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Thalidomide 
and a brilliant woman physician-scientist who saved countless children from life altering birth defects 
, Thread 
and a brilliant woman physician-scientist who saved countless children from life altering birth defects , Thread
As physicians, we are all trained to be careful about prescribing drugs to pregnant women. It is now known that certain drugs can cross the placental barrier and are harmful in pregnancy, causing termination or birth defects. They are now called “Teratogenic drugs”.
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However, this knowledge of teratogens has come at a price of thousands of malformed foetuses and life altering birth defects.
One such drug is Thalidomide.
It was developed in the 1950’s West German pharmaceutical company Chemie Grünenthal GmbH.
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One such drug is Thalidomide.
It was developed in the 1950’s West German pharmaceutical company Chemie Grünenthal GmbH.
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Though Thalidomide was originally intended to be used as a sedative or tranquiliser, it was soon used for treating a wide range of conditions, including colds, flu, nausea and most importantly, morning sickness in pregnant women.
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In the 1950s, scientists didn’t know that the effects of a drug could be passed through the placental barrier and harm a foetus, so the use of medications during pregnancy was not strictly controlled. And in the case of thalidomide, no tests were done involving pregnant women.
Around the world, more and more pharmaceutical companies started to produce and market the drug under license from Chemie Grünenthal.
By the mid-1950s, 14 pharmaceutical companies were marketing thalidomide in 46 countries under at least 37 different trade names.
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By the mid-1950s, 14 pharmaceutical companies were marketing thalidomide in 46 countries under at least 37 different trade names.
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However, despite growing use of Thalidomide worldwide, one country that did not approve thalidomide for marketing and distribution was the USA, where it was rejected by the FDA.
But why?
*Enter Dr. Frances Oldham Kelsey*
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But why?
*Enter Dr. Frances Oldham Kelsey*
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In 1960, Dr Frances Oldham Kelsey was hired by the FDA in Washington, D.C. At that time, she "was 1 of only 7 full-time and four young part-time physicians reviewing drugs" for the FDA.
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One of her first assignments at the FDA was to review an application by Richardson-Merrell for the drug thalidomide.
The task was supposed to be a straightforward review of the sleeping pill already widely used in Europe as a cure for morning sickness in pregnant women.
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The task was supposed to be a straightforward review of the sleeping pill already widely used in Europe as a cure for morning sickness in pregnant women.
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But she withheld approval for the drug and requested further studies. “It was just too positive; this couldn’t be the perfect drug with no risk,” she said. Kelsey noted the reliance on anecdotal testimony in place of clinical data.
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Kelsey’s concerns escalated when in February 1961 she saw a letter from a physician in the British Medical Journal reporting cases of peripheral neuritis — nerve damage in the hands and feet — among patients he’d treated with thalidomide.
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Despite pressure from thalidomide's manufacturer, she persisted in requesting additional data explaining the findings of the English study documenting peripheral neuritis. She also requested data showing the drug was not harmful to the fetus.
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Four times Kelsey had invoked the regulatory lever available to her to reject Merrell’s application on the grounds of insufficient data. Now on the company’s fifth attempt to secure approval, Merrell notified Kelsey it was rescinding its application.
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Kelsey's insistence that the drug should be fully tested prior to approval was vindicated when the births of deformed infants in Europe were linked to thalidomide ingestion by their mothers during pregnancy.
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Researchers discovered that the thalidomide crossed the placental barrier and caused serious birth defects.
She was hailed on the front page of The Washington Post as a heroine for averting a similar tragedy in the U.S.
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She was hailed on the front page of The Washington Post as a heroine for averting a similar tragedy in the U.S.
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On August 7, 1962, President John F. Kennedy awarded Frances Kelsey the highest honor given to a civilian in the United States, the President's Award for Distinguished Federal Civilian Service. She was the second woman to ever receive the award.
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Dr. Kelsey helped shape and enforce amendments to FDA drug regulation laws to institutionalise protection of the patient in drug investigations.
As a result, changes were made to the way drugs were marketed, tested and approved, both in the USA and worldwide.
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As a result, changes were made to the way drugs were marketed, tested and approved, both in the USA and worldwide.
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The new regulations required that drugs be shown to be both safe and effective, that informed consent be obtained from patients when used in clinical trials, and that adverse reactions be reported to the FDA.
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Thus, this was the story of a woman who stood between America and a generation of Thalidomide babies.
Thank you for reading till the end.
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Thank you for reading till the end.
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