X RAY Dye Scandal So Big That They Buried It..
Derek Morrison tells of how the toxic X-ray dye affected him, and prompted his pursuit for justice
DEREK Morrison lost control of his bladder, his bowel and became impotent after he was injected with the dye Myodil during an X-ray on his injured back in May 1977.
“The myelin sheath around the nerves had melted and fused and I never thought I’d move again,” says the former laboratory technician and salesman.
The radiologist who performed the myelogram on Derek left 21mm of the dye in his back and X-rays show some of it travelled to his brain.
He lost his job and sensation in his legs and nearly died before doctors performed 15 hours of microsurgery to save his life.
“They told me I was hypersensitive to the myelogram. I accepted it. At the end of the day you believe your doctors,” he said.
While he gradually recovered the ability to move relapses over the years saw Derek hospitalised numerous times to have weights put on his muscles and nerves to control the pain.
He was in a wheelchair on and off for four years before he was taught to walk again at a rehabilitation centre using secondary muscles in his legs.
His doctors prescribed methadone for 27 years to control the pain and at times it was so bad he was suicidal.
It wasn’t until 1992 that Derek fully understood what had happened to him.
His UK based mother Iris had also been injured after a myelogram and chanced upon an article about a court case on “spider’s disease” caused by myelograms.
The article in the Daily Mirror in 1992 was about how UK patients suffering arachnoiditis after an x-ray were suing drug company GlaxoSmithKline.
It was a Eureka moment for the pair.
Derek’s mother became paralysed by the dye left in her body and died on the operating table when doctors tried to ease her condition.
It was then Derek began a 25 year fight for justice for arachnoiditis victims collecting thousands of pages of official documents relating to the dye and its use worldwide.
These documents are now contained in bulging folders that line his living room and the search this year finally unearthed documents that show the TGB failed Australian patients.
In 2001 Derek began legal action against his radiologist, the hospital and the drug company but in the end the lawyers only went after the radiologist and Derek lost his case.
They told him he would not win a case against the drug company. “They talked me out of it even though 140 other Australians received an out of court settlement against the drug company.”
When Derek lost his case legal aid services across the country refused to take on any more cases.
“The government knew what they’d done and they shut it down knowing there were hundreds and thousands of cases coming behind me. They shut it down,” he said.
“There were millions of injections it would have cost billions to fix it, it was so big they just buried it,” he said.
Despite his work in amassing thousands of pages of documents that showed researchers, doctors and government regulators knew of the dangers of the dye for decades only three pieces of paper were ever used in his court case.
Derek tried and failed to stage a protest at the Sydney Olympics against the company Kodak which made the dye, Kodak was sponsoring the Olympics.
Derek blames the pain and disability he suffered as a result of the dye for the break up of his marriage and estrangement from his children.
“This dye was used in 107 countries. I believe 186,000 people were injected with Pantopaque in Australia, more when you take into account Myodil,” he says.
“The important thing is the TGB was not at the gate at the time protecting us,” he says.
“If the TGB had done their job hundreds of thousands of my fellow Australians like myself would not have been abused in this way,” Mr Morrison said.
“My life would have been very different if it did,” he says.
What Derek wants most is for the truth to be told.
“I want recognition this did happen, that the TGB truly failed us, ninety per cent of the sufferers don’t even know the link or what caused their problems,” he says.
Australians crippled and in chronic pain from dye used in toxic X-rays
Hundreds of thousands of Australians are crippled by pain, and some are paralysed and wheelchair-bound because the nation’s medicines watchdog failed to check the safety of a dye used in spine X-rays for 42 years.
Explosive new documents reveal for the first time how the government body charged with protecting the public approved the X-ray dye Pantopaque without ever obtaining the studies that showed it was toxic to animals and humans.
“There is no evidence that any animal or clinical studies were specifically requested, submitted or evaluated as part of the approval process,” the Regulatory Services Group at the Department of Health admitted in a letter to dye victim Derek Morrison in February.
The dye called iophendylate sold under the brand name Pantopaque and Myodil contains benzene, hydrochloric and sulphuric acids and is toxic enough to eat polystyrene cups and linoleum tiles.
Medical experts who gave evidence to a 2013 parliamentary inquiry have compared the case with the harm caused by tobacco giants and asbestos company James Hardie.
The phones went into meltdown when News Corporation in 2002 revealed the terrible impact of the dyes on Australians.
Medical tests in the 1940s on 15 dogs at Rochester University in the US showed the dye killed one dog, paralysed another and left most of the animals with inflammation of their nerve roots.
Ernie Hughes, one of several importers of the dye, says he never knew the dye was toxic and says it was approved by the FDA in the United States.
“If I’d known I wouldn’t have sold it and I would have demanded that Myodil be taken off the market too,” he said.
There is no suggestion that Mr Hughes knew or should have known about the dye’s risks, or that he was involved in any wrongdoing.
Pantopaque was mysteriously approved by the FDA on the February 22, 1944 after previously being refused a license weeks earlier due to it being ‘too toxic’ for human use.
In 1969 an application for a licence to sell a half strength version of the dye was withdrawn after a dog study found connective tissue lesions in half the animals, three dogs died, and another became partially paralysed. Rabbit studies show it produced malformed babies with bulging eyes and malformed heads. The full strength version remained on the market.
The Health Department never checked these studies before approving the dye for use here.
Now the victims of the dye are demanding the department and the pharmaceutical companies that marketed the dye publicly admit it harmed thousands of patients.
They want their health and support costs covered, funding for research into the best way to alleviate their pain and fund a charity to support sufferers.
Their calls were backed by a parliamentary inquiry into the dye in 2013 which called on pharmaceutical company GSK to set up a charity for the victims, it has refused to do so.
“GSK considers it has acted responsibly at all times in regard to the supply of Myodil including appropriate testing and monitoring, updates to product information, fair engagement in all legal proceedings and participation in the roundtable process,” a spokeswoman for the company said.
“Taking all these points into consideration, GSK came to the view that it would not be appropriate to establish a charitable foundation,” she said.
Mr Morrison believes there has been a massive cover up by doctors, companies and governments who are ‘just waiting for us to die’.
“They couldn’t fix it, it was so big so they buried it,” he says.
Other victims have told News Corp they are furious that the medical records they need to take legal action over the dye “went missing”.
A spokesman for the Minister for Health and Aged Care, Sussan Ley, said they X-ray dyes were considered to be the best method available to diagnose serious conditions of the spine. at the time.
“We are all concerned for those who have the painful and debilitating side effects from the two medicines (Myodil and Pantopaque) which were used in patients from the 1960s until the 1970s,” he said.
“The concerns of patients who received these medications was the subject of a House of Representatives Standing Committee on Health Roundtable on Adhesive Arachnoiditis on 21 September 2012, he said.
“The committee report recommended that the sponsor of the medication, GlaxoSmithKline (GSK), should consider establishing a charitable foundation to assist sufferers of adhesive Arachnoiditis.
“I understand that GSK has compensated some patients, however, access to further assistance for other sufferers should be taken up with GSK.
“If there is any new evidence on this issue it should be brought forward and assessed,” he said..
Actress Jean Howell who co-starred with James Bond star Roger Moore in the television series The Saint was a famous victim of the dye.
Associate Professor Mal McLeod from the ANU’s Research School of Chemistry says the dye iophendylate was marketed under many names including the brands Myodil and Pantopaque in Australia “it’s the same compound,” he says.
In Australia the dye was injected into patient’s spines before X-rays called myelograms for 42 years, it was withdrawn from the market in 1987 and replaced by a new water based dye.
Radiologists knew iophendylate could cause arachnoiditis but say at the time it was the only way to get a decent X-ray image.
They admit they never warned their patients the painful condition called arachnoiditis was a potential side-effect.
Experts told a parliamentary inquiry the condition causes inflammation and fusion of the nerves and membranes of the spinal cord pain and delivers burning pain “like bolts of electricity”.
Victims also suffer loss of muscle function, paraplegia, incontinence, unpleasant sensations such as ants walking on the skin or having hot water poured on one’s legs. Many patients are wheelchair-bound.
In 2000 around 140 Australian victims of the dye received compensation from drug company GlaxoSmithKline which marketed the Myodil brand of the dye.
However, many victims are unaware the dye is the cause of their health problems and those who do have been unable to get compensation cases through the courts.
Now News Corp has learned when it had a chance to check the safety of the dye in the 1970s the Therapeutic Goods Branch (TGB) of the Department of Health failed to get the studies that should have raised alarm.
The Myodil brand of the dye was first used on humans in the 1940s well before Australia had a government body that checked the safety of medicines and medical products.
However in 1966 after the thalidomide scandal the Australian Government introduced the Therapeutic Goods Bill to regulate the sale of medicines and other therapeutic goods.
This meant that in 1972 when Myodil became contaminated and a Melbourne doctor began importing a US brand of the same dye called Pantopaque it was regarded as a new product and was covered by the new medicine regulations.
A letter from the Department of Health Therapeutic Substances Branch to Epworth Hospital in June 1972 explains:
“Pantopaque is regarded as a new therapeutic substance and has not been approved for general marketing in Australia.”
The hospital was granted approval to use it in emergency cases only and as long as guidelines for experimental use were followed and chemistry and quality control data were provided.
In 1973 Nicholas Pharmaceuticals applied to the TGB for a licence to import Pantopaque into Australia.
Over the next two years various arms of the company were repeatedly asked by the TGB to supply studies on the safety and toxicology of the dye.
In February 1975 Cook Industries took over supplying the dye in Australia various Health department documents show.
The company was unable to obtain the studies from the US company Lafayette Pharmacal that marketed the dye.
Ernie Hughes the former managing director of Amyl Chemical Industries, the Australian branch of Nicholas that imported the dye and also former managing director of Cook Industries says he never knew about the studies in dogs that showed the dye was toxic.
“We only dealt with the commercial company selling Pantopaque, it had FDA approval,” he said.
There is no suggestion that Mr Hughes knew or should have known about the dye’s risks, or that he was involved in any wrongdoing.
He says medical practices at the time were very different to today and many radiographers as well as patients were injured by chemicals and X-ray dyes.
“Who do you go to for compensation? … you can go back in history … here were an entirely different set of things done years ago,” he says.
Despite the fact the TGB did not get the safety and toxicity studies it allowed the various companies to import over 13,500 ampoules of the dye for use in hospitals and X-ray laboratories while the marketing permit was being considered.
And in June 1975 it inexplicably gave up asking for animal studies on the dyes, crossing the word “animal studies” off its request for information from the company.
The department should have been alert to adverse events because in 1969 the US FDA demanded the US supplier of the drug include warnings on the label that adverse reactions included “severe arachnoiditis producing headache, fever, meningitis, pain in the back and extremities and elevation of the white blood count”.
In 1977 our health department was asked by the US FDA to supply details of adverse reactions after it emerged the US company had never filed adverse reaction reports as required by law.
A departmental file note in 1971 shows the TGB had received “a number” of adverse reaction reports but was “not investigating these in the laboratory at this stage as an individual approach to each of these is not possible because our background in the testing of these drugs is rather limited”.
Later, in 1978 our National Biological Standards Laboratory had complaints from 8 doctors about Pantopaque.
And in June that year a Heidelberg Hospital patient died after being administered with the x-ray dye and the adverse drug reaction report says “maybe drug casualty possible”.
Despite this the dye was finally approved for marketing in 1979 without the TGB ever obtaining the animal and human studies it asked for to prove it was safe for use in humans.
“Pantopaque was assessed for safe use in humans as part of the assessment for its marketing approval, but as mentioned to Mr Morrison this did not include specific clinical studies or animal studies,” the department told News Corp.
“The sponsor did provide a list of over 100 publications on the use of the dye as part of the evaluation. There was also knowledge of the use of the dye over many years,” the Department said.
Flinders University Emeritus Professor Michael Sage. A radiologist, says he can’t believe the TGB approved Pantopaque for use in 1979 because he was warning them at that time it caused arachnoiditis.
“It was madness to approve it in the 1970s” he says.
“I struggled to get water based dyes approved in the 1970s because I was aware of arachnoditis,” he said.
“At the same time as they were approving Pantopaque we were asking them to approved a new water based dye because of arachnoiditis,” he said.
“They should never have approved Pantopaque in the 1970s, if they approved Pantopaque in the 1970s it was without taking on board people’s concerns about arachnoiditis,’ he said.
Radiologists used the oil based dyes Myodil and Pantopaque until the 1970s because there was no alternative way to get an image of the spine, he said.
“(They) used it because there was nothing better,” he said.
The dye ceased being marketed in Australia from 1987 but many thousands of patients who suffered its adverse effects have never been compensated and many may be unaware the dye caused their symptoms.
Disabled solicitor who ‘faces the rest of his life in a wheelchair after being poisoned by doctors as a child’ is suing drugs giant Glaxo for millions of pounds in damages
- Disabled Keith Lewin, 59, had suffered with back pain since his childhood
- Solicitor says Glaxo chemical injected into his back at 15 has led to life of pain
- In 2013 surgeon found oily myodil still inside his spine, the High Court heard
- Drugs giant GlaxoSmithKline says that Mr Lewin has left it far too late to sue
Keith Lewin, 59, had suffered with back pain since his childhood, and claims an agent injected into his spine as a child means he will spend the rest of his life in a wheelchair
A disabled solicitor who faces the rest of his life in a wheelchair because he was inadvertently poisoned by doctors as a child is suing drugs giant GlaxoSmithKline for millions in damages, the High Court heard.
Keith Lewin, 59, suffered with back pain since his childhood but his health issues spiralled out of control in middle age and led to a devastating diagnosis in 2012.
He was told he had adhesive arachnoiditis, a rare spinal condition which causes debilitating pain and which has left Mr Lewin tetraplegic and confined to a wheelchair.
Mr Lewin, of Farington Moss, near Preston, claims that the blame lies in a procedure he underwent as a 15-year-old boy at Merseyside’s Whiston Hospital.
There, medics injected a ‘contrast agent’ called myodil into his spine so that it could be better viewed on an x-ray.
But the procedure did not reveal the source of Mr Lewin’s pain and instead led to his disability decades later, his legal team claims.
When he underwent an operation in 2013, a surgeon found the yellow oily myodil still inside his spine, the High Court heard.
Suing myodil’s maker and supplier GlaxoSmithKline for compensation, Mr Lewin claims it should have been withdrawn for use in diagnostic procedures years before it finally was in 1988.
‘He has suffered devastating injury,’ his barrister Simeon Maskrey QC told Mr Justice Goss.
‘And its attributability is clear to him and the surgeon who discovered myodil in his spine.’
Drugs giant GlaxoSmithKline says that Mr Lewin has left it far too late to sue over something which happened so long ago
Myodil was used as a contrast medium in imaging of the back from the 1940s, allowing medics to better identify problems around the spine.
Mr Lewin’s lawyers claim it had not been sufficiently tested and, even if it could be used, Glaxo should have warned that it must only be in the most extreme cases.
A ‘better’ warning should also have been given about the need to remove the ‘unstable and toxic’ myodil immediately after x-rays, his lawyers claim.
The drugs giant denies all of the allegations and is trying to have Mr Lewin’s case thrown out.
Glaxo barrister, Jonathan Waite QC, argues that Mr Lewin has left it far too late to sue over something which happened so long ago.
He should have suspected by 1977 that he was suffering from the condition and took action to begin a claim before 1983, he said.
Mr Maskrey told the court that the first symptoms of adhesive arachnoiditis which Mr Lewin had were in 2007 when he felt a sudden excruciating pain while out walking.
But pointing to entries in the 20-year-old Mr Lewin’s diaries back in 1977, Mr Waite said the possibility of arachnoiditis was on his mind even then.
The young man, who was still being investigated for the cause of his back pain, had written of having ‘some symptoms’ of a condition which he spelled ‘racnoiditas’, said the barrister.
That must have come from either his orthopaedic surgeon or GP and should have been the moment when he began to investigate whether he could make a claim.
That he instead left it until he had a diagnosis three decades later meant his claim was ‘time-barred’ by the Limitation Act and should automatically fail.
‘Glaxo’s case is that the information about arachnoiditis imparted to him in 1977 was what should have prompted him, as a reasonable person, to be curious enough to start investigating what the cause of this might have been,’ said Mr Waite.
But Mr Maskrey said Mr Lewin had been told of a variety of possible causes of his pain in the mid and late 1970s, of which arachnoiditis was only one.
The pain he had suffered in those days was totally different from that which led to the discovery in 2012 that he had the condition, he continued.
Mr Maskrey said the earliest time in which Mr Lewin could have begun investigating a potential claim was 2007, but that he only had ‘actual knowledge’ of potential for damages in 2012.
That meant he was in time when he launched his claim and it should continue – unless Glaxo, with its ‘vast financial reserves’, decides to settle, he said.
Mr Lewin’s arachnoiditis, which causes inflammation of the membranes which surround the spinal cord, has left him severely disabled.
He suffers from debilitating pain and is confined to a motorised wheelchair both inside and outside his home.
He has had to make extensive adaptations to his home and his partner provides care. The condition is permanent and the prognosis is said to be ‘poor’, the court heard.
In 1995, Glaxo settled – without any admission of liability in relation to myodil – 426 claims which were due to go to court.
The judge reserved his decision on Glaxo’s bid to have Mr Lewin’s claim thrown out until a later date.