The Indian Central Government have announced the suspension of the HPV vaccine project due to allegations of unethical pratices and deaths of 4 tribal girls in Andhra Pradesh.
Director-General of the Indian Council of Medical Research (ICMR) V.M. Katoch said that he had asked the Health and Family Welfare 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. The government is all for the people, and genuine issues have to be addressed.”
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.
At a press conference conducted in New Delhi on April 7 by representatives of the All-India Democratic Women's Association (AIDWA), Saheli, Sama, All-India People's Science Network, and the Jan Swasthya Abhiyan — Ms.Brinda Karat, the CPI [M] leader 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.
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.
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.
I had posted about HPV vaccine before in my other blog titled
Should I give the cervical cancer vaccine to my daughter?
My conclusion was like this.
I will not recommend HPV Vaccine with the present available scientific evidence due to the fact that the efficacy in preventing invasive cervical cancer is not much and there is a small but considerable risk of adverse events.
Even though India reports more than 70000 deaths yearly due to cervical cancer,this coslty vaccine [around 10000 Rs for 3 shots] is highly unlikely to make any change in incidence of Cervical cancer in India due to low efficacy and prohibitive cost.
Attempt by Pharma companies to make Indian Government buy such expensive and not so needed intervention through this sham of clinical trials conducted by [?pharma funded] 'NGO's has to be stopped at any cost.
Adapted from reports in The Hindu