SPOILER ALERT:
TODAY IS SEPTEMBER 14, 2023, AND I AM HERE TO SAY THAT THIS STUFF IN MY CASE WORKED. IF YOU HAVE TIME, READ ON, BUT SHOT #1 HAD A DEFINITE POSITIVE IMPACT AND I AM HEADED IN THE RIGHT DIRECTION. NOT SAYING THAT YOU WILL HAVE THE SAME RESULTS BUT IT MAY BE WORTH A TRY. I GO DOWN FOR MY NEXT SHOT ON SEPTEMBER 21, 2023, MY THIRD SHOT WILL TAKE PLACE ON DECEMBER 14, 2023, AND MY FOURTH SHOT WILL BE ON MAY 16, 2024.
HERE IS THE POST OF VISITS 1 AND 2:
HERE IS A POST OF VISIT 3:
May 16, 2024 - Visit #4:
THIS WAS AN INTERESTING VISIT (no video this time). I GOT SHOT #4 AND CONTINUE TO HAVE GREAT RESULTS (DOWN TO MY KNEE SO HOPEFULLY 1 OR 2 VISITS MORE). MY NEXT VISIT WILL BE NOVEMBER 14TH, 2024. DR. TOBINICK IS CUTTING THE COST OF THIS AND ANY OTHER VISIT BY A SIGNIFICANT AMOUNT MOVING FORWARD - PRAISE GOD! I ALSO GAINED A LITTLE BIT IN TERMS OF MY ABILITY TO SMELL WHICH IS SOMETHING THAT IS GOOD FOR A GUY WHO LIKES TO COOK.
THE LAST PIECE OF INFORMATION IS LIKELY THE MOST IMPORTANT ONE AND THAT IS "WHY ETANERCEPT?".
THERE ARE 5 TNF BLOCKERS: INFLIXIMAB (REMICADE 1998), ETANERCEPT (ENBREL 2003), ADALIMUMAB (HUMIRA 2008), CEROLIZUMAB (CIMZIA 2008) AND GOLIMUMAB (SIMPONI 2013).
IN MY OWN WORDS (with help of Dr. Tobinick from a patent application 20130022540 "METHODS TO FACILILTATE TRANSMISSION OF LARGE MOLECULES ACROSS THE BLOOD-BRAIN, BLOOD-EYE, AND NERVE BARRIERS" if you care to look it up)
THE BBB (BLOOD-BRAIN BARRIER) IS A PHYSIOLOGIC BARRIER WHICH SEPARATES THE BRAIN AND CEREBROSPINAL FLUID FROM THE BLOOD. IT CONSISTS OF A LAYER OF CELLS WHICH COMPRISE THE CEREBRAL CAPILLARY ENDOTHELIUM, THE CHOROID PLEXUS EPITHELIUM, AND THE ARACHNOID MEMBRANES, WHICH ARE CONNECTED BY TIGHT JUNCTIONS (ZONULAE OCCLUDENS). THE TIGHT JUNCTIONS MAY BE AS MUCH AS 100 TIMES TIGHTER THAN THE JUNCTIONS OF OTHER CAPILLARY ENDOTHELIUM, AND PREVENT MOLECULES LARGER THAN ABOUT 600 DALTONS IN MOLECULAR WEIGHT (MW) FROM TRAVERSING THE BBB WHEN THE MOLECULE IS ADMINISTERED SYSTEMICALLY (E.G. CONVENTIONAL SUBCUTANEOUS).
THE VERTEBRAL VENOUS SYSTEM (VVS) IS AN INTERCONNECTED PLEXUS OF VEINS WHICH SURROUNDS THE SPINAL CORD AND EXTENDS THE ENTIRE LENGTH OF THE SPINE. THIS VENOUS SYSTEM PROVIDES A VASCULAR ROUTE FROM THE PELVIS TO THE CRANIUM WHICH RICHLY INVOLVES THE BONE MARROW OF THE SPINE AND WHICH IS FUNCTIONALLY DISTINCT FROM THE SYSTEMIC VENOUS SYSTEM.
PERISPINAL ADMINISTRATION IS DEFINED AS ADMINISTRATION OF THE MOLECULE INTO THE ANATOMIC AREA WITHIN 10 CM OF THE SPINE. THE VVS IS CAPABLE OF TRANSPORTING MOLECULES TO THE HEAD, INCLUDING INTO THE BRAIN, THE EYE, THE RETINA, THE AUDITORY APPARATUS, THE CRANIAL NERVES OR THE HEAD, VIA RETROGRADE VENOUS FLOW, THEREBY BYPASSING THE BLOOD-BRAIN BARRIER AND DELIVERING THE MOLECULES TO THE BRAIN, THE EYE, THE RETINA, THE AUDITORY APPARATUS, THE CRANIAL NERVES OR THE HEAD.
CYTOKINE ANTAGONISTS ARE ONE TYPE OF BIOLOGIC. CYTOKINE ANTAGONISTS CAN TAKE ON SEVERAL FORMS. THEY MAY TAKE THE FORM OF A SOLUBLE RECEPTOR TO THAT CYTOKINE SOLUBLE RECEPTORS FREELY CIRCULATE IN THE BODY. WHEN THEY ENCOUNTER THEIR TARGET CYTOKINE THEY BIND TO IT, EFFECTIVELY INACTIVATION THE CYTOKINE, SINCE THE CYTOKINE IS THEN NO LONGER ABLE TO BIND WITH ITS BIOLOGIC TARGET IN THE BODY. AN EVEN MORE POTENT ANTAGONIST CONSISTS OF TWO SOLUBLE RECEPTORS FUSED TOGETHER TO A SPECIFIC PORTION OF AN IMMUNOGLOBULIN MOLECULE (Fc FRAGMENT). THIS PRODUCES A DIMER COMPOSED OF TWO SOLUBLE RECEPTORS WHICH HAVE A HIGH AFFINITY FOR THE TARGET, AND A PROLONGED HALF-LIFE. THIS NEW MOLECULE IS CALLED A FUSION PROTEIN IS WHERE ETARNCEPT (ENBREL) COMES IN.
ETANERCEPT HAS A SERUM HALF-LIFE OF APPROXIMATELY 4.8 DAYS. ONE OF THE MOLECULES CAN BE DESIGNATED AS A TNFR:Fc BECAUSE IT IS DIMERIC FUSION PROTEIN CONSISTING OF TWO SOLUBLE TNF RECEPTORS FUSED TO A Fc PORTION OF AN IMMUNOGLOBULIN MOLECULE. THE UNIQUE STRUCTURE OF ETANERCEPT, CONTAINING A DIMER (TWO) SOLUBLE TNF RECEPTORS FUSED TO AN Fc PORTION OF AN IMMUNOGLOBIUN MOLECULE IS NECESSARY FOR THE PROPER PERFORMANCE OF THIS PRESENT INVENTION.
PERISPINAL DELIVERY IS PARTICULARLY ADVANTAGEOUS WHEN BIOLOGICS, SUCH AS ETANERCEPT, WHICH PROFOUNDLY AFFECT NEURONAL FUNCTION ARE ADMINISTERED BECAUSE OF THEIR EFFICACY AT EXTREMELY LOW CONCENTRATIONS (HIGH BIOLOGIC POTENCY).
THIS MAKES THE TNF RECEPTOR PROTEIN GENTLER, MAKING IT THE BEST AVAILABLE SOLUTION FROM A SAFETY STANDPOINT WHEN DELIVERED PERISPINALLY.
A Doctor had a similar conclusion (from the r/stroke blog on reddit):
"The remarkable validation of the triumph of this procedure is clear when seeing patients’ pain-free, extremely excited, recovering movement in compromised limbs, and regaining speech and communication. Therefore, it is very evident that the disruption of brain-TNF homeostasis elicits maladaptive alterations producing numerous neurological disorders.
I wish you the best as you explore treatment options for you.
Best regards,
Tracey"
INTERESTING EXCERPT FROM A PAPER WRITTEN IN 2014 (YOU BE THE JUDGE) AS A REBUTTAL TO WHITLOCK COMMENTING ON THE PAPER:
"Etanercept is providing billions of dollars of yearly
income to its manufacturers. These drug manufacturers are
the only entities that possess the combination of regulatory
expertise and financial capability necessary to achieve
regulatory approval for these essential novel therapeutic
indications. The strength of the emerging evidence argues
for joint industry–government–academic cooperation to
facilitate overcoming the substantial translational barriers
that exist for such an innovative therapeutic approach."
I ALSO FOUND THIS ON THE BRAIN BODY RESEARCH INSTITUTE ( https://brain-body.org/departments/scientific-background/ )
SCIENTIFIC BACKGROUND
"There is increasing recognition that elevated levels of inflammatory mediators such as the principal mediator Tumor Necrosis Factor (TNF), an immune signaling molecule that we have demonstrated is also a neuromodulator, not only is required for normal biological functions in the brain, but in excess interferes with functional connectivity. Our research to date documents the rapid and sustained neurological improvements that ensue after perispinal administration of a single dose of a TNF blocking agent that rapidly neutralizes excess TNF, reduces microglial activation, and modulates synaptic and brain network function. Large molecule anti-TNF agents, when given systemically, are mostly excluded from the brain. Thus, a minimally invasive, perispinal (venous plexus surrounding spine) peripheral injection will be used for effective delivery of TNF blocking drugs to the brain. The success of this approach, paired with limited knowledge of brain TNF signaling, compels us to decipher the role of TNF in the brain ventricles, its TNF receptors, down-stream brain signaling molecules, and blood-brain/cerebrospinal fluid (CSF) barrier mechanisms involved in a plethora of brain pathologies. The founding research team has conducted pioneering research detailing the role of TNF in brain function. This research has been and promises to continue to be of significant value with regard to the understanding of the role of TNF in the modulation of brain function.
Expansion of this research going forward is exciting for the following reasons. By selectively targeting the brain non-invasively with anti-TNF compounds, practitioners can reduce and ameliorate an inflammatory response within the brain subsequent to trauma both in the periphery as well as in the brain. We do know that excess or prolonged inflammation can cause damage to tissues, but in particular the brain parenchyma. The administration of anti-TNF drugs directed solely to the brain can reduce or arrest the inflammatory response. Certainly, achieving reduced inflammation in the brain after succumbing to an insult can reverse damage. These favorable brain effects are consistent with improvements in brain functional connectivity.
This work has paved the way for the usage of anti-TNF biologics to be delivered to the brain by a novel non-invasive perispinal route of delivery (perispinal administration). This work on TNF will markedly change medicine's approach to treating traumatic brain injury (TBI), stroke, depression, neuropathic pain, CRPS, dementia, Alzheimer's disease, and much more. It is our hope that the medical and scientific communities will be inspired and driven by the quest for knowledge, understanding, and alleviation of needless suffering, and thus embrace this game-changing treatment for brain injury-induced pathologies and subsequent disabilities.
To this end, we have established collaborations with the Institute of Neurological Recovery, where Dr. Edward Tobinick is successfully treating neurologic dysfunction using perispinal injection of a TNF blocker (Etanercept), procedures that are based on the founding team’s research findings. The founding team has personally witnessed Dr. Tobinick’s extraordinary clinical procedure in Boca Roton, FL. We have published this case study as well as two review articles (see attached CV) pertaining to this clinical application. These reports explain the success of this clinical application to alleviate neurologic pathology/dysfunction in terms of our novel molecular mechanism model of blocking the pathologic over-expression of brain-TNF and validate our in vitro work and animal model research. Dr. Tobinick’s clinical practice as well as present ongoing clinical trials validate the premise of our extensive basic research that show over-expressed TNF in the brain to be responsible for neuropathic pain and neurologic dysfunction. Dr. Tobinick’s off-label use (treatment of post-stroke/TBI neurological dysfunction) of FDA-approved etanercept via perispinal delivery (peripheral delivery and essentially non-invasive) is therapeutically effective and warrants rigorous scientific investigation as a treatment of TBI disability."
ONE OTHER THING TO CONSIDER IS HOW ONE DEFINES "SUCCESS". I DEFINE IT AS "GETTING OUT OF IT WHAT YOU WANT". IT DOESN'T MEAN THAT YOU WILL RETURN TO 100% NORMAL. SUCCESS VARIES FROM PERSON TO PERSON SO ALTHOUGH YOU MAY FEEL BETTER YOU MAY STILL HAVE DEFICITS IN YOUR HANDS OR LEGS. THIS PERSON SAYS IT ALL IN TERMS OF THE TREATMENT WHEN IT WORKS AND HAD THE SAME TYPE OF STROKE THAT I DID:
SEE YOU IN NOVEMBER 2024...
TODAY IS AUGUST 29TH, 2024 AND I HAD THE PRIVILEGE OF MEETING WITH THE BRAIN AND BODY INSTITUTE'S DR. ROBERT SPENGLER (UNFORTUNATELY DR. TRACY IGNATOWSKI COULD NOT MAKE IT BUT I WANT TO THANK HER FOR ARRANGING THIS MEETING).
A COUPLE OF THINGS RESULTED FROM THIS MEETING THAT I THINK I SHOULD SHARE.
DR. SPENGLER SERVED AS AN EXPERT WHEN TESTIFYING FOR DR. EDWARD TOBINICK (CASE BELOW). HE REFERENCED HOW QUICKLY THINGS COULD HAPPEN FROM "BAD SUBSTANCES" LIKE COCAINE, POT, AND ALCOHOL SO WHY IS IT ANY DIFFERENT IF SOMETHING LIKE PERISPINAL ETANCERCEPT IF SOMETHING GOOD HAPPENS?
HE NOTED THAT A COUPLE OF "BAD OUTCOMES" CAN AND DID HAPPEN BUT HE IS QUICK TO NOTE THAT 2 OF THE PEOPLE HAD IMPROVED TASTE EVEN THOUGH THEY FAILED TO GET THE "FULL OUTCOME" OF THE TREATMENT BECAUSE THE IMPROVED TASTE SHOWS THAT IT WORKED ALTHOUGH TO A LESSER DEGREE THAN HOPED FOR. HE ALSO HAD A SIMILAR EXPERIENCE WITH SOMEONE HE HAD SENT TO RECEIVE THE TREATMENT WHO EXPERIENCED THE SAME THING. AS CITED THE BRAIN IS A MYSTERIOUS PLACE.
HE WILL BE PUBLISHING 5 PAPERS IN THE NEXT YEAR OR SO ON THIS AND OTHER TOPICS TO MEET THE "SCIENTIFIC DEMANDS" THAT SEEM TO BE "MISSING" ALTHOUGH THERE HAVE BEEN MANY ARTICLES PUBLISHED ON THIS TOPIC.
THIS IS FROM DRUGS.COM CALLED "DOES PERISPINAL ETANERCEPT WORK FOR STROKE RECOVERY" BY CARMEN POPE ON JANUARY 12, 2023 (THIS IS THE CASE THAT DR. SPENGLER WAS TALKING ABOUT, THE HARD THING IS TO FIND THE "POSITIVE OUTCOMES")
"Many international experts are confused as to why barriers have been put in place by the American Academy of Neurology (AAN) as well as Big Pharma to prevent clinical trials of perispinal etanercept from being conducted in the United States.
In 2014 a Fellow of the AAN Academy attempted to stop the off-label treatment of perispinal etanercept by Dr. Tobinick through the Court system (California Case No. 04–2012-222007, 22 May 2015). The Fellow lost the case, with the court declaring poststroke etanercept to be within the standard of care, citing that there was enough research about etanercept’s safety and effectiveness to support its use. Despite the Medical Board of California adopting this court decision, the AAN appears to disregard it and has an advisory on its website stating that evidence is insufficient to determine the effectiveness of etanercept treatment and that it may be associated with adverse outcomes and high cost.
Most neurologists in America have ignored invitations to observe or engage in perispinal etanercept, and most have been openly skeptical and scathing of its beneficial effects."
In the case you're referring to (California Case No. 04–2012-222007, 22 May 2015), the fellow who attempted to stop the off-label treatment of perispinal etanercept by Dr. Tobinick was Dr. John M. McCoy. He was involved in legal actions against Dr. Tobinick regarding the use of this treatment for conditions like Alzheimer's disease and other neurological disorders. The case highlighted ongoing debates about the ethics and safety of off-label drug use. Dr. John M. McCoy practices in the field of neurology and is associated with institutions in California.
The case involving Dr. Tobinick and the off-label use of perispinal etanercept centers around the controversial treatment of neurological conditions, including Alzheimer's disease. Dr. Tobinick developed a method of administering etanercept, typically used for rheumatoid arthritis, via the perispinal route. This approach was met with skepticism by some in the medical community, including Dr. John M. McCoy. In 2014, Dr. McCoy sought legal action against Dr. Tobinick to stop his practice, citing concerns over the safety and efficacy of the treatment. The case highlighted issues related to off-label drug use, medical ethics, and the regulation of innovative treatments. It ultimately raised questions about the balance between patient access to novel therapies and the need for rigorous clinical evidence to support such practices. The court proceedings reflected broader tensions within the medical community regarding the adoption of unconventional treatments without established scientific backing. The outcome of the case contributed to ongoing discussions about patient safety, informed consent, and the responsibilities of medical practitioners.
To the best of my knowledge, Dr. Tobinick has treated over 5,000 patients and while not all have been deemed "successes", he has NEVER lost a patient due to the use of etanercept.
Dr.Tobinick has “lost” many Court Cases. In September 2006 California Medical Board against Dr. Tobinick Unprofessional Conduct For Advertising, January 2008 Tobinick on probation with Medical Board of California, May 2013 Steven Novella publishes scathing article in Science-Based Medicine entitled “Enbrel for Stroke and Alzheimer’s”, July 2014 Another paper published by Steven Novella “Another Lawsuit To Suppress Legitimate Criticism – This Time SBM”, and October 2015 Steven Novella “wins” with a Summary Judgement. So I had to take all this into account as well lest anyone think I'm on the take, I am not.
I HAVE ABOUT 2 MONTHS TO GO BEFORE MY NEXT TREATMENT AND I RUN THE DEMONSTRATION OF THIS SUBJECT MATTER AT A COLLEGE-LEVEL COURSE IN JUST A FEW WEEKS SO I'LL BE SURE TO LET YOU KNOW HOW IT GOES.
IT'S SEPTEMBER 24TH, 2024, AND THIS IS JUST AN UPDATE ON MY FIRST TEACHING ENCOUNTER. ALL IN ALL, IT WENT WELL. THE STUDENTS AT ADVENT HEALTH UNIVERSITY WERE KIND, AND ATTENTIVE, AND ASKED GOOD QUESTIONS. I JUST WANTED TO TAKE THIS OPPORTUNITY TO THANK STEFANIE JOHNSON FOR PULLING THIS OPPORTUNITY TOGETHER. WE GO BACK ON OCTOBER 29TH, 2024, TO ANSWER FOLLOWUP QUESTIONS.
JUST A QUICK NOTE, TODAY IS OCTOBER 29TH, 2024 AND THE FOLLOW-UP CLASS WENT WELL. THE STUDENTS ASKED GREAT QUESTIONS AND DR. JOHNSON FOLLOWED IT UP TO CLOSE THE SESSION WITH ONE OF HER OWN. THEY GIVE THEIR FINAL PRESENTATIONS ON DECEMBER 3RD AND 5TH AND I LOOK FORWARD TO IT.
IT'S NOVEMBER 15TH AND I HAD MY 5TH SHOT YESTERDAY AND CONTINUE TO IMPROVE. IT'S GOING TO TAKE 1 OR 2 MORE SHOTS, NEXT ONE WILL BE IN MAY 2025.
JUST A QUICK NOTE ON DECEMBER 3rd, 2024 - THE STUDENTS DID AWESOME, REALLY LOOKING FORWARD TO TEACHING THIS CLASS IN THE SPRING OF 2025.
<<<<<<<<<<<<<<<<<<<< BEGIN NORMAL BLOG >>>>>>>>>>>>>>>>>>>>>>>>>
I ran across this on a website:
Dr. Edward Tobinick (Age 71 years old at the time this is being written) claims that if you take the medicine Etanercept (a TNF blocker, in this case, Enbrel, which is approved for use on Psoriasis and is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients ages 2 and older is being used as an "off label" treatment). In 2010, the Doctor began giving the medication to patients Perispinally (injected into the spine) and achieved positive results in about ten minutes. Tumor Necrosis Factor (TNF) is a multifunctional cytokine that plays important roles in diverse cellular events such as cell survival, proliferation, differentiation, and death. As a pro-inflammatory cytokine, TNF is secreted by inflammatory cells, which may be involved in inflammation-associated carcinogenesis. A dose of 25mg of etanercept is given by injection, directly into the cerebrospinal fluid in the spine by a trained physician. The patient then lies flat on their back and the bed is tilted backward so the patient’s head is below their feet at an angle of roughly 16 degrees for 5 minutes (this is called Trendelenburg Positioning). There are numerous foreign patents and many in the U.S. too. Dr. Tobinick has now treated individuals from every state in the U.S. and from 101 countries (this number will keep growing) around the world. The INR's (Institute of Neurological Recovery) breakthrough treatment is not experimental: it has been used for thousands of patients, from every populated continent in the world. Studies show that dormant circuits in the brain and other parts of the central nervous system, following stroke and other forms of injury, are capable of being re-activated, resulting in rapid neurological improvement.
Dr. Tobinick says in his article which ran in The Philadelphia Examiner on December 22, 2012, what makes up a good candidate:
"WHO'S A CANDIDATE?
The vast majority of stroke and traumatic brain injury survivors living at home or in a rehab center are candidates for etanercept therapy, Boca Raton's Dr. Edward Tobinick said. The best patients are those with some residual function in their mobility and cognition, though he has successfully treated quadriplegics.
Patients who would not qualify for treatment are:
Diagnosed with multiple sclerosis, tuberculous, severe immune suppression or an active infection.
Hospitalized and has not yet been discharged.
Comatose"
It sounds too good to be true, so I went through some of his videos and found one of particular interest. This lady had an Intracerebral Hemorrhagic Stroke in the Left Side of the Basil Ganglia (which was caused by hypertension). So, she had the same thing I had just a different origin (all her problems are on the right-hand side of her body, and she required 3 doses for her treatment). You be the judge by watching her five-minute video (there is an immediate and sustained improvement in severe stroke pain, right-hand function, shoulder range of motion, speech, etc., 3 years after stroke, following perispinal etanercept treatment by Edward Tobinick, M.D., filmed August 15th and September 6, 2022, at the Institute of Neurological Recovery in Boca Raton, Florida.)
She also had her 3rd treatment on November 10th, 2022, and continues to improve:
There are many other videos on their YouTube page if you need more convincing:
Research has found perispinal etanercept results in significant improvements in:
Behavior
Central post-stroke pain syndrome (CPSP) – A disabling condition characterized by pain and sensory abnormalities in parts of the body supplied by those nerves present in the area of the brain injured by the stroke. Mild sensations on the skin, such as touch, warmth, and cold are misinterpreted and registered by the brain as pain.
Cognitive function
Hand function – stronger grip
Hemiparesis – This is the inability to move one side of your body and in stroke patients, it makes everyday activities like eating or dressing, difficult.
Hemisensory defects (these are altered sensations on one side of the body and could include numbness, tingling, or heaviness)
Improvements in swallowing
Mood with reductions in depression and anxiety
Movement
Sensations
Shoulder pain and range of movement. Significant, almost instant improvements have been seen regarding shoulder flexion in the paretic arm (the arm that is paralyzed after a stroke)
Spatial perception (being aware of your surroundings and your position relative to them)
Speech (reduces slurring and increases the speed of speech)
The way a person walks (their gait).
Case studies have also reported regained bladder sensation and control and a reduction in excessive emotionalism.
What to do? It is a very expensive procedure and there are no guarantees that I would have the same results (they make you sign your life away, so they have no liability). But if it got rid of some or all of my pain (a constant 5 or greater) it would be worth it to me.
It's April 12th, 2023, and I had my call with the doctor's office today. I actually spoke with Dr. Edward Tobinick for 1/2 of an hour and he recommended two doses, one week apart. It has an 80% success rate which is 4 out of 5 reacting positively to it. He told me that the work done by Dr. Jayson Stack (my neurosurgeon) was excellent because he took the time to make sure that the blood was gone which is a major factor in stroke post-op. So, I went ahead with it, there is a five-month waiting period, so I'll let you know how it goes on September 14th.
It's April 21, 2023, and I got my Complete Blood Count (CBC) done and sent done to Dr. Tobinick. No red flags in it so that's great news.
So, I was talking to my neighbor Kevin today (4/29/23) and found out he is going to help me out by getting a room because he works for Choice Hotels. God is good!
Another phone conversation and another miracle. I was talking to Gary (5/2/23) who is a long-time friend where I used to work and he told me that he had some good luck and desires to pay it forward, so he is going to cover my second shot (provided the first one does what we hope). You can't make this stuff up, again, God is good!
Another phone conversation and yet another miracle. I was talking to Tony (6/30/23) who is again a long-term friend, and he too is going to contribute to my shots (provided the 1st does what is supposed to do) by covering 20%-25% of the cost. (UPDATE 9/15/23 - Tony will now cover the cost of one shot). You just can't believe how happy I am. I have eleven weeks minus one day and it will be here, God continues to amaze me.
Had my Skin Test for Tuberculosis (PPD) today June 30, 2023, and it was negative. Sent the results down to Dr. Tobinick and all is good from a preop testing perspective.
Today is July 13, 2023, and only 9 weeks to go but God is still working. I had lunch with Laura who is an old friend and a trusted comrade. She too wants "in" on the action and is going to cover one shot for me. I can't even begin to say thank you and I know that God has something in store, and I will soon be able to find out what it is.
Today is Thursday, August 10th, 2023, only 5 weeks to go and we'll answer the question of whether or not I'll respond to this treatment. I have been researching the "thing" that makes this treatment so successful and it is the fact that it uses perispinal as the way to get the etanercept to the proper location. There is a whole discussion of the approach in the write-up on it located on Dr. Tobinick's patent number US 7,214,658 B2 dated May 8th, 2007: METHOD OF DELIVERING A TNF ANTAGONIST TO THE BRAIN OF A HUMAN BY PERISPINAL ADMINISTRATION WITHOUT DIRECT INTRATHECAL INJECTION. Some highlights of the patent are:
Perispinal administration involves anatomically localized delivery performed so as to place the therapeutic molecule directly in the vicinity of the spine, and, for the purposes of this patent, administration which is outside of the intrathecal space (although the subsequent movement of a therapeutic molecule into the intrathecal does occur).
Perispinal administration leads to enhanced delivery of etanercept to the brain in a therapeutically effective amount, via the vertebral venous system and/or cerebrospinal fluid.
Etanercept is delivered to the interspinous space in proximity to the ligamentum flavum by percutaneous injection through the skin by midline interspinous needle injection.
Etanercept which reaches the cerebrospinal fluid will immediately bind and inactivate TNF circulating in the CSF and therefore immediately reduce its adverse biologic effects on the brain.
The vertebral venous system is a non-obvious route of administration for the inventions disclosed herein. The present invention is counter intuitive as it uses the venous system to deliver a therapeutic molecule to the brain.
The inventions disclosed here are counter-intuitive because they rely on the casino-vertebral venous system to deliver the etanercept to the brain, brain stem, meninges, spinal cord, dorsal root ganglion, and nerve roots.
This delivery is accomplished by inducing retrograde venous flow (the opposite direction from the usual direction) which is made possible by the lack of valves in this venous system, and by the proper use of gravity and positioning of the patient so that the venous flow in the retrograde direction is accomplished.
The vertebral venous system is continuous along the length of the spine, but is, closest to the brain in the cervical (neck) region. The vertebral venous plexus is extensive in the cervical region, and in this area defects in the ligamentum flavum are also more common, both of which factors help etanercept delivered to the cervical interspinous space to reach the brain. For all of these reasons, for this invention the usual point of injection for the perispinal etanercept is in the posterior neck, overlying the spine.
Correct positioning of the patient so as to facilitate retrograde blood flow in the cranial direction is utilized as a part of the present invention to achieve improved delivery of etanercept to the brain. After a posterior cervical interspinous injection of etanercept in sterile water the patient is rapidly placed in the prone position and the plane of the examining table is placed head-downward (Trendelenburg) to facilitate retrograde delivery to the brain and the cranial venous system. Etanercept, because of its biological nature, is uniquely suited to delivery via the CVVS to the brain, because of its nearly instantaneous therapeutic effect. This instantaneous effect is the direct consequence of the fact that etanercept, in contradistinction to synthetic drugs that are not of biological origin, does not function by influencing intermediary processes, but rather binds directly to soluble TNF.
One of the advantages of perispinal delivery into the interspinous space is that administration is simplified. The route is simple and safe. Hemorrhage due to the use of long or large bore needles is minimized because perispinal administration, by the subcutaneous route, requires only a short, narrow bore needle.
Local perispinal administration also has the advantage of providing a depot of therapeutic medication in the surrounding tissue, which will provide therapeutic levels of medication to the treatment site for a prolonged period of time.
All of these factors tend to increase the therapeutic half-life of the administered cytokine antagonist. Taken together, all of these forms of localized anatomic administration have significant clinical advantages over the various forms of systemic administration customarily used to deliver etanercept.
That's what Dr. Tobinick feels. Other people say that Dr. Tobinick's claims and methods have been met with skepticism and criticism from the broader medical community. Many experts have expressed concerns about the lack of robust clinical trials and scientific evidence supporting the efficacy and safety of perispinal etanercept for neurological conditions. The use of the anti-inflammatory drug in this manner and the safety of perispinal raises questions about potential risks and unintended consequences.
I decided to call Amgen and see if they had anything to say about perispinal and their medicine and was politely turned down to ask my doctor. Also, a search on their site of 'perispinal' yielded no results.
Paul P. from Orlando, FL wrote the following on 12/30/2012 after giving it a 1-star rating (excerpt from the post):
"If you do a Google search of "Tobinick and Etanercept" you will find many negative articles. Amgen (the manufacturer of etanercept) issued a press release asserting that there is insufficient and unsubstantiated scientific data to support Dr. Tobinick's use of Enbrel and distances itself from Dr. Tobinick's claims with respect to Alzheimer's. Amgen specifically disclaims Tobinick's work using Enbrel saying: "We are not aware of any human data demonstrating that Enbrel reaches either the cerebrospinal fluid or the central nervous system in sufficient concentrations to inhibit the actions of TNF when administered by Dr. Tobinick's method" and "... we believe the reported rapidity of response to be biologically improbable when considering the time required for resolution of an active inflammatory response and the potential impact that this could have on cognition" and that "Amgen does not support this or any off-label use of Enbrel".
I hope the State of Florida's division of medical licensing pulls all of Dr. Tobinick's patient records to either confirm or deny his results vs. expectations of hope that Dr. Tobinick's marketing efforts create. If, indeed, we are in the minority of patients for whom this 'breakthrough' did not help them, I can live with the fact that this is experimental and off-label; if, however, his claims are untrue, he should be stopped."
I also found this appearing in an article 21 January 2008 on the ALZFORUM:
"Amgen, the maker of etanercept, distanced itself from the study. A statement regarding Tobinick and Gross's study on the company website noted: "This study was not supported or endorsed by Amgen. While Amgen and others have long recognized the potential for TNF inhibitors to have an effect on neurological conditions, we have carefully examined this study and believe that at this time there is insufficient scientific data to support the use of a TNF inhibitor as a means of treating Alzheimer's disease."
Reached by telephone, Amgen spokeswoman Sonica Fiorenza confirmed that this statement referred not only to the present paper but that Amgen had studied etanercept's potential for treating AD internally as well. "As common sense would suggest, we have looked very closely at this,", Fiorenza said.
Dr. Karen D. Sulivan, who's site is "I CARE FOR YOUR BRAIN" and is a board-certified neuropsychologist is a nay sayer in her video entitled "Etanercept for Stroke Recovery: Fact or Fiction?". What I find interesting is she doesn't take the time to understand the perispinal aspect of the delivery. You be the judge:
I guess I will find out in five weeks. Most of the reviews online are negative and the most I found was around 10 reviews on any one site. It's supposed to work on 80% of the people who take it. If it works, then hallelujah! If not, I have been making steady progress at the CORE gym and will keep on pushing to get better.
Before I have treatment in a little over three weeks, I thought it would be good to capture one source (my whole right side is a problem) of my pain and that is my foot and inflamed right knee.
This is what I hope to address (along with other ailments) through my treatment, only time will tell whether it is meant to be, and I'll know in about three weeks' time.
In the meantime, I used ChatGPT to write a little song which I hope you'll enjoy.
(Verse 1)
Five and 3/4 long years, I've waited here, With hope and faith, through every tear. A battle fought, with pain in stride, For central post-stroke pain, is on my right side.
(Chorus)
Five and a half months, we've held our breath, September 14's the day, we'll face this test. Perispinal's etanercept, the path, we're on this ride, With Dr. Edward Tobinick, there standing by our side.
(Verse 2)
He said, "This treatment's good, let's make it right, To conquer this pain, and find the light." Amgen, they questioned, but we won't hide, For faith is our shield, and hope our guide.
(Chorus)
Five and a half months, we've held our breath, September 14's the day, we'll face this test. Perispinal's etanercept, the path, we're on this ride, With Dr. Edward Tobinick, there standing by our side.
(Bridge)
With Gary, Tony, and Laura too, They're here to support, in all we do. In the depths of the struggle, we'll find our way, With God above, we'll see a brighter day.
(Verse 3)
As we journey forward, hand in hand, Facing the unknown, across the land. Perispinal etanercept, our beacon bright, With love and support, we'll win this fight.
(Chorus)
Five and a half months, we've held our breath, September 14's the day, we'll face this test. Perispinal's etanercept, the path, we're on this ride, With Dr. Edward Tobinick, there standing by our side.
(Outro)
With faith and hope, our spirits soar, Together we'll reach what we're fighting for. In the face of the storm, we'll find our way, With God and our friends, we'll see a brand new day.
Today is September 14, 2023, the big day. I arrived at INR at 9:25 am and had to wait in the lobby and then took a COVID test. After 15 minutes they let me in, and I filled out the paperwork and paid them for the balance of my first shot. At 10:20 am I went back and the spent an hour doing physical and mental tests, sit down and stand up and a GAIT test which took until 11:20 am. They are now treating 2 patients and I was #2 so I went in at 12noon. After an interview I got my shot at 12:20 pm and then tipped backwards for 10 minutes. Around minute 2 I could feel my fingertips and when it was over, I definitely felt an improvement. I had better movement in my neck, I could touch my toes and improved my walking. I by no means thought this was going to get taken care of with 1 dose. I went from a 7 out of 10 to a 4 out of ten which is huge improvement. I definitely took a step in the right direction, and I go back for shot #2 next week and shot #3 on December 14th, 2023 and I'll post those updates as the occur. Here's a shot of me while I'm waiting for the medicine to take effect:
By the way, this doesn't work for everyone. Check out this link for more info:
Of particular interest is jmolloypisacane (located at the bottom of the link) on August 10, 2023 who did not realize the whole benefit, excepts from our "chat":
I went to dr Tobinick Aug 10 2023 I could breath better now I could now do harder obstacles i could stop on a dime now and improve my confidence a little. My story is
I’ve had rt vertebral artery dissection with 2 brain stem strokes with a small stroke (Tia) the day before MANY symptoms both side I wish the rt eye double vision would go away and the head fuzziness ( feels like you’re drunk)or (feels like someone spun you around quickly and out you down and walked away)would go away and I would talk normal again and my rt side facial paralysis would come back My left side is Like it was stuck in snow for hours then put under hot water I wish The falling asleep feelings and numbness would go away on my left side and my walking was not like a monster and I would not limp when walking and the rubber band feeling on my left knee,calf,and foot would go away!
I wish my taste would come back and my deafness in rt ear would come back and my rt side would not feel so inhibiting !
It happened on august 13 2021 and feels like forever No known reason, spontaneous Left side variant born with it, does not connect to the brain I’m now 47 I’ve had acupuncture more than 15-20 sessions, HBOT 40 sessions, 3 natural paths, stemcell transplant in Florida ( my own 35-45 million cells from my bone marrow) also I have tried grounding and also wearing stones charging them putting lavender on them etc. carrying them with me i take many vitamins and 3 mushroom vitamins I take minimal meds for medical stuff, So I take BP MED , cholesterol med heart rate med Depression med
I also take peptides BPC157 with TB500 GHK -CU TB500 itself CJC1295 ipamorelin INJECTION IN STOMACH or LEG I ALSO DO N-Aceytl Semax intranasal, bio Tesla healer cans Asea water and stem cell spray under tongue X39 patches and Aeon patches they are stemcell patches I did a shot in Florida of Enbrel in back of neck and it helped minimal I am hoping for the best maybe a miracle
AbrocomaSufficient39
·16 days ago
Thank you for sharing and keep at it! My session is September 14th, I had a hemorrhagic stroke on the basil ganglia on the left side of the brain 5-1/2 years ago (so my right side is in pain 24x7 from head to toe). I will let you know how it goes for me in the coming weeks.
AbrocomaSufficient39 ·7 days ago Thank you. I will let you know how it goes later in the week. BTW, my stroke was actually 5 years and 10 months ago (9/19/23), sometimes I'm having too much fun (not!). jmolloypisacane ·3 days ago Good luck tomorrow it’s going to be a long visit they are very strict on Covid They will test you to see if you have Covid. You have to sit in the hallway and take your people walkers done no cover test is done so get ready for that and the Staff is very very helpful
AbrocomaSufficient39 ·3 days ago Thanks for the heads up on the COVID (got through that with flying colors). Had my first shot today and it definitely helped. I am by no means 100% healed but definitely moving in the right direction. I go back for my second shot next Thursday and I am scheduled for a third on December 14, 2023.
As you can see, a very different stroke and a different outcome. The main message is to do your homework and then make your decision.
It's now September 21, 2023 - Shot #2. I arrived at 9:15am, took a COVID test and by 9:40am I was in the back. At 9:55am we did the usual, word games, squeeze test and finger to nose all with fairly positive results. I was done with that by 10:10am, 10:30am I took a baby aspirin, and the Dr. came in at 11:15am. We spent a half-hour with questions such items as "How by you determine where the shot goes? Answer: In the middle (I did not know that)", "How long will the shots last? Answer: That varies by patient. Some patients require one, others require more. In my case I will require more because a hemorrhagic stroke is tough because of the blood that lies around from it.", and "How do you determine the intervals of 0, 1 week, 3 months and 6 months? Answer: Based upon our experience." I also got to tell him of a side benefit of treating my tinnitus in my right ear which went along with the general stuff with the stroke. Come to find out in some patients this is a side benefit of perispinal etanercept and we looked at paper from 1999 that covered this. Dr. Tobinick's patent number US 2001/0004456 A1 dated June 21, 2001: CYTOKINE ANTAGONIST'S FOR THE TREATMENT OF SENSORINEURAL HEARING LOSS (more on this a little later). Had my shot at 11:45am and left very happy that my pain continued to go down I'm now running about a 2 on my upper body, 4 on my mid-level and a 5 on my lower extremities. The biggest thing this time was I for the first time in almost six years can now move my right foot and right toes a little bit, God is good.
From Page 4 of the Patent was an interesting example:
EXAMPLE 1
Etanercept for the Treatment of Sensorineural Hearing Loss
[0048] A 73-year-old Caucasian women patient presented with a history of slowly increasing hearing loss in both ears. The patient had noticed decreasing hearing beginning approximately 20 years earlier, in her 50's. Her father had experienced hearing loss beginning about the same age. One yar prior the patient had noticed that she was having great difficulty hearing conversation at family meetings. Her grandchildren were urging her to get hearing aids about that time. Six months prior to her visit she obtained digital hearing aids and used them daily. The patient had a recent history of sciatica; a history of spinal stenosis; and a previous diagnosis of sensorineural hearing loss. A subcutaneous injection of etanercept was administered at a dose of 25mg. One hour later the patient noticed that sounds were significantly louder. Improved hearing continued for the duration of treatment with etanercept. One day after receiving the second dose of etanercept 25mg, which was administered four days after the first dose, the patient needed to remove her digital hearing aids because her hearing was so improved that sounds were too loud while the hearing aids were in place. This had not been necessary during the entire time of use of these hearing aids, prior to her treatment with etanercept.
While mine is not as good as the patient, I took have had a 50% reduction in terms of my tinnitus and look forward to getting more as the shots continue. An added benefit that I had no idea was coming and I'll gratefully accept it.
Here a picture of Dr. Tobinick and me:
I'll see you all after shot #3 in December, until then be safe.
It's shot #3 time and I continue to make good progress. I look forward to shot #4 in May of 2024 for sure. I did get to meet Michael Skivesen & Tobias who are getting training for a couple of weeks before going back to Denmark to open the first clinic of its kind.
And part of my "give back" was to run a 5k and push Jonathan the entire length of the course which happened on December 16, 2023, it took us 53 minutes to finish the course:
