Saturday, September 1, 2012

Apology for thalidomide defects

  • German pharmaceutical apologizes 50 years later for a drug that caused disabilities
  • Children whose mothers took thalidomide during pregnancy were born without limbs
  • The drug was taken by women to counter morning sickness in the 1950s and 1960s
  • Drugs firm Gruenenthal expresses regret, says long delay is result of its "silent shock"

(CNN) -- A German manufacturer of a drug that caused thousands of babies to be born with disabilities about five decades ago is apologizing for the first time.

The drug, thalidomide, caused babies to be born with shorter arms and legs after their mothers took it during pregnancy in the 1950s and 1960s.

It was marketed to women to counter morning sickness, according to the Thalidomide Trust, a UK body set up in the 1970s to help those affected.

In addition to the disabilities, some children whose mothers took the drug suffered heart problems, damaged hearing or eyesight , and in some cases, brain damage.

The drug was pulled from sale in 1961 after doctors linked it to birth defects.

The chief executive of the company apologized Friday on behalf of pharmaceutical firm Gruenenthal as he inaugurated a memorial to those affected in Stolberg, Germany, where the company is based.

Harald Stock expressed the company's "sincere regrets about the consequences of thalidomide and our deep sympathy for all those affected, their mothers and their families."

Gruenenthal's nearly 50-year delay in reaching out "person to person" to those affected was a result of its "silent shock" over their fate, he said.

"Instead, we have been silent and we are very sorry for that," Stock said in a translated copy of the speech on the company's website.

Many people have only recently started to receive compensation for the drug's effects.

More than 10,000 children worldwide were affected by thalidomide, about 450 of them in Britain, according to Thalidomide UK. An additional 7,500 died in early childhood, it says.

Stock said the need for Gruenenthal to make a public apology had become apparent in recent talks with those affected, especially since 2007. The company also pledged 50 million euros in 2009 to help more of those people affected in Germany and elsewhere, he said.

"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 wish that the thalidomide tragedy had never happened."

But Stock also pointed to how regulatory and testing organizations had changed since the 1950s.

"The thalidomide tragedy took place 50 years ago in a world completely different from today," he said. "The international scientific community, the pharmaceutical industry and governments, legislators and administrations have had to learn a lot from it."

Gruenenthal had "acted in accordance with the state of scientific knowledge and all industry standards for testing new drugs" that were current in that period, he said, and regretted that the drug's potential to cause fetal malformations had not been detected.

The drug was available over the counter in Germany from 1957, under the name Contergan, leading to more cases there than anywhere else, according to the Thalidomide Trust website. In Britain, where it was sold as Distaval, it was a prescription-only medication.

The drug was released only for clinical trials in the United States, the Trust says, because of concerns following reports of certain side effects from Europe.

Compounds that included thalidomide also appeared in a range of other medications, including some for asthma and migraine, the Trust says.

The UK government allocated funds in 2010 to help those affected by thalidomide.