Drug Company Apology for Birth Defects

Thalidomide manufacturer Grunenthal apologizes but survivors say apology is not enough

/ Author:  / Reviewed by: Chris Galloway, M.D.

(RxWiki News) Thousands of children were born in the 1950s and 60s with horrific birth defects caused by the drug thalidomide. Now, the manufacturer of the morning sickness drug has apologized.

Yet some survivors of the drug have stated that the apology is not enough.

They believe the company should offer more compensation to the children born with missing or abnormal limbs and other defects.

The chief executive of the German pharmaceutical company Grünenthal, Harald Stock, spoke in Stolberg, Germany on Friday at a ceremony to honor the victims of thalidomide. He apologized especially to the mothers who took the drug.

The drug was sold over the counter for the nausea of morning sickness to pregnant women starting in Germany in 1957.

Although the company was warned two years later by a gynecologist that the drug causes deformities in the developing babies, the company continued to sell the drug.

It was sold in Europe, Australia, Canada and Japan starting in 1960. It was never approved for use in the U.S. by the Food and Drug Administration.

The drug was finally pulled from shelves in 1961, when doctors across the world connected thalidomide to the horrible defects that had rapidly increased in babies

These defects included extremely short arms and legs, heart problems, hearing or eyesight trouble and even brain damage.

By the time it was pulled, over 10,000 children had been born with disabilities caused by the drug. Today, somewhere between 5,000 and 6,000 of these children are still alive.

"On behalf of Grünenthal 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," Stock said to the crowd.

The ceremony was a dedication for a bronze statue of a child that represented the defects thousands of children have from the drug, and the decision to allow a Grünenthal representative speak was controversial.

"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," he said. "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."

However, Stock also told the crowd that the tragedy occurred in a "world completely different from today" in terms of what drug makers and researchers know and can discover about drug safety.

"Grünenthal has acted in accordance with the state of scientific knowledge and all industry standards for testing new drugs that were relevant and acknowledged in the 1950s and 1960s," he said. "We regret that the teratogenic potential of Thalidomide could not be detected by the tests that we and others carried out before it was marketed."

This statement angered many survivors, such as Freddie Astbury, the president of Thalidomide UK, an organization founded and run by thalidomide survivors that offers help to other survivors.

He pointed out that the company did have evidence about the drug's toxic side effects before it was pulled from shelves. He also said the apology was not sufficient, especially considering the company's silence for over 50 years.

"It's taken a long time for them to apologize," he said on his organization's website. "There are a lot of people damaged by thalidomide struggling with health problems in the UK and around the world."

Stock from Grünenthal attributed the company's silence to "shock."

"We ask that you regard our long silence as a sign of the silent shock that your fate has caused us," Stock said during the ceremony. "We have learned how important it is that we engage in an open dialogue with those affected and to talk and to listen to them."

Astbury said a better course would be for the company to beef up its compensations for victims still suffering from the effects of thalidomide.

A case against Grünenthal began in 1968 in Germany and was settled for 100 million Deutschmark. Today, 100 million Deutschmark (after converting to Euros) would be about 64.5 million dollars.

A foundation for German thalidomide victims was then set up in 1972 with another 100 million Deutschmark from the German government. Grünenthal added 150 million Euros to the fund in 2009.

"We welcome the apology, but how far do they want to go?" Astbury asked. "It's no good apologizing if they won't open discussions on compensation. They've got to seriously consider financial compensation for these people."

In the previous legal settlements, Grünenthal did not admit liability. Some claims and at least one class action suit are still pending.

In 2012, and Australian thalidomide survivor was awarded several million dollars from a settlement with the British distributor of the drug, but Grünenthal refused to settle, according to the Associated Press.

Reviewed by: 
Review Date: 
September 2, 2012
Last Updated:
September 3, 2012