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, http://samawomenshealth.wordpress.com 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. TruthAboutGardasil.org 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.

Other press releases from Truth About Gardasil

• Investigate Gardasil Vaccine Risks NOW! - August 19th, 2010
• Merck wants your Tired, your Poor to be ‘One Less’ - August 16th, 2010
• Drop in Genital Wart Rates a Smokescreen for Rise in HPV Vaccine Injury? - July 23rd, 2010
• Why is Warning Others about Gardasil Dangers Considered Anti-Vaccine? - July 23rd, 2010
• Creating Markets Out of Thin Air TruthAboutGardasil Creates Vaccine Awareness Movement in Response to Merck’s Award Winning HPV Campaign - June 30th, 2010
• Report Concerning Survey of Adverse Events Following Inoculations with Gardasil® - June 28th, 2010
• Merck wants your Tired, your Poor to be 'One Less' Gardasil Access Program Targets Third World Countries - June 24th, 2010
• "What is Wrong with the Gardasil Girls Courtney's Story" - June 16th, 2010
• Spain Weighs In on HPV Vaccines - June 14th, 2010
• Gardasil Girl's Families Issue a Warning to Families with Sons to be Wary of HPV Vaccines - June 7th, 2010