This Is MS Multiple Sclerosis Knowledge & Support Community

I think that the journey is turning a full circle in some ways. The research that has been done to date has been driven by the almighty dollar. To often the research has been about modifying our disease and at the sacrifice of understanding its cause. Money can be made for ever if the cause is not found and understood. The money used in research needs to be directed by people wanting knowledge on cause not profits into the future.
It is sad that the work of so many learned and caring Dr's (BIG plug for our favourite Dr. S ) have been hamstrung by the lack of foresight of the research profession. MS Societies in particular need to be more proactive in getting the dollars driving the search to look for cause! This would enable the ability to measure the benefits of treatments such as CCSVI. At the moment there is no way to compare treatment against non treatment that will show benefit of any treatment in a true/ real/ measurable manor. This is especially true of the DMDs on the market now, you cannot prove benefit of any of them, as you cannot predict or map the disease we have. No two people have the same disease profile, or time profile, or disability profile, or quality of life profile, or disease history profile or any other profile?
There needs to be a BIG change in knowledge about our disease happening in parallel to the work of these brilliant crusaders who have made the stand to further our options.
I'll fall off my soap box now as my TN is killing me!
Enjoy your day.

Cece wrote:

drsclafani wrote:How does one measure improved tolerance to hot weather

Do a quick neurological exam, crank the heat in the room, wait twenty minutes, do the neurological exam again? Or have them do a crossword puzzle, stick them in a hot room for an hour, then do a crossword puzzle again? Hypothesis being that liberated patients would maintain their abilities to do the puzzle, measured in time and errors, while nonliberated would experience a drop-off in abilities.

For depression, there is the Beck Depression inventory.

I'd bet a neuropsychologist has a test for mental confusion.

Even small improvements could be enough to be statistically significant.

I have taken a basic 15 minute cognitive function test as a routine part of my neuro visit.

Like Cece says, there's ways to measure heat tolerance. Putting someone in a hot bath, then testing the reflexes or walking speed, etc., is a very old method.

eric593 wrote:Like Cece says, there's ways to measure heat tolerance. Putting someone in a hot bath, then testing the reflexes or walking speed, etc., is a very old method.

yup...I would fail that test or at least show a decline!

Wouldn't someone who has never taken any of the MS meds be the perfect choice for a control for CCSVI tests? A blank slate.....except for MS of course.

Dear Dr. Sclaffani,

Upon suggestion of member of this forum I am daring to ask you directly:

The more I look at my Doppler, the more suspicious it seems.

I know "they" looked and said it was normal, I still have some questions.

How come my Left Proximal Jugular looks of equal width along whatever distance the image was taken, but the other two images show distinct narrowing. I mean, if the widest part of my Left Distal Jugular image is 5.7mm, what does it make the "skinny" part? About 3mm?

All the while my Right Proximal Jugular is a whooping 22.5mm in the widest part, though looks much skinnier on the other side?

Or is this just the way they do imaging and I am not interpreting it right?

Equal:


Skinny part ~ 3mm?


The fat right one


Thank you in advance!

Dear Dr. Sclafani,

Thank you for your reply - and most especially your assurance that you and your team will figure out how to address compassionate therapies for these patients who cannot be included in the trial.

Please let me know in a "PM" if you are aware of any such studies already started or on the verge of being started - on how to help this group of patients with CCSVI? Any more information that you can provide me with for these patients would be very, very much appreciated. As you are well aware, time - sadly, is of the essence.

Again, I thank you so very much for all that you are doing, Dr. Sclafani.

God Bless You.
Someday...we will all be liberated.



Someday wrote:
Dear Dr. Sclafani,

Thank you for all the support and helpful information you have been providing to us MSers on this site. Your kindness and caring are very much appreciated.

I just read on your post that the IRB, (as part of their approval), has designed exclusions for your research. Anyone is excluded if they have a EDSS of 8.5 - 10.

Dr. Sclafani, what would you suggest the MSers who have a EDSS of 8.5 or higher should do to get the CCSVI testing and treatment - what other options do they have?

Please let me know what these MSers can do.

I look forward to your reply and thank you for any suggestions and guidance you can give me.

Take care and God Bless,
Someday


we were concerned that risks were higher and that it would be difficult to recognize changes so we excluded such patients.

interpret this to mean that such patients would not be included in the trial.

we will figure out how to address compassionate therapies in such patients

NZer1 wrote:
I think that the journey is turning a full circle in some ways. The money used in research needs to be directed by people wanting knowledge on cause not profits into the future.


It is sad that the work of so many learned and caring Dr's (BIG plug for our favourite Dr. S ) have been hamstrung by the lack of foresight of the research profession.


MS Societies in particular need to be more proactive in getting the dollars driving the search to look for cause!


At the moment there is no way to compare treatment against non treatment that will show benefit of any treatment in a true/ real/ measurable manor.

There needs to be a BIG change in knowledge about our disease happening in parallel to the work of these brilliant crusaders who have made the stand to further our options.


I'll fall off my soap box now as my TN is killing me!
Enjoy your day.

What really made me enjoy my day was the realization that I have started something bigger than myself. and that makes me bigger.

here I come into your forum just a few weeks ago with a fresh slate to listen to you because i dont know your disease and I want to understand what is troubling you, what is important to you.

You respond by learning from me as i learn from you.

I listen to complaints about researchers who do not pay attention to what you say, doctors who treat patients in a paternalistic way , and caring funding agencies that see statistics instead of statesmen and women. It is eyeopening, shocking, and humbling.

So yesterday and today we begin and continue a very meaningful discussion about how to design the studies that will give you the answers you want. Amazing!

To empower is so empowering.....thank you

thanks Dr S for explaining upthread ^^^ the open label safety study vs the randomized study.

I would include that post as a quote here, but I can't figure out how to include a quote of that size. You see, I am using my new iPad and it limits the reply size. Perhaps it could use some ballooning to stretch the box out a bit. Bad bad joke.....

Someday wrote:Thank you for your reply - and most especially your assurance that you and your team will figure out how to address compassionate therapies for these patients who cannot be included in the trial.

I think the IRB that's watching over Dr. Sclafani's study would have to grant an exception and allow compassionate treatment done by him, just not included in the study, for those who are at an 8.5 or higher. I hope if that's the case that they would.

drsclafani wrote:as i suggested to colleagues, we need a comparaitive intent to treat study. each diagnostic test would be described. each of several investigators would read the evaluation of the test and make a treatment plan based upon that imaging. Then the group would convene to look at all of the imaging and come to consensus of intent to treat. Then compare the results of each test by each proceduralist to the consensus.

Were your colleagues receptive?

NZer1 wrote:I think that the journey is turning a full circle in some ways. The research that has been done to date has been driven by the almighty dollar. To often the research has been about modifying our disease and at the sacrifice of understanding its cause. Money can be made for ever if the cause is not found and understood. The money used in research needs to be directed by people wanting knowledge on cause not profits into the future.

speaking of dollars, how about working that angle and getting some entities involved whose vested interests are on the other side of the equation from pharma and neuro?

insurance companies are paying out big bucks for MS drugs now, and we know from the co-pay coupon thing that they can be natural adversaries of pharma.

how about this for a study? instead of looking for incontrovertible evidence of CCSVI/MS linkage, let's do a massive, distributed study of the one thing we care most about (well, second-most).

take half the $25K/year/person now spent on MS drugs, and use it to pay for catheter venography for any MSer who signs up. the study would be about the need for MS drugs post-liberation, and participants would stand a 50% chance of getting a placebo of their current MS drug (i trust they make avonex placebos that give you flu-like symptoms?).

what fraction of MS patients would *not* sign up for this?

the study could be huge, with the issues being mainly of scale. 1) you have plenty of patients and can get really accurate stats. 2) you have to train a whole bunch of doctors and their technicians in diagnostic and treatment techniques. 3) you'd have to make sure re-stenosed patients get re-opened right away.

insurance companies should love this, and there would be a huge pool of pre- and post-liberation MS patients available for all kinds of neuro studies.

would dr sclafani be up for spending a lot of his time training other doctors?

drsclafani wrote:There needs to be a group that thinks it got the treatment but didnt to compare to the group that got the real deal.

The stumbling block, I think, is the invasiveness of the venogram. If it is established through the safety studies that a venogram is indicated for people with M.S., that might help.

I would propose a venogram for the control group and endovascular treatment for the treatment group. Waivers signed ahead of time should cover that there will be a control group and the possible dangers and benefits of a venogram. Benefits would include the imaging of their CCSVI, a necessary step in treating it, even if the treatment does not come right away because they're in the control group.

Then the control group should be told that you've found their stenosis during the venogram and are releasing a liquid onto it that will melt it away. There...gone. Venogram over.

It might seem from this forum that every person with MS is hugely informed about CCSVI, but that probably doesn't hold up out in the general MS population. Maybe you would need a questionnaire before you started your trial that would ascertain the level of knowledge the person had about the treatment of CCSVI. (If they know about ballooning, they don't get selected.) Also if there are any out there I would choose subjects who did not have internet in their homes over those who do, for obvious reasons.

I am still against a trial like this taking two years...six months seems more acceptable, but would results show in that amount of time?

What do you think? Ethical?

After all, we have been quite vocal about the fact that we are not treating MS.

Let's get that one out of the way first. You are so.

The test for efficacy: I think you should use something out of the variety of MS symptoms, and use that as an end point for this treatment. Something that most or many MS people have, like clonus or numbness. Admit to everyone and yourself that you are treating MS by treatment of veinous insufficiency, because you believe that much anecdotal, and significant experimental evidence is now available, enough to justify further experimentation. Be honest, because if you're only treating CCSVI, you'll have to limit yourself to things like pressure, flow, and diameter.

If you want a hint, I get twitchy, jumping legs when *they* (my legs) are physically hot. A hot blanket, a hot laptop, it doesn't take much. Bet I share this with quite a few.

For testing, why not just open your practice to first-come, first-served treatments, and make your control someone some way down the list. Test them before the treatment of the ones ahead of them in the list, so they can act as controls, and test them again before their treatment to see how they compare to the first test.

You don't even need to use the same people as controls all the way through, you can select another control and treat the previous one. As long as the number of controls (plus maybe sex and age) stays the same. I don't even think their MS status matters, but keep them all the same if you want.

Shouldn't you even be able to extrapolate or average them or something so time they spent as a control doesn't have to be fixed?

The controls can continue their existing medication or start a new one, just as long as it doesn't change after their randomization counterpart is treated. Or would that invalidate stats?

I don't think it should matter what other medication they are on, but if you want you could probably get a matched pair of those too. There are a lot of us who would probably sign up, especially, if it means they don't have to fly to Poland.

You have said yourself you are comfortable with the association having been established, haven't you?

As far as placebo goes, I am so happy this is being discussed. I really feel strongly about it myself, but there are probably others here, who are more qualified and/or have better ideas. All I have is unfortunate experience.

The written material on this topic (even the Cochrane studies used placebo as a control) has to meet scientific standards as strict as the ones we hold ourselves to, but it is starting to come out of the woodwork.

Thanks, everybody, for working on this problem. It's important.

Cece wrote:

Someday wrote:Thank you for your reply - and most especially your assurance that you and your team will figure out how to address compassionate therapies for these patients who cannot be included in the trial.

I think the IRB that's watching over Dr. Sclafani's study would have to grant an exception and allow compassionate treatment done by him, just not included in the study, for those who are at an 8.5 or higher. I hope if that's the case that they would.

Cece, I also really hope and pray that they would grant an exception and allow compassionate treatment done on these patients.

Take care and God Bless,
Someday

We could always ask the likes of Dr. Freedman and his collegues how they would design such a study.
There would be two outcomes, one that they would realise they have been using us MSers as a cash cow and not doing anything to understand our disease process.Second it would give them something productive to do instead of throwing rocks from a distance, they seem to also be able to extract research dollars for fly by night causes that they could put to good use for us!