Never forget: https://t.co/yvOrPTQK1U
— Ivor Cummins (@FatEmperor) June 4, 2022
For those without a Twitter account,
A little background on Dr. Frances Oldham Kelsey, the doctor at the FDA who withheld approval of Thalidomide in the United States as a drug for morning sickness for pregnant women. Ghastly.
In 1960, Kelsey was hired by the FDA in Washington, D.C. At that time, she "was one of only seven full-time and four young part-time physicians reviewing drugs"[4] for the FDA. One of her first assignments at the FDA was to review an application by Richardson-Merrell for the drug thalidomide (under the tradename Kevadon) as a tranquilizer and painkiller with specific indications to prescribe the drug to pregnant women for morning sickness. Even though it had already been approved in Canada and more than 20 European and African countries,[8] she withheld approval for the drug and requested further studies.[3] Despite pressure from thalidomide's manufacturer Grünenthal, Kelsey persisted in requesting additional information to explain an English study that documented peripheral neuritis,[9] a nervous system side effect.[4] She also requested data showing the drug was not harmful to the fetus.[9]
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.[10][11] Researchers discovered that the thalidomide crossed the placental barrier and caused serious birth defects.[7] She was hailed on the front page of The Washington Post as a heroine[12] for averting a similar tragedy in the U.S.[13] Morton Mintz, author of The Washington Post article, said "[Kelsey] prevented… the birth of hundreds or indeed thousands of armless and legless children."[12] Kelsey insisted that her assistants, Oyama Jiro and Lee Geismar, as well as her FDA superiors who backed her strong stance, deserved credit as well. The narrative of Kelsey's persistence was used to help pass rigorous drug approval regulations in 1962.[1]
After Morton Mintz broke the story in July 1962, there was a substantial public outcry. The Kefauver Harris Amendment was passed unanimously by Congress in October 1962 to strengthen drug regulation.[10][11] Companies were required to demonstrate the efficacy of new drugs, report adverse reactions to the FDA, and request consent from patients participating in clinical studies.[14] The drug testing reforms required "stricter limits on the testing and distribution of new drugs"[7] to avoid similar problems. The amendments, for the first time, also recognized that "effectiveness [should be] required to be established prior to marketing."[10][11
Oh, God. Thalidomide and its derivatives have become the primary treatment in the blood cancer, multiple myeloma. What could possibly go wrong? I mean really, isn't taking prescribe pharmaceuticals like playing Russian Roulette? At least when you experiment with nutritional supplements, your chances of avoiding harm, including death, are much, much higher.
