India’s Supreme Court to study violations in licensing and trials for Cervarix and Gardasil

Many of these young women had been coerced into accepting the vaccine

By CHRISTINA ENGLAND | VACTRUTH | JANUARY 9, 2013

On January 7, 2013, Ms. Leslie Carol Botha, Women’s Health Educator and long-time advocate for HPV vaccine safety awareness [1], released an urgent article entitled: India Women Activists Historic Writ of Petition Accepted by Supreme Court over Unethical Trialing of HPV Vaccines, Gardasil® and Cervarix®.

Based on the press release issued by Kalpana Mehta, Nalini Bhanot and V. Rukmini Rao, representing Gramya Resource Centre for Women from Andhra Pradesh, titled, “India Supreme Court Accepts Writ of Petition on Gardasil & Cervarix Licensing & Trial Violations” implicating the Drug Controller of India, PATH, ICMR and others, ordering the government of India to immediately respond. [2]

Botha outlined the course of history that led to this groundbreaking hearing, as well as the violations that occurred during the clinical trials and the undisclosed international agenda among the Bill & Melinda Gates Foundation (BMGF), the Program for Appropriate Technology in Health (PATH) and the World Health Organization (WHO) to unduly influence the Indian government to adopt the vaccines for introduction in the public sector. Botha also detailed the Petitioners’ requests and reliefs as stated in the Writ of Petition, filed on October 29, 2012.

TAKING ACTION

On October 29, 2012, activists Kalpana Mehta and Nalini Bhanot, along with Dr. Rukmini Rao, President of the Gramya Resource Centre for Women in India, filed a writ petition with the Supreme Court of India under Article 32 of The Constitution of India for Women. The petition was filed against:

• Drug Controller General of India

• Indian Council of Medical Research

• State of Andhra Pradesh

• State of Gujarat

• PATH International

• GlaxoSmithKline Asia Private Limited

• MSD Pharmaceuticals Private Limited

(A writ petition is a document filed to the court that includes an introduction to the issue and an explanation why a petition is needed as a means of preventing irreparable harm. The explanation is supported with allegations by the Petitioner and a memorandum of the issues raised.) [3]

The petition outlines a series of serious allegations regarding the HPV vaccines Gardasil and Cervarix. Petitioners Kalpana Mehta, Nalini Bhanot and Dr. Rukmini Rao reported that the two HPV vaccines were illegally brought into the states of Andhra Pradesh and Gujarat and subsequently administered to thousands of young, vulnerable Indian children before the vaccines were known to be safe.

The three Petitioners told the court that even though the Indian government and the above organizations knew the HPV vaccines were of dubious value and of speculative benefits, they continued to allow a trial using both the Gardasil and Cervarix vaccines without regard to the potential endangerment of the lives of adolescent girls.

The petition outlined how the above organizations vaccinated tens of thousands of vulnerable girls aged between 10-14 years and then abandoned them without providing any information on potential adverse reactions, scheduling follow-up examinations, or 0ffering post-vaccine treatment.

THE UNETHICAL EXPERIMENT

The vaccines were introduced to the public sector by carrying out a trial vaccinating 16,000 adolescent girls (10-14 years) in Andhra Pradesh and an equal number in Gujarat. The petitioners believed that by vaccinating children with HPV vaccines while being fully aware of the potential dangers, the organizations involved knowingly put the lives of tens of thousands of children at risk from potentially serious vaccine-related adverse reactions and death.

The Petitioners stated that the unlicensed HPV vaccines only became licensed midway through the project:

“These vaccines had not been assessed with respect to safety and efficacy for the Indian population where adolescent girls are overwhelmingly anemic and malnourished. No steps were taken to ensure the health and safety of the girls. They were not screened adequately for contraindications. On the contrary, they were told that the vaccine had no adverse effects, not even those that were acknowledged by the manufacturers. Referral and treatment of serious adverse effects was not planned and as a result, private doctors and government hospitals were not aware that the girls coming to them in serious condition were subjects of vaccine trials. No monitoring of the program was done. No course correction was made. After vaccination, the girls were dumped with no follow up.”

To further support their claims, the Petitioners shared a statement, which had been published on the WHO website:

“The short (2-3 years) post marketing surveillance periods of these vaccines do not permit final assessments of possible rare or long-term adverse effects.”  [4]

All girls were vaccinated by the U.S.-based NGO (Non Government Organization) and PATH (Program for Appropriate Technology in Health).

DEATH AND DECEPTION

As stated in the petition, the project was discontinued only after several women’s organizations reported:

• deaths among the participants
• the use of vulnerable population
• lack of informed consent

The Petitioners accused project leaders of falsification of the records and stated that the project had been carried out with severe lack of monitoring, stating that PATH and the Indian Council of Medical Research (ICMR) as well as state authorities covered up the adverse effects and deaths that have been described in the petition:

“Some of the girls died. Some suffered serious adverse effects. Some of the girls developed autoimmune diseases that would require lifelong care. The manufacturers themselves acknowledged adverse events such as anaphylactic shock, seizures and paralysis, motor neuron disease, blood clots, eye, ear and vascular problems and even death, and problems affecting the nervous system, the immune system, the musculoskeletal system, the blood and lymphatic system, the respiratory system, the gastrointestinal system and the vascular system. In the PATH project, these adverse events were grossly under reported and hidden. Records were falsified. Deaths that took place were stated as having nothing to do with the administering of the vaccines and were described as deaths due to suicides, insecticide poisoning and snake bites.” 

In an interview, Kalpana Mehta told me there had been gross anomalies in the death-related documentation, indicating a cover-up and that even the age of the girl who died failed to match the projects records. She said:

“The dates of postmortems were poorly documented and inaccurate and instead of being written on hospital stationary many had been written on plain paper without signatures.”

CONFLICTS OF INTEREST

The citizens of India have every right to be concerned. It appears that their government officials have fallen prey to collusion of international agencies and non-governmental organizations (NGOs), including the Bill and Melinda Gates Foundation, PATH and WHO. They have allowed tens of thousands of young, vulnerable, rural Indian children to be involved in the HPV vaccine experiment, with no benefit.

Ms. Mehta says:

“Even a government appointed inquiry committee found gross irregularity with the consent process. Indian law provides for compensation for violation of the informed consent procedure in addition to the compensation for death and injury suffered by trial subjects. However even after two years the government has failed to act on its own inquiry.

This inquiry committee also noted that by taking vaccines free of cost from the manufacturers, the project was mired in conflict of interest. It also took strong exception to PATH ensuring itself for the project but leaving the girls uninsured.”

INFERTILITY CONCERNS

By this time, a massive 24,000 girls had already been vaccinated and, according to the petitioners, many of these young women had been coerced into accepting the vaccine. Parents were reassured, without scientific basis, that the vaccines would not impact their children’s future fertility.

Concerned about this information, the Petitioners stated:

“As of now there is alarming news of menopause setting in a 16 year-old girl from Australia, where the doctor has found Gardasil to be the only probable cause of this rarest of rare mishap.” [5]

Since the petition was submitted, yet more information on the similar plight of girls in Australia has come to light. The Sunday Telegraph has published a story, first reported in the British Medical Journal, of a previously healthy 16 year-old girl whose premature menopause may be linked to the Gardasil vaccination. [6]

According to The Telegraph, Dr. Ward told reporters that women’s fertility must be protected at all costs. Ms. Botha has been echoing Dr. Ward’s words for years. She has stressed on many occasions that vaccinating girls at menarche – the onset of menstruation, which is the most fragile reproductive time of a woman’s life – is dangerous:

“As the female hormone levels of estrogen and progesterone decrease during the premenstrual phase, the female body begins the process of releasing the uterine lining in the act of menstruation. The decrease in hormones actually affects a woman’s energy levels and her emotions. The immune system becomes more compromised, and that translates to a lowered defense system to fight off invading, foreign toxins.” [7]

CONCLUSION

There has been no evidence to suggest that any of the above crucial issues were ever considered by any of the organizations involved in these vaccination trials.

Time and again, according to the petition, PATH has denied that it carried out a trial in India. It insists that what it was doing was merely a post-licensure study. This explanation was unacceptable to the Indian government’s inquiry. It concluded that by whatever name PATH chooses to call its exercise, under the Indian Drugs and Cosmetics Act, it was indeed a clinical trial and all safeguards should have been observed. Yet PATH and WHO have hailed the trial a resounding success in order to carry on vaccinating other vulnerable communities in the third world with dangerous, potentially life-threatening vaccines.

Undeterred by the government’s silence and WHO pronouncements, the Petitioners have strongly recommended that the court cancel the product licenses for Gardasil and Cervarix and withdraw both vaccinations from the market until their safety and efficacy is proven, as per Indian regulation. Their stance on licensing resonates with democracy as the Indian Parliamentary Standing Committee on Health and Family Welfare has indeed determined that the drug regulations currently favor pharmaceutical companies unduly, leaving consumers at the mercy of untried, irrational formulations.

Acknowledgements

The author offers her sincerest gratitude to Kalpana Mehta, Nalini Bhanot and V. Rukmini Rao for their tireless efforts to restore justice and health to vulnerable populations everywhere, especially in India at this time, and for their willingness to share their petition to the court with VacTruth.

References

1. http://holyhormones.com/womens-health/cancer-womens-health/cervical-cancer…

2.  http://holyhormones.com/womens-health/cancer-womens-health/cervical-cancer/india-supreme-court-accepts-writ-of-petition-on-gardasil-cervarix-licensing-trial-violations/

3.  http://www.ehow.com/facts_6739641_meaning-writ-petition_.html

4.  http://www.who.int/immunization/HPV_ Grad_Adol_girls.pdf

5.  http://pop.org/content/teenage-girl-becomes-infertile-after-gardasilvaccination

6.  http://www.dailytelegraph.com.au/news/hpv-vaccine-link-to-infertility-needs-to-be-tested-says-miranda-devine/story-e6freuy9-1226528052334

7.  http://vactruth.com/2010/01/13/website-documents-over-300-gardasil-horror-stories/