Merck targets low-income countries for further HPV vaccination ‘projects

June 13, 1:34 AMVaccines ExaminerNorma Erickson

The recent findings of an ongoing investigation concerning HPV vaccination ‘demonstration projects’ in India have done nothing to alter Merck’s aggressive marketing efforts for their HPV vaccine Gardasil.

7 April 2010, the Director General of the Indian Council of Medical Research (ICMR) called an immediate halt to any further HPV vaccinations in India pending the outcome of an investigation into allegations of serious moral and ethical violations occurring during rural vaccine ‘demonstration projects.’ It took 58 health advocacy groups conducting their own investigation to bring these allegations to light.

22 April 2010, less than three weeks later, the Ministry of Health and Family Welfare stated that the HPV vaccination ‘demonstration project’ was actually a “post-licensure operational research study.” When pressed for further clarification, the demonstration project was declared to be a phase IV, post-marketing clinical trial.

29 April 2010, the India Council of Medical Research stated that their ethical guidelines had been flouted during the course of this clinical trial.

Just so everyone is on the same page here, we are talking about 14,000 children ages 10 to 14, many of whom were vaccinated without their parents consent, in a rural area with no access to health care facilities and since many of the girls were in boarding schools, no way for their parents to monitor their health for adverse reactions. If that is not enough, there is no system in place for adverse events to be reported should they occur.

Do we see this reported in the news? No, instead we see a newsletter about the Gardasil Access Program. The Gardasil Access Program is an organized effort to donate 3 million doses of Gardasil over the next five years to low-income countries around the world. It is a partnership between Merck & Company, Axios Healthcare Development (AHD) and Axios International. Their newsletter (link provided above) lists no less than 72 countries eligible for their program and a downloadable application form for organizations and institutions in these low-income countries to use.

There are two particularly disturbing pieces of information contained in this newsletter. Number one, is that their featured project in Bolivia found that,

Seeking formal parental consent (not normally required for vaccination in Bolivia) discouraged confidence and acceptance of the vaccine.

Number two, is “volunteers, trained by CIES, played a vital role by providing information, organising meetings to sensitize key stakeholders, obtaining consent from parents and guardians, and managing vaccination days.”

This does not sound too disturbing, unless you look up what CIES is — the organization is the Council for International Exchange of Scholars funded by the Fulbright Program. The Fulbright Program is sponsored by the U.S. Department of State.

It is not very comforting to know that our personal tax dollars are going to fund post-marketing clinical trials vaccinating young children in low-income countries, often without parental consent, in areas so rural they have no access to the annual screening required post-vaccination, and no means to report potential serious adverse events should they occur. Do these children and their families not have rights? Who is speaking for them?



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.