Depo-Provera (“The Shot”) & Lunelle

One way Depo-Provera works is by reducing a woman’s chances of ovulating. However, since it changes the lining of the uterus, it also can cause early abortions when breakthrough ovulation occurs.[1] With perfect use the effectiveness of the shot in preventing pregnancy is very high—about 99 percent. But with typical use 3 percent of women become pregnant each year. [2]

Few drugs have a more controversial history than Depo-Provera. In the 1950s a scientist for the pharmaceutical company Upjohn was experimenting with the hormone progesterone, and he created depomedroxyprogesterone acetate (Depo-Provera). By 1960 the company received FDA approval for the drug as a treatment for endometriosis and habitual miscarriages. However, ten years later the FDA revoked this approval because there was no evidence that the drug worked. Instead it seemed to cause heart defects in babies.

But while the drug was being tested on women in Brazil, researchers discovered that it was also able to prevent pregnancy.[3] As a result of this finding, Upjohn decided to seek approval for the drug as a contraceptive. Studies began on rats, and results looked promising. The FDA granted the drug Investigative Drug Status. This means that it appeared safe based upon previous animal studies, and so research could continue on other animals—and humans. Despite the fact that the drug was still in the early testing phase, doctors from Jamaica to Los Angeles were already prescribing it to women as the newest contraceptive.[4].

By 1965 the drug was being tested on women in foreign countries. A few years later studies began on dogs, monkeys, and over ten thousand women in Atlanta (a disproportionate number of whom were poor and black). The dogs developed breast cancer, and the monkeys developed endometrial cancer. But as for the women in Atlanta, no annual reports were given to the FDA, as required. After eleven years investigators went to assess the situation because of “something funny going on.”[5]

What they discovered was that women were not given adequate information about the side effects, consent forms were absent, and women with medical conditions were given the shot despite the fact that the drug could endanger their health. Some women died of cancer, and others committed suicide (depression is now a well-known side effect of Depo-Provera). Researchers lost track of most of the women in the study, and the research was disregarded.[6]

Years later researchers studied more women from the same area in Atlanta. However, this time they followed up with the women (again, most of whom were poor and black). The scientists showed that about half of the women quit taking the shot after a year. Their main reason was that they were displeased with the side effects. Nonetheless, the summary of this research was entitled “Depo-Provera: an excellent contraceptive for those who continue to use it.”[7] Today African-American women continue to be the primary targets of those who promote Depo-Provera, and they are twice as likely to use the drug as white women.[8] Likewise, the poorer a woman is, the more likely she is to be prescribed Depo-Provera.[9]

Because Depo-Provera was found to cause cancer in beagles, veterinarians stopped giving it to dogs, and the animal version of the drug (Promone) was taken off the market.[10] Testing continued on women, however. A member of the FDA’s Bureau of Drugs testified, “Animal data for this drug is more worrisome than any other drug we know of that is being given to well people.”[11] Unfazed, the pharmaceutical company pushed the drug overseas. According to the makers of the drug, they paid government officials, hospital employees, and others more than $4 million in the early 1970s in order to secure sales of Depo-Provera internationally.[12]

Despite urgings from those in favor of the shot, the FDA denied approval of Depo-Provera at least three times because of safety concerns for both mother and child.[13] Meanwhile, the drug was being used on millions of women in over ninety countries, such as Nigeria, Belize, Honduras, El Salvador, Costa Rica, Thailand, India, and other developing nations.[14] Reports of liver cancer, decreased bone mass, and children born with extra or missing fingers didn’t help Upjohn’s prospects of legalizing the drug in America.

However, in 1991 the World Health Organization published the most comprehensive research of the time, reporting no increased risk of cancer of the liver, ovaries, or cervix. It even demonstrated a protective effect against endometrial cancer. However, breast cancer risk was doubled in the first five years of use. With this new research Upjohn again asked the FDA to approve the drug in 1992. Numerous groups protested, including the National Women’s Health Network, the National Black Women’s Health Project, and the National Latina Health Organization. Despite their objections, the FDA approved the drug in October 1992.

At the time, the acting president of Planned Parenthood was ecstatic, calling the approval “a very exciting development that is long overdue.”[15] Many women did not share his enthusiasm. Since the approval in 1992, many women’s groups have united to request that the FDA impose a moratorium on the use of the shot.[16] While many women do not experience serious side effects from Depo, other women have gone off the drug, saying, “This hideous poison should never have made it out of the lab.”[17]

Even after the FDA’s approval of the drug, many countries were still hesitant to license it. In 1991 Canadian women’s groups and various health associations petitioned their government to keep the drug out of the country. They wrote, “We urge the government to stand by their decision of 1988, and to remain committed to protecting the health and safety of Canadian women.” Aware of the side effects of Depo-Provera, advocates of women’s health were especially concerned about the fact that the shot was “currently being prescribed to teenagers, the physically and mentally disabled, immigrant, Native and Inuit women without their informed consent.”[18]

Unfortunately, these protests were not heeded, and the drug was approved for use in Canada in 1997. But by 2005 women seeking compensation for their suffering brought a class-action lawsuit of $700 million against the makers of the drug.[19] Some of them suffered early osteoporosis and bone fractures, needed knee replacements, and complained that they were never warned about the drug’s ability to thin a woman’s bones. One of the attorneys involved in the lawsuit mentioned that he was defending a woman who was is in her twenties and may soon need a hip replacement.

Nowadays Depo-Provera is made by the pharmaceutical company Pfizer. That name might ring a bell. Pfizer is also being sued because of the heart attacks, deaths, and birth defects attributed to other drugs they manufacture, such as Zoloft and Celebrex.

Objections to Depo-Provera span the globe. Women’s groups in India requested a complete ban on the shot, which had been approved for marketing in their country before the necessary safety trials had been completed. They wrote, “In a country where a large percentage of women in the reproductive age suffer from anemia, irregular and heavy bleeding can have catastrophic consequences. Studies have shown that injectable contraceptives like Depo-Provera can also lead to osteoporosis. This can have grave consequences for poor women with low bone density due to poor nutritional status. . . . The evidence available is already damning and it would be unethical to subject more women to clinical trials with these contraceptives.”[20]

According to India’s Economic and Political Weekly, one reason the FDA approved Depo-Provera was that the U.S. was concerned with population control in third world countries, whose governments were hesitant to approve a drug that was not even licensed in the country that created it.[21] Thankfully the women’s groups in India won a victory for women’s health in 2002, when the Indian government cancelled its plan to introduce Depo-Provera through the government health services systems.[22]

In September 2004 the makers of Depo-Provera received more bad news about their drug: it increases a woman’s risk of contracting certain STDs. According to the journalSexually Transmitted Diseases, when a woman takes the shot, she triples her chances of being infected with gonorrhea and chlamydia (which can sterilize a woman).[23] The scientists speculated that the increased disease risk might be caused by the drug’s interference with a woman’s immune system or by its ability to assist the growth of infections.

Regardless of how it makes a woman more susceptible to disease, the discovery is troubling. For example, when the drug is used in certain population control programs, many women do not have access to modern health care services. Interestingly, the study that discovered this STD link was funded in part by the U.S. Agency for International Development (USAID), who provided over forty million units of Depo-Provera to developing nations, especially in Africa.[24] Undoubtedly the women who used it were unaware of the Depo-Provera–STD connection and were probably also ignorant of the fact that infection with gonorrhea or chlamydia makes a woman up to five times as likely to contract HIV, if exposed.[25]

Disappointingly, the makers of the shot deny any STD connection, stating on their Web site, “There is no proof from clinical studies that shows Depo-Provera increases your risk of acquiring a sexually transmitted disease.”[26] Unfortunately, as of 2008, Pfizer still has not corrected its Web site, despite the fact that the contradictory research was published in 2004.

Two months after the STD connection was discovered, Depo-Provera received more bad press when the FDA slapped a “black box” warning on the label.[27] According to the FDA, “a ‘black box’ warning is the most serious warning placed in the labeling of a prescription medication.”[28] In the case of the shot, it was required because the medicine can cause irreversible bone loss in women, which can lead to osteoporosis. The researchers who discovered this noticed the effects in girls as young as twelve. This is especially problematic for young women, because the teenage years are a critical time for bone development. After years of receiving birth control injections as a teen, a girl in her early twenties could have the bones of a fifty- to sixty-year-old.

However, the same year that the shot received the black box warning, the makers of the drug raked in $200 million in revenue from it.[29] Because of the concerns of bone loss, Pfizer and the FDA now say that the shot should never be used for longer than two years, unless a woman has no other option.

In regard to side effects, the above information is only the beginning. According to the makers of the shot, here are some of the other potential side effects of the drug:[30]

Young women who have taken the shot in the last four years are more than twice as likely to develop breast cancer. Children born to women on Depo-Provera are more likely to have webbed toes and fingers, and chromosomal anomalies. The boys are twice as likely to have genital deformities, and the baby girls are more likely to suffer masculinizing effects of the drug’s chemicals, causing genital abnormalities. Babies conceived to women on Depo-Provera may be at an increased risk of low birth weight, which is associated with an increased risk of neonatal death. (Research not done by the makers of the shot reports that infants exposed to the shot while in their mother’s wombs were 80 percent more likely to die in their first year of life.)[31]

Depo-Provera can pass through a mother’s breast milk to her child. Most studies do not show adverse effects on the baby. However, one study of women who took the shot two days after the delivery of their baby showed it had substantial consequences. The babies in this group had a 75 percent higher incidence of infectious diseases visits to the doctor in their first year of life. Women on Depo-Provera tend to experience weight gain according to how long they have been on the drug: five pounds in the first year, eight by the second, fourteen by the fourth, and over sixteen pounds by the sixth year.

Many women on the shot stop having periods after one year of use. However, when a woman goes off the shot, the menstrual period “will usually, in time, return to its normal cycle.” Many women who take the shot will be able to become pregnant soon after stopping the injections. Sometimes, there is a delay in the return of fertility. For example, about half are unable to conceive within ten months of their last injection. Seventeen percent were unable to get pregnant after fifteen months off the shot, and 7 percent were still not able to conceive after eighteen months.

Other side effects include menstrual irregularities, abdominal pain, dizziness, headache, fatigue, nervousness, backache, breast pain, leg cramps, depression, bloating, nausea, rash, insomnia, acne, joint pain, convulsions, numbness, coughing up blood, severe allergic reactions, spontaneous flow of breast milk, darkening of the facial skin, urinary infections, cysts, chest pain, anemia, artery blockage in the lung, loss of consciousness related to temporary insufficient blood flow to the brain, shortness of breath, fever, excessive sweating and body odor, dry skin, excessive thirst, blood disease, rectal bleeding, nipple bleeding, prevention of lactation (breast milk), paralysis, facial nerve damage, skin disease, excessive uterine growth, varicose veins, painful cramps, no hair growth or excessive hair growth in unusual places, and blood clots.

Depo-Provera is well known for decreasing a woman’s sex drive. Because of its ability to kill a person’s libido, the shot is sometimes injected into child molesters as a punishment![32] In California, the State Senate ruled that “The parolee shall begin medroxyprogesterone acetate [Depo-Provera] treatment one week prior to his or her release from confinement in the state prison or other institution and shall continue treatments until the Department of Corrections demonstrates to the Board of Prison Terms that this treatment is no longer necessary.”[33] So the drug that is too dangerous for dogs but just right for sex offenders is offered to women at their local Planned Parenthood clinic!

Why would doctors allow their patients to ingest such chemicals? In September 2009, newspapers across the country announced that the government was fining Pfizer Pharmaceuticals a record 2.3 billion dollars for illegal drug promotions. In the drug industry, companies hire pharmaceutical sales representatives to pitch their products to doctors. Normally, the business meetings take place in the doctor’s office. However, Pfizer reps have been caught wining and dining the doctors. In the words of one ex-Pfizer employee, “You got exorbitantly large bonuses if you got these large practices to switch to your drugs.”[34] In an effort to butter up the doctors to buy drugs such as Depo Provera, Pfizer sales reps were caught paying for doctors to receive free golf, massages, and resort junkets. Thankfully, the government caught Pfizer in the act (for the fourth time in the past decade), and will now be monitoring their marketing strategies.

______________________________
[1]. Physicians’ Desk Reference (Montvale, N.J.: Thomson, 2006), 2620.
[2]. Hatcher, et al., Contraceptive Technology, Nineteenth Revised Edition.
[3]. “The Case Against Depo-Provera: Problems in the U.S.,” Multinational Monitor 6:2–3, February/March 1985.
[4]. “The Case Against Depo-Provera: Problems in the U.S.”
[5]. Karen Hawkins and Jeff Elliott, “Seeking Approval,” Albion Monitor, May 5, 1996. [6]. “Depo Provera Fact Sheet,” Committee on Women, Population, and the Environment (January 6, 2007) ; Hawkins and Elliott.
[7]. M. Rosser, et al., “Depo-Provera: An Excellent Contraceptive for Those Who Continue to Use It,” Primary Care Update for Ob/Gyns 5:4 (July 1, 1998), 172.
[8]. William Mosher, et al., Advance Data From Vital and Health Statistics 350, Table 7—Supplement (CDC).
[9]. William Mosher, et al., Advance Data From Vital and Health Statistics 350, Table 10—Supplement (CDC).
[10]. “The Case Against Depo-Provera: Problems in the U.S.”
[11]. Hawkins and Elliott.
[12]. “Depo Provera Fact Sheet,” 2007.
[13]. “The Case Against Depo-Provera: Problems in the U.S.”; “Depo Provera Fact Sheet,” 2007.
[14]. Warren E. Leary, “U.S. Approves Injectable Drug As Birth Control,” The New York Times (October 30, 1992); Ehrenreich, et al.; “Depo-Provera Warning for Women 14 Years Later,” press release, Women’s Health Action Trust (November 30, 2004).
[15]. Leary.
[16]. “Clinicians Clash with Consumer Groups Over Possible Depo Ban,” Contraceptive Technology Update 16:1 (January 1995), 11–14.
[17]. “Health: Depo Provera: Asking the FDA to Investigate,” suite101.com.
[18]. “Canadian Coalition on Depo-Provera letter to The Honorable Benoit Bouchard, National Minister of Health and Welfare” December 6, 1991.
[19]. CTV.caNews Staff, “Class Action Suit Filed Over Birth Control Drug,” CTV.ca News, (December 19, 2005).
[20]. N. B. Sarojini, et al., “Why Women’s Groups Oppose Injectable Contraceptives,” Indian Journal of Medical Ethics 13:1 (January/March 2005).
[21]. “Contraceptives. Case for Public Enquiry,” Economic and Political Weekly 29:15 (April 9, 1994), 825–826 (Popline database document no. 096527).
[22]. “Depo Provera Fact Sheet,” Committee on Women, Population, and the Environment (January 6, 2007).
[23]. Charles Morrison, et al., “Hormonal Contraceptive Use, Cervical Ectopy, and the Acquisition of Cervical Infections,” Sexually Transmitted Diseases 31:9 (September 2004), 561–567; J.M. Baeten, et al., “Hormonal Contraception and Risk of Sexually Transmitted Disease Acquisition: Results from a Prospective Study,” American Journal of Obstetrics and Gynecology 185:2 (August 2001), 380–385.
[24]. “Depo Provera Fact Sheet,” 2007; Morrison, et al., 561.
[25]. Centers for Disease Control, “Chlamydia,” fact sheet (April 2006); D.T. Fleming and J.N. Wasserheit, “From Epidemiological Synergy to Public Health Policy and Practice: The Contribution of Other Sexually Transmitted Diseases to Sexual Transmission of HIV Infection,” Sexually Transmitted Infections 75 (1999), 3–17.
[26]. www.depoprovera.com
[27]. U.S. Food and Drug Administration, “Black Box Warning Added Concerning Long-Term Use of Depo-Provera Contraceptive Injection,” FDA Talk Paper (November 17, 2004).
[28]. www.fda.gov.
[29]. “Pfizer Contraceptive OK’d for Added Use,” CNNmoney.com (March 29, 2005).
[30]. Physician Information, Depo-Provera CI, Pharmacia & Upjohn Company (November 2004); Patient Labeling, Pharmacia & Upjohn Company, October 2004.
[31]. “Exposure to DMPA in Pregnancy May Cause Low Birth Weight,” Progress in Human Reproduction Research 23 (1992), 2–3.
[32]. T.A. Kiersch, “Treatment of Sex Offenders with Depo-Provera,” The Bulletin of the American Academy of Psychiatry and the Law 18:2 (1990), 179–187; California Penal Code Section 645.
[33]. Assembly Bill 3339, “An Act to Repeal and Add Section 645 of the Penal Code, Relating to Crimes,” California State Senate, Amended August 20, 1996; 2005.
[34]. Suzanne Hoholik, “Pfizer must pay $2.3 billion: Upper Arlington man helped blow whistle on drugmaker’s marketing,” The Columbus Dispatch (September 3, 2009).