According to the Rebecca Project, Planned Parenthood, one of the largest distributors and providers of Depo Provera in the US and internationally, recklessly promots Depo Provera to a target audience of women of color and asking this question on their website: “What are the Benefits of the Birth Control Shot?” and answering: “There is nothing to do right before having sex”. When in fact using Depo Provera especially warrants condom use before having sex to avoid increased risks of HIV, as verified by esteemed BMGF and NIH funded researcher, Renee Heffron. Furthermore, Planned Parenthood violates medical ethics and FDA regulations by fraudulently promoting an off-label claim: “The shot [Depo Provera] can help prevent cancer of the lining of the uterus” However, a search of Depo Provera’s FDA approval does not list the contraceptive as a cancer prevention drug. Moreover, while making those false claims about Depo Provera, Planned Parenthood further violates FDA regulations by not posting and informing women of mandatory FDA Depo Provera warnings this together with other egregious violations of federal law, demonstrates Planned Parenthood’s intent to misinform and conceal serious harm from women. This systematic fraudulent promotion and illegal rebranding of Depo Provera supported by BMGF, Pfizer, Population Council and USAID, while receiving Medicaid payments and other disbursements from the US government in forms of grants and payments for family planning, is illegal under the False Claims Act (FCA), 31 U.S.C. §§ 3729 – 3733 (details discussed on page 14 -15).
According to University of Cincinnati historian Wendy Kline, the Depro testing of the 1970s at Atlanta’s Grady Memorial Hospital Family Planning Clinic involved mostly black women in public assistance.
Kline’s research into the debate surrounding Depo-Provera in the 1970s and 1980s began when she was visiting the Smith College Women’s History Archive where she found a large box of materials still unprocessed and not yet catalogued. This was among 50 to 60 boxes from the National Women’s Health Network.
She recalled, “The box contained hundreds of individual files, each detailing a woman’s difficulties with the side effects of Depo-Provera or detailing how she had not been informed of those side effects or detailing how she had been given the injection without her consent or by means of manipulation. This coercion, lack of informed consent and testing of the drug has obviously been gathered together in preparation for a class-action suit by the National Women’s Health Network that had never gone forward.”
But the collection did provide Kline with a rich source of material of examining the history of this contraceptive and the U.S. Food and Drug Administration’s public board of inquiry on Depo-Provera held in 1983.
“The use of Depo-Provera captures all of the controversy of this century regarding controlling fertility and who’s ultimately making the decision about who gets to reproduce. My research looks at coercion, risks not fully understood and how arguments were made for and against Depo-Provera at the time,” she explained.
For instance, it was in the Depo-Provera hearings in Washington that the manufacturer and those in favor of the drug had to first contend with the greater organizational powers and force of the feminist movement – but where that feminist movement had to argue its case by focusing narrowly on the flaws in the scientific research methodology applied when testing Depo-Provera.
In other words, those combating the use of Depo-Provera could not make a case against the drug based on morality or sentiment even though it could easily have been argued that this was a case of eugenics since the testing of the drug in the 1970s at Atlanta’s Grady Memorial Hospital Family Planning Clinic involved mostly black women in public assistance.
Instead, because of FDA strictures related to evidence supplied at its board of inquiry hearings, opponents of the drug had to channel their arguments on the science then available on Depo-Provera.
“Of course,” said Kline, “It was and is very difficult to separate science from the society that produced it. There was a reason, given the understood risks of Depo-Provera, that its testing was done on poor women in the U.S. and on women in developing countries.”
According to C-Fam, the Melinda Gates’ campaign targeting African women with a new form of the contraceptive Depo Provera has provoked a coalition of Black religious leaders and human rights advocates. They are asking the U.S. Congress to stop funding the distribution of the injectable contraceptive overseas.
The leaders, who support abortion and contraception, say women of color and low-income women suffer severe health issues from Depo Provera. A new self-administered version puts women at further risk as it will be delivered without them being fully informed of the drug’s potential side effects. The contraceptive carries the potential to contract or transmit HIV at an eight-fold higher rate.
The wife of billionaire Bill Gates recently told the New York Times that she championed family planning after meeting with poor women in developing countries. The women wanted a contraceptive that comes in a shot, Gates said, because they could not negotiate condom use without implying that either they or their husbands had AIDS.
Kwame Fosu says Melinda Gates’ claim that women want Depo Provera is “disingenuous.”
“No African woman would agree to being injected if she had full knowledge of the contraceptives’ dangerous side effects,” Fosu told the Friday Fax. Fosu is policy director for the Rebecca Project for Human Rights.
“In fact,” he continued, “in countries where women are educated on the harmful complications, Depo Provera use is negligible.”
Gates’ comments illustrate an on-going conflict between public health officials’ efforts to contain the AIDS epidemic and family planning advocates who favor long-acting hormonal contraceptives to prevent pregnancy. Unlike condoms, these methods do nothing to prevent HIV transmission.
In the case of Depo Provera, the risks of HIV transmission actually increase, according to data published in The Lancet. The World Health Organization strongly advises that women using progestogen-only injectable contraception also use condoms. Planned Parenthood – one of the largest international distributors of Depo Provera – does not recommend condom use nor do they disclose potential side effects.
According to feminist, Erica Gollub, Depo-Provera, was manufactured by the Upjohn Corporation of Kalamazoo, Michigan has been a source of controversy since its entry into the market in the late 1970s.
In 1978, the FDA found the injectable drug too dangerous for use by American women. FDA’s decision was based on a study done by Upjohn at the agency’s request, which found that rhesus monkeys and beagles injected with the drug developed cancer.
But the agency came under heavy fire from other governmental and private agencies involved in the drug’s distribution in the Third World. Led by the Agency for International Development (AID), these groups feared the impact of the FDA decision on the “image” of Depo and family planning programs abroad. They also opposed any constraints on its overseas distribution.
After years of delay, the FDA finally agreed to hearings on the drug. From the beginning, Upjohn insisted on a scientific inquiry, an approach that limited the scope of issues considered – particularly the more significant ethical and policy considerations raised by the use and promotion of the drug. Nevertheless, evidence presented by opponents of the drug showed that Depo-Provera is considerably more dangerous than Upjohn is willing to admit.
Dr. Christopher Rhodes, called to testify by the National Women’s Health Network, listed the “constellation of defects” that women can experience, ranging from severe menstrual irregularities to permanent sterility to high blood pressure and blood clots. Sybil Shainwal, president of the Network, accused Upjohn of “risking the health of American women with a drug that has never been proven safe.” Public Citizen’s Health Research Group charged that “no reliable studies” have been done on the long-term use of Depo on humans.
In defense, Upjohn cited the conclusions of “three international panels of experts” associated with AID and the World Health Organization. These groups claim that animal studies – the basis of nearly all the evidence on Depo – are “inappropriate” for judging the drug’s effects on women.
But Steve Minkin, former Chief Officer of Nutrition at AID quoted studies from the Office of Technology Assessment and the National Research Council affirming the reliability of animals in cancer research. Minkin worked with some of the first Depo users in Bangladesh in 1979.
National Women’s Health Network witness Dr. Ruth Shearer also disagreed with Upjohn’s “experts.” A cancer and genetics expert, Shearer charged that the AID and WHO groups “were not impartial panels of concerned scientists. They represent organizations which have been responsible for widespread use of Depo Provera.” If they admitted to the hazardous nature of the drug, she said, they “would be admitting their responsibility for future massive human illness.”
Another issue raised at the hearings concerned the use of Depo on women whom doctors say cannot be “trusted” with other forms of contraception. Depo critics have charged that the drug has been used on “powerless groups” such as mentally retarded women and welfare mothers. At the hearings, witnesses described two groups recently “targeted” by doctors: the predominantly Hispanic population at University of Southern California Medical Center in Los Angeles, and the “SS-95%” Black population at Grady Memorial Hospital in Atlanta.
According to Dr. Robert Hatcher of Grady, 11,000 women have been treated with Depo at his hospital since 1967. Usage started several years before any animal testing had taken place.
Dr. Sidney Wolfe of the Health Research Group found this double standard of safety “morally offensive and unacceptable.” Mentally retarded women, said Wolfe, are “the least appropriate candidates for a contraceptive such as Depo-Provera. (They) are the least likely to be able to weigh the benefits and the risks of the drug and give true informed consent.”
But Dr. Hatcher and other family planning practitioners said that their consent form and information booklet accompanying the shot justifies the use of the drug. “Our booklet mentions 11 problems related to Depo-Provera,” Hatcher said. He reasoned that as long as women “know” what they’re getting, the injection should be used.
Dr. Wolfe, however, pointed out that “the whole question of informed consent is a moot question” since the full extent of risk is still unknown. Another witness cited how the drug is administered at one clinic in northern Thailand, where women “are processed in from 60 to 90 seconds,” with little time for “amenities” like consent.
Some population officials used the consent argument to attack the opponents of Depo. Dr. Malcolm Potts of Family Health International said that anti-Depo forces “oppose people having a choice” in contraception. “I see modes of contraception like modes of transportation,” said Potts, and compared Depo with a Volkswagon: “It’s sturdy, dependable, it might rattle and does have some problems, but it should be available.”
But health activists countered that these same “pro-choice” officials spend little time and money promoting the safer, barrier methods of contraception, and often endorse money or food “incentives” for Third World women “choosing injection or sterilization”. “Their priority,” said one activist, “is expediency in population control.
A number of consumer, women’s and human rights groups are mobilizing to stop the spread of Depo-Provera. The National Women’s Health Network maintains a registry of women having received unauthorized shots of Depo, which they say circulates in the blood for three months or longer. The Network recently announced their intention to sue Upjohn for compensation to women injured by the drug.
United Presbyterian Church and the Maryknoll Fathers, members of the Interfaith Center on Corporate Responsibility, have recently submitted a shareholder resolution to Upjohn concerning Depo. Other groups working on the issue include Public Citizen’s Health Research Group and the Boston Women’s Health Book Collective.
Whatever the outcome of the Depo hearings, Upjohn has little to lose and much to gain. FDA approval would mean greater sales for the company on a product whose annual sales already exceed $25 million.