THE THALIDOMIDE TRAGEDY: UNVEILING A PHARMACEUTICAL NIGHTMARE

The Thalidomide tragedy was one of the worst pharmaceutical tragedies of the modern past, wrongly considered as a medical breakthrough at the time. Thalidomide, created by a German company, Chemie Grünenthal, was considered a medical marvel in providing relief to pregnant women from morning sickness, anxiety, and insomnia and was also used as a tranquilliser and a sedative. The drug was deemed safe for humans since it was harmless to test animals and was, therefore, licensed for over-the-counter sale in July 1956. Inefficient medical care and research at the time was the cause of the misuse of the drug resulting in thousands of miscarriages and severe birth defects. Concerns regarding the side effects of the drug were noted in 1961 which eventually led to a ban on the sale and purchase of the same. Now, Thalidomide is used to treat Erythema Nodosum Leprosum, a very painful skin disorder, Myeloma, cancer of the blood, as well as to reduce inflammation in the immune system. 

APOLOGY OF THE AUSTRALIAN GOVERNMENT

In a historical moment, the Australian government is to apologise to the Thalidomide tragedy survivors, more than six decades after the tragedy occurred. When it was discovered that the drug caused horrible side effects in pregnancies and babies in November 1961, the Australian government did not ban the drug as swiftly as the other countries. It is believed that if the government had acted more quickly, a significant difference could have been made.

Australia’s Prime Minister, Anthony Albanese, said in a statement on November 13, 2023, that he would be apologising to the country’s Thalidomide tragedy victims on behalf of the Australian government, people, and parliament on November 29, 2023. He referred to the tragedy as a “dark chapter” in the history of Australia and the world. He added, “In giving this apology, we will acknowledge all those babies who died and the families who mourn them, as well as those who survived but whose lives were made so much harder by the effects of the terrible drug.”

The PM also admitted that he recognized that survivors and the families of survivors had sought this apology for many years and that he sympathised with them. A memorial site will be created for those affected at the shores of Lake Burley Griffin and revealed in a ceremony on November 30, 2023. Minister Butler remarked that they could not change the past or end the physical sufferings of the victims but hoped that the apology would help heal some emotional wounds. There are 146 Thalidomide tragedy survivors registered with the Australian government but the actual number is not known. 

UNCOVERING ITS HISTORY

In the 1950s, scientists were unaware that drugs could affect the foetus by penetrating the placental barrier because of this, most medicines were not tested on pregnant women, and medication for them was not strictly regulated. In the case of Thalidomide, no tests were made to clear it for pregnant women, creating an issue of negligence on behalf of the pharmaceutical industry. By the late 1950s, Thalidomide was being sold in 47 different countries and under multiple names which made it difficult for a connection to be eventually made between the drug and its effects. It is estimated that around 80,000 miscarriages occurred and 10,000 babies were born with birth defects because of the drug, half of whom passed away after birth.

Some of the birth defects included Phocomelia in the limbs, reduction in or incomplete limbs, hearing loss, absent hip joint, eyes, and face defects as well as damage to the internal organs. It was later discovered that as small as one tablet of the medication could cause these defects in under 30 days from fertilisation or conception. 

The drug was not immediately blamed for these issues because the results were very similar to genetically caused limb impairments. However, the work of two medical professionals, Dr. Widukind Lenze and Dr. William McBride brought into light the relationship between the two. Thalidomide was finally withdrawn from the market by the company on 26 November 1961 due to its teratogenic properties but was still sold in some areas under other names.

There were no cases of these deformities reported in America since the U.S. Food and Drug Administration did not approve the drug for use by pregnant women. Dr. Frances Kelsey, a pharmacologist at the administration was given credit for avoiding the tragedy in the country since she did not consider the drug safe for pregnant women. 

LACK OF SUPERVISION AND DAMAGE CONTROL

During the 1950s, even if clinical trials took place, they were not required to be overseen or regulated by the FDA because of which the drug was approved for sale. Even after the ban was regulated, rural areas continued to use and suffer from the drug due to less availability of knowledge and medical facilities. It was realised that since the drug had not been tested on pregnant animals before being prescribed to pregnant humans, the tragedy occurred. Even when the trials were conducted, the drug had to be given to the pregnant animal only in the tablet form during a specific time in the pregnancy, if not, no issues were seen which became the reason why the drug was sold for 5 to 6 long years before being banned. 

This tragedy was a turning point in the history of medicine and paved the way for safer drugs to be approved. It forced the U.S. and international regulatory agencies to enforce proper toxicity testing and reformulate their strategies. The UK Committee on the Safety of Drugs and Medicine Act of 1968, was created after the tragedy. In the same year, the British licensee Distillers’ Company reached a settlement of compensation with the affected families. Furthermore, a campaign undertaken by The Sunday Times led to more settlements for children and families in the UK. 

A Yellow Card Scheme was also introduced to push doctors to share the side effects of medicines that were unknown to date. The tragedy, therefore, led to changes around the world for the better, where medicines could not be sold with only animal texting, and pregnancy medicines had to be cleared for pregnant people first. The British government also apologised to the victims in 2010.

THE USE OF THALIDOMIDE TODAY 

Thalidomide was cleared for treating Leprosy in 1967 by the WHO. It was further approved for treating Myeloma, a form of cancer of the blood, in 2006. After deep research and tests by the FDA, Thalidomide resurfaced as an important drug in the medicinal world after its earlier scandal. 

Women using the drug are advised to take two contraceptive measures simultaneously and regularly take pregnancy tests. The side effects of Thalidomide in men are unknown but are still strictly referred to use contraceptives and take the drug only under supervision. Recently, the drug has also helped treat and research AIDS but its past makes it controversial to use. 

The Thalidomide tragedy was one of the worst moments for man in medical history but has left us with new hope and invaluable lessons. The governments of countries are taking responsibility and providing compensation to the victims. Though the physical harm done can not be changed, the tragedy has paved the way for a more safe and regulated world of medicine. The world became aware of the correct ways to test and scrutinise its practices before introducing them to humans and has made sure that no other horrible tragedy like this one follows.  

Author: Jasleen Kaur Palne