Glaxo, Myodil and The UK Regulator

Thanks to the Truthman for alerting me to what is yet another Glaxo story that seems to have been brushed under the carpet.

Seroxat/Paxil users may or may not be aware that GlaxoSmithKline have known for some considerable time that use of the drug can cause suicide/ideation in both adults and children - some say they have known for as long as 15 years but failed to warn the public or medicine regulators.

What was Myodil?

Robert Brack of the Myodil Action Group explains:

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 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.

You can read more of Robert Brack's report HERE

Now let me bring your attention to the Medicines Regulator in the UK.

Known then as The Medicines Control Agency or MCA.

As most of the readers on here are aware I have been trying to get answers from the UK Medicines regulator (MHRA). It seems the regulator has a history of protecting those that fund it.

Let's take a brief look at 'Mr A'

He had wrote to the MCA (Now the MHRA) in 1999. He wanted information on Myodil. The MCA wern't forthcoming with the information so he complained to the Ombudsman.

MEDICINES CONTROL AGENCY
Case No A.13/99

Refusal to release information about the drug known as Myodil

Mr A complained that the Medicines Control Agency (MCA) refused to provide him with the information which had been used to examine the safety, quality and efficacy of the drug Myodil. He also complained about the time they had taken to reply to his request. MCA told him that much of the information originated from the company which marketed the drug, and the company had not agreed to it being released. MCA took the view that Exemption 13 (Third party's commercial confidences) and Exemption 14 (Information given in confidence) applied because it was supplied to them in confidence; also, Exemption 2 (Internal discussion and advice) applied to information contained in internal papers. In his comments to the Ombudsman, the Permanent Secretary of the Department of Health endorsed the view taken by MCA and added that they had in fact been unable to find the relevant papers containing the information requested. He apologised for the shortcomings in their handling of the request. Following the Ombudsman's intervention, MCA managed to obtain from the company in question copies of some of the documents which would have been examined as part of the review of the drug. The Ombudsman then approached the company; they told him they no longer objected to information about this particular substance being released, provided that the identities of individuals mentioned in the papers were removed. The Ombudsman found that all the information obtained during his investigation, other than the details of individuals mentioned in the documents, which could be withheld under Exemption 12, should be released. MCA provided Mr A with most of the original documents in a suitably anonymised form. They remained concerned that releasing adverse drug reaction reports would harm the integrity of the system in the UK for reporting reactions to drugs (known as the Yellow Card Adverse Drug Reaction Reporting Scheme). They refused to release copies of hand written adverse drug reaction reports because they took the view that individuals could be identified from their handwriting, but they agreed to summarise the information contained in those reports. The Ombudsman found this to be a satisfactory outcome. He criticised MCA for failing to tell Mr A at the outset that they had been unable to locate the relevant papers. He upheld the complaint.

Read the full investigation into Mr A's complaint HERE

Sounds oh so familiar huh?

In 1995, over 400 people made compensation claims against the manufacturers of Myodil, GlaxoSmithKlein. The company paid out approximately £7m in damages but did not admit liability for the injuries.

'...but did not admit liability for the injuries.'

Deja Vu?

Read the GlaxoSmithKline's position on Myodil from 2001 HERE

Some of the lines sound familiar:

Could the following have been written for Alistair Benbow?

GlaxoSmithKline has every sympathy for people who think they have suffered as a result of the administration of Myodil.

Anybody who suffers side effects of any sort I feel every sympathy for….
Dr. Alastair Benbow
Head of European Psychiatry for GlaxoSmithKline 5/11/03

Hmmm - stuck record eh?

And here is how GlaxoSmithKline defended the symptoms people were suffering on Myodil:

...the symptoms and issues surrounding arachnoiditis are complex, with current medical opinion indicating that people's suffering is most likely due to their original condition

Glaxo's stance on the settlement with Myodil claimants:

In July 1995, after 4 years of legal proceedings over Myodil, Glaxo Wellcome reached a settlement with a group of plaintiffs. This was done without any admission of liability by the company, which took the view that a settlement was more equitable and in the best interests of the parties, not least in terms of the legal costs which would have been incurred.

Quite



It appears that the UK Medicines Regulator has a history of not being forthcoming with patient queries/requests too. Transparent huh?

GSK are still manufacturing drugs. The Medicines Regulator are still investigating them!

Do YOU trust them?

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

AVAILABLE FOR DOWNLOAD HERE


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