FDA Issues Warning on CCSVI

A forum to discuss Chronic Cerebrospinal Venous Insufficiency and its relationship to Multiple Sclerosis.

Re: FDA Shutting Down CCSVI Research

Postby Cece » Thu May 10, 2012 4:54 pm

At the end of the SIR response to the FDA letter:
Interventional radiology is a recognized medical specialty requiring dedicated training that encompasses clinical patient evaluation and management, non-invasive venous imaging and the delivery of targeted, image-guided minimally-invasive treatments to patients. Interventional radiologists perform balloon angioplasty and stent placements on a daily basis in thousands of patients with diverse venous conditions, including acute deep vein thrombosis, post-thrombotic syndrome, superior vena cava syndrome and portal hypertension; they also perform procedures to maintain hemodialysis access. Interventional radiologists perform many of the CCSVI procedures in the United States; they are highly qualified to perform such treatments when appropriately indicated.
In other words, interventional radiologists are not cowboys, they're highly qualified specialists who perform balloon angioplasty on a daily basis.
Though determining when jugular venoplasty is appropriately indicated is what's at question.
I would trust my IR over my neurologist to interpret a venogram! I would also trust myself, at this point, to the extent that a layman can achieve.

In the FDA letter, with the emphasis on adverse effects, it would have been more balanced to also mention the safety studies that we have seen.
Dr. Simka's safety study - http://www.youtube.com/watch?v=1czmJBLKhEg
Dr. Mandato's safety study - http://tinyurl.com/6jbpuqn
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Re: FDA Shutting Down CCSVI Research

Postby Cece » Thu May 10, 2012 5:24 pm

Furthermore, the benefits of these experimental procedures have not been proven, and their promotion as a treatment for MS may lead people with the disease to make treatment decisions without being aware of the serious risks involved.

Also from the FDA letter. It is not in our interest to have this procedure labeled as experimental.
I bet this has a bigger impact than what I initially thought. So frustrating.
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Re: FDA Shutting Down CCSVI Research

Postby munchkin » Thu May 10, 2012 6:01 pm

Some how there needs to be more accurate information put out there in the public realm. People listen to this stuff and we lose support and come off sounding like fanatics. How do we change this?
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Re: FDA Shutting Down CCSVI Research

Postby Loriyas » Thu May 10, 2012 6:10 pm

David1949-I wish there was a " like " button for your post! I agree with you 100%!
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Re: FDA Shutting Down CCSVI Research

Postby 1eye » Thu May 10, 2012 6:54 pm

It ain't over till it's over.
Yogi Berra -- In July 1973, when Berra's Mets trailed the Chicago Cubs by 9½ games in the National League East; the Mets rallied to win the division title on the final day of the season.

There is an item on this in the CBC National news tonight. It very uncritically passes the "information" directly from the FDA, to the Canadian public. You were thinking maybe they would kiss by-bye to all those revenue streams without a fight?

I too, liked the Society of Interventional Radiologists' statement
Interventional radiologists perform balloon angioplasty and stent placements on a daily basis in thousands of patients with diverse venous conditions, including acute deep vein thrombosis, post-thrombotic syndrome, superior vena cava syndrome and portal hypertension; they also perform procedures to maintain hemodialysis access.
as it goes directly to the real truth that the FDA is trying to sell the old lie about. You don't even have to ask where they heard it.

Concerned Americans should write directly to their representatives. I can tell you Canadian politicians' e-mails, but I don't have any of the US ones. Actually, I have one, since I did write once to the Michigan governor: I retain my US vote, as I was born in Detroit.

Those over on Facebook should do some writing, too. Anybody care to write a "press release" from TiMS-CCSVI?
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Re: FDA Shutting Down CCSVI Research

Postby CureIous » Thu May 10, 2012 10:30 pm

Well I guess it isnt conspiracy theory if they really are out to getcha.

Seriously though, we could get NO coverage on CCSVI of any import, until the media is able to have headline head-spinners like this:

FDA warns against multiple sclerosis treatment

WASHINGTON — An experimental treatment for multiple sclerosis has caused death, strokes, nerve damage and abdominal bleeding and has no proven benefits for sufferers of the disease, the Food and Drug Administration warned Thursday.

Talk about spin, the vast majority (as opposed to our tiny message board) will get their first taste of us rogue elements like the headline above which appeared in the LA Times.

Every neuro worth his salt will have the above memorized for those few testy patients who dare to broach the subject. First impressions are a bear to overcome. (Its not even "experimental anymore, rather is ineffective, and deadly, any questions?).
We've got a long, uphill battle ahead. Now it will be fairly easy to dovetail the above with CCSVI research proponents, and let the branding begin. Then the adjectives will flow off the tongue with ease.

Not shocking, totally expected from the beginning, the gloves have officially come off. First, you marginialize, then, control the information flow. Imagine where we would be without the internet. Exactly.
RRMS Dx'd 2007, first episode 2004. Bilateral stent placement, 3 on left, 1 stent on right, at Stanford August 2009. Watch my operation video: http://www.youtube.com/watch?v=cwc6QlLVtko, Virtually symptom free since, no relap
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Re: FDA Issues Warning on CCSVI

Postby Squeakycat » Fri May 11, 2012 12:51 am

A number of people are reading the FDA Warning as a sign that the agency is interested in CCSVI treatment, wants to promote research on CCSVI, and is seeking public input on it.

But if you read the headlines, the reaction to the FDA warning is probably exactly what was intended by those who pushed the FDA to issue the warning in the first place.

FDA warns against multiple sclerosis treatment
US FDA warns against controversial 'liberation therapy' for MS
FDA warns against MS 'liberation' therapy
FDA warns MS patients about risky treatment
FDA warns MS patients about risky stent treatment
FDA warns about multiple sclerosis vein procedure
FDA Warns on Controversial MS Therapy
FDA Warns About Dangers of 'Liberation Therapy' for MS
FDA Targets Experimental Multiple Sclerosis Treatment
FDA Itself: FDA issues alert on potential dangers of unproven treatment for multiple sclerosis


Hard to view that as a positive for CCSVI research.

One of the first consequences likely will be that any insurance company now paying for treatment will seize on the FDA warning to back off and they are probably getting phone calls today suggesting this.

Anyone considering providing treatment will also likely be warned off.

The 380,000 or so people with MS who are not participating in This Is MS or Facebook CCSVI discussions will now know that their neuros were right to warn them against seeking treatment.

I have no doubt that all of this is exactly what the people who raised this issue with the FDA intended. Mission accomplished. CCSVI has now been officially marginalized so lets get back to obediently taking those MS "disease modifying drugs." There are billions of dollars at stake.
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Re: FDA Issues Warning on CCSVI

Postby 1eye » Fri May 11, 2012 6:49 am

Weeeellll.....sniff....I ain't a-gonna let no eff-de-aye scare me. I already had my tonsils out. I din't need no stimps, neither.
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Re: FDA Issues Warning on CCSVI

Postby tiltawhirl » Fri May 11, 2012 1:34 pm

1eye wrote:Weeeellll.....sniff....I ain't a-gonna let no eff-de-aye scare me. I already had my tonsils out. I din't need no stimps, neither.


Multi-level funny. Nice. :lol:

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Re: FDA Issues Warning on CCSVI

Postby 1eye » Fri May 11, 2012 2:57 pm

This is more serious than I have been allowing in my facetious response. Dr. Mehta has an unimpeachable reputation in his field. He has memberships in:

PERIPHERAL VASCULAR SURGERY SOCIETY
SUNY AT STONYBROOK ALUMNI SOCIETY
NEW YORK MEDICAL COLLEGE ALUMNI SOCIETY
INTERNATIONAL SOCIETY FOR VASCULAR SURGERY
INTERNATIONAL SOCIETY OF ENDOVASCULAR SPECIALISTS
FELLOW, AMERICAN COLLEGE OF SURGEONS(2005)
GUIDANT ENDOVASCULAR SOLUTIONS-MEMBER PERIPHERAL ADVISORY
ALPHA OMEGA ALPHA, HONOR MEDICAL SOCIETY
NEW ENGLAND SOCIETY FOR VASCULAR SURGERY
SOCIETY FOR CLINICAL VASCULAR SURGERY
AMERICAN MEDICAL ASSOCIATION
MEDICAL SOCIETY OF THE STATE OF NEW YORK
SOCIETY FOR VASCULAR NURSING
EASTERN VASCULAR SOCIETY
SOCIETY FOR INTERVENTIONAL RADIOLOGY
SUNY @ STONYBROOK ALUMNI SOCIETY
American College of Surgeons
Society of Interventional Radiology

Dr. Mehta graduated from SUNY Stonybrook with a B.S. degree in Biochemistry in 1990. He completed his M.D. from New York Medical College in Valhalla, NY in 1994. Dr. Mehta went on to complete his residency at North Shore University Hospital at NYU School of Medicine and his Vascular Fellowship at Montefiore Medical Center at the Albert Einstein College of Medicine in 2001.

Dr. Mehta is Board Certified in both General and Vascular Surgery. Dr. Mehta is an Associate Professor at Albany Medical College and the Director of Endovascular Services for the Vascular Group, PLLC. Dr. Mehta is also the President and CEO of the Center for Vascular Awareness, a not-for-profit organization dedicated to increasing the level of education and awareness of Vascular Disease.

ALBANY MEDICAL COLLEGE, ALBANY, NY: 2001 — present
Albany Medical School
ALBERT EINSTEIN COLLEGE OF MEDICINE OF YESHIVA UNIVERSITY, BRONX, NY: 1999 — 2001
NEW YORK UNIVERSITY SCHOOL OF MEDICINE, NY, NY: 1997 — 1999

Medical School:
New York Medical College
Valhalla, NY, United States
Graduated: 1994
Residency Hospital:
North Shore University Hospital
Manhasset, NY, USA
Year completed: 1999
Fellowship Hospital:
Montefiore Medical Center
Bronx, NY, USA
Year completed: 2001

He is co-author of "The Hospitalist Manual,", People's Medical Publishing House.

Listed as co-author of 54 documents in PubMed, including:

The phase I multicenter trial (STAPLE-1) of the Aptus endovascular repair system: results at 6 months and 1 year.

This was a phase I IDE study.

and:

Pivotal results of the Medtronic Vascular Talent Thoracic Stent Graft System: The VALOR Trial.

He is in Chapter 43. In Situ Vein Bypass by Standard Surgical Technique of Haimovici's Vascular Surgery, Fifth Edition, Blackwell Science

Also Preoperative Saphenous Vein Mapping, from Noninvasive Peripheral Arterial Diagnosis, Springer London

I believe I found him through a book in a library.

The FDA should not be dragging his name through their bureaucratic mud. When I called his office the first and second times, first he would not do this work at all, then not until he had an IRB approval. I think he knows what an IDE is.
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Re: FDA Shutting Down CCSVI Research

Postby David1949 » Fri May 11, 2012 5:18 pm

Squeakycat wrote:
Let's at least hope that the manufacturers and brainiologists provided some intensive care lubricant when they told the FDA to bend over. :>)


Or maybe no lube. :twisted:
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Re: FDA Issues Warning on CCSVI

Postby jskeltonwhite » Fri May 11, 2012 5:51 pm

I have posted on my facebook page the injustice of the pharmaseutical companies denying Canadians even a temporary repreive of horrible symptoms of m.s. that are provided all over the world. Even though my husband has a family history of vascular issues he is denied treatment here and we have to re mortgage our home to get treatment in the states. They have no problem with lipo suction which has a much higher rate of complications and death. Lets raise our voices for the ones we love!!
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Re: FDA Issues Warning on CCSVI

Postby Squeakycat » Sat May 12, 2012 12:12 pm

Someone has stepped forward with a press release to claim credit for getting the FDA to take action on CCSVI treatment, ie, "this questionable procedure:"

Hoag Doctors’ Report Contributes to FDA Action Regarding Unproven MS Treatment

Hoag Memorial Hospital Presbyterian Doctor publishes article alerting people with MS about serious negative effects of Liberation Therapy

FOR IMMEDIATE RELEASE


PRLog (Press Release) - May 11, 2012 -
The executive medical director of the Hoag Neurosciences Institute applauded the Food and Drug Administration today for issuing a warning about the dangers of a “vein-opening” treatment for multiple sclerosis patients.

Michael Brant-Zawadzki, MD FACR, approached the FDA after learning that several patients in Orange County had serious complications after undergoing an unproven treatment, known as "liberation therapy." He and his colleagues published an article “The Liberation Procedure for Multiple Scleroris: Sacrificing Science at the Altar of Consumer Demand” that was included in the basis for Thursday’s FDA warning “alerting people with MS to the risks of serious injuries and death associated with” the procedure.

The article was published in Journal of the American College of Radiology this year. To view the article, please visit http://www.jacr.org/article/S1546-1440( ... 7/abstract.

Read the FDA warning here.

“I’m grateful to the FDA for taking the issue so seriously and for its leadership in assuring that patients with MS are fully informed about this questionable procedure, and particularly the potential risks,” he said. “Our primary mission as doctors is to promote the health and well being of our patients, and offer treatment using best practice guidelines. Today's FDA action supports our mission.”


We are certainly blessed to have doctors like this protecting our "health and well being," not charlatans "Sacrificing Science at the Altar of Consumer Demand."

Dr. Brant-Zawadzki is a neuroradiologist, you know, right up there with brain surgery.
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Re: FDA Issues Warning on CCSVI

Postby 1eye » Sat May 12, 2012 12:37 pm

Doesn't sound worth $30 to me.
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Re: FDA Issues Warning on CCSVI

Postby tiltawhirl » Sat May 12, 2012 12:40 pm

1eye wrote:Doesn't sound worth $30 to me.



That put me off too. 8O

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...and I for one, welcome our new Neurologist overlords!

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