Electromedical Products International Inc. (EPI) issued an urgent call-to-action this past week for practitioners who prescribe Alpha-Stim to their patients. The complete details and formal announcement from Tracey B. Kirsch, President of EPI are below. Briefly, the Food and Drug Administration (FDA) intend to review current evidence for the safety and effectiveness of Alpha-Stim. The FDA posted a notice whereby this matter is now open for public comment, and EPI asks that those who prescribe/use Alpha-Stim to get involved. If the FDA ignores the current positive and plentiful safety/effectiveness data, which they appear set to do, this could mean that Alpha-Stim is removed from the United States’ market until EPI goes through a lengthy and expensive FDA validation process. EPI invites all clinicians and patients who use Alpha-Stim to get involved. Included in this report are detailed instructions on how to get involved, including a suggested letter template and additional background information on this issue.
On a personal note, I am saddened to see this safe and effective product as well as the good folks at EPI to be subjected to this treatment. Alpha-Stim has been used safely in United States for 30 years with no known major side effects. I know this first hand because my first PhD dissertation was with Alpha-Stim, and, although I did not carry out the study, my research design was adapted by Gabriel Tan, PhD at Department of Veteran Affairs, Michael E. DeBakey VA Medical Center, in Houston, Texas – the study is ongoing. I find it bewildering that the FDA holds this safe alternative treatment to an excessively high standard when there are numerous medications currently on the market that can cause serious and permanent side effects, including death. In fact, last I checked, Alpha-Stim is so safe that it is sold over-the-counter in Europe.
Here is EPI’s announcement:
Dear Friends of Alpha-Stim®,
On Monday, August 8, 2011 the US Food and Drug Administration (FDA) published a Proposed Rule in the Federal Register (Volume 76, No. 152) regarding cranial electrotherapy stimulation (CES). This action is directed to the entire CES industry and not just Alpha-Stim CES. They have opened a 90 day public comment period on CES. This 90 day period is for FDA to receive public comment on the possibility of down-classifying CES from Class III to Class II or requiring Pre-Market Approval (PMA) in the USA. At the end of this comment period FDA will issue a final rule which will either down classify CES to Class II or will call for all CES manufacturers to prepare PMA Applications. While FDA conducts its review of these PMA’s, legally cleared CES devices may remain on the market in the USA.
EPI has been through this and similar FDA rulings many, many times over its 30 year history. We are confident in our ability to produce the necessary science and safety data to meet the statutory requir