Whilst researching the subject
of Arachnoiditis I have very often fantasised about being one
of the great political interviewers, a Robin Day, so to speak. Whilst putting material together for the video I was able to take
this a step forward and put questions together for Isabel and
Carl.
Unfortunately for us all, the
British Government declined our invitation to be part of the
production. I say “unfortunate” because their
refusal only increases any sense of distrust we have and the
doubts that the Great British Public may have about their part
in the Myodil fiasco.
The larger picture, involving
the use of Epidural Steroids, pain blocks, water-based dyes,
and anything else that is injected into the spinal column, is
not covered by this list.
In that frame of mind then, here
are the questions that we wanted to ask, together with the facts
that gave rise to them.
We want to include the questions
that you have regarding the subject of spinally administered
drugs and diagnostic substances.
Please send them in, we will gladly add them to the list
with your name and email address.
We undertake to send the amended
list off to the Ministry of Health on a monthly basis, the longer
the list gets, the more difficult it will be for them to ignore
it. Our covering emails and their replies will
be printed on these pages.
Mike Feehan
GSK = GlaxoSmithKline
Myodil is the British name for Pantopaque,
an oil based contrast
medium, which was formulated at Rochester University (founded with donations from George Eastman) with money from Kodak paying for the research and supplying the base chemicals. Glaxo produced it for the UK market.
Is it not also true that no clinical trials were ever
carried out in the UK?
Many historical researchers claim that
Pantopaque was aimed at solving the perennial problem of 20%
of the workforce reporting sick with back pain each year. The theory being that it would allow doctors to separate the genuine
cases of back injury or disease from those which were not using
a simple x-ray technique, called myelography.
Is this figure of 20% correct for the time and what
proportion of the workforce today is taking time off for the
same reasons?
GSK have told us that the UK government requested that
they produce and sell Pantopaque as Myodil, do we have to take
their word on that or can you verify it?
GSK have also told us that Pantopaque/Myodil had, “…. already
been in use in the USA where testing had been carried out”.
Was that why the UK government accepted the American
data on this product without having it tested for themselves?
Dr Van Winkle of the FDA wrote to the
Chief Executive of the manufacturers in Jan of 1944. His letter expresses doubts with regard to
·
chemical control
of the raw material.
·
quality and
purity of the product.
·
validity of
the clinical trials
·
trialists
failing to report their results after receiving samples.
·
control of
the Iodine content
·
stablility
of the product.
·
lack of a
firm warning to remove it after use.
Was the British Government aware that doubts like these
existed?
If they were, why did they not investigate them?
At the very least should they not have attempted to
clarify how much damage the product could do to patients?
Despite these doubts the product
·
got to market
in the US in May of the same year,
·
was described
by British researchers (Dyson Labs,
Oxford) as “non-toxic”
in June of that year,
·
was wheeled
out for the British Supply Mission in October
of 1944 and
·
then, apparently,
exchanged for Penicillin which (the British desperately needed
in bulk quantities) but did not have production capacity for.
Is it the case that Penicillin was bartered for Pantopaque
in this way?
Would you not agree that such an exchange was hardly
value for money?
Also, can you explain why a product that dissolves plastic
and scars wooden floor tiles could ever be thought of as “non-toxic”
by a government sponsored laboratory?
A prominent member of the 1944 Supply
Mission was Harry Jephcott (knighted in 1947) who, at that time,
was employed by the Ministry of Food as well as being the Managing Director of Glaxo. Glaxo being the UK manufacturer of Myodil.
By our standards, and certainly by the
standards prevailing at the time, allowing
a government employee (Harry Jephcott) to broker a deal which
would ensure his own company’s profits, is, at best, inappropriate and also gives rise to suspicions regarding
the efficacy of the product.
It would appear that such a deal would
not be questioned at the time because the information was not a matter of public record and the harmful effects of Myodil would
not become fully understood until much later.
Would you say that it was not the duty of later government’s,
specifically the Labour Government elected at war’s end,
to question Harry Jephcott’s role, suspend use of the product
and order full clinical trials to ascertain just how toxic it
was?
Can you confirm or deny that Harry Jephcott's visit
to the US during WWII was to investigate Pantopaque as an answer
to the UK Government's request for such a diagnostic tool?
In the US medical papers from as early
as 1942 detailed the toxicity of Pantopaque/Myodil as follows:
1942
Dr Wagenen Rochester University
“The chemical meningitis created
by the presence of this preparation varies a good deal from
time to time. It is distinctly the impression that .................................
the chemical reaction is fairly great and probably greater than
Lipiodol."
(Lipiodol being a toxic predecessor
which was abandoned after some terrible adverse reactions.)
1945 Dr
Tarlov Journal
of the American Medical Association
“However, since the
symptom of the arachnoiditis followed the introduction of the
Pantopaque, the burden proof is with those who disclaim a causal
reaction.”
The
paper closes with this statement:
“.................. there
is no doubt that an inflammatory
and proliferative meningeal reaction may follow the intrathecal
introduction of Pantopaque.”
1950
Dr Jaegar Philadelphia Neurological
Society
“When it (Pantopaque/Myodil)
was injected into the cisterna magna of dogs in the same quantities
as those used of the other oil emulsions, there was immediate
death of the animal within 10 minutes.
This effect, demonstrated in
five dogs, indicates that an emulsion of ethyl iodophenylundecylate
(Pantopaque/Myodil) is extremely toxic - even much more irritating
than similar emulsions of the iodised oils previously used.
The lesson to be learnt from
this study is that iodised oils should be instilled into the
subarachnoid space with due regard to their potential irritating
property and, to prevent ill effects, they should be removed
completely whenever possible, either before or immediately after
the surgical procedure.”
“It is beyond doubt the most valuable material yet devised for this
purpose for the reason
that it can be (and should be) entirely removed at the completion
of the myelographic study.”
These
are not state secrets and obviously point to the facts that
Pantopaque/Myodil is extremely toxic and should be removed,
as far as is possible, from the patient’s spinal column.
They also stress the point that it should not be used
as a matter of routine.
Why
was the Ministry of Health, the ultimate purchasing authority,
ignorant of these papers?
If
they were not, how then did the substance come to be used routinely
in the NHS?
What
procedures are now in place to ensure that tragedies like this
never occur again?
Glaxo
have stated in the past that and confirmed to us that data sheet
informational statements were, ".... consistent with medical
knowledge of the product at the time.".
Given the examples of contradictory
medical journal articles, which we have quoted, would you support
that statement?
It
is widely known that Myodil/Pantopaque dissolves syringes made
of modern plastics, it also eats away at rubber and damages
floor tiles. Separate publications in the medical literature appeared in the
years following it's introduction which warned of such damage.
We have to ask, once again, why the
then Ministry of Health, missed these warnings?
Another question which raises it’s
head is why the Ministry of Health thought at the time that
the proposal to inject a toxic substance into the most delicate
part of the human control system was safe?
What is the Department of Health’s
current position on intrathecal and intraspinal injections?
We also have to ask, given the preponderance
of the evidential material, why patients who have had this material
injected into them and later claim to be in pain are treated
with disdain, not only by the medical profession, but also when
trying to claim their benefits?
Knowing that Pantopaque/Myodil was not used in the Scandinavian countries
we asked them why. The
following statements are part of
their answer which took almost 12 months of study. .
“…..
the decision already around 1935 by the leading Swedish neuroradiologists
not to use oil based contrast media was mainly based on clinical
observations among their own patients rather than on published
or unpublished scientific examinations.”
From a paper in the American Journal of Neuroradiology (AJNR) in 1995
about the Stockholm School of Neuroradiology by the two famous
Swedish Neuroradiologists, Professor Erik Lindgren and Professor
Torgny Greitz
"The
Stockholm School took a stand against the use of these (oil
based) contrast media at an early stage, and they were hardly
ever used in Sweden. Considering the number of postmyelographic
arachnoiditis that are now reported, this may seem to have been
a wise
decision."
Professor Lindgren in 1984:
"It
may seem strange that oily based contrast media, especially
Pantopaque, were used to such a large extent (especially in
America), since these contrast media doubtless caused arachnoiditis
……….”
Given such positive statements as these, how can the government
continue to hand out patronising statements concerning the “state
of the medical knowledge at the time”, and “doctors
were using the only tools available for the job” and expect
us to believe them?
The Myodil package insert for 1953 contains the statement:
“Myodil contains 30% organically combined iodine: it is a mixture of isomeric ethyl iodophenylundecylates,
the chief constituent probably having the following structural
formula…” Even
for the time" probable knowledge" of the chemical
formula would have been unacceptable to the public at large
had they known it.
Why then did the government, as their representatives,
also consider this language to be acceptable?
Figures in the MCA file show that the number of reported
reactions to Myodil (iophendylate) climbs in the early 1970's. Whilst Glaxo's
Dr Snell intimated to the CSM,
in 1972, that this
rise was the product of hysteria on the part of patients who
may have heard of an adverse reaction, or a batch recall. He
also blamed many other factors in correspondence with the CSM
and concerned hospital staff including,
·
The sterilising agent used to clean equipment.
·
The possibility that plastic syringes may have been used.
·
The possibility that rubber components may have been used.
·
The fact that the patient was moved too soon after his myelogram.
·
The possibility that certain patients might have something in their CSF.
All of these are
taken from Glaxo’s letters dated 1972.
Glaxo themselves inserted a warning about
Arachnoiditis onto their 1971 package insert, but that was consistently
ignored.
Why did the Committee on the Safety of Medicine
accept such ridiculous and obviously bogus arguments when the
truth had already been printed on the package inserts?
Another obvious question is why, given the
number of incidents reported, the CSM took no action at all?
In
his letter of 14th September 1972 to the Committee on the Safety
of Medicines, Dr Snell thanks them for sending him a list of
patients who had complained to them about Adverse Reactions
involving Myodil.
Why
is this government body, set up to monitor and investigate Adverse
Reactions, sending details of such complaints to the company
concerned, and yet they take no action to suspend or withdraw
the product from use?
Surely,
given the reason for the changes to the package inserts the
year before, these incidents should not have puzzled him. The CSM, as the Government agency policing
medicines, should also have wanted real answers and not excuses. It was also hinted in earlier correspondence
from the CSM that the iodine content had varied over batches
and could be causing adverse reactions.
What
tests were Glaxo required by law to carry out to confirm the
chemical content of their product?
If
Glaxo did carry out such tests and then reported back to the
CSM, were documented records kept which the government can now
reveal to reassure the public that this level of iodine was
constant and not variable?
In his letter of
21st June 1972 to the CSM, Dr Snell discusses further new adverse
reaction reports and concludes, "there
is no legal action contemplated as a result of these reactions". Surely the possibility of damage to patients
should have been the primary concern, not the possibility of
legal action by them.
Why is he stressing the possible legal ramifications
to a Government Organisation and why didn’t the CSM take
any action regarding these new adverse reactions?
Our list ends here.
The ball is now in your court.
Please email your suggested questions with the reason
you want it answered to us under the heading “Government
Questions”. We will tack it underneath with your name and
contact details and include it in our next monthly posting.
Any answers we receive will be posted here in blue script. Keep
watching this space.
Copyright Mike Feehan 2002
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