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Doing the right thing.

This past summer, a landmark study published in The Journal of the American Medical Association determined that Risperdal and other popular anti-depressants were ineffective in treating soldiers suffering from Post Traumatic Stress (PTS). Despite this evidence, standard practice in the VA is that nearly 90% of veterans with PTS treated with drugs are prescribed these medications, often at the exclusion of innovative non-drug therapies available to the civilian population.

Repetitive Transcranial Magnetic Stimulation, also known as rTMS, is one non-drug therapy. The published research on rTMS is impeccable, some of the best in the non-drug therapy industry (full disclosure: rTMS is a competing technology to my own company's tech, so my praise is hard won. rTMS manufacturers have done a terrific job proving their effectiveness). rTMS treats depression by utilizing powerful magnets close to the head that stimulate neurochemical production. It has been shown to produce better results than placebo when treating patients suffering from Major Depressive Disorder and is approved by the FDA. The downside is that patients need to travel to a psychiatrist's office and sit in a special chair as the doctor positions the magnets and operates the machine. A series of rTMS treatments costs patients $8,000-$12,000 out of pocket and comes with no guarantee of effectiveness. As you can imagine, manufacturers of rTMS have raised enormous amounts of venture capital--not surprising when you have a product that costs doctors $70,000 plus expensive service contracts and costs patients $8,000-$12,000. Given the millions of veterans from multiple wars who suffer from PTS related depression (500,000 vets from Iraq and Afghanistan alone suffer from neuropsychiatric conditions), the cost of treating them with rTMS could run into the tens of billions of dollars. This is simply not economically feasible at a time when budgets are being cut in every sector of government and charitable giving is on the decline.

Regardless, the Risperdal study demands that effective non-drug therapies be made available to returning soldiers on a large scale, because drugs simply aren't working.

This is where my personal bias comes into play. My company, Fisher Wallace Laboratories, and handful of other manufacturers are beginning to offer soldiers an affordable alternative to rTMS and pharmaceutical drugs for the treatment of depression, anxiety and insomnia. Fisher Wallace Laboratories manufactures a portable, home-use medical device called the Fisher Wallace Stimulator that delivers a gentle electrical current instead of using big magnets to stimulate neurochemical production (primarily GABA, serotonin and beta-endorphins). By increasing GABA in the brain, we are mimicking the effect of Ambien without the side effects, addiction and feeling of sedation one often gets with Ambien in the morning. As with rTMS, the worst side effect you can get is a headache or some dizziness. Compare that to the list of possible antidepressant side effects, such as severe nausea and suicidal thoughts.

The best part is that the technology--called Cranial Electrotherapy Stimulation (CES)--works so well. So much so, that Fisher Wallace Laboratories can afford to offer patients a 60-day return policy: if the device doesn't successfully treat their symptoms, they can return it within 60 days for a refund. The price for a Fisher Wallace Stimulator is $695, retail, and $495 for veterans and active duty service members.

[ILLUSTRATION OMITTED]

That's my elevator pitch. But there's a lot more than my own words backing this up. Cranial Electrotherapy Stimulation has had FDA clearance since 1991, and a long track record of safety and effectiveness. There are scores of quality studies that have been published on it, albeit not of the same size and scope that rTMS manufacturers have been able to afford for their technology.

CES manufacturers are not as attractive to venture capitalists because we don't offer doctors the same kind of profitable business model that incentivizes doctors to put patients into rTMS chairs. We sell 99% of our devices to the end user, the patient, and provide a relatively inexpensive treatment option. We make a modest profit on the margin we make on each device, not expensive service plans (we offer a free five-year manufacturing warranty) and the only add-ons patients buy are sponges and batteries--not exactly high ticket items. As a result, we are in a disadvantaged position to compete politically and economically against rTMS. But we are an ally of the taxpayer, who will ultimately foot the bill of any non-drug treatment options offered to returning soldiers.

Retired army psychiatrist, Brigadier General Stephen A. Xenakis, sits on our volunteer medical advisory board. He held a wide of variety of assignments as a clinical psychiatrist, staff officer, and senior commander including Commanding General of the Southeast Army Regional Medical Command. Dr. Xenakis has written widely on medical ethics, military medicine, and the treatment of detainees. He recently wrote a Letter to the Editor at the New York Times that was never published--here's an excerpt:
      After many years and billions of dollars, there has been
   little progress in finding and testing promising new treatments
   and diagnostic tests. The current record of experience
   is much like what we saw in the 1970s after Vietnam
   before we even had a label for PTS. Standard treatment has
   been trial and error, and helps in some cases and fails in
   others. Alternatives do exist, but we have had to go outside
   of the bureaucracies of the VA and DoD to test them. As a
   former Senior Adviser to the Chairman of the Joint Chiefs
   of Staff, I advocated for testing alternative tools--such as
   quantitative electroencephalography (qEEG) for diagnosing
   and prescribing, and cranial electrostimulation for treating
   symptoms--and confronted stifling delays. Alternative to
   drugs and smarter prescribing need to be examined closely
   now. Many patients do not like the side effects and will
   stop taking the drugs, and the new SGAs can produce serious
   adverse effects. I have called for a "surge" campaign to
   develop new and better treatments for the emerging
   "Agent Orange" syndrome of our day. Business as
   usual isn't enough. We owe it to the men and women
   who served to go outside of our comfort zone--they
   already have.


In another recent letter, the retired Director of the Defense Centers for Excellence, Colonel (ret.) Robert Saum, recently recommended that the military explore the potential of our technology in treating soldiers:
   During my tenure at the Defense Centers of
   Excellence, which included serving as its Director, I
   was responsible for evaluating numerous methodologies
   for the treatment of PTS and other combat
   related medical conditions. The Fisher Wallace
   Stimulator was a device that attracted my attention
   towards the very end of my tenure, primarily for its
   demonstrated success in treating depression, anxiety,
   insomnia and chronic pain without the use of
   drugs or serious side effects.

   I am aware of an insomnia study now being planned
   for Fort Carson and hope the Fisher Wallace Stimulator
   will be used in the study. The reports I gathered indicate
   that the device has FDA clearance, a long track
   record of patient safety and well-documented effectiveness.
   The device is also portable and reasonably
   priced. Its potential success for our military population
   is promising and should be thoroughly evaluated.


And I want to share one more letter, this one from Dr. Richard Brown, Associate Professor of Psychiatry at Columbia University College of Physicians and Surgeons. In it he describes why CES is a successful treatment modality for sufferers of Post Traumatic Stress:
      In Post-traumatic Stress disorder (PTS), the stress
   response system malfunctions with excess sympathetic
   activity and subnormal parasympathetic activity.
   This imbalance in the nervous system leads to
   high levels of stress, anxiety, anger, over reactivity,
   poor judgment, impulsivity, and difficulty sleeping.

      The Cranial Electrotherapy Stimulator (CES)
   induces a calmer, more meditative pattern of brain
   waves. It also stimulates the parasympathetic part of
   the nervous system which counteracts the stress
   response. Therefore, it calms both the body and the
   mind. This reduces the physical symptoms of PTS
   such as rapid pulse, shaking, sweating, or a knot in
   the stomach. It also addresses psychological symptoms
   by reducing anxiety, restlessness, agitation,
   anger, depression, and sleep problems. Furthermore,
   the improvements in emotion regulation reduce the
   risk of inappropriate impulsive, aggressive behaviors.

      Use of the CES releases gamma amino-butyric acid
   (GABA), the brain's major anxiety reducing neurotransmitter.
   In addition, it releases serotonin, which
   inhibits inappropriate actions. Moreover, it releases
   beta-endorphins, which tone the stress response system
   and induce peaceful, positive mood states, thereby
   reducing the need to use substances of abuse.

      As a noninvasive, easy to use procedure with minimal
   side effects, the CES device has significant therapeutic
   value in the treatment of PTS.


The decades of research that have been performed on CES is convincing--much of it double blinded and with a placebo /sham device. In 2009, the nation's leading non-profit drug and alcohol rehabilitation facility, Phoenix House, performed a pilot study with our device. Keep in mind that 21% of PTS patients are substance abusers, so the relevance to that population is profound. Phoenix House studied nearly 400 patients to determine whether using our device on new patients--heroin and cocaine addicts specifically--had any impact on retention ("retention" meaning whether the patients stayed in rehab as opposed to dropping out). The results were staggering. Patients who were treated with our device had 50% higher retention after 90 days than those who were not treated without device. Patients treated with our device also showed major decreases in anxiety and insomnia.

Fisher Wallace has a half dozen research projects currently underway, including one at Samaritan Village in collaboration with NYU and Columbia University in which we are following up on the Phoenix House research with a more robust analysis. We are also performing research at McLean Hospital (Harvard Medical School), a pilot study of civilian patients with PTS and its treatment with CES, with Scott Lukas, Chairman, Center for Neuroimaging, McLean Hospital, Harvard Medical School, Belmont, Massachusetts.

In short, CES has proven itself as a safe, effective and affordable non-drug treatment option for depression, anxiety and insomnia--especially among substance abusers--and we remain on the cutting edge. I sincerely hope to see the military embrace CES in the future--it will help a lot of soldiers while saving a lot of taxpayer money.

I hope you have found this information helpful. If you have any questions or comments, please email me at chip@fisherwallace.com.

NOTE FROM EP:

THE VIEWS AND OPINIONS SET FORTH IN THIS ARTICLE BY MR. FISHER ARE NOT THE VIEWS AND OPINIONS OF EP AND WE NEITHER AFFIRM NOR DENY THEIR EFFICACY. HOWEVER, THE PRESIDENT AND CEO OF EP HAS USED THE CES DEVICE, AND CAN INDICATE THAT THERE ARE MERITS IN THIS THERAPY WORTHY OF MORE RESEARCH AND CONSIDERATION. THE THERAPEUTIC INSIGHTS PROVIDED BY THOSE REFERENCED IN THIS ARTICLE ARE ACCURATE AS THEY ARE PRESENTED IN THE ARTICLE, AND WHILE EP NEITHER ENDORSES NOR RECOMMENDS ANY PRODUCT OR SERVICE IN THE TREATMENT OF PTSD AND OTHER RELATED CONDITIONS, THIS NON-DRUG THERAPY DOES SEEM WORTHY OF FURTHER CONSIDERATION.
COPYRIGHT 2011 EP Global Communications, Inc.
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2011 Gale, Cengage Learning. All rights reserved.

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Title Annotation:United State Military Section; Repetitive Transcranial Magnetic Stimulation
Author:Fisher, Charles Avery
Publication:The Exceptional Parent
Geographic Code:1USA
Date:Nov 1, 2011
Words:1823
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