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Medicine Government United States

Dr. Frances Kelsey, Who Saved American Babies From Thalidomide, Dies At 101 278

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.
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Dr. Frances Kelsey, Who Saved American Babies From Thalidomide, Dies At 101

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  • by Daemonik ( 171801 ) on Saturday August 08, 2015 @05:35AM (#50274129) Homepage
    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!
    • by serviscope_minor ( 664417 ) on Saturday August 08, 2015 @06:39AM (#50274265) Journal

      Yeah those babies should have voted with their wallets and not bought thalidomide in the first place. After enough consumers suffered hideous deformities, word would have got around and the company would have stopped being profitable. The free market would work as it should.

      • Yes, and since social services have paid for the disabled babies it did not cost the company its existence.

        The system works!

      • by tmosley ( 996283 )
        Uhh, their parents would have sued the company out of existence, and without the corporate veil, a statist intervention in the marketplace, they could go after the assets of the shareholders as well. Actually being liable for the actions of the company you own would make them be a LOT more careful. With regulators, all they have to do is get a thumbs up, file as a corporation, and they are completely shielded from personal responsibility for their actions.
        • Re: But but but.. (Score:4, Insightful)

          by avatar avatar ( 4063787 ) on Saturday August 08, 2015 @10:29AM (#50274965)
          And how would these parents have proven that the drug was to blame? Who would've forced the company to provide samples or hand over data? Would a coalition of parents have pooled their money to employ scientists and rent lab time for the task? I wouldn't care to guess how many millions more would have to suffer deformity to inspire that kind of collective action, but the scenario doesn't exactly make for a free market paradise.
          • by DarkOx ( 621550 )

            Proof does not have to meet incredibly high standards. A Civil trial over the amount of $20 can go before a jury.

            If 100 geographically and economically disperse parents get together and say we all used use this drug while pregnant and all had children with similar birth defects. What would you conclude what do think a jury would likely conclude. If anything the burden is going to be on the company to show some pretty iron clad evidence they are not the problem.

            • A Civil trial over the amount of $20 can go before a jury

              Not really, most western nations have "small claims" courts where the claim is heard by a magistrate or a government mandated arbirator, many of those courts also have a minimum damage limit, IIRC here in Oz it's $100. Aside from that, post-trauma financial revenge on the company who (deliberately or negligently) replaced your child's arms with flippers, is not adequate compensation. Nothing is.

              The FDA plays a critical international role in assessing drugs and food additives before flippers start appeari

          • by tmosley ( 996283 )
            >And how would these parents have proven that the drug was to blame?

            Cause and effect. This would have been a very, very large lawsuit.

            >Who would've forced the company to provide samples or hand over data?

            The courts. It's called discovery.

            > Would a coalition of parents have pooled their money to employ scientists and rent lab time for the task?

            No. They would have noticed they had flipper babies, and then their doctors would have noticed that all their flipper baby patient's mothers ha
            • And the doctors would then have kept quiet to avoid being named in the suit for prescibing the drug.

            • "No. They would have noticed they had flipper babies, and then their doctors would have noticed that all their flipper baby patient's mothers had taken thalidomide."

              Mmm hmm. And instead of that, we live in a country without flipper babies at all.

              And we all get to vote on what kind of policy we prefer, the one where flipper babies have a tiny chance of eventually getting a small payout after enormous legal effort, or one with healthy people with normal arms and legs.

              That's a political question. You can vote

          • And how would these parents have proven that the drug was to blame? Who would've forced the company to provide samples or hand over data?

            The courts. It's called "Discovery." Requests for Production generally have to be complied with.

            • Re: But but but.. (Score:4, Insightful)

              by drinkypoo ( 153816 ) <drink@hyperlogos.org> on Saturday August 08, 2015 @11:26AM (#50275283) Homepage Journal

              The courts. It's called "Discovery." Requests for Production generally have to be complied with.

              Oh, the "requests" which "have to be complied with" or they will be backed up with VIOLENCE. STATIST!!! Seriously, everything about libertarians and similar is hilarious. I would be soooo embarrassed to admit I ever considered myself to be one if I didn't know that wisdom comes with age, if at all.

        • sued the company out of existence, and without the corporate veil, a statist intervention in the marketplace, they could go after the assets of the shareholders as well.

          OK, so you'd rather than a bunch of American babies got all deformed so the parents could then go and sue the shareholders into abject poverty? You do realise that leaves you with a bunch of people in poverty AND a bunch of deformed babies.

          Whereas with the system as it was, neither thing happened.

          Also, I love how you claim to be against stat

        • Comment removed (Score:4, Interesting)

          by account_deleted ( 4530225 ) on Saturday August 08, 2015 @12:23PM (#50275523)
          Comment removed based on user account deletion
      • Re:But but but.. (Score:5, Interesting)

        by amiga3D ( 567632 ) on Saturday August 08, 2015 @10:19AM (#50274919)

        The real thing that should have happened is everyone involved should have been tried and executed. That would be a better deterrent than some supposed market force that doesn't really work since all these assholes have golden parachutes. Every single person behind covering up the continuing damage, not the initial mistake but the coverup once it was clear what was happening is a hideous monster and should be permanently removed from society. The real reason people keep doing this evil shit is that it pays and society should make it unmistakably clear that we wont tolerate it.

        • The real thing that should have happened is everyone involved should have been tried and executed.

          You don't execute them. You imprison them for life, and their only lazy entertainment is video of all the deformities and deaths. Let 'em keep arts and crafts, though. Which brings us to Hitler...

    • Re:But but but.. (Score:5, Informative)

      by cbhacking ( 979169 ) <been_out_cruising-slashdot@@@yahoo...com> on Saturday August 08, 2015 @06:51AM (#50274297) Homepage Journal

      It's interesting how, in the days before the FDE, DEA, and all that, companies marketed all kinds of shit to people. Heroin was Bayer's brand name for their "non-addictive" (total lie, obviously) morphine alternative and *cough suppressant*. Some of their marketing of it targeted kids; hey parents, your little girl can't sleep because she's got a cold? Well, give her some heroin, that'll solve everything!

      Of course, none of these companies ever seem to have suffered any problems in the market as a result of the horrible effects of the stuff they sold, or the lying ways they marketed it. Bayer, of course.is still around, as is the company that brought Thalidomaide to the market (and at the time they were pretty small and new, without much ability to weather a major failing in the market). At least when it comes to pharmaceuticals, the market has shown absolutely no ability to regulate itself.

      • "Did or did not little Betty sleep well after you gave her heroin?"
        "Yes, but... "
        "YOUR WITNESS!"

      • Re:But but but.. (Score:5, Insightful)

        by swb ( 14022 ) on Saturday August 08, 2015 @08:42AM (#50274597)

        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.

        Ironically, opiates saved countless lives from people suffering from intestinal illness where diarrhea would have killed them from dehydration. Considering the state of medical science at the turn of the century and the lack of alternative medications available, the opiates were miracle drugs. You have to wonder how many potentially life saving surgeries (like amputations or excisions of infection) wouldn't have happened without opiate pain relief or how many recoveries wouldn't have happened without opiate pain relief.

        A lot of mass opiate addiction (to the extent that it existed at all) wasn't injected morphine, but smoking opium. For those with an opium habit, a small maintenance dose of a stronger opiate like heroin that allowed them to not spend hours in an opium den may have actually seemed like a cure to them, much as contemporary medicine might consider opiate maintenance with methadone or buprenorphine a therapy for heroin addiction.

        You also have to wonder for some of the old use cases where it seems totally wrong now (like providing it to teething children) if perhaps the nature of its use didn't actually result in, say, toddlers getting addicted. Opiate tinctures were still manufactured medicines that cost money in an era where disposable income was small and geographic access to doctors or pharmacies to obtain it was limited. It's not hard to imagine that it may have been used sparingly due to cost, supply limitations or even medical advice from doctors who were aware of its habit forming potential, resulting in actual use not that different than a bottle of 20 vicodin provided after a wisdom tooth extraction today.

        I had terrible ear infection problems as a child in the early1970s, getting drainage tubes in my ears more than once (which was a real hospital stay back then) and our pediatrician gave us a bottle of demerol to treat the pain from the ear infection something I doubt would even be considered today.

      • Yeah but to be fair when I shoot up with heroin I stop worrying about my cough. That's science, dude.

    • by JWW ( 79176 )

      Yeah because the government never does bad things.

      Oh wait. http://www.huffingtonpost.com/... [huffingtonpost.com]

      Remember, if big powerful corporations are evil just because they are big and powerful then what is big powerful government?

      I would say that it might not be the lawmaking branch of government that saves us from bad companies as much as it is the judicial branch and civil court suits.

      However, as is obvious from the asinine warnings printed on nearly everything that there is such thing as too much of a good thing.

      • Re: (Score:3, Informative)

        by Daemonik ( 171801 )

        No government is blameless for the things it does for it's citizens, but governments have checks and balances. As much as we would not sit quietly while the government decided to, for instance, disband the Supreme Court, nor should we stand by while corporations try to remove the things that balance their interests against the public's.

        As for your ridiculous statement that the judicial branch saves us from bad companies and not the lawmakers, ummm you do realize that the courts can't do a damn thing if a l

      • Corporations have one, and only one, primary goal. Profit. That's their purpose. Any product produced, any service provided, is just the necessary evil to achieve this goal.

        Governments, at least if they deserve the name, first and foremost have the goal of keeping a country running. There you actually have the chance that the service provided IS the primary goal.

        • Governments, at least if they deserve the name, first and foremost have the goal of keeping a country running. There you actually have the chance that the service provided IS the primary goal.

          There's a whole branch of economics [econlib.org] which completely contradicts that, so let's start with some examples... can you name a few governments among the 196 or so in the world today which "deserve the name" under your definition and we can see how the people in those governments actually behave?

          After all, how many lives has the FDA cost? [fdareview.org] What medical devices are we missing [wsj.com] because the FDA delays them?

          What you seem to see as a feature (long delays and hoops to jump through for government approvals), others have

          • by sjames ( 1099 )

            There's an important distinction you're missing. I firmly believe regulation is necessary for food and drugs. That does NOT mean I believe the FDA is particularly good at it. Amputation is not a good solution for an ingrown nail.

      • "Remember, if big powerful corporations are evil just because they are big and powerful"

        Cough cough coustrawmangh coubullshitgh. Oh, sorry, I had a bad argument stuck in my craw.

    • You act like there is no cost to these regulations both in financial and human suffering. How many people live in excruciating pain or end up killing themselves because they can get cheap and effective opiates? How many people don't get the medicine they need because doctors have gave themselves a monopoly as the gatekeepers of effective medicine? I am luck I am relatively wealthy. I had two kids this week that had allergic reactions. From past knowledge and a bit of googling and I knew they needed a course

      • Re:But but but.. (Score:5, Insightful)

        by Daemonik ( 171801 ) on Saturday August 08, 2015 @08:42AM (#50274595) Homepage

        Yet you know with certainty that the doctors prescribed a real medication with actual effects and not just colored water that the doctor makes in the back of his office. You know, with certainty that the bottle Wal-Mart sells you (and really, if you have money wtf are you shopping at Wal-Mart?) will be the actual medicine and that they haven't been mixing water in to increase their profits, or buying counterfeit drugs to again increase their profits.

        The reason you know these things is because the government enforces regulations protecting you from such dishonest practices. The government enforces regulations that save your life and your children's lives from corporate greed every day, and because you don't see that you get to pretend like they aren't necessary, but you are simply deluded.

        Also, you may have money but you certainly aren't very bright if you think googling WebMD is a valid replacement for a medical degree.

        • by tmosley ( 996283 )
          Uhh, you think pharmacies have government agents in them ensuring they aren't distributing sugar pills or watering down medicine?
        • The reason I would have gone to Walmart is they would be the only ones open at midnight when the one kid had an allergic reaction.

          And stores that sell sugar water are comiting fraud it has nothing to do with regation. Businesses that tend to defraud their customers don't stay in business long unless they have a state granted monopoly,

      • by meglon ( 1001833 )

        You act like there is no cost to these regulations both in financial and human suffering. How many people live in excruciating pain or end up killing themselves because they can get cheap and effective opiates?

        Here in the US we call that the free market, because the government isn't the one that sets the prices... the corporation making the drug is.

        From past knowledge and a bit of googling and I knew they needed a course of steroids that cost about $4 for each kid. But I had to go to a doctor for each one and pay the copay and insurance to let them help my kid. So a night of suffering waiting for the doctors to get to work or spend 5 hours in an ER and that associated risk and cost as opposed to going to Walmart and picking up the prednisone.

        ... and by going to the doctor, you didn't inadvertently kill your children by being wrong. Just going to say this as simple as possible: your 5 minutes on google doesn't make you a doctor. You should be glad your doctor solved the problem, and at the same time didn't let you kill your children.

        • "Here in the US we call that the free market, because the government isn't the one that sets the prices... the corporation"

          We have a free market in opiates? Last I checked they were heavily regulated. In my state several doctors lost their licenses for being "pill mills" where they would prescribe pain meds in the doses the patients needed for relief. You know because people can abuse opiates. Meanwhile taking a handful of Tylanol can destroy your liver. Which is why opiates typically are laced with it so t

  • by Opportunist ( 166417 ) on Saturday August 08, 2015 @07:08AM (#50274355)

    In case you wonder what the fuss is about, you might know that drug by the name it had over here: Contergan.

  • by mark_reh ( 2015546 ) on Saturday August 08, 2015 @07:37AM (#50274429) Journal
  • by trout007 ( 975317 ) on Saturday August 08, 2015 @08:05AM (#50274485)

    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.

    • by tmosley ( 996283 )
      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 capt
    • 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/... [wikipedia.org]

      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

      • If there are hundreds of ways please give a few examples.

        • 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/... [wikipedia.org]

          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 inter

          • 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 do

  • by tlambert ( 566799 ) on Saturday August 08, 2015 @08:15AM (#50274503)

    Not exactly the actual story... here's the real deal:

    http://blog.seattlepi.com/stev... [seattlepi.com]

    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.

  • by TheRealHocusLocus ( 2319802 ) on Saturday August 08, 2015 @08:52AM (#50274615)

    Chirality [wikipedia.org] of Enantiomers [wikipedia.org] 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 [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. 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 [cuhk.edu.hk], (+)(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 [discovermagazine.com].

  • by jfbilodeau ( 931293 ) on Saturday August 08, 2015 @09:28AM (#50274711) Homepage
    Dr. Frances Kelsey was also Canadian. Just an FYI.

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