Fresh row over vaccine trial

Centre shielding HPV study protocols from health workers

“The Drug Controller General of India’s (DCGI) office has used a section of the Right to Information Act to deny information on the study protocols as a trade secret and commercial confidence of a third party,” four Indian health workers wrote in a letter to the latest issue of the journal “Lancet”.

The Indian Council of Medical Research too denied information invoking intellectual property rights issue even though it was not clear how information on a public health study done in association with the governments could be a trade secret, they argued.
The trial of two vaccines against HPV for preventing cervical cancer was conducted in 2009 in Khamman district of Andhra Pradesh and Vadodra in Gujarat. Close to 25,000 girls were given three doses of the vaccine.

But after gross violations of ethical norms in conducting the trials surfaced along with reports of death among a few girls who were given the shots, the Central government stopped the trials and ordered an inquiry. The probe panel has recently submitted its final report, which has not been released to the public.

“Protocols are supposed to be in the public domain. Without the protocol, nobody knows what kind of trials were being conducted,” Amit Sengupta from People’s Health Movement and one of the authors of the Lancet letters told Deccan Herald.

“We have now written to the Central Information Commissioner to reveal the information,” said Y Madhavi, another author of the letter and a scientist at the National Institute of Science, Technology and Development Studies, here.  The public health workers also countered the arguments of foreign researchers who blamed the public health activists to stymie the trials for a vaccine, which they claimed was useful.

Research done in the public domain must involve the communities affected and  based on the country’s public health priorities. The focus must be on maximising investment in priority health issues, ensuring safety of health interventions and following not only the letter but also the spirit of ethical protocols and legal obligations, the Indian public health activists said.

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