Study Stokes Controversy Over Vagus Nerve Stimulation for Treatment Resistant Depression
More than a year after VNS was called “the latest moneymaking gimmick” by the Alliance for Human Research Protection, a new longitudinal study suggests benefits of up to 24 months for those with chronic, treatment resistant depression. Does it matter that one of the study’s lead authors is employed by the only company providing VNS devices?
More than a year ago, we commented on the controversy surrounding vagus nerve stimulation for treatment resistant depression. (See “Critics Alarmed at Growing Use of Vagus Nerve Stimulation for Depression”.) At the time, Linda Andre, of the nonprofit Alliance for Human Research Protection in New York, called VNS “the latest moneymaking gimmick” designed to rapidly expand the market for products made by Cyberonics — the only supplier of VNS equipment. While some patients swear by the device, critics have long pointed to the lack of clear scientific evidence that the $40,000 vagus nerve stimulation device alleviates depression at all, let alone particularly effectively.
Now, however, a press release from the Medical University of South Carolina has been making the rounds, announcing long term benefits of up to two years for those participants in a longitudinal study whose symptoms improved at all during treatment. (Readers whose scientific skepticism meter is set to ’sensitive’ will probably notice that this is a subtly different question from the question of whether the device actually works; the study found that when patients made improvements while undergoing treatment, most continued those improvements for up to 24 months.)
Notably, the press release does not disclose that the study’s second lead author, Stephen K. Brannan, is an employee of Cyberonics.
Does it matter that one of the study’s leaders is paid by the company whose device is being tested?
Here’s the original press release:
Researchers at the Medical University of South Carolina (MUSC) have announced the results of a two-year study, which tested the long-term antidepressant response to VNS (Vagus Nerve Stimulation) Therapy(TM) in patients with treatment-resistant depression (TRD). The study, of which Mark S. George, M.D., MUSC Distinguished Professor of Psychiatry, Radiology and Neurosciences is a lead author, is expected to appear in the April 2007 issue of the International Journal of Neuropsychopharmacology. Results showed that, of the patients who responded to VNS Therapy, either early or later in treatment, the majority continued to experience significant clinical benefit for up to 24 months. VNS Therapy is the first and only treatment for TRD to demonstrate such long-term improvements.
Patients included in this study, led by Harold A. Sackeim, PhD, of Columbia University, experienced severe chronic depression which proved to be treatment-resistant. The study participants had a 50 percent improvement in their depressive symptoms at either three months or a year after being treated with VNS Therapy. Between 61 percent and 79 percent of these patients sustained this response for 24 months. The durability of response was not attributable to alterations in other treatments.
“These data showing durability of response with VNS Therapy are pretty remarkable under any circumstances, but particularly for the patient population studied here,” said George. “Patients with TRD don’t respond to medications, and even when they do, they often develop tolerance after 6 months, and the depression returns. These findings regarding long-term sustained effectiveness are very encouraging for psychiatrists and patients with treatment-resistant depression. This study analysis provides additional confirmation that, at least for some patients, the benefits of VNS Therapy for TRD are long-term and improve over time.”
Many people with major depression relapse frequently, often despite numerous other treatment trials. More than 40 percent of patients experience a recurrence after two years and more than 60 percent experience recurrence after five years. Eighty percent to 90 percent of those patients having experienced two or more episodes of depression will have additional episodes. Electroconvulsive therapy (ECT) is considered by many psychiatrists as the most effective acute intervention for TRD. However, the majority of TRD patients relapse during the first year following response to ECT. This study shows that VNS Therapy is an effective long-term treatment option for some of these patients.
The FDA approved VNS Therapy as an adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments. VNS Therapy is also FDA-approved as an adjunctive therapy used to reduce the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications. In addition to treatment-resistant depression and pharmacoresistant epilepsy indications, VNS Therapy is at various stages of research as potential treatments for anxiety disorders, Alzheimer’s disease, bulimia, chronic headache/migraine and morbid obesity.
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This article was last reviewed by on Wednesday, 4th April 2007. You can leave a response below.
The URL of this page is:
http://counsellingresource.com/features/2007/04/04/vns-study/
4th April 2007
Hi,
After 20+ years of chronic depression, I have been depression-free for five years thanks to vagus nerve stimulation therapy( a $25,000 out-patient procedure. It’s truly a miracle.
The most important thing is that this study was led by Harold Sackeim, Ph.D. of Columbia University. Dr. Sackeim is the leading psychiatric thought leader in the country on treating the most severely depressed and difficult to treat patient population.
Charles E. Donovan
http://www.MyDepressionSpace.com
22nd April 2007
To the readership of this forum:
“At the time, Linda Andre, of the nonprofit Alliance for Human Research Protection in New York, called VNS “the latest moneymaking gimmick” designed to rapidly expand the market for products made by Cyberonics — the only supplier of VNS equipment.”
Does it matter that Linda Andre knows as much about this therapy option as she does about surf boarding or rocket science? While I can’t speak about her knowledge of surf boarder or rocket science and I can speak about her knowledge about this therapy. She knows infinitesimally less than Drs. George, Nahas, Sackeim, Rush, Conway, Lisanby, Nemeroff, Pelta et al and to which I’ll add even far less than Mr. Charlie Donovan, who has already responded and me as well as the many the VNS patients who are now benefiting from this therapy after decades of unsuccessful treatment option after treatment.
Does putting some organizational name after Ms. Andres’ name qualify her to know what she’s talking about. How about you folks checking the professional credentials of the doctors I’ve stated. Oh! Was that doctor Linda Andre or PhD after her name? No need for an answer, I already know the answer. Since you or Ms. Andre never took the time to better research the subject I’ll enlighten you to the fact that there are over 200 of the leading Psychiatric researchers, clinicians, educators and thought leaders acknowledging the remarkable long-term remissions being obtained in clinical practice for this most difficult and seriously ill patient populations. I’ll also add that some 36,000 member of the APA (American Psychiatric Association) having nothing whatsoever to do with the sponsor have been polled and acknowledged the benefits and need for the therapy.
I’ll also point out that Joe Namath, Frank Sinatra and J. Edgar Hoover have also been known to have associated with Mafia members. While these associations may appear as improprieties none have been judged in a court of law guilty or to be in violation of any law as it applies to the innuendos being perpetrated in your statements. While many doctors are in one form or another compensated by various sponsors it does preclude that their findings and/or statements are tainted or biased. Maybe you forgot, “Innocent until proven guilty.” The improprieties often take place when disclosure of relationships is omitted. Then to if one reads anyone reads these various medical studies there are often differences of professional opinions.
I’ll dispense with Ms. Andres’ limited or little ill gotten knowledge and her statements on the subject to share with your readers very briefly that my spouse was one of the earliest study subjects for VNS Therapy for TRD (Treatment Resistant Depression) almost 8 years ago. Her results have been nothing short of remarkable. She has been almost continuously depression free with little or no medications for the past 7 years. Similar patient experiences are also being recorded. My wife’s attending Psychiatrist, Dr. Ely Pelta, probably attends to the largest number of VNS patients for depression and while very skeptical at first his clinical experiences with the improvement of some of his most difficult to treat patients is impressive.
The issues relating to this therapy are more related, in my opinion, to our administration’s penchant for “Power/Politics/Money games” than it is to the concerns and wellness for the citizens of this country. Add to which there is the continued discrimination and stigmatization directed to those that suffer from serious mood disorders and the continued lack of parity in health care coverage.
While Mr. Linda Andre and a cadre of her friends and associates advocate from negativism I have maintained and prefer an advocacy of pro-activism and achieving wellness for the patient through whatever means or therapy available.
As noted by Charlie Donovan, his website offering and experiences as well as my more than 8 years of accumulating information both pro and con in a repository of information and commentary in and unbiased and as balanced a format as I could possibly achieve is also available to your readers at:
VNSdepression.com
The link is: http://www.vnsdepression.com
From there I also share other resources to VNS patient message forums in which these caring and supportive individuals can share their experiences as well as knowledge with anyone interested.
If anything I’ve learned from reading and watching the news media and especially websites on the Internet and that is to very, very carefully make every effort to validate the sources and qualifications of the writers and the information being presented.
I place a special emphasis on the patient and his/her support person(s) to be educated to make informed and un-coerced medical decisions with one’s compassionate, caring, knowledgeable and licensed health care professional(s) and I also place emphasis on encouraging hope and persistence.
Warmly,
Herb Stein
VNSdepression.com
.
22nd April 2007
The previously posted sentence should correctly read:
While many doctors are in one form or another compensated by various sponsors it doesn’t preclude that their findings and/or statements are tainted or biased.
.
18th June 2007
I prefer to remain anonymous while I try to figure out if this device is working or not. However, I had the implant six months ago and am relieved to say that I am cutting back on some of my meds and that I’m alive.
18th June 2007
Hi Raq,
Thank you for sharing your impressions so far — nothing beats first-hand experience! :-)
All the best,
Greg
2nd July 2007
Hi Greg,
“Thank you for sharing your impressions so far — nothing beats first-hand experience!” — Greg
You should have told this to CMS when they declined to pay for the therapy. Not only doesn’t first-hand experience count, they’re not interested in listening to the leading psychiatric researchers and thought leaders in the field.
Warmly,
Herb
VNSdepression.com
.