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Home News and Update Year 2010 Cervical Cancer Vaccine Trial Guidelines not Followed

Cervical Cancer Vaccine Trial Guidelines not Followed

Times of India
29 April 2010
By Kounteya Sinha
New Delhi

Even as a high level three–member committee formed by the Union health ministry is trying to probe the link between cervical cancer vaccine Gardasil and the death of four girls in Andhra Pradesh, the secretary of the department of health research has gone ahead and admitted to a parliamentary standing committee that proper guidelines on the vaccine’s administration, as prepared by the drug controller general of India, were actually not adhered to.

The report prepared by the parliamentary standing committee on health headed by Amar Singh says, “During interaction with secretary, health research, his attention was drawn towards the ongoing trials of the HPV vaccine. Attention of the secretary was drawn to DCGI guidelines whereunder third phase trial cannot be conducted on children until a similar trial was conducted on adults. It was admitted by the secretary, health research, Dr V M Katoch, that the DCGI guidelines were not adhered to in the present case.”

“Taking a serious view of the procedural and ethical lapses on the part of the ministry, the committee sought the matter of allowing trial of the vaccine as also the approval for its marketing in the country to be enquired into by the premier investigating agency and to take further appropriate follow up action in the matter. It also asked the findings of the investigative agency,” the report said.

Strangely, the admission came even as Ranjit Roy Chaudhury, a former emeritus scientist at the National Institute of Immunology, along with S P Agarwal, former director–general of health services, and Sunita Mittal, head of gynaecology at AIIMS, is investigating the link and is expected to give in their report by June.

Katoch had earlier told TOI that suspending trials of cervical cancer vaccine Gardasil was just a precautionary measure and not an endorsement that it caused complications and death in a few. Katoch was certain that the four deaths were not due to the vaccine. “It has been confirmed that while two deaths were due to poisoning, one died of drowning and another due to pyrexia of unknown origin,” Katoch had said.

Katoch has also asked the governments of Andhra Pradesh and Gujarat to immediately suspend the cervical cancer control vaccination programme for girls after complaints of violation of ethical guidelines had come in from activists.

It is estimated that cervical cancer affects about 4.9 lakh women globally each year, with more than 2.7 lakh deaths.

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