Thalidomide monument in gold america. "Thalidomide disaster" - the most striking example in history of the consequences of taking untested drugs

Thalidomide is a drug also known as trade name Mirin. Due to its pronounced anti-inflammatory and immunomodulatory properties, it was previously used in the treatment of HIV and AIDS, lupus, stomatitis, and tuberculosis. Currently, the tool is widely used to treat multiple myeloma, and some types of lymphomas, if previous measures have not been successful.

"Thalidomide": the price of the drug

Finding "Thalidomide" in pharmacies in Moscow is often problematic. The tool can be bought on the Internet, but it will take time and effort to find a good deal. So, the Swiss drug "Thalidomide" can be bought at a price of about 39,000 rubles. This is the cost of the package, where 30 tablets with a dosage of 100 mg.

But you can buy the drug "Thalidomide" cheaper - on the website WWW.ONKO24.COM. Here you will be offered a generic drug at a lower cost - 7,500 rubles.

What are the benefits of generics?

Let's start with what a generic is. This is the name of medicines produced by licensed companies according to the original recipe. Generics are cheaper than original drugs, because the manufacturer does not spend money on the development of a pharmacological formula, testing and advertising. This makes it possible to produce medicines at prices several times lower than those of the original. This does not reduce efficiency.

Thus, you can buy Thalidomide at a relatively low price from the Indian manufacturer Natco Pharma. The company has an impeccable reputation and many years of experience.

"Thalidomide": instructions for use

This drug has a lot side effects therefore, only an experienced doctor should prescribe it and select the dosage.

Tablets are taken once a day, a gradual increase in dose is practiced. It is recommended to start taking with a dosage of 200 mg and increase it by 100 mg every week. Maximum daily dose the drug "Thalidomide" is 800 mg. However, when using it, attention should be paid to the patient's well-being. If it worsens, the dosage should be reduced.

"Thalidomide" has a sedative effect, so it is recommended to take it before bedtime, washing down the tablets with plenty of water.

Possible side effects

"Thalidomide" can cause the following unwanted reactions:

• headache;
• weakness, drowsiness;
• anorexia;
• anemia;
• bradycardia;
• bronchospasm;
• nausea, stomach pain;
• muscle and bone pain;
• chills;
• kidney failure;
• swelling;
• the appearance of skin rashes;
• depression;
• photophobia;
• hearing loss.

Contraindications for use

Due to the presence of a fairly extensive list of side effects, the drug is not prescribed to children, women who are carrying a child and breastfeeding.

"Thalidomide" is contraindicated in the presence of intolerance to the main active substance drug.

Since the use of this medicine may affect the ability to conceive, it is used with caution in women and men of reproductive age.

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This story is more like a movie script, but it's true nonetheless. Perhaps it should be learned by heart when entering the civil service and any responsible position in principle. It tells of a woman scientist who managed to resist the pressure of a pharmaceutical corporation and save thousands of children from disability, and reminds us of how far the consequences of our decisions can spread.

We are in website We believe that some stories have no statute of limitations, and the lessons that history teaches need to be reminded so as not to repeat the same mistakes.

About Frances' life before the "thalidomide scandal"

Frances O. Kelsey dreamed of becoming a scientist since childhood (which was not easy for a woman at that time), and at 21 she already received a degree in pharmacology. And then the stars formed in a happy way: the well-known researcher Geilling from the University of Chicago, when considering resumes of applicants, suggested that Francis is the name of a man, and took Kelsey to his team.

The irony is that here Kelsey was able to find the cause of the mass poisoning of people with an antibiotic solution that was not tested before being put on the market. After 30 years, having joined the FDA, she will partially repeat this experience, but not as a scientist, but as an official: Kelsey will not let thalidomide enter the US market.

About thalidomide

Thalidomide was first synthesized in the middle of the 20th century during the research of the Chemie Grünenthal company for the production of antibiotics. For several years of work, conclusions were drawn, which later became fatal.

• Even when overdosed, thalidomide did not kill the test animals. From this, it was concluded that the drug was harmless, and the manufacturer sent free samples to doctors from Germany and Switzerland for the treatment of patients.
• The drug had a noticeable sedative (calming) effect.

What happened in 1960

“Distaval (thalidomide) is not a barbiturate, a sedative and sleeping pill. Safe calm and healthy sleep.

In September 1960, thalidomide reached the United States. Richardson-Merrell has submitted it to the FDA (Food and Drug Administration) under the name Kevadon. The approval seemed to be just a formality. However, the new employee, Frances O. Kelsey, unexpectedly turned down the application.

What confused her?

• Studies of the safety of the drug gave strange results: an absolute absence of toxicity was noted. But what if the body of experimental animals simply could not absorb the drug? This version has not been tested. On the contrary, when the first experiment showed that the animals hardly calmed down when taking thalidomide, the scientists rearranged the test conditions so that they gave the desired result, so strong was the desire to quickly release the drug to the market. Frances considered such safety evidence insufficient.
• Richardson-Merrell was aware of the risk of developing neuritis (these reports began to come in a year ago), but did not mention this in the report to the FDA. In February 1961, there were more such messages.
• No one conducted tests on the effect of the drug on the developing fetus, and in fact at that time it was already known about the permeability of the placental barrier. Frances theorized that thalidomide caused peripheral nerve palsies and suggested that the damage to the embryo could be even greater.

"Rot Your Line"

Frances asked for more details, and a conflict broke out as a result. She received responses from the US manufacturer, the William S. Merrell Company, waited the required 60 days, and made new requests. They put pressure on her, tried to act through the leadership, reproached her for incompetence and complained about the bureaucracy. Kelsey insisted that the safety evidence was inconclusive and pressed Merrell to do her own research.

“Richardson-Merrell were just on edge,” Kelsey noted. “They were very disappointed because Christmas is the season for sedatives and sleeping pills. They kept calling me and paying me visits, saying:“ We want to see this drug on the market before Christmas, because it's our best selling time."

It lasted until the end of 1961, until finally, scientists from Germany and Australia did not reveal a link between taking thalidomide and numerous cases of deformities in children born after taking it during pregnancy. Only under pressure from the press after the publications, Chemie Grünenthal began withdrawing the drug from the market, notifying its American partners as well.

What was the cost of Kelsey's decision

In order to appreciate how difficult it was for this woman to make such a decision, you need to realize several facts.

• At that time, thalidomide had been sold for several years in more than 40 countries. There was an aggressive marketing campaign. It seemed that the signature on the authorization for sale in the US was just a formality.

The only requirement of American laws was the safety of the drug. In addition, a trial application has already been made: Richardson-Merrell has distributed more than 2.5 million tablets through physicians, and most doctors found it effective and useful, which was confirmed by their reports. There were already tons of Kevadon ready for sale in the warehouses.

At that time, Kelsey worked at the FDA for about a month, and this was one of her first assignments. We can only guess how much strength it took her to resist the numerous accusations of incompetence. The pressure on Kelsey was enormous.

What happened after?

• On August 8, 1962, President John F. Kennedy presented Frances O. Kelsey with the Distinguished Civilian Service Award, the highest non-military honor in the United States. She became the second woman in history to receive such an award.

The thalidomide tragedy has forced many countries to review and tighten licensing policies for many drugs. For example, requirements were added to provide evidence of the effectiveness of a licensed drug, and close monitoring was introduced for both patients receiving the drug and prescribing doctors.

In total, according to rough estimates, over 6 years of the drug's presence on the market, up to 12,000 children were born with deviations due to their mothers taking a "harmless sedative." About 40% of these babies did not live up to 1 year. To understand how hard it was for the survivors, just look at the photos of the most famous victims - the star of German documentary Niko von Glazov and bass-baritone from Germany Thomas Quasthoff.

This is scary. Much more terrible is what medicines they can be cured of. Today, we will tell you about thalidomide. At the beginning of its existence, it was known as a sleeping pill and sedative, but it carried a living hell for the future of patients. The birth of freaks, but not moral ones, although judging by your mother, anything can happen. Mistakes in medicine, pain, torment, crippled destinies and other frightening facts. Read, turn gray and learn another stupidity of people.

The infamous sedative and hypnotic drug - thalidomide, invented by German (and what else?) Pharmacologists after World War II, and manifested as a teratogenic agent, or a drug that disrupted human embryonic development. Naturally, they did not immediately learn about side effects, and the Germans in that century loved surprise. And the peak of fame came in 1962, when it was revealed that over the past six years, about 12,000 people were born with congenital defects due to their mothers taking thalidomide during pregnancy.

Half of the victims did not live even a year. After a long ban, thalidomide began to be used to cure the most severe diseases, such as: leprosy, severe oncological diseases, etc. Do you think that's all? No, here's hell in all its glory!

1. Origin and start of sales of thalomid. The German pharmaceutical company Chemie Grünenthal in 1954 worked on the creation of affordable technologies for the production of antibiotics and peptides. As a result of the work, a drug called thalidomide (thalidomide) was obtained, and pharmacologists studied the finished drug to determine the beneficial field of application.

The first direction of application was anticonvulsant action, but experience with animals did not confirm hopes. However, the drug did not kill animals when overdosed. Scientists have decided that it is not dangerous.

And in 1957, the drug went on sale in Germany under the name Contergan, and in the spring of 1958 it came out in England, from the manufacturer Distillers Company with the name Distaval. In general, thalidomide was taken as a panacea for everything - from impotence to diarrhea, the whole world began to teem with drugs, which included this not harmless ancestor of Herbalife. While in the USSR everything was made from Khrushchev's corn and they did not hear about tolidamide, the capitalists are trying to treat dangerous diseases with it, Asmaval - against asthma, Tensival - from high blood pressure, Valgraine - against migraines. But treating a disease with thalidomide is like treating a headache with a guillotine. Well, let's not get ahead of ourselves.

Relax before we show you the hell that comes with thalidomide.

So, thalidomide appeared in 46 countries of Europe, Scandinavia, Asia, Africa, South America, where 37 different names were invented for it. At the same time, the laws of that hippy era allowed no checks to be made, and no one did them anywhere. Only business, yopta.

In the summer of 1958, Grunenthal spamming merchants with his potion - "thalidomide - the best medicine for pregnant and lactating mothers. Marketing geniuses, this cry was picked up in an advertisement in England by the manufacturing company Distiller. At the same time, not a single person in a white coat from Germany or England tested the effect of this muck on the future human fetus. They just attracted a new consumer - pregnant women. And expectant mothers were offered to eat a miracle pill for nausea or insomnia.

At the same time, quite comrades from Grunenthal in 1959 receive complaints about the side effect of the drug, peripheral neuritis ( inflammatory disease peripheral nerves, in which, along with pain, symptoms of loss or decrease in sensitivity, and paralysis are detected). A trifle, but unpleasant, and not treated. Actually, the dog barks, the caravan moves on. Pharmacologists from Grunenthal not only do not respond in response, they themselves have hidden the complaints. And thalidomide is second only to aspirin in terms of sales.

The same therapists approved the drug and found it effective. Damn, were there really kickbacks then? But, such a grymza on guard of Pindos health, Dr. Francis O. Kelsey, who is in charge of the FDA for the control of licensed drugs, did not find the results of the use of the drug so impressive. And the main factor for the negative decision on the drug was the fact that Richardson-Merrell, knowing about the risk of developing neuritis, did not mention this in the report to the FDA. Thanks to the negative opinion of Francis O. Kelsey, the drug did not go on sale in the United States. Pindos very lucky. VERY.

First reported case side effects thalidomide was the birth of a daughter in the family of an employee of Chemie Grunentha on December 25, 1956 in Stolberg, a girl without ears. The employee's wife received from him not yet registered thalidomide, which he had taken at work. However, the people poked about what was the connection between an unlicensed drug and between the birth of a child with a deviation.
And when thalidomide became available in pharmacies, the fool had shag, the growth of newborns with deviations began. Around the world.

On November 16, 1961, Lenz called Chemie Grunenthal and said something bad about thalidomide. Already on November 18, in the newspaper Welt am Sonntag, his article was published describing more than 150 cases of birth defects in newborns and the relationship with the intake of thalidomide by mothers on early stages. Under pressure from the authorities and the press, on November 26, 1961, Chemie Grunenthal begins recalling thalidomide from the German market, but does not recognize the connection between the outbreak and the drug being produced. At the same time, products with thalidomide in the composition are successfully sold throughout South America. However, even then Chemie Grunenthal does not recognize the connection of the epidemic with its drug. (National socialists and capitalists rolled into one. Germany, keep it up).

The Lancet magazine in December of the same 1961 publishes a letter from William McBride, which deals with the connection of thalidomide with congenital malformations in infants. The drug is no longer sold in other countries. The publication of Lenz and McBride began to pour reviews with confirmations from different countries, the situation made a noise all over the world, in all the media, but even after that the drug was still sold for half a year in some pharmacies, even after the first reports. And in Italy and Japan, the drug was sold for another 9 months. The axis of evil, it is always the axis of evil.

3. The most humane court in the world. Germany. At the end of 1961, the first accusations against Chemie Grunenthal reached the prosecutor's office of Aachen, but only by 1968 did the Germans prepare all the case materials that fit on 972 pages. On May 27, 1968, the first court session was held, there were as many as seven representatives of Chemie Grunenthal in the dock, on charges of having put on the market a dangerous drug that had not been tested and caused great bodily harm to a significant number of children. The entire company was accused of hushing up complaints and not responding to incoming complaints.

On December 18, 1970, the last court session was held, it was decided to close the prosecution, in response to the proposal by Chemie Grunenthal published on April 10, 1970, about the obligation to pay compensation of 100,000,000 German marks to affected children from the use of thalidomide. The court decided that, given the entire system for the production and distribution of drugs, this could happen to any company, and the main task would be to build a new drug licensing system, and not blame all seven people. How the hell is it, no one sat down at all, and thousands of babies died or were left crippled.

4. England and thalidomide. From 1962 to 1966, 70 parents and guardians of thalidomide victim children sued the Distillers Company for negligence seeking damages. Also filed a lawsuit and suffering from peripheral neuritis, who claimed that they fell ill with it after the use of thalidomide. The manufacturing company, shouting "in line, sons of bitches", decided not to bring matters to meetings and agreed with 65 of the 70 applicants. The representatives of the affected children were offered to withdraw the negligence claim in exchange for 40% of the amount for which they wanted to sue the company. In this way, 58 claims were withdrawn, in which the company paid 1,000,000 pounds. From people who know how to bargain. Interestingly, did you manage to bargain with your conscience?

As early as 1971, Distillers was under pressure to set up a trust fund to help children with congenital physical disabilities, and by the beginning of autumn the fund was ready to start working with a volume of 3,250,000 for ten years, while not taking into account the amount paid to persons on list X .

However, on September 24, 1972, The Sunday Times published an article "Our thalidomide children are the cause of national disgrace", where he provocatively jacked up payments to the Distillers company. Indeed, the amounts of payments are not comparable with the amount of damage caused to English families, compensation of 3,250,000 pounds, against the background of the company's annual turnover of 64.8 million pounds and assets of 421 million, are weightless. And such milking of money can be understood:

At the same time, everyone throws shovels at Distillers, and they gritting their teeth create a fund project in the amount of 20,000,000 pounds in December 1972, with payments over 7 years.

On August 10, 1973, the Thalidomide Children's Trust was founded by public organizations to support disabled children whose mothers took thalidomide during pregnancy. The government of England exempted payments to child victims of the thalidomide tragedy from taxation.

Considering the fact that the claims were mostly withdrawn and the compensation paid before the trial, the criminal case was not opened and none of the Distillers sat down. Total fucked up! Sorry, it's somehow like that - "Well, your child is disabled, well, he died in agony, well, we established the fund, that's all, what other claims to us?" Money rules this world.

In Japan, the product was completely withdrawn from the shelves only on September 13, 1962, and this is almost 10 months after Contergan was recalled in Germany. 309 children have been identified as victims of thalidomide in Japan. During the trial, the parties were Dainippon and the Ministry of Health of Japan, on October 26, 1974, a decision was made to pay monetary compensation to families with children with disabilities due to the use of thalidomide. Based on the calculations of Dr. Lentz, who spoke at the trial, payments to Japanese families are much higher than payments to families in other countries. Well, cross-eyed, they didn’t jail anyone either.

In all countries where thalidomide was sold, except Italy, funds were set up to compensate victims of thalidomide. Italy is not without reason the birthplace of fascism and Celentano.

By the way, less than 50 years later, representatives of the prosperous German Gruenenthal apologized, noting that the possible side effects of the drug could not be identified before it entered the market. Here, well done, the main thing is not to admit guilt.

Ophthalmologist Professor Robert D'Amato of the Folkman Laboratory at Harvard University from 1992 to 1994 proposed the idea that the teratogenicity of thalidomide is due to its anti-angiogenesis properties.

Did everyone understand? A man at Harvard learns to say that, so don't worry, the uncle said that thalidomide is good in severe cases because it is bad in the lungs. In experiments on chickens and rabbits, thalidomide proved to be a drug that can significantly reduce angiogenesis (see above), which gave grounds to consider the possibility of using the drug in the treatment of severe oncological diseases.

Already in 1997, Professor Bart Barlogi experimentally tested how effectively thalidomide fights against malignant tumors. He gave thalidomide to 169 doomed patients who had the disease and failed chemotherapy and bone marrow transplants from the Arkansas Cancer Research Center. In many patients, the development of tumors slowed down, but 18 months after the start of the experiment, half of the patients were still alive, contrary to statistics. After a two-year study of the drug, in 1999 Barlogi made an official statement about thalidomide as a means of combating multiple myeloma (it is better not to know what it is), in those severe cases when conventional methods of treatment no longer work.

In parallel with the above facts, in the 90s, scientists from the laboratory of the American professor Jilla Kaplan, together with Dr. David Stirling, actively studied thalidomide. They found that yes, thalidomide can effectively treat many terrible diseases, including tuberculosis and AIDS. NOT INSSON IN PREGNANT WOMEN!

Damage to the fetus by thalidomide affects all parts of the body. The most common were defects or absence of upper and lower extremities, lack of auricles, defects in the eyes and mimic muscles (facial muscles, yes, poker face). Also, thalidomide changes the formation internal organs, destroying the heart, liver, kidneys, digestive and genitourinary system, and leads to the birth of children with a very strong delay in mental development, of course, epilepsy and autism.

Recall none of the perpetrators were put in jail. Nowhere. However, there is a rumor that Irwin Welsh wrote his "Ecstasy" not only under ecstasy. But also impressed by the story about how a baby was stolen from one of the creators of thalidomide, and then his hands were sent by mail.

8. How thalidomide works. The thalidomide molecule consists of two optical isomers - dextrorotatory and levorotatory. One gives the therapeutic effect of the drug, while the second is the terrible cause of its teratogenic effects. This isomer is included in cellular DNA at sites rich in G-C ties, and interferes with the normal process of DNA replication required for cell division and embryonic development. In short, one side heals, the other cripples.

And due to the cunning property of thalidomil isomers in the body - to pass into each other, at any moment, the purification of one of them does not have an effect and, as a result, kills the therapeutic effect of the drug. He is like a drunken soldier on the attack - he will either shoot his own or close the embrasure with his chest. Or fall asleep under a bush and not touch anyone.

We decided to insert this picture to distract you a little from what you read.

In addition to the main effect - on the fetus, the use of thalidomide has a negative effect on the adult. Side effects are just childish pranks: dizziness, impaired menstrual cycle, weakness, headache, drowsiness, fever. Or peripheral neuritis.

P.s.

Before, there were no pills, and people were healthy and ruddy on one potato with bacon. Not like you, pale and skinny, jerky primates.

In 1954, the German pharmaceutical company Chemie Grünenthal was conducting research to develop an inexpensive way to produce antibiotics from peptides. In the course of research, the company's employees obtained a drug they called thalidomide (thalidomide), after which they began to study its properties to determine the scope of its application.

Initially, thalidomide was supposed to be used as an anticonvulsant, but the first experiments on animals showed that such properties new drug does not possess. However, it was found that an overdose of the drug did not kill the experimental animals, which gave reason to consider the drug harmless.

In 1955, Chemie Grünenthal informally sent free samples of the drug to various doctors in Germany and Switzerland.

People who took the drug noted that although it does not show anticonvulsant properties, it has a calming and hypnotic effect. People who took the drug reported that they experienced deep "natural" sleep that lasted all night.

The effect of the drug impressed many therapists, a safe sedative and hypnotic agent stood out against the background of existing sleeping pills. The safety of overdose (accidental or suicide attempt) of the drug was emphasized further when promoting this product on the market.

Even though the drug had similar effects in humans, it needed to be shown to be effective in order to be licensed. However, the drug did not have a sedative effect on animals, so representatives of Chemie Grünenthal had to make a special cage for the demonstration, which served to measure the slightest movements of experimental animals. In this way, representatives of Chemie Grünenthal were able to convince the commission that, despite the fact that the mice were awake after taking the drug, their movements slowed down to a greater extent than in animals that were injected with other sedatives. During the demonstration, the representatives of the company made the main emphasis on the fact that the drug is absolutely safe, which made it possible to obtain a license for the production and distribution of the drug.

In 1957, the drug was officially released for sale in Germany under the name Contergan, in April 1958 in the UK it was released by the Distillers Company under the name Distaval. In addition, thalidomide was marketed as medicines for a variety of cases, for example, Asmaval - against asthma, Tensival - against high blood pressure, Valgraine - against migraines. In total, thalidomide went on sale in 46 countries in Europe, Scandinavia, Asia, Africa, South America, where it was produced under 37 different names. No additional independent studies of the drug in any country have been conducted.

In August 1958, a letter was received from Grünenthal to someone noting that "thalidomide is the best medicine for pregnant and nursing mothers." This point was almost immediately reflected in the advertising of the product in the UK by Distiller, despite the fact that studies of the effect of the drug on the fetus were not carried out by either the German company Grünenthal or the English Distiller. Thalidomide has been successfully used to eliminate unpleasant symptoms associated with pregnancy, such as insomnia, anxiety, and morning sickness.

Beginning in 1959, Grünenthal began receiving letters of reports of peripheral neuritis and other side effects from the drug. There were opinions that the drug should be sold only on prescription. Despite this, thalidomide continued to dominate sales and in some countries fell behind only aspirin in terms of sales. Company policy has been to deny the association of Contergan with peripheral neuritis, and Grünenthal has stubbornly resisted attempts to limit sales of the drug.

Francis O. Kelsey

On September 8, 1960, the US Richardson-Merrell Company submitted thalidomide to the US Food and Drug Administration under the name Kevadon. American laws of the time for licensing medicinal product demanded only the safety of its use. These same laws allowed for clinical trial use of a drug prior to licensing, allowing Richardson-Merrell to distribute more than 2,500,000 tablets to 20,000 patients through 1,267 physicians. The drug was approved by a majority of physicians who considered it safe and useful, which they reflected in their reports. However, Dr. Francis O. Kelsey, appointed by the FDA to oversee licensing of the drug, was unimpressed with the results of this test. One of the main factors that influenced Kelsey's decision was that Richardson-Merrell knew about the risk of developing neuritis, but kept silent about it in the report to the FDA. Francis O. Kelsey, despite strong pressure from Richardson-Merrell, did not approve Kevadon and it was not placed on the US market. Of course, at that moment she did not yet suspect how many lives she had saved by making such a decision.

On December 25, 1956, in the city of Stolberg, a daughter without ears was born in the family of an employee of Chemie Grünenthal. This employee was giving his pregnant wife an unofficial thalidomide he had taken at work. At that time, no one saw a connection between taking the drug and a malformation of the fetus, the appearance of children with congenital physical defects was repeatedly observed earlier. However, after the introduction of thalidomide on the market, the number of children born with congenital malformations increased dramatically. In 1961, the German pediatrician Hans-Rudolf Wiedemann drew public attention to this problem, describing it as an epidemic.

At the end of 1961, almost at the same time, Professor W. Lenz in Germany and Dr. McBride in Australia identified an association between an increased number of birth defects in newborns and the fact that the mothers of these children were taking thalidomide. in early pregnancy.

On November 16, 1961, Lenz reported his suspicions to Chemie Grünenthal by telephone. On November 18, a letter was published in the Welt am Sonntag newspaper in which he described more than 150 cases of birth defects in newborns and linked them to early mothers taking thalidomide. On November 26, under pressure from the press and German authorities, Chemie Grünenthal began withdrawing thalidomide from the German market, notifying Richardson-Merrell, whose products had already spread to South America. At the same time, Chemie Grünenthal continued to deny the connection between the epidemic and its drug.

On December 2, Distillers announced the withdrawal of the drug from the markets in an open letter published in the English journals The Lancet and the British Medical Journal.

In December 1961, a letter from William McBride was published in The Lancet, in which he also described his observations regarding the association of thalidomide with birth defects in infants. After that, the drug began to be removed from the shelves in other countries. Confirmation of the words of Lenz and McBride began to come from different countries, the situation received wide publicity in newspapers, on radio and on television, however, despite this, the drug was available for purchase in some pharmacies and six months after the first reports. In Italy and Japan, the drug was sold even 9 months after the publicity.

In early 1962, Lenz speculated that since 1959, between 2,000 and 3,000 thalidomide-victim children had been born in West Germany. In total, according to various estimates, as a result of the use of thalidomide, about 40,000 people received peripheral neuritis, from 8,000 to 12,000 newborns were born with physical deformities, of which only about 5,000 did not die at an early age, remaining disabled for life.

Teratogenic effects of thalidomide

As it turned out, thalidomide has teratogenic (from the Greek. τέρας - a monster, a freak; and other Greek. γεννάω - I give birth) properties and poses the greatest danger in the early stages of pregnancy. The critical period for the fetus is 34-50 days after the woman's last menstrual period (20 to 36 days after conception). The likelihood of a child with physical deformities appears after taking just one tablet of thalidomide in this period of time.

Fetal damage caused by thalidomide affects a wide variety of body parts. Among the most common external manifestations are defects or absence of the upper or lower extremities, the absence of auricles, defects in the eyes and mimic muscles. In addition, thalidomide affects the formation of internal organs, damaging the heart, liver, kidneys, digestive and genitourinary systems, and can also lead in some cases to the birth of children with mental retardation, epilepsy, autism. Limb defects are called phocomelia and amelia (the literal translation from Latin is “seal limb” and “lack of limb”, respectively), which appear as a kind of seal flippers instead of a limb or their almost complete absence.

According to the data collected by Lenz, about 40% of newborns exposed to the drug during the fetal stage died before their first birthday. Some destructive influences (particularly those concerning the child's reproductive system) may not appear until many years after birth and can only be revealed as a result of careful analysis.

No less horrific is the fact that these physical deformities can be inherited. This was stated by representatives of the English Society of Victims of Thalidomide. As evidence, they cited the story of 15-year-old Rebecca, the granddaughter of a woman who was taking thalidomide. The girl was born with shortened hands and three fingers on each hand, a typical deformity associated with this drug.

The mechanism of teratogenic effects

Schematic representation of thalidomide enantiomers

The thalidomide molecule can exist in the form of two optical isomers - dextrorotatory and levorotatory. One of them provides the therapeutic effect of the drug, while the second is the cause of its teratogenic effects. This isomer is wedged into cellular DNA at sites rich G-C bonds, and interferes with the normal process of DNA replication necessary for cell division and embryonic development.

Since the enantiomers of thalidomide are able to pass into each other in the body, a preparation consisting of a single purified isomer does not solve the problem of teratogenic effects.

thalidomide victims

Monument to the victims of thalidomide in London, erected in 2005. The model was Alison Lepper, who was pregnant at the time of the creation of the sculpture. Her child grew up healthy.

In 2012, the German pharmaceutical concern Gruenenthal opened a bronze monument in the city of Stolberg to children affected by the drug thalidomide.

Surveys show that people know very little about the topic of "experimenting on animals" and often consider vivisection to be a justifiable procedure. But is it? Let's take it step by step.

A huge number of animals die in laboratories every second. According to official data alone, this is 150 million a year. The unofficial figures are many times higher. Animals are forced to smoke, inhale poisonous fumes, drink various pills, inject chemicals into their organs, and cut their flesh. Millions of monkeys, dogs, cats, rats, rabbits, birds, frogs, dolphins and other living creatures die in terrible suffering everywhere at the hands of doctors. They test cosmetics, household chemicals, various consumer goods, medicines, and methods of treatment.

But in modern world the need for such a terrible payment for the inventions of mankind is gradually disappearing.

Why is there no urgent need for animal testing?

1. Low testing efficiency. World practice has shown that hundreds of drugs that, when tested on animals, have confirmed their effectiveness, provoked many unforeseen deviations in humans, up to death.

In particular, terrible consequences were observed after the use of a sedative for pregnant women - Thalidomide. The rats did well in the studies, but 10,000 malformed babies were born in humans using thalidomide. A monument to the victims of Thalidomide was erected in London.

Also in England, more than 3,500 asthmatics died after taking Isoprenaline, the rate of which was carefully studied in animal tests, but the same dose turned out to be toxic to humans. By the way, human toxicity has never been tested in animals.
- According to the director (in the past) of the largest vivisection laboratory Huntingdon Life Sciences in the UK, the positive results for humanity and the results of animal experiments coincide only by 5-25%.
- 40% of patients (stable) suffer from all kinds of side effects of drugs not found in animals.
- Experiments on rats (the main victims of vivisection) make it possible to determine the causes of cancer in humans only in 37% of cases.

2. Unjustified expenses of money and time. Studying a single drug in animals costs millions of dollars and roughly 20 years of research. While new humane testing methods allow you to do this many times faster.

3. At least 450 alternative ethical scientific methodologies for drug testing have been developed, more relevant to the human body (these are SkinEthic, EpiDerm, EPISKIN skin models, the 3T3 test designed to measure phototoxicity, also the BCOP test to measure the eye response to stimuli, and many others). In Europe (in all EU countries), the government has encouraged manufacturers to use these products when testing cosmetics.

What alternatives to animal testing are there?

Some scientists give seemingly strong arguments that we have no choice: either we will test drugs on living creatures, or we will stop science, and, accordingly, the invention of drugs that save thousands of human lives. However, today this approach does not stand up to criticism, at least with regard to testing cosmetics. Because Humane Testing Methods Do Exist. But not everyone knows about them or does not want to spend money and learn advanced approaches, preferring to work the old fashioned way.

Humane methods for testing cosmetics/drugs are of several types: genomic, in vitro, computer simulation, studies on healthy and sick volunteers. Also, scientists gave the world all kinds of aggregates, dummies, imitators human body allowing medical students to study without harming animals. Let's consider some methods and tools in more detail.

1. Cell method in vitro. Most efficient and cheapest. Testing of drugs, chemicals, consumer products and cosmetics on a human cell in vitro (in vitro). For example, this is done in one of the oldest laboratories CeeTox. These humane tests completely replace cruel toxicity testing (injecting a toxic substance into the abdomen and lungs of animals, dropping substances into the eyes or an open wound on the body). National Academy of Sciences - in the report of this organization from 2007. it has been confirmed that in vitro tests of the species can completely replace animal tests.
2. Human liver 3-D in vitro. The technology was developed by the biotechnology organization Hµrel. It is used to study the action of chemicals in the human body. Can be used to test cosmetics, drugs, chemicals.

3. Modular IMmune In vitro Construct System capable of creating a full-fledged human immune system from cells. But only in mini-format, the size of a penny. It tests vaccines against AIDS/HIV. Allows you to create immune systems people from different regions of any skin color. The tests replace cruel experiments in which monkeys are infected with HIV and tested for vaccines.
4. Equivalent human tissue 3-D in spec. in vitro MatTek replaces animal tests directly related to radiation exposure, chemical weapons testing, etc.
5. Methods for recording and processing images EEG, MRI, fMRI, PET, CT allow you to explore the human brain to the last neuron, replacing the experiments on the brain of cats, rats, monkeys. And by using transcranial magnetic stimulation, scientists are able to induce temporary and reversible brain diseases, providing rich data about the human brain that cannot be obtained from animals.

6. Method for taking a DNA sample from human cells and further re-creation in the laboratory to obtain antibodies to various pathogens. Previously, for this, cancer cells were introduced into the body of mice.
7. Microdosing method. Allows you to get information about the safety of the drug, about its transfer by people. Volunteers are given a small single dose of the drug, which is not able to cause a pharmacological effect. Then, with the help of image processing methods, it is observed how this drug is broken down in the human body.
8. Created a synthetic simulator of the human body(SynDaver company), simulating the mechanical, thermal and physico-chemical properties of living tissue. This proven technology is used to replace live animals, cadavers, sick people in medical device research, clinical training, and surgical simulation.

9. 95% of medical schools in the United States have replaced the use of animals in laboratories completely by switching to the method of complex modeling, i.e. virtual reality system, Human reactions are recreated with the help of computer tools. They control clinical experience.

Communities of people against vivisection:

InterNICHE - international. Society for Humane Education;
- IAAPEA - International Association Against Painful Experiments on Animals;
- BUAV - the British Union, advocating the speedy abolition of vivisection;
- Vita - the center for the protection of the rights of all animals in the Russian Federation.

Famous people of the past who opposed vivisection: Bernard Shaw, Victor Hugo, Charles Darwin, Robert Burns, Ernest Seton-Thompson, John Galsworthy, Leo Tolstoy, Albert Schweitzer.

Books that justify the cruelty of vivisection:

- “A thousand doctors of the world against animal experts”, “Big medical. deception" - ed. Hans Ruesch;
- “Science is being tested”, “Cruel deceit” - author. Robert Sharp.
- "Experiments on animals with medical. and scientific points of view" - ed. MD Waltz A;
- "Experiments on animals, experimenters" - author. psychiatrists Herbert, Margot Stiller;
What have you always wanted to know about animal testing? A look behind the scenes - ed. Dr. Corina Guericke

Movies and cartoons against vivisection:

- "Absurdity: experiments on animals" - German. cartoon in Russian 2013

"Experimental Paradigm"