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http://clinicaltrials.gov/ct2/show/NCT0 ... SVI&rank=2

Just ran across this, it was linked to at the bottom of the Empire BCBS medical policy change document.

There have been concerns raised that our two safety studies (Dr. Simka and Dr. Siskin's) only dealt with immediate safety, such as what happened during the procedure itself. Still very good that the procedure was very safe in that extreme short term. But the concerns have been what happens in the long term. Thus I am glad to see that in the study details that they have as secondary outcome measures the safety at 3 months, 6 months, 12 months, 18 months and 24 months. ("This is defined as the number and nature of any procedure-related adverse effects.")

Reading the details, I still feel very bad for anyone receiving the sham treatment. Is it patients who have no insurance who would choose to be in such a trial? It's such a long term trial.

When will preliminary data be available? The study began in August of 2010. Completion of the data collection is August 2012 with estimated completion August 2013. I ask because the BCBS policy change document referenced this study and another one and said that no preliminary results were available yet.

I suppose that when an author begins to write a position paper for the insurance industry, that marks the birth of the world, and that before that, nothing of any relevance happened? Certainly it's irrelevant that 12000 people or so have had this procedure, and continue to pay full price for it in large numbers. Yes, eventually, IRs may lower their prices, when people run out of those foreign dollars, and maybe when market manipulators stop trying to mess around with them. I don't think it will matter to foreign doctors much whether an insurance company is paying or not. They might get "a better class of clientele" if they only have payers. It's too bad about all those less fortunate American and Canadian pwCCSVI who don't have much left after paying all the co-pays and stuff. Too bad they have to pay for some of their drugs themselves. Too bad they have to pay part of their neurology bills. The fittest survive, especially in a democracy, where they can elect majorities who will outlast the less fit.