Commenter: Bernstein, Lawrence P.
Title: MD
Organization: Evanston Northwestern Healthcare
Date: 08/18/2006
Comment:
Dear Sir or Madam:
I am the medical director of the Clinical
Neurophysiology Laboratory at Evanston Hospital
the northernmost teaching hospital of the
Northwestern University Feinberg School of
Medicine. I am a board certified neurologist
and neurophysiologist. I completed three years
of post doctoral training in basic
neurophysiology, one as a Sloan Foundation
fellow and two as an NIH individual research
fellow at the University of Chicago Pritzker
School of Medicine. I have served as a faculty
member in the Department of Neurology at the
Northwestern University Medical School for the
last twenty two years. In the last five years I
have supervised treatment of ~ fifty patients
with VNS therapy for pharmacoresistant epilepsy.
I have, as well, participated in the
implantation and initial programming of three
patients with treatment resistant depression.
Many patients with pharmacoresistant epilepsy
experience comorbid depression. It is my
observation that this comorbid depression remits
even in patients whose seizure frequency is not
dramatically reduced by VNS therapy.
My experience in long term follow up of
patients with treatment resistant depression
(TRD) is restricted to a single patient. This
patient experienced marked improvement and was
able to go without ECT for at least one year.
In terms of side effects not a single patient
has requested that their VNS therapy be
discontinued and few have complained of
substantial sisde effects.
I urge you to approve VNS therapy for
pharmacoresistant depression. Published data
suggest it is as effective for TRD as it is for
pharmacoresistant epilepsy and its side effects
are minimal.
I am not a paid consultant to or speaker for
Cyberonics.
Sincerely yours,
Lawrence P. Bernstein, M.D.
http://www.cms.hhs.gov/MCD/viewpubliccomments.asp?nca_id=195&expand=Y#0807200609062006A