The CCSVI Battle Continues with Emotional Pleas to Canadian Subcommittee Session
Tuesday, June 1, 2010 at 6:35PM It was an exciting day in Ottawa. The parliamentary Subcommittee on Neurological Disease met today and had presentations by CCSVI Freedom Fighters, including two people have been liberated, the doctor who was instrumental in their procedures and the man who's trying to perfect the testing.
Despite the brevity - 5 minute limits were given to each speaker - a great deal of information was packed into each speakers' presentation.
E. Mark Haacke, a physicist and MRI specialist was the first witness. He announced that he is establishing the International Society for Neuro-Vascular Disease, a hybrid that will focus on MS and other blood-brain barrier diseases such as ALS and Alzheimers.
Haacke explained that he's worked on a theory between MS and the small veins in the brain for the past 4 years and in September, 2009, he presented his independent work to Dr. Paulo Zamboni, the Italian surgeon who first published his theory on chronic cerebralspinal vascular insufficiency, or CCSVI. Haacke says that since Zamboni first developed his protocol, over 1,000 patients have been imaged and over 500 treated for CCSVI to date, and that some of the people who have been treated do not show obvious signs of improvement after the treatment, but many of them do. Some of them recover their energy, their continence, their motor capabilities.
Haacke says the wait-and-see attitude of neurologists "is simply wrong. The evidence for venous abnormalities is simply overwhelming, and the main goal at this time is not 'should we get funding to continue to pursue this point but rather to get funding to subcatagorize the different sources of CCSVI...We need a subclassification to understand why some people might recover from surgery better than others. To get this information, we need to collect information if not in the hundreds but in the thousands."
"Patients," he continues, "need to know what the lesion content, the iron content and the vascular status in their brain, neck and spine is before they have their surgery in order to monitor how things change after their surgery."
"The questions of the highest import are whether the patient stabilizes or not, and whether the patient gets better and if the lesions and abnormalities tend to subside," Haacke said.
"So again, the question becomes 'how many is enough' and the answer depends critically on the question." He explains that CCSVI is more than blockages in the veins, but in the valves and caused because of bones, in fact many many things that can cause CCSVI. "In order to understand why this treatment works for some and not other people, you have to understand where the problem is. If there are 10 sources of CCSVI and 100 cases are needed for each type of representation of vascular abnormality, then a multivariable study of about a thousand cases would be required. But statistically, in most cases, this would be overkill. In any case, it would behoeve us to create a national MS database in Canada, from both an ultrasound and MR perspective." He goes on to explain how five Cemters of Excellence spread throughout Canada could be used to collect this information making them cost-effective and a hundred times more effective than individual studies.
"With a simple, collaborative effort, we can collect in months what it would take years," Haacke says.
The current wait-and-see attitudes, he says, isn't just a scientific issue but a moral issue. "It is akin to watching someone drown while testing a new flotation device, while all previous ones only sink several hours later. Perhaps this device won't work perfectly at the beginning either," Haacke says, "but if it keeps people afloat rather than watching someone drown, then this testing should be done to save someone's life."
"Are double-blinded studies the testing that should be done to save someone's life?" he asks. "Who is to say that the nay-sayers of today will design the right kind of double-blinded study for the MS population? We don't need strong data to show, at first, what kinds of abnormalities are present, and second, to start following these patients immediately. I would say we should allow to have patients have their data retrospectively reviewed, even if they follow a clinical route where data is not usually used for research. In fact, a retrospective analysis of data is allowed when appropriately presented to Human Studies Committees."
"I think it is extremely important that the Canadian government look at what has been acquired to date and consider imaging MS patients and treating MS patients on a compassionate basis," he concludes.
Dr. Sandy MacDonald, a Barrie, Ontario doctor, began his testimony by pointing out Rebecca Cooney in the audience, explaining that she walked in, without her wheelchair, after having venoplasty performed last week in Albany, NY last week. That was greeted with cheers and a round of applause.
He explained that CCSVI is real, easily treatable, treatable at low cost and low risk to the patient. He doesn't believe that people like Cooney should have to travel to New York or Poland or anywhere else in the world to get it done, with great expense, when they could get it done at home for much cheaper.
He graphically demonstrated the video of venograms that were performed on two his patients, Steve Garvie and Liane Webb, to show normal vein structures compared to the abnormal structures of their veins. Garvie and Webb later gave testimonies of how their CCSVI treatments have changed their lives and how this treatment should become available to all.
Liane Webb, who lived with MS for 20 years, witnessed that MS effects not just the person, but the entire family. She attested that the treatment was painless, her fatigue is gone and life after her CCSVI treatment includes a full time job, rounds of golf each week -- without a cart -- horseback riding and in the four months since her treatment, she's not had a single attack. She described, with a voice wavering at times, holding back tears, how she now has the energy to go for walks and bike rides with her family once again.
"I am living again," Webb says. "I want to try and do so many things now, whereas before, I was so exhausted I couldn't even think about it."
"I can't imagine simply asking someone to put up with the blockage I had. I ask that this Committee do everything possible to remove all possible obstacles for all Canadian patients diagnosed with CCSVI to receive this treatment," Webb says.
Fifty-three-year-old Garvie came close to tears explaining how dependent he was on government-assistance and outsiders to care for him until he was treated for CCSVI and regained his independence.
"People have pride. I had none. My life was taken away from me. These people (the assisted caregivers) gave it back," Garvie said. "I don't know how you put a weight on that."
"I couldn't share my love with the person that I loved because I couldn't.That was totally taken away from me with MS, I was totally disfunctional." Garvie explained that he'd taken antidepressants to "help me get through my life" and tried to commit suicide twice so his three daughters wouldn't have to go through his MS decline with him.
"Pride does that to people. I've been six months fixed.and in those six months, I'd like to know how many people have died needlessly, how many people have become more disabled," he said.
"There's no need. None."
Garvie explained his route to his CCSVI treatment, from the W5 program to his GP in Barrie, Ontario, to Dr. MacDonald and his Doppler scan to show his jugulars were unquestionably blocked.
"It's not an operation. It's a 45 minute treatment.Painless. Live giving. They gave my life back to me," Garvie said, choking back tears. "They're my heroes.I think you should let them be heroes for everybody else."
Garvie said his left hand was useless and numb before the treatment, but when on the operating table, he felt life in it again. "I shook the nurse's hand," he recalled. "My hand works! I can lift my left leg! I couldn't believe it.I went into this procedure thinking I could stop the progression. I'd learned to deal with the other things: I'd got my mind straight on the suicide, I didn't feel like I was worth a whole lot. not with what I was going through, I was getting worse every day, every month, every minute. Secondary Progressive does that to you, so does Primary. You don't get better, you get worse. And that's all you have to look forward to."
"They say that this does not help people with Secondary Progressive. I beg to differ. Would you please look at the evidence? I'm right here."
Since his CCSVI treatment, he's no longer in care. He takes care of himself, washes his dishes, cooks his own dinners.
"I can live my life!"
To the Committee, Garvie's plea is simple: Please take the obstacles out of the way. Everybody deserves to have a life, and with a simple angioplasty, that can be done.
Committee panelist Dr. Kirsty Duncan, the Liberal MP for Etobicoke North was next, and began her question period by reading from a letter from a doctor who had just returned from his CCSVI treatment in Poland. In reading parts of the letter, Duncan became emotional as well as she recounted that he'd met many Canadians there who were treated with positive results, extatic and grateful to have an improvement in their quality of life. The letter explained that two-thirds of the people going to Poland for treatment are Canadians, how there are 2,000 people on their waiting list.
"The argument from neurologists is that we need more studies done in Canada," Duncan read, "The only way you do a study is by treating people and a follow-up. Neurologists should have no input into treating this: they are not vascular surgeons."
The letter goes on to say that improvements to quality of life has no pricetag. We will only know if the positive results from this endovascular surgery will last after months and years of follow-up. There is no problem paying for angioplasty for arterial stenosis or surgery for corroded arterial stenosis. "Why the discrimination for venous stenosis?"
On being asked about ethical dilemmas in treating MS patients for CCSVI, MacDonald said he would have an ethical dilemma as a physician for not treating people with CCSVI. "There's good anecdotal evidence to show that people with CCSVI do well with treatment."
MacDonald was also by Conservative Patrick Brown, MP for Barrie, asked about barriers to treatment. He asked if MacDonald thought there had been a directive from the Provincial Ministries of Health not to do these procedures. MacDonald said "your guess is as good as mine". He was also asked if he knew why the Multiple Sclerosis Society of Canada has a wait-and-see approach. MacDonald says "Again, it's ike waiting for an electrician to work on a plumbing problem. It makes no sense."
The Committee will reconvene on June 15th and, if I understood correctly, both Drs. Paolo Zamboni and Marian Simka will be asked to present.
Reader Comments (10)
It looks like change is coming!! Possibley we are nearing the tipping point? Thanks for the article Colleen! Excellent as per usual.
I look forward to the second debate and to hear the 'Masters' speak and keep this hot issue on fire.
cheers
Thanks WENDY! I can't wait for them to come, either. May mean a little trip to Ottawa...
"..Asked if he knew why the Multiple Sclerosis Society of Canada has a wait-and-see approach. MacDonald says "Again, it's ike waiting for an electrician to work on a plumbing problem. It makes no sense."
I like logical thinking. When was the last time You got an electrician to do Your plumbing? Well said Dr. S. MacDonald!
We just have to keep it factual. The quality of life improves. Placebo? They now can swallow and walk unaided!! They are no longer suicidal and drowning. They Live Life.!
I would like to thank you for writing this amongst many more that you have written. Very well said and a great read!! This situation is the most frustrating thing that I have had to deal with. The only answers we are getting is from the same script back in November 22/09. Worldwide no less. This battle is moving along and due to us not letting go. The nay sayers are hoping we go away and this will not happen. We have to push on and in the end some of us will win our God given right to make our own choices. I just hope to experience this but my spirit is being torn down and I find it so hard to fight this big fight. Daily I expect good news but by the end of the day it seems the same as the day before. I hope so much for this to change and June 15th will confirm this. If the same answer is given by the nay sayers I will have lost all hope.
Hi LAURA!
The plumbing vs. electrician analogy is spot on, and not only is it easily understandable for people without medical problems, it's also a supporting jab at the neurologists (electricians) who are trying to keep the vasculars (the plumbers) out of their domain.
Hi SHIRLEY!
Within the CCSVI Calgary group, which I was part of until moving back to the US lat month, we too have had our ebbs and flows. Some meetings we have more new faces and fewer older ones, some meetings it's just the old faces who show up.
There are many big challenges for the CCSVI battle. First, the battle is being fought by people who are sick - and it's sick to mobilize a sick army who, for the most part, are suffering from chronic fatigue. Compounding this is their historic relationship with their neurologists and many people are worried about burning that bridge when the neuros have been, in many ways, their mentors. Sure, many people go "outside the box" to dabble with alternatives but most are scared to leave the comfort of that box completely, which is what seems to be happening for those pursuing CCSVI treatment.
I don't need to tell you what an event those visits are. That appointment on the calendar for the 6-month or yearly checkup has a large red circle of hope around it year after year, but for the most part, nothing major happens on those dates except for, perhaps, a new round of meds, or the discovery that things are getting worse, or better, or staying the same - a discovery that isn't news to you because you know where you're at. And many people I talk to wonder if the endless pages of surveys they get you to complete are ever looked at.
And last but not least is the expense. It costs a lot of money to travel abroad and lots of people with MS have fixed incomes and little, if no, family or spousal support. And there's the distance/cultural barrier too: many people have never traveled to a country that doesn't speak their native language (Poland, Bulgaria) or have the same food and custome (India) and that's scary for many.
But the point here, Shirley, is to never lose heart. If you feel discouraged today, perhaps you won't tomorrow and tomorrow you can do something - reply to a blog, tell a friend about it - and maybe they'll be encouraged, like I am, to do more.
CCSVI gives not only hope to a disease where there's been little hope before; it also gives tangible results.
xxx to you both!
Colleen O'Shea
The trick
very interesting infotmation about ms, I am hoping against hope that there will be a liberation treatment. I have had ms since 1976 or longer, I am not able to get around or do the things I have for quite some time. hopefully ccsvi will be a reality soon. Keep up the good work. Norah
Hey thanks for the show and especially for the information, I really like it. Great work, keep going!
replica breitling|
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”.
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.
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.
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
“Unnecessary risks are being taken by patients seeking the liberation treatment.” says Dr. Avneesh Gupte of the CCSVI Clinic. “It has been our contention since we started doing minimally invasive venous angioplasties nearly 6 years ago that discharging patients who have had neck vein surgery on an outpatient basis is contra-indicated. We have been keeping patients hospitalized for a week to 10 days as a matter of safety and monitoring them for symptoms. Nobody who has the liberation therapy gets discharged earlier than that. During that time we do daily Doppler Ultrasounds, blood work and blood pressure monitoring among other testing. This has been the safe practice standard that we have adopted and this post-procedure monitoring over 10 days is the subject of our recent study as it relates to CCSVI for MS patients.”
Although the venous angioplasty therapy on neck veins has been done for MS patients at CCSVI Clinic only for the last 18 months it has been performed on narrow or occluded neck veins for other reasons for many years. “Where we encounter blocked neck veins resulting in a reflux of blood to the brain, we treat it as a disease,” says Gupte. “It’s not normal pathology and we have seen improved health outcomes for patients where we have relieved the condition with minimal occurrences of re-stenosis long-term. We believe that our record of safety and success is due to our post-procedure protocol because we have had to take patients back to the OR to re-treat them in that 10-day period. Otherwise some people could have run into trouble, no question.”
Calgary MS patient Maralyn Clarke died recently after being treated for CCSVI at Synergy Health Concepts of Newport Beach, California on an outpatient basis. Synergy Health Concepts discharges patients as a rule without in-clinic provisions for follow up and aftercare. Post-procedure, Mrs. Clarke was discharged, checked into a hotel, and suffered a massive bleed in the brain only hours after the procedure. Dr. Joseph Hewett of Synergy Health recently made a cross-Canada tour promoting his clinic for safe, effective treatment of CCSVI for MS patients at public forums in major Canadian cities including Calgary.
“That just couldn’t happen here, but the sooner we develop written standards and best practices for the liberation procedure and observe them in practice, the safer the MS community will be”, says Dr. Gupte. “The way it is now is just madness. Everyone seems to be taking shortcuts. We know that it is expensive to keep patients in a clinical setting over a single night much less 10 days, but it’s quite absurd to release them the same day they have the procedure. We have always believed it to be unsafe and now it has proven to be unsafe. The thing is, are Synergy Health Concepts and other clinics doing the Liberation Treatment going to be changing their aftercare methods even though they know it is unsafe to release a patient on the same day? The answer is no, even after Mrs. Clarke’s unfortunate and unnecessary death. Therefore, they are not focused on patient safety…it’s become about money only and lives are being put at risk as a result.”
Joanne Warkentin of Morden Manitoba, an MS patient who recently had both the liberation therapy and stem cell therapy at CCSVI Clinic agrees with Dr. Gupte. “Discharging patients on the same day as the procedure is
ridiculous. I was in the hospital being monitored for 12 days before we flew back. People looking for a place to have the therapy must do their homework to find better options. We found CCSVI Clinic and there’s no place on earth that’s better to go for Liberation Therapy at the moment. I have given my complete medical file from CCSVI Clinic over to my Canadian physician for review.” For more information Log on to http://ccsviclinic.ca/?p=866 OR Call on: +1 (404) 461-9560.