In Defense of Thalidomide

Posted on September 6, 2012


German drug manufacturer Gruenenthal recently dedicated a memorial to the victims of thalidomide side effects, along with a much-belated apology for their suffering.  Thalidomide became notorious around 1960 for causing severe birth defects, including missing or greatly shortened limbs.  And that was just among those who survived.  Thalidomide UK estimates that for every affected infant who lived, ten others died.

Survivors were unimpressed with the apology, calling it “an insult,” “insufficient,” and “insincere.”  Freddie Astbury of Thalidomide UK challenged Gruenenthal to “put their money where their mouth is.”  Another survivor, Nick Dobrik, commented that “… a sincere and genuine apology is one which actually admits wrongdoing. ”

Everyone, including Gruenenthal, acknowledges that the company created the drug and the drug had devastating effects for developing embryos.  But Gruenenthal has never admitted liability for the injuries and deaths caused by Thalidomide.  Is Gruenenthal guilty of wrongdoing?

I don’t think so.  As Gruenenthal representatives correctly point out, this happened over 50 years ago, when stringent testing procedures were not yet in place for marketing new drugs.  I don’t think it is fair or right to expect people or corporations to be retroactively held to a standard established after the fact.

Remember, 50 years ago pregnant women smoked and drank alcohol, too.  This is not to minimize the harm that thalidomide caused; it is merely to point out that there were a lot of harmful things that we either did not know or did not pay attention to in those days, that seem so common-sense today.  The CDC didn’t even start collecting data about prenatal care until 1968.  Tamper-resistant drug packaging, which seems so obvious now, didn’t exist before the Tylenol Murders of the 1980s.  And our own Food and Drug Administration rules allowed for automatic approval of new drugs for the market, if the FDA did not act on the manufacturers’ applications within a time limit.  It was not until 1962 – in direct response to the thalidomide disaster – that the FDA rules were amended to require drug companies to prove the safety and effectiveness of their products for their intended purposes.   Well, duh, how obvious is that?  Before 1962, not very.

Thalidomide victims have a valid point that their disabilities cost them a lot of money for specialized care and equipment.   One would think, from their reaction to the Gruenenthal apology, that they have been left completely on their own.  But there has been some help.

Around 1969, Distillers Biochemicals Limited (now Diageo), which was the drug’s distributor in the UK, paid out some £28 million to compensate victims.  In 2009, they doubled their payouts.  Also in 2009, the UK government agreed to pay £20million to the Thalidomide Trust.  In 2010, Diageo agreed to pay another $50 million to 45 thalidomide victims in New Zealand and Australia, and most recently, in 2012, Australian Lynette Rowe won a multimillion dollar settlement against Diageo, opening the way for hundreds of other Australian victims to have their claims heard.

For their part, Gruenenthal has indeed put their money where their mouth is.  In the 1970s, the company paid DM 100 million into a victim support fund for German victims (because the drug was sold over the counter in Germany, the majority of cases occurred there), and received permanent legal indemnity from the German government.  The German government has also made compensation payments to victims, and Gruenenthal added another  €50 million to the compensation fund in 2009.  By 2010, the company says, they had paid out over €150 million.  But I don’t think they will ever be able to do enough to appease those affected by a drug made in good faith by the standards of the time.  And that is why they will never say they were wrong.

And where is thalidomide today?  It still prescribed in the US today as an effective treatment for leprosy and multiple myeloma, with severe restrictions to guard against pregnancy while it is in use by either women or men.  Study continues concerning its efficacy in treating other cancers, AIDS symptoms, macular degeneration, and inflammatory diseases like lupus and rheumatoid arthritis.

A footnote:  the mystery of how thalidomide causes birth defects was not unraveled for 50 years.  In 2009, it was finally discovered that the mechanism affects developing blood vessels, with the result that the timing of the drug will determine embryonic death or the type of defect.  More importantly, it was discovered that thalidomide breaks down into 18 metabolites… and the responsible metabolite has been identified.  This knowledge should help chemists to develop a safer thalidomide-like drug for continued use with cancer and leprosy patients.

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