Supreme Court of India to Hear Case on ‘Risky’ Cervical Cancer Vaccine Drug Trials

Leslie Carol Botha: This is the moment HPV vaccine awareness advocates around the world have been waiting for.  Women in India have created history by getting their Writ of Petition heard by the Supreme Court.  The world will be watching.

Cervical cancer drug trials risky, says plea in court

The Hindu
January 8, 2013

Supreme Court of India

The Supreme Court on Monday issued notice to the Centre on a public interest writ petition against licensing of and trials with the unproven human papillomavirus (HPV) vaccines, ostensibly to treat cervical cancer.

The petition, by Kalpana Mehta and other health activists, cited the Drugs Controller-General of India (DCGI), the Indian Council of Medical Research and others as respondents. It said Gardasil and Cervarix were hazardous HPV vaccines marketed in India by MSD Pharmaceuticals Pvt. Ltd. (a subsidiary of Merck) and GlaxoSmithKline Ltd.

The petition, before a Bench of Justices K.S. Radhakrishnan and Dipak Misra, said the DCGI had granted licence for the vaccines without adequate research on their safety and efficacy, and the Health Ministry too did not inquire into their licensing as ordered by a Parliamentary Standing Committee in April 2010.

Nor did Ministry take any action on the report of its own enquiry committee, despite all irregularities of the project being confirmed. This project was meant to influence the government to adopt these vaccines for introduction in the public sector, the petitioners said.

The vaccines were genetically engineered, whose hazards were unknown even to the scientific community, the petitioners said. “Though r-DNA has been detected in Gardasil in samples from many countries, including India, MSD Pharmaceuticals, in its application for licensing, claimed that there was no hazard because there was no r-DNA.”

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Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.