Author’s Bias Evident in Political Review to Deny Benefits to Veterans

Rebuttal to:
Evidence Insufficient to Support Cranial Stimulation for Chronic Pain. PMN, July 26, 1018

The recent article titled, Evidence Insufficient to Support Cranial Stimulation (sic) for Chronic Pain, Pain Medicine News, July 26, 1018 was a summary of the review article published in the Annals of Internal Medicine titled, Benefits and Harms of Cranial Electrotherapy Stimulation for Chronic Painful Conditions, Depression, Anxiety and Insomnia (2018;168(6):414-421). The review was funded by the Veterans Administration’s Evidence Based Synthesis Program. The search strategy employed by the authors to locate studies appeared to be designed to provide an extremely biased sampling omitting the majority of the available published data. The report focused on studies which used devices that are no longer on the market while omitting most of the research relevant to the Alpha-Stim brand of cranial electrotherapy stimulation devices primarily used in the VA, DOD and civilian markets. Alpha-Stim is the only CES device on the Federal Supply Schedule for the DOD and VA.

The authors set arbitrary and capricious exclusion criteria in finding studies for their review, outside of the government’s definition of science, presumably to arrive at a preconceived position. The government’s actual definition of valid scientific evidence is “… when taken as a whole, is adequate to support a determination that there is reasonable assurance that the device is safe and effective for its conditions of use… (2) Valid scientific evidence is evidence from well-controlled investigations, partially controlled studies, studies and objective trials without matched controls, well-documented case histories conducted by qualified experts, and reports of significant human experience with a marketed device.” CFR Title 21, found here.

Many of the included 1970s studies on CES devices that have not been on the market in decades were held up to the much more rigorous 21st Century scientific standards to advise against the use of modern devices. Following this logic, the National Highway Traffic Safety Administration would not allow Cadillacs on the road today because the Model T Ford (circa 1908-1927) didn’t have seat belts or air bags. Why should the manufacturer of Alpha-Stim, Electromedical Products International, Inc., be held accountable in 2018 for 40 year old research on defunct products? What does that have to do with helping today’s Veterans recover from the trauma of war?

More than half of the VA Medical Centers have used Alpha-Stims and in 2017 more than 100 VA medical centers purchased Alpha-Stim devices for its patients. This article is completely at odds with the judgment and experience of licensed healthcare professionals who actually practice medicine in the VA. It reviewed a legal medical treatment used in the VA for decades independent of the people who actually use it in the VA who know exactly how well it works for the apparent purpose of denying them the right to prescribe it. It was an obvious attempt to cut off these purchases. Not one person who uses Alpha-Stim within the VA was contacted by the authors. The report was successful at stopping all VA’s from purchasing Alpha-Stims for two weeks. Within that time frame so many VA practitioners complained about this junk review of science that 75% of the VA’s were promptly provided waivers. Soon after 100% of the business was reinstated.

One clear cut example of the bias in this review is seen where they dismiss COL Lande’s study at Walter Reed National Military Medical Center by falsely stating that “There was no significantly significant differences between groups…” thus completely misrepresenting the study as proof that CES does not help Service Members. That is clearly not what the author published and if they bothered to check with him they would have found that Alpha-Stim CES is the most used CAM modality at Walter Reed. Are the authors claiming they are more knowledgeable about this treatment than psychiatrists who use it at America’s foremost military hospital? The study actually reported that there were significant findings on days 1 and 4 of the five days and a clear trend towards significance on the fifth day in men. Are pharmaceuticals found to increase sleep on the very first day of use and every day thereafter? Even if that were true, the risk/rewards ratio for sleep drugs is awful and impedes Service Members ability to carry out missions, while CES is very safe and never disables Service Members like drugs. Most importantly the spread between the treatment group and sham treated group in this Service Member study was over an hour of sleep time in this population that only sleeps a few hours a night if that. So how can a one-half to one-third increase in sleep time be described as no difference? And the study was conducted over just five days although we urged them to do it for 3-6 weeks because it was in a partial hospitalization program. That means that the Service Members had serious comorbidities that could impair CES results in such a short study (and even then only 44 of the 57 completed the 5 days). Nevertheless, if the authors did an honest review of this study they would have said there were most certainly significant differences between the groups. Except in females, although this is the first time any CES research reported a gender bias. Females Service Members might need to undergo this treatment longer to get results. Besides five days being inadequate, there were only 11 females in the 57 subject study. Here is an honest review, in part:

The total time slept approached significance (p=0.079) on day 5 in favor of the active CES group. The active CES group average about 43 extra minutes’ total sleep time while the sham CES group subjects reported an average of 19 minutes less sleep time.  A gender difference also emerged. Men in the active CES group who completed 5 sessions of CES reported a significant improvement in total time slept at two points in the study, after the initial (p=0.04, d=0.41) and after the fourth (p=0.03, d=0.49) treatments as compared to men in the sham group. There were no significant changes among the females.

If the authors merely followed the FDA’s definition of valid scientific evidence in CFR Title 21 and limited their review to devices currently on the market, or preferably the Alpha-Stim alone as it is the one used at VA’s nationwide they would have come to a completely different conclusion.

The manufacturer, Electromedical Products International, Inc., loans Alpha-Stim devices to interested researchers who have attained IRB approval but has yet to fund a single study. All Alpha-Stim studies, including many RCT’s done by the US Army and VA’s and American Universities are online here.

An honest, comprehensive review titled, Scientific and Clinical Literature Examination is also available by request. This document, prepared for and scrutinized by the European Device Directives and used for the FDA and other regulatory agencies, contains a brief history of cranial electrotherapy stimulation, a section on mechanisms specific to the patented Alpha-Stim therapy that includes 3 fMRI studies, A LORETA study and several EEG studies, a graphical summary of all the research followed by annotated abstracts of all the studies which report on the indicated uses of anxiety, insomnia, depression and pain. The document also contains results from published peer reviewed Alpha-Stim Service Member and Veteran Surveys which polled active duty and veteran Service Members on if they found the Alpha-Stim effective for their treatment of anxiety (90%), PTSD (63%), insomnia (81%), depression (78%), pain (65%) and headaches (78%). These surveys also contained questions about safety and side effects with the responds overwhelmingly (99%) reporting that they felt the device was safe and effective.

In obtaining a complete picture of the safety and efficacy for CES devices, it is important to note that the current 8th generation Alpha-Stim uses a patented waveform. Drugs with different chemical makeups produce different effects and side-effects and the same is true for CES devices. This distinction was repeatedly validated in court when EPI won five lawsuits against companies who copied the technology. The distinction in waveforms between device brands means that a CES device can only claim efficacy and safety from studies which used that particular device and that particular waveform. The Scientific and Clinical Literature Examination contains 24 randomized placebo controlled trials and 12 open-label and case studies that all used Alpha-Stim as the treatment devices. The latest study published in February 2018 conducted at the University of Texas MD Anderson Cancer Center reported significant improvement in BPI pain (p=0.13), PSQI daytime dysfunction (p=0.002), HADS anxiety (p<0.001), ESAS anxiety (p=0.001), HADS depression (p=0.024), ESAS depression (p=0.025), PSQI daytime dysfunction (p=0.002), and medication use (p=0.006) among advanced cancer patients after 4 weeks of use.  (Yennurajalingam S, Kang D-H, Hwu W-J, et al. Cranial electrotherapy stimulation for the management of depression, anxiety, sleep disturbance, and pain in patients with advanced cancer: a preliminary study. Journal of Pain and Symptom Management.  2018; 55(20):198–206.)

Many VA patients are actively seeking non-addictive, safe and effective treatment options for anxiety, insomnia, depression and pain. In the literature review performed by the Evidence-based Synthesis Program no significant adverse events or serious side effects were found. These findings are consistent with EPI’s safety report to the FDA on February 10, 2012 which found no serious adverse events and the most common adverse events (<1%) were both mild and self-limiting: skin irritation at the site of the electrodes in very light skinned individuals, dizziness and headache. Both dizziness and headache occur when the current is set too high for the individual and these symptoms generally subside when the current is decreased. The Scientific and Clinical Literature Examination also contains a more in-depth safety summary.

It is unfortunate and certainly of no benefit to Veterans that the authors have published a junk science review to support a predetermined political conclusion to deny benefits to Veterans for the benefit of the pharmaceutical industry.

If the VA is actually seeking non-addictive, safe and effective treatments for anxiety, insomnia, depression and pain, and a solution to the opioid epidemic, then a review regarding the benefits and harms of a treatment should consider all valid scientific evidence without bias, especially when no safety issues exist.  That would be a true review of the benefits and harms of CES in 2018.

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