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/