Immediate Action to Prevent Cervical Cancer Deaths Key to Achieving Women’s Health Goals/Trial and Error: Ethical Violations of HPV Vaccination Trials in India

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North Hollywood, California, June 21, 2010 — Within the last month reports from two women’s organizations focused global attention on the silent epidemic of sexually transmitted diseases (STD’s) and their plans to provide accessibility to care.

On June 8, health leaders at the WOMEN DELIVER conference in Washington D.C. called on the international community to commit resources to ensure women and girls have equal access to cervical cancer prevention technologies. A Declaration for Universal Access to Cervical Cancer Prevention was issued by leading women’s health, cancer and business organizations, including PATH, International Planned Parenthood Federation and the International Union Against Cancer.

The Declaration calls for swift action by the international community to provide financial/political commitments to accessibility for cervical cancer screening, treatment and vaccination citing cervical cancer as the leading cause of cancer-related death in developing countries, killing more than 270,000 women annually.

India, May 24, SAMA – Resource Group for Women and Health, issued a declaration citing ethical violations of HPV vaccination trials after reports of four girl’s deaths following administration of Gardasil. During March 27-30, a team of concerned citizens visited one of the districts where the PATH sponsored ‘demonstration project’ was implemented.

Most vaccinated girls were residents of boarding schools. The project appeared to be in violation of ethics as wardens were providing consent for hundreds of children without consulting parents. Parents had no chance to provide informed consent, or monitor/respond to adverse developments.

Select girls were given English HPV Immunization Cards, not understood by girls, or parents. Wardens, teachers and students believed the project to be part of the public immunization program, not a research study. Nor were they aware they had a choice regarding participation.

They thought the government was providing life- long protection with a free expensive vaccine to prevent ‘uterine’ or ‘cervical cancer’ with no side-effects or impact on fertility.

SAMA reports vaccinated girls continue to suffer from stomachaches, headaches, giddiness and exhaustion with reports of early onset of menstruation, heavy bleeding, severe menstrual cramps, extreme mood swings, irritability, and uneasiness. No systematic follow up or monitoring has been carried out by vaccine providers.  Vulnerability is compounded by of lack of information, health care access and mechanisms for reporting adverse effects.

Trial has been suspended temporarily by the government after a strong campaign by health networks, women’s groups and parliamentarians. A committee has been set up by the government to conduct an inquiry.

April 22, The Ministry of Health and Family Welfare, conceded the vaccination project was a “post-licensure operational research study,” confirmed to be a Phase IV, post marketing, clinical trial and that ethical guidelines had been flouted.

Interesting to note PATH sponsored both the trials and the Women Deliver conference raising questions of motivation, integrity and ethics. believes subjecting vulnerable populations to potentially thousands of adverse reactions and/or death by promoting current HPV vaccines without informed consent is unacceptable – especially from women’s health leaders.

Contact Information

Bobbi Cowan
Bobbi Cowan Public Relations
North Hollywood
Phone: (818) 980-2372
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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.