He studied classics at nearby Hanover College before serving as a corporal in the Civil War. Although Wiley later graduated from Indiana Medical College, he never practiced medicine. Rather, he pursued his love of science, obtaining a degree in chemistry from Harvard. In 1874, Wiley became the chair of the chemistry department at the newly opened Purdue University. Ten years later, he was chief chemist at the United States Department of Agriculture (USDA), at a time when the food industry, like the drug industry, was unregulated. Wiley watched helplessly as Americans consumed spoiled meat, sawdust-adulterated flour, and formaldehyde-preserved milk. It was time, Wiley argued, for the federal government to step in.
Samuel Hopkins Adams graduated from Hamilton College before joining the staff of the New York Sun, one of the nation’s most influential newspapers. On October 7, 1905, Adams published the first of a series of articles in Collier’s magazine titled “The Great American Fraud.” Adams wanted Americans to know what they were buying. So he sent samples of patent medicines to chemists, finding that many contained large quantities of alcohol: Paine’s Celery Compound contained 21 percent; Peruna, 28 percent; and Hostetter’s Stomach Bitters, 44 percent. (To put this in perspective, beer contains 4 to 6 percent alcohol, wine 10 to 15 percent, and whiskey 35 to 45 percent.) Patent medicine makers were in the liquor business. They were also in the narcotics business. Adams found that several medicines contained opium, morphine, hashish, and cocaine. These drugs were often given to babies; Winslow’s Soothing Syrup, for example, was loaded with morphine. When Adams asked his maid how she had left her small children alone at night, she replied, “They’re all right. Just one teaspoon of Winslow’s and they lay like dead until morning.” Perhaps the best example of the subterranean narcotics industry was Coca-Cola, introduced in 1886 as an “Intellectual Beverage and Temperance Drink” that offered the virtues of cocaine without the stigma of alcohol.
By the last installment of “The Great American Fraud,” in February 1906, Samuel Adams had exposed 264 companies and individuals, listed scores of people who had died from dangerous drugs, and shown that many patent medicines had caused diseases rather than treated them. “Every man who trades in this market, whether he pockets the profits of the maker, the purveyor, or the advertiser, takes [his] toll of blood,” wrote Adams. “Here the patent medicine business is its nakedest, most cold-hearted. Relentless greed sets the trap, and death is partner in the enterprise.” More than 500,000 Americans read “The Great American Fraud.”
With the public up in arms about Adams’s publication, Harvey Wiley felt the time was right. He proposed a federal law to “cover every kind of medicine for external and internal use,” which would require manufacturers to list all ingredients and prohibit them from selling narcotics without a prescription. Wiley’s proposal angered the Proprietary Association of America, lobbyists for the industry. “Such a law,” advised its Committee on Legislation, “would practically destroy the sale of proprietary remedies in the United States.” Industry executives successfully lobbied to kill the bill.
And that would have been the end of it had it not been for a die-hard socialist who, if anything, wanted less government, not more.
Upton Sinclair was an unknown journalist who railed against the sins of American capitalism. In the early 1900s, he traveled to Chicago to write a fictional work about the plight of immigrant workers in the meatpacking industry. With The Jungle, Sinclair wanted to inspire his readers; instead he nauseated them. “There would be meat that had tumbled on the floor, in the dirt and sawdust, where the workers had tramped and spit uncounted billions of consumption germs,” wrote Sinclair. “There would be meat stored in great piles in rooms; and the water from leaky roofs would drip over it, and thousands of rats would race about on it. It was too dark in these storage places to see well, but a man could run his hand over these piles of meat and sweep off handfuls of the dried dung of rats. These rats were nuisances, and the packers would put poisoned bread out for them; they would die and then rats, bread and meat would go into the hoppers together.” Sinclair described how employees occasionally slipped into steaming vats, later emerging as Durham’s Pure Leaf Lard. Wanting to hit Americans in their hearts, he hit them in their stomachs. Sales of meat dropped by half. Following publication of The Jungle, Theodore Roosevelt ordered Congress to create legislation guaranteeing clean meat and pure food.
The bill that President Roosevelt signed into law, the Pure Food and Drug Act of 1906, was a watered-down version of what Harvey Wiley had wanted. If a patent medicine contained alcohol, cocaine, opium, chloroform, or other potentially harmful drugs, manufacturers had to print it on the label. They could still sell narcotics and dangerous drugs; they just had to tell consumers they were doing it. Most important, no statement could be made that was “false or misleading.” Although the law didn’t ask manufacturers to prove that their medicines were safe or effective, it was a start. The federal government now had a hand in regulating the drug industry.
Enforcement of the Pure Food and Drug Act fell to the USDA’s Bureau of Chemistry. In 1927, the newly minted Food, Drug, and Insecticide Administration took over; three years later, it changed its name to the Food and Drug Administration.
The next federal law was born of the worst pharmaceutical disaster in United States history. It involved one of the first antibiotics: sulfanilamide. In the early 1930s, six companies made sulfa drugs: Squibb, Merck, Winthrop, Eli Lilly, Parke-Davis, and the S. E. Massengill Company of Bristol, Tennessee. Massengill made it poorly. To make sulfa more palatable for children, Harold Watkins, Massengill’s chief chemist, suspended it in diethylene glycol. The final preparation—called Elixir Sulfanilamide—contained diethylene glycol, sulfanilamide, water, and small amounts of raspberry extract, saccharin, caramel, and amaranth, which gave the drug a deep reddish purple color. Unlike other sulfa preparations, Massengill’s tasted great—perfect for children. The drug, however, was far from perfect, and Massengill knew it. Ten months before marketing the mixture, chemists at Massengill found that a 3 percent solution of diethylene glycol caused fatal kidney failure in rats; Elixir Sulfanilamide contained 72 percent.
In September 1937, Massengill distributed 240 gallons of its elixir in the United States. Three hundred fifty people drank it and immediately suffered heartburn, nausea, cramps, dizziness, vomiting, diarrhea, and difficulty breathing. Even worse, more than a hundred people died from kidney failure, thirty-four of them young children. Following the tragedy, the president of Massengill 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 legitimate professional demand and not once could have foreseen the unlooked-for results. I do not feel there was any responsibility on our part.” Massengill’s president, knowing that his company had acted within the law, wasn’t particularly remorseful. Harold Watkins, the chemist who had formulated the product, was. Soon after the incident he killed himself.
The Elixir Sulfanilamide disaster led to the next major drug law: the Food, Drug, and Cosmetic Act of 1938. Now the FDA required safety testing before drugs were sold. The newer, stronger law stated that drugs, cosmetics, and therapeutic devices had to be proved safe; manufacturing plants had to be registered and inspected by the FDA every two years; and foods sold across state lines had to be pure and wholesome, safe to eat, and produced under sanitary conditions. Violators could be imprisoned for a year, with longer sentences for second offenses or fraud.
Although the Food, Drug, and Cosmetic Act of 1938 tightened the reins, manufacturers still didn’t have to prove that their products worked before selling them. It took another tragedy to make that happen.
On October 1, 1957, Chemie Grünenthal, a West German pharmaceutical company, distributed a sedative called thalidomide. Advertisements claimed that it was safe, even for pregnant women. Within three years, hundreds of women in Europe had delivered babies whose hands and feet were attached directly to their bodies—a disorder called phocomelia (cruelly referred to by the press as “flipper babies”). As many as 24,000 fetuses were damaged by thalidomide; half died before birth. Although Chemie Grünenthal had submitted its drug for licensure in the United States, Dr. Frances Kelsey, an FDA physician, turned it down, believing that the first few reports of phocomelia following the introduction of thalidomide weren’t a coincidence.
Because of Kelsey, thalidomide was never marketed in the United States. Still, the