M A I N   N E W S

‘Serious lapses’ in HPV vaccine trial
Aditi Tandon/TNS

New Delhi, May 9
The government’s inquiry into linkages, if any, between the administration of HPV (Human Papilloma Virus) vaccine to seven adolescent tribal girls in Andhra Pradesh and Gujarat last year and their deaths has found serious lapses in the conduct of the said trial by partners-foreign NGO PATH and the Indian Council for Medical Research (ICMR).

Though proclaimed as a “post-licensure observational study of HPV vaccination against cancer of the cervix”, the project, suspended in April last following deaths, was indeed a clinical trial and needed to have followed protocols mandated by the Drugs and Cosmetics Act, 1954 which it didn’t, a government inquiry has concluded, without fixing anyone’s responsibility despite evidence of violation by PATH and ICMR members.

The inquiry voices concerns over hidden agenda (vaccines came free from pharma giants Glaxo Smith Kline and Merck Sharp and Dohme) to push the expensive injections into India’s Universal Immunisation Programme (UIP). Considering 1.25 crore girls enter 9 to 15 years target group annually, and vaccination per girl costs Rs 9,000, annual financial benefit to pharma majors would be Rs 11, 250 crore, were the Government to buy injections under the UIP.

Though the Committee doesn’t link vaccinations to deaths in Andhra’s Khammam (where 13, 791 girls were vaccinated) and Gujarat’s Vadodara (where 9,637 were vaccinated), it doesn’t rule it out either, observing: “The reported deaths were most probably unrelated to the vaccine. However, the cause of death in all cases could not be established with certainty”.

Read this with a shocking observation by Dr Y.K. Gupta of AIIMS, an expert assisting the inquiry, who said it was most unusual for a large observational study to not have diary card-based reporting of serious adverse events (SAE) and for it to target “vulnerable” girls despite directions that no research would be done on tribals unless of specific use to them.

Gupta concludes that the “project design didn’t take the issue of SAE seriously nor appointed an independent monitoring agency which caused unacceptable delays in the reporting of deaths. It resulted in gross underreporting of adverse events and didn’t provide insurance to girls though PATH had a cover.”

Another expert, Dr Rani Kumar, found serious discrepancies in consent forms of the vaccinated girls. Of the 100 forms from Andhra Prasdesh she studied, witness signatures were missing in 69. Over 2,763 forms out of 14,253 in Andhra had been signed by wardens/principals on the behalf of children (by the state government’s order). Kumar concludes: “The project team was very casual in its approach and ignored many ethical issues.”

The inquiry report further questions the ICMR’s role as it sided with PATH to call the project an observational study and no clinical trial. Gupta, whose expert opinion the committee cites, however concluded that the project was a clinical trial and involved the study of a pharmaceutical product on humans and four of its five primary outcomes related to the evaluation of vaccine safety. Even the Drug Controller General of India (DCGI), in April, 2009, asked PATH to follow clinical trial protocols. But in project meetings, the ICMR representative rejected DCGI’s contentions. The ICMR even signed the post-licensure study agreement with PATH in 2007 when vaccine licences were given in 2008.

Gates Foundation was funding the project.