History1968–2000 of the National Eye Institute By Carl Kupfer and Edward McManus with Nancy Berlage 2009 We thank the NationalAcknowledgements Eye Institute, especially Dr. Paul Sieving, Director, Dr. Jack McLaughlin, Deputy Director, and Ms. Rosemary Janiszewski for the support and assistance they have provided to us in this endeavor. We also wish to recognize the superb effort Gale Saunders has contributed to this manuscript in providing support services and editorial as- sistance. Gale strived long and mightily to keep us on track, ensuring the completeness and accuracy of our reference material. We are deeply indebted to her. We would also thank Dr. Nancy Berlage who guided us throughout this effort in organizing, writing, editing, research- ing, and performing a myriad of other logistical tasks involved in completing such a book. We also wish to thank those we interviewed who gave their time so willingly to assist us in telling this story. We express our gratitude to the National Library of Medicine for providing us space, resources, and the intellectual environment to work on this project. Finally, we thank the National Institutes of Health’s Office of History for its support and cooperation in this work. Contents Introduction ...............................................................................................................................i Prologue ..................................................................................................................................iii Chapter 1: Beginnings............................................................................................................. 1 Chapter 2: Organizing for Research ...................................................................................... 19 Chapter 3: Strategic Program Planning and the Five-Year Plans ........................................... 31 Chapter 4: The Intramural Research Program ...................................................................... 59 Chapter 5: The Extramural Program ..................................................................................... 77 Chapter 6: Randomized Clinical Trials ................................................................................ 105 Chapter 7: National Eye Health Education Program........................................................... 141 Chapter 8: International Health Initiatives......................................................................... 161 Appendix A: Abbreviations ................................................................................................. 191 Appendix B: US-JSPS Scientific Exchange Program Participants ......................................... 195 Appendix C: Interviews ....................................................................................................... 201 Appendix D: National Advisory Eye Council Members....................................................... 203 Endnotes ............................................................................................................................. 213 Introduction The creation of the National Eye Institute (NEI) by Congress in 1968 under the umbrella of the National Institutes of Health was a seminal event for vision research. It fully legitimized the field as a distinct and important component in advancing the health and welfare of the American public. It provided the foundation to build scientific and clinical infrastructure for an enduring enterprise that has made significant contributions in the treat- ment and prevention of eye disease. This act of Congress has yielded tremendous benefits to preserving vision for millions of Americans and countless millions more across the globe. This book chronicles the first 30 years of the NEI and its programs. These first years were critical for the development and growth of the intramural research program; the strong commitment to investigator-initiated research; the creation of extramural program areas; and the inception of clinical trials for vision and eye disease. Dr. Carl Kupfer served as the first director of the NEI and was instrumental in envisioning and creating the institute and its structure. His organizational prowess, and his ability to recruit talented staff and scientists, are an enduring legacy. Dr. Kupfer was aided in his quest to develop the NEI into a premiere institute by identifying and selecting Mr. Ed McManus in 1973 as the NEI Executive Officer and later as the Deputy Director. Mr. McManus brought management skills in planning, organization, developmental finance, and public policy, which greatly facilitated the rapid expansion of the NEI. The NEI grew from a budget of $24 million in 1970 to in excess of $500 million when Dr. Kupfer retired 30 years later in 2000. The challenge of attracting this funding and spending these resources effectively is described in the pages that follow. There were many others who also took part in the de- velopment of NEI and the eye and vision research field, starting with Dr. Jules Stein, the president of the Music Corporation of America; David Weeks, the president of Research to Prevent Blindness; and especially Dr. Edward Maumenee, a giant in ophthalmology as the Chief of Ophthalmology at the Wilmer Eye Institute, Johns Hopkins Medical School. Other ophthalmologists, such as Dr. David Cogan and Dr. Bradley Straatsma, also need to be applauded as well for their contributions in founding the NEI and providing advice to the Institute leadership as it developed its programs. Finally, in the ’80s and ’90s, the political and scientific leadership of Dr. Stephen Ryan contributed greatly to the success of the NEI. ii As the current director of the NEI, I read this book with a deep appreciation for the efforts that went into making the NEI and vision research the success that it is today. Under the leadership of these dedicated individuals, the eye health of the American public has flourished. Paul A. Sieving M.D., Ph.D. ii Prologue The year was 1968. It was a typical hot, sunny day in Sarasota, Florida, quite charac- teristic for early May, the usual date for the annual meeting of the Association for Research in Vision and Ophthalmology. Sitting on the rooftop restaurant of the Azure Tides Motel on St. Armand’s Key were three association members. They had taken a break from the lectures and presentations to meet and have a friendly conversation. V. Everett Kinsey, Ph.D., was a senior researcher in the vision research community. He was at the pinnacle of his career, having just been appointed as the first director of the Eye Research Institute which he had co-founded that year at Oakland University, Michigan.1 His outstanding laboratory research in the physiology of the cornea and lens were well known, and he had led a major clinical trial demonstrating that high concentrations of oxy- gen given to premature babies at birth caused the blinding disease known as retrolental fibroplasia. Always a leader and a visionary, he was now enthusiastically discussing rapidly progressing developments in the movement to create a national institute devoted solely to research on the eye, vision disorders, and blindness. Dr. Kinsey had been involved in negotiations to establish an eye institute at the National Institutes of Health (NIH), and he now described the concept to his two younger visitors—Carl Kupfer, M.D., Chair of the Department of Ophthalmology, University of Washington School of Medicine, and Marvin Sears, M.D., who chaired the Ophthalmology Section of the Department of Surgery, Yale University School of Medicine.* The eye insti- tute would be carved out of the National Institute of Neurological Diseases and Blindness (NINDB), where ophthalmology research was currently located at NIH, and that portion of the research portfolio devoted to vision would be transferred to a separate, independent research entity. Kinsey displayed great excitement about this proposition—and yet, his younger listeners could not quite understand why this was such an important issue. To them, NINDB seemed to provide bountiful grant support for ophthalmic research and training. Both Sears and Kupfer had received research grants from NINDB; indeed, they often held more than one extramural grant simultaneously. NINDB extramural staff was solicitous of grantees, it was not unusual for them to visit researchers and inquire about the adequacy of grant support or ask if more was needed. Their staff also provided information on how to negotiate the arcane, complicated, and bureaucratic procedures for obtaining NIH * Dr. Marvin Sears soon became the first chair of the new Department of Ophthalmology and Visual Science at the Yale School of Medicine, which was created in 1971. iii research funds. All in all, NINDB appeared to be anxious to support vision research to its fullest capacity. Kupfer, as a member of a study section that evaluated grants for NINDB, knew that the institute was giving high priority to particular types of grants (center and program project grants) that would help establish specific ophthalmology programs as “centers of excellence” in vision research. NINDB was even sponsoring a new initiative to fund outpatient depart- ment clinical center grants, specifically geared to the vision research community. Thus, Kupfer and Sears were uncertain as to why Kinsey saw the need to create a new institute. Instead, the old adage “If it ain’t broke, don’t fix it” came to mind. Clearly, Kupfer and Sears—both early into their careers—had not experienced the frustration