(This post largely concerns http://www.msdiscovery.org/news/news_sy ... -meets-eye)
I experienced an “epiphany” in 1984-85 when, under the care of a nutritionist/kinesiologist I entirely recovered MS nerve damage through detoxification, optimal nutrition and supplements, and electromagnetic energy therapies. (See My Personal Treatment) I assume the brain’s grey matter healed along with the white matter myelin. Dr. Swank’s “epiphany” www.swankmsdiet.org came over 60 years ago. Dr. Catherine Kousmine’s came about the same time. There were no MRI images to demonstrate the recoveries, only real life experiences and testimonials.
My second great “epiphany” came the summer of 2010 when I read about Dr. Zamboni’s CCSVI “liberation therapy. (He wrote about his “epiphany” in 2006, on the internet in 2008.) Upon realizing that MS is a blood/cerebrospinal fluid circulation pathology of the brain/spine, I’ve been able to get control over Progression. This “epiphany” really has transformed my life.
Unfortunately, the Big Pharma/Neurologist alliance is likely to put obstacles in coming to this “epiphany” since effective treatment is mostly beyond their competence. There may be medications which enhance blood circulation (there already are “off label” treatments), but such drugs are unlikely to be as profitable as immunosuppressive DMDs. Angioplasty for CCSVI is performed by Interventional Radiologists, and functional therapists such as Chiropractors, Osteopaths and Aryuvedic massage therapists may, for some, be most effective in releasing restricted blood/spinal fluid circulation through the central nervous system.
I consult the site Thisisms.com as my MS forum for information, ideas, community, feedback, current biases. This was the first MS site to introduce Dr. Zamboni’s “liberation therapy” which was met with huge excitement as evidenced by the 169 users on line March 4, 2011 at 2:08 am. (Their historical maximum.) Dr. Sclafani performed a wonderful service in posting case histories of people he treated along with images. (“Dr. Sclafani answers some questions”) Worldwide, mistakes that were made were largely corrected with experience. Once the IVUS intravenous ultrasound had been developed, the Interventional Radiologist could see inside the vein he was expanding, could identify the obstructions, could determine the best balloon size (too small the vein re-stenoses, too large there is the risk of thrombosis and injury to the endothelium or vein wall.) While Dr. Zamboni initiated the CCSVI angioplasty treatment focusing on the Internal Jugular Veins, the Vertebral Veins and the Azygos vein, using the Doppler Ultrasound as the diagnostic tool, Dr. Sclafani determined that the “gold” standard is the catheter venoplasty itself using the Intravascular Ultrasound and he increased the number of veins to be examined and treated (e.g. internal jugular, azygous, hemiazygous, iliac, lumbar, left renal, vena cava, transverse and dural sinuses etc) (I, in particular, am certain that I have venous stenosis in the pelvic region, the left renal and/or the iliac vein, and that treatment would relieve longstanding intestinal and urinary tract congestion.) Dr. Sclafani also decided to say he is treating CCSVI rather than MS.
Patient testimony of real relief once the veins have been opened to release the blood flow was nearly universal. Unfortunately, the relief was often short lived if the veins re-stenosed. In some cases thrombosis closed the vein off completely. Stents were problematic because they had been designed originally for arteries, and the Big Pharma/Neurology lobby opposition has retarded development of optimal tools for best results
Progress was abruptly strangled on May 10, 2012 when the FDA declared that the devices used for angioplasty were “experimental’ for MS and forbade their use outside of clinical trials. “You should be aware the FDA has not cleared or approved any angioplasty device or stents for the treatment of CCSVI and use of such devices in treating CCSVI are considered off-label at this time.” May 10, 2012 letter. The procedure is not forbidden or illegal, but insurance won’t pay for it which greatly reduces potential beneficiaries. Also, this opinion cast a pejorative light on the treatment, further discouraging interest and research.
The FDA ordered a halt to the Hubbard Foundation’s CCSVI registry to finally approve it in December 2013. (CCSVI Tracking is another patient Registry with 1,425 participants and 923 treatments thus far). A Registry has the enormous potential of providing accurate information about who can expect the best results. (My own opinion is that for RRMS, the earlier the intervention, the better. I believe that as the body structure is compromised – SPMS and even more so PPMS – the problem lies more in pressure on the spine than in stenosed veins and positive angioplasty outcomes will be increasingly minimized. See my “How RRMS evolves to SPMS” blog.) Of course registered testimony of real life experience would give both patients and Interventional Radiologists a basis of knowing what to expect given each patient’s profile. Unfortunately, the research study proposed by the Hubbard Foundation and approved by the FDA is unfunded which imposes a nearly unsurmountable obstacle to progress because medical insurance won’t pay for the procedure.
This is all the more irresponsible in that the FDA continues to encourage development of DMDs (Disease Modifying Drugs) for MS. Presumably the FDA brought a halt to CCSVI research out of concern for patient safety. Yet they encourage research in which MSers are subjected to repeated MRI’s with gadolinium dyes which are in themselves harmful, stressful and likely to exacerbate the MS condition. Let’s take a look at the use of MRI technology in MS drug treatment and research to see how aberrant the FDA position is.
One could well conclude that the vested interests of the Big Pharma/Neurology lobby are prioritized by the FDA and not the well being of the MS population.
The following was posted by Frodo on Thisisms.com on Feb 5, 2015
“FRODO MS ATTACKS AS A MOVIE.
While reading articles about MS, I have found one with some impressive movies. They were made during a year, taking a MRI picture each week. It is possible to see how lesions develop and heal. The man is reported to be symptoms-free during this period, but the images show that the disease never stops.
The article itself is also quite interesting, speaking mainly about MRI procedures and their uses.
But for me, the most interesting part are the four movies, showing how MS works. Each of the movies show a different section of the brain. Just take a look.
http://www.msdiscovery.org/news/news_sy ... -meets-eye »
I agree, this article “More Than Meets the Eye” by Ingfej Chen, posted by MS Discovery Forum, is well worth reading, and for starters take a look at the images.
The researchers are puzzled as to what these “spots” represent, saying there is “a great heterogeneity in size and course of these lesions.”
Why? For me these lesions represent the “blood reflux” to which the immune system responds, NOT a mysterious auto-immune attack. One would be well advised to see which vein drains the large lesion of the lower left side and in general correlate blood flow with the images. For me this implies a problem with brain blood circulation. An “attack” would likely show these same lesions being overwhelmed as the blood “reflux” is exacerbated.
However, nowhere is the CCSVI theory mentioned in the article.
McDonald Criteria for diagnosing MS (see Wikipedia for full description) were developed in April 2001 (revised 2005 and 2010) by an international panel in association with the American MS Society (NMSS). MRI images representing lesion activity are central to diagnosis, treatment and research. Presumably lesions correlate to “attacks”. The goal is to reduce or eliminate lesions through drug therapy which in principle should relieve the patient of MS symptoms and disability.
The following quotes come from the above MS Discovery Forum (Ingfej Chen) article.
“The stumbling block is the so-called clinicoradiological paradox: Abnormal spots on MRI often don’t manifest in physical or cognitive symptoms. As the movies from Boston illustrate, brain scans can be red herrings, pinpointing neural-tissue changes that don’t match up with how a patient feels. And physicians cannot always trace symptoms to a particular spot on a scan.”
"Conventional MRI identifies differences in water content. For instance, a white spot (or hyperintensity) on a T2 brain scan means excess water, which accompanies inflammation or swelling that can result from various causes,
In MS, lesions arise when white blood cells, having crossed the blood-brain barrier, infiltrate an area and fuel inflammation that strips the fatty myelin insulation from the axon nerve fiber, thus letting additional water in to fill the breach, on top of the fluid of the initial swelling. Neurodegenerative processes gradually destroy the axons and nerve tissue to cause irreversible atrophy (and, later, to allow even more water to move in)…
a bright, water-laden spot on a T2 scan in MS can represent different things, including inflammation, demyelination, and axon loss (Neema et al., “
Now, let’s look at these lesions from another perspective.
Subsequent to the Sherbrook (Canada) CCSVI Conference, Cece posted the following on Thisisms.com, September 30, 2013. Her post refers to a lecture given by Dr. Trevor Tucker.
“Dr. Tucker, a rocket scientist, says CCSVI is 2nd year physics. "It's not rocket science..."
In the photo, you can see a nice flow chart. Venous Obstruction -> Venous Reflux -> Venous Hypertension -> Blood Brain Barrier dysruption -> T/B cell leakage -> Myelin Attack. Those latter three events (from BBB dysruption to myelin attack) are established in the current literature. The first three (from venous obstruction to venous hypertension) are fluid dynamics.”
The Abstract from Dr. Tucker’s paper is well worth reading.
Another scientist interested in CCSVI fluid dynamics is Clive Beggs. (See CCSVI Alliance. www.ccsvi.org/)
When researchers go into long, discursive explanations on what happens when the immune system is activated in MS, it strikes me as much ado about nothing. Better to prevent the wound – the blood reflux – or enhance blood/CSF circulation throughout the central nervous system rather than try to suppress the immune system RESPONSE. By then, it’s LATE.
The MRI paper goes into great detail on advances in MRI technology and what researchers hope to achieve. However, in the end
“When you look at the data in terms of what MRI is able to predict, it’s humbling,” Naismith says”.
In research most patients are followed for 2 or 3 years which in no way can predict long term disability or effectiveness of the drug studied. Researchers at first assumed that disease activity in the brain corresponded to that in the spinal cord but have since discovered that the two areas decline independently of the other and should be studied separately. (See my blog entry “How RRMS becomes SPMS”). One other unexpected discovery. Immune system activity may represent HEALING of the myelin sheath and not damage.
Dr. Ebers was awarded the John Dystel Prize for Multiple Sclerosis March 21, 2013 which freed him to give a lecture titled “Critical Review of outcomes used in MS clinical trials” posted on You Tube November 4, 2013 by the European Medicines Agency. www.youtube.com/watch?v=OqY-_K1fYJY (see my blog post November 7, 2014)
His study of 1000 patients over a 30 year period revealed that relapses are unrelated to long term outcome. His 25 year study of Disease Modifying Drugs revealed they don’t prevent descent into disability.
Quotes from Ingfej Chen article above.
“Meanwhile, a largely unaddressed concern in the field—raised by Ebers and Daumer—is that widespread partnerships and financial ties between academic investigators and the pharmaceutical and MRI imaging industries have created a bias in research findings that favors MRI’s usage, particularly in drug testing (Ebers, 2010). Such potential conflicts of interest have become common across the clinical research world, which continues to grapple with them.”
Though long funded by MS research companies, Dr. Ebers’ conclusions did not support either the use of the MRI nor DMD’s.
I noticed Dr. Robert Zivadinov’s (University at Buffalo School of Medicine and Biomedical Sciences) name at the end of the article and wondered what had become of his early interest in Dr. Zamboni’s CCSVI liberation therapy. (As early as 2011 he had observed venous abnormalities in MS patients.) However, on March 15, 2013 the University of Buffalo News reported as follows:
“University at Buffalo researchers will present their results in an “Emerging Science” poster session March 20 at the annual American Academy of Neurology meeting in San Diego. They discuss the findings in this video: http://youtu.be/94gLM4QlU_A. The Prospective Randomized Endovascular Therapy in MS (PREMiSe) trial is believed to be the first prospective randomized double-blinded, controlled study of balloon angioplasty for MS being performed with Institutional Review Board approval in a rigorous fashion in the U.S. with significant safeguards in place to ensure careful determination of risks and benefits. All screening, diagnostic, interventional and follow-up procedures and visits were performed at no cost to the patients.
The study’s key findings are that while the treatment is safe and was not associated with serious adverse events, it did not provide sustained improvement in MS patients. Based on their findings, the UB researchers’ primary message to MS patients and their doctors is that endovascular treatment for chronic cerebrospinal venous insufficiency (CCSVI) should only be done in the context of randomized, double-blinded, controlled studies like PREMiSe…said Adnan Siddiqui, MD, associate professor of neurosurgery, UB School of Medicine and Biomedical Sciences and PREMiSe principal investigator.”
This report infuriated Ashton Embry PhD who has overseen MS treatment for his son Matt, created the Direct-MS site and raised and donated money to fund CCSVI research undertaken by the University of Buffalo. He denounced what he considered to be a distortion of the actual findings and feared this would lead to negative publicity which could only discourage development of CCSVI treatment. He also surmised that the researchers, being funded by MS drug companies, had succumbed to a conflict of interest.
http://www.direct-ms.org/sites/default/ ... 202013.pdf
“The Actual Data from PREMiSe Do Not Support
the Highly Publicized, Anti-CCSVI Claims and
Warnings of the University of Buffalo Researchers
Ashton Embry, DIRECT-MS, April, 2013
The actual data from the PREMiSe Trial do not support the highly
publicized claim that CCSVI correction by angioplasty is not of value
for MS and may worsen disease activity. In sharp contrast, the data
suggest that CCSVI correction may well be of substantial value for
MS. The misleading claims made by University of Buffalo researchers
are based on irrelevant data from the failed Phase 2 portion of the
trial in which no one had their CCSVI corrected. The anti-CCSVI bias
and baseless claims may be explained by the conflicts of interest…
6) The excellent clinical results of Phase 1 subjects, all of whom
experienced CCSVI correction, compared to the adverse
clinical results of Phase 2 subjects, none of whom experienced
CCSVI correction, suggest CCSVI treatment may be of
substantial value for MS.
An added complicating factor is that some of the researchers involved
with PREMiSe are in a major conflict of interest in that they receive
large sums of money from MS drug companies. Because CCSVI
treatment has the potential to replace drug therapy in some cases,
the compromised researchers and their drug company benefactors
would potentially financially gain from a bogus claim that CCSVI
treatment was of no value and might even be harmful.
The PREMiSe researchers launched a major media campaign a) to
claim their data showed that CCSVI treatment was of no value and
may be of harm, b) to dissuade persons with MS from getting CCSVI
treatment outside of trials, and c) to dissuade practitioners from doing
CCSVI treatment. These claims and warnings are entirely baseless
because of the lack of significance of the results from Phase 2 in
which no one had their CCSVI corrected. They may have been
motivated by the major conflicts of interest referred to above.
The University of Buffalo should retract the currently available press
release and Youtube video and replace them with ones that contain
the real story told by the data of the PREMiSe trial.”
I don’t know what happened with this controversy. Opponants of CCSVI frequently cite the PREMiSe trial.
As of 28 February 2014 Dr. Zivadinov was featured on the Hubbard Foundation Facebook “
“Although their oft-cited prior study found no causal relationship between venous abnormalities in the neck and multiple sclerosis (MS), University at Buffalo neurological researchers are strongly advocating more investigation…) Is There a Link Between the Extracranial Venous System and Central Nervous System Pathology? (BMC Medicine, Dec. 17, 2013)… Robert Zivadinov, MD, PhD, professor of neurology, and his colleagues cite mounting evidence that the extracranial venous system may play a role in a broad range of central nervous system disorders and aging. “The full story and consequence of these venous abnormalities that disrupt normal blood flow will require much more research… Zivadinov has coauthored a debate article, “Potential Involvement of the Extracranial Venous System in Central Nervous System Disorders and Aging,” with Chih-Ping Chung, MD, PhD, of National Yang-Ming University in Taiwan, in BMC Medicine. Zivadinov also published a related editorial, “Is There a Link Between the Extracranial Venous System and Central Nervous System Pathology?” in the same journal. He and Chung call for research examining the incidence and prevalence of venous abnormalities in relation to developmental and demographic factors, as well as cardiovascular, inflammatory and lifestyle risk factors.”
How long must we wait for the epiphany that fluid circulation obstruction is the root cause of what is called MS? Numerous studies have been done revealing slow blood perfusion in MS brains. Let’s look at a recent study brought up by cheerleader on Thisisms.com.
Feb 16, 2015 “Cerebral circulation time in MS is double that of normals” cheerleader
Full paper in pdf form.
Blinded study. Cerebral circulation and hypoxia in MS is not correlated with EDSS, disability, lesions or inflammation. It appears to precede all of this---
http://www.plosone.org/article/fetchObj ... tation=PDF
as Dr. Zamboni tweeted---now we need to understand how the venous system might be impacting this slowed cerebral blood flow in MS.”
The sons of both Dr. David Hubbard (Neurologist) and Ashton Embry, PhD developed MS. After studying the disease, both fathers felt the MS auto-immune theory had not been demonstrated and both recommended angioplasty treatment for CCSVI as well as nutritional therapy.
Dr. Embry created the Direct-MS website www.direct-ms.org/ and researched a MS treatment program for his son Matt which Matt has turned into an excellent Video --http://www.mshope.com . Matt enjoyed renewed venous blood flow from the brain for about three months after his angioplasty. When the Jugular veins restenosed, rather than undergo a repeat procedure he turned to exercise to stimulate blood circulation. This is exactly what I recommend.
Dr. Hubbard created the Hubbard Foundation which has spearheaded CCSVI and MS research. See the excellent site filled with information about CCSVI as well as MS diet, supplements and general treatments. (His son Devon is lucky to have an Aryuvedic Neurologist. Well, he lives in California.)
Another excellent CCSVI site is CCSVI Alliance. www.ccsvi.org/
We will give Joan Beal (cheerleader on Thisisms.com February 2013) the final word.
“wow. We're beyond anecdotes, centenarian--
For those who, in your words, "are too lazy to click the link"
http://ccsvi.org/index.php/component/se ... ask=search
I can summarize--
--there are now hundreds of peer-reviewed and published papers corroborating the connection of CCSVI and MS with hypoperfusion, reduced global arterial cerebral blood flow, truncular venous malformations, altered cerebrospinal fluid dynamics, venous endothelial damage, chronic venous insufficiency, as well as findings that venoplasty for CCSVI exhibit changes in these parameters in many cases.
Yet the EAE mouse model for MS--which is more akin to ADEM, (in that it is a constant inflammatory reaction to a known foreign antigen, rather than a relapsing-remitting response to an unidentified antigen)--is still used to test MS treatments. I'd submit that using a failed mouse model, which is not based in reality, has more in common with blood-letting, quackery and wishful thinking. Who is selling the snake oil?
http://ccsviinms.blogspot.com/2010/10/s ... -were.html
Jeff and I are looking forward to hearing the researchers discuss this new neurovascular science at the 4th annual ISNVD conference, next weekend in San Francisco. We'll be reporting back on twitter, Facebook and my blog. He's now 7 years past his dx with no MS progression--unheard of for a man his age who was dx with over 20 lesions and not given much hope--he's still jogging, working and wanting to help others.
Husband dx RRMS 3/07
dx dual jugular vein stenosis (CCSVI) 4/09
- It is imperative to stop “attacks” since I believe they compromise the body structure which leads eventually to pressure on the spinal cord and Progression. “cheerleader” recommends Copaxone for her huband Jeff.
- Unless their policy has changed, one problem with the Hubbard Foundation research study is that they don’t insist on use of the IVUS (Intravascular Ultrasound) for the angioplasty procedure. I would insist.
Tags: Multiple Sclerosis, MS, CCSVI, MRI, Dr Swank, Dr. Ashton Embry, Dr David Hubbard, Dr Sclafai, angioplasty