Myodil Action Group (UK)



Kenneth Winter
98 Church Street
Langford
Nr. Biggleswade
Bedfordshire
SG18 9NX

The Rt. Hon. Stephen Dorrell, M.P.
House of Commons
LONDON
SW1A 0AA

Dear Mr. Dorrell,

I am writing with reference to your letter dated 20th June 2011. The letter needs a response as a lot of the information from the MHRA spokesperson, for which you were basing your decision upon, needs to be challenged. In addition, in your covering letter, you point out the crucial sentence that is stopping progress. This statement needs to be contested strongly, and with that in mind, the Myodil Action Group wrote to an expert in the field of adhesive arachnoiditis for clarification.

PART 1

I will deal with the point of the crucial sentence first, then move on to the misleading report given to you by Sir Alasdair Breckenridge (Chairman of the MHRA). The crucial sentence you identify is as follows.

Although we have considered the arguments of the Myodil Action Group we do not have sufficient evidence to distinguish and isolate causation in individual cases that could equally have been caused by the original condition or by post treatment surgery.’

You state that challenging this needs the intervention of the relevant Ministers, and though you say this is not something for the Select Committee, I would hope that, after the explanations herein, you would put your weight behind our challenge in your role as an MP.

The sentence is untrue and unjust for a number of reasons. Many of our myodil sufferers did not have operations and the ‘myodil-enhanced’ x-rays showed no signs of arachnoiditis scarring. This rules out the original condition and post treatment surgery leaving myodil as the sole cause, therefore, there should be no further objection to these people receiving damages as the crucial sentence cannot apply in these cases. Then there are the cases of those who had to receive emergency operations because of an immediate reaction to the myelograms (again, the x-rays eliminate pre-existing arachnoiditis): these cases cannot be laid at any other door but myodil. So, with these two groups of people it is easy to distinguish causation and it is wrong and unjust to ignore them just because it is claimed that some other victims may have had complications.

However, the main challenges are with regard to all the arachnoiditis victims. With special regard to the ‘crucial sentence’, MAG asked a leading expert in the field of arachnoiditis – Dr. Charles V. Burton – three questions relating to the MRHA letter. Dr. Burton has been researching and publishing in regard to arachnoiditis for 30 years in a country that has not only excepted the condition, but has made compensation payments to its victims. In his answers, Dr. Burton explains that there are indeed other causes of arachnoiditis, but also that any disability relates to the exact nature of the inflammatory reactions produced: this means that, we know which symptoms are related to the toxic chemical meningitis produced by myodil.

He also explains that arachnoiditis produced by surgery has no clinical significance whatsoever: this agrees with the many statements made by British specialists with whom MAG’s members have spoken. In other words, any arachnoiditis produced by subsequent surgery is irrelevant; also remember, the very x-rays produced using myodil, rule out pre-existing conditions. With no pre-existing or post surgery complications, the ‘crucial sentence’ is seen for what it is – i.e. nonsense. My personal feeling is that the clinicians deliberately put this red herring forward to blind MPs into wrongly thinking that there are complications preventing redress for myodil victims.

Dr. Burtons full two-page letter is attached: it contains genuine information pertaining to the case. A summary of the letter is as follows: Dr. Burton is clearly stating that it is possible to differentiate between local arachnoiditis and diffuse adhesive arachnoiditis. He also states that local arachnoiditis that is of a trauma or post-surgical nature, produces little in the way of clinical symptoms.

Remember, Dr. Burton is one of the foremost authorities on this subject: in his letter he states that the use of oil based substances (e.g. myodil) for radiographic purposes has accounted for the greatest number of cases of clinically significant adhesive arachnoiditis; and that the substances Pantopaque and Myodil have clearly, in all cases, produced a toxic chemical meningitis to some degree. He is saying, clinically significant adhesive arachnoiditis is produced my myodil and not by other causes.

PART 2

The second part of this letter is to contest the information (in the MRHA letter) that you were given with which you made your decision that our case is outside the remit of a Select Committee.

Paragraph 2: This paragraph is outrageous and is a pointer for things to come. It seems that even to the Chairman of the Select Committee, these guilty parties are prepared to muddy the waters and try to distract from the truth. This paragraph states that myelography remains a valuable tool available to healthcare professionals: it gives the impression of a perfectly useful product still in use. Nothing is further from the truth. Banned by Sweden in the forties and by Russia in the fifties it is not seen as a valuable tool. In the UK, myodil has been withdrawn from the markets (for “commercial reasons”) and isn’t used at all. I challenge Sir Alasdair Breckenridge so show where it is still used by our ‘Healthcare professionals’ as he implies. In fact, our investigations show that there is a debate amongst radiographers and healthcare professionals about whether myodil had any beneficial effect on x-rays at all: but this is all just another red herring to take your eye away from the ball: it has no particular relevance to the damage caused by myodil.

Paragraph 3 states the CRM has reviewed the safety, quality and effectiveness of Myodil and granted it a reviewed product license. This is another reason why the Select Committee needs to investigate. Our evidence has shown that animal tests showed myodil to be so dangerous that tested dogs had to be put down early because of their suffering. The whole process of obtaining a license for myodil was flawed – it received a license solely because it was already in use before licensing came into practice. In the light of the animal tests and the serious warnings of side-effects, if the CRM has reviewed the product since the original grant, then its findings need to be looked at very carefully to ascertain how such a dangerous product could permitted to be sold. Our investigation of the paperwork reveals a dubious licensing trail.

Paragraph 4 illustrates a very important injustice done to myodil patients. It describes that clinicians knew that myodil was associated with the painful, chronic condition of arachnoiditis. It states that,

Warnings were included in the Myodil product information supplied to doctors……….. that it was known that post-myelography adhesive arachnoiditis may occur ……….. and may be increased by failing to remove the dye at the end of the procedure……’

This is another aspect that the Select Committee needs to investigate: the extreme dangers were well known; yet none of our members was warned about them. Many of our members underwent myelography for trivial symptoms – myodil was used quite casually and frequently. In addition, the instructions stated the importance of removing the dye at the end of the procedure; this final step was ignored completely by clinical practitioners.

Solicitors that MAG has spoken to argue that this implies that, not only was there no informed consent for these medical procedures, but that the failure to follow Good Clinical Practice could amount to criminal negligence. This is not the route that MAG wanted to go down, but we are losing all other options by the repeated refusals of Health Officials and Ministers to tackle the problem appropriately. We think that a Select Committee investigation, where expert witnesses, other than the guilty parties, are also listened to. It is not an investigation, if only one side is allowed to speak.

Paragraph 5 this paragraph is very important and has been tackled in PART 1 of this letter. Our evidence, we believe, shows this paragraph to be largely nonsense for a number of reasons already described. None of this paragraph should be read in isolation of PART 1 of this missive.

Paragraph 6 states that the issue was considered at ministerial level by a number of people and all concluded that no public enquiry would be held. What it doesn’t say is that all these ministerial levels used the obsolete, one-sided, unacceptable Hayman Report with which to base their decisions. We know this because the Ministers all quoted Hayman as a reason for inaction. The Hayman Report, a short document, was out of date before it was printed. A thorough investigation of the Hayman Report was made by MAG: here, hundreds of people were interviewed and written statements produced that challenged almost every line on the report. A rebuttal of the Hayman report was produced that invalidated the Hayman report. MAG believed this rebuttal to be the second step of a dialog with officials. However, and this is another reason why we think the Select Committee should help, we have had no dialog whatsoever. The rebuttal was ignored and the only answer we receive to our questions and challenges is that the Hayman report states that nothing needs to be done: much as you have just received in Sir Alasdair Breckenridge’s letter. We have never had a reply to the rebuttal. Ministers, MHRA and DoH authorities have hidden behind the discredited Hayman Report, a report that as a start to a dialog may have been of some use, but which, as a final arbiter, is not worth the paper it is written on.

I must repeat, that all the ministerial ‘considerations’ mentioned in this paragraph, were based on the obsolete and incorrect Hayman report. There has been no reference to MAG rebuttal, or to any question posed therein. I strongly suspect that clinicians never showed the rebuttal to any of the Ministers involved. Every time there is a ‘consideration’, the Minister goes to the guilty parties for clarification, and completely accepts their explanations without question: this is another reason why we think the Select Committee should intervene. Ministers, frankly, are just going through tick box actions and not investigating what is a very serious injustice. Adhesive arachnoiditis patients cannot even get palliative care from GPs as there is no adequate knowledge in the medical community, and no recommended procedures of care for these people harmed by the medical profession. We really need the Select Committee to force a fair and professional investigation to alleviate suffering.

Paragraph 7 the last paragraph says that risks, benefits and side effects were weighed up by individual clinicians: but a clinician cannot weigh up these issues without the patient. Patients must be involved in decisions about their own health, especially where there are extreme risks. Clinicians cannot be allowed to perform dangerous invasive procedures, often for trivial conditions, and keep the knowledge of severe risks to themselves. These procedures were carried out quite casually. Moreover, clinicians took it upon themselves to ignore Good Clinical Practice by not removing the toxic chemicals after use. MAG thought that the Select Committee ought to force clinicians to take action to aid adhesive arachnoiditis victims, and to force all officials involved to enter into dialog with their long-suffering victims. Remember, this is an iatrogenic disease, a disease created by the very clinicians who are hiding behind the discredited Hayman Report.

Summary

We have not been able to receive any answers to our questions from Medical officials, Civil Servants or Ministers: they have refused any dialog, despite the support of a good number of MPs who believe that there is a great injustice occurring.

We have shown expert testimony (attached) that refutes the issues used by Sir Alasdair Breckenridge’s to defend clinicians’ actions.

We have shown how the MRHA constantly fog decisions with irrelevancies and illogical thinking. We receive no answers to questions put to DoH or Ministerial officials and no true investigation has taken place: an investigation needs to hear both sides of the arguments; since the one-sided Hayman Report was produced, further inquiry has been forbidden.

MAG understands that you may still decide that this is not a matter for a Select Committee; we hope that this is not the case, but if it is, we hope that you would decide to support us in your role as an MP, perhaps in helping us challenge the sentence you rightly pointed out as being crucial and by recommending to the present Minister of Health to hold a genuine investigation. I fear that another appeal to a new Minister of Health will be met by the discredited Hayman report unless we have political support that is more educated on all the issues of this case and support that is willing to demand answers to outstanding questions.

People are suffering greatly, many have died in great pain after years of suffering, others have taken their lives, and those still living have this to look forward to: the least that should be done is that a fair and proper inquiry should be undertaken.

My apologies for the length of this letter, but the number of inaccuracies in the MRHA letter that was sent to you has forced this. I would like to finish this letter by thanking you, Mr Dorrell, for taking the time to read this and reconsidering your decision in the light of our questioning. I hope that in some way, in the future, you can lend weight to our cause.

Yours Sincerely


K. Winter