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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.
Big goverment! Hurray!
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!
But apparently does nothing for our education system. :(
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.
Regardless of whether you prefer to call it eSports, eSomething or eNothing; eSports has an industry behind to support it. Money is money, and even if it was a "stupid thing to do" (which is not, by the way :-) people would still do it due to the money involved.
Now please enjoy the finals tonight of DotA 2, 6$ millions are at stake for the winner.
The free market would have solved this eventually.
Right guys? The free market is infallible. I'm sure people would have noticed that this thing was killing their kids eventually.
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.
I don't know what I would've done if you hadn't prefixed this news item with your leftie moral lesson for the day.
healthy food ideas - http://foodsideas.com/healthy-... | Quick food ideas - http://foodsideas.com/quick-fo...
Informative, *and* grammatically correct (and justifiable, IMO) use of invective!
There's no place I could be, since I've found Serenity...
Even with her fight, thousands of American babies were afflicted.
Fortunately, her fight DID prevent 10s of thousands. It also got the families of those afflicted support.
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.
I guess you like the way governments take care of people.
Why are you celibrating the life of some old honkey. Don't you realize that the only way he was able to do what he did was because he had the advantage of 300 years of slavery. We should be celibrating the African americans who allowed him to do what he did.
I think we should celebrate trolls on Slashdot who can't even be bothered to read TFS, for fear they might get something correct in their comments.
These brave trolls bear the ignominious weight of enlightening us poor savages and releasing us from our bonds of servitude to factual correctness. This Bud's for you, troll!
here: https://www.youtube.com/watch?...
Thalidomide is a powerful drug, which is now used to treat other problems, such as Leprosy. In its heyday, it caused a lot of deformities, but only the very serious problems got into the news. It is probably one of the main reasons why there are so many really ugly looking people in my generation. My wife was also affected by it. She has some internal problems and she can never find shoes that fit, but she looks 'normal' enough.
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.
With so many scams, trolling, whatnots happen in the patent scene, we desperately need dedicated souls such as the late Dr. Frances Kelsey working in the patent office
RIP, Dr. Frances Kelsey !
Funny how the author says: "[...] causing thousands of babies in Europe, Britain, Canada and the Middle East [...]".
Is Britain no longer in Europe? Or would Kelsey's achievement be deemed as less relevant is Britain is not mentioned?
It keeps are food safe,
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>
He sounds like an SJW, so I don't believe you or your links.
Ad hominem, round #2, FIGHT!
(of an argument or reaction) directed against a person rather than the position they are maintaining.
For those of you who forgot what the term means, since the last time I pointed out a clear ad hominem, I was met with downvotes. Okay, go ahead and mod me down now.
Morning sickness is not a disease to begin with.
So when spin doctors started promoting thalidomide it only highlighted irrationality of individuals and population. Regulation which banned thalidomide is not an evidence that government is a solution to all the problems.
Government does have a role within a functioning society to make it more efficient or, for example, to ensure common defense.
However rationale of governing is many other areas always perverted and illogical: one one side Government allows, heck, funds millions of abortions, meaning killing millions of people all in the sake of choice. On the other hand when people make stupid choice of eating morning sickness pills, smoke weed or get faulty breast implants, all of the sudden, this type of choice is no longer tolerated. Killing with one hand and protecting from voluntary harm with other?
Who get to decide which human choices government regulates and which ones does not?
Pardon the sarcastic introduction. Kelsey is a woman who young ladies should learn about. Proof that women can do science, and if a young girl is interested, she can too. Do important work that can save lives.
Oh, and by the way, a woman who stared adversity right in the eyes and won.
Re-read that sentence above three times, then compare it to the excuses like:
Photos of a playboy model's face keep women out of STEM.
Men telling stupid dongle jokes keep women out of STEM.
Being told you are "bossy" keeps you out.
Barbie keeps you out.
And the list goes on and on and on of these terrible and unforgivable microagressions that are the so called real reason why there aren't so many young ladies in STEM careers.
Good think Kelsey wasn't the type who would quit the first time someone said something she didn't like, or overheard a 5th grade level joke, eh?
The shepherds did so well protecting the flock that the sheep no longer believed that wolves existed.
Mod this up. It's the factual comment in this entire discussion. The political spins are just that, spins - much as I believe Thalidomide is a rare example of predatory capitalism thwarted and proof that regulation is required.
Dr. Frances Kelsey was also Canadian. Just an FYI.
Goodbye Slashdot. You've changed.
Hundreds of ignorant,snarky posts about how anyone supporting the concept of small, efficient government is advocating for No Government, No Police, Fire, etc.
Slashdotters can be so tedious sometimes. Especially on the weekends when their parents allow them more time at the computer.
I really believe that if she were active in this day,
she'd be branded a criminal and placed in jail.
Not just that, but you can also get a cushy job at one of the companies you used to regulate for denying approval to a better drug made by a small company that subsequently went bankrupt, or get a seat on the board of the AMA, which is composed of doctors who make tons of money off of doing unnecessary surgery because you prevented approval of drugs found to be safe and effective, and are in wide use in other countries. Or, you know, just get paid off directly.
More regulations means more regulatory capture. That's about it.
"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."
Whether or not the above statement is true, hitching it as a two-sentence rider onto the thalidomide issue is absolutely batshit crazy.
there are tons of bad regulations and bad regulators. we should get rid of them
with our corrupt politics, there are also regulations written by those that are supposed to be regulated:
https://en.wikipedia.org/wiki/...
but with absolute 100% certainty, i am here to tell you that *zero* regulations is actually far, far, worse. when you have a market unregulated, it is not fair at all. the large players have hundreds of ways to abuse smaller players and consumers to make a few pennies more, and they will
if you don't understand that, if you persist with a wish fulfillment ignorant fantasy that an unregulated market is somehow magically fair, you are a moron. not a baseless insult, an objectively true label for the quality of your thought on this subject
intellectual property law is philosophically incoherent. it is your moral duty to ignore it or sabotage it
If there are hundreds of ways please give a few examples.
I love Jesus, except for his foreign policy.
i am not here to hold your hand and whisper the facts of life in your ear lovingly like i'm your father
it's your fucking job to be minimally educated on a topic before you open your ignorant useless mouth
but here's some intellectual charity for the idiot, start here:
https://en.wikipedia.org/wiki/...
good luck on your education, you low iq douchebag
nothing makes me angrier than free market fundamentalist morons
you are toxic to intelligent discourse on an important issue that is often abused by plutocrat interests, which in the end you retards are just tools of
economics is not a wish fulfillment quasireligion in the service of an ignorant ideology believed by fools with the intellectual and moral maturity of someone still in diapers
the free market fairy is not real, losers. markets do not magically self-regulate
to believe that is on the same "intellectual" order as creationism, climate change denial, birthers, and 9/11 truthers: stupid crackpot mental diarrhea, often purposefully encouraged by vested interests who want to manipulate morons to serve their financial and political agendas
intellectual property law is philosophically incoherent. it is your moral duty to ignore it or sabotage it
I don't see an issue with any of these anti-coorporative behaviours as long as they are agreed upon voluntarily by the parties involved. If you want to form a cartel good luck with that. Let's see how long it lasts when it's everyones interest to lie about their own production.
The ones I have issue with are the ones where people use the power of the state to hinder their compeititon like subsidies, regulations, or monopoly including things like Intellectual Property.
A free market is not magical in the it doesn't prevent bad things from happening. What it does do is allocate resources in the most efficient way possible and punish bad actors swiftly and harshly. Put it this way. In 2008 the market was set to punish a bunch of companies for being poorly run, taking risky bets, and paying too much for poor mangement. They would have been liquidated. Instead the regulators came in and rewarded them so that the worst run companies were able to provide the biggest bonuses to their managment. And why not? It doesn't matter if you make a profit by serving your customers or getting tax dollars. It's all profit in the end.
I love Jesus, except for his foreign policy.
Wanting to sell the drug you developed is "mindless greed" now? I guess a worker who wants to get paid at the end of the work week is also exhibiting "mindless greed" then.
Why can't it be a series of very sad mistakes or oversights? Why is there a need to spin an unsubstantiated tale of villainy?
Shouldn't we want government regulation based on truthful, objective analysis rather than over-dramatized horror stories? (It's already fucking thalidomide. Isn't that dramatic enough without "teh eeevil corporate monster" narrative? Meanwhile doctors who gave it to patients: not mindless or greedy. Because ...?). Can't we add regulations when they make sense and work and make our lives better, and remove or reform regulations when they burden people for no benefit or when the benefits are greatly outweighed by the costs?
Let's have government that's not based on made up stories, or hyped-up stories, or dramatized stories. Let's base it on facts and objective analysis that weighs costs against benefits.
Oh, wait, unfettered greed and corruption destroyed any chance of that working. The same things you are demonizing capitalism for.
Not completely anyway. Insurance companies don't like new drugs they have to pay for. Most of Europe is some single payer
Hi! I make Firefox Plug-ins. Check 'em out @ https://addons.mozilla.org/en-US/firefox/addon/youtube-mp3-podcaster/
(facepalm)
i stopped reading there
you really are a moron
that's not a baseless insult. anyone who would write such a sentence is fucking stupid on the topic. there is absolutely nothing redeemable about you
you can serve yourself and the world by shutting the fuck up on a topic you are only embarrassing yourself on. i mean that with sincerity. you are a genuine complete moron in this topic. dumb. useless
of course you'll keep opening your mouth on the topic. after all, you're a moron, that's what morons do. but maybe you can grow an awareness that everyone else is laughing at you or shaking their head in dusgust
intellectual property law is philosophically incoherent. it is your moral duty to ignore it or sabotage it
I realize you have the rope and the torches already, but you aren't going to take down these snake-oil salesmen. If you even try to bring truth into drug sales, you are decried as someone who wants to "Take critical care from the needy".
Its the same thing when I see people moaning they can't yet have some experimental life-saving drug.
Placebo rates aren't 0 for a reason. People are stupid and will believe anything.
Story is bad enough without the unnecessary hyperbole.
Isn't journalism practiced anymore?
Why do we have "editors" again?
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.
Ethanol is one of the smallest organic molecules, most drugs are huge in comparison. It might help to think of it as a solvent, not unlike water.
Escher was the first MC and Giger invented the HR department.
"Modern society cannot function without effective government regulation" says the communist. Moar regulation is moar freedom!
BIG STUMMIES SCIENTIST
Well, I've been working on a thing. It's, uh, sorta like Stummies.
DON
Go on. I like what I hear.
BIG STUMMIES SCIENTIST
It's exactly like Stummies.
DON
And the twist is?
BIG STUMMIES SCIENTIST
It's a much bigger pill.
DON
I like a lot. Is it ready for production?
BIG STUMMIES SCIENTIST
Yes sir, it's ready to go.
DON
Yeah, have there been any side effects?
BIG STUMMIES SCIENTIST
Yes sir, a few side effects.
NATALIE
Well that's OK. As long as there's no flipper babies, right Don?
Everyone LAUGHS.
BIG STUMMIES SCIENTIST
Well, there have been a few flipper babies.
CUT TO:
23 INT. RORITOR BUILDING
- HALLWAY/ELEVATOR23
Marv and Chris are coming out of the elevator.The Big Stummies Scientist is is hysterical and is being carried away by two security guards.
BIG STUMMIES SCIENTIST
AHHH! It was only a couple of flipper babies!
Shutting down free speech with violence isn't fighting fascism. It IS fascism!
That's about as dumb as claiming World War Two was fine because it worked out in the end.
Maybe you just resort to insults because you have no counter argument?
Unlike you I'll make an argument. Let's take the first Anti-competitive parctice in your link.
Dumping, where a company sells a product in a competitive market at a loss. Though the company loses money for each sale, the company hopes to force other competitors out of the market, after which the company would be free to raise prices for a greater profit.
I don't have a problem with this. If a company wants to lower prices to attract customers and drive out competition go ahead and try. It is always a failure which is why it's rarely tried. The only time it works is when the company uses Intellectual Property or some other government granted monopoly.
A perfect example are radio stations. There are many radio stations that change format and try to gain listeners by going commercial free for a while. They have huge ratings while they don't play commercials and once they have a large marketshare they try to monetaize by selling commercials based on their marketshare. But as soon as they start playing commercials they instantly lose marketshare. So the market harshly punishes this tactic.
Another example is if the company is selling below cost a smart business would buy up the supply at below market costs driving them either out of business or forcing them to raise prices.
I love Jesus, except for his foreign policy.
when she found out that health regulators all over the world reintroduced thalidomide as a treatment for leprosy, AIDS and yes, morning sickness, from the 1970s right up to now where even the NHS in England are cosying up to Celgene for thalidomide as a treatment for - get this - arthritis.
Thalidomide never really went away, and people are still feeling it.
(my sister in law is a thalidomide victim).
Political debates have me rolling my eyes so much I think I got optical whiplash. I should sue. - Foamy The Squirrel
We can assume you would have been fine with your life savings turning into 404?
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.
The thing is that we did have superior FDA gate-keeping. While Europe was worried about efficacy we (our FDA) at the time only cared about safety. Thalidomide passed the efficacy test with flying colors. It worked very well. It just wasn't very safe.
The sad thing is that it was this event that was used as an excuse to transform the FDA into regulating efficacy, the very thing that would not have prevented thalidomide from being sold (see Europe.) Since then, safety has taken a back seat. We are lesser because of it. The Statists shouted "think of the children" and corrupted another department of government. Now nearly all drugs come with a huge list of unsafe side-effects, but at least they "work."
The FDA would absolutely approve thalidomide today.
"His name was James Damore."
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.
The social and political environment that makes federal regulation possible is the same environment that makes successful civil litigation possible.
It is a double-barreled shotgun blast.
When a Switch in Time Saved Nine
if you invest in a company that goes bankrupt there are laws that determine who gets paid first from the revenues of the sale of the company. That is the risk you take when buying stock. You don't get steal from people on fixed incomes via inflation. Well I guess you do since that is what happened but I mean you shouldn't be allowed to steal.
I love Jesus, except for his foreign policy.
It's worth keeping in mind that science (and medicine!) still have "we didn't know!" moments today.
... And apparently true.
No lolz on that one...
Truth isn't Truth - Guliani
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 [youtube.com] 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.
Point of clarification oops --- Feynman is referring not to natural sugar here that is a result of biological process such as beet or cane sugar, but artificial sugars built in the laboratory from constituent carbons, hydrogens and oxygens. The mixture has roughly even numbers of (R) and (S) molecules so it does not 'block' one polarization of light.
Other interesting snippets on chirality: a great 2006 student term paper, How did protein amino acids get left-handed while sugars got right-handed? which gives an overview of the physics and fronts the possibility of biological evolutionary advantage... and a recent Newsweek article that introduces 'Allulose' one laboratory creation of Feynman's "wrong-handed sugar" --- the stuff bacteria doesn't eat --- as the perfect sugar substitute. "Exactly why allulose doesn't have as many calories as fructose isn't completely understood, but studies show that rats don't gain any weight when fed a diet of allulose, but do when given the same amount of fructose. When humans eat it, we basically piss most of it out. They said 'piss'! Heh heh. Then "Allulose has already passed a review by the U.S. Food and Drug Administration, which deemed it "generally recognized as safe" in January 2014, making it eligible for use in food."
So... why would they say "why allulose doesn't have as many calories as fructose isn't completely understood"? A journalist picking up on a scientific hedge? Biologically actionable calories as opposed to mere energy potential? Unexplored effects of recombination in the liver? Inquiring minds aware of Thalidomide horrors would do well to tread carefully with industrial-scale production of 'wrong'-handed organic molecules.
Pointing out that the (R)(S) notation of handed-ness is R=right=Rectus, S=left-Sinister, it is revealed that chemists are insensitive clods.
<blink>down the rabbit hole</blink>
Ethanol is one of the smallest organic molecules, most drugs are huge in comparison. It might help to think of it as a solvent, not unlike water.
I hear ya. Small molecules are why DMSO nicotine patches may exist but not generally, prescription drug patches (never mind the dosing nightmare). Just like the Java Sandbox concept or Microsoft Wallet, many biological barriers/frontiers that were once considered difficult or impossible to breach have been crossed.
The skin: while small-molecule poisons and toxins, even simple hydrocarbons were long known to pass through the skin, it was only ~1963 when it was realized that DMSO can help carry larger molecules into the bloodstream.
The Blood brain barrier has been known to be weakened by inflammation but has been breached outright by gas microbubbles and localized ultrasound (too damned creepy!).
And the Placental blood barrier opens in late pregnancy, presumably to give the developed fetus a survival-edge of antibodies from the mother, but long before that there are specialized mechanisms to transport only fats or glucose or eliminate waste. What if some miracle drug has the unintended effect of compromising the mechanism that decides when and how it is opened? In the case of (S)Thalidomide it was not the drug itself, but compound CPS49 produced from it by the liver (the mother's I think) that crosses the barrier.
So nature's greatest defenses have become small hurdles...
not your grandfather's mandelbrot
I like. This one actually resembles my grandfather.
<blink>down the rabbit hole</blink>
Everyone seem so sure that we should all be taking crazy levels of pharmaceuticals of which vaccines are are a type. None of the common diseases cause autism, or flipper babies. Anyone trully intelligent will recognize it for what it really is. Risky business.
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
From what I've read, I don't think the "non-addictive" nature of heroin was really a Bayer greed conspiracy as much as a byproduct of poorly understood nature of opiate dependence.
From what I've read it was a mistake, due to a testing artifact:
- They were searching for a drug that would have morphine's painkilling effects without producing withdrawal symptoms. (Morphine is the main active ingredient of Opium and was also a then-modern "miracle drug" used for treatment of pain, as a respiratory depressant, and as a life saving antidiarrheal agent.)
- They made minor modifications to the molecule and tested the result.
- With this particular modification they still got powerful painkilling effect. So they tested it for addiction potential - on several of the lab assistants.
- But it turns out that a small fraction of people don't GET withdrawal symptoms from opiates, and it happened that these lab assistants all had this odd metabolism.
- Convinced that they had found this particular holy grail, they reported it to their management, which (also convinced) went to market with it.
- It was called "heroin" because it was believed to be the "heroine" that would rescue the addicted - either from recreational opium use and from medical treatment - from their misery.
- Unfortunately, it was just a nice, soluble, molecule that could be injected - after which the body just turned it into morphine. Oops! Everybody who got withdrawal symptoms from morphine got it from heroin, too, and the injectability made for the same sort of addicting quick rush as inhalation of opium smoke.
So I see the rush to market of Heroin as primarily a matter of a drug company (doing well by doing good) trying to quickly deploy what they believed to be a new miracle drug, to solve a major medical problem (opiate addiction), rather than a "greed conspiracy" to field something they thought would make them money without solving the problem (or while making it worse).
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
The FAA so completely regulates aviation (including particularly avionics) that an avionics maker must not only prove an instrument works, but must also prove it works in each model of plane before it can be installed in that model of plane...... which means many things that would benefit every aircraft operator only get approved for operators of certain planes (where the market was big enough to justify the years and piles of dollars the vendor would have to expend to get approved to get installed in each model). As a result, most private planes lack an "angle of attack" indicator, which in-turn contributes to a large number of loss-of-control accidents and fatalities (often in the form of a stall on the low-speed turn before final approach to a runway). AOA indicators should be cheap on every plane, but they are mostly found on military planes, airliners, and the business jets of the rich.
Actually, there are MANY instances of this in aviation. Nearly everything involving aircraft in the US contains big price markups driven by the overhead costs the manufacturers must build-in to cover their costs of getting over the regulatory hurdles of the FAA. As a result, many plane owners cannot install things into their planes that they would like and which would improve safety because they cannot afford the artificially-inflated prices. This also means that many people are flying around in 40 or 50-year-old Cessna airframes because newer better airframes that are in current production are too expensive (thanks to regulatory burdens, NOT labor or materials) and many other designs that COULD be in production are not because they were never developed because no business model could be made for a decade and millions of dollars to certify something that might only sell 150 instances.
We get it: you finally found a nugget you think wipes out any arguments for freedom. Examples like this are so very rare that your ilk cling to them and celebrate them without even realizing that in doing so you are highlighting their extreme rarity.
For every example like this (one regulatory victory in 50 years) there is a tidal wave of regulations that have never made anybody's life better other than the regulators who got jobs regulating, and the crony-capitalists who made money by getting the government to ban a competitor's product. For every thalidomide, there are a huge number of more-obscure drugs that have been blocked for decades; some end-up having little benefit, but a few end-up being very good and their absence from the marketplace for decades means decades of unnecessary suffering for many people. All this regulation has hidden costs: drug prices are higher, some good drugs are not brought to market, and many suffer without news coverage because there is no approved drug for what ails them.
Have you forgotten all the people who claim their lives were made better by things like cannabis oil which, being a marijuana derivative, is blocked by the very same FDA you are celebrating, and in the case I cite is banned by New Jersey because they are aligned with the FDA regulators on the issue? Whose suffering is more important? The suffering which was dodged by the block on Thalidomide in the US which supports your political position, or the suffering of those with various cancers and other ailments which happen every day all over America because drugs that would help them are being blocked but which does not benefit your anti-libertarian arguments? Government regulation is a far more complex issue than your simplistic cartoon-view of the world makes it.
Oh, and in case you missed it, a number of American women went to Canada and got the drug in the 1960's and some of them did indeed have "flipper babies" - and then the very thing you ridicule happened anyway (even WITH the FDA) which is that there were lots of lawsuits by both American and non-American victims and lots of bad PR for the drug company in question.
Most of the products that modern unionized Democrat school teachers tell people about as "snake oil" products from before the era of wonderful government regulation in what passes for modern education were actually the product of an era before the science existed to either [a] know that these things were bad or [b] provide a safer better alternative. In the 1800's there were many things a person could suffer from and for which there WERE no better remedies because the science just was not yet able to offer better. Propaganda is no substance for actual education. As in everything else, Context is EVERYTHING
Sure, Coke and Pepsi, and lots of other products had ingredients many of us today would think were CRAZY, but at that time these ingredients were not put in by some big evil corporation over the objections of some kindly and well-meaning government do-gooder regulators. Cocaine, for example, was something American adventurers and entrepreneurs had found natives in central America using for all sorts of ailments. Morphine was something well-known for being both an addictive and destructive drug but also a very vital beneficial medical product. In a society that lets people have freedom over their lives and lets them drink themselves to death if they choose, it's hard to argue about a product with a similar potential but just a different chemical content. At a time when people suffer various pains and science has no safe solution, it's hard to justify blocking access to a potentially dangerous and addictive substance which will alleviate some of those issues if simply used responsibly.
The LGF links are meant to distract from the fact that the people supposedly exposing a "hoax" are Think Progress which is a hard-left site partially funded by NAZI collaborator George Soros (who clearly has no moral issue with chopping-up children for fun-and-profit and lying).
Nowhere in the so-called "debunking" do they get around the fact that while the PP videos were edited to make short versions for news people to use (common practice) but the full un-edited videos were also provided online so that everyone on all sides of the issue could see them. The pro-choicers initially denied the videos, then they came-up with the "edited videos" and "hoax" accusations, but they cannot get around the fact that the full unedited videos are online and THAT is why the issue became red-hot. Anybody who watches the hours-long unedited videos knows how deeply dishonest the PP talking points about a "hoax" are.
Oh, and I love the way LGF and TP try to discredit using "guilt-by-association" (rather than disputing the actual facts spilling out of the mouths of their own people in the video). They also dishonestly claim that the same people have previously accused planned parenthood of covering up rapes - this is by wrong BY DEFINITION. When they accused planned parenthood of covering up rapes they were factually correct - PP has been caught NOT reporting abortions on underage girls to authorities (as the law requires them to) and, by definition, and pregnancy of an underage girl is the result of statutory rape. We can disagree on opinions, but facts are non-negotiable.
Thusly proving, once again, that a lot of amazing science doesn't start with 'eureka!' but 'Huh, that's funny....'
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