The subject of adhesive arachnoiditis as a disease entity has been, and continues to be a most serious global health care problem. It is evident to me, as a physician and surgeon who has been intimately involved in studying, publishing, lecturing and treating patients with this disease for over 25 years that there has been a serious failure, in the past, by the medical, scientific and governmental professions to focus appropriate attention on this important entity.

The subarachnoid space represents the most fragile, pristine, and sensitive structure in the human body. The introduction of foreign body substances, for any purpose, is not without patient risk.

All foreign bodies are irritating to the arachnoid membranes. Some substances such as oil-based myelographic media and steroid preparations containing ethylene glycols are known to be particularly irritating and toxic and capable of producing disability and incapacitation.

Adhesive arachnoiditis is the most severe form of arachnoiditis, an inflammatory condition which can be due to many causes including infection. The degree of arachnoiditis in any given individual depends on a number of factors including the nature of the toxic or infectious agent as well as the individual's auto-immune response as well as other factors. The arachnoiditis process is potentiated by the presence of blood, and its break-down products in the subarachnoid space.

From my personal observations, over the past 25 years, it is evident to me that many patients with adhesive arachnoiditis have severe scarring of their nerves without associated clinical signs or symptoms. In fact the great majority of patients with adhesive arachnoiditis due to oil Myelography are asymptomatic because of the slow progression of the inflammatory process. The opposite is true for those who have adhesive arachnoiditis due to the ill-advised deposition of ethylene glycol steroids into the subarachnoid space typically for the purpose of"epidural" steroid administration.

My calculations suggest that although 95% of individuals who have adhesive arachnoiditis causually related to oil myelography are without symptoms, the other 5% (representing about 1 million individuals) are seriously disabled because of this pathologic process.

The reason for this discrepancy appears to be directly related to the degree of initial inflammation and whether the nervous system is given adequate time to acclimate to the progressive insult. The human nervous system (as is the human body) legend in its ability to adjust, and maintain function, despite the most amazing gradually applied insults. The opposite is true for sudden or rapidly progressing insults. It is important to also point out that those patients with adhesive arachnoiditis who are without symptoms live with "a sword over their heads" as apparently minor additional insults (i.e. Myelography, injury, surgery, etc.) can tip the clinical balance.

For many decades clinicians have argued regarding the role of the technique of administering oil substances in regard to risk of adhesive arachnoiditis. Assuming the supposition that the benefit was higher than the risk and informed consent was obtained prior to oil myelography my observations are as follows:

1. The least patient risk was to perform atraumatic entry and subsequent aspiration of the oil media.

2. Next best was atraumatic entry and using the least amount of oil media as possible for the study.

3. To avoid multiple taps on entry or aspiration as this adds free blood to the oil media, thus markedly increasing toxicity.

The failure to appreciate adhesive arachnoiditis as a disease entity has come back to haunt the public through the inordinately common use of ill-advised "epidural" steroid injections with suspensions containing ethylene glycol. Epidural steroid injection is an overused therapy. When performed in the absence of fluoroscopic monitoring with epidurography this procedure the procedure is dangerous. When performed by well-trained procedurist, associated with informed consent, good technique and basically non-toxic steroids it is a reasonable invasive therapy; after quality non-invasive therapy has failed.

Charles V. Burton, M.D., F.A.C.S.

www.burtonreport.com

November 29. 2003

Dr. Burton on Pantopaque

" Pantopaque and Myodil should never have been used for myelography except in emergency situations. I also believe that the medical profession shoulders a large portion of the blame for injuries resulting from the use of the product. The medical profession used Myodil and Pantopaque as a routine diagnostic agent when the known health risk did not support such use. It should be surprising to no one that these physicians are validating their prior actions rather than looking at the situation independently and concluding that the citizens were victimized by both the pharmaceutical industry and the medical profession.

If we had a panel of reviewing physicians, all licensed within the last five to seven years, their view and result would be much different than using the old-time "experts".

Dr. Burton makes following remarks: Yes, it has certainly been my experience that many studies from the U.K, have been inadequate from the diagnostic standpoint where the reviewing radiologist has presumed to venture a specific opinion and has also utilized flawed criteria in the decision making process. Perhaps the time has arrived for these individuals to renew their acquaintance with what the word "physician" is supposed to mean and be more concerned with the needs of society than their personal biases.

I know that Glaxo is supporting the safety of the product by reference to various "epidemiological studies". Any epidemiological study of Myodil induced a.A. will be inherently flawed and weighted towards the manufacturer because the medical literature recognizes that a.A. was one of the most under-reported and undiagnosed back condition in the world. It defies common sense that you can have any epidemiological study if the data is know to be incomplete.

The Hayman report ignored vital information reg. Myodil. Glaxo ignored tests on animals reg. Myodil which proved unsafe. Government ignored MP’s calling for a public inquiry reg. Myodil. Solicitors ignored the truth regarding criteria used for litigation. Legal Aid Dept. ignored Dr. Burton’s comments. Doctors ignored patients who complained of back pains. The word "ignored" must carry a health warning; sadly we suffer the side effects of it.

Governmental Responsibility in Protecting the Public Trust

The Issue of Adhesive Arachnoiditis

The proper exercise of responsibility by government in protecting the public interest has always been a most absorbing issue. When serious transgressions occur, and when these reflect failures of government to act in a responsible manner causing widespread disability or death to the population, the initial "knee jerk" response by government is not infrequently an attempt to cover up guilt. In regard to the area of health care some cases also involve circumstances where government has placed the interests of other parties, such as the medical industry, ahead of the public interest and has incurred, by this act, an even more serious violation of the public trust. It is the clear mandate of government to take action when needed to protect the public welfare. It is also clear that when important decisions are made in health care matters part of government's mandate is to "tell it like it is" so that physicians and patients have access to the facts thus allowing "informed consent" to be present prior to patient diagnosis or treatment.

What appears to determine the zeal by which government polices itself, addresses past wrongs and learns from past failures to do better in the future unfortunately often only reflects the degree of public unhappiness and public outrage regarding such situations (if they become known to the public at all). It is not unique circumstance when government expends greater effort in avoiding public disclosure of such transgressions than their prevention would have required. Without an enlightened attitude toward truth and integrity many sad medical stories simply just terminate with sad endings for all concerned and their etiologies simply continue to be propagated upon unsuspecting patients.

The recent case of more than 4,000 people in France being infected with the AIDS virus in the 1980s after receiving blood transfusions known to be contaminated with the HIV virus and the subsequent death of 40 percent of the afflicted individuals is a good example of this circumstance. A former Prime Minister and two other ex-officials went on trial on February 2, 1999 for allowing French health services to use this contaminated blood. The government official's reasons for their actions were strictly of a political nature. This trial occurred only as a reflection of the great public outrage that poured forth when the French people became bearers of the truth.

There is another saga of devastation and disability existing throughout the world similar to the French example. In this case, however, the population of sufferers is much greater and probably numbers in the many hundreds of thousands possibly even millions. In these cases those disabled were also unsuspecting and uninformed. The circumstance is that of a disease, adhesive arachnoiditis, an advanced form of arachnoiditis (inflammation of the arachnoid membrane surrounding the brain and spinal cord) being caused by the chemical iophendylate (pantopaqueâ , myodilâ ) being injected into the body for the purpose of myelographic examination of the spinal canal.

While the iophendylate story has many similarities to that now under legal scrutiny in France there is one major difference. In the adhesive arachnoiditis situation industry and governments, throughout the world, have so far, after the passage of 50 years, been successful in keeping this story away from the public's view.

In Britain, on February 1, 1999, The Department of Health concluded after the "fullest consideration" that it "would not be justified either to hold a public inquiry or provide government compensation to those suffering from arachnoiditis currently seeking it The government has stated that "the risk of arachnoiditis was known and clinical decisions taken in what was believed to be in the patient's best interests". It is truly unfortunate that the risks being referred to were not known either to the physicians providing, or the patients receiving these foreign body substances at the time that these "clinical decisions" were made.

By ignoring history we are forced to repeat it. With the global advent of non-invasive imaging as characterized by computed tomographic (CT) and magnetic resonant imaging MRI) the need for Myelography as a clinical test has declined dramatically. Clinicians are now better able to diagnose spinal conditions and disorders, often non-surgically. A universally popular treatment is the percutaneous deposition of steroids into the epidural space of the spinal canal in order to decrease inflammation and assist with the natural healing processes. Unfortunately, because of physician failure to know about, or to understand, the potentially dangerous potential of certain steroid substances known to be able of creating disabling adhesive arachnoiditis this disease process still remains rampant throughout the world. Is this another example of "clinical decisions taken...in the patient's best interests"?

One can only hope that elsewhere in the world the term "informed consent" has more meaning than it does today in Britain. A government's responsibility, at the very least, is to tell the truth and do "the right thing" in health care issues. The arachnoiditis affair seems to make clear that a number of governments have, instead, become expert only at averting their eyes.

Egregious conduct by government in not providing information to the public on important health issues is not an uncommon practice. One of the most recent examples of such, in the United States, has been the forced disclosure of the public health liabilities related to the smoking of cigarettes. It has taken about 40 years for information already known to the tobacco industry to be placed into the public domain. In contra-distinction the issue of arachnoiditis and adhesive arachnoiditis still has a long road to travel before the public, or the medical profession, will be informed about the scientific reports and studies carried out by the manufacturers and distributors of iophendylate over the past fifty years.

Charles V. Burton, M.D.

Minneapolis, Minnesota

February 27, 1999