Heightened Expectations: The Rise of the Human Growth Hormone Industry in America

Heightened Expectations

NEW HISTORIES OF SCIENCE, TECHNOLOGY, THE ENVIRONMENT, AGRICULTURE & MEDICINE

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Mark D. Hersey

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Jim Downs

Richard A. Richards

Suman Seth

Vassiliki Betty Smocovitis

Jessica Wang

Heightened Expectations

The Rise of the Human Growth Hormone Industry in America

AIMEE MEDEIROS

THE UNIVERSITY OF ALABAMA PRESS

TUSCALOOSA

The University of Alabama Press

Tuscaloosa, Alabama 35487–0380

http://www.uapress.ua.edu

Copyright © 2016 by the University of Alabama Press

All rights reserved.

Inquiries about reproducing material from this work should be addressed to the University of Alabama Press.

Typeface: Scala Pro

Manufactured in the United States of America

Cover photograph: Young Boy’s Back View by Allie L. Harper; courtesy of the artist

Cover design: Michele Myatt Quinn

∞

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      ISBN: 978-0-8173-1910-6

      E-ISBN: 978-0-8173-8962-8

Contents

List of Figures

Acknowledgments

Introduction

1

Making Short Stature a Medical Matter

2

The Era of Early Growth Hormone Therapy in the United States

3

Short Stature as a Psychosocial Risk Factor in Need of an Effective Cure

4

Living the Promise of Human Growth Hormone Therapy

Epilogue: A Billion Dollar Industry

Coda

Notes

Selected Bibliography

Index

Figures

1. Two young working boys, Rock Hill, South Carolina, 1912

2. Undersized boys outside a garment factory in Gastonia, North Carolina, 1908

3. Young girl at work in a cotton mill in Lancaster, South Carolina, 1908

4. Eight-year-old boy at work in Fayetteville, Tennessee, 1910

5. Baby book record of height measurement for a child

6. Weight and height tables used in well-baby examinations

7. Excerpt from It’s a Small World: All About Midgets

8. Theatrical poster titled The Rossow Midgets, 1897

9. Chart of results of early clinical growth hormone research

10. Midget Village at the Century of Progress Chicago World’s Fair, 1933

11. Bottle of Growth Complex from Armour Laboratories, 1944

12. Anterior pituitary powder and tablets from Armour Laboratories

13. Parade Magazine cover article of a cHGH therapy recipient

14. Donation card of the National Pituitary Agency

Acknowledgments

When I pitched the idea for a paper on the history of the human growth hormone industry in a pharmaceutical history course taught by Elizabeth Siegel Watkins, I never imagined it would evolve into a book. I am so grateful it has and to everyone who supported me in this effort. I would like to thank my colleagues in the University of California at San Francisco’s Department of Anthropology, History and Social Medicine, in particular Dorothy Porter, Sharon Kaufman, Kelly Knight, Vincanne Adams, Barbara Koenig, and Brian Dolan. I am indebted to their collective genius and insight. I would also like to thank Catherine Kudlick for introducing me to disability as an analytical lens for historical scholarship. This book and I are the better for it.

Research for this book was made possible by a National Science Foundation Improvement Grant (#1058143). The funding allowed me to conduct archival research at various institutions, including the American Philosophical Society, the Mandeville Special Collections Library at the University of California San Diego, the National Museum of American History’s Archives Center, and the Louise M. Darling Biomedical Library at the University of California, Los Angeles. Everywhere, I was helped by librarians, archivists, and staff who did not flinch at my sometimes odd requests. I would also like to acknowledge the efforts of Janice Goldblum at the National Academy of Sciences Archives, Polina Ilieva at the University of California San Francisco Archives and Special Collections, and Jim Kay at the Little People of America Archive for their support and counsel.

This book also benefited from the insights of numerous readers, too many to list here. I am particularly grateful for the kind critiques of Elena Conis, the copy editing precision of my initial manuscript by Paul Murray, and the robust discussions held by a writing group comprised of Rebecca Kaplan, Deborah Brown, and Portia Pirnia. Their feedback and encouragement were invaluable. I am thankful to the two reviewers of the manuscript (one who remains anonymous and Heather Munro Prescott). Your thoughtful comments, edits, and suggestions made this book stronger. Finally, I would like to acknowledge Anna Reget, the indexer. Hopefully readers will find her guide to key terms as useful as I have.

Portions of this book were presented at various events, including annual conferences of the American Association for the History of Medicine and the History of Science Society. I am indebted to those colleagues who provided feedback and posed questions at each. It was at the 2013 Organization of American Historians annual meeting that I met an assistant editor from the University of Alabama Press (UAP) and the publishing process began. The team at UAP has been wonderful to work with and I am particularly grateful for acquisitions editor Elizabeth Motherwell’s and managing editor Vanessa Rusch’s guidance and assistance.

Support from my siblings and mother was also invaluable. Their kind words and excitement about this project fueled my perseverance. My deepest gratitude and thanks go to my husband, Mark Medeiros. I will always be indebted to him for the countless hours he spent editing drafts, encouraging me, and taking care of our son during the evenings and weekends I spent glued to my laptop. I would not have been able to complete this book without him.

Lastly, I dedicate this book to our son, Reed Marcin Medeiros, a vivacious boy full of amazing potential. His smile is my sole reward.

Introduction

"Ever wish you had the power to grow taller?

You do

It’s called growth hormone."

Filled with expectation and potential, these lines¹ introduce an adventure story titled The Great Growth Hormone Caper, found in a 2004 activity book marketing biotechnology company Genentech’s growth hormone product, Nutropin. Originally downloadable from the company’s Nutropin website, the book directly addresses short children and their parents with promises of height, eye-catching graphics, games, quizzes, and three activity stories featuring Bobby and his friends, otherwise known as the kids of Nutropinville. The first of the stories is called The Great Growth Hormone Caper, and describes the role of growth hormone (GH) in human development through the device of having Bobby’s doctor inform him that he might be missing this essential hormone. Bobby and the gang go on a quest to hunt down the missing growth hormone; the adventure ends when the mayor of Nutropinville informs them that their hometown was in fact built to help those who are GH deficient. At the end of the story, Bobby begins GH treatment; in the following two stories, the therapy helps him build more confidence on the baseball field (Out of the Ballpark) and gives him the ability to stop harassment by a bully (Bobby and the Big Bully). The activity book successfully frames 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

Genentech walked a fine line by featuring the Nutropinville activity book as an educational booklet on its website. In 2004 the company 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 put together by the FDA a year earlier when Eli Lilly received an identical stamp of approval for its recombinant Human Growth Hormone (rHGH) product, Humatrope. The plan included a commitment on the part of the company to eschew direct-to-consumer advertising, maintain a limited sales force, and practice 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 rhetorically linked to GH deficiency, the stories of baseball and bullies conveyed to potential consumers and their parents the supposed real-life hazards of being a short boy and the genie-like promise of HGH therapy.

Heightened Expectations traces how growth hormone therapy became synonymous with medically treating short boys in the hope of making them tall. The FDA’s approval of Eli Lilly’s Humatrope as a treatment for ISS in 2003 was more a reflection of a decade-long trend in pediatric care than a revolutionary move orchestrated by pharmaceutical companies. In fact, the connection between growth hormone deficiency and therapy had been progressively loosening. A mid-1990s National Institutes of Health (NIH)–funded survey of 434 US pediatric endocrinologists indicated that 58 percent of patients undergoing rHGH therapy had GHD. Girls with Turner syndrome made up the majority of the other 42 percent, and the rest were a hodgepodge of children with various conditions, including chronic renal insufficiency, familial short stature, and ISS. It is important to note that even though the majority of children subjected to rHGH therapy were short because of a diagnosed disease or biological dysfunction, the treatment targeted their stature and not their disease.⁴ Around the turn of the millennium, protocol caught up with clinical practice, as the FDA began granting approval for the use of HGH 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 2014. Heightened Expectations examines the relationship between the rise of the human 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 book features three recurring themes. First, I demonstrate that pharmaceutical companies cannot be considered the sole culprits in framing short stature as a disease. Instead, the pathologization of this somatic reality has a long history, which stretches back to the nineteenth century and is linked to the cultural influence of emerging 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—that together constituted a reference system used by reformers to encourage governmental regulation of abusive labor practices during the late nineteenth and early twentieth centuries.

Anthropometrists codified the anecdotal data from public health reformers and contributed to the normalization of average measurements and the pathologization of short stature by conducting large growth surveys of children. While historians of medicine have described at length both the rise of scientific medicine and the role of the laboratory in establishing the objectives and standards to be used in clinical practice, the manner in which the medical field has used data compiled by anthropometrists has received little attention. At the turn of the twentieth century, the results of the growth surveys began to slowly creep into private pediatric practice through the medium of growth charts, which presented average measurements as healthy norms. In this context, short stature began to signal a need for medical intervention at the individual level. As the medical specialty of pediatrics professionalized, the large growth surveys that provided data to the growth charts where forgotten as these diagnostic tools took on their own meaning by representing standards in child growth and development.

The second theme of this book traces the origins of growth hormone therapy in the United States, and in doing so resets the beginning of the GH industry to the early twentieth century by examining the era before cadaver-based human growth hormone was used. This is in contrast to the traditional narrative that locates the industry’s origins in 1958, the year medical experts first reported on their successful therapeutic uses of human growth hormone. Even though we know today that early growth hormone therapy was ineffective, many early twentieth century medical experts interpreted the results of treatments with GH pharmaceuticals as promising, and it was their trial and error experimentation with growth-promoting medical regimens that brought GH therapy and the medical treatment of short boys closer together. Because clinical trials periodically served up seemingly positive results, it took decades for animal-based growth hormone products to fall out of favor with physicians. Ultimately, however, pediatric endocrinologists were forced to admit the ineffectiveness of these pharmaceuticals. By the early 1950s growth hormone was no longer an option in treating GHD children. Instead, specialists turned to the male sex hormone testosterone for this purpose. According to pediatric endocrinologists of the era, this cure for short stature was a perfect fit for the ideal patient because there seemed to be a synergy between testosterone and the majority of children who sought out medical attention, that is, boys.

Even after human growth hormone therapy was finally developed in the late 1950s, the link between the male patient and growth-promoting hormone treatment remained unbroken. The National Pituitary Agency (the federal agency in charge of the manufacture and distribution of cadaver-based human growth hormone in the United States), the Human Growth Foundation (a parent-run organization of families with children with short stature caused by growth hormone deficiency), and medical experts throughout the country campaigned for Americans to donate their pituitary glands before they died. They did so by advertising the success of mostly boy patients who had grown in height due to cadaver human growth hormone (cHGH) therapy and thereby overcame the pitfalls of being short. These human interest stories demonstrated that HGH therapy saved short boys from disappointing lives by spurring vertical growth. This message reverberated in advertisements for commercial cHGH in the early 1980s and continued to play a major role in recombinant human growth hormone marketing campaigns into the twenty-first century.⁶

The third theme in this history of the rise of the human growth hormone industry focuses on how, in the twentieth century, changing sociological notions about gender and masculinity influenced the development of medical treatment of children with short stature. During the 1960s and 1970s child psychology researchers attempted to substantiate scientifically the psychoanalytical notion that children felt inferior if they were short. These experts also sought to uncover the cause and the extent of the problems short children faced. By the early 1980s many experts believed that short stature impaired academic performance, hindered interpersonal relationships, and caused personality disorders, as short statured children responded in an unhealthy manner to the discrimination they faced.

Sociologists contributed to this discussion by pinpointing who exactly faced the most social discrimination based on stature. In 1971 sociologist Saul Feldman coined the term heightism in a paper he presented at the annual meetings of the American Sociological Association. Feldman argued that American society is a society with a heightist premise: to be tall is to be good and to be short is to be stigmatized. He also explored the ways in which this discrimination manifested itself in language, male-female relationships, politics, economics, popular culture, and degradation of self.⁷ Journalists eager to carry Feldman’s social criticism into mainstream media quickly popularized his ideas. While child psychologists documented the hardships short children faced in childhood, sociologists warned about the adversity boys would continue to endure when they became men if parents did not seek out medical intervention for their short sons.

MANUFACTURING DESIRE

This project treats the development of the stigmatization of short stature and the rise of growth hormone therapy as having equal roles in the making of the human growth hormone industry, a conceptual construction inspired by the notion of desiring-production put forth by Gilles Deleuze and Félix Guattari in their book Anti-Oedipus. Deleuze and Guattari propose that desire is mechanistic in nature; they use the term desiring-machine to explain the way in which the processes of production, distribution, and consumption are intertwined and produce a circular flow of desire. The history of the rise of the human growth hormone industry is a poignant example of the creation of a desiring-machine, demonstrating how anxieties, processes of production, and desires are grafted onto one another.⁸ It also shows how a multitude of actors—from pharmaceutical industry executives to parents—produce desire and contribute to the perpetuation of this billion dollor industry.

Not only does this book treat the histories of HGH and the stigmatization of short stature on the same desire continuum, it also follows the development of scientific notions of the normal and abnormal. Inspired by Georges Canguilhem’s oeuvre The Normal and the Pathological, this book addresses medicine’s methods of assessing and defining normal and pathological phenomena and of framing pathology as a quantitative deviation from an established physiology. Canguilhem argues that once experiences are quantified they become distorted within a continuum of abstract normalcy and pathology; he pinpoints the laboratory’s role in scientific medicine as the culprit in obscuring natural variation.⁹ Heightened Expectations adopts Canguilhem’s perspective and examines how public health supplied scientific medicine with continua, standards, and objectives that distorted natural variety and promoted conformity.

In addition, Heightened Expectations hones in on the reciprocal relationship between disability and disease by exploring how disability provides a keen understanding of the perils of disease and deformity which are made most lucid by it.¹⁰ Although disability is deeply implicated in how we conceptualize health and illness, scholars often overlook the particular meaning-making relationship between it and disease. Historian Beth Linker offers a series of reasons as to why this is the case, including among other things the process of professionalization. According to Linker historians of medicine have adopted a scientific lexicon when describing health and disease in order to gain acceptance by the very field they write about. Privileging the molecular over the body, the cause over the symptom, and the laboratory over the environment, scientific medicine prefers a disease-focused approach to knowledge making. Diseases are defined, well-contained, discernable biological events, while disabilities are ambiguous, subjective, and interpretive phenomena. As Linker suggests, within the history of medicine, we have an abundance of disease (including pharmaceutical) histories that cover smallpox, tuberculosis, and cardiovascular disease, but few—if any—accounts that look at these conditions from a disability perspective.¹¹ I aim to contribute to the subfield of disability in the history of medicine by demonstrating how an axiomatic understanding of ability operates in medicine and how disability provides both an interpretation for difference and a materiality to pathology. In the case of GH therapy, disability often served as a challenge while simultaneously highlighting the treatment’s curative limits.

RELEVANT SCHOLARSHIP

Heightened Expectations tells the history of the human growth hormone industry in America as one filled with unpredictability, setbacks, and doubt. It also explores the long-term effects of the discovery of growth hormone on notions of short stature. Historical scholarship on hormones—which employs the history of a hormone’s discovery and use in therapy as a lens to illuminate complex and changing relationships within medicine, science, and society—is therefore relevant to this project.¹²

The quest to discover GH harkens back to a time known as the goldrush era of hormones," a term referred to by historian Alison Li to identify how the flurry of hormone research that took place during the 1920s and 1930s was interpreted.¹³ According to Nicolas Rasmussen, hormones took pride of place as life’s master molecules, and the endocrinologist took precedence over the geneticist as the scientist offering the means to control life.¹⁴ The role of hormones at this time cannot be overestimated and the history of growth hormone is part of this larger narrative, as this book will demonstrate.

In addition, the histories of GH research and therapy are also part of another larger story about the relationship between government agencies, academic researchers, and pharmaceutical companies. GH can be found at the nexus of public and private interests for most of the twentieth century. Viviane Quirke’s work on cortisone explores the larger post-war trend in medical and pharmaceutical research, which is the close tie between private pharmaceutical companies and governmental agencies. In Making British Cortisone: Glaxo and the Development of Corticosteroids in Britain in the 1950s–1960s, Quirke pays particular attention to the influence the public pressure placed on Britain’s Ministry of Health had on the ability of Glaxo to dominate the corticosteroid market there.¹⁵ Harry Marks and Dominique A. Tobbell have also examined the complex relationships between businesses and government agencies but in a US context. Marks’s analysis is similar to