In Our Control (8 page)

POPs are thought to be more effective for breastfeeding women than for those in the general population (although this assumption is currently undergoing some revision, and some believe they are just as effective for all women).
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Some researchers worry that breastfeeding babies whose mothers are on POPs receive some level of hormonal exposure through the milk, and thus are subject to the same side effects their mothers endure.
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Others, such as the group Family Health International argue that “POPs do not affect the amount or quality of breastmilk,” because “such small amounts enter the infant’s system … no adverse effects on the health, growth or development of the infant have been found.”
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Doctors and health groups are starting to look more closely at POPs because they seem to lack a lot of the unpleasant side effects of combined oral contraceptives (COCs) in trials; they don’t cause as much nausea or as many headaches, and they may be better for mood problems. They also may be safer for women with high blood pressure or certain other cardiovascular risk factors (although it is worth asking why a barrier with spermicide wouldn’t be better still for these women). More research and many more years of experience will be needed to confirm these benefits as well as to discover what dangers the drugs may hold. Still, they provide a promising new alternative to traditional oral contraceptives.

When Gregory Pincus first envisioned the Pill, he wanted it to be progestin-only. There were good reasons—including the tendency of Pincus’s early Pill to cause erratic bleeding when unchecked—that the proto-POP was rejected. Today’s POP still causes bleeding problems, and if you already have irregular or abnormal bleeding, or if you have breast
or reproductive cancers or a history of these diseases, POPs are probably not right for you.

Risky Business: The Risks and Benefits of the Pill

I am out to lunch on a hot August day with a friend of mine who is a doctor. This young woman, in her early thirties, is a committed feminist and critical thinker. One thing that is not up for debate, as far as she is concerned, is the safety of the Pill. “Love the Pill!” she gushes over pizza and garlic knots, “Love it! I can’t imagine advising patients to use anything else.” When I cautiously tell her that I am writing about possible negative side effects, she scrunches her face disapprovingly: “Come on, Laura. This isn’t the old Pill. And besides, it’s the most studied drug in the world.”

This last idea—that the Pill is our most studied drug—has become a mantra in recent years. Indeed, decades of experience and research have created an impressive body of studies and trials that help us understand these drugs.

The same thing was true, of course, for Hormone Treatments (HT) and Estrogen Treatments (ET) for menopause. In fact, ET and HT—drugs that are chemically similar to but lower in dose than the Pill—were approved for use in the United States twenty years before hormonal contraception. For decades women heard study after study insisting that taking estrogen or estrogen and progestin during the years prior to and immediately following menopause would offer a host of health benefits. Doctors assumed that prescribing these drugs to healthy patients was the most responsible thing to do.

Between 2001 and 2003, everything changed. The Women’s Health Initiative, a massive fifteen-year trial that followed 161,808 women, became the first long-term, randomized double blinded clinical trial of HT and ET. When it got underway, doctors assumed it was a done deal; the study would only confirm what enormous amounts of prior science had shown: that taking the drugs was the healthiest thing that a mid-life woman could do. But the hormone trials came to early and screeching halts. The
women taking HT and ET were having serious health problems: more heart disease, cancer, strokes, pulmonary embolisms, and blood clots than women taking placebos. These findings flew in the face of decades of research. It was a shock that sent doctors and their patients reeling. One of the reasons that the results of the WHI were so different than the findings of a staggering number of previous studies was because it was a different kind of study. Much of the prior research on hormones was based on small clinical trials, large observational trials, and meta-analysis—the same kinds of research that we have on the Pill.

The results of the WHI aren’t applicable to young women and the Pill. The same hormones work very differently in women’s bodies before and after menopause. Indeed many doctors believe that if the women being studied in the WHI had been younger, the results of the trial would have been very different. But the WHI does provide instruction for people of all ages about the limitations of observational research.

Unfortunately, we will never have a WHI for the Pill. This is for largely practical reasons: it is impossible to ask such a large group women to stay on the Pill for such a big portion of their fertile years. Ethical problems make placebo controlling pill trials difficult, and in the context of such a massive experiment, impossible. Even though the Pill is so studied, it has only been studied in certain ways.

HT and ET were on the market for sixty years before conventional wisdom about those medicines was overturned. There is still much that we don’t know about the Pill, and because of limitations on the type of research we can do, much we may never know.

Taking Heart: Cardiovascular Side Effects of the Pill

One of the most terrifying aspects of the first generation of birth control pills was their tendency to cause blood clotting and strokes in young women. In 1969, Barbara Seaman documented the story of Julie Macauley, a mother of five who died at age twenty-nine from a pulmonary embolism. Macauley had been taking the Pill for less than a year
when she began to have dizzy spells. After two brief hospitalizations, she died, leaving her devastated widower to care for their large family. Tom Macauley was stunned when the doctor treating his wife asked, “Was she taking birth control pills?”
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In the early years of the Pill, doctors often denied the increased cardiovascular risks of Pill use that were confirmed a decade later. Today’s Pill is significantly safer, but some risk remains, especially for women over thirty-five, those who smoke, and patients with other health conditions that make such problems more likely. Women who don’t fit these special precautions still have more blood clots, strokes, and heart attacks on the Pill, even if they are taking “low-dose” versions of the drug.
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As I was writing this book, I learned firsthand that cardiovascular risks are not totally a thing of the past. My childhood friend was hospitalized with multiple blood clots that led to a stroke. As she recovered from emergency surgery that left her unable to walk, write, read, or tie her shoelaces, her Columbia-trained neurosurgeon told her devastated parents that he suspected use of a menstrual suppression drug had contributed to the stroke. My friend wasn’t taking a Pill for contraception; in fact, she did it because she had terribly painful periods and hoped to eliminate some of them.

I do not share this story to scare women away from the Pill—in fact, very few women who take hormonal contraceptives will experience a side effect this serious. Rather, I tell this story to highlight the fact that taking the Pill is never a simple choice; there is always risk involved. I believe denying or ignoring that such outcomes can happen makes it harder for the extremely small number of women who suffer them to receive proper care. My friend’s care was delayed by assumptions among medical care-givers that she was inventing her symptoms.

As Dr. Richard P. Dickey notes, “Virtually all the excess mortality in OC [oral contraceptive] users is due to CVD [cardiovascular disease].”
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In other words, if you are going to die from taking the Pill, it will be because of CVD. CVD can be caused by blood clotting in the vessel, such as deep vein thrombosis and pulmonary embolism; changes in the vessel wall, such as high blood pressure and isechemic heart disease; and problems
that happen because of a combination of these factors, such a heart attack (myocardial infarction) and stroke.

Who Is Most at Risk?

With cardiovascular problems, certain preexisting conditions make oral contraceptive use more dangerous. These include high blood pressure, smoking, migraine headaches that are characterized by visual symptoms called auras, thrombophlebitis (an increased tendency to form blood clots), a family history of abnormal clotting, and obesity.
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While the Pill is a very studied drug, we have barely begun to scratch the surface on some very important safety issues. For example, how might the various Pills work differently in the bodies of women in different racial groups? Like age, race is a factor often left out or understudied in many drug trials. One recent article notes “studies of OCP [oral contraceptive pill] use have either not enrolled African American women or enrolled too few African American women to allow for the assessment of metabolic consequences of the OCP.” After looking specifically at a population of black women taking the Pill, study authors concluded, “In African American women, OCP use is associated with an increase in markers of cardiovascular risks.”
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These warning signs included insulin resistance, glucose intolerance, and elevated triglycerides.
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Risk/benefit analysis is always a tricky business, but it is made more difficult by science that doesn’t acknowledge and study the particular benefits and drawbacks posed to specific communities.

Blood Clots

While blood clots remain a rare outcome for pill users, new progestins and new systems of distributing hormones have made this serious problem with the early pill something that women need to worry about again. Only thirty-two cases of thromboembolism (blood clots) per million women are seen between ages twenty to twenty-four, but this number goes up to forty-six cases between ages thirty and thirty-four, and fifty-nine cases between
forty and forty-four.
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Women who take the Pill face a threefold increase in the risk for this problem,
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and it seems to be related to estrogen dosage,
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with a risk around one to two cases per ten thousand women.
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Regardless of what pill you take, certain genetic factors (such a V Leiden mutation) and preexisting clotting problems make thromboembolism on the Pill more likely. If you have a family history of blood clotting or thrombosis, you may want to consider screening for such problems before starting oral contraceptive use.

There is growing evidence that certain newer third generation progestins may cause an increase in clotting more comparable with first generation pills. This possibility first made headlines in the mid 1990s when the Committee on Safety of Medicines (CSM) in the United Kingdom uncovered three unpublished studies that showed that clotting was more likely on OCs with third generation progestins gestodene and desogestrel.
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These findings were controversial,
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but they have been confirmed by further studies.
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In 2007 the consumer group Public Citizen petitioned the FDA to pull pills with desogestrel,
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but they remain on the market in the United States.
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In two 009 studies Danish researchers again found that newer progestins were, in some cases, less safe than older ones, and that those with desogestrel, cyproterone, drospirenone, and gestodene caused more problems than those with levonorgestrel or norgestrel.
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What this tells us is that newer isn’t always better, and that much more research is needed before we can start to understand what the differences between these compounds mean.

Drospirenone, the progestin in Yasmin and Yaz, has fallen under particular scrutiny in recent years for its potential to cause blood clots. Approved in 2001 and 2006 respectively, Yasmin and Yaz became the top-selling pharmaceutical line for their maker, Bayer, and Yaz became the top selling birth control pill in the United States.
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One twenty-one-year-old recently told me Yaz was the “classic” pill for college girls—but these pills may carry extra problems.

Serious troubles for Bayer began in October of 2008 when the FDA decided that ads for Yaz were misleading enough to require correction.
Exaggerations of the benefits—including claims that the drug could fix mild depression and acne—led to required mea culpas in advertisements that cost $20 million and showed a pretty young woman sheepishly admitting that viewers “may have seen some Yaz commercials recently that were not clear.” In all, by the fall of 2009, seventy-four lawsuits had been brought against Bayer by women using either Yaz or Yasmin, many of whom had experienced blood clots. One of these, Anne Marie Eakins, developed blood clots in both lungs after taking Yaz to control PMS and skin problems.
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The history teacher and mother of two survived, but lost part of her right lung. The literature on drospirenone reveals few differences from traditional oral contraceptives, but reviews on the progestin all conclude that a lot more research will be necessary to discretely understand it.
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The lesson of Yasmin and Yaz (and as we shall see, the contraceptive patch and ring) is that newer is not necessarily better; in fact, when it comes to pills, it is often wiser to stick with the drug you know. Hopefully consumers will not need more unexpected side-effects and avoidable tragedies to take this lesson to heart. Judy Norsigian, the tireless women’s health activist who has worked with Our Bodies, Ourselves for over thirty years tells me, “It’s so sad what has happened with some of the new contraceptives. It’s all because the drug makers want new patents. So many of these adverse events were completely avoidable.”
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