CCSVI MS hindered by big money

[vesta]

I am hesitant about finding an, Interventional Radiologist to treat me for CCSVI MS.

When in May 2012 the FDA began to attack Dr Zamboni's CCSVI treatment « Liberation therapy » I assumed that the MS community was particularly targeted by Big Pharma to deny any alternate treatment to their drugs... However, I can see that the suppression of CCSVI treatment for MS is part of the same politic. We can't count on the established medical authorities (FDA, CIC, NIH, NIAID) who have discredited themselves during the recent crisis.. We can consult FB sItes like the MS Stenosis Society or the Jugular Outflow group in the hope of finding information and therapists who treat vascular and blood flow issues. For starters see the Kathleen Lynch video CCSVI Treatment 101, also CCSVI Alliance.org.on the MS Stenosis Society FB group.

An ongoing registry of CCSVI treaments would guide us in making an independent treatment decision. Tragically the FDA shut down the HUBBARD Foundation CCSVI registry sometime in 2012. (See below"cheerleder"s May 30, 2012 post on ThisisMS)

"Re: FDA Raids Hubbard Foundation.Post by cheerleader » Wed May 30, 2012 4:56 pm

Hi Cureious--
not sure it can be called a "raid"...since they didn't take anything or shut them down. But it sure was a surprise!

from Arlene Hubbard-
Yesterday, the FDA made a surprise visit to one of our sites. They asked to see all of our documentation and will be returning again today. They provided no information on the reason for the visit or why that site was chosen first but did say that they would be doing inspections “all over the country”. The FDA did not shut down the site and as we have posted before we have already applied to the FDA for an exemption. Although the FDA’s primary intent is to prevent “advertising non approved uses for stents and balloons” it is unclear, so far, whether they also will stop research on CCSVI.

"The Hubbard Foundation intends to continue to collect data on adverse events and changes in symptoms related to venoplasty (and ,hopefully, soon in relation to dietary and supplement interventions). An analysis of our first 259 patients has been accepted for publication and our multicenter Registry has collected data on over 400 people so far. We can’t see why the FDA would not want this data to be collected but we’ll keep you posted.

Venoplasty is performed every day in a variety of situations around the globe, and all of these procedures use balloons, catheters and stents in an "off label" manner. (The label refers to the FDA approved usages of a device or drug.) This is because angioplasty was designed for arteries, not veins. Any of these procedures in veins is considered an off label use of devices created for arteries. An this is within the FDA's realm. The reason why the FDA does not get involved in other venous procedures is anyone's guess. But the fact is, they do not. Renal veins are stented for Nutcracker syndrome, and iliac veins are stented for venous insufficiency, and the FDA doesn't say a word.

I think it is naive not to consider the 15 billion a year market in MS drugs. Not that there is a grand conspiracy, but perhaps we need to consider that there is an established business model interested in keeping MS treatments within the immune system paradigm. And power structures will get involved when corporate interests are challenged.

cheer
Husband dx RRMS 3/07
dx dual jugular vein stenosis (CCSVI) 4/09
http://ccsviinms.blogspot.com"

The following quote comes from the ThisIsMs.com website from 1eye July 15, 2012 (under the entry CCSVI, MS
Fatigue, Brain Oxygen) who corrected my original FDA remarks as follows.

"The FDA has not banned patients from seeing doctors or even banned the procedure from being done by a specialist. What it has done is to withhold permission from some randomized prospective trials, that they possibly thought were being done under group and other IRB approvals, without a permission slip called an IDE or Investigational Device Exemption. The IDE allows the trial to be prospective (outcome unknown) when they are using devices such as catheters and stents. What I think that does, is to hinder research, and perpetuate the statement that the use of the catheter or stent on a vein is "Investigational" or experimental,
when the only thing under question is its effect on "MS".These pw"MS" have been saddled with fighting bureaucrats, turf-scared neurologists, the AMA, the CMA, the MS societies, judicial and quasi-judicial organizations, drug vendors, professional associations (the list goes on), to make this procedure a legal entity for those with "MS", paid for by their paid insurance premiums.The FDA has succeeded in slowing research on the procedure to a snail's pace in the US. But they have not banned, and have no power to ban the procedure itself. Many doctors believe the FDA are acting in the interest of the patient. Unfortunately, nobody speaks for the Patient, without having a financial interest to protect."

The end result is that insurance companies and Medicare are refusing to re-imburse the procedure (which they did before this FDA action) since it is considered "investigational". Doctors refuse the procedure rather than risk legal consequences. A recent death of a Canadian woman who was forced to go to Mexico to obtain angioplasty and was subsequently refused post-operative care "she so desperately needed" in Canada highlights the negative consequences of this ban. (Canada follows the same policy as the US.) Roxane Garland, age 37, died of an untreated bladder infection, not CCSVI. I believe she was punished by her Canadian Doctor for having gone against "established norms, beliefs or paradigms." (See the Semmelweis Reflex) She left a grieving husband and 2 children."

Sometime in 2012 the Hubbard CCSVI registry WAS shutdown, a serious loss for me and other MSers who need to know what to hope for (or fear) in undergoing the CCSVI venoplasty. So we can see that the FDA attack on CCSVI treatment for MS in 2012 was a precursor to their recent attack on appropriate early treatment for THE VIRUS.. The Medical regulatory agencies and scientific research have been corrupted by Big Pharma.

So let's return again to me and CCSVI. After a friend returned from Poland where she underwent the CCSVI procedure by the renowned Interventional Radiologist MD CCSVI specialist Dr Salvatore Sclafani,. she urged me to consider doing the same. (Since the NY clinic where Dr Sclafani was working feared his CCSVI work would lead to legal complications, he has transferred it to the Polish clinic.) Another friend in California is urging me to look into venoplasty for CCSVI MS, (Both contacted me through my site..) Both experienced impressive recoveries after their first procedures. Unfortuntely this recovery hasn't persisted for various reasons. Blood clots remain a serious complication..

Since I'm convinced my current problem is orthopedic, that the blocked pelvis "twists" my body such that cerebral spinal fluid and blood are unable to flow freely through the central nervous system, I doubt jugular venoplasty will be of much use And all this because I couldn't obtain osteopathic treatment during the lockdown.

Previously published on my site mscureenigmas.net

mscureenigmas.net
https://www.mscureenigmas.net

[ElliotB]

Perhaps the treatment is hindered by the fact that CCSVI has serious risks and unproven benefits.

[vesta]

Please refer to Petr75's post Re:Association Dec 25 2023 and my reply below: The whole point is that research has been throttled in the West due to the malignant pressure of big money. Angioplasty is not necessarily the only/best treatment for CCSVI.

Re: Association
Post by vesta » Thu Dec 28, 2023 11:55 am

"Conclusions: Chronic cerebrospinal venous insufficiency is significantly associated with multiple sclerosis and it is more prevalent in patients with multiple sclerosis than in healthy individuals, but considerable heterogeneity of results is still observed."

My reply:

I am happy to see that a serious paper linking CCSVI to MS has been published. Notice this study comes from China.
Chinese scientists are apparently free of the tyranical censorship by big pharma which plagues scientists in the West. The following quote comes from my site MScureenigmas.net

"When MS Neurologists derisively mocked Interventional Radiologists as "plumbers", they weren’t altogether wrong. The vascular pathology in MS can be more complicated than simply opening a « plugged » tube. A venologist in Southern California Dr. Owiesy has observed that when the middle layer of the vein composed of smooth muscles go into spasms, blood flow is obstructed. Again the problem resides “exterior” to the vein, not “interior”. The veins may be weak or somehow defective, but the mechanism which shuts off the blood flow isn’t “intima”. This corresponds completely to my experience. The treatment? Dr. Owiesy administers a mixture of dexamethasone/lidocaine/thiamine in the area around the Internal Jugular Vein in order to relax and open it. Apparently outcomes have been impressive, risks and expense minimal (though I’ve never tried it.)

However, one may not even need this medical drug solution. A non-inflammatory diet/supplements alone may prevent the release of molecules which lead to spasms and constricted veins. The role of C-Reactive Protein, Birth Control Pills, so much can be understood by looking at the veins, the endothelium and now the veins smooth muscle layer. Dr Owiesy’s observation that veins can « shut off » through stress for instance tends to cast in doubt the mechanistic approach of angioplasty. Anyway, the problem does not lend itself to an easy solution, and one size fits all clinical trials cannot provide a simple « answer ».

My interest here is two fold : 1) I intend to address the CCSVI MS question in its complexity and 2) I will address how recent events have illustrated the power of Big Money to « capture » medical science and regulatory agencies to the detriment of CCSVI MS patients such as myself. We need to take matters into our own hands, find the help we need and side step those who would do us harm."

Previously published on my site mscureenigmas.net

[ElliotB]

If the treatment really worked, things would be a lot different. There is big money in doing the procedure.

I did a lot of research on the procedure and my conclusion is that while it does work for some patients, it does not work for everyone. Too risky for me to try, frankly. And too expensive for a procedure with such a poor track record in every way.

Plus, I don't think that there is conclusive evidence that CCSVI is THE one and only cause of MS. There have always been many theories, but unfortunately, I don't think the true cause has yet been determined. (But if I am wrong, please provide info that shows otherwise.)

Many are having better results at a fraction of the cost through other simple protocols - diet, exercise and supplements, for example.

[Leonard]

It's the inertia in the system that impedes progress. The business model for health, the investment in health systems and therapies, the protocols doctors that cannot deviate from...

Of course, the majority of cases of MS is caused by narrowed neck veins in the drainage. And no, relative to the cost of an MS patient, the vascular liberation procedure is not costly. But may often come too late.

My kids were all three checked on ccsvi. Fortunately they don't have it. And hence they won't get MS. What I don't understand is why they don't check the children of MS patients because there you might have a lot to gain.

When Dr. Zivadinov did his study back around 2012 with 1200 MS patients and 400 controls in Buffalo, he found overwhelming evidence of the relationship of MS with ccsvi. The raw data are very clear on this! Unidentified forces have then tried to water down the results.

It would be most interesting today, now some 10 years later, to see how many of the control have developed MS. Zivadinov found that about 20% of the controls had a forms of ccsvi, so that makes 80 persons. I guess by now at least 40 of them will have developed MS. Which could have been prevented if they would have had the procedure.

Dr. Zamboni worked as a young doctor on the island of Sardinia. As a vascular doctor, he diagnosed many young people with narrowed neck veins (IJVs). Many years later he was back on the Italian mainland when his wife developed MS. He searched the Internet and found the Austrian Dr. Steiner who had proposed in the 1980s that vascular problems in the neck caused MS. And he talked with him. Then he went back to Sardinia to see what had happened with the young people who he had diagnosed with vascular narrowings. To his own surprise, he found that more than 90% of them had been diagnosed with MS!

It is the true story, I have got it from the horse's mouth. Today I am surprised like you that nothing has been done with this.

[81Charger]

I always felt that this would have helped me but I've never had it done. Now I don't even know of anyone that's doing it in the US. I think big pharma has a lot to do with this becoming something of the past.

[vesta]

Thanks Leonard and 81 Charger for your inputs. I'm convinced the MS lobby in general (pharma, MRI, neurology) did everything to quash research and treatment. By now we should have a stent which could mesh with the vein to prevent its ending in the heart. Other treatments to prevent complications such as blood clots, damaged veins, could have been developed. There is an overwhelming bias in favor of chemical intervention (big pharma again) Just when the neurologist prepared to halt my first big "attack" with steroids, I stopped it myself by getting a shiatsu massage (1980). I only understood why upon hearing about CCSVI. The massage opened the cramped/stressed azygous vein to release the blood flow. As for angioplasty, there is the risk of damaging the vein, for years I was able to keep the blood circulating through mechanical manipulation (osteopathy, chiropractic,) as well as acupuncture. Leonard is right, the angioplasty cost is minimal compared to the drugs. Dr Sclafani had to move his wortk to Poland. Recent events have revealed how much big money has corrupted medical research.