So far as I can tell, it’s gotten no attention whatsoever, but today is the 25th Anniversary of the Food and Drug Administration’s approval of the very first ever biotech medical product: Humulin, a recombinant version of human insulin invented by the biotech company Genentech, and marketed by Eli Lilly.
This was a stunning breakthrough because, until Humulin was approved, diabetics used insulin taken from pig and cow pancreases to treat their condition. Using recombinant DNA techniques, Genentech was able to create a product consisting of actual human insulin. FDA completed the review in a remarkably fast five months, at a time when the average review of new medical products was close to three years. CEI adjunct scholar and Hoover Institution fellow Henry I. Miller, who was the FDA medical reviewer in charge of the Humulin dossier, told The New York Times that the speedy review confirmed the ”scientific and commercial viability of” recombinant DNA technology and the biotechnology industry.
Biotechnology has revolutionized the practice of medicine and the pharmaceutical industry. Over the past 25 years, more than 187 biotech medicines have been approved in the United States, and they have been prescribed to an estimated 325 million patients. Over 300 more such biopharmaceuticals are in development. The biotechnology industry has delivered extraordinary medical advancements and has helped to create medicines that treat diseases once thought intractable. Biopharmaceuticals currently are used to treat cancers, stroke, multiple sclerosis, diabetes, cystic fibrosis, and many other diseases. Many forms of cancer that were invariably fatal a decade or two ago have now become treatable and even curable. Other once-fatal diseases have now become manageable conditions for many sufferers thanks to biotech medicines.
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, today, 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.