Dear Sirs:
I am the Director of Clinical Research at a
psychiatric teaching hospital and on the faculty
at the University of Maryland School of
Medicine. I am also a board certified
psychiatrist and a Distinguished Fellow of the
American Psychiatric Association. One of my
prime research interests has been in the
treatment of severe, refractory mood disorders
including treatment resistant depression. I was
an investigator in the Cyberonics D-02 study,
taking over the University of Maryland patient
cohort and am a prinicipal investigator in both
the D-21 dose finding study and the Treatment
Resistant Depression Registry.

We desperately need new treatments for these very
ill patients. I worry that psychiatrically ill
patients get short shrift when it comes to paying
for their care. It feels as though expensive
treatments for other medical conditions such as
cancer or heart disease are far more likely to be
funded with little fanfare.

As for the concerns with the VNS data in TRD,
several problems exist in interpreting the
facts. As researchers we have dealt with TRD
using the same scales and the same methodology as
a routine depression. TRD is a different
illness. Response criteria of a 50% drop in a
depression rating scale is too high. If we can
make these folks even 25% better, that may mean
the difference between working and being on
disability. My patients would argue that even a
reliable 10% improvement would be worth the
effort and expense. When viewed from a 25%
improvement threshold, close to 60% of implanted
patients have meaningful benefit. That number
resonates as accurate to me. At this point I
have about 20 implanted patients under my care
with another dozen scheduled for the procedure.

The time frame of eight weeks of actual treatment
in the acute phase of the D-02 study wound up
being too short to demonstrate statistically
significant benefit. It would be unfortunate to
deprive patients of this useful treatment due to
not knowing before the study was designed when
the separation point would occur.

The recent publication of the NIMH STAR-D study
supports the notion of just how hard it is to
treat TRD. Response and remission rates for
patients drop below 20% once two levels of
treatment have occured. The VNS patients have
generally failed four and more levels of adequate
interventions. At this point interventions tend
to lead to response only about 10% of the time

I very strongly hope CMS will understand the
devastating nature of TRD, the inadequacies of
current interventions and agree to support the
continued use of this helpful treatment.

Scott T. Aaronson, MD
Director, Clinical Research Programs
Sheppard Pratt Health System
Baltimore, MD