Senate Finance Committee Delays FDA Approval of Vagus Nerve Stimulation Therapy for Depression


On June 15th, 2004, FDA's Medical Devices Panel recommended that the U.S. Food and Drug Administration approve vagus nerve stimulation as a therapy for chronic or recurrent treatment-resistant depression. I was at the meeting, seated in the first row and made a presentation to the Panel.

Yet, one year later, we still do not have a final approval from the U.S. Food and Drug Administration (FDA).

What's the delay? Senator Chuck Grassley, Chairman of the Senate Finance Committee, unexpectedly decided to examine the FDA's decision to allow this therapy to be used to treat depression. Vagus nerve stimulation therapy has been FDA approved for epilepsy for eight years. Although this is not a formal investigation, it is apparently an impediment to the immediate issuance of FDA's final approval. I am not aware of the Senate Finance Committee's scientific and medical credentials. However, I do have first-hand knowledge of certain FDA Medical Device Panel Members lack of familiarity with the FDA's own regulations and guidelines.

If you would like to express your outrage at the continued delay of final FDA approval, please contact:

U.S. Senate Committee on Finance
219 Dirksen Senate Office Building
Washington, DC 20510-6200
Sen. Grassley Staff: (202) 224-4515
Sen. Baucus Staff: (202) 224-5315

Senator Chuck Grassley
Chairman, Senate Finance Committee
135 Hart Senate Building
Washington, DC 20510-1501
(202) 224-3744 Telephone
Web Link for e-mail: http://grassley.senate.gov/index.cfm?FuseAction=Contact.Home

Ironically, this one-year anniversary coincides with the issuance of a $20 million landmark study sponsored by the National Institute of Mental Health. This is the most comprehensive mental health study undertaken by the government. The study reported that 25% of Americans suffered a psychiatric disorder in the year prior to the survey, but most failed to get adequate care. Dr. Thomas Insel, Director of the National Institute of Mental Health commented that "mental disorders are highly prevalent and chronic." As expected, researchers found that the most common disorder was depression. Depression typically started in early adulthood, 20's and 30's, and progressively got worse and more difficult to treat. If you suffer from chronic or treatment-resistant depression, you don't need a $20 million research study to tell you that depression is difficult to treat.

Charles Donovan was a patient in the FDA investigational trial for vagus nerve stimulation and depression. He testified to the Panel at the Advisory Meeting on June 15th, 2004. After 25 years of chronic depression, vagus nerve stimulation completely cured his chronic depression. The author is most grateful and humbled by this remarkable device. Learn more at his website: http://www.VagusNerveStimulator.com or read about this life-saving, life altering therapy in his book:

Out of the Black Hole: The Patient's Guide to Vagus Nerve Stimulation and Depression.

It is available at on Amazon.com, Barnes & Noble.com, 1-888-VAGUS-88 or on his web site, http://www.vagusnervestimulator.com/book/

More Resources

Unable to open RSS Feed $XMLfilename with error HTTP ERROR: 404, exiting

More Depression Information:

Related Articles

Acidity Depresses Thyriod Function
THE RISKAccumulation of acids in your body, due to insufficient digestion of food, food allergies and consumption of acid-forming substances, can depress thyroid function. Acid-related causes of hypothyroidism also include exposure to heavy metals and toxic chemicals in the water supply and in highly processed food.
New Treatment for Depression to be Presented at the American Psychiatric Association Annual Meeting
Within the next few weeks, the FDA is expected to issue its final approval of a medical breakthrough treatment for chronic or treatment-resistant depression. This new therapy will be presented at the American Psychiatric Association's Annual Meeting in Atlanta from May 21st-May 25th.
Depression is Underdiagnosed in College Students
Everyone feels down or blue once in awhile. Especially during difficult times, it's normal to feel sad or discouraged.
Is it ADHD or is it Depression?
During the assessment process it is of great importance for the physician or clinician to consider other possible causes of inattention, impulsivity, or hyperactivity in your child, or teen, or yourself. In fact, this is probably the most important element of a good assessment.
Antidepressants: Control or Cure?
What's curious is that most of them will be on these drugs for life. Equally curious is that over seventy percent of people who stop taking them, for any length of time, will relapse into another painful episode of their illness.
Major Symposium About Vagus Nerve Stimulation & Depression at the American Psychiatric Association
A major symposium about vagus nerve stimulation as a treatment for chronic or recurrent depression will be presented at the American Psychiatric Association's Annual Meeting in May. This is the largest gathering of psychiatrists in the world and over 25,000 psychiatrists will be in attendance.
5 Super Effective Tips To Kill Depression
Being lonely is a normal part of our everyday lives. We get sad when we fail in our exams, when we're rejected by the person we love, or when someone very close to uspasses away.
Tips to Beat Depression
We all have days when we are down, worn out and just not feeling all that happy.That's okay.
Depression After A Heart Attack
There are several factors can lead to depression after heart attack. The stress of being in the hospital, the fear of another heart attack, time away from work can all contribute to feeling depressed, helpless, down and despondent.
Depression in Teenagers: Now What Can We Do?
No doubt you have seen the recent news headlines about a federal panel that recommended to the FDA that anti-depressant medications carry the strongest possible warning label for use in children and teenagers. This recommendation to the FDA shook the medical community, especially those who work with depressed young people.
It Aint Easy Being Brave
A zoo attendant entered a lion cage carrying only a broom. He casually swept with no concern for the wild animal.
Depressed? Wise Woman Ways Offer a Helping Hand
Winter time is depression time for many women. Perhaps it is harder to look at the bright side when days are short, perhaps the holidays and family demands take their toll on us.
Depression And Celiac Disease
Depression is a condition which affects about 15% of the population. Women are more likely to be affected than men.
Major Depression and Its Serious Complications
When suffering from clinical depression, people have different ways of confronting it. Some acknowledge it, face it just like any problem, and seek help.
The Formula for Preventing Depression
While it is arguable that depression is not always preventable, there are many cases, when using the following ideas, will keep you in good spirits - most of the time. Unfortunately, we cannot be happy all of the time, but there is something we can do about it.
FDA Deems Vagus Nerve Therapy Approvable as a Treatment for Depression
On February 3, 2005 the U.S.
Recognizing Depression
Depression is a serious issue. There are simply hundreds of thousands of people who deal with depression on a daily basis.
Chronic Fatigue Syndrome And Depression Are Not The Same Thing!
Chronic Fatigue Syndrome is a very misunderstood illness and this is perhaps why there are so many myths about it. Perhaps the most common myth about Chronic Fatigue Syndrome is that it is effectively a mental condition, and another name for depression.
Manic Depressive Episodes And Scientology
Scientologists believe that chemical imbalances do not exist. In their view manic episodes should be treated with periods of introspection and audits; a notion which is particularly bizarre and scientifically untenable.
Eliminate The Belief That Your Illness Is Genetic
Many illnesses, emotional and otherwise, are often said to be genetic in origin. When one is told that their particular problem is of a genetic nature it often leaves them feeling helpless since, to date, the idea of reversing something that is stored deep within one's structural DNA, which exists in every single cell of one's body, is considered an impossibility.