This past Friday, Frances Oldham Kelsey, a true American hero, passed away at the age of 101. Her death received relatively little notice, with only a few obituaries on NPR and in newspapers. However, she deserved far more public acclamation than many other more famous Americans, having saved potentially thousands of American infants from a horrible fate. For nearly two years, she blocked Food and Drug Administration approval for thalidomide. As most of you are aware, thalidomide lead to severe birth defects in the children of women who take it.
The Thalidomide Incident was tragic enough as it was. Worldwide, 10,000-20,000 children suffered from deformities as a result of their mothers taking the drug. A large percentage of these children died within a few months of birth. In spite of the lack of FDA approval, some American children still suffered because samples of the drug were released to American doctors for "investigational research." Had Frances Kelsey not acted, thousands more children would have been afflicted.
My Gut Reaction: It's disturbing that more Americans can name the Kardashians than Frances Kelsey. Part of the reason may be the lessons her story has to offer us.
The story of Frances Oldham Kelsey is one of the best arguments I know of for strict regulation of new drugs, a grim repost to libertarian claims that the free market will ensure that only safe drugs are released. In a world with free market fanatics out to defang regulatory agencies, the story bears repeating.
Kelsey had learned the importance of close regulation of medicines the hard way, through her involvement of the now obscure Elixir sulfanilamide case in the 1930s. As the medical blogger David Gorski reports at Respectful Insolence, Elixir sulfanilamide consisted of the drug sulfanilamide, then used to treat sore throats, dissolved in the chemical diethylene glycol. Unfortunately, diethylene glycol turned out to be toxic - something a review of the then current medical literature would have revealed - causing kidney failure and painful death, as described below:
Victims of Elixir Sulfanilamide poisoning–many of them children being treated for sore throats–were ill about 7 to 21 days. All exhibited similar symptoms, characteristic of kidney failure: stoppage of urine, severe abdominal pain, nausea, vomiting, stupor, and convulsions. They suffered intense and unrelenting pain. At the time there was no known antidote or treatment for diethylene glycol poisoning.
The mother of one victim sent a letter to FDR describing her family's trauma:
"The first time I ever had occasion to call in a doctor for [Joan] and she was given Elixir of Sulfanilamide. All that is left to us is the caring for her little grave. Even the memory of her is mixed with sorrow for we can see her little body tossing to and fro and hear that little voice screaming with pain and it seems as though it would drive me insane. … It is my plea that you will take steps to prevent such sales of drugs that will take little lives and leave such suffering behind and such a bleak outlook on the future as I have tonight."
You may ask, "Surely the company responsible for all this suffering went out of business. No sane person would buy anything from them after that." However, the head of
S. E. Massengill Company, which had released Elixir sulfanilamide, denied all responsibility, claiming "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 Company remained in business as an independent entity until the 1970s, when it was purchased by Beecham plc.
Kelsey had been part of the research team that discovered the danger posed by Elixir Sulfanilamide, and the memory may well have guided her in the thalidomide case. The William S. Merrell Company, which planned to be the American distributor of thalidomide, put intense pressure on Kelsey to approve the drug, to the point that she reported that "Most of the things they called me, you couldn't print." However, Kelsey demanded more testing, pointing to reports from Europe suggesting that thalidomide could harm developing fetuses.
Kelsey's heroism should be remembered now more than ever. In an age where a company like Merck can tell its salespeople to "Dodge" questions about the safety of a drug like Vioxx, we need aggressive regulators more than ever.