Myodil Action Group (UK)

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Index Page 2

This is a document showing the major points from the comprehensive research report conducted by Dr. Susan Parisian about the production, testing, and use of Pantopaque/Myodil.  Some original animal test result documents and other mateial she refers to can be found on this website.


    1918, Dandy created radiographic visualisation of the spinal cord by injecting air in to the spinal column.
    1922, Iodinised Poppy Seed Oil (commercially available since 1901) began to be used in doses less than 5cc's, but was recommended that it be removed.
    A 1932 statement of opinion by the American Medical Association had discouraged the introduction of any foreign oily material into the spinal cord.
    1936, Eastman Kodak supply Ethyl Iodophenylundecylate as the main ingredient of Pantopaque to Lafayette under trade mark.
    1937 to 1938, Warren and Strain conducted animal studies using Pantopaque which indicated that a inflammatory reaction with production of Fibrosis was triggered.
    1938, unlicensed Pantopaque was distributed as a investigative drug to Physicians without proven safety data.
    1941, T.B. Steinhousen's doctoral research of Iodinated compounds showed that in his opinion Lipidol (iodinised Poppy seed oil similar to Pantopaque) was unsafe to use in humans intrathesically.  After reviewing cat studies he found one died after injection, he also cited earlier 1925 Rabbit studies that after intrathecal injection there was a 47% mortality rate, and a 1938 study by Metier and Leake reported numerous untoward reactions.  Also 1941 study by Brown and Carr indicated significant danger injecting iodinated Poppy seed oil in to the spinal canal.  His thesis included a study of the new compound Pantopaque, in a series of tests using three dogs Pantopaque produced meningial irritation symptoms ranging slight to severe.  In another series using fifteen dogs, 46% had slight meningial irritation, 20% moderate, and 7% severe, one dog was unable to walk, and one dog died of gangrenous terminal ileum.  At termination of the study and autopsy, histological and gross meningial changes were more severe than had been clinically suggested, including granulamatis foreign body reactions, with acute inflammatory polymorphonucleocytes (PMNs), phagolytes and fibroblasts with fibrous adhesions involving the nerve roots, also clear cyst areas dispersed throughout the spinal column, and scattered macrophages.  Steinhousen did the same test on nine dogs using iodinised Poppy seed oil, the results were similar plus one dog died.  Steinhousen's research in dogs foreshadowed the acute and long term adverse events that came to be reported in humans.
    26/02/1942, Dr. Rigler, University of Minnesota, wrote reporting his facilities unfavourable clinical experiences with Pantopaque, indicating in his and his staff's opinion it did not improve imaging quality and was extremely difficult to remove.
    05/09/1942, Major R.G. Spurling wrote indicating Pantopaque produced as many irritative symptoms as Lipidol.
    In 1942 there appears to have been a conscious decision to disregard clinical ethical conduct and intentionally ignore clinical findings and fail to provide physicians with test results on animals and humans but describe Pantopaque as safe using misleading statements.
    04/11/1943, Lafayette, America, New Drug Application, Dr. Walter Van Winkle FDA. requested from Dr. Strain animal safety data.  Dr. Strain stated he did not have very good figures on the acute toxicity.  In the 1960's the FDA also found that test results carried out on mice (22/02/1943) were also inadequate to support Pantopaque safety.
    1944, on the basis of safety for use the FDA were hesitant to permit a NDA, the reasons being that reports gave the impression large numbers of reactions of varying degrees of severity had been observed, but that the entire product circular created the impression that reactions were minor and infrequent.
    24/02/1944, Major Robert Robertson, Chief of Neurosurgery, Brook General Hospital, Fort Sam, Houston Texas, reported a patient developed Adhesive Arachnoiditis.
    14/04/1944, Despite unfavourable animal test results not being supplied to the FDA, Pantopaque NDA was approved in the US, appearing to have occurred without resolution of Dr. Van Winkle's FDA concerns regarding product safety issues, but purely on "grandfather rights" based on a few hundred favourable Military Hospital Myerlograms performed,
    1946, Glaxo produce Myodil (Pantopaque) in the U.K.
    21/12/1950, complaints on certain lots of Pantopaque proved to be due to it containing 5% of Iodophenylundecanoic acid, rather than 0.9%.  A letter from Mr. Mees of Kodak's Distillation Products Industries (suppliers of ethyliodophenylundecylate to Lafayette) sought to create a legal distance from Lafaet's distribution of Pantopaque assuming no responsibility.
    03/12/1953, the American Journal of Roentgenology, Radium Therapy and Nuclear Medicine indicated a usual injection of 6 or 9cc's of Pantopaque, however the 1944 NDA recommended a dose of 2 to 5cc's.
    Lafaet's labelling continued to make no reference to potential serious acute or long term consequences associated with Pantopaque (the expressed concern of FDA's Dr. Van Winkle), did not recommend doses of 2 to 5cc, nor emphasise the removal of all material, but did emphasise injecting a larger dose than had been submitted for NDA.
    1964, Mr. Hagan of FDA wrote of his concern regarding the fever induced from Pantopaque injections which appeared to be related to the Pyrogenisity of the product.
    03/10/1966, FDA's James E. Wilson PhD. wrote Iophenylate has been on the market for twenty years, but deaths have been attributed to it's use.
    Swartz, 1965, sights a 61 year old woman who died of oblitaritive Arachnoiditis.
    27/11/1967, Lafayette wanted to introduce a new drug, Pantopaque ii. New tests were carried out on 24 pure bread Walker hounds by Hazelton Laboratories, comparing Pantopaque i and ii.  Results showed 5 dogs had clotted blood at the base of the brain and anterior spinal cord (1 dog Pantopaque i, 4 Pantopaque ii), 8 dogs had meninges visibly thickened (3 dogs Pantopaque i, 5 Pantopaque ii), in 6 dogs oily material was grossly seen in the meninges (3 dogs Pantopaque i, 3 dogs Pantopaque ii).  At autopsy 2 Pantopaque i dogs had moderate to severe granulamatis reaction surrounding large vacuoles in the space under the meninges and surrounding some of the spinal nerves.  There was moderate to severe Fibrosis surrounding the spinal cord and scattered areas of granulamatis reaction were present within the white matter of the spinal cord.  The spinal cord was surrounded by moderate amounts of old blood present under the meninges.  The following was the summary of Hazelton Laboratories: In conclusion it can be stated that the intrathecal administration of Pantopaque i and ii stimulates a Granulamatis Meningitis in the areas were the compounds appear to localise.  The majority of the inflammatory reactions present in the animals on this study were of a sub-accute to chronic nature.  Pantopaque i stimulated granulamatis reaction in primarily the lumbar region.  Both Pantopaque i and Pantopaque ii produced severe reaction in the cervical and thoracic cords.
    14/04/1969, FDA recommended Lafayette delete the statement: the small amount of material left in the sub-arachnoid space usually is absorbed in two months (it actually remains for many years).  In the adverse reactions section to include severe Arachnoiditis producing headache, fever, meningismous, pain in the back and extremities and elevations in the white blood count and the protein count of the cerebro spinal fluid and instances of lipoid granuleomas obstruction of the ventricular system and venis intravation producing pulmonary emboli.  In contrainedations section Pantopaque is contrained in patients with hypersensitivity to Iodine or its compounds.  In precautions section diagnostic tests of thyroid function involving Iodine maybe invalid for many years, it is my understanding none of these recommendations were followed..
    25/06/1969, Lafayette withdrew NDA for Pantopaque ii, from the memo and letter to FDA there appears to be no mention of the adverse findings of the animal studies done by Hazelton Laboratories relevant to the poor safety performance of Pantopaque I, the approved product.  Therefore the FDA were never informed of the animal toxicity studies which showed Pantopaque i unsafe.
    07/02/1972, Two hours after injection of Pantopaque two patients at Holy Family Hospital, Atlanta, GA, developed Cerebral Adema, Focal and Grandmal seizures, Hypotension, loss of bowl/bladder control and Aspiration Pneumonia.
    1977, Alcon purchased Lafayette.
    18/09/1978, Medical World News Journal, reported on a Dr. Henry L. Fefer article, "Arachnoiditis Risk after Pantopaque Myerlography," that of 400,000 yearly Myerlograms 25% will probably develop Arachnoiditis and patients having two or more, 50%.  Confirmed by animal studies, but denied by Lafayette.
    13/08/1979, Dr. Newton reported to a distributor of Pantopaque an adverse reaction.  Another physician/father reported concern about his 25 year old daughter's condition being in a great deal of pain, excitable and upset.
    June 1982, a paper appeared in "Radiology" journal regarding Pantopaque versus Amipaque used in monkeys which outlined Pantopaque as a causative factor in Arachnoiditis.
    July 1982, Johnston and Matheny studied 28 patients with Arachnoiditis stating four of the patients had Myerlography after spinal surgery and all four had severe Arachnoiditis.
    25/04/1983, Eastman Kodak, supplier of Iophenylactulate to Lafayette, became aware of legal activity surrounding Pantopaque and the falling popularity compared to the new water-based Amipaque (Metrizamide).
    1984, Lafayette released a caution against the use of plastic syringes.
    29/04/1985, Ms. Galene Tsipis of Drug and Poison information control, Ohio, wrote a irate letter to  Alcon Laboratories (owners of Lafayette) about a adverse drug reaction (paralysis of the lower extremities) involving a patient in a local hospital.  She requested clinical trial data and adverse reaction reports on Pantopaque, she was told no information was available and she felt she was given the run-around.
    June 1987, Alcon's drug experience complaint record listed thirteen patient complaints of Arachnoiditis, Focal seizure, burning in the lower back, Nausea, Allergic phenomenon and suspect Meningitis, and two suites in Dade County, Florida.  Label changes were made adding severe Arachnoiditis has been reported.
    1987, Alcon ceased production, but had stock with a shelf life of five years.
    15/03/1990, Scott Kerby reporter for Inside Edition rang Mr. West (FDA) in connection with a patient who had three Myerlograms in the early 1970's and was now severely paralysed with Arachnoiditis and had attempted to sue Alcon Laboratories, but was told statute of limitations had elapsed.  Mr. West indicated in the 1970's the consumer/patient would have been unaware of the risks, but the occurrence was well documented in Radiological text books.
    12/06/1990, Pantopaque was discussed on a T.V. consumer show hosted by Geraldo Rivera.
    26/09/1990, 25 plaintiffs launched a class action suite against Alcon alleging permanent severe injuries, chronic pain, paraplegia, quadriplegia and death from incurable Arachnoiditis.
    30/08/1990, Wall St. Journal reported a suite of 300 plaintiffs.
    1990, The Management of Pain magazine reported a noted decrease in Arachnoiditis since the decrease in use of oil based Myerlograms which was also recognised by the medical fraternity.
    Conclusion: Physicians reported difficulty in removing all the Pantopaque, not as described by the producers, Pantopaque primarily remains unabsorbed in the body and is associated with chemical meningitis, fever, shock, respiratory arrest, oblitirative Arachnoiditis, neurological deficit, paralysis, focal and grandmal seizures, blindness, corda equina syndrome, obstructive hydrocephalus, bowl and bladder dysfunction, syphilis, sexual organ pain and dysfunction, trauma, numbness, paraplegia, loss of sensory and motor function, pain in lower trunk abdomen and legs, coma and death, intractable burning pain worsened by physical activity which stretch the lumbar nerve roots and not ameliorated by narcotics.  Resulting in a lifetime of severe unremitting pain.   
    After 40 years doses were increased from 5cc's to 30cc's (the original NDA 2 to 5cc) increasing patient risk.