Document No.4 -
The Doctor tells the tale - 1972
Extracts from Glaxo's Letters to Hospitals and the MCA
These are signed by Dr Snell - Medical Director
Replying to various concerned
hospital doctors and the Committee on the Safety of Medicines,
Dr Snell attempts to explain away instances of Adverse Drugs
Reactions following Myodil myelograms.
Please note that he never
brings the readers' attentions to those all important changes
on the 1971 Package Inserts regarding Arachnoiditis. But
everything else, including the cleaning fluid is blamed
for these reactions.
9th May 1972(1) to a complaining
Hospital
It seems probable that the action of recalling these Batch
Numbers has alerted people's excessive suspicions about
the product and led them to report reactions that might
otherwise not have been thought to be out of the ordinary
from the procedure. Hence some of the reactions we would
not think are unexpected and take the form of an increase
in the patient's pre-existing symptoms or a mild degree
of backache and headache
9th May 1972(2) to a complaining
Hospital
It is an unusual situation in which there is a certain amount
of symptomology to be expected from myelography with Myodil
- the incidence and severity varying in a rather unaccountable
manner. If in a Centre where a number of such investigations
are being done there arises any suspicion about the product
or procedure, then it seems as though the physicians concerned
with it can become excessively alarmed with these symptoms.
These form the basis of an epidemic of complaints to us
(and perhaps to you) but ones which are not repeated at
other centres where there may not have been the same feeling
of anxiety.
............. There is
a curious delay in the onset of these meningeal sterile
inflammatory reactions. Some of them seem to have been quite
severe. I cannot account for them.........
11th May 1972 to a complaining
Hospital
............. wondered it certain patients because of some
biochemical variation, had something in their CSF which
reacted with Iophendylate ("Myodil") to produce
an irritant substance. .........otherwise I am afraid these
reactions remain a mystery.
14th June 1972 to the Committee
on the Safety of Medicines
... Davies reports that in 125 myelogarms 70 patients showed
"abnormal reactions", while that by Wright et
al states that in a series of 223 myelograms the authors
only saw minor sequelae.
21st July 1972 to the Committee
on the Safety of Medicines
........... One patient was moved by ambulance to another
hospital not long after myelography and this may have played
some part in the adverse effect he suffered. Otherwise we
could find nothing relevant.
The writer
then discusses three other patients, one had it all removed
and his symptoms settled the other two were given hydrocortisone
injections after remaining Myodil became fixed and their
symptoms settled. But what is it that concerns the writer
most? His next sentence tells it all.
As far as is known there
is no legal action contemplated as a result of these reactions.
14th September 1972 to
the Committee on the Safety of Medicines
Thank you very much for your letter of 11th September 1972
about Myodil reactions. The list of patients who have encountered
reactions that you sent is most helpful. We will compare
the list of patients with our own list and then write to
you again.
12th October 1972 to the
Committee on the Safety of Medicines
............., it appears from the attendant correspondence
that there has always been a tendency for the reports (of
Adverse Effects) to come in bursts. This seems to have been
either as a result of grapevine contacts with the source
of a spontaneous complaint or sparked-off by a notice of
withdrawal of material, which rare occurrence has always
been for reasons unconnected with clinical complaints.
............. Certainly
I would welcome an opportunity to compare the details contained
in our respective registers in order to bring them into
agreement one with the other.
There are
no further letters of complaint in the MCA file. Therefore,
should we just assume that 1972 was a bad year? I think
not. Glaxo compiled the file in my possession after the
MCA admitted that they had "lost" their original,
still it is nice to know that everything else in the world
was reponsible for these reactions.
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