Compassionate Treatment

radeck · Post by **radeck** » Sun Oct 18, 2009 3:12 pm

The compassionate treatment idea would be an interesting idea to pursue for secondary progressive patients, for whom there are no FDA approved drugs.

I feel it would be important however to make sure that the diagnostics would be clearly defined and controlled, and the methods used to treat potential vascular issues would have been demonstrated to be safe.

CureIous · Post by **CureIous** » Sun Oct 18, 2009 3:33 pm

mrhodes40 wrote: the idea that progressed persons at the end of the rope might have to wait makes me ill.

this is already about 2 decades late.......

Amen. If this was just a "take the medicine and run" kind of thing I'd be gone already, but there are so many out there and so many angles to touch on here, patients/doctors/institutions, that I think the grassroots walking hand in hand with some media "splash", and some name dropping (say "Stanford"), just to get ears to perk up, will do more at this point than anything, in fact HAS done more or few of us would be here on this board talking about it. My heart is truly with the people that don't have time to wait, or are just one more relapse away from things that are permanent in nature. Aint no laurels around here to sit on, somebody put thumb tacks on all the seats!

Great thread btw I gotta go read it thru again. Simply brilliant.

Mark.

mrhodes40 · Post by **mrhodes40** » Sun Oct 18, 2009 4:52 pm

You seem to be expressing a different argument, or I don't understand the problem. Originally, you were expressing concern that the FDA might ban CCSVI treatment, without proper trials having been completed. Now, it's about big pharmaceutical companies squashing the treatment.

you are right I was talking about lobbying the FDA for a designation that this was available for compassionate use as a way to lobby for treatment to get essentially a "go ahead" for individual doctors, then switched to a possible way that pressure could be brought directly on the school to stop treatment of people off label for an unproven treatment. I believe no such pressure could be brought if CCSVI treatment were allowed for compassionate treatment.

I don't know what record Dr. Kerr used to mention compassionate treatment, but it doesn't really matter. Revimmune is not a new drug; it was alrady approved as a chemotherapy treatment. There were no phase 2 trials, and if you think Hopkins had an easy time getting it installed as a treatment, since it supports the autoimmune model and wouldn't draw anyone's ire, you should re-read this:

http://www.hopkinsmedicine.org/hmn/W08/feature1.cfm

I am aware that revimmune had difficulty getting going. My observation is that no one is going to report JH to the FDA for treating people for compassionate purposes with that approach. Chris repeatedly said he was in the stage 2 trial.

With all of these proposed future conspiracy theories, this forum has gotten a little too strange. Of course, if people are that afraid of big phramas, one way to limit their revenue and possible influence would be to boycott their drugs

Sorry for seeming strange......

sou · Post by **sou** » Mon Oct 19, 2009 12:24 am

Hi.

Like I have said in the past, I think that methods do not have to undergo the same trials that drugs have to do. Let's say, something 100% unrelated to MS pathology: I have broken my arm! Shouldn't I treat it with the standard treatment for it? Or should I wait for a trial called "Broken Arm TReatment In MS (BATRIMS)" to finish and stay on my MS meds till then?

Isn't a broken arm unrelated to MS pathology? Obviously, yes. But has it been proven unrelated? Nope... Is treating it a compassionate action? Would the MS meds make it heal?

We are not treating MS. We are treating anomalous blood flow with the standard treatments for it, established during the 80s and 90s. Regardless their effectiveness, the MS drugs are only for our MS and not for any other "unrelated" condition.

If treating broken arms with established methods was found that it might benefit the MS course, would that mean that everybody that breaks one should leave it broken till the trials are over?

The most reasonable approach would be CCSVI treatment as if it were 100% unrelated to MS and continuation of the MS drugs. Nobody can force a patient to take his/her drug but nobody can prevent a patient to seek help for any other problem he may have, like anomalous blood flow.

My 2 cents. This story has made me really angry!

sou

whyRwehere · Post by **whyRwehere** » Mon Oct 19, 2009 12:41 am

Yah what Sou said, and by the way what good English you have!

ErikaSlovakia · Post by **ErikaSlovakia** » Mon Oct 19, 2009 12:47 am

Hi Sou!
I agree with you.
I have not even told my neurologist so far. She has nothing to do with my broken arm.
Erika

radeck · Post by **radeck** » Mon Oct 19, 2009 5:55 am

double post - removed

patientx · Post by **patientx** » Mon Oct 19, 2009 6:06 am

mrhodes40 wrote:Sorry for seeming strange......

Marie,

Given your contributions to this board, I don't think you have to apologize to anyone, let alone me (though I realize this was probably, at least in part, sarcastic).

I just don't understand why people are getting spun up about the drug companies and the FDA using their influence and power to deny people surgery, when there's nothing to indicate that this will happen. I would think the bigger problem would be finding doctors willing to perform the surgery at this early stage of CCSVI investigation, like Dr. Dake has been willing to do - and you can't force a doctor to perform surgery he doesn't want to perform.

Arcee · Post by **Arcee** » Mon Oct 19, 2009 6:50 am

One thing that we can do something about now is to continue outreach efforts to appropriate doctors. It's kind of like any good marketing campaign: target the right people, increase their awareness, figure out how to get them to consider, and then encourage them to select.

Obviously there are barriers to physicians being willing to partake, but as Michelle pointed out, the North East outreach is humming along. Not clear yet what will motivate people - - curiosity, the ability to be a part of something potentially huge and enormously helpful, ego, a personal connection, financial gain for their hospital. Most likely a combo of different things for different people. But we won't really know until we get enough data of our own.

Daisyduck · Post by **Daisyduck** » Mon Oct 19, 2009 9:56 am

Sou: I agree with your throught-provoking, interesting and realistic view point. I have said to all of us in this forum to please, at least for the time being, let's not "marry" CCSVI and MS on this forum if just awhile longer. I so want to see treatment for as many CCSVI sufferers as possible so let's let the CCSVI treatment protocol grow (alone). Before that who had ever heard of stent being used in veins? When I tell my friends I have four venous stents they assume I have a heart condition and am taking Coumadin every day! This will still take awhile, I mean, to prove up that CCSVI and MS may be cause and effect, whichever comes first. I agree it's past high time that we have interested people working on our side, and it's funny that those interested people are not out of neurology. People that go untreated right now break my heart, and I wanted to respond at this time to the question of SP MS which I now have --no more RR for me -- but that I benefited quite a bit, and that Dr. D was very happy with my progress. The first six weeks at home after surgery I thought that I had not gotten all that much out of it. BUT that is not true. I had been under my own personal misconceptions that the loss of mobility and stiffness in the legs was all neurologic, and when we saw Dr. D the second time he and I discussed that. He said he thought that many of my problems in my legs and back would improve with an exercise program. I now am in PT, doing so much better and plan to look for a trainer after my 12 appointsment are over. So there is hope for us, kids. Now this is just me, and I know some people on this panel disagree (and that's o.k.), but this is how I see the problem:
As many people as possible should get treatment for CCSVI NOW or asap.
We all know the risks, and some of us will be getting better benefits than others. Alongside the treatment (under FDA compassionate rules conditions?), there should be independent studies run as in Buffalo, for instance. But we also need to look at this thing with "political eyes," as in how will this treatment best survive for the benefit of all? What interests would want to quash it? How can we help Dr. D and Stanford as they stuck their necks out for us? How can we ourselves best live up to the promise of the treatment we received? The answer is the only answer I know: by feeling as good as possible even if it takes some work BY OURSELVES. So let's do it, let's feel good. Daisyduck

radeck · Post by **radeck** » Mon Oct 19, 2009 2:52 pm

Following up on DaisyDuck, I strongly believe that one of the most effective ways for us to raise the interest of other physicians who would be able to do diagnose CCSVI or do the liberation procedure would be FOR THOSE WHO HAVE BEEN DIAGNOSED WITH OR RECEIVED A CCSVI PROCEDURE TO POST ON THE TRACKING THREAD. Right now there are 6 posts, by the most active forum members, who posted within a week but there haven't been any new additions since then. So it seems like this is stagnating. How would a physician make up his mind about this if there is an unpublished paper rumored by Zamboni and 6 anecdotal accounts? There have been over 200 liberation procedures altogether in Italy, USA, and UK. We have 30 people here on TIMS who had their treatment from Dake. There are NO Italian contributors for some odd reason (maybe they're not allowed to talk about their experiences? However GiCi is. Maybe they don't read/write english?).

So if I were a physician I would look at the 6 posts from the outside as perhaps showing a strong bias: the small number of patients who posted are doing relatively well, while those who don't post are doing bad since the procedure and don't want to bring it up. It would be good to have experiences especially from early RRMS patients, since these tend to have the quickest turnaround time for good results. That said, after this pledge has been made so many times in various threads I don't believe we're going to get any more tracking information and will probably have to look for other ways....

mrhodes40 · Post by **mrhodes40** » Mon Oct 19, 2009 3:01 pm

Radeck is right about that I STRONGLY second that idea.

I am aware that some people are waiting for "something" to happen, but don't. Just go and write what happened so far, you can edit that post later to encompass later changes---

homefront · Post by **homefront** » Tue Oct 20, 2009 4:13 am

Very quickly, we are new to this site. My wife was diagnosed ppms about 2 years ago. The information that can be found here and the efforts being made are incredible and thank you all for this.

My question is (we are in UK), if you were to try to get treatment, including detection, for ccsvi without associating it to ms, how would you make initial approach and to who? Hope I have made this clear!

sou · Post by **sou** » Tue Oct 20, 2009 4:17 am

Hi.

There is a thread about UK here:

http://www.thisisms.com/ftopict-8446.html

HTH,

sou

bestadmom · Post by **bestadmom** » Wed Oct 21, 2009 4:42 am

Radeck,

You are right about doctors needing proof of results.

I've heard from a group of neurologists and interventional neuroradiologists at a very large university hospital in NYC, and they have been following ccsvi but said they won't proceed with an intervention until there is data.

We need Zamboni's paper to be published and let's hope for statistically significant concurrene of the results of first 250 to be unblinded at JNI. That might be just enough to convince the group that they cannot ignore this.

Your anecdotal stories post surgery can only help, and you can be sure that there are lots of docs lurking on this forum.

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Compassionate Treatment

Getting doctors attention