Notes from the Hubbard Foundation conference on Chronic Venous Disease in MS
by Joan Beal
I was fortunate to represent the CCSVI Alliance at the wonderful all day event in Liberty Station, San Diego, hosted by the Hubbard Foundation. I shared a table in the exhibition area with PAB member and author of the CCSVI book, Marie Rhodes. link to CCSVI Book It was great meeting many in our community for the first time, as well as seeing familiar faces and friends. The event provided information on alternative treatments for those with MS and the latest information on CCSVI research in the US. The FDA announcement made the prior day was a concern for many present, and we’ll discuss the implications of this later in the note.
The Hubbard family has become advocates for all with MS, after looking for answers and better health for their son, Devin. This has lead the family into CCSVI research and the study of brain perfusion as well as dietary and alternative treatments for MS.
For more information and links---
link to Hubbard Foundation
Alexandra Meyerowitz, Executive Director welcomed us to the conference. Her father, neurologist Dr. David Hubbard, began the day with information on his recent study, which will be published in the coming weeks.
This study looked at 259 patients, 75% were not on DMD treatment. Patients were treated for CCSVI through the Hubbard registry and were self-referred to sites. Their MSIS and psychological scores were self-reported after treatment. There were no adverse affects or hospitalizations. 66% of those treated had overall improvement in physical abilities and MSIS scores at three months.
Part of this study was trying to understand why certain people, yet not all, benefit from treatment. In this study, women fared better than men, those with SPMS did less well than those with PPMS and RRMS. There was no difference in disease duration, in disability level, or age. Lifestyle, diet, exercise and supplements did make a difference in how patients did after treatment. Dr. Hubbard believes we need studies that combine lifestyle and aftercare as part of the equation in recovery.
Dr. Hubbard discussed the importance of understanding the collateral venous network in those with CCSVI, as blood is shunted away from the jugular veins. He discussed the BOLD fMRI studies pre and improvements post treatment in brain activation, as well as improvements in gray matter on MRI. This data cannot be called placebo.
Dr. Michael Dake gave a fascinating presentation via skype called “Valves in Veins, oh my!”
He explained that we need to learn more about venous valves. If it was just about gravity, than “horizontal creatures”, such as snakes, would not have venous valves---yet they do.
He reviewed what areas of the human body have valves---The emissary veins, the IJVs, the intercostal and azygos veins all have valves. The leg veins have valves, as do the veins of the digestive system. There are microscopic valves in the leg veins, of 3x the diameter of red blood cells! (That was a very cool slide!) These are tiny valves, and we do not know why they are there.
Valves develop in the human fetus, while the baby is inverted in the womb, without the influence of gravity. Valves exist to give direction to the blood stream during muscular activity when blood might reflux. This is why they are in the stomach, neck and legs---areas of increased muscular activation--to prevent reversal of flow during muscular compression.
Venous valves have not been studied adequately. We need collaboration to understand their effect of blood flow from the brain, and how malformed valves may impact venous return.
Dr. James McGuckin spoke via skype on the need for continuing research into CCSVI
We seek to understand the aetiology of MS and continuing the research is the way forward. We need to continue to the Hubbard registry, which is following patients pre and post treatment-
82% of patients seen by Dr. McGuckin have responded positively to treatment. Dr. McGuckin has been treating venous stenosis in vena cava, cancer, dialysis and renal disease all his career.
Dr. Donald Ponec spoke on the efficacy of CCSVI treatment.
CCSVI single center and multicenter trials were encouraged by JVIR in 2011 to see what the associations are. These trials are an important part of the discovery process.
He believes IRs and vascular specialists have an obligation to do this right and they need to learn more about the veins. There needs to be agreement. Centers have used doppler US, but there has been no consensus. Most are not able to replicate Zamboni protocol. Venous intervention is not new. Most IRs perform 20 to 30 venoplasties per one single CCSVI intervention.
He further commented on the soon to be published Ponec/Hubbard single center registry trial as an extension of Hubbard fMRI study. Every patient with MS had abnormal MRV.
Dr. Ponec reiterated something we heard all day---It is time for randomized and controlled clinical trials.
Dr. John Cooke was the first keynote speaker. I was thrilled to be able to introduce Dr. Cooke, from Stanford University. Dr. Cooke is an endothelial specialist, and we began an e-mail conversation on the connection of the vascular system and blood flow in MS back in 2008. His presentation was on the endothelium as the interface between CCSVI and MS.
Dr. Cooke and Dr. Dake’s research was just published as a retrospective. This included the first patients treated at Stanford in 2009. There were large collateral channels in most of the pwMS seen at Stanford. The average patient had an 80% stenosis, which was reduced to 0% after stenting. The paper was delayed a year, due to political factors, but it is published now.
The endothelium is a single layer of cells, and it exerts control over circulating blood elements. Changes in venous flow and pressure can set up cerebral inflammation. increased strain increases endothelial cell (EC) adhesion molecules, EC chemokines, EC permeability, vein wall thickening, perivenular cuffing, oxidative stress, local hypoxia and plaque formation.
Dr. Cooke likes to say, “One is as old as one’s endothelium”---
The endothelial cells regulate vessel tone and the force of blood flow causes sheer stress, EC cells like blood flow. Blood vessels adjust to flow, changing diameter size. Flow mediated vasodilation is completely mediated by the endothelium. Structural changes of blood vessels long term. Endothelial cells line up in response with flow and hemodynamics.
There is disturbed blood flow in bends and arches of blood vessels--like an eddy in a river. Plaque forms in these areas where EC are exposed to abnormal flow. Platelets adhere to EC cells at bends, branches and bifurcations. Disturbed venous pressure--creates more adhesion, more inflammation is responding.
Zamboni’s evidence looked at how venous disease in the legs is like MS---venules in skin of venous insufficiency. Low shear stress starts epigenetic activation, which is causing thickening of vessel wall.
Smooth muscle cells are increased. CCSVI changes venous flow patterns, and creates hemodynamic alterations. White blood cells are attracted to endothelial adhesiveness.
Dr. Cooke would like his lab to study the endothelial cells in CCSVI. He would also like to create animal models of CCSVI beyond the mouse model. He has applied to all his previous sources to fund his research (like the NIH) He also applied to the MS Society, but this is the first time in his career he has been turned down. Controversy is keeping money away from this. We need funding to investigate this hypothesis.
Gregory Berkoff, DC spoke on the chiropractic perspective of CCSVI
There is a consensus emerging that blood flow less than 8 ml per second out of the brain is pathological. Not everyone with CCSVI has MS---but he believes everyone with MS has CCSVI-
Chiropractic doctors treating upper cervical spine have good results in treating those with MS, but they can hype their results. Desperation is breeding ground for opportunism-- and the upper cervical literature search is disappointing. No randomized clinical trials on upper cervical care in MS published.
But the CCSVI theory makes sense of why cervical interventions work temporarily, even if they are not a cure.
The MRV is done while patients lie down, and we do not get the full picture. How much does a healthy brain rely on jugulars veins? If vertebrals can be sufficient, why do we need jugular veins? There must be a reason for their presence.
Dr. Berkoff looked at 1 patient and 4 normals, after one treatment- studying cervical traction on venous flow, using MRV. Imaging is done prior to and after traction. In normals, there is an upward flow in carotid arterial flow after treatment. 4% increase in flow. Pretraction 9.24ml/sec. Post traction 9.69 Vein size is increased in normals---increased reflux.
PwCCSVI-- Pretraction combined flow is less than 8ml/sec.
There was a dramatic increase 2.2ml/sec or 30% increase in flow after traction. After traction, the blood flow reading is normal range. Decreased reflux after traction. But we do not know how long this effect lasts.
Dr. Berkoff’s hypothesis is that traction at C1 vertebra decreases compression of jugulars--and increases flow. But there is much more work ahead.
Dr. Terry Wahls, the second keynote speaker, discussed her book, Minding my Mitochondria---and her Tedx talk on her MS recovery, which has become an internet sensation.
link to Dr. Wahls
Her basic diet includes 9 or more cups of vegetables and fruits a day. That means 3 full dinner plates.
She quoted this proverb--
Superior doctors prevent disease, mediocre doctors treat impending disease, inferior doctors treat actual disease---
Dr. Wahls stressed that pwMS need to take personal responsibility for their nutrition.
She listed environmental factors that impact MS--
Our genetic intervention w/environment, potential vascular problems, nutrition, vit. D, toxins, smoking, stress hormone excess, allergies, exercise, family connections, and a purpose in life. All of these factors can make a difference in symptoms and disease prevention.
She quoted a recent study that showed that the amount of B vitamins and omega 3 oils found in plasma was related to cognition. Lower amounts were related to brain atrophy. Lower cognition is related to higher intake of transfats, fried food, processed food.
NAC and sulfer vegetables, magnesium, B vitamins and antioxidants feed the body’s mitochondria. Too much inflammation damages vessels. Blood viscousity, inflammation, hypercoagulation, fibrinogen levels can be changed by food and exercise. Beets, green and berries protect blood vessels, maintain endothelial cells.
Garlic, onion, chives and kale can be used to treat blood related disorders.
Humans were created as foragers, hunters and gatherers. Food sources were adapted to locale and micronutrients were part of these diets.
Look for fruits and vegetables that contain color all way thru, not just skin. This means that they have more phytonutrients and antioxidants. This is why berries are better than an apple of banana. It’s the color.
Eat only high quality protein, such as grass fed meat, wild game, and fish.
Eat organ meat, which contains vitamins, minerals and coenzyme Q
Dr. Wahls is currently conducting clinical trials, utilizing her diet. She is supported by Direct MS and other organizations, but needs more financing to carry on her research.
Ann Boroch, CNC continued the discussion on the importance of nutrition in regaining health. She is the author of Healing Multiple Sclerosis, and spoke very passionately about her illness, MS diagnosis, and path to healing. Ann has also written the book, The Candida Cure, and suggests that most people have an issue with yeast overgrowth, due to diets high in sugar and carbohydrates.
She sees MS patients in her private practice, and spoke about the healing and relief of symptoms she has seen in patients who have adapted her recommendations.
Dr. Kulreet Chaudhary had an interesting perspective as a doctor trained in Ayuverdic Medicine on the role of nutrition, lifestyle and stress reduction in relation to diseases of inflammation.
The final presenter was Fred Fox, president of BioMed Institutional Review, the company which has granted the Hubbard’s their registry approval. I was very interested to hear Mr. Fox’s take on the FDA warning letter and press announcement on CCSVI treatment.
The term “off label” comes from the pamphlet-like label on the bottle of prescription medication or a medical device...this pamphlet states how this medicine or device can be used and in what applications. If a treatment is not “on the label” it is considered an off label usage. This is how the FDA views the use of stents or balloons in the veins of pwMS. They were created for arteries, and veins are not on the label. Doctors are allowed to treat off label---it’s a personal decision between you and your doctor. This happens everyday.
However, If the doctor promotes off label usage it is illegal.
When did off label use cross the line in CCSVI treatment? When this treatment became promoted and advertised to patients.
A warning letter is the FDA stating that there is non-compliance. Once linked on their website, it becomes public humiliation. It is a “big club” used to get attention.
The makers and importers of devices (balloons and stents) know that higher sales are because of off label uses are significant. They are supposed to go to the FDA to negotiate the study. The device makers need to be compliant, as well.
So, there is much responsibility and accountablity to go around, including treating IRs, device makers and patients. There are a few current and potential trials which have received permission for the off-label use of stents and balloons in the treatment of CCSVI in MS, including Dr. Gary Siskin’s trial. The good news to take away from this is that it is now up to vascular doctors, universities, researchers and device makers to come forward and present research in support of the safety and efficacy of PTA for CCSVI in MS. The FDA has invited CCSVI Alliance to participate in this dialogue, and we look forward to collaboration and future clinical trials in the US.
The gluten free and nutritious snacks and lunch were a real treat. Thanks to the Hubbards for encouraging healthy nutrition and lifestyles! I can't wait to start cooking Arlene's incredible recipes in my Hubbards' Cupboard recipe book. Chomping on asparagus spears and chatting with Dr. Terry Wahls about phytonutrients was a highlight. As was hugging my dear friend Marie Rhodes--since this was our first time meeting in person. There is much work to be done, but the Hubbards provided a chance for CCSVI advocates and the alternative community to connect---and we found out how much we really do share. Blood flow to the brain is important, and there is much to be learned as to how nutrition, lifestyle, exercise and venoplasty might effect neurovascular disease. I left the conference motivated to continue this important work.
Marie at the CCSVI Alliance/CCSVI Book table.
Dr. Cooke discusses disturbed blood flow and the endothelium
Joan Beal and Marie Rhodes meet (at last!)
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