Public Health

the New Law
by Food and Drug Administration (FDA)

(Page 4 of 6)

The most famous example came in fall 1937. The Massengill Co. of Bristol, Tenn., was selling a drug called sulfanilamide. It was a new drug in the first great family of anti-infectives, effective against several bugs. As these drugs came on the market, doctors and patients snapped them up instantly. Salesmen for Massengill reported back to headquarters that patients also would like to trade the bad-tasting pills for a more palatable liquid version.

The chief chemist at Massengill, Harold C. Watkins, tried one solvent after another before settling on diethylene glycol, a sweetish but largely tasteless fluid. The concoction was checked for flavor and fragrance, and then manufactured in batches totaling hundreds of gallons. The liquid, Elixir Sulfanilamide, was put into bottles of 4 ounces each and shipping began on Sept. 4, 1937.

Tulsa, Okla., was the first city in which reactions were reported. By early October 1937, 10 patients in the practice of James Stephenson, M.D., had died immediately after taking the bright red liquid.

When FDA inspectors reached Massengill's Tennessee plant, they found that Tulsa would not be the only site of the problems. Two hundred forty gallons of "elixir" had been shipped across the country, from California to Virginia.

A short time later, Walter Campbell, the FDA's chief chemist, held a press conference in Washington, D.C., during which he said that 14 people had died after taking the Massengill product. He said that the FDA could not legally investigate or prosecute the matter unless it could be shown that there was something wrong with the label on the bottles. He had, however, begun a national investigation, as his agency was the only one with any possible jurisdiction. Campbell would go on to become Commissioner of Food and Drugs in 1940.

The 1906 law had no prohibition per se of dangerous drugs. Campbell was fortunate in that the medicine was labeled an "elixir," which technically is a liquid containing alcohol, so he went ahead with his investigation in hopes that the technicality would be sufficient cause to investigate.

The full field force of the FDA in the United States, 239 inspectors, began to search out the druggists and doctors who had received the shipments. Massengill proved to be trouble. At the beginning of the crisis, on Oct. 15, 1937, the FDA had asked the company to recall from doctors, druggists, and distributors whatever was left of the shipments. The company sent out a notice that all should send back the preparation, but said nothing about the reason for the return or the emergency nature of the recall. The recall was largely ignored. It wasn't until four days later that the company was told it had to send out a second notice, indicating that the drug was life-threatening.

By the end of November 1937, 107 deaths had been reported, many of them children. Not counted in the statistics was Watkins, the chemist who had caused it all, who died while cleaning his gun. It is unclear how many more victims there were beyond those reported, but the FDA investigators kept the number of deaths down by recovering, within four weeks, more than 90 percent of the original shipment. About 6 gallons, apparently, accounted for all the deaths.

Less than a month later, when it was clear the episode was over, the question of prosecution arose. Samuel Massengill himself wrote to the AMA, staking out the company's position. The deaths were regrettable, he said, "but I have violated no law."

The AMA, pushing for a new law, issued a statement noting that the death toll from ill people taking useless quack medications was far higher than 107. A proposed law was already in Congress, and pressure to pass a stricter food and drug law had been on for four years. The mail poured into Congress and the bill, left for dead, was revived and readied for passage. The new Food, Drug, and Cosmetic Act was passed on June 15, 1938. It has provided the framework for drug research and marketing that stands to the present.

Meaning of the New Law

The crisis of 1937 had been a modern one. It was not about crank products and false claims, but rather technical knowledge and potent modern medicines, about checking potent substances before selling them.

The law came at a time when the drug industry was just beginning to realize that the nature of its business for the future would not be to stamp out millions of bottles of chemicals, but rather to fashion drugs that could attack the underlying bases of disease.

The 1938 law made it clear that companies could not survive without increasing their number of scientists and laboratories, without knowing something substantial about the drugs they were selling, and about human illness itself. They would have to, at least, produce scientific tests of safety for the FDA.

The 1938 law was a landmark in civil governance, not just for the United States, as it turned out, but for democratic governments around the world. In the years to come, each nation of the developed world would adopt its central principles. It was the first law to require the checking of drugs before they went to market. It put into law the notion that the scientific approach - not the commercial, not the anecdotal - would be the standard for modern society. It was, in fact, one key factor that created the modern pharmaceutical industry.

By the 1940s and the advent of penicillin from a British university laboratory, most pharmaceutical companies had not yet made that crucial transition, from being chemical factories to basing their business on medical research and development. When scientists offered commercial companies the right to penicillin, for free, one company after another turned the chance down. Taking penicillin from the lab to commercial quantities was carried out prominently in a government laboratory in Peoria, Ill. But by the 1950s, the companies had made a big transition. They dropped thousands of useless patent medicines and similar products from manufacture - as in the case of Smith, Kline, which dropped 14,940 of its 15,000 products and began concentrating on only 60 products for its success. Until 1940, none of the important medicines had been created in industry, and the Sharp and Dohme Catalog contained not a single exclusive prescription medicine.

By the 1950s, the situation was changed completely. The death rates for a variety of the worst human illnesses, such as tuberculosis, had been cut by 99 percent in the developed countries, and the pharmaceutical industry was now a leader in the campaign to conquer disease. With an array of new antibiotics, steroids, vitamins, and other truly useful products, the prospect of humanity actually conquering among the most terrifying features of nature seemed possible, and the effort was under way.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.