According to an AP article that appeared in our local daily this morning, one of the tools the federal government may use in going after Stewart Parnell and other management of the Peanut Corporation of America is the Federal Food, Drug, and Cosmetic Act of 1938. Ironically, the 1938 law has its roots in an incident of corporate hubris and disregard for public safety not unlike the present salmonella-tainted peanut butter case.
"A spoonful of sugar," Julie Andrews sang in her role as Mary Poppins, "Helps the medicine go down." In the middle of the Great Depression, the S. E. Massengill Company found something much better than sugar. Or so they thought. The disaster unfolds on the flip.
Sulfa drugs were the miracle of the first half of the twentieth century. We toss around the term "wonder drug" rather casually these days, but in the 1930's Sulfa drugswere the miracle wonder drug, the archetype behind the term. A game changer. Sulfa:
was the first medicine ever discovered that could effectively treat a range of bacterial infections inside the body. It had a strong protective action against infections caused by streptococci, including blood infections, childbed fever, and erysipelas, and a lesser effect on infections caused by other cocci.For the developer and marketer of the first Sulfa drug, the Bayer AG division of German pharmaceutical company I. G. Farben, there was one teensy-tiny little problem. In 1935 it was discovered that the actual active agent that made sulfa drugs effective had already been discovered -- as a dye-making agent -- in 1906. It had been patented, its patent long since expired, and the formula now in the public domain. It was a pharmaceutical company's worst nightmare -- after all their R&D investment, anyone could freely make sulfa drugs, without paying a penny of their profits to Bayer / Farben.
As the first and only effective antibiotic available in the years before penicillin, sulfa drugs continued to thrive through the early years of World War II. They are credited with saving the lives of tens of thousands of patients including Franklin Delano Roosevelt, Jr. (son of President Franklin Delano Roosevelt) (in 1936) and Winston Churchill. Sulfa had a central role in preventing wound infections during the war. American soldiers were issued a first aid kit containing sulfa powder and were told to sprinkle it on any open wound.
Wikipedia: Sulfa Drugs
And make sulfa drugs they did. In the libertarian fantasy world where there are no patents and copyrights, anyone can jump in and try to prove their mettle as the most efficient, lowest-cost producer; the most creative developer can try his hand at improving the product and marketing that proverbial 'better mousetrap'. And that's exactly the environment that unfolded in a couple of heady years between the revelation of the drug's public domain status and the events that transpired in 1937, as hundreds of manufacturers jumped into the fray.
One of those manufacturers was a name that will be familiar to many readers today, the S. E. Massengill Company of Bristol, TN. Although S. E. Massengill no longer exist as an independent company, the Massengill name is still in use as a brand of feminine hygiene products manufactured by Glaxo-Smith-Kline . In June of 1937 one of its salesmen reported a demand for their sulfa drug, then available in tablets and powders, as a liquid. The company chemist set about to fill that demand. His goal was to develop a raspberry-flavored liquid version of the company's sulfa drug. However, there were problems to overcome.
Despite the fact that sulfonilamide was relatively insoluble in the typical pharmaceutical solvents, Massengill's head chemist, Harold Cole Watkins, was not deterredWatkins' formula was sent to the company's Kansas City, MO branch where an initial batch of 40 gallons was mixed, and Watkins himself mixed another 40 gallon batch at Bristol, and shipped the liquid to distribution branches in New York and San Francisco. By September, 1937 Massengill's Elixir Sulfanilamide hit the market.
[H]e set out to find a liquid vehicle for sulfonilamide at the company and turned his attention to the glycols. He based this decision on their chemical similarity to glycerine, a commonly used solvent in liquid pharmaceuticals . He soon discovered that he could dissolve as many as 75 grains of sulfanilamide in 1 fluid ounce of clear, odorless diethylene glycol. However, the resultant solution tended to separate on chilling, so he reduced the antibiotic concentration to 40 grains per fluid ounce
No animal or clinical tests were conducted by Watkins or the company at large to determine the toxicity of the individual ingredients or that of the combination. Any possible effects of diethylene glycol on sulfanilamide were also left to chance. The company's sole process for quality control consisted of checking the elixir for its appearance, flavor, and fragrance.
Pathophilia: Massengill's Elixir Sulfanilamide: Inspiration, Formula, and Distribution
Our research department has just released an Elixir Sulfanilamide...It is ideal for your patients who can take liquids—but little else. Also, it is not unpleasant to take, so is suitable for children.And then the children started to die.
"Nobody but Almighty God and I can know what I have been through these past few days. I have been familiar with death in the years since I received my M.D. from Tulane University School of Medicine with the rest of my class of 1911. Covington County has been my home. I have practiced here for years. Any doctor who has practiced more than a quarter of a century has seen his share of death.The majority of the victims were children. Deaths were particularly gruesome:
"But to realize that six human beings, all of them my patients, one of them my best friend, are dead because they took medicine that I prescribed for them innocently, and to realize that that medicine which I had used for years in such cases suddenly had become a deadly poison in its newest and most modern form, as recommended by a great and reputable pharmaceutical firm in Tennessee: well, that realization has given me such days and nights of mental and spiritual agony as I did not believe a human being could undergo and survive. I have known hours when death for me would be a welcome relief from this agony." (Letter by Dr. A.S. Calhoun, October 22, 1937)
FDA: Taste of Raspberries, Taste of Death: The 1937 Elixir Sulfanilamide Incident
Victims of Elixir Sulfanilamide poisoning--many of them children being treated for sore throats--were ill about 7 to 21 days. All exhibited similar symptoms, characteristic of kidney failure: stoppage of urine, severe abdominal pain, nausea, vomiting, stupor, and convulsions. They suffered intense and unrelenting pain. At the time there was no known antidote or treatment for diethylene glycol poisoning.Diethylene glycol, the liquid in which Watkins dissolved Massengill's sulfanilamide, may sound somewhat familiar to the automotive-minded among you. It is related chemically to (mono-)ethylene glycol, commonly used as automotive antifreeze. Ethylene glycol is highly poisonous, its most common victims being being cats and dogs which lag up the sweet-tasting liquid following an accidental spill, although over 3,000 cases of human poisoning occur in a typical year. If Watkins had stumbled across the right literature in those pre-Google days, he might have discovered early studies, one in 1931 and one in 1937, linking diethylene glycol to deaths in experimental animals. If he had asked the right people at the Food and Drug Administration, they might have told him they had been discouraging the use of glycols in foods and medicines for several years.
In a letter to President Franklin D. Roosevelt, a woman described the death of her child:
"The first time I ever had occasion to call in a doctor for [Joan] and she was given Elixir of Sulfanilamide. All that is left to us is the caring for her little grave. Even the memory of her is mixed with sorrow for we can see her little body tossing to and fro and hear that little voice screaming with pain and it seems as though it would drive me insane. ... It is my plea that you will take steps to prevent such sales of drugs that will take little lives and leave such suffering behind and such a bleak outlook on the future as I have tonight."
But he didn't, and the company didn't perform any of its own experiments, and the drug went to market and by the time it was over more than 100 people in 15 states, as far east as Virginia and as far west as California, were dead of its effects.
And then came the time for punishment, for penalties, for society to extract the price to be paid for such callous and reckless disregard for human life. And there began another tragedy.
The S. E. Massengill Company freely admitted they had not tested their new concoction for harmful effects. In fact, that was part of their defense:
A few simple tests on experimental animals would have demonstrated the lethal properties of the elixir. Even a review of the current existing scientific literature would have shown that other studies--such as those reported in several medical journals--had indicated that diethylene glycol was toxic and could cause kidney damage or failure. But in 1937 the law did not prohibit the sale of dangerous, untested, or poisonous drugs. Dr. Samual Evans Massengill, the firm's owner, said: "My chemists and I deeply regret the fatal results, but there was no error in the manufacture of the product. We have been supplying a legitimate professional demand and not once could have foreseen the unlooked-for results. I do not feel that there was any responsibility on our part." The firm's chemist apparently did not share this feeling; Harold Watkins committed suicide after learning of the effects of his latest concoction.There was little, it turned out, that the federal government could do. The most recent law to regulate medicines was the seminal Pure Food and Drug Act of 1906; subsequent attempts to update the law for the evolving industry had run afoul of the same conservative, pro-business Supreme Court mentality that had handed down the Lochner decision. In the end, the Massengill company was found guilty of mis-labeling their product an 'elixer', which would have required that it contain alcohol, which it did not. The company paid a fine of $16,800.00.
FDA: Taste of Raspberries, Taste of Death: The 1937 Elixir Sulfanilamide Incident
Now, as it so often does, the outcry of an enraged public, coupled with a scare put into the Supreme Court by the Judiciary Reorganization Act of 1937 knocked down barriers that no longer dared stand in the way of reform. In 1938, as a direct result of the Massengill case, Congress passed the Federal Food, Drug, and Cosmetic Act, greatly strengthening the FDA's power to oversee the pharmaceutical industry, and giving the FDA broader powers than most of its counterparts in other developed countries in the industrial world.
So that, dear Kossacks, is where regulation comes from, not some bored bureaucrat sitting in an office in Washington trying to think up ways to make life miserable and expensive for some innocent and unsuspecting businessman, but from real human suffering and tragedy brought about, all too often, by people who shirk what should be obvious responsibilities, who neglect basic diligence, who sacrifice safety for profit. They bring suffering on those who trust them and their products, and society adopts measures to make sure it never happens again. We have to force them, through regulation, to behave as they should have been behaving all along. That's how Regulations come to be.