Vagus Nerve Stimulator
(VNS) Therapy™, a treatment for depression using an implanted device
manufactured by Cyberonics, Inc., Houston, TX, was approved for the treatment
of treatment-resistant depression by the U.S. Food & Drug Administration
in July 2005. VNS Therapy is also approved for use in Europe and Canada
for depression in patients with treatment-resistant or treatment intolerant
major depressive episodes including unipolar depression and bipolar disorder
(manic depression).
 What
is VNS?
The device is a totally implanted vagus nerve stimulator (VNS) for the
long-term treatment of chronic or recurrent treatment-resistant depression.
The device is to be used only in patients 18 years of age or over who
have failed to respond to at least 4 medication and/or ECT treatment regimens
prescribed by their physician. The device was initially approved in 1997
for epilepsy. To date, more than 30,000 patients have been treated with
VNS Therapy. Many of the patients with epilepsy who were treated with
VNS Therapy reported improved mood and subsequent clinical studies demonstrated
this improvement.
How does it work?
During a short, outpatient procedure, a pulse generator, similar to a
pacemaker, is surgically implanted just under the skin of the left chest
area and an electrical wire is connected from the generator to the left
vagus nerve. Once activated by the physician, the device sends precisely
timed and measured mild electrical pulses to the left vagus nerve. These
signals are in turn sent to the brain. To turn the stimulator off, the
patient holds a magnet over the generator. VNS Therapy modulates blood
flow and/or metabolism in many areas of the brain that are affected in
mood disorders.
How
effective is VNS Therapy?
This therapy may be required for several months before any benefit is
noticed by the patient. In a clinical study, during the first three months
of therapy, patients who had the device implanted and turned on did not
show any significant advantage over patients in whom the device was implanted
but not turned on. At one year, two or three out of every 10 subjects
had a clinically significant improvement in symptoms of depression with
about half that number having almost no remaining depressive symptoms.
Many of the patients who had a significant response within the first year
of treatment continued to have a similar degree of response through two
years.
| Vagus Nerve Stimulator (VNS) Therapy™ is a controversial treatment.
Its FDA approval and review in a psychiatric journal have come under
fire by the US Senate Committee on Finance, the Wall Street Journal,
and medical publications. Read why… |
Some patients, however,
had no improvement in symptoms and some actually got worse. This therapy
is intended to be given along with other traditional therapies, such as
medications and ECT, and patients should not expect to discontinue these
other treatments, even with the device in place. Patients will require
regular visits to their physicians for adjustments to their device and
other treatments.
Are there side effects?
The U.S. FDA reports that patients receiving VNS therapy may experience
various side effects including hoarse voice, cough, shortness or breath,
difficulty swallowing, and neck pain, some of which may persist as long
as the device is active. According to Cyberonics, Inc. VNS Therapy is
well tolerated and there are no drug interactions with VNS Therapy and
concurrent antidepressant medication.
Will my insurance cover VNS therapy?
Cyberonics, Inc. reports that through September 2006, case by case approvals
and/or reimbursement have been obtained from 248 different payers. Most
state Medicaid agencies have yet to develop their own coverage policy
for VNS Therapy for depression and a national coverage decision from Medicare
has not yet been developed. Cyberonics, Inc can provide you with information
specific to your state.
Source
U.S.
Food and Drug Administration
Cyberonics, Inc
More articles
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Senate
committee questions FDA approval process of VNS
US
Senate Committee on Finance.
Review of the FDA's approval process for the vagus nerve stimulation therapy
system for treatment resistant depression. February
2006.
…the events and
circumstances surrounding the FDA's review and approval of the VNS Therapy
System for TRD-including the rare involvement of the CDRH Director and other
high level FDA officials in the review of a device; the insistence of a
single official to continue review of the PMA-S despite the repeated recommendations
of over 20 FDA scientists, medical officers, and management staff to not
approve the device throughout approximately 15 months of review; a ''highly
irregular'' meeting between the sponsor and the FDA; and external pressure
from the sponsor as well as hundreds of health care providers and TRD patients
through letters, e-mails and phone calls-raise legitimate questions about
the FDA's decision to approve that device for the treatment of TRD.
In light of the significant scientific dissent within the FDA regarding
the effectiveness of the VNS Therapy System for TRD and the conclusion not
only of the review team for the sponsor's PMA-S but also of high level officials
in the FDA that the effectiveness data were weak, concerns persist that
the FDA's standard of reasonable assurance of effectiveness may not have
been met…
Is
this the perfect storm of corruption?
Alliance for Human Research Protection
July 19, 2006
The Wall Street Journal and Bloomberg News report about a case involving
Neuropsychopharmacology, the official journal of the American College
of Neuropsychopharmacology (ACNP) that will likely go down in history
as psychiatry's Watergate…
An article published in this, one of psychiatry's leading journals, purports
to review the scientific evidence for the efficacy and safety of a controversial,
experimental treatment for depression, called VNS (vagus nerve stimulation).
All eight prominent academic psychiatrists whose names are penned to the
article, failed to disclose their financial ties to Cyberonics, the manufacturer
of this controversial implanted device…
Vagus
Nerve Stimulation and Depression: Conflict of Interest's "Perfect
Storm"?
Psychiatric Times December 2006
A controversial treatment, an industry-funded article with no financial
disclosures, a ghostwriter, a lead author who is editor-in-chief of the
journal and who is later hired by the company funding the article, and
a lucrative order of 10,000 reprints—these were the potent ingredients
of what the New York Times recently termed an "egregious set of events"
that involved the journal Neuropsychopharmacology…
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