Tuesday, February 16, 2010

CCSVI- What to make of the BNAC press release.

In my previous posts I predicted that last week’s release of the preliminary BNAC results could confirm Zamboni’s work, could disprove Zamboni’s work, or could fall somewhere in between. As the day of Dr. Zivadinov's announcement (BNAC direcctor, picture to the right) drew nearer, the unofficial “buzz” was that the results would strongly support Zamboni’s theory of CCSVI. My head kept my heart at bay though.  I didn’t get caught up in the buzz. Then, just a few days prior to the announcement, BNAC released a newsletter. Nowhere in the newsletter did they make any promises, but the text was sprinkled with statements like:
"We believe our CCSVI studies testing Dr. Paolo Zamboni’s controversial CCSVI theory will result in groundbreaking discoveries in the field of MS."
    And…
"I speak for the entire BNAC-JNI research team and Dr. Bianca Weinstock-Guttman to let you know that this particular research is having an impact like no other we have known."
This time I bought into the hype. I allowed my heart to seduce my usually scientific mind. In fact, because I wanted to be one of the first bloggers to comment on the significance of the findings, I got up early on the morning of the press release day and drafted perhaps the most inspirational piece I’d ever written.  I never published it, because the press release didn't shape up as expected.  I'm ashamed that I allowed my emotions to cloud my objectivity.  I suffered from temporary irrational exuberance. 

Instead of minimizing expectations ahead of an announcement, BNAC had inflated expectations- a classic public relations error.  The results were, by most accounts, mixed. This was the sort of announcement that any individual could spin to support their personal view of CCSVI. Here’s a sampling of what people wrote after the BNAC press release:

From the “this makes it more unlikely that Zamboni was right” camp:
"The whole notion of cause and effect is out the window," Dr. Mark Freedman, an Ottawa Hospital neurologist and leading MS researcher. As quoted by the National Post.
"There is not a shred of real evidence anywhere that messing around with these veins does anything to help MS patients," said Dr. Paul O'Connor, a neurologist at Toronto's St. Michael's Hospital, again in a National Post article.
Note to readers:  I include these two quotes not because I consider them to have merit, but rather to illustrate that there are vocal detractors to CCSVI theory, and that their statements are being carried regularly by the National Post.  These are quotes of the "negative sound bite" variety, and are not particularly helpful to advancing the debate.   

From the “this makes it more likely that Zamboni was right” camp:
“…what was reported in the Canadian Press was that, while the incidence of CCSVI in ALL MS patients was 55% (as the BNAC press release said), Zivadinov indicated that it was 80% in Clinically Diagnosed MSers….while the incidence of CCSVI MAY be 55% (or 65%, depending how you count it) for some sort of broadly defined category of MSer (and we don't know how that was defined) it is 80% for people who have been clinically diagnosed.” From a post at thisisms.com.
“Multiple sclerosis researchers have made an important breakthrough sparking hope of a cure for the disease.”- Sky News
And from the “we can’t read too much from this announcement” camp:
“The trial results released today by the University at Buffalo fall more in line with what would be expected of an MS breakthrough given science's current body of knowledge regarding the disease. While not the eye-popping numbers reported in the previous studies, the 2:1 ratio of CCSVI found in MS patients when compared to healthy subjects is still dramatic and exciting, and should give curious researchers much reason for continued and vigorous investigation of the theory.” WheelchairKamikaze.com
“I believe that the preliminary findings of Dr. Zivadinov and his colleagues in Buffalo are significant and support a link between MS and CCSVI. However, their early data are not as robust as Dr. Zamboni’s and their study raises many new questions.” Dr. Lorne Brandes at The Multiple Sclerosis Resource Centre.
“Over the coming months, much intense research will be underway attempting to answer the many questions surrounding CCSVI. This report out of the University of Buffalo is only the first of many to come, and it would be a mistake to draw anything but preliminary conclusions from it.” WheelchairKamikaze.com
So what is this blogger’s humble opinion? As much as I had hoped these results would solidify the concept that CCSVI is a major cause of MS, the information released so far from BNAC does not do this. And as much as I feared that there might be no researchers, other than Zamboni, who could show a relationship between CCSVI and MS, this is not the case either.

It is so very tempting to draw long awaited conclusions from this press release, one way or another, but there simply isn’t enough here to work with. The suspense is killing me, but we’ll need to wait a while longer before the whole picture comes into focus.  We need more information about this study, which should be available in April, and we need more studies, which are in the planning and funding stages now. 

I remain optimistic that one day CCSVI can be proven as a major cause of MS.  I’m grateful for all of the researchers and physicians around the world who are studying the relationship between CCSVI and MS.  I’m equally grateful for members of the MS patient community who are doing so much to advance the cause of CCSVI research- too many names to mention here.  You know who you are. 

Time, however, is not on my side. I can’t wait for the picture to become clear before taking action. I’m working my tail off to find a doctor who will diagnose, and if blockages are found, then treat me for CCSVI. Given the speed at which my MS is progressing, patience puts me at more risk than taking early action does.  CCSVI remains my best chance to halt the progression of this disease before it completely consumes me.

15 comments:

Anonymous said...

Great posts. Here is a conspiracy theory for you with a bit of hope atached. If things are black or white, scenarios 1-3 in your last post would there be any money in these outcomes? If we are kept in a bit of grey area, could this lead to a substancial amount of money for research and study of ccsvi. Just some food for thought

Randall Doser said...

As I understand it, the first BNAC study used ONLY doppler ultrasound on the IJV's (not the azygos). This procedure requires a high degree of skill and cannot detect all venous abnormalities. You can read the Interventional Radiology literature and it will recommend MR venography for the diagnosis of venous malformations. Doppler is simply cheaper for a first-line study of this type with limited funding. Add to that, that in the medical field, a prevalence of over 50% is highly significant. If you can, get hold of Dr. Dake's power-point presentation at the St. Joe's workshop in Hamilton. He and Dr. Simka in Poland along with others have found rates of venous malformations that are similar to Zamboni's.

Peace Be With You said...

Thank you once aqain for helping us put CCSVI into perspective. I too felt deflated but there are more news to come, I am sure. I wish we all had the luxury of abundant time to wait and see.
Judy

Enjoying the Ride said...

Anonymous,

I'm not big on conspiracy theories myself, but I can understand why you would pose the question...

Randall,

You are correct with all of your points. But the medical community, and just as importantly the insurance companies, won't accept CCSVI until the points you make are taken into acccount in a clinical trial setting. So, I have some confidence we'll get there, but there is just so much work remaining. Don't you think so?

Judy,

I think there are two tracks we have to consider. We need to advocate for proper studies through proper channels, while at the same time seeking out compassionate doctors who will help us get better now.

Anonymous said...

National Post is in famous media war w/ CTV which got the scoop. Even their negative articles admit CCSVI is worth investigating aggressively. BNAC did offer lower expectations, their data actually suggests 80% correlation. dig deeper. keep watching.

Anonymous said...

All due respect, I don't think you should use the publicity photo from the BNAC study to illustrate your opinion. It confuses newbies.

Randall Doser said...

ETR,
Of course there is more work to be done. I just felt like you were being a little "glass is half empty" that's all. Plus I cannot believe you quoted from that quack, Dr. Freedman. The man should be censured by the medical board for his bombastic and unprofessional rhetoric. He probably still believes peptic ulcers are caused by stress. CCSVI will be proved right. Placebo effects do not last two years from treatment, especially when it involves a degenerative disease like MS.

Enjoying the Ride said...

Thanks to all of those who have commented. This is such a complex subject.

Anonymous,

In the press release referred to in the title of this post:

http://www.buffalo.edu/news/10937

Zivadinov presents numbers of 55% or 62% of MS patients showing CCSVI. These are important numbers, when compared to the 26% of healthy controls showing CCSVI. But these numbers frankly do not blow me away. They don’t prove what I had hoped they would prove.

Later in the same day Zivadinov apparently told a Canadian media outlet that if you consider only the data from people with Clinically Definite Multiple Sclerosis, as opposed to including people with Clinically Isolated Syndrome, a precursor of MS in many people, then the correlation is all the way up to 80%. Here is that piece:

http://www.google.com/hostednews/canadianpress/article/ALeqM5h9fFcp3BUaMrK7YnuZlWEAgfVkvw

BNAC does incredible scientific work, but their communications are inconsistent. Perhaps we will get the entire picture when Zivadinov presents this data to the American Academy of Neurology in April. In my mind there is a huge difference between about 60% and about 80%.

If their data “suggests” 80%, I wish they had just come out and said this in their press release.

Anonymous (2),

Sorry. I don’t understand what you mean by Zivadinov’s photo confusing newbies.

Randall,

I probably do come off as glass half empty in this post, to some readers. That was not my intention though. I was attempting to come off as “CCSVI is still viable, but the press release from BNAC will not change many minds. More work will be required.” Crap, I could have saved 800 words if I had just said that :-)

I wanted to include the Freedman quote to illustrate that there are some vocal detractors out there. But I see your point. I’ve added some commentary so that readers understand my thoughts, and yours I think, about these quotes.

weeble said...

As far as Freedman's comments are concerned I believe it is probably a combination of real doubt, ego, and possibly politics. As little as two short years ago, Freedman was "the man" doing autologous stem cell transplants on MS patients in Ottawa. People were clamoring to see him. His method was conceded as having greater risk than benefit. I don't believe there doing any of it at all. He was a very forward thinker and spent years developing this stem cell program, based on MS being an autoimmune disorder. Maybe this is too hard for him to accept right away. I'm not excusing him. Just trying to understand him.

My point is that when you're working in the forefront of medicine, you can go from Hero to Zero very quickly. Right now I see Zamboni walking the line between Nobel Laureate and Quack. I'm sure hoping he lands on the Nobel side.

As for the BNAC including CIS in the MS control, I am baffled. Why muddy the waters? I think such a preliminary study should have been between people assumed clearly Healthy and Dx'd with MS. Should CCXVI be proven correct, CIS would be an incredible group to investigate. This is where MS could be prevented all together. I'm getting ahead of myself now.

Keep up the good information sources Mitch.

Enjoying the Ride said...

Weeble,

Thanks for stopping by. Freedman's behavior certainly is perplexing. Zamboni's reputation is indeed at stake here, and like you, I'm rooting for him.

I think BNAC is the real key to CCSVI research right now, but they do some odd things, and that has me a little worried.

Debbie said...

I see that you live in Maine. I was just at Johns Hopkins in Baltimore, MD yesterday. My Neuro said that the jury is still out on it but it looks like Hopkins might be doing a study on it soon. Not to place a stent but to take a look and see what the blood flow is actually doing. It might be worth contacting them. I found you through Herrad and I have just started a new blog. MS and Me : My Story I would love it if you would add me to your blog roll. Debbie

Debbie said...

p.s. After rereading the last paragraph of your post I thought I would add this. My neuro did say that there were some in CA (sorry I don't know where) that were putting stents in. However he also said that they have had problems with one of them ending up in the heart and one in the brain.

Anonymous said...

Very well written. Even someone who is not familiar with MS (like me) can understand without being filled with medical mumbo jumbo. Great read! Jen

Anonymous said...

hey...clicking twice worked :-) Jen...again

Enjoying the Ride said...

Debbie,

Thanks for stopping by and introducing yourself, and thanks for the tip on Johns Hopkins. I checked out your blog- very nice. Welcome to the blogging world. I encourage my readers to drop by and check it out. I've added you to my blog roll: MS and Me: My Story

The California situation that your neurologist referred to is Dr. Michael Dake at Stanford University. They did have the complication you describe, and as a result Dr. Dake has temporarily suspended his procedures. Stanford is working on a clinical trial in the future though.

Jen,

Glad you liked the post. I don't know why it is sometimes so hard for folks to leave a comment at these google sites, but you've got a workaround at least.