FDA Impedes Company with Medical Device Mostly Used By Recovering Veterans

By: Rachel Blevins Jun 20, 2014

  

Mineral Wells, TX – Last week, a publication in the Federal Register brought a glimmer of hope to a company that has been fighting for proper recognition and classification from the United States Food and Drug Administration for the last 33 years.

Electromedical Products International, Inc. or EPI, was founded by Dr. Daniel L. Kirsch in 1981. The premise of EPI revolved around the Alpha-Stim, a Cranial Electrotherapy Stimulation (CES) Device. It was originally cleared by the US FDA to treat the conditions of anxiety, insomnia, and depression. However, EPI ran into problems with the FDA, when it came to classifying their device.

While the Alpha-Stim is sold over the counter in Europe and Canada, the FDA in the United States has limited it to only being available to patients, by or on the order of a licensed healthcare practitioner. Also, whereas the Alpha-Stim is classified as a Class II device, according to the regulatory authorities in Europe and Canada, it is classified it as a Class III device in the United States. The main difference is that at Class II, the Alpha-Stim is subject to special controls, while at Class III, it is subject to the Pre-Market Approval Process.

According to EPI’s President, Tracey B. Kirsch, “Arbitrary actions by FDA were first experienced by EPI in 1990 for its 510(k) submission for CES indications. This statutorily mandated 90-day review process took 22 months, and more than once during this lengthy process FDA would request more valid scientific evidence to support the application on the 89th day of review, thereby restarting the FDA’s 90-day clock.”

It wasn’t until May 12, 1992, that EPI received its substantial equivalence letter from the FDA. “Years of hard work and substantiation had finally been completed, or so we thought,” said Mrs. Kirsch.

In 1993, the FDA issued a proposed rule to reclassify CES devices, which was finalized in 1995. EPI complied, and submitted a Pre-Market Approval, or PMA, in November of 1995, for its Alpha-Stim CES technology. EPI received a refuse to file letter in the following month, in which the FDA claimed that EPI’s PMA did not contain the required information, therefore the application could not be filed and EPI would have to cease distribution of its CES technology.

In 1996, EPI filed suit against the FDA in Federal District Court, and in 1997 there was a Federal Register notice published which revoked the FDA 1995 regulation requiring PMA’s for CES devices. This allowed commercial distribution through 510(k) clearances. According to Mrs. Kirsch, “There was no reason given for this revocation.”

“EPI was allowed to market and distribute its CES products in relative peace from 1998 until 2009, when FDA requested CES manufacturers again provide their research to FDA so that a proper final classification could be made,” said Mrs. Kirsch.

In 2012, representatives from EPI were called before with the Neurological Devices Panel of the Medical Devices Advisory Committee to the FDA. The FDA wanted to keep CES devices in Class III, but EPI presented their safety and effectiveness data in an attempt to reclassify the Alpha-Stim to a Class II device.

The FDA published a Proposed Rule in 2011, and then, after ignoring EPI’s compliance, they published a similar mandate in 2013, this time a “Proposed Order.” EPI responded with over 300 letters, filled with practitioner and patient testimonials. Sixteen of those letters were written by Dr. Kirsch, himself.

The subject matter in Dr. Kirsch’s letters ranged from wanting to know why the FDA was supporting studies that turned anonymous individuals into experts on the Alpha-Stim, to accusing the FDA of discarding 360 of the 392 studies on Cranial Electrotherapy Stimulation that were presented to the Neurological Devices Panel.

Dr. Kirsch wrote that the FDA had left the Neurological Device Panel with “no useful data upon which to make their recommendation as to effectiveness of CES in the treatment of anxiety, insomnia and depression.” He went on to write, “We ask that FDA review all of the valid scientific evidence and present it to the Neurological Devices Panel in a fair and unbiased manner so that the Petitions for Reclassification submitted on behalf of CES devices can be adequately considered.”

In the same Proposed Order where the FDA demanded that all Cranial Electrotherapy Stimulation devices be classified as Class III devices, it also suggested reclassifying sorbent hemoperfusion devices for the treatment of poisoning and drug overdose, from Class III into Class II.

One of the largest things setting the two devices apart were the side-effects. While sorbent hemoperfusion devices had side effects such as blood loss, platelet loss, and Leukopenia, CES devices had a much smaller list, which included side effects such as headaches and skin irritation.

“We feel it is appropriate to highlight the standards FDA has imposed on CES manufacturers in FDA’s review of their petitions to reclassify CES as a Class II device and compare that with the standards imposed by FDA in its review of sorbent hemoperfusion devices,” explained Dr. Kirsch. “A review of the standards imposed for each device shows a clearly arbitrary and inconsistent process of review which FDA is implementing in its determination of a device’s classification.”

In regards to the Cranial Electrotherapy Stimulation Devices made by EPI, Dr. Suresh Kotagal, a member of the Neurological Devices Panel in 2012, said, “I just have a very simple comment, that the device is safe. There is really no convincing evidence of any potential adverse effects.”

The long, continuous battle has taken a toll on Dr. Kirsch. He told Benswann.com, “Every day for over 20 years when I woke up in the morning I worried what the FDA may do to us. Indeed they did a lot. I often thought I lived in a nightmare version of the movie Groundhog Day.”

The recent publication in the Federal Register showed that the FDA was finally taking steps to accept the multiple reclassification petitions submitted by EPI to put CES devices into their proper category. Dr. Kirsch sees this as great news, which will lead to removing uncertainty from EPI’s future. ”Now while they still will regulate us with a harsh hand, they can not just make our 33 year history go away ever again and force us to start over,” said Dr. Kirsch.

Currently, the largest customer of the Alpha-Stim is the United States Government. The US Department of Defense and Veterans Affairs Medical Centers accounts for over 60% of EPI’s sales, using the CES Devices primarily for treatment of depression, anxiety, insomnia, and Post-Traumatic Stress Disorder. “More than half our business is with the same government that has lied and ignored their own rules to try to run us out of business,” acknowledged Dr. Kirsch.

Army Reserve Psychology Consultant, Dr. Kathy Platoni, testified, “In my experience, without exception, there is no more powerful form of therapeutic intervention, either as an adjunct or a stand alone treatment than Alpha-Stim CES.”

Dr. Kirsch tells Benswann.com that he looks forward to the majority of EPI’s profits no longer going to staying in business, but rather to more productive uses such as helping our Service Members come all the way home. “The FDA finally doing the right thing means more Service Members and Veterans will regain their optimism for life and more insurance companies will pay for Alpha-Stim,” said Dr. Kirsch.

Dr. Kirsch believes that the spreading of Alpha-Stim technology will lead to America becoming a safer place, due to the fact that the Alpha-Stim is a safe alternative to using anti-depressant drugs, which, according to the International Coalition For Drug Awareness, not only have horrendous side effects, but are also the main cause of all the school, church and mall shootings we have seen since there drugs became popular.

“Perhaps Alpha-Stim can now achieve my personal goal to make America a safer, kinder and happier place for all freedom-loving people,” said Dr. Kirsch.

See source article at www.benswann.com...

NEW STUDY: Cranial electrical stimulation (CES) and insomnia

Efficacy of cranial electric stimulation for the
treatment of insomnia: A randomized pilot study

R. Gregory Lande, Cynthia Gragnani
Click here for full study. 

Summary
Objectives: This pilot study examined the potential efficacy of cranial electric stimulation for
the treatment of insomnia.
Design: The researchers tested the hypothesis through a randomized, double-blind, and placebo
controlled clinical trial. The researchers approached eligible subjects who scored 21 or above
on the Pittsburgh Insomnia Rating Scale. The researchers then randomly assigned the subjects
to receive either an active or sham device. Each study subject received 60 min of active or
sham treatment for five days. Following each intervention the subjects completed a sleep log,
as well as three and ten days later.
Setting: The researchers conducted the study among active duty service members receiving
mental health care on the Psychiatry Continuity Service (PCS), Walter Reed National Military
Medical Center in Bethesda, MD.
Main outcome measures: The study’s primary outcome variables were the time to sleep onset,
total time slept, and number of awakenings as reported by the subjects in the serial sleep logs.
The researchers identified a nearly significant increase in total time slept after three cranial
electric stimulation treatments among all study subjects. A closer examination of this group
revealed an interesting gender bias, with men reporting a robust increase in total time slept
after one treatment, decay in effect over the next two interventions, and then an increase
in total time slept after the fourth treatment. The researchers speculate that the up and
down effect on total time slept could be the result of an insufficient dose of cranial electric
stimulation.

Published by Elsevier Ltd

Click here for full study.

Sept. newsletter from American Institute of Stress

The September issue of the American Institute of Stress newsletter is fully dedicated to PTSD and the treatment of this tragic disease. Click here to read the full Issue.

Looking to treat your or your family member's PTSD? Go to www.beginhealing.com to read more about cranial electrical stimulation (CES) and how it can help. 

Military Spouse "Silencing the Stress" - Alpha-Stim success story

Helping our active duty service members and veterans is a top priority for Begin Healing so I am happy to share with you the most recent news article on Alpha-Stim in Military Spouse. "Silencing the Stress" provides a detailed report on the success of Alpha-Stim. 

Use of Alpha-Stim at NICoE

National Intrepid Center of Exellence (NICoE) talks about some of the modalities utilized there. Cranial electrotherapy stimulation (CES) and microcurrent electrical therapy (MET) are mentioned under complementary medicine.

http://www.nicoe.capmed.mil/Shared%20Documents/CAM_Fact%20Sheet_FINAL_06%2018%2012.pdf

Are We Too Shallow About Drugs to Truly Help Vets With PTSD?

by Kevin Bell

Researcher, Army Veteran

Seven months ago, PFC Sonny Mazon opened my eyes to the tragic link between depression, drugs, incarceration, and suicide in the military community.

I had been so naïve. Of course, during the deployment many of us swapped stories of comrades abusing prescription drugs like Ambien while overseas, and I had a vague sense that this would get worse when my platoon returned home in 2009. Even so, I never expected that almost 2 years after I left the Army I would still be receiving tragic news about my soldiers, their families, and the ending that awaits those who never get the help they need.

click here to continue reading on the Huffington Post site...

Promising PTSD treatment faces hurdle (Stars and Stripes)

By WYATT OLSON

Stars and Stripes
http://www.stripes.com/news

Published: August 19, 2012

Devices such as Electromedical Products 

International’s Alpha-Stim M are used to 

administer cranial electrotherapy stimulation 

treatment for troops suffering from PTSD.

COURTESY OF ELECTROMEDICAL PRODUCTS 

INTERNATIONAL, INC.

YOKOTA AIR BASE, Japan — For decades, Ed Gaumer’s restless sleep was plagued with snippets of dreams arising from his three tours in Vietnam as a Marine in 1967-70. By day, he was hyper-alert to certain smells and sounds, any of which might leave him breathless and scanning for threats.

They were classic symptoms of post-traumatic stress disorder, and by 2005 the flashbacks were interfering with his civilian job for a Defense Department agency that provided logistical support for overseas operations.

Based at Wright-Patterson Air Force Base near Dayton, Ohio, Gaumer began seeing a psychologist who had experience treating soldiers in combat zones, who introduced him to cranial electrotherapy stimulation, or CES, a treatment she used on combat-stressed soldiers in Iraq.

“For 40 years I’d been kind of chasing the things in my flashbacks. I’ve finally been able to put them to rest so I can move on,” Gaumer said, crediting CES.

While CES worked for Gaumer, others might not get the chance to see whether they respond to the treatment.

An FDA panel recommendation to change the classification of CES devices could take them off the market until lengthy and expensive testing is completed.

The possible delay comes at a time when there is no single magic-bullet therapy for the symptoms of PTSD — including anxiety, depression, insomnia — and a growing number of doctors are turning to alternative methods like CES to treat servicemembers and veterans.

Researchers found that CES activates and deactivates certain parts of the brain via micro-electrical current delivered by a device resembling a smartphone with ear buds.

Although the mechanisms of how CES works aren’t fully understood, mental health professionals who advocate its use say that it is easily folded into any treatment regimen because there are no serious side effects or harmful interactions with prescription drugs and other therapies. Most devices cost between $500 and $1,500.

The owner of the largest producer, Texas-based Electromedical Products International, said the technology has been proven safe and effective on thousands of patients while on the market for 40 years. But now, a U.S. Food and Drug Administration panel has recommended changing the classification of CES devices — a move that could take them off the market pending lengthy, expensive testing.

Col. Dallas C. Hack, director of the Army Combat Casualty Care Research Program at Fort Detrick, Md., told Stars and Stripes that the prevalence of CES treatment in the military is “moderately widespread,” but its use depends mainly on whether a particular practitioner has adopted it.

In January, Hack sent a letter to the FDA on behalf of the Army requesting expedited review of CES because “continued and uninterrupted availability of these devices for further study is in the best interest of patients.” The letter noted that a Veterans Affairs study found “limited efficacy of drugs in the treatment of depression in soldiers who are suffering from PTSD.”

An alternative to drugs

Sales of CES devices to the military have grown steadily since 2007.

EPI, whose Alpha-Stim brand dominates the industry, filled 3,000 prescriptions for the device for the Department of Defense, Tricare and the Veterans Administration from 2007 to mid-2011, according to company data submitted to the FDA.

The Army Office of the Surgeon General’s Pain Management Task Force in 2010 recommended CES for pain management.

CES is a key component of PTSD treatment in the Warrior Combat Stress Reset Program at the Darnall Army Medical Center in Fort Hood, Texas, according to a letter submitted to the FDA by program director Jerry E. Wesch. CES is particularly useful in suppressing hyper-arousal and improving sleep, Wesch wrote, noting his comments did not reflect Army policy.

The program also uses CES to treat pain and headaches, “a real boon for the many combat soldiers in our program who have chronic neck, back and joint pains.”

“I am reluctant to treat PTSD in our population without this tool in the mix,” he wrote, adding that about 80 percent of the 500 soldiers completing the program had opted to use CES in their follow-up plan.

Kathy Platoni, the Ohio clinical psychologist who treated Gaumer, is an Army Reserve colonel and a psychology consultant to the chief of the Medical Service Corps. She has used CES extensively during deployments in Iraq and Afghanistan.

The devices were routinely used to lessen symptoms typically arising from PTSD: insomnia, irritability and outbursts of anger, lack of concentration and feeling “jumpy.”

“Medications in many cases render soldiers mission incapable,” she said. CES “allows soldiers to function without medications that might impair them.”

Gaumer, who now lives in Akron, compares the immediate after effects of CES to the elation felt after intense exercise. “You feel good. You feel light on your feet,” he said.

There is a slight tingling sensation at the connection points, which is on the earlobes for the model Gaumer uses. He said he knows the current is a notch too high if he feels pressure on his temples.

At first, he used it daily, often during his “talk therapy” sessions with Platoni. He began sleeping better and started understanding the origin and nature of his flashbacks.

“What happens is that these little flashes of memory are hidden in your mind,” he said. “You’re trying to figure out what’s real and what’s not. I did that for years.”

CES, he said, “kind of opened up some of that so that I can finally start walking back in time and finding out why some things bother me more than others. That was part of the healing.”

Most users feel the effects of CES after one use, but lasting benefits normally come only after repeated, regular use.

Studies on CES suggest that the microcurrent stimulates certain nerve cells in the brain stem that produce chemicals called serotonin and acetylcholine. Those chemicals act on the nerve cells throughout the brain and nervous system.

Various levels of CES micro-current have been found to alter alpha brain waves, sometimes activating areas, shutting down others. Those zones are apparently responsible for feelings of agitation, anxiety, depression and physical pain in some people.

Dr. Stephen Xenakis, a retired Army brigadier general and psychiatrist in Washington, has been prescribing CES for about two years.

“I like it for patients who’ve been on many drugs, and you don’t want to give them another drug,” said Xenakis, who sits on the medical advisory board for Fisher Wallace Laboratories, a maker of CES devices. He said he is not paid by the company and owns no stock in it.

“Anxiety makes pain feel worse,” he said. “And, of course, if you have pain, then you feel more anxious — or you feel depressed about it. All these things interact.”

FDA steps in

The FDA began stringent regulation of medical devices in 1976, although many that were in use at the time were “grandfathered” in without broad testing. The Safe Medical Devices Act of 1990 required the FDA to re-examine those grandfathered devices to determine what classification they should carry — Class I, II or III. Class III devices are considered life-support or life-sustaining, such as pacemakers.

In February, an FDA panel proposed formally categorizing CES devices as Class III, which would require extensive trials for market approval. Although acknowledging the device posed no serious risks — some users have reported headaches, and it’s advised that people with epilepsy not use it — the panel disregarded dozens of studies published in medical journals indicating varying levels of effectiveness.

“They threw out all our studies, which left us with no research,” said Daniel L. Kirsch, chairman of EPI.

Explaining their elimination, the panel’s report concluded: “The reviews that FDA has performed on the data have demonstrated that while there is an abundance of published literature on the use of CES for the treatment of anxiety, depression and insomnia, the studies have limitations that preclude favorable interpretations of the effectiveness results, even if those results are mostly positive.”

The watchdog group Public Citizen submitted a letter to the FDA supporting its proposed reclassification. It urged the FDA to require “rigorous, well-designed, controlled, double-blind clinical trials” for all CES devices. The group wrote that the device’s most serious risk was “a worsening of the condition being treated due to the ineffectiveness of the device.”

Xenakis, like other CES proponents, said that no competent doctor would stick with a treatment that wasn’t working when others were available. “In my practice I like to only make one or two changes in treatment at a time to figure out what’s working or not working,” he said.

In a letter to FDA Commissioner Margaret Hamburg, EPI complained that the review panel had not followed federal regulations that define valid scientific evidence as including “well-documented case histories conducted by qualified experts” and “reports of significant human experience with a marketed device.”

Xenakis questions the wisdom of the FDA taking any action that would remove a therapy option with so many servicemembers returning from Iraq and Afghanistan with PTSD and other emotional disorders.

“My feeling is, from the standpoint of the military, we’re facing what I’d say is an epidemic,” Xenakis said. “We’ve got hundreds of thousands of people with problems with alcohol and misconduct and suicide risk, all those kinds of things. We’ve got treatments that are safe that might work. We’ve got to jump on it.”

olsonw@pstripes.osd.mil