Girls are harmed by HPV vaccine study in India

In 2009, 23,000 tribal girls living in hostels in two Indian states were inoculated with either Merck’s Gardasil or GSK’s Cervarix vaccine, for the prevention of the HPV virus said to be a cause of cervical cancer as part of what was called an observational study. During the course of the study seven girls died and many others were injured. The deaths were not investigated but were attributed to “speculative causes” such as “suicides, accidental drowning in well (why not suicide?), maleria [sic], viral infections, subarachnoid haemorrhage (without autopsy), etc.”¹.

In March 2010, a women’s non-profit conducted a fact-finding mission; they were told that as many as 120 girls experienced adverse reactions such as epileptic seizures, severe stomach ache, headaches and mood swings, as well as cases of early onset of menstruation following the vaccination, heavy bleeding and severe menstrual cramps among many students².

In April 2010, the Indian Council of Medical Research (ICMR), India’s primary governmental agency tasked with conducting biomedical research, halted the trials, which it had conducted together with Programme for Appropriate Technology in Health³ (PATH).

In 2012, a petition was brought to the Indian Supreme Court, demanding action against various government entities, PATH, and the vaccine manufacturers.⁴.

Gates Foundation found to have funded illegal clinical trials

In 2013, the Parliamentary Standing Committee on Health and Welfare of India issued a report on the “Alleged Irregularities in the Conduct of Studies Using Human Papilloma Virus (HPV) Vaccine” by PATH in India. The Bill and Melinda Gates Foundation was found to have funded PATH’s observational study of the Gardasil and Ceravix vaccines for HPV in order to determine how best to introduce it into the Indian market.  Vaccine manufacturers donated the vaccines⁵.

This was called an observational study in order to skirt rules for a clinical trial. (Emphasis in original document.)

The Committee finds the entire matter very intriguing and fishy. The choice of countries and population groups; the monopolistic nature, at that point of time, of the product being pushed; the unlimited market potential and opportunities in the universal immunization progammes of the respective countries are all pointers to a well planned scheme to commercially exploit a situation. Had PATH been successful in getting the HPV vaccine included in the universal immunization programme of the concerned countries, this would have generated windfall profit for the  manufacturer(s) by way of automatic sale, year after year, without any promotional or marketing expenses. It is well known that once introduced into the immunization programme it becomes politically impossible to stop any vaccination. To achieve this end effortlessly without going through the arduous and strictly regulated route of clinical trials, PATH resorted to an element of subterfuge by calling the clinical trials as “Observational Studies” or “Demonstration Project” and various such expressions. Thus, the interest, safety and well being of subjects were completely jeopardized by PATH by using self-determined and self-servicing nomenclature which is not only highly deplorable but a serious breach of law of the land⁶.

Among the many serious legal and ethical violations found to have occurred by PATH’s blatant violation  of “all regulatory and ethical norms laid down by the Government of India” was regarding informed consent:

… In the case of Andhra Pradesh 9,543 forms were signed, 1,948 had thumb impressions while hostel warden had signed 2,763 forms. In the case of Gujarat 6,217 forms were signed, 3,944 had thumb impressions and 545 were either signed or carried thumb impression of guardians. The data shows that a very large number of parents/guardians were illiterate and could not even sign in their local language i.e. Telugu or Gujarati.

… Out of 100 consent forms for AP Project taken for study, it was found that signatures of witnesses were missing in 69 forms. In many forms there were no dates while in others the signature of just one person appeared in seven forms The legality of the Andhra Pradesh State Government circular directing all Headmasters/Wardens in all private/government/ashram schools to sign the consent forms on behalf of parents/guardians was also questionable⁷.

Furthermore, the study documents did not include any column for Serious Adverse Events (SAE) and no diary was to be maintained as part of the protocol. Additionally, although many side effects were known before the start of the trial such as anaphylaxis (severe allergic reaction), syncope, convulsions, asthma, central demyelinating diseases, acute disseminated encephalomyelitis, Idiopathic Thrombopenia Purpura, etc., PATH did not provide for urgent expert medical attention in case of serious adverse events whether known or unexpected⁸.

Similar studies also took place in Uganda, Peru and Vietnam.

Related articles:

• Validity of the HPV Vaccine
• HPV Vaccine: Safety Research/Clinical Trials
• HPV Vaccine and Ovarian Failure
• Other HPV Vaccine Damage

Additional resources:

Indian Parliament Comes Down Hard on Cervical Cancer Trial,  https://www.sciencemag.org/news/2013/09/indian-parliament-comes-down-hard-cervical-cancer-trial