Click on Home for the full story “The Beginning of the End”.

The abuse of ‘off-license’ toxic Injectable chemicals used in Medical Procedures

‘PAIN MAKING’

‘THE ONGOING ADDITION OF DOCTORS’.

Today, here in Australia and around the world patients are being not only harmed but disabled due to the continued use of ‘off-label’ Injectable chemicals into the cerebrospinal fluid of the spine without Regulatory Approval. Epidural steroid injections for instance are a classic example of this today through such being used on ill-informed or non-informed unsupecting patients and in some case directly ‘ordered by Insurance Companies’ to “hopefully” improve their moveability and able them to return to the workforce. Those that carry out these procedures have ‘also’ been ‘mixing’ two or more of these ‘off label’ toxic chemicals together, and injecting them Intrathecally into the patients without any awareness such was safe or had Regulatory Approval.

The question is ‘why’ have they been allowed to do so for decades without being challenged, “is such safe”??? The answer to this, is this, when such injections started way back in the early 1920’s in fact 1921 there were NO regulatory requirements Governments placed the trust and expertise in the hands of the Medical Profession without any checks and balances in place. In fact, the first injectable toxic chemical used as a dye in x-rays soon led to Chemically Induced Adhesive Arachnoiditis within the subarachnoid space, [spine] and due to such was stopped not by the Government but by the end-users themselves, the Doctors injecting such into the patients. This was due not so much for the welfare of the patients, but ‘self protection’ legally.

The American FDA being the World Regulatory of new drugs had in place by the early 1900s a set regulatory requirements known as a New Drug Application [NDA] for Companies wishing to submit a new drug for Marketing. What was NOT in place was a set regulatory requirements for Companies wishing to submit an application for a General Marketing License for diagnostic radiographic x-ray toxic contrast mediums. [Dye] for until then end-users were using ‘Air’ in such procedures. [“Air is cheap”]

A specific regulatory requirement on x-ray contrast mediums [dyes] never arrived until 1969 almost half a century later, due to the thalidomide issue, by this time the medical profession had injected this “dye” injuring close to 60 million patients throughout the world and tens of Thousands here in Australia without any knowledge of doing so. Why was this, well those carrying out these injections were not ‘linked’ to the patent’s GP, Specialists and such like, furthermore, the development of chemically induced adhesive arachnoiditis is insidious the slow damage to peripheral nerve roots and the related man-made disability develops overtime and a relationship to the cause, a passed injection of what was deemed to be safe, was never considered.

Today, here in Australia and around the world such practice of ‘off-label’ use continue without any Governmental oversight or Regulatory approval of such practice in place. I believe not only these end-users need to be held accountable BUT also the Government Regulators, of each of the 107 Counties where it was used, sadly many of those once employed by these Government Regulators throughout the world are NOW working for the the Manufacturer’s or subsidiaries.

My Blog attached to this post explains how many Australians [millions in fact] today have been harmed by this unregulated x-ray dye and ‘other’ such injectable substances into the CSF of the spine [and elsewhere]. The first causing horrendous pain and disability being Iophendylate Pantopaque or Myodil an x-ray dye [1936 – 1991, my Blog] https://pantopaquemyodil.wordpress.com [CLICK ON HOME ABOVE TO GO THERE] causing chemically induced adhesive arachnoiditis. Also, my research and that of others show that even the newer water base x-ray dyes cause chemically induced adhesive arachnoiditis  and the related horrendous pain and disability.

Its clear today, what has happened and its cause, it now up to you the reader to understand how this was allowed to happen, please read my Blogs, get angry and speak out.

PLEASE FORWARD TO OTHERS ESPECIALLY THE MEDIA, DO NOT JUST READ.

My AUSTRALIAN Blog covers its illegal marketing 1972 – 1979 throughout the country including its USE for ‘HUMAN EXPERIMENTATION’and then from 1979 – 1991

https://pantopaquemyodil.wordpress.com

My AMERICAN Blog covering Pantopaque from its start in 1936 by Eastman Kodak to its end in 1996 by ALCON.

https://pantopaque.wordpress.com

Currently I have documented the American Blog up to 1971 should be completed soon. Again, [all data used] ‘copies’ are held elsewhere around the world, to be released to the media I have done this, ‘just in case’ I end up in the sand hills.

For those interested in the Myodil Story go to http://myodil.wordpress.com

Still being built should be up by end of year, this is due to the limited Glaxo data only now obtained via my “little squirel” within Glaxo. [Too late Guy’s, we got it!!!] 4 copies now distributed and held elsewhere in the world, just in case.

God Bless,

Derek

Derek Morrison BCW, ADCW, NDA, CTE, ATSUM, AWT.                                                                                  

[Behavioural Scientist and Medical Researcher] 0413676954

Aussie Redback

4/2/2016

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Hi Lori,

 

pantopaque ampoule

This Dye is NOW back on the world market out of China to destroy another Generation, ‘your children‘. They have changed the name somewhat its NOW known as Iofendylate.

Its 30 times cheaper than that currently being used.

TO MY BLOG

MEET ARTHUR KUNZ

HE WAS THE OWNER OF LAFAYETTE PHARMACAL THE MANUFACTURER OF IOPHENDYLATE PANTOPAQUE AFTER BUYING THE CHEMICAL COMPONENT FROM KODAK.

This was taken in 1995, he died 10 years later in 2005.

DOCUMENTS UNEARTHED SHOW THE FDA STATED THAT ‘PANTOPAQUE WAS TOO DANGEROUS FOR USE’ 32 DAYS BEFORE THEY LICENSED IT.

PLEASE REMEMBER MYODIL AND PANTOPAQUE ARE THE SAME,

AS WELL AS THE OTHER 21 BRAND NAMES USED WORLDWIDE 1936 – 1996.

===============

Myodil was contaminated here in Australia in the early and mid 70s and Pantopaque was used to replace it at Hospitals that were previously using Myodil, BUT at the same time in America Pantopaque was also being seen as contaminated!!!

EPSON MFP image

Evidence now available to me [and held elsewhere] shows ALL the Australian Hospitals, X-Rays Clinics, Government Departments and Private Practises where Pantopaque was used over this period and much later, including after Myodil returned back on the Australian Market. List of ALL these Hospitals, Private x-rays Centres etc etc can be found later in this blog, it also makes mention of the Head end-users.

This must have happened also in United Kingdom?

And around the world.

Glaxo has questions that need answering so I will ask them, and post their response here.

PLEASE COME BACK AS FURTHER EVIDENCE WILL BE ADDED ON A ONGOING BASIS.

CLICK

THE AUSTRALIAN STORY

“I am only one, but I am one.

I cannot do everything,

but I can do something.

And because I cannot do everything I will not refuse to do the something that I can,

what I can do, I should do.

         And what I should do, by the grace of God, I will do.”

‘Edward Everett Hale’.

me 12

Hi, my name is Derek Morrison [Aussie Redback]

aussie_redback66@yahoo.com.au

I too suffer from Chemically Induced Adhesive Arachnoiditis [CIAA]

Please note ALL on here is under copyright ©

Like all the content on this site I ask that you respect my copyright and do not simply copy the information here to your own website, but rather LINK to this page.

 If you would like to print out this information to share with others feel free to do so, but please acknowledge its source, thank you.

Awareness of how this happened and by whom is part of my mission and goal,

especially

The Australian Story

The American Story where it all began can be accessed by visiting http://pantopaque.wordpress.com

—————-   —-   —————-

I hope the contents help you understand what happened to you, or a love-one.

HERE’S THE ‘TRUTH’

IOPHENDYLATE PANTOPAQUE WAS ILLEGALLY USED ON MANY OF YOU AS AN X-RAY DYE HERE IN AUSTRALIA, REMEMBER IOPHENDYLATE MYODIL WAS THE SAME JUST A DIFFERENT BRAND NAME.

BRING IT ON EASTMAN KODAK, LAFAYETTE PHARMACAL, GLAXO AND  ALCON.

‘FROM A DOT TO A DASH’

============

Australia-flag-small

Have you been injected in the past with an oil base dye into your back or neck [subarachnoid space] whilst having a Myelogram of Diskogram this ‘dye’ would have been named either Pantopaque or Myodil.

And for all my friends in Canada

who had  

Iophendylate Ethiodan

 And you have been getting steadily worse since?

Or are you like me, it happened many, many years ago, and you have been trying to find answers as to why you are in so much pain and suffering a disability no one has an answer as to why. Well look at the graphic above that’s an inflamed nerve ending, you have millions and specific groups of them are linked to muscles, body organs and the such = PAIN AND DISABILITY.

‘No one believes you, and for many of us, the “Medical Professional” has convinced your love ones otherwise, ‘its all in their head’, or its not as bad as they are making out.

So you search for answers as to why you feel this way since injuring you spine, neck etc, as the “medical professional” prod, bend and twist you, then send you for multiple x-rays, CT’s then on to further specialists who do likewise, all saying “its a mystery” and there you are, steadily getting worse taking more and more pills and no one is believing you, even those around you are starting to doubt you,

“it cant be that bad, you look so well”.

Well, yes it is.

So I wrote this little piece below it’s call Isolation way back in the mid 90s, its was really how I felt at the time, things have sadly not changed.

Its a piece expressing how Chemically Induced Adhesive Arachnoiditis © [1994 Derek Morrison] effects one’s life, becoming isolated from main stream society and/or from one’s family, like I.

——  —  ——

ISOLATION

Isolation for a CIAA sufferer, seem to strike in many ways, first, is the feeling that you are alone in a world of fit and mobile people, all in complete command of their healthy bodies. No one else seems to understand the hell you are living and the torment you are having to endure. Many family members and friends although it’s never ‘spoken’ have doubts of the level of disability and pain you the CIAA sufferer are experiencing, “could it be really be THAT bad”? In the end many CIAA sufferers stops expecting others to understand for it’s too painful for them, ‘for how can they understand when it took years of living with the pain to understand it yourself’ [or maybe you are finding out now for the first time]. CIAA sufferers have to to survive, accept the fact that one’s family and friends realisically would never totally understand what has happened to us and the consequences of the progressive disease we now have to live with. This isolation is compounded by the fact that CIAA sufferers also have a physical disability as well as a progressive neurological disease and as the muscles start to waste away movement becomes more and more restrictive. This reduced activity due to physical isolation and related limitations, is equally difficult to cope with, oh, I wish I could………! It helps some sufferers to think about family and friends and how one can interact ‘when together’. For the more one reaches out, the more one receives, it is natural for a sufferer to feel guilty for its difficult to continuously adjust and re-adjust as this progressive disease takes hold, for to ask for help comes with it a realization one is getting worse. This feeling or realization that one is getting worse brings with it a feeling of failure, bills don’t stop coming in, and many are now related to ones health condition with the related financial income almost obsolete especially if the CIAA sufferer was once the bread winner like I, whilst I kept working ‘yes’ off and on but my body was in control, not me. ‘But someone had to work’, put food on the table, pay the rent cloth my two children, and being the only bread winner such was hard for me, and later became impossible, so they left. Being a previous bread winner a CIAA sufferer feels a failure now that they are no longer able to bring home a ‘wage’. Similar applies to the CIAA sufferer whom was once the “super mum” of the home, once working ‘tirelessly’ cleaning, cooking meals, washing and being a “taxi driver” for all and sundry now finding it difficult to even get off the lounge or out of bed, losing friends to “comply”. The impossibility now to carry out the washing basket or bend to pick up the kids toys, more and more being done by “others”. Sometimes its impossible not to think one is “just in the way” and life for ones love-ones would be far better if they were no longer around, in my case it was them that went, leaving me to struggle on alone. This sad fact, feeling like one is ‘just in the way’ is common place for many CIAA sufferers for continuously apologizing for ones inability to do almost nothing at the same time subconsciously apologizing for ones existence making the life of the CIAA sufferer all that more difficult. For those that “battle on” seeing others taking up the roles once done by the sufferer, the sufferer has to, with much difficulty accept that the pain and disability and all that comes with it, is NOT ones own fault. Realizing there is NO cure and the anger and fear of knowing it’s only going to get worse overtime, saps ones ability to be positive. As one tries to fight the realization that this is a life-long condition with no reprieve, one looks for answers as to why, ‘why me’. Being positive is easier said than done, some days CIAA sufferers feel like crawling off into a corner, or spending more and more time in bed pulling the blanket over one’s head, for sleeping and dreaming returns them to how they once were, running, jumping, laughing, smiling. This “escape” for many becomes more and more of a regular occurrence further distancing them self from family and friends, as they further internalize all that they are experiencing and have lost, with no one to ‘really‘ to talk to. This circle of a feeling of ‘hopelessness’ can if allowed to develop can cause a withdraw of one’s belief that one can no longer cope with this progressive disease and that’s where the support of fellow sufferers comes in, so please, if you feel this way make contact with others or if you do now, continue, for like you they wish to feel wanted and understand of what they are going through.

——  —  ——

Let the Story begin.

Fellow sufferers, those specific “Medical Professionals” Neurologists, Neuro-Radiologists and the like, are and have been lying to you since you were injected, not so much your local GP they have been kept in the dark, for they are just the “foot soldiers”.

To set the scene, the x-ray ‘dye’ injected into you called Iophendylate Pantopaque Myodil and the like, was too toxic for use and should never had been licensed by the FDA. However, they were mislead by the developers with data that was fraudulent and by doing, accessed a ‘License to Market’, later selling it worldwide to destroy 100 or more million lives. [1936 – 1996] The manufacturer seen below in this video has admitted since they were aware that it caused Adhesive Arachnoiditis since 1945.

This was done under oath on camera so ‘setle in’ if you are going to watch it for in total it goes for over 6 hours.

HERE’S THE FIRST HALF OF THE VIDEO


AND NOW THE SECOND HALF

——  —  ——

But how was such allowed to happen here in Australia?

The answer to that is quite simple, our Federal Government let us down by not ensuring this ‘dye’ was safe, the body responsible to ensure such is the TGA [known previously as the TGB] people, you are like you are today, because of them, they were incompetent, and the Australian Importer/Agent took full advantage of that.

This Blog records how such happened and those involved supported with all historical evidence to substantiate this claim.

For those that are reading this whom migrated here or initially lived in one of the other 107 Countries [list below] where it also happen, read on for ‘the same’ criminal action took place in your Country.

Today, more thana 100 Million have been abused this way.

Its time to get angry fellow sufferers not only here in Australia by around the World,

‘IT STARTS HERE’. 

EPSON MFP image

This story is mine, but it might as well be yours. Mine started when I injured my spine don’t really know how I did it, was it the ‘fall’ on the ship coming back from the UK, or whilst I played in goal as a young fellow, maybe it was when I was thrown down the stairs by my violent-step father when I was just a child, who knows.

My own Journey started way back in 1974 I was 25 married with two young children my son at that time was aged 4 and my daughter aged 3, however I will not share with you my life up to this period and how I ended up writing this here, but if you wish understand more, you can visit my link at https://aussieredback.wordpress.com to find out.

In 1993 aged 44 after experiencing sixteen years of ‘hell’ after being injected with Iophendylate [1977] which no one could understand other than other CIAA sufferers, but after losing my wife and two by this time adult children who walked away believing that there nothing wrong with me, “he’s just putting it on”, convinced by my wifes family and extended family, today. I have finally found out the truth.

This disbelief did not stop with my wife and children, it slowly spread through my wife’s extended family to my friends and those that “knew me”, this was after many hours of having microsurgery on my spinal cord to save my life and the many months afterwards recovering as I was unable to move. Later between 1977 and 1983 I initially tried to lead a ‘normal’ life I even returned to work but that didnt last long before I collapsed. In 1982 we left the area to try and start anew but soon I collapsed once again, this time I was shipped off to our Australia Government Rehabilatation Centre where they taught me to retrain my secondary muscles in my legs as my ‘carriers’ for they were not working damaged secondary to the related nerve damage causd by the dye. I share you this only to have you grasp the abnormity of such for me [and maybe you too] as my life continued in and out of my wheelchair and the denial of my wife and her extended family, my only family were in England, I had no one to share my wows with.

My ‘awaking’ would be 10 years later in 1992 after sighting a Middle Page spread from a UK Newspaper sent to me by my late Mother [whom also had Chemically Induced Adhesive Arachnoiditis] also from Myodil injected 10 years earlier, hers in the UK, mine here in Australia sadly she died later.

Neither of us at the time of the story appearing in this Newspaper had any idea of what had truly happened to us, so as I read this newspaper story I am becoming bloody angry and I wanted answers, today 23 years later I have those answers, BUT no one is listening.

I have tried many ways to get this investigated be it by our Federal and the NSW State Government, forming a Australian Association with thousands of fellow Australian CIAA sufferers as members within 47 Support Groups throughout the Country. At that time here in Australia we had 168,000 people that had been injected with Iophendylate, however, 99% had no idea what was causing their suffering, because they were not being told, and most still don’t know, those that are alive that is.

Stories written of my research ended up in National and Local Newspapers, [see the link ‘Newspaper clippings’ on here] not forgetting National and International Magazines, and of course massive internet exposure including linking up with fellow sufferers around the world with no avail, for they too shared the same frustrations as I, unable to get any personal help for their CIAA or anyone to listen to them.

 Or in my case, the evidence of how this happened and by whom.

Now you will know.

 But you know what is sad about this, tens of thousands in fact have since died here in Australia, [and in your country] since and it is you their love-ones and those sufferers still alive, whom will finally know the truth.

Did you listen to your love-one ‘unconditionally’?, I hope so, for there are still thousands here in this country still suffering from this ‘too toxic’ dye used between 1936 -1996.

Before I go on I have decided to place a copy of that Newspaper centre page spread here so you too can understand my horror when I learnt that my condition as well as my late mothers was ‘Man made and not God given’ as we were led to believe, [individually] here it is.

newspaperSeeing and reading this article started me off on a 24 year quest to know the truth, a journey now completed. Much has happened since that time, and within this blog I will share with you my research findings of how I and you end up this way. You will become angry at first, you will find it hard to believe, so much so I have decided to walk you through how it was allowed to happen here in Australia, providing you with documented evidence to support what I say such as Letters of Correspondence between the American Manufacturer of Iophendylate, the Australian Importer Ernie Hughes, [see his picture below] and of course our very laxed Australian Federal Government Health Department the TGB/A to establish authenticity. And if afterwards, I have the strength I will do the same likewise of how it was allowed to happened worldwide, especially America where it was made, again with gathered supportive documented historical evidence.

See: http://pantopaque.wordpress.com

Here is a photo of Ernie Hughes taken last year.

Ernie Hughes 1 However, initially I need to share the following important facts with you.

It’s critical that you understand the following, until 1992 the sole agent of Iophendylate [Chemical name] for Pantopaque into Australia from Lafayette Pharmacal America or American X-Ray Distributors whom Lafayette Pharmacal supplied, they were General Electric Company, Picker X-Ray Corporation, Standard X-Ray Company, E.M. Parker Company, Kelley-Koett Manufacturing Company was a Mr Ernie Hughes of Melbourne Victoria.

Furthermore, Pantopaque was illegally distribution throughout this country between 1972 and 1979 for Human Experimentation’, also by the same person.

In January 1978 Lafayette Pharmacal America sold their Company and the manufacturing Rights of Iophendylate Pantopaque to ALCON whom then continued to ship it either directly or through American distributors to Hughes here in this country and elsewhere for the next 18 years.

Here’s a little overview, Alcon purchased Lafayette Pharmacal in January 1978, however, Lafayette Pharmacal continued to distribute Pantopaque until 1983 when Alcon sold Lafayette Pharmacal, ‘the business’. Nevertheless, Alcon continued to distribute Pantopaque through their newly formed Company known as Lafayette Pharmaceuticals who had the distributorship of Pantopaque for Alcon Laboratories, this continued up to 1988 when they ceased the manufacturing of Pantopaque and sold Lafayette Pharmaceuticals to a Company known as EZM.

EZM ‘never‘ had the ‘rights’ to distribute Pantopaque.

Alcon ceased the production of Pantopaque the year before in 1987.

Remember Pantopaque had a 5 years shelf life so Pantopaque was still being used until 1992 around the world. Alcon ‘surrendered’ its License for Iophendylate Pantopaque in 1996 to the FDA.  

However, it NOW being manufactured in China and “business” must be good for now 3 factories are manufacturing it, it goes by the name iofendylate.

——  —  ——

I continue.

It’s important to note Hughes was always the sole illegal importer/agent of this too toxic radiographic positive ionic contrast medium [dye] used in myelography and diskogram here in this country. Most recently evidence has come to light that Ernie Hughes MAY have been also the initial Australian agent for Myodil from the uk, later becoming a distributor.

Which if true will really open a can of worms.

Please also note, it was used in many other medical procedures as well, evidence of such can be found on Medline, especially the MJA’s where it was used as a sclerosis agent, [think about that, they were using this SAME dye as a sclerosing agent something they deny can lead to CIAA] it was used to cause a growth of fibrous tissue in cysts after injecting them with this dye, something is terribly wrong here.

——  — ——

So lets begin our Journey.

As I write this, I wonder what you the reader wants?

Naturally, you want to know what happened to you and how you ended up this way, but to do so, you have to be patient, to truly understand what happened to you, you will have to battle through this blog to get the answers, it will be tedious and in some parts down right boring BUT to reach the truth, its a journey you will have to take.

[It took me 24 years so a few hours for you ‘cant be too bad’ eh?]

Oh, at the bottom of this blog you can ‘comment’, ask questions or request specific information or documented evidence missed here, please ask BUT remember I too have CIAA and such requests will take time for me to answer,

but I will, that I promise.

For me to lead in to the development of Chemically Induced Adhesive Arachnoiditis [CIAA] here in this Country I will initially have to touch on a little of the historical information, forgive me.

So, lets begin,

The development of what was to become Iophendylate Pantopaque [USA/WW] and Myodil [GB/WW] was done by the developer Eastman Kodak fraudulently byway of submitting manipulated supportive data on the safety of this x-ray dye to the FDA.

This is in itself a damning indictment of what can happen ‘behind close doors’ when a World War is on.

This period [in time] is currently being documented in my American Blog at HTTP://pantopaque.wordpress.com with ALL supportive historical documented evidence, be it copies of correspondence between all parties, which includes Rochester University, Eastman Kodak, Strong Hospital, Lafayette Pharmacal, Hazelton Laboratories, the American High Brass [Army and Navy] and a “select” group of Military Hospitals where it was trialled on unsuspecting injured soldiers and Navy personnel [1942] prior to its 1944 FDA NDA [New Drug Application] and approval currently this American Blog is up to 1969.

This submitted data to the FDA consisted of “selected” animal studies as well as Human clinical trials [injured Military personnel] for its Marketing License Application’ I will provide another list  later in this blog showing how toxic this dye was, did the FDA see them? Well considering the contents of the animal studies I doubt it. So, after finally tracking them down I will make available to you a copy of each of these animal studies and clinical human trials in full via a link to the right of this page.

For your interest in June 1998 the American National Institute of Health listed 80 secondary related medical conditions and/or symptoms as a ’cause or effect’ to exposure [injection] of Iophendylate. [Pantopaque] which means also Myodil and the other 21 Brands sold throughout the world, being the “same” product. I will now list these 80 secondary related medical conditions and/or symptoms below, however, please remember these were listed in 1998, seventeen years ago I have not yet brought this list up to-date, however, explains a lot of that which you are suffering from today.

I need to place this here, NOT all these secondary related conditions /symptoms listed here will you develop, the development are individually based, based on a range of variables which I will not go into here but this list is just that, a list of medical conditions/symptoms that people have developed since being injected, ‘It doesn’t mean YOU will develop it/them’, ok. 

 This list is as was written by the FDA’s Spontaneous Reporting System of the Division of Epidemiology and Surveillance on the 12th June 1998.

To get the full name, just enter it into Google to find.

ALLERG REACT. AMNESIA. AMBLYOPIA. ANOREXIA. ANXIETY. ARACHNOIDITIS. ASTHENIA. ATAXIA. ATROPHY MUSCLE. BRAIN SYND CROM. CARDIOVASC DIS. CNS DEPRESS. CONSTIP. CONVULS. CRAMPS IN LEGS. DELIRIUM. DEPRESSION. DIZZINESS. DYSPHEA. EDEMA PERIPH. EMOTION LABIL. ENCEPHALOPATHY. FEVER. GAIT ABNORM. GI DIS. HALLUCIN. HEAD PAIN. HEART ARREST. HEM. HEMATURIA. HYPERTONIA. INCONTIN FECAL. INCONTIN URIN. INJECT SITE REACTION. INSOMNIA. INTEST PER. JOINT DIS. MALAISE. MIGRAINE. MYALGIA. MYASTHENIA. MYOPATHY. NAUSEA. NEOPL CHS. NERVOUSNESS. NEURALGIA. NEURITIS. NEUROPATHY. PAIN. PAIN BACK. PAIN CHEST. PAIN INJECTION SITE. PAIN KIDNEY. PAIN NECK. PARALYSIS. PARALYSIS SPASTIC. PARAPLEGIA. PARESTHESIA. POLYNEURITIS. RASH. REFLEXES DEC. RHINITIS. SCLEROSIS MULTI. [Interesting eh] SEX FUNC ABNORM. SHOCK. SKIN DISCOLOUR. SPEECH DIS. SWEATS. THINKING ABNORM. TINNITUS. TWICHES. URIN RETENT. URIN TRACT DIS. URIN URGENCY. VISION ABNORM. VOMIT.

In America between 1991 and 1995 a total of 335 adverse reactions were reported after patients were injected with the chemical x-ray dye known as Iophendylate (Pantopaque) of these, 275 developed [Chemically Induced] Adhesive Arachnoiditis. This is a 82.3% ratio NOT the ‘less than 1%’ that has been used always in the past to state it was ‘RARE’. In fact, this less than ‘1%’ was taken from the use of Lipiodol NOT Iophendylate Pantopaque.

However, until now this fact has never been challenged, consider yourself challenged Eastman Kodak, Glaxo, Lafayette Pharmacal,  Alcon.

——   —   ——

I continue.

Iophendylate Pantopaque was mysteriously approved by the F.D.A. on the 22 Feb 1944 after previously being refused a license weeks earlier due to it being ‘too toxic’ for human use, how was this so? After Iophendylate Pantopaque had gained its License through such fraudulent means, another Company obtained  the ‘right’ to copy it, this Company was to become Glaxo UK, the product Myodil.

It is ‘critical’ that I record here the following for it shows HOW this ‘abuse of human life’, was allowed to happen.

However, if you wish to read the history of HOW this was allowed to happen LATER and wish to go straight to what happened here, sorry unable to tab a direct link, so go to the top left hand side and click on Edit, then click on ‘Find on this Page’ write in

THE AUSTRALIAN STORY

to take you there.

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For others whom wish to understand how this happen to you, and millions of others

read on.

Please note, due to the perceived safety of Iophendylate, Iophendylate became the “dye” of choice of end users and continued to be the only contrast medium for Myelograms and Diskograms in 107 Countries [listed below] until 1978 only a few Countries decided not to use it because of their concern over its too toxic nature, deciding instead to use “much safer water base dyes” available in their country.

You see, Iophendylate Pantopaque was praised by the developers being Rochester University and Eastman Kodak for the sharp crisp images it produced but it’s toxicity to the patient or as I discovered the men and women of the American military it wasn’t. On the 30th November 1942 [18 months prior to it being licensed by the FDA] the developers of this ‘too toxic’ “dye” received a response from the Office of the Surgeon General War Department (Service of Supply) and Surgeon General of the U. S. Navy Bureau of Medicine and Surgery Department of Navy in Washington D.C. to their letter dated 17th of November 1942 from Eastman Kodak the developer. These two letters which you can see here below show that they are approving the “use” of Ethyl Iodophenylundecylate (also known as Iophendylate Pantopaque) without the direct knowledge to US service personnel that it was ‘too toxic’ and dangerous to them.

 Navy
    Navy
 Army
Army

This enabled the “establishment”, to promote the “safety” of Iophendylate byway initially of Military Hospitals and end-users, later to the regulatory authorities and finally the general community, and on hundreds of thousands of injured Soldiers, Sailors and Air Force personnel. What wasn’t being reported was that Iophendylate was found to cause what is known today as chemically induced adhesive arachnoiditis, [CIAA] and caused it in those exposed, which lead to a life of misery and indescribable distress. This has a flow on effect for not ‘only’ the sufferer themselves but their partner and/or love-ones, are you one of them?

A requirement of the FDA regarding ALL FDA licensed products was and still is, the License holder [in this case Eastman Kodak] must report any adverse reaction of their product to them immediately it happens, (under 505J) and 130.13 of the Food Drug and Cosmetic Act) and to furnish an Annual Report on the Product each year. The most important piece of damning evidence of the ability of this ‘deadly’ toxic chemical to cause untold suffering is to be aware of the following, once Eastman Kodak had obtained a Commercial License to market this chemical (in 1944) and by agreeing as part of its license to inform the F.D.A. of any adverse reactions to it by them, they ignore it.

Eastman Kodak disregarded this F.D.A. ruling for 25 YEARS YES 25 years enabling this product to be sold (easily) by way of the already ‘established’ (Kodak) photographic/Dentistry agencies and distributors worldwide.

Whilst initially those reading this will be Australian this happen worldwide so for those reading this elsewhere or for that matter now living in Australia after migrating here, you may be wondering was it used on you, in your home country?

So, here is that list I promised you of those countries that have been listed as having used Iophendylate (1944 – 1996) I have listed them in alphabetical order some of the names of these countries have changed since that time.They are Argentina, [all of] Asia, Australia, Brazil, Barbados, Belgium, Bermuda, Bosnia, British Guiana, Burma, Canada, Ceylon, Chile, China, Columba, Costa Rica, Curacao, Cyprus, (both North and South) Czechoslovakia, Denmark, Dominican Republic, Dutch East Indies, East Africa, Ecuador, Egypt, England, France, Germany, Goa, Greece, Guatemala, Holland, Hong Kong, South China, India, Iran, Iraq, Ireland, Italy, Jamaica, Japan, Korea, Lebanon, Malta, Mauritius, Malaya, Mexico, Netherlands, Newfoundland, New Zealand, Nicaragua, North America, South America, North China, Norway, Palestine, Panama, Pakistan, Philippines, Rhodesia, Salvador, Saudi Arabia, Scotland, Siam, Singapore, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Tangiers, Thailand, Trinidad, Turkey, Uruguay, Venezuela, Vietnam, Wales, Yugoslavia, and Zanzibar, this totals 87.

There are 20 countries that still need to be confirmed.

Please contact the writer if your country is not here but you believe you may have been exposed to Iophendylate.

To those that have been injected with ‘other’ contrast mediums I wish to share the following, MOST of the water-base radiographic mediums used have NOW been reported to also cause ‘chemically induced adhesive arachnoiditis’.

See what happens when one medium is allowed to be used using a range of highly toxic chemical, others believe such is safe chemicals that is, and they too use them, perpetuating the harm.

‘Now as I promised’

THE AUSTRALIAN STORY

The story I am about to share with you below has been written before in 1999 sixteen years ago for 60 minutes here in Australia, also by me, but no one wanted to know then, maybe now. [60 Minutes America?] As I mentioned, Australian 60 Minutes who after spending months with me looking at all the documented evidence [seen here, and much much more ] then took the story to New Zealand and using my information to create a story around CIAA sufferers there.

I have accessed a video copy of that NZ Program if anyone is interested, what is interesting is NO mention of the source of the evidence was used in the program, being mostly me. Maybe, I should sent them a bill.

I will post the NZ video here in the future.

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This blog or story really starts here with my letter to 60 Minutes Australia, to a Howard Sacre sent in 1999 regarding my research and findings.

He’s still there today 16 years later, maybe you would like to ask him why he kept this from you.

Here is Australia’s 60 Minutes phone number to help you 02 9906 9999 which whilst it is the switchboard, BUT if enough of you ring and ask why they never ran the story here in Australia, not forgetting to make reference to this website I am sure they will take a second look at this. For if NOT we will as a collective picket the Station.

I have added new pieces of uncovered evidence since this was written, BUT the full contents of the original letter still remains the same.

[Again, I have had to touch on ‘how’ this was allowed to happen, so you will read some of what I have shared with you earlier, sorry]

So here’s my letter dated 1999 to Howard Sacre of Australia’s 60 Minutes.


Dear Howard,

Finally I’m able to send you an ‘Overview’ of the story I wish you to consider and which I discussed with you late last year by phone, sorry about the delay but due to certain related problems I had to put it on hold. Howard, this story cannot be covered in such a short brief, furthermore I would not permit it too many of my fellow Australian sufferers deserve better, so once you have a basic understanding of what has occurred (the overview) we will meet, where I can make available ‘all’ supportive documentation supporting my research into this horrific abuse of ‘human life’.

You made it quite clear to me whilst we were speaking that you would require names of those whom have participated in this abuse, those names are furnished at the end of this initial brief.

My credentials, lam qualified Community Welfare Worker and (Medical) Researcher and I have dedicated the last 6 years (full-time) to be able to share my findings with you. [now 23 years]

Although the story l am about to share with you, is an ‘Australian story’ to fully understand ‘how’ it happened. I must take you back in time, back to the early 1900s.

First I need to set the scene.

I would like to pose a question to you,

Look around you,

Why are there more people suffering disabilities through-out the World today, (including Australia) than say 50 years ago?

World Wars, no!

Natural disasters some, but in the main, only in known risk areas.

Epidemics again some. AIDS for Instance, Meningococcal and Streptococcal but leading to physical and neurological paralysis,

no.

One then must ask, has this Worldwide increase of physical and neurological disabilities with secondary symptoms been ‘created’ rather than God give?

The answer is. Yes.

But to convince you without documented evidence (which is available) is beyond this brief, notwithstanding, let me share with you how this has happened, and ask you to consider the ramification to not only the perpetrators when they are exposed, but the out-cry through-out the World (1O7+ Countries) of those ‘abused’ for nothing more than for profit!

The only way for this story can be told is for you to stay ‘value’ free, and to keep an ‘open mind’ to what I’m about to share with you.

Remember,

all that I say, can be backed up by ‘documented evidence.  

To understand how, one must return to the past, ‘way back in time’ although, I should take you back to the end of the eighteenth century when many great discoveries were taking place, to do so will again create a dragged out history lesson which is not the aim of this brief (at this time).

However, to ‘set’ the scene, I must refer to a particular ‘collective group’ of discoverers such as the German physicist Willelm Conrad Rontgen and his accidental discovery of x-ray, George Eastman (of Eastman Kodak) and his wondrous discovery and ‘enlightenment’ of photography and that of Thomas Edison not so much with his discovery of the electric light, but his discovery of motion pictures and the ‘need’ of celluloid film, for they all byway of their individual discoveries are together linked after ‘their deaths’ to the abuse of 100s of million of people worldwide we see today.

Wars create not only horrific pain and suffering to those directly, or indirectly effected, but create for some an opportunity to benefit financially, this can sometimes take place by honourable or fraudulent means without the normal safeguards which in peace time will it is hoped protect the community at large. This brief, is about one of those occasion’s, which has laid silently unexposed until now. I ask that you keep an open mind, and I ask for no more than your indulgence by considering what I share with you, and its relationship to the massive increase of my fellow citizens that are now disabled.

Until World war 2 most medical pharmaceutical substances were produced in Germany but the war change that, especially after the fall of France to the German’s, for until that time a large percentage of the world was using Lipiodol (labeled Ethiodol in the USA), also known as ethiodized oil manufactured from France.

 Great Britain and her allies were face once again as in the first World war with the lack of such required and much needed products especially these medical substances. An urgent call took place by the then British ‘Ministry of Defence’ to acquire such products by other means, an urgent request was sent to all British pharmaceutical Companies to “somehow” reproduce these products.

Most of the British Pharmaceutical Companies at that time were not established to provide such an requirement, especially at such quick notice however one ‘small’ company known as Joseph Nathan & Co was, this Jewish Company whose origins were from New Zealand and later to become he largest pharmaceutical Company in the World GIaxo Wellcome decided to respond. At that time, a Joseph Nathan & Co employee by the name of Harry Jephcott (much later to become Glaxo’s Managing Director) had developed a ‘close’ relationship with not only America Pharmaceutical Companies but also with the American Multi-lnternational Company known as Eastman Kodak, a relationship which in time will prove to be ‘very costly’ to Glaxo-Wellcome.

[You still have time to come to the party, Glaxo]

Prior to George Eastman’s suicide in 1932 George Eastman had established not only a world­wide market for his process film, camera’s, and dental x-ray plates but more importantly a worldly reputation as a person not only of greatness in the wondrous discovery of ‘pictures’ but as a person’ whose name one could ‘trust’ implicitly, prior to his death, George Eastman had mixed not only with mere mortals but Kings. Queens, Prime-Ministers and Presidents through-out the World, a relationship which again becomes another pinnacle in the development of this created abuse World-wide. No matter of what station in ‘life’ you belonged to, one wanted to be a friend of George Eastman the genius, and for some, thought of as a Messiah.

Whilst George Eastman’s interest was in photography he also had humanitarian nature possibly developed after his mother was ‘cured’ of uterine cancer in 1890. for in 1913 his worldly travels exposed him to the plight of needy children and their appalling teeth, children were good subjects for Kodak pictures, however, whilst Eastman knew this, but without good teeth children would become undernourished and suffer needlessly. So in the I920s he designed a special camera for the use in orthodontic work and set forth to establish Dental Clinics not only in Rochester in America but Rome, Paris, London and Brussels. This established market for dental x-ray plates will also play a pinnacle role in the ability of Eastman Kodak to sell his future developed “Pharmaceutical substance” of which Jephcott of Joseph Nathan and Co (now Glaxo Wellcome) seeked.

Due to the ‘need’ of an replacement of the Radiographic X-Ray dye know as Lipiodol Jephcott approached Kodak for their help as for sometime the Radiological World had been calling for a “safer” radiological substance than Lipiodol as it was known to cause Chemically Induced Adhesive Arachnoiditis when used in a procedure known as ‘Myelography’. (…’An enhancement an “enlightenment” of the inside of the patients spinal cord and nerve roots whilst taking x-rays’…) the second World War had just hurried it on somewhat.

Jephcott knew Kodak at that time were the world leaders in photographic emulsions used in film processing,

Could one of Kodak’s products be adapted for the use in Myelography?

Evidence now available to the writer shows that although Eastman Kodak developed this Radiographic Substance from the bio-product of one of their process films the product was also known to them to be too toxic for human use and have since been found to contain bacteria and parasites.

For those that are wondering how, I will just touch on it here, to make gelatin emulsion for film Eastman Kodak initially used calf skins and later cow bones in fact, years later they needed to purchased 80 million pounds of cattle skeletons annually from slaughterhouses. [See Alec Klein Staff Reporters article in the Wall Street Journal dated 19th Jan 1999] Back in the early 40s when quality control was not like it is today, could these parasites and bacteria have ended up in the waste water of Kodak’s film processing from the Kodak made gelatin, to later travel in the  1 gallon brown glass bottles to Lafayette Pharmacal to manufacture Pantopaque, as well as in the 1 gallon brown glass bottles that were shipped to UK for Myodil.

This is not a far stretch is you consider this.

….’In 1930 Kodak after buying a batch of bones from cattle fed with mustard seed, it caused the gelatin to overexpose the film before the pictures were taken’….

At this time there would have be little or no consideration given for any parasites or bacteria being in the wastewater of film processing, however many years later when this waste water was sold on to Lafayette Pharmacal to produce Iophendylate Pantopaque or shipped of to the UK to Glaxo to produce Myodil a check on the purity of this new product by those trained to do so at Lafayette Pharmacal seemed to have not taken place

However, I obtained a American Court Depositions where it shows that no one employed at Lafayette Pharmacal from the beginning of production of Iophendylate Pantopaque including the Owner Mr Kunz had any medical or biological training to ensure its safety. Especially, when its transferred into 3cc ampoules after adding iodine and sold on to end up in patients cerebral spinal fluid within their spines at a later date. Alarmingly, this was the case for next 42 years until Lafayette Pharmacal was off loaded to ALCON distancing Eastman Kodak from what had happened.

SEE  DETAILS OF LAFAYETTE PHARMACAL STAFF AND MEDICAL EXPERIENCE TAKEN OFF AN 8 HOUR VIDEO COURT DEPOSITION

EPSON MFP image

As Eastman Gelatine’s general manager, Wayne C. Jones  once stated  “We couldn’t say no. We’d just say, ‘How much?’ [Taken from the same 1999 Wall Street Journal article] whilst this comment was in reference to bone costs, it shows that anyway Kodak could make money, they would.

However, from a diagnostic radiology standpoint this radiographic substance did what it was suppose to do, enable diagnostic radiologists and “others” to obtain and develop pictures of the inside of a patient body, but because of the products chemical makeup it later damaged/destroyed peoples nervous systems. The damage to the patient was slow and insidious for some taking up to 20 years to develop (‘like rust in a car’) for others, as soon as they had the injection or months later, the reason for this, is somewhat complex, it was due to dose use, how much was left in, and percentage of inflammation being experienced at time of myelography and if it reached the venous system. [Intravasation]

Sadly what most of those injected did not know at the time was the chemical make-up of this Kodak or Glaxo radiographic agent iophendylate (Pantopaque or Myodil) dye being injected into them. In fact, if they did they would never have permitted it, for it consisted of Hydrochloric Acid, Sulphuric Acid, Benzene, (now the number one carcinogenic in the world today) and Potassium Permanganate to name just a few, not forgetting the 30% of Iodine, don’t believe me, look it up, the evidence lies gathering dust in the Perrin Library at Oxford University in England, or in your Biomedical Library at your University.

Yes I have a copy.

Naturally by now those reading this would have doubts of the authentically of this brief, but keep an open mind of all that I report, because as I have stated before, all I report will be backed up with documented proof. This brief now divides into two parts which I again hope doesn’t cause to much confusion (trying to keep this brief short and to the point is difficult enough.) but I must walk you through the shadows of the past if we together are to come out the other end in the “enlightenment” of full understanding.

Harry Jephcott from Joseph Nathan & Co (now Glaxo-Wellcome) took the Eastman Kodak Chemical formula back to England. the precise ‘agreement’ of access is still not clear to the writer [yet] but if you look at Glaxos history one becomes aware of an enormous bargaining chip available to Glaxo at that time. This bargaining chip was by way of a recent discovery by Alexander Fleming of extracting penicillin from mould, with the help of scientists at Oxford University Glaxo went Into mass production of penicillin (antibiotics) for the war wounded, At the same time America was in desperate need for increased supplies of penicillin due to their heavy causalities being experienced since entering the War, local ‘mass’ production was urgently required, did Glaxo and Kodak exchange formulas I think so (both Companies will not release any evidence of such agreement, however, they have never denied it either.

(But soon I am receiving the documented evidence of what sort of an agreement transpired)

This access of the chemical formula by Glaxo from Kodak was put into mass production as soon as Jephcott returned to England, what Glaxo didn’t know at that time (although the do know now) Eastman Kodak had fraudulently manipulated the required documentation they submitted to gain the General Marketing License, or did they know?

Its interesting to go back in time and read Steinhausen Thesis titled: An Experimental Study of Iodinated Compounds for Intrathecal Use, for his Doctor of Medicine he was aged 66 at the time. His Thesis and findings were the basis of the future development of Ethyl iodophenylundecylate. [Pantopaque/Myodil and the like] All in all, quote: …’this was the less toxic of all the iodinated compounds for intrathecal use’… he investigated, and this is where the findings reported later in this blog regarding the test subjects being dogs, ’15 in fact, using the same process as all other compounds.

As I report later, of these 15 dogs tested 11 were injected by the cisternal route and only 4 by the lumbar route.

I will now place here some of his findings taken from his thesis regarding his use of Ethyl iodophenylundecylate. [Pantopaque/Myodil and the like] Normal print is my comment, bold italic print taken from Steinhausen Thesis as here… [it] was designed to be more slowly broken down’… …’Globulation appeared on the second day’… …’Absorption of the material occurred rapidly in the first month.  From that time on, the disappearance was much slower’… …’7% showed severe meningeal reaction’… [with]…’one [lumbar] dog dying’… …’Autopsy revealed a six inch loop of gangrenous intestinal ileum’… [normally caused by a blood blockage due to foreign matter in this case possible microscopic fibrous adhesions from the injected Ethyl-iodophenylundecylate. The writers thoughts] …’However, a Histological section of the lumbar cord through a small collection of radio-opaque medium, revealed definite pathological reaction.’… …’The subarachnoid space was filled with large, dense oval collections of cells surrounding small droplets of oil’… …’a predominant mononuclear response was observed with this compound. There were moderate number of phagocytes and fibroblasts, a few polymorph mononuclear leukocytes and plasma cells. The cells were supported by a fine network of fibrous tissue. This network of fibrous tissue had produced adhesions between nerve roots, the arachnoid, and the pia.’… …’Section taken through the cord where the compound was last demonstrated by radiograph, showed a few cystic areas up to 1 mm. in diameter in the subarachnoid space’…

Due to these findings the developers had to manipulate not only the animal but the Human Clinical Trials of this newly developed radiographic substance Iophendylate [Pantopaque] so they could falsify the “safety documents” needed to obtain it’s Marketing License. To support this “safety” they obtained support by those that used it ‘prior’ to the FDA License, being the end-users at “selected” groups of Military Hospitals whom produced Medical Journal Articles in support of its safety, however, today one can see the contents were misleading, in fact scandalous, I will go as far to say ‘down right lies’, bought and paid for by the developers.

All reference to what transpired prior to Pantopaque’s FDA Marketing application and throughout the life of Pantopaque in America [1936 – 1996] and around the world with ALL documented historical evidence can be found in my WordPress blog here at http://pantopaque.wordpress.com 

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As you will read here, these 1941 Animal toxicity tests showed that Iophendylate Pantopaque was found to be too toxic on all animals injected.

Here is a breakdown of them.

Intrauterine Injections on rabbits using Iophendylate Pantopaque results chronic toxicity, so toxic it destroyed the uterus and other reproduction organs.

Was later licensed to be used on Pregnant Women.

[See graphic later into this blog]

Many women after injection via the subarachnoid space were unable later to conceive,  ‘you are still in my thoughts’ C.[North UK]

If you read this C leave a comment below, so I can re-contact you.

I GO ON.

The same chronic toxicity was found when they injected it intrapleurally into dogs and rabbits leading to death.

This chronic toxicity was also found when they injected Iophendylate Pantopaque intraperitoneally in a various species, [Lethal Dose is 1.2 g/kg body rate in Rats] Guinea pigs, Rabbits and dogs, as well as orally into Rats.

Of course, by now they were very concerned that this proposed  ‘new’ contrast medium was a failure, so they decided to test it Intrathecally in dogs.

NOW was this a massive trial, NO only 15 dogs 11 cistern and ONLY 4 Lumbar, yes, people Iophendylate Pantopaque was deemed to be safe for lumbar Intrathecal injection in humans based on only 4 dogs. Oh, one died.

See/hear the Depo of Mr Kunz of Lafayette Pharmacal in the Walsh Case who oversaw the FDA DESI requested 1969 dog tests where 7 dogs died after injection intrathecally.

Here is a Copy of this Video Kunz Deposition  its in two parts and goes for 6 hours.

 

Oh, if this isn’t bad enough, Glaxo’s UK toxicity test on Iophendylate Myodil consisted of, wait for it, 3 rabbits only.

Related documents sent from an Glaxo whistleblower will be placed here in due course.

For those interested here is the complete list of the 1941 Animal toxicity tests.

1941. TESTS. Intrathecal dog experiments with Ethyl-w-(4-iodophenyl)-n-valerate.

1941. TESTS. Intrauterine Injections of liquid contrast media in rabbits, using Ethyl-iodophenylundecylate [Pantopaque].

WARNING before you sight the pages taken from this specific test, be warned they are graphic and alarming so if you are squeamish DONT READ.

EPSON MFP image

EPSON MFP imageEPSON MFP imageIn Feb 1969 the same rabbit test was done again by the developers. BUT this time at ‘half the strength’ of the 1941 test. Again, please be WARNED the content is horrendous and disturbing.

Here findings in 1969

EPSON MFP imageEPSON MFP imageBased on the findings above, one would think that to go ahead and injected it into the amniotic sac of pregnant women before they gave a unborn child a blood transfusion would be a definite NO, but sadly they did, here’s a photo of how they did it, the dark area around the baby is Pantopaque.

BABY

More Tests 1941. TESTS. Intrathecal dog experiments with iodised poppy seed oil.

1941. TESTS. Using Ethyl-iodophenylundecylate [Pantopaque]. Findings. Chronic Toxicity following intraperitineal injections of liquid contrast media in various species. Rats, Guinea pigs, rabbits and dogs..

1941. TESTS. Using Ethyl-iodophenylundecylate [Pantopaque]. Findings. Acute Toxicity of Ethyl-iodophenylundecylate (Pantopaque) by oral Administration to rats.

 

1941. TESTS. Intrathecal dog experiments with ethyl-iodophenylundecylate [Pantopaque]. Please note, whilst the ‘other’ mentioned 1941 tests on all other animals and their injectable sites REPORT the outcomes, the 1941 test on dogs intrathecally, ONLY explains the procedure, NOT the outcome.

Following this, I will show you another set of intrathecal dog tests done in 1969 following the same procedure as that in 1941 using not only iophendylate Pantopaque I which was being sold and used worldwide, but iophendylate II [where they used 15% iodine being half the strength of Pantopaque I] however, what they were NOT expecting was the horrendous results they found when using half strength.

This explains why they covered it up in 1941.

‘CRIMINAL’

As an add on to this, the developers Kodak when realising their mistake of trying to develop an “new” Pantopaque at half of the strength of that currently on the World Market they also needed to now ‘cover this up’ due to the results. What they did next shows the deviancy of Eastman Kodak and all others involved, they wrote to the FDA to inform them that Pantopaque II tests would not continue and withdrew their application.

In the normal sense, when withdrawing such an application, ‘all’ related tests and findings are sent with the withdraw of the application to the FDA at the same time. However, Eastman Kodak withheld them for 18 months before slipping them ‘quietly’ into the FDA archives.

By doing, no one at the FDA picked up on these findings and their  relationship to Pantopaque I and the consequences of such, exactly what Eastman Kodak wanted.

  As mentioned earlier, here are some of the 1941 Intrathecal dog experiments with ethyl-iodopheny-lundecylate where only the process was reported, and NOT the outcomes you can see here, below.

1941 Test.

to see the complete set of these pre-license animal studies go to the links on right.

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  CRITICAL Please note above on page 4 it refers to this test using 7 – 10 times more than that recommended for humans. When one equates that the average dose recommended for humans is 2.85cc, so what is that saying, its saying that based on the developers recommendation this is the dose deemed to be safe.Furthermore, this recommended dose was also promoted prior to Iophendylate Pantopaque’s FDA License, by those trialling it at Military Hospital and its end users were they used 3cc.Lets now go to these 1969 Test on dogs using both Pantopaque I and Pantopaque II IMPORTANT TO NOTE THIS TOXICITY STUDY WAS CARRIED OUT BY A SUBSIDARY OF EASTMAN KODAK. WHICH IN ITSELF IS ‘OPEN’ TO SELF-MANIPULATION CONSIDERING EASTMAN KODAK WAS THE DEVELOPER OF IOPHENDYLATE PANTOPAQUE I.  EPSON MFP image AS THIS IS A VERY LARGE STUDY I HAVE PLACED HERE ONLY THE FNDINGS AND A BREAKDOWN OF ONE OF THE RESULTS RECORDED, OF ONE OF THE 55 DOGS TESTED AND THE SUMMARY. THE FULL STUDY IS AVALABLE EPSON MFP image EPSON MFP image EPSON MFP image NOTE BELOW THIS RESULT IS PANTOPAQUE HALF THE STRENGTH SOLD WORLDWIDE FOR BY THIS TIME 33 YEARS.EPSON MFP imageEPSON MFP imageEPSON MFP imageEPSON MFP imageEPSON MFP imageEPSON MFP image 1941. TESTS. Acute Toxicity of Ethy-iodophenylundecylate [Pantopaque] by intravenous injection in Dogs and Rabbits.
  1941. TESTS. Physiological Assay of Ethyl-iodophenylundecylate [Pantopaque] by Intrathecal injection.
  1941. TESTS. Absorption of Ethyl-iodophenylundecylate [Pantopaque] from the Subarachnoid Space.[It doesn’t absorb it just loses its opaqueness. Writers view]
   

In the case of Kodak they sold this radiographic substance from 1944 to 1996 although they jointly ceased selling the product through-out the world in 1987 the product itself had a shelf life of 5 years, Glaxo likewise sold their copy throughout the world, where it was used on 100s of million of patients. (still does, but not in Australia)

ALCON

Surrendered its Pantopaque Marketing License to the FDA in 1996.

A question often asked of me is ‘why’ hasn’t this abuse of ‘human rights’ been made public, the answer lies not only in the size of the two companies involved, but others involved indirectly, the Governments and Health Departments of these 107 countries, and what it means in political terms for this atrocity to become public, especially when many of their x-government personnel later went to work for one or the other of these companies “for very attractive salaries” some still there.

This also includes retired heads of ‘related’ Medical Departments who now are ‘paid’ consultants for them, including those who’ve published company drafted Medical Journal Articles which can now be seen as misleading.

I wrote this below when I hosted which was at the time, the largest Chemically Induced Adhesive Arachnoiditis Website in the World.

‘Multi-National (ism) by Corporations brings with it, not only consolidation but also ‘power and influence’. So much so, that sometimes they become more powerful than those who regulate them. This ‘power and influence’ over time seeps into the structure of Governments and those elected to protect the community at large. Some of these Government Ministers, Senior public servants or Department heads elected or appointed to oversee the ‘ethical behaviour’ of such powerful Corporations, will themselves in time become future Company “men” not only compounding future power, but “legalising” these already out of control Corporations.  ©  DM  2006

 Sadly Glaxo you were NOT quick enough regarding ‘getting removed’ these disclaimers, not everyone in the ‘seat of power’ are in your pocket’.

Copies held with my legal people, you stopped me in 2001 BUT not this time.

——  —  ——

Between 1944 and 1969 (25 years) and then on to 1996 this too toxic chemical rampaged the world, there was no protection for the patient, this didn’t come into place until 1970 due to the Thalidomide issue which made world government legislate to protect their citizens.

However, sadly this same Ethy-iodophenylundecylate [Pantopaque] is now back on the world market via China 3 Companies manufacturing it there, but now its marketed as iofendylate. Remember, Lipoidol was stopped being used in the late 30s due to it was found to cause Chemically Induced Adhesice Arachnoiditis especially when Pantopaque became available because it was reported to be ‘safe’.

Well people, Lipiodol was reintroduced back onto the world market in the 50s to the 60s, it went back off the market until the 80s when it came back to remain until today. Remember, they stopped using it because it was found to cause Chemically Induced Adhesive Arachnoiditis so how come it came back onto the world market? It seems that they realised if Pantopaque is allowed to be marketed whilst causing Chemically Induced Adhesive Arachnoiditis so could theirs.

People, check these dates don’t these dates coinside with the problems found with Pantopaque. It seems Lipiodol manufacturers ‘ducked below the parapet’ until things cooled off. Historical documentation now shows they all knew it caused Chemically Induced Adhesive Arachnoiditis, but because they believed that all reported adverse reactions of Iophendylate totalled less than 1%, “they felt the risk was acceptable to the patient”. Remember there was no Regulatory reporting mechanism in place at the FDA until 1969 so a true reaction to Pantopaque was not known. And by Pantopaque developers withholding all these adverse reaction being reported to them from around the world for the first 25 years created a belief by the end-user that it was safe to use, well at least up to1969.

After that period ALL end-users where aware of the relationship and should if still was going to use ‘inform the patient of the risk’ however, for most patients this was never done.

In 1969 the American Government called for an DESI inquiry into Pantopaque and Eastman Kodak’s behaviour.

SEE BELOW THE OUTCOME OF THIS INQUIRY

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 Delivery into Australia CEASED for awhile.

Until 1969, Pantopaque had been sold throughout Australia by Kodak for about 17 years [1952] with their knowledge they had obtained Pantopaque’s license by fraudulent means through manipulating the pre-licensing human clinical trials, in fact, checking on the TGB Card Index below In fact, Eastman Kodak endangered the lives of my fellow Australians not once but twice, the trial of human abuse through-out this country surrounds me silently, as I write.

Interestedly, an Australian Radiologist make mention in at least on old Australian medical Journal article that they were using Pantopaque in 1944?

However moving on, I have shared with you a ‘little’ of the past (a snap-shot) including the development of this horrendous crime against ‘human rights’ by Eastman Kodak with the support of others through-out the world, now I wish to share with you what has transpired here in Australia since the stopping of Pantopaque temporary into Australia between 1969 and 1972.

The reason Pantopaque was stopped being imported into Australia wasn’t because Hughes didn’t want to, it was because the American FDA was investigating Iophendylate Pantopaque safety and he didn’t want to be implicated, so he stopped importing, but in so doing he forgot to renew his import License and had to re-apply.

The story of its re-introduction into Australia by Hughes in 1972 and his continued stalling of the New Drug Application Animal and Human Clinical Trials to the TGB/A for Pantopaque [because it showed them to be ‘too toxic’ for human use] for the life of the “dye” in Australia for the next 15 years. As you can see by the documents below.

Details of The American Story ‘the life and death’ of Pantopaque can be sighted elsewhere on another WordPress Blog of mine mentioned earlier, again with ALL supporting historical documents be it related correspondence, reports etc between the FDA, Eastman Kodak, Rochester University, Strong Hospital, Military Hospitals and letters from its Doctors, Lafayette Pharmacal, Taylor Labs, Hazelton Labs, 1936, 1963, 1969, Distillation products Industries, and all other related parties]

Due to this FDA investigation Hughes knowing there were NO ‘true safety and acceptable animal and clinical human trials’ regarding Pantopaque available decided as I mentioned earlier to stop the importation of Iophendylate Pantopaque until the dust settled. Hughes had a serious problem Pantopaque was his major income source, and to make things worse the Australian Government the following year [1970] introduced regulative controls on all new Pharmaceutical Drugs released into Australia (‘because of the Thalidomide issue’) this requirement was on ‘all’ new drugs not available at that time in Australia, those already here were “Grandfathered”. (Including that of Myodil the Glaxo copied product of Eastman Kodak PANTOPAQUE) however, Hughes as I said had let his Import License lapse, my belief is he wanted to distance himself from what was being discovered by the FDA and of course any future legal redress here in Australia. Whilst Glaxo’s Myodil continued its sales in Australia without its competition Pantopaque, Hughes was losing money, what could he do, until I prove differently it is my contention that Hughes was also the Australia Distributor of Myodil at that time, whatever the case ‘conveniently’ in 1972 Myodil became unavailable due to a “contamination issue” and Hospitals were running out of Myodil. On checking, I cannot find ANY other hospital here in Australia where this happened. Was this a way for Hughes to get Pantopaque back into Australia, stop Myodil supplies, get Pantopaque back in?

See the following internal report below dated the 8th June 1972 outlining contact from a Dr Hosking of the Epworth Hospital informing the TGB that they were unable to access Glaxo’s product Myodil (because of contamination problems of the last TWO shipments) and the Hospitals Radiologist tried to bring in a shipment of PANTOPAQUE ‘illegally’ [Drug running with a difference, my words ] which had been supplied to him by Eastman Kodak in America however, this shipment was stopped by Australian Customs. Although the shipment was small’ only consisting of 15O ampoules it was sufficient for a ‘one off’ shipment in the eyes of Epworth Hospital as you can see by the written record accessed from the T.G.A. Federal Department of Health shows that because PANTOPAQUE had not met the (now in place) strict Licensing requirements an assurance by the Hospital that this was a one off shipment until the “approved” Glaxo product became available, was this as I said earlier, a rouse by Hughes to get Iophendylate Pantopaque back onto the Australian Market for it seems so, especially, if he was also the importer of  Myodil from Glaxo UK?  [I will find out Hughes]

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The following is a copy of a TGB internal memo dated the next day the 9th of June 1972 was signed by the same person B Ashley instructing a Dr Levi to arrange the release of these 150 x 3 ampoules of Pantopaque to Dr Hoskings at Epworth Hospital .

EPSON MFP imageHere is  a copy below of that Government PERMIT to Import Therapeutic Substances under Regulation 5A or the Customs (Prohibited Imports) Its Permit Number 5143 in this case Pantopaque. Written on the permit as one can see, is for – 15O x 3 Ampoules PANTOPAOUE from Kodak USA. It further states that it was for . . .(Limited Authority for this quantity only)…. it further states … ‘This preparation will only be used for emergency cases only, the Doctor will be fully responsible for the use of this drug which Is regarded as experimental only he will follow the NH&MRC Guidelines for …‘HUMAN EXPERIMENTATION‘… this was signed by a J. Richards. Delegate of the Australian Director-General of Health.

Here is a copy of that Permit also signed by J Richards.

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On the 30th of the same month being June a letter was sent to Dr Hosking at Epworth Hospital from A.N. Walshe the assistant to the Director General of the Therapeutic Substances Branch of the Department of Health notifying him that a permit has been issued regarding his request for Pantopaque, [see below] of course by this time he would have received the 150 x 3 ampoules weeks earlier. This letter goes on to inform Dr Hosking that its use under the principles set out in the National Health and Medical Research Council’s Statement on Human Experimentation are followed. He goes on further to point out [that] the responsibility for the use of this product is that of the investigator concerned, it would be of assistance if you would provide details of any suspect adverse drug reactions finishing the letter with the following …’Your written assurance that these points will be followed, is required. File number 72/3851.

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On the 7th July Dr Hosking replies to Dr Walshe of the TGB regarding his letter sent on the 30th of June which can be seen above. This letter dated the 7th from Dr Hoskings  stating that he has no intention of regularly importing Pantopaue BUT goes on to encourage the TGB to approve it for general marketing in Australia. He then stated that its been on the US market since 1942 and refers to the brochure which he has attached to this letter.

This I am sure has been promoted by Hughes.

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Dr Walshe, as you can see is not satisfied with the “brochure” as being an explanation of the ‘safety’ of Pantopaque, and good on him, he want the evidence from the developer to which they supplied to the FDA in 1944 for the TGB to evaluate. Due to such he sent a further letter to Dr Hoskings stating such, please see a copy of that letter below.

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Oh, just as a matter of interest whilst Iophendylate and Myodil are the “same”, Myodil was placed on the Australian Suspect Drug List from 1973 onwards. Also 2 years later, in the Adverse Drug Reaction Bulletin dated the 1st of February 1975 the Australian Drug Evaluation Committee noted the relationship between the retention [non-removal from the subarachnoid space] of Iophendylate Myodil [remember this is the “same” as Pantopaque] and Adhesive Arachnoiditis.

Between the 8th of August 1972 and the 4th of March 1974 a period of 19 months no further documentation can be found [yet] regarding the importation of Pantopaque into this country by Hughes via Amyl Products Industries.

On the 4th of March 1974 Mr Kevin Power Victorian Sales Manager for Amyl Chemical Industries Pty Ltd Chadstone Victoria the Importer of Pantopaque wrote to its Manufacturer in America requesting all the Australian Federal Health Department had asked him for. [See copy of this letter below] This letter was addressed to the Owner/President of Lafayette Pharmacal Inc where he informed them that the Australian Commonwealth  Department of Health had ordered the Australian Importer to stop supplying end-users and that …’no further distribution of this product may be undertaken until these data are supplied and evaluated’… He goes on to state that and I quote‘you will note that they require 15 copies of the label, package insert and other product literature. We have forwarded copies of these but have no data on any animal toxicity (acute and prolonged) or evidence of safe us in humans’….. End quote.

EPSON MFP imageRecently unearthed was an internal TGB ‘Note for File’ dated the 8th of March 1974 where a ‘Monica’ of the TGB sends this note [see below] to [looks like JS, but unsure] she writes initially some details which I am unable to read completely, however, she does on to write …’Mt Crocker advised Nicholas Pty took over Watts and Victor who had taken over Amyl (Mr Hughes) B1 requested but no NDF3 enclosed. Please send NDF3 [something I cannot understand]  today. Monica last call at this stage no further details. Do you mind attending to this [then a name which I cannot understand] Thanks Judy 8/3.

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What is very noticeable here is the operations at the TGB was at the time in a shambles ‘everyone’ is passing the responsibility onto someone else’ but no one is really overseeing the operation of the department and the Australian community at large.   One could say, the Manager was relying on his staff and the staff were working independently of each other, one begs the question as to why, was the any ‘inducements’ taking place here between staff and Hughes? Whatever was going on, Hughes realised the TGB office was in a ‘shambles’ due to these new changes and used such to his advantage by the  ‘divide and conquer’ technic.

He befriends each of the 3 women separately in the TGB office who issues the importation permits, [Guy. Staton. Atkinson.] without these women realising they are each signing separate permits for the same thing, by doing Hughes is obtaining multiple shipments. In fact, as we will see later he was able to obtain 3000 boxes of Pantopaque over just a 1 month period, all illegally, what one needs answers to is ‘why’ the Head of the Department was not signing these. Remember, this all began as just a one off order of 150 ampoules for Epworth Hospital in Melbourne, not 150 x 3 that has developed sincewhere he did sign, most of the others were sighed by these women.

In fact, throughout Australia between 1972 and the 6th of March 1979 due to Hughes accessing these permits this way, more and more patients were being exposed to this ‘too toxic and very dangerous illegally sold ‘x-ray ‘dye’. Whilst at the same time the Regulatory Department of the TGB continued to pressure Hughes to provide the safety documents they require, without the knowledge that elsewhere at the TGB they are issuing importation Permits ‘willy nilly’.  What is terribly disturbing, is how could such have been allowed to happen, well one can only surmise, my theory is this, prior to 1970s and the new regulatory requirements on drug importation there was NO Regulatory oversight regarding the importation of drugs. We could further surmise that pre-1970 things were still pretty lax regarding ‘safety’ of these “new”drugs, relying on oversees past licensing, as prove of safety.

Whilst new Regulatory rules on the importation of new drugs had been legislated and things had changed at the TGB, they were very weak and slow in enforcing these new changes.

Evidence now available to the writer shows Hughes could NOT provide such ‘safety and Sterility data’ because ‘there wasn’t any’. In fact, by the time Iophendylate ceased being imported into this Country 100s of thousands of people here were exposed to this highly toxic chemical some now ‘lie in silent graves’ awaiting other Australians like you Joel (the reader) and I to ‘get this horrific story told’ and give purpose to their lives.

Whilst the ‘referred to’ copies of original letters reports etc mention in my letter to 60 Minutes Australia, were just that ‘referred to, I have included them here in this Blog. However, separate copies [4 sets in fact] are held in other parts of the world ‘just in case’!!! To be released if I am no longer able to share such with you.

You maybe interested to know that early in my Research, my life was threatened if I continued, this was done via my daughter living interstate. Our Police ‘Special Branch’ [before it closed down] oversaw our safety, later they apprehending the person concerned, BUT was unable to press charges due to lack of evidence.

I digress, lets move on.

Here is a copy of the card index of the Federal Department of Health TGB Permit releases for Pantopaque from 1st of November 1974 that I have been able to obtain where you can see those that signed off on these Permits and by doing endangering the lives of citizens here in this country.

They just didn’t do their job, its as simple as that.

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Its interesting to note that this TGB Card Index for Pantopaque showed the first Permit issued after the new Regulatory requirement was 1/11/1974 although I am sure there is other Card Index’s for between 1970 and November 1974, it just seems the TGA did not release them to me. I wonder why?
 Particularly, when one can find Australian Medical Journals showing Pantopaque was being used here between 1970 and 1974 especially in the 1973 period, and causing harm See below:
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Interestedly, are the comments on the Report regarding ‘Outcome’ where it states …Recovered without sequelae…however, underneath that it states…’Causality Probable’… which in a sense, implies that ‘a risk of use and such consequences’, were known.
However, such risk and such consequences was also not shared [‘informed’] with other patients with grave consequences as you will read later [see 20th of June 1978] farther into this Blog.

See below a copy of the Letter dated 12th of March 1974 which was written to Mr Victor Power Sales Manager of the Australian Importer of Pantopaque Amyl Chemical Industries Pty Ltd in Chadstone Victoria. This letter was from Pantopaque’s Manfacturer Lafayette Pharmacal Inc in Lafayette Indiana, America in response to Mr Kevin Powers earlier request for all relevant data [eg: Toxicity studies etc etc] requested by the Australian Federal health Department. However, Dr. W Griggs [non-medical doctor, but a pharmacist] who penned the letter stated that such toxicity and safety evidence would NOT be necessary since this product has been marketed in the United States for over twenty years however, what he is not sharing is that this initial toxicity and safety studies submitted to the FDA in May 1944 were fraudulent.

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This letter below is dated 19th of March 1974 and is from the Australian Importer Mr Ernie Hughes (agent of Pantopaque) of AMYL Chemical Industries Pty Ltd [Managing Director to “another’ Dept of Health Staff Member thanking her for approving a further ‘wait for it’ NOT 150 x 3 ampoules BUT 500 x 3 ampoules see following a copy of THAT Permit below dated the 14th of March 1974. Please NOTE [this is critical] the ampoules which were previously sent were the standard 3cc but now have been increased to 5cc ampoules [see written on permit] NO approval by the FDA has been applied for by the Manufacturer to increase size of the ampoule from 3 to 5cc, in fact, my investigation of 100s of medical journals etc etc I have found no mention of any Hospitals receiving or using 5cc believe this is an error and should have read 3cc. Between 1974 to 1987 ampoules increased from 3cc to 9cc to 12 cc none of these increases were ever approved by the FDA. Naturally the level of toxicity increased as the dose was increased [the initial recommended dose at initial license by the developer [NOT the manufacturer] to keep the CSF neutral was 2.85cc [that’s why the original ampoules were 3cc] any higher would increase a meningitis reaction and of course the greater one used the greater the reaction.

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Here below is a copy of that Import Permit

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Interestedly, whilst Hughes is thanking Ms Fay Guy by letter, he is also writing a further letter to Mr Griggs [same date] of Lafayette Pharmacal Inc USA informing him that he needs that which the TGB requires, he further lists what is required suggesting that a “Arthur Kunz” could supply all the information [further information regarding Kunz will be included later,] however, he is the main player with Hughes BUT in America at Lafayette] here is a copy of that letter below.

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For the next 5 years Hughes and Kodak/Lafayette manipulate the Australian system to continue shipment and access to the Australian market illegally by continuing to stall the process of this required ‘safety’ documentation. Although this manipulation did not stop Hughes and Co accessing permits for ongoing shipments of this highly toxic and ‘deadly chemical into this country.

Remember, the initial shipment in 1972 was as I said earlier ‘a one off shipment of 150 x 3 ampoules’ only.

On the 16th of April M.A. [being Miss M Atkinson from the TGB] responds to Mr Hughes further requesting I quote …’I also request (again) written confirmation of statement to Ms F Guy re Pantopaque —  see folio 79 (b). He said he will arrange… [further stalling, my words]

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On the 17th of April 1974 Mr Ernie Hughes replies to Ms M Atkinson [see copy of letter below] where he again tries to delay what the TGB require, that being the Sterility Results on Iophendylate Pantopaque for he cannot provide such ‘there isn’t any’. This letter is basically tell her that Pantopaque has been imported into Australia sine 1967 [by them] he goes on to state that previous to this, a Company by the name of Watson Victor imported it from 1952 what he forgets to mention here was ‘he was the Owner of that Company’ and when joining Amyl took his importing License with him.

Ernie Hughes has been the ONLY importer of Pantopaque into Australia other than ALCON and should be held accountable criminally for the serious injury and deaths he has caused.

For information regarding ALCON and their involvement see later on in this blog, from 1978 onwards.

If you wish to go there now.

[It’s not there yet you will have to wait until I get to that time, hang in there it’s ‘well worth it’]

Going back to this letter of Hughes as you can see he goes on to share with Miss M Atkinson that and I quote…’PANTOPAQUE has been on the world market for over twenty years and is listed in the United States Pharmacopeia’…[he goes on to say]…’Please find enclosed a copy of a recent letter received from Lafayette Pharmacal, Inc. attesting to this fact’…end quote.

Again, reinforcing the fact Pantopaque is “safe”.

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The following is critical to the ability of Hughes to continue.

By this time the Australian TGB is getting frustrated about NOT receiving the requested toxicity, sterility and safety data and related documentation for Pantopaque from Hughes, well Dr Walshe is, the 3 women supplying Hughes with these permits are patiently awaiting the delivery of the NDF 3 etc without YET realising what is going on and what Hughes is doing. Dr Walshe is clearly running out of patience [nearly 3 years have passed and whilst the TGB has been waiting for the ‘safety and sterility’ data, thousands and thousands of patients in this country are having their lives destroyed] so he writes directly to Lafayette Pharmacal Inc, however, it seems this was to be Dr Walshe’s last involvement with the Pantopaque ‘safety and sterility’ issue soon after there was a change at the TGB of the Assistant to the Director – General, from Dr A.M. Walshe to a Dr B.C. Ashley who now becomes the Acting Assistant to the Director – General of the TGB. What is interesting is that Dr A.M. Walshe was pressuring the American Manufacturer Lafayette Pharmacal Inc, and Mr Ernie Hughes for the required documentation to prove that Pantopaque was safe for human use. Please remember Pantopaque as I have said before, is way too toxic for human use and causes CIAA and many other secondary related medical conditions/symptoms, so Hughes couldn’t get what wasn’t there, “but he had a great little business”.

“How could he keep going”? 

The question that needs to be answered is this, why did Walshe get replaced? For what is interesting, the letter below INITIALLY written by the replaced B.C. Ashley [Brad] was ‘STOPPED’ from being sent, the copy is very poor, so I have had to type it out also.

[to enlarge double click on image, that applies to all images]

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This below is very concerning, it’s a copy of an TGB internal note to a Brew from ??? I believe, this Brew to be Dr Brew Ashley the new assistant Director General of the Department of Health, where the writer refers to a letter that has been written and was about to be sent to Lafayette regarding Pantopaque, asking does it require alteration. However, what is disturbing is the contents of this Note where it seems the letter referred to, is now going to ‘watered down’ due what was shared with him by Judy Stanton. This note goes on to say YES, here are the exact words written as you can see below….’Yes, It seems that Pantopaque has been imported steadily by various companies for ??? years…[HE HAS NO KNOWLEDGE THAT THE SAME PERSON HAS BEEN IMPORTING IT INTO AUSTRALIA ILLEGALLY BUT JUDY STANTON DOES] it goes on to say…In the circumstances I believe we can allow limited marketing until B1 is obtained and cleared, and make a less demanding request for ????? toxicity and human safety . Sorry’….. [18/8] date? Not sure for he’s referring to the letter dated in April. However, what I am sure of is that the person advising him needs to held accountable for her actions.EPSON MFP image Our next piece of information that I was able to accessed was a letter dated 26th April 1974 from a C.W. Griggs of Lafayette Pharmacal Inc to the Director – General of Health TGB [Therapeutic Substances Branch] initially opening with an overview of Pantopaque being sold for the past 30 years trying to [and doing so] portraying that Pantopaque was safe, [if you look at the enormity of adverse reactions being reported to Lafayette and to the FDA, at that time this was not the case] Griggs then goes on to make reference to the chemical name being 100% Ethyl-Iodophendecanoate [Pantopaque] and how its prepared etc and what size ampoules they came in. What he doesn’t refer to was Ethyl-Iodophendecanoate [Pantopaque] chemical content which was Hydrochloric Acid. Sulphuric Arid, Benzene, (now the number one carcinogenic in the world today) and Potassium permanganate for to do so, would expose everything [as I said earlier don’t believe me, check the chemical formula] was nothing more that waste water from film processing, think about it a photographic ‘negative’ and a radiographic ‘X-ray’ not much different appearance wise is there, but unlike Kodak’s slogan of …’You press the button – We do the rest’…maybe it should read ‘You press the needle – And it will do the rest’… (c) 2015 Derek Morrison. Griggs then goes on in this letter to say the following…’We would appreciate knowing if there is any special forms we need to complete an file with your office to market Pantopaque in Australia. Your attention to our request would be appreciated’…. This highlighted section makes reference to ‘special forms’ special forms that the TGB have been trying to obtain from Hughes and Griggs for almost 3years and here was Griggs completely disregarding the TGB multiple past requests [a way to once again stall the TGB finding out that Pantopaque was too toxic and unsafe for human use] Soon Australia was recording further deaths due to Pantopaque injecton, BUT the TGB still does nothing even though the requested toxicity and human safety data had still NOT been provided. In fact they never were for the whole period it was sold here in Australia illegally [1952 – 1978] 26 years. Just for the record here is a list of Australia’s Commonwealth Director – Generals of Health from 1921, 1921 – 1945 Dr John Howard,  Lidgett Cumpston …1945 – 1946 Dr Frank McCallum… 1947 – 1960 Dr Arthur John Metcalfe Health…  1960 – 1973 Sir William Refshauge… 1973 – 1982 Dr Gwyn Howells… 1983 – 1984 LJ (Lawrie) Willett. [The last] EPSON MFP image

On the 8th of July 1974 [see below] the TGB receive a follow up letter from Griggs of Lafayette Pharmacal to the previous letter sent by them on the 26th of April almost 6 weeks ago, where they worried about the Australian TGB ‘becoming aware of what they have been up to with the assistance of Hughes?

The question needs to be asked why the delay by the TGB?

Had they realised what’s been going on, and now in panic mode.

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Next we find a Australian Federal Health Department TGB internal memo dated the 15th of July where they itemised ‘concerns’

please see below.

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As one can see, our Australian Government Department of Health the TGB have still NOT received any verification of the Radiological X-ray dye Pantopaque being sold throughout Australia was safe for human use, this was of course impossible they could never do so as I have said on many previous occasions.

What you are reading here, my worldwide research shows that in America ‘the same has been going on’ as you can see below the FDA is on to them.

What is inexcusable, this took place 5 YEARS EARLIER.  

Here you will find a 1969 Lafayette response to the American FDA whose requesting ‘same data’ regarding Pantopaque toxicity and safety as our TGB, so Griggs in the US and Hughes here in Australia cannot deny knowing the unsafe nature of Pantopaque.

See below the 3 page letter from the FDA to Griggs of Lafayette Pharmacal.

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EPSON MFP imageFor 25 years [1944 – 1969] since the fraudulent manipulation of Iophendylate Pantopaqe FDA License Eastman and Lafayette Pharmacal have NOT been meeting their FDA obligations as a Corporate citizens by furnishing Annual Reports on Iophendylate Pantopaque, in fact, they’ve been withholding a multitude of adverse reactions being reported to them, from around the world. What they have done here is ‘shot themselves in the foot’ by trying to develop and introduce another Iophendylate Pantopaque being Pantopaque II [15% less iodine] they registered their intentions with the FDA and got found out regarding NO Reports for 25 years since this product came on the world market.

  This will naturally open a ‘can of worms’.

For further American information see http://pantopaque.wordpress.com

I will now return to the Australian story and supportive evidence in image form.

Below is a letter from Ernie Hughes [managing Director and Owner] of AmyI Chemical Industries where he notifies Ms Atkinson and Ms Guy of the TGB that …’distribution of Pantopaque in Australia has ceased pending our submission of relevant items of NDF 3 & 4 being supplied by Lafayette Pharmacal’….

EPSON MFP imageBelow is an internal TGB memo dated at 7th of August 1974 where ‘instead of Hughes’ requesting more Pantopaque because he has informed the TGB that all distribution of Pantopaque has ceased, he gets the Head of the Dept of Radiology at Alfred Hospital a Dr Luke to ring the TGB and do so, by informing them that Glaxo Iophendylate Myodil is unavailable due to product contamination. Hughes holds the sole Agency for Pantopaque in Australia whilst he works for Watson Victor as part of Amyl Industries, he supplies Nicholas Chemicals stock as and when needed, and this is a classis case of a ‘smoke screen’ of the TGB to continue not only supplying those he has been in the past BUT extend Pantopaque into Alfred Hospital also in Melbourne like Epworth Hospital.

EPSON MFP imageIt seems that no one in authority at TGB has the courage to stop permitting this ongoing supply of Pantopaque to Hughes without any knowledge that its safe to be used on humans. As I made mention to such above, its Dr Luke asking the TGB for stock of Pantopaque because Myodil [Pantopaque copy] is unavailable due to “contamination”. However, it’s not Epworth Hospital this time requesting this as they did in June 1972, BUT this time its Alfred Hospital using the same ploy as in 1972, in 1974.

However, the letter below from Ernie Hughes dated the 13th of September 1974 for Pantopaque not only acknowledges receipt of 500 boxes of Pantopaque [funny, as the Australian Agent/Sole Distributor he must have just given the stock to himself, and then forwarding it on to Dr Luke at Alfred Hospital] whilst at the same time he’s also providing stock to another Hospital in Victoria and elsewhere. Although if Myodil was in “short supply”, such is somewhat understandable but to do so without permission of the Regulator the TGB is criminal.

EPSON MFP imageFirstly, I draw your attention to the written notes bottom left, where it says,…’Dr Aurora [‘another replacement’ of the assistant to the Director General] is this ok, please? beside it is an initial, MM [being Monica]… he writes below the following…’OK, but BO to sign… [I have no idea who BO is, I wrote this DM] …Monica get letter permission granted to supply Dr S at Allendale with Pantopaque… .

Furthermore you can see by the way this letter has been written by Hughes he writes this letter to ALL 3 women whom have been individually issuing these import Permits, this I believe is deliberately done putting them on notice as a collective what has happened and their involvement as individuals. He then informs them that he has now provided Pantopaque to not only another new hospital being The ‘Alfred Hospital’ [without TGB Permission I might say] Ernie Hughes is now clearly ‘a loose cannon’, doing exactly what he wished and no one at the TGB is stopping him. One can also see in this letter he has the audacity to inform the TGB that he also provided Pantopaque to another hospital, this time the Allendale Hospital without any concerns regarding the correct protocol.

I cant help but write here the following, ‘all the TGB had to do was contact the FDA and ask about Iophendylate Pantopaque’ and then thousands and thousands of patients here would not be like they are today, if alive’.

Remember The TGB/A. [the name changed in 1974 to the TGA] has still not received ANY of the toxicity, sterility data under NDR 3 & 4 that they requested concerning Pantopaque safe use on Humans, and now almost 3 years have passed since they first requested it, but they still permit importation and use on patients throughout Australia.

Where are these thousands of boxes of Pantopaque going?

As you will see later, Hughes with the full knowledge that’s its too toxic for human use and caused Adhesive Arachnoiditis continues to sell it across Australia to any Hospital Public or Private, X-Ray Clinic’s, Government Medical Storage Depots, including Private Doctors and Specialists who will buy it.

Names of these Doctors and Specialists and their addresses provided further in this Blog.

For those that may doubt that Hughes knew of the relationship between Pantopaque and adhesive arachnoiditis, he and the Owner of Lafayette Pharmacal Dr Kunz [a non-medical doctor, but a pharmacist] knew each other for many years, in fact, Hughes often visited him in Lafayette.

Here’s a picture of Dr Kunz

Kunz

Lets return to what happened here in Australia.

It’s now the 19th of September 1974, and below you will see a copy of a letter from C. W. Griggs of Lafayette Pharmacal in America where it seems they are getting very worried due to no correspondence from the TGB.

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See below a letter dated the 22nd September 1973 to Hughes [now Managing Director Ltd] of Watson Victor Ltd from Dr B, C, E. Ashley confirming that Dr Luke at Alfred Hospital may be supplied with Pantopaque on request. This is regards to the previously verbal advice by Mrs Stanton/Mr Green and Hughes on the 8th August. He ends his letter by the following…’It is advised that application must be made for permission to distribute this product to any other end user’… . 

You will see later that Hughes completely disregards this instruction.

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I have made a mistake in my assumption regarding the changing of the Acting Assistant to the Director General of Health. I have now realised there are at least 3 acting assistants to the Director General of Health, furthermore, the 3 women may have been secretaries to them. This is clearly how Hughes manipulated the access to these Permits. It seems each were doing what they believed to be ‘right’ but no one was overseeing what was happening as this collective.

On the 8th of October1974 Dr Awrites another letter to Hughes informing him that he has written directly to Lafayette Pharmacal outlining all that is required to obtain marketing approval here in Australia. He also encloses a copy of that letter which will follow.

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I don’t know about you, but I need a break “lets put the jug/kettle on” and have a cuppa, ok.

that’s better

lets continue

Well its not like the TGB wasn’t writing letters to Hughes regarding ‘giving permission’ for him to supply Pantopaque to those specific Hospitals, what wasn’t being addressed by them was in regards to Hughes not only providing the Hospitals without any authority from the TGB [that came later, after he had done so]

As you can see at the bottom of this letter below, TGB ‘again’ notifies Hughes that…’Pantopaque can be supplied only to specific end-users as approved by his Department’… . It’s a shame they didn’t enforce such.

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Below is a letter dated the 23rd of October 1974 from Hughes to the Federal Department of Health informing them that the Australian Agent for PANTOPAQUE has changed from Watson Victor Ltd.(Division of Amyl Chemical Industries) to Cook Incorporated what Hughes had not mentioned to the Department of Health is that HE was the original Agent and STILL was, its just that he had changed jobs (once again) taking the Australian Agency for PANTOPAQUE with him these changing jobs also entailed “paperwork and confusion” at the Dept of Health, this changing of Australian Agency meant the ‘required’ SAFETY data which had been outstanding since 1972 ‘again’ is of secondary importance to the TGB. Hughes is aware of this, it’s a ploy used elsewhere in the world with this chemical. (By Eastman Kodak and Lafayette Pharmacal) Confuse the importing Country stall the ‘required safety data’, ‘transfer ownership/Company who’s importing it by way of the change of Company but keep the ‘same’ Australian Agent in this case Hughes who ‘take’s’ PANTOPAQUE with him as he moves from one Company to another.

Furthermore, it’s a great bargaining chip when applying for a new position.

As you can see in this letter Hughes then requests that access to PANTOPAQUE be increased to TWO MORE Hospitals, ‘Sir Charles Gardiner Hospital in Perth and the Royal Melbourne a continuing exposure of a most dangerous chemical x-ray “dye” slowly starting to spread itself through-out Australia.

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Some weeks have passed until another letter is received this time dated the 28th of November 1974 sent by Hughes  [now at Cook Incorporated which interestedly has been Incorporated in Indiana USA] but this time it was NOT sent as normal to the TGB attention Mrs J Stanton,[or anyone else there] but sent to the to the Department of Health’s via it’s Box Number in Woden in the A.C.T. Hughes makes mention  of the current restriction on Pantopaque being supplied only to approved institutions being :-1. Dr G Shnier, Allendale Hospital in Melbourne.2. Dr H Luke, The Alfred Hospital also in Melbourne. No mention of Epworth Hospital. But Hughes is not finished he wants more sales, so he informs Mrs Stanton [funny how her name keeps popping up] at now [new name] the TGA that two more institutions have now requested supply of Pantopaque. They are (a) Dr J. Glancy, Sir Charles Gardiner Hospital, Perth. (b) Professor W. Hare, Royal Melbourne Hospital.

Well Christmas has arrived and no further correspondence received or sent until the 11th of February 1975 when Hughes visits the TGA and again makes contact with Judy Stanton the first part of this two page TGB note refers to the fact Hughes delivers a B1 submission on Pantopaque  [B1 refers to Product Labels and or Product Inserts] interestedly, it makes mention that no ‘record of this visit’ ever got onto the file. The first page of this TGB note also raises the fact, that …’more data on animal and human toxicity is to be supplied but, pending its arrival could a General Marketing Action Sheet be initiated please…. . At the bottom of this first page one can read the following …’I ‘THINK’ other relevant correspondence from C(PI) files is already on file,’… HE THINKS!!! As you will see this request of General Marketing is about to be approved WITHOUT the required toxicity Sterility data that have been asked for, being provided for now 3 or more years. Once again, she JS requested the required Toxicity, Sterility data to prove the safety of Pantopaque from Hughes, and its NOT that she is unaware that such a request has been falling on deaf ears for all these years,

something is a miss here?

We are NOW in the fifth year of the Changes to the Regulatory requirements for new drugs being enacted, what is going on? For while the TGA wait, more and more people are injected with this far too toxic disabling x-ray dye. Also within this TGA internal note reference is made to a range of matters including the transfer of Pantopaque stock from Amyl or Weston victor.

Here below is that two page TGA internal note.

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As you can also see bottom right [above] there is a reference to the following …’Please raise Marketing Action Sheet and send B1 and NBSL [WHILST THEY STILL DO NOT HAVE THE NDF 3] for comment’… These comments have been added later, on the 18th June 1975 4 months and one week later. So did they receive the toxicity, Sterility Studies finally from Lafayette almost 4 years after first requesting them. I still cant believe that the TGB/A permitted a unknown drug to be injected into patients in this country for years without knowing it was safe.

[And of course now we know it wasn’t safe.]

10 days later the TGA receive a letter from Mr Crocker of Watson and Victor see letter below where they inform them that they had closed down Amyl Division and all stock of Pantopaque has been purchased by Hughes and taken it with him, to his new position as Marketing Manager at Cook Incorporated. [Registered in Indiana USA] Funny why Watson and Victor did not continue selling Pantopaque maybe they got a ‘wiff’ of what was going on, and wished to distance themselves from not on Pantopaque but Hughes himself.EPSON MFP imageOr were all these past “Companies” just fronts for Hughes? Company Records would tell us that, lets take a look shall we?

CompanyRecords [Owner] of ……………….., ………………….,

…………….,   ……………………, to add later

On the 18th of March 1975 Hughes received a letter [see below] from the TGA informing him that …’there are no objections to the supply of “Pantopaque”  to Dr Glancy and Professor Hare on request’… . At the bottom of the letter, the writer, writes the following …’ It is to be noted that “Pantopaque” can only be supplied to specific end users, as approved by this Department. The TGA letter is signed by a PWP? On behalf of A/assist Director – General PB which stands for  Mr P Bohum].

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On the 29th of April 1975 Hughes contacts the TGA requesting 500 boxes [each box consists of 3x3cc ampoule] of Pantopaque 1500 ampoules in total. below is the internal note of that phone call. Within this note there is NO reference to the outstanding NDF 3 data only the B1 data which I mentioned before as the Product Label and Product Insert. The critical data on Pantopaque toxicity, sterility and safety for use on Patients is still outstanding years since first being directed to supply by the TGB/A.

On reading this internal TGA note it seems the TGA believes that Hughes has provided the NDF 3 data.

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Incorrect!

Two further Department of Health TGA Permits for the ‘restricted’ product known as PANTOPAQUE is obtained all within the May period the first is Permit 14440 dated the 1st of May 1975 signed by an E Marlow for 500 boxes 3x3cc, the next Permit 14768 dated signed once again by E Marlow again for another 500 boxes 3x3cc totalling a further 3000 units all these and all others past tense have been signed off by the TGA, without them knowing it was safe to use on patients.

Between these two issued import permits for Pantopaque, [see farther below] a letter arrived at the TGA addressed to Mr Bohum from Hughes [see below] where it refers to the attached copy of the Sterility data on Pantopaque, and a copy of the listed Publications on Pantopaque.

Hughes also hopes this information will assist in the application to market Pantopaque here in Australia.

The problem was, there were NO Sterility data, ONLY data on Labelling and a list of Publications.

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As you can see in this letter Hughes in closing requesting a further 500 boxes of 3x3cc Pantopaque.

My words, I have applied for a copy of this sterility test results to be released in full, as I have help from a friend a Federal Government Senator who has family members that have been injected, I am sure I will get what I have asked for.

So pop back here later its now the 7th of May 2015.

Here are the copies of these two Permits.

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EPSON MFP imageMarlow is another “new” delegate of the Director General of Health, with no idea what has been going on regarding the NDF 3 data requirement. It’s time once again to reinforce the fact, that in 1972 the Australian TGB ONLY initially permitted the use of 150 ampoules [being 50 boxes] of this unlicensed and untested Radiographic Positive Ionic oil base contrast medium called Pantopaque at one Hospital only, the Epworth Hospital for HUMAN EXPERMENTATION.

Over the next 3 years the TGA permitted further supply of this untested and licensed ‘dye’ used in x-ray to 4 other Hospitals 3 in Melbourne and one in Perth.

Again ALL for

HUMAN EXPERMENTATION

A x-ray dye that has yet to be proven as safe to be injected into Humans.

Let me show you how deadly toxic Iophendylate Pantopaque/Myodil was/is,

[Its NOW being sold out of China to destroy another generation, and it must be popular for now there are 3 Factories making it especially for India where a Professor of Neuroradiology there, told me “we only use it on poor, poor people”]

remember this was injected into hundreds of millions of unsuspecting patients across the world for 60 years until 1996. Lets show you a picture of what Pantopaque did when it was poured on this plastic cup and left overnight.

cupThis cup is made out of an inert inert molecule.

Don’t believe me, lets re-watch a mid 90s video clip below where the Reporter pours pantopaque onto this cup and see what happens in just 6 hours that I posted at the beginning of this Blog.

 THEY KNEW WHAT IT WOULD DO TO US, BUT THEY STILL INJECTING INTO OUR SPINE!!!

Click on the link below.

https://youtu.be/EN1ArGBZaKM

On the 18th of June 1975 the TGB sends a copy of Cook Inc General Marketing Application for Pantopaue to the National Biological Standards Laboratory for and I quote…‘This product is subject to regulation 5A (1.)/(3.) of the Customs (prohibited Imports) Regulations’… [it goes on to say ‘next paragraph’] …‘Enclosed for your information/evaluation regarding chemistry, quality control and animal studies are:

WHY ARE THE ANIMAL STUDIES CROSSED OFF?

Please see on this letter reference to… Associated data… where they have written RE: B1 for your evaluation…. There is no reference to Sterility data for evaluation, in fact, the crossing out of animal studies proving that none was provided or submitted by the TGB. Again on the next letter same date sent to the National Biological Standards Laboratory its the same regarding the crossing out of the animal studies, however, where it shows Associated data it lists Stability data (1.) NOT STERILITY DATA and next line Listed Publications (1.) Did they get the Sterility data?

Here is a letter [dated 25th of June 1975] from the NBSL regarding Sections 3.1.1, 3.1.2, 3.1.3, 3.1.4 and 3.1.5 even today the 16/6/2015 the TGB still cannot find them or why the animal studies were crossed off, I will not let up, either I get them or get an explanation before I press for a Federal Government Enquiry.

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Well as you can see below as of the 3rd of November 1976 and 5th of November 1976 regarding the Evaluation Results and Findings the animal studies were crossed out, why was this? I have recently returned from the Australian National Archives where I sighted ALL documents held in the Pantopaque NDF4 file application and NO Animal studies were found, in fact, evidence shows they were NEVER provided to the TGB by Cook Inc.

Oh, yes this took 16 months to evaluate, and in the mean time thousands of patients here in this Country were being injected with this too toxic “dye”.

Here are those two letters.

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Still not Sterility data to ensure Pantopaque was ‘safe’.

Prior to going to the Evaluation Results and Finding by Bernice Bell on behalf of the National Biological Standards Laboratory Hughes is up to his old tricks again, asking for more boxes of Pantopaque as you can see in the TGB internal note dated the 28th of May 1976 again 500 boxes 3 x3cc = another 1500 ‘where did the TGB think all these ampoules were going we have to be up to close to 10,000 units and if you divide this by 9cc which whilst was not the correct dose it by now had become the ‘norm’ being used in this Country.

So, as we are aware only 4 Hospitals have been permitted to use Pantopaque for HUMAN EXPERMINATIONclose to 3350 Myelograms or Diskograms over 4 years, don’t think so, considering 3 of these Hospitals were in Melbourne. As I mentioned earlier, Hughes has been selling Pantopaque ‘illegally’ all over Australia without permission of our Federal Government. If we return to this TGB internal note [see below] you can see Hughes has wore the TGB down within the centre of this note it reads…(‘This is PENDING Marketing Approval being given : NDF 4 submission) Remember they still don’t have the Sterility data.

signed D Thurfall 28/5

Here are those Evaluation Results and Findings

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On the 5th of November 1976 the Director of the TGB writes to Ernie Hughes who now has the title as Assistant Marketing Manager, not Marketing Manager as before, is asked by the TG B Director to comment or take action regarding points raised in the letter. Please note reference to 5. where it states …’The sterility data supplied are unsatisfactory. You should show that the material complies with Section 3.1.2, 3.1.3., 3.1.4., and 3.1.5 of the NDF4.

Here is that Letter below.

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On November 9th 1976 Hughes contact Griggs of Lafayette Pharmacal regarding the 10 questions posed by the Australian National Biological Laboratory based on Cook Inc [Hughes] General Marketing Application.

Below is Lafayette Pharmacal reply on the 24th January 1977.

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Its now the 17th of January 1977 Dr R.W. Temple of the TGB writes a shot letter to Hughes at Cook Inc raising the fact that the TGB forwarded to them issues they had raised regarding their General Marketing Application for Pantopaque here in Australia, asking when a rely will be furnished in respect of the matters raised.

Here is that letter.

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On the 7th of February 1977 Hughes writes to the Australian National Biological Standards Laboratory thanking them for their letters sent on the 5th of November and on the 17th January 1977, interestedly, this letter was sent to Dodson and Temple [once again] apologies for the delay in reply given the reason as being having to wait for Lafayette Pharmacal their supplier.

See letter below.

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Dodson replies [letter not dated but must be after 7th Feb 1977]  asking Hughes who now it seems have become “Australasian Marketing Manager” of Cook Inc to …’comment or take action on the following matters’… being 8 points that they have raised based on their response.

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Hughes answers these 8 points sadly I have NO date, but these responses would have come via Giggs of Lafayette Pharmacal in America. What is of interest to us [sadly this doesn’t seem to be the same for TGB] is their response to number 2. Sterility of Pantopaque. Again, they duck the question on the Sterility of Pantopaque, rather than provide animal and clinical human studies, they provide the Australian National Biological Standards Laboratory ‘the process’ of how such is done.

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It’s time for me to say this,

someone needs to explain to those injected with this illegally accessed too toxic x-ray ‘dye’, why they the TGB knowing the most important data required before any drug was released onto the Australian market,

‘was is it safe’?

So why did the TGB permit it to be obtained so easily, when still awaiting ALL the specific data relating to its ‘toxicity and safety’, being the most important data that showed that all the related animal tests and clinical human trial met our safety requirements to ensure safety to us their citizens.

Why was it the LAST to be sought, don’t you find that quite odd? 

There is NO record that such had ever been provided, I am awaiting further contact regarding such data.

Ok, remember my letter to Australia’s 60 Minutes to a Howard Sacre well here we briefly must return to that letter.

‘Sorry if you again re-read a little of which I shared earlier.

================

Letter continues here…

It’s important Howard to take you back once again to 1969, as you will recall PANTOPAQUE ceased to be imported into Australia from America why was this, one may ask? Again one has to look at the acquired historical documentation. In 1969, as you may recall the American FDA became concerned about the increasing amount of patients getting adverse reactions after receiving PANTOPAQUE, be it in America or around the world. So much so, they informed the Supplier Lafayette Pharmacal that …’arrangements [had] been made’ with the National Academy of Science and the National Research Council to assist [them] in evaluating the evidence of [the] drug’s effectiveness’… this came about because Eastman Kodak/Lafayette had not submitted the required on-going adverse reaction Reports on Pantopaque FOR THE PAST 25 YEARS. sales by that time had extended through-out the world and had reached into the millions. The FDA then wrote to overseas countries to whom Kodak had supplied PANTOPAQUE to, including those receiving PANTOPAQUE under different brand names.

One of these countries was Australia, this took place around the same time as importation of PANTOPQUE STOPPED in Australia.

Soon after the Australian Federal Government Department of Health (the Therapeutic Goods Branch) contacted the Managing Director of the Australian Importer and Agent Ernie Hughes,This letter from the Assistant Director-General of the Federal Dept of health to Hughes requesting him to …’forward distribution figures…[of Pantopaque]…including details of those supplied, from November 1974 to-date… ( why not from 1970,  when the changes took place) they also make mention of the …’limited marketing status of PANTOPAQUE’ under it’s ‘restricted’ use for Human Experimentation only.

Before I continue for we have still a fair way to go, I wish to say this to you,

YES YOU.

Truly reader (s) an Australian Royal Commission is needed to address this, BUT the only way this will happen is if this Blog gains traction, and that can only happen if you play a part. What I want you to do once you have finished reading this, send it to all those you know, some of you have media contacts, or friends of prominent people [distant family members etc] that could help. Contact other CIAA sufferers and their love-ones here in Australia and around the world. I have said time and time again, I cant do this alone.

Has anyone noticed how correspondence between Hughes and the TGB and the NBSL has dwindled, our next letter [seen below] is sent from the Director of the NBSL to the TGB providing them with a copy of Bernice Bells Evaluation of Cook Inc Marketing Application for Pantopaque, no rush only almost two years, and while they drag the chain thousands more are being injected, with as you will see soon dying. Another 5 months pass, its now the 13th of September 1977 with still NO Safety data forthcoming from Hughes and it seems, that the TGB is in no hurry to chase it up either.

However, things were about to change, Dr R. E. Wilson [how many Assistants does a Director General of Health need there seems to be a revolving door at the TGB, no wonder they have no control on what really is going on there] Well the Director of the TGB receives a letter from the FDA Department of Health, Education and Welfare ‘Public Health Service’ where the Director Division of Cology and Radiopharmaceutical Drugs Products Bureau of Drugs a Dr William J Gyarfas M.D. informed Dr Wilson that due to recent reported clinical information concerning contrast media, they were gathering all available information on adverse reactions in the use of iophendylate Pantopaque manufactured in the US by Lafayette Pharmacal and ask that they inform them of any such happening here in Australia.

EPSON MFP imageDr Wilson of the TGB send what is the only record of such adverse reactions reported here in Australia at that time being 4 Pantopaque and 2 Myodil, although thousands exist. However, before I go on, I need to paint a picture of why this is so, its in three parts.

First, there was NO regularity requirements in place here in Australia or in fact many Countries around the world for end-users to report such, at that time the ‘Blue Card’ here in Australia is a voluntary means of doing so, likewise in the UK where its the ‘Yellow Card’ same thing applies.

Two, what end-user would report an adverse reaction if they didn’t have to, and also an end-user would believe that it was THEY that had caused the adverse reaction by an  incorrect procedure. And finally

Three, most [not all] adverse reactions take time to surface, and for 99% of patients this is way after the injection has taken place, whilst they are in pain etc from the reason they had to have the myelogram/diskogram in the first place. Sadly for many they finally find out the cause ‘if they are lucky’ most never do [until now] however, when they do they are ‘Out of Statute’ something these perpetrators rely on in the Courts of the World, however, maybe this evidence of what has been going on will enable one or more countries to act on behalf of their citizens abused this way. Oh, before I forget 95% of ALL patients reporting back pain in the lower back around the L3/4 & L4/5, have a disc bulge in that area. There are NO medical reason for a Myelogram, all good orthopaedic Specialists would be aware of the problem, a bulging disc, more so, the Surgeon. So all of us that had such, ‘there was NO need’, its only done when they suspect a tumour etc. So, as I said, most patients that complain of a burning disabling pain as well as a condition that instead of improving is slowly getting worse, their local GP not being aware of this too toxic  x-ray dye being the cause, would respond saying especially if you have had a later spine operation since the injection, “its normal it takes time to settle” In fact, 99% of end-user, [the diagnostic Radiologist] NEVER gets to know you have a problem that is related to the injected dye, and because of that, this is another reason why NO adverse reaction to it is reported to the TGB. Here below is a copy of that letter sent to the FDA by Dr Wilson of the TGB.

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I have placed here the latest publication of the Product Insert for Pantopaque dated the 3/1/1978 as you can see on page two, 2/3rds down, it reports the sizes of these ampoules being available 3cc, 6cc, & 12cc.

Interestedly, NO FDA safety/toxicity data can be found regarding these increases of dosage from the initial 3cc at NDA License in 1944, for 2.85cc was deemed by the Developer to be the optimal safe dose to use on humans. [>LD 50]

Furthermore, NO FDA related Animal of Human Clinical trials for safety/toxicity and Sterility were requested on these increased dosages to see if any adverse reactions where to be found they relied on the end-users Professsionalism“.

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There was NO follow up by the TGB regarding this enquiry by the FDA, in fact, “its back to business”. I have been unable to find any information regarding any follow up from the TGB with Hughes, or the AMA [Australian Medical Association] or RANZCR [Royal Australian and New Zealand College of Radiology by the TGB especially Wilson.

On the 27th of October 1977 Dr Isaacson from ? [possibly the TGB] providing the answers posed to Hughes of Cook Inc regarding the Sterile Manufacture and Sterility Testing Evaluation of Pantopaque. Based on those responses Dr Isaacson requested  Dr S Walters of the Australian National Biological Standards Laboratory obtain answers to the 5 listed points from Hughes.

Please see that 2 page letter below.

27 10 77a

27 10 77On the 15th of November 1977 Bernice Bell asked Alan ? for his comments regarding the missing toxicity studies [both animal and human clinical trials] which she had sent him with this note, she only makes mention of the pyrogen tests and …‘only mentioned on page 5 of the B1’[interestedly, this B1 and its multiple pages were NOT in the Archive Files held at the Australian National Archives, this also applied to much of the other required NDF4 required documentation, my search started in 2014 today its April 2016 and the Senator responsible for these critical documents Senator Ley in a letter to me states “she cant find them“, as its NOW the responsibility of Senator Nash [TGA] who continues to ‘duck and weave‘ getting a Dr Gill from the TGA to write a ‘fob off letter’ to me, without addressing the issue being ‘where are the Animal and Human Clinical Studies required to License this dye???

Since that time, I have written back to Senator Nash informing her that such a response is unexceptable. Furthermore, after speaking to the Office of the ‘President of the Senate’ [Hon Stephen Parry] I have been asked to ‘put this in writing to him, this also applies to the Attorney General’s Office who also requires ‘the same’. 

Here below is that note to Alan from Bernice Bell, note that she requests he returns the file to Dr Susan Walters. I have made contact with Dr Susan Walters [in fact it was only 9 minutes from sending her a email she rang me] and we have arranged to speak tomorrow being Saturday 20th of June 2015 where I will be asking her about the animal and human clinical trials, not found or the other relevant NDF4 documents. Sadly, I was ‘fobbed off’.

Here is a copy of that note.

15 11 77On the 1st of March 1978 a D. B. Smythe of the Pharmacology Section of the TGB sent the following letter to the Director of the NBSL regarding the Pyrogen testing where he recommends the following …‘The applicant should be requested to state the dose used in the pyrogen test. This request need not delay general marketing approval’

[This is very disturbing, my words]

1 3 78

What is very interesting is the following which you have read in the above letter, where it states the following …’The USP monograph for Iophendylate Injection does not require a pyrogen test’… How did Eastman Kodak arranged such an omission from the USP monograph for Iophendylate goes a long way enabling Iophendylate Pantopaque to “slip through the FDA NDA”, and destroy millions of lives worldwide.

The next letter that one finds is a letter from the Australian National Biological Standards Laboratory to the TGB dated the 11th of April 1978 providing them with a copy of Denice Bells Evaluation of Pantopaue where it CLEARLY points out that they are concerned. They further go one to say …’General Marketing is not recommended until satisfactory replies are received to points 1 to 5, 7 and 8 in the latest letter to the company’… signed by L.F. Dodson Director. It also refers to ‘Limited Access’ of Pantopaque and the reasons why…’Sterility data’ still outstanding’….

No mention regarding the ‘outstanding’ Animal and Human Clinical Studies the most critical requirement of any Application for a General Marketing License.

See a copy of this letter below.

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Attached to that letter, the TGB sends a 2 page letter [see below] to Hughes at Cook Inc requesting further information regarding the 8 listed points they have raised.

here is that 2 page letter.

11 4 78

11 4 78a

Our next correspondence is dated the 10th of May 1978 where the TGB writes to Cook Incorporated in regards to the chemistry and quality control evaluation evaluation of Pantopaque 3ml and 6ml. He also reinforces the limited status of Pantopaque has been granted while evaluation is continuing. [Now in its 6th year] The TGB then asks ..’you are requested to forward distribution figures, including details of those supplied, from November to date’… .

As you can see, this letter has put in place a problem for Hughes for as I have shared with you whilst the TGB believes Hughes has been supplying just 4 Hospital 3 in Victoria and 1 in Western Australia, he’s been selling it throughout Australia.

Here is that letter.

EPSON MFP imageIn reply Hughes sends a letter with an attachment a list of Hospitals and Medical Institutions that he as the Australian Agent had supplied PANTOPAQUE to, this follows his letter. This list is self explanatory, but what it shows is the complete disregard to human safety by Hughes and Eastman Kodak/Lafayette Pharmacal of my fellow Australian citizens through-out the Commonwealth. In all 9899 units of Pantopaque was sold here in this country between 1974 and 1979 a total far outreaching the agreed initial ‘one off’ delivery of 150 x 3 units.

EPSON MFP imageI decided to place below a copy of Hughes list of Hospitals and Medical Institutions including the names of the of Doctors working in private practise that he as the Australian Agent had supplied PANTOPAQUE to, you will see it consists of 15 pages.

I initially placed them in 3 groups of 5 but you were unable to read so I have had to place them individually.

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Total end-users based on product/units sold [remember they came in packs of 3] runs into the thousands throughout Australia.

In NSW the total Patients injected with this too toxic substance known as Pantopaque between 1974 and 1978 was 3507.

In Victoria the total Patients injected with this too toxic substance known as Pantopaque between 1974 and 1978 was 2559.

In WA the total Patients injected with this too toxic substance known as Pantopaque between 1974 and 1978 was 1978.

In Tasmania the total Patients injected with this too toxic substance known as Pantopaque between 1974 and 1978 was 213.

In Qld the total Patients injected with this too toxic substance known as Pantopaque between 1974 and 1978 was 488.

In ACT the total Patients injected with this too toxic substance known as Pantopaque between 1974 and 1978 was 636.

Just in passing, these totals were reported to be over a four year period what is noticeable is how high the ACT is in comparison to the other States.

Please do not disregard the enormity of those abused by this too toxic “dye”

So, as you can see, Hughes accessed

13,500 boxes of Pntopaque which is 40,500 3cc ampoules!!!

this is disgusting, in fact it’s criminal and the TGB/A also needs to be held accountable, but as I said on more than one occasion ‘no one cares’ especially our Federal Government and their representatives our MPs and Senators.

Between 1944 and 1992 close to a million Australians were injected with Iophendylate.

The next piece of information I have been able to access is an TGB internal memo/note dated the 22nd of June 1978 which is damning to say the least, its self explanatory however will touch on what I believe ‘show’s how the TGB was going through the motions, with multiple staff members all having an involvement in the Pantopaque debacle. It seems whilst multiple staff members were involved, no one was overseeing ‘due process’, [for if there was, they need to be held accountable] for such is clearly seen when one reads the memo. The first line explains the lack of knowledge of when Pantopaque was first used here, it is reported to be 1967 when in fact it was 1952. The last paragraph, regarding Hughes’s abuse of regulatory requirements laid down by the TGB on behalf of the Australian Federal government, is clearly known by this stage BUT instead of taking action (Federal Police etc] it is suggested that …’we just let matters be‘…. which makes them complicit. Here is that paragraph in full  …’Dr Wilson, although NBSL have no objection to continue conditional marketing, they have ?? ??? …..[it looks like …‘no get’…, but does not flow grammatically] ….been able to recommend marketing approval’… .

…’Do you wish that the [word missing] to be asked to explain this expanded distribution OR SHOULD WE JUST LET MATTERS BE?’… .

The next day the person [Dr Wilson presumably] pens a short answer which you can see bottom left of this memo, where he writes the following …’Les, have the outstanding matters relating mainly to sterility and death, its reasonable to ask for an explanation’ [he then initials and dates it]

Ok, lets move on, its now the 28th of June 1978 [see letter below] and the TGB NOW realises what Hughes has been up to, due to TGB incompetence. In fact, as you will see soon people are now dying after being injected with Pantopaque.

The TGB in this letter asks Hughes to explain the enormity of this abuse but NOT a hearing to the Federal Governments instruction regarding ‘Restricted Marketing’ to the 4 Hospitals approved for ‘Human Experimentation’. …’The distribution list supplied with your letter of the 16th of May 1978 shows that Pantopaque has not been restricted to the ‘approved end users’ but, apparently has been supplied to all parts of the commonwealth. Your urgent explanation of this unauthorised distribution of Pantopaque is requested’… .

[As you can see the TGB blacked out this area, but I was able to raise the words]

QUESTION

 [My words, were they blind, 40,500 ampoules released by the TGB that’s over 10,000 per Hospital “lot of bad backs it seems in Melbourne” who was keeping stock of what was being released??? No one it seems.] 

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The next piece of evidence shows how the TGB reacts once becoming aware of Hughes breach by NOT following the Federal Government Regulatory Guidelines regarding the restriction on the marketing of Pantopaque. Did they take affirmative action, by notifying the Federal Police, and all end-users other than the 4 hospitals permitted to use it for Human Experimentation. Nope!

Those responsible need to be held accountable.

For it shows how the continuous ‘changing of staff’ at TGB within this specific office, has led to 10 thousand or more people being injured by this unproven to be safe x-ray dye between 1974 and 1978. In fact, over the lifetime of Pantopaque being used in this Country [1952 – 1996 when ALCON ceased production] there isn’t a true figure but over 44 years Australia wide it must run close to a million people that have been injected and injured [could be more] and thousands that have died as a consequence. Please note, this Blog is regarding Pantopaque sold in Australia, NOT Myodil from Great Britian however, as Myodil was also sold here in fact, on a far greater percentage between 1946 – 1991.       I am sure most death certificates have NO mention of the dye being the cause, for most died later from “complications” of surgery, remember many went on to have a Laminectomy [spine operation, brain surgery and the like] Yes, this continuous changing of staff at the TGB and the lack of accountability and oversight, is clearly seen.

Unbelievable

At the same time as this had been happening here in Australia with some patients dying the same had been going on in America and around the world. The FDA after allowing this too toxic substance on the World market for 25 years ‘unchecked’ decided to investigate Pantopaque.

Once they received the DESI Report on Pantopaque safety, INSTEAD OF A WORLD RECALL and quickly notifying all concerned especially the World Health Organisation all they did was to get the wording of the Product Inserts changed, whilst these changes are most welcome, this “dye” should never be on the world market in the first place.

I have placed below a copy of those changes for you.

DESIWhilst this information or should I say Direction is mainly in regards to the ‘restrictions’ place on it by Kodak around Patent, it does show that the current Product Inserts at that time, were ‘misleading to say the least‘, and these directions by the FDA went someway in the reinforcement of the NEED to aspirate due to such risks, something ignored by Glaxo and the end-users of Myodil and others around the world. This reason for such disregard of the need to aspirate, was promoted by the British and European “Expert” Professor William Bull who believed it was not only safe to leave it in the patient’s body, giving  the following reason,…’well it saves the patient being injected again’,... [see his MJA on Myelography below] with NO evidence that such was safe to leave in the body, oh, he was a consultant of Glaxo ‘funny that’, eh.

BULL MJA ‘Myelography’ front page.

Full MJA as a PDF.

Lets back up a minute, for I wish to share with you the reader some recent undiscovered facts that go to the heart of what happened. These facts are disturbing, for they are regarding those who worked at Lafayette Pharmacal prior to the Company being bought by ALCON, at NO time were the any medically trained staff at the Company this didn’t happen until much later after ALCON purchased the Company. In fact, those that worked there other than factory hands had only Pharmacy Qualifications, without ANY knowledge of Pharmacology, a critical requirement in such an operation.

These two professions are very different as you can see below.

A pharmaceutical Scientist is an expert in the science related to the development of drugs – how drugs work, how safe and effective pharmaceuticals are taken to market, their impact on the body and their effect on the treatment of disease.

A pharmacist dispenses medicines, provides advice and manages a patient’s medication requirements.

Seen below is a Lafayette Pharmacal document that list its ‘key’ personnel and their responsibilities, dated May 1974. 4 years before they sold to ALCON.

1 5 74bIt’s quite clear by now that these “key” personnel at Lafayette Pharmacal had NO idea, all they were doing was receiving the one Gallon brown glass bottles from Eastman Kodak full of Pantopaque with or without the 30% iodine. I could find out who was purchasing the iodine wouldn’t be too difficult, Kodak of Lafayette? For whoever, the amount would have been massive, and ongoing for decades.

As you can see whilst they were having serious trouble with Pantopaque in America  [see below, page 1 missing]

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WAIT A MINUTE

DIDN’T HUGHES REQUEST IMPORTATION INTO AUSTRALIA OF PANTOPAQUE, BECAUSE MYODIL WAS CONTAMINATED???

AT THE SAME TIME AS PANTOPAQUE WAS BEING TESTED IN AMERICA FOR CONTAMINATION TOO?

THE TGB APPROVES SUCH AND LAFAYETTE PHARMACAL EXPORTS PANTOPAQUE TO AUSTRALIA. SEE BELOW AT HOSPITAL ADVERSE REACTION REPORT SUSPECTING ALPHA HEMOLYTIC GRAM POSITIVE COCI LEADING TO MENINGITIS THIS TOOK PLACE ON THE 12TH OF MAY 1978.

[Remember America puts their month first and day second the opposite to many other countries including us.]

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ON THE 20TH OF JUNE 1978 AN AUSTRALIAN RETURN SOLIDER DIES AT THE HEIDELBERG REPATRIATION HOSPITAL IN VICTORIA AFTER BEING INJECTED WITH PANTOPAQUE.

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Further details regarding this return soldier death further into this Blog.

To-date this death and it’s true cause sits in the Victorian Coroners Office still ‘open’. His family still unaware of the ‘truth’, the truth it seems no one’s interested in, except the writer of this brief, whom has tried for the last year to get answers.

On the 1st of August 1978 the Director of the NBSL writes to Hughes at Cook Inc requestion advice and comments concerning them awaiting a reply from their suppliers being Lafayette Pharmacal here below is a copy of that letter. tp Hughes sends a letter to the Department of Health apologies for the delay he had been overseas [possibly in America where he would be very much aware of Pantopaque contamination] he then tries to justify the supply of Pantopaque Australia wide, by blames such on a NOW x employee BUT it was he that collected or obtained many of the Permits and clearly written on them were ‘Restricted Marketing’.

EPSON MFP imageOn the 3rd of August 1978 Ernie Hughes of Cook Inc writes to Griggs at Lafayette Pharmacal enquirying about his letter sent in April 16 weeks earlier. It seems no one is in a hurry, especially the TGB they just keep issuing Import Permits as and when Hughes wants them, and no one it seems at the TGB is overseeing this. 3 8 78a 3 8 78

On the 22nd of August 1978 the TGB replies to Hughes Letter of the 2nd 3 weeks earlier [no rush here] where Hughes if you remember blames an x employee for the distribution of Pantopaque to all corners of Australia disregarding the Safety and toxicity data request of the TGB. REMEMBER the Sterility as well as the safety and toxicity data is still OUTSTANDING and its NOW 6 years. I have no words to express my outrage at this, it’s unbelievable.

Between 1972 and 1978 nearly 10,000 fellow Australians were exposed to this, not only illegal but untested x-ray “dye”. However, one ‘MUST GRASP’ this is only a snapshot of what has been going on, remember Iophendylate Pantopaque and its Glaxo copy has be used in this country on unsuspecting Patients for 52 years, [1944 to 1996] unbelievable.

No wonder they want this covered up. 

Read this letter carefully, [its someway down] the Federal Government disregards the ‘horrific’ consequences to those exposed to Pantopaque, because of the …’apparent PAUCITY of adverse reactions reported’… . BUT remember, there is NO mechanism in place or Regulatory requirement for end-users to report any adverse reactions as I explained earlier.

[2 DEATHS REPORTED, BELIEVE TO BE MANY MANY MORE, AND SUCH DOESN’T COUNT???]

The question I ask once again, is ‘what end-user’ is going to report an adverse reaction to a chemical which was illegally used by them between 1972 and 1979, the answer is none!

Within this letter is a further alarming decision, remember the restricted 4 Hospitals that the TGB permitted Hughes to supply for ‘HUMAN EXPERIMENTATION’, well as you can see in this letter ‘by a stroke of a pen’ the TGB gives Hughes …’Approval to continue to supply those who have previously BEEN SUPPLIED ‘ILLEGALLY’ IS [NOW] GRANTED’…

Which is NOW all, not just the 4 Hospitals but the 72 Hospitals Public and Private, X-ray Centres, private doctors practises and Government Stores throughout Australia, unbelievable.   

The letter closes off with the following…’It would however be appreciated if efforts to resolve the outstanding sterility matters could be undertaken (if not already done)’… Where are the required safety and toxicity data thats been asked for 6 years.

[this shows the state of control by the TGB regarding, ‘Regulatory oversight’)

Shame on you TGB.

Here is that letter below.

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The next correspondence was from Hughes of Cook Incorporated to the Department of Health, the letter is dated the 25th of August 1978 and he thanks the TGB for their “considerate letter” of the 22nd of August 1978 in relation to Pantopaque. He then informs them that in due course he would be travelling to the US [in September] and that he would endeavour” to obtain the information they require [now in its 6th year] and also the latest product information. He then informed them that he would provide them on his return.

As you read all these letters between Hughes and the TGB it seems that Hughes is in control, NOT the TGB!!!

This cannot happen without help’ within the TGB, JS comes to mind.

Its now the 12th of September 1978 and the next letter found was from Griggs at Lafayette Pharmacal to Hughes, again, saying they are “sorry” for the delay [yep, 6 years delay] but goes on to say he has enclosed the information necessary for him to answer questions from the Department of Health…[TGB]… regarding the marketing of Pantopaque in Australia.This letter is below

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After Hughes receives Griggs letter from Lafayette Pharmacal in America ‘he waits a month’ before he sends the letter dated 10th October 1978 below to the Director of the National Biological Standards Laboratory. He writes…’Dear Sir, Attached please find copy of letter and information requested from Lafayette Pharamcal in reference to your letter of 11th of April 1978… .

Here is that letter

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Next is an interesting twist of affairs, we have two letters [see below] from the TGB to Hughes in response to Hughes letter of the 16th of October 1978, the first letter was written 3 weeks later on the 6th of November 1978 the second letter on the 11th of January 1979 the contents are identical and written by the same person at the TGB being …’would you please advise when the information and product information requested by the Department’s letter of 22 August 1978 may be forthcoming’… These 2 letters may be due to the TGB being in shock due to a reported Pantopaque death two days after they sent the first letter. I am sure the TGB are now at a heighten level of concern, “for they have been permitting a drug that they have NO idea is safe, loose on the general public across Australia”. Furthermore, evidence now available shows that Glaxo GB has publically stated that they have …’no idea of the chemical mix of Myodil’… So, today it can been seen that this dye was fraudently submitted to the American FDA to gain a General Marketing License it was then sold around the world. Australia like elsewhere never received the requested safety and toxicity data to the Australian Regulatory. This behaviour was ‘mirrored’ by Glaxo UK and since that time the FDA and the British Government Regulatory  now known today as the MMHRA have denied access to data that should be available to the general public.

See these two letters they follow each other.

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 Whilst I seem to be repeating myself ‘time and time’ again, how many of these letters have been written in the past requesting the same, it goes back to 1972.

On the 13th of November between those two [same] letters above a Australian Department of Health internal memo records the death of a Return Soldier after being injected with Pantopaque medical notes which I will post later mentions he died 30 minutes after being injected. When I read these medical notes, at first I didn’t understand one said 30 minutes another 6 days later, then I realised two people died not one see on this internal memo right at the bottom. I will not re-write the contents of the internal memo as it is self explanatory however, I have decided to write here that which has been penned at the bottom. …’Mike, please advise U.S.A. authorities further to f 47 – 48 that a FURTHER … [I put this word in capitals]...adverse reaction of meningitis leading to death has recently been reported following the injection of Pantopaque. This penned note was dated 9 days later being 22/11/78’… .

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EPSON MFP imagePlease see below five internal Medical records regarding this death its also dated the 13th and 15th of November 1978. The first medical record [13th] outlines the dye used, being Pantopaque with “possible batch number” for they really don’t know which one it was, batch 31237 or 101137. Its reported later that NO record is kept of which batch is used at most hospitals, so checking on relationship to cause is not possible. It also states that the rest of the two batches were sent to NBSL [National Biological Standards Laboratories in Canberra.] It is also recorded within this Medical record that the Forensic Department of the Victorian Police Force were notified. These batches were ordered on the 14th of November 1978, but were manufactured in 1977.

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This is critical, above the Doctor reports the patient dies 30 minutes after receiving the injection. Later below you will see the its later reported that the patient died 5 to 6 days later, and more to the point its reported the patient had an angiogram after the myelogram, which is it? Furthermore, you will read that the same Hospital reports that the DO NOT have any of the specific Batch of Pantopaque left, and that Canberra Hospital has some of the same batch there. The question is, did the samples tested come from the specific Hospital where the patients died or DID IT come from Canberra Hospital, which is a breach of protocol due to the fact Canberra Hospital storage of Pantopaque etc may have been different to that of Heidelberg Repatriation Hospital in Melbourne Victoria.

 I also obtained a copy of a letter from the Doctor at The Heidelberg Repatriation Hospital and their Pantopaque Stock Card for that period. Sadly its small, so enlarging it, it blurs so left as is, if YOU enlarge on your computer by sliding the bar, its fine.

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Whilst the Hospital and the Victorian Department of Health are gathering evidence regarding this death, I have been able to obtain a copy of the TGB internal memo of the Federal Department of Heath [TGB] who have documented the ‘steps’ that have been so far taken by the Hospital, for instance contacting the Veteran Affairs as this person that died was a return soldier. Within this 5 page memo, one can see they have no idea which batch cased this mans death. Sadly, due to their ignorance of the risk of exposing the patient to ‘MORE IODINE’ via an angiogram [Iodine based] a possible mixing of such if the Pantopaque entered the blood system at the myelogram which would lead to a high risk of death.

Here is that memo

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I have NOW been provided with a clear copy without the blacked out sections, will post soon.On the 24th of November 1978 [See Letter below] the TGB notifies Dr Gyarfas of the FDA of the death of the return soldier here in Australia giving the cause as a consequence of meningitis after an injection of Pantopaque.I obtained a copy of Dr Gyarfas letter received from the TGB from the FDA please note its the second of these two letters, please also note the date being the 8th of December [remember US puts the month first] but not only the date BUT he has circled the word Pantopaque.

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A day later on the 9th of January 1979 [See Letter below] a Hospital in America contacts Lafayette Pharmacal informing them that a Patient at their Hospital has died after being injected with Pantopaque. [Batch [lot] Number of #71398 with a expiry date of July 1983.]If one was to check if ‘any Pantopaque deaths’ has taken place also in other countries I am sure a similar outcome would be found. Is also important to once again remind you the reader that Alcon was like Lafayette Pharmacal and Estman Kodak they also never reported these deaths to the FDA.

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Its now the 2nd of January 1979 [see letter below] and the TGB have now been asking Ernie Hughes to provide them the Sterility/Safety/Toxicity data for Iophendylate Pantopaque for the past seven years. However, Hughes has continued to stall them and with NO enforcement by the TGB for these critical safety data, thousands of patients here in this Country have been injured and some killed.

This letter is from Hughes to the TGB apologising for the delay in responding to a letter they had sent him on the 6th of November 2 months earlier. He makes mention that he did provide to B.S. a copy of the response he received from Lafayette Pharmacal and attaching the required information they required. In fact, if you remember he provided everything the TGB asked for, BUT the sterility data. Hughes also makes mention within this letter that “it must have gone astray in the mail“, and informs them that he has provided another copy of that data with this letter.

See the note added at the bottom right of this letter which is dated the 2nd of March 1979 [another 2 months have passed] where the author writes …’Mike, please check for this advice, however, request of copy of ??? info which has not been provided, as requested’… . 

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 Remember I mentioned earlier that the TGB wrote to Hughes on the 6th of November 1978 and shared with you that the same letter was ‘again’ sent on the 11th of January 1979.

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One can wonder why the TGB sent the same letter twice, the second 9 weeks after the first maybe the got wind of the reported deaths happening also in America. See the letter below dated the 9th of January 1979 from a Doctor to Lafayette Pharmacal.

9 jan 79On the 15th of January 1979 the NBSL issued two Certificate of Official Analyst for sample 31237 and 101137 being of 3ml ampoules each. Interestedly, the samples tested …’were taken from Cook Incorporated Surry Hills, Victoria’… which is a bit confusing considering the Hospital reported using 6ml ampoule and they had NONE of the specific batch left, to which they suggested that Canberra Hospital had some, so exactly were did these samples come from?

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I have decided to once again place a copy of the Adverse Drug Reactions System [below] where the reporting of the Return Soldier is recorded. As you can see, it recorded using 9ml however, the Doctors notes/report posted elsewhere show they used multiple 6ml ampoules

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On the 22nd of January 1979 a letter is sent to the TGB from the NBSL [Dr L.F. Dodson] regarding the testing of the two samples provided to them by the Heidelberg Repatriation Hospital [Dr Rose] they inform the TGB that all PASS. [ed] see below. Interestedly, if you cast your eyes to the bottom of this letter you will see an added note from the Director of the NBSL its dated 17/5/79  …’Dr Temple, Phoned Paul Bohum (TGB) on 16/5/79 and ???????? him with this knowledge that evidence would more than likely be required at the Coroner Inquest to be held soon. After informing Mr Bohum informed me that advise had been sent to Dept of Veterans’ Affairs Canberra but he would contact them on the impending inquest’… .

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At the same time [22nd January 1979] another related death takes place in America.

Below is a certified letter arrived from a Richard A. Hamer Lafayette Pharmacal Division of Alcon Laboratories, Inc landing in the Document Control Room #17B-34 Division of Oncology and Radiopharmaceutical Drug Products Bureau of Drugs (HFD-1500 at the FDA regarding the reporting the death of a patient following a myelogram with Pantopaque at [the rest has been blanked out]

22 1 79aThree weeks later a further certified letter arrives this time dated 12th of February] once again from Richard A. Hamer of Lafayette Pharmacal Division of Alcon Laboratories, Inc landing in the Document Control Room #17B-34 Division of Oncology and Radiopharmaceutical Drug Products Buteau of Drugs (HFD-1500 at the FDA notifying them that the ‘retention sample and field sample’ of Pantopaque Lot 71398 where they were found to be within USP specifications.

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What should be seriously investigated is the Laboratory that Lafayette Pharmacal used to test these samples, the Laboratory was Alcons own Laboratory.

I  have been able to access an internal note of the NBSL dated the 12/2/79 where a B Clancy asks a Dr Pomeroy to …‘comment on the company’s reply to Q6 of the letter of the 11/4/78 (f 23 and 30)… .

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Four days later on the 16th of February a Dr D. B. Smythe wrote to the Director of the NBSL in regards to item 6 of folio 23 referred to above being Pyrogen testing stating …‘The dose used in the pyrogen test is satisfactory’… .

See that letter here

16 2 79On the 6th of March 1979 [see letter below] The Australian National Biological Standards Laboratory notifies the Assistant Director – General of Health in writing that attached to this letter …’is a copy of correspondence between N.B.S.L and the company’… [being Cook Inc]…’concerning chemistry and quality control aspects of the product’…[Pantopaque]…’The company has indicated that the current U.S. package label could be modified by the addition of an adhesive strip carrying the instruction “Store below 30°C”.This is acceptable and the company should be advised as such’…’There are no further objections in respect of chemistry and quality control to general marketing approval… 

                         THE SAFETY & TOXICITY DATA IS STILL OUTSTANDING.

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On the 8th of March 1979 the TGB writes to Hughes at Cook Incorporated …’thanking him for his letter of the 2nd of January 1979 and for the enclosed advice from Lafayette Pharmacal Inc. The then asks Hughes to forward duplicate copies of the current product information as requested in my letter of 22nd of August 1978 (reference 74/7863)’… . When I refer back to that letter of the 22nd of August 1978, one can see two critical points, the second one refers to a further requesting of the SAFETY DATA STILL OUTSTANDING. The first, higher up in the letter is in reference to the illegal marketing of Pantopaque throughout the Country but because of the  …’apparent PAUCITY of adverse reactions reported.

On the 16th of March 1979 Hughes responds to the TGB letter of the 8th of March regarding their request for duplicate copies of all that is sent to them from Lafayette Pharmacal.  Hughes also “resends” the response from Lafayette Pharmacal where they addressed the 8 points the TGB asked them for. When we look at these 8 responses its quite clear that in regards to number 2 the Sterility data whilst the TGB requires the evidence that Pantopaque is safe, and the multi-Animal and Human clinical studies results and supporting data will do that. However instead of Lafayette Pharmacal and Hughes providing this, they sent ‘how the Sterility tests are carried out, ‘the Protocol’ how the test is done, NOT its outcome. This also applies regarding the pyrogen test on Rabbits, number 6 in their response. Well we know the results of the Rabbit tests carried out initially in 1941 and again in 1969, [I placed a few pages of both of these two tests on the blog earlier] and they were as you saw, horrific.

Below, is Hughes letter and the two page 8 point response from Lafayette Pharmacal

garding Pantopaque safety.

 

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A month later PANTOPAQUE was ‘officially’ Licensed by the Australian Federal Government Department of Health (Therapeutic Goods Branch) for General Marketing. What is concerning is that this chemical has now been proven to be TOO TOXIC FOR HUMAN USE so how did the TGB arrive at the point of approval, being safe that is, without the Safety/Toxicity Data?

On the 4th of October 1979 David Marlow  [TGA] pen’s a note on ‘Pantopaque which I believe is ‘just for the record’ he writes’  …’The product information appears to be reasonably presented and due ???? given to the hazards of ??? It is after all a minor surgical procedure and would only be used by those familiar with the technique of Myelography. My only comment is that the address of the distributor should be shown on the P.L’… . [My words P.L. possibly stands for product literature]

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On the 8th of October [see below] the TGB issues Cook Inc [Hughes] a 2 year Import Permit [No 35602] until 31st of October 1981 to import Pantopaque and supply Australia wide to anyone that would buy it.

    HOLD ON, ISN’T THAT WHAT HUGHES HAS BEEN DOING FOR THE PAST 9+ YEARS WITHOUT AUTHORITY!!!

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On the 9th of October 1979 the Therapeutic Goods branch sent a letter to the Managing Director [Hughes] informing him that the TGB …’there is now no objection to the general marketing of Pantopaque, iophendylate injection, for use as a contrast medium in myelography. A permit to enable importation on a continuing basis is enclosed’… They do on to say…’This approval is given on condition that –

(a) all reports of suspected adverse reaction or related experience are to be provided immediately on receipt;

(b) any proposed changes to the chemistry and quality control details are to be forwarded for approval prior to implementation;

(c) any proposed amendment to the product information are to be forwarded for approval prior to distribution.

At the bottom of this letter to the right you can see the following which has been added by pen. It says… Note: this product has been restricted in Aust, for some years. Data requested on change of distributors & L/A have been issued. Bi1 & prior info now ????’… [word unable to make out its either clear or done]  this penned note is dated 8/10/79.

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I now return to my letter sent to Howard Sacre Australia 60 Minutes 16 years ago. 

Howard, I have only ‘touched’ on what is a story that ‘needs’ exposing, the Australian part of this brief can be repeated in 107+ Countries through-out the World, no wonder the societal health costs are out of control here and around the world, especially in America. Interestedly, guess who owns the patents or ‘rights’ for drugs to treat the millions abuse yes, correct the same manufacturer of this x-ray “dye”.

It’s now up to you with my help, to expose this.

Yes, through-out the World as well as here in Australia the increase of those suffering physical and neurological disabilities have been for many ’caused’ rather than ‘God Given’. I have shared with you how, I have also share with you ‘a little’ of my documented evidence collated. (Full-time) I’ve even given you the perpetrators. Yes, Eastman Kodak and their products have not only left their mark through-out the World wherever one looks. But Company profits have not been gained by film, cameras or X-ray dental plates alone, there’s a more sinister side to the ‘profit’ making of Eastman Kodak one of ‘tremendous’ cost of human suffering through-out the world today.

I await contact

SIGNED BY MYSELF

Derek Morrison BCW. ADCW. CTE. ATSUM. AWT.

****************

Whilst this is where I finished the letter to Australia 60 Minutes, I have added a few more damning pieces of evidence of the mis-management by those we put our trust in, the TGA, or at that time the TGB and other related parties.

The following is an internal memo from the TGB [Date unknown] where it shows the author has limited knowledge of the History of Pantopaque and its Application for General Marketing. This can be seen at the beginning where they write …’Files are sketchy Both products grandfathered 1970’… Now this is interesting, if one wished to be suspicious one could surmise that anyone reading this internal TGB memo/note would have NO reason to dwell or investigate into Pantopaque History removing any possible knowledge by the reader that NO SAFETY/TOXICITY DATA was ever received by the TGB for this too toxic deadly substance known as Pantopaque.

The rest I will let you read other than to mention ‘the last line written. …’unable to say when first introduced’…

This once again shows the lack of awareness of the author that has truly happened and the harm such has caused to close to so many Australians  between 1944 and 1987.

Seems to have been removed ‘interesting’!!! Will replace

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This Blog is about Pantopaque in Australia and NOT Myodil the SAME chemical formula Iophendylate but manufactured by Glaxo in Great Britain, which was also sold here over the same period and WAS Grandfathered’ so it wasn’t monitored. Well lets be honest NOR was Pantopaque.

This story needs someone to investigate it legally.

BUT I believe such will not happen.

Our Australian Government have as much to lose as the TGB, so with the medical profession’s help they have buried it.

But ‘not deep enough, eh’.

Its now 1980 and for the next 6 YEARS no regulatory oversight takes place by the TGB regarding the Marketing of Iophendylate Pantopaque here in Australia. They, the TGB are naturally aware of the adverse reactions that have taken place in the past, they are fully aware they NEVER received the Safety/Toxicity data on Iophendylate Pantopaque and they are also aware of the related deaths here in Australia, in America and throughout the World due to Iophendylate Pantopaque injection, so what has been going on.

Well on checking it seems nothing has been going on, NO such oversight took place, this also applied to Myodil being the same chemical formula, and people if it was happening to patients being injected with Pantopaque it was surely happening with patients being injected with Myodil.

I know, for I am one of those Myodil patients.

Its now 1986, months away from Pantopaque and Myodil being removed from the Australian market, the reason, it is my contention that prior to being granted a General Marketing License they really couldn’t be held accountable for a substance being used for ‘HUMAN EXPERMINTATION however, once they gained general marketing permission, they were.

Between the time ALCON purchased the ‘Rights’ of Pantopaque in 1978, and when they surrendered Pantopaque License to the FDA in 1996 [18 years] many many people across the world including Australia had became seriously disabled and in horrendous pain others sadly, died.

At the end of this blog, I will give you an overview of these 18 years of ALCON marketing of Pantopaque, their lack of notifying the FDA of reported ‘adverse reaction’ to Pantopaque, and their FDA Fine. I will also list the enormity of these adverse reactions later recorded by ………………………………………[place correct name] this section will be very large and may have to do a separate blog due to the evidence gathered.

——  —  ——

Lets continue

On the 16th of July 1986 [see below] a Dr M.M. Kehoe from the Australian Commonwealth Department of Veterans Affairs writes to the Chief Commonwealth Medical Officer at the Department of Health a Dr D. de Souza informing him he has attached some papers sent to them from an Attorney in America. These papers were regarding a court case he was involved with regarding a patient that had died after an injection of Pantopaque, and wished to know more of the return soldier that had died here in Australia also from an injection of Pantopaque. Dr M.M. Kehoe goes on to discuss this further in the letter and closes off by inviting Dr D. de Souze to join their discussion particularly with their FAS Legal Services. At the bottom of this letter he pens a short note to a Dr Donovan where he writes …’Please give this matter your urgent attention after consultation with Legal Services Branch and advise Dr Kehoe of an appropriate contact officer (eg: yourself). So far as I can assertion our role was essentially the testing by NBSL of certain batches/batch of Pantopaque.’…

This note was initialled by ? and dated 16/7/1986. 

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Interestedly I came across the following, its a internal note from ? [Just an initial] possibly from the DOH written 2 days later on the 18th of July 1986 its written by Dr Donovan to a Dr Coller [I think] where he writes the following …’Please extract all relevant filo’s, have filo’s identified and pass on to Legal Services. They are NOT to be returned to DVA without their agreement on them its obviously a question of wether we should be involved ourselves at all. Please also arrange for whomever extracts these records, to be identified to Dr Kehoe (6719)’… .

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Again, I am able to obtain an internal memo dated this time on the 31st of July 1986 again I believe from the DOH the writer is unknown has only an initial prior to the date at the bottom. It states …’Dr Kehoe has agreed to release filo’s their point of view is that the test was requested by a Repatriation Hospital. Dr Kehoe stated they will be identifying by letter that tests were done but will not be releasing personal data other than public documents eg: coroners report.  As the letter from the solicitor/attorney is addressed to the DOH it is our responsibility to respond. I would recommend a letter be sent indicating the samples tested and the results. Draft letter attention for John Castle’…  

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Well its now 1987 and both Pantopaque and Myodil have ceased being available here in Australia, reason for Pantopaque well that’s quite obvious, ALCON had no choice but cease manufacturing Pantopaque. ALCON believed that in time, ‘things would settle’ and it would be back to Business, wrong it maybe almost 30 years later BUT you have to answer for your part in this, [1978 – 1991]

Likewise, Myodil ceased being sold here and in GB as well, but continued to be sold elsewhere in the world. A question which has always puzzled me is the reason given by Glaxo, saying that Myodil was stopped being imported into Australia and New Zealand as well as being distributed in Britain as it had been “superseded” by other dyes. Its funny how both ceased being manufactured at the same time, but are ‘separate’ Companies. Maybe Kodak withdrew iophendylate because they were having trouble with the iophendylate portion of the formulation and this led to the suspension of manufacture, well that’s what the suppliers were tell the Australian users.

ONLY took them 43 years.

However, Australia isn’t finished using Iophendylate, although now not available here  the following has a ‘familiar ring to it’, [remember Epworth Hospital 1972 where this all began] a Hospital unable to get Pantopaque or Myodil is asking for another preparatory brand to be permitted into this Country ‘untested‘. It’s ‘still Iophendylate but NOT Pantopaque or Myodil, but Ethiodan the brand sold by British Drug House in the UK [they get it from Glaxo UK] to Allen and Hanbury in Canada. It seems this Hospital the Royal Perth Hospital have been using Iophendylate as an additive to cyanoacrylate tissue GLUES, yep you read it right, to mix with glue I will let you read the letter yourself below.

It’s dated the 29th of October 1987.

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Its now the 8th of December of the same year 1987 the author of the above letter from the Royal Perth Hospital has as you can see written ‘again’ to the Drug Evaluation Branch at the Commonwealth Department of Health [DOH] requesting an early reply regarding obtaining permission to import Ethiodan from the USA from Picker Corporation.

Again, by the note which you can see at the bottom the DOH is looking favourably at granting such a request, by it seems relying on their past granting of a General Marketing License [9th Oct 1979] for Iophendylate Pantopaque without the Safety/Toxicity data.

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No further correspondence can be sourced from the DOH until the 29th of September 1988 when a internal memo was drafted regarding an enquiry by ‘someone’ name blacked out, however, it addresses 4 points.

The first, is regarding Myodil and its source, being Glaxo in the UK, and Pantopaque from Lafayette Pharmacal USA distributed by Cook Inc Melbourne Australia.

The second point addressed is in regards to its approval here in Australia where the writer informs the enquirer that …’the background information to the marketing approval of Pantopaque is spread over several files’… .

The third point raised, and answered, is regarding an interpretation of these files where the writer states …’that the product had been available for approximately 25 years before the institution of controls including the apply to nominated users only in 1974’… .

The final point raised by the enquirer was regarding what evidence is there on file of how the products were supplied before that. The writer states that …’the grandfather clause that products supplied in Australia prior to 1966 were allowed marketing unless doubts were held as to their safety and efficacy’… .

Just as footnote, prior to Hughes

Sadly throughout the life of Pantopaque and it’s lack of regulatory overseeing by the Australian TGB, such has been more than poor, its been criminal. Even within this memo incorrect ‘share information’ compound the errors on the history of Pantopaque. especially in the last point, Grandfathering, Iophendylate Pantopaque WAS NOT grandfathered as stated ONLY Myodil, but by stating such, a further distancing of the lack of oversight by the TGB on Pantopaque takes place.

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The next piece of correspondence obtained comes from the DOH from Joy Kelly to Dr McEwen is in a ‘Note for File’ dated 29th of March 1989. The Subject is…Iophendylate Distribution – 1974. (see f 33) what I don’t understand here is Joy Kelly providing answers to questions THAT Dr McEwen already knows, why is this, well you see, a reason for such can been seen in the previous entry 29th Sept 1988 place a ‘misdirection’ on the record so ‘others’ when they go to these files obtain incorrect information that supports the ‘lie’, around the fact that NO SAFETY/TOXICTY DATA that related to ‘outcome’ NOT process and protocol has been provided. Joy Kelly notifies Dr McEwen that Departmental approval was originally granted to Amyl Chemicals to import Iophendylate. In the middle she makes mention that the importer was authorised to distribute to approved users only [being the 5 Hospitals] although here they list 4, it seems the initial Hospital in 1972 Epworth Hospital doesn’t get a mention. She finishes this note by mentioning that the distributor [Hughes] did not abide by this and as we are [now] aware he sold it throughout Australia to 72 end-users.

But WHY did Dr McEwen what this? He was already aware.

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 On the 19th of April 1989 a three page letter was sent to ? [blacked out] by Dr McEwen of the DOH regarding a range of question being posed by ? in regards to Iophendylate Pantopaque, this a follow up of the questions asked by him to Joy Kelly. [Above]

I will leave you to read this, but within he makes mention of the pre-1970 period stating the Commonwealth Government was LESS rigorous than now [1989] He then refers to any drugs that had been available prior to this were permitted to continue to be marketed in this country without further evaluation unless specific problems of safety had arisen. This is misleading and needs investigating, his answer portrays that Pantopaque wasGRANDFATHERED this is a direct lie, Myodil was grandfathered BUT Pantopaque wasn’t for the importer ‘Hughes’ if you remember did NOT renew his Importation License for Pantopaque and had to reapply, Dr McEwen has deliberately mislead the inquirer for he was very much aware of this fact. Again, this is to once again placing a ‘misdirection’ on the record, so as I mentioned earlier  ‘others’ when they go to these files and read this and other letters etc later obtain incorrect information that supports the ‘lie’. Dr McEwen  in this last paragraph covers his back by informing the writer that …’Although it appears that active distribution had ceased before 1972, it maybe that the material used was from stock’… What he withholds is the fact the distributor Ernie Hughes ceased importation of Pantopaque in 1969, PRIOR to the NEW Australian Regulatory Requirements were legislated. Hughes had as I said earlier became aware of the American FDA DESI Investigation of serious injury and deaths being reported to them not only in America but around the world, this was compounded by the fact, the FDA had also discovered that Eastman Kodak the developer HAD NOT provided any Annual Reports for Iophendylate  Pantopaue or reported ANY ‘adverse reactions’ since gaining their NDA Marketing License, 25 years earlier.

This is again a misleading remark given by Dr McEwen to the author of the letter, for it portrays that Pantopaque had a TGB approved General Marketing License due to it being ‘Grandfathered’, when of course as I mentioned earlier, it wasn’t.

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19 4 89 a

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I have accessed many letters from Dr McEwen to doctors around the country giving them a ‘piecemeal’ account of how Pantopaque was approved, the contents do not mention the receipt by the TGB of receiving the required Sterility data, being the protocol NOT the Safety/Toxicity data.

This in itself is very disturbing.

The next letter I was able to source was a letter dated  the 24th of October 1994 and in fact it was in response to a letter I had written to a Dr Andrew A. J. Refshauge MP as I was endeavouring to get some information regarding Iophendylate Myodil. He had forwarded to the Minister for Human services and Health a Dr C.M. Lawrence whom sent it on to a Senator Rosemary Crowley the Federal Minister responsible for therapeutic goods and author of this letter. I have included her letter here although its not about Pantopaque a reference given by her needs to be shared. Please see the 2nd and 3rd paragraphs of this letter… [Myodil] …’It had a number of adverse reactions, arachnoiditis being one of the more serious’…Attached is its entry in Martindale: The Extra Pharmacopoeia (29th edition).  [I have added a copy after this letter below]

The third paragraph is interesting for it reinforces the role of the TGB prior to 1970 and the changes of its Regulatory requirements imported drugs. it reads …’As it was in use [Myodil] before the Commonwealth began to evaluate drugs of this class, it was NEVER evaluated by the TGA [as we know was known at that time as the TGB] for efficacy and safety;… So what is this telling us, its telling us that neither Myodil or Pantopque was ever evaluated in this country, ‘well’ they report that Pantopaque was, BUT we all know that the most important data required the SAFETY/TOXICITY DATA was never evaluated for safety leading to hundreds of thousands of citizens here disabled and in horrendous pain, and many since died.

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PLACE MARTINDALE HERE

13 months has pass without any further correspondence until I received a personal letter dated the 8th of November 1995 from a Dr S Hill Acting Director of the Drug Safety and Evaluation Branch of the TGA where he writes …’A registered medical practitioner may LEGALLY prescribe…[use]…a product outside its registered indications’…this goes to the heart of one of the major stumbling blocks in this County and throughout the world.

[Joel, if you get this far that statement above goes to the crux of the matter, use anything  without any legal redress]

‘It’s time this was addressed and corrected’ as a matter of urgency’.

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On the 3rd of July 1997 I wrote once again to the TGA this time under a FOI [Freedom of Information] request, I ask for answers to a range of specific questions ALL addressed early in this Blog, my reason in asking them was to get in writing not only an admission of, but to address my request for an inquiry. I knew they would never agree, please see their response of the 24th of July 1997 [below] …’At the present time, the Department is not involved in any specific action regarding the supply of Pantopaque’… I expected this response, for whom would want the TGA anywhere near an inquiry into their lack of ‘Professionalism and Oversight’.

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The last correspondence and entry on here is a letter from Dr John McEwen Head of the Evaluation Support Branch to an unknown person. As you can see he addresses a  few specific questions which you can sight below. The reason I have enclosed this letter is his remark regarding arachnoiditis. …’I think the major reason that the product has been discontinued is that newer products with less of a propensity to cause adverse effects including ‘ARACHNOIDITIS’… . [I place the capitals]

17 5 79a

As you can see ‘THEY ALL KNEW, THEY JUST DIDN’T TELL YOU’ what is further damning is that there is a statute of limitations on such happenings, and to deliberately withhold such critical information from you meant that any medical treatment that you could have had to minimise this long term suffering was denied to you.

 Remember the Owner and Manufacturer of Pantopaque verbally stated at a video court deposition that they knew it Caused Arachnoiditis in 1945.

 Before I touch on Australian Federal Government Health and Ageing – House of Representatives Standing Committee

Living with the pain of adhesive arachnoiditis: Report on the roundtable into adhesive arachnoiditis Report, dated February 2013.

The question always asked of me is  …’was there any Adverse Reactions to Pantopaque reported to the FDA in ???? year? ‘… . So let me answer that specific question asked of me by 100s of people living in America that were injected say in 1991, the last “official year” of Pantopaque’s life by showing you 6 pages of 40 pages totally 334 of such Reports.

How many WASN’T REPORTED!!!.  

ar mm

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CHEMICALLY INDUCED ADHESIVE ARACHNOIDITIS-WORLDWIDE

Overview go to internal Link, FULL story go to

THE ALCON STORY 1978 – 1996  [Coming soon]

**********************************************

This has been taken from the Australian Federal Government Health and Ageing – House of Representatives Standing Committee

Living with the pain of adhesive arachnoiditis: Report on the roundtable into adhesive arachnoiditis Report, February 2013.

However, this is in regards to Myodil and Glaxo, however we know Iophendylate Pantopaque and Iophendylate Myodil are the same, like the other 20 preparatory names [other brand names for the same product] used around the world.

As GSK noted in correspondence to the Committee, the regulation of therapeutic goods has significantly changed since Myodil was first introduced in the 1950s. The legislation for comprehensive national regulation of medical products in Australia was reviewed and replaced with the Therapeutic Goods Act 1989.

2.27 The Committee did not receive a great deal of evidence at the roundtable on the extent to which the Australian authorities reviewed Myodil or Pantopaque. However, in a 2003 response to a question on notice, the then Government stated: In the late 1970s, the Therapeutic Goods Administration’s predecessor, the Therapeutic Goods Branch of the then Department of Health, evaluated an application to register Pantopaque, for general marketing in Australia. This application was approved in October 1979. 2.28 An audit report in 1984 found there had been little progress in implementing the Therapeutic Goods Act 1966. The development of Australian standards was virtually dormant and the Therapeutic Goods Standards Committee, which inquired into the standards and advised the Minister on them, had only met three times since 1972. Further, there had been no progress on the National Register of Therapeutic Goods. 2.29 Given these findings and the lack of information about what actually occurred in any assessment of Pantopaque or Myodil, the Committee is not in a position to draw any conclusions about what actions the Commonwealth took to regulate or evaluate these products.

Scary, I should ask them to read the above then they will be able to re-evaluate.

THE AUSTRALIAN PERPETRATORS’.

Australian Importer of Pantopaque (1972 – 1974) Mr Ernie Hughes Divisional Manager of Amy Chemical Industries Pty. Ltd. 699 Warrigal Road Chadstone. Victoria.
Australian Importer of Pantopaque (1974 – 1974) Mr Ernie Hughes Divisional Manager of Watson Victor Ltd. NOW a Division of Amy Chemical Industries.(Same address as above)
Australian Importer of Pantopaque (1974 – 1979) Mr Ernie Hughes Australian Marketing Manager of Cook Incorporated. Incorporated in Indiana USA. Australia/Victoria. Address: 7 Allenby Rd, Canterbury. Melbourne.
Mr Ernie Hughes. Address as of 1998 (1980 – 2003) Hon. Secretariat Australian Institute of Radiology 32 Bedford St, Collingwood Victoria 3066.  Ph (03) 94193336
Mr Kevin Power (1972 – ????) Pantopaque Sales Manager. Amyl Chemical Industries Pty Ltd 699 Warrigal Road, Chadstone. Victoria.
Alcon Laboratories ( 1978 – 1989) Pantopaque License Holder including Australia
Alcon Laboratories Australian General Manager as of 1998 Mr David Rath As of 1998
Alcon Laboratories Australian Representative currently handling the Pantopaque issue here in Australia Mrs Hilary Crilly As of 1998
Alcon Laboratories Vice president and Associate General counsel on behalf of Alcon Laboratories America. Ms Kathleen Knight. USA as of 1998
 
Will correct this for it seems someone has been hacking this Blog and deleting information
   
   
   

================================================================================================

Now I list here names and position held of Australian Government personnel whom were party to this, and have covered it up by ‘not’ speaking out.

============================

B.C.E. Ashley  1972

TGB and Epworth Hospital Richmond Victoria.

Ms L. Richards 1972

Delegate of the Director-General of Health who signed and issued initial Permit to import the restricted Therapeutic Substance (Pantopaque) for the used in ‘Human Experimentation’ at Epworth Hospital.

Dr A.M. Walshe 1972

Assistant Director – General of Health Therapeutic Substance Branch.

Ms Fay L. Guy 1974

Delegate of the Director-General of Health who signed and issued Permit No. 10360 to import the restricted Therapeutic Substance (Pantopaque) for the used in ‘Human Experimentation’ at these approved 4 Hospitals.

Mrs Stanton 1974

TGB Dept of Heath Re: further release of Pantopaque.

Dr. H.R.K. Aurora 1974

Approves the release of these Permits at this time.

Petterson 1974

Releases further shipments of Pantopaque to Ernie Hughes authority given by Mrs S/Mr G/& Mr H) as signed

W.P. 1975

Assistant Director – General of Health Therapeutic Goods Branch permitting the use of Pantopque at Sir Charles Gardiner Hospital Perth (Head of the Dept of Radiology Dr J Glancy 1972 – 1979 and at the Royal Melbourne Hospital Melbourne Victoria. (Director of the Dept of Radiology Professor W. Hare 1974 – 1977)

R.E.W 1975

Requesting ‘evaluation’ of Pantopaque stability data by the National Biological Standards Laboratory Canberra (Evaluator Bernice Bell)

Bernice Bell 1976

…’died soon after’….

Findings of the above Evaluation….’The Company submission is very badly present there is no Form A and no Index and much of the data are repeated. Because the submission was received some years ago, it has been evaluated in spite of the poor quality of the ‘presentation. Please note NO ‘Sterility’ evaluation ‘other than [they stating] ‘it has been evaluated’…. separately…No data can be found of this ‘ever’ taking place.

[As well as the B1 Safety data ‘Animal and Human Clinical Studies asked for throughout the life of its use here in Australia.]

Dr. L. F. Dobson 1976

Other than a Letter sent from the Director Dr L.F. Dobson to Ernie Hughes informing him …’that the sterility data supplied are ‘Unsatisfactory’ and that you should show that the material complies with Section  3.1.2…3.1.3…3.1.4…and 3.1.5 of the NDF4’… [Please note, There were never any Sterility/Safety data ever received by the Regulators, so its baffling to say the least to read above …’that the sterility/Safety data supplied are Unsatisfactory’… when in fact none was ever received.] Talk about the left hand not knowing what the right hand is doing, this lack of accountability and oversight played right into the hands of Ernie Hughes.

Dr L.F. Dobson and Mr R.W. Tempe 1977

Director of the Biological Standards Laboratory Canberra was informed that attached to the letter from Mr E.M. Hughes was a ‘detailed’ reply of the American Supplier Lafayette Pharmacals on the issue of the products alleged STERILITY/SAFETY/TOXICITY.

Dr R.E. Wilson 1977

Assistant Director General Therapeutic Goods Branch receives a letter from William J. Gyarfas M.D. Director of Drugs FDA America Department of Health, Education and Welfare informing him of the reported clinical information being received by them from end-users not only in America but Worldwide of serious injury and deaths taking place after injection of Iophendylate Pantopaque. Remember Iophendylate Myodil and the other 21 brands have the SAME Chemical make-up of Iophendylate Pantopaque.100s of millions injected worldwide between 1942 and 1992, 50 years of human abuse, and what is sad is that they knew prior to it being Licensed by the FDA it would do this. Also if one was to check up on the ‘Patents and ‘Rights’ of drugs needed to try and manage this terrible man-made condition one would find they are owned by the developers/manufacturers of Iophendylate. 

Ms J Richards 1978

Therapeutic Goods Branch

Dr R.W. Tempe 1978

Therapeutic Goods Branch

Paul Bohum 1978

Therapeutic Goods Branch

Dr. L.F. Dodson 1978

Director Biological Standards Laboratory Canberra concerning a death of a Veitnam Vet patient due to the use of Iophendylate Pantopaque.

Mr. Koegn 1978

Commonwealth Dept of Veteran Affairs notified on a further death.

Victoria Department of Health 1978

no names available in reference to the two deaths mentioned.

Victoria Health Minister 1978 was notified.

[Name ? ]

Diagnostic Radiology Department Heads as of 1978

Royal North Shore Hospital as of 1978

[ ? ]

Prince of Wales Hospital as of 1978

[ ? ]

Royal Melbourne Hospital as of 1978

[Professor Hare]

The Alfred Hospital Melbourne as of 1978

[Dr Mackay]

Annendale Private Hospital as of 1978 now know as Hawthorn Private Hospital

[ ? ]

Canberra Hospital as of 1978

[ ? ]

Mr P.R. Duguid as of 1979

Analyst for the National Biological Standards Laboratory Canberra.

L.F. Dodson to Mr D Threlfall as of 1979

Mr D Threlfall an Assistant Director – General Therapeutic Goods Branch stated that…’There are no further objections in respect of Chemistry and Quality control to the general marketing approval’…. Although STILL no SAFETY/TOXICITY data had been provided by way of the TGA required Application process for new drugs etc by the developer/manufacturer, in fact the NBL

Please note, this process of getting an approval of their Application to Market Pantopaque has been in process since 1974. The objective was to ‘NOT’ to have Pantopaque Licenced within that time, because to do so required SAFETY/TOXICITY’ data byway of the required Animal and Clinical Human Studies. Whilst Ernie Hughes continued to stall they could continue to sell their untested Product without approval under N.H.M.R.C. Guildlines for HUMAN EXPERIMENTATION. Once the product was granted a General License here in Australia (still without the required sterility ever being supplied) Hughes and Lafayette Pharmaca sold it on to  ALCON in 1978 funny that date eh, Alcon never check what was going on with the FDA with this too toxic contrast medium, but when they did it was too late, so they started to “adjust Adverse Reaction Warning leaflets” playing down the relationship between Pantopaque and Chemically Induced Adhesive Arachnoiditis. This was due to the fact as of 1978 Alcon became responsible for the safety of Pantopaque when still being used in Australia and around the World. Evidence will be placed here in due course. At no time did Mr Ernie Hughes supply the required ‘SAFETY/TOXICITY RESULTS’ required by the TGB, Why!!! As I reported earlier throughout the world people were dying with related meningitis complications after being injected with Iophendylate Pantopaque, including here in Australia. [1972 to 1979]

I will now list here ALL the Federal and State Government Members of Parliament and Department Heads who were contacted at the time without success continuing this lack of ‘oversight’ on behalf of all Australians.

The Hon Dr Michael Richard Lewis Woodridge.

The Federal Minister for Health and his Dept of Health.

Ms Susan Alder MBBS PH.D.

Therapeutic Goods Administration Commonwealth Dept of Health. Director of Drug Safety and Evaluation [at the time was currently employed there]

Dr John McEwen

Director of the Therapeutic Goods Administration Commonwealth Dept of Health

Dr S. Hill

Acting Director Drug Safety and Evaluation Branch [Previous] Therapeutic Goods Administration Commonwealth Dept of Health

Dr P Purcell

Medical Officer Drug Reactions Section Therapeutic Goods Administration Commonwealth Dept of Health

Dr A Rohan

Secretary Adverse Drug Reactions Section Therapeutic Goods Administration Commonwealth Dept of Health

Ms Marie Louise Stokes

Disease Prevention Therapeutic Goods Administration Commonwealth Dept of Health

FEDERAL SENATORS

at the time contacted without support.

Rosemary Crowley.

Via her Secretary Ms Rachael Kelly and Senior Adviser Ms Donelle Wheeler.

Meg Lees

The Hon Jim Llyod

Federal Member for Robertson my Electorate

NSW MEMBERS OF PARLIAMENT OR DEPARTMENTAL HEADS ETC.

J Amos

Director – General Department of Health

The Hon Bob Carr

NSW  Cabinet Office

The Hon Andrew J Refshauge

who at the time of contact [17th June 1994] was NSW opposition Minister for Health stated to me that as soon as the Labor Party gain Office he would instigate a Government Inquiry. Since that time he has ignored the writer in this most serious matter, maybe it has to do with the fact his Father Sir William Dudley REFSHAUGE AC CBE ED let Pantopaque into Australia due to he being the Federal Director General of Health at the time. Whilst researching the life of Sir William Dudley REFSHAUGE AC CBE ED I discovered prior to him becoming Federal Director General of Health he was Deputy Director of Army Medical Services, then Director in 1956, having helped set up the School of Army Health.

Was It is within this period was he approached to promote Iophendylate Pantopaque here in this Country?

For it arrived in Australia initially in 1952 only future obtained documents will tell us.

NSW DEPARTMENT OF HEALTH

Mr John Lumby

Chief Pharmacist. Manager, Pharmaceutical Services Beach.

NSW DEPARTMENT OF HEALTH

Director of Clinical Policy and Practice

Mr Andrew Wilson [later] Dr M. Stokes 

NSW DEPARTMENT OF HEALTH

Associate Director  Centre for Clinical Policy and Practice

Amanda Adrian  

NSW DEPARTMENT OF HEALTH

Manager, Ministerial Correspondence Section

L Watson 

NSW DEPARTMENT OF HEALTH

General Manager, Public Affairs Marketing

Ms Nancy Consaul 

NSW DEPARTMENT OF HEALTH

Director of Health Public Affairs

Ms Deborah A. Hyland

Louise Houlahan 

NSW DEPARTMENT OF HEALTH

Manager, Health Services Technology

Ms Kathy Meleady 

NSW DEPARTMENT OF HEALTH

Director Complaints Unit

Ms Merrilyn Walton

(prior to her becoming H. C. C. Commissioner)

NSW HEALTH CARE COMPLAINTS COMMISSION

Ms Merrilyn Walton

( when contacted stated ‘no action due to outside the Act, being more than 5 years’.)

Ms Agnes Levine

Ms Leigh Mckay

MINISTER OF THE ENVIRONMENT N.S.W. GOVERNMENT

Ms Pan Allan MP

(concerns raised by the writer of possible Radiation exposure above level deemed to be safe. Overseas reports of 700% to 900% increase if this Chemical is LEFT within the Patients body reported in a early Medical Journal)

Mr Dick Sheppard

Senior Policy Advisor to the Minister for the Environment

AUSTRALIAN DEMOCRATS

Elizabeth Kirkby MP

Research Assistant to Elizabeth Kirkby MP

Ms Dominic Wong

Media and Research Officer for Elizabeth Kirkby MP

Simon Disney

LOCAL (sitting at the time) MEMBER FOR PEATS

Ms Marie Andrews



Will continue this tomorrow on the 21/07/2017 that’s if I don’t disappear ending up in some land fill that is, oh, just in case I do, I have provided 4 x 1 copied sets of all my 24 years of worldwide research to others living overseas, updating daily.

Furthermore, I have instructed them to release their set to the National Media of their own specific Country, if such takes place.

Well today its the 20/07/ 2017 and I am still here, however its time for bed

‘BIG DAY’

Tomorrow

‘what have I started’?

Until tomorrow, hopefully.

Good Night.

 

ALL Pantopaque Animal studies carried out pre-license 1936 – 1944. I will also list a copy of the 15 week 1969 Dog studies as well as the Teratology Rabbit Study using Pantopaque II ordered by the FDA after the findings of the DESI Report. Also ALL documented evidence of the Pantopaque ll trials which whilst HALF the strength of Pantopaque l. Pantopaque ll was found to be still TOO TOXIC for use.

Please see below a list of the Pantopaque Animal Tests [1936 – 1944] prior to Eastman Kodak INITIAL application for a General Marketing License in early1944.

As you can see, each has a link to a PDF file showing the specific test data and most importantly the result/findings.

Also please note in this article/test below refers to the dose and refers to the dose in Humans if one as I did calculate that, it arrives at 2.85cc.

This 2.85cc became the recommended dose for human that’s why they not only produced 3.00 cc ampoules but supplied such to the US Military Hospitals to try, prior to their FDA License application.

‘The follow piece which I share here explains the cause of CIAA by Pantopaque around the world. When Eastman Kodak and Partner applied for the Iophendylate Pantopaque License they CHANGED the previous recommended dose [given to these Hospitals] FROM 3.00cc to 3-5cc [from a dot to a dash] by increasing the recommended dose this way they changed the dynamics of CSF toxicity using Pantopaque which in turn started off the development of CIAA’ worldwide. (c)

‘The severity of CIAA is caused mainly by the level of the dose of this very toxic chemical above 2.85cc used as well as multiple build-up through multiple Myelograms that is most popular in America as they aspirated 70% to 90% after the procedure was completed’. (c)


This clearly explains the 2 causes of CIAA using Iophendylate [Pantopaque/Myodil and the like] one of a build-up [Pantopaque] the other non-removal [Myodil and the other 20 brands of the same sold around the world. (c)


Pantopaque Animal Tests [1936 – 1944]

[1.]

Intrathecal dog experiments comparing iodised poppy seed oil, Ethyl-w-(4-iodophenyl)-n-valerate and ethyl-iodopheny-lundecylate [Pantopaque] LINK ………Intrathecal Injection of Pantopaque in Dogs………


[2.]

Using Ethyl-iodophenylundecylate. Findings. Chronic Toxicity following intraperitineal injections of liquid contrast media in Rats.

 LINK ……..Intraperitaneally……..


[3]

Intrauterine Injections of liquid contrast media in rabbits, using Ethyl-iodophenylundecylate

LINK ….Iophendylate Pantopaque was later to be licensed by the FDA for Intrauterine Injection in women……


[4.]

Chronic toxicity of liquid contrast media by intrapleural injections using Ethyl-iodophenylundecylate by intravenous injection in Dogs and Rabbits.

LINK


[5.]

Using Ethyl-iodophenylundecylate. Findings. Acute Toxicity of Ethyl-iodophenylundecylate (Pantopaque) by oral Administration to rats including Table 1.

LINK ………….Oral Admin to Rats 1936……………


If you have difficulty reading ANY of the links just click on each page and it will change to blue and become easier to read.


[6.]

Acute Toxicity of Ethy-iodophenylundecylate by intravenous injection in Dogs and Rabbits.

LINK ……….Intravenous Injection in Dogs and Rabbits………..


[7.]

Physiological Assay of Ethyl-iodophenylundecylate by Intrathecal injection.

LINK ….Physiological aspects of Pantopaque pre-FDA GML…..


[8.]

Absorption of Ethyl-iodophenylundecylate (Pantopaque) from the Subarachnoid Space.

EPSON MFP image


[9.]

Provisional Specification prior to Pantopaque FDA Application for General Marketing License. [October  27th 1943]

EPSON MFP image

It’s important to be aware that Eastman Kodak INITIAL FDA New Drug Application for a Pantopaque General Marketing License was refused due to the above animal tests.

Reason, the FDA found that Pantopaque was far ‘too toxic’ for human use, however, less than a month later they approved it, and it seems even today, NO ONE cares.

Well I do,

I want answers.


Whilst a copy of the FDA finding regarding above will be posted elsewhere, a copy will be placed here in due course.

Place here the FDA Initial Refusal and then the Approval


HERE IS THE FRONT COVER OF THE 1969 15 WEEK INTRATHECAL TOXICITY STUDY USING DOGS

PANTOPAQUE I OR PANTOPAQUE II

FINAL REPORT.

BELOW THIS COVER IS A PDF LINK TO THE FULL COPY OF THIS STUDY.

1-QQQ

15 week study

This 15 week Dog Study was carried out not for altruistic reasons but to try and reduce the toxicity of Pantopaque that now had been directly linked to Chemically Induced Adhesive Arachnoiditis, just as Lipiodol had previously. The difference between Lipiodol being the first oil base x-ray dye and Pantopaque the second dye produced, was that ‘fairly quickly’ Lipiodol was stopped being used’ for Myelography due to it’s direct link to Chemically Induced Adhesive Arachnoiditis.

However, this was not the case regarding Pantopaque the developer Eastman Kodak and the manufacturer Lafayette Pharmacal being aware that Pantopaque was also causing Chemically Induced Adhesive Arachnoidits just like Lipiodol in a wide range of Animals [see the Animal tests referred to above] but also in Humans didn’t care, they just did NOT report such to the FDA as required, they just continued to manufacture and distribute it throughout America and around the world.

What they did was they just didn’t report all the related adverse reactions and deaths to the FDA for the next 25 years, and the FDA did not oversee its use in America and around the world, something I will requesting an answer to, in person, in due course.

AND NOW HERE IS THE FRONT COVER OF THE TERATOLOGY STUDY IN RABBITS ALSO CARRIED OUT IN 1969

PANTOPAQUE II

FINAL REPORT.

BELOW THIS COVER IS A PDF LINK TO THE FULL COPY OF THIS STUDY.

EPSON MFP image

PDF FILE OF THE FINAL REPORT.

TO BE ADDED LATER DUE TO IT BEING VERY LARGE BUT MORE IMPORTANT VERY DAMNING

PANTOPAQUE l vs PANTOPAQUE ll

Further related data [attachment] place here

As you can see by the above attachments the Development of Pantopaque ll having 50% less iodine was trialled in comparison to Pantopaque l but it was a failure, even at half the toxicity of Pantopaque l the data/results of Pantopaque ll were damning, it was still too toxic for use on humans. Eastman Kodak and Lafayette Pharmacal were in trouble, “what if the FDA finds out”?  For whilst they had applied and was approved by the FDA to trial a 50% less iodine Pantopaque ll this did NOT reduce the toxicity of Pantopaque ll something they were not expecting.

As it is a requirement of all Companies testing a possible new drug, they have to supply the results to the FDA, especially when such a test/trial is stopped by the Company furthermore, they must provide the reasons for such and the related animal test/trial results, to them.

Of course this was not possible for to do so, for the FDA would closely look as the results provided by them, so what did they do? Well, they ‘officially’ withdrew Pantopaque ll trial but DID NOT provide the related Pantopaque ll findings/data, they sat on it for more than a year, and then sneakily hand delivered the data to the FDA Archive Department, and what did the FDA Archive Department do, well as the Drug trial had been terminated for more than a year they just filed away the data without bothering to sight it, just what Eastman Kodak and Lafayette Pharmacal wanted, for why would the FDA bother doing so if the proposed drug had been withdrawn.

Of course this would NOT have been the case if the findings/data as required by the FDA had been provided at the same time as they withdrew their application to test/trial Pantopaque ll.

 

 

 

 

 

All Medical Journal Articles, Textbooks, Pharmacopeia’s, US and UK, and many Incidentals I have. I will also provide copies of the following MJA Library contents held by the following. Eastman Kodak, Glaxo and Alcon and the dates which go back to 1909.

I will list here copies of all medical journal articles, Textbooks, Pharmacopeia’s, US & UK, and many Incidentals. I will also provide copies of the following MJA Library contents held by the following. Eastman Kodak, Glaxo and Alcon and the dates which go back to 1936. 

I will also make available by a link full copies of ALL those MJA referred to in my Blog, so stay tuned. 

So first my own list, although initially it will not be my complete collection for I have many other MJA’s that have yet to be added.

click below on anyone or all.

MEDICAL JOURNAL ARTICLES 1909 – 2015

PHARMACOPOEIAS AND PRODUCT INSERTS

INCIDENTALS

.

Glaxo and Eastman Kodak hidden 1940s Iophendylate correspondence, never seen until now. Also the Plati’s Thesis and Steinhausen Thesis, and a comparison between Steinhausen Thesis and his medical journal article which is VERY DIFFERENT.

First of all my thanks and I am sure from all CIAA Sufferers to an x Glaxo staff member whom believe this cover-up of abuse of human life has gone on long enough. 

Please note prior to posting this correspondence, I have copied and supplied it to the 4 holders of all my research [again full copies] in other parts of the world, ‘just in case’, to be released if such were to happen.

This correspondence is from Glaxo to and from Eastman Kodak not forgetting Lafayette Pharmacal and Bill Bucke input will finally expose their joint cover-up.

THE CORRESPONDENCE

ADD HERE


In 1940 as part of a Ph.D degree at the University of Rochester John T. Plati [see below] synthesised a range of liquid contrast mediums which were all ethyl esters of iodinated aryl acids and were …’designed to be absorbed at the site of injection, as well as to provide adequate contrast for radiographic diagnoses’… .

Whilst Plait’s Thesis was awarded to him in 1940, the synthesising of these liquid contrasts mediums began in the early 30’s and from one of those mediums named ethyl iophendyl-undecylate’ became Pantopaque before commencing on its journey into unknown.

Plati’s Thesis 1940

Steinhausen Thesis 1941

AND NOW

‘THE DIFFERENCES BETWEEN STEINHAUSEN 1941 THESIS

 AND HIS PUBLISHED MEDICAL JOURNAL ARTICLE OF 1944′.

In June 1941 Theodore B. Steinhausen submitted in part a thesis [see above] to fulfil the requirements for the degree of Doctor of medicine with honour in the School of Medicine and Dentistry at the University of Rochester.

This thesis was titled: AN EXPERIMENTAL STUDY ON IODINATED COMPOUNDS FOR INTRATHECAL USE and was the ‘beginning’ of the devastation throughout the world today, of ‘ethyl iophendyl-undecylate Adhesive Arachnoiditis’.

This paper will share with the reader the findings of Theodore B. Steinhausen, which he recorded in his thesis, and the differences between this and his (jointly) published medical article that was submitted for publication June 1944. You can find it in the medical journal ‘Radiology’. [Copy with be provided here in due course] Both of these studies were aided by a grant from the Research Laboratories of the Eastman Kodak Company.

In this thesis, Theodore B. Steinhausen acknowledges Dr Joseph B. Furst who he states carried out much of the preliminary work reported, he also acknowledges Dr Clarence Dungan whom not only completed these preliminary studies but with Theodore B. Steinhausen performed the early experiments with ‘ethyl iophendyl-undecylate’.

Even in the ‘Introduction’ of Theodore B. Steinhausen thesis he refers to the fact that ethyl-iodophenylundeclate although at investigation was deemed satisfactory for clinical use in myelogrphy, it was only being used in a…‘limited way’….

If the reader wishes to gain a insight into ‘why’ iodinated oils were regaining a position in radiological diagnosis at this time one needs to return to 1918, and Dandy’s introduction of air as a suitable contrast medium to outline the subarachnoid space. However, with…’air the radiographic contrast was poor’…although what air was compared with is some what of a mystery to the writer, maybe it was more to do with the fact that air was free and didn’t turn a profit like iodinated oil.  In 1921, Sicard and Forestier “accidentally” introduction Lipiodol a iodinated poppy seed oil into the subarachnoid space instead of the epidural for which it was licensed, this was twenty years after it was initially prepared by LeFay of Paris in 1901. However straightaway adverse reactions were being reported when injected into the subarachnoid space, …’it is interesting that iodised poppy seed oil had been used in practically every cavity and sinus in the body for roentgenologic exploration’

Be it in chest x-ray which commenced in 1925,1926 for gynaecologic x-ray, and the visualisation of the seminal vesicles, urethra, bladder and paranasal sinuses. In 1936 these x-rays of the paranasal sinuses had now extended to fistula tracts, but were they safe, the answer to this is no when the dose is above 5 c.c. In fact, Sicard stated that…’iodised poppy seed oil should only be used as a diagnostic aid; no more than 5 c.c. should be used where a local or general inflammatory disease of the meninges, is suspected’… it is critical that one understands that due to the cerebrospinal fluid being encapsulated within the subarachnoid space any dose increase greater than 1:40 ratio will increase the toxicity within cerebrospinal fluid due to the toxic nature of the radiographic agent. The Council of Pharmacy and Chemistry of the American Medical Association because of an increase in related adverse reactions to the used of Lipiodol published a Report in 1932 that adopts a more conservative attitude and …’discourages the use of any foreign body unless there is no other means of establishing an accurate diagnosis’…When one reviews the medical literature at that time very limited pathological studies can be found on human tissue, after Lipiodol was used. Theodore B. Steinhausen in his thesis reports that as of 1941 he found very few early experimental studies before Lipiodol was introduced into the subarachnoid space of humans. I have reported those few early experiments referred to by Theodore B. Steinhausen to assist the reader, in 1924 three years after the commencement of usage of Lipiodol Ayer and Mixter carried out a study on six cats by injecting cisternally 1 to 1.5 c.c. of iodised oil, the oil diffused slowly throughout the CSF, with no evidence of absorption. Its important to note that three days after the cats were injected with lipiodol the CSF’ fluid count were found to be as high as 4,420. Ayer and Mixter also reported that one cat died immediately after the Lipiodol was injected, and the dose used was blamed as the cause by Sicard stating that the dose was too much for the weight of the cat. A year later seventeen rabbits were injected with a varying dose of poppy seed oil, with nearly half dying, with findings at autopsy of droplets of Lipiodol adherent to the meninges and cyst formation found histologically. Within the ganglion cells the granules were clubbed and definitely reduced in number, they were also pale and had lost their definite outline. Klose and Peiper also noted necrosis of the tissue adjacent to the spinal canal, which they believe is due to the mechanical pressure of the oil globules directly on the grey matter and indirectly on the white matter. An interesting similarity to iophendylate adhesive arachnoiditis to that of using Lipiodol in myelography can be seen within in a 1926 J.A.M.A. Article titled: Lipiodol in Neurosurgery  by Maclaire, he reports that once Lipiodol was injected into the subarachnoid space it caused thickening and adhesions of the leptomeninges with cysts of the arachnoid containing lipiodol.

Maclaire, also reports that Lipiodol not only increased nervous tissue and leptomeningeal damage but was irritating. Sicard, whom recommended the use of Lipiodol in 1921 for the use within the subarachnoid space defended its use when responding to Maclarie’s article stating that Maclaire did not observe the precautions and contraindications laid down for the use of iodised oil. However, a year later in 1926 in Sweden, a report by Lindblom supported Maclaire’s article on the effect of Lipiodol on the meninges, Lindblom found that after injecting Lipodol into the subarachnoid space of seven rabbits one died of severe meningitis after 48 hours like Ayer and Mixter study. Lindblom also found that the surviving rabbits exhibited varying levels of meningeal reaction for nearly three weeks. At sacrifice the cord sections showed …’an acute leptomeningities charactarized by leucocytic invasion of the meninges around the oil droplets, two months after the injection no histological changes could be demonstrated, even though large amounts of oil were still present’… this is an important to note, for in the same 1926 Lindborm article he reports on a human clinical study when using Lipiodol three patients developed meningeal irritation for between 2 – 6 days with spinal fluid cells count up to 1000/cu.These meningeal reaction was accompanied by nausea, vomiting and a spiked temperature, up to 39c.  Further, medical journal articles started to be published worldwide reporting on the same reaction to Lipiodol however, many patients were suffering from degenerative nervous disorders prior to the Lipiodol Myelography, the use of Lipiodol for disc problems was still in it’s infancy. Its interesting to note ethyl iophendyl-undecylate had a recommended dose of 3 to 5 c.c at it’s FDA License in February 1944. However, like Lipiodol ethyl iophendyl-undecylate the only dose found to be safe was at a level no greater than 2 to 3 c.c, not 3 to 5 c.c. as it’s FDA licence states. Keeping the toxic neutrality of the radiographic agent within the CSF cannot be obtained if the dose of either Lipiodol or ethyl iophendyl-undecylate is above, as I stated 2 to 3 c.c.

The neutral dose of 2 to 3 c.c relates to an average Adult CSF not a child, where toxicity will be a factor, so a regulated dose comparative to size of child (spinal column) is critical.

Lipiodol unlike ethyl iophendyl-undecylate was a iodised poppy seed oil however, authors of published medical journal article that reported on its toxicity differed in their findings. I have listed a collection of such including those referred to by Theodore E. Steinhausen to show the wide range of findings which in its self is disturbing.

It is my belief that those that found it to be “safe” were “F” linked to the developer, and those that reported its relationship to CIAA were NOT. Furthermore, considering it was to be later removed due to such a relationship, draws into question those that said “it was safe”.  

LIPIODOL

The first oil based contrast medium to be used in the World, after a very small study to be used in the Subarachnoid Space.

Below are the articles referred to above.

Sicard and Forestier (1921)

1st used lipiodol to outline the epidural space, then the Subarachnoid Space and reporting its usefulness in demonstration by Roentgenography including technique and contradictions

Sargent (1923)

In England and in support of lipiodol use based on a ‘very’ Small Study used in the Subarachnoid Space.

Ayer & Mixter (1924)

Study in 6 cats using 1.0 to 1.5 c.c. of lipiodol no evidence of absorption spinal fluid count above 4,420 on 3rd day of injection. 1 death.

Klose & Peiper (1925) Study of 17 rabbits with 47% mortality
Maclaire (1925)

Findings of thickening and adhesions of leptomeninges with lipiodol within formed cysts. It also reports of increased nervous tissue and leptomeningeal damage and was irritating.

Ballon (1925) 1st used lipiodol in chest roentgenography.
Ballon (1926) “                             “                “                     “
Sicard (1926)

Report on the dangers of lipiodol if used incorrectly dose and non-aspiration.

Lindblom (1926)

In Sweden 7 rabbits used by way of 1 died severe Subarachnoid Space Meningitis. Also 3 human studies again findings of meningeal irritation.

Ebaugh & Molla (1926)

Clinical study of 13 humans by way of cisternally injection. Again, found aseptic meningitis but ALL patients had a current central nervous system. [CHECK WORDING]

Sharpe & Peterson (1926)

All patients had a inflammatory reaction, elevation of cell in CSF 2 patients were suffering at the time of injection a degenerative nervous disorders

Rubin (1926)

A review of the use of lipiodol in gyneologic x-ray

Sicard & Forestier (1926)

2 Reports, one on the various ways lipiodol could be used as a diagnostic aid. The other they state lipiodol did NOT act as a for body. Sicard followed patients for 4 years with a finding of NO irritating effects. [check dose used]. At post mortem found oil fixed to the arachnoid network made up of mononuclears and phagocytes, but no true cysts.

Preety (check z or y) (1926)

Reporting the value of lipiodol in paranasal sinuses x-ray.

Wolfsohn & Morrisey (1927)

Findings of aseptic meningitis and definite inflammatory changes and cyst formation.

Globus & Strauss (1929)

Reported NO adverse reactions, [however, NO spina fluid cell count was done.]

Craig (1929)

Review of 10 cases, findings of definite signs of irritative meningitis in 4 cases.spinal fluid cell count was up 26 per cu. Mm. Remaining at 143 per cu. Mm on the 28 (?) day, root pain in one patient. Craig found encysted iodised oil in 2 cases with evidence of localised inflammation around the oil

Doughty (1929)

Found no adverse reaction other than transient increase of temp to 100 degrees F. in all cases. At operation 7 days later, NO adhesions were found.

Davis (1930)

An experimental study on 10 dogs, 1.5 cc of lipiodol was Injected cisternally 1 dog died 3 days after injection. 1 dog developed a spasticity of an hind leg that lasted 6 months. 8 of the dogs developed general malaise and anorexia that lasted up to 2 days. At autopsy, definite pathological changes were found. There was a thickening and infiltration of the leptomeninges by round cells, macrophages, and a few plasma cells. Small globules of oil had become encysted at the site of the reaction. As was found at Klose & Peiper in 1925. Davis also found degenerative changes in the anterior horn cells which were also thrombosed, which were diminished in size and number and took stain poorly.   Davis also reported that lipiodol was irritative and caused destruction to nervous tissue.

Bruskia & Propper (1931)

Carried out a study of 8 dogs no sensory or motor Disturbances found [CHECK TIME PERIOD OF STUDIES POSSIBILY 3 MONTHS] however, there are adhesion around the oil droplets with cyst formation.The walls which were made up of fibrous tissues with round cells infiltration. These are the pseudogranulomata or fatty granulomata Described by Lindblom in 1931.

Lindblom (1931)

Carried out a range of studies on various iodised oils on the meninges. Animal oil was very irritant, uniodinated vegetable oil, such a soy, sesame, almond, linseed and poppy, were much less irritating.

The degree of irritation being ‘DIRECTLY’ related to acidity, soy is the lowest, and poppy the highest. Iodination increased the irritative qualities slightly. Impurities were the main cause of irritation, be it free fatty acid, iodi fatty acid, and occasionally hydrogen iodide.

The Council of Pharmacy and Chemistry of the AMA (1932)

In regards to a Report of the use of ‘any’ foreign body within the Subarachnoid Space and it use be conservative and as a last result.

Sicard and Forestier (1932)

A review of lipiodol usefulness in demonstrating intraspinal lesions

Rose???? (1936)

Reports the value of lipiodol in sinus and fistula tracts in x-ray.

Doubilet (1937)

Supporting Rose MJA Biliary tract visualisation x-ray.

Randell (1937)

Another review as Rubins 1926 MJA of lipiodol use in gyneologic x-ray.

Kraus (1937)

A review supporting Preety recommended use of lipiodol in paranasal sinuses x-ray note….

THE ROLE OF INFLAMMTORY TISSUE AND MUSCLE AT THE TIME OF INJECTION WHICH IS NOT RECOMMENDED TO BE USED BECAUSE OF KNOWN ADVERSE REACTION. Page 9.

LIPIODOL WAS REMOVED OFF THE WORLD MARKET FOR SUCH USE, DUE TO THE BELIEF IT WAS TO TOXIC AND THE SOURCE OF CHEMICALLY INDUCED ADHESIVE ARACHNOIDITIS WORLDWIDE.

ITS NOW BACK ON THE MARKET BECAUSE IT’S CHEAP.

World Health Expert Committee Report of 1969. ‘Specifications for Pharmaceutical Preparations’ where TGB was represented.

I am currently awaiting a copy of the TGB Standards drafted after this Meeting in 1969 4 years prior to Iophendylate Pantopaque General Marketing Application NDF4 etc in 1974.

Interesting reading below of this Meeting

1969 World Health Committee on Specifications for Pharmaceutical Preparations where the TGB attended