Zantac Lawsuit


Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

Sunday, September 02, 2012

The Thalidomide Apology and the SmithKline Suppression

What was the role of GSK's predecessors in the  thalidomide scandal?


Many people, particularly those affected by the thalidomide disaster, are just not satisfied with Gruenenthal, the German manufacturer of the drug who, after 50 years, have just issued an apology via their CEO, Harald Stock.

It's a surprising move considering Gruenenthal are the subject of litigation, also surprising because pharmaceutical companies don't often admit to their mistakes, let alone make a public apology.

So, what happened all those years ago?

Well, court documents are alleging that Gruenenthal knew that their sedative, thalidomide, marketed in Germany as Contergan caused harm to the fetus as early as 1956 but never revealed that risk. Five years later the drug was withdrawn from the market after it was learned that babies were being born with foreshortened and distorted limbs, including curved spines, malformations to the eyes, ears and genitals, which were sometimes missing and malformations to the intestines, kidneys and hearts. One of the more common birth defects was a complete absence of the anus.

Not to be deterred by such trivial adverse events, they went ahead and gave it the all clear.

The lawsuit, also states that Gruenenthal were a Nazi led company whose motto was "succeed at any cost". At the time, Gruenenthal's director of their research and development group was Dr Heinrich Muckter. Two years before this role Muckter was a medical scientist for the army of the Third Reich. The lawsuit states:

"Specifically, he was the medical officer [Stabsarzt] to the Superior Command of the German Occupation Forces occupying Krakau, Poland, with the additional ominous title of 'Director for the Institute of Spotted Fever and Virus Research'. Given the role that military medicine played in the objectives and methods of the Nazi occupation of Krakau, Muckter's work there involved the science of killing rather than healing."

If this wasn't in black and white on a court documernt we'd be correct to assume this was some sort of Hollywood horror movie. Documents are provided at the end of this post.

I'll move on from the Nazi link, I once got threatened by GlaxoSmithKline's lawyers for referring to their head of psychiatry, Alistair Benbow, as a former Nazi dictator - far be it for me to draw comparisons.

The Apology

The apology by Harald Stock on behalf of Gruenenthal is cold, so cold that it chills to the bone. Gruenenthal have kept this suppression under wraps for 50 years, in fact, in 1972 they settled a lawsuit in Germany, a settlement where they accepted no liability, they just paid out plaintiffs and kept quiet.

It's always been said that it takes a brave person to apologize and, I guess, in this instance Stock was on a hiding to nothing. No apology would be seen as cruel whilst an open apology would show how transparent Gruenenthal were, particularly if it could be shown that they had learned from their mistakes. It's also classic deflection of blame, new CEO means 'not my fault, it was the fault of my predecessors.'

Enter the blame of the 'era'

Just like GlaxoSmithKline's CEO, Andrew Witty, did about a month ago, apart from apologizing, Gruenethal blamed this tragedy on an era. "...the suffering that occurred with Contergan 50 years ago happened in a world that is completely different from today"

Great detective work Mr Stock.

We have computers, phones that we can take out with us, more TV channels than we could possibly watch and we can even send men to the moon and robots to Mars.

An apology quickly followed by a reason for that apology is not an apology at all. It's a disgraceful act of depravity that, sadly, we, as onlookers, just shrug our shoulders at and go about our daily routines of uploading fluffy bunny pictures to our Facebook buddies or typing out our 140 characters to Twitter.

There should be global outrage about this latest stunt by a pharmaceutical company, alas we are all too busy to spare a thought for the families affected, we are all too busy to stand up with them and demand that criminal charges be sought and that those responsible be imprisoned for life for their part in covering up this utterly abhorrent scandal.

The role of GlaxoSmithKline

The lawsuit has also implicated British pharmaceutical giant GlaxoSmithKline for it's role in keeping the birth defects behind close doors. Glaxo, who were known back then as SmithKline and French, [SKF] are alleged to have carried out clinical trials of thalidomide on 875 women, some of whom were pregnant. During the trials it is alleged that two women gave birth to babies who were deformed.

SKF decided not to market thalidomide, a wise move. They also, the suit alleges, decided not to inform anyone that two women had given birth to deformed babies during their own clinical trials. SKB, cites the suit, had a legal duty and a common law duty to report these findings, at least, to Gruenethal. They also had a legal duty to report their findings to US Congress. When asked for results SKB told Congress that all the results had been submitted to Gruenethal.

Quite why SKB never told Gruenthal or indeed the public remains a mystery.

To date Andrew Witty, head of SKB's succsessor GSK, has issued no apology.

Andrew Witty was knighted in the 2012 New Year Honours for services to the economy and the UK pharmaceutical industry.

Here's those documents that should, but probably won't, see Andrew Witty blame another era of the company he is head of.












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