We’ve seen a lot of India in the news recently. A lot more than we usually do. There’s an apocalypse of sorts going on there, if the popular media is to be believed. But as is often the case, these reports are devoid of any context or perspective.
While the world’s media can’t get enough of India today, in its rush to support a narrative of terror about Covid-19, twelve years ago when there was a real story going on there, the world’s media was nowhere to be seen.
In 2009, a Bill and Melinda Gates Foundation (BMGF) funded NGO carried out unauthorised clinical trials of a vaccine on some of the poorest, most vulnerable children in the world. It did so without providing information about the risks involved, without the informed consent of the children or their parents and without even declaring that it was conducting a clinical trial.
After vaccination, many of the participating children became ill and seven of them died. Such were the findings of a parliamentary committee charged with investigating this wretched affair. The committee accused the NGO of “child abuse” and produced a raft of evidence to back up its claim. This entire incident barely registered on the radar of Western media.
PATH (formerly the Program for Appropriate Technology in Health) is a Seattle based NGO, heavily funded by BMGF but which also receives significant grants from the US government. Between 1995 and the time of writing (May 2021), PATH had received more than $2.5bn from BMGF.
In 2009, PATH carried out a project to administer the Human Papillomavirus (HPV) vaccine. The project’s aim was, in PATH’s own words, “to generate and disseminate evidence for informed public sector introduction of HPV vaccines”. It was conducted in four countries: India, Uganda, Peru and Vietnam. Another Gates-funded organization, Gavi, had originally been considered to run the project, but responsibility was ultimately delegated to PATH. The project was directly funded by BMGF.
Significantly, each of the countries selected for the project had a different ethnic population and each had a state-funded national immunisation program. The use of different ethnic groups in the trial allowed for comparison of the effects of the vaccine across diverse population groups (ethnicity being a factor in the safety and efficacy of certain drugs).
The immunisation programs of the countries involved provided a potentially lucrative market for the companies whose drugs were to be studied: should the drugs prove successful and be included on these countries’ state-funded national immunisation schedules, this would represent an annual windfall of profits for the companies involved.
Two types of HPV vaccine were used in the trial: Gardasil by Merck and Cervarix by GlaxoSmithKline(GSK). In this article, we are going to examine PATH’s trial of Gardasil in India.
It’s worth noting here the relationship between BMGF and one of the companies whose drugs were being tested. In 2002, BMGF had, controversially, bought $205m worth of stocks in the pharmaceutical sector, a purchase which included shares in Merck & Co. The move had raised eyebrows because of the obvious conflict of interest between the foundation’s role as a medical charity and its role as an owner of businesses in the same sector.
The Wall Street Journal reported, in August 2009, that the foundation had sold its shares in Merck between 31st March and 30th June of that year, which would have been around the same time that the field trials of the HPV vaccine were starting in India. So for the entirety of this project (which was already in operation by October 2006), right up to its final field trials, BMGF had a dual role: as both a charity with a responsibility for care, and as a business owner with a responsibility for profit.
Such conflicts of interest have been a hallmark of BMGF since 2002. When Gates was making regular TV appearances last year to promote Covid-19 vaccination, giving especially ringing endorsements of the Pfizer-BioNTech effort, his objectivity was never brought into question. Yet his foundation is the part-owner of several vaccine manufacturers, includingPfizer, BioNTech and CureVac.
HPV vaccine aims to prevent cervical cancer. Gardasil had been launched successfully by Merck in the US in 2006, but its sales suffered after a series of articles in American medical journals had judged that its risks outweighed its benefits. Especially damaging was an analysis of reports made to the CDC’s Vaccine Adverse Event Reporting System (VAERS) about adverse reactions to Gardasil.
This analysis was published in the Journal of the American Medical Association (JAMA) on August 19th 2009. The 12,424 adverse reactions which had been reported included 772 which were considered serious, 32 of which were deaths. Other reported serious side effects included autoimmune disorders, venous thromboembolic events (blood clots) and Guillain-Barré syndrome.
In the same edition of JAMA, Dr. Charlotte Haug, then editor-in-chief of the Journal of the Norwegian Medical Association, wrote,
Whether a risk is worth taking depends not only on the absolute risk, but on the relationship between the potential risk and the potential benefit. If the potential benefits are substantial, most individuals would be willing to accept the risks. But the net benefit of the HPV vaccine to a woman is uncertain. Even if persistently infected with HPV, a woman most likely will not develop cancer if she is regularly screened. So rationally she should be willing to accept only a small risk from the vaccine.”
Dr. Haug also noted, “When weighing evidence about risks and benefits, it is also appropriate to ask who takes the risk, and who gets the benefit”, in a clear dig at Gardasil manufacturer Merck.
Merck’s attempts to promote Gardasil had been controversial. Dr. Angela Raffle, one the UK’s leading experts on cervical cancer screening, described Merck’s marketing strategy as “a battering ram at the Department of Health and carpet bombing on the peripheries.”
Dr. Raffle was concerned that the push to mass vaccination would harm the successful screening programme which had operated in the UK since the 1960s.
“My worry is that the commercially motivated rush to make us panic into introducing HPV vaccine quickly will put us back and worsen our cervical cancer control programme.”
When Merck launched a huge public relations campaign in 2007 to persuade European governments to use the product to vaccinate all the continent’s young girls against cervical cancer, she said:
Mass vaccination programmes (would be) a great big public health experiment….We don’t know a lot of things. We don’t know the vaccine will continue to be effective. To be honest, we don’t have efficacy data in these young girls right now. We’re vaccinating against a virus that attacks women throughout their whole life and continues to cause cancer. If we vaccinate girls at 10 or 11 we won’t know for 20 to 25 years whether it is going to work or not. This is a big thing to take on.”
So at the time that PATH was carrying out its trials in India, Uganda, Peru and Vietnam, Gardasil was a controversial vaccine: its safety, efficacy and Merck’s attempts to promote it were being questioned, not by “anti-vaxxers” and “conspiracy theorists”, but by the international medical establishment and the respected mainstream media.
THE GIRLS OF KHAMMAM
Khammam district, in 2009, was a part of the eastern Indian state of Andhra Pradesh (boundary changes made in 2014 mean that today Khammam district belongs to the state of Telangana). The region is predominantly rural and is considered to be one of the poorest and least developed parts of India.
Khammam is home to several ethnic tribal groups,with some estimates putting its tribal population at about 21.5% (approximately 600,000 people). As is common for indiginous people throughout the world, the tribal groups of Khammam suffer from a lack of access to education. Consequently, their level of literacy is of a standard considerably lower than that of the region as a whole.
Some 14,000 girls were injected with Gardasil in Khammam district during 2009. The girls recruited for PATH’s project were between 10 and 14 years of age and all came from low-income, predominantly tribal backgrounds. Many of the girls did not reside with their families; instead they lived in ashram pathshalas (government-run hostels), which were situated close to the schools the children attended.
Professor Linsey McGoey, of the University of Essex, later stated she believed girls at ashram pathshalas had been targeted for the project as this was a way of:
side-stepping the need to seek parental consent for the shots.”
Although we have seen a lot of India in the news recently, coverage of this country and its affairs is usually low-key. Despite being home to almost one fifth of the world’s population, reporting on India is sparse.
Such failings have been taken advantage of by unscrupulous profit-seekers for decades. Western media only reports on the consequences of these actions when their magnitude is too great to ignore.
We learned that up to 7,000 people were killed and more than half a million were injured after being exposed to deadly methyl isocyanate gas, following a gas leak at the Union Carbide pesticide plant in Bhopal. But we learned nothing in the years leading up to it of the culture of poor standards and disregard for regulation which was ultimately responsible for the disaster.
So it was typical that PATH’s project to administer and study the effects of the HPV vaccine went unheralded in the West. Typical, too, that the same was true in India itself: the Indian media is no more renowned for its reporting on tribal groups than the Western media is for its coverage of Indians. Despite concerns expressed about the project in October 2009 by Sama, a Delhi-based NGO that advocates for women’s health, the matter remained absent from India’s news.
This project, then, couldn’t have been more off-the-map had it taken place on the moon, and it remained so for several months until, early in 2010, stories began to filter out from Khammam that something had gone terribly wrong: many of the girls who had been involved in the trials had subsequently fallen ill and four of them had died.
In March 2010, members of Sama visited Khammam to find out more about the emerging stories. They were told that up to 120 girls had experienced adverse reactions, including epileptic seizures, severe stomach ache, headaches and mood swings. The Sama representatives remained in Khammam to investigate the situation further.
The involvement of Sama finally brought the matter to the attention of the Indian media and, amid a barrage of negative publicity, the Indian Council of Medical Research (IMCR) suspended the PATH project.
At this point the Indian Parliament’s Standing Committee on Health began an investigation into the affair.
On May 17th, Sama produced a damning report highlighting, among other things: that the trials had been promoted as a government immunisation programme and not a research project, that the girls had not been made aware that they could choose not to participate in the trials, and that parental consent had neither been asked for nor given in many cases.
The report stated that:
Many of the vaccinated girls continue to suffer from stomach aches, headaches, giddiness and exhaustion. There have been