FDA hero reminds us of the need for government meddling

     One evil is so clear to Republicans that it didn't need to be discussed at all during their presidential debate in Cleveland last week: government regulation.
     The 10 candidates jostled to condemn government meddling.
     "We cut regulation by one-third of what my predecessor put in place," bragged New Jersey Gov. Chris Christie.
     "You get in and change every aspect of regulations that are job killers," said Jeb Bush.
     "We need to have a regulatory budget in America that limits the amount of regulations on our economy," said Marco Rubio.
    By an odd coincidence, one of the better known of those demonized regulators, Dr. Frances Kelsey, died the next day, at age 101.

Frances Kelsey at the FDA

     In 1960, Kelsey, University of Chicago Medical School class of 1950, was a new hire at the Food and Drug Administration in Washington, D.C. One day in September a trio of three ring binders, each the size of a phone book, landed on her desk.
     It was an application from William S. Merrell, an Ohio drug company, that wanted to sell a drug it called Kevadon in the United States. Kevadon was a sedative, effective against nausea in pregnant women. Approval was expected to be routine: the drug was already being sold under various names all over the world.
     But as she read the Merrell application, Kelsey had qualms. "There was something a little different about this one," she later remembered thinking.
     According to law, the FDA had just 60 days to register an objection. Otherwise, Merrell could go ahead and sell the drug in the United States—it was already giving samples to U.S. doctors; eventually 1200 doctors would get them, and starting handing out free pills without telling patients they were unapproved, a field test by the unaware, all completely legal.
     But before the 6o day limit ran out, Kelsey wrote to Merrell saying despite their findings' bulk, they were "incomplete." She had questions about methodology.
     Merrell howled. Executives came to Washington in droves 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 any Republican presidential candidate knows by heart.
     While Kelsey was engaged in what Scott Walker would call "out-of-control regulation," a letter was published in the February, 1961 issue of the British Medical Journal noting reports of "a possible toxic hazard" with the drug. After the letter, Merrell wondered if they could perhaps sell their drug with a warning label. As 1961 dragged on, the company expressed concerns it would "miss the Christmas market."
     But by Christmas the struggle was over. In West Germany, where the sedative had gone on sale in 1957, a report linked an epidemic of malformed children to the drug, which was sold under 50 brand names, but generically known as thalidomide. Tens of thousands of children around the world were born with severely malformed limbs resembling flippers, or no limbs at all.

Dr. Kelsey received the President's Award for
Distinguished Federal Service from JFK.

     But not in the United States, except for a few whose mothers got those free samples. President Kennedy gave Kelsey a medal. Laws were tightened. She worked for the FDA for nearly 45 years. Long enough for the thalidomide story to fade from the public mind.
     I don't want to let one dramatic story goad me into extremism. The flip side of the "Frances Kesley ethic" is that valuable drugs are sometimes needlessly delayed. There can be too much government interference in business, as the advent of Uber demonstrates. Certain trades—hair braiding—are licensed that shouldn't be licensed at all.
     That's called "nuance." It might not play well in a sound bite, but in real life there is a balance, or should be, between caution and expediency. We need the government to rein in business because otherwise it'll sell thalidomide and put 12-year-olds to work in thread factories. We know they will because they've done it before. Government regulators make mistakes, but they also do enormous good, and don't deserve the sneering, blanket contempt Republican candidates heap upon it. Nor does the public.
     Among those watching the GOP presidential debate were countless 54-year-old businessmen and Tea Party grandmothers, jaws clenched in righteous anger at the foolishness of government meddling, who owe the presence of their arms and legs, hands and feet, to one stubborn FDA bureaucrat, Frances Kelsey, who understood the need for government regulation. These lucky men and women have no idea of the truth underlying their entire lives. There's a lot of that going around.