Here’s a piece from today’s (October 3, 2005) Wall Street Journal. As we ponder drugs from foreign nations and increasingly aggressive counterfeiters, we would do well to remember what life was like before “safe and effective” was the order of the day.
How Elixir Deaths Led U.S. to Require Proof of New Drugs’ Safety
Only 70 years ago, American companies could legally sell poison in a medicine bottle.
Obviously, no drug maker would knowingly kill its customers — the free market would punish that kind of bad business. But a company that inadvertently sold a drug resulting in multiple deaths faced no legal penalties.
In 1937, however, the consequences of Americans’ unfettered right to buy and sell medicine became disastrously clear. An antibacterial syrup called Elixir Sulfanilamide killed at least 75 people, some of them young children who had been suffering from nothing more serious than a sore throat. “Even the memory [of our 6-year-old daughter, Joan] is mixed with sorrow, for we can see her little body tossing to and fro and hear that little voice screaming with pain,” wrote a grief-stricken Tulsa, Okla., mother to President Franklin Roosevelt.
The elixir’s manufacturer, S.E. Massengill of Bristol, Tenn., wasn’t expected to test its drugs for safety, and it didn’t. The company’s owner later said he and his chemists “regret the fatal results,” but “do not feel there was any responsibility on our part.” The company eventually paid a fine, but only for misbranding: Under existing federal law, the term “elixir” was restricted to solutions containing alcohol.
Massengill, like other drug companies of the time, had been doing a brisk business in the newly discovered miracle drugs known as sulfa, which were manufactured in tablets or powder. But many of Massengill’s customers, particularly young children, preferred their medicine in liquid form. A Massengill chemist found that sulfa could be suspended in water, raspberry flavoring and diethylene glycol, an industrial chemical sometimes used to make antifreeze.
The company’s laboratory “tested the mixture for flavor, appearance and fragrance and found it satisfactory,” wrote Carol Ballentine in a 1981 article in FDA Consumer magazine. Some 240 gallons of the syrup were shipped across the country. Even if customers had wanted to check the ingredients, they couldn’t. The drug companies had the right to keep their formulas secret.
At the time of the elixir debacle, the food and drug industries were still regulated by a 1906 law that was stuffed with loopholes and mostly unenforceable. In 1933, a new bill was introduced in Congress. Among other provisions, it proposed to outlaw the sale of medicines that might kill someone who ingested them. For the next five years, the bill and its successors were stalled and gutted by the brawny proprietary-medicine lobby, with help from friends in the newspaper industry, which had become addicted to advertising revenue from wonder drugs like Paw-Paw Pills and Cherry Pectoral.
“Your pocketbook is about to be filched,” wrote a medicine maker to newspapers in which he had placed advertising. “We ask you to take an active, aggressive stand against this bill, not as a matter of cooperation to us but for your own business interests … An isolated editorial or two will not suffice in this matter.”
The opponents of new drug and cosmetic regulation, nicknamed the “pain and beauty boys” by the press, argued that Americans’ belief in their right to self-medicate was as deeply held as their belief in the right to free speech or worship. People wanted the convenience of buying their medicines over the counter, the critics argued. Under the new law, a simple headache would mean a costly trip to the doctor. And why should the federal government play gatekeeper to private citizens’ medicine cabinets?
It was frightening, said the head of an advertising agency that specialized in patent medicines, to see “such a sweeping grant of autocratic power being placed in the hands of any bureau or department of government.”
Added the general counsel of a drug industry trade group in congressional testimony, “I have never in my life read a bill or heard of a bill so grotesque in its terms, evil in its purpose and vicious in its possible consequences.”
Elixir Sulfanilamide provided the emotionally wrenching case history the bill’s supporters needed to mobilize public opinion. By the time anyone realized the elixir was poison, it had been distributed in at least 15 states and bought over the counter by many customers unknown to the pharmacists.
The Food and Drug Administration put almost its entire staff of 240 agents on the trail of the elixir, and their attempts to trace every pint provided a dramatic running narrative for the press. Based on the death rate of those who took the medicine, if all 240 gallons had been consumed, more than 4,000 people would have died.
In 1938, Congress passed the Food, Drug and Cosmetic Act, under which, for the first time, pharmaceutical manufacturers would have to prove the safety of their products before putting them on the market. That year, the FDA also decided that sulfanilamide, among other powerful drugs, should be taken only under the direction of a doctor, putting another nail in the coffin of some pain and beauty boys.
Write to Cynthia Crossen at email@example.com