"The hallmark, defining quality of Thalidomide was its safety"

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.  

Dr. Mary Ruwart on the FDA, Libertarian Party, Licensing, and More . . .

Show comments start here.  Date on this show is two years old, April 20, 2014.

"When you use morally acceptable means, you get good results.  When you use aggression as your means to an end, you get aggressive [possibly violent] results."  Whether it's banking, small business, pollution, or foreign policy, case after case you get aggression if you use aggression.  Aggression boomerangs on the perpetrator. 

One of her favorites is the FDA.  These regulations 1962, in the wake of the Thalidomide tragedy, have left people to die waiting for life-saving drugs.  AIDS community tested and used black market drugs.  By the time the FDA gave its approval to test on humans, every AIDS patient in the country who wanted her drugs said they'd already had them and had developed resistance to them.  Wow!!  So she had to wait for new diagnoses before she could actually do the tests.  Incredible.  FDA is tragically behind the curve.  Regulations that take choice away from the consumer actually harm the consumer.  F"DA is going to keep some effective drugs off the market, but it does its job to keep people safe, so maybe it's just a wash" asks Dr. Woods in the hypothetical.  Her answer?  "Well, actually, it's not a wash.

FDA regulation because we want to be protected from poisonous drugs, particularly from 1962 with the thalidomide tragedy, takes 5 to 15 years to get life-saving drugs to the market.  By the time AIDS drugs were marketed, they had to change the drug because people became . . . .

FDA drug policy is not a wash.  Problems with drugs are due to the fact that we don't have enough science to test them.  We're so different genetically.  With the foods we eat.  A small group reacts poorly to some drugs--even penicillin--can kill people because drugs have side effects.  Adding 10 years to development time increases the costs and time so much, that life-saving drugs aren't developed.  People can die from allergic reactions.  Development time does not give us protection at all.  New life-saving drugs aren't developed because it's too difficult to please the FDA.  She has a patent for liver disease.  But if you've got a patent or a drug to cure, she doesn't know how much to give.  By the time you get the drug to market, your patent has run out, it goes generic, and you can't recover your costs.  Long timeline increases costs so much that companies aren't willing to take a chance to design a cure. 

"What about licensing?" Tom asks.  Certification.  It gives people greater choice.  With licensing comes monopoly.  With certification you've got more choices.  Still can have bad players in the market, but certification at least gives you the opportunity to go elsewhere.  Whereas licensing only allows you to go to someone else within the same licensed system.  You get certification from certain professional groups where you have to meet certain requirements.  Beauty is that you always have a choice as a consumer.  Certification does signal testing.   Example: