Human papillomavirus vaccine trials in India

The Lancet

Volume 377, Issue 9767, Page 719, 26 February 2011

Amit Sengupta a, Anjali Shenoi b, NB Sarojini c, Y Madhavi d

SAMA (Sama Resource Group for Women and Health, Malviya Nagar, New Delhi India) Letter to the Editor in Response to Recent Lancet Article:

Heidi Larson and colleagues in their Comment,1 and Mark Feinberg of Merck in his response,2 call for more effective ways to engage with public advocates who question new health interventions, or studies, particularly for diseases that affect developing countries. We disagree with Larson and Feinberg about the human papillomavirus (HPV) vaccine’s public health value and would like to reiterate the importance of transparency in research. We are dismayed by its absence in the Indian HPV projects, particularly after two of us (AS, NBS) found evidence of gross ethical violations on a visit to the project site in Bhadrachalam, Andhra Pradesh (report available from the authors).
Feinberg states that the India projects are not clinical trials, but studies to facilitate speedier access to a vaccine in the country. The Drugs Controller General of India (DCGI), in a response to an application under the Right to Information Act has described the project as involving “Phase IV studies as per the Schedule Y of Drugs & Cosmetics Act and rules there under”. The Minister of Health and Family Welfare has also described it “as an epidemiological study which needs to be carried out on a bigger population and a larger number of subjects”.3 These quotes contradict the claims that these were not clinical research. The DCGI’s office has used Section 8(1)(d) of the Right to Information Act, to deny information on the study protocols as a “trade secret and commercial confidence of third party”. The Indian Council of Medical Research has also invoked intellectual property rights to deny this information. It is not clear how information from a study done in collaboration with government organisations can be a trade secret.
Research done in the public domain must involve the communities affected, and be 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.

Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.