Three women in India have brought the world’s attention to the unethical procedures that they say have been carried out by pharmaceutical companies, the Gates Foundation and governments around the world. The Supreme Court of India should be lauded for hearing their case. What we are witnessing is a historical event. It is rare for lay people seeking justice to protect the innocent to be given the opportunity to be heard by the greatest court in their land.
Gardasil & Cervarix Head to Supreme Court in India
January 11, 2013
by Christina England
Once again Ms. Leslie Carol Botha, Women´s Health Educator and long-time advocate for HPV vaccine safety awareness, has hit the Internet by storm. On January 7, 2013, Ms Botha released an important article titled: India Women Activists Historic Writ of Petition Accepted by Supreme Court over Unethical Trialing of HPV Vaccines, Gardasil® and Cervarix®
Her article was based on a press release issued by Kalpana Mehta, Nalini Bhanot and V. Rukmini Rao, representing Gramya Resource Centre for Women from Andhra Pradesh, entitled, India Supreme Court Accepts Writ of Petition on Gardasil® & Cervarix® Licensing & Trial Violations implicating the Drugs Controller of India, PATH, ICMR and others, ordering the government of India to immediately respond.
Having worked with Kalpana Mehta, Nalini Bhanot, and Dr. Rukmini Rao for several months leading up to their historical move, Ms Botha was able to outline the course of history that led up 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. Her article is a must read.
The Writ Petition
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
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.)
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 offering post-vaccine treatment.
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.”