THE CONTINUOUS TESTING OF THE PILL
The way in which the oral progestins were finally approved as contraceptives is a rather intriguing story. Based on the Rio Piedras trial and a handful of small – scale clinical trials in the continental USA, the FDA approved Enovid in 1957, not as a birth control pill but only as a treatment for menstrual disorders. According to Garcia this was a political choice:
The first application was not as an oral contraceptive but as a gynecological agent to treat menstrual aberrations, and that was done with political calculation and it wasn’t done with any other thing in mind because the contraceptive properties of it were well-known at that point.
(Garcia in Anonymous 1978:60)
Many actors understood very well what the FDA approval actually meant. In McCormick’s words:
Of course this use of the oral contraceptive for menstrual disorders is leading inevitably to its use against pregnancy—and to me—this stepping stone of gradual approach to the pregnancy problem via the menstrual one is a very happy and fortunate course of procedure.39
In May 1960, the FDA eventually granted its approval for the marketing of Enovid explicitly for contraceptive purposes (Maisel 1965:142). Pincus and Rock’s representation strategy turned out to be successful. The FDA executives used both the results of the clinical trials and all the studies, “every page of them,” from the Puerto Rican and Haitian field trials.40 The Caribbean trials functioned as an important ingredient in convincing the FDA, the medical profession and health officials of the “universal” character of the new contraceptive: it was proven that it could be used by women of any color, class and educational background.
Following FDA approval, the new contraceptive could be put on the market. G. D.Searle and Company, very much aware of the novelty of the product and its potential to damage the company’s reputation, did not take any risks. Its executives developed a careful marketing and public relations campaign. Ahead of the launching date for the product, they approached the editors of the Saturday Evening Post and Reader’s Digest and negotiated three major articles, telling the story of “the new contraceptive that was being tested in Puerto Rico.” This strategy was chosen to test whether their new product might generate any protest. The expected angry letters to the editors, however, did not appear. Searle had obviously misjudged the situation. Times were changing during the years that the pill was being developed. Despite the fact that contraception was technically a forbidden subject in Massachusetts, the moral attitudes to contraception and sexuality in general were relaxing in the 1960s (McLaughlin 1982:137-138; Vaughan 1972:5253). Actually, by late 1959, half a million American women were already taking Enovid, originally prescribed to them as a drug for menstrual disorders, as contraceptives. Both doctors and patients knew the pill’s contraceptive power well before it was marketed as such. The FDA, in its first approval of Enovid, had “mandated Searle that the drug would carry a warning to the doctors that women would not ovulate while taking the pills,” a mandate which worked like a “free ad.”41 A similar practice existed in European countries. In The Netherlands a combined estrogen-progesterone preparation was first marketed in 1962 for the treatment of menstrual irregularities, carrying a warning that women would not become pregnant while taking this medication. This strategy was chosen to anticipate possible protests from physicians, the media, the lay public, as well as the mainly Catholic production personnel of Organon, the firm that introduced the pill to the Dutch market (Haspels 1985:20). In Spain, this cautious attitude was even found up until the 1980s. “The Spanish Pharmacopoeia described estrogen-progesterone combinations as effective in regulating menstrual cycles, but as having the serious side effects of preventing pregnancy” (Veatch 1981). This practice exemplifies how the activity of a drug is not dictated by nature, but is the result of a socially conditioned selection process, in this case religious and moral attitudes toward birth control (Bodewitz et al. 1987).
Searle soon witnessed the profits from its “daring decision” to market Enovid as a contraceptive: the company’s shares doubled in value in the years following FDA approval (Seaman 1969:179). Other American drug companies, such as Syntex and Parke-Davis, did not take this risk. They felt that contraceptives were not a suitable business for an ethical firm (McLaughlin 1982:137). Parke-Davis in particular was afraid that the marketing of a contraceptive would ruin their market in the Roman Catholic areas (Anonymous 1978:36-37) The market, however, was more than ready to accept the new contraceptive.
The FDA’s approval of the first oral contraceptive had an immediate impact on the health care system in the US. In the spring of 1960, many health department directors and welfare officials began to plan the opening of new contraceptive clinics (Maisel 1965:216). The acceptance of Enovid as an officially approved drug did not mean, however, that testing had come to an end. Research and development of the new contraceptive remained a major issue on the research agendas of Pincus and Searle, and those of the many other scientists and companies that now joined the bandwagon.
Since the 1960s, field trials of Enovid and other related compounds have been continued and expanded. One of the problems to be solved, which would remain a major issue for further testing until well into the 1980s, was the proper dosage of the drug. The dosage used in the early clinical and field trials was merely guesswork, “a shot in the dark,” as one of Pincus’s colleagues described it (Vaughan 1972:48). Systematic studies of reductions of the dose, needed to make the contraceptive “physiologically safer, but also more economic” (Pincus et al. 1962:440) were not included in the early trials. This might have increased the risk of pregnancies, thus lowering the “success” rate of the medication, which was measured only in terms of nonpregnant cycles. After FDA approval was obtained, new trials were organized to give more serious consideration to the side-effects that continued to be reported by women and physicians, the most important of which was the risk of cancer (Ramirez de Arellanoa and Seipp 1983:123).
The development of a pill with reduced dosage levels was taken up when the new contraceptive came to be used regularly by a great many women, underlying the necessity of producing a pill that required less raw material and that would cause fewer side-effects. A second generation of oral contraceptives under the brand name of Ovulen, with one half and later one – quarter of the dose of Enovid, was tested and put on the market in 1963. This first made the pill available outside the USA: in Britain, Austria and South Africa. The third generation of the pill, available in the 1990s, contains a dosage that is only one-tenth of the progesterone and one-third of the estrogen levels of the first generation of oral contraceptives (Maisel 1965: 195, 201; Vaughan 1972:49). The use of hormones as contraceptives since the early 1960s can therefore be described as an “infinitely large unofficial field trial” including women all over the world (Maisel 1965:146).
This episode in the story of hormones illustrates how scientists reoriented the hormonal enterprise to a totally new purpose: the control of fertility. As I indicated, medical innovation can only be successful only if scientists succeed in selecting and creating the required contexts in which knowledge claims can be established. In this respect, the development of hormones into contraceptives faced serious constraints, which shaped the entire development trajectory, from the search for the required test locations to the enrollment of women in the trials, and from the approval of the FDA to the eventual marketing of the contraceptive pill. The pill was a novelty since it was a compound to be prescribed for healthy women. This meant that the organization of clinical trials could not easily follow the routines of other clinical testing. Trials for the testing of drugs to cure a specific disease could rely on patients who could be assessed in clinical settings. For the pill, such patients did not exist. The testing of the pill required “healthy patients” who did not suffer from any particular disease and consequently did not belong to the clientele of a specific clinic.
The search for the required test locations was highly constrained by the political and moral taboos on birth control. The major quest was therefore: where to find test subjects and a politically feasible test location. Due to these constraints, the history of testing the pill reads as a detective story in which the participants try to conceal their real intentions from anyone who might hinder their endeavor. In this respect, the first trial in which hormones were tested in humans speaks volumes: the contraceptive potential of the hormones was tested first among women who were being treated for infertility problems! Subsequent trials were organized in settings where only very specific groups of subjects could be assessed: a mental hospital, a medical school and a women’s prison. These trials were not very successful in enrolling women. Established medical institutions could obviously not provide the required infrastructure for the development of the contraceptive pill.
What all this implied was that pill researchers had to create the required contexts themselves. The quest for “healthy patients” could be solved only by removing the tests to a completely different location: the infrastructure of the family planning organizations, particularly the Family Planning Association in Puerto Rico. This displacement did not necessarily imply a preference for Puerto Rico. It is very likely that the required test location might as well have been found among family planning clinics in those states of the US continent that had no laws prohibiting birth control activities. Actually, one such trial was organized, in Los Angeles, at about the same time that the third trial in Puerto Rico took place.42 The choice of Puerto Rico must therefore be understood as a mixture of cultural imperialism and practical testing considerations. Since the contraceptive pill was called into existence mainly because it was considered a technological fix for the population problem in “underdeveloped countries,” its testing required a population that reflected this ideology: poor, illiterate women. Puerto Rico, with its poorly educated and impoverished population, provided such a testing ground.43
The hormone story thus evolved into a highly political story which clearly shows the crass manipulatory strategies of big politics which can ignore other communities. This is very different from the intimate involvement of the communities I described in the previous chapters, where there was a kind of see-saw of dominance that kept everyone very aware of whom they were dealing with.44
The displacement of the clinical tests from the medical institutions to the clinics of the family planning organizations had enormous consequences in terms of the women who eventually became the major test subjects for the contraceptive pill. The first large-scale trials, with all the risks involved, did not take place among the white majority of Americans or Europeans. It was Caribbean women who entered this history as the guinea-pigs of one of the most revolutionary drugs in the history of medicine. Obviously, women do not have the same position as “objects of scientific inquiry.” This means that we cannot continue to address women as a group if we focus on knowledge production about the body. This conclusion is in line with the postmodernist approach in women’s studies, which suggests that the feminist preoccupation with the category of woman tends to obscure and mystify the vast differences among women’s experiences and characteristics in different cultural settings. Black feminists specified this claim by suggesting that feminist studies should take into account the differences between women that are created by the social contexts of being black or white.45
Applying this theoretical notion of the construction of differences to the story of the pill shows a rather peculiar pattern. The choice to test progestins in Caribbean women could be made only because scientists did not assume a priori fundamental bodily differences between women. All women are equal in scientists’ theories on the role of progestins in reproductive functions, even to such an extent that scientists make women disappear from their reports altogether. We saw how, in publications about the pill, women who participated In the trials are replaced by menstrual cycles: woman is represented as “cycle.” This representation strategy enabled scientists not only to make the most of their results, but also emphasized the similarities between women. The use of such categories as “cycle” replaces the individual subject by the group, suggesting a continuity that did not exist in the trials. That suggestion simultaneously affirms continuity while obscuring discontinuity by framing new scientific categories for data measurement. A representation in terms of cycles implies an abstraction from the bodies of individual women to the universal category of a physical process.
The history of the pill thus reads as the intriguing story of how scientists tried to construct similarities between women. This construction of similarities was not just a matter of discourse. During the testing of hormones, similarities were literally created by the introduction of a specific regimen of medication. As I indicated, Pincus could have made a menstrual cycle of any desired length by changing the prescription of how to use the tablets. He chose to make a “normal” menstrual cycle that subsequently became materialized in the pill. This diminished the variety in menstrual patterns among women: all pill-users have a regular four-week cycle. The pill thus literally created similarities in women’s reproductive functions.
This emphasis on similarities was a prerequisite for the quest to develop a universal technology: a contraceptive that was meant to be used by women of any color, class or educational background. This dream of making the ideal contraceptive for any woman, regardless of her specific background, was not fulfilled. The main acceptance of the pill has been among middle – and upper- class women in the western industrialized world, with one major exception: China. Most women in Third World countries have adopted sterilization and intra-uterine devices as means of contraception (Seaman and Seaman 1977: 76). Despite the development of the pill, the problem of fertility control is not yet solved. Even in the 1990s, there still exists a large and unmet need for fertility control among women worldwide (Hardon and Claudio-Estrada 1991).