Cancer vaccine programme suspended after 4 girls die

Vineeta Pandey / DNAThursday, April 8, 2010 0:39 IST

http://www.dnaindia.com/india/report...ls-die_1368681

New Delhi: The Indian Council of Medical Research (ICMR) has told Andhra
Pradesh and Gujarat to immediately suspend the cervical cancer control
vaccination programme for girls. The programme is part of a two-year study
to look into the utility of a vaccine in public health programmes and
acceptability of Gardasil, the human papillomavirus (HPV) vaccine made by
Merck. Gardasil, available in medical stores across the country, is marketed
in India by MSD Pharmaceuticals Pvt Ltd.

The programme was marred by controversy after four deaths and complications
among 120 girls were reported after vaccination. The girls complained of
stomach disorders, epilepsy, headaches and early menarche. Women activists
fear the vaccine may impact the mental health of girls who have shown no
signs of distress so far.

Health ministry sources said the vaccination programme is being conducted by
Gardasil, jointly with PATH, a Seattle-based NGO, ICMR and the two state
governments. About 32,000 girls, aged 10-14, were to be tested in the study.

ICMR chief Dr VM Katoch clarified ICMR was only a technical partner, with an
advisory role, in the project. But Katoch said they were checking out who
was at fault.

Questioning the study, CPM leader Brinda Karat said: "How has the government
embarked on the study of giving three injections to the girls when it is
also planning a massive multi-centric dose determination study to see if two
doses will suffice?"

For a drug to be administered to children, Karat said, it has to go through
stages of clinical trial, including phase 3 adult clinical trials. With
Gardasil, only one trial has been carried out with a small sample of 110
girls, which has followed up with them for a month after completion of
vaccination and that too only to look at the immune response
post-vaccination, Karat said. The vaccine has also been approved for adult
women aged 27, Karat said, without any trials on them.

Karat also alleged scientific logic and ethical guidelines have been
violated at each step during drug and vaccine trials.