SKY NEWS, May 05, 2011

Birth Defect Group Wins Legal Aid Battle

Campaigners who believe a pharmaceutical company is responsible for them being born with physical defects have won the first round in a new fight for compensation.

Primodos was a drug manufactured in the 1960s by German company Schering and taken by women who suspected they were pregnant.
Studies later suggested a link between hundreds of mothers who took Primodos and babies born with various physical malformations.
Legal action was launched against Schering in 1982 but failed due to a lack of evidence that the drug was directly responsible.
But papers discovered by one campaigner hidden in a suitcase in his loft opened the door for a new legal challenge.
Now the first round of legal funding has been granted to investigate whether there is enough new evidence for more legal action.

Camaigners protest outside the drug company's headquarters
Key to the decision was evidence that original studies into Primodos, conducted by a Schering scientist, could not be trusted, as other studies he produced were flawed.
Karl Murphy, 38, was born with misshapen fingers after his mother was given Primodos in 1972.
He has been instrumental in the campaign for compensation.
He told Sky News: "My mum and I have been waiting 38 years for this; we're absolutely over the moon.
"We've let the other members of the campaign know and there have been tears of joy.
"It's not the end of it but it's the start we've been waiting many years for."
Schering is now part of Bayer plc, which denies Primodos is responsible.
In a previously-released statement, it said: "We sympathise with Mr Murphy, both in relation to his abnormalities and the related difficulties that he continues to face.
"However, based on the facts and on the law, we do not accept Bayer has any case to answer in relation to the marketing of Primodos by Schering, and Bayer maintains Primodos was not responsible for the congenital abnormalities with which Mr Murphy was born."

April 11, 2011, Sky News (UK)

Fresh 'Forgotten Thalidomide' Legal Claim

Children born physically deformed in the early 1970s are launching a fresh challenge for compensation against the drugs company they believe is responsible.

Documents discovered in a loft and given to Sky News will form the basis of renewed legal action brought by victims of what is being called 'the forgotten Thalidomide'.
Primodos was an oral test for pregnancy first available in 1959. It was in tablet form and worked by affecting a woman's menstrual cycle to indicate whether she was expecting.
Concerns were soon raised by doctors that Primodos could cause children to be born with misshapen hands and feet.
The drug was eventually taken off the market by its German manufacturer, Schering - a company later taken over by another German firm, Bayer.
Parents and children who believed Primodos was to blame for their deformities fought hard to take Schering to court.
But in 1982 lawyers advised there was insufficient evidence and the action failed to get off the ground.
Now documents recently uncovered by one campaigner have cleared the way for a new legal battle.
Karl Murphy's mother was given Primodos in 1973. When Karl was born he had several fingers and toes missing.
He was known as the 'monster child' at school and his father had to make special handlebars for his bike. Karl believes Primodos was responsible.
In the 1970s, Karl was visited at home by German journalists investigating the Primodos affair.
The reporter left behind a large pile of documents which Karl's mother put in the loft and forgot about.
But 30 years later, Karl discovered the papers and was stunned when he read them.
They were copies of letters between scientists at Bayer-Schering UK and their head office in Germany.
The correspondence expressed concern Primodos might be responsible for birth defects in children and the company was advised the drug should be withdrawn.
Despite the possible dangers, Primodos remained on the market for several more years.
Karl, 37, said: "That is the drug company's own file confirming this drug has done the damage. So why? Why did they let this go? They need to answer questions and this file gives the evidence."
The number of children who may have been affected by Primodos is unknown.
But recorded figures indicate 3,540 people have had an adverse reaction after taking other drugs containing the active substances found in Primodos, according to former health secretary Mike O'Brien.
In a statement, Bayer-Schering said: "Bayer denies Primodos was responsible for causing any deformities in children. "According to the published medical and scientific literature, there is no association between the hormones contained in Primodos and congenital deformities of the type alleged by Mr Murphy."
Lawyers representing Karl and other campaigners are now applying for legal aid to mount a new challenge against Bayer-Schering.

Evidence in the Attic

Jason Farrell April 11, 2011

Karl Murphy can't escape the fact that his hands and feet are deformed. It affects everything he does, from housework to driving a car. But his claw-like fist is not just an inconvenience itÂ’s a question. Why was he born this way?
After five years of trawling through the Internet looking for answers, he opened a briefcase in his mother's attic. Inside was what Karl believes is the answer to his life long puzzle.
The case contained a prescription for a pregnancy test drug his mother had taken when she was pregnant with Karl. The drug Primodos, prescribed by her GP, had later been withdrawn amid concerns it could cause deformities in babies.
Among other papers Karl also found what would become the basis of his legal challenge: confidential documents from the manufacturers of primodos.
His parents and others had tried to take action against drug makers Schering back in 1982, but failed due to lack of evidence. Shering always denied that the drug was harmful. However, there's no suggestion that what Karl's mother had in her loft formed part of the original case. These were documents left by German Journalists that Pamela Murphy never got round to reading herself.
When I went to meet Karl for the first time, I had no idea what to expect from the papers, other than Karl's conviction that they were important. When I started reading - I couldn't stop.
You'll see from my report that letters between scientists working for Schering showed a growing concern about hormone pregnancy tests of which Primodos was the market leader.
The first potentially significant research from Queen Mary's Hospital was flagged to Schering in 1967. A Dr Isabel Gal found a higher incidence of spinal malformations in children of parents who used hormone pregnancy tests. I recently met Dr Gal. She is retired but is still strongly convinced of the link having continued to research the subject for many years.
The Schering papers show that the Royal college of GP's also did a report finding higher rates of miscarriage, stillbirths, infant deaths and abnormalities in children of mothers who used Primodos. The report Author Norman Dean concluded, "the drug should be withdrawn." Not long after this a Dr Pitchford who was the lead UK scientist at Schering wrote to the head office in Berlin saying it was all "extremely disturbing" that several studies "all point clearly to the possibility that Primidos interferes with a pregnancy." These are just a few examples of correspondence between the medical scientists at Schering, which tend to show a growing unease about the drug.
Verifying a four-decade-old set of papers has not been straightforward. Dr Pitchford died in 2005. There was a co-author to some of his correspondence called Dr Bye. He is alive but says it was too long ago and he doesn't remember writing the letters. Another key author of the letters Dr Briggs is also dead. His authority was very significant in the 1982 legal battle, but he was later discredited in a Sunday Times article for making up research.
I managed to trace Dennis Cooke, the statistician employed by Schering. He's 85 now and didn't want to give a full on-camera interview, but he showed me his analysis of sales of primodos compared to the incidence of malformations. The correlation is almost a straight line. He confirmed that he'd told Schering this was a "strong correlation" and "rather alarming"
He gave me his original correspondence and findings and I have passed this on to Karl's lawyer Peter Todd.
Bayer who took over Schering has released a statement and says that modern research contradicts these earlier findings and there were flaws in much of the original research.
I noted that most of the more recent studies relate to oral contraceptives. While these sometimes use the same substances as Primodos - the dosage and compounds are not the same. Bayer was unable to point towards recent studies that relate directly to Primodos. (Which is understandable, as it is no longer made.)
So the question now is should Karl, and the many others who believe they were harmed by Primodos, get their day in court? That's up to the legal aid committee who will decide next week. Is it good use of public money to pursue a mostly forgotten question, and a case that failed years ago? Is it still relevant if the drug is no longer sold? For Karl and many others its relevant every day of their lives and the question never went away.

CAMPAIGN INFO: Primodos victims demand apology and compensation from Bayer Schering