Disturbing details have emerged about the recent public health drug disaster, where a meningitis outbreak killed 25 people, sickened hundreds, and may have put as many as 14,000 more at risk. A federal inspection of the company that made the tainted pain medicine found mold, dust, and dirty sterilization equipment, as well as an air conditioner that was shut off at night, when it ought to have been running nonstop in order to retard the growth of microbes. The fungus contaminated vials of methylprednisolone acetate, an injectable pain medicine.

The last time a disaster of this magnitude occurred in the U.S. was in 1937, when another tainted drug killed over a hundred people. Sulfanilamide was a drug used to treat streptococcal infections, and had been used safely for some time in tablet and powder form. But salesmen for the Massengill Company in Bristol, Tennessee, asked for a liquid form of the drug. A company chemist and pharmacist., Harold Cole Watkins, experimented and found that sulfanilamide would dissolve in diethylene glycol. He added some raspberry flavoring, which gave it a pretty pink color as well as a pleasing sweet taste. They called it Elixir Sulfanilamide.

I asked my friend Amanda to help me understand diethylene glycol (DEG). She has a PhD in chemistry. The upshot is, diethylene glycol is a compound of ethylene glycol, which is used in antifreeze and brake fluid. It’s used in cosmetics, household products, as a solvent for paints and plastics, and as a softening agent for cellophane. It creates the artificial smoke and mist for theatrical productions. And all the glycols and their compounds (eth-, dieth-, polyeth-) are deadly poisons if you ingest them. (On a side note–it’s worth checking the label on your shampoo bottle. I’ve started not buying products that contain this ingredient, whenever possible. It’s even found in some of those “natural” liquid hand soaps.)

At the time, food and drug laws did not require that safety studies be done on new drugs. The company compounded a quantity of the elixir and sent 633 shipments all over the country.

Bodies quickly piled up. Victims suffered symptoms characteristic of kidney failure—severe abdominal cramps, nausea, vomiting, convulsions—and intense pain. Many of the victims were children, who’d been given the medicine for their sore throats.

It didn’t take long to determine that Elixir Sulfanilamide was the cause of the deaths. FDA agents fanned out across the country, trying to retrieve the elixir. In many drugstores, it had been sold without a prescription to people the druggist didn’t know. One physician postponed his wedding to help an FDA agent search for a 3-year-old boy whose family had moved into the mountains after purchasing the medicine.

The incident hastened the enactment in 1938 of the Federal Food, Drug, and Cosmetic Act.

Although the Massengill Company refused to assume responsibility for the incident, Harold Cole Watkins, the company pharmacist who’d concocted the elixir, committed suicide, soon after learning of what he had done.

source: http://www.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/SulfanilamideDisaster/default.htm

image: Elixir Sulfanilamide, from the FDA website (www.fda.gov) via Wikimedia