How Did One Woman Change the FDA's Drug Approval Process?

it wasn't always that way. For the article of this episode is based on hows to work. Spoke with Katherine Donovan, a senior scientist at the Dana Farber Cancer Institute in Boston, Massachusetts. She explained that back in the day, quote, drugs were not developed on target. It was more like trial and error. So what's changed Today's FDA drug approval standards developed sixty years ago were largely the product of a single drug and a woman who refused to give it FDA authorization.

But we're talking about Francis Oldham Kelsey. She was born on Vancouver Island, British Columbia, in nineteen fourteen. She had developed an interest in science early in life that She earned a master's degree from McGill University in Montreal at age twenty, and would go on to complete both an m d and PhD in pharmacology at the University of Chicago. Unlike many women in science at the time, Kelsey faced opposition from the overwhelmingly male scientific establishment. She suspected that

her gender neutral first name helped launch her career. The letter of acceptance for her PhD program was even addressed to Mr Oldham. She later wrote, I knew that men were the preferred commodity in those days. I do not know if my name had been Elizabeth or Mary Jane whether I would have gotten that first big step up. Nevertheless, she eventually joined the University of Chicago as a full

fledged faculty member in ninety too. It was there that she met and married fellow staff member, Dr. Fremont Kelsey. In nineteen sixty, the couple moved with their two daughters to Washington, d c. Where Francis accepted a position as a drug reviewer for the f d A. A little did she know she was about to alter the course

of history. Just as Kelsey was stepping into her new role at the f d A, A new drug was making the rounds in Europe, Africa, and Asia, known as the litamide, the drug was originally developed in the early nineteen fifties as a sedative. Donovan explained. Back then, it was post war time and things were a little bit crazy, so the world was in need of a decent sedative

to help people sleep. Patients taking the litamide for anxiety quickly realized that it also worked wonders on an upset stomach, and it soon caught on as a cure for morning sickness. A few people reported tingling in their hands and feet after prolonged use. However, these negative effects wore off as soon as they stopped taking the drug, and so it was generally considered safe. By nineteen fifty seven, it was approved for over the counter sale in Germany and available

by prescription in dozens of other countries. The f d A application for the linamide crossed Kelsey's desk in September of nineteen sixty, just seven months after she began working there. At the time, the FDA's approval process for new drugs lasted just sixty days, during which the reviewer would wade through a hodgepodge of assorted data from the trials done with mice and other materials submitted by the applicants. Given the littamne's popularity, it seemed destined to sail through with ease,

but Kelsey had some concerns. An English study which included some reports of tingling and similar nerve related symptoms gave her pause. She was also wary of the lack of data regarding the drugs effect on pregnancy. Without further research, she refused to approve the drug. It was a bold move, Donovan said, there was a lot of pressure from a own the world to approve it. Still, Kelsey stayed firm,

and one year later her caution was vindicated. Around the same time that the litamide was under scrutiny for approval in the United States, doctor William McBride of Australia and Dr vindekun Lens of Germany both noticed a strange pattern, an unusual number of children born with strikingly similar congenital

limb abnormalities, all within a relatively small geographic area. The common denominator they discovered was that their mothers had all taken the litamide for morning sickness early in their pregnancies. McBride raised the alarm with a bombshell piece published in the journal land Set in nineteen sixty one, sending shock waves through the medical community. The littamide was pulled from shelves in Germany almost immediately. Other countries followed suit shortly thereafter.

Kelsey's contribution in keeping the litamide largely out of U S pharmacies might have gone unnoticed by the public if not for a Washington Post article published in nineteen sixty two. That same year, President John F. Kennedy awarded Kelsey the President's Award for Distinguished Federal Civilian Service and signed the

key Father Harris Amendments into law. This key bit of legislation is the reason that drugs in the US must meet strict clinical trial standards in order to be approved by the f d A. Kelsey would go on to serve the FDA for forty five years, helping hone the organization's drug approval process all the while. But curiously, and that's not where the story of the litamide ends. In the wake of its disastrous legacy, scientists began looking deeper into the mechanism of the drug itself to discover why

it caused such unexpected side effects. Okay, so most drugs that bind two nerve receptors in the body will only bind to one. Donovan explained that the litamide actually recruits other things to bind and that leads to those proteins being removed from the body completely. This can be either good or very bad to ending on which proteins get removed. But by fine tuning the litamides molecular structure, A researchers believed it might be possible to target specific bad proteins

for removal. In two thousand and six, this research revealed the drugs potential for treating leprosy and plasma cell my aloma, an uncommon type of bone marrow cancer. Since then, two different drugs based on the structure of the litamide have been approved for cancer treatment by the f d A. Today's episode is based on the article Francis Kelsey stopped the litamide in its tracks and changed the FDA forever on hous to works dot com. Written by Joanna Thompson.

Brain Stuff is production of iHeart Radio and partnership with hous to works dot com, and it's produced by Tyler Clang. Four more podcasts my heart Radio. Visit the iHeart Radio app, Apple podcasts, or wherever you listen to your favorite shows.