ARTSSCI 4FC3: How Science Speaks to Power
This paper aims to highlight the importance of involving the extended peer community in risk assessments of the applied sciences. To do this, the paper will discuss the history of the first oral contraceptive (OC) in America; specifically, the Nelson Pill Hearings, which were a highly publicised trial intended to evaluate the safety of the OC Enovid. During the trial, it became clear that excluding women’s perspectives resulted in a large distrust of scientific authorities. This distrust of the scientific community led to professional opinions being ignored and damaged the relationships between women and their doctors, thereby putting women’s health at risk. Many of these issues could have been avoided if post-normal science ideals had been implemented sooner. It was not until feminist activists protested their concerns that a post-normal science framework was implemented. For context, post-normal science refers to a potential approach for how to analyse and apply scientific knowledge in risk assessment (1). It is intended for use when uncertainty and risk are high (1). This approach suggests that in order to successfully apply scientific knowledge in policy decisions, both the scientific and extended peer community (the groups affected by the issue at hand) need to be consulted (1). In the case of Enovid, failing to recognise the importance of involving women in this scientific breakthrough created a barrier for women to benefit from said breakthrough. The issues discussed in this paper (specifically, a drop in Enovid sales and OC use) could have been avoided had women’s perspectives been included in the process of Enovid’s risk assessment.
America’s first oral contraceptive (OC) was trademarked as Enovid and available for sale in 1960 (2). Prior to Enovid, other contraceptive methods were seen as messy and cumbersome (3). The public applauded Enovid as a convenient and effective measure for pregnancy prevention, and hailed it as a possible solution to the growing concerns of overpopulation (2,3). Unfortunately, Enovid had a significantly higher concentration of hormones than was necessary for efficacy. With this higher concentration came an increased intensity and likelihood of negative side effects including bloating, nausea, headaches, and more (3). However, out of all the side effects, it was the pill’s blood-clotting effects that turned out to be life-threatening.2 Despite this danger, the first formulations of the pill remained on the market for years.2 When the negative side effects of the pill garnered public attention, there was an uproar against the paternalistic nature of medicine and a significant drop in OC use and sales (2,4).
While initially approved for the treatment of menstrual disorders in 1957, Enovid’s contraceptive properties were researched beginning in the early 1950s (2). In 1959, researchers submitted a supplementary application to allow Enovid to be used for contraception (2). The drug review process was hindered by low staffing and was pressured to review drugs quickly; as a result, drug approval applications were rushed (2). Within this limitation, the FDA had to rely heavily on external sources for review and approval of NDAs (New Drug Application) (2,5). G.D. Searle, the producer of Enovid, provided the FDA with a comprehensive twenty-volume collection of clinical research data, the largest NDA given to the FDA up to that point (2). The NDA largely referenced the work of George Pincus and his colleagues (2). The research clearly outlined that the side effects were significant enough to stop some participants from continuing the trials (2). However, Pincus’s research also suggested that women who stopped taking the pill could still have successful pregnancies (2). The FDA willingly accepted the risk in part because the side effects were physiologically understood.2 Enovid was approved as an OC in 1960, around seven months after the application’s submission (2).
The subsequent scientific and medical responses to Enovid were contradictory, to say the least. One 1962 Los Angeles Times headline proclaimed: “Birth Control Pill Probed in Death of 6.” The next day, the headline would read: “Birth Control Pills Cleared in Six Deaths”. (5)(p. 295). Science referred to the issue in its 1963 headline as a “… Continued Medical Dispute”. (5)(p. 295). Different studies drew different conclusions regarding the safety of OCs; many called for more research to be done (5). In 1962, Searle released a review which concluded that Enovid posed no serious threat (5). Within the year, the FDA reported an increased risk for women older than 35, but quickly withdrew the report after uncovering mistakes in their calculations (5). Physicians also disagreed about the level of risk they were willing to accept for their patients. Some argued against OCs like Enovid because they believed the risk outweighed the benefit (5). Meanwhile, other clinicians argued that the health risks associated with unplanned pregnancy, along with the need for family planning, outweighed the risk posed by Enovid (5). It was not until the late 1960s that a consensus on the correlation between OCs and thrombosis began to form (5). By 1970, a close relationship between estrogen and thromboembolic disease was established (5).
While the scientific and medical community debated the ethics and safety of Enovid, women taking the pill started to doubt scientific and medical authorities. From 1961 to 1962, the tragedy of Thalidomide garnered global attention (2). Thalidomide had been recommended to alleviate the effects of morning sickness during pregnancy (2). It was considered to be very safe, so much so that it was a non-prescription drug in Germany. Thalidomide was immediately pulled from shelves when the medical community discovered that it had caused a significant number of serious birth defects (2). While the drug was never approved in the United States, the Thalidomide controversy heightened mistrust in epistemic communities and increased concern over putting women of child-bearing age at risk (2). An additional provocation was the frequently cited sample size of only 132 women for the clinical research done on Enovid as an OC (2). The small sample size enraged many women and further put into question the safety of Enovid (2). In reality, many more than 132 women took the pill before it was approved as an OC (2). However, this information eluded the public because of the FDA’s legal obligation to keep certain commercial information confidential (2). It seems that the commonly reported sample size of 132 came from a memo written by the FDA’s Drug Division based on research data, so it may have just been the easiest information to publicise legally (2). The FDA’s lack of transparency resulted in an intense distrust of the organisation. This distrust heightened with the publication of Barbara Seaman’s The Doctor’s Case Against the Pill in 1969 (3). Seaman’s book included testimonies from doctors, medical researchers, and women, all of which completely denounced the pill.3 The book caught the attention of Senator Gaylord Nelson, who, at the time was holding hearings on the pharmaceutical industry, the abuse of antibiotics, barbiturates, and tranquilizers; he decided to take on the pill as well (6).
The Nelson Pill Hearings were held from January 14th to March 1970 (2). The purpose of the trial was to assess: 1) the safety of the pill and 2) whether women had access to enough information to make informed decisions (2). The trials were sensationalist, volatile, and gathered much publicity; at the time, public discussions about sex or birth control were rare (6). The hearings aired on all three of the national television networks (5). Many women were horrified when they learned the full extent of the potential side effects associated with the medication they were taking (6). Since many women were ill-informed about the level of risk associated with the pill, they felt that decisions about the level of risk they were accepting were out of their control (6). Somewhere along the way, what some physicians defined as ‘acceptable risk’ for contraception differed from how women defined it. The trial started making headlines, however, after several feminists expressed outrage (7). During the trial, members of the D.C. Women’s Liberation Group (such as Alice Wolfsen), would often loudly interject to express their opposition to the lack of female representation during the trials (6,7). Many of the women attending the trials were upset to see that not a single woman was asked to testify (7). Women did not see themselves being represented in the trial. In the end, the level of uncertainty associated with the safety of the pill angered many women and the trials raised serious concerns about patient autonomy.
During the trial, there were many contradictory accounts about the safety of Enovid (8). Epidemiological modelling was hindered since there were so many variables for every woman on the pill (2). When the dosage, time on the pill, and physical differences between patients were so variable, it was difficult to find a clear connection between one factor and the safety risks associated with the pill (2). Additionally, the scientists and regulators behind Enovid seemingly shifted their assessment of Enovid from safety to efficacy (2). Early scientists such as Gregory Pincus have been criticized for seemingly prioritising the effectiveness of Enovid while downplaying the seriousness of the side-effects (3). Throughout the trial, the pill was openly defended by explaining it posed less risk than pregnancy (2). This argument was problematic considering the reality that a significant portion of women did not know the risk associated with the drug they were taking (9). Many women were not warned of potential side-effects and as a result they were less informed about their options and less likely to consider (potentially safer) alternatives. The focus on efficacy over safety shifted the focus from whether Enovid was safe to arguing that it was safer than an unplanned pregnancy (2). Despite other contraceptive methods being available at the time, if a physician wanted to make the case that Enovid was dangerous they would not only need to prove the pill was unsafe, but also that it was worse than an unplanned pregnancy (1).
The trial produced several significant outcomes. Many women wrote letters to the FDA, demanding that manufacturers advertise information about the potential side effects of their medication (3). During the trial, the FDA announced that every pill package would include an insert with information about the pill’s side effects (3). Opposition by the American Medical Association delayed the official insert requirement until 1978 (3). This change was pushed in part by the National Women’s Health Network (NWHN) which led a series of protests against the FDA in 1975 (9). The NWHN was founded by Barbara Seaman and Alice Wolfsen, who met at the Pill Hearings (7). However, there was also a drawback to the hearings. It seems likely that the trial caused unplanned pregnancies (2). A 1970 Newsweek-Gallup poll showed that two-thirds of women on the pill were never warned by their physicians about potential health hazards (10). The sudden awareness regarding the negative side effects of the pill resulted in many women being hesitant to take the pill. After the trials, another Gallup Poll of 8.5 million American women said that 18% had stopped taking the pill, and 23% had seriously considered discontinuing use (11).
Throughout Enovid’s history, the perspective of the people who were most affected by use of this medication was excluded. There was little to no transparency in the drug approval process, many women were not aware of the risks they were taking, and women were excluded from testifying at the trials. The lack of women’s involvement resulted in a distrust of any study or regulation. As stated by Betz: “…participation is an effective means to foster the citizens’ trust in their government" (12) (p. 251). Instead of allowing participation, the factors discussed resulted in women seeing the government and scientific authorities as untrustworthy and illegitimate. Had the uncertainties and risks been expressed to women, we would not have had the sudden drop in sales and usage of Enovid that followed the trials. The level of risk that is acceptable depends on the person, and as we have seen with the development of the hearings, women were not included in these conversations. The forced interjection of women’s perspectives was the pushback stakeholders needed to act accordingly with the importance of including all relevant perspectives. The policy changes brought on by women’s groups resulted in post-normal science ideals such as conveying risk and uncertainty to the extended peer community (via package inserts included with medication). Ultimately, the pill was only effective when women chose to take it.
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