Mauled by Myodil
Toxic GSK drug ... toxic GSK deception
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Before continuing, please take two minutes to view the following short video clip, and if you have time the following: Myodil Investigation — A New Zealander Speaks Out. (Windows Media Player or RealOne Player required.)
"Toxic Drugs Are Good For You"
January 2000, Glaxo Wellcome announced a merger with SmithKline Beecham. This will ensure its place as the biggest company in the UK, and one of the world’s leading pharmaceutical companies, controlling approximately 7.4% of the market. Glaxo has exercised considerable power over health provision in the UK since the company was formed in 1929. But its behaviour has not always been in the best interests of those consuming its drugs.
Robert Brack of the Myodil Action Group reports below how — for forty years — Glaxo knowingly sold a toxic drug to tens of thousands of people.
Between 1946 and 1988 Glaxo made and sold a spinal x-ray contrast medium called Myodil. Injected into the spinal canal in order to show up problems on x-rays, the drug was sold in approximately fifty countries including the UK. But Myodil, an oil-based yellow dye, was far from harmless itself — once injected into the spine it has been shown to cause a disease called Adhesive Arachnoiditis.
This causes chronic, intractable pain and is characterised by the inflammation of one of the three membranes surrounding the brain and spinal cord. The inflammation results in thickening of the middle membrane, called the arachnoid, causing it to adhere to structures near it. Finally the spinal cord nerves clump against the inner membrane and impair the flow of the spinal fluid. The chronic pain which sufferers have to endure is caused by inflammation and nerve atrophy. There is no cure and no treatment. Accounts of the number of people who have developed Adhesive Arachnoiditis due to Myodil vary between different sources , but it is likely to be tens of thousands.
Glaxo must have known that Myodil was toxic when it was first released onto the market in 1946, since the company was under an obligation to gather reports of adverse reactions to its drugs. By that time many studies had already been published which showed this.
Glaxo Laboratories Limited was incorporated on 28th May 1929 to deal in pharmaceutical drugs, with only one director, Alec Nathan. Nathan formed the company when it was discovered that the dried baby food ‘Glaxo’ was the cause of rickets in children. The first product Glaxo Laboratories Ltd produced was therefore Ostelin, a vitamin D concentrate to replace vitamins that were destroyed in the food drying process.
Glaxo realised that to manufacture a medicinal product is one thing, to sell the manufactured product profitably was another. It had to have influence in the local health departments and infirmaries. Glaxo advertised its products through medical and nursing publications and by writing directly to a selected group of doctors. Sales of the company's products grew and Glaxo, previously familiar to only a limited number of doctors, became more widely known. By targeting the people who prescribed Glaxo’s products it was able to sell to the Public Health Departments of a number of cities including Sheffield, Manchester and Birmingham. Sales of Nathan's products steadily increased.
Nathan had another method of influencing the Public Health Authorities — this was through the appointment to Glaxo of a government chemist called Harry Jephcott.
This recruitment drive led to other employees from the Public Health Authorities joining Glaxo's staff: a Mr Hunwicke from the Somerset County Public Health Laboratory, a Ms. Allchorne and a Ms. Findlayson from the government laboratory.
These staff officials naturally had connections and influence in the Public Health Departments. From this time on Glaxo was able to market its products from the inside.
The Second World War gave Nathan an opportunity to capitalise on the new recruits’ contacts and with government backing he set up a drug factory in Durham. By the end of the war his factories were producing 90% of the UK's supply of new drugs.
Harry Jephcott became Chairman of Glaxo Laboratories Limited in 1946. He soon recognised that the new National Health Service, established in 1948, could be his single most profitable customer. Instead of having to influence the hundreds of different Public Health Departments scattered around the country he needed contacts within the new emerging bureaucracy to ensure that he became prominent in supplying the service with Glaxo's drugs. He did this by targeting senior civil servants who were to run the Department of Health and Social Security from Whitehall.
Jephcott's appointment had proven to be a profitable one — soon Health Service officials were signing major deals with Glaxo. This strategy was to become an important factor in the significant growth of the company. Many competitors were taken over by Glaxo Laboratories Limited. The company now called itself the Glaxo Group and consisted of various companies that were each individually limited in their liability.
The Thalidomide tragedy in the 1960s resulted in the introduction of the 1968 Medicines Act. Previously there had been only a voluntary code of practice for the pharmaceutical industry to comply with. But the Thalidomide tragedy exposed the code as inadequate, and measures were introduced to bring the industry under legislation. The main purpose of the Licensing Authority was to test the safety, quality and efficacy of existing drugs on the market and to licence them. Under the new proposals a body corporate called the Medicines Commission was to be established with no less than eight members appointed by the Licensing Authority (Government Ministers) and to include representatives of the pharmaceutical and chemical industries. Part of the Act provided the members of the Medicines Commission with powers to establish advisory committees. The Committee on Safety of Medicines (CSM) and the Committee on the Review of Medicines (CRM) were set up when the Act came into effect on 1st September 1971.
The new legislation would mean stricter controls on the pharmaceuticals industry. This was unacceptable to the industry, which fought hard to have the Medicines Act drafted in such a way that it would benefit its own interests. Many companies also made sure that they had representatives present in the different committees. Usually they were heads of the research laboratories and many of the drugs they were testing for safety, quality and efficacy were their own company's drugs.
The contacts within Whitehall established so many years previously enabled Glaxo's drugs to be granted concessions that other companies’ drugs were denied. Myodil was one such drug that was not licensed through the proper procedures. All drugs on the market were given a one-year statutory period in which to register with the Medicines Commission: once registered each company’s drugs would be granted a non-transferable Product Licence of Right (PLR). The first PLR granted for Myodil was on the 19th November 1973 — one full year after its registration period had ended.
The files containing the licensing history of Myodil have been ‘mislaid’ by the Medicines Control Agency. After pressure from the Myodil Action Group, which fought for an investigation, the Parliamentary Ombudsman recommended a release of the documents. However, the Permanent Secretary to the Health Department refused to release the major part of the Myodil licensing documents.
On the 19th September 1988 Glaxo notified the Department of Health that Myodil was to be discontinued in the UK for commercial reasons, but they wished to retain the product licence issued in June 1987 as the product was not being discontinued worldwide. Myodil is thus still manufactured and sold overseas - it has found new markets in countries that are vulnerable to the marketing strategy that made Glaxo one of the largest pharmaceutical companies.
Glaxo has always maintained that the links between Myodil and adhesive arachnoiditis have not been proven. But in an out of court settlement in 1995, whilst denying liability Glaxo Laboratories Limited paid out, on average, £16,000 to each of 425 claimants suffering from Myodil Adhesive Arachnoiditis. A further 3,000 claimants had to withdraw because of what many of them felt to be Glaxo's solicitors’ bullying tactics. Settling out of court meant that Glaxo effectively closed the door on any further litigation in the UK.
Glaxo was certainly aware from an early stage that Myodil was an irritant. Equipped with that knowledge it could have investigated further given the nature of Myodil's use. It did not. If it had, it would have concluded that Myodil was toxic and should be withdrawn. It was not withdrawn until 1988, and then only for ‘commercial’ reasons.
The Board of Glaxo sits in its plush Head Office in Berkley Square planning the future of the company. The fact that one of their products has caused suffering to so many people around the world, and that many more are still being injected with this highly toxic drug, does not appear to be ranking high on the list of priorities.
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Thousands of Australians are living in chronic pain after their spines were injected with a dye in an X-ray procedure that was used for 42 years. The Daily Telegraph has documentary proof the Federal Government, state health authorities and doctors sanctioned the use of the dye even though they knew the devastating effects of the chemicals in it. The dye enabled doctors to see the spine more clearly in a type of X-ray called a myelogram and was used between 1945 and 1987. Victims of the dye's effects suffer burning back pain, incontinence, loss of bladder control, visual impairment, seizures and paralysis. Known as adhesive arachnoiditis, the disease is caused by the inflammation and fusion of the nerves and membranes of the spinal cord. The condition can take up to 10 years to develop. Derek Morrison, a sufferer who has spent 10 years researching the dye's use and has organised a national support group for around 3000 Australian sufferers, is demanding an independent inquiry into the use of the chemical. Mr Morrison can't believe the government licensed the chemical for use.
"You've seen the chemical make-up of the substance — it contains benzene, hydrochloric acid and sulphuric acid," he said. "How could they ever think that injecting those chemicals into somebody's back would not be harmful?" Doctors were warned not to spill the chemical on rubber because it destroys it and dissolves polystyrene cups. Sufferers want to know why the Therapeutic Goods Administration the federal body charged with checking the safety of medicines allowed its use when studies from 1945 had linked it to a adhesive arachnoiditis. They also want to know why doctors never warned them. They want to know how many victims there are and help to cope with the disease.
The Therapeutic Goods Administration never tested the oil-based chemical iophendylate known as Myodil and Pantopaque which was injected into people's spines. "It was before the Commonwealth began to evaluate drugs of this class," former federal Family Services Minister Senator Rosemary Crowley told state MP Andrew Refshauge in 1994. Documents supplied by Mr Morrison show that in June 1995 the NSW Health Department's radiology advisory committee stated that "Myodil caused arachnoiditis, can cause chronic, severe and debilitating pain and may rarely progress to cause motor and sensory deficits". But it advised that the benefits of the chemical outweighed the risks. Stanley Fraser's life became agony after he had a myelogram in 1976. Aged 69, he is now dependent on 100mg of morphine a day and his wife has to help him dress and bathe. "I get all this pain, like walking on broken glass, problems with my bladder," he told The Daily Telegraph.
His problems began when, aged 43, he had an X-ray for head and neck injuries caused in a coal mine. He said the dye injected before the X-ray was never removed. Four years later he was in such pain he was forced to leave work an invalid and it has taken him until this year to reach a settlement with the Hunter Area Health Service. Documents supplied by Mr Morrison show that although the drug Pantopaque was supplied in breach of the rules to many hospitals in the 1970s the therapeutic goods branch of the Health Department took no action against the supplier. The Therapeutic Goods Administration now says Pantopaque was used intermittently during the 1960s and 1970s but it was only given general marketing approval in 1979. It was at this point it insisted warnings about arachnoiditis be included in the prescribing information, including that it be removed after the X-ray.
But radiologists say it was not standard practice to remove the dye.
GlaxoSmithKline, previously Glaxo Wellcome which owns Myodil, claims there is "no conclusive evidence that Myodil causes arachnoiditis".
A spokesman said the company sympathises with those people who believe they have suffered as a result of Myodil use but it says their original condition or surgery may be the cause of their pain. The company no longer sells the Myodil.
A Prince Henry Hospital radiologist, Professor Palmer, says he performed 1500 myelograms and supervised a similar number from 1966.
He told The Daily Telegraph although he knew Arachnoiditis could be a consequence of the procedure he did not routinely warn his patients about the risk of developing it.
Myodil Related Articles and More
Action Group Calls for Drug Inquiry
Class Action to be Launched Against Myodil Manufacturer
Myodil — The £7m Back Pain
Myodil: The Hon. Elisabeth Kirkby Speaks Out
The Spider Man in a Race Against Time (PDF)
Veteran in Plea for Drug Enquiry
Myodil Survivor Links
Australian Arachnoiditis Sufferers QLD Association
Arachnoiditis Help and Information
Dutch Organization Of Victims Of Medical Contrast Media
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