Why Do I Love Drug Regulation? Simple: It Keeps Us Safe
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examples of drugs (referred to then as tonics and elixirs) that were neither; they caused serious harm or even killed those who took them while providing no benefit. From 1918 to 1928, the Bailey Radium Laboratories of New Jersey promoted a tonic advertised as “A Cure for the Living Dead.” Known as RadiThor, it consisted of distilled water containing two different isotopes of radium. It was promoted as being “harmless in every respect” and was used as a recreational drug by the wealthy. As an elixir, it was meant to capitalize on the public’s fascination with the recent discoveries of radioactivity and X rays. The company even published a book in 1928 entitled “RadiThor, the Modern Weapon of Medical Science,” although they did no studies to support this claim. Sales derailed soon after the Wall Street Journal published an expose detailing the gruesome death of socialite and sportsman Eben Byer, who had consumed large quantities of this “medicine.” The article was entitled “The Radium Water Worked Fine Until His Jaw Came Off.”
During Prohibition, safe legal alcohol was replaced with illegal hooch that was frequently adulterated with deadly intoxicants such as methanol. Bootleggers and manufacturers, operating outside of laws and regulations, made large fortunes. Sadly, though, their deadly brews killed and sickened thousands of people nationwide. The story is nicely recounted in Deborah Blum’s “The Poisoner’s Handbook: Murder and the Birth of Forensic Medicine in Jazz Age New York.” The horrendous body count was one of the primary factors that eventually led to the repeal of Prohibition in 1933.
Quackery was not limited to drugs, drinks, and devices, but encompassed medical procedures as well. One of the most interesting chapters in medical history is wonderfully depicted in “Charlatan: America’s Most Dangerous Huckster, the Man Who Pursued Him, and the Age of Flimflam” by Pope Brock. The book details the career of John Brinkley, a patent medicine huckster with a purchased medical diploma. In the 1920s and 30s, he popularized the technique of transplanting goat testicles (whole or in pieces) into impotent men to restore their “vigor.” Not surprisingly, the technique provided no benefit but was associated with significant sickness along with the death of a number of recipients. Seeking to end his career was Dr. Morris Fishbein, Editor of the Journal of the American Medical Association. The two engaged in a cat and mouse game over a number of years that finally ended when Brinkley sued Fishbein for libel and lost in a spectacular trial.
Before the advent of modern antibiotics such as penicillin, sulfa drugs were the wonder medicines of their age for treating infections. The discovery of these agents is beautifully described in “The Demon Under the Microscope: From Battlefield Hospitals to Nazi Labs, One Doctor’s Heroic Search for the World’s First Miracle Drug” by Thomas Hager. Back in 1937, however, corporate greed and incompetence turned a lifesaving medicine into a killer. The pharmaceutical firm S.E. Massengill Co. decided to formulate a version of the sulfa drug sulfanilamide so that it could be easily administered to children. To give their drug a sweet, pleasant taste they dissolved it in the highly toxic solvent diethylene glycol (more widely used today as automobile antifreeze). They did no testing to ensure that this solvent was safe. Their Elixir Sulfanilamide killed 105 people in 15 states, and was the primary impetus for passage of the Federal Food, Drug, and Cosmetic Act of 1938. Amazingly, the only law that Massengill broke at the time was labeling their medicine an Elixir, since that term was reserved for medicines containing alcohol, and their drug did not.
One FDA scientist who helped pinpoint diethylene glycol as the poisonous agent in Elixir Sulfanilamide was Dr. Frances Kelsey. She went on to become a legend at the FDA in a separate context. The drug thalidomide was developed by the German pharmaceutical company Grünenthal and sold in Europe in the late 1950s. It was promoted as a tranquilizer and painkiller, and also to combat nausea, i.e. morning sickness, in pregnant women. Dr. Kelsey refused to approve an application by the Richardson-Merrell Company to sell thalidomide in the U.S. without further studies. Later, scientists learned that the drug causes birth defects, and the consumption by pregnant women led to the birth of over 10,000 deformed children worldwide. Many of us who came of age in the 1960s recall the widely published photos of children born with missing or truncated limbs. The thalidomide disaster led the U.S. Congress to pass new laws requiring … Next Page »