How many Frances Kelseys were let go from the federal government last week? Probationary workers were fired en masse, in a sham lunge at savings — really an enormous transfer of expenditure from organizations benefiting regular Americans to more tax savings for the rich.
Was there one future Dr. Kelsey? A hundred? We’ll never know. One would be too many.
What? The name Frances Kelsey doesn’t ring a bell? Of course not. People forget. Even though she was a hero — a local hero, too, University of Chicago Medical School, class of 1950, where she studied pharmacology.
Dr. Kelsey was a fresh hire at the Food and Drug Administration in September 1960 when a stack of three-ring binders, each the size of a phone book, landed on her desk, busywork for the new girl who joined the agency the previous month.
It was an application from Richardson-Merrell, an Ohio pharmaceutical company, for a drug it wanted to sell called Kevadon — a sedative introduced in Germany in 1957, and sold all over Europe. Approval was expected to be routine. The FDA had just 60 days to register an objection. Otherwise, Richardson-Merrell could go ahead and sell the drug in the United States.
The company already was giving samples of Kevadon, a brand name for thalidomide, to U.S. doctors; eventually 1,200 doctors would start handing out free pills to 20,000 American patients, often to pregnant women, where it controlled the nausea of morning sickness. Without telling women the pills were unapproved. A field test conducted on the unaware, all completely legal.
But the application bothered Dr. Kelsey who, though new to the FDA, had years of experience in her field.
“There was something a little different about this one,” she later remembered thinking. Before the 60-day limit ran out, Kelsey wrote to Richardson-Merrell saying its studies were “incomplete,” despite their bulk. She questioned the company’s methodology.
Richardson-Merrell cried foul. Executives hurried to Washington to complain about the “stubborn bureaucrat.” They sent letters to her superiors, made phone calls, placed editorials in medical publications denouncing “dilatory tactics which certainly cause a loss to the industry of millions of dollars … and even loss of life.” Kelsey was being “unreasonable and irresponsible.”
Language echoing in my ears when Elon Musk called for a “wholesale removal of regulations.” And regulators — thousands of workers at the Department of Health and Human Services, which includes the FDA, were summarily fired over the weekend.
“Regulations = Bad” has been the mantra of the Republican Party for years. But it was applied with an unprecedented frenzy over the past three weeks by the world’s richest man, given free rein over the government by President Donald Trump. Fortunes are not built by providing the safest product assembled by well-paid workers under humane conditions. They are built by mixing sawdust into the bread, by putting 10-year-olds to work in Southern textile mills. And by selling drugs that haven’t been tested on pregnant women.
All common practices until the government put an end to them. With regulations. Musk said that whatever dropped regulations are later found to have been necessary, after all, can be reinstated. In the same way that 10,000 deformed European babies — thalidomide babies had shortened arms, or mere “flippers” on their shoulders — added heft to Kelsey’s argument. A strategy acceptable only if they aren’t your baby or you, or you just don’t care.
Are some regulations over the top? Sure. Anyone who has tried to remodel a bathroom and gone to the town hall for a permit knows that. But ditching regulations wholesale because of excesses is throwing the baby out with the bathwater. Sometimes literally.
We used to be better than this. In the United States, only 17 children were deformed by thalidomide. President John F. Kennedy gave Frances Kelsey the Presidential Medal of Freedom. Trump would have summarily fired her.
I was born in the summer of 1960, so I might have been a thalidomide baby. My mother wasn’t given thalidomide by her doctor. Dumb luck protected me. But “We Rely on Dumb Luck” is not a mantra embraced by a great nation, the past three weeks notwithstanding. We don’t know what the next thalidomide will be, or how many disasters bothersome bureaucrats and annoying regulations saved us from. Or what harms will come from having our government ripped apart.
We’re going to find out in the years to come, to our sorrow, as we tear down the wall that protects regular Americans from the tender mercies of big business. The harm is certain to be enormous.
It’s funny. Some of the people shaking their fists at government regulation have fists to shake only because of government meddlers like Frances Kelsey.