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Irish Thalidomide Survivors Society

thalidomide survivors

Witness-Thalidomide

http://www.bbc.co.uk/iplayer/episode/p00lmvyn/Witness_Thalidomide/

 Fifty years ago the drug thalidomide was found to cause serious damage to the unborn child.


Devastating consequences of drug

As the biggest drug scandal began in postwar German history - our archivist Frank Girmann the events documented again:

1954: Two employees of the company, "Chemie Grünenthal" in Stolberg near Aachen, it is possible to manufacture the drug thalidomide, which in a calming and sleep aid "thalidomide" Germany is sold later.

1. October 1957: Thalidomide is launched.

1959: The manufacturer receives reports of serious nerve damage in older people who had taken thalidomide long time.

1960: The German Society for Pediatrics is surprised by a new "syndrome" is striking that many children are born with deformities.

18. November 1961: The Hamburg-based pediatrician and geneticist Widukind Lenz expressed at a meeting for the first time the suspicion that "drug that showed up in 17 20 histories, the cause of responsibility could be given a". A few days earlier, doctors had informed the company Grunenthal and invited them to products from the market to take the thalidomide.

27. November 1961: Thalidomide is taken off the market.

1968: Employees of Grünenthal be for negligent and intentional injury, partial loss of life to the accused.

10. April 1970: Comparison to the court: "Chemie Grünenthal" will provide 100 million dollars available to provide unique, in return, the person concerned to renounce their claims if necessary. The sum is in the Foundation's Fund for disabled children "paid.

18. December 1970: The criminal trial against the holder Hermann Wirtz and eight executives of thalidomide manufacturer Grunenthal is 283 days of negotiations, partly due to lower debt by the state court in Aachen to set.

May 1997: The payments to the victims of the Foundation are used up. It follows a dispute over the re-establishment of the Foundation with a view of the company's profits and assets of the holder of the Wirtz family.

July 1998: U.S. thalidomide may be administered as a remedy in the. In the 50s it was not approved here.

19. October 2005: The "Law on the Thalidomide Foundation for Disabled People" (Thalidomide Foundation Act) comes into force.

February 2006: A pharmacist provides Koblenz for cancer patients with no hope of the former drug scandal in her small amounts.

7. and 8 November 2007: The ARD film "A single tablet" illuminates the thalidomide issue. Manufacturer Grünenthal tried lawsuits against the WDR for violation of privacy rights to prevent transmission with - in vain.

May 2008: The Bundestag decides to double the compensation for thalidomide victims.


 

BOOKS

 FACTUAL

The Challenge of Thalidomide: A pilot study of the educational needs of children in Scotland affected by the drug  (Author) M.L. Kellmer Pringle and D.O. Fiddes

Publisher  The National bureau for co-operation in child care, Longman 1970

Beyond Thalidomide 

 by McCredie (Author) Publisher: Harper Collins Canadaltd

 

by McCredie (Author)
Hardcover: 418 pages 
Publisher: Royal Society of Med Press; 1 edition (Jun 15 2007) 
Language: English 
THALIDOMIDE STORY 
Past
 Thalidomide was  developed by German pharmaceutical company Grünenthal in Stolberg (Rhineland) near Aachen , although this claim has recently been challenged. A report published by Dr Martin W Johnson, director of the Thalidomide Trust in the United Kingdom, detailed evidence that suggested the drug had been developed as an antidote to nerve gases such as sarin in Germany in 1944, ten years before Grünenthal secured a patent in 1954. Other sources have suggested that it may have been first synthesised by British scientists at the University of Nottingham in 1949. 1954: Two employees of the company, "Chemie Grünenthal" in Stolberg near Aachen,made it possible to manufacture the drug thalidomide, as a calming and sleep aid.Thalidomide, launched by Grünenthal on 1st October 1957, was found to act as an effective tranquiliser and painkiller and was proclaimed a "wonder drug" for insomnia, coughs, colds and headaches. It was also found to be an effective antiemetic which had an inhibitory effect on morning sickness , and so thousands of pregnant women took the drug to relieve their symptoms. At the time of the drug's development it was not thought likely that any drug could pass from the mother across the placental barrier and harm the developing fetus .
Thalidomide was a drug, which after years of extensive animal tests, was first marketed as an over-the-counter sedative. before being marketed, the danger signs had already appeared: during the 1950s at the University Clinic at Bonn, Thalidomide had been tested on 140 children. Doses used were 11 to 20 times higher than the recommended dose for adults. Half the children were mentally disturbed or had brain damage and had been given the drug for up to nine weeks. The parents were not asked for their permission, nor were they informed that their children were being treated with an entirely new sedative.
Sales rocketed and many pharmaceutical companies produced the drug under license to Chemie Grünenthal from as early as 1955 and 1957.
1957, after launching Contergan (Thalidomide) in West Germany, reports began to appear regarding peripheral neuritis which revealed thalidomide's toxic effects on the nervous system of the user. The same problems were confirmed by doctors who reported ill- effects from the drug, while observing their patients. followed by a surge of universal medical agreement that severe nervous damage was being caused by Thalidomide. During this time, of the marketing and sale of the drugs containing Thalidomide in Ireland, the Irish Government, under the auspices of its Department of Health, approved the marketing and sale of Softenon, Entero-Sediv, Poli-Gripan, Nocto-Sediv, Predni-Sediv. Despite the surge of universal medical agreement, that severe nervous damage was being caused by Thalidomide. 
Such a suspicion was suggestive enough to cause Dr Frances Kelsey, the Medical Officer of the American Food and Drug Administration, to reject the pharmaceutical company's application to market Kevadon (Thalidomide) in the United States, because among other reasons, she was not satisfied that the drug would be safe to take during pregnancy. In 1962, the United States Congress enacted laws requiring tests for safety during pregnancy before a drug can receive approval for sale in the U.S. Some other countries enacted similar legislation, and thalidomide was not prescribed or sold for decades. 
Nevertheless, the drug went on to cause an outbreak of physical deformities in tens of thousands of children across the world. Many of these did not survive early childhood, and countless more had already died in the uterus.
Correspondence from Dr. Victoria Coffey’s sent on the 23rd March 1963 by to the Department of Health and subsequently on October 12th 1964 to Prof. Lenz, Germany). Stated, “The number of babies in Ireland with limb anomalies considered attributable to the drug Thalidomide was 105.  Of these, 87 were actually born alive but 23 died in the neonatal period.  The remainder of 64 had malformations of varying severity”. We now no there is 27 
Irish thalidomide beneficiaries recognised by the Irish and German authorities. this is officially recorded in 2009. However, it is claimed that there are 32.
The US presidential candidate Mr. Ralph Nader claimed in 1973 that The Irish Times had withheld an article on the problems associated with thalidomide at a time when the drug was presumed to be safe, according to files in the National Archives.
However, it was withdrawn in the early November 1961 when it was discovered that it was causing severe deformities in babies. 
Mr Nader claimed that the Government knew that the drug was dangerous in 1961 yet waited almost seven months - until June 1962 - before telling the public that the drug had been removed from sale and was dangerous.
 It was also disclosed at the trial by Dr Muckter, the director of the scientific laboratory of Chemie Grünenthal, that all the company's records were destroyed - or had 'disappeared' during 1959....Because Chemie Grünenthal had performed the required animal safety-tests, and because these did not show evidence of any danger, the manufacturers of Thalidomide were found not guilty by the court of consciously marketing a harmful drug.
PRESENT SITUATION IN IRELAND
In 1975 after a decade of intense lobbying by our parents a commitment was entered into by the Irish Government to provide compensation to us and provide essential services and facilities. 
One of the key points of the said agreement was that the above objectives would meet pace over time with increasing money values and cater for the increasing essential services and aids necessitated by our disabilities.
Thirty-five years on, we assert that the treatment we now receive is inadequate to keep the spirit of the aforementioned agreement. we have had degrading disputes with various public authorities, regarding our health and services, induced by the lack of an inadequate and unfair financial compensation package We feel that the commitment embodied in the agreement has been made in recognition of our unique situation as Thalidomide survivors.Some of the basic normal activities that were once possible now cause aggressive pain and inability to carry out these tasks.
The current level of support we receive does not address our ever-increasing need for more facilities particularly given the infirmities that old age now brings on top of our already significant disabilities.
marketing and sale of the drugs containing Thalidomide in Ireland,

 Thalidomide - A Medical Dictionary, Bibliography, and Annotated Research Guide to Internet References.

(Author) Health Publications        Publisher: Icon Health Publications (June 2004)

 

Suffer the Children: The Story of Thalidomide (Author), Elaine Potter

Publisher: Viking Press (February 1979)

 

Thalidomide: Index of New Information for Research, Reference & Therapy

 (Author) Max C. Dobber Publisher: Abbe Pub Assn of Washington Dc (March 1998)

 

 The Thalidomide Children and the Law: a report by Sunday Times

 Publisher: André Deutsch Limited (1973)

 

 Thalidomide and the Power of the Drug Companies

 (Author) Henning Sjöström and Robert Nilsson  Publisher: Penguin Books (1972)

 

 Contergan/Thalidomid : Ein Unglück kommt selten allein  (Author) Catia Monser

 Publisher: Eggcup-Verlag (1993)

 

 Thalidomide Embryopathy in Japan

 Edited by Mitsushiro Kida and Published by Kodansha LTD (1987)

 For bibliographies see amazon

 http://www.amazon.com/s?ie=UTF8&page=1&rh=n%3A283155%2Ck%3AThalidomide


No Hand to Hold & No Legs To Dance On: A Thalidomide Survivor's Story by Louise Medus

 


No Hand to Hold & No Legs To Dance On: A Thalidomide Survivor's Story by Louise Medus
By Henning Sjöström and Robert Nilsson
Penguin Books (1972) 
by London Sunday Times

The History and Implications of Testing Thalidomide on Animals

 

 

The authors became interested in this topic as a result of reading: The Dark Remedy [74] and Thalidomide and the Power of the Drug Companies [45].


About the Authors
Ray Greek, MD is the president of the not-for-profit group Americans For Medical Advancement (www.AFMA-curedisease.org). Dr. Greek is the corresponding author and can be contacted atDrRayGreek@aol.com.

Niall Shanks, PhD (deceased) was the Curtis D. Gridley Distinguished Professor of History and Philosophy of Science at Wichita State University.

Mark Rice, MD is chief of the liver transplant division at the University of Florida, Department of Anesthesiology, has seven US patents, and reviews for several major journals.Thalidomide was  developed by German pharmaceutical company Grünenthal in Stolberg (Rhineland) near Aachen , although this claim has recently been challenged. A report published by Dr Martin W Johnson, director of the Thalidomide Trust in the United Kingdom, detailed evidence that suggested the drug had been developed as an antidote to nerve gases such as sarin in Germany in 1944, ten years before Grünenthal secured a patent in 1954. Other sources have suggested that it may have been first synthesised by British scientists at the University of Nottingham in 1949. 1954: Two employees of the company, "Chemie Grünenthal" in Stolberg near Aachen,made it possible to manufacture the drug thalidomide, as a calming and sleep aid.Thalidomide, launched by Grünenthal on 1st October 1957, was found to act as an effective tranquiliser and painkiller and was proclaimed a "wonder drug" for insomnia, coughs, colds and headaches. It was also found to be an effective antiemetic which had an inhibitory effect on morning sickness , and so thousands of pregnant women took the drug to relieve their symptoms. At the time of the drug's development it was not thought likely that any drug could pass from the mother across the placental barrier and harm the developing fetus .
Thalidomide was a drug, which after years of extensive animal tests, was first marketed as an over-the-counter sedative. before being marketed, the danger signs had already appeared: during the 1950s at the University Clinic at Bonn, Thalidomide had been tested on 140 children. Doses used were 11 to 20 times higher than the recommended dose for adults. Half the children were mentally disturbed or had brain damage and had been given the drug for up to nine weeks. The parents were not asked for their permission, nor were they informed that their children were being treated with an entirely new sedative.
Sales rocketed and many pharmaceutical companies produced the drug under license to Chemie Grünenthal from as early as 1955 and 1957.
1957, after launching Contergan (Thalidomide) in West Germany, reports began to appear regarding peripheral neuritis which revealed thalidomide's toxic effects on the nervous system of the user. The same problems were confirmed by doctors who reported ill- effects from the drug, while observing their patients. followed by a surge of universal medical agreement that severe nervous damage was being caused by Thalidomide. During this time, of the marketing and sale of the drugs containing Thalidomide in Ireland, the Irish Government, under the auspices of its Department of Health, approved the marketing and sale of Softenon, Entero-Sediv, Poli-Gripan, Nocto-Sediv, Predni-Sediv. Despite the surge of universal medical agreement, that severe nervous damage was being caused by Thalidomide. 
Such a suspicion was suggestive enough to cause Dr Frances Kelsey, the Medical Officer of the American Food and Drug Administration, to reject the pharmaceutical company's application to market Kevadon (Thalidomide) in the United States, because among other reasons, she was not satisfied that the drug would be safe to take during pregnancy. In 1962, the United States Congress enacted laws requiring tests for safety during pregnancy before a drug can receive approval for sale in the U.S. Some other countries enacted similar legislation, and thalidomide was not prescribed or sold for decades. 
Nevertheless, the drug went on to cause an outbreak of physical deformities in tens of thousands of children across the world. Many of these did not survive early childhood, and countless more had already died in the uterus.
Correspondence from Dr. Victoria Coffey’s sent on the 23rd March 1963 by to the Department of Health and subsequently on October 12th 1964 to Prof. Lenz, Germany). Stated, “The number of babies in Ireland with limb anomalies considered attributable to the drug Thalidomide was 105.  Of these, 87 were actually born alive but 23 died in the neonatal period.  The remainder of 64 had malformations of varying severity”. We now no there is 27 
Irish thalidomide beneficiaries recognised by the Irish and German authorities. this is officially recorded in 2009. However, it is claimed that there are 32.
The US presidential candidate Mr. Ralph Nader claimed in 1973 that The Irish Times had withheld an article on the problems associated with thalidomide at a time when the drug was presumed to be safe, according to files in the National Archives.
However, it was withdrawn in the early November 1961 when it was discovered that it was causing severe deformities in babies. 
Mr Nader claimed that the Government knew that the drug was dangerous in 1961 yet waited almost seven months - until June 1962 - before telling the public that the drug had been removed from sale and was dangerous.
 It was also disclosed at the trial by Dr Muckter, the director of the scientific laboratory of Chemie Grünenthal, that all the company's records were destroyed - or had 'disappeared' during 1959....Because Chemie Grünenthal had performed the required animal safety-tests, and because these did not show evidence of any danger, the manufacturers of Thalidomide were found not guilty by the court of consciously marketing a harmful drug.
PRESENT SITUATION IN IRELAND
In 1975 after a decade of intense lobbying by our parents a commitment was entered into by the Irish Government to provide compensation to us and provide essential services and facilities. 
One of the key points of the said agreement was that the above objectives would meet pace over time with increasing money values and cater for the increasing essential services and aids necessitated by our disabilities.
Thirty-five years on, we assert that the treatment we now receive is inadequate to keep the spirit of the aforementioned agreement. we have had degrading disputes with various public authorities, regarding our health and services, induced by the lack of an inadequate and unfair financial compensation package We feel that the commitment embodied in the agreement has been made in recognition of our unique situation as Thalidomide survivors.Some of the basic normal activities that were once possible now cause aggressive pain and inability to carry out these tasks.
The current level of support we receive does not address our ever-increasing need for more facilities particularly given the infirmities that old age now brings on top of our already significant disabilities.
marketing and sale of the drugs containing Thalidomide in Ireland,
Thalidomide was  developed by German pharmaceutical company Grünenthal in Stolberg (Rhineland) near Aachen , although this claim has recently been challenged. A report published by Dr Martin W Johnson, director of the Thalidomide Trust in the United Kingdom, detailed evidence that suggested the drug had been developed as an antidote to nerve gases such as sarin in Germany in 1944, ten years before Grünenthal secured a patent in 1954. Other sources have suggested that it may have been first synthesised by British scientists at the University of Nottingham in 1949. 1954: Two employees of the company, "Chemie Grünenthal" in Stolberg near Aachen,made it possible to manufacture the drug thalidomide, as a calming and sleep aid.Thalidomide, launched by Grünenthal on 1st October 1957, was found to act as an effective tranquiliser and painkiller and was proclaimed a "wonder drug" for insomnia, coughs, colds and headaches. It was also found to be an effective antiemetic which had an inhibitory effect on morning sickness , and so thousands of pregnant women took the drug to relieve their symptoms. At the time of the drug's development it was not thought likely that any drug could pass from the mother across the placental barrier and harm the developing fetus .
Thalidomide was a drug, which after years of extensive animal tests, was first marketed as an over-the-counter sedative. before being marketed, the danger signs had already appeared: during the 1950s at the University Clinic at Bonn, Thalidomide had been tested on 140 children. Doses used were 11 to 20 times higher than the recommended dose for adults. Half the children were mentally disturbed or had brain damage and had been given the drug for up to nine weeks. The parents were not asked for their permission, nor were they informed that their children were being treated with an entirely new sedative.
Sales rocketed and many pharmaceutical companies produced the drug under license to Chemie Grünenthal from as early as 1955 and 1957.
1957, after launching Contergan (Thalidomide) in West Germany, reports began to appear regarding peripheral neuritis which revealed thalidomide's toxic effects on the nervous system of the user. The same problems were confirmed by doctors who reported ill- effects from the drug, while observing their patients. followed by a surge of universal medical agreement that severe nervous damage was being caused by Thalidomide. During this time, of the marketing and sale of the drugs containing Thalidomide in Ireland, the Irish Government, under the auspices of its Department of Health, approved the marketing and sale of Softenon, Entero-Sediv, Poli-Gripan, Nocto-Sediv, Predni-Sediv. Despite the surge of universal medical agreement, that severe nervous damage was being caused by Thalidomide.
Such a suspicion was suggestive enough to cause Dr Frances Kelsey, the Medical Officer of the American Food and Drug Administration, to reject the pharmaceutical company's application to market Kevadon (Thalidomide) in the United States, because among other reasons, she was not satisfied that the drug would be safe to take during pregnancy. In 1962, the United States Congress enacted laws requiring tests for safety during pregnancy before a drug can receive approval for sale in the U.S. Some other countries enacted similar legislation, and thalidomide was not prescribed or sold for decades. 
Correspondence from Dr. Victoria Coffey’s sent on the 23rd March 1963 by to the Department of Health and subsequently on October 12th 1964 to Prof. Lenz, Germany). Stated, “The number of babies in Ireland with limb anomalies considered attributable to the drug Thalidomide was 105.  Of these, 87 were actually born alive but 23 died in the neonatal period.  The remainder of 64 had malformations of varying severity”. We now no there is 27. 
PRESENT SITUATION IN IRELAND
In 1975 after a decade of intense lobbying by our parents a commitment was entered into by the Irish Government to provide compensation to us and provide essential services and facilities. 
One of the key points of the said agreement was that the above objectives would meet pace over time with increasing money values and cater for the increasing essential services and aids necessitated by our disabilities.
One of the key points of the said agreement was that the above objectives would meet pace over time with increasing money values and cater for the increasing essential services and aids necessitated by our disabilities.
Thirty-five years on, we assert that the treatment we now receive is inadequate to keep the spirit of the aforementioned agreement. we have had degrading disputes with various public authorities, regarding our health and services, induced by the lack of an inadequate and unfair financial compensation package We feel that the commitment embodied in the agreement has been made in recognition of our unique situation as Thalidomide survivors.Some of the basic normal activities that were once possible now cause aggressive pain and inability to carry out these tasks.
The current level of support we receive does not address our ever-increasing need for more facilities particularly given the infirmities that old age now brings on top of our already significant disabilities.
marketing and sale of the drugs containing Thalidomide in Ireland,
Thirty-five years on, we assert that the treatment we now receive is inadequate to keep the spirit of the aforementioned agreement. we have had degrading disputes with various public authorities, regarding our health and services, induced by the lack of an inadequate and unfair financial compensation package
We feel that the commitment embodied in the agreement has been made in recognition of our unique situation as Thalidomide survivors.Some of the basic normal activities that were once possible now cause aggressive pain and inability to carry out these tasks.The current level of support we receive does not address our ever-increasing need for more facilities particularly given the infirmities that old age now brings on top of our already significant disabilities.
marketing and sale of the drugs containing Thalidomide in Ireland,

In 1975 after a decade of intense lobbying by our parents a commitment was entered into by the Irish Government to provide compensation to us and provide essential services and facilities. 
One of the key points of the said agreement was that the above objectives would meet pace over time with increasing money values and cater for the increasing essential services and aids necessitated by our disabilities.
Thirty-five years on, we assert that the treatment we now receive is inadequate to keep the spirit of the aforementioned agreement. we have had degrading disputes with various public authorities, regarding our health and services, induced by the lack of an inadequate and unfair financial compensation package We feel that the commitment embodied in the agreement has been made in recognition of our unique situation as Thalidomide survivors.Some of the basic normal activities that were once possible now cause aggressive pain and inability to carry out these tasks.
The current level of support we receive does not address our ever-increasing need for more facilities particularly given the infirmities that old age now brings on top of our already significant disabilities.
marketing and sale of the drugs containing Thalidomide in Ireland,
In 1975 after a decade of intense lobbying by our parents a commitment was entered into by the Irish Government to provide compensation to us and provide essential services and facilities. 
One of the key points of the said agreement was that the above objectives would meet pace over time with increasing money values and cater for the increasing essential services and aids necessitated by our disabilities.
Thirty-five years on, we assert that the treatment we now receive is inadequate to keep the spirit of the aforementioned agreement. we have had degrading disputes with various public authorities, regarding our health and services, induced by the lack of an inadequate and unfair financial compensation package We feel that the commitment embodied in the agreement has been made in recognition of our unique situation as Thalidomide survivors.Some of the basic normal activities that were once possible now cause aggressive pain and inability to carry out these tasks.
The current level of support we receive does not address our ever-increasing need for more facilities particularly given the infirmities that old age now brings on top of our already significant disabilities.
marketing and sale of the drugs containing Thalidomide in Ireland,
In 1975 after a decade of intense lobbying by our parents a commitment was entered into by the Irish Government to provide compensation to us and provide essential services and facilities. 
One of the key points of the said agreement was that the above objectives would meet pace over time with increasing money values and cater for the increasing essential services and aids necessitated by our disabilities.
Thirty-five years on, we assert that the treatment we now receive is inadequate to keep the spirit of the aforementioned agreement. we have had degrading disputes with various public authorities, regarding our health and services, induced by the lack of an inadequate and unfair financial compensation package We feel that the commitment embodied in the agreement has been made in recognition of our unique situation as Thalidomide survivors.Some of the basic normal activities that were once possible now cause aggressive pain and inability to carry out these tasks.
The current level of support we receive does not address our ever-increasing need for more facilities particularly given the infirmities that old age now brings on top of our already significant disabilities.
marketing and sale of the drugs containing Thalidomide in Ireland,
PRESENT SITUATION IN IRELAND
In 1975 after a decade of intense lobbying by our parents a commitment was entered into by the Irish Government to provide compensation to us and provide essential services and facilities. 
One of the key points of the said agreement was that the above objectives would meet pace over time with increasing money values and cater for the increasing essential services and aids necessitated by our disabilities.
Thirty-five years on, we assert that the treatment we now receive is inadequate to keep the spirit of the aforementioned agreement. we have had degrading disputes with various public authorities, regarding our health and services, induced by the lack of an inadequate and unfair financial compensation package We feel that the commitment embodied in the agreement has been made in recognition of our unique situation as Thalidomide survivors.Some of the basic normal activities that were once possible now cause aggressive pain and inability to carry out these tasks.
The current level of support we receive does not address our ever-increasing need for more facilities particularly given the infirmities that old age now brings on top of our already significant disabilities.
marketing and sale of the drugs containing Thalidomide in Ireland,
In 1975 after a decade of intense lobbying by our parents a commitment was entered into by the Irish Government to provide compensation to us and provide essential services and facilities. 
One of the key points of the said agreement was that the above objectives would meet pace over time with increasing money values and cater for the increasing essential services and aids necessitated by our disabilities.
Thirty-five years on, we assert that the treatment we now receive is inadequate to keep the spirit of the aforementioned agreement. we have had degrading disputes with various public authorities, regarding our health and services, induced by the lack of an inadequate and unfair financial compensation package We feel that the commitment embodied in the agreement has been made in recognition of our unique situation as Thalidomide survivors.Some of the basic normal activities that were once possible now cause aggressive pain and inability to carry out these tasks.
The current level of support we receive does not address our ever-increasing need for more facilities particularly given the infirmities that old age now brings on top of our already significant disabilities.
marketing and sale of the drugs containing Thalidomide in Ireland
Irish thalidomide beneficiaries recognised by the Irish and German authorities. this is officially recorded in 2009. However, it is claimed that there are 32.
The US presidential candidate Mr. Ralph Nader claimed in 1973 that The Irish Times had withheld an article on the problems associated with thalidomide at a time when the drug was presumed to be safe, according to files in the National Archives.
However, it was withdrawn in the early November 1961 when it was discovered that it was causing severe deformities in babies. 
Mr Nader claimed that the Government knew that the drug was dangerous in 1961 yet waited almost seven months - until June 1962 - before telling the public that the drug had been removed from sale and was dangerous.
 It was also disclosed at the trial by Dr Muckter, the director of the scientific laboratory of Chemie Grünenthal, that all the company's records were destroyed - or had 'disappeared' during 1959....Because Chemie Grünenthal had performed the required animal safety-tests, and because these did not show evidence of any danger, the manufacturers of Thalidomide were found not guilty by the court of consciously marketing a harmful dru
Nevertheless, the drug went on to cause an outbreak of physical deformities in tens of thousands of children across the world. Many of these did not survive early childhood, and countless more had already died in the uterusThe History and Implications of Testing Thalidomide on Anima

The thalidomide controversy involves numerous issues. Our claims are as follows and will be examined in order:

  1. Scientists did know that chemicals crossed the placenta.
  2. Scientists did test thalidomide on pregnant animals.
  3. More animal testing would not have prevented the disaster.
  4. Current requirements for teratogenicity testing in animals are based on the mistaken notion that animal models can predict human response.

Scientists did know that chemicals crossed the placenta
A myth dating back to the Middle Ages said that the placenta did not allow harmful chemicals to cross over to the fetus. Some  have claimed that animal studies, specifically studies using pigs in the 1920s and 1930s were responsible for finally disproving this myth. In fact, scientists had good evidence that the placenta was permeable in the late 1800s based on human observations. By the 1930s, a combination of human and animal data had definitively disproven the myth. Moreover, drugs like thalidomide, that crossed the blood brain barrier thereby decreasing nausea, would also be expected to cross the placenta.

In 1874, Zweifel  performed research that revealed that chloroform crossed the human placenta. . This was again demonstrated in dogs in 1912. Other anesthetic agents such as opioids, barbiturates, and tranquilizers (e.g., chlorpromazine), were also known before the 1950s to cross the placenta. In 1878, a case was published that reported sodium salicylate was found in the urine of the baby after having been given to the mother 30 minutes prior to delivery.  This appears to be the first time the scientific literature suggested that chemicals were able to cross the placenta. In 1909, alcohol was measured in the umbilical cord blood and revealed to be in the same concentration as in the mother. The alcohol had been administered one hour prior to delivery. Between 1909 and 1933, Nicloux and others had conducted research that led them to think that drugs such as quinine passed through the placenta. Taylor wrote in 1935: “that the placenta is permeable to drugs is well established.”Dille  in 1934 had shown that Amytal passed the placenta in cats, rabbits, and guinea pigs and pointed out that the effects of morphine had been demonstrated numerous times on the human fetus. Pettey , in 1912 had pointed out a case where a newborn infant from a mother addicted to morphine was also addicted and went so far as to suggest that any infant born to an opiate addicted mother should receive an opiate for three days following birth. He based this on the fact that opiates crossed the placenta and, since the placenta had been severed, no more opiates were available for the infant. Burnet, in 1920 suggested the same. Taylor, in 1932 also reported that cyanosis of the newborn had all but been eliminated by abandoning twilight sleep, a practice involving giving opiates to women in labor. Taylor summarized by stating: “The obstetrician has long since recognized the permeability of the placenta to drugs.” Clearly, human and animal data was available in the 1930s that proved drugs did cross the placental barrier.

(Statements such as Taylor’s must be interpreted in the context of the day. The fact that any drugs crossed the placenta would have been viewed as proof of the concept that at least some drugs were capable of crossing, not that all drugs could or did cross the placenta. As we now know, placental transfer is highly dependent upon a number of factors including the lipophilicity of the drug. All drugs do not, in fact, cross the placenta. For example, polar molecules such as muscle relaxants (like curare) do not cross.)

Thiersch  in the 1950s, had shown repeatedly that some drugs could cross the placenta and cause the mother to abort the fetus. Sjöström and Nilsson [45] referred to Thiersch when they stated in court testimony at Södertälje that by 1959 at least 25 chemicals had been shown to affect the fetus, either killing the fetus or inducing malformations, that these studies had been performed in the US, Japan, and Europe, : “The findings by the various investigators were published in scientific journals and distributed internationally.” Other studies supporting the placental transfer of a number of drugs were also available to the manufacturer of thalidomide. It had been shown that any chemical with a molecular weight less than 1000 was at least a candidate for crossing the placenta. it was written in 1957 that chemicals with a molecular weight below 350 or 450 Da were known to be capable of crossing the placenta.  The molecular weight of thalidomide is 258 Da and entering the fetal circulation should have been considered a strong possibility based on the knowledge of the time.

Conclusion  the scientific community was clearly aware of the fact that chemicals could cross the placenta before thalidomide was developed and marketed. With the passage of time, more has been learned about the mechanisms of placental transfer. Chemicals can pass via simple diffusion, pumps, plasma membrane carriers, and biotransforming enzymes  but the general principle was appreciated well before the 1950s.

Scientists did test thalidomide on pregnant animals
Testing for teratogenicity was common practice in the pre-thalidomide era. Review articles had been published in the 1950s and early 1960s tracing the history of teratology testing. The first use of animals for this purpose dates back to 1891, when Dareste experimented with chick embryos and induced congenital defects. Scientists had studied the effects of radiation, nutrients, hormones, and eventually chemicals including specific drugs.. Many others continued this research using various mammals. some went so far as to suggest that publications regarding teratogens and teratology in general did not even increase because of thalidomide.

Nobel laureate chemist Roald Hoffmann observed:

Indeed animal testing for teratogenicity of new drugs was routine in the major pharmaceutical companies. Hoffmann-LaRoche’s Roche Laboratories published a major reproductive-system study of its Librium in 1959. Wallace Laboratories did so for Miltown in 1954. Both incidents antedate the thalidomide story.

The Sunday Times of London, on June 27, 1976 published the results of their very extensive investigation into the thalidomide disaster and stated that, by 1958, teratogenicity testing was routine. Moreover, according to a German medical journal of the era, toxicity tests on animals were conducted prior to thalidomide’s release.

Because all the records from Grünenthal were destroyed , we will never know exactly what testing was performed with thalidomide. However, we do know that teratogenicity testing on animals was common at that time. This leads us to the critical question: Would more animal testing have prevented the thalidomide disaster?

Thalidomide causes numerous birth defects in humans including microphthalmia (small eyes), coloboma (a hole in a part of the eye), other abnormalities of the eyes, and abnormalities of the ears, internal organs, and genitals. However, the congenital anomaly for which it is most infamous is phocomelia. Phocomelia comes from the Greek meaning seal and  limb— seal limbs. It was coined by Étienne Geoffroy Saint-Hilaire in 1836. Today, it is synonymous for the thalidomide-induced complete absence of limbs or the presence of very abbreviated limbs. In order for the human fetus to suffer from phocomelia, thalidomide must be administered between days 39-45 post-menstruation. Other birth defects can be seen if thalidomide is administered from day 34-50 post-menstruation.

In the mid-1960s, Karnofsky stated what has subsequently been referred to as Karnofsky’s law:

Any drug administered at the proper dosage, and at the proper stage of development to embryos of the proper species-and these include both vertebrates and invertebrates-will be effective in causing disturbances in embryonic development.

In other words, all medications are teratogenic in at least one species, if given in a large enough dose and at the proper time in development. To illustrate the sensitivity level for some species to some chemicals, even sodium chloride (common table salt) and water are teratogens in some species when they are administered in the required dose at the right time. An immense amount of animal testing has proven Karnofsky correct. Therefore, some form of congenital abnormality can be found in one or more animal species for essentially every drug.

The significance of this observation is further complicated by the fact that even drugs that are routinely given to women in pregnancy may occasionally be associated with a birth defect in an individual woman—an idiosyncratic response. The only way to assure that women will not give birth to a baby with birth defects secondary to taking drugs during pregnancy is to avoid administering or prescribing drugs to women who may be pregnant. There is no foolproof testing scheme, even today, for determining whether a specific woman will react to a specific drug by giving birth to an infant with congenital malformations. The drugs that are prescribed to pregnant women are given based on a long history of safety, epidemiological data relating the same, or based on chemistry that precludes placental transfer, not because of animal testing. 

Many species have been studied in an attempt to discover the mechanism for thalidomide–induced phocomelia. These studies have been frustrating for many reasons. First, thalidomide does not cause phocomelia in all species or even most. Second, thalidomide is metabolized to possibly greater than 100 metabolites.Third, an abundance of factors that can lead to phocomelia. Over thirty hypotheses have been offered to explain thalidomide’s developmental effects. Therapontos et al.  recently provided evidence that, at least in some animals, angiogenesis inhibition is responsible for the limb defects seen from thalidomide. Thalidomide acts as an anti-inflammatory agent and as an angiogenesis inhibitor, either of which can account for the changes in limb formation associated with its use. Changes in the signaling system have also been proposed. 

Taussig, writing in 1962, provides an interesting note regarding Grünenthal’s after-the-fact testing:

Grunenthal has tried to reproduce phocomelia in rats, mice, and rabbits and has failed. In Keil the drug was fed to hens and the chicks were normal. Grunenthal has shown that the drug passes through the placenta of rabbits but in their experience the offspring were normal.

Recent work  has revealed the chick embryo to be sensitive to thalidomide despite early reports that they were not , proving yet again that even the same species under different testing conditions will yield different results. Stephens perhaps unintentionally summarized the mindset of some that use animals in teratology research today when he stated:

The historic irony is that even though it has been clearly demonstrated that thalidomide does not cause limb defects in mice and rats, these animals are still being used to examine mechanisms of thalidomide’s teratogenic action.

 the United States government did not approve thalidomide because animal tests had raised suspicions about the drug. Reality tells a different story. Frances Kelsey, a medical officer at the FDA, stated the decision not to allow thalidomide was based on resulting peripheral neuritis—numb and tingling fingers in adult humans. Animal tests had nothing to do with the decision. Kelsey noticed a case report in the British Medical Journal that linked thalidomide to peripheral neuropathy. She wrote to Richardson-Merrell, who was trying to obtain license to market the drug, expressing concern that they had known about these cases but had failed to include them in their report (this turned out to be true) and stated they would now have to prove that the link between thalidomide and peripheral neuropathy was false if they wanted to gain a license for thalidomide in the US. Interestingly, Kelsey had also aided in repudiating the notion that the placenta was impermeable to all drugs. In the 1930s, she and her future fiancée conducted research on quinine using rabbits. They found that adults easily metabolized the drug, but that fetuses did not metabolize any of the drug. They showed that quinine crossed the placenta and that the mother and fetus did not necessarily metabolize all chemicals the same.

The deleterious effects of thalidomide appeared very early, after the disaster was noted, to vary among species and strains.[162-164] Testing numerous species would have produced a hodgepodge of results and been uninterpretable to the scientists of the 1950s, just like the results from animal testing for teratogenicity are             un-interpretable to scientists today. Red flags are not raised because a drug-to-be is teratogenic in an animal species. This is the norm and is part of the reason why most new drugs are labelled Class C. Animal tests did not and could not have prevented the thalidomide disaster and, in fact, delayed the acknowledgment of its severe side effects. When an Australian physician observed the link between thalidomide and birth defects, he sounded an alarm  that was largely ignored because of messages from Chemie Grünenthal asserting that if thalidomide crossed the placenta, it would be unlikely to cause harm. .

Currently, the only way to determine for certain whether a drug is a teratogen is through epidemiology. Better monitoring of medication intake could facilitate establishing a safety profile.

Conclusions

Based on the above, we conclude the following:

  1. Informed scientists and physicians knew the placenta allowed drugs and other chemicals to pass to the fetus well before the development of thalidomide.

  2. It is likely that thalidomide was tested on pregnant rats and rabbits prior to its release and that birth defects were not seen.

  3. A vast majority of animal species does not metabolize or exhibit the same fetal effects to thalidomide as humans.

  4. Claiming that animal testing could have predicted thalidomide’s teratogenicity is not scientifically viable. This is especially true in light of the fact that animal models even today do not have a high positive predictive value or negative predictive value for assessing teratogenicity or any human response to drugs or disease.

  5. There are important philosophical / ethical implications for using animals in drug testing as a consequence of a correct understanding of the role of animals in thalidomide disaster and other areas of research .

  6. Society has not suffered another thalidomide disaster because it has followed Sellers’ advice and not administered drugs to pregnant women without extremely good reason.

  7. A proper appreciation for the science of complex systems, specifically living complex systems that have different evolutionary histories, allows us to place, not just the data from teratology, but the data from toxicity testing and other uses of animal models, into the appropriate framework..

 

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EU talks in campaign for drug settlement

Published on the

08 January

2014

00:01

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A THALIDOMIDE victim from Yorkshire is to hold talks with the EU Health Commissioner as he steps up his fight for justice against the German pharmaceutical company which developed the anti-morning sickness drug.

 

Guy Tweedy and four colleagues – who are representing the UK’s 469 remaining Thalidomiders – have secured a meeting on Friday with Antonio Borges, in the hope of brokering a compensation talks with Grunenthal and the German government.

 

The meeting comes after a concerted lobbying campaign of UK MEPs by leading Thalidomide victims, who aim to secure a financial settlement from Grunenthal for UK, Swedish, Canadian and Australian victims of the “wonder drug”.

 

Mr Tweedy, 51, a businessman from Harrogate, said: “Over the last few months we have had a series of meetings with UK MEPs and, thanks to their support of our campaign, we now have a face to face meeting with Mr Borges.

 

“We hope we will be able to persuade him to use his influence to mediate a solution that will lead to us sitting down with representatives of both Grunenthal and the German government, and, ultimately, receiving compensation for the lasting damage their drug has done.”

 

Mr Tweedy, who was born with shortened arms and fingers fused together, added: “In 1971, the German government passed a law protecting Grunenthal from anyone taking legal action against it in relation to Thalidomide.

 

“However, the company needs to own up to its responsibilities and help those who have been living with the side effects of 
Thalidomide for more than 50 years.”

 

Thalidomide was administered to pregnant women to combat the effects of morning sickness, however, in May 1962 the drug was withdrawn after it was linked to crippling side effects in new-born babies.

 

At least 2,000 babies in the UK were born with deformities brought about directly by Thalidomide, and more than half
of them died within their first 
year.


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