Response to the FDA's Proposed Rule

Nation-wide support for re-classification...

Issue #6

 

If the FDA takes action which will reduce or eliminate patient’s access to this device, many patients will suffer needlessly and will be forced to return to dependence on analgesic, anxiolytic, or antidepressant medications.

- Dr. Harbin (excerpt from letter)

Recently the FDA published a Proposed Rule in the Federal Register regarding cranial electrotherapy stimulation (CES) and opened a 90 day public comment period on CES. This rule would require Pre-Market Approval (PMA) for CES, while for the past 30 years CES devices have been legally cleared to market in the USA by the FDA.  At the end of this comment period the 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.  To view the FDA docket including proposed rule, please click here.  

Approved for over the counter sales in Europe, China and Canada, the Alpha-Stim devices have gone through an extensive review process for the FDA six times since 1981 and have been cleared to market.

The response we received in support of down-classification is astounding! We would like to take this opportunity to share some of the letters with you.  These doctors, patients, chaplains, and military personnel have great stories about the results they have received from using the Alpha-Stim in their practices and at home.  

Please review some of these astounding letters, so you can see why we are energized to continue the "good fight" and explain what a valuable tool Alpha-Stim is for practitioners.

COL Platoni's Letter

Ms. Ehrlich's Letter

Chaplain Fair's Letter

Fr. Mangoian's Letter

MAJ Hutchison's Letter

Dr. Harbin's Letter

Dr. Eidelman's Letter

Dr. Nichols' Letter

Dr. Dereberry's Letter

Dr. Overcash's Letter

EPI’s Response

 

The Military and Alpha-Stim...

We are pleased to have new survey data from the military.  Military Personnel Survey Analysis Summary, written by Larry Price, PhD., is a must read and a great breakdown of the effectiveness of Alpha-Stim among our different indications with or without medication. Click Here for the full version of the survey.

SPECT Brain Imaging

S.P.E.C.T Brain Imagining 

Issue #5

At the American Association of Christian Counselors (AACC http://www.aacc.net/) conference in September, Begin Healing shared the exhibit hall with the SPECT Brain Imaging booth run by The Clements Clinic.  Dr. Todd Clements found some time to sit down with us and talk about his practice and how he has incorporated the Alpha-Stim.

SPECT (Single Photon Emission Computed Tomography) Imaging is a nuclear brain scanning technique developed by Dr. Amen, MD (author of Change Your Brain, Change Your Body).  Dr. Todd Clements, MD, joined the Amen Clinics in 2006 where he trained in SPECT Imaging.  In 2008 he became Medical Director of Clements Clinic, his own out-patient psychiatric practice in Plano, Texas, which specializes in the SPECT scan.

A SPECT scan is performed by injecting a very small dose of a radioactively tagged compound (Ceretec) that is taken up by the brain.  Once in the brain the Ceretec emits energy for the next few hours.  The cameras in the SPECT scanner slowly rotate around your head and detect this energy in the form of light.  The most active brain cells will emit the most energy and the least active ones will emit the least energy.

Whereas MRI and CT scans look at the structure of the brain, SPECT looks at the functioning of the brain in terms of cerebral blood flow and activity patterns.  With these 3D images they are able to evaluate 1) areas of the brain that work well (2) areas of the brain that work too hard and (3) areas of the brain that do not work hard enough. Among other reasons, this is helpful because there are many cases where the brain’s structure is normal, but the way it is functioning is abnormal.  

Brain with ADD before treatment

Brain with ADD after treatment

The Clements Clinic website helps explain this difference with an analogy: “If you were flying in an airplane today you would want to know that the engine was working right.  Taking a picture of the engine (CT/MRI) shows you all of the parts, but does not give you any information about how well the engine is running (functioning).  A brain SPECT image identifies important information about your brain’s functioning.  Identifying areas of abnormal functioning can be vitally important in helping you doctor make the best diagnosis and treatment plan for you.”

When asked about how he generally uses the Alpha-Stim in his practice, Dr. Clements said he usually uses it with teens, and for patients with sleep, anxiety, or anger problems.   First, the patient comes in for a SPECT scan, and if their brain shows over-activity in the basal ganglia or in the thalamus, then the patient is a likely candidate Alpha-Stim treatments. 

“Instead of taking a Xanex when they feel anxious,” said Dr. Clements, “they can do a 20 minute session with the Alpha-Stim. I find it’s a good tool. A lot of people come in on benzos or clonazepam. These people just get used to popping [a pill] when they get anxious, so I find it’s a good alternative for these drugs.”

He has also found that the Alpha-Stim helps chronic marijuana users feel less anxious when they stop using.  Such cases are examples of patients that show over-activity in the thalamus in their SPECT scans. Dr. Clements also pointed out that when patients dealing with addictions can actually see how their substance abuse is effecting the brain, they are more likely feel motivated to change their behavior.

Along with evaluating the specific brain patterns associated with mood disorders, the SPECT Imaging can also evaluate memory loss, the effects of brain trauma, aggressive and/or violent behavior, cerebral cardiovascular disease, the extent of impairment that drugs, alcohol and other toxins have done to the brain.

Perhaps the most important aspect of the SPECT technologies is that a scan can help determine the type of ADD, anxiety, or depression that is present. Far too often are people diagnosed with ADD and immediately prescribed a stimulant, when their type of ADD could be treated more effectively with multivitamins, fish oil supplements, and/or CES.  The more we know about a persons specific condition or type, the better we will be at treating them.

FDA Cautions: Common Pain Killers Risky

In response to a growing number of people suffering from acute liver damage, the FDA has issued cautions about the dangers of taking the over-the-counter pain killer acetaminophen (also known as Tylenol, Anacin-3, Tempra, Datril, and still other names abroad).

            This may come as a surprise to most of us, to whom the term “over-the-counter” is usually synonymous with “safe.”  However, we know now this is not the case, for acetaminophen toxicity is the leading cause of acute liver failure in the U.S. and may other Western countries.

Among other cautions, the FDA has recommended stronger warnings and stricter dose limits for drugs that contain acetaminophen because they pose an increased risk of liver injury to those who use them improperly.  For example, they have urged that the maximum adult daily dosage be reduced from the current amount of 4,000 milligrams to 3,250 milligrams.  They also have proposed a limit on the strength of immediate release versions of the drug and on the use of liquid formulations for children.

            We know the Alpha-Stim micro-current treatments to be a safe alternative or supplement to pain relief and pain management drugs. It is approved by the FDA to treat pain with no significant reports of side-effects. Adverse effects are usually mild and self-limiting. Out of approximately 4,541 patients in controlled, open, and uncontrolled conditions, by physician survey and reasonably associated with the use of CES are dizziness (6 cases, 0.13%), skin irritation/electrode burns (5 cases, 0.11%), and headaches (9 cases, 0.20%).

           

Interview with Dr. Kevin Green, MD

Interview with Dr. Kevin Green, MD

Issue #4 February 2011

This interview took place at the SCRIPPS conference in San Diego, California, which is hosted by the Center for Integrative Medicine and the American Board of Integrative Holistic Medicine.  Marlene Stenlund RN and Clinical Adviser for Begin Healing Inc. sat down with Dr. Kevin Green MD to talk about his work and how he has incorporated the Alph-Stim into his practice.  Dr. Green is a family medicine provider based in Wisconsin.

Marlene:  Just tell us a little bit about who you are, and what kind of practice you have.

Dr. Green:  Okay, I am Dr. Kevin Green and I work with Aurora currently in Osh Gosh, Wisconsin.  I am a family medicine and integrative medicine provider.  And I try to look at all kinds of alternatives for helping people.

Marlene:  Okay, and how long have you been using Alpha-Stim in your practice?

Dr. Green:  I think probably for about five years. And I use it a lot.

Marlene:  What kind of patients do you use it on?

Dr. Green: Mostly anxiety, insomnia, and depression.  I do use it some for pain, some in the office, most of it is people obtain their own unit and use it out of the office, under my guidance.

Marlene:  What kind of results are you getting with Alpha-Stim?  How do you see Alpha-Stim helping people to be less reliant on pharmaceuticals?

Dr. Green:  I have had very good results.  I would say that I am able to get probably 95 percent of my clients off of their medications.  And I usually have them use the Alpha-Stim for at least a month, and then I start tapering their medications.  Usually for about six weeks, I have them off their medications.

Marlene:  Do they have any difficulty going off those medications?

Dr. Green:  I taper them, and there are certain SSRIs that you have trouble getting them off, just because of the side effects, but you just taper it very slowly – and the hardest is probably Alprazolam because the people who are really anxious like to have that – even if they do not use it, they like to have that available to them.  And eventually I can convince them that they haven’t used it for so long, that they don’t need it anymore.  So I have had very good luck getting them off their medicines.

Marlene: Tell us about a patient situation that you have had that was especially interesting to you.

Dr. Green:  I have been completely surprised all the time.  The longer I use this I’m finding out it actually fixes the problem.  And after a while they find they probably don’t need the Alpha-Stim anymore either, that was a surprise.  I am finding it helps with addictions, drug addictions and cigarette smoking: that was a surprise. 

I had one gentleman that was a very successful business person, and he had a very severe stroke.  And he had a huge tremor of his wrist and his ankle on the same side, and it was in constant motion, and he had been to six doctors, three neurologists.  All of them told him, “Live with it,” because there’s nothing that can be done.  He came in to see me because of depression, and I put the Alpha-Stim on him.  And really what bothered him was his ankle was in constant motion because that kept him from sleeping.  I came back in the room in about 30 minutes and his ankle was, for the first time in eight years, silent.

And due to that, I predicted that if he kept using this, that it would improve.  And actually I saw him probably several months ago, and the tremor is virtually gone. The hand still has a little bit of the tremor, but that doesn’t bother him at all.

Marlene:  Oh, that’s wonderful.

Dr. Green:  But his life has been dramatically changed by the Alpha-Stim.

Marlene: What about pain treatments? How much time would you actually spend doing an in-office treatment with them? 

Dr. Green:  I, generally, if I am going to use it for pain, will see them in the office and maybe give two or three or four treatments in the office.  That doesn’t take long, usually 15 minutes is plenty.  And I do that over a week to two weeks, and I see what kind of results they get.  If they respond favorably, most of them will just purchase the unit and we just teach them how to do it at home.

And actually I’ve had better than expected luck with some very tough cases.

Marlene:  What would the diagnosis be for some very tough cases?

Dr. Green:  Mostly arthritis, or chronic pain from an injury.  I had one gentleman.  And I saw him on my schedule and he came in for pain.  And what I didn’t realize is that he was 84 years-old and hurt everywhere, and walked in like a probably 95 year-old.  He couldn’t sleep on his right side because of the pain.

So we treated [him] three times in the office, and the third time he came back, and he said, “I’m sleeping on my right side, and I haven’t done that for years.”

I saw him probably six months afterwards, and he was walking like a 40 year-old, which totally amazed me. So it’s really worked well for him, and I thought that was a set up for failure.

Marlene:  Right.  Great, is there anything else that you want to tell us about…?

Dr. Green:  It works.

Marlene:  It works, okay.

Dr. Green:  It works as advertised, and even more than advertised.  The amazing thing is that I didn’t realize that it actually fixed problems, and that is what I am seeing – that after people use it for a period of time, usually a couple of years, they probably can put it away and keep it if they need it again.  But, so far not many have needed to pull it back out.

Marlene:  That’s wonderful.

Dr. Green:  And it works for everybody in the family – so that’s the other good thing too!

Marlene:  That’s the other good thing too!

Dr. Green:  Yes, that’s the other good thing.  You can’t share a pill with somebody, but you can share this with somebody.

Interview with Dr. Paul Olson, MD

Interview with Dr. Paul Olson, MD

 Issue #3 August 2010

Dr. Olson is a graduate of the University of Minnesota, Twin Cities Medical School, and currently practices Diagnostic Radiology in and around Grand Rapids, MN.  He is affiliated with 5 hospitals, including University Medical Center-Mesabi.  Marlene Stenlund RN and Clinical Advisor for Begin Healing Inc. requested that we interview Dr. Olson because of his expertise with Alpha-Stim, and also because she believes he is an extraordinarily compassionate physician.  She has seen chronic pain patients comforted by his skill level and understanding of pain on a personal level.

            Dr. Olson is also a photographer and French horn player in the Itasca Orchestra.  Editor Ian Stenlund contacted Paul Olson to ask him a few questions about his experience with the Alpha-Stim and its role in his practice.

Hello Dr. Olson, first tell me who you are and what you do.

I’m a radiologist.  There are two ways to do pain management: radiology and interventions. I am a radiologist that does interventional pain management.

How is radiology related to pain management?

What intervention is all about is sticking needles into people.  The typical thing you hear about is the steroid injection, people say “I got an epidermal shot today.”  But the diagnostic part [of my job] is to locate the pain generators, to find where the pain is, then and look into therapies for the pain. 

‘

Whether its needles (steroids), neuroablation [a precise x-ray guided technique for destroying a pain generating nerve], implanted devises in the spine, implanted electrical stimulator devices -- I look for what works best for the person.

How do you implement the Alpha-Stim in your practice?

I have used the Alpha-Stim myself for six years.  The groups of people I saw that were the most receptive to the Alpha-Stim were those patients who have sympathetic nerve pain.  If I do a nerve block they get a couple of weeks free of pain, but if I use the Alpha-Stim, they can be pain-free for months.  I have been combining the Alpha-Stim, biofeedback, and sympathetic nerve blocks.

I also use it on patients that are very nervous at an appointment or they are afraid of my needles.  I’ll leave it on during the procedure, and they tend to calm down and for some people the procedure is less painful.

Do you use the probes or the electrodes in your office?

No, I send them to Marlene Stenlund [RN] and she uses the probes.  I just find people who are going to have good response to Alpha-Stim.  I don’t tell them anything, I just say, “Hey,  let’s try this thing,” and then we sit together and talk.  After a while I ask “how is the headache or the pain now?”  If they have results I suggest they see Marlene.  Usually the Alpha-Stim works for people with a sympathetic component to pain, if it’s a mechanical source of pain, I don’t use it.  Sympathetic pain has no known mechanical component.

The sympathetic is a non-controlled system.  Basically, think of Fibromyalgia stuff, that’s the sympathetic nervous system amped up.  Every nerve in body has a connection to the sympathetic and everyone’s geography is different.  I use the Alpha-Stim to shut down sympathetic nervous system so I can find the typical pain generator.

People who use a TENS unit usually say that it only makes [the pain] worse, and I say I got a trick for you, and Marlene gets another patient.  Its pretty obvious that when TENS doesn’t work that the Alpha-Stim will be good for the person.

Marlene loves my referrals because I’ve already tested whether they are going to benefit from the Alpha-Stim.  This pain management stuff is all about matching the right patient to the right treatment.

How has your practice changed since adding the Alpha-Stim to your repertoire of tools for pain management? For example, has your client load decreased because people find they can manage their pain at home?

I don’t see decrease in client load. I see more and more once word gets out. Everybody is so different, so I’m always trying to match the best therapy for patient.  Now I have a tool that can help me treat sympathetic pain that I didn’t have before.

Actually, I’m writing a paper on the effectiveness of the Alpha-Stim on a certain type of headache and other extremity pains.

How do you explain the technology and science behind the Alpha-Stim to your clients?

I don’t tell them anything.  If they ask, “What is this?” I say it’s just a little electrical activity, let’s see if it works.  I don’t explain much so they don’t immediately attach a negative stigma to it.  If they’re really skeptical, I send them to the website.  Most people don’t care because if they’re pain goes away, that’s good enough for them.

If you don’t mind me asking, Do you use the Alpha-Stim for personal treatments? And if yes, please tell me some of your experience and/or results.

I have chronic chest pain. And I have tried everything to quiet it down.  I could barely make for three hours in the morning before I couldn’t do anything because of the pain.  At first I thought it wasn’t helping. But then I noticed I could stand a couple more hours in the morning, and then after anther month I could sleep at night.  That’s how I use it, to keep things manageable.  I use it for my pain everyday.  I also love it when I go on an airplane, I put it on and go to sleep. 

Interview with Dr. Ray Varlinsky, MFT

Interview with Dr. Ray Varlinsky, MFT 

Issue #2 June 2010 

Editor of the Alpha-Wave Monthly, Ian Stenlund, contacted Ray Varlinsky for this month’s issue. Ray is a marriage and couples counselor based in Paradise, California. He discovered micro-current therapy while working in a neuropathy clinic and has been using the Alpha-Stim for over 20 years in his practice. Varlinsky has also found good results using the Alpha-Stim 100 in his own home, treating himself as well as his family (including their dog!).

Ian: “Hi, Ray. Before I ask any questions, tell me a little about your experience with the Alpha-Stim.”

Ray: “Well, I just had a client this afternoon who was really distressed, in tears, and I had her wear the ear clips right away, and by the end of the Alpha-Stim treatment she said, “that makes such a difference in helping me deal with things.”  It helps people to process and deal with anxiety and stress.”

Ian: “When and how did you hear about the Alpha Stim?”

Ray: “I used the Electro-acuscope first, another micro-current device, but I got the Alpha-Stim 100 when the first it came out.  The Alpha-Stim opened up portability and usability. Now I market the 100 myself.”

Ian: “Were you skeptical at first? or did you understand how micro-current technology can be used as a therapy?”

Ray: “I had been using TENS, so I was familiar with using electro-stimulation for chronic pain.  I wasn’t skeptical because Harley Sheer, a colleague of mine at the neuropathy clinic, was using it for low back pain and surgeries.  The referrals he received were from doctors who gave up on patients not responding to traditional therapy.”

Ian: “The March issue of Alpha-Wave Monthly featured an article on the latest study on anti-depressants, which concluded that placebos were just as effective as anti-depressants for patients with mild to moderate symptoms. From your experience, do you find this to be true?”

Ray: “There was an article in Newsweek February 9^th I think, written by Irving Kirsch (no relation to Dan Kirsch, inventor of the Alpha-Stim). It was a meta-analysis of the studies on anti-depressants submitted to the FDA. [His findings showed that] anti-depressants are not as effective as we would want them to be.

I hated to put my patients on anti-depressants because of the side effects – and people only get prescribed new ones when their current brand stops working. Anti-depressants don’t cure depression. People’s belief [in a treatment] tends to wan, and the placebo effect starts to not work.

One of the greatest things about the Alpha-Stim is that the body does not acclimate to the good feeling effect.”

Ian: “How is Alpha-Stim better than placebo?”

Ray: “It has some placebo effect, around 35%. There is always going to be some belief attached to treatment, which is good.

But the side effects of the Alpha-Stim are good. Also, if you are using Alpha-Stim and stop, you are not going to have any of the negative side-effects that a person taking anti-depressants experiences.”

Ian: “Does this device work as augmentation to other therapies in your practice or as a stand alone therapy?”

Ray: “I use it in conjunction with other therapies.

People can use it as stand alone though. Having some kind of practice like mediation, praying, or visualization is always helpful. Self help is good as a foundation, but other tools can help with day-to-day depression, anxiety, and insomnia.

Being able to address underlying issues is the key. Anxiety is blocking the underlying issues, so if they can put on the Alpha-Stim and calm down, they are more able to deal with the big issues. Once they’ve dealt with these issues, they can use the Alpha-Stim off and on.

I’ve seen bi-polar patients cut back on medication by a third, which is easier on the body”

Ian: “If you don’t mind me asking, Do you use the Alpha-Stim for personal treatments? And if yes, please tell me some of your experience and/or results.”

Ray: “I use it for anxiety, which is part of my family history.

It works for my wife’s insomnia. The treatment she has found most useful is not regular protocol. If she wakes up at 2:00 a.m., she puts it on and falls back to sleep. If I have a difficult time sleeping, I use it too.

I also use it on my dog, who has separation anxiety. He likes it.

The value of the Alpha-Stim is that it’s safe, and the counter-indications are minor. The family can use it; the pet can use it; it manages pain; it controls stress – and we are going through stressful times. The family can use it with safety, without fear of side effects and harm.

My daughter uses it for her migraines. She used it when pregnant, which is not recommended by the Alpha-Stim company, but it worked very well. I do not suggest use of the Alpha-Stim for people who are pregnant because of the legality issues, but my daughter and other woman have done their own research and decided to use it.

Even if you don’t have anxiety or depression, it can help with general day-to-day stress for anybody.”

Natural Hand Sanitizer

With the rise of the H1N1 flu pandemic, we have seen more concern for quick and easy hygiene methods, such as placing hand sanitizer dispensers in offices, at conferences and throughout public places like bus stations and shopping malls. But almost all of these gels are alcohol based (usually ethyl or isopropyl alcohol), which irritates existing cuts or scrapes and causes skin to dry.

There are, however, natural alternatives to the alcohol-based gels. In The Whole Child, an interactive pediatrics blog (http://www.thewholechild.us), Lawrence D. Rosen, MD suggests mimicking the ingredients of Thief Oil, a patented blend of naturally antiseptic oils. 

Into a small dispenser bottle filled with filtered water and 1 tsp aloe vera gel, mix 1-2 drops of cinnamon bark, clove, rosemary, eucalyptus oils and 5 drops of lemon oil (or grapefruit or orange, if you prefer).