In 1954, the German pharmaceutical company Chemie Grünenthal undertook research to develop an inexpensive way of producing antibiotics from peptides. In the course of research, the company's employees received a drug they called thalidomide, after which they began to study its properties to determine its scope.
Initially, thalidomide was supposed to be used as an anticonvulsant agent, but the first experiments on animals showed that the new drug does not possess such properties. 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 unofficially 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 sedative 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, the safe sedative and hypnotic drug stood out against the background of existing hypnotic drugs. The safety of an overdose (accidental or attempted suicide) of the drug was especially noted in the future when promoting this product on the market.
Although the drug had a similar effect on humans, it had to be shown to be effective in order to be licensed. However, the drug did not have a sedative effect on animals, so the representatives of the Chemie Grünenthal company had to make a special cage for the demonstration, which served to measure the slightest movements of the experimental animals. Thus, 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 company's representatives focused on the fact that the drug is absolutely safe, which allowed them to obtain a license for the production and distribution of the drug.
In 1957, the drug was officially marketed 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 has been marketed as medicines for a wide variety of cases, such as Asmaval for asthma, Tensival for high blood pressure, Valgraine for migraine. In total, Thalidomide went on sale in 46 countries of Europe, Scandinavia, Asia, Africa, South America, where it was produced under 37 different names. No additional independent studies of the drug have been conducted in any country.
In August 1958, someone received a letter from Grünenthal stating that "thalidomide is the best medicine for pregnant and lactating mothers." This point was almost immediately reflected in an advertisement for the drug in the UK by Distiller, despite the fact that research on the effect of the drug on the fetus was not carried out by either the German company Grünenthal, or the English company 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 with reports of peripheral neuritis and other side effects from the drug. There were opinions that the drug should only be sold as directed by a doctor. Despite this, thalidomide continued to hold the leading position in sales and in some countries lagged behind only aspirin in terms of sales. The company's policy was to deny Contergan's association with peripheral neuritis, and Grünenthal stubbornly resisted attempts to restrict sales of the drug.
Francis O. Kelsey
On September 8, 1960, in the United States, the Richardson-Merrell Company submitted thalidomide to the FDA under the name Kevadon. American laws of that time required only the safety of its use for the licensing of a drug. These same laws allowed clinical trial use of the drug prior to licensing, allowing Richardson-Merrell to distribute more than 2,500,000 tablets to 20,000 patients through 1,267 therapists. The drug was approved by most doctors who found it safe and beneficial, which they reflected in their reports. However, Dr. Francis O. Kelsey, appointed by the FDA to oversee the licensing of the drug, was not impressed 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 did not report it to the FDA. Frances O. Kelsey, despite strong pressure from Richardson-Merrell, did not approve Kevadon and it did not enter the US market. Of course, at that moment she still did not suspect how many lives she saved by making such a decision.
On December 25, 1956, a daughter without ears was born in the family of an employee of Chemie Grünenthal in the city of Stolberg. This employee gave his pregnant wife thalidomide, which had not yet been officially released, which he took at work. At that time, no one saw the connection between taking the drug and fetal malformation, the appearance of children with congenital physical defects was repeatedly observed earlier. However, after thalidomide entered the market, the number of babies born with congenital malformations increased dramatically. In 1961, the German pediatrician Hans-Rudolf Wiedemann (German 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 found a link between the 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, his letter was published in the Welt am Sonntag newspaper, in which he described more than 150 cases of congenital malformations in newborns and linked them to mothers taking thalidomide in the early stages. On November 26, under pressure from the press and the German authorities, Chemie Grünenthal began recalling thalidomide from the German market, notifying Richardson-Merrell, whose products had already been distributed in 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, the Lancet published a letter from William McBride, in which he also described his observations regarding the connection 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 was widely publicized in newspapers, on radio and on television, however, despite this, the drug was available for purchase in some pharmacies even six months after the first reports. In Italy and Japan, the drug was sold 9 months after the publicity.
In early 1962, Lenz suggested that, since 1959, between 2,000 and 3,000 thalidomide children were born in West Germany. In total, according to various estimates, as a result of the use of thalidomide, about 40,000 people got 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 - monster, freak; and other Greek γεννάω - I give birth) properties and represents the greatest danger in the early stages of pregnancy. The critical period for the fetus is 34-50 days after the last menstruation in a woman (20 to 36 days after conception). The likelihood of a child with physical deformities appears after taking just one thalidomide tablet during this period of time.
Fetal damage caused by thalidomide affects a wide variety of parts of the body. 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 facial muscles. In addition, thalidomide affects the formation of internal organs, destructively acting on the heart, liver, kidneys, digestive and genitourinary systems, and can also lead in some cases to the birth of children with mental disabilities, epilepsy, autism. Limb defects are called phocomelia and amelia (literal translation from Latin is “seal limb” and “absence of limb”, respectively), which appear in the form of a kind of seal flippers instead of a limb or their almost complete absence.
According to data collected by Lenz, about 40% of newborns exposed to the drug during the developmental stage of the fetus died before their first birthday. Some destructive effects (in particular, concerning the reproductive system of the child) can manifest themselves only many years after birth and can only be identified as a result of careful analysis.
No less horrifying is that these physical deformities can be inherited. This was stated by representatives of the English Society of Thalidomide Victims. As evidence, they cited the story of 15-year-old Rebecca, the granddaughter of a woman taking thalidomide. The girl was born with shortened handles and three fingers on each hand, a typical deformity associated with this drug.
The mechanism of teratogenic effects
Schematic representation of the enantiomers of thalidomide
The thalidomide molecule can exist in the form of two optical isomers - right and levogyrate. One of them provides the therapeutic effect of the drug, while the second is the cause of its teratogenic effect. This isomer wedges into cellular DNA at sites rich in G-C bonds and interferes with the normal DNA replication process necessary for cell division and embryo development.
Since the enantiomers of thalidomide are able to pass into each other in the body, a drug consisting of one 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 sculpture's creation. Her child grew up healthy.
In 2012, the German pharmaceutical concern Gruenenthal opened a bronze monument to children affected by thalidomide in the city of Stolberg.
In January 1961, John F. Kennedy became the President of the United States, in April for the first time in history man conquered the vastness of space, and in August the foundation stone of the Berlin Wall was laid. At the end of the same year, the world was shocked by a disaster of an unprecedented scale - it turned out that thousands of people were victims of a drug based on thalidomide. This catastrophe went down in history as the "thalidomide tragedy." Everyone knows the outcome - almost 10,000 children with congenital limb deformities and other defects caused by thalidomide.
After 50 years, about 3,500 people with disabilities survived (most of them, 2,700 people live in Germany), who had to face additional problems related to the death of their caring parents. Grunental ”2, which developed the drug, additional payments in the amount of 4 million euros. And this despite the fact that as of December 2005, the victims had already received benefits in the amount of over 400 million euros.
Thalidomide was developed by the Grunental company in 1954. It was originally planned to use it as an anticonvulsant, but animal tests did not reveal such an effect. Informal human studies have shown that the drug has sedative and hypnotic effects. Unlike other sleeping pills of that time, it was not addictive and was well-tolerated.
Tests in rodents (common practice at the time) showed no side effects. And since in the mid-1950s there were no standards for the development, production or promotion of medicines on the market (there were no federal laws regulating these types of activities, or a special licensing body), then, accordingly, there were no obstacles to that. that on October 1, 1957, Contegran appeared on the German pharmaceutical market. In April 1958, it was also released in the UK by Distillers under the name Distaval. In total, thalidomide went on sale in 46 countries in Europe, Asia, Africa and South America, where it was produced under 37 different names. No additional independent studies of the drug have been conducted in any of these countries.
In the shortest possible time, thalidomide became the sales leader among hypnotics and sedatives not only in Germany, but throughout the world, and among the people acquired the status of a "miracle cure" for insomnia, coughs, colds and headaches. Thalidomide has also been found to be effective against morning sickness, and thousands of pregnant women have taken the drug to relieve symptoms of toxemia. At the time of the development of the drug, it was believed that the placenta reliably protects the fetus from the effects of any medical drug.
"The darkness covered the city hated by the procurator"
At the end of 1956, a girl without ears was born into the family of an employee of the Grunental company. However, they did not attach much importance to this fact - children with birth defects were born earlier. Only later it was established that the same thalidomide, which the employee of the company illegally brought home from work for his pregnant wife, was guilty of the child's disability.
In 1958-1959. the number of children with birth defects has increased dramatically. However, no one associated their appearance with the use of a thalidomide-based drug by pregnant women. The reasons were given for a variety of reasons, including nuclear weapons tests. Since the largest number of children with birth defects appeared in Germany, it was there that the German Research Foundation DFG (Deutsche Forschungsgemeinschaft3) launched a large-scale project to investigate the case. To no avail. In September 1959, the Department of Health of the German Ministry of Foreign Affairs created a Working Group on Genetics, in particular, its jurisdiction included the investigation of the causes of birth defects in children and radiation damage. However, there was absolutely no use from this group either.
In 1961, the "epidemic" took on a frightening scale. In the fall of that year, Vidukind Lenz, a Hamburg pediatrician and university professor of human genetics, began his own investigation to confirm his suspicions that thalidomide could be the cause of the teratogenic effect. On November 15, 1961, he reported the probable teratogenic effects of thalidomide to the head of the Grunental Research Center and duplicated his message the next day in a letter to the company's board members.
On November 27, 1961, Grunental withdrew its product from the market, 12 days after receiving the first information about its unsafeness. In December, the British company Distillers recalled the drug. At the same time, independently of Lenz, identical conclusions were made by another doctor, Australian gynecologist William McBride. After that, the drug began to be withdrawn from sales in other countries. In Italy and Japan, however, thalidomide was sold 9 months after the publicity.
The teratogenic effect of thalidomide was experimentally confirmed only 3 years later, in 1964, by tests carried out on New Zealand white rabbits. On ordinary laboratory animals, the effect of the drug was not manifested. Only a few years later did the research community come to the conclusion that humans are about 100 times more sensitive than rodents to the effects of thalidomide. Last but not least, the thalidomide tragedy prompted the medical community to realize that substances that appear almost harmless in standard animal testing can subsequently have devastating effects on humans.
Another harmful effect of thalidomide, peripheral neuritis, became known to Grunental as early as 1960. As soon as the fact of such an effect was confirmed, the company switched the drug from OTC to prescription (this happened in 1961).
In total, according to various estimates, as a result of the use of thalidomide, about 40,000 people got peripheral neuritis, from 8,000 to 12,000 newborns were born with physical deformities, of which about 5,000, who did not die at an early age, remained disabled for life.
The case is being heard
In 1968, a criminal case was initiated against the management of the Grunental company, the hearing of which took place in Alsdorf pod Aachen (Germany) from May 27, 1968 to December 18, 1970. The trial became the longest and most expensive in legal history Germany at that time. As a result, the court ruled that, given the entire system of production and distribution of drugs, this could happen to any pharmaceutical company, and the first priority is to change the existing system, and not to blame several people for the tragedy. At the same time, it was found that the employees of the company adequately tested about: sedative and hypnotic drugs in accordance with the norms of the time. And the quick recall of the product from the market was viewed in an extremely positive manner.
And yet, even before the end of legal proceedings in April 1970, an agreement was reached under which Grunental pledged to pay DM 100 million to the victims of the drug. This agreement put the company on the brink of financial collapse. The amount of compensation approved at that time, according to unbiased experts, exceeded all the resources of the company by 20 million German marks.
The government also did not stand aside, taking responsibility for what happened, and pledged to find funds to adequately compensate the victims of the thalidomide tragedy. As a result, in 1972 the Foundation for Helping Children with Disabilities (Hilfswerk fur behinderte Kinder) was founded. 110 million DM was donated by Grunental to this fund, and the German government contributed another 100 million DM. From the resources of this fund, thalidomide victims still receive a monthly pension, the amount of which depends on the degree of violation.
Criminal cases appealing against the decision to establish the Fund as punishment for those responsible for the tragedy were dropped in the mid-1980s. The German Constitutional Court upheld the decision of the District Court of Aachen.
Two-faced Janus
The thalidomide molecule has a cyclic structure with two rings: left-handed phthalimide and right-handed glutarimide with an asymmetric carbon atom. Thus, thalidomide is present as a racemate with optically active S (-) and R (+) isomeric forms.
The thalidomide molecule can exist in the form of two optical isomers - right and levogyrate. One of them provides the therapeutic effect of the drug, while the second is the cause of its teratogenic effect. This isomer wedges into cellular DNA at sites rich in G-C bonds, and interferes with the normal process of DNA transcription, which is necessary for cell division and embryo development.
Since the enantiomers of thalidomide are able to pass into each other in the body, a drug consisting of one purified isomer does not solve the problem of teratogenic effects.
"Sometimes they come back"
In 1964, at the Hadassah Hospital in Jerusalem, Yakov Sheskin accidentally gave thalidomide to a patient with leprosy, and the drug was unexpectedly effective against the disease. Later, a series of studies in Venezuela showed that of 173 patients who took the drug, 92% were completely cured. Further studies by WHO on 4552 patients with leprosy showed 99% improvement. In 1998, the FDA approved thalidomide "for use in the treatment of leprosy symptoms." Research is under way to determine the effectiveness of thalidomide in treating symptoms associated with AIDS, Behcet's disease, lupus, Sjogren's syndrome, rheumatoid arthritis, inflammatory bowel disease, macular degeneration, and certain cancers. To prevent possible fetal exposure to thalidomide, which has returned to the market, the drug manufacturer has developed the STEPS program:
1. Thalidomide can only be dispensed by STEPS registered pharmacists who are instructed to reduce the risk of serious birth defects when using thalidomide during pregnancy.
2. In addition, the drug should not be prescribed without a negative pregnancy test confirmed in writing by a physician, carried out 24 hours before the start of therapy. A pregnancy test should be done weekly during the first month of treatment, and then every 4 weeks in women with a regular cycle and every 2 weeks in women with an irregular cycle. Recipes are only valid for 1 month. The patient should refrain from sexual intercourse or use reliable contraception at least one month before starting treatment and after a month after taking the last dose of the medicine. For all patients, special questionnaires are started, which will further help to detect any adverse effects of thalidomide use and, possibly, identify areas in which precautions should be strengthened. In vitro fertilization, breastfeeding, and blood donation are also contraindicated in women taking thalidomide.
3. Male patients should also abstain from sexual intercourse or use condoms during intercourse while taking the drug and for 1 month after the end of treatment, since it is not known whether thalidomide in semen is dangerous. Sperm or blood donation is also prohibited.
4. It is imperative that each patient understands that thalidomide is prescribed only to him, it is strictly prohibited to transfer it to third parties.
One of the most important lessons that the thalidomide tragedy has taught the world has been the development of a wide range of measures to reduce the risks associated with the licensing of new pharmaceutical products. For Germany, the Medicines Act (AMG - Arzneimittlgesetz) 1976, which entered into force on 1 January 1978, marked the beginning of a new era. In Russia, we recall that Pharmacovigilance was created only in 1997.
Technological progress, the strengthening of the pharmacological control service, the introduction of the FDA system - all this largely helps to ensure that a modern person will henceforth be protected from such completely undesirable influences. However, no one can give full guarantees that one day some already known and even approved drug will not suddenly show some undesirable side effect. That is why the overwhelming majority of drugs according to the FDA classification are marked "Category C: risk during pregnancy is not excluded"
Because a study on pregnant women of an unknown drug is impossible (also due to the thalidomide tragedy). And this is good.
Mikhail Tamarkin, Department of Obstetrics and Gynecology with a course of perinatology, PFUR (Moscow),
source - StatusPraesens. Gynecology, obstetrics, barren marriage ",
Copywriting: Irina Lebedeva
The "thalidomide disaster" is the most striking example of the consequences of taking untested drugs in history.
In 1954, the German pharmaceutical company Chemie Grünenthal developed a peptide-based antibiotic drug called Thalidomide. Initially, it was assumed that the drug would become an inexpensive and effective anticonvulsant agent, however, during clinical trials it turned out that it does not have an anticonvulsant effect, but is an excellent sedative and hypnotic drug.
Therapists around the world have been impressed by the effects of thalidomide. During tests of the drug on animals, in particular, mice, the drug showed itself exclusively from the best side and did not reveal any side effects. Representatives of the manufacturing company insisted that thalidomide is absolutely safe and cheap to manufacture, which made it possible to obtain a license for the production and distribution of the drug.
In 1957, the drug was released on the market in Germany, and by 1958 it was produced and sold in 45 countries of the world under 37 different names. No additional research has been carried out in any of these countries. Since August 1958, thalidomide has been advertised as "the best medicine for pregnant and lactating mothers" for prenatal anxiety and toxicosis.
On December 25, 1956, a daughter without ears was born into the family of an employee of Chemie Grünenthal herself. The man gave his pregnant wife thalidomide, which he took at work. No one paid much attention to this fact, but by 1961 the number of babies born with congenital deformities had increased so much that the German pediatrician Hans-Rudolf Wiedemann called it an "epidemic".
Further proceedings and courts revealed extremely negative consequences of thalidomide use by pregnant women: the drug literally disfigured the embryo, affecting both external and internal organs. 40% of “thalidomide children” did not live to see their 1st birthday. Those who survived are distinguished by various external defects, among which the most common are: complete absence or severe underdevelopment of arms, legs, ears, eyes, underdevelopment of facial muscles. During the period from 1956 to 1962 all over the world (Germany, France, Great Britain, USA, Japan and others) from 8000 to 12000 “thalidomide children” were born, whose bodies are permanently mutilated due to the negligence and greed of pharmaceutical corporations.
Thalidomide is currently used to treat leprosy, multiple myeloma, and other serious cancers.
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This story is more like the script of the film, but nevertheless it is pure truth. Perhaps it should be learned by heart when entering the civil service and any responsible position in principle. She talks about a woman scientist who has managed to withstand the pressure of a pharmaceutical corporation and save thousands of children from disability, and reminds us how far the consequences of our decisions can spread.
We are in site we believe that some stories do not have a statute of limitations, and the lessons taught by history need to be reminded so as not to repeat the same mistakes.
About Francis's life before the thalidomide scandal
Since childhood, Frances O. Kelsey dreamed of becoming a scientist (which was not easy for a woman at the time), and at the age of 21 she already received a degree in pharmacology. And then the stars formed in a happy way: the famous researcher Geilling from the University of Chicago, when considering the resume of applicants, suggested that Francis was the name of a man, and took Kelsey to his team.
The irony of fate is that here Kelsey managed to find the cause of the mass poisoning of people with an antibiotic solution that was not investigated before being launched 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 allow thalidomide on the US market.
About thalidomide
For the first time, thalidomide was synthesized in the middle of the 20th century during the research of the Chemie Grünenthal company on the production of antibiotics. For several years of work, conclusions were drawn that later became fatal.
- Even with an overdose, thalidomide did not kill experimental animals. From this, it was concluded that the drug was harmless, and the manufacturer sent free samples to doctors from Germany and Switzerland to treat 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 sedation and healthy sleep. "
In September 1960, thalidomide reached the United States. Richardson-Merrell brought it to the FDA under the name Kevadon. The approval seemed just a formality. However, new employee Francis O. Kelsey unexpectedly turned down the application.
What confused her?
- The safety studies of the drug gave strange results: there was an absolute absence of toxicity. But what if the body of experimental animals simply could not assimilate the drug? Nobody tested this version. On the contrary, when the first experiment showed that the animals almost did not calm down when taking thalidomide, the scientists changed the conditions of the tests so that they gave the desired result - so strong was the desire to quickly release the drug on the market. Frances found this proof of safety inadequate.
- Richardson-Merrell was aware of the risk of developing neuritis (these reports began to arrive a year ago), but did not mention this in her report to the FDA. In February 1961, the number of such messages increased.
- No one conducted tests on the effect of the drug on the developing fetus, but at that time it was already known about the permeability of the placental barrier. Frances developed the theory that thalidomide caused peripheral nerve paralysis and suggested that the damage to the embryo could be even greater.
"Bend your line"
Frances requested more information, and a conflict ensued as a result. She received responses from the US manufacturer, William S. Merrell Company, waited for the allotted 60 days, and made new inquiries. They pressured her, tried to act through the leadership, accused her of incompetence and complained about the bureaucracy. Kelsey insisted that the safety evidence was inconclusive and demanded that Merrell conduct her research.
“Richardson-Merrell was just at the limit,” Kelsey noted. “They were very disappointed because Christmas is the season of sedatives and sleeping pills. They kept calling me and making visits, saying, 'We want to see this drug on the market before Christmas. because this is the time of our best sales "".
It lasted until the end of 1961, until finally scientists from Germany and Australia did not reveal a connection between taking thalidomide and numerous cases of deformities in children born after taking it during pregnancy. It was only under pressure from the press after the publication that Chemie Grünenthal began to withdraw the drug from the market, notifying its American partners as well.
What was the cost of the decision of Kelsey herself
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 on sale in more than 40 countries for several years. An aggressive marketing campaign was under way. It seemed that signing for permission to sell in the United States was just a formality.
The only requirement of American law was the safety of the drug. In addition, a trial application has already been carried out: the Richardson-Merrell company managed to distribute more than 2.5 million tablets through therapists, and most doctors found it effective and beneficial, which was confirmed by their reports. The warehouses already had tons of Kevadon ready for sale.
At that time, Kelsey worked at the FDA for about a month, and this was one of her first assignments. We can only speculate about how much strength it cost her to withstand the numerous accusations of incompetence. The pressure on Kelsey was enormous.
What happened after?
- On August 8, 1962, President John F. Kennedy presented Francis O. Kelsey with the Distinguished Civil 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 revise and tighten their licensing policies for many drugs. For example, requirements have been added to provide evidence of the efficacy of a licensed drug, and careful monitoring has been introduced for both patients receiving and prescribing the drug.
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 disabilities due to their mothers taking a "harmless sedative". About 40% of these babies did not live up to 1 year old. 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.
