Ocracoker16 Posted July 16, 2005 Share Posted July 16, 2005 The FDA has finally approved VNS. Link to comment Share on other sites More sharing options...
StrungOutOnLife Posted July 16, 2005 Share Posted July 16, 2005 All right! Link to comment Share on other sites More sharing options...
mel1 Posted July 16, 2005 Share Posted July 16, 2005 Very cool!Does insurance pay for it? Link to comment Share on other sites More sharing options...
SunshineOutside Posted July 16, 2005 Share Posted July 16, 2005 I'm thinking of doing it. My doctor has reccommended it. It has already been performed at MUSC in Charleston SC, not far from Columbia SC where I live. I have talked to a college professor who had it done several years ago in a study. She says she is depression free. She is also still on her meds. I read something about the first clinical trial not being approved. I think it had something to do with control groups or something. Do you know what it wants? I'm likely to undergo this procedure as soon as my Pdoc can find a doc. and my insurance company says yes. Any thoughts, opinions? Rhonda Link to comment Share on other sites More sharing options...
Ocracoker16 Posted July 16, 2005 Author Share Posted July 16, 2005 This is final approval that comes after a long period after an "approvable" letter was issued. <{POST_SNAPBACK}> One of the reasons why it was an especially long period is because their first clinical trial was a bust. <{POST_SNAPBACK}> Jerod, I was referring to the second time it was submitted for approval. The appovable letter was issued in February, but it took until July. That was just the prescribing information and other talks with the Senate Finance committee. You are completey right about their trials not being too good when they were submitted the first time. Katie Link to comment Share on other sites More sharing options...
Greenyflower Posted July 17, 2005 Share Posted July 17, 2005 Very cool!Does insurance pay for it?I checked on my carrier's website; yes for epilepsy, no for depression. It's still being considered investigational. I couldn't tell if the information had been updated since the FDA approval. The cost, by the way, is somewhere in the $12,000 - $20,000 range. I have talked to a college professor who had it done several years ago in a study. She says she is depression free. She is also still on her meds. It does appear to work better as adjunctive therapy. I read something about the first clinical trial not being approved. I think it had something to do with control groups or something. Do you know what it wants? I'm likely to undergo this procedure as soon as my Pdoc can find a doc. and my insurance company says yes. Any thoughts, opinions? Hereis a long letter recommending disapproval. It discusses the trials, their deficiencies and some seriously problematic issues that Cyberonics didn't investigate deeply. Some of the biggies are a statistically low response rate (varies from 15 - 30%). Over the long term 30% experienced worsening depression and there were 11 suicide attempts in the 205 people in the study. It also does not appear to work as well in people who have had ECT at least once. Damn. Such a nice concept. A mechanical device with no side effects. It looks like it may be too good to be true. Greeny Link to comment Share on other sites More sharing options...
Guest Guest Posted July 17, 2005 Share Posted July 17, 2005 I can't find it now, but I read a really good article on this. Essentially, the device was approved even though it only had a 30% success rate because the 30% of people who it DID help, it helped so tremendously that the FDA actually decided to be humane and approve it. It would be nice if as much research money as goes into drug research went into these other avenues as well. The more options, the more chances of helping people. Especially for people like me, who have such severe stomach problems that almost all drugs are intollerable. At this point, this should be considered a last resort, but if you have run out of options, you have a one out of three chance of it working. Oh, the article also pointed out that this device put one bipolar recipient into hypomanic irritability. So, this may not be an option for the BP. Interestingly enough, rTMS can also cause mania, whereas ECT stops it. Again, more research/money is needed to find out more about the potential of these treatments. Link to comment Share on other sites More sharing options...
SunshineOutside Posted July 18, 2005 Share Posted July 18, 2005 Well shit, just kill me now. Rhonda Link to comment Share on other sites More sharing options...
spudnut Posted July 18, 2005 Share Posted July 18, 2005 Well shit, just kill me now. Rhonda <{POST_SNAPBACK}> No, no, no Sunshine Out. Every treatment is individual, as we all are. I like your plan of going through the medical center -- and asking opinions along the way. If nothing else, you could put this on the "to do" list and watch developments for ?? awhile. Gotta agree with someone's mention of vns being used for epilepsy. There ARE success stories. Good wishes -- Spudnut in the North Link to comment Share on other sites More sharing options...
Guest Guest Posted July 18, 2005 Share Posted July 18, 2005 Rhonda--you should still look into it. Obviously, they will screen you to see if they think they can help you. Don't give up. Link to comment Share on other sites More sharing options...
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