Military Review

Side effect of sedative. The Contergan disaster

38

Teratogen number 1


The first wake-up call regarding thalidomide was back in the 1956 year, before it was launched into over-the-counter distribution. One Chemie Grunenthal employee decided that his pregnant wife needed to treat morning sickness and malaise with the new Contergan (the trade name for the first version of thalidomide). The daughter was born without ears!


Then, of course, no one revealed a causal relationship, and a year later the drug went into series. It is noteworthy that initially the drug was considered as an anticonvulsant, but tests showed not the highest efficacy of thalidomide in this direction. Therefore, it was decided to use its "side" property to soothe patients and give deep sleep. In the pharmaceutical market of that time, Contergan was almost the most effective drug, causing rave reviews from both patients and their doctors. Pregnant women have successfully used the novelty in the fight against morning sickness, insomnia and anxiety.

Side effect of sedative. The Contergan disaster
Contergan Sedative Pack


It is worth mentioning that no one conducted preliminary tests of the drug on pregnant animals, and even less so on women “in position”. And thalidomide conquered new markets every year: at the peak of its career, it was sold in more than forty countries of the world. Except the USA. But more on that later. In particular, only in the UK could thalidomide be found on drugstore shelves under the trade names Distaval (Forte), Maval, Tensival, Valgis or Valgraine. Four years after the launch of thalidomide drugs on the market, a German doctor, Hans-Rudolf Wiedemann, indicated an abnormally high percentage of congenital malformations and directly associated this phenomenon with a side effect of a sedative. Prior to this, many doctors from Germany pointed out the increasing incidence of stillbirth and deformity, but attributed this to atmospheric nuclear tests in the United States. In 1958, they even sent requests to the defense department.


Structural formulas of thalidamide molecules. One of them has a medicinal effect, the second - teratogenic


Chemie Grunenthal Logo


The action of the teratogen was terrible: the fetus inside the mother lost its eyes, ears, internal organs and often came to light already dead. The most common is phocomelia, or the syndrome of seal extremities, when the newborn was either completely deprived of the limbs, or they were underdeveloped. At the same time, thalidomide did its dirty work not only in the female body, but also disrupted sperm formation, dooming future fathers to inferior offspring.

In this stories There is an interesting person - Australian gynecologist William McBride. In December 1961, he published an article in the reputable journal The Lancet on the teratogenic effect of the sedative Chemie Grunenthal. It was from him and from the mentioned Hans-Rudolph Wiedemann that the world community learned about the terrible drug. McBride immediately became famous and even received a prestigious French medal and cash prize from L'Institut de la Vie. But fame is very variable - after some time, the thalidomide scandal subsided, and they forgot about McBride.


William McBride, one of the discoverers of the dark side of thalidamide


The gynecologist later tried to draw attention to his person with the supposedly existing connection between the deformities and methods of certain antidepressants, but nothing was proved. And in 1981, he suddenly accused the drug Debendox of a similar teratogenic effect on thalidomide, fabricated test trials and published all this. Only in 1993, doctors and pharmacists understood fraud and deprived the former celebrity of the right to practice medicine until 1998.


Typical fetal developmental disorders


Orthopedic costume for thalidomide victims


German director Niko von Glazov


But back to thalidomide. He was removed from the market in December 1961, immediately after the publication of the publication in the reputable medical journal The Lancet, but the picture of his atrocities was amazing. About 40 thousand people were affected by peripheral neuritis, the most harmless side effect of thalidomide. More than 10 thousand children were born (data differ in sources) with severe developmental disabilities, of which more than half survived. Now many of them have been able to sue Chemie Grunenthal for compensation and life-long maintenance. The German government also supports birth-disabled people with monthly allowances, some of which are barely enough. So, in 2008, several victims of thalidomide immediately demanded three times higher disability pensions and went on an unlimited hunger strike.

Francis Kesley - US Savior


Why is thalidomide such a powerful teratogen? The mechanism of its action was discovered just nine years ago, and before that they only knew that a molecule of a substance can exist in two optical isomers (this is the course of the school chemistry program). One form heals, and the other, accordingly, cripples. Moreover, even a simple purification of the drug from teratogenic isomers will not help: our body will independently produce a particularly dangerous molecule from its useful form. After revealing publications about the Contergan disaster, many medical centers began testing thalidomide-based drugs in pregnant rodents. And it turned out that mice do not have any teratogenic effect even at exorbitant dosages. That is, even if Chemie Grunenthal had conducted Contergan preliminary tests on laboratory animals, a dangerous medicine would have successfully passed them. Even repeated studies on pregnant monkeys did not reveal any contraindications for the withdrawal of the drug to world markets.


Francis casley


Monument to victims of thalidomide in Germany ...


... and in London


However, thalidomide still could not convince one pharmacist of its own safety. Francis Kesley, an employee of the US Food and Drug Administration (FDA), had expressed serious doubts about the safety of the drug for pregnant women even before the start of the Contergan scandal. This was indicated by mild side effects or it was Francis's professional instinct, we cannot say for sure, but the drug was not allowed on the US market. A small number of free lots for testing does not count. And when the whole world found out about the disaster with thalidomide, Kesley became the country's national hero. It turned out that the researcher made her decision under pressure from Richardson-Merrell (a marketing division of Chemie Grunenthal), which in every way imposes a new drug on the FDA. If Kesley hadn’t sent the drugs for an additional study in 1960 (which, as you know, would have led nowhere), time would have been lost and thalidomide would have ended up in pharmacies. But while the test cycle on pregnant animals was started, while the results were being evaluated, December 1961 of the year came, and all further work turned out to be superfluous. John Kennedy personally presented Francis Kesley with a state award for professionalism that has saved thousands of American lives.


Modern drug


A lawsuit was launched against Chemie Grunenthal, but the real culprits were not identified. Rumor had it that employees had destroyed a lot of documentation on the test results of the drug on time. Be that as it may, the company paid 100 million marks to the thalidomide victim fund, which still pays lifelong pensions to people with disabilities around the world.

The Contergan catastrophe forced tightening of control over medicines and sharply increased the costs of pharmaceutical companies for the development of new drugs. The most interesting thing is that doctors around the world still prescribe drugs for thalidomide to their patients. Of course, not to expectant mothers and not as sleeping pills, but as a powerful anti-cancer agent. There is research that the notorious thalidomide can almost be cured of AIDS.
Author:
Photos used:
en.wikipedia.org, ru.wikipedia.org, pikaby.ru
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  1. Far B
    Far B 10 September 2019 05: 22 New
    -1
    Nifiga did not understand. Why is a medical article posted on VO? What is the attitude, so to speak?
    1. Ravik
      Ravik 10 September 2019 05: 59 New
      0
      Yes, everything is simple!
      Thalidomide influenced the brains of NATO leadership. In childhood, of course ...
      Or maybe not only NATO suffered.
    2. Amurets
      Amurets 10 September 2019 06: 03 New
      +6
      Quote: Far In
      Nifiga did not understand. Why is a medical article posted on VO? What is the attitude, so to speak?

      Apparently they decided to recall old problems and expand the theme. [
      The most interesting thing is that doctors around the world still prescribe drugs for thalidomide to their patients. Of course, not to expectant mothers and not as sleeping pills, but as a powerful anti-cancer agent. There is research that the notorious thalidomide can almost be cured of AIDS.
      It may sound cynical, but then potassium cyanide will be considered a powerful cure for these diseases.
      1. Far B
        Far B 10 September 2019 06: 17 New
        +2
        And from a headache - an ax? "Good doctor Aibolit will heal everything in the world" laughing laughing laughing
      2. Mikhail3
        Mikhail3 10 September 2019 14: 43 New
        +4
        It may sound cynical, but then potassium cyanide will be considered a powerful cure for these diseases.
        First of all it sounds stupid, sorry. As far as the material can be understood, the drug causes damage during reproduction. If you do not plan to breed, then why not try a cure for a disease that will almost certainly kill you? For the most extreme case, you can provide for the mandatory use of the drug in conjunction with sterilization. We think. We speak later.
    3. Same lech
      Same lech 10 September 2019 06: 25 New
      +1
      Nifiga did not understand. Why is a medical article posted on VO?

      They’ll do it right ... who knows, maybe some kind of cunning businessman or bastard wants to cheat on us for our money ... and now we know that this is more likely not a medicine but a chemical weapon that can be used against us.
      1. Far B
        Far B 10 September 2019 06: 32 New
        +2
        Any chemistry is potentially dangerous. But in this article it is precisely the medical problems of the drug that are not related to the military industry. And so, and with salt, the enemy can be tortured to death, there would be a desire.
        1. akunin
          akunin 10 September 2019 08: 06 New
          +3

          our option
    4. Reptiloid
      Reptiloid 10 September 2019 20: 29 New
      +3
      Quote: Far In
      Nifiga did not understand. Why is a medical article posted on VO? What is the attitude, so to speak?
      there is a very fine line between medicine and chemical weapons. Or she is not at all.
      And the material side is more advantageous for pills bought by the inhabitants of another country for their own death for their own money. Than any weapon.
  2. thinker
    thinker 10 September 2019 07: 36 New
    +2
    Quote: The same Lech
    maybe some cunning businessman

    Yes, any number! negative
    You can buy thalidomide in the online store in the form of Mirin, the approximate cost is 6 thousand rubles for 30 capsules, 50 mg each.
    1. vadimtt
      vadimtt 11 September 2019 06: 42 New
      +3
      Fuck pharmacists feed on people’s hopelessness. A “fashionable” anti-cancer drug with a cost price of 20-30 rubles per pack is sold at an exorbitant price. Drug and arms dealers fight hysterically and weep in three streams ...
      1. your1970
        your1970 11 September 2019 10: 10 New
        0
        Quote: vadimtt
        Drug and arms dealers fight hysterically and weep in three streams ...
        -if you think that the standard course of chemotherapy (free for citizens) is much cheaper, you are mistaken ... it cost (in 2009) 64 000 .....
      2. Evgeny Fedorov
        11 September 2019 11: 36 New
        +2
        One reason for such high drug prices is the sheer cost of developing new drugs. By the way, the story with thalidomide further complicated the procedure for certification of drugs. Now the creation of a new pharmaceutical product in the West costs several billion dollars. And the most unpleasant thing in this story is that the corporation can cancel everything at the very last moment, since, for example, with blind testing, the medicine did not show its advantages or even became dangerous to humans. So pharmaceutical companies have to recapture the costs of other means. In addition, a considerable portion of the money goes to advertising companies and “pushing” drugs among the medical community. In Russia, the situation, in comparison with the whole world, is simply awful. If you delve into it carefully, then you can talk about a threat of national proportions.
        1. Dude
          Dude 11 September 2019 18: 30 New
          +1
          Crocodile tears, about the need to "beat off" the cosmic size, the costs of pharmaceutical companies spent on development, somehow do not convince.
          For some reason, the costs are “beaten off” by medicines for the most serious diseases, when the sick person faces a dilemma - either treatment, or inevitable, and often, quick death, for example - oncology, AIDS, viral hepatitis. It is clear that if you want to live, you will give anything you want. Means, it is necessary to snatch from the patient more.
          1. Evgeny Fedorov
            11 September 2019 18: 38 New
            0
            I wrote "one of the reasons." And I completely agree with you - in modern pharmacology there is not a drop of sympathy and compassion.
            1. Dude
              Dude 11 September 2019 18: 49 New
              0
              And without regulation, in this matter, there was no sympathy, no, and never will be. And not only in this matter. And not only in pharmaceuticals. Capital and profit - everything is as before.
              Thanks for the interesting article! good
  3. Olgovich
    Olgovich 10 September 2019 08: 44 New
    +4
    Good. after all, sometimes lagging behind the global "progress"!

    This abomination did not have time to reach the USSR ....
    1. Reptiloid
      Reptiloid 10 September 2019 20: 22 New
      +4
      Interestingly, when I read the article, I somehow thought kindly about the iron curtain of the USSR. Indeed, at that time, the 50s and 60s, there were much fewer drugs in the USSR in general than we have now. Around the 50s, according to my grandmother, there were balls of some kind of antibiotic with sugar, they were swallowed like vitamins. Many thanks to Eugene for the article. It is timely in connection with new permissions regarding some medicines, unregistered or something ..... ??? It is necessary to clarify about these permissions, or absence. ..... Under these new conditions, anything will leak.
      A huge request to Eugene, to tell about these new conditions of sale, and how not to fit.
    2. Luvad
      Luvad 14 November 2019 10: 17 New
      0
      Oak bark is your option
  4. Undecim
    Undecim 10 September 2019 10: 56 New
    +13
    Nifiga did not understand. Why is a medical article posted on VO? What is the attitude, so to speak?
    The global pharmaceutical industry has long turned into a weapon of mass destruction, focusing not on healing, but on enrichment due to the health of trusting and ignorant people.
    In 2018, revenue from the sale of the pharmaceutical industry amounted to $ 1 billion.
    The net profit of such a well-known company as Johnson & Johnson, received a net profit of $ 16 billion.
    Pharmacy in many countries finances more than half of medical research and occasionally scandals show that often these studies are aimed at manipulating the mass consciousness with the goal of expanding the market.
    It is enough to trace the history of a disease such as depression and the antidepressant market to see this.
    By the way, the antidepressant Prozac, widely and freely sold in Russian pharmacies, is just one of the defendants in one of the high-profile scandals in the pharmaceutical market. It turned out that in addition to the antidepressant, it also has a suicidal effect, but the manufacturing company "modestly kept silent about it."
    And in the Russian market, the share of imported drugs in monetary terms is 70%.
    So such publications make sense. Only they should not be campaigning, but informational.
    1. Catfish
      Catfish 10 September 2019 13: 55 New
      +3
      As the hero of Yuri Nikulin said in one very good film: "There is only one proven remedy for this ailment - good old booze." (film "Business People", the novel "Soul Mates"). wink
      1. Korsar4
        Korsar4 10 September 2019 20: 41 New
        +2
        “And in Russian we will take the soul” (c).
        1. Mordvin 3
          Mordvin 3 10 September 2019 20: 59 New
          +1
          Quote: Korsar4
          And we will take the soul in Russian ”

          Three times per day... wink
    2. Dude
      Dude 11 September 2019 18: 39 New
      0
      But what, is Fluoxetine (Prozac) an over-the-counter drug? It is somehow doubtful, and more harmless drugs are sold only according to prescriptions ...
      1. Undecim
        Undecim 11 September 2019 18: 52 New
        +1
        Do you really think that prescription drugs cannot be bought without a prescription?
        1. Dude
          Dude 12 September 2019 18: 34 New
          0
          Those drugs that are in 107 form - yes, do not buy.
      2. Vladimir_R
        Vladimir_R 15 September 2019 00: 42 New
        0
        Quote: Dude
        only for recipes sell ...


        What is a recipe? "Recipes", with the exception of the "prescription" (List of narcotic drugs of the 2nd and 3rd List) on the accountable form with the "red" seal, is an inscription on a piece of paper, often of the advertising nature of the prescribed drug.
        1. Dude
          Dude 15 September 2019 07: 37 New
          0
          Quote: Vladimir_R
          Quote: Dude
          only for recipes sell ...


          What is a recipe? "Recipes", with the exception of the "prescription" (List of narcotic drugs of the 2nd and 3rd List) on the accountable form with the "red" seal, is an inscription on a piece of paper, often of the advertising nature of the prescribed drug.

          The following prescription forms apply in the Russian Federation:

          Form No. 107 / u-NP - a special prescription form for a narcotic and psychotropic agent of List II of the List

          Form No. 148-1 / u-88 "Prescription form"

          Form No. 107-1 / y "Prescription form"

          Form No. 148-1 / y-04 (l) "Recipe"

          Form No. 148-1 / u-06 (l) “Recipe”

          The third list - without any "red seals, by the way, EMNIP.

          What you called a "piece of paper" - in general, is not a recipe, from the word "completely."
          I wrote directly about the 107 form, directly above your post hi
          The use of promotional forms for appointments is currently prohibited if not mistaken.
    3. Vladimir_R
      Vladimir_R 15 September 2019 00: 39 New
      -1
      Quote: Undecim
      in addition to antidepressant, it also has a suicidal effect

      These are mutually exclusive concepts. In Russia, by the way, fluoxetine is not as common as benzodiazepines (for example, tazepam, which "burst" in tons). And then the question arises, what would happen without these drugs? Indeed, suppose that the cause of death is suicide - the leader after CVD and road accident.
      Quote: Undecim
      in the Russian market, the share of imported drugs in monetary terms is 70%.

      This is according to the most conservative estimates (I am inclined to 90%), because "the share of imported drugs" in most cases is a substance of Indian or Chinese origin, developed in the USA or Germany, we only have it in bulk. If you mean development, then nothing comes to mind except Mildronate and Phenibut.
      1. Dude
        Dude 15 September 2019 08: 17 New
        0
        These are mutually exclusive concepts.

        Sorry, but you are fundamentally wrong. Antidepressants are different, divided into several groups, and among them there are also those in which such a combination is possible. That is why, at the risk of suicide, such drugs are not prescribed, or strictly according to the indications and under medical supervision, for example, in a hospital.
        ... benzodiazepines (for example, tazepam, which "burst" in tons).
        Nowadays, with many diseases, benzadiazepines are not first-line drugs. Now they prefer to prescribe the same SSRIs, tricyclics, serotonin receptor blockers. In addition, they cost more, and they should be taken with very long courses = profit for pharmacologists)) Diazepam, in general, was almost equated with opiates wassat So already tons do not "burst".
        ... except for Mildronate and Phenibut, nothing comes to mind at all.
        There is something else. Cycloferon, for example, EMNIP, domestic development, for example.
        1. Vladimir_R
          Vladimir_R 17 September 2019 00: 23 New
          0
          Quote: Dude
          Diazepam, in general, was almost equated with opiates


          Nobody equated anything to anything. I did not write about diazepam, but about tazepam, which is not even close to Opiates on the Lists.

          Quote: Dude
          Antidepressants are different, divided into several groups, and among them there are also those in which such a combination is possible.

          Please provide names. As far as I know, suicide is considered a kind of "derivative" of depression. And what antidepressants combine a depressive effect?

          Quote: Dude
          Cyclopherol


          You are joking? Can we start seriously discussing homeopathy now?
          1. Dude
            Dude 24 September 2019 19: 07 New
            0
            Nobody equated anything to anything. I did not write about diazepam, but about tazepam, which is not even close to Opiates on the Lists.

            Do not literally, but rather ask the doctors who are faced with this at work.
            Please provide names. As far as I know, suicide is considered a kind of "derivative" of depression. And what antidepressants combine a depressive effect?

            Suicide is not necessarily a “derivative” of depression. However, even if you make such an assumption, in the context in which you mentioned:
            Venlafaxine, Sertraline, Valdoxan, and a bunch of antidepressants that can have such a side effect. In some it is more common, in others (for example, Mirtazapin) - less often. You also need to consider interactions with other drugs that are simultaneously prescribed to the patient. The topic is big, if there is interest - dig the sources, they are on the network. Only (Sic!), Filter the information, a lot of nonsense is written.
            You are joking? Can we start seriously discussing homeopathy now?
            Absolutely not joking, do not compare the soft with the warm. Cycloferon, when used, according to the schemes, has a pronounced antiviral activity.
  5. spech
    spech 10 September 2019 17: 17 New
    +3
    The mechanism of its action was discovered just nine years ago

    About this drug in the "science and life" read in the late 80s
    1. Evgeny Fedorov
      11 September 2019 11: 26 New
      +2
      Yes, indeed, they have been aware of the severe side effects of thalidomide since the beginning of the 60 year. But they did not know how exactly all this happens at the molecular and cellular level. That is, they found only a causal relationship Only at the beginning of the XXI century it was possible to fully reveal the mechanism.
  6. serge siberian
    serge siberian 10 September 2019 20: 00 New
    +2
    So we have today all medicine is a business in the blood, education is a business in the brain. Those in power have ruined their production of everything, even bandages. repeat
    1. your1970
      your1970 11 September 2019 10: 12 New
      0
      Quote: Serge Siberian
      So we have today all medicine is a business in the blood, education is a business in the brain. Those in power have ruined their production of everything, even bandages.
      - Actually, the story happened TAM, not ours.
      However, this is also the case with us — even in the USSR it could very well have happened. Suffice it to recall DDT and its mass application
    2. Reptiloid
      Reptiloid 14 September 2019 10: 32 New
      -1
      There was a plot of Semin about drugs in the Russian Federation. Or rather, about their absence. Here the military doesn’t need to do anything ---- in the absence of foreign drugs, ((somehow the Germans basically occupied our market.)) The population itself will suffer and decrease.
      Private drug industry. Business and nothing personal. What about the ministry?
  7. Vladimir_R
    Vladimir_R 15 September 2019 00: 59 New
    0
    it turned out that mice do not have any teratogenic effect even at exorbitant dosages


    Fun for the sake of.
    Rodent studies cannot say anything about toxicity to humans. The famous food supplement is monosodium glutamate. Mice go blind from him. But people eat tons of it and no one has yet gone blind. Himself, I will not hide, I love, if not too much ... good
    Research should be carried out on people, of course, on volunteers, everything else is just speculation.