India: Melinda & Bill Gates funded-Cervical Cancer Vaccine trials suspended due to ethical flaws Print E-mail

The HPV vaccine, Gardasil, meant to prevent cervical cancer among women, has reportedly led to the death of four girls who were administered the dose in Khammam district of Andhra Pradesh. Over 120 girls, who were given the shots, have reported adverse side-effects. Read More HERE

Thursday April 08 2010

Centre halts HPV vaccine project

By Aarti Dhar

NEW DELHI: In the wake of reports of violation of ethical guidelines and exploitation during the “clinical trials” of HPV (human papilloma virus) vaccine, meant to prevent cervical cancer among women, the Centre on Wednesday advised the State governments to suspend the vaccine programme until the issue is settled.

Director-General of the Indian Council of Medical Research V.M. Katoch told The Hindu that he had asked the Health Ministry, the State governments and the people not to go ahead with the programme. “There can be no compromise, if ethical issues have been violated by any non-governmental organisation or pharmaceutical company.”

“I am not prematurely judging that the NGO is at fault, but if there are allegations, they need to be investigated, and concrete evidence has to be brought to our notice. But, until this happens, the programme needs to be suspended,” he said.

CPI(M) MP Brinda Karat said it was important to know what would happen to those who were already vaccinated.

Explaining that the ICMR was only “technical facilitator,” Dr. Katoch said a memorandum was signed with PATH-International in February 2007 for a project allotted to it by the Bill and Melinda Gates Foundation for assessing the feasibility of introducing HPV vaccine in India. Merck and GSK were to provide the vaccine and ICMR helped in protocol preparation.

Initially, the NGO conducted a survey of the social acceptability of the project with the help of a questionnaire among the socially disadvantaged groups, as cervical cancer occurred more among the women from the disadvantaged sections with less health facilities and low-capacity for buying expensive drugs. By the time the trial ended, the Drugs-Controller of India gave approval for marketing the two vaccines.

Pointing out that the trial started after approval from the State Advisory Committees and the ethical committees of the Andhra Pradesh and Gujarat governments and the National Technical Advisory Group as per the agreement with the NGOs, Dr. Katoch said: “Everything was going fine until we received complaints of violation of guidelines and exploitation of people from civil society groups some months ago following the death of four girls, who were given this vaccine.”

 Thursday April 08 2010

Brinda seeks impartial probe into HPV vaccine programme

By Aarti Dhar

“Law states that no trials can be conducted among children before trials on adults”

CPI(M) Polit Bureau member Brinda Karat addresses a press conference in New Delhi on Wednesday against the use of a controversial cervical cancer vaccine on thousands of minor girls in Khammam district of Andhra Pradesh. N.B. Sarojini of SAMA is also seen.

NEW DELHI: Calling for an immediate suspension of the ‘clinical trials' of the HPV (human papilloma virus) vaccine being conducted by a non-governmental organisation with the approval of the governments in Andhra Pradesh and Gujarat, Communist Party of India (Marxist) Polit Bureau member Brinda Karat on Wednesday demanded an impartial enquiry and action against those responsible for granting permission to carry out the trials for a pharmaceutical company.

The HPV vaccine, Gardasil, meant to prevent cervical cancer among women, has reportedly led to the death of four girls who were administered the dose in Khammam district of Andhra Pradesh. Over 120 girls, who were given the shots, have reported adverse side-effects.

The trials are being described as a “demonstration project” by PATH-International, a U.S.-based non-governmental organisation, which is conducting the project for American pharmaceutical company Merck since July 2009.

The girls, aged between 10 and 14 and belonging to the most vulnerable sections of society, were enrolled in the study approved by the Indian Council of Medical Research (ICMR) and the respective State governments, and is funded by the Bill and Melinda Gates Foundation.

The objective of the two-year study is to look into the “acceptability and service delivery issues” of Gardasil, marketed in India by MSD Pharmaceuticals.

At a press conference here ­ along with representatives of the All-India Democratic Women's Association (AIDWA), Saheli, Sama, All-India People's Science Network, and the Jan Swasthya Abhiyan ­ Ms. Karat accused the pharmaceutical company of misleadingly promoting the vaccine as preventive for cervical cancer as it prevented the cancer of only two strains of hundreds that caused cervical cancer.

“The literature circulated in the project makes outright false statements about its safety, efficacy and duration of effectiveness. The girls and their parents have been told through the project documents that the vaccine will give life-long immunity, has no side-effects other than minor ones like fever and rash, and would not affect future fertility of the young girls,” the speakers said at the press conference.

Drawing attention to the gross violation of informed consent of the “subjects” being used for the trials, Ms. Karat sought to know how the Drugs Controller-General of India granted approval to the vaccine without proper research in India.

She said: “The process of licensing the vaccine in India raises many serious questions, as time and again scientific logic and the ethical guidelines have been violated at each step.

“Our law clearly states that no trials of drugs can be conducted among children before trials are conducted on adults, and the vulnerable sections of society cannot be used for human trials.

“In this case, the children from the Scheduled Castes, the Scheduled Tribes and the Muslim communities, who are economically poor, were used for experimenting. A number of children were from families displaced from Chhattisgarh, who could not even understand Telugu.”

Ms. Karat demanded that each vaccinated girl be examined by an independent authority to assess the range and incidence of side-effects, and sought an enquiry into the use of the National Rural Health Mission (NHRM) logo on the vaccination card given to the girls, which was titled ‘HPV Immunisation Card.'

“The vaccination is not part of the universal immunisation programme of the country,” she said, adding that while PATH claimed it was a promotional programme for the vaccine in India, the ICMR had clarified that it was, indeed, a clinical trial.

She had written two letters to the Health and Family Welfare Minister and was awaiting a response.

After visiting some of the areas where the vaccine was administered, Ms. Karat had said the people were given to understand that it was an expensive vaccine and that they would not be able to afford it once the company's project was over, hence they should get their daughters vaccinated.

Since the NRHM logo was on the card, the villagers went for the injection.
 Friday April 9 2010

Groups write to Azad on HPV vaccine trial

By Aarti Dhar
  • ‘Centre should come up with national policy on this kind of medical experimentation'
  • Efficacy of Gardasil and Cervarix highly suspect; serious side effects were reported
  • Set up inquiry into death of tribal girls

NEW DELHI: Close to 70 civil society groups, public health organisations, medical professionals, human rights organisations, women's groups and individuals have voiced their opposition to the nature of the HPV (human papilloma virus) vaccination ‘projects' carried out in Andhra Pradesh and Gujarat by PATH International, in collaboration with the Indian Council of Medical Research (ICMR) and the respective State governments.

They urged the Union government to come up with a national policy on this kind of medical “experimentation” and a pro-people vaccine policy based on public health needs.

In a memorandum submitted to Health and Family Welfare Minister Ghulam Nabi Azad, the groups pointed out that the efficacy of the vaccines, Gardasil and Cervarix, was highly suspect and a number of very serious side-effects, including deaths of vaccinated girls, were reported across the world.

As per extensive documentations made after fact-finding missions by local groups in Khammam district of Andhra Pradesh (where 14,000 girls in the age group of 10-14 years have been vaccinated with three doses of the HPV vaccine), 120 reported adverse side-effects.

The groups also demanded that the government set up an inquiry into the death of four tribal girls and into the side-effects of the vaccine on affected girls so that responsibility could be fixed and action taken.

All agencies involved in the project need to be held accountable and culpable for any ethical, legal, medical violations that emerge in such an inquiry, they said.

Suggesting that the State governments take immediate action ­ including providing compensation to the families that have lost their children and to the children suffering from side-effects ­ the memorandum said those administered the vaccine should be provided proper medical treatment and follow-up.

The government should place in the public domain all documents pertaining to the agreement with the vaccine manufacturers and all other bodies regarding the Centre's plan to introduce the vaccine.

The list of projects planned, proposed, approved and completed should also be made public, as also the names of the agencies involved, donors and proposed locations, and the results of the pilot phase and clinical trials.

Among the signatories to the memorandum are, the Jan Swasthya Abhiyan, the All-India Democratic Women's Association, All-India Drug Action Network, Sama-Resource Group for Women and Health, Action India, HAQ-Centre for Child Rights, Jagori, Breastfeeding Promotion Network of India, Delhi Forum, at least 26 groups and individuals from Andhra Pradesh, Mira Shiva, Saheli, and several groups from Maharashtra, Karnataka and Delhi.