Progress
In Medicine UPDATE

Newsletter of the Progress in Medicine Foundation
Volume 01 No. 01    Jan-Mar 1999

• Update on the Attack on EPD
• What is EPD?
• What Do the Patients Say About EPD?
• What is the Progress in Medicine Foundation?
• What Does the Orange Ribbon Stand For?
• More Information About EPD
• Possible Advantages of EPD
• Possible Adverse Reactions to EPD
• Research on EPD
• Citizens for Health
• HOME

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UPDATE ON THE ATTACK ON EPD
The Medical Board of California
has gone way too far …

In a shocking decision by an Administrative Law Judge, the Medical Board has decided that Californians should not be treated with EPD. Judge Ruth Astle, who received her medical training at a 5-day seminar put on by the Medical Board itself, ruled in Finding No. 81 in her Decision against San Francisco allergist Robert Sinaiko, MD, that such treatment causes "harm to the public by lending the legitimacy of a physician's reputation to unproven, disproven and potentially harmful diagnoses and treatments such as … EPD."

And thus it happened that Administrative Law Judge Ruth Astle recommended revocation of Dr. Sinaiko's license to practice medicine.

Board "experts" even tried to attack Dr. William (Butch) Shrader - the top EPD physician in the States - by claiming:

• That the list of diagnoses in the EPD Information Booklet (called the Pink Book) is "fraudulent" because "unproven" disorders such as MCS, CFS, and Candidiasis were listed as benefiting from EPD treatment.

• That "fraudulent" claims are made in the EPD literature put out by Dr. Shrader about ADHD and other disorders which could not possibly respond to EPD, according to the decision of this Administrative Law Judge.

• That the writings and statements made by Dr. Shrader at scientific conferences and elsewhere, reporting high rates of success with EPD treatments, - are bogus.

• That the EPD web site at epdallergy.com is not only an "advertisement" and "promotion" for EPD, but it is also a "false advertisement."

• All reports that EPD is successful - are bogus. The "experts" were sure this was so, because, as one said, "if it were any good, I would have heard of it."

• That witnesses who testified that they benefited from EPD did not really benefit, but just think they did. The judge diagnosed this as a placebo effect. (And she ought to know - after all, she did have 5 days of medical training, which is 5 days more than the prosecuting attorney who made this stuff up.)

No, indeed, EPD is not the only issue in this case but it sure is a big one; it is mentioned in the judge's Decision no less than 27 times. In fact, there were two separate sections of the Decision headed by the title "Enzyme Potentiated Desensitization."

The prevalence of EPD in this case is even more startling when you consider that the main case being discussed did not even involve EPD. This case - the subject of the original Accusations against Dr. Sinaiko - involved a child Dr. Sinaiko was testing for allergies. The Board did not agree that a child with ADHD should be tested for allergies, and did not find the allergy testing (IgG Food & Mold MAST) acceptable. They also accused him of using the Feingold* diet and of "considering" EPD for the child.

Needing more cases to cite, they pursued 2 other patients who had indeed received EPD treatments but had not complained to the Medical Board.

How can you protect yourself if you are a physician offering EPD?

• Don't live in California.
• If you live outside California, hope that these prospective precedents do not spread across the country, ~ OR ~
• You can help us fight:
  • Read the web site of the Medical Defense Fund at www.treatmentchoice.org
  • Put an orange ribbon on your website to show your support.
  • Donate to the Medical Defense Fund to help win this case.
  • Tell your neighbors, relatives, friends, and patients
  • Support your state's Medical Freedom Bill (See Page 6)

Dr. Sinaiko is now preparing for the next phase of Appeal when the Board reads the testimony and reconvenes the Hearing. He hopes to make EPD safe in California in the hope that this will go a long way toward making it safe across the country.

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What is EPD? *

Enzyme Potentiated Desensitization (EPD) is an allergy treatment developed in the 1960's by Dr. Leonard M. McEwen, an immunologist in England. Extremely low dose allergens are administered with an enzyme called beta-glucuronidase. The enzyme "potentiates" the immunizing effects of the allergens. EPD appears to specifically induce the production of "activated" T-"suppressor" cells, and creates a much longer lasting desensitization than does any other existing immunotherapy. For more information or to find a physician in your area trained in EPD, call the EPD Society at 505-983-8890.

* This information is from EPD Society.

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What do the Patients Say about EPD?

These are real people. Their names and addresses are on file in the PIM office.

My son [C] … is almost eight years old, and has multiple diagnosis including epilepsy, Landau Kleffner Syndrome, autism and mental retardation. … He just received his twelfth and last [EPD] shot. Since he began receiving these shots, his hyperactivity has decreased, and he appears more focused.
-- C.M.

As I was in need of treatment for an allergic condition, I first carefully re-searched the literature. I found the best hope for my condition to be EPD treatment. Then I found a doctor offering EPD treatment, Dr. Sinaiko. I am pleased to say his treatment was dramatically successful in a condition which had persisted all my life despite conventional treatment. If this is Voo-doo medicine, we need more of it and less of the "alter-native."
-- R.K., MD

Dear Editor,

My 11-year-old daughter was born allergic to life. She had two anaphylactic reactions by the time she was a year and a half. She cried all the time. Traditional medication was useless. We were told to keep her away from things she was severely allergic to - she could take antihistamines and just live with the rest. After nine [EPD] treatments, my daughter is much better. She is still allergic to molds, but is able to eat a normal diet. She has an optimistic, sunny personality and is rarely ill. I don't live in fear anymore..
-- M.W.

Dear Editors,

I have received 15 injections of EPD. This treatment has had the most profound and positive impact on my health. After I completed the first sequence of EPD injections my autoimmune thyroiditis (for which I'm genetically predisposed and had been receiving treatment for 13 years) spontaneously healed. I no longer need any thyroid medication. My endocrinologist and I believe this is an indirect effect from the EPD injections on my immune system.
-- K.S.

To The Editor,

With regard to enzyme potentiated desensitization, … it is simply an attempt to improve upon the oldest method of allergy treatment, that of hypo-immunization. Hypoimmunization, commonly referred to as "allergy shots," administers a small dose of the antigen of the allergen or sub-stance to which the person is allergic in increasing concentrations over a prolonged time period. [This] conventional immunotherapy requires weekly or biweekly office visits for injections of two to five years, with the success rate of approximately 70% for allergic rhinitis. The time commitment and expense prohibits many patients from completing or benefiting from the therapy. EPD is an attempt to prime the immune system to respond to less frequent injections and still have the development of immunological protection against the allergen which causes the allergic reaction. EPD is used and accepted in Europe, and is considered to be "cutting edge" allergy medicine in this country.
-- R.T., MD

Dear Editors,

At 70, I am still leading a productive and adventuresome life thanks to the medical knowledge of Robert Sinaiko…I was one of the first receivers of the EPD treatment and responded most favorably. I could again work; I could again drive a car; I could again be around people and not suffer from their colognes and perfumes; I could eat and drink many items that had previously made me seriously ill. And, I could get up at 5a.m. put in a full day without the feelings of complete exhaustion. Life became meaningful again! Yes, the procedure was expensive. Yes, I had to pay for it, for my insurance company wouldn't. But, the results have far exceeded the cost. I am up and doing! Thank you, Robert Sinaiko, for giving me back my life!
-- C.K.

What is the Progress in Medicine Foundation?

This is a new organization set up for the purpose of discovering promising new and old therapies that are under-used or sitting on a shelf because research is insufficient and/or be-cause physicians and/or patients do not know the therapy exists.

PIM will be raising funds to promote and support research into such therapies, to publicize the results of such research, and to educate the physicians and public about such treatments. Citations and (with permission) full text of the research studies will be available on our web site, at www.treatmentchoice.org. Our 501(C)(3) forms have been filed, and we are able to accept VISA/MasterCard donations.

We are aware that there will be problems for physicians who are brave enough to incorporate such therapies into their practice. They will, as they do now, run the risk of angering their state medical board. We will do all we can in such cases, as we are doing now in the case of Robert Sinaiko, MD. We know that at this time over 80% of physicians accused by their medical board give up without a fight because of the financial and emotional devastation this brings. We want to help them fight unjust prosecution.. And we believe that media exposure will help keep such issues from being "killed in the closet."

Our emblem is an Orange Ribbon. Please take the graphic (below) to display on your web site, and let us know you have done it, so we can link to your page. Please also buy a ceramic and gold metal "Yellow Ribbon" Lapel Pin for $3.00 (or FREE with a minimum donation of $25.00) You may order it on the enclosed form, or on the web site at www.treatmentchoice.org
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What does the Orange Ribbon stand for?

Progress in medicine without fear of reprisal. Support for research into "orphan" medical treatments Support for physicians who, working with these treatments, become casualties of the medical wars.

HOW MUCH THE ORANGE RIBBON CAN DO WILL DEPEND ON HOW MUCH YOU CAN GIVE.

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More Information About EPD

EPD is usually administered by one or more tiny intradermal injections (similar to the old TB test). For patients with life-threatening allergies, it can be administered by a special "cup," usually on the inner side of the forearm, where it is absorbed slowly over a period of 12-24 hours.

The EPD kit comes in a set consisting of the allergen preparation and the enzyme, beta-glucuronidase. Each is inert until mixed right before use.

The beta-glucuronidase likely acts as a lymphokine, "potentiating" the immunizing effects of the allergens. EPD appears to specifically induce the production of "activated" T-"suppressor"-like cells (possibly CD8+ cytotoxic cells or a variety of T-cell with similar properties). Perhaps because these cells have a (variable) half life of approximately 24 weeks, EPD appears to create a much longer lasting desensitization than does any other existing type of immunotherapy.

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1. EPD appears to be much less costly in the long run than other immunotherapies.

2. A wider variety of conditions appear to be successfully treatable by EPD than by any other form of immunotherapy and possibly drug therapy.

3. Many conditions which appear to be responding to EPD are not adequately treatable by other forms of therapy.

4. EPD may be used to treat patients far more ill than by most other methods of immunotherapy, including patients with severe adverse reactions to chemicals and other substances, and who have life-threatening anaphylaxis to foods, such as shrimp and peanuts, or to unknown substances.

5. EPD may often (85% of patients) be permanently discontinued at some point in time, usually after 2 years.

6. Perhaps most importantly, EPD appears very often to have the ability to return patients to a "normal" life, without the continual "environmental controls" and dietary restrictions generally inherent with other forms of therapy.

7. The mechanism by which EPD appears to function makes it the most likely candidate for a definitive immunotherapeutic treatment in the foreseeable future.

Rarely, EPD has made patients worse for a prolonged period of time. Generally, it can effect patients who have discontinued therapy following an adverse effect to one of the first EPD treatments. These prolonged adverse effects occur primarily in patients with severe chemical sensitivities that are also being treated with one or more of the drugs available.

It is also possible that EPD could have an adverse effect if the patient has an unrecognized underlying condition.

Adverse responses (or poor responses) to EPD are likely due primarily to: (1) failure of patients to follow the necessary guidelines indicated for EPD therapy; (2) inadequate patient preparation for EPD; (3) discontinuance of injections after an early (or occasionally after a late) adverse response.

T-cells live a long time, and it takes quite awhile for what may be "mis-sensitized" T-cells to die off. However, this should not generally occur with patients who have had more than 6 EPD treatments when EPD therapy has been administered using proper precautions and current accepted pre-treatment regimens. There could be exceptions, and the EPD Society is looking for those.

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Research

1. Angelini G. et al. (in press). Pollinosi: una nuova metodica di immunoterapia.
2. Astarita C. et al. 1996. Effects of enzyme potentiated desensitisation in the treatment of pollinosis: A double-blind placebo-controlled trial J. Invest. Allergol. Clin. Immunol.; 6: 248-255.
3. Cantani A. et al. 1996. Enzyme potentiated desensitisation in children with asthma and mite allergy: A double-blind study. J. Invest. Allergol. Clin. Immunol. 6: 270-276.
4. Caramia G. et al. 1996. The efficacy of E.P.D., a new immunotherapy, in the treatment of allergic diseases in children. Allergie et Immunologie 28, 308-10.
5. Eaton KK et al. 1995. Gut permeability measured by polyethylene glycol absorption in abnormal gut fermentation as compared with food intolerance. J R Soc Med 1995 Feb;88(2):63-6.
6. Eaton KK. 1991. Preliminary studies with enzyme potentiated desensitization in canine atopic dermatitis. Environmental Medicine. 8:140-1.
7. Egger J et al.. 1992. Controlled trial of hyposensitisation in children with food-induced hyperkinetic syndrome. The Lancet 339:1150-1153.
8. Egger J. et al. 1992. Hyposensibilisierung bei nahrungsmittelin-duzierter Migrane. Aktuelle Neuropadiatrie 1992. Lischka A, Bernett G (Eds.) 1992 pp.287-291. Ciba-Geigy Verlag, Wehr 1993.
9. Egger J. et al. 1993. Controlled trial of hyposensitisation in children with food induced migraine. Cephalalgia 13 (Suppl. 13), 216.
10. Fell P, Brostoff J. 1990. A single-dose desensitisation for summer hay fever. Results of a double-blind study-1988. Eur. J. Clin. Pharmacol. 38: 77-79.
11. Galland L, McEwen LM. 1996. A role for food intolerance in childhood migraine. World Ped. & Child Care. 6: 2-8.
12. Ippoliti F, Rivi R, Businco L. Effect of preseasonal enzyme potentiated desensitisation (EPD) on plasma-IL-6 and IL-10 of grass pollen-sensitive asthmatic children. Allerg Immunol (Paris) 1997 May;29 (5):120
13. Kroker, G.F., 1987. Chronic Candidiasis and Allergy in Food Allergy and Intolerance (First Edition). Brostoff, J., Challacombe,S. (eds) London: Bailliere Tindall. pp. 850-870, Chapter 49
14. Longo G, Poli F, Bertoli G. 1992. Efficacia clinica di un nuovo trattamento iposensibilizzante, EPD (enzime potentiated desensitisation) nella terapia della pollinosi. Riforma Med. 107: 171-176.
15. McEwen, L.M., May, 1997. Allergy and EPD, pp. A11-22. (EPD Manual: Use of antifungals as an essential part of EPD)
16. McEwen LM. 1987. A double-blind controlled trial of enzyme potentiated hyposensitization for the treatment of ulcerative colitis. Clinical Ecology. 5(2):47-51.
17. McEwen LM et al. 1975. Enzyme potentiated hyposensitization III: Control by sugars and diols of the immunological effect of beta-glucuronidase in mice and patients with hay fever. Annals of Allergy. 34: 290-5.
18. McEwen LM. 1975. Enzyme potentiated hyposensitization V: Five case reports of patients with acute food allergy. Annals of Allergy. 35:98-103.
19. McEwen LM el al. 1973. Enzyme potentiated hyposensitization IV: Effect of protamine on the immunological behavior of beta-glucuronidase in mice and patients with hay fever. Annals of Allergy. 34: 290-5.
20. McEwen LM. 1973. Enzyme potentiated hyposensitization II: Effect of glucose, glucosamine, N-acetyl-amino-sugars and gelatin on the ability of beta-glucuronidase to block the anamnestic response to antigen in mice. Annals of Allergy. 31:79-83,1973.
21. McEwen LM. 1973, April. Effects of sugars and diols on enzyme potentiated desensitization. Journal of Physiology. 230(1): 65-6.
22. McEwen LM. Starr MS. 1972. Enzyme potentiated hyposensitization I: The effect of pre-treatment with beta-glucuronidase, hyaluronidase and antigen on anaphylactic sensitivity of guinea pigs, rats and mice. International Archives of Allergy. 42:152-8.
23. McEwen LM. Ganderton MA. Wilson CW. Black JH. 1967. Hyaluronidase in the treatment of allergy. British Medical Journal. ii: 507-8.
24. Shrader Jr. WA. McEwen LM. 1993. Enzyme potentiated desensitization: A sixteen month trial of therapy with 134 patients. Environmental Medicine. 9 (3&4): 128-38.

Who is Citizens For Health?

Citizens for Health was formed by a group of ordinary people who believed that good health is a right, not a benefit that should be determined by government or based on economic or social status. An idea that grew into a movement, Citizens for Health is now a national and international network of thousands of individuals - young and old, at every level of society - who want to exercise their right to make informed choices regarding their own health care.

Mission of Citizens For Health

Citizens For Health is the national grassroots advocacy organization committed to protecting and expanding consumer natural health choices. Through a nationwide network of community-based chapters and members, Citizens For Health initiates and monitors legislation with the goal of ensuring access to health information and the freedom to choose from a broad range of health options.

Citizens For Health works to expand your health care choices because you have a right to:

• Choose your physicians, including naturopaths, homeopaths, chiropractors, acupuncturists and others providing alternative therapies.
• Choose treatments, including vitamin supplements, herbs, homeopathy and other nonconventional modalities.
• Purchase vitamins, herbs and other supplements easily and in the dosages you require.
• Obtain water that is free of harmful chemicals.
• Eat natural foods grown and prepared without pesticides, hormones or antibiotics
• Be fully informed if foods for purchase have been irradiated or genetically engineered.
• Be fully informed on issues affecting your freedom of choice.

Join Citizens For Health. There is strength in numbers.

• 50 State Chapter Coordinators guide members
• Representation in the US Congress designed to maintain visibility for natural health and alternative medicine.
• Growing International Chapters tracking legislation and scientific information in their countries to ensure free access and trade worldwide.

Now is the Time to Take Action!
Here's Why

• Government agencies have proposed barriers to many products and services that emphasize alternative options and preventive care.
• The legal climate is restrictive in many states where nonconventional practitioners have literally been run out of town.
• Many physicians using alternative therapies are being prohibited from giving medicine to their patients.
• Parents turning to nonconventional treatments for their children are being sued by the government.
• Spouses are suing for child custody claiming unfit parenting because the other spouse is taking the child to an alternative physician.

• Educate you on your rights as a citizen concerning access to nonconventional health care therapies and products.
• Teach you how you can most effectively communicate with your state and federal legislators to successfully secure choice in your state and on the national level.
• Send you a regular newsletter featuring important federal and state legislative updates, state chapter new, interesting related health news, book reviews and much more.
• Update you on important issues through Action Alerts that allow you to take timely and direct action to impact state and federal legislation.

Contact California Citizens for Health - Currently presenting 2 bills to the Medical Board of California: The Physician's Right to Practice Bill and the Midwives Right to Practice Bill. Also involved in the effort to support EPD and Dr. Sinaiko.
Frank Cuny, California State Director
Phone: 530-534-9758
E-Mail: calcfh@cncnet.com
Web Site: www.citizenshealth.org
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