Day: August 29, 2024

Aug 29, 2024

Incident

More than 100 people after using a drug – Elixir Sulfanilamide, died.

Sulfanilamide, a drug used to treat streptococcal infections with dramatic curative effects, and safely used in tablet and powder form. In June 1937,  S.E. Massengill Co., in Bristol, Tenn., manufactured the drug in liquid form with diethylene glycol. No toxicity and pharmacological studies had been done on the new sulfanilamide preparation. Diethylene glycol (antifreeze) is a deadly poison.

On Oct 11, 1937, the American Medical Association (AMA) received incidental report from physician in Tulsa, Oklahoma, that an unfamiliar sulfanilamide compound was responsible for a number of deaths, and  AMA laboratory isolated diethylene glycol as the toxic ingredient and immediately issued a warning through newspapers, and radio that Exlixir Sulfanilamide was toxic.

Next year 1938, FDA set out to make sure all of the drug was retrieved. 239 FDA inspectors and chemists was assigned to the task, and state and local health officials joined the search, and newspapers and radio stations continued to issue warnings.

Chaos

In some drug stores, the elixir had been sold without prescriptions to purchasers whose names the druggiest did not know. In other cases, doctors had incomplete records, or none at all- of the names and address of patients for whom they had prescribed.  Even one East St. Louise woman told an inspector she had destroyed the drug. The inspector persisted in his questions how did she destroy. Her answer was that she had thrown the bottle out the window into an alley. The inspector found the bottle still unbroken, still containing enough elixir to kill any child.

A South Carolina doctor told an inspector that he had dispensed the medicine, but none had died, but the inspector found all his patients had died after taking the elixir. 

Of 240 gallons manufactured and distributed, 234 gallons and 1 pint was retried.

Victims

Many of them were kids, treated for sore throats. All exhibited similar characteristic of failed kidney, stoppage of urine, abdominal pain, nausea, vomitting, stupor, convulsions.  

However, the firm was not illegal, because in 1937, the law did not prohibit the sale of dangerous, untested, or poisonous dugs. 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 Chief Chemist, Harold Watkins committed suicide after learning of the effects of his latest concoction.

1938 Federal Food, Drug and Cosmetic Act

FDA Commissioner Walter Campbell pressed for better federal regulation of drugs, and pointed out how the inadequacy of the law had contributed to the disaster. 

The Elixir disaster hastened enactment of the 1938 Federal Food, Drug, and Cosmetic Act. New Drug section, added to prevent such tragedies, gave the US a new system of drug control which provided superior protection and 25 years later, this Act saved the Nation from an even greater global drug tragedy— a thalidomide disaster 

In the 1938 Food, Drug, and Cosmetic Act, requires perform animal safety tests.

However, currently, that requirement, especially cosmetics is not mandatory, if the company provides an evidence of the safety

Reference: Carol Ballentine, FDA consumer magazine, June 1981 Issue