Last week, I wrote about alternative therapies for post-traumatic stress disorder and got a number of very interesting responses. We’ll delve into some profoundly troubling research and some promising future remedies in the next few weeks.
But today’s 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. 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, Montana, where the founders raved about it.
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’ve been safely used by thousands of patients over the past 40 years.
By coincidence, Stars and Stripes also wrote about the controversy last weekend.
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.
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’t use previously conducted research. “FDA 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,” said the FDA in a statement provided me in lieu of an interview with the official who signed the order.
“They threw out all our studies, which left us with no research,” said Kirsch.
That’s 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’s Administration in that period, and the Army Office of the Surgeon General’s Pain Management Task Force recommended CES for pain management in 2010.
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. “I am reluctant to treat PTSD in our population without this tool in the mix,” 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.
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. “I like it for patients who’ve been on many drugs and you don’t want to give them another drug,” he said.
It’s 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. 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.
“We 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,” said the FDA’s statement.
“My feeling is, from the standpoint of the military, we’re facing what I’d say is an epidemic,” Xenakis told Stars and Stripes. “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.”
I couldn’t 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.