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.