Whatever individual women (and men) may feel about having children, the home pregnancy test (HPT) has become one of the most common diagnostic tools available over the counter today. In recent times, Indian pharmaceutical companies have marketed the product both to the “traditional house-wife” as well as to the “Generation Z’ers” using glamorous Bollywood stars.
The now ubiquitous home pregnancy test was very different back when it was first launched in the United States during the late 1970s. It came at a time when women were collectively organizing themselves across the world. Medical professionals and government regulators alike felt unequipped and threatened by the emergence of this new technology. Joan H Robinson analyzes the historical phenomenon of the home pregnancy test (HPT) in a well researched and extremely readable article in the October 2016 issue of Social Studies of Science. Using scholarship in science, technology and society studies (STS), Robinson narrates how various institutions navigated a tortuous legal and technological maze in society, to result in the now uncontested product.
Today’s HPTs test for a positive presence of hCG in urine (hCG – Human chorionic gonadotropin is a hormone produced in the female, generally after pregnancy). But it was not so till 1960; testing for pregnancy required tests on live animals in suitable laboratories. In 1960, the first in vitro pregnancy test was developed by a team of Swedish scientists, without using live animals but only ‘an agglutination of red blood cells of a sheep in a simple test tube’. While this test created a momentous shift in pregnancy detection, it still remained a laboratory based test.
The 1960s and 70s also saw monumental shifts in the way women saw their bodies, and indeed, how the State began to see women’s bodies. In 1965, the US Supreme Court struck down a law that banned married couples from using contraceptives, effectively banishing the State “from the marital bedroom”. In 1973 came the Roe v Wade case which legalized abortion in the first and second trimesters of pregnancy. While these landmark judgments appeared to reduce the authority of the State over women’s choices, doctors still retained their power as mediators between the State and women. Women’s health activists demanded ‘greater control over their bodies, including knowledge, choices and alternatives to mainstream medical care’.
In 1967, Meg Crane, a graphic designer working for Organon, a Dutch pharmaceutical company, designed a home based pregnancy test based on the Swedish test developed in 1960. In 1971, Organon patented the test in Crane’s name. But it was Faraday’s Laboratories that first marketed HPTs to American consumers in late 1971. Calling the product ‘Ova II’ with the tagline ‘When you want to be the first to know’, Faraday’s claimed that the test was identical to those used in laboratories, with reasonable accuracy even when used by laypeople. We need to know that this test had to be conducted using a test tube, a dropper, and a chemical additive – a bit more complex than the hCG based HPTs in use today.
Robinson analyzes how Ova II presented a strange challenge to the Food and Drug Administration (FDA). It was a time when there was widespread concern over the risks associated with medical devices. Unlike drugs, the FDA could regulate non-drug products (like medical devices) only after they had been sold to consumers and had proven to be harmful. The early 1970s also marked political chaos – President Nixon had resigned after the Watergate scandal. During those uncertain times, the FDA ordered the recall of Ova II from the market claiming that the the tests were ‘inaccurate, unreliable, and prone to give false results’. Faraday’s Laboratories questioned FDA’s jurisdiction over Ova II and decided not to comply with the recall order. The FDA went to federal court over the matter.
Robinson points out that the fundamental issue in the battle between the FDA and Ova II was not if Ova II was safe and effective. Rather, it was whether Ova II was a ‘drug’ which could be regulated by the FDA. In 1975, the judge held that “A test for pregnancy, then, is not a test for the diagnosis of disease. It is no more than a test for news…” and thus, Ova II was not a ‘drug’. The judge had held that the FDA did not have the power to regulate Ova II or any related devices.
Robinson’s submits an interesting analysis of the fears expressed by FDA and others regarding HPTs. There seem to have been no question about pregnancy tests as long as they remained in the hands of medical professionals. But when the test entered hands of lay women, it was deemed to be “inaccurate, unreliable and potentially even harmful”. What emerges is that “an image of women using chemicals in test tubes in their own homes to determine their own pregnancy jarred some social groups and social norms more than did other home health devices.”
The above views on lay women determining their own pregnancy is reiterated in what a technologist said in 1976: ‘I am becoming increasingly worried by the escalating use of such kits by nontechnical staff such as nurses, receptionists, and clerical employees in health centers and in private practice, and especially, as in this case, by the patient herself.’ Note the examples used: ‘Nurses, receptionists, and clerical employees’ were generally women, just like ‘the patient herself’. Robinson submits that it reflected the gender stereotype that women were less technologically competent.
Interestingly though, there were medical professionals who expressed support for HPTs using the ‘rights language’ of the women’s health movement: that women could gain ‘control over their bodies which is their right’. Those in favour of HPTs suggested that issues of reliability and complex procedures could be solved through ‘scientific testing’ and by issuing instructions that were easy to understand.
In 1976, the US Congress enacted the Medical Device Amendments (MDA) with a detailed classification to regulate medical devices. The Ova II judgement came on July 26, 1975 and the MDA regulations were supposed to take retroactive effect on May 28, 1976; products already in the market and those to be introduced later would be governed under this. Under the Ova II ruling, HPTs could be marketed without pre-market approval if they were to be introduced before the law was enacted. The pharmaceutical company, Warner-Chilcott, cleverly utilized this opportunity to test market its new HPT called e.p.t, “Early Pregnancy Test”.
By the time MDA was implemented in 1978 e.p.t had gained the status of the most widely marketed HPT in the US, becoming more popular than Ova II. Full page ads in women’s magazines and newspaper articles contributed to the publicity of e.p.t. Vogue magazine stated that ‘E.P.T. Early Pregnancy Test gives women a new power, the power of time to help control the quality of their pregnancies.’ Similarly, articles interviewing physicians and weighing the merits of HPTs appeared in several regional and national papers. But the general message in these articles was that doctors still had negative opinions of the test, primarily regarding its reliability and stress due to test results.
Doctors argued that the test procedures were so complicated that their results could be inaccurate ‘even under laboratory conditions’. There was also a concern that a woman ‘may be under stress when she administers’ the test as it is ‘a very emotional thing and women can get so nervous that the test will have a very dubious end point’. Robinson indicates that the basis of these assumptions is “that stress about a possible pregnancy would make a woman more likely to commit errors than a lab technician, neglecting the possibility that women may commit fewer errors because they strongly feel the gravity of the situation”.
Warner-Chilcott responded to these claims by saying that the test is beneficial for ‘the large segment of women who, for whatever reason, would like to do her own test and be knowledgeable of her condition first before she decides to share it’. ‘But’ the company added that ‘it is not a substitute for good medical care and for people who want the security of having a doctor perform the test’. In effect, the company attempted to pacify the two groups that mattered the most – women’s health activists and medical professionals.
Soon enough, the business community had taken cognizance of the market potential of this new product. By 1979 there were three more tests to compete with e.p.t. By the time the FDA issued formal rules for HPTs in 1979 the tests were already widespread in the market. MDA regulations had also smoothed the process for future changes to the HPT. Today, there are hundreds of variants of the HPT used by women all over the world.
From test tube based HPTs in 1976 to the plastic-enclosed tests in use today, the home pregnancy test is a classic case of how an emerging technology navigated several controversies to step out of the laboratory into the hands of the commoner, in this case, lay women. Robinson has used her STS scholarship to bring a rich social analysis to what initially appeared to be simply a legal case.