March 19, 2010

CCSVI and the terrible temptations


Ah, CCSVI. The solution to MS, the advertising-ready "Liberation procedure", the legions of fanatic followers racing all over the planet for treatment.
Sounds suspiciously like the stem cell tourists of 6 months ago....
I really no longer know what to think about CCSVI. Initially, I thought it sounded sensible, like an explanation for the initial start of MS. Why wouldn't it be reasonable that iron deposits from stenosis led to inflammation led to MS?
But I'm a scientist at heart - degrees in epidemiology, etc. And the study by Zamboni left me scratching my head. I wanted more info. I wanted a bigger study. I wanted double blind stuff. And I wanted to see the results after more than a few months. MS, unpredictable disease that it is, can look good for a while no matter what one does, or doesn't do, about it.
And I knew from my work in health care that we just didn't have the resources here in Canada to take it on. We don't have enough trained technologists to run the MRI machines, or radiologists to analyze the results. Heavens, we don't even have the right MRI machines, or enough of them.
I met with some of the local advocates for CCSVI here, who were banging the drum for research to be done here, now, treatment to be done here, now, and the MS Society needs to be pistol whipped for not changing all research funding over to this, now.
It was unreasonable, and childish, and overwhelmingly selfish. Look, I'm not going to push someone with cancer out of the MRI tube just so I can have it. Most of my family died of cancer - and it was horrible - and I could never say that my existence, trying as it often is, is worse than what they suffered.
What stunned me was that some of these people were the same ones who were abusing the docs for not doing stem cell treatments on them, now, right now, not six months previous.
Has it occurred to any of these folks that there are others in need? Or that there are good reasons not to rush into treatment?
I suggested that advocacy regarding increasing the numbers of MRI machines and technicians and radiologists might be a good place to start, and that perhaps by partnering with the Cancer society or the ALS society or the Alzheimer's society, we might have a stronger voice.
But no. We want it all for US, only us. Sharing might mean waiting.
And then we complain about being guinea pigs.
What the hell do we want?
Occasionally, I want a cure, too. And I get tempted to cash in my savings and go for CCSVI treatment, too. But what if I do, use up all my money, and it doesn't help - I live in greater poverty....
For a webcast: MS Society: April 7th

14 comments:

Anonymous said...

I appreciate your piece. I have never flown off for any experimental treatments yet but am hoping that this one pans out in the future. In the meantime, I eagerly await more research on CCSVI and MS.

CCSVI Clinic said...

It is estimated that the failure rate of the “liberation therapy” may be 50% or higher, even through the most experienced and best-known surgeons in Poland and Albany, NY. As more and more people receive the therapy there is growing concern amongst patients that the procedure needs to include a post-procedure protocol that is more effective than simply releasing the patient from the hospital or clinic within hours or a day of the procedure.
CCSVI Clinic Physicians have applied for an International Ethics Board study approval entitled: “PROSPECTIVE, OPEN-LABEL STUDY OF THE SAFETY, EFFICACY AND RE-STENOSIS RATES IN MS PATIENTS WITH CCSVI UNDERGOING ENDOVASCULAR TREATMENT WHO RECEIVE AN ENHANCED HOSPITAL AFTERCARE PROTOCOL. Important previous studies on non-MS patients who have had the same venous angioplasty indicate that it’s critical to position and movement control patients post-procedure, monitor them for days afterward in the hospital with various imaging techniques, and re-treat if necessary. CCSVI Clinic is already sponsoring patients for this protocol with a 10-day stay in the hospital where patients will be imaged daily, post procedure. If there is evidence of re-occlusion, they will be taken back to the OR and re-treated. Past studies of non-MS patients with the same venous blockages have noted a cascade of failure points distally in venous vessels post angioplasty, and the hypothesis proposes that the study on MS patients will produce the same results. Once home, patients will be screened and interviewed at regular intervals by CCSVI Clinic Physician Researchers for several years after the treatment to study the changes and make comparisons between those who have followed the protocol and others who have had the procedure on an outpatient basis.
It should be mentioned that our research is under much scrutiny and attack from elements that are trying to control the industry and the dialogue. A well-organized campaign to discredit CCSVI Clinic and our research is underway in the social media. We would ask you to have the independence of thought to see through their campaign of deceit.
Regular research updates will be published on the CCSVI Clinic website http://www.ccsviclinic.ca/ . Questions about participation may be directed toward the CCSVI Clinic administration at 1-888-419-6855.

Dabble and the Mad Sow said...

It is interesting that those who seem to benefit from CCSVI also receive an intensive physiotherapy program afterwards. I wonder sometimes if it is the physio that helps the most.
My other concern is about the re-venoplasty - is it good for veins to be opened again and again? Won't that cause scarring?
So many questions, yet to answer.

Lisa Chapil said...

There is a difference between responsible reporting and what Melissa Martin chose to write about the CCSVI Clinic in this article. She was in possession of factual information and documents that put the CCSVI Clinic in a favorable light but chose to withhold the information she received from the physicains and researchers at CCSVI Clinic that would have conflicted with her agenda to smear our reputation in order to sensationalize her story. At no time did anyone from the CCSVI Clinic pressure patients into going to India for the Liberation Procedure. She should have considered that the one single person who made that claim clearly had her own agenda because she was disheartened by her 'borderline' results. We simply provide information to people about our enhanced hospital stay and aftercare program should a patient decide to have the procedure. You can't pressure someone to make an important decision about their health and all of our literature clearly states that. These MS patients are more knowledgeable about the CCSVI condition and about the options for treatment than most physicians are. To suggest that they can be pressured into a decision to have the procedure done in India is ludicrous. Patients who have signed up to be part of our open-ended study on the safety and efficacy of an enhanced aftercare protocol to reduce the rate of re-stenosis versus having the procedure on an outpatient basis (which may be contributing to long term failure of the procedure) have done so to ensure that they are getting the best care possible and because they want to be part of the important work we are doing for MS patients. http://www.ccsviclinic.ca/

Greg Mills said...

CCSVI Clinic Receives Joint IRB Approval for Aftercare Protocol Study.
The joint application between Noble Hospital and CCSVI Clinic has been approved through the IEC Institutional Review Board (IRB) that will allow researchers to use patient data to study their new extended and enhanced aftercare treatment protocol. The study hypothesis states that in MS patients with CCSVI undergoing endovascular treatment, those receiving the enhanced hospital aftercare protocol will have an improved long-term outcome over those patients not receiving this same protocol. The study is a Prospective, Longitudinal, Cohort Study in which patients are given the enhanced hospital aftercare and post-procedure protocol and then followed at regular 3 month intervals post-procedure, with the same measurements including symptoms and clinical examination, EDSS scale, Quality of Life Scale (QOL) and Doppler U/S.
Dr. Anand Alurkar, an Interventional Radiologist has done thousands of Intra and Extra cranial angio-procedures over the past 10 years. His previous studies may indicate that it’s critical to position and movement control patients who have had a venous angioplasty post-procedure, monitor them for days afterward with various imaging techniques, for other symptoms of restenosis, and re-treat if necessary. Previously unpublished data for patients who have had venous angioplasty may support a much lower restenosis rate (< 20%) in non-MS patients with the same neck vein blockages, (while conventional liberation treatments of MS patients who undergo the procedure are treated mostly as outpatients) have a restenosis rate of over 50% (at 400 days). Currently, this means that over half of all of the MS patients who get the liberation therapy can expect to be looking to get the procedure done again within a year or so, which would not be considered a successful outcome. This may also be the biggest hurdle to overcome in getting the liberation therapy approved in North America short of clinical trials. If the positive effects of the liberation procedure disappear in many patients after only a few months, it would be reasonable to assume they are placebo unless data is collected to show otherwise. Apart from confirming restenosis rates, the study will establish whether it’s just as important to observe a strict protocol after the procedure for a period of up to 10 days to prevent restenosis. Dr. Avneesh Gupte, an Interventional Neurosurgeon involved in the study says “If our daily Doppler Ultrasounds post-procedure come up with anomalies that indicate the beginnings of restenosis in the veins, we’ll take them back and do another balloon angioplasty where the occlusion is starting to occur. It should be no different for MS patients than the non-MS patients but the key is really that they be position controlled, movement controlled, and then monitored for 10 days afterwards to be sure”.Please log on to http://ccsviclinic.ca/?p=830 for more information.

Greg Mills said...

CCSVI Clinic Receives Joint IRB Approval for Aftercare Protocol Study.
Dr. Don Simonson, the Principal Investigator for the study agrees; “Of course there are other reasons that patients restenose, depending on the condition of their veins in the first place, and operator inexperience, so we have designed a study that isolates the aftercare protocol because we feel it may be at least as important, and in any case well worth studying.”
CCSVI Clinic is already sponsoring patients for this protocol with a 10-day stay in the hospital where patients will be imaged daily, post procedure. If there is evidence of re-occlusion, they will be taken back to the OR and re-treated. To comply with the IRB approval, once home, patients will be examined and/or surveyed at regular intervals by a Principle Investigator (PI) for several years after the treatment to study the changes. Patients will have regular consults with the surgeon who performed their procedure as part of the protocol.
More and more MS patients are reporting initial success (including vascular and some neurological differences) as a result of the venous angioplasty (liberation therapy) but then regression to previous symptoms sometimes within weeks post-procedure. It is estimated that the failure rate of the “liberation therapy” may be 50% or higher, even through the most experienced and best-known surgeons. Consequently, there is increasing concern amongst patients that the liberation therapy hypothesis needs to include a post-procedure protocol that is more refined than simply releasing the patient from the hospital or clinic within hours or a day of the procedure. If the study hypothesis is correct, it means that there are many other considerations that indicate a post-procedure stabilization period, re-examination, and re-treatment if necessary.Please log on to http://ccsviclinic.ca/?p=830 for more information.

Greg Mills said...

CCSVI Clinic Receives Joint IRB Approval for Aftercare Protocol Study.
A recent intake of Canadian patients confirmed that they were most satisfied with the protocol. “I am convinced that CCSVI Clinic has been by far the best choice available”, says Nicole Magnan, speaking on behalf of her husband, Robert who underwent the therapy under the 10-day protocol. “And nobody in this world that can convince me otherwise. Robert came in here a broken man. He had no hope. His next step was the nursing home. Today he is walking with the aid of a walker and with consistent daily physiotherapy he will make more steps every day. Most importantly, we are hoping that the positive changes will be permanent and the doctors at CCSVI Clinic explained that. They are such special people that will remain in our hearts forever.”
Regular research updates will be published on the CCSVI Clinic website. Questions may be directed toward the CCSVI Clinic administration at 1-888-419-6855 . Persons wishing to participate in the study must agree to the informed consent process, qualify through an inclusionary and exclusionary process and agree to be followed for several years by the study research team. They must be prepared to travel to Noble Hospital in Pune, India, but all arrangements will be taken care of by staff associated with the study. Interested persons should ensure that applications are in as soon as possible since there are limitations on the funding for the study population.Please log on to http://ccsviclinic.ca/?p=830 for more information.

Dabble and the Mad Sow said...

Thanks for all your comments, Greg. Very helpful.

jessica forester said...

After 6 months of offering stem cell therapy in combination with the venous angioplasty liberation procedure, patients of CCSVI Clinic have reported excellent health outcomes. Ms. Kasma Gianopoulos of Athens Greece, who was diagnosed with the Relapsing/Remitting form of MS in 1997 called the combination of treatments a “cure”. “I feel I am completely cured” says Ms. Gianopoulos, “my symptoms have disappeared and I have a recovery of many functions, notably my balance and my muscle strength is all coming (back). Even after six months, I feel like there are good changes happening almost every day. Before, my biggest fear was that the changes wouldn’t (hold). I don’t even worry about having a relapse anymore. I’m looking forward to a normal life with my family. I think I would call that a miracle.”

Other recent MS patients who have had Autologous Stem Cell Transplantation (ASCT), or stem cell therapy have posted videos and comments on YouTube. www.youtube.com/watch?v=jFQr2eqm3Cg.

Dr. Avneesh Gupte, the Neurosurgeon at Noble Hospital performing the procedure has been encouraged by results in Cerebral Palsy patients as well. “We are fortunate to be able to offer the treatment because not every hospital is able to perform these types of transplants. You must have the specialized medical equipment and specially trained doctors and nurses”. With regard to MS patients, “We are cautious, but nevertheless excited by what patients are telling us. Suffice to say that the few patients who have had the therapy through us are noticing recovery of neuro deficits beyond what the venous angioplasty only should account for”.

Dr. Unmesh of Noble continues: “These are early days and certainly all evidence that the combination of liberation and stem cell therapies working together at this point is anecdotal. However I am not aware of other medical facilities in the world that offer the synthesis of both to MS patients on an approved basis and it is indeed a rare opportunity for MS patients to take advantage of a treatment that is quite possibly unique in the world”.

Autologous stem cell transplantation is a procedure by which blood-forming stem cells are removed, and later injected back into the patient. All stem cells are taken from the patient themselves and cultured for later injection. In the case of a bone marrow transplant, the HSC are typically removed from the Pelvis through a large needle that can reach into the bone. The technique is referred to as a bone marrow harvest and is performed under a general anesthesia. The incidence of patients experiencing rejection is rare due to the donor and recipient being the same individual.This remains the only approved method of the SCT therapy. For more information visit http://ccsviclinic.ca/?p=838

Dabble and the Mad Sow said...

I hasten to say I do not support any of the treatments mentioned in the comments. Of course all of you must make your own decisions, but the use of stem cell transfers has only been shown effective in cases where the prior bone marrow has been eradicated through chemotherapy (the very dangerous study done by Dr.s Friedman et al). Reinjecting stem cells when the immune system is still alive and doing what it normally does has not been proven effective, nor has CCSVI.
Please wait for the studies - of if you cannot, at least do two things: 1. DO not have stent placement - this is totally unproven and dangerous and 2: avoid expensive invasive and potentially fatal interventions unless they are within the context of a carefully managed and FOLLOWED-up clinical trial.
I know this disease sucks, and it's easy to cling to hopes of the ephemeral variety - but it is a forest of wolves out there and you are taking a chance with every therapy you try (drugs or other). Everyone stands to make a buck from people with chronic disease and there are no unmitigated heroes in this fight. Buyer beware.

Leo Voisey said...

Chronic cerebrospinal venous insufficiency (CCSVI), or the pathological restriction of venous vessel discharge from the CNS has been proposed by Zamboni, et al, as having a correlative relationship to Multiple Sclerosis. From a clinical perspective, it has been demonstrated that the narrowed jugular veins in an MS patient, once widened, do affect the presenting symptoms of MS and the overall health of the patient. It has also been noted that these same veins once treated, restenose after a time in the majority of cases. Why the veins restenose is speculative. One insight, developed through practical observation, suggests that there are gaps in the therapy protocol as it is currently practiced. In general, CCSVI therapy has focused on directly treating the venous system and the stenosed veins. Several other factors that would naturally affect vein recovery have received much less consideration. As to treatment for CCSVI, it should be noted that no meaningful aftercare protocol based on evidence has been considered by the main proponents of the ‘liberation’ therapy (neck venoplasty). In fact, in all of the clinics or hospitals examined for this study, patients weren’t required to stay in the clinical setting any longer than a few hours post-procedure in most cases. Even though it has been observed to be therapeutically useful by some of the main early practitioners of the ‘liberation’ therapy, follow-up, supportive care for recovering patients post-operatively has not seriously been considered to be part of the treatment protocol. To date, follow-up care has primarily centered on when vein re-imaging should be done post-venoplasty. The fact is, by that time, most patients have restenosed (or partially restenosed) and the follow-up Doppler testing is simply detecting restenosis and retrograde flow in veins that are very much deteriorated due to scarring left by the initial procedure. This article discusses a variable approach as to a combination of safe and effective interventional therapies that have been observed to result in enduring venous drainage of the CNS to offset the destructive effects of inflammation and neurodegeneration, and to regenerate disease damaged tissue.
As stated, it has been observed that a number of presenting symptoms of MS almost completely vanish as soon as the jugulars are widened and the flows equalize in most MS patients. Where a small number of MS patients have received no immediate benefit from the ‘liberation’ procedure, flows in subject samples have been shown not to have equalized post-procedure in these patients and therefore even a very small retrograde blood flow back to the CNS can offset the therapeutic benefits. Furthermore once the obstructed veins are further examined for hemodynamic obstruction and widened at the point of occlusion in those patients to allow full drainage, the presenting symptoms of MS retreat. This noted observation along with the large number of MS patients who have CCSVI establish a clear association of vein disease with MS, although it is clearly not the disease ‘trigger’.For more information please visit http://www.ccsviclinic.ca/?p=978

Dabble and the Mad Sow said...

Ah yes, Leo, but now we are wondering about the chicken and the egg. Does CCSVI result from inactivity caused by MS? (If there is such an entity as CCSVI, which has NOT been proven).
Or does MS result from "CCSVI"? Or do they just coincidentally co-exist? Association does not equal causality, and the positive results seen through the surgery seem transient and possibly placebo-induced. The thought of causing scarring in the veins is terrifying. You could be causing more, ongoing damage than you seek to relieve.
Of course, if you want MS patients to just up and die, this might be a good approach. Damaged veins through angioplasty, when there is no definitive proof that the apparent occlusion is at ALL dangerous, well, I'm horrified that these procedures are still being done.

James Bostrom said...

http://www.youtube.com/watch?v=ysFiW26MHfQ&feature=player_embedded#t=0s
http://www.youtube.com/watch?v=BfSOmij8tfk&feature=youtu.be
Over the past year, CCSVI Clinic and its researchers and specialists have been studying the Combination venoplasty/autologous stem cell infusion protocol developed by Regenetek Cellular Technologies with the collaboration of outside labs and bioproducts manufacturers. As laboratory techniques gain ever-increasing sophistication based on new scientific methodologies for enhancing somatic cells into preferred lineages in vitro, the therapeutic outcomes for patients with neurological disorders have also been improving. Deb O’Connell who was treated at the Clinic in mid-September, 2012 recovered so quickly from her serious long-term degenerative disease condition that she experienced a wave of improvements while still in the hospital.
It’s a matter of medical record that Deb had been wheelchair bound for 10 years (completely non-ambulatory) with multiple co-morbidities when she entered the program on September 9; she was 9.5 on the EDSS scale as assessed by a neurologist, was down to 80 lbs in body weight, could not breathe effectively, speak, or take in food by mouth due to dysphagia. Her pain was chronic and significant. When she left the Clinic on September 24th , she walked out of the doors and into a waiting van to go to the airport. At the time of her discharge from the Clinic, she could breathe normally, effectively speak once again, eat any types of food she desired and her pain had all but disappeared. At the time of this writing she is back home in Canada and reports that she continues to recover (especially her contractured hands), shows no signs of new disease symptoms, and has gained 18 lbs since her therapies, less than 3 weeks ago. She has now begun a regular physiotherapy program and is gaining walking strength and balance. The recapitulation of the course of her disease (MS) within days, provides evidence that the in vitro requirement of cell pluripotency has correctly been identified with respect to adult cell source origin, time, and manipulation in culture. http://www.ccsviclinic.ca/?p=1084
http://www.youtube.com/watch?v=ysFiW26MHfQ&feature=player_embedded#t=0s
http://www.youtube.com/watch?v=BfSOmij8tfk&feature=youtu.be

James Bostrom said...

A significant world-wide population of multiple sclerosis (MS) patients have a chronic progressive neurological disease that is characterized by increasing disabilities. No treatments are currently available that slow, halt, or reverse the advancement of the disease in established cases of MS. The frustration in a growing number of patients and their readiness to pursue unproven therapies speaks to the lack of effective treatments available and is further indicative of a vast, unmet clinical need. On the basis of evidence that there is a vascular association to MS (characterized by anomalies of primary veins in the neck that restrict the normal outflow of blood from the brain to the heart), and that mesenchymal stem cells (MSCs) have a beneficial effect in acute and chronic cases of multiple sclerosis as determined in various clinical trials, we undertook the assessment of the safety, efficacy, and reproducibility of a novel approach that has vascular-protective, neuroprotective and regenerative therapeutic potential for all phases of multiple sclerosis.For more information please visit http://www.ccsviclinic.ca or you may call the toll free number at 888-468-1554 or info@ccsviclinic.com