Concerns surrounding Bill Gates’ involvement in HPV vaccine trials, marred by serious irregularities and fatalities, raise questions about ethical conduct. What is Bill Gates up to with vaccine-related deaths underreported and press freedom restricted?
After reading the 72nd report by the Department Related Parliamentary Standing Committee on alleged irregularities in studies involving HPV vaccines by Path in India, it was surprising to see Bill Gates nodding and smiling enthusiastically on prime time television while the Prime Minister addressed him in Hindi about his plans for the country. The memory of the public tends to fade quickly, allowing politicians of all kinds to continue their policies without considering the impact on public health.
Dr. Peter Daszak testified at a hearing held by the House Select Subcommittee on the Coronavirus Pandemic, just days after whistleblower documents revealed more details about dangerous research conducted in Wuhan.
In 2010, news stories about the deaths of female children in Andhra Pradesh after receiving HPV vaccines shocked “the entire world.” This project was reportedly funded by the Bill & Melinda Gates Foundation. The role of government agencies such as the Indian Council of Medical Research (ICMR) and the Drug Controller General of India (DCGI) in approving these trials, along with the misuse of government funds for a “private project of dubious nature,” came under parliamentary scrutiny. The unauthorized use of the National Rural Health Mission (NRHM) logo to lend respectability and official endorsement, along with the National Ethical Committee’s approval of these trials, were also questioned. Disturbed by these reports, “the Central Government directed an enquiry be conducted by the premier investigation agency,” and state governments were advised to halt further vaccinations during the investigation period.
The committee assigned to investigate the matter discovered that it seemed “very intriguing and fishy.” They pointed out that the monopolistic nature of the product being promoted and the vast market potential suggested a “well-planned scheme to commercially exploit a situation,” which would generate significant profits for manufacturers through automatic sales, year after year, without the need for promotional or marketing expenses. The American organization Path was accused of resorting to subterfuge, and its actions put the “interest, safety, and well-being of subjects” at risk. As early as 2006, the committee found that the main objective of Path was to push the introduction of the HPV vaccine Gardasil into government-funded immunization programs in India.
Experts consulted by the enquiry committee indicated that “the design of the project itself was faulty.” They observed that the survey documents lacked a section for serious adverse events, even though “severe allergic reactions and other considerable side effects were well known” before the trials began. ICMR was concerned about bad publicity due to side effects, which led Path to avoid providing “urgent expert medical attention in cases of serious adverse events,” despite these being known or anticipated. There was also no preparation for dealing with severe incidents like cardiac arrest and seizures at the vaccine administration sites, and no insurance coverage for the children involved.
The committee took note that “both the Ethics Committees existed as a formality” and highlighted a “clear dereliction of duty.” They remarked that the credibility of the Universal Immunization Programme was being used to promote “private, foreign interest” and advised against “diverting public funds for advancing interest of a private agency” in the future.
The Committee discovered that the project was “reportedly funded by Bill and Melinda Gates Foundation,” and that “vaccines were donated by the manufacturers.”
When the Committee inquired “whether criminal enquiry was initiated against Path,” they did not receive a response. In reviewing the action taken report, “the Committee was amazed at the audacity of DCGI to merely repeat various steps to be taken as if they were new additional measures.” Aside from a slight adjustment to the informed consent form, there was nothing new in the report, and no one was held accountable.
Regarding the American organization Path, the Committee expressed concern that it established an office in India without obtaining the necessary mandatory approvals or permissions. They found it “surprising that security and intelligence agencies did not raise an eyebrow” about how a foreign entity entered India through the back-door. The Committee concluded that the actions of Path constituted “a serious breach of trust, of medical ethics, and a clear cut violation of the human rights of these girl children.”
The Parliamentary Standing Committee questioned the Indian Council of Medical Research’s (ICMR) decision to endorse the HPV vaccine for inclusion in the Universal Immunization Programme in 2007, which was a year before the vaccine received approval in India in 2008.
The Committee also reiterated the Central Drugs Standard Control Organization’s (CDSCO) guidelines that no clinical trials on children should take place until trials on adults have confirmed the vaccine’s safety and efficacy. This project planned to vaccinate about 30,000 children aged 10 to 14 years. The alarming factor was the reported deaths among children following vaccination, which were dismissed as “unrelated to vaccination without in-depth investigation.”
Regarding informed consent, the ICMR admitted that there were “gross violations of norms in Andhra Pradesh.” Of the 9,543 consent forms signed, 1,948 had thumb impressions, and 2,763 forms were signed by hostel wardens. In Gujarat, 6,217 forms were signed, and 3,944 had thumb impressions. Many parents or guardians were illiterate and could not even sign their names in their native language. Hostel wardens, teachers, or headmasters signed on behalf of the children without written authorization from the parents or guardians. Several forms lacked witness signatures, and photo identification of parents, guardians, or wardens was not affixed to the consent forms. Investigators did not sign many forms, and in some cases, the parents’ or guardians’ signatures did not match their names. Furthermore, the date of vaccination on some forms was earlier than the date on which the form was signed. The Director General of ICMR conceded that “many consent forms were filled up by the principal on behalf of the students,” acknowledging the existence of “gross violations in the recording of serious adverse effects.” The Committee concluded that these consent forms were completed in a careless manner, were “incomplete and inaccurate,” and contained “grave irregularity.”
Senior officials acknowledged that the Indian Council of Medical Research (ICMR) being part of the Project Advisory Committee indicated a “conflict of interest,” suggesting that ICMR had a moral responsibility for the many irregularities that were reported. This lack of proper conduct led to ICMR “apparently acting at the behest of the manufacturers.” For instance, “States were not even capable of monitoring the adverse effects.” The Committee harshly criticized Path, noting that its actions deserved “the strongest condemnation.”The Drugs Controller General of India (DCGI) also faced intense criticism. The Committee stated that “DCGI played a very questionable role… remained as a silent spectator even when its own rules and regulations were being so flagrantly violated.” This suggested that the regulatory body did not take appropriate action despite clear violations of its rules.The Parliamentary Standing Committee identified conflicts of interest in the makeup of the Enquiry Committee. There was no disclosure of any conflict by the Enquiry Committee members or experts. The Committee discovered that one individual accepted the hospitality of the trial sponsors during a conference in Seoul, without revealing this connection. When the Committee inquired into the matter, they found that this “serious matter” was handled in a “casual manner.” This indicated a general lack of seriousness in addressing conflicts of interest.
The success of vaccine manufacturers and promoters in evading accountability for numerous illegalities in marketing HPV vaccines, along with their endorsement by the Prime Minister of India, set the stage for the covert approval of COVID-19 vaccines in India. Serious adverse events related to these vaccines were kept hidden from public knowledge. The actual count of people who may have died due to vaccine-related reasons may never be known. The unexpected and unexplained deaths of young people shortly after getting vaccinated are likely to remain uninvestigated. The judiciary seems reluctant to allow any inquiries, perhaps due to concerns that such scrutiny could fuel vaccine hesitancy. As a result, the large number of deaths potentially linked to COVID-19 vaccines has become India’s best-kept secret. Meanwhile, there are excellent studies ready for publication that explore these issues but cannot find a willing outlet due to the restricted freedom of the press in India.
This article was authored by Colin Gonsalves.
