In June 2013, Rebecca Project for Human Rights published a policy report: Depo-Provera: Deadly Reproductive Violence. Kwame Fosu, Policy Director for the Rebecca Project for Human Rights explains, “this is a definitive report that details incidents of misconduct by Pfizer major health providers.” In addition, the Rebecca Project analysis also examines reported concerns of Depo Provera research in Ghana.
Pastor Lennox Abrigo, who is President, National Action Network DC Chapter, and President of the Civil & Human Rights Depo Provera Coalition said, “this Depo Provera briefing is going to be a respectful, thoughtful discussion about the dignity and health of Black women, and women of color, in the United States and globally. Our community’s harm and voices have to be heard by our elected leaders, Pfizer, Planned Parenthood and all Public Health institutions that continue to promote this dangerous drug without Black Box warnings.”
According to the report:
The governmental imprimatur is supplied by the pro-Depo Provera policies of the USAID. This policy provides the cover for private foundation money, and our government policy is influenced and advocated by the Population Council, Planned Parenthood and population control advocates, ostensibly advocating for a woman’s right to choose. To
administer Depo Provera injections, especially if one is receiving federal funding, Medicaid and USAID payments, without enforcing full information requirements about side-effects and harm, robs millions of women of their dignity and fundamental civil rights, denying them of their inalienable right to be free to reject a dangerous drug and choose safer contraceptives. BMGF, Planned Parenthood, Pfizer and Depo Provera advocates constructively arrogate to themselves a separate standard of regulatory oversight. They illegally promote and administer Depo Provera by concealing its danger, minimizing fatal harm to women and making false claims with impunity. They are legally required to disclose side effects of Depo Provera and other drugs with Black Box warnings to patients/consumers.
In 2004, the FDA identifying that Depo Provera causes serious side-effects8 issued a Black Box Warning.
UNETHICAL DEPO PROVERA EXPERIMENTS
1967-1978: The largest test on humans of Depo-Provera begins and is conducted for eleven years through the Grady Clinic in Atlanta, Georgia on 14,000 low income women. These “trials” were conducted on women human subjects without being aware of the fact that they were part of an experiment; and, the researchers deliberately did not inform the women participants that Depo Provera had grave side effects. Many women developed cancer and/or died during the trials, but these cases were not reported to the FDA.
The director of the study, Robert Hatcher, further violated the law refusing to submit an annual report during the entire study. Women with medical conditions, such as cancer, were still given the shot. Record keeping on the clients was sloppy and more than 13,000 women had no follow-up44 (Committee on Women, Population, & the Environment).
The African continent has been a theater for unregulated, unethical human experimentation and turpitudinous malpractice, without informed consent forms (sample) normally provided to American women. In a seminal family planning experiment, discussed in the Rebecca Project Human Rights’ 2011 report: The Outsourcing of Tuskegee:
Nonconsensual Research in Africa46, researchers experimented with Depo Provera on approximately 9,000 impoverished women in Navrongo, Ghana. The Navrongo Experiment47 occurred in Navrongo, Ghana (1999-2006, Funded by: USAID/Population Council/Rockefeller Foundation). Dr. James Phillips and Population Council researchers violated US research laws by withholding informed consent forms from the women they used as human subjects and injected with Depo Provera. The African women in Navrongo were told they were being provided with routine healthcare, while data was specifically collected and analyzed for the research experiment and published by Dr. James Phillips et al.
Furthermore, the Navrongo Experiment was designed by Dr. James Phillips who deliberately fabricated and falsified research data for desired outcomes. Phillips co-published with Dr. Binka and other compensated Ghanaian doctors who are knowledgeable and/or complicit in this fraud.
Presently, Dr. Phillips serves on the faculty of the Mailman School of Public Health at Columbia University and his research fraud spans from Africa to Southern Asia. The problem with Columbia University and USAID supporting Phillips’ extensive research fraud in Africa is, as with the Tuskegee Experiment (conducted by Dr. John Cutler with the United States Public Health Service- PHS), and the Guatemala Experiment51 (also Dr. John Cutler with PHS), is that Dr. Phillips’ fraudulent Navrongo research is routinely referenced in UN and US documents as valid family-planning policy. USAID is fully aware that informed consent was not provided (the Rebecca Project provided details to the DHHS, DOJ, and USAID) and that violates US ethical research IRB procedures52 and international law. Fabricated research outcomes and unethical experiments should not be referenced in official US policy. U.S. drug companies and U.S. researchers have effectively outsourced the Tuskegee Experiment and routinely conduct nonconsensual and/or unethical research in Africa and the developing world. Pfizer v. Abdullahi directly confronted the issue. In a July 2009 ruling, a U.S. Court of Appeals found that the prohibition of non-consensual medical experimentation on humans is binding under customary international law, thereby allowing Trovan victims in Nigeria the right to seek relief against Pfizer in U.S. courts. In June 2010, the U.S. Supreme Court rejected Pfizer’s appeal after the U.S. Acting Solicitor General, Neal Katyal, submitted his brief
urging the court to deny Pfizer’s petition.
Congressman William Lacy Clay and the Congressional Black Caucus held a briefing to examine a comprehensive report released by the Rebecca Project.
Panelists at the briefing called for an end to the federal funding of Depo Provera and for accountability for healthcare administers that fail to inform women of the “black box warning” issued by the drug’s manufacturer Pfizer.
Many foreign governments that fund Depo Provera for use in Africa now prohibit the unethical administering of the drug and require women have full knowledge of potential health risks prior to receiving the shot, however, according to the Rebecca Project the U.S. has yet to enforce such mandatory guidelines in their distribution of Depo Provera through overseas health contractors.
Even more egregious, USAID, Gates, Rockefeller and Mellon Foundations, and the Population Council funded a Depo Provera trial (1994-2006) on 9,000 poor women in Ghana without disclosing they were being used for a reproductive health experiment.
Long before Depo Provera received FDA approval in the U.S. – USAID directed funding overseas for its use on women in poor developing countries.
Depo Provera was denied FDA approval three times before the FDA approved the contraceptive for domestic use in 1992. This was after regulations were changed requiring clinical trials in rats and mice instead of the dogs and monkeys from previous tests that showed high frequency of cancer.
Despite calls from a coalition of Black religious leaders and human rights activists USAID and partners — the Gates Foundation, DFID, UNFPA, and PATH, continue to direct millions for the distribution of Depo Provera to poor women in sub-Saharan Africa and South Asia.
Depo Provera side effects listed in the Rebecca Project report:
In 2004, the FDA identifying that Depo Provera causes serious side-effects issued a Black Box Warning stating: (1) women may lose significant bone mineral density that is not fully reversible and, therefore, (2) Depo Provera should not be used as a long-term birth control method for more than two years. Other serious side effects, with mandated Patient Counseling and Information are: (3) blood clots in arms, legs, lungs, and eyes, (4) stroke, (5) bleeding irregularities, (6) weight gain, (7) ectopic pregnancy, and (8) delayed return to fertility and lack of return to fertility. (9) In addition, scientific research in 2012 reported that women using Depo Provera have double the risk of developing breast cancer.