in this demonstration project. Scientific 
evidence continues to show that the vaccines have excellent safety profiles, 
with more than 100 million vaccine doses delivered and not a single death 
causally associated with the vaccine anywhere in the world.

HPV vaccines are currently licensed and available in India and more than 120 
other countries. At least 40 countries include them in their national 
immunization programs. The HPV vaccines used in the project had been licensed 
and approved by the Drugs Controller General of India before any vaccines were 
administered, and HPV vaccination had been recommended by the Federation of 
Obstetric and Gynaecological Societies of India, the World Health Organization, 
and the US Centers for Disease Control and Prevention, among others. HPV 
vaccines remain available in India today from private medical providers serving 
primarily wealthy families but not from the Indian public health system.

An essential goal of the project was to understand the challenges of equitable 
introduction of HPV vaccines in routine public-sector immunization services. In 
support of that goal, state authorities and PATH worked together to ensure an 
economically diverse group of project participants, including urban, rural, and 
tribal populations. Specific districts and blocks within those districts were 
selected in consultation with state officials, the ICMR, and state-level 
project advisory groups to ensure that project participants were representative 
of all segments of society. HPV vaccines were then made available to 10- to 
14-year-old girls in the project sites, regardless of their social, economic, 
ethnic, or religious status, if their parents or guardians provided written, 
informed consent and if the girls provided verbal assent.

India bears a disproportionate share of the burden of cervical cancer deaths, 
and girls in low-income areas are least likely to have access to the vaccines 
that could save their lives. It is both scientifically sound and morally 
imperative to include underserved populations in our work to improve health in 
India and around the globe. For adult women, who would not benefit from the 
vaccine, PATH also worked to strengthen screening programs in the project areas.

The demonstration projects in India, Peru, Uganda, and Vietnam generated 
important new evidence on the best ways to introduce HPV vaccines and are 
informing the work of governments across Africa, Asia, and Latin America to 
help prevent cervical cancer deaths. The results paved the way for Peru and 
Uganda to launch national immunization programs against HPV and contributed to 
the GAVI Alliance�s decision to subsidize HPV vaccines for the world�s poorest 
countries.

PATH�s mission is to improve the health of people around the world by advancing 
technologies, strengthening systems, and encouraging healthy behaviors. We 
believe that no woman should die from cervical cancer because of where she 
lives or her economic circumstances. A comprehensive cervical cancer prevention 
strategy that includes vaccination and screening has the potential to save 
millions of lives over the next decades. PATH is committed to collaborating 
with our partners, in India and around the world, to help ensure that every 
girl has access to HPV vaccination and every woman has a chance to be screened 
for cervical cancer at least once in her adult life.
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