Thalidomide
The 50-year global cover-up
SECRET files reveal the German maker of thalidomide ignored and covered up repeated warnings that its drug could damage unborn babies.
Read the affidavit material containing confidential Grunenthal files - Part 1 Part 2
The Age has obtained excerpts of never-before-published files from the archives of pharmaceutical giant Grunenthal which detail explicit warnings the company received about its drug's potential to harm foetuses well before it was withdrawn from sale in late 1961.
An estimated 10,000 babies worldwide - including hundreds in Australia - were born in the late 1950s and 1960s with severe physical deformities because their mothers had taken thalidomide drugs, which were marketed as a safe sedative and remedy for morning sickness.
The Grunenthal files expose a 50-year global cover-up and demolish the company's long-held position that the scandal was unforeseeable tragedy and that its ''actions were consistent with the state of scientific knowledge and prevailing standards of the 1950s''.
The files reveal that for at least two years before the drug was banned in late 1961, German medical professionals had told Grunenthal staff of concerns that children's deformities were caused by women taking thalidomide during pregnancy.
Between 1959 and 1961 - while the drug was still being marketed as safe - Grunenthal employees and their families began having deformed babies.
In one company file, it is noted that ''eight families, which, as dependants of the Chemie Grunenthal Company, during the years between 1959 until 1961, had had deformed children''.
Rather than act on the internal warnings, Grunenthal simply told concerned doctors there was no information to suggest the drug was unsafe.
The Grunenthal documents have come to light after they were lodged in the Victorian Supreme Court by Slater & Gordon lawyer Michael Magazanik in support of a compensation claim by Melbourne thalidomide victim Lynette Rowe.
Ms Rowe, in a case led by prominent plaintiff lawyer Peter Gordon, last week secured a multimillion-dollar payout from UK company Diageo, which bought thalidomide distributor Distillers in 1997.
Diageo is considering settlements with up to 130 other thalidomide victims in Australia and New Zealand. But Grunenthal continues to deny any culpability and is aggressively defending lawsuits.
The Grunenthal files include a statement by German pharmacist Friedrich Koch revealing that he wrote to the firm in late 1960, having spoken to a mother who took Contergan - a brand name for thalidomide - during pregnancy and whose child was born with internal injuries.
''After my discussions with (a patient), I felt compelled to write a letter to the company Grunenthal on 24 November 1960. In this letter … I inquired whether a child could develop injuries if the mother had taken Contergan regularly during pregnancy.
''The thought that medication might possibly affect a foetus … did not seem absurd to me, but rather worth investigating,'' Mr Koch wrote.
Grunenthal wrote back to Mr Koch enthusiastically giving the drug the all clear. ''Based on the contents of the letter, I was then able to tell the parents that according to the company, their babies injuries were not caused by the mother taking Contergan during pregnancy,'' Mr Koch's statement says.
''Naturally I presumed that the scientists in Stolberg [Germany] had already looked into the problem of their Contergan breaking through the foetus or that they would at least look into it after receiving my letter.''
A year before Grunenthal assured Mr Koch the drug was safe, the firm was contacted by a German medical practitioner, Dr K, with similar concerns.
Dr K's statement reads: ''I can recall with certainty that I made a possible connection between Contergan and my son's deformities as early as 1959.
''In the same year, my wife and I had discussed this problem with [Grunenthal employee] Dr Mannheim at various times … He always explained that he just could not imagine thalidomide causing these types of injuries … I established at least a further two malformations during 1959 which I also connected to Contergan.''
Several files reveal Grunenthal was receiving an increasing number of queries about the drug's potential to harm babies at the same time it was telling the public it was safe.
An internal document dated February 1961 - almost a year before thalidomide was banned - poses a question about its potential to effect the foetus. Another document includes a reference to Grunenthal being told that thalidomide was ''known as an abortive drug''.
A March 1961 document says animal testing might shed light on the effect of thalidomide on a foetus while also acknowledging that the company had no idea what this impact could be. ''[We have] no experiences ourselves
regarding [thalidomide] and pregnancy,'' the March 1961 memo states.
Around this time, Grunenthal sales representatives wrote confidential memos to the firm about what doctors had told them about possible impacts of the drug. A February 1961 letter from a doctor working in sales for Grunenthal states that his ''main objective'' in responding to such concerns was ''once again … to generate general interest and cause confusion''.
An April 1961 memo from another Grunenthal sales representative deals with the drug's potential to cause nerve injury, finding that in one medical ward there were ''20 clear Contergan [thalidomide] allergies and 2 cases of polyneuritis''.
''On the psychiatric wards with huge use of 271 [thalidomide] no side effects at all (maybe the idiots are happy when they are tingling!),'' the sales representative noted.
Another file reveals that in the months before July 1961, a German doctor quizzed Grunenthal about the potentially harmful effects of the drug during his wife's second pregnancy, given she had previously miscarried after taking Contergan.
The doctor's wife gave birth to a severely deformed child in July 1961 and he immediately suspected ''the potentially harmful effect of Contergan on the child''.
In mid-1961, a Grunenthal doctor told a fellow employee ''that in regard to Contergan, significantly more severe injuries than those already known were to be anticipated in his opinion''.
Yet another company doctor also confidentially flagged concerns, telling a Grunenthal meeting that the firm ''needed to investigate the diaplacental transfer of [thalidomide] by way of animal test to determine the possibility of damage to the foetus."
According to one of Mr Magazanik's affidavits, ''by May 1961, Grunenthal knew that its own medically trained staff had 'a very real fear of [thalidomide] side effects' and were refusing to use thalidomide drugs within their own families.''
By late 1961, when United States regulators had refused to licence thalidomide due to safety concerns, Grunenthal's internal files reveal a growing acknowledgment inside the company that there may be a serious problem with its drug.
In September 1961, the company wrote to a medical expert querying if it could draw on his expertise on the ''effects of medication on the foetus''.
But no tests were done in the last six months of 1961, despite further concern expressed to Grunenthal that their drug might be harming or killing babies.
It wasn't until November 1961 that the company finally moved to ban the drug after getting now well-known reports by Dr Widikund Lenz and Australian obstetrician William McBride about the links between the epidemic of birth defects and thalidomide.
The company at this time began formulating its position that it was not to blame.
But privately, Grunenthal's own lawyers had their doubts about aspects of the company's behaviour, including its response to hundreds of reports of nerve damage caused by thalidomide which prompted them to warn it was facing ''a dangerous and uncomfortable situation so injurious to the reputation of the organisation''.
Source : The Sydney Morning Herald
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Thalidomiders win payout 50 years on
The government has agreed a historic deal to give annual payments of up to £8m to the surviving victims of the drug thalidomide while also publicly apologising for their suffering over the past 50 years.
The settlement, which is receiving its final clearance this weekend and is expected to be announced within days, comes after a successful campaign, backed by The Sunday Times, to secure vital state funding for the “thalidomiders”.
Under the terms of the deal the Department of Health (DoH) will pay a grant of £20m, spread over three years, to the Thalidomide Trust, which dispenses aid to the roughly 450 thalidomide victims living in the UK.
The £20m could be boosted by up to a further £5m if, as the DoH hopes, extra funds are procured from the devolved governments of Scotland, Wales and Northern Ireland.
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In an apology, which could be made by Gordon Brown, the prime minister, the government will express its “sincere regret and deep sympathy for the injuries and suffering” endured by thalidomide victims and their families.
The thalidomiders were born in the 1950s and 1960s with deformed and stunted limbs and even brain damage as a result of their mothers being prescribed the drug as a treatment for morning sickness or insomnia while pregnant.
After thalidomide was withdrawn from sale in 1961 the affected families fought a lengthy legal battle, backed by this newspaper, for compensation from its UK manufacturer, Distillers Biochemicals.
The money from Distillers — about £28m — was paid to the Thalidomide Trust in the 1970s, which handed out disbursements to its beneficiaries. Currently each victim receives an average of £18,000 a year from the trust. Many are unable to work and the money forms their only income.
However, as their contorted bodies have aged, the thalidomiders’ health problems — and the cost of treating them — have multiplied, leaving the victims financially pressed. They are forced to buy their own specialist wheelchairs and adapted cars, which can cost up to £60,000 each.
In 1958 a state agency, the Cohen committee, agreed that thalidomide, as a supposedly “proven remedy”, should be exempted from purchase tax, thereby in effect approving it for prescription on the NHS. Despite this, no British government has ever seen fit to offer a financial settlement to the victims or apologise for its role in the tragedy.
When The Sunday Times first announced the new campaign in February this year, the position of Alan Johnson, then the health secretary, was that he was “not persuaded” by their call for government compensation.
However, following the 10-month campaign, which saw one victim, Gary Skyner, go on hunger strike and a string of stories in The Sunday Times about the hardships being endured by other victims of the drug, the government has now met the campaigners’ demands in full.
Nick Dobrik, the leader of the campaign, expressed his satisfaction with the settlement and praised the role played by Mike O’Brien, the health minister, in agreeing it.
He said: “I was very impressed with the way Mike O’Brien handled the negotiations with the national advisory council of the trust.
“He was sympathetic and attentive to the difficulties facing our community and always acted in good faith and with integrity.”
Mikey Argy, chairwoman of the trust’s advisory council and a single mother of two girls, said the settlement would mean she would now be able to pay for £80,000-worth of life-enhancing alterations to her home.
Argy, who was born with drastically shortened arms, said: “I had architects draw up plans of how my house could be altered to make it more manageable for me, but until now I could never have afforded it. Now I may be able to secure a mortgage based on these new payments.”
Argy said that because her arms were unable to reach inside her overhead kitchen cupboards she has to climb up to use them.
New cupboards, however, would be fitted with sliding shelves, enabling her to use them safely.
Her bathroom would also be equipped with a walk-in shower, since at present she has to negotiate a normal bath in order to wash.
“Having short arms makes falling very dangerous and the last thing you want to be doing is stepping over a slippery- sided bath,” she said.
Argy added: “With this settlement the government is recognising its role and responsibility for the thalidomiders and this money will go some way to assisting us to get the adaptations we need to enable us to live as independently as possible and go towards getting the extra medical care we need.
“It’s not just about the money. I know quite a few thalidomiders who have said that all they ever wanted was an apology. It is a huge thing for us.”
Martin Johnson, the director of the trust, said he was pleased that the DoH would allow the trust to use its discretion as to how to distribute the money.
He said: “The money is set to be distributed on the basis of the trust now. We have jumped an awful lot of hurdles.”
Ministers tried to protect industry profits
The question of the state’s responsibility for part of the thalidomide tragedy has dogged governments since the 1960s.
Documents released by the National Archives show ministers and civil servants have repeatedly denied any official culpability and tried to protect drug industry profits.
In January 1973, in response to newspaper claims that the state had “moral responsibility” for the scandal, Sir George Godber, chief medical officer, wrote a memo for ministers in which he said the pharmaceutical industry should not be further burdened with checks in case profits were affected.
“There has to be some sort of a balance between the extent of the testing required and the possibility of recouping its loss from subsequent sales,” he wrote.
Source: Sunday Times Dec 2009
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