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Dr. Frances Kelsey, Who Saved American Babies From Thalidomide, Dies At 101
circletimessquare writes: Plenty of regulations are bad (some because big business corrupts them) but the simple truth is modern society cannot function without effective government regulation. It keeps are food safe, our rivers clean, and our economy healthy. Passing away at age 101 Friday was a woman who personified this lesson. In 1960 the F.D.A. tasked Dr. Frances Kelsey with evaluating a drug used in Europe for treating morning sickness. She noticed something troubling, and asked the manufacturer William S. Merrell Co. for more data. "Thus began a fateful test of wills. Merrell responded. Dr. Kelsey wanted more. Merrell complained to Dr. Kelsey's bosses, calling her a petty bureaucrat. She persisted. On it went. But by late 1961, the terrible evidence was pouring in. The drug — better known by its generic name, thalidomide — was causing thousands of babies in Europe, Britain, Canada and the Middle East to be born with flipperlike arms and legs and other defects." Without Dr. Kelsey's scientific and regulatory persistence in the face of mindless greed, thousands of Americans would have suffered a horrible fate.
Corporations can regulate themselves! We can totally trust them not to put greed ahead of public safety! Really, they've learned their lessons and besides, we have all the regulation the market needs with civil lawsuits! Just let us reform a few tort laws and cut a few useless regulations holding back all the awesome good things we want to bring to people and we'll all be living in a utopia!
Herald the guy
Dr. Frances Kelsey was a woman.
Herald the guy who saved babies from being killed as a hero, while simultaneously saying its no big deal that planned parenthood is trafficking baby parts after they rip them out of its mother's womb.
You're a fucking moron, and so is anyone else stupid enough to believe that hoax.
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And no, I can't say that any nicer. Anyone who believes planned parenthood is selling baby parts or that they're "ripping them out" is a fucking idiot who needs to have their brain taken away by social services.
In case you wonder what the fuss is about, you might know that drug by the name it had over here: Contergan.
We used to have a Bill of Rights. Now, with the rights gone, all we have left is the bill.
This is why bureaucracy is so dangerous. You are declared a hero if you stop something bad and are declared a failure if you let something bad happen. But if something is beneficial it doesn't matter if you let it go to market or not. The millions that suffer and die because of delays to get products to market are invisible. No stories are written about them and you are never blamed.
With those incentives it's easy to see why the bureaucrat must delay things as long as possible.
Take the OP quote of how the government ensures a healthy economy. We all know that's a complete joke. After 2008 what was needed was for the poorly run companies to go bankrupt and be bought by the well run companies. But that is risky from a bureaucratuv position. The status quo is preferable. So instead you take money from the well run companies and you give it to the poorly run ones as a bailout and everything is fixed right? Well right up until the house of cards falls again.
I love Jesus, except for his foreign policy.
Not exactly the actual story... here's the real deal:
http://blog.seattlepi.com/stev...
SKF declined to market the drug in the U.S..
Grunenthal signed a distribution agreement with the William S. Merrell Company.
Merrell started human trials in the U.S. in Feb 1959, and expanded it to include pregnant women in May 1959.
Merrell submitted an NDA (New Drug Application) in Sep 1960 under the drug name Kevadon.
Merell began the "Kevadon Hospital Program" and ramped up distribution.
Mostly Dr. Kelsey demanded testing on pregnant animals; while that was happening, news broke on the effects in July 1961.
The NDA was withdrawn on March 8, 1962.
All in all, 2.5M doses were distributed to 20,000 patients in the U.S.. The FDA did not have the teeth to prevent this, and Dr. Kelsey merely prevented approval, not distribution.
There were actually a lot of victims of the drug in the U.S., and the FDA didn't (couldn't) prevent it.
Chirality of Enantiomers is usually not, but may be important in the consideration of new drugs. And if chirality is an issue, then a benign molecule may be broken apart by the liver and (possibly) recombined back into the same substance, but in a wrong, harmful way. We now "know" this. We did not know this then.
TA portrays Thalidomide as a simple case of 'superior' FDA gate-keeping in the United States that prevented a harmful drug from reaching the market, a drug company dismissing (with hubris implied) what turned out to be serious danger. And this is true --- Dr. Kelsey was basing her judgement on a just a few reports of adverse effects, a numbing condition in arms and legs which indicated nerve damage. And Kelsey's projection that what ever caused this symptom might also impair development of the fetus was prescient and brilliant. It's a win.
As to why the medical community maintained the myth that drugs would not pass through the placental barrier when alcohol clearly did, that's a clearly a what-the-fuck.
To be fair however, there was an aspect to Thalidomide that confounded everyone at the time, and may even have confounded Dr. Kelsey herself had she been a chemist at the pharmaceutical company she fought. Trials on humans had indicated Thalidomide to be effective and safe, and the manufactured batches distributed in Europe were chemically indistinguishable from those that had yielded early successful trials.
To dispense with the jargon of chemistry in favor of the delightful aphorism of Richard Feynman, "Nature is screwy," so-called organic molecules can have left and right handed "threads". He introduces handed-ness or chirality, in his his lecture on symmetry in physical laws as he describes a simple experiment where sugar is dissolved in water... (astoundingly, almost precisely!) only abut half of it is taken in by bacteria. And yet, though the bacteria cannot digest the remaining "wrong-handed sugar", chemical tests of composition would reveal that it is the same. And the half that remains is clearly different somehow, and that difference can be seen when light is passed through it with a polarizing filter. This optical property of chemistry was observed by Louis Pasteur in 1812, but not until the tragedy of Thalidomide did we realize that chirality matters.
As described in this nice succinct PDF, (+)(R)-thalidomide was safe by itself, the enantiomer responsible for the beneficial sedative effect, but (-)(S)-thalidomide inhibits new blood vessel growth. Perhaps early batches used for testing had disproportionate amounts of (R) --- or something else happened. Perhaps I'll be down-modded if I suggest any reason that does not distill down to greed and malfeasance. But what is certain is that the tragedy brought chirality out of the realm of scientific curiosity to become a crucial part of drug development.
For a time it was thought that a more refined manufacturing process which created (R) to the exclusion of (S) may have rendered Thalidomide "safe". And it would have, except that normal liver function involves breakdown and recombination of such molecules in equal amounts. Just like that dissolved left-handed and right-handed sugar.
Today the chirality of new drugs is carefully considered and (R) and (S) enantiomers are tested separately. While Dr. Kelsey made a good judgement call, at the time she could not know precisely why it was a good call.
The actual mechanism by which (-)(S)-thalidomide impairs the fetus has only recently been discovered.
<blink>down the rabbit hole</blink>