India's premier research organistaion has violated its own ethical guidelines by partnering in a programme that is vaccinating young girls against cervical cancer without consent, said Rajya Sabha MP Brinda Karat in a letter to Union Health Minister Ghulam Nabi Azad.
India has 1.32 lakh new cases of cervical cancer every year. Of the 2.7 lakh cervical cancer deaths globally, 75,000 occur in India.
The international NGO PATH, in collaborations with the Indian Council of Medical Research (ICMR) and the Andhra Pradesh government, is vaccinating about 14,000 girls between 10 and 14 years in Khammam district.
"This is not a phase-3 clinical trial but a post-licensure observational study as the vaccine — Gardasil by MSD Pharmaceuticals — is approved for use in India. ICMR just evaluated the study's protocols and methodology. The state has to monitor ethical compliance, but following the objections, we have asked Andhra to suspend the programme till a review is done," said Dr V M Katoch, director general, ICMR.
"It's an eyewash. The first round of vaccinations are over and second round will happen in June, after schools reopen. Currently, there's nothing to suspend," said Kalpana Mehta of Saheli, an NGO working on health issues.
The government has a bigger role to play than it is admitting, said Karat.
"The National Rural Health Mission (NRHM) logo and the NRHM district immunisation officer's address is being on the vaccination card. How can the government say it does not know about the four deaths and 120 side effects — epileptic seizures, severe stomach aches, cramps, dizziness, headaches and mood disorders, among others — following vaccinations," said Karat.
According to the records of the District Medical & Health Officer, Khammam district, two deaths were attributed to
suicide by ingestion of poison, one to viral fever and one to drowning.