Vagus Nerve Stimulaton for Depression - Does it work?
In mid-2005 the FDA approved Vagus Nerve Stimulation or VNS for major depression.
Reversing its earlier ruling denying approval to Cyberonics for its Vagus Nerve Stimulator to be used in the treatment of refractory depression, the FDA now allowed them to go ahead and implant the devices, though only under certain conditions. Labeling eligible patients with the invented term "treatment-resistant depression" conveniently abbreviated to TRD, they could accept only those who had failed at four other anti-depressant therapies, from drugs to ECT.
Now I quite clearly recall that when the notion that VNS was anti-depressant was first floated, it was debunked as bad science with fudged, even falsified data. But no matter how I search, I cannot find those papers on the internet now. No mention of the earlier discussions is available. Instead, we are given a lot of anecdotal evidence for efficacy: testimonials that VNS works miracles and very little research that actually proves it does more good than harm. In one research study in fact, there was one suicide -- in the treatment group, not in the control group! But the research that I have seen -- one group of patients acting as their own controls, a lousy way to do research! -- seems to point to some vague improvement of a third of treated patients, coupled with a worsening of about a third of treated patients, which, since all were concomitantly on medication, seems to say nothing at all about VNS. Nothing that can actually be proven to come from VNS and not some other factor.
Testimonials are powerful and convincing when you hear them, and you don't want to take anyone's miracle away by telling them it is the placebo effect, or that the device or medication is actually ineffective, but anecdotal evidence of usefulness is not proof, and it seems to me that that is ALL that cyberonics has, that and the fact that enough patients are desperate enough to try anything just to have hope...But you could tell them to press their fingers into their eyes and hold until they see stars ten times a day and that could be just as effective in providing hope, or tell them you have to amputate their tongues...some with TRD would probably let you, being that desperate.
But the desperation of the depressed for a cure and the desperate greed of a company for profits should not sway one into thinking that it justifies any and all interventions, "just for the sake of doing something that might work..." Who said it might work? Where's the proof? Did lobotomies work? Sure, people swore that they did, and they probably had plenty of testimonials to prove it, but we know now how brutal and cruel they really were and regret that so many were done to innocent sufferers.
So watch out for those who try to sell you on this new surgery. It may not be brain surgery; they just open up your chest and neck, place a disk like a stop watch in your chest and wrap wires around a nerve in your neck. But it is surgery and things can go wrong. There are testimonials too from those who were tortured by the VNS and begged to have it removed, and could not have it all taken out because to remove the wires around the vagus nerve would be too dangerous. So take those anecdotes and testimonials for what they are worth, perhaps the grain of salt they should be swallowed with, and read the research and think carefully before you listen to the drug company or device company hype. Find out who is being compensated by what company and then writing up a positive review in the journal he himself edits, as Dr Nemeroff did in the case of Cyberonics' VNS. That's a conflict of interest and obviously self-serving, biassed and unobjective. Clearly he is selling the device because he wants to SELL the device, not because he in an outsider convinced by the research that it is efficacious.
And why do the companies producing these drugs and devices get to do the research and prove their usefulness and efficacy to the FDA? That is so absurd. It's like asking the fox to prove there are chickens in the hen house. Of course the companies are going to find that their drugs/devices work. It is in their financial interest to "discover" that. And if they have bad results, it is in their interest to hide them until they can cook the books or get better results from a different study...But why do we tolerate this? Why does the FDA do NO testing and studies of its own? It's ridiculous to trust the corporations and Big Pharma etc to tell the FDA the truth, the Whole Truth and Nothing But the Truth. Can pigs fly?
Posted by pamwagg at February 15, 2007 09:55 PM
If you've tried VNS and it has worked, great! I'm happy for you. But it does no one any good to tell us about it here. We know there are people who swear by it, as there are those who have just as dismal tales to tell about it. The thing is, we need to hear the results of good research that proves or disproves efficacy once and for all. If anyone has a link to that, do let me know.
Were you being funny, or did you know that pressing your fingers to your eyes actually does stimulate the vagus nerve? I was looking for documentation of this on the net and was googled to your blog - I have partial complex seizures but didn't want to get the VNS due to insufficient evidence...BUT... I have discovered, and my friends have learned, when my seizure starts, if they tell me "press your eyes!" and I do it relatively early in the seizure, sometimes the seizure actually stops. Nothing else has ever stopped a seizure once it starts.
Now I'm not saying people with depression or other illnesses should press their eyes 10 times a day until they see stars...and this won't work for all epilepsy patients, I'm sure...I just thought it was amusing that you used that example in what you wrote, when it actually is effective, at least for me, anecdotally speaking. If you've ever heard of any research or info on this "eye pressing" treatment, I'd love to read it.
Feel free to write back if you wish. Good luck and thanks for the info.
Posted by: Karen at July 9, 2007 02:42 PM
I am pleading for someone to answer Wendy's question, as I, too, suffer from severe depression and thought that alpha-stim could help em. It has given me something to hope about, but don't want to spend all that money if it is as Wendy said,"another quack company".
Posted by: julie at April 29, 2007 03:14 AM
I suffer from severe depresson and am researching alternatives to anti-depressants which don't work for me. I'm currently researching the Alpha-Stim SCS. Is this another quack company?
Posted by: Wendy Kahn at April 4, 2007 01:36 AM
YES...I HAVE THE V.N.S. INSTALLED SINCE 2001. I HAVE PARTIAL COMPLEX SEIZURES SINCE 12 YEARS OF AGE (NOW 49). MY SEIZURES WERE HELTER SKELTER 4-10 TIMES A WEEK. ITS NOT GREAT, BUT, SINCE UNIT WAS INSTALLED, I NOW HAVE A 6-8 WEEK PERIOD OF BEING 100% SEIZURE FREE. AND YES, DEPRESSION IS A PROBLEM SINCE V.N.S. WAS INSTALLED. PLEASE CONTAC ME IF I CAN BE OF ANY HELP.
Posted by: BART at March 24, 2007 08:05 AM
I am glad to hear that your implant is doing all that it is supposed to do. I stand by my blog entry however, and caution anyone searching for information on the internet to be absolutely sure you know what the source of your information is: do they have a connection to VNS -- financial or otherwise? Do they stand to benefit from the position taken vis a vis VNS? Is the evidence they cite merely anecdotal or based on double blind research? Hint: there hasn't been any; patients who get VNS can tell they have it, because of the sensation it produces when turned on. The whole point of double blind research is that neither the doctors nor the patients know which patients have the device or take the drug under study...so with VNS this has not yet been possible.
It is very encouraging to hear from Nancy, but there are others we could hear from for whom VNS does NOT work...An anecdote about VNS is NOT evidence; until the proper evidence is in, I cannot vouch for this therapy: there are too many holes and cracks in the surface for me to trust the underpinnings.
Posted by: Pam W at February 24, 2007 02:59 AM
DEAR PAM ....
I HAVE HAD MY "VNS" FOR OVER A YEAR NOW, AND YES, YES,... IT DOES INDEED HELP. AND THE LONGER IT IS IN YOUR BODY THE MORE IT WORKS. IT CAUSES TINY SEIZUERS (SP?) WHICH CAUSES THE BRAIN TO RE-LEASE ALL THE 3 MAIN CHEMICALS NEEDED FOR RELIEF FOR DEPRESSION. I HAVE SUFFERED WITH IT MOST OF MY LIFE, I'M 50 NOW AND PRIOR TO GETTING THE IMPLANT I TRIED TO OFF MYSELF AT LEAST 5 TIMES. EFFEXOR & WELLBUTRIN ALSO HELPED. MOST INSURANCE COMPANIES WILL PAY FOR IT WITH A LETTER FROM YOUR PSYCH DOCTOR. IF YOU ANYWHERE NEAR MY AGE GROUP.. GO HAVE A BLOOD TEST FOR YOUR HORMONES LEVELS AND THE THYROID. EITHER CAN BE A BIG CONTRIBUTOR TO DEPRESSION INCLUDING BI/POLAR. THE COMPANY JUST GOOGLE VAGUS NERVE STIMULATOR YOU WILL GET ALL THE INFORMATION YOU NEED THERE. GOOD LUCK BUT IT WORKED FOR ME. AND I WAS CONSIDERED TREATMENT RESISTANT. NANCY
Posted by: NANCY at February 24, 2007 01:05 AM
CBT is the one therapy that is KNOWN to work, and is a Best Practices therapy, often paid for by insurance when no other psychotherapy is covered. It is short-term but quite effective, at least for certain conditions, and it could be very helpful for you if you "self-talk" into not doinog things or not being motivated, or think that self-talk could help you get over a lack of motivation. I believe CBT works on the principle that we think ourselves into feeling something...i.e. we think we are worthless and so we feel depressed, so if we can self talk ourselves out of the thoughts of worthlessness, we could lessen or even cure the depression, that sort of thing.
If you try it, do let us know. And if anyone else has tried it, tell Kate and all of us about it. Does it work? And for what sorts of things?
Posted by: Pam W at February 18, 2007 09:16 PM
Well said Kate!
Posted by: Paula Kirkpatrick at February 18, 2007 11:53 AM
It is absurd that the drug companies are the ones doing all the research and testing. I don't understand it either. It also makes me think of the prevalence of commercials pushing drugs that seem to have a zillion possible side effects. And often I have little idea what exactly the drug is or is for. So manipulative! And the message: you, too, can be as happy as all these super well adjusted people are just by popping their pill. Add to that that the people in the commercials are all actors, doesn't give me much confidence. I wonder what kind of commercial they have or are working on for this new but questionable treatment for major depression? Except here it's a matter of sugery, far harder to sell unless, as you pointed out, you're a bit desperate to have hope of a recovery.
Major depression is so vicious, if only this new treatment did help, even some people (any people) for sure, that would be good news. Have you heard anything about Cognitive Behavioral Therapy? I wonder if that helps. It does seem to me that my depression has always centered around a lack of motivation and this lack has something to do with the thoughts I think. If only we could successfully change ourselves as a solution to the problem. Yes, some drugs do help but it seems that one has to still work with the nature of their own thoughts and learn to redirect them towards positive outlets. I don't know, but it's worth thinking about.
Posted by: Kate K. at February 16, 2007 01:19 AM