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Bob,

I anticipated this kind of response from you - which is one we are accustomed to seeing. Basically your approach to anything to do with CCSVI is that it is all too early and that we need to wait until everything is in place - funding, trials, expert opinion, whatever etc etc. On the surface that kind of POV can be attractive and get traction with some people. Political opponents use this mechanism to garner support, all the time.

Problem is, how realistic is it for CCSVI?

Who, other than those with a vested interest in exploring and resolving the issues with CCSVI is going to do the things you require, quickly enough? We might be waiting many years for all the niceties to be in place.........or maybe forever. You said in another thread that you and your wife had time on your side - to sit back, watch and wait. Fine, if that's going to be your CCSVI legacy.

ThisIsMS is a very powerful tool for the progress and resolution of issues associated with CCSVI - the involvement of Dake, ctv, Simka's treatment, Zamboni's publicity etc all started here. Realistically, the resolution of issues associated with CCSVI is going to come from the ground up.

It might mean a little trial and error in the early stages but this will probably seperate out those who want to take control of their lives, from others, thereby reflecting the human psyche in any field of endeavour, you care to look at.

Phil

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Lyon wrote: I can't say that's not what is happening, but it doesn't seem like utmost caution is being exercised.

I agree on this one regarding the stents. Perhaps they already are, but people should perhaps be signing waivers that say something along the lines of "this is a completely novel surgery, and complication rate is unknown and may include XYZ as well as a host of other as-of-yet undiscovered complications..." Presumably people are well-informed when they sign up (I hope!) that the effect on their MS is also an unknown.

Zamboni seems a bit more careful, esp as he is sticking to angio only and has received approval from an ethics board (of what? EU or Italy??). Plus he is part of a clinical trial and people know going in that it's basically all experimental.

I should add that Dr. Haacke's assistant used the thalidomide example of why this research has to be performed carefully and, unfortunately, slowly.

Brainteaser wrote:Bob,

I anticipated this kind of response from you - which is one we are accustomed to seeing. Basically your approach to anything to do with CCSVI is that it is all too early and that we need to wait until everything is in place - funding, trials, expert opinion, whatever etc etc. On the surface that kind of POV can be attractive and get traction with some people. Political opponents use this mechanism to garner support, all the time.

I think you're being a little too hard on Bob. Remember, the doctors at NIH do not recommend stenting of the jugulars, because of known and possible unknown complications. Doctors at JNI do not recommend treatment at this time. Even Dr. Zamboni himself is reluctant to use stents.

ThisIsMS is a very powerful tool for the progress and resolution of issues associated with CCSVI - the involvement of Dake, ctv, Simka's treatment, Zamboni's publicity etc all started here. Realistically, the resolution of issues associated with CCSVI is going to come from the ground up.

It might mean a little trial and error in the early stages but this will probably seperate out those who want to take control of their lives, from others, thereby reflecting the human psyche in any field of endeavour, you care to look at.

TIMS is a fantastic resource for MS in general, CCSVI in particular. It has helped make people aware of the various research, tests and procedures being conducted on CCSVI. And those who have undergo testing/procedures can relate their experiences. However, there are limits to what a website can accomplish. Resolution of issues associated with CCSVI is one. Without this website, I wouldn't have known that stent migration into the heart is a potential problem. But, unless one of the members here is a vascular surgeon or a biomed engineer with knowledge of stents, I don't think that problem will be resolved here.

And I think open-heart surgery is a bit more serious than a little trial and error.

if veins get bigger as they head to the heart veinous stents shouldn't be cylinder shaped. They should get bigger too but just a little extra so they can't slip.

I agree that that the possible risks of CCSVI stenting should be set out for each patient, and the patient should know that they are assuming the risk for any unforeseen negative consequences. But I don't really know how you can have a clinical trial for vascular surgery. I think the best they could do would be to experiment with the vein stenting procedure on animals.

In my opinion, the thalidomide story is one that demonstrates that achieving government regulatory standards for safety and efficacy is not necessarily definitive. Thalidomide did meet all of the standards, but the regulatory agencies and the researchers tragically didn't consider the basic chemical principle that the good form of thalidomide could convert to the bad form in vivo.

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Some people will wait, some people won't.

We didn't and are glad we didn't but for others the procedure was nowhere near as straight forward.

Same with all MS treatments though, none are without risk.

Doing nothing is a risk in itself.

There's no right answer.

Cheer wrote

The doctors try to ascertain what it going on in each individual case. We've seen double valves, cysts, malformations, and now for Joel (and potentially Marc) we see bones. Each MS patient will have a different cause.

To add:
My daughter had a boney structure at the C-1 level. The right jugular vein was plastered against the structure. Dake was able to insert a stent and open the vein.

Sharon

Some people will wait, some people won't.

We didn't and are glad we didn't but for others the procedure was nowhere near as straight forward.

Same with all MS treatments though, none are without risk.

Doing nothing is a risk in itself.

There's no right answer.

Jamie really captures my thoughts and experiences too.

I agree we need vigilence when looking at the safety of opening the veins. In terms of needing clinical trials to "prove" the benefit of opening the veins on MS symptoms, the subjective accounts on this board are good enough for me. I say that as someone looking for treatment for my husband as well as a scientist.

As you know, clinical trials incorporate a large number of people. Within that large number, there are a lot of inherent variables. The large number is required to see if there is a benefit even taking into account those variables. Showing a benefit this way convinces doctors, insurance companies, and patients that the treatment is worth a try based on a risk/benefit analysis. But when you talk about whether the treatment will help one person, those variables are important. For example, if a treatment says that relapses were reduced by 30%, you don't know if everyone had a reduction of 30% or if half had no reduction and the other half had a reduction of 60% (unless they include this analysis in the work-up). Also, even if the control group had a reduction of 15%, the result is treported that the treatment reduced relapses by 30%. (If anyone is reading this, feel free to correct me - I haven't actively looked this up in a couple of years).

So the trial rightly convinces everyone that the possible benefit is worth the risk, but tells me very little about whether the treatment will help my husband. That is why the reports on this board, which seem credible and unsensationalized, mean just as much to me, and I don't need to wait for a clinical trial.

However, if a trial shows that there is absolutely no benefit, I'd have to reconsider everything, including the design of the trial.

Sorry again for the long post...I need to get back to work.
Theresa

Theresa,

I don't disagree with your line of thinking. However:

Also, even if the control group had a reduction of 15%, the result is treported that the treatment reduced relapses by 30%

I don't think that is quite right. For instance, in the trials for Copaxone, the Copaxone group had 29% fewer relapses relative to the placebo group (1.19 relapses/year for the Cop group vs. 1.68/year for the placebo group).

http://tinyurl.com/ykwv34y

Other trials have different endpoints (disability progression, # of new lesions, etc)., but they are usually given relative to the control group.

But when you talk about whether the treatment will help one person, those variables are important. For example, if a treatment says that relapses were reduced by 30%, you don't know if everyone had a reduction of 30% or if half had no reduction and the other half had a reduction of 60% (unless they include this analysis in the work-up).

This is very true, but I think some of this depends on the primary endpoints of the study. Some are more valuable than others, in my opinion. For example, some trials use the number of patients who are relapse free after a certain period of time. I think this is a better indicator of how individual patients might fare on the treatment. And even if they aren't part of the primary endpoints, some studies may report on individual patient statistics (again, see the Copaxone trial).

If it is properly designed, I think a CCSVI trial could provide valuable data on how much the treatment helps. Reports are Zamboni has already done just that, so, like everyone else, I eagerly await his paper. Of course, I can understand that waiting for further trials will take time that many MS'ers don't have.

I agree with you that the primary endpoints make all of the difference. I was encouraged by the fampridine results which targeted the main symptoms that my husband has - walking and leg strength - although I understand that there were deficiencies in the study design?

Regarding the placebo effect (which the blinded control group is meant to correct for) - I must of read a paper way back that showed a reduction in relapses when comparing a group who is untreated (to get a baseline) and then treated with a placebo. I was just struck at some point that a the number that is reported incorporates the placebo effect. But, practically speaking, if the placebo effect can make people feel good on top of an actual benefit from a treatment, what's the harm?

When is that paper coming out....

Patientx - you are dead right, open heart surgery is a little more than trial and error. It is extremely serious and warrants detailed investigation.

Unfortunately I have to do some work to pay my health costs, but just quickly...........

At present, as a result of Radeck's unfortunate experience, there is a lot of fear and concern regarding stents. Patients who have them are worried, those scheduled are concerned and others generally. Fear-mongering and mis-information will not help (I saw somewhere here where Zamboni was being tarred with the stent brush).

We as a CCSVI/MS community need to get the right answers very quickly. I think we need to get to the bottom of what happened with Radeck, Holly and others.

So how is this going to occur? I think maybe we should start by talking with those doing the treatments. Maybe it is already happening - I don't know.

Phil