Source document: https://docs-lawep.s3.us-east-2.amazonaws.com/1697641166866.pdf (Australia)
"INQUIRY INTO SUPPORT FOR AUSTRALIA'S THALIDOMIDE VICTIMS with particular reference to a. b. c. d. Adequacy of compensation and support Responsibility for providing support Provision of financial compensation Role of Australian Government in compensation and support e. Any related matters."

Professor Janet McCredie AM, MD, FRCR, FRANZCR.

Support for Australia’s thalidomide survivorsSubmission 67 Before addressing these five headings, I must define the disease to be discussed.
Thalidomide embryopathy is a lifelong disease of the sensory nervous system.

It does not stop with birth of a malformed baby.

It has a second phase later in life.

Thalidomide is a sensory nerve poison.

It attacks the sensory nerves of the embryo, causing either MAJOR or MINOR damage.

MAJOR DAMAGE kills developing nerve cells.

If enough nerves are killed, growth stops in the area supplied by that nerve, leaves a gap in the anatomy of that area.
The baby is born with a longitudinal reduction deformity or embryopathy.

The birth defects or embryopathy are well known to this audience and have been compensated in the past to some degree.

What has not been recognized or compensated so far is thalidomide's MINOR damage.

MINOR DAMAGE is when thalidomide's assault is less severe for various reasons: perhaps fewer nerves are killed, or perhaps more are able to recover and keep functioning.
With MINOR damage, there is no physical birth defect visible, but there is an invisible reduction in the population of nerves.

Because there are sufficient numbers of nerves to continue to function, MINOR nerve damage goes un-noticed.

Neurologists recognize it and do tests to establish its presence.

Neurologists call this a "subclinical neuropathy", meaning that there is minor damage to the nerves, insufficient to cause symptoms or signs.

Life goes on normally, UNTIL MIDDLE AGE.


All ofus start the ageing process in middle age - skin loses elasticity, wrinkles appear, memory falters, hairs go white and drop out.

Like hairs, nerves also wither and die.

Normal people without thalidomide exposure, have a huge surplus of nerve cells, plenty to buffer the ageing process without symptoms.

BUT when the ageing process arrives in middle-aged thalidomiders, it eliminates another batch of nerve cells from an already reduced population.
There are not enough nerve cells left to function Support for Australia’s thalidomide survivorsSubmission 67 properly.

Symptoms now erupt.

Nerves send wrong messages like pain, tingling, confused hot/cold sensations.

Nerves may fail to function at all, and the part goes numb.

The thalidomiders were robbed by thalidomide before birth.

They were born with reduced numbers of nerves: without the normal buffer against future damage.
Thus in middle age, thalidomide's MINOR nerve damage combines with age changes to cause a profoundly debilitating sensory neuropathy resulting in the premature onset of old age.

Victims aged 50 have physical problems of normal 70 yr olds.

For the last few years, this new disorder has been taking over their lives.

They suffer chronic pain and stiffness in the neck, spine, pelvis, shoulders, hips and knees.

Pain causes extreme fatigue and interferes with all their daily activities.

Deafness gets worse.


Loss of independence causes anxiety and depression.

Previously diligent workers have to take 2-3 days off work to recover from one normal days work.

They lose jobs and income.

Sometimes social support falls apart because of the extra strain of this second phase of nerve damage.

This "post-thalidomide syndrome" is happening right now.

So any plans for their future support must include it in the equation.
It is not just their birth defects to be considered, but an additional late onset sensory neuropathy.

It is happening internationally: in German and UK thalidomiders as well.

See reports from Heidelberg, from North Rhine- Westphalen, and from UK (PLOS paper), proved by neurologists from these centres.

All medical reports stress that this is a premature ageing process.
Therefore I intend to propose today that the Federal Government allows access to the old age pension NOW to proven thalidomiders who have had to leave their jobs and incomes because of this early ageing process.

Support for Australia’s thalidomide survivorsSubmission 67 Now to the specific questions: a)ADEOUACY OF COMPENSATION AND SUPPORT: Compensation: Fifty six Australasian thalidomide victims received substantial ex gratia payments from Diageo in 2010, calculated to last until 2028.
The recipients are anxious for the future - they have no promise of compensation beyond 2028.

There is no promise that Diageo will respond again, with a new board in charge.

Support: Medical support has always been more difficult to provide in Australasia because of its geography: relatively few victims are scattered across a large continent.

The possibility of forming one specialist clinic for them, like the EX-Centre in Stockholm was not a viable option in Australia.
As children, they attended clinics in paediatric hospitals in Australian cities.

As adults, they have relied on local GPs, with varying results.

Until recently, they have survived very well on ex gratia payments from Diageo in 2010.

But as the second wave of neuropathy takes hold, their living costs increase.

Both financial and personal supports are stressed by chronic pain and stiffness, fatigue, anxiety and depression.

They will explain in their submissions better than I can.
Suffice it to say that present compensation will be insufficient in the near future.

4 Support for Australia’s thalidomide survivorsSubmission 67 b) RESPONSIBILITY FOR PROVIDING SUPPORT Initial Compensation was provided after 1971 by Distillers Co which had marketed the drug throughout the British Commonwealth.

By mid-2000s, this compensation was running out.

Distillers meantime had disengaged from pharmaceutical interests and were unwilling to continue compensation payments.
Renamed Diageo, it was the world's biggest alcohol company.

Enter Ken Y oudale, CEO of Coca Cola Amatil Australia, and father of a badly thalidomide-affected daughter who had died.

Ken Y oudale negotiated with board members of Diageo - negotiation between equals - all top businessmen.

They accepted their responsibility for disabling these people and agreed to fund a review of Australasian thalidomiders and to increase financial support by ex gratia payments from 2010 - 2028.
Details of the 2010 Review in Sydney In 2010, fifty six confirmed thalidomide victims living in Australia or New Zealand were traced by Thalidomide Australia Inc and invited to spend three days in Sydney at the Four Seasons Hotel as guests of Diageo.

During this time in Sydney, each one was interviewed and examined to assess their disabilities, and XRayed if necessary.

I did the medical assessments, assisted by Professor Earl Owen the microsurgeon.

It took 4 weeks.

All costs were covered by Diageo.


There were tears on both sides when the Ian Wilson of Diageo UK formally apologized on behalf of Distillers Co.

The adequacy of the ex gratia payment, and other support will emerge from the evidence given by the thalidomiders themselves, and will vary from case to case.

Let them speak to the present state of their financial and general support.
5 Support for Australia’s thalidomide survivorsSubmission 67 The experience overseas has been addressed in the reports from North Rhine-Westphalen and Heidelberg in Germany, the EX-Center in Stockholm, and the Thalidomide Trust in UK.

In summary, past financial compensation has been provided in several forms: lump sums; managed investments; pensions; special payments, etc.

Discussion of relative merits of financial formats is best left to the victims, their representatives and their financial advisers.
In general it can be said that they need substantial financial support from now on because of the damage done by the post-thalidomide syndrome in addition to their original birth defects.

d) ROLE OF AUSTRALIAN GOVERNMENT IN COMPENSATION AND SUPPORT: 1.

AS OVERSEER: There is a role for the Australian Government to oversee that justice is done to these citizens, and that their need for adequate compensation and support does not fall through the cracks and leave them destitute.

2.
2.

AS ADVOCATE: * With Governments of Germany and UK to put pressure on drug companies involved, when these companies dodge responsibility *With boards and managements of delinquent drug companies: not a fertile field in the past: possibly a recent swing back to original stance of resistance to taking responsibility for causing disasters?

14 Support for Australia’s thalidomide survivorsSubmission 67 3.
OLD AGE PENSION: A strong case could be made for allowing thalidomiders early access to the old age pension.

It is agreed internationally that these people are suffering the early onset of old age.

At the age of 50 they are having to give up work whereas this happens at 65 or 70 in the normal community.

They are suffering the psycho-social, physical and emotional health problems of old age: chronic intractable pain, stiff joints and muscles, and neurological symptoms dominate their lives.
Most have been workers and taxpayers all their lives and are entitled to the old age pension, but it is not known if they will survive until they reach the statutary age to claim it.

They need it now.

Physically, they are prematurely old aged now.

The Australian Government could surely allow early access to the pension by proven thalidomiders who have been forced to give up work because of the post-thalidomide syndrome and premature ageing.
While the old age pension would not cover all of their many anticipated expenses, it would provide a future safety net for their basic costs of living in the future after the Diageo ex gratia payments cease in 2028.

Assurance of this access to a regular pension would relieve some of the financial anxiety for the future that is a major concern at present.

4.
4.

NDIS ACCESS: I am not in a position to give an opinion on this complex issue except to comment that there can be few citizens with greater disabilities than this group.

However their costs will require additional funding, as the pension will not provide all the future care they need.

5.

DEPARTMENT OF HEAL TH : Should authorize and manage a website of information for hospital doctors and GPs who may be consulted by thalidomiders.
15 Support for Australia’s thalidomide survivorsSubmission 67 Could provide official web sites to assist GPs and their patients.

Could the material from this meeting be held in Canberra as a reference site?

Every medical faculty should have information available and preferably within the undergraduate medical curriculum.

This needs to be vetted for authenticity of facts, because the era of false facts is upon us, and commercial interests have silenced proper scientific criticism.

6.
6.

DRUG REGULATION: A review of current regulations on access to the Australian market for new pharmaceuticals would be a timely conclusion, to confirm that the Australian public is protected from a recurrence of the thalidomide disaster.

That is a good note on which to end this deposition.

16 Support for Australia’s thalidomide survivorsSubmission 67 c) PROVISION OF FINANCIAL COMPENSATION Amount of compensation needs to be proportional to the degree of disability.
Therefore assessment of each applicant needs to be relative to other applicants and seen to be fair to all parties including the donor.

My task as medical assessor was to arrange the 56 Australasian thalidomiders in order of degree of disability.

I also wanted to ensure that justice was done between the applicants.

My method was to convert every disability into a number of points that added up into a numerical score for each applicant.
I aimed for an objective, arithmetic measurement to eliminate any subjective bias.

a) I used the maps of peripheral sensory nerve supply ( see end papers in my book) to identify the damaged spinal nerves in limb defects in XRay films.

For each damaged segmental nerve, I gave a score of 1 for mild, 2 for moderate, 3 for severe = absent segment.

Any damaged spinal nerve thus earned a score of 1 to 3.

The worse the defect, the more nerves involved and the larger the score.
b) Neuroanatomy provides similar maps of nerve supply for head and neck structures.

The 12 cranial nerves were all subject to thalidomide damage, robbing the person of hearing, eyesight, facial expression.

The head and neck cases, over 1 Oo/o of the total group, were much more profoundly damaged than the limb group, because their future education, emotional development, social relationships and employment were profoundly reduced by deafness, poor vision and absence of facial expression.
For this reason, I gave cranial nerve injuries scores from 1 to 6. c) A third component covered additional damage such as 1 point for absent gall bladder or for absent appendix, neither of which are lethal: and 3 to 6 points for congenital heart disorder which was often lethal.
6 Support for Australia’s thalidomide survivorsSubmission 67 d) The total disability score = spinal +cranial nerve scores +other components e) Each thalidomider was represented by a number, a "disability score", which compared fairly with others across the group.

This method and the numerical result were discussed with lawyers, approved and passed on to Diageo, who then multiplied each score by an amount of money per unit score to reach a fair ex gratia payment.
Comment: A similar disability scoring system was evolved by the orthopaedic surgeons running the North Rhine-Westphalen group, 2 years later.

Like me, they gave double points to the head and neck group in recognition of the profound impact of loss of sensory functions on the life of the victim.

In the Australian group, some cranial nerve victims had become hermits, so profound was the damage to their communication.

A quiet, deaf fellow with long shaggy hair was a typical case.
Long hair hid the fact of no ears: this was external evidence of internal damage: reduction in middle and inner ear structures due to gth cranial nerve damage(= deafness =social isolation).

Associated in many cases was ih cranial nerve damage(= no facial expression), and 6th cranial nerve damage (Duane's syndrome= fixed forward stare because lateral rectus muscle of eyeball is paralysed).

These three cranial nerves 6, 7 and 8 are side by side and evolve in the embryo at the same time.
Thalidomide caused a cluster of these injuries when it struck immature cranial nerves between days 21 and 23 of gestation.

So a mother taking thalidomide in these 3 days would have a baby with head and neck defects but normal limbs, as long as she stopped taking thalidomide before day 24.

From day 24 the baby would have arm defects, even though the arm bud is not present until day 28.
7 Support for Australia’s thalidomide survivorsSubmission 67 The precision of thalidomide's timing was worked out by Nowack and Lenz early in the German experience, from interviews with the mothers and sighting of diaries, doctor's records and prescriptions.

The vascular hypothesis cannot explain these cranial nerve palsies at all.

About 10% of any thalidomide series is comprised of head and neck cases.
Nor can it explain why thalidomide acts 4 days before the arm bud, or its arteries, exist, to induce absent radius/thumb.

Sensory nerves are there from day 18 of life.

Lenz stated that day 24 was the first day of thalidomide exposure for upper limb defects.

8 Support for Australia’s thalidomide survivorsSubmission 67 THE POST-THALIDOMIDE SYNDROME I had first learned about this new development in 2000, when I was dining with two friends at home in Sydney.
At 11 pm my phone rang: it was a thalidomide victim phoning from Liverpool UK.

He had four limb reductions and was confined to a wheelchair.

He told me that he was friends with 18 other thalidomiders, and that many of them, now in their 40s, were complaining of pins and needles in hands and feet, and shooting pains in limbs.

Two friends had been diagnosed by neurologists as having sensory peripheral neuropathy.
Knowing that I was interested in nerves, and knowing that thalidomide was a nerve poison, he was phoning to ask whether the thalidomide taken by their mothers during pregnancy could still be circulating in their systems and was now causing their neuropathy.

Back to bite after 40+ years?

I assured him that this was impossible.

The pharmacology of thalidomide is that it breaks down by simple hydrolysis at 1 hour after ingestion, and is all cleared from the body in 12 hours.
However I did suggest to him that it sounded like a similar process to the "post-polio syndrome".

A combination of ageing with previous polio virus damage to motor nerves is thought to be the mechanism of post polio syndrome which strikes polio victims in middle age.

This "post- thalidomide syndrome" in middle age now afflicts over 90% of the original thalidomide victims, both here in Australia and worldwide.
Both the North Rhine and the Heidelberg studies recognize this second neurological episode and have verified it with different neurological tests.

Please see those reports for details.

Since 2000 the Thalidomide Trust in UK has recorded more complaints each year.

In 2000 I warned the Trust to investigate what was happening.

The Trust sent 17 of its beneficiaries all with upper limb deformities to the Neurology Dept of Charing Cross Hospital.
The neurologists there examined the peripheral nerves of 9 Support for Australia’s thalidomide survivorsSubmission 67 all four limbs of the thalidomiders and also their carers, included as normal controls.

Sensory neuropathy was confirmed in the deformed arms.

Sub-clinical neuropathy was also found in the anatomically normal legs of thalidomiders, proving a widespread reduction across the peripheral nervous system - more extensive than expected.

See PLOS paper.
See PLOS paper.

The symptoms of this affliction are more extensive as years pass.

The situation today is bad and getting worse.

We do not know if the neuropathy will bum out and stop, plateau or get worse.

THE FUTURE These neurological symptoms threaten the quality of life and independence of victims.

Fatigue and backache are increasingly interfering with their lives.

More days off work, loss of jobs, income and confidence, are recorded.
Increasing anxiety, financial insecurity and worry about their future are now presenting features.

There is also increasing depression and risk of mental illness.

Family and social networks are strained and collapsing.

They need more expensive medication for pain, although the ideal drug does not yet exist.

Frequent physiotherapy and massage are helpful; some have used acupuncture and other paramedical modalities.
There is no doubt from the North Rhine-Westphalen study of the neurology that only 50% of the pain is explained by nerve compression and overuse of malconstructed bones and joints.

The other 50% of pain was shown to be neurigenic - ie, originating in the nerves themselves.

Such pain is very severe and notoriously difficult to treat.

The thalidomiders themselves recognize that "the drug they seek for pain relief does not yet exist".
Dr Rudolf Beyer an anaesthetist in Hamburg, has specialized in analgesia for extreme pain, and is an excellent opm1on.

10 Support for Australia’s thalidomide survivorsSubmission 67 PREMATURE AGEING: The post thalidomide syndrome in middle age causes the 50 year old victims to age rapidly and prematurely.

Both the Heidelberg and North Rhine-Westphalen studies recognize the widespread neuropathy that reduces thalidomide individuals of 50 to the physical state of normal 70 year olds.
Chronic pain and stiffness require extra assistance for the simplest life functions such as going to the toilet or doing up buttons.

Therapists and some carers must be paid.

The costs in 2019 are much greater than they were in 2010 because of the rapid deterioration in health.

Deaf people, getting deafer, need better hearing aids.

Wheel chairs for others ...

Survivors of TE foresee a future of chronic pain, rapidly failing health, costly drugs, anxiety/depression and increasing dependence upon others.
Existing compensation and support is not geared for this steep decline and will certainly be inadequate for their future needs.

They can furnish details of their individual situations, but this is an overview based on the actual disease process.

One must bear in mind that thalidomide embryopathy is a lifelong disease of the cranial and peripheral nervous systems, with two major clinical stages: first being birth defects, and second being widespread, sensory nerve dysfunction at middle age.
This is medical history being played out in real time.

We do not know how it will end but the hapless victims caught up in it require outside support for living.

CONCLUSION 1.

The adequacy of compensation and support for thalidomiders at present is best described by submissions to this committee from the thalidomiders themselves.

Reports from TAI president Lance Fletcher, and from Lisa McManus are recommended to the Committee.
Papers written by Mark Chorlton, psychologist and a NSW thalidomider, are also highly recommended, such as Coping with Chronic Pain.

11 Support for Australia’s thalidomide survivorsSubmission 67 2.

The present levels of financial and physical support for the future of the thalidomide victims is predicted to be inadequate for their future care, given the rapid and steep deterioration in all aspects of their lives, caused by their premature ageing process.

3.
3.

Medical support for the victims is deficient following the hiatus of 30 years when thalidomide was banished from the market.

It was deemed unimportant and it dropped out of the medical curriculum.

Its revival in the 1990s introduced a spate of flawed science, spin, and fake news often driven by financial enterprise.

This was in addition to the ignorance of new graduate doctors who may not have even heard of thalidomide or its notorious history.
There is a need for the Federal Dept of Health to issue an information booklet or website about the post-thalidomide syndrome.

b) RESPONSIBILITY FOR PROVIDING SUPPORT: Those who made and sold the drug have been held responsible for 50 years.

1.

Chemie Grunenthal GMBH, makers of the original thalidomide.

They have a long history of denial and refusal to take responsibility.
In the 1960s it took the combined pressure of governments, the media and court cases lasting 11 years before the company gave 100 million Dmarks towards compensation of about 3,000 German victims.

Finally a criminal case was proposed, whereby the directors of the firm would probably go to jail.

This threat elicited compensation money for Germans, but not for anyone born outside Germany, a position from which they refuse to shift.
The German government has a system for compensation that was used in this situation.

12 Support for Australia’s thalidomide survivorsSubmission 67 2.

Distillers/Diageo the alcohol makers.

Thalidomide was the first and last foray into marketing of pharmaceuticals by this huge whisky conglomerate.

Their record of taking responsibility for damage done by their product is not good: They tried to dodge responsibility for compensation of UK victims when the catastrophe struck in 1961.
Persistent parents; the support of Harold Evans, editor of The Sunday Times; a public boycott of Distillers' products; political action, and shareholders' support of the children finally drove Distillers board to make compensation available.

Britain has The Thalidomide Trust, financed by Distillers UK/Diageo, and charged with providing for the wellbeing of the thalidomide community.
The government oversees the provision of money - the charity fund set up by Distillers UK is balanced by tax deduction from the British Government.

The Thalidomide Trust provides physical alterations to homes, cars etc and many other services.

In 1961/2, Distillers UK claimed that Distillers Australia was not a branch of their firm and that the UK firm was not responsible for Australian thalidomide children.
This required 2 Sydney barristers to take the case to the Privy Council, which ruled that the UK firm was responsible for the Australian cases.

The first compensation payments followed when the children were aged 9 to 11 years.

The 2010 Review of Australasian thalidomiders was funded by Diageo and attended by some board members.

Their delivery of a formal apology reprieved the reputation of that firm.

Tears were shed on both sides.


c) PROVISION OF FINANCIAL COMPENSATION : This section is best addressed by the thalidomiders themselves.

13 Support for Australia’s thalidomide survivorsSubmission 67