enfrdees

 The Hidden Risk of Exposure 

Injured Worker and Patient Input Warnings for Epidural Corticosteroid Injections 

Submittal to FDA Advisory Panel by Terri Anderson 

On behalf of NFFE Forest Service Council to Prevent Harm 

On behalf of All who suffer the Horrors of Adhesive Arachnoiditis 

November 24, 2014 

************************************

Factors Contributing to the Hidden Epidemic of Harm 

1.Adverse events are grossly misdiagnosed 

2.The standard of care is repeated injections 

3.Studies evaluating risk are corrupted by a financial conflict of interest and lack of integrity 

4.Particle Size Distributions (PSD) of common steroid suspensions are variable in size and tendency to aggregate (depending on the steroid, diluent, and dilution ratio) 

5.Severe impacts to the central nervous system cannot be evaluated with current technology 

****************************

FINAL Submittal FDA Hearing Nov 24 2014.jpg

 

Centralized Pain Conditions Not Recognized by Many Clinicians 

The U.S. Government Accountability Office reported (2000): “while adverse events have been recognized as a serious problem, the full magnitude of their threat to the health of the American public is unknown” and “gathering valid and useful information about adverse events is extremely difficult.” 

**************************************

 

Lumbar Transforaminal Steroid Injection with Fluoroscopy 

In 2012, The Doctors Company reported: "Fluoroscopy, while advocated as a safety measure by a number of authors clearly cannot alone prevent neurologic injury and, while quite valuable, should not provide a false sense of security.” 

****************************

 

Risk Assessments Must Include Repeated Injections 

The FDA recently received a Citizen’s Petition claiming interlaminar epidural injections do not carry the same level of risk as transforaminal epidural injections. 

True risk must be disclosed for the “standard of care,” typically 3 injections within a 6 or 12 month timeframe. 

IF the error rate for dura puncture is only 0.8% for the more conservative technique (interlaminar epidurals with fluoroscopy), THEN: 3 injections results in 2.36%* risk of dura puncture 6 injections results in 4.61%* risk of dura puncture * Error Rates calculated based on Bernoulli Trials Equation (Appendix A) 

Spinal surgery adds more risk because of changes to anatomy and scar tissue, which interferes with correct needle placement 

 

 

Subarachnoid Space Dimensions vs. Particle Size Distributions 

Particles in steroid suspensions are significant in size (Benzon etal. 2007, Table 1) when compared to the thickness of the subarachnoid space, measuring an average of 2.5 mm on the right and left sides of the spinal cord, and 1 to 5 mm front and back of the cord. Limited studies focused on the cervical spine, leaving a lack of data (Zaaroor etal. 2006). 

***********************************

 

 

 

CSF flow studies are essential to evaluate patient harm 

The long term impacts (misplaced steroid suspensions) are absent from the literature. Technology to map CSF flow velocities and pressure gradients (lumbar cistern) is not available in the U.S. The mathematical model breaks down as flow dynamics vary significantly from the brain and cervical spine. Photo CSF Flow Study, Fonar

**********************************

 

 

Arachnoiditis: A LIVING HELL 

Many arachnoiditis sufferers consider SUICIDE as a viable option for pain relief. 

Some are coerced into more injections before they are accurately diagnosed. 

*****************************************

 

 

We ask the FDA to consider Three Options: 

1.Issue a Black Box Warning for epidural use of corticosteroids containing unpredictable and unregulated Particle Size Distributions. Important Questions for the Panel are included in Slides 10 and 11. 

2.Issue a warning for steroids misused in spinal surgery. Neurotoxins placed directly over the spinal canal have resulted in adhesive arachnoiditis. 

3.At the very least, contraindicate All steroids for epidural use for patients who suffer Adhesive Arachnoiditis. Physicians are reluctant to diagnose this devastating complication. More injections results in catastrophic outcomes. 

 

Thank You for Listening to the Patient Perspective 

****************************************

Questions for FDA Advisory Panel 

1.Is there consistency in particle size distributions (PSD) for steroid suspensions? Why is this information not readily available from manufacturers for steroid suspensions? 

2.According to Benzon etal. (2007), the increased dilution of methylprednisolone acetate (MPA 80) with saline increases the proportion of larger particles. Cerebrospinal fluid is comprised of a large proportion of saline, or sodium (Na++) and chloride (Cl-) ions. Is it possible that the mixture of this steroid and spinal fluid results in the aggregation and formation of even larger particles after the steroid is misplaced in the intrathecal space? Note: The 2007 Benzon etal. study reveals there is variability in particle size and tendency to aggregate, depending on the steroid, the diluent, and the dilution ratio. 

3.How does the maximum particle size compare with the nominal thickness of the subarachnoid space in the cervical, thoracic or lumbar spine? In males? In females? 

4.How do steroid suspensions impact CSF flow velocities and pressure gradients when injected into the subarachnoid space? 

5.How do misplaced steroids affect the permeability and hydraulic conductivity of the arachnoid membrane? 

6.What happens when large particulate matter is transported by spinal fluid to the brain? NOTE: These questions do not address intravascular complications, or harm to neural tissues caused by neurotoxic preservatives in steroid suspensions. 

**************************************************

 

References 

1.Aldrete, A (2012). Arachnoiditis, The Evidence Revealed. 

2.Bartynski WS, Grahovac SZ, Rothfus WE. Incorrect needle position during lumbar epidural steroid administration: inaccuracy of loss of air pressure resistance and requirement of fluoroscopy and epidurography during needle insertion. AJNR Am J Neuroradiol. 2005 Mar;26(3):502-5. 

3.Benzon HT, Chew TL, McCarthy RJ, Benzon HA, Walega DR (2007). Comparison of the particle sizes of different steroids and the effect of dilution: a review of the relative neurotoxicities of the steroids. 

4.Derby R, Lee SH, Date ES, Lee JH, Lee CH (2008). Size and aggregation of corticosteroids used for epidural injections. 

5.Donaldson S, Aldrete, A (2012). ABC News: Epidural Steroid Injection Risks Include Incurable Arachnoiditis. 

6.Damadian R, Chu D (2011). MRI Cines of CSF Flow Obstruction in 8 Multiple Sclerosis Patients. 

7.Guarino A (2006). Observational Study of Dural Punctures, A retrospective review of the rate of dural punctures as a complication of lumbar epidural steroid injection—with and without guiding fluoroscopy. 

8.Manchikanti L, Malla Y, Wargo BW, Cash KA, Pampati V, Fellows B. A prospective evaluation of complications of 10,000 fluoroscopically directed epidural injections. Pain Physician. 2012 Mar-Apr;15(2):131-40. 

9.Nelson DA, Landau WM (2000). Intraspinal steroids: history, efficacy, accidentally, and controversy with review of United States Food and Drug Administration reports. 

10.Pfizer NZ (2014). Medsafe New Zealand, Depo-Medrol datasheet, http://www.medsafe.govt.nz/profs/datasheet/d/Depomedrolinj.pdf 

11.Tennant F (2014). Practical Pain Management, Adhesive Arachnoiditis Part 1: Clinical Description. 

12.The Doctors Company (2012). Complications of Cervical Epidural Steroid Injections: A review of medical malpractice claims. 

13.U.S. Government Accountability Office (2000, Feb. 9). Surveillance Systems for Adverse Events and Medical Errors. 

14.Zaroor M, Kósa G, Peri-Eran A, Maharil I, Shoham M, Goldsher D (2006). Morphological study of the spinal canal content for subarachnoid endoscopy. Minim Invasive Neurosurg. 2006 Aug;49(4):220-6 

Editors' Note: PRF member Terri Lewis is a rehabilitation counselor and volunteer patient advocate. Lewis submitted the following perspective and commentary on the fungal meningitis outbreak that occurred when pain patients received spinal injections of contaminated steroid preparations. We invite our readers to respond to Lewis' remarks by leaving a comment below.

 

In the late summer of 2012, the event we now refer to as the fungal meningitis event was broadcast as a recall of medications made by New England Compounding Center (NECC) of Framingham, Massachusetts, US. As the event unfolded, we learned that some 14,000 persons had been impacted by the receipt of contaminated injections of a variety of types—epidurals (transforaminal, intralaminar, and caudal) into the cervical, thoracic, and lumbar spine; joint injections; and trigger point injections. Thanks to the work of an alert infectious disease clinician, April Petty, and the Tennessee Department of Health, this event was called relatively early, but not before many people were negatively impacted and not before serious adverse events had already begun to unfold as unrecognized deaths associated with contaminated medications.

 

The role of the media in overcoming some barriers to collaboration cannot be understated. The public media was instrumental in facilitating a heightened national conversation and creating awareness. The Tennessean newspaper in Nashville, then ground zero, created a social media platform for readers to track the national conversation and to follow the events. As a rehabilitation and mental health specialist myself, familiar with the potential gravity of these events, I dropped into this platform to help steer affected individuals to supports and clinical services. I did this because I am from the Nashville area, am familiar with the Nashville spine community, and I am familiar with the reasons the affected persons sought interventional pain supports—they had an acute, chronic, or intractable pain problem for which they had been referred to one of 75 interventional pain clinics or doctor's offices in 24 states.

 

My professional interest in tracking chronic spinal pain stems from dealing with consumers with injuries highly correlated to traumatic surgical interventions, epidural steroid injections, and childbirth injection-related injuries. I am also the parent of a young adult who developed an onset of arachnoiditis at the age of 15 after a traumatic spinal injury and multiple failed lumbar fusions. I provide supportive counseling to a rapidly growing group of injured consumers aged two to more than 80 years of age. Some have longstanding injuries, while others demonstrate fresh injury post-epidural steroid injection, surgery, or fungal exposure.

 

To understand this outbreak, one has to examine it in totality—the characteristics of the consumer who sought treatment; the quickly growing field of interventional pain treatment; the equally rapid growth of compounding manufacturing; the supply chain that feeds pharmacy operations; and the state and federal regulatory systems that failed to understand the scale of this problem or respond quickly enough. While there is plenty of concern at every level about what could or should or will be done differently, our first concern must be for the continued support of those who have been affected and the prevention of similar events in the future.

 

Epidural steroid injections

The "National Quality Forum (NQF) Standard 0309-Back Pain: Appropriate use of epidural steroid injection" defines the use of this procedure as appropriate for persons ages 18 through 80 years of age who seek short-term relief from pain and have radiculopathy or neural pain radiating down one or both legs. As part of the examination in preparation for this procedure, the standard conditions of "NQF 0322-Back Examination" must also be met. Transforaminal, intralaminar, and caudal injections are associated with varying reports of short-term effectiveness, but none are associated with long-term effectiveness, nor should they be considered a substitute for other rehabilitative approaches that address restoration of function. The Center for Medicare and Medicaid Services (CMMS) has placed these injections on their list of procedures that require investigation due to increasing numbers of complaints. These procedures are being routinely used to deliver steroids purchased from registered manufacturers for off-label applications or to deliver unapproved, un-field-tested medicants produced under less than sterile conditions and derived from compounding manufacturers.

 

These injections are administered with corticosteroids of a variety of types. However, with few exceptions, these are not recommended by the manufacturer for any use except topical applications, intra-lesion or dermal injection, intra-joint (into the synovial space) or intramuscular injection. Nevertheless, with few exceptions, none are appropriate for any use except intramuscular injection. Systemic and intravenous uses are specifically contraindicated. The FDA has not approved methylprednisolone acetate (MPA) for intrathecal use due to its known neurotoxicity and association with the onset of arachnoiditis. Indeed, the manufacturers of Depo Medrol-MPA notified the FDA in 2002 of adverse events reported with epidural steroid use (Pharmacia letter to FDA, 3 November 2002) and requested a notification to manufacturers. This action was never undertaken, but an associated label change was approved for use. Triamcinolone contains a specific label warning by the registered manufacturer against epidural administration due to adverse events associated with intrathecal administration. The label for betamethasone also identifies adverse events associated with intrathecal administration (see Drugs.com).

 

The consumer

Within the group of consumers whom I have had contact with, the youngest was 16 years of age at the time of injection, and the oldest was 92. There are reports of affected persons up to 100 years old, as seen in Michigan (Malani et al., 2013). Presenting problems included chronic lumbar pain due to spondylolisthesis, stenosis, radiculopathy, and prior back fusions. Other conditions include complex regional dystrophy syndrome (CRPS), multiple sclerosis (MS), lupus, carpal and tarsal tunnel syndrome, plantar fascitis, diabetic neuropathy, degenerative disc disease, fibromyalgia, failed back syndrome, trauma from car accidents, neural pain, and more variants too numerous to mention. Not one of the individuals I have come into contact with presents as an addict or a malingerer. All were compliant with physician directives, and all sought to participate as fully as possible in their daily lives.

 

Their history of pain intervention and treatment in some of these cases is longstanding and in other cases quite spotty. Individuals who presented for treatment as the result of a worker’s compensation-related injury have a history of epidural injections being administered as few as three times or as frequently as every two weeks in the prior 12 months. Individuals who were referred for treatment due to an acute injury (e.g., recovery from a car accident) were more likely to receive a series of three injections. For many affected individuals, it was their first experience with an epidural steroid injection. One woman in the contact group, however, reports that she has had nearly 500 injection procedures in the last four years without relief, as directed by her worker’s compensation carrier.

 

Interventional pain services

Injections are among the top 20 procedures reimbursed by the Medicare program at a cost of more than US$3.6 billion annually. As a group, these include epidural steroid injections, trigger point and facet injections, and joint injections.

 

In their recent viewpoint article published in JAMA, Staal, Nelemans, and de Bie (Staal et al., 2013) are quite right to point out that there is increasing evidence that disputes the efficacy of these procedures. Indeed, there is increasing evidence of accidentality and even deaths associated with the administration of epidural steroid injections (FDA Adverse Event Reporting System; Weinstein et al., 2006Epstein, 2013; and the LESS clinical trial in progress).Among the risks associated with the administration of these procedures at this time are the clear, unresolved issues associated with the lack of effective oversight over compounding manufacturing, unsafe injection practices, inappropriate patient selection, and lack of adequate physician training. There is clear concern that the differences which devolved into the expression of illness throughout this event result from the many variants of injection administration, the conditions of administration, the range of medications delivered, and patient characteristics themselves. Patients who received fungal inoculation of the cerebral spinal fluid appear to have suffered a dural puncture with material placement directly into the CSF. The development of illness and subsequent lumbar punctures may have served to inoculate the CSF with fungi secondary to the epidural injection. In recent days, the CDC has released a summary of pathology studies that document the migration of fungal materials to the brainstem where they then invade venous tissues (Ritter et al., 2013).

 

Compounding manufacturing

The delivery of injection materials into the industry is supported by an unknown number of compounding manufacturers who operate at unknown levels of quality and safety. As of this date, 47 compounding firms in 26 states have been asked to recall their products for production, safety, and sterility issues. Currently, the responsibility for oversight rests with State Departments of Health through their respective Pharmacy Boards. The culprits in the case of the NECC disaster are the fungi aspergillus, exserohilum, and cladosporium, with exserohilum being the most prevalent. An additional number of bacteria and viruses have been identified.

 

Management of the outbreak

As this event is iatrogenic in nature—the result of a medical treatment and not an infectious disease process—it falls under the purview of federal-state agreements. Had it been a declared national health emergency, it would have tripped the processes that would have resulted in a single management system from which to operate. This single fact has introduced tremendous variability in the national response. Every affected state has mounted its own system of support with varying degrees of resources, communications, and commitment.

 

Early in the event, this illness was characterized as a fungal meningitis, and the response system for triage resembled that which would ordinarily be associated with a widespread meningitis of a viral or bacterial nature. Communications were deployed into the field that directed the use of lumbar puncture without regard for prior patient characteristics, the trained capacity of community health organizations, or recognition of potential disease and organism spread by the procedure itself. For those of us who were acquainted with these issues, the concern began to elevate that the response had the potential to significantly increase harm due to secondary adverse effects. We have, in fact, seen that through the advent of spinal leaks, dural punctures, and so forth. The CDC messaged early that their modeling indicated that the event would begin to wane at 42 days. At 60 days we were still seeing new cases develop and more states affected. The modeling was revisited, as direct care physicians became more experienced and involved. We are still seeing cases permute into new expressions of illness that indicate systemic fungal presence (see recent news coverage).

 

In the same issue of JAMA, Malani and colleagues (Malani et al., 2013) describe the use of magnetic resonance imaging (MRI) to identify spinal and paraspinal infections associated with injections of contaminated MPA. Initially, as consumers were directed in local emergency rooms to navigate the variety of procedures employed for diagnosis, I became quite concerned that the MRI was being underutilized by the CDC protocols. Over time, I was ecstatic to see the MRI become the tool of first response due to its noninvasive characteristics and ability to find infections that had not revealed themselves in total as of yet. However, there were barriers to the use of this tool.

 

First, it must be noted that many patients reported and expressed symptoms that did not become associated with the outbreak because of the way in which the CDC had characterized the expression of illnesses. Second, because this was a fungal inoculation event with widespread variability in onset, the range of indicators and consumer geographic dispersion did not make these indicators apparent to all. Third, differential diagnosis of this symptomology was made much more difficult due to the range of prior injuries associated with chronic pain syndromes present in the affected population. Fourth (and most importantly), across the states, all diagnostic access was passed to consumers—those with insurance or resources got diagnosed. But those who relied on worker’s compensation or their own cash resources often were denied uniform access to MRI. Malani and colleagues note that a significant number of their studies gave results that were not clear enough for unequivocal interpretation. Despite these limitations, it has become clear over time that early detection through the use of MRI with contrast is important to ascertainment and identification of the overall outcomes. Its use can be correlated with other measures.

 

While MRI has demonstrably proven its worth as the tool of choice for characterizing the disease footprint, there are some secondary effects that we have yet to know very much about. The antifungals are very hard on the liver and kidneys. Because they are combined with repeated exposure to gadolinium, we have yet to determine what we will see over time in terms of consumer health. As expected, a number of consumers have demonstrated liver and kidney impairment over the many months, and some are notably endangered. The knowledge that this problem had the potential to develop has kept us searching for alternatives that are less invasive, efficient, valid, and reliable.

 

Where we stand today

Pain management in this population has become a crisis. Nearly 60 cases of arachnoiditis have been newly detected among the 800 cases of infections identified to date, and we believe there are many more who remain undetected (see Centers for Disease Control Health Advisory Information). Given the unknown natural history of many of these cases, one cannot clearly state that these individuals got this disease from the fungal meningitis. From patient reports and medical records, there are indications that the arachnoiditis may well have been present before the contaminated injection was administered, particularly where there was a history of failed back surgeries and/or repeated epidural steroid injections. When requested, I have arranged for an independent outside review of imaging studies and medical records on behalf of some patients who cannot navigate this system on their own. Review of historical MRIs, together with recent imaging, leads to the conclusion that in many cases, patients have been overexposed to percutaneous procedures with accumulating injury—the contaminated injection was simply “icing on the cake.”

 

Increasingly, interventional pain physicians fail to employ the procedures necessary to determine patient health or structural status prior to administration of percutaneous procedures. This shows up as increased accidentality and deviation from the existent NQF standard 0309—if one injection or 80 mg dose is ineffective, then subjectively, more is employed at greater frequency. This approach is documented in patient records and is associated with at least one outbreak-related death. I am very concerned about the path forward for these families in both this outbreak and the newest outbreak associated with contaminated medications purchased from a compounding pharmacy in Tennessee.

 

It is my belief and observation, based on working with hundreds of cases, that epidural steroid injections are ineffective as used, and their increasing use supplants other therapeutic approaches. We do not learn of adverse events as negative data in studies simply because there is currently no requirement to report injury as a sentinel event. Further, the use of these procedures offers us none of the translational capture of knowledge needed to understand chronic intractable pain as a disease process all by itself. Importantly, it is becoming harder and harder for patients to obtain support for pain without being subjected to a routine that forces epidural steroid injections first and other measures second. More and more, the messaging about chronic intractable pain is interpreted and controlled by an industry with clear designs on the Medicare dollar. More frequently, we see people with disease processes due to legitimate injuries classed as malingerers and addicts when in fact they are being harmed by the very procedures forced upon them.

 

That we need pain research is clear. This single event demonstrates the necessity for assuring consumers they will not continue to be exposed to highly risky, arbitrary, inefficacious, and even dangerous procedures. The role of epidural injections is being studied as we speak by Janna Friedly at the University of Washington, Seattle, US, in cooperation with George Washington University, Washington, D.C., US. Her results are pending, but other results are offered to us for consideration. I include these in the references.

 

We have established an informal work group with Thomas Walsh at Cornell University, Ithaca, New York, US; David Perlin at the New Jersey Medical School, Newark, US; and Sarah Sellers, a leader in pharmacy safety. I invite your participation and collaboration as we explore safe interventions for pain treatment in this group of injured consumers. I can be reached at This email address is being protected from spambots. You need JavaScript enabled to view it..

 

Systemic failures in the fungal meningitis outbreak.

 

References:

The risks of epidural and transforaminal steroid injections in the spine: Commentary and a comprehensive review of the literature.

Epstein N.

Surg Neurol Int. 2013 Mar 22;4(Suppl 2):S74-93.

 

Magnetic resonance imaging screening to identify spinal and paraspinal infections associated with injections of contaminated methylprednisolone acetate.

Malani AN, Vandenberg DM, Singal B, Kasotakis M, Koch S, Moudgal V, Jagarlamudi R, Neelakanta A, Otto MH, Halasyamani L, Kaakaji R, Kauffman CA.

JAMA. 2013 Jun 19;309(23):2465-7.

 

Exserohilum Infections Associated with Contaminated Steroid Injections.

Ritter HM, Muehlenbachs A, Blau DM, Paddock CD, Shieh WJ, Drew CP, Batten BC, Bartlett JH, Metcalfe MG, Pham CD, Lockhart SR, Patel M, Liu L, Jones TL, Greer PW, Montague JL, White E, Rollin DC, Seales C, Stewart D, Deming MV, Brandt MV, Zaki SR.

Am J Pathol. 2013 Jun 21.

 

Spinal Injection Therapy for Low Back Pain.

Staal BJ, Nelemans PJ, de Bie RA.

JAMA. 2013 May 16:1-2.

 

Surgical vs Nonoperative Treatment for Lumbar Disk Herniation: The Spine Patient Outcomes Research Trial (SPORT): A Randomized Trial.

Weinstein JN, Tor D. Tosteson TD, Lurie JD, Tosteson AN, Hanscom B, Skinner JS, Abdu WA, MS, Hilibrand AS, Boden SD, Deyo RA.

JAMA. 2006 Nov 22;296(20):2441-50. 

 

Additional Resources:

Facebook group: Meningitis Outbreak, sponsored by the Tennessean news organization

 

CDC FAQs for Clinicians: Multistate Outbreak of Fungal Meningitis and Other Infections.

 

The Burton Report: History of Epidural Steroid Injections

 

Is epidural injection of steroids effective for low back pain? Editorial

Samanta A, Samanta J

BMJ.2004 Jun 26;328(7455):1509-10. 

 

Utilization characteristics of spinal interventions.

Abbott ZI, Nair KV, Allen RR, Akuthota V.

Spine J. 2012 Jan;12(1):35-43. Epub 2011 Dec 3. 

 

Why don’t we know whether care is safe?

Pham JC, Frick KD, Pronovost PJ.

Am J Med Qual. 2013 Mar 24. 

 

Real-world experience in the midst of an Exserohilum meningitis outbreak.

Thompson GR, Kontoyiannis DP, Patterson TF.

JAMA. 2013 Jun 19;309(23):2493-5. 

 

Fungal meningitis from injection of contaminated steroids: a compounding problem.

Wilson LE, Blythe D, Sharfstein JM.

JAMA. 2012 Dec 19;308(23):2461-2.

Oxygen: an unreliable friend, page 15   March 1 2010  -   The antioxidant prescription - excerpts    Bruce Wylde 

 

Your average well balanced  atom has a nucleus at the centre, and whizzing around the nucleus is the familiar cloud of electrons -just the right number of them. Under certain circumstances, however, atoms can lose an electron or two, and such atoms then wander around looking everywhere for replacement electrons attached to other atoms. There are the needful characters call radicals -  and sometimes free radicals. None of them are more reactive than the oxygen radicals. 

Apoptosis ( programmed cell death)

In 1961, Leonard Hayflick and Paul Moorhead, working at the Stanford University School of medicine, determined that normal cells can divide only a limited number of times, after which cells effectively commit suicide.  The number of times a cell is generically programmed to reproduce, dubbed the ‘‘hayflick limit’’, varies from species to species. In the case of human cells, the Hayflick limit is about fifty and is directly linked to the lifespan of individuals, Put bluntly, its’s difficult for you and me to live on when our cells are preprogrammed to conk out after so many recycles. Here, suggested Hayflick and Mooread, might be the truth about aging.

As work in this area progressed, it turned out that free radicals played a role in this programming, In fact, free radicals have turned out to be nature’s preferred mechanism of self-destruction when a cell’s time is up. The scientific name for this programmed death is ‘‘apoptosis’’.

Meanwhile the study of antioxidants has also moved forward.. Dr. Lester Packer, a senior scientist Lawrence Berkeley Laboratory, was among the first to describe the role of antioxidants in the health of organisms. He proposed that antioxidants function not singly but as a network to balance overall free radical activity. Packer demonstrated that antioxidants synergies with one another and, even more importantly, recycle one another. In order to neutralize free radicals antioxidants need to work like a team of firemen putting out a fire: some man the pumper truck, some are up the ladder, some are at the hose. Some move right in close to the fire to up out the flames, where others help the victims of smoke inhalation back away the fire. You can’t get away with sending only one antioxidant - say vitamin E - into the fray: that would be like having all the firemen rush to the end of the hose, with no one left to turn on the water. As you’ll learn later in this book, using single antioxidants in high doses can actually do you more harm than good. 

Dr. Packer has focused, rightly, on the synergy of antioxidants. He has described five pivotal antioxidants, which he calls network antioxidants: alpha-lipoid acid, coenzyme Q10, vitamine C, the naturally occurring forms of vitamin E, and glutathione. His conclusion; theres’a synergy between these antioxidants that slows aging and prevents and treats disease.  The clear  message that emerges from Packer,s review of the literature and from his own work is that antioxidants should be taken as a balanced network and at does specific to the individual case or condition. 

People who live to be 110 or older have higher levels of antioxidants in their bodies than less long-lived individuals. 

When stress is high for any prolonged period of time, the body breaks down rapidly and blood pressure can rise. High blood pressure and stress can push you over the boiling point. Free radicals are produced at alarming rates and they end up causing damage to artery linings. You’re on track for a heart attack. 

Not only do I have the privilege of having administered an  intravenous infusion of lidocaine but I also, over the years, developed a formula to achieve relief and support the lidocaine treatment. 

You see, I am one of those patients who react very badly to prescribed medications such as anti-depressants, anti-psychotics, anti-epileptics, narcotics, opioids … For example, cymbalta, an anti-depressant that sent me to bed for one week, after ingesting one pill at a low dosage. Or Tramadol, a narcotic that sent me to the bowels of obsession after ingesting one pill. My brain felt like it was being taken over by the chemicals and frozen in place. One thought ran through my mind only:"I have to do myself in''  -   like a ticker tape, running so fast and furious. I could visualize the phrase going around and around. A very frightening experience, indeed. Opioids did help somewhat to lower the pain at a level of tolerance. Nevertheless, the chemicals were interfering with certain area of my brain. I am an artist, love doing portraits but under the influence of opioids, I could no longer capture the essence of a person on paper. I could no longer get the resemblance in place. You can see here the trial and errors of sketching a portrait and not succeeding while taking fentanyl and morphine. You can compare it to the finished portrait once I was receiving the lidocaine infusion after weaning myself off the opioids and narcotics. 

Over the years I have been asked what I do, in order to obtain relief. I have decided to share with you the information. From here, you can easily tweak and research what would be best for yourself if you are so inclined to do this. 

Here we go:

Natural supplements: 

MSM (sulfur) from the Flora company, the quality of its product is at its optimum.  I find it tames the burning, the muscle spasms, the deep aching within. In tough days I can ingest up to 6,ooo mg per day. 

Carnitine in powder. Very strong and effective anti oxidant against the pain.

Kelpasan from A.Vogel natural manufacturer of supplements. This is basically iodine in pills. It supports my thyroid gland. 

PGX - I am hypoglycaemic - Pgx helps control my blood sugar levels. It is also high in fibre, a bonus for the poop department. 

Vitamine C  occasionally only. If I find that I need an immune system booster to counteract some cold viruses. 

Tea tree oil(melaleuca)is a very powerful  natural antibiotic made from a tree in Australia. I use it for everything including ingesting few drops in water. Very efficient if you have an infection in a tooth, it helps with the pain and the infection.  For earaches, apply externally under the lobe of the ear, it also alleviate the pain and the infection. WebMD recommends that it is not safe to drink it. I don't agree, I have been ingesting this remedy, as needed, for years. It tastes awful! but it works and delivers its promises. 

Prescriptions:

for the pain:

lidocaine infusion:  Mild anesthetic administered intravenously to alleviate the pain. I am currently receiving 6mg on a monthly basis, with a saline solution. 

Ketamine   an anesthetic that I receive orally. I ingest 15 mg per day. I received 20 mg in an infusion along with lidocaine, 5mg. It was not effective for me in this form of administration. I have better results with the compounded ketamine taken orally. 

Ointment: composed of Ketoprofen/Gabapentin/lidocaine. this cream is compounded by a pharmacy. It is excellent for muscle spasms, ache, burning, electrical shock pain. It is a universal compound that all pharmacists have access to. 

Percocets:  This pill is split in quarters.  I detest the high that comes with ingesting a whole pill. I very rarely use this form of painkiller. During the summer, I might need one quarter  every other day. In wintertime, depending of the weather, I might take an average of ¾ of a percocet per day. 

 

DHEA: is a natural hormone that is secreted by our adrenals. As we age and reach menopause, the level declines. Corticosteroids and opiates deplete the level of DHEA. I ingest 25 mg per day. (on hold)

 

DIET: Very simple anti inflammatory diet.  

Beef is no longer part of my regular diet. Pork is never ingested, as it is the most contaminated meat on the market. Have you heard of tape worm? That is what pork brings you as a gift to your colon . 

Fish in abundance. Certified organic chicken is certainly welcome. 

No more pasta. Very little bread but if elected to eat it, it must be multiple grains. Absolutely no refined sugar. substitutes such as XYlotol, natural palm sugar, cane sugar, agape are safe if there is no excess. 

Fruits, vegetables, nuts, fibre in greater quantity.   

 

Health of colon

Cleansing every year. Fasting on fruits and veggies for 10 days is beneficial for a healthy colon. It also helps with the pain. Kefir and yoghurt are the favourite means of keeping regular bowel movements. 

Go to top