Wednesday, January 23, 2013

1959 – 2013 The Thalidomide Scandal



  The danger of inadequate drug testing and the lack of a drug regulatory process were brought into public focus in the late 1960’s by the by the horrific maiming of children from the drug thalidomide. Moreover, the thalidomide scandal saved this horrific phenomenon from happening again and spared the live of thousands of children who were born after this time.

One of the most chilling aspects of this scandalous narrative is the assertion that “in the immediate post-war years, convicted Nazis, and mass murderers who had practiced their science in notorious death camps, ended up procuring employment at a high level within the company Chemie Grünenthal (which made a financial killing, producing thalidomide).
 
Two of the most reprehensible of these, were Otto Ambros and Heinrich Muckter. Otto Ambros, was the inventor of sarin (the nerve gas), and was also convicted of mass murder at the Nuremberg trials but subsequently freed and Heinrich Mückters who had a colourful war career which included medical experiments on concentration camp prisoners.

Following the war, he invented thalidomide, receiving huge bonuses for rushing the drug to market in the 1950s. In addition, Mückters shared in the profits of the patent of thalidomide.

Together and alongside others, they brought knowledge and skills in experiments that no civilized society would ever condone. It is no small irony or surprise, that the outcome of this inconceivable narrative, along with this mixture of people, evolved the thalidomide scandal.

Chemie Grünenthal first manufactured thalidomide in West Germany in 1953. Thalidomide was hailed as a "wonder drug" providing a "safe and sound sleep".
Globally Thalidomide was as one of the most successful prescription drugs ever marketed.  It was marketed and distributed throughout the British Isles, Australia, New Zealand Japan and Europe under many different names.

It is estimated; approximately 20,000 fetuses in 46 countries were born with birth defects worldwide. Although, the official casualty figures in many of the poorer countries like Brazil, India and Africa could never precisely be assessed.
The first child afflicted by thalidomide was born on December 25th, 1956 to an of employee of Chemie Grünenthal’s

The effects of thalidomide on the children were severe deformities; facial disfigurements, severe to mild intellectual impairment, internal organ damage, deafness, blindness, missing legs, arms, fingers, and ears. Nevertheless, for the majority of these babies, they were afflicted with a mixture of more than three of these deformities.

In view of the fact, Chemie Grünenthal had performed all the basic required animal safety-tests. On the18th December 1970, after two years and seven months of trial, the courts were forced to find the manufacturers of Thalidomide not guilty; of consciously marketing a harmful drug.  Dr Mückters by this time, the director of the scientific laboratory of Chemie Grünenthal disclosed at the trial, that a great deal of the company's records were destroyed - or had ‘disappeared’ during 1959... It took a long time and pressure, from our parents to finally get the Irish government represent us.  

In September 1959 the use of Contergan (Thalidomide) was stopped in German Hospitals because of severe reactions. Chemie Grünenthal resisted moves to withdraw the product despite a growing number of reported deformities.  On the 27th of November 1961 Thalidomide was banned globally for any treatment concerning pregnant women and taken off the market. (Yes, that excluded Ireland).
In Ireland, in 1959 under the auspices of its Department of Health, (Thalidomide)  Soften-on, Entero-Sediv, and some others were approved for marketing and sale.
However, despite the global ban in November 1961 and despite overwhelming universal evidence of its particular dangers, drugs containing thalidomide in Ireland were not fully withdrawn until mid to late 1962.  Moreover, in November 1961 the department of health send letters to Irish doctors to stop prescribing Thalidomide.  Yet, thalidomide officially continued to exist as a over the counter non-prescription drug in Irish pharmacies for a further seven to ten months.  Dr John O’Connell, a one-time Health Minister, reported that three years after thalidomide’s withdrawal, he was still able to buy it in  pharmacy's in Ireland.

In 1973 US presidential candidate Mr. Ralph Nader wrote a strongly worded letter to the Taoiseach of the time, accusing the Government of twice neglecting its duty to protect the health and safety of its citizens.

Mr. Nader claimed the Government knew definitively that the drug was dangerous in 1961 yet waited almost seven months before telling the public the drug was banned. Mr. Nader went on to say.  "Indeed, so passive was the Government's silence that media of the time held back the story in January 1962, deciding to wait until the Government broke the story, immediate steps should have taken been to remove the drug from sale and distribution and to warn citizens who might have previously obtained the drug against using it".   Finally, Mr. Nader wrote, "We are dismayed at the Government's strange unwillingness to act on behalf of these Irish citizens in the settlement negotiations". He called for "vigorous intervention" to ensure that the tragedy would not be compounded "by a tragically meager settlement". 

The Taoiseach's private secretary did acknowledge the letter, but there is no evidence of its contents ever been challenged by the Taoiseach or his officials.
In 1975 after a decade of intense lobbying by the parents, the Irish Government entered into a commitment to provide:  ”compensation and services and aids necessitated by our disabilities in order for us to lead as normal a life as possible”. In particular, Tánaiste and Minister for Health Mr. Brendan Corish, on January 9th, 1975. Our parents believed the Irish Government would deliver on this promise. Thirty-eight years on, we protest that the treatment we now receive is inadequate to keep even the basic essence of that agreement.

Due to pressure from Irish thalidomider organisations, in April 2010 the state claims agency published a report to emphasis lack of responsibility on their part. (In reality due to time lapsed and statutes bared this is possibly true.). However, morally there is just cause for debate. The report was commissioned by the then Minister for health, quoting the following;  “In relation to the Thalidomide survivors, the events giving rise to the survivors ‘injuries, namely the innocent taking of Thalidomide preparations by their mothers, occurred between the years 1958 and 1962. Moreover, it is notable that the Public Prosecutor’s Office in Aachen received its first complaints in 1961”...  

Followed by; “The National Drugs Advisory Board (predecessor to the Irish Medicines Board) was only established in 1966”. 

In addition; “Having taken legal advice, the Minister is informed that the State does not have a legal liability for the injuries suffered by Irish survivors of Thalidomide. All Attorneys General who have considered this issue have concurred with this position“. 

The British government claimed the same level of liability as our own, yet they morally stepped up to the plate. On Thursday, December 20, 2012, The British government announced, “over the next 10 years, a grant will given to the British survivors in the region of £80 million - it will be paid on an annual basis, rising each year in line with inflation”. In addition, in 2009 – The British Government agrees a £20 million grant, to be paid by the Department of Health to the Thalidomide Trust over three years, SHAME ON YOU IRELAND.

From 2009 to today, the department of health has repeatedly released the following statement to the public. Issued On September 9th 2012 Minister Reilly stated, “I have previously indicated that I am willing to enter into discussions about a financial gesture of goodwill towards Irish survivors of thalidomide”. …
From 2007 to today, The Irish Thalidomide Survivors Society has strived to do exactly that and maintain this relationship even at the cost of accelerated pain and further debilitation of their members. ITSS felt to have a cooperative relationship with government outside of the public eye, was a positive and constructive way forward.

Now in 2013 we have gained very little ground with our compliant approach.  The Irish thalidomide survivors have written to the minister three times and have has numerous representations from local TD’S to Minister Reilly regarding proposed care plan and requests for a meeting with Minister Reilly, to no avail.
Minister Reilly made it clear he “favours a non-statutory solution”. He went on to say, “he requested ITSS, in good faith, to continue to engage with the HSE in developing and participating in a health care assessment process”. 

 Minister Riley's proposed care plan in its present form is no different from that of any other disabled person in Ireland; including budgetary status. There is no special provision of security in recognition of our unique requirements or circumstance as Thalidomide Survivors within his proposal. Minister Riley is offering what we as disabled citizens of Ireland are entitled to anyway. Minister Riley claims that "the Care plan in its entirety is not in his remit".

We would appeal to Government and Minister Riley to deliver their promise. To stop deceiving the public and TD’S with false intention of a Care plan and ex-gratia payments. We would appeal to Minister Riley to negotiate, some form of statutory agreement, so to have a sense of security and not find ourselves in the same predicament in another 10 years.

Our request is reasonable. We are 32 persons, government know the level of our lobbing power and it would seem they deem it morel to take full and plenty advantage of the fact. We refuse to believe it is not possible to configure a statutory agreement without liability concerns. The British Government did.

If this catastrophe happened in these times, there would be no question to the future the thalidomide survivors. In addition, because this tragedy happened in a time when no one could fight hierarchy and troubled mothers were too exhausted and beaten to fight, the survivors of thalidomide were left to suffer in silence.  From that time to this, the mere mention of the word thalidomide causes doors to slam tightly. It is a word that has always created fear, embarrassment, and trepidation of liability.

We will never know the truth the about thalidomide scandal, from the Nazis to its regulatory process and distribution. However, what we do know is this was a man-invoked injury to thousands of defenseless babies and their mothers. Moreover, nobody will take the responsibility for the damaged caused in Ireland.

My name is Carmel Daly McDonnell and I am a thalidomide survivor and spokesperson for the Irish Thalidomide Society.  My mother bought thalidomide as an over the counter non-prescription drug after the ban.                                                                                                                        

My health is getting worse and I am terrified. I cannot fight any more. I am too old, too tired. My husband and I cannot spend the rest of our life’s worrying about the future. I am worried all the time.

Saturday, September 1, 2012

RE:The Irish Thalidomide Survivors Society release the following statement. re; Grunenthal's thalidomide apology to Thalidomide Survivors


50 years on and Grünenthal think that they can offer an apology now
An apology will not give us back our childhood, or wrap full-length arms around our children or grandchildren to console them when they are crying. It will not act as a painkiller when we are awake at nights suffering horrendous pain that no painkiller can cure. It cannot give us dignity when our spouses and personal assistants need to help us change our clothes use the toilet or have a bath.   For some it will not allow us to have a normal basic social, lads or girls night out without a mammoth planning exercise.

 It will not provide the finances to adapt are homes our cars or even have are clothes made to suit our damaged. it can not get our provide us with wheelchairs or any other helping tools to stop more deterioration in are bodies. So, Mr Stock how valuable is your apology

Tuesday, July 6, 2010

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