Toxic Shock. Sharra L. Vostral
Читать онлайн книгу.
other uses for the materials and to dispel the notion that absorbent means bulky.” Because traditional materials required more volume rather than less to absorb an equivalent amount, this common wisdom needed to be dispelled to show that “new-and-improved” translated into a sleeker, smaller product.
Problematic Female-Specific Technologies
That tampons should be artifacts worth “modernizing” fits into the ideological scope of progressive science and technological determinism offered during the 1960s and 1970s. NASA experienced great success with the space program, inspiring a new generation of scientists to dream big in spite of the risks. Faster, nonhuman mainframe computers crunched mathematical formulas at blistering speeds. Insecticides and herbicides applied to crops yielded greater harvests, with abundance to share. And petrochemicals and plastics could be manufactured more efficiently and more cheaply than just about any material that they replaced. Scientists, it seemed, held the keys to nature itself and could not only solve the world’s problems but also do it better than ever imagined. Though we now recognize there are costs for all this “progress” that were oftentimes conveniently ignored, nonetheless these huge scientific and technological gains created the impression that no problem was beyond the scope of technoscientific solutions.
The science of medicine developed further as well, with women’s bodies and health needs receiving renewed attention. With the wild success of the birth control pill, corporations could no longer ignore women’s desires to manage their own fertility and experience better pregnancies. Thus, progressive science and scientific medicine heeded the cultural message and began delivering more options to women, ranging from disposable baby bottles, to New Freedom sanitary pads, and, more ominously, products that caused injury as well.
One such pharmaceutical was thalidomide, a sedative prescribed to pregnant women to treat morning sickness and nausea. Widely available throughout Europe, Australia, and Canada during the 1950s and 1960s, thousands of women took the medication, unknowingly exposing their fetuses to toxins that caused birth defects, most notably the absence of limbs. Interestingly, it was a female physician hired in 1960 by the Food and Drug Administration (FDA) who stalled the drug’s application in the United States, ultimately refusing its approval. Frances Kelsey, a pharmacologist who worked on a treatment for malaria among other projects, upended the erroneously held assumption that the placenta was impervious to chemicals by recognizing that its porous composition allowed pharmaceuticals to pass through it. Furthermore, pharmaceuticals affected adults, children, and fetuses quite differently. Her readings of British studies on thalidomide pointed to enough concerns that she requested further scientific testing rather than relying on more testimonials from the Richardson-Merrell pharmaceutical company. Kelsey held firm, despite pressure and bullying for the drug’s approval, and demanded more proof of safety. By late 1961, German health authorities had linked thalidomide to birth defects, and they recalled the drug, which was available there over the counter. The March of Dimes estimated that more than 10,000 children were born with defects due to thalidomide, though only seventeen were connected to it in the United States, in no small part due to Kelsey.24 It took until 2012 for the manufacturer Gruenenthal Group and its chief executive to apologize for the tragedy unleashed by the drug.
In a similar example, the Dalkon Shield, an intrauterine device (IUD) intended to prevent pregnancy, by all accounts seemed to be a promising method of birth control yet it also delivered unintended injuries. Though IUDs were not new, the design of the Dalkon Shield was unique—a plastic horseshoe crablike insert with fins, that when installed in the uterus encouraged white blood cell activity that in turn attacked sperm when present. With national marketing beginning in January 1971, over 2.5 million women used the Dalkon Shield, manufactured by A. H. Robins Company, until it was voluntarily withdrawn from the market in 1974.25 At that time, the FDA did not require stringent testing of medical devices, and the agency’s only recourse was to issue a recall after a sufficient number of physicians and patients reported problems.26
The undoing of the Dalkon Shield was its multifilament tail string covered in a nylon sheath that remained attached to the device after insertion so that it could be removed at a later date. It turned out that this string was prone to knotting and perforating, thus creating a perfect wicking agent, drawing bacteria from the vagina into the usually sterile uterus. For many women, pelvic inflammatory disease resulted, including infection, scarring of the fallopian tubes, and, in the worst cases, damage leading to a hysterectomy. For some women, the plastic fins on the device embedded into the uterus. For others, the device did not prevent conception and instead led to “septic spontaneous abortion” in which bacteria that wicked from the IUD infected the placenta and then the woman; this resulted in not only unwanted pregnancies and illness, but also eighteen deaths.27 Compounding the grief brought on by a birth control device that caused permanent infertility was the revelation that A. H. Robins had previous knowledge of its defects. When A. H. Robins purchased the IUD from Dalkon Corporation, confidential memoranda noted the device’s proclivity to wick.28 More than 300,000 parties sued A. H. Robins in product liability cases, which continued well into the 1980s and ultimately led to the downfall of the company.
Medicines and devices related to women’s reproductive health that caused far worse problems than the ones they promised to solve understandably created fear and anger. It was unwelcomed and unwanted news that novel solutions to maternal health and birth control led to damaging consequences in this era of “progressive” technoscience. There was also something particularly troubling about the damage caused to women’s reproductive health when some scientists, physicians, and business representatives chose to ignore problems and instead narrow the frame of vision to exclude glaring errors. It is not a large leap to apply Langdon Winner’s provocative thesis that politics are embedded into objects and technological artifacts to understand how these devices embodied societal ignorance and sexism.29
Yet, in the same era, women’s liberation gained traction and feminism provided tools to critique medical “progress” and generate dissent.30 In part, the women’s health movement, begun in the late 1960s, called for woman-friendly, woman-centered approaches to women’s life-course health needs, epitomized by information distributed in Our Bodies, Ourselves, edited by the Boston Women’s Health Book Collective.31 When the universal male stood in for all things human, and an androcentric approach devalued women’s health concerns, the women’s health movement insisted on the normalcy of women’s reproductive life cycles, as well as the need for woman-friendly health advice. The force of women’s health advocates was abundantly clear at the congressional hearing on the pill in 1970, with protesters bringing a halt to the all-male proceedings. Feminist health advocates could now mark side effects and ill health associated with medical “progress” as a significant cost rather than mere inconveniences to be endured.32 They pressured public health officials and regulators to be accountable, and this marked an important shift in medicine to recognize patients’ rights.33
Medical Device Amendments of 1976
The way that medical devices were viewed changed as well in the 1970s as a result of new regulatory policies brought forth by the 1976 Medical Device Amendments (MDA) to the Federal Food, Drug and Cosmetic Act (FFDCA). The FFDCA currently provides definitions for food (including chewing gum), food additives such as food coloring, dietary supplements, and even tobacco. In 1938, the FFDCA gave the FDA authority to oversee not only food and drugs, but cosmetics as well, in part to quell the cases of misleading labeling, egregious health claims, and outright dangerous additives to comestibles and medicines. However, there was no formalized review process specifically for devices, ranging from instruments to diagnose diseases to apparatuses worn on or implanted into the body, and the products required no official approval. Items such as sanitary pads and tampons, however, were classified as cosmetics (an odd fit rationalized because they touched the skin) and received minimal regulatory attention.
Passage of the MDA of 1976 gained traction in Congress, with Senator Edward Kennedy its prime advocate. Serious, undisclosed defects in technologies such as pacemakers, IUDs, and intraocular lenses caused harm and injury to patients, leaving a trail of product liability lawsuits in their wake. To address this regulatory deficiency, the amendment also created the Bureau of Medical Devices within the FDA specifically to monitor applications for approval.34 According to the amendments, a medical device covers a broad range of instruments, diagnostic