The investigations of the conduct and results of HPV vaccine trials in India (2014)
Controversial vaccine studies: Why is Bill & Melinda Gates Foundation under fire from critics in India? The Economic Times | August 31, 2014 (https://economictimes.indiatimes.com/industry/healthcare/biotech/healthcare/controversial-vaccine-studies-why-is-bill-melinda-gates-foundation-under-fire-from-critics-in-india/articleshow/41280050.cms)
In 2009, there were HPV vaccine trials using Gardasil (manufactured by Merck) administered to thousands of girls in Khammam, India.
Months later, many girls started falling ill and by 2010 five of them died. Two more deaths were reported from Vadodara, Gujarat, where an estimated 14,000 children . . . were also vaccinated with another brand of HPV vaccine, Cervarix, manufactured by GSK.
There was also an Associated Press report that many girls were hospitalized in a town in Colombia “with symptoms that parents suspect could be an adverse reaction to Gardasil.”
An Indian parliamentary standing committee investigated the irregularities regarding the studies in India and tabled its report on August 30 (2014).
Note that there were irregularities with the **CONSENT FORMS** and I would hope that we would at least expect to have consent forms for anything NEW and unusual that we are faced with here in Canada or anywhere–or any drug at all! There should be no coercion involved with any vaccination for anybody–not using someone’s job as a rationale for example–based on mere beliefs generated by marketers!
Even with consent forms, what happened:
In one village, out of 9,543 consent forms, “1,948 forms have thumb impressions while hostel wardens have signed 2,763 forms” and it was a similar scandal in the other village. A large number of the parents were illiterate.
The Indian Supreme Court asked the government agencies to explain what happened.
An NGO called Sama was told the following when they visited one of the provinces:
as many as 120 girls experienced adverse reactions such as epileptic seizures, severe stomach ache, headaches and mood swings. . . . early onset of menstruation . . . heavy bleeding and severe menstrual cramps . . .
The standing committee rebuked the state government investigations which had dismissed vaccination as the cause of death. The committee disagreed with that. They also said that the vaccine studies were carried out by an American NGO called PATH (Program for Appropriate Technology in Health).
The committee observed that after US approval of Gardasil (June 1, 2006), a November 2006 memorandum of understanding had been drawn up between PATH and the ICMR (Indian Council of Medical Research)
. . . to explore collaboration . . . to generate necessary evidence to allow the possible introduction of HPV vaccine into India’s Universal Immunization Programme
The report also mentioned that the study was funded by the Bill and Melinda Gates Foundation, which partnered with PATH for different vaccines in different countries, mainly in Africa and Asia.
Various organizations defended the project, claiming the vaccines were safe.
An activist is quoted as saying that it’s unethical when those “championing the cause of vaccines” are also “investing in vaccine development.” The Gates Foundation funded two organizations which played a major role in India’s immunization program: GAVI (Global Alliance for Vaccines and Immunization) and Public Health Foundation of India [PHFI].
The main charge against GAVI is that it has representatives from pharmaceutical companies on its board while the PHFI accepts grants from pharma companies.
Another vaccine is discussed:
Pentavalent was a vaccine begun in 2011 in India, a combination of five vaccines: “diphtheria, tetanus, whooping cough, hepatitis B and haemophilus influenza type b (the bacteria that causes meningitis and pneumonia).”
The vaccine created a furore after many infants from across the country were reported to have died . . . . A reply by the health ministry to an RTI application shows that the deaths of three infants in Tamil Nadu have “a consistent causal association to immunization”. . . . In all, 54 cases of deaths of infants who were vaccinated with Pentavalent have been classified as ‘adverse events following immunization’(AEFI) . . .
This vaccine “has been controversial in Sri Lanka, Bhutan and Vietnam, too, where it was temporarily suspended.”
. . . GAVI is a first-of-its kind funding agency that brings together poor countries, donor nations, global agencies, foundations, individual donors and pharma companies to enhance vaccination in poor countries.
In an article in the The Guardian three years ago, leaders of international aid agencies such as Oxfam and MSF said the representatives of companies needed to step down from the GAVI board.
Public health activist and pediatrician Dr Arun Gupta alleged that PHFI had a conflict of interest with its connections to pharma companies and a consulting firm.