In Our Control (20 page)

What the Columbia researchers failed to unpack were the reasons that long-acting contraceptives inspired such resistance and anger from many women, particularly in communities of color. Like it or not, a device that a woman cannot insert or remove herself and that renders her unable to conceive for several years, takes immediate agency over a woman’s fertility out of her hands. The mere existence of such a method creates potential for abuse, and in America we have a documented history of
using contraceptive technology in unjust and coercive ways. If women like Dorothy Roberts hadn’t been so vocal in their criticisms of Norplant, it could very easily have taken up where forced sterilization left off. The very act of placing Norplant in the context of other technologies used as agents of social engineering probably prevented it from becoming one.

This is not to say that women aren’t the losers when a birth control option is pulled from the market: indeed, greater contraceptive variety is a good thing for women, assuming they are given accurate safety information, and the removal of Norplant from the market narrowed an already slim field. Recognizing the potential for terrible mismanagement, however, is crucial to ensuring that such options remain in the service of individual women and not government bodies, empowered social groups, or even the medical community. The extent to which improper coercion went on behind physicians’ doors remains unknown, but it does seem that a disproportionate number of young, nonwhite, and low-income women received the method during its short tenure.

The problems with Norplant had as much to do with rapid and under-informed marketing and with concerns about social pressures as it did with the unacceptability of the device for many women. It is hard to know what might have been if the time had been taken to properly train doctors, assess side effects, and educate patients.

But it was not to be, and Norplant became a pharmaceutical cautionary tale, a sort of “that’s what you get” for other drugmakers already wary of contraceptive research and development. Hundreds of women experiencing various side effects filed lawsuits against Wyeth Ayerst—so many that other drugmakers dubbed the situation “Norplant Syndrome.”
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Even when a second-generation version of the device, Jadelle, also called Norplant II, was approved by the FDA in the late 1990s, manufacturers began to reconsider the advisability of marketing Norplant at all. In 2000, the rumblings became official, and Norplant was withdrawn from the market completely.

As Andrea Tone notes, the controversy highlighted an ongoing debate about “what defines the threshold between acceptable risk and product liability.”
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In other words, to what extent should a product maker ensure that a new product be risk-free, and to what extent are patients who seek new methods already agreeing to be part of an experiment? When are
drug companies being irresponsible, and when are patients being unrealistic about the risks of contraception in general, and new birth control devices in particular? Barbara Seaman used to advise people not to “be the first kid on your block to take a new drug,” but of course, if we are to have any knowledge about medicines, someone must eventually be willing to try them. Making sure that those who do aren’t disproportionately low-income women or populations who have been disempowered in other ways is an important part of the project of responsibly developing new drugs. The decision to be part of a medical experiment can be a noble one, but it should always be a choice. The Norplant example shows that while institutionalized versions of this type of medical discrimination—such as the formal testing of the original birth control pill on poor Puerto Rican women—are far less common, less formal incarnations of this dynamic still make certain populations of women more vulnerable to the risks inherent in any new drug.
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That said, women in all situations should be allowed to decide if they are willing to be at risk for certain dangers to receive certain benefits. Adults should have the option of taking a drug even if it carries risks as long as they are fully informed about their options and have true access to them.

Sadly, today, in part due to the Norplant fallout, drugmakers have retreated even further from contraceptive research. It was a mediocre drug that might have gotten better and which was still a welcome choice for many women. It was a potential health hazard whose rapid introduction and removal from the market ultimately means fewer birth control options, both because of its withdrawal and because of the limits it imposed on future contraceptive research.

Jadell, a later version of Norplant, is composed of two rods, both longer than the original Norplant’s six. Each contains 75 mg of levonorgestrel, which is released in the body at a rate of 80 μg per day in the first month of use. This gradually reduces over time to 25 to 30 μg by the end of nine months. It can remain in the body up to five years. Although Jadell is approved in the United States, it has never been marketed here. It is available in other countries but is still relatively uncommon. There is no reason to believe that the side effects of the new device would be very different from those of the older one.
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The only implant currently available on the American market is
Implanon, a device that lasts for three years. It is made by Organon, a Dutch drugmaker that is now a division of European pharmaceutical giant Schering-Plough (currently in the process of merging with Merck). Organon also markets the contraceptive ring. Implanon was approved in the United States in 2006 after the Norplant debacle. It is made up of one 4 cm rod containing 68 mg of the progestin etonogestrel (also the progestin used in NuvaRing). It is inserted in the nondominant arm and is invisible when placed under the skin, though it can be felt by lightly pressing on the area over it. A doctor who has been trained by the device’s manufacturer should insert it approximately five days after a menstrual bleed begins. It must be removed within three years or a patient is at higher risk for infertility or ectopic pregnancy.

The effectiveness of Implanon is on par with the Pill: less than one woman per hundred (.38) will become pregnant using it in the first year of use. Like oral contraceptives, it works by suppressing ovulation and changing cervical fluids. Implantation and removal are relatively simple; on average, it takes less than a minute to put it in and three and a half to five minutes to take it out.
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A small group of women may experience more trouble with removal, either because the rod has become displaced or because it breaks while it is being taken out. Because it has only one rod, these problems are less likely to occur, but doctors can opt to use ultrasound to locate the device before attempting to remove it to minimize the likelihood of problems if they are anticipated
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(meaning the doctor can already tell that the device isn’t where it’s supposed to be). While Implanon seems to be better than Norplant when it comes to insertion and removal, users still have some of the same problems with unpredictable bleeding.
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Authors reviewing eleven clinical trials concluded, “Implanon use is associated with an unpredictable bleeding pattern which includes amenorrhea, frequent, and/or prolonged bleeding.” So while you could have normal or lighter than normal bleeding with this method, you could also have either no bleeding or prolonged bleeding.
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This side effect is the reason that 36 percent of women in clinical trials discontinued the method.
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Other side effects are similar to the Pill: headaches (15.3 percent), weight gain (11.8 percent), acne (11.4 percent), breast pain (10.2 percent), mood changes (5.7 percent), and decreased libido (2.3 percent).
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The manufacturers caution that few very
overweight women were included in the trials of Implanon and efficacy for this group is uncertain.

Today, a patient can also choose Mirena, a hormonal IUD that many women’s health activists argue is actually a contraceptive implant. Like Implanon, it is active for several years (in this case up to five years) and contains progestin only. Mirena, which I discussed at greater length alongside the copper IUD earlier, is most decidedly a hormonal method and an alternative distribution system with all the risks and benefits of these drugs.

Still Standing? Depo-Provera and Injectable Contraceptives

Elsimar Coutinho wasn’t ready to go back to Brazil just yet. The young doctor had been enjoying an exciting fellowship in New York City through the Rockefeller Institute. Coutinho’s adventures in the United States began in 1959, just as the Pill was spreading through the American market. Among other things, he met Dr. George Corner, one of the “discoverers” of progesterone, and worked with other bright lights in the field of hormone science.
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Before going home, Coutinho visited Upjohn, the pharmaceutical company in Kalamazoo, Michigan, where he learned about a new progestin, medroxyprogesterone acetate (MPA). When he finally arrived back at his medical school in Bahia, he began working with this compound, testing its usefulness for the prevention of premature delivery or spontaneous abortion. To Coutinho’s credit, he stuck with the evidence and admitted that the drug didn’t prevent miscarriages, something that may have prevented another DES-style tragedy of dangerous fetal exposure to hormones. What he found during his trials, though, was that even six months after ceasing MPA injections, patients still hadn’t started ovulating again. As he would note years later, “The study serendipitously led to the discovery of the first long-acting injectable contraceptive.”
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The contraceptive shot, which came to be called Depo-Provera, would have a rocky road to approval in the United States. Unsuccessful attempts were made by Upjohn to bring the drug to market in 1973 and 1975. Women’s health and consumer groups, such as Public Citizen, lobbied strongly against prematurely approving a drug that they felt had too many open health questions. Animal studies had shown higher cancer risks as
well as slower than normal return to fertility after discontinuing use. Another deeply troubling feature of Depo-Provera was the fact that despite its health uncertainties, it had been tested on women in developing nations for ten years and low-income African American women in Atlanta, Georgia, for eleven.
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These tests were conducted long before issues about the injection’s potential to cause cancer, stroke, and permanent sterility had been resolved. In 1992 the FDA finally took the plunge and made Depo-Provera available to American women for birth control (it had been used off label for many years). It is currently available in more than eighty countries and has been used by over 90 million women.
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Since 2005, a lower-dose subcutaneous
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version, Depo-SubQ Provera, has also been available.

Women who opt for Depo-Provera receive an injection of 150 mg of MPA every three months at their health care provider’s office, usually before the eighth day of a menstrual cycle. Pregnancy rates are low on Depo, with less than one pregnancy (.3) per hundred women in a year of use. Depo shares side effects and risks with the Pill, including a small increase in cancer risks. Like the Pill, Depo can cause headaches, skin changes, fluid retention, breast tenderness, and libido and mood changes. As with oral contraception, patients with migraines, cardiovascular complications, and trouble with depression should discuss with their doctor whether this contraceptive is the right choice for them.

Depo-Provera also comes with its own unique risks, which are thought to be due to the administration of excess progestin and not enough estrogen in the body or perhaps to the particular progestin used. The worst of these risks is that its use, particularly over long periods of time, leads to bone loss. While the reason for this isn’t certain, it seems likely that it is the result of not having enough estrogen in the body working on the bones.
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As evidence of this serious problem emerged in the years after approval, it prompted great concern. Young women, especially those still in their teens and early twenties, are a population particularly drawn to injectables because of both ease of use and the ease with which use can be concealed. This is also an age that is crucial for laying down bone mass to prevent skeletal problems, such as osteoporosis, later in life. As young women were opting for the shot in the hopes of hiding birth control use from parents, their own skin was concealing an equally distressing fact:
thinning bones. In November 2004 the FDA placed a “black box” warning on Depo. In an accompanying “talk paper,” the agency noted that while the “contraceptive injection has been used as birth control for decades throughout the world and remains a safe and effective contraceptive,” it was also becoming clear that “prolonged use of the drug may result in significant loss of bone density, and that the loss is greater the longer the drug is administered.” They added ominously, “this bone density loss may not be completely reversible after discontinuation of the drug.”
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Because of this, the FDA warned in the black box that “Depo-Provera Contraceptive Injection/depo-subQ Provera should be used as a long-term birth control method (i.e., longer than two years) only if other birth control methods are inadequate.”

Studies in teenage girls have shown bone loss in the hip, femoral neck, and lumbar spine
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—areas of concern as women age (a hip fracture can be disabling and even fatal for an older person). The real fear is that as young girls fail to attain high bone mass at certain ages, it will put them at greater risk for serious fracture when they are postmenopausal (a time when bone thinning accelerates). It seems that while women experience more density loss during the first years of treatment, they lose more over time and are less likely to regain bone after many years of use. If you already have lowered bone density or osteoporosis, or if you have a family history of these conditions, it should inform your decision about using Depo-Provera. The same is true if you use other chemicals that can reduce bone mass, such as drinking excessively, smoking, or taking corticosteroids and anticonvulsant drugs.