Also in the article a psychiatrist states that he has several patients
that he thinks would qualify for this "treatment" which have been un
responsive to drug and shock treatments. Did he ever consider that
since the patients were not responsive to the drug and shock treatments
that their depression is not a physical or neurological problem, but
actually a psychological problem? So instead of getting them to pull
their heads out of their asses, he would rather turn them into happy
little robots or mindless drones. Reminiscent of lobotomies. Not to
mention the fact that if it were a neurological problem, what good is a
psychiatrist? Not that they are any good to begin with. No, I don't
think all neurologists are ethical either.
Here is the article and link to the site containing it:
FDA approves implant against depression
By Daniel Rosenberg / Dow Jones Newswires
CHICAGO -- Cyberonics Inc. received U.S. Food and Drug Administration
approval Friday for a pacemaker-like treatment for depression, the
first such device.
The news comes after a long and twisted process that includes last
year's FDA decision to turn down the Houston-based company's
application, despite an earlier recommendation in favor of the device
by an FDA panel of medical experts.
Earlier this year, the FDA reversed course and told Cyberonics the
product was approvable, which in turn inspired an inquiry by the U.S.
Senate Finance Committee, which is ongoing.
Cyberonics' vagus nerve stimulation, or VNS, device for
treatment-resistant depression, or TRD, is the first implantable device
approved in the United States for treatment of depression. The FDA has
approved the device for long-term use in treatment of chronic or
recurrent depression for patients 18 years and over who are
experiencing a major depressive episode and who haven't had adequate
response to four or more adequate anti-depressant treatments.
"We believe TRD approval will prove to be a transforming event for 4
million Americans with TRD who get their first and only FDA-approved
long-term treatment option," Cyberonics Chief Executive Robert "Skip"
Cummins said in a telephone interview with Dow Jones Newswires before
the approval.
The approval also has a personal side for Cummins, who said two members
of his own family committed suicide after years of depression.
Cyberonics' device is implanted just under the skin in the left chest
area. It sends mild, intermittent electrical impulses through a wire to
the left vagus nerve, which in turn sends signals to the brain. The
cost is about $20,000 for the device and implantation. The device is
already approved for epilepsy and has been implanted in over 30,000
patients.
Cummins said Cyberonics, which has hired hundreds of new salespeople,
is ready to get the device into doctors' hands immediately.
"There's clearly an opportunity for $300 million in U.S. sales in the
first 12 months," he said, referring to sales of VNS for both epilepsy
and depression. The device received FDA approval for epilepsy in 1997.
In fiscal year 2005, Cyberonics had sales of $103.4 million.
Cummins noted that in trials, one in three patients had responded after
one year with the device and one in six had achieved remission. In
addition, roughly one in five to one in six patients was free of
depression after two years of treatment. Many of these patients had
failed 20 previous therapies with drugs and shock treatment. The trials
didn't find any major safety concerns with the device, though it can
cause mild side effects such as a hoarse voice.
The market for TRD, Cummins said, is large and growing. He estimates
there are 12 million patients worldwide with either depression or
epilepsy who haven't responded to treatment, and noted that diagnosis
of TRD has risen 700 percent over the last 10 years.
The challenge, Cummins said, is to get major insurance payers to adopt
the same coverage for depression as the company now has for epilepsy.
Within a year, he added, the company should have most of the private
insurers as well as Medicare and Medicaid "on board." Until then,
coverage will be a case-by-case decision.
Dr. John O'Reardon, assistant professor of psychiatry at the University
of Pennsylvania, said he has a number of patients who might be
candidates for VNS therapy. Such a device, he said, will help with
treatment adherence, which can be a challenge for depressed patients.
"That's the advantage of a medical device," said O'Reardon, who has no
connection with Cyberonics. "It helps patients stay on board with their
treatment ... I don't think VNS will fix everything, but it's one more
important tool to treat this tough-to-treat group."
Shares of Cyberonics fell 18 cents, or 0.4 percent, to close Friday at
$44.98 on the Nasdaq Stock Market.
http://www.detnews.com/2005/health/0507/23/healt-249544.htm
Death to spychotronic weaponry. All religions are conspiracies.
Pseudoscience is fraud. Big brother is paranoid. James M. Vierling
Jr.
Death to psychotronic weaponry. All religions are conspiracies.