Wednesday, January 20, 2010
Glaxo's Myodil and Seroxat - A case of Déjà vu?
I've been reading about Glaxo's drug, Myodil and the UK group action that was 'settled out of court'. It bears striking similarities to the current UK group action regarding Glaxo's Seroxat.
Sadly, the original location of this post has been removed but it still remains on an Internet forum where it was disseminated.
Here is the post in its entirety. All credit goes to the original author, whom I believe was part of the Myodil Action Group.
You will note how the MHRA, then the MCA, conveniently 'mislaid' the Myodil licensing history. You can draw your own conclusions to that 'mishap'.
Magazine Issue 10 - Spring 2000
Toxic drugs are good for you
This January, 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 targetting 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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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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About the Author :
Bob Fiddaman has been writing about the dangers of antidepressants since 2006. In 2011 he was presented with two human rights awards from the Citizens Commission on Human Rights.
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