Last week, I wrote about alternative therapies for post-traumatic stress disorder and got a number of very interesting responses. We\u2019ll delve into some profoundly troubling research and some promising future remedies in the next few weeks.<\/p>\n
But today\u2019s column is about one of the therapies I mentioned last week, a small hand-held device called Alpha-Stim that clips onto each earlobe and blows an alpha wave across the brain.\u00a0 The alpha wave, the same wave produced during deep meditation, calms hyper-active patients and allows them to sleep. I saw it used at the Rimrock Foundation in Billings, Mont., where the founders raved about it.<\/p>\n
But my column drew an anguished blast from Dr. Daniel Kirsch, chairman of the board of Electromedical Products International, which produces Alpha-Stim. He charged that the federal Food and Drug Administration has been trying to shut down his product and others like it, which are called cranial electrotherapy stimulation (CES) devices, even though they\u2019ve been safely used by thousands of patients over the past 40 years.<\/p>\n
By coincidence, Stars and Stripes also wrote about the controversy last weekend.<\/p>\n
According to its article, the FDA has been regulating medical devices since 1976, but the Safe Medical Devices Act of 1990 required it to evaluate even devices that had previously been grandfathered in to determine which classification they should carry: Class I, II, or III. Class III is considered a life-sustaining or life-support device.<\/p>\n
The FDA concluded earlier this month that CES devices were Class III, which requires extensive and expensive trials for market approval. And it concluded that it couldn\u2019t use previously conducted research. \u201cFDA reviewed scientific literature provided by CES manufacturers and other available information, and concluded that the effectiveness of CES has still not been established by adequate scientific evidence,\u201d said the FDA in a statement provided me in lieu of an interview with the official who signed the order.<\/p>\n
\u201cThey threw out all our studies, which left us with no research,\u201d said Kirsch.<\/p>\n
That\u2019s a problem because CES sales to the military have grown steadily in the past five years. EPI has filled 3,000 prescriptions for the Department of Defense, Tricare and the Veteran\u2019s Administration in that period, and the Army Office of the Surgeon General\u2019s Pain Management Task Force recommended CES for pain management in 2010.<\/p>\n
According to Stars and Stripes, Jerry Wesch, director of the Warrior Combat Stress Reset Program at the Darnall Army Medical Center at Fort Hood, Texas, called CES a key component of PTSD treatment, as well as pain management. \u201cI am reluctant to treat PTSD in our population without this tool in the mix,\u201d he wrote the FDA, adding that about 80 percent of the 500 soldiers who completed the program had decided to continue to use CES devices during their follow-up treatment.<\/p>\n
Dr. Stephen Xenakis, a retired Army brigadier general and psychiatrist in Washington, D.C., told Stars and Stripes he had been prescribing CES devices for about two years. \u201cI like it for patients who\u2019ve been on many drugs and you don\u2019t want to give them another drug,\u201d he said.<\/p>\n
It\u2019s an issue that has come to public attention because PTSD and traumatic brain injuries are the signature injuries in our wars in Iraq and Afghanistan. According to the most recent Pentagon data, military doctors have confirmed traumatic brain injury in more than 244,000 of the 2.5 million troops who fought in those wars.\u00a0\u00a0 And the VA says that more than half the Iraqi\/Afghan vets are seeking medical help after returning from service and that half of them (28 percent of the returning 1.3 million vets) are seeking mental health treatment for PTSD, TBI or major depression.<\/p>\n
\u201cWe are working as expeditiously as possible towards final adjudication of these devices and the other remaining Class III pre-amendment device types to minimize uncertainty for industry and other stakeholders,\u201d said the FDA\u2019s statement.<\/p>\n
\u201cMy feeling is, from the standpoint of the military, we\u2019re facing what I\u2019d say is an epidemic,\u201d Xenakis told Stars and Stripes. \u201cWe\u2019ve got hundreds of thousands of people with problems with alcohol and misconduct and suicide risk, all those kinds of things. We\u2019ve got treatments that are safe that might work. We\u2019ve got to jump on it.\u201d<\/p>\n
I couldn\u2019t agree more. Sleep is the time when the brain repairs, rewires and heals itself. And a device that calms an agitated, anxious soldier down enough that he can sleep at night is a valuable tool.<\/p>\n
<\/p>\n
<\/p>\n
<\/p>\n","protected":false},"excerpt":{"rendered":"
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