American Medical Professionals and the Politics of Safety

Endorsed by the BHC and SHFG

Thursday, March 30, 2023, 2:45 PM - 4:15 PM

Type: Paper Session

Tags: Business and Economy; Medical History; Politics

Abstract

This panel aims to bridge business history and the history of medicine to situate a conversation about the relationship between commercial products, health and safety, and government regulation as it developed throughout the twentieth century United States. Many business historians have traditionally privileged the private firm, but recent works in this field have begun to consider how societal norms and state action have shaped business practices and outcomes. The studies presented here show that when government officials, scientific experts, advocacy groups, and consumers argued that more extensive regulation and oversight of economic activity was in the public interest, businesses responded by cultivating the appearance of safety or, in some cases, co-opting the rhetoric of safety to their own ends. Thus, this panel contends that the history of firms that supply goods and services to consumers must be understood in the context of changes in regulatory policy, public perceptions of scientific expertise, and societal norms around public safety that have been elucidated by historians of science, technology, and medicine. Whereas previous histories of medicine have focused on how markets impacted the practice of medicine, this panel elucidates how medical knowledge traveled into business, examining how medical practitioners alternately commercialized their expertise and deployed this expertise to argue for or against constraints on contemporary free enterprise. We add to the existing literature on the safety of pharmaceuticals, food, and medical services by considering the public health implications of medical devices and consumer appliances. The historically contingent rationales behind the interventions of physicians into business and government, as well as the reasons for their success or failure, help to capture the expanding role of medicine in late twentieth-century American life. In his presentation, Parry analyzes how the U.S. National Commission on Product Safety challenged the efficacy of voluntary product standards and sought to justify increased federal regulation of domestic goods. In contrast, Bowrey’s work describes the central position of physician entrepreneurs in shaping the political economy of the emerging medical device industry and advocating for less restrictive regulations in the latter decades of the twentieth century. Wei adds to the discussion of medical devices with an examination of the regulatory and commercial niche created by the Dalkon Shield intrauterine device, which briefly revolutionized the contraceptive market before its eventual removal from the market due to serious side effects. Lastly, Grisinger examines how airlines appealed to safety considerations in banning physically disabled passengers, and how those travelers pushed both regulated entities and regulators to recognize and protect a right to air travel.

Papers Presented

Safe Enough? Public Health and the Case for Consumer Product Regulation at the National Commission on Product Safety, 1968–1970

Responding to pressure from lawmakers, bureaucrats, medical professionals, consumer advocates, and the media, U.S. President Lyndon Johnson appointed the National Commission on Product Safety (NCPS) to analyze the hazards of everyday consumer products and the extent to which existing laws and voluntary standards protected the American public from harm. From 1968 to 1970, the NCPS held twenty-two days of hearings, many of which revolved around the efforts of corporations and nonprofits to ensure the safety of consumer goods without federal intervention. Underwriters Laboratories, the United States of America Standards Institute, and several trade associations and retailers discussed their programs to test and to certify domestic appliances and testified to the advantages of industry self-regulation. The commissioners and many other participants at the hearings, however, questioned whether nonstate measures did or even could adequately prevent injuries. Consumer protection, they asserted, warranted at least some regulatory constraints on free enterprise. This presentation uses the transcripts of the NCPS hearings to investigate the historical rationales for voluntary product standards and the drive for federal regulation culminating with the 1972 Consumer Product Safety Act. I show how the interests and political ideologies of the business community, experts from nonprofits like the National Safety Council, and the consumer movement influenced their perspectives on the effectiveness of voluntary safety programs and the need for state action. Each of these groups, moreover, professed to speak on behalf of their fellow Americans as consumers, taxpayers, patients, and citizens. Drawing on recent literature about the “ventriloquism” of political discourse related to consumers, I explore how the NCPS hearings incorporated different visions of safety and the public good. Safety thus came to define the sale, use, and perception of consumer products as much as their manufacture.

Presented By
Alexander Ian Parry, Johns Hopkins University

Physician Entrepreneurs: Medical Professionals and the Making of Modern US Medical Device Regulation, 1970-2000

Although the Federal Food, Drug, and Cosmetic Act gave the U.S. Food and Drug Administration (FDA) significant authority to regulate the safety of pharmaceuticals in 1938, the FDA was not granted substantial authority to regulate medical devices until 1976. This disparity and the subsequent shift in policy was a result of the unique economic and technological history of the medical device industry. Specifically, new technologies brought to market by medical device firms in the 1960s forced the courts to reconsider their definitions and conceptions of medical devices. Later, once the FDA was granted the authority to regulate the industry, the vast number of small firms involved in the production of devices and the intimate relationships between medical experts and manufacturers stymied the FDA’s attempts to regulate the market. Considering these findings, this presentation proposes a four-phase interpretative framework of medical device regulation in late twentieth century America: In the first phase medical devices were largely unregulated. In the second phase the courts granted the FDA some authority to regulate devices, but the FDA did not fully exercise these powers. The third phase began with the passage of new legislation that failed to account for the brisk pace of innovation and rapidly changing structure of the nascent industry. The lack of support for this legislation within industry and the medical community precipitated the fourth phase, in which Congress relaxed the regulations established in the third phase. This framework highlights the importance of industry-specific dynamics and technological innovation in the formation of regulatory regimes. It also strives to recognize the agency and influence of the regulators tasked with enforcing and interpreting the laws that bind businesses and shape markets.

Presented By
Briceno Lihar Bowrey, University of Maryland, College Park

Media Crisis, Entrepreneurial Doctors, and the Transition from the Pill to the IUD, 1970-1985

Throughout the 1970s-80s, commercialized reproductive technologies experienced a reputational crisis. After the high-profile 1970 Nelson Senate hearings, a reported 18-30% of U.S. women stopped taking or receiving the Oral Contraceptive Pill (OCP). The intrauterine device (IUD), particularly the Dalkon Shield manufactured by A. H. Robins Company, was announced to the medical community and consuming public as the OCP’s ideal alternative. Displacing the defamed OCP from the market niche of contraceptives-seeking American women, Dalkon Shield became the most popular IUD. Yet, like its predecessor, it experienced its own media crisis. In 1974, information surfaced about Dalkon Shield’s serious side effects, including uterine wall perforation, ectopic pregnancy, and death. Robins filed for bankruptcy in 1985, when the product had been removed from market and 11,000 lawsuits filed. In this presentation, using scientific publications, deposition records, and physicians’ personal papers, I trace the strategies of two physicians: Hugh Davis, co-inventor of Dalkon Shield, who discredited the OCP and marketed his Shield as its logical successor; and Howard Tatum, inventor of the Tatum T IUD, who exposed Dalkon Shield’s harms and unseated it with his own competing product. In unearthing the interpersonal networks underlying this litigious and regulatory drama, I argue that these commercial contraceptives were not natural heirs to one another but rather constructed as such by their influential physician-inventors. I join historians’ debates about the usefulness and perils of using ecological metaphors, such as “niches,” to describe social phenomena. Market desires are not natural phenomena, but rather, malleable to human construction, capable of being molded, captured, redirected, and produced. This succession of commercial products—from OCP to Dalkon Shield to Tatum T—reveals the strategies for mutual leveraging among commercial marketing, consumer safety regulations, and medical expertise in the 1970-80s U.S.

Presented By
Jiemin Tina Wei, Harvard University

Access to the Air: Disability Rights and Airline Regulation in the 1970s

In the late 1960s and early 1970s, physically disabled people were increasingly frustrated about the failure of airline regulators to protect their ability to travel. While airplane manufacturers had poured tremendous amounts of time and money into the passenger experience, air travel had not been designed with the protection of physically disabled travelers in mind. Travelers willing and able to navigate physical hurdles, however, often found themselves turned away by airline staff who were skeptical about physically disabled travelers’ ability to fly on their own (regardless of what the passengers themselves said about their own abilities). While airlines were heavily regulated by both the Civil Aeronautics Board and the Federal Aviation Administration, on safety matters they were given wide discretion to turn away passengers. Like the airlines themselves, airline regulation had not been designed with the protection of physically disabled travelers in mind. In the early 1970s, such travelers drew on an increasingly common set of rights claims. Physically disabled travelers argued that they had a right to travel, that airlines (as federally regulated entities) had a duty to carry all passengers, and that airlines’ failure to accommodate them was discriminatory. They demanded that the federal government promulgate clearer rules that would limit the discretion of airline employees and protect their own ability to travel. These demands—and the agencies’ slow response—demonstrates both the possibilities and the difficulties of public interest group mobilization within the administrative state.

Presented By
Joanna L. Grisinger, Northwestern University

Session Participants

Chair and Commentator: Ashton W. Merck, NC State University
Ashton Merck is an interdisciplinary social scientist who studies the historical dimensions of risk governance. She holds a Ph.D. in history from Duke University, where she wrote her dissertation on business self-regulation in food safety. Currently, she is a Postdoctoral Research Scholar at NC State University, where she works with scientists to conduct stakeholder engagement on emerging technologies in food and agriculture. In addition to her work at NC State, Ashton is affiliated with the Duke Center on Risk and serves as the Associate Editor for H-Business.

Presenter: Briceno Lihar Bowrey, University of Maryland, College Park
Brice Bowrey is a Ph.D. student studying the history of science, technology, and medicine at the University of Maryland, College Park. His dissertation will use both archival research methods and computational techniques from the field of digital humanities to investigate the development of the American medical device industry in the late twentieth century. He is particularly interested in exploring how the exercise of professional power by physicians has shaped patterns of innovation in private firms and regulatory practices at the Center for Devices and Radiological Health. His preliminary research on this topic has been supported by a doctoral fellowship from the Ed Snider Center for Enterprise and Markets at the University of Maryland and an exploratory grant from the Hagley Museum and Library.

Presenter: Joanna L. Grisinger, Northwestern University
Joanna Grisinger is Associate Professor of Instruction at the Center for Legal Studies at Northwestern University. She received her J.D. and Ph.D. in History from the University of Chicago; her research focuses on the modern administrative state in twentieth-century U.S. legal and political history. Her first book, The Unwieldy American State: Administrative Politics Since the New Deal (Cambridge University Press, 2012), offers a political history of administrative law reform. Her current research explores public interest participation in administrative decision making; she is currently working on a book manuscript that examines airline regulation as a site for mobilization around issues of race and apartheid, disability, consumer rights, and the environment.

Presenter: Alexander Ian Parry, Johns Hopkins University
Alexander Parry is a fifth-year Ph.D. candidate with the Institute of the History of Medicine at Johns Hopkins University writing his dissertation on home accidents and U.S. product safety from 1920 to 1980. His research has received funding from the Consortium for History of Science, Technology, and Medicine, National Science Foundation, Linda Hall Library, and Johns Hopkins Center for Injury Research and Policy. Alex has presented at the American Association for the History of Medicine and Society for the History of Technology conferences and has published on public health and the American home with the Journal of the History of Biology, the Washington Post, and Lady Science.

Presenter: Jiemin Tina Wei, Harvard University
Jiemin Tina Wei is a fourth-year doctoral candidate studying the history of the culture of and ideas surrounding medicine, work, leisure, and gender—particularly the use of self-help, mind-body medicines, and workplace-management techniques in the treatment of “industrial fatigue” in the 19th and 20th century United States. Her research is supported by the National Science Foundation (NSF) Graduate Research Fellowship (GRF) and the Smithsonian Institute Graduate Fellowship at the National Museum of American History (NMAH).