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 requirements. However, FDA has consistently acted in an arbitrary and capricious manner in regulatory reviews submitted by EPI regarding CES. Because of this history we are not confident that a fair review is possible by FDA and therefore there is a real risk of CES being removed from the market in our country.
As always, EPI will comply with this rule making process under the guidance of its expert legal team. We will pursue all means necessary, but we need your assistance for CES to remain on the market in the USA. It is vital for the public to take advantage of sharing with FDA, through this public comment period, its opinion, whether expert or lay, of the effectiveness of Alpha-Stim CES. In this proposed rule, FDA is asserting that CES is not effective and therefore CES manufacturers should be required to complete the very expensive and time consuming PMA process. This ruling notes a price tag of $1,000,000 for the preparation of the PMA application by the sponsor (EPI) and an $8,490,000 cost to taxpayers for FDA to review the PMA’s submitted as a result of this action! It is EPI’s expert opinion that there is more than ample scientific evidence in existence to provide “reasonable assurance” that Alpha-Stim CES is safe and effective for its indications.
Please share your comments regarding your experiences with CES, including your opinion of harm that may be done to patients by removing this safe and effective technology from the US market. Please forward your comments to the FDA via the public docket as outlined in the Federal Register in the Electronic or Written Submissions section on page 48062.
The following links [links are at the end of this report] will lead you to the Monday, August 8, 2011 Federal Register notice, a Fact Sheet EPI prepared to assist in breaking down the rule making process and the validity of FDA assertions and for background information, we are providing a history of the arbitrary and capricious regulatory handling of CES by the FDA in the last 30 years and the last link is to Dr. Kathy Platoni’s expert opinion letter in response to the Proposed Ruling. The EPI Team is embarrassed that our government could produce such a misguided document under the guise of protecting public health. We pray that our community of support will be able to save CES in the USA! Please act now. We have until November 7, 2011 to be heard.
Please contact me or your Alpha-Stim Team member should you wish to discuss this further or have any questions or concerns.
Tracey B. Kirsch
How To Take Action – Instructions from EPI
If you find Alpha-Stim® to be an effective and safe tool for your practice or for yourself, we invite you to share that information with FDA. EPI showing FDA that CES works is good, practitioners and patients telling FDA that CES works is great!
Step 1. If you would like to respond to FDA, you must click on the link below and look at the “Submit a Comment” box in green at the upper right corner. You can use this suggested letter template from EPI for your comments.
Step 2. You must add all this information to your comments (the Docket Number must be in your filing):
The Federal Register, Vol. 76, No. 152, pgs. 48062-48070.
Proposed Rule: “Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator.”
[Docket No. FDA-2011-N-0504].
Step 3. All comments should be addressed to the signatory on the Proposed Rule:
Nancy K. Stade
Deputy Director for Policy, Center for Devices and Radiological Health.
Here is the link to upload your letter mentioned in Step 1 above: http://www.federalregister.gov/articles/2011/08/08/2011-19957/effective-date-of-requirement-for-premarket-approval-for-cranial-electrotherapy-stimulator.
Step 4. Please also fax your letter to FDA at 301-827-6870 so they cannot say they never received the upload.
Step 5. Please also send EPI a final copy of your letter to [email protected] or 940.328.0888 (facsimile).
Thanks! EPI is asking that you simply tell FDA the truth about how safe and effective CES is for you and/or your patients. EPI will deal directly with the issues in the Proposed Rule. Thank you for your time and attention on this important matter.
Need Help Or Have Questions?
If you have any questions or concerns please do not hesitate to contact: Scott Elder, Vice President ([email protected] or 817-458-3279).
Financial Disclosure: BMED Report receives income from EPI for advertisements on this website (this post is not an advertisement, but rather a genuine concern for these recent developments).