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�� Early standardization of the insulin unit Barry Fields, MD 28 The Pharos/Winter 2011
The author is chief resident in Internal Medicine at the Yale Primary Care Residency Program. From its advent in September 2006 until its removal from the market in October 2007, inhaled insulin for diabetes mellitus represented the first effective alternative to subcutaneous injections in more than eighty years. Aside from its administration modality, Exubera (Insulin Human [rDNA origin]) also transformed dosage labeling from the traditional insulin “unit” into milligrams. While this conversion may have appeared novel, it actually harked back to a time early in insulin therapy’s history. Indeed, defining insulin quantity in terms of milligrams sits at the heart of post-World War I efforts to ensure the new product’s safety and reliability. These early attempts at its international standardization laid the foundation on which insulin dosage is still based today. Frederick Grant Banting. Courtesy of the National Library of Medicine. Producing an insulin extract In the autumn of 1920, Canadian surgeon Frederick Grant Banting scribbled, Diabetus Ligate pancreatic ducts of dog. Keep dogs alive till acini degenerate leaving Islets. Try to isolate the internal secretion of these to relieve glycosurea [sugar in the urine]. 1p50 In this short note, Banting outlined how he would find the quintessentialtreatment for a disease he could not even spell. Over the next year, Banting worked in the University of Toronto physiology laboratory of Professor J. J. R. Macleod. With the help of graduate students Charles Best and Clark Noble, he purified his first insulin extract from the degenerating pancreases of canine subjects and showed it could transiently reduce the animals’ blood sugar. Banting presented his findings to the American Physiological Society conference in December 1921. Among attendees expressing interest in extract production was George H. A. Clowes, research director for the Eli Lilly Pharmaceutical Company of Indianapolis. Though his offer was initially turned down, it caused the researchers to patent their process to maintain their control over the integrity of the extract’s manufacture and purification. The University of Toronto’s Board of Governors subsequently licensed the process to Lilly’s laboratories. 1 American production supplemented the relatively meager yields at Toronto’s own Connaught Antitoxin Laboratories, supplying a burgeoning international market with insulin therapy. To oversee insulin’s future licensing and distribution, the Board of Governors organized Toronto’s Insulin Committee (IC) in 1922. One of its first actions was to offer patent rights to the British Medical Research Council (MRC), thus giving Europe its first access to insulin. The MRC sent Dr. Henry H. Dale, a department director at their National Institute for Medical Research, to Toronto. Dale quickly recognized the promise of insulin and suggested the The Pharos/Winter 2011 29
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