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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.
I don't know. Are food safe?
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.
http://littlegreenfootballs.co...
http://littlegreenfootballs.co...
http://littlegreenfootballs.co...
http://littlegreenfootballs.co...
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.
You're a fucking moron, and so is anyone else stupid enough to believe that hoax.
+1 Informative, +1 Swearing. Well done, sir.
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.
here: https://www.youtube.com/watch?...
Anyone who uses littlegreenfootballs for anything but mocking or even as a credible source, should be applying the moron label to themselves. Especially after the mass purging for thought-crimes.
Om, nomnomnom...
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.
Anyone who uses littlegreenfootballs for anything but mocking or even as a credible source, should be applying the moron label to themselves. Especially after the mass purging for thought-crimes.
You mean when he threw out all the white supremacists like Pamela Geller?
That's not purging. That's quality control.
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>
The authorities in at least 2 US states (Indiana, Massachusetts) beg to differ.
They concluded that Planned Parenthood is not engaged in *any* such transfer of bodies or even bits of them, not even through donations.
Let's see your videos that you're so confident in that you couldn't be bothered to link to them, shall we?
Be sure to let us know who's prepared to go on the record as to their authenticity and provenance, too.
We want to know!
Il n'y a pas de Planet B.
Dr. Frances Kelsey was also Canadian. Just an FYI.
Goodbye Slashdot. You've changed.
Now it's just a few hundred thousand a year dying of heart disease in America, while a drug that prevents arterial blockage with a 100% effectiveness rate while costing almost nothing exists in Europe and elsewhere. Regulatory capture by heart doctors is killing far, far more people than non-market based regulation ever saved.
Side effects include nausea, sleep disturbance, constipation, flatulence, vomiting, severe diarrhea, rectal bleeding, runny nose, dizziness, decrease in semen, dry mouth, insomnia, coma or death, and trouble swallowing.
It actually would have. Lawsuits would have quickly ended the operations of the offending company, and gone further, severely punishing its shareholders, who would not have been protected by the corporate veil. In fact, with that huge pool of money and lawyers salivating over huge settlements, companies would have quickly instituted their own testing procedures, which would ensure safety enough to actually be safe while still getting their drugs out into the market to help people.
Also, seeing as the company in question actually did safety testing, but inexplicably buried the results, they would also be liable criminally. But for some reason (campaign contributions), rich people tend to avoid criminal prosecution in this country--at least that was definitely the case back in the 60's.
https://en.wikipedia.org/wiki/...
Seems I misremembered a lot about it, including mechanism of action and exaggeration of its effects, but it does have a huge impact on heart failure rates (reduces risk of death from heart failure by 26%). I also see that it has finally been approved in the US as of April. Only took ten years longer than Europe.
Yes, be melodramatic. Thalidomide killed about 40% - 50% of affected children.
https://en.wikipedia.org/wiki/Thalidomide
Wow, you really believe that?
You think it is a "hoax" that actual Planned Parenthood officials said what they said, on tape? Really?
Were they actors? Were their words dubbed? Were those fake baby parts? What part exactly was a "hoax"?
I guess your brain just can't face the truth. It's amazing the contortions you will go through though.
Removing hydrogenated Oil from our food supplies and increasing the Omega 3 in our actual food would have more effect and not have any bad side effects. The problem is your food is poisoned and the average wage has dropped so low they needed to cheapen the foods you find with more poison so the producers can get enough margin to stay in business.
Raise the median(not average) wage in America to middle class standards and watch the effects.
Aspartame and Rumsfeld should probably also go on trial at some point, but I doubt the Reaganites(Bush Senior's personal alzheimer ridden boss) will let that happen.
Either way the food is tainted, that is the core issue currently. You wont find many doctor's like the ones of old, because they are killed or bought off before they can have any effect.
No economy, not even primitive bartering economies, can exist without law. Specifically property law.
BTW: Russia/USSR has never been a "socialist state" in any meaningful sense of the term. Yes it labeled itself "socialist", in much the same way as the present day "Democratic republic of Congo" labels itself "democratic".
And did you exchange a walk on part in the war for a lead role in a cage? - Pink Floyd.
We have a rather distorted view of opiates these days.
No kidding. As I understand it, from some reports I've noticed. (I am not a doctor...)
Pressure from the Federal authorities (including such things as examining how often and in what dosages particular doctors prescribe opiates and other controlled substances - massively dinging those whose practice involves treating people with severe chronic pain) has resulted (over several decades) in substantial undermedicaton for pain.
Recent research appears to show that adequate doses of opiate painkillers in the several days following a severe trauma (such as battlefield injures) tends to prevent development of post traumatic stress disorder (PTSD).
So perhaps the massive rise in diagnosed PTSD among veterans of modern warfare (and other misadventures, such as being the victim of a criminal assault or rape) is at least partly the result of this undermedication.
Bantam Dominique roosters crow a four-note song. Once you've heard it as "Happy BIRTHday" you can't NOT hear it that way
Link to Wikipedia article on Ivabradine]
What's particularly annoying is that they did it TWICE!
Beta blockers do the same thing: Cut the death rate due to secondary, follow-on, heart attacks by about a quarter - which, given that heart attacks are one of the few remaining common ways to die, is a LOT of unnecessary deaths. Ivabradine does the same thing for some people for whom beta blockers don't work.
A few decades back beta blockers had been approved in Europe for post-heart-attack preventative treatment. But the FDA held up approval of this ("off-label") use in the US for years. (If I recall correctly, it was because they wouldn't accept the results of the European research and required it to be re-run under US rules. You can see the conceptual similarity to the Thalidomide situation.) Not much incentive to spend the millions, since beta blockers were already approved for other things so the funder wouldn't get a lock on the new treatment to make back the cost. Meanwhile, people were dying like flies, for over a decade.
What finally got them off the dime was apparently a Wall Street Journal article on the subject. It ran under the headline "100,000 Dead!". (If you read the text, though, you'd see that the number was actually more like 400,000. The WSJ was just being conservative - and setting things up so that a challenge to theheadline would drag the larger number into the light. B-) )
It is great that Kelsey's "prove it" stance saved a lot of babies from birth defects. But it also helped set up the bureaucratic incentive structure that has lead to the 8-figure cost and decade-scale delays in getting new drugs and treatments to market - while people suffer and/or die for lack of the new technology.
I hear that, during the original debates on the law creating the FDA and giving it the gatekeeper power over drugs (and cosmetics) the congresscriters were pretty much agreed that it would be counterproductive if it resulted in more than a six-month delay in the deployment of new drugs. Oops!
Bantam Dominique roosters crow a four-note song. Once you've heard it as "Happy BIRTHday" you can't NOT hear it that way