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David B. Allen, Growth Hormone Post-Marketing Surveillance: Safety, Sales, and the Unfinished Task Ahead, The Journal of Clinical Endocrinology & Metabolism, Volume 95, Issue 1, 1 January 2010, Pages 52–55, https://doi.org/10.1210/jc.2009-2364
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Twenty-five years ago, the pediatric endocrinology community was stunned by news of Creutzfeldt-Jakob disease transmitted by treatment with pituitary-derived GH (pit-GH). With remarkable serendipity, recombinant DNA-derived human GH (rhGH) became available within months. In an environment fertile with concerns about unexpected adverse effects, postmarketing surveillance studies (PMSSs) were established, managed, and supported by manufacturers of rhGH, of which the Genentech National Cooperative Growth Study (NCGS) has been the largest and most comprehensive in scope. This action appeared prescient when, in the late 1980s, a possible link between GH therapy and new-onset leukemia was published (1). This association was later disproved (2, 3), but a number of possible rhGH-associated adverse effects were subsequently identified, systematically tracked, analyzed, and reported. In this issue of JCEM, Bell et al. (4) report more than 20 yr of NCGS safety data covering approximately 55,000 patients and nearly 200,000 patient-years of rhGH exposure. The gathering and analysis of this vast amount of drug experience information will likely not be accomplished again, making its value, in some respects, inestimable. It validates for the sponsoring company and participating physicians the rationale, commitment of resources, and hopes for the NCGS that marked its inception.
