Thalidomide Apology 50 Years Later

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Main Category: Litigation / Medical Malpractice
Also Included In: Pharma Industry / Biotech Industry
Article Date: 02 Sep 2012 - 0:00 PST


Gruenenthal Group's CRO has apologized to mothers who took Thalidomide in the 1950s and 1960s and gave birth to children with congenital birth defects. Exactly 50 years ago today, Thalidomide was pulled off the market.

In the 1950s and 1960s, Thalidomide was approved in 46 countries for the treatment of morning sickness during pregnancy, as well as aiding sleep. It was not sold in the USA. Thalidomide became extremely popular in Australia, West-Germany, and the United Kingdom. It was taken off the market in 1961 after it was found to be closely linked to birth defects.

Unfortunately, by the time it had been pulled of the shelves, thousands of children had been born with deformities. Worldwide, nobody knows exactly how many victims of the drug there were - estimates range from 10,000 up to 20,000.

There was a long trial in Germany. Gruenenthal set up a foundation to compensate those and their families who were affected by the drug. For the last 50 years many victims have said that not enough was done, and that the company should apologize.

In 1972, eleven years after Thalidomide was withdrawn, the company settled a lawsuit and expressed "regret" to the victims. However, "regret" is very different from a full apology; it does not admit liability. In 1972, Gruenenthal said it had followed all protocols regarding clinical trials.

On Friday, 31st August, 2012, exactly 50 years after the drug was taken off the market, Harald F. Stock, PhD., Chief Executive Officer of the Grünenthal Group, said: (translated from German)

"On behalf of Gruenenthal with its shareholders and all employees, I would like to take the opportunity at this moment of remembrance today to express our sincere regrets about the consequences of Thalidomide and our deep sympathy for all those affected, their mothers and their families. We see both the physical hardship and the emotional stress that the affected, their families and particularly their mothers, had to suffer because of Thalidomide and still have to endure day by day."

We also apologize for the fact that we have not found the way to you from person to person for almost 50 years. Instead, we have been silent and we are very sorry for that."

On the 31st August, 2012, a bronze statue of a child born without limbs because of thalidomide was unveiled in the city of Stolberg, Germany.

Mixed response from Thalidomide victims' organizations

EDRIC (European Dysmelia Reference Information Centre), which runs the online DysNet Limb Difference Network, announced that a full apology must be accompanied by help for all the victims who have had to live with physical impairments caused by thalidomide for the past five decades.

Geoff Adams Spink, Chairman of EDRIC and a thalidomide survivor, said:

"Having tried to remind them of their criminal behavior across a negotiating table on several occasions, I didn't think this company would ever make things right. This is important first step. The next is to compensate everyone damaged by their so-called 'totally harmless' drug."

UK charity, The Thalidomide Trust, is still today trying to seek a permanent financial settlement for all those victims who reside in the United Kingdom and are having to live with progressively worsening health problems caused by their disabilities as they get older.

The DysNet Limb Difference Network wrote that in Australia, Thalidomider Lynette Rowe managed to secure a multi-million dollar settlement from the company that distributed the medication, Diageo, in a class action suit.

The Association of Contergan Victims described today's apology as "too little, too late". Ilonka Stebritz, spokesperson for the association, said:

"The apology as such doesn't help us deal with our everyday life. What we need are other things."

Thalidomide was sold under the brand name "Contergan" in Germany.

Thalidomide is currently being studied for the treatment of some cancers and autoimmune diseases. It is used, under strict control, for the treatment of leprosy and multiple myeloma.

Frances Oldham Kelsey M.D. resisted pressure to approve thalidomide in the USA

Frances Oldham Kelsey M.D., an American pharmacologist, resisted pressure from Richardson-Merrell, a pharmaceutical company, and turned down a submission for approval on behalf of the FDA (Food and Drug Administration).

Kelsey stuck to her guns and insisted that further studies on the drug were required. However, even though thalidomide was never allowed to be sold in American, millions of tablets had been given to doctors during a clinical testing program. Nobody really knows how many pregnant mothers were given these tablets for the treatment of morning sickness or to aid sleep.

Kelsey received an award from President John F. Kennedy in 1962 for refusing to allow thalidomide to be sold in the United States.

Written by Christian Nordvist
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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