Document No.3 -
Package Insert Warnings 1971

So, having read what goes before, we now know that Glaxo, in whichever guise are saying the same, thing, "We warned everybody about the dangers of Arachnoiditis on the 1971 Package Inserts".

Here we publish the relevant sections of those Package Inserts which form their defence against culpability. Please note the differences before moving on to our final document in this series. I would also like to bring to your attention that these package inserts were clearly marked: "For the medical profession."

The patient therefore was most unlikely to have access to them. So who is repsonsible for the patient being deprived of their right to "informed consent"? Both of our examples contain some medical vocabulary which the general public does not have to deal with. Here is our short glossary of terms which you should read before proceeding:-

Aspirate
A procedure to remove fluids from the body using a syringe.

Cerebrospinal Fluid
A clear, colourless fluid which contains small quantities of glucose and protein, it bathes the brain and the spinal cord.

Contrast Medium
A substance that is introduced, using a syringe and catheter, in this case, into the sub-arachnoid space, and, because of the difference in abosorption of x-rays, ensures that doctors can see that structure in greater detail than would be the case without it.

Lumbar puncture
A dianostic procedure where a sterile needle is introduced into the lower spine to collect cerebrospinal fluid for diagnostic purposes.

Lumbo-sacral
Lower part of the back from just below the ribs to the sacral, or tail bone, structure.

Iophendylate
This is the chemical name of both Myodil and Pantopaque. Supplied to Glaxo, through the British Drug House, this substance was merely sterilised and bottled before being shipped out as Myodil.

Photophobia
Abnormal intolerance to light.

Pyrexia
A fever type reaction which causes high temperatures.

Sciatica
Pain radiating from the back into the buttock and down into the legs.

Subarachnoid space
The space between the arachnoid layer of the spinal cord and, the interior layer, the pia mater, which encloses, and protects, the spinal nerves.

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Package Insert Warnings - February 1971

After Effects
These are only slightly greater than after simple lumbar puncture. Some workers aspirate as much Myodil as possible after radiological examination has been completed. Other radiologists leave the contrast medium in situ and it is stated that no harm ensues. The material often tracks down the nerves sheaths in the lumbo-sacral region, or remains in the lumbo-sacral sub-arachnoid space. It is slowly absorbed, about fifty per cent disappearing after a year.

Contra-indications
As for simple lumbar puncture. The examination should not be made within 14 days of a previous lumbar puncture.

Package Insert Warnings - August 1971

Contra-indications
As for simple lumbar puncture.

Warnings
In the presence of blood in the cerebrospinal fluid (arising either as a result of lumbar puncture of the original disease) myelography with Myodil may cause sever after-effects. Under these circumstances the examination should be postponed. If Myodil enter the blood stream, it can cause shock and violent coughing.

Ideally, all glass syringes should be used, as Myodil may dissolve out toxic substances from some plastic syringes and/or their rubber plungers. If a plastic syringe is employed, the Myodil should be drawn into it immediately prior to injection to minimise contact with the syringe.

Precautions
If possible, ten to fourteen days should elapse between lumbar puncture and subsequent myelography.

Many workers remove as much Myodil as possible after myelography in the belief that this reduces unpleasant after-effects. However, when only moderate amounts of the medium are involved, some consider it better not to aspirate if this requires another lumbar puncture.

Adverse Reactions
Provided a suitalble technique of injection is used, preferably with television control, serious after-effects are rare. As with simple lumbar puncture, headache is frequent, and after myelography it is sometime severe, with vomiting and photophobia. Pyrexia and stiff neck can occur, usually soon after myelography; rarely, they appear some weeks after the examination. Symptoms normally resolve within several days. Some patients react to myelography with low back pain, an previous symptoms such as sciatica may be exacerbated.

Occasionally arachnoiditis has been reported, but that type of reaction has not been associated with a specific disease or technique of investigation. The literature contains references to adhesions and fibrous exudate being found on operation in patients who had at some time undergone myelography with iophendylate. The sporadic nature of these reports, and sometimes the sparseness of information about the patient's condition prior to myelography, make it difficult to evaluate the role of Iophendylate. However, these reports probably add weight to the case for removing as much Myodil as possible at the time of investigation.

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