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  • Digg it UP - May 6th deadline: Medicare's final decision to cover vagus nerve stimulation therapy for depression

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    Charles Conway, M.D. was the lead study investigator at the St. Louis University site for the investigational trial of vagus nerve stimulation therapy for chronic or severe depression. . I had my first screening interview in November of 2000 with Dr. Conway.

    Dr. Conway authored the following compelling and thoughtful editorial, which was widely published last week. I hope you will find it very informative.

    Government should pay for a new treatment for a grave condition By Charles R. Conway, M.D.

    Monday, Apr. 09 2007

    Clinical depression is not sadness. It is a serious medical condition that has a profound impact on an individual's capacity to function and his or her quality of life.

    Clinical depression is among the most disabling conditions in the developed world, second only to heart disease in disability because of lost productivity and suicide, according to recent studies. The World Health Organization predicts clinical depression will be the No. 1 cause of disability worldwide by 2020.

    About 20 percent of those who have depression — approximately 4 million Americans — suffer from a particularly severe form of the disease known as treatment-resistant depression. As a psychiatrist who specializes in the study and treatment of those with severe mood disorders, I have seen firsthand the devastating toll the disease takes on the lives of these patients.

    In February, however, the Committee on Medicare and Medicaid Services made a preliminary ruling against funding a new Food and Drug Administration-approved therapy for treatment-resistant depression called vagus nerve stimulation. A final decision is due by early May. If the initial recommendation is endorsed, the decision will lead to needless suffering by patients and their families, significant unresolved illness and tragic deaths by suicide. Failure to reimburse severely depressed patients for this procedure would be shameful.

    I have been intimately involved in the study of vagus nerve stimulation. The therapy involves surgically implanting in the chest a small stimulation device similar to a cardiac pacemaker. Through wires that run under the skin to the vagus nerve in the neck, the device delivers pulses that trigger changes in the brain. Originally approved to treat epilepsy, the device was approved in 2005 by the Food and Drug Administration to treat severe depression that did not improve with other therapies.<

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    . Conway, M.D.

    Monday, Apr. 09 2007

    Clinical depression is not sadness. It is a serious medical condition that has a profound impact on an individual's capacity to function and his or her quality of life.

    Clinical depression is among the most disabling conditions in the developed world, second only to heart disease in disability because of lost productivity and suicide, according to recent studies. The World Health Organization predicts clinical depression will be the No. 1 cause of disability worldwide by 2020.

    About 20 percent of those who have depression — approximately 4 million Americans — suffer from a particularly severe form of the disease known as treatment-resistant depression. As a psychiatrist who specializes in the study and treatment of those with severe mood disorders, I have seen firsthand the devastating toll the disease takes on the lives of these patients.

    In February, however, the Committee on Medicare and Medicaid Services made a preliminary ruling against funding a new Food and Drug Administration-approved therapy for treatment-resistant depression called vagus nerve stimulation. A final decision is due by early May. If the initial recommendation is endorsed, the decision will lead to needless suffering by patients and their families, significant unresolved illness and tragic deaths by suicide. Failure to reimburse severely depressed patients for this procedure would be shameful.

    I have been intimately involved in the study of vagus nerve stimulation. The therapy involves surgically implanting in the chest a small stimulation device similar to a cardiac pacemaker. Through wires that run under the skin to the vagus nerve in the neck, the device delivers pulses that trigger changes in the brain. Originally approved to treat epilepsy, the device was approved in 2005 by the Food and Drug Administration to treat severe depression that did not improve with other therapies.

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    No. 1 cause of disability worldwide by 2020.

    About 20 percent of those who have depression — approximately 4 million Americans — suffer from a particularly severe form of the disease known as treatment-resistant depression. As a psychiatrist who specializes in the study and treatment of those with severe mood disorders, I have seen firsthand the devastating toll the disease takes on the lives of these patients.

    In February, however, the Committee on Medicare and Medicaid Services made a preliminary ruling against funding a new Food and Drug Administration-approved therapy for treatment-resistant depression called vagus nerve stimulation. A final decision is due by early May. If the initial recommendation is endorsed, the decision will lead to needless suffering by patients and their families, significant unresolved illness and tragic deaths by suicide. Failure to reimburse severely depressed patients for this procedure would be shameful.

    I have been intimately involved in the study of vagus nerve stimulation. The therapy involves surgically implanting in the chest a small stimulation device similar to a cardiac pacemaker. Through wires that run under the skin to the vagus nerve in the neck, the device delivers pulses that trigger changes in the brain. Originally approved to treat epilepsy, the device was approved in 2005 by the Food and Drug Administration to treat severe depression that did not improve with other therapies.

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    rvices made a preliminary ruling against funding a new Food and Drug Administration-approved therapy for treatment-resistant depression called vagus nerve stimulation. A final decision is due by early May. If the initial recommendation is endorsed, the decision will lead to needless suffering by patients and their families, significant unresolved illness and tragic deaths by suicide. Failure to reimburse severely depressed patients for this procedure would be shameful.

    I have been intimately involved in the study of vagus nerve stimulation. The therapy involves surgically implanting in the chest a small stimulation device similar to a cardiac pacemaker. Through wires that run under the skin to the vagus nerve in the neck, the device delivers pulses that trigger changes in the brain. Originally approved to treat epilepsy, the device was approved in 2005 by the Food and Drug Administration to treat severe depression that did not improve with other therapies.

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    een intimately involved in the study of vagus nerve stimulation. The therapy involves surgically implanting in the chest a small stimulation device similar to a cardiac pacemaker. Through wires that run under the skin to the vagus nerve in the neck, the device delivers pulses that trigger changes in the brain. Originally approved to treat epilepsy, the device was approved in 2005 by the Food and Drug Administration to treat severe depression that did not improve with other therapies.

    Current studies and safety data support using vagus nerve stimulation to treat depression in patients after multiple other therapies have failed to improve their conditions. These patients are the "sickest of the sick" and deserve our help.

    It's difficult to emphasize strongly enough the degree of suffering and imminent life-threatening nature of this virulent brain disease. Even the general medical community has little understanding of the degree of torment experienced by these patients and their families. They deal with failed treatment after failed treatment, the incapacity to maintain work and family roles, suicide attempts and psychiatric hospitalizations that recur year after year. Many of these individuals literally spend more than half of their lives incapacitated by depression.

    From 2000 to 2003, I was the principal investigator at St. Louis University's School of Medicine of a clinical trial on the effectiveness of vagus nerve stimulation for patients who have treatment-resistant depression. I was very impressed by what I observed: Of the 10 subjects we enrolled in the trial — all of whom had suffered depression for more than 15 years — four had complete resolution of their symptoms of depression. Even more amazing, all of these patients remain depression-free to this day, five years later.

    Any practitioner who deals with people with treatment-resistant depression will tell you that such a positive outcome is unheard of: Typically, those with treatment-resistant depression either do not respond to a therapy, and those who do certainly don't sustain the response. This treatment worked better than any other therapy I ever have observed in this group of severely depressed patients.

    Of course, not everyone who might want this therapy should get it. Vagus nerve stimulation should be given only to the sickest of the sick. I would propose that candidates for this therapy should have tried

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