The making of a milestone in consumer protection, 1938-1988

FDA Consumer, Dec-Jan, 1988 by William Grigg, Wallace Janssen

THE MAKING OF A MILESTONE IN CONSUMER PROTECTION

Despite the despair and hard times of the 1930s, there were exciting new products coming onto the market--among them, drugs that actually halted infections.

This progress was used as an argument against changing the 1906 Food and Drugs Act. People might well hesitate before passing any new law that might hold back such wonder drugs. Look at the German-developed Prontosyl and the related sulfa drugs that were curing bacterial infections such as pneumonia, blood poisoning, and meningitis.

Sulfanilamide, one of these first sulfa drugs, was effective against gonorrhea and other infections. Too bad this early sulfa drug was hard to swallow as a tablet and hard to dissolve into a liquid medicine.

It was left to a chemist at an old and reputable company called S.E. Massengill of Bristol, Tenn., to find a way to dissolve it into a liquid product, easier for children to swallow. The company, confident in the solvent as well as the active ingredient, put the liquid on the market without safety testing.

It was Oct. 11, 1937, when the American Medical Association received reports from physicians in Tulsa, Okla., of six deaths from this new elixir of sulfanilamide. And in New Orleans, one doctor alone had six patients die, one of them his best friend. ("Nobody but Almighty God and I can know what I have been through these past few days," he wrote in a letter. "I have spent hours on my knees . . . I have known hours when death for me would be a welcome relief from this agony.")

The solvent that had liquified the sulfa had proved to be poison. As a result, children who may have been treated for an infected and sore throat suffered intense pain with stoppage of urine, vomiting and ultimately convulsions, stupor and death. Mrs. Maise Nidiffer of Tulsa wrote President Roosevelt that even the memory of her daughter Joan is cruel because "we can see her little body tossing to and fro and hear that little voice screaming with pain [until] it seems as though it would drive me insane." The 6-year-old had been in this condition for nine days before dying.

Most physicians went to great lengths to track down patients given the medicine to try to stop them from taking it. One postponed his wedding in order to help FDA's inspector track down a 3-year-old mountain boy.

However, another physician apparently sought to avoid any possible responsibility by denying he had prescribed the drug. It was a practice in that part of the South to leave personal effects on a grave, and an FDA inspector found a partly empty bottle of the elixir on the grave of the denying doctor's child-patient.

Only six gallons of Elixir Sulfanilamide killed 107 people, mostly children. The Associated Press reported "a nationwide race with death" as every agent of the FDA scoured the country for the 700 remaining pints of the deadly drug. Amazingly, 99.2 percent of this remaining supply was rounded up.

One inspector spent four days trying to track down a bottle, knowing only that it was purchased by a member of a family named Long. He traveled through several small towns in Arkansas, finally reaching the right Long family--as a funeral for their 7-year-old daughter, who had taken the medicine, got under way.

Sulfa was such a new drug that no one was sure whether it was the active ingredient or the solvent that was killing people, Dr. Frances Kelsey recalls. As a graduate student at the University of Chicago, she helped with one of several studies conducted to find the answer. It proved to be the solvent, diethylene glycol, similar to a substance used as an antifreeze. (See "Taste of Raspberries, Taste of Death: The 1937 Elixir Sulfanilamide Incident" in the June 1981 FDA Consumer.)

(A Canadian, Dr. Kelsey later became an FDA employee--and prevented another drug catastrophe, birth defects from thalidomide, by blocking that drug's sale here.)

The tragedy of sulfanilamide led to the suicide of Massengill's chemist, although he was charged with no crime, and to a fine of only $26,000 for the company--the highest possible under the old law. Public outrage led swiftly to passage of the 1938 Food, Drug, and Cosmetic Act with a provision requiring drugs to be cleared for safety before they go on the market.

The law was no longer derided as the "Tugwell bill." In truth, many changes had been made. As modified, the legislation was now called the Copeland bill after Senator-physician Royal S. Copeland of New York, who had labored over it, improving it, compromising, modifying. The struggle hastened his death. He collapsed on the Senate floor and died soon after the bill's passage.

The grieving Mrs. Nidiffer, after describing her daughter Joan's death, had asked President Roosevelt, "as you enjoy your grandchildren of whom we read about, 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."

President Roosevelt signed the bill into law on June 25, 1938. By that time, many newspapers, many businesses, much of the advertising trade, and various professional associations had lined up with the consumer groups in favor of it.