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How I Hold Remission From Behcet's Disease By: Dot Tutt, March 2001 (slight revisions as of October 2001 and again in September 2002) -------------------------------------------------------------------------------- This is dedicated to my late father, Joseph E. Watson Sr. Dad was a man always willing to help others even though he had to contend with severe and baffling symptoms from (then-undiagnosed) Behcet's Disease. He lost his battle in March 1999. I draw upon the strength of his legacy to keep fighting to save others from sharing his fate. -------------------------------------------------------------------------------- Contents of this document NOTE:: This document started out as a large email. It has been coverted to a webpage, and a word for Windows Document. Please forgive any mistakes. I have successfully achieved remission from Behcet's Disease. It was induced and held by employing a new experimental medication, environmental controls, and taking several dietary supplements. This document contains information (not in order) about: Experimental low dose oral interferon alpha lozenges (150 IUs each) A medical journal that contains a lot of pertinent technical information A company that provides services and products that can help us control our "triggers" for flares A good source of informational books about Behcet's Dietary vitamin and mineral supplements that I take A lab that can help with uncovering hidden sources of triggers A new bovine extract dietary supplement that will hopefully be sold over-the-counter very soon How to advocate for yourself if you are considering a similar treatment plan I now receive a large number of questions about how I have been able to recover from severe Complete Behcet's Disease (BD) by using the experimental low dose oral interferon alpha lozenges. Due to time constraints and concerns about personal legal liability (I only want to help - I don't want any lawsuits!!!), I have given up trying to respond individually and have put together the following information. It is a compilation of a number of different emails, documents, and observations gathered from different sources. It rambles around and some is redundant but it contains most of the information that I think is permissible to release in all countries. I hope it answers any questions you may have about my personal treatment as it relates to Behcet's Disease. This letter will be my standard response to all requesting this information. Should anyone reading this document discover any errors, please email me at email@example.com and I will promptly check it out and make any corrections necessary. If I have stepped on any copyright toes, I beg forgiveness and promise to make the appropriate changes upon request. I cannot possibly keep up with all of the governmental regulations around the world so I can only hope I am not breaking any governmental regulations with anything that I have written or included. Many contact me for information (usually via email) about my personal treatment plan. Since I volunteer a lot through international support groups I usually do not even know what country the emailed requests are from. I may appear to be advertising for a number of different companies or organizations but I am including their information only because their products or services have helped me. I do not receive any commissions from any of these companies or organizations. If a company or organization does not want to be listed in this email, please contact me and I will remove the information. Dot Tutt -------------------------------------------------------------------------------- Liability statement Treatment/medication/drug name defined Other uses, my focus My role in the oral interferon project My background and experience Low Dose Oral Interferon Alpha -A Possible New Treatment For Behcet's Who invented it? Who makes it? My initial testimonial (written March 2000) Disclaimer I have Complete Behcet's Why I tried the oral interferon Why it does not have the side effects like the injectable interferon How it can be effective at such a low dose My experience using the low dose oral interferon alpha lozenges The results from other individual trials from around the globe Possible mini-flares; concomitant medications For more information . . . An update on my testimonial (written March 2001) (includes contact information for The Allergy Relief Shop) Update as of September 2002 How the oral interferon lozenges work in simple terms Potential Mechanisms of Action of Low Dose Orally-Administered Journal of Interferon & Cytokine Research Press Release Ingredients Translation into layman's terms of the above . . . Reporting results Alternative Treatments (other than the IFNa lozenges) Pregnancy Monitoring Dosage; Storage; How I Take The Lozenges Supplements Being tested for food allergies (includes contact information for Immuno Laboratories) Other diets and treatments unrelated to those I have tried Concomitant medications with low dose oral interferon Don't overdo it during your recovery A word about possible changing symptoms during recovery How to advocate for yourself for the oral IFNa Press Release - October 2001 Informational books about Behcet's Informational book about allergies Ordering oral interferon lozenges Canadians Non-Canadians, non-Australians, non-Americans Australians IMPORTANT NOTICE FOR AMERICANS * * * Americans have more restrictions!!! Americans How To Order Low Dose Oral Interferon Alpha Lozenges Steroid wean - keep it S L O W Bovine Extract Dietary Supplement Conclusion (with my contact information) I owe so much to so many people . . . Copyright -------------------------------------------------------------------------------- Liability statement I, DOT TUTT, AM NOT A DOCTOR OR OTHER HEALTH PROFESSIONAL. I AM SIMPLY A BEHCET'S PATIENT THAT SUFFERED FROM SEVERE "COMPLETE BEHCET'S/NEURO BEHCET'S" AND WAS FORTUNATE ENOUGH TO ACHIEVE AND HOLD A REMISSION BY USE OF A NEW (NON-FDA APPROVED IN AMERICA), EXPERIMENTAL TREATMENT WHILE ALSO EMPLOYING A FEW OTHER SUPPLEMENTS AND TECHNIQUES THAT I DISCUSS IN THIS DOCUMENT. THERE IS NO GUARANTEE AND I DO NOT GUARANTEE THAT THE TREATMENT PLAN I PERSONALLY USE WILL WORK FOR OTHER BEHCET'S PATIENTS. THERE IS NO GUARANTEE AND I DO NOT GUARANTEE THAT OTHER PATIENTS WILL NOT EXPERIENCE ANY SIDE EFFECTS FROM SHORT TERM OR LONG TERM USE OF THE TREATMENT PLAN I PERSONALLY USE. ANYONE THAT PRESCRIBES OR TRIES TO FOLLOW THE TREATMENT PLAN I PERSONALLY USE DOES SO AT THEIR OWN RISK AND I AM NOT LIABLE FOR ANY DAMAGES OR ANY UNFORTUNATE RESULTS THAT MAY BE INCURRED BY OTHERS DUE TO THEIR OWN DECISION TO PRESCRIBE OR TRY THIS OR A SIMILAR PLAN OF TREATMENT. THE INFORMATION CONTAINED IN THIS DOCUMENT IS PROVIDED ONLY IN AN ATTEMPT TO HELP EDUCATE MEDICAL PROFESSIONALS AND OTHER BEHCET'S DISEASE PATIENTS ABOUT WHAT I HAVE LEARNED ABOUT TREATING THIS DISEASE. BEHCET'S PATIENTS SHOULD ONLY TRY THE MEDICATIONS, SUPPLEMENTS, TECHNIQUES, AND METHODS I DESCRIBE UNDER THE ADVICE, GUIDANCE, AND MONITORING OF THEIR OWN PERSONAL PHYSICIANS. -------------------------------------------------------------------------------- Treatment/medication/drug name defined I refer to the low dose oral interferon alpha lozenges several ways. I sometimes refer to it as oral interferon, interferon, lozenges, IFN, or IFNa. The abbreviation for interferon is made up of the first, "middle", and last letters (all in upper case) or IFN for InterFeroN. The lower case "a" that is sometimes used represents the "alpha" that is used to differentiate it from the beta, gamma, or other types of interferon. Through this document, regardless of which interferon term I use, I will always be referring to low dose oral interferon alpha lozenges (150 IUs per lozenge) unless I specify otherwise. -------------------------------------------------------------------------------- Other uses, my focus Although the oral interferon has demonstrated anti-viral and anti-tumor capabilities along with being an immune modulator, I am trying to concentrate on the immune modulation aspects of it as that is what relates the most strongly to the treatment of Behcet's Disease. I have received a number of requests for information from patients with Hepatitis B and C, lymphatic leukemias, fibromyalgia, chronic fatigue, Sjogren's, HIV, opportunistic infections in HIV positive patients, MS, and a host of other viral, cancerous, immune, and auto-immune disorders, diseases, and infections. Although I personally believe the low dose oral interferon will also be effective for many other health problems, I am not familiar enough with those other topics to feel comfortable discussing them. I will focus this document on how I achieved my remission from Behcet's Disease and must respectfully decline to respond to those requests. -------------------------------------------------------------------------------- My role in the oral interferon project I have been so thrilled with my rapid recovery due to my personal treatment plan, that I have dedicated quite a bit of time to educating other patients and their doctors about the new oral IFNa treatment in hopes that others can also experience the same relief/remission. Along the way, I picked up the nicknames of the "oral interferon lady" or "oral interferon liaison". I do not want anyone to be mistaken - I am not an employee, researcher, or business partner of any kind for the company that produces this treatment and I do not receive compensation for my efforts. When I order the lozenges, I provide the same documentation and do it like everyone else around the globe. I am simply a volunteer. -------------------------------------------------------------------------------- My background and experience Since I began researching this treatment and working to educate others, I have communicated with hundreds of BD patients that were interested in this treatment. I have belonged to two Behcet's support groups, 3 email lists/digests, followed bulletin boards, participated in a Behcet's chat room on a regular basis, and talked on the phone or emailed with countless patients and/or their doctors. I attended a Behcet's Disease conference hosted by the American Behcet's Disease Association in September 1999. I worked with the (former?) Behcet's Organisation Worldwide - BOW (an international, non-profit, registered charity based in the U.K.) to develop a webpage with a lot of information about this treatment. (This web page was removed when Atrix Labs licensed the rights to the low dose oral interferon for the treatment of Behcet's Disease patients in the USA and Canada. I no longer volunteer for, or am associated with, the BOW and am not sure if it is still a legal, registered charity as of September 2002.) I have received and responded to several thousand emails with people from all over the world. After a number of BD patients around the world started individual trials, Genevieve Vanasco and I co-authored an extensive survey to gather information from many of these patients. The information that I include in this document reflects my personal experience and the knowledge that I have gained through all of these other sources. Since my own recovery, I have again started working very long hours in our office (we own a software development company) in addition to volunteer work for several organizations (new business organization for software developers, scouts, Behcet's groups, etc.) so my time is very limited. Therefore, rather than try to keep up with all the individuals that have written to me privately from around the globe, I will post future announcements or tidbits of information that I turn up on the ABDA (American Behcet's Disease Association) daily email list and/or the ABDA newsletter. (The ABDA also accepts international members from around the globe - not just Americans.) If you are interested in this treatment and would like to keep up with anything new that I have to post, please sign up for the ABDA and their email list via the following link: ABDA website www.behcets.com. -------------------------------------------------------------------------------- Low Dose Oral Interferon Alpha A Possible New Treatment For Behcet's Founded in 1984, Amarillo Biosciences has been a pioneer in the development of oral interferon alpha as a treatment for a wide variety of diseases and disorders. Compared to other treatments commonly used for Behcet's, I think this new treatment is inexpensive; convenient to store; has few side effects; and has been demonstrated to be effective both locally and systemically. It is administered as a slightly sweet lozenge with no flavor and is usually taken three or four times a day. It is easily carried in pocket or purse for convenience. A number of Behcet's patients around the world have tried the low dose oral interferon alpha during the past two years and although not everyone responds to it, many have demonstrated a rapid, remarkable recovery from their symptoms even after years of failed attempts to achieve remission or relief using other treatments. To my knowledge, no serious adverse effects that can be attributed to the oral interferon have been reported. Injectable interferon, long known as a "big gun" treatment effective for Behcet's, has always carried the draw backs of being administered via injections, was expensive, and usually caused side effects that were frequently severe enough to prevent long term usage. This new lozenge form appears to provide the same benefits without the drawbacks. This treatment is still considered to be experimental and non-approved in many countries. This medication is not approved in any country specifically for Behcet's as of March 2001. (To tell you the truth, I don't think many, if any, other treatments have been approved specifically for Behcet's Disease because it is considered to be so rare and most companies will not waste their time and money doing trials for an "orphan disease" like Behcet's!!!!!) -------------------------------------------------------------------------------- Who invented it? Who makes it? This is usually one of the first questions I get asked. Amarillo Biosciences, Inc. ("AmarBio" or "ABI" for short) is the American company that holds the patents for the low dose oral interferon alpha lozenges. I think they have around 20 patents on it so far. The inventor of this treatment is Dr. Joe Cummins and he is the president of that company. Unfortunately, due to American FDA restrictions regarding the possible promotion for profit of an unapproved treatment, Americans are discouraged from contacting anyone at Amarillo Biosciences directly. If American, please direct additional questions to me and I will attempt to secure the proper answers. If you are not American and your doctor has questions after thoroughly reading this email, your physician may contact Dr. Joe Cummins at firstname.lastname@example.com. As you can imagine, he is very busy but is good about responding to emails. Please first thoroughly read through all of this document. The lozenges are currently distributed only from one location and that is in Canada. I will list information about that later on in this email. -------------------------------------------------------------------------------- My initial testimonial (written March 2000) Disclaimer I am not a doctor; I have no formal medical training. This is written solely from personal experience as a Behcet's patient. I do not warrant the accuracy of any statements or medical information herein. Should anyone else try this treatment, they take it at their own risk. I am not liable for any decisions made by others to prescribe/accept similar treatment for poor results, side effects, or toxicity. I have Complete Behcet's I am a 47 years old female (as of March 2000). We have multiple cases of Behcet's Disease (BD) in our family. I have suffered from BD since infancy with eventually nearly every body system involved to some degree. Symptoms evolved through the years but my most notable recent symptoms immediately prior to my treatment with the oral interferon included chronic bloody diarrhea and intestinal lesions, sero-negative rheumatoid arthritis, fibromyalgia type symptoms, chronic fatigue, blood sugar imbalances, extremely low blood pressure, oral/genital ulcers, possible ulceration of nerves in my joints (never did officially diagnose this problem), depression, frequent small retinal bleeds, vision distortions, and other neuro manifestations. Uveitis was not active at this time though it has been a problem during my past. My permanent BD injuries include deafness (left ear), sacroiliac deterioration, and scar tissue throughout lungs, sinuses, retinas, and abdomen. I had two miscarriages and two premature births. Surgeries included a radical hysterectomy, removal of scar tissue causing intestinal obstructions along with portions of my small intestines, large lumpectomy for calcifications in breast tissue (thought to be cancerous until after review by two pathologists), and removal of a deviated septum, tonsils, adenoids, and nasal polyps. Until treatment with the oral interferon, I had delayed allergic reactions to over 25 foods plus multiple chemical sensitivities that set off BD flares. I could eat only organic, non- allergenic foods. As you can see, I have "Complete Behcet's" and was suffering from multiple symptoms when I came across this new treatment that is now undergoing clinical trials for a number of other autoimmune and viral diseases. Why I tried the oral interferon While researching BD, abstracts indicated immunoglobulin (Im) levels are out of balance and some interleukin (IL) levels are deficient during flares. I found that interferon (IFN) is heavily involved with the balance of the IL levels and subsequent Im levels. Injectable interferon is known to be a generally effective treatment for BD but it is expensive and it can cause uncomfortable and possibly dangerous side effects. I was searching for a life- long treatment so I kept researching. While doing research about interferon via the internet, I found a company in the USA called Amarillo Biosciences that had created a new medication - Low Dose Oral Interferon Alpha lozenges, that was being tested (in various countries) as a treatment for disorders such as Sjogren's Syndrome (dry mouth and eyes), fibromyalgia, chronic fatigue, hepatitis, measles, and even HIV. It may potentially be a treatment for multiple sclerosis. Since many of these were autoimmune related disorders known to be secondary disorders to BD, I wrote to the company using their email link on their web- site. They had not tried it for Behcet's but I begged for the chance to try it since I was just about at the end of my rope and my previous treatments had not worked or I could not tolerate their side effects and the remaining approved treatments that I had not yet tried carried substantial risks. Since I was the first Behcet's patient to ask for a trial, there were no pending clinical trials. They agreed to offer me a personal trial under the status of 'personal use exemption.' My conservative doctor, an extremely good internist, and I both did more research on the oral interferon because we were worried about effectiveness, long term toxicity, and side effects. We were surprised to find that the low dose oral IFN side effects were comparable to those experienced by people taking a placebo. In fact, it has actually been in development for many years and well over a 1000 people have tried it for these other disorders without the flu-like symptoms associated with injectable interferon. (An update here - I think that by the summer of 2001, over 1500 patients have tried this treatment under the guidelines of official clinical trials approved by the American FDA - Food and Drug Administration with the same results.) Why it does not have the side effects like the injectable interferon Skeptical at first, we found that most Behcet's patients treated with the injectable IFN were receiving as much as 3 MU (million international units) per injection on a daily basis. The oral interferon is provided in small tablet size lozenges of only 150 IU (international units) each and in some of the previous trials single lozenges were taken three times a day for a total of just 450 IU per day. This low dosage for the oral interferon was about 1/20,000th of that frequently taken by Behcet's patients on the injectable variety! Now it made sense that it would not be as toxic as the injectable. How it can be effective at such a low dose That brought up the question of 'how can it be effective?' It turns out that the human body produces interferon, usually in response to the immune system detecting a viral invader, and distributes it via nasal secretions and throughout the body via other tissues. The interferon that is naturally found in the nasal secretions probably attaches to lymphocytes, dendritic cells, or macrophages in the mucous lining and these carry a message to other cells that are normally active during an immune response. This new oral interferon treatment works on the same principle. When the patient dissolves one of the odorless, tasteless (slightly sweet) lozenges in their mouth, it too is utilized in the same way - attaching to the same types of immune related cells in the oral pharyngeal cavity to modulate the immune response in the same manner. Since it is the same type of interferon as that produced by our bodies, it is referred to as 'natural human' interferon - not recombinant or genetically altered/engineered interferon. I still do not fully understand the medical answers of exactly how it works to modulate the immune system, but apparently it allowed my immune system to work like it should. It seems to stop the tremendous overreactions we all suffer through during flares and even between flares. Subsequently, it has the potential to stop many, or even most, of the inflammations and ulcerations throughout our various body systems. After completing our research, my doctor and I felt comfortable that we had found a treatment that was natural to our bodies, assimilated in a natural way, convenient to store and take, relatively inexpensive, with no known long term toxicity, and with little to no side effects. It sounded perfect – if only it would work in real life for Behcet's! My experience using the low dose oral interferon alpha lozenges My doctor wrote a prescription for the oral IFN and a letter stating that he would monitor my progress and I ordered it from the manufacturer in Canada. I received my first three month's supply of this experimental medication within a few days. I had started to log my symptoms into a health journal, tracking over 17 symptoms on a daily basis, the previous week and continued to log and report them to both my doctor and the lab for the six weeks that followed the beginning of my trial. I took my first dose the morning of October 8, 1999. By the end of the second day, I noticed a definite increase in saliva and I seemed to feel a little better but thought it must just be a placebo effect kicking in. By the third day, I woke up feeling good. I got out of bed without my normal stiffness, my joints were not hurting nearly as much as before, my muscle pains were gone, my stiff neck had stopped, and best of all, my brain fog (befuddlement) and horrendous headache had disappeared! I was elated. I dropped my anti-inflammatory pain medication (Celebrex) that day. The greatest relief was in the ease of thought. I can only describe it as a physical sensation of being able to think easily again. The oral and genital ulcers that I already had when I started taking the medication still took about 10 days to heal, but they did not recur. The violent, bloody, chronic diarrhea that I had suffered from continually since childhood disappeared within the first week! Within the first two weeks my blood pressure and blood sugar levels evened out. Soon I regained a larger range of motion in my 'bad' shoulder. My fatigue evaporated, my depression lifted, my neuro symptoms disappeared. I was able to ride 300 miles to visit my mom, eat in restaurants again, and I was able to trot up a full flight of stadium steps at a basketball game! This was an enormous improvement over having my sons drive me everywhere because I was too befuddled to drive and to having them push me around the grocery store in a wheelchair because I hurt too badly and was too fatigued to walk. At the end of the first month, my doctor conducted a CBC (complete blood count), full blood profile, and a liver scan blood test. Everything came up in the normal range. In short – I was healthy for the first time in memory. I was told that this treatment usually does not reach its peak until somewhere between four to twelve weeks from initiating the treatment. I felt very lucky indeed! This oral interferon is not a 'cure' for Behcet's – the good effects quickly fade away if I discontinue the treatment and I am not naive enough to think that this treatment will bring about an immediate or full drug induced remission in all patients like it did me. I do think it may very well help many others like it did me, and many more to a lesser extent. I do not think a trial of this treatment will hurt those that remain, even if it does not help them. There are no known drugs that interact with the oral interferon and a patient's current medications can be continued during a trial. There are indications that some immunosuppressants (such as steroids) and anti-inflammatories (NSAIDs) may reduce the efficacy of the treatment but the patient has the option of starting the oral IFN first, then weaning off their other medications after the interferon kicks in and they are experiencing some improvement. Please keep in mind that this is just my own personal, non-medical opinion based on my own experiences. Since this is still an experimental, non-approved treatment in the USA and Canada (and some other countries), it is not permissible to advertise for it in those countries. However, I am using this personal email forum to discuss my experiences with it and I have been trying to educate the doctors of some of my fellow Behcet's patients about the potential of this new treatment. I do not receive any compensation in return for my efforts. My reward will come in the knowledge that others have been helped by this treatment throughout the world and by seeing the day when it receives widespread approval for the treatment of Behcet's - especially since both of my teenage sons have also suffered from Behcet's since they were infants. (As of the time of this writing, they are still in the process of being formally diagnosed.) I am now on a regular diet with very few restrictions. My husband and I are self- employed computer programmers and I am working over-time in an effort to catch up after only being able to work a few hours a day, if at all, for so long. I think clearly. I feel good. I am happier than I have been in many years. I am relieved to know there will be an acceptable treatment option for my sons in the future. The results from other individual trials from around the globe A number of other Behcet's patients have tried this new treatment, most with success very similar to mine. A few have had no response at all within the first few weeks but nearly all of those patients are either currently on strong immunosuppressants or just recently came off of them. It is my own personal opinion that their immune systems may be so suppressed that the oral interferon cannot yet effectively modulate their immune system. One Behcet's patient, a friend that I met through an on-line Behcet's group, tried this treatment soon after I did. She is 5'6" tall and only weighed 86 pounds because her digestive system had such severe involvement. She had deep throat ulcers the size of large coins that had been constant for many years, yet she experienced a recovery that included healing of her throat ulcers and a weight gain of nearly 10 pounds along with a lifting of her fatigue, pain, and brain fog. A European woman found that within the first week she could again eat numerous foods with no repercussions when previously they had sent her into huge flares. An Asian woman that had been declared a "hopeless case" tried the oral interferon along with traditional Chinese herbal medications and she was able to return to work within 6 days. One Australian woman on an oral interferon trial wrote "I feel so great, I can't explain, this is a new feeling for me...I hope it lasts." I responded ". . . that feeling that you cannot describe is a "sense of well being" that is so foreign to us with BD that we have a hard time recognizing it. You are also experiencing the lifting of your "brain fog" that was probably more pervasive than you realized. I found that I could think so easily that it was almost a physical sensation of my thoughts just zipping and slipping right through. Pretty cool, huh?!?" Another Behcet's patient, Genevieve Vanasco, had been in and out of hospice. Having BD from an early age, a sampling of just a few of her problems included: her backbone was collapsing (possibly from long term steroid use), she was losing her eyesight, her intestines could no longer digest or assimilate the nutrients from her food, her teeth were disintegrating, she had open skin ulcers, and her pain levels and fatigue were off the charts. She had tried just about every treatment in the book and had very toxic reactions to nearly all of them. They finally told her there was nothing else they could do, surgically implanted a morphine pump into her, and essentially sent her home to die. As a last resort, she tried the low dose oral interferon and started responding within days. She is now weaning down off of her morphine (more about that later). She has also started working her way through a list of surgeries and procedures to repair some of her serious injuries now that she can tolerate the medical procedures. Genevieve has become a very dear friend to me and also volunteers very long hours to this oral interferon project in hopes of helping others. After waiting nearly a year and a half, we finally met in person last week (March 2001). She was as wonderful in person as she is on the phone and internet! She deserves big hugs from all of those that have found relief using the low dose oral interferon. {{{Genevieve!!!}}} These success stories have convinced me that I was not simply one of a very lucky few. I think there is hope for many more Behcet's patients – probably most! Possible mini-flares; concomitant medications Most Behcet's patients have found that it is still possible to relapse into mini-flares if they severely challenge the oral interferon with chemical/food sensitivities, strong emotional stress, or other triggers that previously set off large flares. It does not stop all allergies or make the patient impervious to all stress! It simply lets the BD patient's body respond like a non-BD patient would. The good news is that subsequent mini-flares are usually very mild and of very short duration as compared to previous bouts; sometimes only hours or days. Since there are (currently) no known interactions with other medications, other medications with low side effects may be useful as intermittent concomitant treatments (such as Carafate, Celebrex, Trental, traditional Chinese herbal medications, etc.) dependent upon the response of the individual. It has also been noted by a number of the BD patients in individual trials that a temporary dosage increase is useful for preventing/stopping mini-flares when a known stressor is encountered or for initial control of stubborn, established symptoms. The patient has the option of taking a lower maintenance dose if that is all that is normally needed but increasing to a higher dose of the lozenges when necessary or they may even elect to use the oral interferon only as needed to control intermittent flares. (This is what my sons do.) For those lucky enough to have a history of only periodic BD flares, the oral interferon can be taken only when needed; there is no problem with abruptly ending the treatment when not needed (you do not have to "wean" off of it like steroids or immunosuppressants). For more information . . . I provide information a little further down regarding an issue of a medical journal dedicated entirely to science oriented articles relating to oral interferon. For more information about Amarillo Biosciences, the company that makes this medication, please check out their web-site at www.amarbio.com. This site also gives more information about other trials they have conducted and there is an email link on their page and they actually do read their emails! If you still have some questions after reading all of this information that is available on- line, you may contact me at firstname.lastname@example.com but please do not be upset if I do not respond immediately as I work long hours as President and CEO of our own software company, I travel periodically, and I am a wife and mother. I usually spend several hours a day on this volunteer work and I will try to respond as quickly as possible. Dot Tutt. -------------------------------------------------------------------------------- An update on my testimonial (written March 2001) After nearly a year and a half, I have continued to do extremely well using this treatment, living a normal healthy life. If I stop taking the lozenges, my symptoms begin returning within days but then go back away as quickly as they came as soon as I start taking the lozenges again. I still slightly moderate my diet to eliminate the foods I am the most allergic to (yeast, pecans, walnuts, and corn syrup in high concentrations) and I usually try to not overload my system with a multitude of allergenic foods at one time. For example, since I am allergic to just about everything in pizza, I don't eat it very often and when I do I don't eat very much of it. Also, since foods with corn syrup and other corn derivatives (dextrose, multidextrine, sorbitol, fructose from corn, etc.) used to trigger flares, I limit the number of those kinds of foods by not eating them every single day although I can now eat a couple of Oreos every night without any reactions! X-rays taken one year after the start of my treatment showed that my lungs and my joint degeneration had not progressed during the year and inflammation surrounding the previous damage was reduced. My retinal bleeds have not returned. All of my blood tests throughout the year demonstrated results within normal ranges. My lungs remain free of fluid; I do not have any more asthma attacks. My fatigue has not returned. My joints and muscles do not hurt. My brain fog, depression, and other neuro type symptoms have not returned. My gastrointestinal tract has recovered and I no longer show signs of malnutrition (pitted fingernails, breaking hair, etc.). Those horrendous BD headaches that felt like two sided migraines that also involved a still neck and pain throughout my back and shoulders have not returned. In short - I am still in my medicine induced and held remission. I just returned from a week long vacation in Florida, USA (March 2001) and stayed in normal hotels (chemicals, musty molds, and all) without asthma, ate restaurant foods without getting oral ulcers, spent two days walking around Disney (no wheelchair!!!), and toasted myself in the sun on the beach without getting big red blotches all over my skin. I no longer carry a breathing filter mask, an inhaler, or an emergency kit containing epinephrine for anaphylactic shock (severe allergic reaction) in my purse like I used to. In the past, I was terrified to ever be without them. Now I don't even bother to carry them at all. I did pack them in a suitcase for our vacation but I didn't even bother to take them with me to Disney World. That shows how far I have come. Although I am not nearly as sensitive as before, strong exposures to chemicals or molds can still give me a headache although not that blinding kind that cause the stiff neck, vision distortions, etc. that BD patients are so used to. Still, I am enjoying my freedom from pain and to prevent even mild headaches, I reduce my exposures to chemicals and molds by using cleaning products and such that are designed for people with allergies. I will give one of my favorite companies that distributes these kinds of products some free advertisement here because I think they can help a lot of Behcet's patients: The Allergy Relief Shop 865/494-4100 (consultation line) 800/626-2810 (U.S. toll free phone number for sales only) www.allergyreliefshop.com (website) email@example.com (email) They have a retail store located near Knoxville, Tennessee, USA and also have a mail order catalog, microbiology lab, consulting service, and construction/consulting services for those that must avoid exposures to allergens, chemicals, and other such bodily assaults. They do deal with sales internationally and you can order products directly via their website. Their paper catalog contains more products than their website. They offer products like water and air filtration products, organic all cotton bedding products, non- toxic cleaning products, health and beauty aids, non-toxic paints, solvents, and sealers. I still buy their all-purpose cleaner and mold inhibitors. At this point I could probably tolerate most products bought at a regular store but I have learned so much about how toxic our man-made environment is that I would still use these safer products even if I no longer reacted at all to anything. My husband and I made a conscious decision to continue to use only non-toxic products to protect ourselves, our friends and family, our employees and visitors, and the environment. Besides, we love our multitude of pets. (It boggles my mind that a company with a natural treatment with as few side effects as the low dose oral interferon lozenges must spend many millions of dollars and many years to fight for approval from so many governments in order to drastically improve the quality of life or even save the lives of thousands upon thousands of people - yet the same governments allow toxic products to be bought in any market for use in the normal household! What is wrong with this picture?????) -------------------------------------------------------------------------------- Update as of September 2002 Nearly 3 years after starting the lozenges, everything essentially remains the same but with a few more improvements. I have switched to a dosage pattern of 3 lozenges twice a day and am doing even better on that schedule. I have been able to add moderate servings of yeast back into my diet with no problems. I can eat moderate servings of candy and such with corn sugars in them but pecans still cause a severe, rapid onset, systemic reaction. The good news is that after several recent accidental ingestions of pecans as hidden ingredients in foods served in restaurants, I have rapidly recovered by temporarily increasing my dosage of the lozenges and taking Celebrex as a precaution. Where I used to not be able to go into movie theaters because the mere fumes from popcorn caused instant asthma - I now sit and eat a big bucket by myself. Heavy molds and lots of dust are still bad for me but again they don't bother me much unless I have been slacking off on taking my lozenges and my supplements. If I do react now because of my own stupidity, my BD normally manifests itself as mild vasculitis (spontaneous swelling or bruising of veins in my legs and tender arteries in my temples), a normal headache, twinges in my joints, mild fatigue, and/or a few minor oral ulcers. Usually only one or two symptoms appear at a time. I don't have that awful BD fatigue but I think I do get tired faster than others my age (50) which I attribute to the fact that I no longer do much of anything to avoid things that I know previously caused me to flare. I have finally become secure enough in my health to not worry about so many things and I enjoy nearly everything that normal people do which exposes me to a lot of things that used to be deadly. Now I usually just feel a little fatigue for a day or so after. :-) I have decided that the enjoyment of a normal life is worth the minor symptoms I may have in return. Other than these things, the previous update from March 2001 is still pretty accurate. -------------------------------------------------------------------------------- How the oral interferon lozenges work in simple terms Many BD patients have asked for a simple explanation of how the low dose oral interferon lozenges work. That is easier said than done. To fully grasp the importance of interferon, go to www.lerner.ccf.org\labs\williams\ and check it out. This link refers you to a site listing the approximate 600 genes that are modulated by interferon. The full explanation of how the oral interferon works is extremely complex and varies drastically between those issues that deal with viruses, tumors, and autoimmune disorders since the different conditions, viruses, antibodies, and other stimuli present in the body greatly impacts the way the body responds to any given immune situation. Also, there is a big difference between the way the injectable interferon and the oral interferon work; that is why Amarillo Biosciences holds about 20 patents on the oral interferon and is undergoing clinical trials for the oral interferon even though the injectable is already approved. The low dose oral interferon alpha is still officially considered to be an experimental, non-approved medication in the USA, Canada, and in many other countries. ~~~~~~~~~~ Based on my research, the following is a very simplistic explanation in layman's terms of how it is thought the low dose oral interferon alpha lozenges may work to help Behcet's patients: Each low dose oral interferon alpha lozenge contains natural human interferon just like that produced by the body's own cells. The lozenge is dissolved in the mouth by saliva and the interferon from the lozenge binds to special dendritic cells in the mucosal membranes of the mouth and throat. Interferon is a cytokine, one of a large group of low-molecular-weight proteins secreted by various cell types and involved in cell-to-cell communication - coordinating anti-body and T cell immune interactions. The oral interferon essentially sets in motion a modulation of the body's own production of some interferons, some interleukins, and some immunoglobulin levels which are crucial to the immune cascade. By modulating these levels, the interferon modulates the lop-sided, over-reactive Behcet's autoimmune cascade that causes the Behcet's flares. When these Behcet's flares are brought under control, the body is again able to sustain normal functions and recuperate over time. ~~~~~~~~~~ The following is the official description of how they believe this treatment works. I requested a copy of this info in 2000. It was written by a researcher for Amarillo Biosciences. Potential Mechanisms of Action of Low Dose Orally- Administered IFNa IFNa is the major IFN produced in response to viral respiratory tract infections of calves and man.1 This is one of the earliest responses of the innate immune system to microbial challenge. Although IFNa is not detected in the NS of normal healthy individuals, it is rapidly induced in the NS by viruses, rickettsia, mycoplasma or chlamydia.1-3 Following exposure to viruses in vivo, IFNa can be detected in the nasal secretions at low concentrations ( 10-100 IU/ml). These small, physiologic concentrations of endogenously produced IFNa are believed to exert their biological activities by stimulation of an elaborate immunological cascade. Exogenous IFNa administered in similar doses to the oral cavity by a slowly dissolving lozenge likely mimics this physiologic mechanism of action. IFNa binds to type I-specific interferon receptors located on tissues in the oropharyngeal region. These receptors have been demonstrated in mammals on lymphoid tissues in this area and on mucosal epithelial cells. When radiolabeled IFNa was given orally to mice, there was retention of the labeled IFNa on the posterior tongue, posterior nasal cavity and small intestine.4 In 5 human cancer patients, radiolabeled IFNa injected intravenously was transiently, but significantly, detected in the mouth, nose and paranasal sinuses 60-75 minutes after IV administration.5 Activity of orally-administered IFN has been shown in many experimental models. Following oral dosing with 10,000 IU of murine type I IFN (a mixture of IFNa and IFNb ) in mice, a marked increase in 2',5'-oligoadenylate synthetase (2-5AS) activity (a marker for IFN activity) was found in lymphoid tissues of the oropharynx (but not spleen) 24 hours after treatment.6 In contrast, mice given murine IFNa at 0.1-100 units/day for 7 days have a significant increase in 2-5AS activity in the spleen, but not the cervical lymph nodes.7 Clear evidence exists for the central role of IFN receptors in induction of effects following oral dosing. Critically, systemic effects of orally administered IFN, such as protection of mice against lethal viral challenge, were lost in animals where the IFN receptor had been inactivated by homologous recombination.8 IFNa given orally and swallowed additionally may reach receptors located in more distal regions of the gastrointestinal tract. Increases in Mx mRNA expression (a marker for type I IFN receptor interaction) have been shown in splenocytes and peripheral blood mononuclear cells after IFN ingestion.9 It is also possible that orally-administered IFNa could reach sites within minor salivary glands by traversing the short ducts which communicate with the mucosal surface. Although there is abundant evidence that low dose oral IFNa can stimulate systemic responses, it appears clear that these effects are mediated through ligation of specific, localized receptors and not by drug distributed via the circulation, as IFNa cannot be detected in the serum after oral dosing. Indeed, studies with radiolabeled IFNa given orally have shown that radioactivity subsequently detected in serum represents biologically inactive low molecular weight degradative products.6 The lack of detectable IFNa in serum following oral dosing makes standard pharmacokinetic studies impossible and has raised questions as to the ability of this method of administration to have significant biological and therapeutic effects. However, there is now convincing evidence that specific biologic effects can be recognized with oral dosing, often at low doses, even in the absence of measurable serum levels of the cytokine. For example, when mice were infected with a lethal dose of encephalomyocarditis virus and then were given either oral or injected IFN, both groups were protected to a similar extent, although the orally-treated animals did not have detectable serum levels of IFN.4 Similarly, MHC class I antigen expression was upregulated on oropharyngeal lymphoid tissues in mice after oral IFN dosing, without effects on peripheral blood mononuclear cells or splenic lymphocytes and without measurable increases in serum IFN concentrations.6 As noted above, the binding and activation of IFN receptor-bearing cells present at epithelial borders, recognized as a cardinal component of the innate immune system, obviate the need for obtaining circulating levels of IFNa to induce biological responses. At present, the specific signal transduction mechanisms and subsequent messengers induced by receptor ligation are unclear. What has been shown in extensive animal and in vitro studies is that low dose oral IFNa can induce a number of significant systemic immunological effects, including upregulation of IFNg , induction of Th1-type cytokines, modulation of activities of mature T and B cells, and increased NK cell activity.6-8,10 Oral administration of IFNa , with subsequent activation of oropharyngeal lymphoid and epithelial cells, may induce production of potent soluble factors which could mediate immunological reactivity at a distance. Oral IFNa also might activate specific cell populations in the oropharynx which could then be distributed in the circulation and function distally. For example, it has been suggested that IFN potentiates clonal expansion and survival of CD8+ cells. Stimulating effects have been shown on NK cell activity, as well. Thus, it is clear that IFNa , administered orally in low concentrations, does not only act locally, but also has systemic effects.4,10-13 In summary, low dose oral IFNa administration is felt to exert its biological effects by triggering physiologic mechanisms of the innate immune system via ligation of type I IFN receptors in the oropharyngeal region. This helps to explain the wide range of beneficial therapeutic effects found in clinical studies of numerous indications and the minimal adverse effects of the treatment. -------------------------------------------------------------------------------- Journal of Interferon & Cytokine Research The Vol. 19, No. 8, August 1999 issue of the Journal of Interferon & Cytokine Research contains 21 review and scientific papers on the oral use of interferon (IFN) and other cytokines. Physicians may wish to view or purchase this publication. Journal of Interferon & Cytokine Research is published by Mary Ann Liebert, Inc. and is available online via CatchWord. http://www.catchword.com/titles/10799907.htm This Journal is highly scientific in nature and is recommended for physicians, not the general consumer. -------------------------------------------------------------------------------- Press Release The following is a press release dated February 2000. When I copied it into here, it came in as green text and I can't make most of it change to black for some reason; I hope it will transmit and print OK on normal household printers. It is an American press release but I am including it here to assure BD patients around the world that AmarBio is really trying to help us although it is a long, slow, expensive process. ~~~~~~~~~~ Amarillo Biosciences, Inc. NEWS RELEASE CONTACT: Amarillo Biosciences, Inc. (301) 320-8200 For Immediate Release AMARILLO BIOSCIENCES ANNOUNCES ORAL INTERFERON-ALPHA GRANTED ORPHAN DRUG DESIGNATION FOR BEHÇET'S DISEASE Amarillo, Texas --- February 1, 2000 Amarillo Biosciences, Inc. (OTC: AMAR.OB) announced today that the Office of Orphan Drugs has granted Orphan Drug status to its natural human lymphoblastoid interferon-alpha for the treatment of Behçet's disease. The orphan designation process is the mechanism by which sponsors of drugs and biologics for rare diseases qualify for the tax credit and marketing exclusivity incentives of the Orphan Drug Act. Office of Orphan Products Development also administers a clinical research grants program, whereby researchers may compete for funding to conduct clinical trials to support the approval of drugs for rare diseases. Behçet's disease is a severe chronic relapsing inflammatory disorder marked by oral and genital ulcers, eye inflammation (uveitis), skin lesions, as well as varying multisystem involvement including the joints, blood vessels, central nervous system, and gastrointestinal tract. The oral lesions are an invariable sign, occurring in all patients at some time in the disease. Behçet's disease is found world-wide, and is a significant cause of partial or total disability. The US patient population has been estimated as 15,000. There are inadequate treatment options for patients with Behçet's disease. Therapy is often only partially effective or carries the burden of serious adverse effects. Injectable interferons have been shown to be beneficial in the treatment of Behçet's disease, but exhibit numerous side effects, which can be severe. In contrast, Amarillo Biosciences' low dose orally-administered interferon-alpha (Veldona®) has been shown in clinical trials to have minimal and mild side effects. The oral formulation is administered as a lozenge which is allowed to dissolve slowly in the mouth. Oral dosing with interferon- alpha has a number of advantages over the injectable form. In addition to the substantially lower level of side effects, the lozenge is a more convenient and cost effective route of administration, and lozenges do not require refrigerated storage. Amarillo Biosciences is planning a clinical development program to commence later in 2000. Behçet's Disease is extremely debilitating for the patient, with significant morbidity and mortality, and with few satisfactory treatment options. Dr. Joe Cummins, CEO of Amarillo Biosciences stated "We believe that low dose orally-administered interferon-alpha will show real therapeutic benefit in Behçet's disease with a virtual absence of side effect liability." Alex Knight, Chairman of Behçet Organisation Worldwide (BOW - www.behcets.org) stated: We at BOW support a number of Behçet's patients reaching over 44 countries. By far the largest population of our constituency reside in the United States. BOW is always in support of new medications that bring rapid, pain free relief to our population, particularly those medications with far lower side effects than current medications. We stand in full support of Amarillo Biosciences and are deeply grateful for their work and efforts on our behalf." Amarillo Biosciences, founded in 1984, is a pioneer in the development of low dose orally-administered interferon-alpha as a treatment for a variety of conditions including Sjögren's syndrome, fibromyalgia syndrome, hepatitis B and opportunistic infections in patients who are HIV positive. ABI is conducting a Phase III clinical program in Sjögren's syndrome in the United States and has already enrolled approximately 400 of the targeted 500 subjects in pivotal trials. The company is targeting an initial filing for regulatory approval in Sjögren's syndrome by the end of this year. The Company is also conducting a clinical trial testing oral interferon for the treatment of fibromyalgia and 120 patients have been enrolled in a confirmatory Phase II study. Except for the historical information contained herein, the matters discussed in this news release are forward-looking statements that involve risks and uncertainties, including uncertainties related to product development, uncertainties related to the need for regulatory and other government approvals, dependence on proprietary technology, uncertainty of market acceptance of oral interferon alpha or the company's other product candidates and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission. In particular, see "Item 1. Description of Business" of the company's Form 10-KSB for the year ended Dec. 31, 1998. -------------------------------------------------------------------------------- Ingredients Each lozenge contains 150 International Units of IFNa as the active ingredient. The lozenge also contains the inactive components maltose (a sugar) and magnesium stearate (an excipient). The IFNa lozenges are composed of natural lymphoblastoid interferon alpha with 2 major subspecies: IFN alpha 2b (72%) and IFN alpha 8 (28%). There are 6 very minor subspecies also identified. Each lozenge is formulated in 200 mg. of anhydrous crystaline maltose. An article written in 1995 entitled "Interferon-a2 Variants in the Human Genome" proposed that the alpha 2b version of interferon is the normal interferon produced and alpha 2a interferon is almost never expressed. The alpha 2a gene was cloned from the KG-1 myeloblastoid cell line and is not a normal gene which might explain why interferon alpha 2a from this gene seems to cause more side effects and generates more neutralizing antibody in treated patients using the standard injectable interferon. The low dose oral interferon lozenges contain the interferon normally produced in higher quantities in our bodies. -------------------------------------------------------------------------------- Translation into layman's terms of the above . . . To translate that above information into simple terms: When a "normal" body detects a virus or other "invader" that it thinks needs to be fought, it "normally" responds by creating interferon in the nasal secretions in very small amounts. It then distributes this interferon to the cells in the mucosal membranes of the nasal passages, throat, etc. performing its job of directing and controlling the immune response appropriate for the invader detected. This is the same interferon that is cultured and distributed in the lozenges in roughly the same quantity as that normally produced by the body in response to such an invader. It works the same way. A Behcet's patient has a problem in their natural immune system. Somewhere along the line in the immune response, something goes awry. Some level of the immune cascade either over-reacts or reacts inappropriately to whatever their body has decided to recognize as an invader. (To a BD body, anything from foods to chemicals to physical or emotional stress can be interpreted as a invader.) These over-zealous, inappropriate reactions tend to zap things they shouldn't creating a major long term immune response rather than just a simple allergic reaction like sniffles or hives or else the immune system gets so hyped up that it not only zaps the invader but it manages to zap everything around it including the blood vessels, nerves, and tissues. That accounts for the multitude of symptoms encountered by a BD patient such as systemic vasculitis, lesions all over the place, neuro damage, and all the other weird symptoms a BD body can create. Many doctors think of interferon treatments as a drastic last ditch step. That is par for the course because nearly all doctors only know of injectable kind. When they inject IFN, they use dosages measured in the millions - 3 million units (3 MU) at a time is typical. It takes that much in an injection into your muscles to get what is necessary (circulating systemically) to reach the target problem. The normal oral dosage used by Behcet's patients is a tiny fraction of the injectable - usually only 150 to 300 IUs at a time. That is 3,000,000 vs. 450 to 900 IUs. And those 3 MU are put into our bodies in a very unnatural fashion. Now even though they have had toxic side effects when injecting 3 million units at a time into our muscles, the tiny doses we take in the lozenges is miniscule and has not been shown to cause any side effects significantly different from placebo for the many hundreds of people (well over a 1000) that have used it during the last few years. The tiny oral dose can still work because it mimics the same kind and the same amount our body naturally creates in our nasal secretions during times when our body is fending off some kind of virus. It seems to work so well because it is absorbed through the mucosal membranes of our mouth and throat just like it does with the natural interferon in our nasal secretions. We don't need to pound our bodies with huge doses to make it effective; we just need to apply the natural kind to the body in a natural way. The oral IFN apparently does not travel to the site of problem tissues to tackle the problem directly; rather it appears to modulate or regulate our immune system to work correctly. Essentially, if you have BD and your immune system is going nuts and attacking your body lots of ways that it shouldn't while ignoring tasks that it should be tackling, the oral IFN triggers it to balance out and work right. It doesn't heal your lesions or battle the inflammations, it stops you from getting new ones and allows the old ones to heal. All over your body. Amarillo Biosciences has been doing clinical trials, formal studies, and individual trials with oral IFN for a number of years throughout the world with a lot of people taking it on a long term basis for a number of diseases and disorders. The oral version has not shown nearly the number or severity of the toxic side effects normally associated with the injectable interferon. IFN has been shown to regulate the interleukin levels that have been demonstrated to be deficient in BDers. (My Mosby's Pocket Dictionary defines interleukin as "one of a large group of cytokines produced mainly by T cells or in some cases by mononuclear phagocytes or other cells. Most interleukins direct other cells to divide and differentiate.") IFN may sound like a toxic drug to your doctors but I consider the oral IFN to be a natural treatment. Consider this: You are thirsty. You drink 8 ounces of water and you are no longer thirsty. Try to visualize how much water would have to be injected with a syringe into your muscles before you had the same amount of thirst relief and how long would it take? That much water injected into your muscles would also cause some nasty problems with your body! It is not natural to your body to absorb it that way. Ditto with the interferon! The kind and dose of interferon received via the lozenges is probably physiological compared to the toxic injections given to most folks. That is why it has the potential to work as well or better than the injectable interferon without the nasty side effects. -------------------------------------------------------------------------------- Reporting results Many countries (not the USA) allow Behcet's patients to import this treatment for individual trials. No one can guarantee that a patient will benefit from a trial of the low dose oral interferon lozenges. Regardless of the results of a trial, it will help Amarillo Biosciences if you keep a careful journal of your symptoms prior to, during, and after a trial (should you discontinue it) to help determine whether this treatment should be studied further as a treatment for Behcet's Disease. I am sure your doctor will also want this information. -------------------------------------------------------------------------------- Alternative Treatments (other than the IFNa lozenges) While there appears to be no single effective treatment for BD at this time, there are many other treatments available to try to treat the various symptoms and some other experimental treatments that try to reach the root of the disease. I have read of BD patients using combinations of immunosuppressants, steroids, chemo treatments, antihistamines, anti-inflammatories including the standard NSAIDs, inhalers, creams and ointments, eye drops, anti-TNF drugs, herbal treatments, acupuncture, Reiki, heart medications, variations of blood thinners, magnetic therapy, physical therapy, plasmapheresis, CamPath, neuro drugs, psychiatric drugs/treatments, and a host of treatments for localized symptoms. (CamPath may not be available now because the inventor died in a boating accident.) I have heard BD specialists refer to these drug and treatment combinations as "Behcet's Cocktails" and even have read recipes for various combinations. It is not uncommon for a BD patient (especially in the USA) to be taking a very long list of these drugs. The sad part is that most of these are relatively ineffective, are too toxic for long term use, and/or carry a high risk of side effects for Behcet's patients. Before I found out about the oral interferon, I had to sit and helplessly watch my father as he died a very slow, very painful death and it was from the treatments as much as it was from the disease. If only I had known then what I know now!!! -------------------------------------------------------------------------------- Pregnancy This is a common sense warning for BD patients that want to try the oral interferon: If you are pregnant or breast feeding a baby, please do not try this treatment. Women of childbearing age should use birth control while trying this treatment because it is not known what effect the oral interferon might have on an unborn child. If you are on this treatment then discover that you are pregnant, you should immediately notify your doctor. I don't think clinical trials in any country to-date have tested this treatment for pregnant women, unborn babies, breast-fed babies, or infants. -------------------------------------------------------------------------------- Monitoring My doctor performed blood tests very frequently during my initial trial and continues to do so on a regular, although less frequent, basis now as I continued to always receive perfect results on all my tests. I get a full blood profile, CBCs (complete blood counts), and a blood test for liver function. He has also taken x-rays of previous trouble spots (degenerated joints and lungs), conducted mammograms, and taken PAP smears. He listens to my lungs and heart, he checks the freedom of movement of my joints, he pokes and prods all the normal points for a full physical. He cannot find anything wrong. He told me on my last visit that I used to be one of his most complicated cases; now I am his easiest. -------------------------------------------------------------------------------- Dosage; Storage; How I Take The Lozenges (Because so many people have asked!) NOTE: I am simply a Behcet's patient that takes the oral interferon lozenges. I am not a medical professional. Although I and my doctor have had extensive communications with the pharmaceutical company that produces this medication, I am not an employee or associate of that company and I receive no compensation from them. I am speaking strictly from my own experience. If you have any questions, please talk to your physician. Always follow the guidance of your personal physician. After personal experimentation and communicating with many other BDers that take these lozenges, as of 2002 I routinely take 3 lozenges twice a day. This dosage allows me, like many others, to lead a more normal lifestyle with very few restrictions. Six lozenges a day is now considered to be the normal dosage for patients with Behcet's although some patients have found that a higher dosage (prescribed by their physician) is even more beneficial; to the best of my knowledge, those on the higher dosage are not suffering from side effects due to the increased dosage. I tend to vary my dosage depending on whether or not I have been "mistreating" my body. If I have been exposed to things that used to trigger my BD flares such as eating a lot of foods that I know I am allergic to, have been exposed to harmful chemicals (exhaust, gasoline, ammonia), pushed my body very far physically (hiking, spending a day stacking firewood, etc.), and/or have been under a lot of emotional stress - then I may use a higher dosage. Also, I tend to forget to take them because I don't have symptoms to remind me and after slacking off for a while I may start feeling symptoms. When this happens, I increase my dosage for a day or two to bring my immune responses back under control, then go back to my normal dosage of 6 lozenges a day. Dosages vary quite a bit between patients. A few do well on a lower dose but most need to take six lozenges a day although the dosage pattern also varies between patients. Only personal trials of different doses and schedules will let you determine what is best for you. Discuss this with your doctor and follow his advice. After nearly 3 years of talking with others using this treatment, it has become obvious that most do best on at least 6 lozenges a day and a few doctors prescribe higher dosages. The following dosage schedules are the most common: two lozenges three times a day, three lozenges twice a day (best for me), or two in the morning upon arising, one lozenge after lunch, two lozenges after supper, and one lozenge at bedtime (some Neuro-BD patients seem to have reduced their seizures using this latter dosage that I refer to as the 2-1-2-1 dose). One thing learned over the last three years is that a smaller dose may not only not be beneficial but it might possibly work against a Behcet's patient by stimulating their immune system; the full dosage of six lozenges a day appears to bring the level of interferon up to where it modulates the immune system like we need. With immune disorders like Behcet's, the focus is to modulate the immune system so I no longer recommend that BD patients start with a tiny dose then work up. A mouse study for a different immune disorder appears to back this theory up. >From personal experience, we discovered that one of our sons could not tolerate a very small dose of 1/2 or even a 1/4 lozenge twice a day but when he took the plunge and started right off with 2 lozenges two or three times a day - he did great. He also does well on a dose of 3 lozenges twice a day. Most patients need to experiment with their schedule to see what works best for them. The good news is that the doses that we take is so low that I don't think anyone could overdose on the dosages listed here. My personal experience has shown that keeping a perfect schedule (i.e. set times of day, every 6 hours, every 4 hours, etc.) does not work best for me. I am speaking only from personal experience, but I do best by following my body's natural schedule of sleeping and eating. I take my first dose (if I remember it!) after breakfast or after lunch. I always take my final dose when I go to bed. Some BD patients seem to do best when they are careful to not spread out their doses more than 8 hours apart. It is my understanding the lozenges tend to do their good stuff for about an 8 hour time period so this may explain it. I used to be careful to never exceed the 8 hour limit; I used to follow the 2-1-2-1 dose myself for that very reason. If I took the first dose at 8 a.m. and the last dose at 8 p.m., then there was a 12 hour period between the doses - essentially letting my body run amuck for around 4 hours prior to the following dose. I used to get more mini break-through flares when I let that happen so I switched to the four times a day dosage and did much better. Now, possibly because the progression of my disease appears to have been halted or simply because my immune system is learning to over-react less often and behave more like a normal immune system should, I do very well on the 3 lozenges twice a day dose. Keep in mind this is my own personal decision. Please follow the advice of your personal physician. The good news here is that there is no reason to "wean" down slowly from a higher dosage to a lower dosage. It is not like taking steroids where the body stops making the necessary substance naturally. The body continues to make interferon whether or not a person is on these lozenges and a "weaning" process is not necessary. I think one of the beauties of this medication will be the fact that it can be taken on an "as needed" basis only for those that only suffer occasional flares. I have had trouble remembering to take my lozenges because I am no longer experiencing any pain to remind me. I have no rebound effect when I forget to take them and start skipping doses - my normal Behcet's just starts creeping back in and I promptly go back to taking my lozenges on a more regular basis! Please keep in mind that this is a new, experimental medication. One of the things that we are working to figure out right now is the correct dose for Behcet's patients. It may easily take more for us than it does for someone with Sjogren's or fibromyalgia. The 'normal' dose listed on clinical trials for those patients is the dose determined to help those types of patients and a simple dosing schedule easy to maintain during clinical trials. Remember, the people receiving the injectable interferon are usually taking 3 million IUs per day; if you are taking 6 lozenges a day - you are still only taking 900 units per day or .03% (no that is not a typo) of the injectable dose. When I use more than one at a time - I dissolve the lozenges simultaneously. The directions on the box states otherwise but when taking more than a single lozenge, we need to do them simultaneously. I try to not eat much for a little while before I take my lozenges, especially greasy foods. Common sense tells me that first coating my mouth with foods will reduce the ability of the interferon to make contact with the cells in my mucosal membranes. After I finish taking my lozenge(s), I wait 15 minutes before I eat or drink anything so as to not wash it right back out. They work through contact with the mucosal membranes in your oral pharyngeal cavity – not through what is absorbed through your stomach or intestines so you don't want to wash the traces from your mouth too soon. I will mention here that the lozenges come prepackaged in little individual foil squares and are easy to store and convenient to carry in a pocket or purse. The directions on the box say to keep refrigerated but I was told that this is not necessary for short term usage. I do keep my boxes of packets in the refrigerator but I also carry some little foil packets in my purse for times that I am away from home. If traveling, I take as many as needed in my suitcase. I do not open a packet until I am ready to use the lozenge as moisture is not good for them. If I open one and do not use it right away, I am careful to securely reseal the packet until I am ready to use it. Try to not "cook" them by leaving them in a car baking in the hot sun or by placing your purse containing lozenges directly under the heater outlets in the car. Also, exposure of open lozenges to moisture can reduce their efficacy. Keep them sealed. If you have broken the seals, then keep them dry and sealed as well as possible until time to use them. I do not let those little lozenges stop moving in my mouth when I dissolve them. I swish them from side to side and over and under my tongue until they have dissolved, then I swish that saliva around for about 5 more minutes after that. I can't prevent my swallow reflex from kicking in but I have learned to "dry swallow" until I am ready to swallow my saliva. I just keep my saliva in the front of my mouth while my throat goes through its swallow reflex. It has become second nature at this point. I then tip my head back, gargle it a time or two (my own quirky way of coating my throat – I was never told to do this), then swallow it a little at a time. Even if there is a possibility of a slight allergic reaction to any of the ingredients in it, by keeping the lozenges moving around, it will hopefully prevent any localized reactions. Also, I feel like the more the mucosal membranes come in contact with the medication, the more I will get out of it. I am careful to completely coat my mouth: under my tongue, between my gums and teeth, the roof of my mouth, etc. I also tend to swish this around for a little longer than the 3 or 4 minutes recommended (I shoot for 5 minutes) because I want to get every little smidgen of good out of it. I have been informed several times that this is not necessary but I am trying to honestly report my own experiences and practices! I have talked to other Behcet's patients that have found great success with this treatment following this same routine - even the extended swishing. Dot Tutt. -------------------------------------------------------------------------------- Supplements Based on the recommendation of several BD specialists that I met at a BD conference, I take several supplements every day. They really seem to help even while on the oral interferon. I will list them below. 1 capsule daily (instead of the 4 recommended by the manufacturer) of OsteoPrime (by EnzymaticTherapy) which is a bone support supplement with lots of various vitamins including: Vitamins C, D, K, B1, B2, B6 (lots of B6), Folic Acid, B12, Calcium, Magnesium, Zinc, Selenium, Copper, Manganese, Chromium, Molybdenum, Betaine HCL, Silicon, Boron, and Strontium. Please note that I only take one of these capsules a day or 1/4 of the dosage suggested on the bottle. 1 tablet of 800 mcg of Folic Acid with lots of Vitamin B12 (by NOW). Every BD specialist seems to recommend taking folic acid although I do not understand the science behind it. I do know that it does help me, even when I am on the oral interferon. 400 IUs of Vitamin E. Dropping this does not seem to make a difference but I take it for good measure because so many doctors advise that everyone take it. 1000 mg. of Omega-3 fish oil. This is another one that I simply take for good measure because they recommend it for just about everyone. 1200 mg. of Calcium with 400 IU of Vitamin D because osteoporosis runs in my family and I used to take a lot of steroids before I discovered the oral interferon. I feel better when I take this at least once or twice a day even when I am on the oral interferon. I do not take this at the same time as my other vitamins and minerals because I have been told it might interfere with the absorption of some of the other supplements. I usually take a 5 mg. Valium at bedtime to help me conquer my quirky kind of insomnia. I doubt this has anything to do with BD - there is a strong history of sleep disorders in our family such as insomnia, sleep talking, sleep walking, nightmares, etc. The only other meds that I take is an occasional Celebrex (maybe one every week or so) for everyday muscle strains from activities like gardening, rock hopping along the lake, etc. or a mild tension headache from working 16-18 hours straight on my computer. I no longer require any steroids, immunosuppressants, inhalers, or similar medications for Behcet's. -------------------------------------------------------------------------------- Being tested for food allergies I have found that environmental exposures (chemicals, allergenic foods, etc.) can trigger BD flares. These are certainly reduced when on the oral interferon but it is still wise to identify them if possible. The oral interferon is an immune modulator but please do not rely on it to overcome every allergy you have. There are labs that can test your blood for both immediate and delayed allergies to foods, inhalants, and other allergens. These tests will not be accurate if you are on immunosuppressants or steroids and I imagine the interferon would interfere also. Therefore, if you are about to go onto the oral interferon and are relatively "clean" of other medications, I would highly recommend getting this test done beforehand. The results might surprise you. BDers tend to develop a LOT of allergies but may not realize it because they experience delayed reactions that are hard to recognize. These delayed reactions are very different from standard allergy reactions like sneezing, sniffles, hives, or itching eyes. In my own case, the delayed reactions were all triggering nasty BD flares just as the immediate reactions did; they were just very puzzling as it took a lot of detective work to figure out what was triggering them. Allergists literally kept me alive until I found the oral interferon. Most allergists can handle these tests but please be careful; one of my skin test reactions was larger than my first allergist had ever seen in all of his years of practice! (That was to yeast.) My son and I found that we reacted to everything in the skin tests and nearly everything showed up as at least a level 1 reaction; eventually we figured out that we were simply showing a skin pathergy reaction to every needle prick so then we just paid attention to the higher level reactions on the skin prick tests. Also, the skin tests riled up my BD and I was thrown into nasty flares every time we tried it. I also underwent some sublingual tests for common chemicals that really made my mind and body freak out. They were a real eye opener and uncomfortable but well worth it. My sons and I all fought our way through a very strict elimination/rotation diet that included some rather strange foods. The food generally tasted awful but again we made some new discoveries about what we reacted to. I definitely prefer the blood tests. They don't hurt, itch, or taste bad. I am going to list one laboratory that I used to conduct the blood tests for both immediate (IgE mediated) and delayed (IgG mediated) allergic responses. They also check the IgA and IgM mediated responses but I am not sure what those prove in relation to Behcet's. It just takes a simple blood draw and spin out at the doc's office before being shipped to them. You can make the arrangements with the lab in advance, they send you the necessary vials with instructions, then you send off your blood. If your insurance company will not cover the procedure, ask if they can reduce the fee. They did for me. (I talked to "Nathan" but I have no idea if he is still working for that lab or not.) I still ended up paying $546.00 for my test but it was worth it since I was killing myself with constant flares until I had it done. (This was BEFORE I tried the oral interferon !!!) By the time I was 47, I was reacting to nearly everything. We were discussing literally building a studio apartment with all glass walls, floors, and ceilings that I could retreat to to keep me alive when I was crashing. Most of my antibody levels for the 16 foods that they uncovered with the blood tests for delayed reactions were level +1 out of a possible 4 (brewer's and baker's yeast was a +2) but they were still enough to set off Behcet's flares when I ate them. By controlling my environment (avoiding all chemicals, mold, jute backed carpets, etc. that I reacted to big-time with the bubble skin allergy tests and the sublingual tests), eliminating my allergenic foods uncovered by our detective work, and eating all cooked-from-scratch, made-from-fresh organic foods and free-range meats (because the additives and pesticides in foods were a problem) - I was able to reduce the severity of my flares and survive until my latest doc finally figured out that I had Behcet's and prescribed the oral interferon for me. Now I can again follow a "normal" diet as long as I just eat my allergenic foods in moderation with the exception of pecans, walnuts, and concentrated corn syrup. I avoid those for the most part. Pizza is my big weakness! I can now eat pizza once or twice a week with no reactions. :-) Back to the blood tests. I ordered the full round of tests to check everything they could; I think it was called the "Golden Assay" or "Complete Assay" or "Golden Complete Assay" or something like that. The contact info for the lab is: Immuno Laboratories 1620 West Oakland Pk. Blvd. Fort Lauderdale, FL 33311 Phone: 800-231-9197 Tax ID#: 59-2192736 (for insurance requirements) I hope this can help you take a proactive role in getting your Behcet's under control with or without the low dose oral interferon alpha lozenges. -------------------------------------------------------------------------------- Other diets and treatments unrelated to those I have tried I do not want to imply that my suggestions will necessarily work for everyone. While I underwent a number of sets of extensive allergy tests by various doctors to see what foods I needed to eliminate from my diet, other BD patients are also testing other diets and treatment plans. It is a commonly held belief (and one that I agree with) that foods of an acid nature (orange juice, tomatoes, etc.) tend to induce oral ulcers in many BD patients. Also, smoking cigarettes seems to reduce oral ulcers in Behcet's patients although the bad effects on the lungs, blood vessels, and heart far outweigh the good effects so please don't start smoking cigarettes to reduce oral ulcers! Just don't be surprised if you are lucky enough to have little to no oral ulcers if you smoke cigarettes. Also don't be surprised if your oral ulcers increase or if you trigger a BD flare if/when you cease smoking cigarettes. Another supporter of BD has been researching a possible link between BD flares and foods naturally containing sulphur. She, and a number of other BD patients, are highly allergic to sulphur in its many guises. For those people, eliminating those foods tends to reduce or eliminate their flares providing that was the source of their triggers. Another patient, Christian Fotache in Romania ( email@example.com ), has been following another variation of a diet and treatment plan. He posted messages in a BD email listserve/digest about the treatment plan he adheres to. Following numerous trials of various standard BD medications, he found a doctor that recommended that he try a number of things including avoiding cold temperatures under 10 to 15 C, maintaining reasonable work hours with plenty of rest breaks, reducing emotional stress as much as possible, and a strict diet. On this diet, he was not allow to eat any kind of black colored food or liquids such as black grapes, eggplant, black wine, or dark colored beverages. Also, no gristle (cartilage), no kind of skin or food derived from skin, no kind of gelatin or jelly derived from animals or fruit, no meat from young animals, limited citrus fruits and limited home made citrus juices but only when no oral ulcerations are present, only natural juice from the allowed fruits (made at home, not chemically preserved), no bottled carbonated beverages like sodas, and no fried meat or vegetables. He responded to this combination of environmental controls and diet within 6 months and saved his eyesight while greatly improving his other symptoms. When he dropped this diet, he flared. When he returned to it, he improved. He also takes a few medications but thinks those should be determined by each patient's personal doctor. Christian just emailed me with an update on his progress and said that he has nearly forgotten what it feels like to suffer from a major flare. He has had a few small flares with knee pain, short term oral ulcerations, and some fatigue. He must be careful to take rest breaks during his work day or he cannot work a full 8 hours. Still, these symptoms are minor compared to what he used to suffer from during his previous flares. Another internet friend, Lu Di in China, has written to me about success using Traditional Chinese Medicine or TCM. I will include a few excerpts (some are paraphrased) from a recent email Lu Di to me: There is a group of local [China] TCM Doctors who have been studying various aspects of this problem for several years. They have been using the team approach using many disciplines collectively. Last year they published an article on their BSD findings and recommendations. Their claim is that this problem is totally controllable, and can be put into permanent remission following three months of treatment. I know two sisters that had medical examinations at the hospital then started on the TCM recommended program. One sister, who was very ill, has made a remarkable recovery, feels extremely well and has returned to work, no more ulcers or fatigue, in fact she looks great. At this time she is still taking the medication. She has now been on the program for 2 months. I pass on this information for your interest. Lu Di can be reached at email@example.com. I want everyone to understand that there are a number of triggers that can cause BD flares and a number of ways to try to avoid those triggers. There are also innumerable treatment options open to you. Play detective - it might improve your quality of life. -------------------------------------------------------------------------------- Concomitant medications with low dose oral interferon These are highly unscientific observations so take them for what they are - my own opinion. From those that I have talked to that have tried the oral interferon lozenges, it appears that those patients that are on any of the "big-gun" immunosuppressants do not tend to be very successful when starting the oral interferon. The immunosuppressants or exactly that - they suppress the immune system. The oral interferon is an immune modulator. It is hard to modulate an immune system that is being artificially suppressed by other medications. Judging by phone conversations and emails, it appears that treatments like Methotrexate, Imuran, etc. severely suppress the efficacy of the oral interferon. This is not a drug interaction; it just means that it keeps the oral interferon from helping. Some of the meds that seem to reduce the efficacy of the interferon but don't completely stop it include Cell-Cept, Prednisone, Colchicine, and high doses of standard NSAIDs such as ibuprofen, sulindac, aspirin, naproxen, etc. Also, some immunosuppressants like Colchicine and the other NSAIDs tend to leave the body rather quickly so they are not too hard to wean off of. Bad news: Weaning off the lower strength of immunosuppressants and NSAIDs may be possible but it may mean a flare lasting one or more weeks. Put into perspective, most BDers must face those periodically regardless of what they are taking so it may be worth the gamble. Good news: The new COX-2 inhibitor version of NSAIDs, Celebrex, does not seem to inhibit the oral interferon at all. Bad news: The really long lived immunosuppressants like Methotrexate are not easily weaned of off. Methotrexate stays in the body for so long (6 months or so) and inhibits the oral interferon for so long that I have not found patients that were able to get off of Methotrexate long enough to wait on the oral interferon to work without going through flares so bad that they had to give up on the attempt. I have no idea what might happen to anyone coming off of Thalidomide, Enbrel, Remicade, or other anti-TNF meds and going onto the oral interferon lozenges! I have not talked with anyone that has tried this yet. Good news: A number of people have been able to VERY SLOWLY wean down or off of their steroids as they were taking the oral interferon and the interferon apparently picked up and controlled their BD as they came to rely less and less on their steroids. The same for some other medication generally used by BDers. Whatever you do, do NOT drop all of your other meds cold turkey!!! This would be inviting a major flare as it will take time for your immune system to adjust to the change in medications. The oral interferon works differently! It does not treat the symptoms or suppress the immune system over-reactions - it works by preventing the over-reactions. If you have found any other safe and effective medications/treatments for your BD, please do not stop those treatments to try the oral interferon. The statements in this section are just my personal observations and educated guesses based on communications with patients. They are not statements made by a physician. Be sure to follow the advice and guidance of your own doctor. ~~~~~~~~~~ The following is the official Amarillo Biosciences statement about concomitant medications written in the first quarter of 2000: Concomitant Medications Dr. Phil Fox Director of Research & Development Amarillo Biosciences, Inc. Patients need not and should not discontinue their present medications when they begin low dose oral interferon alpha. If an individual feels clinical improvement while using oral interferon, they may wish to begin a very gradual withdrawal of other medications. This is something which should only be done in consultation with their physician. Through previous clinical trials, we have not discovered adverse interactions between oral interferon and other medications that patients may be taking; therefore patients do not need to discontinue any medications prior to starting a course of treatment with the low dose oral interferon alpha. It may take some time and dosage adjustments for any benefit to be recognized. Use of oral interferon for Behçet's Disease is experimental and cannot be viewed as a substitute for conventional medications that a doctor has prescribed. We urge any patient who is using, or contemplating using, any new therapy to speak with their doctor and plan a program that will judge the effects of the new medication and provide careful monitoring. Effective medications should not be stopped to begin oral interferon. -------------------------------------------------------------------------------- Don't overdo it during your recovery I think I need to write something here about recovering from BD. A number of patients have found early success with the oral interferon and resumed a normal lifestyle. They increase their work hours, the variety of foods that they eat, the places they travel, and their activities. After a while we get to feeling rather invincible and take on the role of SuperWorker, SuperMom, or SuperMan. We jump back into hard physical exercise, determined to get back into shape after being so weak for so long. We start consuming all kinds of junk foods because it is fun after all of the years of denial. We want to make up for the years lost with our children so we start getting very active in their lives again. The list goes on. After living in constant pain and fatigue or on the edge of death, we tend to greatly overdo it when we start feeling normal. Please keep in mind that we still have a disease. We still have allergic reactions. We still have physical limitations. We still need to be careful. Every time I have had a mini break-through flare it has been because: I overdid the physical stress; I overdid the emotional or mental stress; I ate foods I shouldn't have; I was traveling; I was exposed to chemicals or molds or other allergenic inhalants or contact allergens because I was no longer being careful about protecting myself; I would visit another house or office and be heavily exposed to things that are not in my house but can be hidden triggers for me such as phenol in new vinyl flooring, formaldehyde in particle board, "microcrystalline corn starch" in Febreze, or jute fibers from old carpet backing; or I forgot to take my oral interferon or supplements. Believe it or not, the last one has been the hardest one for me to control. Without the pain, fatigue, asthma, etc. to remind me that I am sick - I simply forget to take my oral interferon and supplements. Not a bad problem to have, right??? After a while, I get a headache or maybe a twinge or two in my joints then I start thinking back trying to remember when I took my last dose. When I realize it was a day or two ago, I get back into my normal dosing rhythm and I pop back to normal. I have also had a few bouts in 2001/2002 where I unwittingly ingested pecans to which I am highly allergic and that set off short termed flares. A friend pointed out that it is a sign of how far I have come - that I no longer bother to inquire as to the ingredients in restaurant food. During prior years, I used to interrogate the chefs before eating anything outside of my home! A few people have written to say how well they were doing, how much they took on, then how they were again having some problems. This is very common after traveling due to the added stresses, new foods, physical exertion, and exposure to chemicals and such in strange places. Please be careful. Do not overdo it. Do not challenge the oral interferon or your body by testing the limits too much. This treatment is not an absolute shield against all BD flares. The more you broaden the scope of what you do and where you go, the more likely you are to come in contact with additional physical, mental, or emotional stressors that may try to induce flares. -------------------------------------------------------------------------------- A word about possible changing symptoms during recovery A few patients have reported that they first did well, then seemed to develop new pain or strange sensations in their muscles/joints. This seems to be more common among those that were previously experiencing neuropathy of some sort or those that already suffered Neuro Behcet's symptoms like tingling, numbness, vision distortions, shaking, brain fog, loss of muscle or bladder control, seizures, etc. This is just a guess on my part but it may be that this happens when a body is trying to regenerate the nerves and tissues. As lesions heal in the brain and nerves regenerate, you may experience heightened sensations or even rather intense pain. Some patients give up at this stage and drop their trial. Others have waited it out and discovered that their discomfort went away as their recovery continued. I do not think this is a side effect of the medication, rather it is something that some people must endure as their bodies recover. If their fairy Godmother showed up and waved a magic wand over their heads and made their BD magically go away, they would still have to endure the symptoms inherent in recovering from ulcerations and lesions on nerves and in the central nervous system which includes the brain and spinal cord. In such a case, it might help to reduce the dosage to slow the recovery to lessen any discomfort during the process until the patient can work up to a normal dose. Sometimes after years of illness, it may be difficult to endure the healing. It may simply take a while and the fastest route might not be the best route. Another thing I would like to point out is about symptoms regressing. It appears that some people recovering on the oral interferon seem to regress back through old symptoms until they fully recover. For example, if they used to get a lot of spontaneous bruises, then they progressed to skin rashes, pustules, or target lesions, then they started getting large open skin ulcers - it seems like they tend to discover that their open skin ulcers may clear up only to be replaced by their old rashes and target lesions, then later on those disappear and the bruising comes back. Eventually all of the symptoms may go away. If in general the patient responds well to the oral interferon but notices some strange changes in their symptoms, it may be a good sign. Such a patient should talk it over with their personal physicians and follow their guidance. It may just be transitory. If you had BD for years and your body was deteriorating for years, please do not expect to recover overnight - especially if you are still clearing other medications out of your body. -------------------------------------------------------------------------------- How to advocate for yourself for the oral IFNa I am being deluged with emails from patients wanting help to convince their doctors to prescribe the oral interferon lozenges for them because their docs all think it is "too new", "too experimental", "too unproven", "too toxic", or "too dangerous". I can no longer find the time to keep answering each of these emails individually so I want to write the general game plan that seems to be the best route to getting doctors to learn and understand about the oral interferon. Personally, I am a firm believer in the new low dose oral interferon alpha lozenges because they have worked so well for me and for so many others with BD. It apparently works to modulate the immune system to keep it under control, rather than treating the symptoms that occur after it is out of control. It also does not suppress the immune system. (Suppressing the immune system is dangerous as it can lead to many side effects and problems such as systemic infections.) Don't forget that the oral interferon is experimental and is non-FDA approved in the USA but it has been under research since the 1970s and has been used for a number of years in a lot of trials around the world with no severe side effects and there has been no indication of any long term toxicity. There is more info about this on the Amarillo Biosciences (Amar-Bio) website at www.amarbio.com. Regardless of where you live, you will find that doctors tend to fall into two groups. Some doctors are progressive, do a lot of research, and keep up with the latest treatments and news in medicine and those are the ones that have consented to let their BD patients try the oral interferon. Other doctors are more prone to stay in their safe "comfort zone" and only prescribe the "tried and true" medications until others prove the effectiveness of a new treatment. Education of the doctors is key here. There is not much you can do to change a "comfort zone" doctor into a "progressive" doctor without going into a big-time education push on your own. It is amazing how fast they are converted upon witnessing one of their patients with severe BD turn around and recover after failing at so many prior attempts with other treatments. They then tend to prescribe it for a number of other patients. Many BD patients have found that by printing up all the info they can (like this long document), reading up on info found at the Amarillo Biosciences site, printing up the success stories posted in the various email lists/digests and on the bulletin boards, and personally taking the time to study and understand this information has empowered them to approach their doctors after being more fully informed. This enables the informed BD patient to convince the doctors about the potential for success and the relative safety of this treatment. It may take a lot of work on your own part to advocate for yourself but your life, or at least the quality of your life, may be at stake here. Most doctors have never heard of this new treatment and if you are truly interested in trying it after reading about it, I would highly suggest taking the time to learn all you can so you can advocate for yourself BEFORE you ever first approach the subject with your doctor. Almost always, when you first ask your doctor about it, the doc will (knowing only about the injectable interferon) start flipping out the standard objections like: "interferon has too many side effects", "interferon is too expensive and hard to administer", "oral interferon cannot work because the gastric acid would destroy it", etc. It will help your case immensely if you print up all the information you can and put it in some kind of a binder (you may want to highlight and print it sections at a time so you can index your binder), carefully study it so you can advocate for yourself, and rehearse the answers to the above questions so you can counter your doc's initial objections. After you get past those first objections, then hand the binder to your doctor and ask the doctor to read it before making a decision that may effect your quality of life for many years to come. For a number of us, this treatment has saved our very lives. Tell your doctor about the August 1999 issue of the Journal of Interferon & Cytokine Research that I wrote about above. It has about 160 pages of information appropriate for physicians and scientists. You may be able to get the oral interferon lozenges at your corner drugstore someday. The company that makes the oral interferon, Amarillo Biosciences, has conducted 4 clinical trials in the USA for Sjogren's (dry mouth/eyes syndrome that is so commonly diagnosed secondary to Behcet's). They intend to conduct additional trials to try and satisfy all FDA requirements and hope to make application for approval in 2002 or 2003. (Knock on wood, cross your fingers, and pray!) In the USA, once it is fully approved for any disorder, doctors will also be allowed to prescribe it for other diseases/disorders including Behcet's Disease. :-) I have no inkling of a time frame for other countries although it appears that approval by the American FDA seems to spur the approval of the medication in some other countries. In 2001, another pharmaceutical company, Atrix Laboratories, has licensed the rights from Amarillo Biosciences to conduct clinical trials for this treatment in the USA and Canada for the Papilloma Virus (oral warts) in AIDS patients and for Behcet's Disease. (A press release about this is included below.) As of September 2002 their website shows they are nearing the end of an early (Phase II) clinical trial using the oral interferon lozenges for the treatment of the Papilloma Virus (oral warts) for AIDS patients. Assuming they are successful and their continued clinical trials are also successful, we may find that this treatment will be approved by the FDA and available in pharmacies via this path first. In the meantime, regardless of where you live - if you need the oral IFNa now, do your homework as there is a little red tape to wade through to get it. The best way (regardless of country) is to find a doctor that is willing to pen his name to a firm diagnosis and apply for a Compassionate Personal Use Exemption providing you meet the qualifications for one. I will go into this in more detail later in this document. These exemptions are essentially reserved for those that are experiencing very serious or life threatening symptoms for which you have been unable to find an acceptable/safe/effective/approved treatment. If you find your doctors being resistant to the idea of a trial of this treatment, they are not being rude; they are really doing their best to protect what health you may have left. But as a rule, they are uneducated when it comes to the new, experimental oral interferon. This stuff has been around for quite a while and has undergone lots of clinical trials but knowledge about it is not widespread yet. The lab must take extraordinary steps to prove its efficacy and safety for every individual disorder it is being used for. It is a long, drawn out, expensive undertaking. That is why most docs don't know of it yet even though it has been undergoing clinical trials for many years. Plus Amarillo Biosciences is not one of the huge multi-billion dollar pharmaceutical companies that invented it so they don't have an unending stream of profits from other drugs to fund even more extensive studies of this treatment and it is harder for them to get publicity without risking being labeled as promoting a non-approved treatment. A fine line to walk. I think it is worth the fight to get the oral interferon. It has completely turned my life around and has been such an improvement that I can't even contemplate life again without this treatment and there are a number of other BDers that now agree with me on that. I expect that someday it may also be the salvation for my BD sons and brother. Don't forget that I am not a medical professional and be sure to talk all this over with your personal physicians as they are the ones that should guide you here and help you decide if a trial of this treatment makes sense for you. -------------------------------------------------------------------------------- Press Release - October 2001 The following press release was posted on the www.amarbio.com website in October 2001. Hopefully clinical trials will soon be underway for Behcet's Disease! :-) AMARILLO BIOSCIENCES, INC. LICENSES RIGHTS TO LOW DOSE ORAL INTERFERON FOR ORPHAN DRUG INDICATIONS Amarillo, Texas, October 2, 2001 Amarillo Biosciences, Inc. (OTCBB Symbol: AMAR) announces the company has signed a licensing agreement with Atrix Laboratories, Inc. providing the rights to oral low-dose interferon-alpha for the treatment of Behcet's disease and oral papillomavirus warts in HIV-positive patients. The U.S. Food and Drug Administration (FDA) has granted this product orphan drug status for both indications. Dr. Joseph M. Cummins, President and CEO of Amarillo Biosciences, Inc. said, "Data from our human clinical trials and our mechanism of action studies show that our low- dose oral interferon-alpha is biologically active and well tolerated. We are excited to partner with Atrix to take oral low-dose interferon-alpha to the next level in clinical trials. They have the expertise to make this an excellent near-term revenue generating opportunity." Under the terms of the agreement, Atrix paid $485,000 for licensing, orphan drug designations, and clinical supplies. Atrix will fund the research and development of the product and will perform the work at their facilities in Fort Collins, Colorado. As part of the agreement, ABI will receive payments for specific clinical and regulatory milestones and will receive a royalty based on sale of any product developed. Amarillo Biosciences, founded in 1984, is a pioneer in the research of low dose orally- administered interferon-alpha as a treatment for a variety of conditions including Sjogren's syndrome, fibromyalgia syndrome, Behcet's disease, hepatitis B, C, and opportunistic infections in patients who are HIV positive. Except for the historical information contained herein, the matters discussed in this news release are forward-looking statements that involve risks and uncertainties, including uncertainties related to product development, uncertainties related to the need for regulatory and other government approvals, dependence on proprietary technology, uncertainty of market acceptance of oral interferon alpha or the Company's other product candidates and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission. In particular, see "Item 1. Description of Business" of the Company's Form 10-KSB for the year ended December 31, 2000. Joseph M. Cummins, DVM, PhD President & Chief Operating Officer Amarillo Biosciences, Inc. 800 West 9th Avenue Amarillo, TX 79101-3206 e-mail: firstname.lastname@example.com Tel:806-376-1741 ext 13 Fax:806-376-9301 Jim Drewitz Investor Relations (972) 355-6070 -------------------------------------------------------------------------------- Informational books about Behcet's I think this would be a good place to list a wonderful source of basic information and informational books about Behcet's Disease. I am speaking of a webpage, books, pamphlets, and wallet cards that were authored, compiled, and/or reprinted by Joanne Zeis who also has Behcet's Disease. She has spent a great amount of time putting together this information to the benefit of us all. I have purchased several. Her website is called Behcet's Basics and can be found at www.behcetsdisease.com. I shared my books with my doctor and other Behcet's Disease patients. This is a great place to start arming yourself with information to better understand this disease. -------------------------------------------------------------------------------- Information book about allergies Another good source of information about understanding our immune system, allergies, and how to control them is the book The Whole Way To Allergy Relief & Prevention. I have the second edition. The cover describes itself as: A Doctor's Complete Guide To Treatment & Self-Care, A Practical Encyclopedia. The cover lists the following topics: Stopping reactions quickly and naturally, New natural & pharmaceutical treatments, Testing for food and chemical sensitivities, Choosing the right physicians, and Lifestyle tips for wellness. In my opinion, this book gives a wonderful overview of how the immune system works, things we can do to control our allergies (that translates into "flares" for BDers), sources of chemicals, nutrients, etc., and a host of other goodies pertinent to our care. As an example: The allergist proved I was highly allergic to the chemical phenol which meant nothing to me at the time; this book listed about 50 items/products that I needed to avoid. I credit this book for keeping me alive for many years when I was still going to doctors that had no clue about Behcet's, that I even had Behcet's, or what to do about my weird symptoms in the meantime. The authors are Jacqueline Krohn, MD; Frances A. Taylor, MA; and Erla Mae Larson, RN. The ISBN # is 0-88179-134-2 and costs around $25 in the USA or $30 in Canada. It is published by: Hartley & Marks, Publishers. -------------------------------------------------------------------------------- Ordering oral interferon lozenges Here is information about how to order the oral interferon if you are eligible. If you are an American, be sure to read the paragraphs toward the end of this message about restrictions in the USA. If you have already contacted me, you probably already know that I am a patient with Complete Behcet's taking the low dose oral interferon alpha lozenges. I am not a doctor, medical professional, or attorney! If you try this treatment, you do so at your own risk. I am not liable for any medical/legal problems/actions that may arise out of your attempts to secure this treatment or for any unsatisfactory results experienced by trying this treatment. I will be happy to accept {{{cyber-hugs}}} if you find relief from your suffering! I am simply a patient with severe Behcet's Disease. I personally have found great success using this treatment, but that may not necessarily be the case for other people with Behcet's. I communicate with a large number of other Behcet's patients through various support groups/organizations and have told many of them about my recovery. Many of my Behcet's friends and associates have contacted me privately to ask questions about this new treatment. I have spoken to so many Behcet's patients that I have become the unofficial oral interferon project liaison, helping to educate people of all nationalities about the potentials of the oral interferon as a treatment for Behcet's. As such, I have received many requests from people all over the globe asking about how they can legally secure a personal trial of this treatment if their doctor wants to prescribe it for them. To make it easier for me to provide this information and to make sure you are provided with the complete directions I have prepared this email to answer the most common questions and provide the contact information you may need. Contact info: I can be reached at: email@example.com. You may direct mail to me at: Dot Tutt, 2017 Lovell Road, Knoxville, TN 37932. My internist, Dr. Jeffrey Boruff, is the physician that first investigated this treatment with me and eventually prescribed it for me. After watching my rapid recovery, he is now a true believer! He is a very busy doctor with a heavy schedule but he can verify that I am legitimate should anyone question whether I am just some kind of "internet kook" or not. He may be reached at 865/690-5262 (voice). His mailing address is Dr. Jeffrey S. Boruff, M.D., HealthCare Partners, 7210 Oak Ridge Highway, Knoxville, TN 37931 USA. I owe my life to this man. After seeing dozens of doctors and specialists throughout my life, he was one of the few that was familiar enough with the various symptoms of Behcet's to recognize it. He tirelessly researched and worked with me on my personal treatment plan. I would never have found remission without his skill, knowledge, and compassion. A large number of remote BD patients have written to me about the possibility of getting an appointment with "Dr. Jeff" but unfortunately, due to restrictions in the corporate policy of his physicians group and concerns about the inability to maintain close contact to monitor remote patients, he cannot accept non-local patients or those on Medicare. The lozenges are manufactured in Canada and are distributed from there to Canadian patients and to patients in all other countries. This is the only location that you can order the low dose oral interferon alpha lozenges from. Canadians: This medication is available in Canada through the Canadian Special Access Programme. Contact: Mr. Don McTaggart at Don McTaggart & Associates Consulting Services, Inc., 1945 Kerns Road, Burlington, Ontario, Canada L7P 3J1. His phone number is: 905-332-4492. (This telephone number is a combination voice/fax line; their fax machine will automatically pick up if a fax tone is detected, otherwise it will be answered as usual.) He can give you the information regarding how to handle the Canadian paperwork. Non-Canadians, non-Australians, non-Americans: Contact the distributor, Mr. Don McTaggart, at the above address or phone number to see if he thinks it is legal to import into your country and if there are any special instructions for importing the treatment into your country. Otherwise, you should will follow the directions below in the section entitled: "How To Order Low Dose Oral Interferon Alpha Lozenges. . . " Australians: Please simply follow the directions below in the section entitled: "How To Order Low Dose Oral Interferon Alpha Lozenges. . . " The American company that conducts the research and holds the patents for the low dose oral interferon alpha lozenges, Amarillo Biosciences, is not involved in any promotion or distribution of this treatment. Please do not contact Amarillo Biosciences regarding prescriptions. American FDA (a governmental regulatory agency) regulations prevent their involvement at this time. Until this treatment is granted approval by the FDA, we do not want to jeopardize the wonderful work they are doing by making demands that they cannot respond to in the USA. * * IMPORTANT NOTICE FOR AMERICANS * * Americans have more restrictions!!! Americans: The low dose oral interferon alpha lozenges are not approved in the USA at this time so Americans have special regulations that they must qualify for. The following paragraphs apply only to Americans: Please note that this medication is experimental and non-FDA approved for use in the USA as of this date. Amarillo Biosciences has completed a number of FDA approved clinical trials for other viral and autoimmune disorders but as of this date, they have not conducted official studies or clinical trials of this medication in the USA specifically for the treatment of Behcet's. Therefore, they are not free to advertise, promote, sell, or profit from this product in the USA. Even though they may not and do not solicit or distribute to Behcet's patients in the USA, they are compassionate and recognize the seriousness of Behcet's. If you have any questions for them, please direct those questions to me in writing and if I don't have the answer on hand, I will try to research it for you. On February 1, 2000, Amarillo Biosciences, Inc. announced that the Office of Orphan Drugs has granted Orphan Drug status to its natural human lymphoblastoid interferon- alpha for the treatment of Behçet's disease. Amarillo Biosciences is planning a clinical development program to commence at a later date. Assuming they can make the necessary arrangements and receive FDA approval to conduct them, they hope to arrange for several sites to participate in these clinical trials. They would like to direct interested American Behcet's patients to consider attempting to enter into one of the later clinical trials if at all possible. The participating doctors have not been identified yet but will be announced later as the clinical trials approach. There is currently no way to predict how soon clinical trials might begin for Behcet's patients or the location sites of the trials. (Personally, I do not expect the clinical trials to be hosted at very many sites around the country.) I have been queried repeatedly about "compassionate use" or "personal use exemptions". It is my belief that the regulations (printed below) support such exemptions for American Behcet's patients in serious need when other treatments are not effective or carry too high of a risk. Read the following regulations with your doctor and make your own decision (the words in [brackets] are my own personal comments: "This medication may be imported by a patient in the USA when a) the intended use is unapproved [true] and for a serious condition for which effective treatment may not be available domestically either through commercial or clinical means [true for those that have not found relief using available medications that may be safely prescribed]; b) there is no known commercialization or promotion to persons residing in the U.S. by those involved in the distribution of the product at issue [true]; c) the product is considered not to represent an unreasonable risk [previous clinical trials have shown it to have a low rate of very mild side effects]; and d) the individual seeking to import the product affirms in writing that it is for the patient's own use (generally not more than 3 month supply) and provides the name and address of the doctor licensed in the U.S. responsible for his or her treatment with the product [your responsibility to provide this letter], or provides evidence that the product is for the continuation of a treatment begun in a foreign country [only if you started it elsewhere first!]." As I said above, it is certainly preferable for Behcet's patients to wait for a clinical trial. Not only is that very strongly preferred by the FDA and all companies concerned, the tabulated results will also help others in the future. If a clinical trial is not available, the next best option is to have your doctor apply for an individual Physician's IND (particularly if they treat a number of Behcet's patients) although this can carry additional costs, take an uncertain amount of time to be approved by the FDA, and it also places an additional burden on Amarillo Biosciences to monitor the individual INDs. NOTE: Currently this IND option is NOT available as the FDA has decided to stop the individual INDs in favor of waiting for the full-scale clinical trials to start. If, despite the approved treatments available in the USA, you are in serious danger or your doctor judges you to be in imminent risk of going blind, are currently experiencing seizures, becoming paralyzed, losing your mental capacity, are suffering from such severe weight loss or GI bleeds as to be life threatening, are losing your spine and/or other joints from heavy steroid use, or other such dire problems, it is my belief that you should qualify, according to the parameters of the above regulations, for importation of this medication. Others that may fall into this category are patients whose previous treatments (such as with chemo, extensive use of steroids or other strong immunosuppressants, or bone marrow transplant recipients) have failed or who may have already sustained severe damage to their bones, bone marrow, blood, or organs and are no longer eligible for other appropriate approved treatments. If you are an American and think you may fall into this category, please talk to your doctor about applying for a Compassionate Personal Use Exemption. You may be able to have your doctor fax a prescription and documentation as detailed below under "How to order . . ." and import this medication. Be careful to complete all of the documentation listed and have the doctor use his official office letterhead paper for his letters. If the Canadian distributor finds all of your documentation to be in order and approves your exemption, your prescription will be shipped to you in the USA and you will be invoiced for the shipping and handling charges only (the medication itself will be provided free of charge). We must all, as a group, be careful to limit the number of personal use exemption requests or the FDA may decide that the Canadian company is exporting too much of this product to the USA and clamp down on them. We need to reserve these exemptions for those with serious problems that cannot wait until the clinical trials start or until the FDA approves this medication in the USA for sales through local pharmacies. I will ask that you please be very honest here and not exaggerate your symptoms. The FDA will scrutinize these exemptions and we do not want to have them stop all American shipments. If they do, others will suffer needlessly because they will be unable to secure this treatment when it is truly their last resort. We simply cannot afford to risk letting some patients die, go blind, lose their joints or organs, or suffer permanent dementia simply because too many people were fed up with fatigue, minor oral ulcers, or minor joint pains and requested exemptions. There is a reason for the exemptions. Please do not abuse it. If you can control your symptoms by altering your environment, your diet, or by using other drugs that are safe and effective for you, please do not apply for a compassionate personal use exemption. -------------------------------------------------------------------------------- How To Order Low Dose Oral Interferon Alpha Lozenges Prescriptions/Compassionate Personal Use Exemptions Canadians may contact Don McTaggart & Associates using the contact information listed below for information about acquiring this treatment via the Canadian Special Access Programme. I believe the cost for a three month supply in Canada is $180 Canadian dollars but I am not absolutely sure of this. Please contact Don McTaggart for more information. Non-Canadians may order the lozenges as follows: The Behcet's patient must be a citizen of the country of importation; the prescribing physician must be legally authorized to write prescriptions in the same country. Although the prescriptions are written for refills that should be sufficient for a year, it is highly recommended that patients/physicians resubmit a new prescription and new documentation every six months to reduce the likelihood of the American FDA or importation authorities in any country from holding up the delivery of the lozenges. For convenience, I have bolded and underlined the actual wording that may be used on the prescription and letters. Every piece of documentation should be dated and contain the written signature of the appropriate person. 1) Prescription: The prescription should read: 560 interferon alpha lozenges @ 150 IU each; dissolve one or two lozenges in the mouth 3 times per day. May be refilled 3 times. Be sure to clearly write the name and address of the patient. (The refills may be ordered by having either the patient or physician send a fax or email to Don McTaggart & Associates at firstname.lastname@example.com. 2) Monitor letter: Include a signed and dated letter from the prescribing physician on the physician's office letterhead that reads: I, [prescribing physician name], will monitor the treatment of patient, [patient name], while the patient takes interferon orally for the treatment of Behcet's Disease. 3) Compassionate Personal Use Exemption request: Include a request written by the prescribing physician on the physician's office letterhead that reads: Other available treatments have failed to control the progression/symptoms of this patient's Behcet's Disease. This patient has suffered from severe/life threatening manifestations and I feel treatment with oral interferon alpha is warranted in this situation. I am requesting a compassionate personal use exemption for this patient, [patient name]. 4) Patient's Importation Letter: Include a letter (on plain paper) from the patient seeking to import the product that reads: I, [patient name], am importing low dose oral interferon alpha lozenges for my own personal use for the treatment of my Behcet's Disease. I understand that I may only import a 3 month supply at a time. The doctor that will be monitoring me while I take the lozenges is [prescribing physician name], [clinic name], [clinic mailing and street address]. Include your (the patient's) full name, home street and mailing address, phone number, and email address (if available) after your signature. 5) Patient's Proof Of Citizenship: Photocopy of proof of citizenship for the country of importation such as a passport, driver's license, official governmental ID card, social security card (for Americans), etc. Be sure to include the street addresses along with the postal mailing addresses; the medication will be shipped via courier directly to the patient's home address and cannot be delivered to a post office box or drawer. Fax the 5 pieces of documentation (making certain the patient's and physician's names and addresses are complete and legible) directly to Mr. Don McTaggart at 905/332-4492 in Canada. (The lozenges are manufactured in Canada.) This telephone number is a combination voice/fax line; their fax machine will automatically pick up if a fax tone is detected, otherwise it will be answered as usual. The above number is for Don McTaggart & Associates, Consulting Services, Inc., 1945 Kerns Road, Burlington, Ontario, Canada L7P 3J1. It costs Don McTaggart & Associates approximately $90 US dollars per shipment for the packaging, shipping, and filing of importation documentation; it costs Amarillo Biosciences approximately $90 US dollars per shipment to cover the actual production costs of the medication. Therefore, the patient will be invoiced $180 US dollars for shipments to all international sites outside of Canada and the USA. Americans will be invoiced $90 US dollars for the costs incurred by Don McTaggart & Associates for shipping and handling because American FDA restrictions prevent charging American patients for the actual costs of the drug because it is not approved yet in the USA. Important notice for physicians and patients: Please do NOT discontinue any other medications (immunosuppressants) when first prescribing/taking the oral interferon for Behcet's. After the patient is established on the IFNa, is stable, and only under the recommendation of the prescribing physician - the patient may want to start very slowly weaning off of their immunosuppressants and other medications. Do so only under the guidance of the physician. Dropping medications like Cell-Cept, Methotrexate, Prednisone, etc. when initially starting the IFNa is an invitation for a major flare. Please do not drop prior medications "cold turkey" when starting the oral interferon (especially steroids!!!). There are no known interactions between the oral IFNa and other medications although there are some indications that immunosuppressants and NSAIDs may tend to reduce the efficacy of the IFNa. The slow weaning of other medications after starting the IFNa seems to be the most effective way of handling this change of medication based upon personal trials by other Behcet's patients. Please review the long email sent previously - as it contains more information about taking other medications with the oral interferon lozenges. The optimum dosage varies widely between individual patients. A few patients have reported doing best on just 1/2 lozenge one to three times a day. Most Behcet's patients seem to do best on two lozenges three times a day (every 8 hours) and this is now considered to be the normal dose for Behcet's patients. Please start with a very small dose and gradually increase the dose over time to find the best dose. If you have any other questions, feel free to email me at firstname.lastname@example.com. Dot Tutt. Oral Interferon Liaison -------------------------------------------------------------------------------- Steroid wean - keep it S L O W Please remember, I am NOT a doctor or health professional. I am including this information about weaning off of steroids based solely upon what I have been told by several patients that were having trouble weaning off of their steroids after becoming stable on the oral interferon. Almost invariably, when people start feeling much better, they are so anxious to get off their steroids that they start an aggressive wean that usually causes them to flare. The following is a pattern for a slow wean that may seem to take forever but it is a much safer method and much more likely to work in the long run than an aggressive wean. Consider the following simply as a suggestion that you may want to discuss with your doctor; please be sure to follow the advice of your personal physician. Always keep in mind that you may have been sick for a long time, perhaps for many years, and the reality is that your body may take a long time for everything to recover and come into balance. For some people, the good effects of the oral interferon won't reach their maximum levels until up to three months into the treatment. Some of my minor symptoms like Raynaud's syndrome, breast tenderness, and severe tinnitus did take nearly three months to go away. I kept thinking I was as fully recovered as possible, then something else would slowly get better and I would realize that I was still on the way up - I was not there yet. I had many miscellaneous symptoms that I had not associated with BD. Behcet's is much more pervasive than most people think. Don't get anxious and drop other meds too quickly, especially the steroids. For many patients that have been on steroids long term, their own adrenal glands stop producing natural cortisol and the body becomes used to having the higher dosages found in the oral steroids. To get off may take some work. >From what I have been told, most patients that make it to very low maintenance doses or clear off of the steroids do so using a very slow wean. As the doses of steroids vary so widely, I will simply pick a number to use as an example. I will pretend you are already stable on 25 mg. a day of oral steroids at the beginning of the wean. This weaning pattern reduces the steroids by 2.5 mg. every twenty days at first, then drops to a reduction of only 1 mg. every twenty days after that. Please consider this pattern: 1st ten days: Alternate 25 mg. one day with 22.5 mg. the next day. IF you are stable, continue to the next step. Next ten days: Take 22.5 mg. every day. IF you are stable, continue to the next step. Next ten days: Alternate 22.5 mg. one day with 20 mg. the next day. IF you are stable, continue to the next step. Next ten days: Take 20 mg. every day. IF you are stable, continue to the next step. Repeat this pattern of 10 days of alternating doses followed by 10 days at the lower dosage. Hopefully this routine will work until you get down to around 10 mg. (Some people hit a plateau at 15 mg. and must start a slower wean at this level.) At this point, you follow the same routine but drop the weans to just 1 (one) mg. at a time. You would take 10 mg. alternated with 9 mg. for 10 days, then 9 mg. for 10 days. Then 9 mg. alternated with 8 mg. for 10 days, then 8 mg. for 10 days. If you are lucky and your own adrenal glands kick back into gear and start making their own cortisol, you might be able to continue this 1 mg. wean every other 10 day period and get off of it altogether. If you get to just a few mg., don't get antsy and drop it altogether. Wean all the way down until you are alternating the 1 mg. with none for ten days before giving it up. Some people find that because they were on steroids for so long, their own adrenal glands simply will not come out of their "dormancy" and they must remain on a low maintenance dosage of steroids of 8 mg. a day or so. I think the normal healthy body makes something in the neighborhood of 7 to 8 mg. of cortisol in its natural state. (I have no idea if this varies according to body size or gender. Please know that I am a short, small boned female and that was the estimated amount of cortisol estimated for me. Ask you own doctor.) When a person is on steroids very long, this ability to produce cortisol naturally tends to shut down. With the slow wean, you are trying to tickle your adrenal glands into waking back up. Some are lucky and some are not. This kind of wean can be difficult to keep up with logistically so mark the doses on a calendar in pencil at the start of each ten day period. If you start to flare, try to just go back up to the last previous higher dose that worked for you and hold that for 10 days to see if that will let you stabilize before you start weaning again. If you take a large jump up, you have that much to try to wean back down through again. Also, if you are doing well then have a sudden flare, consider that it might be exposure to a trigger and not the steroid wean - you might have to consider your environment. (i.e. Did you just paint a room in the house or install new carpeting? Did you just get a new pet? Did you decide it was safe to suddenly pig out on Twinkies and pizza after years of abstinence????) This slow wean may seem maddeningly slow but it is worth it. Don't get upset at the idea that each step down takes twenty days. Think of each step down as another success. If you push it, you won't win. If you are on steroids and oral interferon, your immune system is currently trying to function with two treatments that alter/modulate your immune responses. It is a hard balancing act. Take it slow and easy and you should get there. The long term results are certainly worth the wait. Many doctors that don't deal with a lot of BD patients are used to seeing some patients handle a much faster steroid wean. We BDers simply do not have a normal immune system and we do not handle those weans well at all. We need to take a much more conservative path. Although not on the oral interferon or other immunosuppressants at the time, my youngest son's last steroid "burst" that was supposed to last only 6 days ended up taking a number of months to get off of. Every time he tried to come down, he would develop another batch of acneform cysts and target lesions and have to go to an even larger dose to prevent more from developing. At 16, his x-rays were already showing signs of joint degeneration in his ankles so we were anxious to get him off of the steroids. We finally gave in, went into a slow wean pattern, and he was successfully able to get off of it altogether. Bovine Extract Dietary Supplement (Another new treatment from the same inventor) Order instructions Included Dr. Joe Cummins, the same man that invented the oral interferon, has also invented another treatment that is doing well for a number of Behcet's patients. It is a bovine (cow) extract dietary supplement that incorporates extracts from bovine immune system secretions. It is similar to the oral interferon lozenges in the way it controls our BD reactions yet it is different from the oral interferon lozenges in that it does not include any human interferon. For some people, it appears to be even more effective for Behcet's Disease. I can personally speak of four BD patients that have tried this new treatment including Genevieve Vanasco (many of you know her through the BD email lists, chatrooms, and bulletin/message boards), both of my teenage sons, and myself. We have all been amazed at the positive response we have experienced from this new bovine extract dietary supplement when used in conjunction with the oral interferon lozenges and also as a stand-alone treatment. Genevieve tried taking it full time while just tossing in a couple of lozenges about every other day or so. My sons took nothing but this supplement and promptly became totally symptom free and remained that way as long as they remained on it. I started by taking a reduced number of lozenges but I tossed in the supplement about once a day and quickly reached the stage of not having to watch anything I eat. I mean I could eat all the yeast and other foods that were huge BD triggers before the oral interferon and that I still tried to eat in moderation even with the oral interferon lozenges to prevent any mini break- through flares. With the bovine extract, I could eat half a supreme pizza with a side of Fritos, wash it down with two beers, and follow that with yeast raised glazed donuts for dessert. Previously (without any IFNa or the bovine extract) that would have ulcerated me from one end to the other, caused violent bloody diarrhea, swelled my tongue and throat until I was choking, caused my lungs to fill with fluid, caused vision distortions and a headache of unbearable proportions, and promptly landed me in the hospital along with a major battle to stop the bleeding in my retinas. To be honest, I probably would have died before I ever reached the hospital. While taking the bovine extract dietary supplement, that diet did not phase me in the slightest. During the trial of the new supplement, if I ate foods like that - I could just follow it with a medium dose of this dietary supplement and I never had any reaction of any kind. My oldest son and I even tested a stronger strength that enabled us to take just one smaller sized dose just once each morning. No other treatments at all other than normal vitamin supplements. I mean no lozenges. No anti-inflammatories. No additional doses of the supplement. Nothing whatsoever other than the one, single dose in the morning. It was truly amazing. With that single dose, no matter what I ate, I could not trigger a flare. The bovine supplement, marketed through another company by the name of Shady Nook Farms, now comes in a sterile saline solution. Taken orally, it apparently provided us with the same type of immune modulation effects as the oral interferon lozenges . but, you know us BD patients. We are determined to see what else we can do with any given treatment so a few of us decided to test it by applying it directly to lesions. It worked! In other words, it helped with nasal ulcers, oral ulcers, genital ulcers, and skin lesions when applied topically. Genevieve, my sons, and I have tried it for all of the above. In addition, Genevieve has discovered that this bovine extract dietary supplement stops her withdrawal symptoms as they turn down the levels on her internal morphine pump! We are hoping it will work the same for other Behcet's patients that are trying to wean off of addictive pain medications and suffering from the fevers, sweats, shakes, dizziness, pain, and other symptoms that can accompany that. Genevieve and I tested this new product by reducing/dropping our oral interferon lozenges until our old symptoms started to pop back up. In the case of my sons, they were not on the oral interferon lozenges yet anyway due to the FDA restrictions so they already were fighting a number of symptoms. After inducing/experiencing symptoms, we then tried treating the oral ulcers, nasal ulcers, genital ulcers, and skin lesions with the bovine extract. It was amazing how quickly they responded. I am talking about seeing results starting overnight. Do not mistake what I am writing here. The bovine extract is being marketed solely as a dietary supplement - not to be applied topically anywhere else on our bodies. What I am writing about here regarding topical application and using it as a tool during morphine withdrawal was our own test variations done without the urging of Dr. Cummins. With so many people fighting oral, nasal, genital, and skin ulcerations - we just had to try it. I guess where we happen to stick a dietary supplement is our own business, right? Again - be sure to follow the advice of your personal physician for any and all treatments for Behcet's Disease. Also, Dr. Cummins does not promote this bovine extract as a treatment or cure for Behcet's Disease but based on the anecdotal reports he received from those of us with BD that tried it, he said he could understand why those of us with BD would love to see this on the shelves of our local health food and nutrition store as soon as possible! Good news: Dr. Cummins has filed the appropriate Notification of Statements of Nutritional Support with the U.S. Government and is allowed to sell the bovine extract as an immune modulator over-the-counter without a prescription required. As of Sept 26, 2002, Bovine Dietary Extract Supplement is in production and will be available very soon. If you are interested in purchasing the Bovine Dietary Extract Supplement, email Dr. Cummins at email@example.com. Please do not expect a reply. He will use your email as in indicator of future interest for the bovine extract. If you are interested in prepaying for a month supply of Bovine (which will be delivered as soon as it is available) then send a check to D-J Nutraceuticals for $6 x 30 = $180 plus $21.50 for FedEx Standard Overnight delivery. You will receive 30 individual syringes which you should freeze upon arrival and then you will thaw one syringe each time you are ready for dosing. D-J Nutraceuticals 800 West 9th Avenue Amarillo, TX 79101-3206 firstname.lastname@example.com T:806-376-1741, #13 F:806-376-9301 Even though Dr. Cummins has said he will not market the bovine extract dietary supplement as a treatment or cure for BD, we have begged him to allow BD patients to get access to it as soon as possible. Accordingly, as soon as this new bovine extract dietary supplement gets back into production, Dr. Cummins has promised to make this treatment available to Behcet's patients first before opening it to the general market because he recognizes our desperate need for safer, more effective treatments for our rare orphan disease. I imagine for most Behcet's patients, a combination of both the low dose oral interferon lozenges and the bovine extract dietary supplement will be the most effective. I am now back to my oral interferon lozenges and still doing well. I miss the once a day bovine extract dietary supplement that I was on just a short while ago but I still function great without it; I just skip most of the pizza, beer, and donuts. Fritos are still OK. Dot Tutt. -------------------------------------------------------------------------------- Conclusion My life prior to the low dose oral interferon alpha was pure agony. I couldn't walk due to the pain. I couldn't drive due to my brain fog. I could barely function due to my screwed up blood sugar levels, chronic diarrhea and gastro-intestinal lesions, super low blood pressure, and headache/stiff neck that drove me berserk. I couldn't take a deep breath without coughing. I was terrified by my visual disturbances and had constant oral/genital ulcers. Those, along with so many other weird symptoms, are all gone. I feel good and I am as healthy as many, if not most, "normal" people my age. I still get tired rather easy when trying to do extended strenuous activities but I think that is because I have never taken the time to exercise and get back into shape. I am now the same as any slightly overweight lady nearing 50 years of age that sits on her fanny all day in front of a computer nearly every waking hour. I have no complaints and am very thankful for the relief I have found. I have an entirely new appreciation for life. Just when I thought things were totally hopeless, I found the light at the end of the tunnel. I believe in the power of prayer. Please everyone, don't give up hope. Whether it is one of these new treatments, learning to control your environment, or another new treatment that is in the research pipeline - you may very well find yourself enjoying a normal life again someday. With Hope and {{{Hugs}}}, Dot Tutt. firstname.lastname@example.com 2017 Lovell Road Knoxville, TN 37932 865/539-9977 (work number) -------------------------------------------------------------------------------- I owe so much to so many people I would like to thank Amarillo Biosciences for all they are doing to help those of us with Behcet's Disease. There is not a very strong business case for spending their resources on trying to help those of us with such a rare disease; they are doing so out of their compassion. I may be out of line to remark on this, but Dr. Cummins has mentioned the biblical verse James 4:17 a couple of times. I think it is their guiding principle at AmarBio. I looked it up and it reads: "Anyone, then, who knows the good he ought to do and doesn't do it, sins." I personally am very thankful they follow that principle! I would like to thank the volunteers that work so hard to help other Behcet's patients through the various BD support groups. Without these folks, I would never have found a way to reach so many Behcet's patients around the world. I would like to thank my husband, Bradford, for being so understanding of the time I spend on this project. I also want to recognize Brad, our sons, and Brad's mother, Ruth Tutt, for doing so much to care for me when I was really down and out before my remission. I would like to honor my sons, Lee and A.J. Tutt, both of whom have bravely faced Behcet's Disease from the day they were born. They are a constant reminder to me of why we must never give up the effort to help others even if we have personally recovered from the wrath of Behcet's. I cannot begin to express the depth of my gratitude for what Dr. Joe Cummins and Dr. Jeff Boruff have done for me. I did not think my life was worth living before I was finally diagnosed with Behcet's and found a safe and acceptable treatment; now I look forward to every single, wonderful day full of blessings. I want to thank Genevieve, Marcia, Joanne, Laurie, and so many others that have helped me. You know in your hearts who you are. May you all be blessed with good health and happiness. {{{Hugs}}} Dot. -------------------------------------------------------------------------------- Copyright 2001- 2002 Dorothy J. "Dot" Tutt All rights reserved. This document may not be changed, mass produced, reproduced, or distributed without the express written consent of the author. Permission is granted for individuals to print, read, and to present this document in its entirety to the Behcet's patient's physician for the purpose of evaluating the possibility of prescribing/using this treatment for Behcet's Disease.
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