Title: VNS Should Not Be Approved for TRD
Description: Public Citizen Tells FDA
Birdbomb - May 14, 2005 09:08 PM (GMT)
LINK
Electronic Device Should Not Be Approved for Treatment of Depression, Public Citizen Tells FDA
Effectiveness of VNS Therapy Unproved, Safety Questionable
WASHINGTON, D.C. – An electronic device implanted in the base of the neck that is currently used to treat epilepsy patients should not be approved for use in patients with treatment-resistant depression, Public Citizen told the U.S. Food and Drug Administration (FDA) today.
In a letter sent to Daniel Schultz, the director of the FDA’s Center for Devices and Radiologic Health, Public Citizen questioned both the effectiveness of the device and the soundness of the studies submitted by the company seeking approval.
The device, known as Vagus Nerve Stimulation (VNS) therapy, was developed by Cyberonics of Houston, Texas. It consists of a pulse generator that delivers electrical signals to the left cervical vagus nerve, a major nerve that connects to the heart, the gastrointestinal tract, the brain and other parts of the body. It is programmed to be on for 30 seconds and off for five minutes.
The device was approved for use in epilepsy patients in 1997 and is currently used by approximately 30,000 people. If the FDA approves the device for severely depressed patients, it would have access to a market of 4 million patients, according to the Cyberonics.
“The principle is simple: If it doesn’t work, it shouldn’t be approved,” said Dr. Peter Lurie, deputy director of Public Citizen’s Health Research Group. “The FDA would never approve a drug under these conditions. They certainly shouldn’t approve this device.”
The agency itself has raised questions about increased suicides, worsening depression and sudden death in patients using this device – all of which require further investigation, Public Citizen said.
In 2003, Cyberonics asked the FDA to approve the use of the device in patients 18 or older with chronic or recurrent depression who had failed to respond to two or more antidepressant treatments. In 2004, the FDA sent a “major deficiency letter” that cited serious flaws in the company’s data. The company responded, and an advisory committee later voted 5-2 to approve the device with conditions. The FDA took the unusual step of overruling the committee’s recommendation because of concerns about the device’s effectiveness as well as data showing worsening depression in many VNS patients.
The company submitted more data, and the FDA reversed itself in February 2005 and reportedly told the company that the device was approvable.
The company has submitted data about only a single randomized, controlled trial (in which all patients had the device implanted but only half had the device turned on), and that trial failed to convincingly demonstrate the effectiveness of the device. It also produced long-term, non-randomized data comparing VNS to another comparison group, but an FDA statistician called that analysis “highly questionable.”
“The FDA should not let justified empathy for this patient population lead to the unjustified approval of a device that does not come close to meeting the agency’s approval standards and may do more harm than good,” said Nicholas Stine, a researcher at Public Citizen who worked on the letter.
To read a copy of the letter, click here. Petunia - May 16, 2005 06:22 PM (GMT)
The part that I don't understand about all of this is , if they won't appove it for depression why is it still being used for seizures?
Elisa
Bernard - May 16, 2005 06:58 PM (GMT)
AFAIK, the FDA has not made their decision yet on VNS for depression.
Public Citizen based their opinion on the apparent lack of rigorous proof of efficacy for VNS for depression. Perhaps the data for epilepsy was more compelling.
I wonder how long it will be before the safety issue is revisited with a more critical eye.
Petunia - May 16, 2005 07:58 PM (GMT)
I know that they are still looking into it, but the question is " are they looking into the safetly for all uses". To be quite honest, I think people with Depression have a lot more luck with it then people with seizures.
Of course this is just an observation from me who knows.
labrat - June 1, 2006 09:08 AM (GMT)
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I have TRD and am BiPolar II. I was implanted 10-19-05. I have come off 900 mgs of Lithium, am depression free, and have last 40 pounds.
The VNS has done what 10 years of taking every kind of antidepressant couldn't do.....IT HAS GIVEN ME MY LIFE BACK!!!!!!!
Bernard - June 1, 2006 01:08 PM (GMT)
That's great to hear labrat! You should probably have started a new thread to tell your story though rather than resurrect a year old thread!
Best I can tell, industry (docs + insurance companies) has not fully embraced the VNS for TRD.
labrat - June 11, 2006 02:59 PM (GMT)
:)
Thank goodness my psychiatrist embraced the idea and is still running with it fighting the insurance companies all the way.
Like he said, he is also a Dr. in every since of the word. He has PH.d certificates all over his walls. He is a very educated man. I'm thankful my former psychiatrist literally gave up on me and GAVE me to Dr. Holt.
Labrat
:im_033: :im_033:
nitarita34 - June 23, 2006 05:20 PM (GMT)
labrat, so much congratulations to you with it!!!! It is great to see that it has the effect that it is suppose to with some.........would love to hear your whole experience with it.
Anita
novice - September 6, 2006 09:49 PM (GMT)
Considering the date of this post, is the question still relavent or is the VNS now effective against TRD. I was better when implanted than I am now approx 19months later and appear to be keeping it for a further period of time but I have the little nagging doubts about exactly what effect its having. I wasnt classed as TRD until about a month ago.
Bernard - September 6, 2006 10:09 PM (GMT)
labrat - September 6, 2006 10:44 PM (GMT)
I continue to have success with the VNS. The 19th of this month will be 11 months since I was implanted. After I hit 9 months, although my family had seen great improvements with me, my husband commented that every week now I seem to do better and better. I don't want to give the impression that it has been a piece of cake. I have stated before, I spiraled out just as I spiraled into depression. There have been ups and downs. Relationships that had to be and some that still have to be worked on. Friendships lost. Coming to grips with a more than 30 years of memory loss. ( I'm 47 ) My children werevery young, now they are 15, 19, and 23. I missed or don't remember so much due to memory loss due to ECT's. I know they were a necessary evil at the time. I was just as determined to die as my doctor was for me to live, medication wasn't working. I choose to look toward the future; if not, I will be in the same situation as I was before. No, VNS does not work for everyone. If patient's that do not respond to any medication ( I have taken everything there is )
I have no idea how many different kinds there were; 25+. I know for a fact I have lived in hell for years. I wish that everyone could have the same experience with VNS that I have. I realize how fortunate I am to have the VNS work, my husband of 28+ years is still here and still loves me, my 3 children seem to be well adjusted, happy, don't do drugs, don't drink, and I give their father credit for that.
I wish I had a magic wand to make all TRD and all Epilesy patients well. Life can be so cruel.
From all I've experienced, seen, heard, the VNS works the best for the people that are the sickest. There is not really a way to test who it will work for and who it won't. I wish there was.
I wish you well in whatever way you choose to go. If only I had a magic wand :-)
:im_033: Labrat :im_033:
labrat - September 6, 2006 10:51 PM (GMT)
I don't look at the negatives of it now. The time to do that is BEFORE you are implanted. I strongly advise anyone to investigate everything you can find out about the VNS before you have the surgery.
:im_033: Labrat :im_033: