FDA Issues Warning on CCSVI

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Re: FDA Issues Warning on CCSVI

Postby 1eye » Sat May 12, 2012 12:45 pm

"Still... not exactly rocket science, is it?" :lol: :lol: :lol:
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Re: FDA Issues Warning on CCSVI

Postby Cece » Sat May 12, 2012 2:50 pm

The Hoag hospital, from the article on the other page with the doctor claiming credit for getting the FDA involved, is in Newport Beach, where a high volume CCSVI clinic is, and two patients treated at the clinic ended up in the ER at the Hoag hospital. They're the two listed in the FDA alert. The Hoag hospital has seen the two patients who'd had a stroke or a subdural hematoma after the procedure, with one of those patients dying and one facing a tough recovery, and they haven't seen the thousands of patients who have benefitted from the procedure.

When I first learned about CCSVI, it was a few weeks after radeck's stent migration to the heart and a few months after Holly's passing. It was clear to me that even though this was an outpatient procedure, there were some risks involved, as there would be in any surgical procedure.
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Re: FDA Issues Warning on CCSVI

Postby Squeakycat » Sat May 12, 2012 3:36 pm

Cece wrote:The Hoag hospital, from the article on the other page with the doctor claiming credit for getting the FDA involved, is in Newport Beach, where a high volume CCSVI clinic is, and two patients treated at the clinic ended up in the ER at the Hoag hospital. They're the two listed in the FDA alert. The Hoag hospital has seen the two patients who'd had a stroke or a subdural hematoma after the procedure, with one of those patients dying and one facing a tough recovery, and they haven't seen the thousands of patients who have benefitted from the procedure.

When I first learned about CCSVI, it was a few weeks after radeck's stent migration to the heart and a few months after Holly's passing. It was clear to me that even though this was an outpatient procedure, there were some risks involved, as there would be in any surgical procedure.


The article Cece is referring to in which the two adverse reactions including death of a patient treated at Synergy Health Concepts is here.

Here's the key detail from the article related to the death:
Lamb released Clarke's medical records, which include examination notes. Hoag neurosurgeon Dr. Richard B. Kim says the cause "of the subdural hematoma remains unclear, but seems temporally and physiologically related to the internal jugular vein dilation procedure." An autopsy was not performed.
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Re: FDA Issues Warning on CCSVI

Postby Cece » Sat May 12, 2012 5:40 pm

Thanks, Squeakycat.

A response from Dr. Hicks, president of SIR, in an email to Health Imaging:
“The studies that have been reported to date, including the studies reported at the SIR meeting, have been single center retrospective series which have highlighted the potential for this treatment to improve the quality of life in patients with MS. These are the types of studies which must first be performed and reported on in order to build an initial understanding of the procedure and the entity being treated. These initial studies are also able to highlight the potential safety issues that may be encountered with these procedures. Most of the studies published or presented to date have seen little risk for significant complications in association with this procedure. However, scattered significant complications have been reported and we agree that patients should be made aware of these risks when considering this procedure,” Hicks noted.
http://www.healthimaging.com/index.php? ... -patients-

This answers my question about if the various single center studies were prospective, which would need to follow FDA guidelines including the IDE application. But, no, they're retrospective. It also emphasizes the lack of complications seen in the studies so far.

Again, much appreciation to Dr. Hicks and the Society of Interventional Radiologists for their response to the FDA alert.
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A view from across the pond

Postby MarkW » Sun May 13, 2012 1:06 am

I am sad at the FDA warning but not surprised. The approach in the USA appears to have been 'just do it' for the procedure. This has left pwMS in the vunerable position that they do not exactly know the procedure they will receive. This has left the door open for critics to complain to the FDA. In the UK, people like CCSVI-UK and myself have publically stated that stents should not be used (Prof Zamboni has not mentioned their use in published papers). In the UK, CCSVI advocates say that a cautious approach using catheter venography and intravascular ultrasound should be used for diagnosis. A simple step by step guide to the procedure is being developed and has been submitted to NICE. This collects safe practise so that anyone starting a 'robust controlled trial' in the UK is aware of current thinking on CCSVI syndrome.
MS Neurologists (and major MS Charities) in the UK have not mentioned the NICE guidelines since their publication. I suspect this is because they hate the idea that pwMS in the UK can access the procedure in a private trial under NICE procedure IPG420.
My suggestion for the USA is that CCSVI advocates are vocal about safe practise for the CCSVI procedure. A document to the FDA would be a sensible approach. Otherwise CCSVI is in danger of being stopped in the USA and the Neuros will win.
Happy to consult on the approach used to NICE (thru verbal communication) if serious CCSVI advocates in the USA request this.
Kind regards,
MarkW
Mark Walker - Oxfordshire, England. Registered Pharmacist (UK). 10 years of study around MS.
Mark's CCSVI Report 7-Mar-11:
http://www.telegraph.co.uk/health/8359854/MS-experts-in-Britain-have-to-open-their-minds.html
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Re: FDA Issues Warning on CCSVI

Postby 1eye » Sun May 13, 2012 11:01 am

I think the handful of deaths and serious adverse events, out of all the procedures performed globally, show (yes, not in a court of law, or a scientific journal) that the studies which have been done are correct, in concluding the procedure is safe almost all of the time. There are many procedures, including cosmetic ones, not banned by any government body and yet less safe.

The patients who are having this done are not in the peak of health. The risk of inaction, while not quantifiable, is very real. I shudder to think what my life would be like now, if I had not had it. Many who do not see me everyday, have told me I was worse before it, than I am even now with restenosis. I would certainly be in a wheelchair full-time, whereas now I am in a walker, except for trips out of town or evening events. I have regained some things which have remained. The quality of my life is appreciably better. Last night I made my son a square-knot macrame case for his iphone out of 5/32 inch leather lacing. I went on my recumbent tricycle on Friday last week to the local Tim Horton's, according to my odometer, about 1.4 kilometers each way.

I don't think anyone can put a price on that, and no one is justified in denying it to anyone else. That's my opinion, and I think many share it with me.
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Re: FDA Issues Warning on CCSVI

Postby Cece » Mon May 14, 2012 8:35 am

www.facebook.com/notes/ccsvi-alliance/h ... 9974047036
The final presenter was Fred Fox, president of BioMed Institutional Review, the company which has granted the Hubbard’s their registry approval. I was very interested to hear Mr. Fox’s take on the FDA warning letter and press announcement on CCSVI treatment.

The term “off label” comes from the pamphlet-like label on the bottle of prescription medication or a medical device...this pamphlet states how this medicine or device can be used and in what applications. If a treatment is not “on the label” it is considered an off label usage. This is how the FDA views the use of stents or balloons in the veins of pwMS. They were created for arteries, and veins are not on the label. Doctors are allowed to treat off label---it’s a personal decision between you and your doctor. This happens everyday.

However, If the doctor promotes off label usage it is illegal.

When did off label use cross the line in CCSVI treatment? When this treatment became promoted and advertised to patients.
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Off Label Use in the UK

Postby MarkW » Mon May 14, 2012 9:47 am

Cece wrote:The term “off label” comes from the pamphlet-like label on the bottle of prescription medication or a medical device...this pamphlet states how this medicine or device can be used and in what applications. If a treatment is not “on the label” it is considered an off label usage. This is how the FDA views the use of stents or balloons in the veins of pwMS. They were created for arteries, and veins are not on the label. Doctors are allowed to treat off label---it’s a personal decision between you and your doctor. This happens everyday.
However, If the doctor promotes off label usage it is illegal.
When did off label use cross the line in CCSVI treatment? When this treatment became promoted and advertised to patients.

Hello Cece,
I share my understanding from a UK position, I think it is the same in the USA but it is years since I kept up-to-date with the FDA.
You are correct that a doctor (or pharma co or clinic) must not promote off label uses.
I distingush between stents and balloons because a stent remains in the body so a higher level (long term) safety is required. In the UK, a doctor or clinic may inform patients that it has used arterial balloons in a trial to treat stenoses in veins. This is lawful. However, saying this is a treatment for MS is off label and unlawful. It is a fine dividing line.
Hope this helps,
MarkW
PS Using arterial stents in veins is off label (except in emergency situations) in my opinion.
Mark Walker - Oxfordshire, England. Registered Pharmacist (UK). 10 years of study around MS.
Mark's CCSVI Report 7-Mar-11:
http://www.telegraph.co.uk/health/8359854/MS-experts-in-Britain-have-to-open-their-minds.html
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Re: FDA Issues Warning on CCSVI

Postby Cece » Mon May 14, 2012 10:48 am

thanks, MarkW.
I should clarify that what I quoted was written by Cheer, over on Facebook, who in turn was summarizing the thoughts of Fred Fox, a presenter at the recent Hubbard Foundation conference.
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Re: FDA Issues Warning on CCSVI

Postby MrSuccess » Mon May 14, 2012 9:19 pm

MrSuccess is delighted to read of the FDA warning on CCSVI.

As with CCSVI gaining exposure within the Neurology Professional Trade Rag's ....

it is now looking at them ....straight in the face .

We move on from here.



Stay Calm .... and ..... Carry On.



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Re: FDA Issues Warning on CCSVI

Postby Cece » Tue May 15, 2012 1:23 pm

Dr. Arata's comments on the FDA warning:
The FDA regulates drugs and devices in the US. It doesn't control individual physicians. Attempts to go after an individual doctor by complaining to the FDA will not impact an individual doctor.

Rather the entire CCSVI movement will be hurt by theses acts of selfishness. In particular, research efforts will be limited and far more difficult. Personally, I will strive to move CCSVI forward. No matter who or what obstacles arise. The truth is CCSVI treatment works and there's no stopping the truth.
FDA warning is just that. A warning that adverse events could happen when undergoing CCSVI treatment. It is something we all need to keep in mind. It also means that CCSVI is on their radar. That is fantastic news. I look forward to sharing my CCSVI experience with the leaders of the FDA.
http://www.facebook.com/Dr.Arata/posts/312827728794974

Dr. Sclafani made his comments over in his thread:
chronic-cerebrospinal-venous-insufficiency-ccsvi-f40/topic10680-6825.html#p191658
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Re: FDA Issues Warning on CCSVI

Postby Cece » Tue May 15, 2012 8:22 pm

Extremely upsetting news over in this thread on CCSVI Locator: http://ccsvi-ms.ning.com/profiles/blogs ... 1#comments

Dr. Arata says that the Hubbard registry has been ceased!! Is that true? Dr. Arata says that you can check the FDA website and no IDE has been issued by the FDA, does that mean not for any of the CCSVI research underway? He believes that more centers will stop doing research and the FDA has targetted CCSVI research. :sad: :sad: :sad:

AND, in the same page, Bonnie says that she spoke to her clinic today and was told that "they cannot call insurance companies and none of the insurance companies will approve any procedures or visits for CCSVI."

And Dana Dernberger also says that the FDA has shut down more clinics today and that they will be visiting every clinic that is doing research.
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Re: FDA Issues Warning on CCSVI

Postby 1eye » Tue May 15, 2012 8:35 pm

No research. No registry. Somebody wants to emulate Canada? Won't be happy until the drug vendors shut down every interventionalist? What don't they want to know?
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Re: FDA Issues Warning on CCSVI

Postby Cece » Wed May 16, 2012 5:12 am

Dr. Ferral has joined in with his thoughts over on the CCSVI Locator thread. It's the first time in his 20-year career that the FDA has paid attention to the off-label use of angioplasty balloons.

Has anyone heard if it is true or not if the Hubbard registry was shut down? Also curious to hear if anyone in addition to the woman at the other thread is being told that insurance is not being accepted anymore, and at which clinics? That has me frightened on a personal level.
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Re: FDA Issues Warning on CCSVI

Postby muse » Wed May 16, 2012 7:37 am

Press Release of the Association in response to the U.S. F.D.A. announcement about the safety of the treatment for CCSVI

The association CCSVI nella Sclerosi Multipla - ONLUS, made by patients and relatives of MS patients, agrees with the need for science to continue its own course to study the CCSVI, with its time and manner, but does not accept the restrictive and concerned evaluations of U.S. F.D.A.
about:

1. the existence of CCSVI
2. the correlation between this venous disease and multiple sclerosis,
3. the safety and effectiveness of the Percutaneous Transluminal Angioplasty (PTA) in MS patients.

In fact, it was published an important amount of international independent outstanding studies demonstrating exactly the opposite on each of these issues.

These studies since 2008 (published in large numbers especially during last year) show:

1. that CCSVI exists as a separate disease. In September 2009 a panel of 50 experts of the UIP, the largest scientific organization that deals with venous disease, included it among the congenital truncular venous malformations, or between those that have a development between the 3rd and 5th month of intrauterine life. The international consensus document will endorse the therapy PTA. Since then, many other studies confirm this;
2. that the correlation between CCSVI and MS is very high: the latest diagnostic studies, performed with venography - internationally considered as the most effective method NOT operator-dependent differently from Doppler ultrasound (ECD) - report conclusively about a correlation more than 90% . This is a result processed by ISNVD (International Society for Neurovascular Disease) that examines 13 studies of 8 countries and finds a correlation that ranges from 92.3 to 100%.

Inevitably, it means that any further epidemiological study about the correlation between CCSVI and MS, will necessarily be confronted itself with these international data.

Regarding the safety of Percutaneous Transluminal Angioplasty (PTA), the studies thus far published show that angioplasty (a technique used for decades even in the field of deep venous system), is safe in safe hands. Prof. Paolo Zamboni, who discovered CCSVI and indicated the methodology to dealt with it, ABSOLUTELY DOES NOT recommend the use of stents in the veins. It clearly means that all adverse events due to use of stents are NOT IMPUTABLE to his methodology.

Anyway, we wish to underline that the percentage of so-called adverse events, attributed to the use of stents is very low, like very low is the risk of this technique on the veins by scholars who have dealt with it. The PTA is rightfully part of safe techniques as defined by science.


Regarding the efficacy, preliminary published studies show PTA brings undoubted benefits to MS patients, improves the quality of life, and in many cases can block the progression of the disease.

In fact, we wish recall what recently UK NICE (National Institute for Health and Clinical Excellence www.nice.org.uk/ipg420) expressed. In essence the institute, analogous to the Italian Consiglio Superiore della Sanità:

• encourages further research in this area noting that treatments currently available are very poor of efficiency;

• taking into account the data of the literature considers the available data on the safety certainly significant to certify the legality of the PTA treatment within the research trials.

Similarly, the SIR (Scientific Society of Interventional Radiologists) though is rightly prudent on the results achieved so far (we agree on this), answers to FDA statement on CCSVI:

1. "Strongly supports high-quality clinical research to determine the safety and efficacy of interventional therapies in MS and is working actively to promote and accelerate the completion of necessary studies."
2. "Recognizes the challenge and the potential opportunities presented by promising early studies of an interventional approach for treatment of multiple sclerosis."
3. "It’s pleased that activist groups pushed forward the medical community to respond to this challenge and is committed to take a leader role in national launch of necessary efforts."

At last, we desire to remind that in Italy and around the world clinical trials aimed to evaluate the safety and effectiveness of the angioplasty procedure in MS patients, are underway or at the starting line. They, we believe, will have the last word.

Rome / Bologna, May 12th, 2012
Association CCSVI nella Sclerosi Multipla - ONLUS

Press Office
Gisella Pandolfo + 39 347 4074986
Dora Carapellese + 39 347 4581906

Translated by

Gabriele Reccia gr.ccsvi@gmail.com

Source: http://www.ccsvi-sm.org/?q=node/1077
"MS" doesn't exist! - CCSVI dx Nov.2009, 1. angio LVJ & RVJ June 2010, 2. angio RVJ April 2011, January 2012 2. restenosis, reversed after ~1 year intake of high dosage Magnesium only. ThisIsCCSVIinMS: http://goo.gl/QWMFy7
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