Reporting as one of the few who were 'turned away at the gate'...
While on my drive to the Atlanta airport to depart, Alex called to tell me my procedure had been canx...but that I should still come out and do the testing...so I did...and I'm glad I did...I found out some very useful & interesting information...
1. I like Dr. Dake very much. I trust Dr. Dake very much. We had a very open discussion...
2. He told me that it was the Neurology dept, here at Stanford, that complained to Stanford Head Administrators to have Dake stop the treatment. They said that when this CCSVI thing is found NOT to have anything to do with MS, it is going to irrevocably hurt Stanford's reputation (and so, trickling down the logic chain, cost them grants, donations and humiliation). The Neuro's here at Stanford are the reason Dake stopped the procedures. His own words were that he was "under siege"by them. They are working to convince the administration that because there has been no study, there is no proof and the attention it is receiving, is not good without proof. It is a good thing for us, that Dake's Dept. Chair believes in him & is tackling the politics (which is what he is supposed to do...and we all believe the Neuro Dept will have egg on their face while retracting some of their more immflamatory statements...although, I'm sure they will admit to no wrong doing...)
3. As far as clinical trials/studies go...they normally do take a long time to set up, however, this 'study' (different rules apply for studies, which are different than clinical trials) is almost ready to start, as Dake has been working on the protocols and he has put many stents in veins before this, just not in THESE veins. This study has been 'fast tracked'. (I know fast tracking is not uncommon.)
The people who have had their testing done and want to continue with treatment, will be able to, acoording to Dake, at the beginning of February.
And, Dake told me, I would be put in the study as one of the people who would get stents. I'm assuming there are plenty of others who would volunteer for the control group, the ones who don't get any treatment, and no one will get any 'sham surgeries.' So not to worry there. If you have your testing done and there is a problem and you WANT stenting, you will get it...another benefit of a study...
And by the way, Dake has performed 160+ of these procedures, not just 65. So we need to adjust our statements regarding complications...should be 1/160, instead of 1/65. (Don't know where the other people came from, but this info came from Dake to me. AND he has now received 750 emails just from Canadians wanting in on this trial.)
Although, the same 'category' of requirements must be addressed for this study (i.e., safety, efficacy, quality, etc) as they would with an NDA (new drug or device application) the criteria that must be met is not as rigorous because of issues such as: stents have been put in veins many times before, (not just in arteries) so there is no 'safety' issues that must be addressed, as if it were a totally new procedure...instead, a doctor, who works for the stent manufacturer, is able to 'sign off' on the fact that there is no new safety issue with that...and there are other issues here, that are working similiarly...like the stent is not a totally new device, nor is it a totally new device being used unconventionally...only the placement is what is new...this cuts down a lot of the time it would ordinarily take to set up a clinical trial, as opposed to a study of this type. Under the umbrella of a study, there will be little 'chatter' from the opposing neurologist, because it is just that...'a study' not a cure, not a treatment.
4. Radeck's most unfortunate complications did not cause the procedures to be stopped. However, Stanford's liability will be dramatically decreased by doing the procedures under the study.
5. As for my personal venous insufficiency issues...I found out that my right jugular, although appears large & unblocked, may have a valve problem, as it has a collateral vein that goes around where the valve is, and connects back into the big vein on the other side of the valve. He will do a video venography so he will be able to tell the flow and the pressure gradients. I basically do not have a left jugular (and am missing additional left side flow to the upper part of my brain that I definitely should have and Dake said he has never seen this before and so, doesn't know what the ramifications might be...) There actually is a flattened out tiny vein on the left side, that empties into what looks like 3 or 4 cul de sacs, where my jaw bone and ear intersect, but then doesn't go anywhere...he said he had not seen this particular presentation before, either, and is afraid that even with stents, I could experience restenosis, as the vein is so flat and so tiny and then just disappears. So, this little interlude will give Dake some time to figure out what to do with my left side, instead of having to 'wing it' in what would have been next day surgery.
6. Although, I will have to pay for the testing...the procedure will be covered by funding (partially, from one of the stent manufacturers, as we had speculated.) I won't be on the hook for the cost of the procedure, which was substantial. So, that's really good for me.
7. I will be having the procedure and I do believe it will not be more than 1 - 2 months out.
8. Dake never said this would cure my MS. But he did say, he was confident that at least, at the very least, it would cut down my fatigue and brain fog by 50%, cut out the heat intolerance and headaches and he 'believed' it would have an impact on many of my other symptoms, as well.
That's good enough for me...once you look at the pictures of what is actually happening (and what is not happening, that should be) inside your head, like Dake, said...whatever the impact is, because of the venous insufficiency shown here...it's not good!
So, even though I am disappointed about having to go home without my 'fix' I do have pictures that show my venous insufficiency and Dake said that he did not think I would be negatively impacted by having to wait a little longer. (If I believed it would be more than a couple of months at most, I would be more than just disappointed, but I am choosing to believe that it is going to turn out well for me.)I am sorry that I have to be stuck out here until Friday because I can't change my tickets...I would have to buy new one way tickets back to Atlanta AND would lose my frequent flier points for the round trip tickets out here...if I felt better, I wouldn't mind because I might be able to do some touristy stuff...and I might try to do something light, anyway...I am really trying not to let this get me down...
I do wonder, though, if we did do ourselves a disservice by spreading the word out to the neuro's as fast as we did, because the Stanford Neuros began getting a ton of calls and email, etc., about CCSVI and THAT is what really brought their attention to what Dake was doing...and neurology doesn't want to give up any of its 'MS domain' to the vascular guys...so they, fundamentally, threw a hissie fit and then brought up the money issue and Stanford's reputation being at stake and there you go...not good to go, anymore...And because of all the publicity in Canada, he has been beraged by so many people wanting information, wanting to be included in the study, wanting treatment...he had to stop and regroup to accomodate everyone and the Neuro's scrutiny.
But this is only a TEMPORARY setback...and Dake did say that there would soon be many hospitals wanting to do the procedure...so, even if Stanford is not cost effective for whatever reason, he believes this will be available in an area near you, sooner than later.
Whew! That's about all I know for now...thanks for listening...