Friday, August 13, 2010

Mary Berukoff's second Letter to MS Society Canada (Savoie)

From Easy to Serious Questions for MS Society of Canada and Mr. Savoie, CEO

Thank you for your recent letter called
CCSVI: New Hope for MS? By Yves Savoie, President and Chief Executive Officer, Multiple Sclerosis Society of Canada
    Matt and Dan, my twin brothers, are going to Mexico this week to open their restricted veins. One report states “there is considerable delay in contrast enhancement of both arterial and venous systems…right jugular enhancement is noted at 103 seconds… the left jugular vein optimally enhances at approximately 225 seconds…It is abundantly clear there is significant delay in both arterial and venous contrast enhancement ...the left jugular vein particularly demonstrates delayed or diminished blood flow.” AIM Medical Imaging MRI Centre.. attending physician Dr. Henderson
    They are going because hope is keeping them alive for a normal and better future. They are going because they are informed enough about the scientific evidence that unplugging congested veins will result in better blood flow which may dissipate some of their MS symptoms over time.
   Mr. Savoie, you have provided some easy answers with little hope for their future because the serious questions with life-changing answers have yet to be addressed. We hope you will read this letter, dig a little deeper, and answer the questions that really matter.
   Your first comment:
The MS Society is privileged to play a role in better understanding CCSVI and look forward to seeing research results, as quickly as possible, in order to best help those living with MS.
   Serious questions:
So what kinds of research studies have been recently approved with the CCSVI tag? It seems the 7 studies with small selected groups are mostly designated to radiology and neurology specialists to compare pictures of restricted veins. Will researchers take the next obvious step to open up blocked veins or will they not be permitted because that would be considered treatment? See descriptions

What is your timeline in discovering or replicating vein irregularities in a double blind studies specifically set for large trials for single drug reactions in normal versus sick people? It is a clear assumption that 60 years of experimenting with the brain’s neurons have delivered very few positive testimonials…(estimated 9% effectiveness vs 97% improvement to some degree with better blood flow.) It is common knowledge that most medications involve large randomized trials because huge numbers are needed to offset marginal effects.

Your question: What is CCSVI?...CCSVI as a condition in which the venous system is not able to efficiently remove blood from the central nervous system

Serious question: Why not initiate clinical trials that study both structure and function at the same time with vascular specialists who can actually help to improve blood flow? At the same time, open up communication with many international doctors who are actively learning about veins, right balloon sizes, right stents if necessary, better outcomes with the azygous vein which is difficult to image, and evaluating techniques and long term results.

Your question: What is the MS Society’s position on CCSVI?

The concept of CCSVI as a cause of MS, and the use of stents or balloons to widen veins as treatments, are ideas that need to be replicated and validated in much larger, well-designed studies

Serious question: What if, scientists need to rethink some other concepts for the cause and progression of MS as an autoimmunity disorder? After all, the conventional wisdom about demylienation where the immune system attacks the body's own cells is theory only with an unknown origin, an unknown trigger, no known cure, and is still a mystery within the medical fraternity. Oddly, the link between vascular abnormalities and MS was seen at least 30 years ago (Dr. Schelling) but was largely dismissed by the medical world. In the meantime, if your focus is to prove blood flow is a causal factor, not a side-effect, this could reasonably take decades in the same manner as current experimentation with the immune system. Because MS is such a complex disease, double blind studies may prove unfeasible because clinical outcomes are so subjective and the natural history so irregular.

Has there ever been a double blind study for any other form of angioplasty or heart transplants?

Besides, the serious question is how to improve blood flow and reduce reflux, a standard procedure for several other conditions.

Your question: What are some of the research questions that need to be answered?

First, there must be a consensus about how to image narrowed veins—this will take research.

Serious question: What is wrong with the current state-of-the-art methods available such as MIR, MVR, and Doppler Ultrasound? In time, there may be more standardization, but many vein occlusions are found only with catheter venoplasty actually on site rather than on scans. This is still the Gold Standard for assessing veins, including the azygouz vein, a main contributor to venous outflow resistance.

Your comment: There also has to be a clearer understanding of the relationship between narrowed veins and MS...and the best way to treat narrowed veins.

Serious question: Why not, take into account, that there are possible 2,000 to 3000 venous angioplasties already performed by world class doctors, interventional radiologists and vascular surgeons? Lead from their results. Recent formation shows the International Society for Neurovascular Disease, CCSVI seminars, conferences and other symposiums are actively discussing the best techniques to open veins and keep them open. The history of MS is changing and Canadian doctors are missing out on this rapid learning curve.

Better yet, take MS out of the equation. In fact, CCSVI is a condition in its own right that needs intervention…Venous angioplasty is not experimental or controversial.

Your comment: Some of this research can be accomplished in a relatively short time, but as with any MS therapy, measuring the real impact requires long-term observation.

Serious questions: First, is there any illusion here that a minimal physical intervention has implications similar to long-term drug use? Here’s where the so-called impact becomes really confusing. Hopefully, you have seen the numerous effects of CCSVI treatment as video testimonials at this time because clinical trials are not allowed which would also show similar benefits …people walking better, less fatigue, less brain fog, better speaking...even after two days. Is it any wonder it has been dubbed Liberation?

Show me any MS drug with a similar impact or story. This is the sharpest point that hurts the most…there is nothing else with hope for improvement!

For example, one of the most recent drugs is FTY720 (fingolimod) described as “an encouraging and important milestone for the MS community," said Dr. Patricia O'Looney, Vice President, Biomedical Research at the National Multiple Sclerosis Society” Further down is a long disclaimer: You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with FTY720 to be materially different from any future results, performance or achievements expressed or implied by such statements. FDA Advisory Committee Unanimously Recommends Approval Of Novartis Investigational Treatment FTY720 To Treat Relapsing Remitting MS07 Aug 2010

If you’re concerned about proper protocol, why did the FDA granted FTY720 priority review status in February 2010, reducing the standard 10-month review to six months?

Second, here’s a personal question: Given a choice, what would you choose... a simple safe 45 minute treatment to open restricted veins or swallowing some “sphingosine1-phosphate receptor (S1PR) modulators, which work by retaining certain immune cells (lymphocytes) in the lymph nodes, preventing them from reaching the central nervous system and causing damage.”

Would you rather pay $1500 for this treatment or have Health Care pay out $30,000 yearly?

Remember, the MS Society approved the anti-body drug Tysabri in November 2004 which was pulled from the market the next year after cases of a rare but lethal brain inflammation in some patients. It was reintroduced in 2006 under an FDA-approved distribution program.

The problem is that the newer drugs work — although in different ways — by suppressing parts of the immune system. That leaves patients vulnerable to infections and even cancers.

Ashton Embry - New Studies Show the MS Drugs Don’t Slow Progression:

Your question: Why does the process take so long?

There are many important questions relating to CCSVI and MS, and the research must be done properly so we will have answers that can guide people with MS, their physicians, the MS Society and governments in making reliable decisions about treatment options.

Serious question: Do you really believe that your guidance as a fundraiser and the MS Society will competently “open the box” for treatment options now considered non-conventional and even dangerous? Honestly? What are your medical qualifications? See The Saddest, Maddest Letter in Reply to Canada’s Health Minister...previous blog.

Your question: Can CCSVI be tested or treated now?

The CCSVI concept is not a proven therapy for MS… not widely tested or treated at this time in Canada.

Serious question: What do you consider a proven therapy? Your MS Society Home Page lists the following six therapies: Avonex Interferon beta-1a, Betaseron Interferon beta-1b, Extavia Interferon beta-1b , Copaxone Glatiramer acetate, Rebif Interferon beta-1a, and Tysabri Natalizumab.

Is the implication here that only drugs are proven therapies? Pharmaceutical companies have never been in the business of making people well but managing symptoms for long term care customers.

Your statement: While testing and treatment is available in several other countries, Dr. Zamboni recommended that people not be treated until more research is completed.

Serious question: Why do you think this statement has been frequently quoted out of context with such miscomprehension? Dr. Zamboni, a vascular surgeon and prolific scientific writer, understands the importance of long term, longitudinal studies following this procedure. This cannot happen if you are forced to travel to other countries for a single treatment with limited follow up. Why not mention that he has also advised for medical treatment for compassionate reasons if drugs have had no effect?

Your question: What is the MS Society of Canada doing to bring pressure on the Governments… to make CCSVI screening and treatment available?

… Over the past 15 years, the MS Society has led advocacy efforts for inclusion of scientifically proven drug therapies on provincial drug-funding plans, once Health Canada approval has been secured.

Serious question: Have you seriously read this answer, word for word?

Your words: If the treatment of CCSVI is proven to be a valid therapeutic treatment option for MS, then the MS Society will advocate to make it widely accessible.

Serious question: Who is the MS Society with such power and competence to advocate for medical scientific procedures? Your advocacy so far has been woefully couched in drugs and more drugs. You are part of the buck-passing, finger-pointing to your family doctor who says talk to your neurologist who says it is unproven because pharmaceuticals can only deal in drugs as a lifetime solution which MS charities add to their proven therapies and vascular surgeons are shut down by Internal Review Boards in hospitals while MS patients are dying. This is the reality and your stated position.

Why should we trust you now? If supporting evidence shows that stenosis (vein restriction) is a factor in the onset of autoimmunity...then drug companies have been shamelessly exploiting medical experimentation on the immune system of long suffering MS patients for decades. And the National MS Society and MS Society of Canada have been riding shotgun all the way.

You recently stated after the contentious election of board members (who still have not disclosed their backgrounds) that the MS Society’s “house” is divided. But remember this is the house built on behalf of MS patients and you have closed the door indefinitely, if, you believe that, somehow, you will structure our medical rights without our input. Do not treat us as servants to follow your “competitive” bidding and condone your high salary. Treat us as equal partners and advocates who can see that the status quo is simply not acceptable. “We must insist that new ideas be taken seriously, and demand that the vested interests of those who have profited from our collective misery not hold sway any longer.” (Mark)

Mr. Savoie, in conclusion, it seems you have made a sincere case in simple rhetoric and a little bravado (words like privileged, first MS organization to establish research competition). To the public, it may even sound that the MS Society is riding with the times and looking forward to “rigorous” research to facilitate standardization and safety.

To the MS sufferers we can see through the smoke and mirrors. Your main excuse is lack of randomized trials that work best for drugs and you have overtly omitted undeniable, indisputable clinical evidence of CCSVI and treatment results.

But you now have the opportunity to answer these serious questions:

Why keep CCSVI research exclusive of treatment? If doctors find a vein confluence…use a gentle balloon to open it.

What is a reasonable timeline in discovering or replicating similar vein patterns and procedures to treat them with the understanding that every body is different?

What if, there are other concepts for the cause of MS as an autoimmunity disorder? What if, the standard MS inflammatory response is more related to vascular structures and the immune system is only trying to naturally help relieve toxins?

What is the best way to plug into current CCSVI procedures from 1000’s of case studies with improved results to maximize scientific research and not “reinvent the wheel”? Time is such a precious commodity for this devastating disease.

Why is it a good idea to set up a tracking system to gather data about everyone who is tested and treated within a global community of doctors?

Why not listen to MS patients who are interested in opening their diagnosed stenosis (vein restrictions) to pursue an elective procedure and pay a fee for having it done if a certain lack of trials restricts it from government funding? At least the money would stay in Canada and you will honour your mission statement to respect “the right of individuals to make decisions as it relates to their personal health.”

We look forward to your thoughts and ongoing dialogue.

In the meantime, there is no hope with the MS Society outside of hamburger sales and Christmas dinners where 48% of money raised goes to pay administration salaries.

There is no hope when non-medical personnel at the MS Society override professional doctors.

There is no hope if the MS Society aligns itself with neurologic circles, as well as with the pharmaceutical industry, which stands to lose untold billions in the sales of drugs designed to suppress the immune system.

We will not live in a hopeless house with your rules. This is the 21st century and we will choose diagnostic tests and treatment for ourselves with health-care professionals we want. You may block some of the reality…but you will not continue to block our veins with simple bureaucratic answers.

There is hope with abundant evidence and astonishing testimonials worldwide.

There is hope in seeing real pictures of once narrowed veins that are open and flowing freely with benefits of lesser symptoms.

There is sadness that these medical breakthroughs will happen in countries outside of Canada.

There is hope that CCSVI will reduce the huge spiraling health care costs in provincial budgets in tough economic times.

There is hope, even with the many variables about understanding CCSVI and the new treatment, that only experienced doctors will provide the proper information.

There is a magnificent gratitude for all the doctors (and politicians) who have offered their hands and expertise to help this unprecedented possibility to repair broken lives.

There is hope that CCSVI is the most important advance in MS research in 50 years, maybe ever.

There is optimism that the treatments for Matt and Dan will provide first steps to recovery. The excitement is real…the worst fear is no treatment and a terrible subsistence. The Mexican surgeons are looking forward to the challenge of twins’ venoplasties. Medical images and results will be gladly shared.

For the first time in years, my brothers are viewing the world with a glass full of hope, not half empty or filled with drugs. And that is making all the difference, with or without you.


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