On October 28, 1982 biosynthetic human insulin (BHI) called Humulin, received FDA marketing approval for human use, and marked the first drug product developed through recombinant DNA techniques, a genetically modified (GM) drug. It represented a “technological advance through the demonstration of scientific and commercial viability of recombinant DNA technology”
Dr. Henry Miller, the medical officer in charge of the FDA approval said it approval stated it “launched a revolutionary new era in pharmaceutical development…both the drugmakers and regulators were exploring unknown territory…” [3, 4]
Approval was awarded in only 5 months, and that was allegedly delayed, Miller was ready to approve after 4 months. The NY Times reported such apporval would normally take 20 to 30 months. [2]
It is called human insulin because it is claimed to be an “exact copy of the insulin molecule produced by the body and therefore it would produce less antibodies.” The synthetic insulin is said to cause the patient to be unaware they are hypoglycaemiac and may be connected to ‘dead in bed syndrome‘, wher patients die suddenly in their sleep! [1]
Following the isolation of a ringlet of DNA called a “plasmid” from a bacterium in 1973, which sparked the GM revolution, Eli Lilly and Co. obtained from startup Genentech, Inc., the licence for the recombinant Escherichia coli bacteria that contained the insulin genes, they developed the processes for the large-scale cultivation of the bacteria…and for the purification and formulation of the insulin. Lilly began the clinical trials in July 1980 with “400 patients in 12 medical centers in the United States” were tested some insulin-naive (101) others changed from animal insulin (112) and followed for 6 and 3 month respectively. The submission was made to the FDA in May 1982, and approval received just 5 months later.[2, 5]
Prior to this GM insulin, people with diabetes used animal pancreas derived insulin, originally beef insulin. In the 1970s highly purified pork insulin became available. These non-synthesised animal insulins didn’t have a patent. It was claimed animal insulins would run out and so GM versions would be needed and would be cheaper. The 2 manufactures (Novo Nordisk & Eli Lilly) of animal insulin systematically withdrew them from the market, even as concerning side effects were reported from use of the GM version.
Britain approved it one month earlier (according to NY Times), similar to COVID-19 vaccine approval a few weeks apart for UK versus USA in December 2020.