EDWARD C. KONDROT, MD (H), CCH, DHt: Patients with chronic eye disorders are investigating alternative therapies especially when traditional medicine offers very little hope. It is frustrating when patients are told, "Nothing can be done." It is more frustrating when the medical establishment refuses to investigate new therapies that might have a possible role in the treatment and reversal of these problems. When dealing with controversial treatments it is important to keep and open mind and investigate both sides thoroughly.

As a Board Certified Ophthalmologist and licensed Homeopathic doctor I have been interested in alternative therapies for the treatment of retinal problems. My approach is to look at the whole person evaluating both the physical and emotional components of the disease. Therapies that I utilize include nutrition, homeopathy, chelation and microcurrent therapy. Like many new therapies microcurrent has been met with extreme skepticism.

My initial results of Microcurrent Stimulation were published in the Townscend Letter a peer review journal for both lay and professionals. (If you are interested in a copy of this article please email me a request or call the office below) I also published the book, Microcurrent Therapy: Miracle Eye Cure? To educate the public on this new treatment and to encourage patients to consider this therapy to slow and in many cases reverse the effects of this degeneration.

It is a false statement that Sam Snead retracted the benefits of MCS. Mr. Snead's dramatic improvement in his eye sight was reported by Tim Franklin Publisher of the Hot Springs Star on March 17, 1998. Sam was quoted as saying, "I am going to get a drivers license next year. This is exciting." In fact this information was on the MDF web page in 1999 and the MDF was advising patients on how to obtain treatment.

I had the pleasure of performing micro current on Sam Snead at his home in Palm Springs, Florida Feb 11-14. 2000. This was done under the supervision of his family doctor Ramesh Khurana, MD. At this time we recorded over a two line improvement in both eyes. Mr. Snead was extremely delighted and he volunteered to give the microcurrent therapy a testimonial.

There are two proposed mechanisms to explain the reversal of macular degeneration and improvement of visual acuity in patients who undergo microcurrent stimulation. The first is that the microcurrent stimulates the blood flow to the macula. This is substantiated by several studies have found that using the TENS unit increases blood flow and stimulates wound healing. Kjartansson and Lundeberg in 1990 did a study on 20 patients who had poor skin circulation due to plastic surgery. After using the TENS treatment the skin showed a significant increase in blood flow.

Debreceni in 1995 reported the results in using the TENS unit for circulatory problems. Twenty-four patents were studied who had blockage of the arteries to their lower leg, which resulted in poor circulation and pain. After the TENS treatment, twenty patients showed marked improvement. There was decrease in pain, reduction in pain on walking and healing of persistent ulcers after the TENS treatment.

Kaada in 1982 studies the effects of TENS in four patients with Raynauds disease and two with diabetic polyneuropathy. Both of these conditions produce narrowing and spasm of the small blood vessels, resulting in symptoms of coldness, numbness, pain, and loss of movement. Results of his study showed that treatment with the TENS unit increased the skin temperature and gave the patients relief from their pain.

The following year in 1983, Kaada studied the effect of TENS in the treatment of chronic leg ulcers. There were 10 patients who were treated. These patients had leg ulcers, which had resisted the standard medical approaches. After the TENS treatment 8 of the 10 patients had successful healing of their leg ulcers.

The second proposed mechanism is the effect of microcurrent on the cellular level. Ngok Cheng in 1982 studied the effects of TENS on the skin of the rat. He applied different levels of current on the surface of the rat skin and then studied the changes in the cells using electron microscopy. This technique enabled him to observe the changes in the cellular mechanics. His results indicated that between 50 and 500 microamperes will cause an increase in mitochondria and an increase of 300 to 500 percent in ATP levels. He also noted that at this level there was an increase in protein.

References:

1- Kjartansson J, Lundberg T 1990 Effects Of Electrical Nerve Stimulation (ENS) In Ischemic Tissue. Scandinavian Journal of Plastic and Reconstructive Surgery and Hand Surgery 24: 129-134.
2-Debreceni L, Gyulai M, Debreceni A, Szabo K 1995 Results Of Transcutaneous Electrical Stimulation (TES) In Cure Of Lower Extremity Arterial Disease. Angiology 46: 613-618.
3- Kaada B 1982 Vasodilation Induced By Transcutaneous Nerve Stimulation In Peripheral Ischemia (Raynauds Phenomenon And Diabetic Polyneuropathy). European Heart Journal 3:303-314
4-Kaada B 1983 Promoted Healing Of Chronic Ulceration By Transcutaneous Nerve Stimulation. (TNS) VASA 12: 262-269
5-Cheng, Ngok, The Effects Of Electrical Current On ATP Generation, Protein Synthesis And Membrane Transport In Rat Skin, Clinical Orthopedics and Related Research, 171 (Nov.-Dec. 1982) 264-271

MARY: I realize that some may benefit from microcurrent stimulation therapy, and I am glad if you know some who have REALLY been helped. I had no success with it, however, and I have never found anyone who has. It angers me that some doctors may be taking advantage of desperate people. If it is possible to improve vision, there should be a way it doesn't cost hundreds of dollars to find out. I feel the same about the alternative medicines. I just can't help feeling that this may be snake oil. But of course, we must try it and test it out.

BRYAN GERRITSEN (Certified Low Vision Therapist): About last March this was a hot topic following a news piece on CNN. Like many professionals in the field, I received numerous calls from persons with a vision loss or their families, wanting to know about the efficacy of microcurrent stimulation. My colleague at Johns Hopkins Medical Center in Baltimore called me and asked me if I knew of the source of this information, and any relavent studies or data. I began calling, and had some revealing conversations. I learned that CNN's story came from an interview with an ophthalmologist in the Portland, OR area. A person doing microcurrent stimulation in Oregon had earlier approached the doctor, asking for his opinion on the subject. (I have since discarded my notes on this, so I apologize that I can't recall names of the opthalmologist or the man doing microcurrent stimulation who made the inquiry). The doctor informed me that he basically told the man that he knew of no research to support the practice of microcurrent stimulation, or that it had any value to slow or reverse visual loss. However, he said that without such research, he could not entirely rule out any possible benefit. With that latter statement, the man doing the microcurrent therapy evidently contacted CNN, and got them to do a story, who unfortunately got things turned around, and the opthalmologist was quoted inappropriately. He received calls on this almost non-stop from across the country, and had to repeat many times a day that he does not support microcurrent stimulation therapy, and was misquoted in the story.

To better understand research that would support or not support a specific practice or product that in fact may be efficacious, one needs to know more of the background and rigors of research practice. Research is usually classified as "Phase 1, Phase 2, or Phase 3 research." Each phase becomes progressively more constrictive, with more arduous stipulations. Before the AREDS (Age Related Eye Disease Study) was released to the public in October, 2001 by the National Eye Institute (NEI), regarding implications of nutrition on visual impairment, it had undergone years of scrutiny in all three phases or research. Such is the case with most other funded research. As far as I know, microcurrent stimulation has only been in the proposal stage for Phase 1 trials of research until now. Rosie Janiszewski at NEI could comment more conclusively about whether they are now actually into Phase 1 trials. Regardless, it is likely far too early to comment about the effectiveness of microcurrent stimulation therapy on macular degeneration or related eye disease at this time.

One of the five ophthalmology practices I work for in Utah includes a retinal specialist who is currently doing funded research on acupuncture for macular degeneration. He is speaking to the staff at lunch today about some of his research and studies. However, until any researach gets into the late Phase 2 stage or completes the Phase 3 trial stage, it is usually very premature to comment on almost any such research.

Persons with a visual impairment and those of us who serve as professionals in the field are extremely anxious to find something new that offers hope for a solution to macular degeneration and related diseases. But we must be cautious to not offer false hope, which can mislead and perhaps be very destructive.

DAN ROBERTS: Dr. Kondrot, in reply to my comment that Sam Snead had rescinded his much-advertised testimonial for microstimulation therapy, you responded,"It is a false statement that Sam Snead retracted the benefits of MCS."

Since Mr. Snead is now deceased and not able to confirm my statement, I contacted his son and daughter-in-law, Jack and Ann Snead, for verification. Here is a link to a resulting article which I have published with Jack and Ann's permission in the MD Support Library:

"Microcurrent Stimulation Testimonial 'Blown Out Of Proportion'"

As you see, Sam's son and daughter-in-law confirm that he was not helped by MCS, and that his name is being used without license. Further, Ann Snead made the following comment in her recent email to me:

"It is not right for Sam's name to be used as a marketing tool for something that did not help his eyesight. I hope your article will put a stop to such usage. It is sad to think that people desperate to find a 'cure' are spending money on a treatment that may not help them at all."

Finally, Dr. Kondrot, please comment on the following references to your above remarks, about which there are several inconsistencies:

1. According to Jack Snead, Sam did not live in Palm Springs, Florida (he says there is no such town), rather, he was raised in Hot Springs, Virginia, and lived for a while in Fort Pierce, Florida.

2. If Ramesh Khurana, M.D., is the neurologist who practices at Johns Hopkins and Union Memorial Hospital, he denies knowing Sam Snead personally, and Jack Snead says that no doctor by that name was ever their family physician. I could find no other Dr. Ramesh Khurana to ask about this, so I hope you can clear up the mystery.

3. Jack Snead does not recognize your name, and he says that his father had no further microstimulation therapy after his 1998 appointment with Dr. John Jarding in South Dakota. Another mystery about which I would appreciate your clarification.

Thank you for your time, and I hope to hear from you soon, either personally or through this open forum.

DR. KONDROT: I would like to supply you and the readers some additional information regarding Sam Snead. I examined and treated Sam Snead at his home in Panther Wood Golf Course which is located in Fort Pierce which is I believe North of West Palm Beach (Not Palm Springs as I mentioned in error). Dan I am going to send you a few pictures that were taken during Sam Snead's 4-day treatment of Microcurrent in February 2000, along with a shot of Sam giving me some golf lessons.

The medical doctor who observed the treatment was Dr. Ramesh Khurana, who has an office in Pittsburgh, PA, but who also has a home in Fort Pierce. He had become Sam's friend and medical advisor when Sam stayed at his home in Panther Wood. It was Dr. Khurana who arranged the treatments and who observed his improvement of vision. I will be sending you his office address and phone number for you to confirm these facts.

Another interesting note: I had several meeting with Sam's manager, Joe Bachman, who was planning to develop Sam Snead Macular Degeneration Clinics. These clinics would utilize Microcurrent, Nutrition and vitamin therapy for people with ARMD. Joe Bachman had produced a prospectus for these clinics and was in the process of raising money for this project. I am going to see if I can find a copy of his prospectus for you to review. Sam Snead was happy with his treatments in Florida and was interested in writing a forward for my book Microcurrent Stimulation: Miracle Eye Cure? Joe Bachman advised him against this, because he wanted Sam to be focused on the macular degeneration clinics.

There have been several independent studies of Microcurrent Therapy by medical investigators. Dr. David Williams in his Newsletter Alternatives and recently, Robert Rowan in his popular Newsletter 2nd Opinion, devoted an issue on microcurrent in August 2002. His conclusion is, "I recommend MCS along with nutritional therapies for all of my MD patients. This is a wonderful breakthrough to avoid crippling visual loss."

Dan, I will email the phone number of the medical writer Dr. Robert Rowen.

DAN: Thank you for clarifying the discrepencies regarding the location of Sam Snead's therapy and the status of Dr. Khurana as a personal advisor, rather than as a family doctor. That would explain why the family had not heard of him.

It appears that Mr. Snead's manager, Joe Bachman, was planning to capitalize on the publicity that was gained from the therapy, and Jack and Ann Snead were not aware of it. Such ventures are a manager's job, and I'm sure he was within his rights. Jack, however, intimated to me that his father was easy to take advantage of, due to his amiable nature, so I wonder how much input he actually had in the project. In any case, it is a moot point since Sam's passing, and the license to use the Snead name has reverted to the family.

On another point, I have noticed that nutritional supplements are part of the microcurrent stimulation therapy program. Is it possible that the observed improvement in visual acuity is due to this variable? Also, as I looked at the photos of you and Sam Snead playing golf during the 4-day treatment period (thank you for sending them), I wonder if there is a psychological effect that may be influencing the results, i.e. 4 days in a relatively stress-free environment with an increased amount of personal attention.

Such variables will be eliminated when MCS is put through the rigors of clinical testing, so those questions will surely be answered in the process. Drs. John Jarding and Ed Paul are both making separate efforts to begin FDA-approved studies, and I am very interested in following their progress. If MCS proves to be beneficial, even in combination with supplements and stress therapy, that would be good news for all of us. On the other hand, if the trials show no significant improvement, then by proving the hypothesis in reverse, it will still have been time and money well-spent.

DR. PAUL: [ Regarding the letters of warning sent by the FDA to Drs. Miller and Khouri. See Dr. Watt's comments, page 1.]

The FDA issued warning letters to these doctors for various marketing and promotion methods that were questionable. The treatment of retinal disease with microcurrent stimulation machines is perfectly legal as an "off-label use." Microcurrent stimulation machines are currently FDA approved for "the symptomatic relief of chronic intractable pain and as an adjunctive treatment in the management of post surgical traumatic pain problems." Once the FDA has approved a medical device, a doctor may decide to use that device for other indications if the doctor feels it is in the best interest of a patient. The use of an approved device for other than its FDA approved indication is called "off-label use."

Here is an excerpt from the FDA's website at www.fda.gov/oc/ohrt/irbs/devices.html:

"Does FDA require IRB review of the off-label use of a marketed device?"

YES, if the off-label use is part of a research project involving human subjects. NO, if the off-label use is intended to be solely the practice of medicine, i.e., for a physician treating a patient and no research is being done. The FDA recognizes that off-label use by prescribers is often appropriate and may represent the standard of practice.

We are currently preparing documentation for IRB review so that we can conduct FDA-approved research, however as stated above, it is perfectly legal for physician's not engaged in research to treat patients with the device as a part of the practice of medicine.

DR. WATT: Dr. Paul, you wrote, "The FDA issued warning letters to these doctors for various marketing and promotion methods that were questionable."

The FDA said in the warning letter to Damon Miller, "We advise you that claims for the treatment of age-related macular degeneration or any other disease conditions (not specifically cleared) represent a major modification in the intended use of these devices and require the submission of a new 510(k)." This refers to the treatment of MD, etc., not marketing and promotion. Saying that it is a "major modification in the intended use" doesn't sound like they condone this "off-label" use.

Promoting the MicroStim 100-2C and/or the MicroStim 100i for claims of age-related macular degeneration is a violation of the law. On their web site, the FDA says, "There is a provision in the Federal Food, Drug, and Cosmetic Act that allows a practitioner to use a cleared device for an unapproved or 'off label' use." There are a number of restrictions that do apply in this case. The practitioner can only use the device "off label" in a legitimate practitioner-patient relationship. They may not advertise or promote the "off label" use of the device in their practice, and the manufacturer may not promote, advertise, or label the device for the "off label" use.

It is questionable whether the people who promote MCS always have a legitimate practitioner-patient relationship when they sell the instruments over the phone or over the Internet. They often do this without ever seeing the patient or consulting with a referring doctor who is trained as an eye care specialist: someone who has physically examined the patient and who is referring the patient to the practitioner for treatment.

A while back, you were discussed on the RPList email group. To quote one of the posts:

"I live in the UK, so I inquired as to how I would be able to try it. [Dr. Paul] told me that it cost $2400 for the treatment and equipment and 4 days in-house treatment and checkup which I thought fair enough. However, I was sceptical, because he offered an alternative, whereby he would send me the treatment and equipment for a charge of $1000, which he was willing to do without even physically seeing me, not knowing my history my RP status. So does anyone know how a doctor would be able to administer treatment like this without knowing anything about me or seeing me for tests etc.?"

You and others who treat with microcurrent stimulation are advertising and promoting the "off-label" use of the device you are using. This is counter to the FDA restriction mentioned above. Aren't you doing just what you interpreted that the FDA was warning the others about by advertising and promoting the instrument's "off-label" use?

To quote from your web site, "MicroCurrent Stimulation (MCS) is an enhanced adaptation of a FDA-approved therapy." But is the "enhanced adaptation" FDA-approved? In their letter to Dr. Khouri, the FDA states, "The MicroStim 100-2C and the MicroStim 100i [machines]...do not have approved applications for premarket approval [or] investigational device exemptions." The FDA also states that Model 100 TENS units have not been approved or cleared for therapeutic treatment of ARMD.

In your remarks above, you wrote that the FDA requires Institutional Review Board (IRB) review of the off-label use of a marketed device if that use is part of a research project involving human subjects, but not if that use is solely for the practice of medicine where no research is being done. The study you posted shows that you are doing research involving human subjects, as are the others treating patients with MCS. It is clear that none of you are using the MCS machines solely for the practice of medicine.

You also quoted from the FDA's website about the need for IRB review of the off-label use of a marketed device: "YES, if the off-label use is part of a research project involving human subjects. NO, if the off-label use is intended to be solely the practice of medicine, i.e., for a physician treating a patient and no research is being done." It also states, "The investigational use of approved, marketed products differs from the situation described above." This refers to off-label use as part of a research study involving human subjects. Aren't the patients you have treated in your office with MCS the ones listed in your study?

In your response, you also wrote that you are currently preparing for IRB review so that you can conduct FDA-approved research, and that "it is perfectly legal for physicians not engaged in research to treat patients with the device as a part of the practice of medicine."

More is needed than just an IRB review. You need to submit for an Individual Device Exemption (IDE). You are engaged in research, as are Khouri, Miller, Kondrot, and Halloran. In Dr. Khouri's warning letter, the FDA wrote that the Microstim (and other instruments similar to it) are Class III and require premarket approval. According to them, "Class III is the most stringent regulatory category for devices [requiring] scientific review to ensure...safety and effectiveness." The Micro 400, which you use, is virtually identical to the Microstim in its electronic specifications. That device, therefore, must be proved to be safe and effective in the new intended use. The bottom line is that the FDA and the FTC regulate devices, and they do not permit a new or modified Class III (the highest risk class) medical device to be tested in humans for safety or effectiveness without an IDE.

In their warning letter to Dr. Miller, the FDA stated, that "promoting the MicroStim 100-2C and/or the MicroStim 100i for claims of age-related macular degeneration is a violation of the law." They did not say, "Since you are doing research, or since you are not doing research, it is perfectly legal for physicians to treat patients with the device as a part of the practice of medicine."

The following links lead to examples of how the FDA views off-label use:

Manufacturers and Users of Lasers for Refractive Surgery
Primer on Medical Device Regulation Part III. Regulatory Mechanisms and Import/Export Regulation
Townsend Letter: Robert Sinaiko, MD, Placed on Probation
Clinical Trial Issues Result in Criminal Prosecution - U.S. v. Prigmore, 243 F.3d 1 (1st Cir. 2001)
Medical Research Issues
Legal Status of Off-label Drug Use (contained in letter written by Robert J. Sinaiko, M.D.)

The bottom line is that the FDA and the FTC regulate devices, and they do not permit a new or modified Class III (the highest risk class) medical device to be tested in humans for safety or effectiveness without an IDE.

The legal requirements for medical devices are detailed by the Food, Drug and Cosmetic (FD&C) Act of 1938, which prohibits the movement of adulterated or misbranded products in interstate commerce. Performing a "prohibited act" is a violation of the law, which is subject to FDA action, including monetary and other penalties. The FDA ensures compliance with legal requirements. They meant business when they sent the warning letters. The patients who are purchasing the instruments don't realize that the instrument can be recalled, seized, and destroyed, with no refunds or other financial considerations.

Also, according to the court case in California, "A doctor can lose the license to practice medicine by using a new treatment learned at a medical conference or in a medical journal. A doctor can lose the license to practice medicine by an off-label use of a safe drug even when such use is supported by the medical or research literature, and even when the patients get better."

In the information about lasers, the FDA admitted that they do not seek to regulate the practice of medicine. The practice of medicine, however, does not allow the advertising of the device for off-label uses. The FDA believes that "the best data and protection of patients are achieved when these unapproved uses are studied under an FDA approved investigational device exemption," and that, "practitioners who use these lasers [lasers not approved by the FDA for this new use] are not operating within the legal requirements of the Federal Food, Drug, and Cosmetic Act, unless they have an IDE that has been submitted to and approved by the agency." So, according to this view, wouldn't those treating with microcurrent stimulation without an IRB and/or an IDE, and who are advertising the unapproved off-label uses, be challenging the law?

Sorry that this has been so lengthy, but all of it is important.

CAROL:Human research requires an enormous amount of "paperwork," planning, investigation, and approval. Then, there is are vast differences between the terms "Study" and "Research." The scientific methods of research must follow strict guidelines by any and all participating in investigations. Research is as a multi-faceted gem. It is critically important that ALL of the facets be examined, measured, and determinations be finalized before any conclusions may be presented in ANY way. Those conclusions must be replicated by other teams of investigators at other institutions. At that point, the FDA phases may be applied for, and possibly, a Phase I granted.

That being said, we cannot overlook how individuals perceive a practice, mores, a benefit, a response, utilize tradition, communication, etc. It's important to bear in mind reality, and it is a reality that people who can afford to try alternatives that have no given scientific proof, are just going to do it. Yes, they could be out enjoying life in a special way during such treatments, and realize that there's no objective, clinical analysis that can prove they are being benefited . . . but they won't and/or cannot accept they are not either cured or being helped.

It is difficult enough in the U.S. to be a prepared health care consumer in such a fragmented medical system. It is beneficial, however, to pick our fights and protect our time carefully.