Speaker 1: Welcome to Brainstuff, a production of I Heart Radio, Hey
Speaker 1: brain Stuff Lauren Wogelbaum. Here in the United States, the
Speaker 1: Food and Drug Administration or f d A is responsible
Speaker 1: for approving medication for use by the American public, but
Speaker 1: which means that they've reviewed the medications effects and found
Speaker 1: its potential benefits to outweigh its potential risks. The FDA's
Speaker 1: approval of any drug is no small matter. The process
Speaker 1: is rigorous and often lengthy, and that's by design, but
Speaker 1: it wasn't always that way. For the article of this
Speaker 1: episode is based on hows to work. Spoke with Katherine Donovan,
Speaker 1: a senior scientist at the Dana Farber Cancer Institute in Boston, Massachusetts.
Speaker 1: She explained that back in the day, quote, drugs were
Speaker 1: not developed on target. It was more like trial and error.
Speaker 1: So what's changed Today's FDA drug approval standards developed sixty
Speaker 1: years ago were largely the product of a single drug
Speaker 1: and a woman who refused to give it FDA authorization.
Speaker 1: But we're talking about Francis Oldham Kelsey. She was born
Speaker 1: on Vancouver Island, British Columbia, in nineteen fourteen. She had
Speaker 1: developed an interest in science early in life that She
Speaker 1: earned a master's degree from McGill University in Montreal at
Speaker 1: age twenty, and would go on to complete both an
Speaker 1: m d and PhD in pharmacology at the University of Chicago.
Speaker 1: Unlike many women in science at the time, Kelsey faced
Speaker 1: opposition from the overwhelmingly male scientific establishment. She suspected that
Speaker 1: her gender neutral first name helped launch her career. The
Speaker 1: letter of acceptance for her PhD program was even addressed
Speaker 1: to Mr Oldham. She later wrote, I knew that men
Speaker 1: were the preferred commodity in those days. I do not
Speaker 1: know if my name had been Elizabeth or Mary Jane
Speaker 1: whether I would have gotten that first big step up. Nevertheless,
Speaker 1: she eventually joined the University of Chicago as a full
Speaker 1: fledged faculty member in ninety too. It was there that
Speaker 1: she met and married fellow staff member, Dr. Fremont Kelsey.
Speaker 1: In nineteen sixty, the couple moved with their two daughters
Speaker 1: to Washington, d c. Where Francis accepted a position as
Speaker 1: a drug reviewer for the f d A. A little
Speaker 1: did she know she was about to alter the course
Speaker 1: of history. Just as Kelsey was stepping into her new
Speaker 1: role at the f d A, A new drug was
Speaker 1: making the rounds in Europe, Africa, and Asia, known as
Speaker 1: the litamide, the drug was originally developed in the early
Speaker 1: nineteen fifties as a sedative. Donovan explained. Back then, it
Speaker 1: was post war time and things were a little bit crazy,
Speaker 1: so the world was in need of a decent sedative
Speaker 1: to help people sleep. Patients taking the litamide for anxiety
Speaker 1: quickly realized that it also worked wonders on an upset stomach,
Speaker 1: and it soon caught on as a cure for morning sickness.
Speaker 1: A few people reported tingling in their hands and feet
Speaker 1: after prolonged use. However, these negative effects wore off as
Speaker 1: soon as they stopped taking the drug, and so it
Speaker 1: was generally considered safe. By nineteen fifty seven, it was
Speaker 1: approved for over the counter sale in Germany and available
Speaker 1: by prescription in dozens of other countries. The f d
Speaker 1: A application for the linamide crossed Kelsey's desk in September
Speaker 1: of nineteen sixty, just seven months after she began working there.
Speaker 1: At the time, the FDA's approval process for new drugs
Speaker 1: lasted just sixty days, during which the reviewer would wade
Speaker 1: through a hodgepodge of assorted data from the trials done
Speaker 1: with mice and other materials submitted by the applicants. Given
Speaker 1: the littamne's popularity, it seemed destined to sail through with ease,
Speaker 1: but Kelsey had some concerns. An English study which included
Speaker 1: some reports of tingling and similar nerve related symptoms gave
Speaker 1: her pause. She was also wary of the lack of
Speaker 1: data regarding the drugs effect on pregnancy. Without further research,
Speaker 1: she refused to approve the drug. It was a bold move,
Speaker 1: Donovan said, there was a lot of pressure from a
Speaker 1: own the world to approve it. Still, Kelsey stayed firm,
Speaker 1: and one year later her caution was vindicated. Around the
Speaker 1: same time that the litamide was under scrutiny for approval
Speaker 1: in the United States, doctor William McBride of Australia and
Speaker 1: Dr vindekun Lens of Germany both noticed a strange pattern,
Speaker 1: an unusual number of children born with strikingly similar congenital
Speaker 1: limb abnormalities, all within a relatively small geographic area. The
Speaker 1: common denominator they discovered was that their mothers had all
Speaker 1: taken the litamide for morning sickness early in their pregnancies.
Speaker 1: McBride raised the alarm with a bombshell piece published in
Speaker 1: the journal land Set in nineteen sixty one, sending shock
Speaker 1: waves through the medical community. The littamide was pulled from
Speaker 1: shelves in Germany almost immediately. Other countries followed suit shortly thereafter.
Speaker 1: Kelsey's contribution in keeping the litamide largely out of U
Speaker 1: S pharmacies might have gone unnoticed by the public if
Speaker 1: not for a Washington Post article published in nineteen sixty two.
Speaker 1: That same year, President John F. Kennedy awarded Kelsey the
Speaker 1: President's Award for Distinguished Federal Civilian Service and signed the
Speaker 1: key Father Harris Amendments into law. This key bit of
Speaker 1: legislation is the reason that drugs in the US must
Speaker 1: meet strict clinical trial standards in order to be approved
Speaker 1: by the f d A. Kelsey would go on to
Speaker 1: serve the FDA for forty five years, helping hone the
Speaker 1: organization's drug approval process all the while. But curiously, and
Speaker 1: that's not where the story of the litamide ends. In
Speaker 1: the wake of its disastrous legacy, scientists began looking deeper
Speaker 1: into the mechanism of the drug itself to discover why
Speaker 1: it caused such unexpected side effects. Okay, so most drugs
Speaker 1: that bind two nerve receptors in the body will only
Speaker 1: bind to one. Donovan explained that the litamide actually recruits
Speaker 1: other things to bind and that leads to those proteins
Speaker 1: being removed from the body completely. This can be either
Speaker 1: good or very bad to ending on which proteins get removed.
Speaker 1: But by fine tuning the litamides molecular structure, A researchers
Speaker 1: believed it might be possible to target specific bad proteins
Speaker 1: for removal. In two thousand and six, this research revealed
Speaker 1: the drugs potential for treating leprosy and plasma cell my aloma,
Speaker 1: an uncommon type of bone marrow cancer. Since then, two
Speaker 1: different drugs based on the structure of the litamide have
Speaker 1: been approved for cancer treatment by the f d A.
Speaker 1: Today's episode is based on the article Francis Kelsey stopped
Speaker 1: the litamide in its tracks and changed the FDA forever
Speaker 1: on hous to works dot com. Written by Joanna Thompson.
Speaker 1: Brain Stuff is production of iHeart Radio and partnership with
Speaker 1: hous to works dot com, and it's produced by Tyler Clang.
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