Grünenthal, maker of thalidomide, issue apology after 50 years

Those involved in the pharmaceutical industry for any length of time will recognise the thalidomide tragedy as one of the industry’s darkest hours. The FYI 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. Read here.

Thalidomide was developed in the 1950s by Chemie Grünenthal GmbH. During development it was observed that it was practically impossible to achieve toxic drug levels and therefore it was perceived to be a very safe drug. However, regulations at that time did not require testing in pregnant animals. Thalidomide was licensed in 1956 for over-the-counter use in Germany and then in other European countries. As the drug was observed to reduce morning sickness it quickly became popular in pregnant women.

By the 1960s, doctors were reporting concerns over possible side effects. Some patients reported nerve damage in long-term use. 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. Over 10,000 children had been born with thalidomide-related disabilities before the drug was removed from the market.

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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