In August of 2011, we asked that practitioners and patients who use Alpha-Stim for CES purposes (i.e., anxiety, insomnia and/or depression) provide the Food and Drug Administration (FDA) with a letter stating how you use Alpha-Stim, how beneficial you find the device to be and if you believe it is safe. We were blown away by the support we received at that time. Since then we have been waiting for the FDA commissioner to rule on the comments FDA received from practitioners, the public and manufacturers of CES devices, as well as the reclassification petition we submitted, as we await a final classification ruling from FDA on CES devices.
On April 4, FDA requested additional public comments on the classification issue for CES. It has long been the position of Electromedical Products International, Inc. (EPI) that Alpha-Stim devices are safe and effective, and therefore should not be Class III devices. If you are familiar with the FDA’s classification system then you know Class III was intended to be reserved for medical devices that cannot establish adequate controls to assure safety and efficacy and are life-supporting or life-sustaining. Alpha-Stim has been on the market for over thirty years, and its safety and efficacy are well established, not to mention the fact that the devices are not life-sustaining or life-supporting. We firmly believe that CES should be classified as a Class I or Class II device, and certainly not Class III. If FDA classifies CES as Class III then EPI will need to go through the onerous Pre-Market Approval process on a device which has been on the market for over thirty years with a fantastic safety record.
This is a link to this latest FDA action (don’t be fooled by the title):
FDA is justifying their action in two ways. First, FDA created potential side effects to make CES appear unsafe, such as claiming CES can potentially cause seizures. Second, FDA is ignoring ALL CES research including that which meets the FDA’s own definition of “valid scientific evidence.” For example, if a study had less than 50 subjects or if the State Trait Anxiety Index was used rather than the Hamilton Anxiety Scale, FDA decided not to review the study. Somehow FDA managed to even overlook the positive outcome in the very study of the CES device in France from which they alleged that CES can potentially cause seizures. From that abstract: “…anxiety and insomnia were exacerbated in the placebo group whereas anxiety decreased and sleep duration improved in the active treatment group.” All mechanistic studies using fMRI or EEG were discarded, as were all animal studies although FDA rules say they are to evaluate the scientific evidence to provide a “reasonable” assurance of safety and effectiveness when such evidence is “taken as a whole.” In the end FDA ignored ALL of the valid scientific evidence supporting CES and then concluded they cannot tell if CES is effective. FDA asserted CES is life threatening because it could “potentially” cause seizures that never happened since Alpha-Stim entered the market in 1981. Inexplicably, FDA somehow completely ignored every single fact in our 32 year history-every study, the actual reports of side effects and all those years of our considerable regulatory compliance.
If you were wondering what the Affordable Care Act might be like when the government takes over healthcare you can get a taste of it by seeing how the government treats CES science. Just click on the picture of the guy wrapped up in red tape on the bottom of our homepage at www.alpha-stim.com for a full disclosure of what we have been going through over the past year and a half, to read the transcript of the FDA’s Neurological Devices panel meeting, see video excerpts, and read over 200 letters from those opposing this action. As a bonus feature there is a déjà vu segment from the 1990s when different people at FDA with the same mind set did the same thing.
Do we have your attention? Good. Now we plead for you to please take a little time to help us fight for truth and justice. We ask for your support in providing FDA a letter or comment explaining how you use the Alpha-Stim and how you find the device to be safe and effective for the indications of anxiety, insomnia and/or depression. Below you will find links to four of the many letters which were submitted on our behalf in the fall of 2011. Please review these letters, and then please take a moment and share your own experiences using Alpha-Stim with the FDA, highlighting the safety and effectiveness of the Alpha-Stim device. You might also consider urging FDA to be honest in their evaluation of CES as did Dr. Francine Nichols, a retired NIH scientist who benefited from Alpha-Stim.
Here is a form letter we prepared for you that you can use as a starting point for your own letter and then upload via the link below:
Sample Letter for Practitioners (Microsoft Word document)
To submit your comments please follow this link:
Please note that the headline on this page refers to “Sorbent Hemoperfusion Devices”, which are also Class III devices, but believe it or not this is the correct place to add your comment about CES reclassification. You can either type your comment on the page and submit it, or upload a letter you typed in a word processing format or as a pdf file. We ask that you submit your comments as soon as possible, and no later than April 30, 2013, or they will not be considered by FDA. Please also send a copy of your letter to .
Also please consider having your patients write a comment to the docket as well. Alpha-Stim is not hurting anyone. In the majority of people who use it the effects are immediately obvious.
The process we are in now with FDA will consume most of our time and will be quite expensive – yet again! If you have any questions or concerns over this process please do not hesitate to call or email us. Our desire is to provide you with as much information as you would like on this very complicated issue.
Thank you for your continued support of Alpha-Stim.
Electromedical Products International, Inc.
Dr. Daniel L. Kirsch
Chairman of the Board