If you have never heard of Thalidomide, this may be a useful place to start. Interest in the scandal and its past ongoing consequences has recently been revived in the local media. It deserves to be analysed here, albeit briefly.
Thalidomide is a sad and tragic story about the failure of many things: it is a case study of political, regulatory, legislative failure, or corporate greed and corruption, of human suffering and ruthless deceit. It raises several challenging and provocative issues such as the role and place of ethics, politics and law in business. Thalidomide also raised issues on the freedom of the press and the difficulties involved in suing big pharmaceutical companies and in getting compensation for damage caused, of instituting class actions or the lack of them.
Medicines and drugs are big business. An eye-opening book published many years ago was named “There’s gold in them thar pills” (Penguin Special, Alan Klass, 1975). In my consumer protection classes, I always inevitably refer to this massive Thalidomide scandal. Thalidomide has been considered a foreign scandal for many years, but we now discover that the scandal extended its tentacles even to our islands, and this is the subject of a small book just recently published by an old colleague of mine. He does not know I am writing this article just as I did not know that he was a victim of Thalidomide. Anatole Baldacchino, a qualified accountant, has for the first time narrated the local story and published relevant supporting documents: The Malta Thalidomide Affair, Anatole Baldacchino, Thalidomide Survivors Association (Malta) 2023; foreword by Prof J Chircop). It makes unhappy reading.
The Thalidomide affair is a sordid and sad one, and can make one angry at the way big companies can corrupt scientists and foreign governments, test dangerous new drugs on unsuspecting patients, sometimes with deadly results and with complete impunity. The pill was deceitfully, recklessly and aggressively advertised as a new safe wonder-drug especially indicated for morning sickness. It was sold in about forty countries and often without the need for a prescription.
It results from research that Thalidomide was not only allowed to be sold in Malta, but it was also tested in Malta on Maltese, including pregnant women, without their knowledge or consent. Prof John Chircop has written: “From 1959 to 1961, clinical trials with thalidomide were conducted in Malta, the West Indies and Australia. Without any official authorisation, Distillers decided to use the local population for their trials merely through their supremacist colonial assumption that no such approval from local authorities was required as Malta was still a de facto British crown colony.”
Readers may also recall that John Le Carre’s novel “The Constant Gardener” (2001: also a great drama film in 2005) dealt with a similar devilish scheme. Here a big pharmaceutical company illegally tries out a new anti-tuberculosis drug in Kenya, with disastrous results for the poor patients in the impoverished country, including lethal side-effects, especially for pregnant women.
In the US, the FDA refused approval to market thalidomide, saying further studies were needed. This decision reduced the impact of thalidomide in U.S. patients. The refusal was largely due to pharmacologist Frances Oldham Kelsey, a lone and unusually brave regulator, who withstood pressure from the promoters of the drug, and kept it from entering the US market. President Kennedy even appeared on TV alerting US families to the dangers, asking them to seek out and destroy any remaining Thalidomide pills that might still be in their possession. The pro-business and anti-regulation Republicans in Congress worked hard to stop him taking drastic federal action to ban the drug.
The producing company, and its agents and distributors, have for many years sought every excuse to escape responsibility for the all the terrible harm caused by its supposedly wonder product. They have blamed everybody and everything including nuclear radiation and natural causes at some point, viciously contesting any claims for compensation. No doubt they had followed the hallowed legal advice to deny, deny, deny, and not to ever apologise. On this point, we can conclude with a brief but useful timeline:
- The Maltese Medicines Act was adopted in 2003: finally a framework to ensure the safety of medicines sold in Malta, making up for long years of indifference and lack of action.
- The British government apologised in 2010
- Distillers apologised in 2012
- The Australian government apologised in November 2023
David Fabri LL.D., Ph.D. (Melit) has been involved in consumer protection, regulation and company law since 1980. He was formerly Head of the Commercial Law Department at the University of Malta.
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