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The History of the Human Growth Hormone Industry in America by Aimee Medeiros DISSERTATION Submitted I

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The History of the Human Growth Hormone Industry in America by Aimee Medeiros DISSERTATION Submitted I Heightened Expectations: The History of the Human Growth Hormone Industry in America by Aimee Medeiros DISSERTATION Submitted in partial satisfaction of the requirements for the degree of DOCTOR OF PHILOSOPHY in HISTORY OF HEALTH SCIENCES in the GRADUATE DIVISION of the UNIVERSITY OF CALIFORNIA, SAN FRANCISCO Copyright 2012 by Aimee Medeiros ii Acknowledgements Research for this dissertation was funded in part by the National Science Foundation’s Social, Behavior, and Economic Sciences Doctoral Dissertation Research Improvement Grant #1058143 iii Abstract Heightened Expectations: The History of the Human Growth Hormone Industry in America This dissertation examines the rise of the human growth hormone (HGH) industry in America. I make three key arguments in this work. First, I argue that the medicalization of height and the modern social stigmatization of short stature, which began to take shape during the late nineteenth and early twentieth century, were essential ingredients in the making of the human growth hormone industry. Secondly, I demonstrate how sociological notions of gender during the last half of the twentieth century influenced the development of HGH therapy in the treatment of children with short stature. Finally, I show how the amount and type of growth- promoting hormone therapeutically available have framed popular and expert perceptions of short stature and its treatment. Heightened Expectations draws on a diverse set of sources, including government agency records and publications, popular and scientific publications, internet archives, legal documents, corporate archives, and personal files of scientists. It contributes to the histories of pharmaceuticals, public health, and masculinity as well as disability studies and gender studies. Throughout the dissertation, I have employed an innovative technique of simultaneously dealing with the history of the pathologization of short stature in children and the emergence of human growth hormone therapy. Rather than giving preference to one side of the pharmaceutical equation over the other, this dissertation examines how the histories of the human growth hormone therapy and the pathologization of short stature found each other during the era of scientific medicine. While the pathologization of short stature speaks to the medicalization of somatic realities perceived as deficits, the quest to discover, isolate, and clinically use growth iv hormone reveals the development in medicine to search inside the body for causation instead of outside in the environment. Once these stories intertwined during the mid-twentieth century, the short, middle-class, full-of-potential, white boy became the poster-child for the human growth hormone industry. Together these histories make us question the implications of the medicalization of social stigmas, the reflexivity between pathology and treatment, and how height matters. v Table of Contents Introduction 1 Chapter 1 Short Children and Long Hours Nineteenth Century Roots of the Modern Stigmatization of Short Stature and the Medicalization of Height 19 Chapter 2 “Utilize What We Have and Do the Best We Can.” The Discovery and Early Uses of Growth Hormone Therapy 64 Chapter 3 “I am just dying to grow taller. It’s agonizing to be short.” Short Stature as a Psychosocial Risk Factor in Need of an Effective Cure 107 Chapter 4 “We can end Dwarfism!” Living the Promise of Human Growth Hormone Therapy 143 Epilogue A Billion Dollar Industry 194 Bibliography 210 vi Introduction Ever wish you had the power to grow taller? You do! It’s called growth hormone.1 Filled with expectation and potential, these lines serve as the introduction to an adventure story titled “The Great Growth Hormone Caper,” found in an 2004 activity book marketing Genentech’s growth hormone product, Nutropin. This downloadable book from Genentech’s Nutropin website targeted short children and their parents with promises of height, eye-catching graphics, games, quizzes, and activity stories featuring Bobby and his friends, otherwise known as the kids of Nutropinville. “The Great Growth Hormone Caper” was the first of the three stories and it described the role of growth hormone (GH) in human development after Bobby’s doctor informed him that he might be missing this essential hormone. Bobby and the gang decided to hunt down the missing growth hormone until the mayor informed them that the whole city was built to help those who are GH deficient. At the end of the story, Bobby begins GH treatment, and the following two stories demonstrate how growth hormone therapy helped Bobby build more confidence on the baseball field in “Out of the Ballpark” and the ability to stop harassment from his bully in “Bobby and the Big Bully.” The activity book successfully framed growth hormone therapy as an appropriate remedy not only for growth hormone deficiency (GHD) but also for the social anxieties short boys face in sports and social settings.2 1 Genentech Inc.’s Website for Nutropin, “The Nutropinville Kids,” accessed December 17, 2008, http://www.nutropin.com/pdf/13898_gene_ntrpnvlle_fa4.pdf. 2 Ibid. 1 Genentech walked a fine line by featuring The Nutropinville Activity Book as an education booklet on its website. In 2004, Genentech received approval from the Food and Drug Administration (FDA) for the use of Nutropin in treating children with Idiopathic Short Stature (ISS) with an important caveat; the company had to adhere to a “risk management plan” composed a year earlier when Eli Lilly received the identical approval for its GH product. This plan included no direct-to-consumer advertising, a limited sales force, and controlled distribution.3 While the “Great Growth Hormone Caper” story helped Genentech stay true to its promise to the FDA by keeping the use of Nutropin linked to GH deficiency (GHD), the stories of baseball and bullies spoke to potential consumers and their parents about the real-life hazards of being a short boy and the genie-like promise of GH therapy. This dissertation reveals how growth hormone therapy became synonymous with medically treating short boys in the hope of making them tall. The FDA’s approval of growth hormone therapy for ISS in 2003 was more reflective of a longer trend in pediatric care rather than a revolutionary move orchestrated by pharmaceutical companies as the tie between growth hormone deficiency and therapy had been loosening over the years. Even when this link was strong, the intent of commercial growth hormone was to spur linear growth in GHD children and not necessarily to make up for growth hormone per se. This focus to kick start vertical growth continued and expanded throughout the late 1980s and early 1990s as biotechnology made a variety of GH 3 Food and Drug Administration, Letter from David G. Orloff, Director of the Division of Metabolic and Endocrine Drug Products, Office of Drug Evaluation II, Center for Drug Evaluation and Research to Pat Harada of Genentech, Inc. regarding a labeling revision approval of Nutropin for long-term treatment of Idiopathic Short Stature, Application number NDA 19- 676/S-020, S-021 (June 28, 2005), accessed May 20, 2012, http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019676s020,021_rel2_ltr.pdf. 2 pharmaceuticals possible. By the early 1990s pediatric endocrinologists prescribed GH therapy to a series of children in order to make them taller. A mid-1990s NIH-funded survey of 434 U.S. pediatric endocrinologists indicated that only 58% of patients they were treating had GHD. Girls with Turner Syndrome made up the majority of the other 42% and the rest were a hodge-podge of children with various conditions including chronic renal insufficiency, familial short stature, and ISS.4 Around this time, protocol caught up with clinical practice as the FDA began granting approval for the use of GH in a series of stunting but non-GHD conditions including Turner Syndrome (1996), Prader- Willi Syndrome (2000), Small for Gestational Age (2001), Idiopathic Short Stature (2003), Short Stature Homeobox-Containing Gene SHOX (2006), and Noonan Syndrome (2007).5 Although the range of syndromes and conditions treated by growth hormone has expanded, promoting linear growth in children remains the main goal for the majority of the approximately thirteen growth hormone products on the market as of 2012. My dissertation examines the relationship between the rise of the growth hormone industry and the development of the modern notion of short stature, its stigmatization, and science's mission to quantify and fix it. This dissertation features three recurring themes. First, I demonstrate how pharmaceutical companies cannot be blamed as the sole culprits of framing short stature as a disease; rather the pathologization of this somatic reality has a long history, which stretches back to the nineteenth century and is linked to the emergence of Enlightenment 4 Leona Cuttler, J.B. Silvers, Jagdip Singh, Ursula Marrero, Beth Finkelstein, Grace Tannin, and Duncan Neuhauser, “Short Stature and Growth Hormone Therapy: A National Study of Physician Recommendation Patterns,” Journal of American Medical Association 276, no. 7 (August 21, 1996): 532-534. 5 Leona Cutter and J.B. Silvers, “Growth Hormone and Health Policy,” Journal of Clinical Endocrinology and Metabolism 95, no. 7 (July 1, 2010): 3150. 3 philosophy and modern capitalism. Short stature developed into an indicator of substandard working and living conditions and joined a series of other somatic realities, including small frames and waif-like body types,
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