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/

---

Ebooks, Scripts, Websites, and more...

Adsense websites

Depression

Many of us feel depressed at one time or another,... Read More

Being A Victim Is Always A Choice

Do you blame your past, your family, your partner, your... Read More

Depression Explained

Depression is a mental state marked by melancholy, pessimism or... Read More

Depression is the Number One Cause of Disability in the United States

According to the World Health Organization, 4 of the 10... Read More

Seven Ways To Deal With Your Depression

It has just been announced, after a study by a... Read More

Aspartame and Your Mental Health

In 1965, a chemist working to develop an ulcer drug... Read More

Vagus Nerve Stimulation as a Treatment for Depression to be Launched in May

Final FDA approval of vagus nerve stimulation as a therapy... Read More

Vagus Nerve Stimulation and Depression

Vagus Nerve Stimulation for Chronic or Treatment-Resistant Depression About Vagus... Read More

Eliminate The Belief That Your Illness Is Genetic

Many illnesses, emotional and otherwise, are often said to be... Read More

When Your Fears and Depression Have the Best of You

What do you do when your fears and depression are... Read More

Adult Men and Women Who Suffer From Chronic Depression

Market surveys on women, men and depression suggest an estimated... Read More

FDA Nears Completion of Review of Vagus Nerve Stimulation For Chronic Depression

On June 2 at 8:00 pm ET, Reuters news service... Read More

How to Uncover the Reason You Cant Sleep Tonight

If you are like me ...you love your sleep!Sleep deprivation... Read More

How Do You Know if You Have Manic-Depression

Nancy was doing very well until about two years ago... Read More

St Johns Wort and Depression

The bright yellow flower of the St Johns Wort (hypericum... Read More

Sources of Online Suicide Help for People Suffering from Severe Depression

There are Many Resources for Online Suicide HelpFirst of all,... Read More

Is it ADHD or is it Depression?

During the assessment process it is of great importance for... Read More

Depression and Procrastination: Twins in the Job Search

My definition of procrastination is that a person delays and... Read More

Recognizing Depression?s Warning Signs

Depression is a serious illness, not a harmless part of... Read More

Chronic Fatigue Syndrome And Depression Are Not The Same Thing!

Chronic Fatigue Syndrome is a... Read More

Depression: Escape Your Mental Prison

There is an illness all around me in modern society... Read More

How to Get Rid of Your Worries: 5 Golden Rules and a Warning

Suresh was a worried person when he came to me... Read More

Recognizing Depression

Depression is a serious issue. There are simply hundreds of... Read More

Depression and EPA Fish Oil - Does It Really Work?

It is now no secret that people all over the... Read More

Depression is Underdiagnosed in College Students

Everyone feels down or blue once in awhile. Especially during... Read More