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

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<v Speaker 1>Welcome to Brainstuff, a production of I Heart Radio, Hey

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<v Speaker 1>brain Stuff Lauren Wogelbaum. Here in the United States, the

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<v Speaker 1>Food and Drug Administration or f d A is responsible

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<v Speaker 1>for approving medication for use by the American public, but

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<v Speaker 1>which means that they've reviewed the medications effects and found

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<v Speaker 1>its potential benefits to outweigh its potential risks. The FDA's

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<v Speaker 1>approval of any drug is no small matter. The process

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<v Speaker 1>is rigorous and often lengthy, and that's by design, but

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<v Speaker 1>it wasn't always that way. For the article of this

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<v Speaker 1>episode is based on hows to work. Spoke with Katherine Donovan,

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<v Speaker 1>a senior scientist at the Dana Farber Cancer Institute in Boston, Massachusetts.

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<v Speaker 1>She explained that back in the day, quote, drugs were

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<v Speaker 1>not developed on target. It was more like trial and error.

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<v Speaker 1>So what's changed Today's FDA drug approval standards developed sixty

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<v Speaker 1>years ago were largely the product of a single drug

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<v Speaker 1>and a woman who refused to give it FDA authorization.

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<v Speaker 1>But we're talking about Francis Oldham Kelsey. She was born

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<v Speaker 1>on Vancouver Island, British Columbia, in nineteen fourteen. She had

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<v Speaker 1>developed an interest in science early in life that She

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<v Speaker 1>earned a master's degree from McGill University in Montreal at

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<v Speaker 1>age twenty, and would go on to complete both an

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<v Speaker 1>m d and PhD in pharmacology at the University of Chicago.

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<v Speaker 1>Unlike many women in science at the time, Kelsey faced

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<v Speaker 1>opposition from the overwhelmingly male scientific establishment. She suspected that

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<v Speaker 1>her gender neutral first name helped launch her career. The

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<v Speaker 1>letter of acceptance for her PhD program was even addressed

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<v Speaker 1>to Mr Oldham. She later wrote, I knew that men

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<v Speaker 1>were the preferred commodity in those days. I do not

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<v Speaker 1>know if my name had been Elizabeth or Mary Jane

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<v Speaker 1>whether I would have gotten that first big step up. Nevertheless,

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<v Speaker 1>she eventually joined the University of Chicago as a full

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<v Speaker 1>fledged faculty member in ninety too. It was there that

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<v Speaker 1>she met and married fellow staff member, Dr. Fremont Kelsey.

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<v Speaker 1>In nineteen sixty, the couple moved with their two daughters

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<v Speaker 1>to Washington, d c. Where Francis accepted a position as

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<v Speaker 1>a drug reviewer for the f d A. A little

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<v Speaker 1>did she know she was about to alter the course

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<v Speaker 1>of history. Just as Kelsey was stepping into her new

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<v Speaker 1>role at the f d A, A new drug was

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<v Speaker 1>making the rounds in Europe, Africa, and Asia, known as

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<v Speaker 1>the litamide, the drug was originally developed in the early

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<v Speaker 1>nineteen fifties as a sedative. Donovan explained. Back then, it

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<v Speaker 1>was post war time and things were a little bit crazy,

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<v Speaker 1>so the world was in need of a decent sedative

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<v Speaker 1>to help people sleep. Patients taking the litamide for anxiety

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<v Speaker 1>quickly realized that it also worked wonders on an upset stomach,

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<v Speaker 1>and it soon caught on as a cure for morning sickness.

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<v Speaker 1>A few people reported tingling in their hands and feet

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<v Speaker 1>after prolonged use. However, these negative effects wore off as

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<v Speaker 1>soon as they stopped taking the drug, and so it

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<v Speaker 1>was generally considered safe. By nineteen fifty seven, it was

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<v Speaker 1>approved for over the counter sale in Germany and available

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<v Speaker 1>by prescription in dozens of other countries. The f d

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<v Speaker 1>A application for the linamide crossed Kelsey's desk in September

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<v Speaker 1>of nineteen sixty, just seven months after she began working there.

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<v Speaker 1>At the time, the FDA's approval process for new drugs

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<v Speaker 1>lasted just sixty days, during which the reviewer would wade

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<v Speaker 1>through a hodgepodge of assorted data from the trials done

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<v Speaker 1>with mice and other materials submitted by the applicants. Given

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<v Speaker 1>the littamne's popularity, it seemed destined to sail through with ease,

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<v Speaker 1>but Kelsey had some concerns. An English study which included

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<v Speaker 1>some reports of tingling and similar nerve related symptoms gave

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<v Speaker 1>her pause. She was also wary of the lack of

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<v Speaker 1>data regarding the drugs effect on pregnancy. Without further research,

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<v Speaker 1>she refused to approve the drug. It was a bold move,

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<v Speaker 1>Donovan said, there was a lot of pressure from a

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<v Speaker 1>own the world to approve it. Still, Kelsey stayed firm,

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<v Speaker 1>and one year later her caution was vindicated. Around the

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<v Speaker 1>same time that the litamide was under scrutiny for approval

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<v Speaker 1>in the United States, doctor William McBride of Australia and

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<v Speaker 1>Dr vindekun Lens of Germany both noticed a strange pattern,

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<v Speaker 1>an unusual number of children born with strikingly similar congenital

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<v Speaker 1>limb abnormalities, all within a relatively small geographic area. The

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<v Speaker 1>common denominator they discovered was that their mothers had all

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<v Speaker 1>taken the litamide for morning sickness early in their pregnancies.

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<v Speaker 1>McBride raised the alarm with a bombshell piece published in

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<v Speaker 1>the journal land Set in nineteen sixty one, sending shock

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<v Speaker 1>waves through the medical community. The littamide was pulled from

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<v Speaker 1>shelves in Germany almost immediately. Other countries followed suit shortly thereafter.

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<v Speaker 1>Kelsey's contribution in keeping the litamide largely out of U

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<v Speaker 1>S pharmacies might have gone unnoticed by the public if

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<v Speaker 1>not for a Washington Post article published in nineteen sixty two.

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<v Speaker 1>That same year, President John F. Kennedy awarded Kelsey the

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<v Speaker 1>President's Award for Distinguished Federal Civilian Service and signed the

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<v Speaker 1>key Father Harris Amendments into law. This key bit of

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<v Speaker 1>legislation is the reason that drugs in the US must

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<v Speaker 1>meet strict clinical trial standards in order to be approved

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<v Speaker 1>by the f d A. Kelsey would go on to

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<v Speaker 1>serve the FDA for forty five years, helping hone the

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<v Speaker 1>organization's drug approval process all the while. But curiously, and

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<v Speaker 1>that's not where the story of the litamide ends. In

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<v Speaker 1>the wake of its disastrous legacy, scientists began looking deeper

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<v Speaker 1>into the mechanism of the drug itself to discover why

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<v Speaker 1>it caused such unexpected side effects. Okay, so most drugs

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<v Speaker 1>that bind two nerve receptors in the body will only

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<v Speaker 1>bind to one. Donovan explained that the litamide actually recruits

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<v Speaker 1>other things to bind and that leads to those proteins

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<v Speaker 1>being removed from the body completely. This can be either

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<v Speaker 1>good or very bad to ending on which proteins get removed.

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<v Speaker 1>But by fine tuning the litamides molecular structure, A researchers

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<v Speaker 1>believed it might be possible to target specific bad proteins

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<v Speaker 1>for removal. In two thousand and six, this research revealed

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<v Speaker 1>the drugs potential for treating leprosy and plasma cell my aloma,

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<v Speaker 1>an uncommon type of bone marrow cancer. Since then, two

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<v Speaker 1>different drugs based on the structure of the litamide have

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<v Speaker 1>been approved for cancer treatment by the f d A.

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<v Speaker 1>Today's episode is based on the article Francis Kelsey stopped

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<v Speaker 1>the litamide in its tracks and changed the FDA forever

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<v Speaker 1>on hous to works dot com. Written by Joanna Thompson.

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<v Speaker 1>Brain Stuff is production of iHeart Radio and partnership with

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<v Speaker 1>hous to works dot com, and it's produced by Tyler Clang.

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