This Is MS Multiple Sclerosis Community: Knowledge & Support

I am ready now. All i need is about $5M.

That's $1000 from 5000 families (or 1 year of fingolimod for 104 MS patients). Seems like it's time for e-fundraising.

Take 1-2 hundred patients, half with MS and half healthy controls with no symptoms and compare their venography and IVUS blindly. if there is a difference we establish by gold standards once and for all that patients with MS have abnormal venous drainage. If there is no difference, then we go home.

take 1-2 hundred patients with MS, catalog all signs and symptoms, divide them into two groups: one group receives venoplasty, or valvuloplasty using venography and IVUS to confirm successful treatment, the other group receives a sham operation. Both groups blinded to whether they have had treatment or sham. Compare improvements in symptoms for a year.Determine whether there is a benefit in the treated patients. DO NOT focus on whether there MS improves or not. That is a study for later.

That is my opinion.

Would you say that pictures a,b and c are sonographic evidence of an immobile upper valve leaflet? It hardly changes position in relation to the vein wall.

I thought that the letter was one sided and rather negative. as to the concept of CCSVI. However, the FDA was following the letter of the law in critiquing dr Mehta's study for lack of an IDE. It is well known that an IDE is expected when devices are investigated for new indications.

How difficult will the FDA be in approving IDEs? Will the FDA delay worthwhile studies? or inhhibit investigation? Will it object to investigatory studies because of divergence in results of ultrasound studies? Will the FDA efforts worsen the political atmosphere for scientific investigation? Or will it embrace the concept, and guide and aid development of good studies? because some studies using ultrasound did not confirm the Zamboni results? Will anyone ever study CCSVI as a separate entity that seems to happen with prevalence in MS rather than debate endlessly whether CCSVI causes MS or whether treatment of CCSVI has an effect on MS.

As I said from the beginning, i thought it was premature for trials last year. Given the experiences i have had in treating patients previously treated by others with underdiagnosis, under- and overtreatment, excessive usage of stents, etc, i am quite confident that i made a correct decision.

I am ready now. All i need is about $5M.

As far as treating patients, i could not in good conscience stop treating now after seeing first hand the positive effects in so many patients. I have thought about liability but there are good safety studies in print and there are good outcomes data that i cannot ignore. I will continue to treat patients. I will also definitely notify them of the FDA opinion on this. It is all part of good practice: an informed patient, making intelligent decisions.

I can see why it takes a special talent to read ultrasounds. To me they all look like ink blot tests.

[A] This is Figure 3 shows, verbatim, "a representative case of pMS having a CCSVI pattern but normal VGF.". The full caption is:
"FIGURE 3: (A) ECDS in pMS patient in the supine position: IJV stenosis with septum. (B) Venography in the same patient, supine position: no lumen irregularities.

The recent FDA advisory regarding CCSVI deviates from previous advisories from the FDA in that it was not signed. This suggests it may not have been fully vetted. Perhaps coming from a regional branch rather than headquarters in Maryland.