Sign
the Myodil Action Group e-petition
Index Page 2
Please note: When referring to Myodil, Pantopaque,
and Ethiodan, they are marketing names given to the chemical
Iophendylate which is one of the contrast mediums used in myelograms.
Pictures and Diagrams
This page contains pictures and diagrams which help to explain in a graphic
nature the devastating effects that Myodil has on the spinal cord. Also the
chemical composition of Myodil.
Information on Iophendylate
Patent
1942: Steinhausen conducted his doctoral thesis (funded by Eastman Kodak) on Iophendylate. He conducted tests on Rats and Dogs to
compare the affects of Lipiodol with Iophendylate. The tests showed
that Iophendylate had the same affect on the spinal cord as Lipiodol,
he discovered cysts in the arachnoid layer which he attributed to a
foreign body reaction. Nevertheless,
in
his paper, Steinhausen concluded ?With the assurance from these
experimental studies that the new medium was safe." (Link
to
journal article on Burton Report).
1942: Van Wagenen (a neurosurgical colleague of Warrens, at the
University of Rochester) identified Iophendylate as causing chemical
meningitis in 30 patients. Van Wagenen states the severity of the chemical
meningitis in closed spaces such as those created by a tumour is worse with
Iophendylate than Lipiodal. (Link
to
Van Wagenens speach on Dr. Burtons website)
FDA Hand Written Letter to Walter Van
Winkle about Lafayette's Pantopaque (1943)
This is a hand written letter which I believe was sent from a FDA
investigator to Walton Van Winkle regarding the dangers associated with
Lafayette's Pantopaque (Myodil). I have published the original
letter, but is very difficult to read so I have typed it out again
underneath but there are words which are illegible, I have typed in red what
I think they are.
A letter from Walton Van Winkle of the FDA to
Lafayette (1944)
Van Winkle expresses concerns about quality control during manufacturing of
Pantopaque, adverse reactions of animal tests and reports of the same in
Humans. He was also unhappy about the lack of testing for free Iodine
in the product and other concerns. These issues were never resolved.
1944, A letter from R.P. Herwick M.D. Chief of
Drug Division, FDA to Lafayette granting permission for the marketing of
Pantopaque.
Tests on Dogs which died within ten Minutes,
1950
A paper by Dr. Rudolph Jaeger published in the Journal "Archives of
Neurology and Psychiatry," about Iophendylate (Pantopaque) tests carried out
on dogs, the dogs suffered severe reactions to Pantopaque and were dead
within ten minutes.
Death of a Man Caused by Severe Reaction to
Myodil, 1952
Short report in The British Medical Journal dated 30th August 1952 about a
man who's death was caused by severe epileptic fits due to a reaction to
Myodil.
Death of a Man Within 15 Months of Undergoing
a Myelogram, 1953
A case study written by Dr. Theodore C. Erickson and Dr. Hans J. van Baaren
published in the Journal of the American Medical Association describing a
case study of a man who underwent a Pantopaque Myelogram, the Pantopaque
entered his cranium and triggered a severe reaction, causing his death
within 15 months of undergoing the procedure.
Experimental Data and Case Studies 1954
Summary of experimental data and case studies by Dr. Everett F. Hurteau, Dr.
William C. Baird, and Dr. Ernest Sinclair, published in The Journal of Bone
and Joint Surgery. The report shows the damage Pantopaque caused to to the
brains of test dogs, and concludes that the assumption that Pantopaque
aspirates naturally is wrong.
Lancet Article 1956
This is a study carried out at Middlesex Hospital in the UK by Dr. Davies on
119 patients who had all undergone Myodil Myelograms and were all
suffering Adhesive Arachnoiditis as a result of their Myelogram.
Death of a Man Within Seven Months of
Undergoing a Iophendylate (Pantopaque) Myelogram, 1962
A case study written by Dr. Michael S. Mason and Dr. John Raaf and published
in an American medical journal, the Journal of Neurosurgery. The case study
concludes that the patient died as a result of the procedure.
1962: A report by ARJUN D. SEHGAL, M.D., W. JAMES GARDNER, M.D. and DONALD
F. DOHN, M.D. published in the Cleveland Clinic Quarterly. The
investigators admit that Pantopaque causes Adhesive Arachnoiditis but
claim that patients' symptoms can be relieved using cortisone injections.
[Ed: We now know this relief was probably short lived because epidural
injections also cause Adheive Arachnoiditis] (Link
to report)
1965: Case report by Morton Swartz M.D. and Philip Dodge M.D. of a 61 year
old woman who died of Obliterative Arachnoiditis with hydrocephalus one year
after cervical myelography using Iophendylate. (Link
to
Journal article)
Death of a Man Within Five Years of
Undergoing a Myelogram, 1966
A case study written by Dr. James H Greig and Dr. Norman Wignall, and
published in a Canadian medical journal "The Journal of the Canadian
Association of Radiologists" about a man who underwent a Pantopaque
Myelogram, after his death a postmortem was carried out and his spinal cord
examined, severe Adhesive Arachnoiditis was discovered.
Unpublished Walker Hound Tests
Conducted by Lafayette Pharmacal, 1969
The documents detail a 15 week intrathecal toxicity study comparing the
effect of Pantopaque I and Pantopaque II on the spinal cords of Walker Hound
dogs. Pantopaque I was already being produced and marketed by Lafayette
Pharmacal, Pantopaque II was developed with the hope that it would be easier
to remove from the spinal cord after Myelography. The investigation
concluded that Pantopaque I and II produced granulomatis meningitis in all
of the dogs. These test results were never made available to the FDA or
published publicly.
FDA warning to Lafayette, 1969
Two letter's from the FDA to Lafayette pharmaceutical in which the
FDA criticizes Lafayette for not providing regular
reports on Pantopaque, and also the FDA ordered Lafayette to change
the labeling of Pantopaque and to include warnings of severe
reactions it causes, namely Adhesive Arachnoiditis.
1971: A report by Ronald G. Clark, Ph.D., Thomas H. Milhorat, M.D., Walter
C. Stanley, Ph.D., and Giovanni Di Chiro, M.D., published in the
Journal of Neurosurgery, please note no copy is available at this time. It
documents a study carried out on Beagle dogs in which Pantopaque is injected
in to the Sub-Arachnoid space in the dogs' spinal cords. The researchers
conclude that the effects of Pantopaque on the spinal cord are greatly
understated by previous research findings and that Pantopaque actually has a
devastating effect on the animals tested. (Link
to
journal)
1972. Glaxo change product packaging documents to include reference to
removal of Myodil after Myelography. 1973, Glaxo again change product
packaging documents advising Myodil be aspirated after Myelography.
This same year they also advised that if low back pain and sciatica
symptoms persisted to inject hydrocortisone sodium succinate intrathecally,
which is now known to be an extremely dangerous procedure which also
involved a cocktail of chemicals that would probably have accelerated the
onset of Adhesive Arachnoiditis. (Link
to
Hansard record where this information can be found)
Tests on Rats 1973
A study conducted by J. K. Jakobsen and published in the medical journal:
Acta Radiologica, in which the spinal cords of rats are injected with
Iophendylate and Methiodal to determine the effects of the procedure,
55 rats die immediately, the rest are sacrificed at later dates and
examined. The study concludes that Iophendylate causes meningitis and
Adhesive Arachnoiditis even if the contrast medium is removed after the
procedure.
Myodil License Application, 1974
Glaxo's 1974 application for Product License of Right to produce and market
Myodil in the UK and abroad, in which they admitted Myodil caused Adhesive
Arachnoiditis, was this the License to Kill?
1974: A report by Dr. A.J. Keogh published in the medical journal: Clinical
Radiology. Meningeal reactions seen with Myodil Myelography: Four cases of a
meningeal reaction giving a characteristic radiographic appearance with
Iophendylate injection B.P. (Myodil) Myelography are reported. Steroids seem
to have helped in two of these cases. Mention is made of a review of
symptoms in a further 111 cases. The morbidity associated with Myodil may be
higher than has previously been appreciated. (Link
to
abstract).
1976: A report by Dr. W. Ward, Dr. M. Matheson, and Dr. A. Gonski, published
in the Medical Journal of Australia, please note no copy is available at
this time. Three cases of Arachnoiditis after use of oil based media in
Myelography are presented. The study concludes at that time Iophendylate
(Myodil) is the best contrast media for use in Myelography, however it's use
causes serious problems such as pain and disability and therefore should be
avoided. (Link to
journal)
Arachnoiditis Risk After Myelography,
1978
A short article by Dr. Henry L. Feffer on the high risk of Arachnoiditis
after Iophendylate Myelography.
1978: An investigation carried out by Drs. Zawirski M, Szapiro J, Doli?ski
A, Kun M, Polis Z. and published in the Polish medical journal Pol
Przegl Radiol Med Nukl., please note no copy is available at this time. The
title of the report is: [A trial of evaluation of the diagnostic usefulness
and safety of Ethiodan (Myodil), Conray 60 and dimer X in cerebral
ventriculography (author's transl)]. British Drug Houses were given sole
rights to sell Myodil in Canada under the marketing name Ethiodan. (Link
to journal title)
1978: An article by Dr. Burton published in the medical journal: Spine,
please note no copy is available at this time. One hundred patients with
lumbosacral adhesive Arachnoiditis documented either directly at surgery or
by unequivocal Myelography served as the basis for this report on the
pathologic process. The entity appears not to be rare, as previously
thought, but common in patients with severe back and/or leg pain and
functional incapacitation due to the failed back surgery syndrome. The
importance of Pantopaque in contributing to this disease process appears to
be quite significant. (Link
to journal)
1978: A report by Dr. John D. H. Johnston and Dr. Joetta B. Matheny
published in the medical journal: Spine, please note no copy is available at
this time. The results of a long-term study of 28 patients operated on for
adhesive lumbar Arachnoiditis are presented. The technique involved was
microscopic lysis of adhesions. The first case of surgery was performed in
1966 and the last, in 1970, with follow up through 1976. Numerous
observations are made regarding the clinical picture and the appearance of
Arachnoiditis at the time of surgery.
Some
conclusions
are drawn regarding the causes of this condition with some emphasis on
the role of Pantopaque, multiple surgeries, and other trauma. (Link to journal)
1980: A case study by Dr. M.K. Greenberg and Dr. S. C. Vance published in
the medical journal The Lancet. Describing how tiny droplets of Iophendylate
entered the cranium and caused focal seizures which lead to loss of
consciousness. (Link
to
journal)
1980: Report of a case and review of the causes of postoperative convulsions
due to iophendylate (Myodil). A 58-year-old man underwent a Myodil
Myelogram, postoperatively convulsions occurred. Large quantities of
intracranial iophendylate (Myodil) were seen on postoperative skull X-rays.
(Link
to
journal)
Tests on 16 Monkeys 1982
An article by Dr. Victor M. Haughton and Dr. Ho Khang-Cheng published in the
medical journal: Radiology, it describes tests on Monkeys comparing the
effects of Iophendylate and Metrizamide (Amipaque) which is a water based
contrast media.
1983: In response to increasing competition from other products (Amipaque,
Metrizamide etc.) Alcon stepped up their marketing campaign by advertising
directly to physicians stating, "Pantopaque has been used for several
million Myelograms and the incidence of side effects has been
extremely low." This is evidence of the huge number of Pantopaque Myelograms
that have been performed in America alone since the introduction of the
product, as well as the manufacturers blatant disregard of the truth about
Adhesive Arachnoiditis.
1984: June 1984, a message was sent from Hazleton to Alcon requesting
Alcon's permission to publish an article about the clinical disease and
death in rabbit pyrogen studies using intravenous Pantopaque (which were not
as damning as the intrathecal dog study). Alcon's response is illustrative
of the blatant disregard the company had of statutory and ethical
requirements of them (and leaves us under no illusion as to their motive): "
R&D does not support publication by Hazleton, it cannot benefit Alcon in
any way and may prove to be damaging to our product." Documents relating to
the rabbit studies are not available at this time.
1984: A report by Johansen JG, Barthelemy CR, Haughton VM, Lipman BT, Ho KC.
A study on monkeys to test the hypothesis that blood entering the spinal
cord when injecting Myodil is responsible for the formation of Adhesive
Arachnoiditis. They found that Arachnoiditis was as severe after Myelography
alone as after Myelography and laminectomy. Minimal Arachnoiditis was found
myelographically and histologically after myelography with metrizamide 300
mg l/ml, and severe Arachnoiditis was found after Myelography with
Iophendylate whether or not laminectomy was performed. Laminectomy alone
produced insignificant arachnoid changes. Experimental Myelography preceding
laminectomy did not increase the risk of Arachnoiditis. Please note no copy
is available at this time but here is a link to the abstract (Link
to journal)
1985: A report by Dr. B. Baessler and Dr. R. Lahl in a German medical
journal Zentralblatt fur Neurochirurgie. Case reports of three people who
underwent Myelograms, two had Amipaque injected in to their spinal cords and
one had Pantopaque. All three people suffered severe reactions, one of the
Amipaque cases died within 17 days of the procedure and the Pantopaque case
died within 13 days of the procedure. Please note no copy is available
at this time but here is a link to the abstract (Link
to journal).
Report by Dr. Burton
This is a report by an American spinal specialist, Dr. Burton, it
describes the problems caused by Pantopaque Myelograms and the process of
Adhesive Arachnoiditis. This report was never accepted for
publication. Please note this takes a few moments to download since it is a
large file.
1988: An article by Dr. R.M. Pascuzzi, Dr. K.L. Roos, and Dr. J.A. Scott.
published in the medical journal Epilepsia, please note no copy is available
at this time. A 46-year-old woman developed focal seizures 10-15 years
following Iophendylate Myelography. Focal epileptogenic abnormalities on
electroencephalogram corresponded to the localization of residual
Iophendylate in the right sylvian fissure. Intra cranial Iophendylate may
have produced chronic meningeal reaction leading to cortical irritation and
a chronic seizure disorder. (Link
to journal)
Long Range Prognosis of Arachnoiditis
1989
An
study
by Dr. D.W. Guyer, Dr. Leon L. Wiltse, Dr. Marjoire L. Eskay, and Dr. Betsy
H. Guyer published in the medical journal: Spine. A long term study on 50
patients who all suffered with Arachnoiditis and had undergone
Pantopaque Myelography examinations.
A report for your GP, 1990
An article by Dr. I. H. J. Bourne in the Journal of the Royal Society
of Medicine, written for GP's as opposed to specialists such as
Neurologists, with the aim of describing Adhesive Arachnoiditis.
Dr.
John
M Stevens article, Imaging of the Spinal Cord 1995
Dr. Stevens writes a lengthy article on the various techniques used for
obtaining images of the spinal cord. He criticises Myodil as being a cause
of Adhesive Arachnoiditis.
Letter from St Mary's Hospital, 1995
This letter discusses the publication of a research paper in the medical
journal Neuroradiology. The paper documents the investigation in to the
prevalence of Adhesive Arachnoiditis following back surgery and whether the
patient underwent a Myelogram or not before surgery, and how this will have
increased the likelihood of Arachnoiditis. The paper concludes there is
greater risk of Arachnoiditis after surgery where Myelography has also been
used. (Link to journal)
Dr Susan Parisian's expert report condensed,
2002
This is a document showing the major points from the
comprehensive research report published in 2002 by Dr. Susan
Parisian about the production, testing, and use of Pantopaque. Some
original animal test result documents and other material she refers to can
be found on this website.
Case Report
of Myodil Induced Adhesive Arachnoiditis 2006
A case report by Kanna
K.
Gnanalingham published in the European Spine Journal, describing a
woman who underwent a Myodil Myelogram 30 years previously who presents
symptoms of Adhesive Arachnoiditis and an Arachnoid cyst. The case report
concludes that Myodil was the sole cause of her symptoms because she hadn't
undergone any other treatments or investigations.
2006
Dr.
Aldrete
Suspecting & Diagnosing Arachnoiditis
Three Short Articles Written
By Dr. Burton on the subjects of Pantopaque (Myodil), Adhesive
Arachnoiditis, and Governmental Responsibility
December 2010: An article by Gopalakrishnan CV, Mishra A, Thomas B.
published in the British Journal of Neurosurgery describing a case of
Iophendylate myelography induced thoracic arachnoiditis, arachnoid cyst and
syrinx, four decades later. (Link
to report)
Dr. Burton's
November 2011 letter
Letter written to Ursula Coxhead in which Dr. Burton states in all cases
Myodil caused toxic chemical meningitis, and then progressed leading to the
secondary condition diffuse Adhesive Arachnoiditis.
September 2012, Good friend Dr. Charles V. Burton
M.D. F.A.C.S sent Ursula Coxhead an article, "Mengele
in America: Human Experimentation and the Walter Reed Connection," which he wrote for the Journal: Ethics in Biology;
Engineering and Medicine.
September 2012: Australian Parliamentary round table inquiry attended by
health care professionals and Myodil sufferers. Three doctors all gave
testimony stating Myodil is responsible for the onset of Adhesive
Arachnoiditis. (Link
to
minutes)
February 2013: Australian Parliamentary round table inquiry committee
publishes report stating amongst other things that Glaxo should consider
setting up a charitable foundation to the assist the Australian sufferers of
Myodil induced Adhesive Arachnoiditis. (Link
to
report)
February 2013: An articel by Ririko Takeda, MD and Hiroki Kurita, MD, PhD
publisehd in the journal Neurology. Residual contrast media found around a
patients brain 49 years after Myelography. In September 2011, a 67-year-old
man underwent 3-dimensional CT angiography for preoperative evaluation of an
unruptured cerebral aneurysm, which revealed numerous pearl-like drops along
the cerebral arteries (figure 1). He had undergone myelography for lumbar
disc herniation in 1962, and the drops were thought to represent remnant
oily contrast medium that had been in place for 49 years. At surgery,
several oily drops and yellowish gelatinous substance were identified and
partially removed (figure 2). Histopathologically, the drops were compatible
with artificial material. (Link
to report)
May 2013: An article by Sang-Kook Lee, Daniel H. Kim, Se-Hoon Kim, Dong-Jun
Lim published in the European Spine Journal. A case study of a 63 year old
woman who presented with symptoms of incresaing back pain and lower
limb paresthesia and incontinence. An x-ray was taken which showed a
large drop of Pantopaque present in the thoracic level of the spinal cord. (Link
to journal)