Document No.1A - The Questions Answered(?)

The answers to your questions are as follows:

Q: Does Glaxo accept responsibility for those people who have been disabled by Myodil induced chronic Arachnoiditis?
A: Whilst the company has every sympathy for patients who think they have suffered injury as a result of the administration of Myodil, Glaxo believes it acted responsibly at all times in relation to the supply of Myodil. Glaxo supplied this diagnostic product to meet the needs of a very knowledgeable and specialist medical profession for many years, until it was superseded by newer products and technology. (Note 1)

Q: Do you have any idea how many people in Britain had Myodil myelograms between 1945 and 1987?
A: Using sales of Myodil as an indication we estimate that over 300,000 patients received a myelogram using Myodil.

Q: Do you have any idea how many people suffered long-term spinal damage as a result?
A: No, we do not. The symptoms and issues surrounding arachnoiditis are complex. Current medical opinion indicates that the symptoms of which patients are complaining are most likely due to the original condition, degenerative back disease, or surgery and other medical procedures. It should not be overlooked that people undergoing myelograms were by definition already back-sufferers. (Note 2)

Q: Given that Glaxo acknowledged in its product data sheets from August 1971 onwards that arachnoiditis could result from Myodil myelograms, would Glaxo like to offer an apology to those people who have suffered long term spinal damage as a result of Myodil myelograms?
A: We have every sympathy with people who think they have been injured, but the company believes that it acted responsibly at all times. All pharmaceutical products have side-effects which doctors have to take into account by weighing up against the benefit to be gained by using the products. The company warned of the possibility of arachnoiditis as soon as it became aware of the issue. (Note 3)

Q: Is Glaxo prepared to consider a compensation scheme for those sufferers who were not among the 425 who benefited from the 1995 settlement.
A: The settlement was achieved following over four years of complex litigation involving the in-depth analysis of individuals' medical records. Over this period (and before) the issues surrounding Myodil and arachnoiditis were subject to extensive publicity which gave potential claimants the ample opportunity to put forward their cases in the lead-up to the settlement. We therefore consider the matter closed. (We are of course in the process of working towards similar settlements in Scotland and Northern Ireland.) (Note 4)

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Q: What safety and toxicity tests did Glaxo carry out in the development of Myodil?
A: When Myodil was first sold by Glaxo at the request of the UK government a very similar product had already been in use in the USA where testing had been carried out. Glaxo carried out chemical and animal testing which was extensive by the standards of the time. Even using today's standards it is not possible to devise testing in patients which would have been scientifically or ethically appropriate. Initial use in patients at least two major hospitals was carefully monitored by Glaxo. (Note 5)

Q: What evidence did Glaxo rely on for it's February 1971 data sheet information that Myodil had "little or no irritant effect" and would be gradually absorbed?
A: These statements were consistent with medical knowledge of the product at the time. It was not until 1971 that Glaxo received a report of chronic arachnoiditis associated with the use of Myodil. (Note 6)

Q: Why did the data sheets never insist on aspiration of Myodil following a myelogram.
A: Glaxo recommended aspiration but recognised that aspiration was a difficult procedure which could cause considerable discomfort and even nerve damage. Therefore a medical judgement had to be made by the doctors involved on a case-by-case basis. (Note 7)

Q: Why did you not respond to earlier concerns in the medical literature about the link between Myodil and arachnoiditis before August 1971?
A: We do not believe that the earlier literature showed that there was such a connection. In April 1971 a case of chronic arachnoiditis associated with the use of Myodil was reported to Glaxo. Although it was uncertain whether Myodil was the cause of the arachnoiditis, Glaxo at that time inserted a warning in the package insert.

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Q: What research did you ever fund or carry out to determine the incidence of Myodil induced chronic arachnoiditis?
A: We do not believe that there was any acceptable research which would have given us the information. Research before the introduction of non-invasive techniques such as magnetic resonance imaging (MRI) would have required administering myelograms which would have been the only way of diagnosing arachnoiditis. This would not have been ethically acceptable. (Note 8)

Q: What do you believe the incidence to be, as a percentage, and what do you rely on in support of that belief?
A: It isn't possible to arrive at such a figure for the reasons given earlier, i.e. the symptoms and issues surrounding arachnoiditis are extremely complex, with current medical opinion indicating that people's suffering is due to factors such as their original conditions, degenerative back disease or surgery and other medical procedures.
(Note 9)

Q: Glaxo was told in 1971 that the toxicity of Myodil was "surrounded in mystery". What was done to solve that mystery?
A: As indicated in the answer above chemical and animal testing had been undertaken. To undertake further research prior to the introduction of non-invasive techniques such as MRI would have required undertaking a myelogram. It was considered unethical to administer myelograms solely for research purposes.(Note 10)

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Q: Glaxo conducted a reviews of Myodil and concerns surrounding it in October 1971. What action was taken following that review?
A: As stated earlier in 1971 a case of chronic arachnoiditis associated with the use of Myodil was reported to Glaxo. As a result and despite it being unclear whether or not Myodil was the cause of the arachnoiditis, Glaxo inserted a warning in the product's packaging. (Note 11)

Q: Given the "mystery" of toxicity, the spate of ADRs in 1970 and 1971 and the growing evidence in medical literature of a link between Myodil and chronic adhesive arachnoiditis, why was the product not withdrawn until 1987?
A: The product was not withdrawn. Rather, it was discontinued when other products and procedures were available and the doctors had become skilled in using them. (Note 12)

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Note 1- Mislead Medical Profession(?)
As we will show you in the Medical Archive Section "this knowledgeable and specialist medical profession" were mislead into believing that the product was non-toxic by the first paper on it in 1944. The US package inserts also praised it as an absorbable substance, which it is not.

My own dose of Myodil from 1974 lights up my 2001 MRI scans.

We now have copies of the Glaxo package inserts for 1953 to 1971. Extracts from the relevant ones are included here. We will be publishing them in full in due course.

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Note 2 - "Muddying the waters" - Underlying Injuries
This is hogwash heard time after time, in courts in the US and the UK, pharmaceuticals companies have employed their own medical experts to "muddy the waters".

Derek Morrison's case is another example of this "muddy the waters" process. Towards the end of his compensation hearing the defendant's medical expert, Dr Petty, produced a scenario on the flight down to Sydney.

This proposed that the disc which had originally caused his pain had been traumatically thrust forward by something (he did not know what), and had damaged the spinal cord in that area. This was solidly repulsed by the Plaintiff's experts as a very creative, but inaccurate piece of nonsense.

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Note 3 - Spreading the Word?
Like Mr. Garner, who interrogated Barry Newton of Lafayette in 1994, I would like to know what methods, apart from the small print on package inserts, either Lafayette or Glaxo took to underline these dangers to the medical profession and their patients?

Note 4 - Adverse Reactions and Time
Sometimes, as all Arachnoiditis sufferers know, the adverse reaction may take as much as 20(plus) years to cause enough damage leading to identyfiable symptoms. What about those who are now disabled but were not in 1995 and furthermore had no knowledge of this action.

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Note 5 - Reviews of the Literature
Did they carry out an extensive review of the literature at the same time? This is the usual practice. If it was extensive, why did they miss the comment on the 1944 paper by Strain, et al, which stated that the sequelae (arachnoid cysts) in patients who were injected with Iophendylate were smaller than those with Lipiodol.

Can they tell us why the initial paper in the UK described the product as "non-toxic"? Did they take any notice of Tarlov's 1945 paper and Jaegar's paper in 1950, amongst others?

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Note 6 - Absorbability
Please refer to the Newton Transcript on the subject of absorbability. There is also report from Dr Snell of Glaxo to the Committee on the Safety of Medicines which is reproduced below. Click here.

Note 7
Their 1973 package insert states: -

Dosage and Administration
Myelography: In general sufficient Myodil is introduced into the spinal subarachnoid space to allow all the structures under suspicion to be outlined by simple posturing of the patient. Usually 6 to 9mls are adequate. Occasionally up to 18mls are necessary if the subarachnoid space is wide. The material should be removed by aspiration after the examination unless it is required for further study.

We know from our research that the doctors in the UK usually left the Myodil
inside the patient in, this was a general practice. In the USA they normally aspirated (or removed) Pantopaque - the US version.

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Note 8 - And the Scandinavians
Was it also acceptable to ignore the research being done in the Scandinavian countries on a water based contrast agent? Why did they feel that was neccessary?

Note 9
So they could compare the number of cases of arachnoiditis reported to them with the amount of product sold, averaging out the dose at 5mls to take account of variances in dosage between 3 and 9mls.

Note 10 - The Scandinavian rejection of Myodil and Pantopaque.
Did this not concern a company who were trying to win world market share? Did they not question why their product was rejected?
If there were doubts regarding Myodil, which there obviously were, did Glaxo not think it unethical to keep injecting it into peoples' spines, thereby ignoring those doubts, which existed among physicians and patients?
Thirdly, the continuing sale and use of Myodil despite the doubts, was this not just a larger experiment on the part of Glaxo to see how long they could keep the product going? Like Lafayette in the US, Glaxo ended the war without any major products for the market except this one.

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Note 11 - Doubts?
Surely any doubts surrounding a product are unacceptable. The product should be withdrawn and only released again once those doubts have been fully investigated. Any continuance of sale and use following such doubts being raised is unethical.

Note 12
Though now thought to be almost as dangerous as Myodil, water based contrast media were available from the invention of Isovue in 1959 and Amipaque in 1969. Did Glaxo not consider replacing the old oil based products in favour of these less dangerous water based substances, or, were they locked into some agreement with the producers of Iophendylate - Kodak?

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