Frederick Sanger (b. 1918), Herbert Boyer (b. 1936)
In 1922, insulin was shown to successfully treat diabetes in human patients. Within one year, Eli Lilly and Company began the first commercial production of a purified insulin extract from the pancreas of pigs (porcine) and beef. Early on, several problems were recognized: Scientists predicted a shortage of animal organs in the foreseeable future, and allergy and adverse reactions would result from the subtle differences between human and animal insulin.
A GIANT STEP FOR GENETIC ENGINEERING. In the early 1950s, Frederick Sanger, at the National Institute for Medical Research in London, determined the amino acid structure of insulin, for which he was awarded the first of his two Nobel Prizes in Chemistry in 1958. In 1977, Herbert Boyer of Genentech (Genetic Engineering Technology) produced the first genetically engineered, biosynthetic human insulin in the laboratory, which was licensed to Lilly. Utilizing the process of recombinant DNA technology, Boyer produced the insulin by inserting the genetic code for human insulin into an everyday bacteria. Maintaining the production of insulin to meet the world’s needs ceased to be a problem.
Clinical trials in 1981–1982 established that the biosynthetic human and animal-derived insulins possessed comparable effectiveness but that the human insulin was not less likely to cause allergic reactions. Nevertheless, in 1982, the Food and Drug Administration and British authorities approved Lilly’s human insulin, Humulin—the first approved drug developed by biotechnology but only a modest advance for medical science.
When insulin is injected too rapidly, the diabetic’s blood sugar drops precipitously. Early signs of hypoglycemia may be missed, causing the diabetic to lose consciousness and perhaps even die. This has been a particular problem for patients switching from animal insulin to Humulin. More than 95 percent of insulin users in most parts of the world use biosynthetic human insulin, with the remainder using the porcine-derived type.
Biotech drugs—used to treat a variety of disorders including cancers, blood and clotting disorders, multiple sclerosis, cystic fibrosis, and growth deficiency—are among the most exciting new arrivals in medicine. And they all started with human insulin.
SEE ALSO Food and Drug Administration (1906), Insulin (1921), Orinase (1957), Glucophage (1958), Biologic Drugs (1982), Avandia (2010).
This illustration shows a ball-and-stick model of human insulin, which consists of two chains: one with thirty linked amino acids, the other with twenty-one.