May 6th deadline: Medicare’s final decision to cover vagus nerve stimulation therapy for depression
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
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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
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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
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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
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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
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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 six or seven other
treatments without success; the current FDA recommendation is four.
Additionally, failure to respond to such aggressive treatments as monoamine
oxidase inhibitors and perhaps electroconvulsive therapy also could be
considered as criteria for eligibility.
But
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psychiatrists patients should be eligible for vagus nerve stimulation, and
Medicare should pay for it. Any other decision by the Committee on Medicare and
Medicaid Services would represent discrimination against people with brain
disease and would bring needless suffering to those who already are suffering
enough.
Dr. Charles Conway is an assistant professor of psychiatry at St. Louis
University School of Medicine in St. Louis.
Charles Donovan was a patient in the FDA investigational trial of vagus nerve stimulation as a treatment for chronic or recurrent treatment-resistant depression. He was implanted with the vagus nerve stimulator in April of 2001. He chronicles his journey
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Out of the Black Hole: The Patient’s Guide to Vagus Nerve Stimulation and Depression
His all inclusive book prepares depression sufferers to make an informed decision about this ninety-minute out-patient procedure. It is a “must read” before you discuss this treatment with your psychiatrist. A prescription for the procedure is required from an M.D. and it is covered by most insurance plans.
He is the founder of the http://www.VagusNerveStimulation.com Web Site and Bulletin. His writes daily for his blog; http://www.MyDepressionSpace.com