Dr Hubbard's response to the 10-28-12 NY Times article "The Zamboni Effect. A controversial 'Cure' for MS"

“The Zamboni Effect. A Controversial ‘Cure’ for M.S”  tells a bitter-sweet tale of four MS patients, Devin, Jeff, Elena and Adam, their families’ efforts to bring new light and hope to a mean and miserable disease, and the demeaning response of neurologists. Devin is my son and I am a neurologist, trained at Yale, Stanford, and Einstein where I was chief-resident in 1982.  When he was diagnosed with MS I consulted my neurology colleagues, studied the research literature and concluded that the orthodox explanation – immune T cells were attacking normal myelin – was false, and that the $40,000/year drugs that disable T cells offered little hope.  My wife Arlene found Jeff’s wife Joan on her Facebook site where she had compiled a massive library of research on MS and in particular the research publications of Zamboni, a vascular surgeon at the University of Ferrara.  Zamboni’s wife Elena had been diagnosed a decade earlier and since then he had rediscovered and re-invigorated a different explanation - abnormal venous drainage from the brain and spinal cord causing inflammation and damage to the myelin-making cells around the small veins.   Joan reached out to a courageous vascular surgeon at Stanford who found obstructions in Jeff’s jugular veins and opened them with balloon catheters inserted though the femoral vein in the thigh.  Today we are good friends; we have a new medical society, the International Society of NeuroVascular Disease, and several charitable foundations including CCSVI Alliance, the Annette Funicello Research Fund and our own Hubbard Foundation.

The hostile and demeaning response from the neurologists is the underlying theme of the NYT story and its subtitle, “just experiencing the power of suggestion?”  Neurologists stopped the Stanford surgeon from continuing his research and have lined up for a law suit against him. A Cleveland Clinic neurologist says “it offers false hope.”  A Dutch neurologist is quoted saying my own review of 259 cases published this year in the Journal of Vascular and Interventional Radiology has zero scientific value; he apparently also told the reporter he believes MS complaints are mostly “psychological.”  The FDA announced last May that any researcher on venoplasty must apply for their approval (our Foundation has done so).  The story begins and ends with Adam whose brother Chris is a neurologist at Yale.  Chris is quoted as saying “It’s one of the saddest and most outrageous stories of scientific misconduct,” provocative language against authors of peer-reviewed scientific journals challenging the status quo.  I found some publications by Adam’s brother on cocaine dependence, but none on MS (his website states he specializes in Botox for headaches). When learning that a fellow MS patient was seeing his brother,  Adam says, “poor guy,” echoing the feeling of many patients who have stopped seeing  neurologists..

Here’s what we say to patients and their families: consult a vascular specialist to investigate your blood flow/perfusion; consult an integrative medicine specialist to investigate inflammation and toxins, but above all, don’t let the neurologists get you down!

 

ECTRIMS Abstracts on CCSVI 2012

 ECTRIMS Abstracts on CCSVI 2012

Reviewed by David Hubbard MD, Hubbard Foundation
Summary
Very brief summaries of each abstract are presented below. First we summarize the highlights:
There is an abstract from a doctor in Kuwait reporting that patients were actually worse 1 year after treatment. Here is an email to me from Tariq Sinan MD, the lead author of the work referred to in this abstract.

Oct 1, 2012
Dear David,
Absolutely. you can forward my emails to anybody you want.
Furthermore his poster is not just repudiated. its illegal. he did not get permission neither from all investigators nor from the Kuwait research authorities. All papers and results have to be approved by them. same paper was rejected from ANM after we wrote to them. The author in his poster is not even part of the study team.
Dr. Alrougani met less than 30 % of patients once only. the rest of the patients refused to go to him because they thought he was biased. We used another Neurologist. its now more than 2 years since we started the study. 70% of patients feel they have benefited from the procedure. 1 patient got worse, he got thrombosis in one vein and the neurologist thought he got worse because he stopped Tysabri suddenly.
We hope our 2 yrs follow up prospective study will be out soon.
Best regards,
Tariq Sinan. MD Kuwait

The British Columbia CCSVI Registry reported that most patients who had the treatment said it “met their overall expectations,” and that there were no serious adverse events.
Zivadinov reported that venoplasty improved CSF flow.

A method not previously studied, called transcranial brain photplethysmography, may shed light on what is happening in the brain microcirculation.

Thirteen of the 21 abstracts were ultrasound studies and predictably were negative, inconclusive, and/or repetitive. I think we have all learned that ultrasound is not able to provide diagnostic criteria for the hypothesis of chronic cerebro-spinal venous insufficiency, and internal jugular ultrasound will not help us understand what is happening in the small veins of the CNS white matter where MS lesions occur.

Abstracts in the order listed by ECTRIMS:

Panczel etal. Hungary
20 aneurysm patients and 14 MS patients were tested with Doppler and DSA. Normal flow was found leading the authors to conclude that their DSA findings were "not real," and explained by dilution by flow from the subclavian vein.

Trufyn et al. British Columbia Group
Burton's group found "incidental findings" such as thyroid cysts on MRI of brain and neck in 22 of 156 MS patients.

Yee et al. British Columbia CCSVI Registry
Of 50 MS patients interviewed by phone, 68% said their venoplasty "met their overall expectations. 5 patients reported minor complications including 1 hospitalization for arrythmia.

Diaconu et al. Fox's group at Cleveland Clinic
11 MS patients and 5 normals had additional ultraounds. 5 of 7 subjects with abnormal ultrasounds became normal after hydration.

Wolinsky et al. Houston MS Clinic
3.88% of 206 MS patients and 7.14% of normals met CCSVI ultrasound criteria, that correlated poorly with MRV findings in a sub-group of 83 patients.

Alroughani and Lamdhade. Kuwait (not Sinan’s group)
42 MS patients had venoplasty and were signicantly worse at 1 year by relapse rate, EDSS score and MRI .

El Sankari et al. France
17 MS patients were compared to 12 normals with fast cine PC-MRI and showed no differences.

Denislic et al. Argentina
Cadavers of 15 non-MS patients had normal extracranial veins.

Karmon et al. Zivadinov's group
In 30 MS patients IVUS (intravenous ultrasound) was more sensitive to abnormalities than catheter venography.

Dolic et al. Zivadinov’s Buffalo Group
In 240 normals, heart disease, obesity and smoking increased the risk of Doppler ultrasound abnormalities.

Zivadinov et al. Zivadinov’s Buffalo Group
In 15 patients, venoplasty significantly improved CSF flow using a cine MRI method.

Hoogervorst et el Netherlands
Of 14 MS patients 6 had CCSVI by color-Doppler ultrasound. No correlation was found between these abnormalities and chronic fatigue measured by the Fatigue Severity Scale.

Burton and the Canadian CCSVI Systematic Review Group
A literature search of 14 studies of CCSVI ultasound found a statistically significant association with MS compared to normals.

Banwell et al. Toronto.
Of 26 MS patients under age 18 only 2 met ultrasound CCSVI criteria.

Knox et al. Saskatoon, Canada.

Blinded ultrasonographers found CCSVI in 4 of 5 MS patients, 0 of 10 with CIS, and 2 of 15 normals.

Zivadinov et al.
Echo-color Doppler found CCSVI criteria in 53.9% of patients with "other" neurological diseases, and 29.9% of normals.

Zivadinov et al.
Ultrasound found CCSVI criteria in 43.5% of pediatric MS patients, 40% of patients with "other" neurological diseases, and 30% of normals.

Simka. Poland
In 126 MS patients and 13 normals, ultrasound was compared to catheter venography and correlated poorly.

Visser et al. Netherlands
Echo-color Doppler met CCSVI criteria in 8.9% of 90 MS patients and 0% of 41 normals.

Viola et al. Italy.
Transcranial Brain Photoplethysmography, that measures microcirculation in capillaries and venules, was used over the frontal lobes before and after 10second compression of both int. jugular veins. Cerebral blood volume increase was 80.4% less in MS patients than normals, suggesting lower flow-pressure posssibly due to CCSVI.

Blinkenberg et al. Denmark.
In 24 MS patients, color Doppler, transcranial Doppler and phase-contrast MRI were all essentially normal compared to 15 normals. 

FDA Response to IDE request

On Sept 9^th, 2012 we finally received an FDA response to our May 17^th request for an evaluation of our on-going CCSVI Multi-center Registry.  

The Agency has determined that our Registry is a “clinical study,” that we must submit to them an IDE (investigational device exemption) application, and that all enrollment of subjects must be suspended, although already enrolled subjects should continued to be monitored.  Other main points are as follows:

·    .

        - Each individual device (balloon or stent) must be specified, including manufacturer.

·      - The procedure and post-procedure (e.g. Use of blood thinners) must be standardized.

·      - The diseases to be treated (e.g. multiple sclerosis, Parkinsons, Alzheimers, Migraine, Fatigue, Lyme disease) must be standardized.

·       -The informed consent must be revised to emphasize risk of death (we have not had any).

·       -In addition, the Agency made suggestions regarding our quality of life measure (SF-36vs) and the definition of “CCSVI.”

We plan to have a face-to-face meeting with the FDA and to discuss these recommendations with the IRs (interventional radiologists) participating in the Registry and hope to move forward quickly with an IDE application.  In the meantime, the only IDE-approved study that may enroll CCSVI patients in North America is Dr. Siskin’s at Albany Medical College.

Dr. McGuckin (Vascular Access Centers) dropping out of Multi-Center Registry

Citing concerns about the FDA warning, Dr. McGuckin has notified the Hubbard Foundation that VAC is dropping out, and will no longer be enrolling patients.  We understand that many of you who were treated through VAC may have concerns regarding follow up data collection and treatment. We do not have any answers regarding this as of yet, but this is a concern of ours as well. As we know more, we will keep you updated.

Surprise FDA Inspection May 29, 2012

FDA Site Visit

May 29th, 2012, the FDA made a surprise visit to one of our Multi-Center Registry sites. They asked to see all of our documentation and will be returning again May 30th, 2012. They provided no information on the reason for the visit or why that site was chosen first but did say that they would be doing inspections “all over the country”. The FDA did not shut down the site and as we have posted before we have already applied to the FDA for an exemption. Although the FDA’s primary intent is to prevent “advertising non approved uses for stents and balloons” it is unclear, so far, whether they also will stop research on CCSVI.

The Hubbard Foundation intends to continue to collect data on adverse events and changes in symptoms related to venoplasty (and ,hopefully, soon in relation to dietary and supplement interventions). An analysis of our first 259 patients has been accepted for publication and our multicenter Registry has collected data on over 400 people so far. We can’t see why the FDA would not want this data to be collected but we’ll keep you posted.

Letter to the FDA dated May 16th, 2012

Letter to the FDA dated May 16th, 2012



"In response to the FDA warning about CCSVI posted on the internet last week, I've attached our IRB-approved Multi-Center Registry and informed consent, and request that you review it for a pre-IDE and advise me as the sponsor on corrective action if appropriate.  I have also attached our analysis of 259 patients that has been accepted for publication by a peer-reviewed medical journal.  Although not a double-blind placebo-controlled study, we obtained MR venography and fMRI BOLD data that advances the science of underlying pathophysiology and diagnosis of venous insufficiency, had no serious adverse events and found statistically significant clinical improvement using the Multiple Sclerosis Impact Scale (MSIS-29).  This study was performed at one site in San Diego, was approved by a local hospital IRB, has been completed and is no longer enrolling.  Our on-going Multi-center Registry was approved by a national IRB, currently has 7 P.I.'s around the country, and has enrolled approximately 365 patients with symptoms of CCSVI, most but not all of whom have multiple sclerosis. You will note that the protocol does not allow recruitment or advertising as the use of venoplasty for neurological disease is not currently FDA approved.  The protocol calls for completion of the Short-Form 36 quality of life questionnaire before and at 1, 6 and 12 months following venoplasty.  The rationale for this Registry is that patients who choose to undergo this procedure should have a repository for collection of their adverse events and changes in their subjective symptoms, and that such a registry will assist in the design of blinded and placebo-controlled studies going forward.

David Hubbard MD" (Hubbard Foundation, May 16, 2012)


In response to this letter, the FDA assigned the Hubbard Foundation a pre-IDE document control number on May 17th, 2012. 

Hubbard Foundation Update April 18th 2012

Dr. Ponec and his North County Radiology team in San Diego, CA are no longer using the Del Mar Facility for CCSVI treatment. It has been bought out by a German dialysis company, and the IRs are now in the process of negotiating an acceptable treatment price from Pomerado Hospital, where Devin was treated.  In addition, we have completed our functional MRI and perfusion study pre and post venoplasty.  Our study of the first 260 patients has been accepted for publication, but we cannot publicize our data until the paper is published.  Furthermore, our Multi-Center Registry for CCSVI Testing and Treatment is treating patients at 26 sites around the country and we are continuing to collect their data, having collected data on over 500 patients so far. You can find that information on the Hubbard Foundation web site. www.HubbardFoundation.org

The Hubbard Foundation is focused on patient advocacy, education and expanding our research into dietary treatments and basic science studies.  For those interested in coming to our center in San Diego, CA, we can test you in early May but we think it's risky to assume that Pomerado Hospital will agree to a lower treatment price by the conference then.  We will have a lot more information at the conference, May 12th, including latest research findings from the Hubbard Foundation and other researchers.  Please go to www.HubbardFoundation.org for more information about the conference.

If you have any questions email Arlene at HubbardFoundationArl@gmail.com

Hubbard's Cupboard- Healthy cooking for your body and mind!

Black Bean Fudge Brownies!?!

Who would have thought to make a tasty dessert from beans.Well, check it out for yourself. 

Arlene Hubbard is the queen of healthy cooking, using organic ingredients, with high nutritional content, and gluten-free products!  With lots of great tips to increase vascular and neurological health, this is not your every-day cooking video.

Enjoy, stay well, and let's go with the flow!



If you are allergic to any of the ingredients, this recipe is not for you.

www.HubbardFoundation.org

MS and Heavy Metals

The body has its own system to remove metal, but in some cases chelation therapy is used. For example, chelation removes heavy metals like lead in lead-poisoning. Some practitioners have considered chelation for MS as well, but Chelation IV is very controversial, speak to your health practitioner before starting any new regimen to look at the pros and cons.

It is estimated that tens of thousands of people with MS in the US use chelation. There are two types of chelation: chelation IV, and oral chelation (oral chelation has not been proven to work as well).

More resources, Click Here

Foods that Help Remove Heavy Metals

1.Cilantro

Cilantro mobilizes toxic metals from the central nervous system and other tissues. A researcher named Dr. Yoshiaki Omura, using bioenergetic measures, discovered that some patients excreted more toxic metals after consuming a Chinese soup containing cilantro. Cilantro is the leafy part of a common herb whose seed, coriander, is a familiar culinary spice. Its active component is a mercaptan that can penetrate the blood brain barrier.

     Cilantro stimulates the body's release of mercury and other heavy metals from the brain and CNS into other tissue. Cilantro’s postulated mechanism of action is to act as a reducing agent changing the charge on the intracellular mercury to a neutral state allowing mercury to diffuse down its concentration gradient into connective tissue.

2.Garlic

Garlic, contains both chelating amino acids L-methionine and L-cysteine, mobilizes and extracts cadmium, lead, arsenic and mercury within our bodies. 


Heavy Metal Detox Pesto Recipe

Parsley and cilantro (corriander) are very powerful natural green plant foods for detoxing heavy metals out of your body. Add these amazing herbs to juices, salads, soups and meals. Mike Adams from Natural News talks more 

about this also in the new upcoming 'Food Matters' film.

http://www.foodmatters.tv/_webapp_513323/4_Simple_Detox_Tips_For_The_New_Year

 

 Heavy Metal Detox Pesto Recipe:

•                4 cloves garlic

•                1/3 cup Brazil nuts (selenium source) or macadamia nuts

•                1/3 cup sunflower seeds (cysteine source)

•                1/3 cup pumpkin seeds (zinc, magnesium sources)

•                1 cup fresh cilantro (corriander)

•                1 cup parsley

•                2/3 cup cold pressed olive oil

•                4 tablespoons lemon juice (Vitamin C source)

•                Big pinch of sea salt and or dulse flakes to flavor

Soak the seeds and nuts over night to release the enzyme exhibitors. Process the parsley, cilantro (corriander) and olive oil in a blender until chopped. Add the garlic, nuts, and seeds, salt / dulse and lemon juice and mix until the mixture is finely blended into a paste. Store in dark glass jars if possible. It freezes well also if needs be. Enjoy!

ISNVD Patient Day- Orlando, Florida

Don't miss the International Society for NeuroVascular Diseases' first MS Patient Day, February 18th in Orlando Florida. 

There will be an overview of CCSVI, a roundtable discussion, and even some debates.  David Hubbard MD, CCSVI research neurologist, will be discussing the research and theory with fellow neurologist Dr. Krolczyk. 



http://isnvd.org/index.php?site=patientday#content