Twenty-nine years ago tomorrow, the U.S. Food and Drug Administration approved Eli Lilly’s and Genentech’s Humulin, making it the first ever fully approved product of recombinant DNA, or what we now call modern molecular biotechnology. Humulin was the first biosynthetic human insulin, produced by splicing the human gene that codes for insulin production into a harmless microbe. Previously, diabetics who needed supplemental insulin used bovine or porcine insulin that was purified from the pancreases of cows and pigs. They worked reasonably well, but were not perfect analogues of human insulin. With the introduction of Humulin they could now take actual human insulin, which improved the treatment’s safety and efficacy.
According to The New York Times, my friend and colleague “Dr. Henry Miller, the medical officer in charge of Humulin at the F.D.A., said the development was a major step forward in the ”scientific and commercial viability of'” recombinant DNA techniques. ”We have now come of age,” Dr. Miller said.”
Since 1982, biotechnology has revolutionized the practice of medicine and the pharmaceutical industry. Over the past 29 years, some 200 or so biotech medicines have been approved in the United States, with roughly 900 more now being developed to treat more than 100 diseases ranging from cancers and infectious diseases to autoimmune disorders and cardiovascular diseases.
Unfortunately, while food biotechnology has the same potential, it has not fared nearly as well. A broad scientific consensus has concluded that rDNA technology (known variously as gene splicing, genetic engineering, and genetic modification) is merely an extension, or refinement, of less-precise breeding techniques that scientists have long used for similar purposes, but it’s use has been hobbled by vast over-regulation in the U.S. and around the world — a phenomenon I have written about at length elsewhere. So, let’s celebrate the tremendous success of the medical biotechnology industry, but let us not forget how government has nearly strangled food biotechnology in its crib.