Authors: Laura Eldridge
As the Society for Menstrual Research points out, “Historically, nasty surprises with hormonal therapies for women (e.g., heart disease and hormone therapy for menopausal women, the link between oral contraceptives and blood clots, DES and various health problems) have taken many years to surface.”
52
Until we have more extensive long-term data on the repercussions of suppressing periods and exposing the body more continuously to synthetic hormones, use of the drugs for lifestyle purposes should be limited. Susan Rako doesn’t mince words: “Manipulating women’s hormonal chemistry for the purpose of menstrual suppression threatens to be the largest uncontrolled experiment in the history of medical science.”
53
That said, menstrual suppression drugs provide another choice for women, and that is a good thing. If a patient takes the drugs and finds that she feels good on them, that they improve her quality of life or improve her health in one way or another, she should feel confident taking them as long as she does so as an informed consumer who understands all the risks and unknowns. As one (male) commentator reasons, “Pills can liberate you from old burdens. They can also impose new ones. I’m glad women are free to take Lybrel. I hope, in the future, they’ll also feel free not to.”
54
Chapter Seven
Like Candy: The Politics of the Morning-After Pill and Bringing Hormonal Contraception Over the Counter
Medicine is always a political process
.
—L. L. Wynn and James Trussell
Susan Wood is not prone to grand gestures. A serious woman with striking white hair and deadpan delivery, she had been working at the FDA’s Office of Women’s Health (OWH) for several years when she decided, in late summer of 2005, to walk out on her job. She had been closely monitoring the FDA’s debate about the approvability of Plan B—the so-called morning-after pill—for over-the-counter status. Wood was furious over what she saw as the FDA’s willful disregard for scientific evidence showing Plan B to be safe, and its apparent decision to treat the drug as a special case not subject to the usual evaluative methods. Why was this contraceptive drug being treated differently than other pills sold to both sexes? Why was it being held to a higher standard?
The controversy over Plan B has stretched over many years and illuminates critical controversies and patterns in women’s health care. It has touched on fundamental issues of patient access; the right of doctors, hospitals, and pharmacists to refuse medicines on moral grounds; and the ability of women who aren’t medical professionals to assess the appropriateness of contraceptive methods for themselves without gatekeepers. As L. L. Wynn and James Trussell of Princeton University’s Office of Population Research write, “New medical technologies are good to think with. Their very novelty makes them prime subjects for debate over the meaning of medicine and science in a social and political order. Examining these debates can reveal cultural categories, social conflicts, and the relationship between individual bodies and the body politic.”
1
Old cultural enemies clashed over this new drug, and pharmaceutical control became, as it has been in the past, a potent metaphor for talking about female reproductive control.
What can women learn from the long journey of Plan B, and what issues remain with this drug? Should the Pill follow in the footsteps of its sister drug and become available without a doctor’s prescription? What must female patients understand about the social, political, and governmental forces—such as the FDA—that make key decisions about which methods will be available and under what terms?
The FDA Gets Political Over Plan B
The FDA has been playing a significant role in American women’s health for many decades.
2
In the past fifty years, several women’s health tragedies have changed the way the organization does business. One of these involved a woman at the FDA named Frances Kelsey, who in her first month of work for the organization in 1960 withheld approval of Thalidomide, a morning sickness drug for expectant mothers that was available and popular in Europe. Kelsey didn’t think the evidence was there, and after Thalidomide was shown to cause serious deformities in infants whose mothers had used it during gestation, her newer, stricter standards were put in place to make sure that patients were protected.
The FDA approval process involves a flawed but rigorous set of standards. In order for a drug to be approved, its maker must demonstrate that their product is both safe (it won’t cause any terrible side effects) and efficacious (it works for the purpose for which it is being approved). A pill may meet one of these criteria but fail on another one. For example, the medicine Vioxx helps ease joint pain, but it has been found to cause cardiovascular problems. Other pills are safe but ineffective.
Pharmaceutical makers must demonstrate these qualities in a series of trials called phases 1, 2, and 3 before a pill is approved for public use. Prior to initiating this series of tests, animal trials must first demonstrate basic safety. Once that is accomplished, phase 1 trials begin with a small number of human subjects, generally between twenty and fifty. During this time, drugmakers and scientists can experiment with dosage and check for any obvious safety problems. A phase 2 trial expands the testing to a couple hundred patients. By the time a phase 3 trial occurs, testing the medication on potentially thousands of people, it is well on its way to
becoming available. But since it often takes decades and tens of thousands of patients taking a drug in a real-world setting before side effects and even general usefulness are determined, most drugs’ true safety and efficacy remain open questions even years after the FDA gives them the green light.
In 1998, the first dedicated emergency contraception (meaning the pill was made for the sole purpose of preventing pregnancy after sex), Preven, was approved for use in the United States. A year later Plan B hit the American prescription drug market.
3
The drug is a progestin-only (levonorgestrel) preparation that, when taken within a certain window of time after having unprotected sex, offers defense against pregnancy by stopping ovulation, potentially (though not definitely) impairing sperm mobility and preventing implantation of a fertilized egg.
Women have been using “morning-after” options since the 1960s. In 1974, a Canadian gynecologist named Albert Yuzpe published instructions for just such an option that remained the primary means of emergency contraception for decades.
4
The Yupze regimen advised patients who wanted postcoital protection against pregnancy to take larger doses of already available birth control pills. Sure, it might cause nausea, vomiting, and even dizziness, strange bleeding, and headaches, but it was better than having an unplanned pregnancy or an abortion. Plan B simply streamlined this process by providing a prepackaged two-dose option for women whose contraceptive had failed them or who had not used protection.
In 2003, the Women’s Capital Corporation (later acquired by Barr Pharmaceuticals, Inc.) sought over-the-counter approval for their pill. The initial process went smoothly, and the advisory committee voted overwhelmingly—twenty-three to four—in favor of letting women decide for themselves if Plan B was a good option for them. This vote happened after a day-long hearing in which medical experts and individuals were given an opportunity to testify. Both liberal and conservative groups had their say, and over sixty medical organizations, including the American Medical Association and the American Association of Pediatrics, spoke in favor of OTC approval.
Despite overwhelming support from the medical community, not everyone thought that changing Plan B’s status was a good idea. Using
arguments that were often at first based on medical literature but that grew increasingly emotional and ideological, groups such as Concerned Women for America and the American Life League argued that increased access to emergency contraception (EC) would endanger young women. Among other social maladies, Plan B would promote promiscuity and risky sexual practices, it would remove a girl’s ability to say no to lusty male suitors, and it would perhaps provide a way for pedophiles and perpetrators of incest to hide their crimes. Wynn and Trussell have pointed out that these arguments relied on sexual paradigms in which women lack powerful and autonomous sexual desire and instead serve as the gatekeepers for supposedly less controllable male urges.
In retrospect, the looming questions that still haunt EC—for example, the exact mechanism through which the pill prevents pregnancy—were already circulating in the room. Pro-life activists equated Plan B with abortion. Others worried that removing doctors from the path to pills would cause a fundamental disruption of the doctor-patient relationship.
Also evident from the start was the role of George W. Bush’s administration in influencing FDA decision making. Of the four committee members who voted against OTC approval, three were Bush appointees with noted conservative and pro-life positions. Two, W. David Hager
5
and Joseph Stanford, were doctors who refused prescriptions for conventional oral contraceptives to all unmarried patients. Another committee member, Susan Crockett, was on the board of the American Association of Pro-Life Obstetricians and Gynecologists.
6
(Further evidence of the Bush administration’s desire to inform medical policy through whatever means necessary came to light with the departure of former US Surgeon General Richard Carmona, who went public with the ways he was censored by the president, including being forbidden to discuss contraception.
7
) These committee members’ objections were inconsistent with the conclusions of medical experts: while political groups disagreed about whether the drug should travel over the counter, doctors and scientists were overwhelmingly in agreement that the pill should be available. When it came to safety and individual efficacy, there was no reason not to let women make up their own minds about Plan B. When the hearing concluded, OTC approval seemed likely to happen in short order.
Plan B then traveled up to the FDA’s Office of New Drugs, which also
agreed that the drug should be given OTC status. Soon, though, problems began mysteriously cropping up. The FDA began asking for data that wasn’t required of other drugs, such as actual-use studies and information on patient label comprehension. While it is certainly admirable to ask in advance if patients will be able to understand drug instructions, these questions hadn’t been posed with regard to other medications. The FDA was making up new rules to delay the approval of OTC status for Plan B.
In particular, the FDA dwelled on the health of women under age seventeen who might take the drug.
8
The crux of the issue, again, was not medical concern, but rather anxiety about adolescent sexuality and who would make decisions about it. The answer, as far as the government was concerned, was clearly not teenage girls.
In May 2004, the FDA sent Barr a nonapprovable letter suggesting that there was no quick fix for emergency contraception (when the FDA issues an approvable letter it means that while there is more work to do—perhaps further study or providing the FDA with more data—there are clear and easy steps to take to ensure the drug will pass muster). Immediately, many interested parties in the women’s health and medical worlds cried foul and began publicizing the oddities of the FDA’s decision. A 2005 report from the Government Accountability Office (GAO) found that “the decision was … highly unusual and … was made with atypical involvement from top agency officials and may well have been made months before it was formally announced.”
9
Undaunted, Barr resubmitted their application in the summer of that year.
And then things went quiet. The FDA made no formal claims on the subject; they simply stopped moving on the issue of emergency contraception. Nothing happened as months rolled by. Susan Wood wasn’t the only one who was frustrated. Senators Hillary Rodham Clinton of New York and Patty Murray of Washington withheld approval of new FDA commissioner Lester M. Crawford in protest (he had served as acting commissioner throughout the debate). A condition of his acceptance was assurance that the status of the pill would be resolved by September 1 of that year (2005).
10
Once Crawford was put in power, he immediately set about blocking Plan B.
It was a hot Friday afternoon in August 2005 when the controversy,
which had been building for years, came to a head. Crawford finally announced the FDA’s decision: Plan B’s OTC status would not be approved at that time. The process would be opened for public commentary and the final decision would be indefinitely delayed. Wood, Clinton, Murray, and countless women and activists knew what this meant. It was effectively another no for emergency contraception.
Wood decided enough was enough. “The point of my resignation was to help clarify the problem—that the FDA was totally out of whack,” said Wood four years later.
11
Plainly, there was much to be clarified, about the role of a conservative religious administration in making secular and sexual health policy, the tendency of organizations like the FDA to treat women’s health and products as special cases, and of course, the desire of established authorities, both governmental and medical, to maintain more direct control over women’s contraceptive choices.
Within three months, Crawford was gone, a victim of personal controversies more than public missteps (he was accused of having an inappropriate relationship with a staff member as well as of financial improprieties). When he left, women who had been burned in the Plan B brawl and betrayed by Crawford didn’t mince words. Clinton noted, “With the resignation of Dr. Crawford, the FDA has a real opportunity to restore its battered reputation and nominate a leader with vision and drive to ensure that the FDA upholds its gold standard of drug regulation.”
12