‘Cervical cancer vaccine trial guidelines not followed’

The Times of India

Kounteya Sinha, TNN, Apr 29, 2010, 04.47am IST

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.

MORE…

PG

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.