Latest Annals of Neurology article on Dake & Stanford

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

Very Interesting Times

Postby Squeakycat » Sat Feb 27, 2010 12:08 am

Bob Dylan foresaw all of this in his song, "The Times They Are A-Changin'" Just substitute neurologist for mothers and fathers!

Come mothers and fathers
Throughout the land
And don’t criticize
What you can’t understand
Your sons and your daughters
Are beyond your command
Your old road is rapidly agin’.
Please get out of the new one if you can’t lend your hand
For the times they are a-changin’.


The Annals of Neurology editorial and forthcoming Kahn article show several things very clearly:

1. People who live OFF of MS have a very different perspective on CCSVI than people who live WITH MS.

2. Those with a stake in the existing system are naturally going to be very skeptical of anything new, without necessarily being evil, especially something that completely upsets the apple cart and in essence, makes everything they have been telling patients wrong. Some of these people have a financial stake in opposing and delaying CCSVI.

3. Completely absent from the Annals editorial and the Khan, et alia article, Chronic Cerebrospinal Venous Insufficiency and Multiple Sclerosis is any consideration of:

* The fact that time is brain. Risk is not an absolute. It is relative. There are certainly risks from angioplasty and stenting cranial veins. But these risk have to be weighed against the known costs of doing nothing, and the awful side effects of existing treatments. I'll see your Holly Shear and raise you 10 Tysabri deaths.. (Anyone hear Dunn, Khan et alia shouting that patients should be PROTECTED from Tysabri? Didn't think so because this is not about evidence-based medicine. It is about defending turf.)

If they want to live up to their professional standards, they should be advocating rapid, large scale testing of CCSVI and the funding and creation of treatment trials. That is not what they are doing and Dylan has some advice for them:

Don’t stand in the doorway
Don’t block up the hall
For he that gets hurt
Will be he who has stalled
There’s a battle outside and it is ragin’.
It’ll soon shake your windows and rattle your walls
For the times they are a-changin’.


* Existing treatments carry a very heavy price: 1) they don't stop MS, 2) they have damaging side effects. The evidence so far is that CCSVI is the opposite on both counts.

It is completely disingenuous to tout the need for years of research.

You have to blind at this point to think there is any reason not to be doing CCSVI testing on a large scale to fully understand the link between CCSVI and MS.

And there is just no reason for not advocating and promoting large scale CCSVI clinical trials of treatment.

There is an enormous amount of medical practice that is based on very small clinical studies, especially when it comes to surgical procedures.

Finally, if Larry Steinman doesn't understand why there are very different standards for a relatively benign procedure such as angioplasty compared with drugs such as Tysabri, I think someone should write a script for him for Tysabri or any of the other DMDs. I think he will be able to better understand that difference in about 6 months.

[Edited to correct the number of Tysabri deaths from 23 to 31 as of January 21, 2010.]

Edited again to correct the number of reported deaths--10, not cases of PML--31--from the February 5, 2010 FDA Safety Announcement and to drop the snide comments re: Larry Steinman and Tysabri in light of Marc's comments.
"Since July 2006 (when marketing resumed) through January 21, 2010, there have been 31 confirmed cases of PML worldwide in patients using Tysabri. Of these 31 case reports, 10 were from patients in the U.S. As of January 21, 2010, eight patients have died."
Last edited by Squeakycat on Sat Feb 27, 2010 7:37 am, edited 2 times in total.
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Postby Katie41 » Sat Feb 27, 2010 12:38 am

So well stated!
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Re: Very Interesting Times

Postby marcstck » Sat Feb 27, 2010 1:37 am

Squeakycat wrote:Finally, if Larry Steinman doesn't understand why there are very different standards for a relatively benign procedure such as angioplasty compared with drugs such as Tysabri, I think someone should write a script for him for Tysabri or any of the other DMDs. I think he will be able to better understand that difference in about 6 months.

[Edited to correct the number of Tysabri deaths from 23 to 31 as of January 21, 2010.]


Just wanted to point out that Larry Steinman was one of the inventors of Tysabri, who later loudly and publicly renounced its use as being too dangerous. He's not exactly a darling of the pharmaceutical companies.

He recently went public with the fact that he could not get any funding from Big Pharma for a trial of lisinopril, an off patent blood pressure medication, which he thinks might be effective in treating MS.

Very little in this world is black and white, and painting with too broad a brush often leads to obscuring important details...

And Tysabri deaths are now up to 35, BTW...
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Re: Latest Annals of Neurology article on Dake & Stanfor

Postby NHE » Sat Feb 27, 2010 1:59 am

jr5646 wrote:The Stanford neuro's may have stopped Dake from doing procedures, but not from talking/presenting his findings and consulting.. He is friends with Dr. Mehta in Albany, NY who is on track to begin testing / treating in March....


While it is good news that Dr. Dake is working with other doctors developing testing and treatment programs, it is my understanding from a post on this forum that Dr. Dake had a research article on his CCSVI stenting work accepted by a journal but a letter to the journal editor from the Stanford neuros stopped its publication. I cannot imagine the frustration that this has caused Dr. Dake. Science is all about presenting one's work and then debating it out in the open. All I can say is that governments have gone to war for much less.

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Postby euphoniaa » Sat Feb 27, 2010 6:07 am

While I agree with much of the sentiment expressed here, and every one of the MS meds scares the holy crap out of me, the most recent Tysabri report shows 35 cases of PML, and not deaths. The MSRC site that Squiffy posts from keeps a whole page of regular Tysabri updates, most recently this one:
http://www.msrc.co.uk/index.cfm?fuseact ... ageid=1905

Biogen Idec Inc. disclosed four more cases of a rare brain infection in multiple sclerosis patients on Tysabri, which it sells with Elan Corp., bringing the total number of cases to 35.

The number of deaths remains at eight with patients that have developed progressive multifocal leukoencephalopathy, or PML, according to the Cambridge, Mass., biotech company.


While I had always assumed that PML was so horrible & brain destructive that living with it was probably worse than dying from it, somewhere there was finally a report on the prognosis of those with PML whose lives were "saved." Can't find it right now, but I think it states that some even had major improvement. Not sure how that could have happened, but...
Last edited by euphoniaa on Sat Feb 27, 2010 4:07 pm, edited 1 time in total.
Dx'd with MS & HNPP (hereditary peripheral neuropathy) 7/03 but must have had MS for 30 yrs before that. I've never taken meds for MS except 1 yr experiment on LDN. (I found diet, exercise, sleep, humor, music help me the most.)
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Postby Lyon » Sat Feb 27, 2010 7:47 am

..
Last edited by Lyon on Mon Nov 21, 2011 6:15 pm, edited 1 time in total.
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Postby jr5646 » Sat Feb 27, 2010 8:09 am

Steinman "is" Pharma... and didn't he pair lisinopril with Bayhills BHT (MS) drug in a trial??

Bayhill Therapeutics, Inc. Founder Lawrence Steinman, M.D. Recognized for Leadership in Multiple Sclerosis
3/16/2009

SAN MATEO, Calif.--(BUSINESS WIRE)--Bayhill Therapeutics Inc., a clinical-stage biopharmaceutical company leveraging its proprietary BHT-DNA™ platform to develop novel and targeted autoimmune disease treatments, today announced that Lawrence Steinman M.D., Professor of Neurology, Pediatrics and Genetics at Stanford University and Founder, Director and Scientific Advisory Board Chairman of Bayhill Therapeutics, has been awarded an endowed chair at Stanford as the George A. Zimmerman Professor. Dr. Steinman is the inaugural holder of the chair, funded to support multiple sclerosis (MS) research. A member of Stanford’s faculty since 1980, Dr. Steinman has focused his 30-year career on translational and clinical research in MS.

http://www.biospace.com/news_story.aspx ... yId=130737

Dake presented his findings at Hamilton - so Stanford Neuro's cannot stop him from speaking... . I was under the impression that MD's were patient orientated anyway, so I'm hopeful that Dake is "more" frustrated with the fact that he can't help patients any longer and not so much that his work didn't get published... I'm sure "pure" scientist's would take a bridge if their work was not published, because that is all they have...
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Postby tazbo » Sat Feb 27, 2010 8:40 am

http://www.webmd.com/stroke/news/201002 ... ing-stroke
It will be nice when CCSVI gets into the hands of vascular mainstream.
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Postby Squeakycat » Sat Feb 27, 2010 8:47 am

Marc,

Thank you for pointing out the problem with my snide remarks about Dr. Steinman. Your knowledge of MS and your ability to share it are certainly real assets to the community!

Steinman would like to go directly to a human trial to test his proposal, but there are practical difficulties. "Who's going to pay for it?" he asked. A standard proof-of-concept study with about 200 patients would cost in the vicinity of $20 million. ACE inhibitors are as inexpensive as any prescription drug at this time, so pharmaceutical companies won't see any profits from financing a study, he said.

Steinman said he plans to apply to the U.S. National Institute of Neurological Disorders and Stroke for funding, but he acknowledges that "in general, NINDS doesn't have that kind of money."

http://news.healingwell.com/index.php?p=news1&id=630065


Dr. Steinman and those who would like to see CCSVI fully tested have something in common: The need for government/patient funded clinical trials.

This is not a new issue. Private insurance has no economic incentive to reduce the cost of treating people with MS. In fact, the economic incentives are the opposite because they more they have to spend, the greater their income from markups on that spending.

That's perverse to say the least, and sadly, the kind of key issue that appears to have been ignored in the political posturing that passes for discussion of reform of the health care system.

With four of the major MS drugs in the Top 100 list (#26 Copaxone, #56 Avonex, #69 Rebif, and #82 Betaseron), there is every incentive for pharmaceutical companies to spend money on pharmaceutical solutions which sadly leaves those who pay for health care (employers, government and patients) out in the cold when it comes to low cost pharmaceutical or non-pharmaceutical solutions to expensive health care problems.

Surely we can solve such a simple problem!

Just as fuel for thought, here are some ideas that I know have been batted around:

1. Direct patient funding. The reality is that there are some patients who can afford experimental treatments. Every reason to make them available in the context of formal clinical trials so that the knowledge gained benefits others.

2. Direct government funding. God only knows that we fund a lot of relatively useless things with our tax dollars. Why not fund efforts that will not only lower government funded health care costs, but generally help lower those costs?

3. Require private insurance to pay for participation in government-approved, cost-reduction clinical trials.

Again, surely we as a country are capable of figuring this out and doing something about it quickly.
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Re: Very Interesting Times

Postby Cece » Sat Feb 27, 2010 12:21 pm

Squeakycat wrote:* The fact that time is brain. Risk is not an absolute. It is relative. There are certainly risks from angioplasty and stenting cranial veins. But these risk have to be weighed against the known costs of doing nothing, and the awful side effects of existing treatments. I'll see your Holly Shear and raise you 10 Tysabri deaths..


This strikes me as very true (and sad)...as an MSer, risk is there no matter what you do.
"However, the truth in science ultimately emerges, although sometimes it takes a very long time," Arthur Silverstein, Autoimmunity: A History of the Early Struggle for Recognition
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Postby cheerleader » Sat Feb 27, 2010 2:27 pm

please, people. Let's not be so cruel and use Holly's name like that. She was a beautiful person...someone's daughter, lover, sister, friend. really, let's show some respect...
ugh
Husband dx RRMS 3/07
dx dual jugular vein stenosis (CCSVI) 4/09
http://ccsviinms.blogspot.com
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Postby rainer » Sat Feb 27, 2010 2:39 pm

my 2 cents: I agree with marc's assessment and found Embry's response to be overly defensive and paranoid. Also agree that using Holly in any argument is entirely distasteful.
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A fair article

Postby ScutFarkus » Sat Feb 27, 2010 2:54 pm

rainer wrote:my 2 cents: I agree with marc's assessment and found Embry's response to be overly defensive and paranoid.


Well said, and I agree as well.

I actually found the Annals of Neurology article to be pretty fair and positive. As much as I hope CCSVI pans out, the fact is that aggressive treatment is not currently supported by solid evidence. It's one thing for someone to gamble with their own health, and I have no problem with those who chose to roll the dice and sign up for balloon angioplasty or even stenting. But the job of those in the medical profession is to take a reasoned, science-based approach. Doctors are humans, too, which means some will make mistakes or let their feelings get the best of them, but overall, I believe a cautious approach to CCSVI is fully justified at this point in time.

/Scut
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Postby marcstck » Sat Feb 27, 2010 2:55 pm

euphoniaa wrote:While I agree with much of the sentiment expressed here, and every one of the MS meds scares the holy crap out of me, the most recent Tysabri report shows 35 cases of PML, and not deaths. .


Thanks for that correction, I mispoke (wrote)...
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Postby Loobie » Sat Feb 27, 2010 4:11 pm

marcstck wrote:Just a few quick points:

I thought the article was actually encouraging, as the CCSVI theory was not dismissed outright, but was treated as a viable hypothesis that needs to be fully researched.

...
+

This I agree with. They say many times in the article that rigorous testing, yada, yada, needs to be performed. And really wasn't all of our intent to GET this whole thing on the radar and get the bucks to get it pushed? I think those words are potentially the start of that. May be wrong, but it sure seemed encouraging to me on that front anyway.
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