Twisted research and lies: how an approved and publicized drug crippled thousands of children

The publication spoke about how an “innocent” medicine broke thousands of lives TSN.ua.

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This drug was called the “best” medicine for pregnant women and a panacea for any disease. But mistakes, a thirst for money and insufficient research led to dramatic consequences.

It is no secret to anyone in the modern world that the arbitrary intake of drugs can lead to serious consequences.

But in the 50s, when the pharmaceutical industry and medicine were not yet as developed as they are now, people did not have round-the-clock access to information and did not really think about the power of the side effects of drugs. This is how one of the most terrible disasters in the history of the 20th century happened, which forever changed the world of medicine and pharmacology.

Team of like-minded people

It all started in Germany in 1954, when the German company Chemie Grünenthal, which produced soaps, cosmetics and household chemicals before World War II, decided to change its profile to pharmacological.

The company began research to develop an inexpensive peptide antibiotic. The leadership, led by Hermann Wirtz, gathered many scientists in the laboratories, but not all of them were ordinary people.

The fact is that the war ended quite recently, but the supporters of the former ideologies of Nazism remained, although for Germany at that time it was commonplace. Wirtz, who was himself a former Nazi party member, recruits several highly controversial personalities.

The Chief Scientist is Dr. Heinrich Mücker, 32, with a rich track record. During World War II, he worked as a Nazi physician, pharmacologist and chemist, and during the occupation of Poland was deputy director of the Krakow Institute for Typhus and Virus Research.

Together with colleagues, he conducted experiments on prisoners of the concentration camp in Buchenwald. Many of Muckter's test subjects died.

The second employee hired by the company was Otto Ambros.

He also distinguished himself by his work during Hitler's time, in particular, he was one of the creators of the nerve gas sarin, the action of which he personally explained to the Fuhrer. Ambros was also a supporter of concentration camps and led the construction of one of the IG Farben factories in Auschwitz.

The third scientist employed at Chemie Grünenthal was Martin Stemmler.

This employee distinguished himself during the war as one of the supporters of the ideas of “racial hygiene” and eugenics in the Third Reich. At his new job, he headed the pathology department.

The perfect medicine

While working in 1954, Chemie Grünenthal scientists managed to isolate a completely new drug - thalidomide. The laboratory began studying the properties of the substance in order to determine its scope of application and strength of action.

The experiments were carried out only on laboratory animals (rats, mice, guinea pigs, rabbits, cats and dogs) and initially it was assumed that thalidomide would become an anticonvulsant drug, but the drug had no effect on four-legged experimental subjects. Therefore, the anticonvulsant theories were abandoned.

Scientists also gave animals huge doses of the drug to understand the strength of its action, but thalidomide did not even kill laboratory mice.

Thus, it was called “non-toxic” and it was decided that the drug was safe and scientists took a new step - testing on humans.

In 1955, the company unofficially sent free samples of thalidomide to various doctors in Germany and Switzerland, who distributed it to their patients to prevent seizures in epilepsy (although previously no anticonvulsant effect was found).

But the reviews of the experimental patients surprised both doctors and the pharmaceutical company.

It turned out that thalidomide acted on patients as a sedative and sleeping pill. Everyone who took the medicine reported that their sleep became calm, healthy and lasted all night. Serious side effects, like in animals, were not found, and it was concluded that an overdose of thalidomide was impossible, as well as addiction.

The researchers were amazed - they had created a safe and cheap sedative and sleeping pill. Compared to drugs from other pharmaceutical companies that were already on the market, Chemie Grünenthal would have become sales leaders, but a license was needed.

Licensing of drugs in the 50s was not as harsh as it is now, but it was still necessary to launch large-scale production.

To convince the panel of the safety and efficacy of thalidomide, experiments in mice were again used. The only problem was that the drug did not have any sedative effect on them.

Therefore, scientists developed a “jigging cage” that showed the slightest movements of rodents, preventing them from sleeping (here we also need to clarify the strange chronology of the behavior of the company’s management, since the properties of drugs are usually demonstrated on animals before they are tested on humans).

The evidence from scientists at Chemie Grünenthal was that the mice were not as active as those given the placebo. Moreover, the company insisted that the drug was completely safe and that death from an overdose was impossible.

They received a license.

Advertising campaign

On October 1, 1957, thalidomide went on sale under the name Kontergan.

Since the manufacturer assured that the drug was completely safe, it was sold without a prescription, first in Germany, and then in other European countries.

Chemie Grünenthal launched a huge advertising campaign, thanks to which sales of the drug grew rapidly and until 1961 thalidomide became the best-selling sedative in Germany, and soon without any checks or tests it was sold to another 46 countries in Europe, Scandinavia, Asia, Africa and South Africa. America, where it appeared in pharmacies under various names. The medicine was positioned as a “pill for everything” and was recommended for insomnia, headaches, coughs, colds and nausea.

Also in 1958, thalidomide began to be added to other drugs.

In the same 1958, Chemie Grünenthal wrote a letter to all doctors in Germany, in which it was said that thalidomide is the best drug for pregnant and nursing mothers, because it helps to cope well with malaise and nausea.

Following this announcement, the British drug distributor Distillers even added a special label “for pregnant women” to thaledomide, which it distributed in its country.

There was a new wave of popularity.

But it is important to note that the effect of the drug on pregnant women has never been studied.

Perhaps the manufacturers were not afraid of the distribution of the drug among pregnant women, since at the time of the 50s there was a misleading opinion that the placenta is an ideal barrier, and the fact that teratogenic substances (such as thalidomide) can penetrate through it was ignored.

Side effects

The first victim of thalidomide was the family of an employee of Chemie Grünenthal.

Even before the drug was launched on the market, the man brought his pregnant wife, who apparently suffered from toxicosis, a new drug developed by his company. On Christmas Day, the couple had a daughter without ears.

Then no one compared the connection with the intake of completely unexplored drugs and the child with missing organs, because children were still born with physical injuries. But the family learned the truth years later, when the world was stirred up by a series of childhood deaths and developmental defects. All of them were caused by the new fancy medicine.

A year after the drug's resounding success on the market, there were first reports of side effects, among which was peripheral neuritis.

When Chemie Grünenthal was asked about it, they openly lied that it was all a lie. Although at the time of 1960, the company received about 100 letters with reports of severe neuropathy and about 1500 other side effects.

Despite such claims, thalidomide continued to break all sales records, and the company adopted a position to deny any connection between their product and peripheral neuritis. This resistance was driven by fear of losing the ability to sell the drug without a prescription.

In 1961, pediatricians from different countries began to associate the sudden birth rate of babies with deformities precisely because their mothers took a “miracle pill” in the early stages of pregnancy.

The most common were phocomelia and amelia - “seal limb” and “absence of limb”.

Also, children were born with eye defects, facial expressions, defects of internal and genital organs. In addition, even one tablet could affect the development of the fetus:

• the use of thalidomide on the 20th day of pregnancy leads to brain damage in the fetus;
• on the 21st day, the drug disrupts the formation of the eyes;
• on the 22nd day - the ears and face suffer;
• from the 24th to the 28th day - arms and legs
• after the 42nd day of pregnancy, thalidomide does not seem to harm the fetus. A particular scandal erupted when the German pediatrician Vidukind Lenz published his observations in the newspaper Welt am Sonntag, according to which he linked about 160 cases of congenital malformations in newborns with thalidomide.

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At that time, thalidomide was sold over the counter in 52 countries. At first, Chemie Grünenthal refused to withdraw production and denied this connection.

Nobody can name the exact number of victims.

Another reason for this was that in post-war Germany the public and medical professionals opposed mandatory notification of birth defects through previous Nazi Germany laws on “prevention of the birth of offspring with hereditary diseases” and the T-4 eugenics program.

However, according to various sources, from 1956 to 1961, from 8 to 12000 babies with mutations were born due to thalidomide. Of these, about 5000 survived. In 40000 people, after taking the medicine, peripheral neuritis developed.

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The situation received wide publicity, it was talked about on television and on the radio.

But it didn’t end so quickly - the drug was on sale for about 9 months in different countries.

Courts and impunity

The lawsuit against Chemie Grünenthal was opened on January 18, 1968, and the trial began on May 27.

Evidence of the crime was collected for six years. Among the defendants were company employees Hermann Wirtz, scientific director Heinrich Mücker and seven other employees who held managerial positions.

They were accused of having allowed on the market a dangerous medical product that did not pass proper testing and caused damage to health.

The company was also accused of not only not responding properly to the negative reviews about the drug that were received, but also making efforts to suppress this information.

Theories also appeared in the press that thalidomide was synthesized by scientists during World War II as an antidote to the nerve gas sarin.

A significant role in this version was played by the past of the scientists who worked on the drug. But no one was able to prove this version, so it was not continued.

It all ended on December 18, 1970.

The last session of the court was held, where it was decided to close the case, since on April 10, 1970 Chemie Grünenthal pledged to pay compensation in the amount of DM 100 to children affected by thalidomide.

As a result, the court ruled that, given the entire system of production and distribution of drugs, this could happen to any pharmaceutical company.

Therefore, the primary task, according to the court, was to change the existing system at that time, and not to blame several people for the tragedy.

In other countries, there were also trials and payments among companies that distributed thalidomide.

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Later, in Germany and in the affected countries, foundations were organized for children affected by the thalidomide disaster.

The drug has not officially entered the United States, but the requirements for licensing medicinal products have intensified, as in Europe. In the USSR, thalidomide was not officially sold either.

As a result, no one went to prison.

But not only the employees of the companies involved in the tragedy were tried.

Desperate mothers who tried to get rid of their children also went to the dock. The case of Suzanne van de Puth received special publicity.

She gave birth to a child disfigured with thalidomide and decided to take his life by adding a tranquilizer to the bottle. Her husband, mother, sister and a doctor who prescribed a tranquilizer were also put on trial for complicity.

The drug is still in production

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Despite the fact that the World Health Organization imposed an official ban on the drug in the 60s, it still found its place in the medical world.

In 1998, thalidomide was registered as a cure for leprosy and certain cancers. They are also treated for tuberculosis and autoimmune diseases.

But now a special safety system has been developed for the use of thalidomide:

• training of doctors and pharmacists;
• registration of all patients receiving medications;
• regular pregnancy tests;
• refusal of breastfeeding and artificial insemination;
• patients who are prescribed thalidomide are prohibited from donating blood and sperm
  you can not have unprotected sex.

A monument to those affected by thalidomide was unveiled in Cardiff, UK in 2016.

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