In Part Two of our serialisation of the book HPV Vaccine on Trial by Mary Holland, Kim Mack Rosenberg and Eileen Iorio, we analyse what happened when an NGO, supported by the Bill and Melinda Gates Foundation, recruited girls in India to test the HPV vaccine. More than 25 per cent of all newly diagnosed cases of cervical cancer in the world occur in India. It is the second leading cause of cancer death in women, claiming approximately 74,000 lives a year. Despite this large number, cervical cancer deaths by 2005 had dropped almost 50 per cent. This occurred without the vaccine and without widely accessible screening because of several factors including better hygiene, cleaner water, and improved nutrition, among others. You can read Part One here.
IN 2010 seven girls died in India allegedly after taking part in Gardasil and Cervarix HPV vaccine trials. A cover-up was then instigated stating that they had died of insecticide poisoning, snake bites or suicide, it is alleged. The vaccine trial is now being described by the Indian authorities as child abuse.
While India’s parliament says the trials were unauthorised and unethical, manufacturers Merck, GlaxoSmithKline (GSK), and their allies, strongly disagree. However, an investigation discovered that the ‘safety and rights of children were highly compromised and violated’ as it emerged that their parents and guardians had not given proper informed consent.
A fact-finding report by physicians detailed several interviews with subjects and their family members. They learned that families were told that the vaccine would protect the subjects from ALL cancers, they were not told about any side effects, and they were not provided with any medical insurance in the event of injury or death. They learned that several of the girls suffered adverse events including loss of menstrual cycles, and psychological changes such as depression and anxiety. The report concluded that ‘the safety and rights of the children in this vaccination project were highly compromised and violated’.
Here is the background.
Shortly after the US Food and Drink Administration (FDA) approved Gardasil (Merck) in June 2006, an international NGO called Programme for Appropriate Technology in Health (PATH) began a five-year project described as a ‘demonstration project’ (to test and measure effects of drugs in real-world situations). Its objective was to generate and disseminate evidence for informed public sector introduction of HPV vaccines. They chose India, Uganda, Peru and Vietnam to monitor safety and efficacy. All four countries have state-funded immunisation programmes and if Gardasil and Cervarix were adopted, Merck and GSK (the maker of Cervarix), stood to make major financial gains.
Two remote provinces in India, Andhra Pradesh and Gujarat, were chosen for the trials in 2009 and 2010. The subsequent investigation, while initially focusing on the girls’ deaths, uncovered systemic failures in government agencies and their oversight of the trials.
PATH engaged in extraordinary practices to obtain ‘informed consent’ from minors in economically vulnerable areas. Indian law requires parents’ or guardians’ consent on behalf of minors to participate in clinical trials. For the uneducated, an independent person must be present to explain and witness the consent process.
A 2011 parliamentary committee reviewed thousands of consent forms from the two provinces signed by dormitory supervisors in schools where the girls lived without their parents. These supervisors were not the girls’ legal guardians. The committee found forms with no witness signatures and signatures by thumb impression of those who could not write. Many forms had no dates. Direct interviews revealed that trial participants had received grossly inadequate information about potential risks and benefits while being offered financial inducements to participate.
The committee harshly criticised PATH’s treatment of adverse events. They noted that there were clear situations when a vaccination should not have been given to a girl, but those conducting the study ignored contraindications. The committee observed that this was ‘clearly an act of wilful negligence’. They noted that the project design failed to account for the possibility of serious adverse events and failed to provide for an independent monitoring agency. ‘Investigations into causes of deaths took an unacceptably long time’ and there were critical discrepancies in the investigation.
The report noted: ‘PATH’s wrongful use of governmental logos made it appear as if the project were part of the Indian Universal Immunisation Program.’ The committee found governmental responses ‘very casual, bureaucratic and lacking any sense of urgency’. They concluded that ‘PATH exploited with impunity the loopholes in the system’ and ‘had violated all laws and regulations laid down for clinical trials by the government’.
PATH’s sole aim had been to promote the commercial interests of HPV vaccine manufacturers who would have reaped windfall profits had PATH been successful in getting the HPV vaccine included in India’s immunisation programme. ‘This act of PATH is a clear-cut violation of the human rights of these girl children and adolescents . . . and an established case of child abuse.’
A second Parliamentary Committee report in 2013 described how PATH entered into a memorandum of understanding to study HPV vaccination with the Indian Council of Medical Research (ICMR), the highest medical research body in India. PATH said the project would vaccinate around 23,000 girls aged between ten and 14. They said it did not conform to the definition of a clinical trial, so it was an observational study.
Merck and GSK supplied the vaccine to PATH free of charge. In turn, PATH distributed the vaccines to local medical agencies free. The Bill and Melinda Gates Foundation funded the other costs of the study as part of its global public health activity.
(The Gates Foundation has invested heavily in India’s vaccine programme through two organisations that have influenced vaccine policy since 2002: the Global Alliance for Vaccines and immunisation (GAVI) and the Public Health Foundation of India (PHFI), India’s largest non-profit organisation. Pharma executives sit on GAVI’s board, which has a public-private partnership with the Indian government, providing hundreds of millions of dollars to fund vaccine programmes. Although the Indian government set up PHFI, the Gates Foundation largely funds it, causing potential conflicts of interest.)
The parliamentary committee dismissed PATH’s explanations that these studies were not clinical trials, and the report alleges that PATH resorted to subterfuge, jeopardising the health and wellbeing of thousands of vulnerable Indian girls. The report makes clear that these de facto clinical trials could not have occurred without corruption within India’s leading health organisations. The committee noted ‘serious dereliction of duty by many of the institutions and individuals involved’ and accused some of having ‘undisclosed conflicts of interest with the vaccine manufacturers’.
In October 2012, activists on behalf of the girls in the trials filed a petition in the Indian Supreme Court against the drug controller general, the Indian Council of Medical Research (ICMR), the State of Andhra Pradesh, the State of Gujarat, PATH, GSK, Merck and others. The petition alleged that the clinical trials for Gardasil and Cervarix were unethical, that the vaccine use was illegal, and that various actors enlisted girls in an experiment and then abandoned them without follow-up treatment or adequate information.
The complaint stated that ‘adverse events were grossly under-reported and hidden. Records were falsified. Deaths that took place were stated as having nothing to do with the vaccines and were described as deaths due to suicides, insecticide poisoning, and snake bites.’ To date, the case has not been heard and proceedings seem to have stalled.
Largely because of the HPV vaccine scandal, the Indian government restricted clinical trials in 2013 and forced an end to the Merck and GSK demonstration projects. That same year the Supreme Court suspended 162 drug approvals pending the creation of a better monitoring system. In 2014, the government published new guidelines for audio/visual recording of informed consent in clinical trials.
Since 2015, though, provinces obtained the right to approve some drugs without national approval, bypassing general regulators. The Delhi government launched a school-based HPV vaccination programme in November 2016, and the Punjab government followed suit in early 2017.
In the US, there are currently about 80 cases pending in federal court against Merck for injuries associated with Gardasil, with hundreds more cases likely to be filed in the coming months.
Trey Cobb, 22, was injured by Gardasil aged 14 and developed autoimmune symptoms and severe fatigue. He won a major victory recently when the federal vaccine court ruled that he is entitled to compensation under the National Childhood Vaccine Injury Act of 1986.
In the meantime, Gardasil 9, which replaced Gardasil, is expected to generate £1.2billion a year in sales.
PATH contests any notion that there may have been conflicts of interest in India: ‘Any suggestion that inappropriate collusion existed in this project is baseless, wholly inaccurate, and defies the very spirit of our cross-sector partnerships, which are essential in India and around the world.’
Merck and GSK strongly deny any wrongdoing.
The HPV Vaccine on Trial was written and researched by Children’s Health Defense legal expert Mary Holland, lawyer and advocate for autistic children Kim Mack Rosenberg, and vaccine safety advocate Eileen Iorio.