McGuckin disciplined in TX for CCSVI procedures

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Cece
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McGuckin disciplined in TX for CCSVI procedures

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http://www.yourhoustonnews.com/memorial ... 1a460.html
McGuckin, James Frederick, Jr., M.D., Lic. No. N1760, Philadelphia, PA

On June 10, 2016, the Board and James Frederick McGuckin, Jr., M.D., entered into an Agreed Order requiring Dr. McGuckin to comply with all terms as required by the Agreed Order issued by the Washington Medical Quality Assurance Commission. Dr. McGuckin shall not perform angioplasty and stenting procedures of the venous system for chronic cerebrospinal venous insufficiency (CCSVI) procedures or multiple sclerosis patients in the state of Texas. The Board found Dr. McGuckin entered into an Agreed Order with the Washington Medical Quality Assurance Commission which was based on the determination that Dr. McGuckin performed CCSVI procedures on patients without ensuring Bio-Med IRB obtained an approved Investigation Device Exemption (IDE) from the Food and Drug Administration.
Is that a legit cause for disciplining? His IRB didn't obtain an IDE from the FDA. Is an IDE even needed for an angioplasty procedure? Or was the issue the stenting? Are any of the other CCSVI docs in danger of getting a disciplinary action from their state medical boards? This is upsetting.
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ThisIsMA
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Re: McGuckin disciplined in TX for CCSVI procedures

Post by ThisIsMA »

Hi CeCe,

Wow, I'm so sad to hear that about Dr. McGuckin's run-in with Texas. I wonder what the backstory is.

Also I wonder if there is a typo in the quote:
shall not perform angioplasty and stenting procedures of the venous system for chronic cerebrospinal venous insufficiency (CCSVI) procedures or multiple sclerosis patients in the state of Texas.
Was the word "OR" supposed to be the word "ON"? It seems like the word "ON" makes more sense in the sentence. On the other hand, isn't it also really odd that they specified a specific patient group that he can't work on? Does that mean that he can do angioplasty and stenting on the venous systems of people with other diagnoses (or no diagnosis) as long as its not CCSVI? Like what about the procedure Dr. Arata does (stimulating the vagus nerve). It sounds like its o.k. for him to do that procedure in Texas as long as he's not doing it on people with MS. Maybe some MS'ers should sue Texas for discrimination based on disability status! :smile:

Actually, its kind of like a ghost town around here lately. Makes me very sad. I remember so fondly back when it seemed like new discoveries and reports of recoveries were happening almost daily.

Wasn't there recently the annual conference of the group that Dr. Sclafani cofounded? I have not heard any reports on how that went. Anyway, I'm just checking in to say that I do still stop by to read this board from time to time. And I hope that the "powers that be" have not permanently squelched the potential of CCSVI to help people with MS. :sad:

Having said all that, now I'd better go back to the list of posts and see if I missed any...
DX 6-09 RRMS, now SPMS
Cece
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Re: McGuckin disciplined in TX for CCSVI procedures

Post by Cece »

Dr. McGuckin shall not perform angioplasty and stenting procedures of the venous system for chronic cerebrospinal venous insufficiency (CCSVI) procedures or [treat] multiple sclerosis patients in the state of Texas.
Yeah, if the "or" isn't meant to be "on," then maybe they left out a word. I added "treat" which could also help make the sentence make sense. Regardless, what the heck. Why can't a doctor open a closed blood vessel? That is what angioplasty is for.

edited to add: if you take out this part (chronic cerebrospinal venous insufficiencey CCSVI procedures or), then the sentence is: "Dr. McGuckin shall not perform angioplasty and stenting procedures of the venous system for ... multiple sclerosis patients in the state of Texas" then that works too. Awkward phrasing but the intent is clear unfortunately.

Yes, it is quiet. CCSVI Facebook is my main source of info but I like the format here since it allows for discussions. ISNVD happened a few months ago! You're right, I don't think we've parsed everything presented there.

Here's a slideshow from Dr. McGuckin on CCSVI, not sure when this is from:
http://slideplayer.com/slide/3556076/

I like what he says, briefly, about medicine changing and evolving. And of course the improvements reported: patients who walked, a patient who spoke again, a patient who got to leave the nursing home and go home. He also shows a venogram of a Budd-Chiari patient (accepted condition) and a CCSVI patient and compares the similar look of the dilated vein with collateral vessels. "Venous narrowing look the same regardless of location."
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Re: McGuckin disciplined in TX for CCSVI procedures

Post by 1eye »

I think if you have MS you'd better not live in Texas. The FDA should be dissolved.

Dr. Zamboni's talk is fascinating. https://www.youtube.com/watch?v=7o2c2gkjV4c By the time the world catches up to him I am afraid we shall all have passed on. He is adamant that CCSVI is very prevalent in MS. His work on microgravity's effect on venous return is invaluable to NASA, showing that astronauts suffer something similar to CCSVI. His new method using film/video and graphing to objectively and quantitatively measure pulsatile changes in pressure and venous flow under both 1G and microgravity can be used to diagnose CCSVI, and to detect the anomalous condition where there is no jugular flow in any posture.

A lot of drug vendors and neurology practitioners are justifiably scared for their gravy trains. No sympathy for them will be found in anything I write. They, the FDA, research grant recipients, and particular media people have consistently shown bias, willingness to lie and defame, dereliction of their responsibilities and their morality, for purposes of personal gain. There are a few notable exceptions.

I think Dr. Zamboni might agree with CureIous that jugular cross-section is an ephemeral thing and changes wildly. And it ain't circular.

Brave Dreams: has anybody heard anything?
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Cece
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Re: McGuckin disciplined in TX for CCSVI procedures

Post by Cece »

1eye wrote:I think Dr. Zamboni might agree with CureIous that jugular cross-section is an ephemeral thing and changes wildly. And it ain't circular.
Review Article
Why Current Doppler Ultrasound Methodology Is Inaccurate in Assessing Cerebral Venous Return: The Alternative of the Ultrasonic Jugular Venous Pulse

Paolo Zamboni
Vascular Diseases Center, University of Ferrara, Via Aldo Moro 8, Cona, 44124 Ferrara, Italy

Received 19 October 2015; Revised 24 December 2015; Accepted 1 February 2016


Abstract

Assessment of cerebral venous return is growing interest for potential application in clinical practice. Doppler ultrasound (DUS) was used as a screening tool. However, three meta-analyses of qualitative DUS protocol demonstrate a big heterogeneity among studies. In an attempt to improve accuracy, several authors alternatively measured the flow rate, based on the product of the time average velocity with the cross-sectional area (CSA). However, also the quantification protocols lacked of the necessary accuracy. The reasons are as follows: (a) automatic measurement of the CSA assimilates the jugular to a circle, while it is elliptical; (b) the use of just a single CSA value in a pulsatile vessel is inaccurate; (c) time average velocity assessment can be applied only in laminar flow. Finally, the tutorial describes alternative ultrasound calculation of flow based on the Womersley method, which takes into account the variation of the jugular CSA overtime. In the near future, it will be possible to synchronize the electrocardiogram with the brain inflow (carotid distension wave) and with the outflow (jugular venous pulse) in order to nicely have a noninvasive ultrasound picture of the brain-heart axis. US jugular venous pulse may have potential use in neurovascular, neurocognitive, neurosensorial, and neurodegenerative disorders.
http://www.hindawi.com/journals/bn/2016/7082856/abs/

Yes, that was the impression I got from the abstract of this 2016 paper from Dr. Zamboni. Thanks for the link to the talk.

If you have MS, you'd better not live in Texas because of the heat alone! But yes, I agree.
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Re: McGuckin disciplined in TX for CCSVI procedures

Post by lorimayb »

I just have a comment about the "quietness" regarding CCSVI. There are 3 clinical treatment trials close to completion in Australia, Italy, and Canada. My correspondence from the Health Minister of Canada indicates she will not address the issue until she receives the results of the Canadian trial. There have been numerous time-frame estimates that keep getting pushed further into the future. Because of the "alert" from the FDA in May, 2012, there are fewer convenient places to obtain treatment, since it is too expensive for facilities to do a clinical trial as insisted upon by the FDA, especially without pharmaceutical sponsorship. I can't blame anybody for not wanting to talk about it too much when there are so many negative trolls on the internet (I speak from experience). It's been over 5 years since my treatment--no stents and all improvements holding! I highly commend Dr. McGuckin for his compassion. The medical politics of this reprimand in Texas is disgusting and I suspect has something to do with the loudly outspoken anti-CCSVI Canadian neurologist, a member of a Texas pharmaceutical company's scientific advisory board, who doesn't want any minimally-invasive competition with risky stem cell treatments.

It may be quiet but it's not over!
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Re: McGuckin disciplined in TX for CCSVI procedures

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lorimayb wrote:=The medical politics of this reprimand in Texas is disgusting and I suspect has something to do with the loudly outspoken anti-CCSVI Canadian neurologist, a member of a Texas pharmaceutical company's scientific advisory board, who doesn't want any minimally-invasive competition with risky stem cell treatments.

It may be quiet but it's not over!
I do not wish to say anything negative about the patients, for whom recovery from MS (and recovery from the treatment) are indeed miraculous.

Risky stem cell treatments: yes, he had one fatality, and if we are playing that game, stent treatment had one too. Once the first ball is thrown out, one might count the poor soul who died because he couldn't get treatment, in of all places, Canada! The problem is, Canadian health practitioners are afraid of the loudly outspoken, and his paid legal help. They are very afraid. Afraid enough to refuse treatment, and let somebody die.

I think it's about time some young person told the media audience this emperor has no clothes on. Why, he even went after Dr. Zamboni when he was interviewed about the Lancet article on him. The [sic] anti-CCSVI forces have declared victory, that ding-dong the witch is dead, when they have proved nothing. To nobody. It's not Lewis-Carollean, it's Kafkaesque. That a whole population of disease sufferers numbering in the millions could be berated to death by a supposedly helping professional makes dytopian nightmares like the Trump candidacy look like Santa's sleigh-ride.
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Re: McGuckin disciplined in TX for CCSVI procedures

Post by 1eye »

It seems there is a concerted effort to discredit anything that comes close to theorizing a relation between internal jugular vein incompetence or reflux and problems such as exertional and other headaches, or transient global amnesia. Negative results are the norm.

However methods of assessing jugular vein and jugular vein valve incompetence and insufficiency are not using anything like the methodologies used in Dr. Zamboni's experiments for NASA, or explained in his papers. The problems discussed include the pulsatility, shape, and changeability of these veins.

My feeling is that there have been too many unnecessary studies, and that it has become fashionable to deny any role for the jugular in human health. It seems the belief is that if we don't use it for anything, nothing can go wrong with it, and vice versa. Rather than argue over the accuracy of these studies, perhaps treatments aimed at helping the venous circulation, such as massage and diet changes, will mean a problem will be actually closer to being solved.
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