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DRUG LABELS AND REPRODUCTIVE HEALTH: HOW VALUES AND GENDER NORMS SHAPE REGULATORY SCIENCE AT THE FDA Christopher James ChoGlueck Submitted to the faculty of the University Graduate School in partial fulfillment of the requirements for the degree Doctor of Philosophy in the Department of History and Philosophy of Science and Medicine, Indiana University June 2019 Accepted by the Graduate Faculty, Indiana University, in partial fulfillment of the requirements for the degree of Doctor of Philosophy. Doctoral Committee _____________________________________ Elisabeth Lloyd, PhD _____________________________________ Jutta Schickore, PhD _____________________________________ James Capshew, PhD _____________________________________ Justin Garcia, PhD May 13, 2019 ii Chapter 1 © 2019 Springer Nature All other materials © 2019 Christopher James ChoGlueck iii I dedicate my labor to my partner Taeyin, for awakening me, bringing me joy, and grounding my life, to my parents Nancy and Jon, for their open-mindedness and unconditional support, and to my mother-in-law Yoo a, for nourishing me throughout the journey. iv Acknowledgements There are certain people I would like to acknowledge for helping and supporting me throughout this process. First, I thank my adviser Lisa Lloyd for more than I can remember. She taught me the power of feminist philosophy of science and the pragmatic approach. “Fully baking” my “half baked” ideas, Lisa helped me develop this project from the earliest stages and encouraged me to take the project wherever I saw fit. I cannot imagine this achievement without her support. I have also enjoyed the privilege of working with Jutta Schickore, especially our reading groups and course on values in science. She inspired me to integrate philosophy of science with history. Jutta taught me that demarcations between the disciplines are more distracting than they are helpful for understanding science. I have always been able to rely on her for incisive criticism. Justin Garcia provides me tremendous advice for navigating gender studies and research on sex and reproduction. Justin has been especially helpful for advising me on how to augment my philosophy with empirical approaches from sociology. I also thank Jim Capshew for counseling me on planning my historical research. Jim helped me strategize how to collect primary sources and get in touch with FDA contacts in the face of busy schedules and government shutdowns. I am also grateful for conversations on my work from Meagan Allen, Ben Almassi, Josua Aponte-Serrano, Evan Arnet, Robyn Bluhm, Matt Brown, Dé Bryant, Jordi Cat, Taeyin ChoGlueck, Kevin Elliott, Archie Fields, Tom Gieryn, Anna Geltzer, Sandy Gliboff, Maya Goldenberg, Kate Grauvogel, Ashton Green, Stuart Green, Nora Hangel, Darryl Heller, Dan Hicks, Teresa Hoard-Jackson, Bennett Holman, Rebecca Jackson, Suzanne Kawamleh, Ashley Graham Kennedy, Samuel Ryan Ketchum, Janet Kourany, Dan Li, April Lidinsky, Helen Longino, Ali Mirza, Monica Morrison, Erin Nash, Jared Neumann, Taylor Nutter, Ryan O’Loughlin, Naomi Oreskes, Manuela Fernandez Pinto, Emanuele Ratti, Sarah Reynolds, v Marsha Richmond, Jon Schommer, Thomas Stapleford, David Teira, Jenn Tonn, Alison Wylie, and Nick Zautra. I am also thankful to the editors and reviewers of Synthese and Lady Science for helping me develop and publish chapter 1 (Synthese, Spring Nature) and the overture to Chapter 4 (Lady Science). I am especially grateful for regular conversations with Nora Hangel for keeping me on schedule, reflecting on methods, and venting my hang-ups. I am also very appreciative to everyone who came to my conference presentations, especially those who voiced their comments, questions, and objections, including the 2016 Society for the Philosophy of Science in Practice meeting (Glassboro, New Jersey), the 2016 Philosophy of Science Association meeting (Atlanta, Georgia), the 2017 International Society for History, Philosophy and Social Studies of Biology (Sao Paulo, Brazil), the 2018 Values in Science, Medicine, and Technology meeting (Dallas, Texas), the 2018 Meeting of the Consortium for Socially Relevant Philosophy of/in Science and Engineering meeting (Atlanta, Georgia), and the 2018 Philosophy of Science Association and History of Science Society joint meeting (Seattle, Washington). I also thank the organizers of departmental talks for inviting me to speak, including Anna Geltzer and Robert Goulding for the Notre Dame History and Philosophy of Science colloquium series and April Lidinsky for the Indiana University South Bend Public Forum for the Women’s and Gender Studies Program. On the empirical end of this project, I am indebted to my interview participants Sandra Kweder, Ruth Merkatz, Susan Wood, and Lynne Yao for generously sharing their time with me. I found our conversations the most enjoyable part of this entire process, and I hope to continue collaborating. I also thank several archivists for help locating primary sources, including Suzanne Junod and Vanessa Burrows at the FDA History Office and Zoe Hill at Harvard’s Schlesinger Library. vi This material is based upon work supported by the National Science Foundation (NSF) Graduate Research Fellowship Program under grant no. 1342962. Any opinions, findings, and conclusions or recommendations expressed in this material are those of the author and do not necessarily reflect the views of the National Science Foundation. Finally, and most importantly, I am forever grateful to my partner and spouse Taeyin for their generosity, support, and wisdom during this process. Taeyin awakened me to feminism and racial justice, and they challenged me to think outside my limited worldview and understand privilege in my life. They have suffered through my exhausting work ethic, helped me prepare for countless talks, and celebrated my achievements. Taeyin is my rock, and this work would not be possible, successful, or nearly as fulfilling otherwise. vii Preface So there’s a puzzle: what are women held to be guilty of doing or being? Withholding and failing to give, I think; being cold, callous, and heartless; neglecting their natural duty to provide a safe haven and nurture, by evicting a vulnerable being from their rightful home, their birthright. Hence women who seek abortions, even to save their own lives, are a blank canvas on which to project a set of grievances borne of unmet felt needs in turn borne of a sense of entitlement. -Kate Manne, feminist philosopher Down Girl: The Logic of Misogyny (2018, p. 99) Abortion is the only personal decision that is subjected to this level of governmental oversight. More states require waiting periods before obtaining an abortion than buying a gun or getting married. … The presumption undergirding abortion decision making is that women who have had sex and are accidentally or unintentionally pregnant can’t be trusted to comprehend the consequential weight of their actions. The law requires them, like bad little girls, to “prove” to authorities that they have thought carefully about what they’re about to do. -Dr. Willie Parker, abortion provider Life’s Work: A Moral Argument for Choice (2017, p. 141) This dissertation is about science and its social functioning, particularly how medical knowledge functions to control women and their bodies. Feminists—including academics, activists, and healthcare professionals—are highly attentive to these social dynamics and their contribution to structural forces of domination. This relation between knowledge and practice is what Kate Manne (2018) illustrates when she shows how acts of misogyny are grounded in the sexist ideology of male entitlement. It is what Dr. Willie Parker (2017), an abortion provider, challenges when he criticizes paternalistic laws that are based on diminutive views of women for restricting abortion access. And it is what I explore when I analyze how drug labels are shaped by sexist gender norms and then used to keep women down, particularly poor women and women of color. As with any scholarly work focused on values, there is always a question about the values of the author. Writing this dissertation has transformed me professionally and personally, and I viii would be remiss to neglect a more personal introduction to this work. I entered this project as a young Catholic man, raised in “pro-life” culture and interested in the ethics and science of reproductive health. I have since left the Catholic church and become a committed feminist and activist for reproductive justice. I have learned that while the events I cover might not appear to be about men like myself, they are intimately related to what it means to be a man like myself. The values with which I finalize this work are partially the result of the process of writing and researching this dissertation. The project started as a grant proposal to the National Science Foundation (NSF). My graduate studies at IU began in the fall of 2014. I had just graduated from the University of Notre Dame and had spent much of the previous year researching environmental justice with Professor Kristin Shrader-Frechette. My final project involved ethical and scientific issues in the cleanup of a Superfund in rural Illinois. The former smelter site was exposing a disproportionately poor, Latinx community to high levels of lead and other toxic heavy metals. I had continued to work with Prof. Shrader-Frechette through the summer, and if you had asked me during the first week of classes what I expected to research in graduate school, I would have said environmental health,
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