FDA Issues Warning on CCSVI

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

Re: FDA Issues Warning on CCSVI

Postby Cece » Wed May 16, 2012 8:11 am

good find, muse

Here's some thoughts from blogger Trevis Gleason:
Don’t get me wrong, I am still a skeptic, but a hopeful skeptic. An FDA Safety Communication issued yesterday affirms my skepticism, but does not quash my hope.

www.everydayhealth.com/blog/trevis-life ... -patients/
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Re: FDA Issues Warning on CCSVI

Postby 1eye » Wed May 16, 2012 9:37 am

The FDA are in a difficult position, charged with enforcing safe experimentation, with only the opinions of lobbyists and powerful people who have obvious biases to instruct them. Of course, if scientists did no experimentation at all, health would never suffer on the FDA's account.

MrSuccess is delighted to read of the FDA warning
I'm glad you're delighted. You seem to be a very delight-able sort. Asking scientific investigation that has been ongoing for years to stop in its tracks would have delighted Pope Urban's Inquisition in the 1630s.
Last edited by 1eye on Wed May 16, 2012 12:53 pm, edited 1 time in total.
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Re: FDA Issues Warning on CCSVI

Postby MrSuccess » Wed May 16, 2012 12:37 pm

let me simplify the situation -regarding FDA issues warning on CCSVI -

This is similar to building a house . There is an organization dedicated to making sure
it is built correctly and is SAFE to live in. As in CCSVI ..... the skill and experience of
those involved in building your house ..... vary's. Some good .... some not.

Either way ..... an acceptable standard needs to be established.

The Good News of course ...... is that the FDA can call on established CCSVI medical Professionals ..... and they can attest to any concerns the FDA may have.

May I suggest the Annette Funicello Scientific Advisory Board.



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Re: FDA Issues Warning on CCSVI

Postby Cece » Wed May 16, 2012 2:43 pm

https://www.facebook.com/CCSVI.BC
Hello all,the head of our national IRB [Institutional Review Board] spoke at our conference and explained the implications of the FDA warning to Dr Mehta. He has been told he must stop enrolling patients and must seek FDA approval ( so called investigative device exemption (IDE)) with no certainty that the FDA will accept his efforts at "corrective action". So David has been talking with the IRB, Dake, Siskin, Ponec, and others to plan the right thing to do. David will seek an IDE from the FDA so that the multi center Registry can continue and even grow but needs to work out the details.
The Hubbard registry does not have an IDE but it is unclear to me that they need one. If a study using angioplasty catheters is prospective, it needs an IDE; if it is retrospective, it does not. Are registries prospective?

Anyway the Hubbards' response is to attempt to get an IDE. The FDA's response will be indicative of which way this is going.
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Re: FDA Issues Warning on CCSVI

Postby 1eye » Wed May 16, 2012 4:54 pm

This is my unschooled interpretation, of just the words: if it is an Investigational Device Exemption, first of all, what is it an exemption from? Secondly, what do they mean by Investigational Device? Is it an exemption for the device, or for the investigation? Whether it is for the device or its use, surely physicians have accepted it in veins of this nominal size for many years!

Is this just another misuse of the diagnosis of "MS" to discriminate against people who need angioplasty and think it might alleviate symptoms? No wonder people have a hard time complying with "MS" drug regimens, when neurologists, and those they advise, act in such a precipitous and prejudicial manner, seeming only to care about the power they wield over usurious expensive drugs, and very little about patients.

Anyone can see through this, when so many other procedures include catheters, many in veins, some more dangerous, and no-one has to ask for 'exemptions' to do studies.

We have to assume that expert physicians who have used these tools know how, have done for 40 years, and go on from there. Tens of thousands of CCSVI procedure patients have had this done, and yet the only hue-and-cry is from neurologists and drug dealers. Credibility of professionals is being lost here. Don't they care?

As for prospective and retrospective they used to mean looking forward, as in something we are going to do in the future, and looking back, as in something that has already been done.
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Re: FDA Issues Warning on CCSVI

Postby Cece » Thu May 17, 2012 5:58 am

1eye wrote:Anyone can see through this, when so many other procedures include catheters, many in veins, some more dangerous, and no-one has to ask for 'exemptions' to do studies.
I would hope that the IDE rules are applied equally. The IDE rules seemed to indicate that anyone doing an angioplasty study would need an IDE before beginning the study. But I don't know if that has been enforced in all studies.

I am still looking for information to trickle out. There are rumors. So far the ramifications are
1 - Dr. Mehta's study terminated
2 - Dr. Hubbard's registry on hold as they apply for an IDE as corrective action
3 - Dr. Hubbard's testing facility shutting down, as had been planned for awhile, according to Arlene Hubbard
4 - a patient who says that a well-known clinic is no longer taking insurance
5 - a gazillion news articles about the FDA warning about the risks of jugular venoplasty
6 - unknown if other researchers are affected

Definitely not a nonstory...
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Re: FDA Issues Warning on CCSVI

Postby muse » Thu May 17, 2012 7:32 am

Dr. William Maisel
Deputy Director, Center for Devices and Radiological Health, FDA

Dear Dr. Maisel,

We are writing to you regarding the alert that the FDA issued on May 10, 2012, on chronic cerebrospinal venous insufficiency or CCSVI. Like Health Canada, the FDA’s mandate is to ensure the safety of patients undergoing treatments or following drug therapy for medical conditions. The work that these two organizations perform in Canada and in the United States is essential to the health of the citizens of both countries.

Consequently, we were dismayed to read the CCSVI alert since it seems to be based on out-of-date information and a particular way of thinking that has led, in Canada, to a medical turf war between MS neurologists and vascular specialists with patients caught in the middle.

First, CCSVI is a vascular condition characterized by the stenosis of the veins responsible for draining blood from the brain. In December 2009, the International Union of Phlebology issued a consensus document confirming the view of this organization’s members, who are the world’s vein experts, that CCSVI lesions are truncular venous malformations and that CCSVI is congenital and preceding MS lesions ( HYPERLINK "http://csvi-ms.net/en/content/consensus-document-international-union-phlebology-iup-2009" http://csvi-ms.net/en/content/consensus ... y-iup-2009.

Second, the treatment for CCSVI is a treatment to correct venous malformations; it is not a treatment exclusively for Multiple Sclerosis and should not be characterized as such. Consequently, whether or not it is effective in relieving some of the symptoms of MS is irrelevant. Proper blood flow is essential to good health as we are sure you know. People who wish to be tested and treated for CCSVI should be encouraged to discuss the treatment with vascular specialists who can give expert advice and counsel based on experience and knowledge.

Third, some of the world’s leading vascular specialists (including those in the United States) have no doubt that CCSVI exists and have been treating patients for this condition since early 2010. Indeed, a prominent neurologist, Dr. Zivadinov, who heads one of the largest CCSVI research programme in the world in Buffalo, told an audience in Florida earlier this year – at the International Society for Neurovascular Disease – that there is no doubt that CCSVI exists and his research and the research of others prove it.

Fourth, it is unclear how many serious events – death and stroke – prompted the FDA’s alert. To date, over 30,000 treatments for CCSVI have been performed in 60 countries. We know of three deaths, one of which was the result of a brain aneurysm, one a result of follow-up care being denied in Canada, and one whose cause of death remains unknown at least to us. These deaths are tragic and we extend our heartfelt sympathies to the families of these people. We also extend our sympathies to the 232 people (88 in the United States) who have developed permanent brain infection linked to Tysabri and to the 49 who have died (data as of 5 April, 2012). Our sympathies also go to the families of the 11 people whose deaths have been linked to Gilenya. Tysabri and Gilenya, MS disease modifying drugs, have been approved by Health Canada and FDA and aside from “reviewing” these drugs and changing the label for Tysabri, no alert similar to the one just issued for CCSVI has been forthcoming regarding these drugs.

Fifth, the FDA alert does not acknowledge three safety studies that have been done on CCSVI treatment and that have been published in peer reviewed journals:
Endovascular treatment for chronic cerebrospinal venous insufficiency: is the procedure safe?
Ludyga, T. et al. Phlebology. 2010 Dec;25(6): 286-96

Safety profile of endovascular treatment for chronic cerebrospinal venous insufficiency in patients with multiple sclerosis.
Petrov, I. et al. J Endovasc Ther. 2011 Jun;18(3): 314-23

Safety of endovascular treatment of chronic cerebrospinal venous insufficiency: a report of 240 patients with multiple sclerosis.
Mandato, KD. et al. J. Vasc Interv Radiol. 2012 Jan;23(1): 55-9 Epub 2011 Nov 15

Together these three studies involved 1,261 people with CCSVI and MS and none of them found the major complications cited in the FDA alert.

Sixth, the criteria for diagnosing CCSVI using Doppler ultrasound has been well established by
Dr. Paolo Zamboni and conflicting results seem to materialize when researchers do not use the ultrasound techniques established by Dr. Zamboni. People who have been properly trained do not seem to have a problem detecting CCSVI. Obviously, some of the veins that are responsible for draining blood from the brain cannot be tested using ultrasound so a venogram is required to determine, for example, if the azygous vein in the chest is stenosed, but that poses less risk than an angiogram and both are performed every day in hospitals around the world. We could argue that a lumbar puncture to diagnose MS is far more dangerous than the diagnostic methods used to detect CCSVI (possible complications of a lumbar puncture include headache, intracranial bleeding, cardiac arrest, seizures, infection, and damage to the spinal cord or spinal nerve roots resulting in weakness or loss of sensation or even paraplegia - HYPERLINK "http://www.mult-sclerosis.org/news/May2000/ComplicationsofLumbarPunctureandTheirPrevention.html" http://www.mult-sclerosis.org/news/May2 ... ntion.html).

Seventh, while the cause of MS is not known it is clear that MS has a vascular component and an autoimmune component. Whether or not CCSVI causes MS is irrelevant, however, CCSVI is the only “explanation” that has been offered to date to explain why the autoimmune system is activated so that nerve damage occurs. The idea of a vascular component for MS is not new; a French anatomist first noticed in 1839 that plaque in the brains of people with MS occurs around the veins in the brain.

Finally, people with MS and healthcare professionals need to know as much as possible to make informed decisions. The FDA alert falls short of providing the balanced information that is required.

Linda Hume-Sastre
President, CCSVI Ontario (526 members)
Source: http://www.facebook.com/notes/ccsvi-ont ... 5723355005
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Re: FDA Issues Warning on CCSVI

Postby erinc14 » Thu May 17, 2012 7:36 am

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Re: FDA Issues Warning on CCSVI

Postby cheerleader » Mon May 21, 2012 7:10 pm

CCSVI Alliance is in dialogue with the FDA, and has issued the following statement--

https://www.facebook.com/notes/ccsvi-al ... 7036984663
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Re: FDA Issues Warning on CCSVI

Postby 1eye » Mon May 21, 2012 9:28 pm

As stated in the FDA alert, investigators of clinical trials involving “off-label” use of devices will need to obtain the FDA’s Investigational Device Exemption (IDE). If a device is not involved, FDA approval is not required (i.e. registries and/or diagnostic clinical trials). The FDA has oversight over device manufacturers and prohibits them from advertising any “off-label” use of devices. The FDA does not have the same jurisdiction over physicians. The general rule is that when physicians advertise their service, they must adequately and accurately describe the risks and benefits of a procedure in the advertisement. The FDA encourages patients to make informed decisions by being alerted to the risks and benefits of medical procedures and pharmaceutical drugs.
I'm no lawyer, but it sounds to me like a study could be done, of patient responses after the angioplasty has already occurred, in the context of treatment by a doctor, when they have been informed of the FDA's warning and of the risks. I would not think the doctor who provides data to subsequent studies would need an exemption.

This sounds like the definition of a retrospective study. Collecting data prior to these treatments would be expected, due to the requirement for baseline data before any treatment, to assess either positive or negative effects. I think this data could later be used, if angioplasty treatments were ever undertaken. Such data could be compared to similar data, collected after the treatment. I would expect the same could be done for CCSVI symptoms and observations.

I would not think a sham arm could be done without applying for required exemptions, as that kind of study would be prospective. I doubt it could be blinded or randomized either.
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Re: FDA Issues Warning on CCSVI

Postby Cece » Wed May 23, 2012 11:22 am

Since the FDA alert focused on safety unknowns about venoplasty, we should include the safety studies in this thread if they haven't already been posted:
1. U.S. Study - "Safety of endovascular treatment of chronic cerebrospinal venous insufficiency: a report of 240 patients with multiple sclerosis" published in the journal of Vascular Interventional Radiology - Pub Med reference http://www.ncbi.nlm.nih.gov/pubmed/22088659.
2. Polish Study - "Endovascular treatment for chronic cerebrospinal venous insufficiency: is the procedure safe?" published in the international review Phlebology - Pub Med reference http://www.ncbi.nlm.nih.gov/pubmed/21107001.
3. Bulgarian Study - "Safety profile of endovascular treatment for chronic cerebrospinal venous insufficiency in patients with multiple sclerosis." Published in the Journal of Endovascular Therapy, Pub Med reference - http://www.ncbi.nlm.nih.gov/pubmed/21679067.
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