If you have been involved in the pharmaceutical industry for any length of time will recognise the thalidomide tragedy as one of the industry’s darkest hours. The Niche team thought that recent events should not pass without our comment.
Marketed as a sleeping pill that was so safe it could be used in pregnant women, thalidomide caused babies to be born with malformed limbs. After more than 50 years the manufacturer has apologised [1].
Thalidomide was developed in the 1950s by Chemie Grünenthal GmbH. During research, it was seen that it was almost impossible to get the drug to a level that would be harmful. This led to the idea that it was a very safe drug. At that time, though, the rules did not say that tests had to be done on pregnant animals. It was legal to buy thalidomide over-the-counter in Germany in 1956, and then it spread to other European countries. As soon as it was seen that the drug helped with morning sickness, it became very popular among pregnant women.
By the 1960s, doctors were worried about the possible side effects. Some people said that long-term use hurt their nerves. Reports began to emerge of children with severe congenital abnormalities born to women in Germany who had taken thalidomide. However, a link with the drug was not made until 1961. Before the drug was taken off the market, more than 10,000 babies were born with problems linked to thalidomide.
Mr Stock, Grünenthal’s chief executive, issued his company’s apology at the unveiling of a bronze statue symbolising a child born without limbs because of thalidomide. “We ask for forgiveness that for nearly 50 years we didn’t find a way of reaching out to you from human being to human being,” he said at a ceremony in the western German city of Stolberg, where the firm is based. He also commented: “We ask that you regard our long silence as a sign of the shock that your fate caused in us."
This was the pharmaceutical industry's perfect storm. However, the question remains as to whether Grünenthal could have acted earlier. The apology has not been universally well received, particularly by activist groups seeking further compensation. Some compensation has been paid, for example by thalidomide’s British distributor. Grünenthal has paid compensation to some victims of the drug, many in Germany, but despite its outward expression of regret it has not admitted liability. Compensation claims are still outstanding, including one key class action in Australia.
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