Information on the demonstration project and licensing of two vaccines to prevent cervical cancer has been exempted from public disclosure under Section 8 of the Right to Information Act, 2005.
This is the reply received in response to an RTI application, submitted to the Union Ministry of Health and Family Welfare, seeking information on the status and basis of approval granted to Merck Sharp and Dohme (MSD) Corp. and GlaxoSmithKline (GSK) to import, sell and market Gardasil and Cervarix in India, and the status, design and intent of the trials conducted by MSD and the Indian Council of Medical Research (ICMR). It also sought information on the protocols adopted for granting permission to the Program for Appropriate Technology and Health (PATH), a non-governmental organisation, and the ICMR to conduct the ‘demonstration project.'
All RTI applications have evoked a stock reply from the office of the Drugs Controller-General of India: the requested information is a “trade secret and commercial confidence of the third party and exempted from disclosure under Section 8 (1) (d) of the RTI Act.”
The applications were filed by health activist Deepa Venkatachalam of Sama-Resource Group for Women and Health. The Union Ministry of Health and Family Welfare directed them to the Central Drugs Standard Control Organisation, which responded to the applications. Another application is still pending with the ICMR.
The ‘clinical trials' of Gardasil (of Merck) and Cervarix (of GSK) in Gujarat and Andhra Pradesh were suspended in April this year after allegations emerged of violations of ethical norms by PATH, which conducted the trials for MSD and GSK. Some girls suffered side-effects after being administered the vaccine.
To a query on the design and purpose of the demonstration project, the government said the aim was to demonstrate a suitable strategy for delivery of vaccine to girls aged 10-14; to raise community awareness of HPV (human papilloma virus) and cervical cancer and its prevention; to gain experience in HPV vaccination and build evidence-based vaccine delivery strategies for introduction of HPV. However, information on the protocols followed during the demonstration, the criteria for selection of the area and population, and the approval for the project has been withheld.
Responding to another query whether the demonstration project was a clinical trial, and if so, which phase it was in, the government said it was “phase IV” of post-licensure observation study under the Drugs and Cosmetics Act. It said documents related to the project were exempted from public disclosure.
“We are not going into the ethics or efficacy of the vaccines but just sought information on the study design or the protocol of a demonstration project that sought to gain experience and build evidence for future introduction of HPV vaccine in the public health system. How can it be considered a trade secret,” asks Sarojini, another SAMA activist.
With reference to “RTI Act not applicable to HPV vaccine project” (August 9, 2010), the Programme for Appropriate Technology in Health (PATH) clarifies that in collaboration with State governments and ICMR, it conducted the demonstration projects to assess HPV vaccine delivery strategies as part of a global project on comprehensive cervical cancer prevention. Dr. Martha Jacob of PATH writes that the vaccines used in the study were donated by Merck Sharp Dohme (MSD) Pharmaceutical Pvt. Ltd. and GlaxoSmithKline (GSK), but no study funding has been provided by these companies to this project. Hence it would be incorrect to say that PATH had “conducted the trials for MSD and GSK.”