FDA Warns About Dangers of 'Liberation Therapy' for MS

[barbara]

Has anyone had this type of treatment? If so, what was the outcome?


MedScape Today
Robert Lowes
Posted: 05/10/2012


May 10, 2012 — A controversial treatment for multiple sclerosis (MS) called "liberation therapy" comes with serious risks and unproven benefits, the US Food and Drug Administration (FDA) warned today.

The treatment, also called the "liberation procedure," involves widening narrowed internal jugular or azygos veins with stents or balloon angioplasty in patients with chronic cerebrospinal venous insufficiency (CCSVI). Some researchers think that the impaired blood drainage associated with CCSVI may trigger MS, or else worsen its progression, according to the FDA. Yet "studies exploring a link between MS and CSSVI are inconclusive," the agency stated, adding that "there is no clear diagnostic evidence that CCSVI exists as a distinct clinical entity."

A meta-analysis of these studies published last fall in the Canadian Medical Association Journal reported a strong and statistically significant association between the 2 conditions, although researchers said they could not reach a definite conclusion about the role of CSSVI in MS.

In its announcement today, the FDA said that there is no clear scientific evidence showing that liberation therapy is safe or effective in lessening MS symptoms or improving the quality of life of patients with the disease. Some patients undergoing the procedure have experienced serious and sometimes fatal adverse events such as bleeding in the brain, stroke, migration of stents, venous injury, blood clots in the jugular vein or stents, cranial nerve damage, and abdominal bleeding.

The FDA also said that physicians and clinical investigators who plan to conduct clinical trials to treat CCSVI with vein-widening devices must first obtain an investigational device exemption from the agency because of the significant risks involved. In February, the agency warned a CCSVI investigator in Albany, New York, that he lacked this exemption. The investigator, a vascular surgeon, voluntarily stopped the study, according to the agency.

More information about today's FDA announcement is available on the agency's Web site.

To report adverse events related to CCSVI procedures, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm, or by mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

 

[MARIE]

Dr Zamboni's theory is that blocked veins in the neck and chest cause a back up and poor blood flow in the head and brain. He and his team have been researching this since 2006. They have produced many published peer reviewed papers on their research, as have many other researchers worldwide. BTW "liberation" is a media buzz word, not advocated by any serious person in the field because its misleading.

I was the second person treated in the US with venoplasty for occlusions in the jugular veins. I have stents high in both jugulars. It was successful at restoring my blood flow to a more normal range and I felt better soon after with spasms reduced significantly (I stopped taking baclofen and requip every night) and a return of better sleep, and better temperature control (I was not freezing all the time) and I had much better energy.

I was using a walker before the surgery and still doing so afterwards-obviously mere better blood flow was never going to regenerate nerves and return me to "normal." I do know of a few people who have had a really unexpected improvement, including one who was so disabled she had a trapeze above her bed so she could hang on to that to get up...amazingly she can walk now.

And another patient was wheelchair dependent for several years and now walks well with walking poles--her neurologist actually said on camera that she is far better than she was and that the improvements were unexpected. That patient is still doing well 2 years after treatment (it was not a placebo).

see her neuro here http://www.youtube.com/watch?v=9BNL42wcFLE

and see her eariler video http://www.youtube.com/watch?v=44DM0NPEBUk&feature=relmfu

That kind of dramatic improvement is not typical. Several observational studies have shown that about 1/3 of patients have good improvements, 1/3 modest improvements and a final 1/3 nothing they can notice. In these trials the patient self-evaluates using the MSIS which is a "validated" MS survey (it's used in other MS research already). None of these trials had blinded neurologists evaluating the patients.

What the original research by Zamboni and colleagues found was that all the MS patients had blocked veins in the neck. Because of these blockages the blood hits the obstruction then re-routes by turning backwards up the vein to go down a different path. Not all researchers ahve seen these blockages but meta analysis of all studies to date shows these blockages --called CCSVI for chronic cerebrospinal venous insufficiency-are much more common in MS than others.

This kind of chaotic blood flow is seen in other areas of the body and causes the immune system to activate and adhesion molecules to allow t-cells and b-cells to go into the tissue near the stretched out vein. it also causes fibrin cuffs around the vein and iron deposits in rings around these veins....they know this is true in legs with blocked veins, in livers with blocked veins and in kidneys with such blockages.

And it's been known for decades that MS has fibrin cuffs around the veins, that there is iron deposits around the veins in rings, and of course we all know that adhesion molecules are up-regulated (thus Tysabri is a medicine for us) and immune activity with t-cells and b cells is occurring.

And that is the reason proponents think CCSVI could be the initial trigger for MS lesions. Numerous papers have been written on the idea; there've been 3 years of research at this point with authors on both sides

I wrote a book about this which was published by McFarland in their health topics series. It's called "CCSVI as the Cause of Multiple Sclerosis: The Science behind the Controversial Theory" You can read more about it at ccsvibook.com if you are interested. There are important risks to consider and balloon angioplasty may only last temporarily--the area may block up again.

Some of the CCSVI doctors think stem cells will be the perfect add on to treatment; they want to correct the blood flow and also give a boost to healing for both the area that got treated with angioplasty and the brain as well. Ivo Petrov in Bulgaria and his partner Dr Grozdinski is already gone that way and has presented that this is going to be the best method at a conference:
http://www.youtube.com/watch?v=T9dfv3dWrWU
http://www.youtube.com/watch?v=BQA03OqRJ5k

the first of those 2 videos is an in depth review of stem cells in MS by a hematologist Dr Grodzinski...it's tough to understand for the english speaking ear, but worth it; there's TONS of stem cell facts pertaining to MS!

I have been distracted by CCSVI in the last couple of years and I am distressed to turn back to stem cells and find that it is so very unbelievably slow getting out to us patients with MS. I thought we'd have it by now.

The recent research that FINALLY showed beta interferon does not slow progressive disease in MS even though it reduces relapses is exactly what we need to understand after 20 years of that type of drug being out. Other research has been saying that interferons have little effect on long term progression for some time-it's good the JAMA finally published a paper revealing this to a wide audience.

It's important to notice that all the currently available drugs are "proven" with the same "proof" as the interferons--reduction of lesions, relapses and inflammation because that's all you can really see in a 2 year study. If reduction of relapses, lesions and inflammation by interferon does not slow eventual progression then it is not at all certain that "better" reduction of those things will do it either. It'll be 10 years before we know if Tysabri/Gilenya/etc patients have significantly reduced progression.

But with regards to autologous stem cells they need to stop telling us that we should stand by for another 10 years while they work their way slowly through the research process--we are not "fine" as we wait. I first read of mice with strokes who were given stem cells--they recovered well and their brains were full of new nerves. That was in '93.......I feel like the wait has been unreasonably long.
Marie

 

[barbara]

Marie administers a Facebook page with 20,000 active members.

Marie - Please tell members how they can join you on FB. We need to start building numbers any and everywhere we can to fight what is going on. As you stated, we are not fine and we do not have 10 years to wait. It is very obvious that the effort to block our access to our own stem cells as a practice of medicine is all about money. Researchers want to protect their jobs, universities love the money they receive for research projects and Big Pharma wants to stall until an off the shelf product can be brought to market so they can make billions. The FDA supports Big Pharma and they also have their jobs to protect. However, this is killing patients - the very people that supposedly such restrictions are to protect. It is wrong, very wrong, but the media and the general public have no clue what is going on. We MUST band together and get the word out.

 

[MARIE]

Thanks barb

Thanks Barb! I am with you very much!

The Facebook cause page for CCSVI is

https://www.facebook.com/pages/CCSVI-in-Multiple-Sclerosis/110796282297

I regularly write essays there. I am on the patient board of the patient-formed charity CCSVI Alliance a 501(3)c charity. The publisher has only sold about 1,000 books and I am always interested in letting proplr know it is there--it's the only way to get the word out when we are talking about new treatments that aren't pharma.

And I am on the science advisory board of the Annette Funicello fund for Research of Neurologic Diseases--we'll be reviewing grant requests.

All of us are concerned about the abrogation of patient rights. There seems to be a corporate takeover in which diseased people are considered a captive audience---and the thing that holds them captive is the velvet shackles of the "evidence"

unfortunately almost all the research done in this country is done by corporate entities who only do this research on things that will benefit them.

Obviously if small little clinics can do things like stem cells or balloon angioplasty there isn't any big corporation to do a large-scale trial. Furthermore, if small little clinics can do these things it will eat into the profits of the large corporations because there be less demand for their products. It's just obvious that there's a huge commercial incentive in fear mongering about CCSVI treatment or stem cells and that such companies would naturally do so.

I am not claiming that these things are completely safe, nor claiming they are effective but what I do know is that they are used on label all the time. Therefore they are not some terrifying unknown as Pharma would have us believe.

What they really want is to have every single medical treatment from large corporations with big marketing and PR budgets. While we would always have trials to point to because big budgets pay for big trials. But big trials aren't necessarily truth: books like The truth about drug companies by Dr Angell, or Pharmageddon by Dr. Healy, or Selling Sickness document that studies produced by pharmaceutical companies are manipulated to produce the finding they want.
http://www.naturalnews.com/036417_Glaxo_Merck_fraud.html

witness the interferon studies that have been produced over the last 20 years all suggesting that because interferon reduces relapse inflammation and lesions, it must also reduce progression. This was widely held to be true, and marketing blatantly stated it was true. But now it turns out not to be true these drugs do not reduce long-term progression in multiple sclerosis.
http://www.ncbi.nlm.nih.gov/pubmed/22797642

they've known for a long time relapses don't change MS progression
http://www.ncbi.nlm.nih.gov/pubmed/11078767

and that patients become progressive at about 39 on average
http://www.ncbi.nlm.nih.gov/pubmed/16415309

and that two or 3 or even 10 year studies won't evaluate progression
http://www.ncbi.nlm.nih.gov/pubmed/16948219

So what are we supposed to do? Apparently thank the FDA for protecting us from therapies that might not work---as long as we exclude drugs from that list of "things that don't work" ...

....because they want us to beleive that by definition the pharma product does work BECAUSE a study was done...never mind that every doc knows that most drugs only work for a fraction of the patients they try it on.

It really is all about market share and monopolies.

I say let the free market work. Let the FDA publish a list of "unproven treatments" and make a law that says doctors doing such unproven treatments have to alert the patient that this is an unproven treatment.

We sign HIPPA forms every time we see a doctor: why not a form that says "the FDA wants you to know that this treatment is unproven for off label use such as____________"

Get people's signatures on that and then get the heck out of the way so patients can do what they like to do to try to save their lives when they are in a desperate situation with a chronic disease that has no cure.

thanks Barb for the great forum-looking foward to collaborating
marie