How Alpha-Stim Passed FDA Regulations for Brain Stimulation Treatments

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@ferephFerdinand Ephrem

Neuro-technology expert who brings research in neuroscience to the fields of Marketing and Ergonomic

Electromedical Products International, Inc. (EPI) has conducted extensive clinical research to come up with a solution using Brain Stimulation that can help patients ease Pain, Insomnia, Depression and Anxiety. Taking advantage of advances in electronics and computer technology Alpha-Stim brings the size and price down significantly for the CES device while improving efficacy and ease-of-use.
In this interview with Dr. Daniel L. Kirsch, a renowned pain and stress specialist and chairman and founder of Electromedical Products International, Inc. (EPI), the manufacturer of Alpha-Stim prescription brain stimulators. We discuss how brain stimulators are used to treat anxiety, depression, insomnia and pain.

Tell us a bit about yourself and your Company?

I am a philosopher-scientist, board certified pain specialist and award-winning pain educator, former military contractor as a pain and stress educator working with the Operational Combat Stress Control Teams in Iraq and Afghanistan, president of The American Institute of Stress, and perhaps best known as the inventor of Alpha-Stim technology. I started Electromedical Products International, Inc. 39 years ago with $25,000 I borrowed at 17% interest, to build and market a device housing the waveform I perfected that normalized the peripheral and central nervous systems. The first Alpha-Stims cost $4,500 and took 64 hours to build in 1981. Today, eight generations of products later, thousands of them roll off an assembly line every month and sell for $795-$1,195. Used at home with a prescription in the USA, or in doctor and therapists’ offices, millions of people have seen improvements in their quality of life from controlling or helping them recover from anxiety, depression, insomnia and pain, even, and usually, when nothing else has worked.
Our biggest customer is the US government, as it is used by the military and in over 100 veteran’s hospitals. Our biggest claim to fame is we have more research than any other therapeutic device in the field, with over 100 published studies with consistent results.

What brought you to this field?

My first three years of college I was a philosophy major, with an interest in 17th century philosophy. I was most interested in René Descartes, the French philosopher, mathematician and neuroscientist. He interested me to learn more about how the body worked so I eventually switched to premed and also studied acupuncture. I realized that the medical profession was ignoring a lot of information about the physics of physiology because it was all so drug oriented. As it turns out all systems of health care and all religions are based on vitalistic philosophy except Western medicine which is based on mechanistic philosophy meaning we are just the sum of our parts.
Physics controls chemistry. The Alpha-Stim waveform is able to talk to cellular receptors to normalize cellular activity and control anxiety, depression, sleeping and pain. It is consistently effective even among the worst conditions, such as PTSD from unbearable memories of war, advanced cancer patients and just people who either failed drug therapy or could not tolerate the side effects. Alpha-Stim is completely safe. You might get a mild headache for a little while after treatment but even that is rare. You usually don’t feel anything except the results. Medal of Honor recipient SGT Dakota Myers said it melts his anxiety away. In fact you can watch him say that and a lot more in a new documentary by Justin Smith called The Brain Electric where I am somehow inserted into a Star Trek scene to my delight. It is posted on YouTube for free.

What are some challenges you face with emerging technology?

It’s all been challenges. All 40 years for me. From competitors, doctors who must prescribe them but don’t want to be first to do so, to the biggest scourge of my career, the Forget Doing Anything Agency, also known as the FDA. I planned to retire this year and spend more time at the nonprofit American Institute of Stress, but the FDA hit us with another burdensome year long task. I would have loved every minute of my career if the FDA was an honest agency.
I have helped millions of people cope with the worst kind of debilitating pain and mood disorders but most of my time has been bogged down in FDA reports, such as the PREmarket approval application, similar to a new drug application, we have to do this year for a device that has legally been on the market for 39 years. I got so sick over working on FDA reports that in 2014 I spent two years suffering with an incurable disease that all 19 drugs I was put on couldn’t even manage, until I found a cure in osteopathic manipulative therapy. If FDA regulated computers and not medical devices, our phones would still be attached to the wall by cords and I’d have achieved my goals to make the world a less stressful place and I’d be able to buy Wal Mart and Amazon from Alpha-Stim sales.

How do you explain your product to the public?

The brain is electrical, so why not treat it with mild electricity, similar to the type and amount you have naturally? Especially if it’s been proven safe over 39 years. Neurological acting drugs fit into receptor sites on cell walls and can send a choice of a few messages into the cells. Many people know this as the lock (receptor) and key (ligand, which in this case, is a drug) principle of pharmacology. But today we know it is a matter of the ligand matching frequencies with receptors, so the key doesn’t have to fit in the lock, it just needs to be in the vicinity. the Alpha-Stim provides a wide range of biological frequencies in a ten-minute waveform. The receptors only “hear” the ones they need. The others don’t cause any side effects any more than standing in a room among people speaking several languages you don’t know would cause. You might only understand and react to one. A good analogy is that we used to have to use a physical key to open a car door, but now we do so by pressing a button on a fob that emits frequencies (like the Alpha-Stim waveform) and yet only your car reacts to it among all the others parked around it. The Alpha-Stim’s patented waveform normalizes the brain so if you have anxiety it brings you down, or it brings you up if you have depression. There is no possibility of overdose, addiction or tolerance.

How far are we from getting this technology into the hands of the users? If it’s already there, what does it take for this technology to become practically in the hands of everyone?

I guess that’s a matter of money. All Navy SEALS and Special Forces Operators get one because they are expensive to train and maintain and Alpha-Stim helps them recover from the hardest job on Earth. After that service members and veterans get them on an as needed basis depending on which clinic or hospital they are at. It is the most used complementary modality at the psychiatry dept at Walter Reed National Military Medical Center, and some VA’s order them by the hundreds. But other than that, insurers are reluctant to pay because FDA miscategorized it as a Class III device which means life threatening or life sustaining, and it is clearly neither of those. The National Healthcare Service of the UK published a study last year showing it was safe and surprisingly effective and saved them a lot of money on anxiety which is the number one medical complaint.
So they are in the process of moving it to the front of the line, to be tried before cognitive behavioral therapy (CBT) and drugs in treating anxiety patients while continuing their research at the University of Nottingham on depression. It is considerably less expensive than a course of CBT and much less expensive than drugs. And in Europe and most of the world you don’t even need a prescription for it so people are more prone to pay for it out of pocket or with their health savings accounts. You don’t need to have major depressive disorder or generalized anxiety syndrome to be stressed. If you are alive you can benefit from a fast and easy brain mood, pain and sleep regulator.
My whole family certainly likes having them around our house. I can’t imagine life without it, especially having two overachieving teenage daughters and my wife, Tracey, is the president of EPI so she works hard and long hours to keep up with explosive growth. So it’s a matter of paying for it, and unfortunately a large part of that cost is dealing with FDA and foreign equivalents.

How do you envision its implementation in our daily lives?

Right now, people wait until after work to drink which is the reason for happy hour, or do drugs or take a nap to help turn off the workday’s increasing stress dosage.
Alpha-Stim actually increases alertness in most people and relaxes them while increasing their resilience to stressors so there is no reason not to use it at work during the day to avoid the need to recover from the days stress build up.
The only caution about when to use it is before going to bed because some people finds it makes them too alert to sleep unless they do a 20 minute treatment at least 3 hours before bed. Others can do it just before sleep just like some people can tolerate a double expresso after dinner while others wouldn’t dare disrupt their sleep with that. It improves sleep because it makes you relaxed, less worried, but it shouldn’t make you drowsy so it can be used at work, or when watching TV or doing light chores around the house. But not driving because we don’t want you too relaxed when you are doing that.

What features and benefits will your product bring to the consumers?

Right now, a less moody, more peaceful life with anxiety, depression, insomnia and pain under control. I think that’s quite a lot. It can do more, but the FDA is a huge barrier to finding out more about the other important “off label” uses.

What problem will this product solve?

I hope it could get the Democrats and Republicans talking again and achieve world peace.
I know that sounds like a rather lofty goal, but if everyone was happy and less moody and reactive why couldn’t we all get along?
Right now, today, if the FDA, Medicare and insurers would read the research and give it an honest appraisal, talk to the practitioners who prescribe it and the people who use it, or simply follow the UK lead to make it the first intervention for anxiety, since they already did all of that across the pond, plus their own research, it would save enough money to make the American healthcare system great again by taking the burden off everyone from family practitioners to emergency rooms for panic attacks so that health care workers could concentrate on taking care of people with everything else. And to do so calmly. To the best of my knowledge every practitioner who orders Alpha-Stims for their patients use it themselves as well. People are only skeptical until they try it.

Where do you see the product in a few years from now?

I am working on the next generation of Alpha-Stims now, then I will retire. These will track the results of everyone who opts in and compares an individual to all users so our clinical support staff can help those who aren’t getting adequate results and we can learn from those who have the best results to be able to improve how the devices are used. Doctors and insurers would be able to see the patient’s progress on graphical reports as well so it might save them some paperwork.

Is the market large enough? Are there competitors?

We will never run out of pain, anxiety, depression and insomnia patients. At least not until everyone has an Alpha-Stim or access to use one in a clinic. There are many competitors. We have most of the market for cranial electrotherapy stimulators (CES) devices because Alpha-Stim is the only device in the market that has so much research and the only patented waveform. People who buy the others often return them or toss them and then end up with an Alpha-Stim. Of course the biggest competitor is drugs, as we live in a drug society and antidepressants are handed out like candy. And then there is alcohol and street drugs.

Would the product be influenced by other markets, and why?

Alpha-Stim is already on the market throughout much of the world, including Europe, China, South Korea, Israel, Canada and other places. I see it as a disruptive technology against drugs and other competition rather than anything disrupting it. It’s been called the best kept secret in healthcare.

Will you give us a closing remark and areas of improvement?

Nothing is more intimate than a person’s relationship to their health care.
In a perfect world, FDA would do an honest appraisal of drug or device risk/reward ratio primarily from a safety perspective and allow people and their doctors to make their own decisions.
A PhD epidemiologist and other staff at FDA told it’s expert panel on neurological devices, none of whom had any expertise on CES, that it could cause seizures, repeated 25 times on February 10, 2012. When pressed to tell the panel more about seizures Laura Min, PhD actually told the panel that the seizures occurred in France, in patients who enrolled in a study of CES for major depressive disorder and the seizures occurred in 2 study participants during a benzodiazepine washout period prior to the use of CES but she added, stuttering, that we wanted to report all of the side effects in the studies. I almost fell off my chair. The FDA is actually saying you can have side effects prior to treatment! What a kangaroo court that day was.
We made some mini-documentaries from that meeting which are posted on YouTube at the Electromedical2012 channel. They are going after homeopathy now and that is the medication system my family has been using successfully for over 20 years. It saved my youngest daughter’s life when medicine failed. As Editor in Chief, I am devoting the Spring 2020 issue of Contentment magazine to that; it is an open access publication posted on stress.org. We all need to fight for health freedom. And certainly not accept universal health care run by the government.

What are you reading right now?

Funny you should ask that. I have been reading and rereading to get a perfect edit on what is so far, a 104 page report on using Alpha-Stim for depression for FDA. But when I get a chance to relax I like to read fiction and right now I am rereading my favorite book by my favorite author — Wilbur Smith’s River God. I have read all his books. They take me away deep into historic places with characters I come to care about.
None of the links is an affiliate link, and all the information provided in this article is for general information and review purposes only and is the expressed opinion of , Dr. Daniel L. Kirsch and not the Publication.
Originally published at 
https://www.saintrino.org
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