I am writing to submit a public comment
regarding vagus nerve stimulation for the
management of treatment resistant depression. I
am Clinical Professor of Psychiatry with the
State University of New York at Buffalo School
of Medicine and in full time private practice
with the Buffalo Medical Group. I am board
certified in Psychiatry and Geriatric Psychiatry
and I have also been elected Distinguished
Fellow of the American Psychiatric Association.
I have been in private practice for over 15
years and have a practice largely devoted to the
treatment of depressive disorders, specifically
treatment refractory depression. By and large
most patients are able to be managed with a
combination of pharmacotherapy and psychotherapy
for their mood disorders. Unfortunately, a
small number of individuals are refractory to
all available treatment regimens. It is not
uncommon in my practice to have patients fail
five, ten or more antidepressants. Some
ultimately never respond to anything, including
lesser known treatments such as the use of MAO
inhibitors and ECT. Treatment resistant
depressed patients are a burden to their
families and our economy as they often go on
Social Security Disability and are not able to
maintain gainful employment. They are high
utilizers of medical services including and not
limited to prescriptions services, physician’s
visits and hospital services.
It is my opinion that the vagal nerve
stimulator offers a new and effective approach
to managing this difficult to treat population.
Since its approval by the FDA last year, I have
implemented vagal nerve stimulation treatment in
several patients, some of whom have begun to
respond for the first time in many years, if not
decades, of treatment. I have received e-mails
from individuals around the globe hearing that I
was offering the service asking whether they
could come to the United States to seek
treatment. These individuals would pay
privately for the service which I believe
reflects the desperation individuals with
depression experience when nothing seems to work
for their illness. Thus far I have come to
experience VNS as a fairly benign procedure in
terms of risk to the patient, yet it has already
provided a clear benefit for some patients and a
tremendous amount of hope for individuals who
have been long suffering.
I would ask that VNS be a covered service
through your agency so that more individuals
would have access to this intervention. Those
for whom I am recommending VNS have often been
more refractory than the FDA approval defined.
Some of those for whom VNS has been proposed
have failed over a dozen antidepressants and
have had little or no other alternatives. I
understand the financial ramifications of
widespread use of VNS. I believe it is not
appropriate for everyone. It may in fact not
even be appropriate for those who have failed
only four adequate antidepressants trials.
Nevertheless, I believe that some individuals
especially those who have been compliant for
years and have failed many, many medications,
perhaps even including ECT, should be allowed to
have this option available to them. This is
especially true since there is a growing body of
literature suggesting that some of these
individuals will improve with VNS whereas
antidepressant trials may provide no further
benefit leaving patients to continue their
suffering until a “new breakthrough” arrives.
This intervention is available now and I believe
this is a reasonable intervention for well
selected patients. It appears reasonable to me
that individuals who have failed many
antidepressants and have little or no other
alternatives should be allowed to pursue this
FDA approved intervention with informed consent
and when appropriate. I would hope that you
agree. I am sure that if you have any friends
or family who has suffered with this form of
depression that you would agree that we as
clinicians need to offer all reasonable
treatments to these patients. I believe VNS is
reasonable and appropriate and should be
reimbursed.
I appreciate your willingness to consider
funding VNS treatment. Enclosed please find a
copy of my CV and biography which was attached
to a separate email.
Please contact me should you have further
questions. Thank you for your attention to this
matter.
Sincerely,
Adam K. Ashton, M.D.