Source document: https://docs-lawep.s3.us-east-2.amazonaws.com/1697630401115.pdf (Australia)
SUBMISSION TO SENATE INQUIRY ON THALIDOMIDE I wish to submit the following to the Senate Inquiry on the use of the drug Thalidomide and the effects suffered by those whose mothers unknowingly took it with trust in their Doctors and Government that it was safe to do so.

I am fortunately not a victim of this, however as a bystander I grew up with children who were and I have a friend who I have known for around 20 years.
I have watched this friend of mine raise her daughter and negotiate all the daily things that the rest of us take for granted.

This has had a devastating effect on all involved.

I know her story and I feel humbled to know her.

These victims are people too and whether we like it or not someone has to answer to this travesty.

As a mother of two healthy children I cannot imagine what the mothers and families would have had to endure.
I also cannot imagine how these victims cannot be given some form of compensation both monetary along with some form of an apology.

I also cannot believe that this company is allowed to operate in our wonderful country without demanding some form of compensation from them.

Just as in the case with the victims of Mesothelioma and Agent Orange, there has to be accountability.

We have compensation for many things now including victims of crime.

These victims are indeed that and entitled to something.
This needs to end here and not when the victims lives end after being swept under the carpet for so long.

Unfortunately, data is still being gathered on how many victims and families have suffered from this drug in Australia and only an inquiry and possible legal action will be able to ascertain that information.

Not all victims can have a say as it has affected them all in many different ways.
Also, it needs to be considered that the families are also victims here and further investigation should happen into the effects of this drug and if this could be something that is passed down through generations of the future.

Too many issues remain unanswered and I welcome a full inquiry into this.

I also look forward to finally seeing some recognition and compensation for these victims.
The following is a basic outlined history so far: - 1953 –Thalidomide was created in Germany by the Grünenthal Group.

Primarily prescribed as a sedative thalidomide also claimed to cure anxiety, insomnia, gastritis, and tension.

Later, it was used against nausea and to alleviate morning sickness in pregnant women.

1956 –The first Thalidomide-affected baby was born in West Germany to a Grünenthal employee.

1958 –Thalidomide was first licenced for use in the United Kingdom under the brand name Distaval.
1960 –Thalidomide was marketed in Australia.

MARCH 1961 – Distaval is declared a potent drug in Victoria, Australia.

This restricted its sales to Chemists.

APRIL 1961 – Australian Dr. William McBride, notified Chemie Grünenthal’s Australian distributor Distillers about his suspicions of the link between Distaval (Thalidomide) and malformations.

Distillers claim they never received the written report.
Yet sales promotion of the drug was stepped up and a quarter of a million leaflets distributed saying Thalidomide is "harmless even over a long period of use" and "completely harmless even for infants".

MAY 1961 – Dr. William McBride reported further malformations due to Thalidomide and succeeded in convincing his superiors at Crown Street Women's Hospital, Sydney, that the drug must be withdrawn from use in the hospital.

In October and November Dr. McBride reported further malformed babies.
OCTOBER 1961 – Approved for sale over the counter without a prescription in Victoria, Australia.

NOVEMBER 1961 – Thalidomide was withdrawn from the British and the Australian markets by the manufacturer, Chemie Grünenthal.

DECEMBER 1961 – Australian distributor Distillers withdrew from sale, Distaval, Asmaval, Tensivale, Valgis, and Valgraine.

All (5) of these medications contained Thalidomide.
Whilst Distaval was most commonly associated with morning sickness and baby abnormalities, the other medications were prescribed for symptoms of headache, toothache, hay fever, bronchitis, migraine, fibrositis, asthma, neuralgia, arthritis.

The reality was, that any of these tablets (or syrup) could be given to an unsuspecting woman, her child be mutilated or murdered, and the connection between Thalidomide and Thalidomide babes, not be made.
Whilst Thalidomide (under the collection of trade names listed above) was withdrawn by Distillers, the Australian Government did nothing to alert the public and/or search and destroy remaining stock.

DECEMBER 1961 – Dr McBride's observations were published in the Lancet highlighting the connections between Thalidomide and birth defects.

His observations were also published in the Australian Medical Journal on December 23.
1962 – Prof. Widijung Lenz who had warned against Thalidomide in Germany published evidence of deformities in the Lancet.

Chemie Grünenthal continued making and distributing Thalidomide, stepping up its advertising and intensive marketing despite criticism of doctors Support for Australia’s thalidomide survivorsSubmission 22 -2- MARCH 1962 – Thalidomide was removed from the shelves in Germany because of public opinion and against the wishes of Chemie Grünenthal.
News of the dangers of Thalidomide was played down by the media.

In many cases, malformed births occurred after the drug was withdrawn as many households were in possession of the drug.

Pregnant mothers took it never realizing the risks involved.

APRIL 1962 – Classified as a drug to be sold only on doctors’ prescriptions in Victoria, Australia.
JULY 1962 – FDA inspector Frances Kelsey, prevented the drug’s approval within the United States despite pressure from the pharmaceutical company and FDA supervisors.

Kelsey felt the application for thalidomide contained incomplete and insufficient data on its safety and effectiveness.

Kelsey was also concerned that there were not yet any results available from U.S. clinical trials of the drug.
AUGUST 1962 – President John F. Kennedy immediately responded to the recommendations of Frances Kelsey, by; * Alerting the people of America to the dangers of Thalidomide.

He personally made appearances on television warning of the dangers.

* Had warnings flashed on the television screens and over the radio at regular intervals throughout the day and night for weeks.

* Called for a nationwide search of every home and medicine cabinet in the country.
* Ordered for the destruction of every Thalidomide tablet found.

* Allocated a team of 200 men to track down every doctor who may have obtained supplies from outside sources, giving orders that any Thalidomide found to be destroyed on sight.

JULY 1962 – New Zealand Department of Health issued a directive to seize Thalidomide from Chemists and hospital shelves, under the Section 12 of the Food and Drug Act.
AUGUST 1962 - New Zealand Government prohibited the importation, manufacture, sale, and use of Thalidomide in New Zealand.

Australian government FINALLY bans the sale of Thalidomide.
Minister for Health (Senator Wade) said no action was necessary on the drug Thalidomide in Australia, because “the manufacturer had withdrawn it from the market.” (The Age, August 9, 1962) * Because of this “no action”, it was still possible to walk into a Chemist shop and purchase 100 tablets 7.5 months after “the manufacturer had withdrawn it from the market”.

* Because of this “no action” it was also possible for the manufacturer to make supplies available to hospitals at any time.
1962 – HANSARD - The following citations from the Federal Parliament Hansard suggest a delay occurring between when the Australian Health Department became aware of the effects of Thalidomide, and the banning of the drug.
AUGUST 22 - “Why was not the ban on Distaval imposed then, instead of four months afterwards, when a question was asked in this House?” Senator Turnbull (Tas), 22 August 1962; AUGUST 30 - “The reason why I raise this matter, Mr. Deputy President, is that I have a disquieting feeling that our Department of Health is not suffciently aware of what is happening.” Senator Turnbull (Tas),30 August 1962; OCTOBER 17 - “I think that not only every honourable member but everybody in the country was shocked by the tragedy of babies born deformed as a result of the use by their mothers during pregnancy of the drug thalidomide.
Australia's Minister for Health does not seem to have been shocked suffciently to do much about it”, Mr. Webb (Stirling), 17 October 1962.

DECEMBER 1962 - Letter from J.F.

Cairns (Member of House of Representatives) writes to Senator Wade (Federal Health Minister) to inquire as to the possibility of Thalidomide being contained in Tensival, Valgis, and Valgraine.

These medications were on sale for common complaints.
Federal Health Minister Wade replies to J.F Cairns responding, “he would have to investigate this matter”.

JANUARY 1963 - As written by the Director General to Minister Wade; “On the 10th December, The Melbourne Herald published your warning to householders to destroy supplies of Thalidomide preparations in their possession, but so far as can be ascertained, your statement did not appear in Interstate newspapers.
Minister Wade responds: “I am of the opinion that a further press statement on Thalidomide would serve no useful purpose at present time” MAY 1963 – Senator McClelland, addresses the Australian Federal Parliament; “The fact is, as I have said, that very little, if anything at all, is being done to assist these 23 malformed Australians.

Perhaps it is that society, consciously or unconsciously, wants to forget about them.
Perhaps it is that a collective family group of 23 cannot be regarded as a pressure group.

In any event, very little, if anything at all, is being done in Australia to alleviate the problems of the parents of these children or to assist the afficted children themselves.” The Senate Appropriation Bill (No.2) 1962-63.

May 14,1963.
May 14,1963.

(Note: only 23 babies were identified as Thalidomide at this stage) MID-LATE 1960S – The Australian Government made available the facilities of Veterans Affairs to provide the fitting of artificial limbs for those children missing either upper or lower limbs.

1968 – Chemie Grünenthal is brought to trial in Germany charged with intent to commit bodily harm and involuntary Support for Australia’s thalidomide survivorsSubmission 22 manslaughter.
Support for Australia’s thalidomide survivorsSubmission 22 -3- 1970 – The trial against Grünenthal is brought to a premature end by the German government stating that the trial “was not in the public interest”.

1974- The Australian government made a one-o!

payment of $150,000 to offset the taxes earned by the Thalidomide Foundation.
2010 – United Kingdom Health Minister (Mike O’Brien) makes a formal apology to their Thalidomide Victims, expressing “sincere regret and deep sympathy” on behalf of the government.

2012 – The inventor of Thalidomide (the Grünenthal Group) releases a statement saying it regrets the consequences of the drug.

“We ask that you regard our long silence as a sign of the silent shock that your fate has caused us!” Company Chief Executive, Harold Stock.
Following any settlements in 1974 (Distillers), 2010 (Diageo), and 2014 (Diageo), the Australian Federal Government passed legislation ensuring that the lump sum and ex-gratia payments were not considered income and therefore not liable for payment of income tax.

CURRENTLY – The Grünenthal Group have never recognised and/or compensated its Australian victims.

In 2015, The Grünenthal Group boasts a revenue of 1.2 billion euro.
The Grünenthal Group are present in 32 countries with products sold worldwide in 155 countries.

Chemie Grünenthal is STILL operating here in Australia unencumbered by sanctions or penalties.

The Australian Government is still ignoring the Thalidomide victims they helped create.
THE ROLE OF THE AUSTRALIAN GOVERNMENT IN COMPENSATION AND SUPPORT Other governments worldwide have taken the responsibility for their people and the following support has been given: - UK NATIONAL GOVERNMENT The Thalidomide Trust was set up to administer payments made by Distillers, who had distributed the Thalidomide drug in the UK.

Distillers (now Diageo), agreed to pay £20 million sterling in compensation.
The British government donated £5 million sterling to the Thalidomide Trust, which was an offset of tax on the original £20 million paid in by Distillers.

The British government, without offering any particular reason, donated a further £7 million.

2004 - The UK government introduced new legislation (Statutory Instrument 2004 1819) so that the Annual Grants received by beneficiaries were treated as damages for personal injury and were therefore exempt from Tax.
2005 - Distillers agreed a complex new multi-year financial settlement estimated to cost in the order of £153 million as additional compensation for Thalidomide victims.

The additional funding provided for covenant payments to be increased and for the payments to be extended from 2022 to 2037.

This was calculated on the basis of the money required to double beneficiary annual payments from 2004 levels by 2022.
JANUARY 2010 - British Health Minister, Mike O’Brien, confirmed a new £20 million support package, which had been announced during the month of December ’09.

This was for three years funding (initially on a pilot basis) to meet the increased health needs of beneficiaries.

The £20 million will be administered through the Thalidomide Trust.
If the £20 million was to be divided equally across all surviving Thalidomide victims in the UK, each victim would receive in the order of £43,000 sterling (dependent on their level of Thalidomide damage).

United Kingdom Health Minister (Mike O’Brien) makes a formal apology to their Thalidomide Victims, expressing “sincere regret and deep sympathy” on behalf of the government.

DECEMBER 2010 - British government paid £80-million sterling into the Thalidomide Trust.
2017 - The UK government introduces a "benefits disregard" so that the funding received by the UK Thalidomide victims from the Thalidomide Trust is disregarded when they are assessed for eligibility to receive state-funded benefits.

CANADIAN GOVERNMENT 1980 - Thalidomide victims settled with William S Merrell (Canadian distributors).

1991 - Federal Government gave victims of Thalidomide a one-time pay-out of $8.5 million.
(between $52,000 - $82,000 a person depending on level of disability) 2015 - Federal Government offered a second lump-sum payment of $125,000 to victims.

The Government also promised $168- million availability as annual compensation, (although did not explain how victims would access that fund).

MAY 2015 - Details provided on the $168-million included victims of Thalidomide receiving annual payments of up to $100,000, depending on level of disability.
Federal Government to create an annual Extraordinary Medical Assistance Fund of $5000,000 to assist victims with medical, living, and transport expenses.

Health Canada to allocate an administrator to manage the EMA Fund and compensation re-assessments levels.

NATIONAL GOVERNMENT OF IRELAND 1970 - the German government set up a compensation scheme from which Irish Thalidomiders received financial support.
In detail Thalidomiders received the following; 1) A lump sum ranging between DM7,500 (IR£1,250 approximately) and DM25,000 (IR£4,200 approx), and 2) A monthly allowance for life ranging between DM100 (IR£17 approx) and DM450 (IR£75 approx).

Support for Australia’s thalidomide survivorsSubmission 22 -4- 1973 - Irish government provided the following; 1) A lump sum ranging between IR£6,600 and IR£21,300, and 2) A monthly allowance for life ranging between IR£31.75 and IR£95.00.
The allowances, German and Irish, are tax-free, are not reckonable for State benefits and each of the Thalidomide victims are the holders of medical cards.

In addition, a Thalidomide victim can also claim disability allowance of approximately €849 per month or €10,192 per annum (2010 figures).

If disability allowance is added (€849 per month – 2010 figures) the total tax-free sum claimable by a Thalidomide victim is €1,773 (least severe) or €3,381 (most severe) monthly i.e.
€21,280 or €40,568 annually (2010 figures).

Updated figures are still being researched by this website.

The Irish government as a matter of principal decided to significantly increase the German compensation scheme.
In addition to the German scheme the GERMAN FEDERAL GOVERNMENT Grünenthal, the German manufacturer of the drug, set up a €50m (£41m) fund for 3,000 thalidomide victims on the Continent, mostly in Germany, and unveiled a memorial last September when, for the first time, it expressed its “sincere regrets” and “deep sympathy” for those affected.

But it has never compensated the British victims.


2012 - The inventor of Thalidomide (the Grünenthal Group) releases a statement saying it regrets the consequences of the drug.

“We ask that you regard our long silence as a sign of the silent shock that your fate has caused us!” Company Chief Executive, Harold Stock.

On average, German victims of Thalidomide receive the equivalent of £10,000 sterling a year from a foundation funded by Chemie Grünenthal and the government.
FEDERAL GOVERNMENT OF AUSTRALIA Mid to late 1960’s - The Australian Government made available the facilities of Veterans Affairs to provide the fitting of artificial limbs for those children missing either upper or lower limbs.

1974 - The Australian government made a one-off payment of $150,000 to off-set the taxes earned by the Thalidomide Foundation.
Following any settlements in 1974 (Distillers), 2010 (Diageo), and 2014 (Diageo), the Federal Government passed legislation ensuring that the lump sum and ex-gratia payments were not considered income and therefore not liable for payment of income tax.

Support for Australia’s thalidomide survivorsSubmission 22 QUESTIONS THAT NEED TO BE ASKED: - Is the Australian Government liable in the actions of Grundenthal?

-5- Should the Government have acted sooner?


Why wasn’t action taken earlier to suspend the distribution and recall the drug?

By making a small payment to some of the parents, why were the rights of these victims taken away?

Bearing in mind that victims weren’t expected to live very long, or beyond the age of consent, were their future rights to any claim taken away from them?

How can parents be held responsible for the compensation claims of their children past the age of 18?
This was not an illegal drug and was taken by mothers under the assurances and complete trust of doctors and government.

If the public can’t trust the government to regulate and act on these matters who can they trust?

Is it the drug that should be compensated for or the lack of action by those responsible for the distribution?

If there is a class action then all victims need to be taken into account as there are many without a voice or ability to fight for their rights.
Compensation from the drug company should be sort and future compensation should be accounted for as the full effects of this drug is possibly still unknown.

Will it affect future generations?

Whilst the drug caused this, is it the drug or the use of the drug that is to be questioned?

Some precedent needs to be set and a clear message sent to drug distributors that this will not be tolerated and compensation should adequately reflect damages on whole of life for these victims.
Victims could possibly live into old age and with the average now in their mid-fifties suffering ongoing medical expenses and lifestyle issues, how will they be compensated for and why should the drug company not be made fully responsible for this?

Well recognised world-wide governments have acted on behalf of their citizens who were victims of the use of the drug Thalidomide and have responded accordingly.
They have recognised, designed, implemented and reviewed packages that will support these victims and enable them to have a future with financial security enabling them to be members of society who have a level of pride and a sense of respect.

If the Australian Government denies culpability then they should at least head a compensation claim on the drug company.

Support for Australia’s thalidomide survivorsSubmission 22