In Germany, a sleeping pill with lasting effects

BERLIN — It was late 1957 when Contergan, the first sleeping pill with virtually no risk of fatal overdosing, went on the German market.

“As harmless as sugar cookies,” an original advertisement said. ”Contergan gives peace and sleep. This harmless medicine won’t burden the liver metabolism, affects neither blood pressure nor circulation, and is well tolerated even by sensitive patients.”

Within a year, the new “wonder drug” under various names had made its way into prescription and over-the-counter markets in the UK, Australia, Canada, Japan and dozens of other countries, where it was frequently used to treat morning sickness.

But by late 1961, an increase in severe limb malformation in infants finally led German pediatrician Dr. Widukind Linz and Australian gynecologist Dr. William McBride to link the cases to thalidomide, the active ingredient in Contergan. Twelve days later, the drug’s German manufacturer Grunenthal removed it from the market.

The damage had been done, however, with some 10,000 cases of infant deformities due to thalidomide recorded worldwide. Of the 5,000 instances that occurred in West Germany – which was hit hardest by the over-the-counter availability of the drug – roughly 2,800 survivors remain today.

The victims’ lifelong struggle for formal recognition and monetary compensation from Grunenthal is thought to be part of the catalyst for the pharmaceutical company’s first-ever public apology to the victims of the thalidomide scandal on August 31 – some 50 years after the drug was discontinued.

“We also apologize for the fact that we have not found the way to you from person to person for almost 50 years,” Grunenthal CEO Dr. Harald F. Stock said during the inauguration of a thalidomide memorial commissioned by the company.

“Instead, we have been silent and we are very sorry for that. We ask that you regard our long silence as a sign of the silent shock that your fate has caused us.”

But questions turn to the responsibilities of business in the manufacture of consumer products, as thalidomide victims worldwide continue to age – and original compensation set out for those affected proves to have been an underestimate of the overall cost.

Following several years of case research and a trial, in which Grunenthal was never found guilty of negligence (there were no drug testing laws in place in West Germany between 1957 and 1961), the pharma company settled with families and paid 110 million Deutsche Mark (55 million USD) to a foundation for victims, while the German government contributed 100 million DM (50 million USD), according to the country’s Sueddeutsche Zeitung.

But Grunenthal’s portion of the fund was used up by 1997, at which point the government covered the cost of inflation, as well as the doubling of victims’ annual pension allowance in light of increasing living costs as ailments became worse with age.

“The original agreement was established at a time when everyone thought we hardly had a life expectancy,” Udo Herterich of the Contergan Association of North Rhine Westphalia told the paper.

“Our bodies are giving out,” Margit Hudelmaier, head of the National Association of Contergan Victims, told the paper, explaining that many survivors had to quit working early, were in need of massages, wheelchairs and above all – helping hands just to get through their daily lives.

“To help us live as comfortably and independently as possible costs money,” journalist, advocate and thalidomide victim Geoff Adams-Spink explains on CNN.com.

“Adaptations, medical costs and personal assistants are not cheap. Thalidomide has deprived us of the lives we should have had and many more of any life at all. I believe that both morally and legally, Grunenthal has a responsibility to help us and will continue to fight until that happens.”

Following talks with families in recent years, Grunenthal voluntarily paid another 50 million Euros to Germany’s Contergan Foundation in 2009. It also supports what it calls a hardship fund, which takes specific requests for compensation from severely disabled victims, Grunenthal spokesperson Frank Schönrock told SmartPlanet. But many survivors say the fight for compensation will not end until Grunenthal can guarantee survivors the full financial security they are unable to provide themselves with for the rest of their lives.

“The Wirtz family has grown fat on the backs of thousands of families whose lives have been torn apart by a medicine originally marketed as ‘totally without harm,’” says Adams-Spink. “If they really want to make amends, they should put their entire wealth at the disposal of the world’s thalidomide survivors before it’s too late.”

According to Grunenthal, it made thalidomide available for humanitarian reasons only after the tragedy and completely discontinued it in 2003. The company also says that thalidomide was not commercially marketed after 1961, and that it derived no profit from the drug.

PHOTO: Flickr/Robert S. Donovan