# CLINICAL REPORT ABSTRACT: LEAP Program In Treating Digestive Complaints



## Mike NoLomotil (Jun 6, 2000)

Clinical Report of the LEAP Program in Treating Digestive ComplaintsDr. Herbert Pardell Dr. Mark J. Pasula *Submitted to Journal Of Advancement In Medicine July 1999, Pending PublicationComplete report posted at www.leapallergy.com ABSTRACT Functional digestive disease is one of the most common conditions reported in clinical practice. In most cases etiology remains largely indeterminate. Dietary causes have been shown to play a role but have not been thoroughly investigated nor are they well understood. Sensitivity to foods and food substances is likely to be an important factor in better understanding and treating many gastrointestinal conditions in which there is no evidence of pathology or anatomic dysfunction. This report shows the results of a new method of treating a variety of common gastrointestinal complaints. By combining MRT, a new in vitro assay that identifies immunologic reactivity to foods and food substances, with proprietary, patient specific dietary strategies, the LEAP Program appears to offer a safe and effective alternative to conventional pharmacotherapy treatment or trials of dietary alteration. 86 patients suffering from specific gastrointestinal symptoms, treated from February 1999 to January 2000 were evaluated. Results show an overall success rate of 84%, suggesting that delayed food allergies and sensitivities play a major role in the presence of gastrointestinal symptoms.


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## flux (Dec 13, 1998)

> quoteroprietary, patient specific dietary strategies


That agents at the patent office must be drinking too much







if they are patenting what I suspect any competent dietician can probably do -- and without apparently any such tests.[This message has been edited by flux (edited 08-18-2000).]


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## Mike NoLomotil (Jun 6, 2000)

No, Flux, nobody said the patent office is patenting the dietary protocol. The patent office is issuing patents on the "technology" (method of analysis of blood for three-dimensional particle mass and extracellular mass differentials)and the Application of the method of measurement in the form of the Mediator Release Test. The dietary protocol (1 of them) is proprietary. It based upon clinical trials in over 1,000 patients in a beta clinic between 11/96 and 11/99. The dietary protocols were developed by the M.D.s and R.D.'s in cooperation with Signet's research and development staff (research immunologist, biomedical enginners, and outside consulting physicians) utilizing the test results as a tool, and monitoring clinical outcomes in different symptomologic sets to determine which protocol best suited each symptomologic set. Further, the staff had to ascrtain when and what modifications might have to be made based upon patient response. Approximately (10) different protocols were evaluated to reach the current protocols that are used. These included protocols very similar to waht you suggest "any dietician could do" given access to the test results. These were generally found to be less effective when monitoring outcomes (inlcuding likelihod of compliance and symptomology).One of the final protocols is proprietary (though, once a patients get their treatment plan and follow it, of course, the way the protocol works has been revealed. It cannot be done without test results to base it on, however). The other is a standard generally-accepted method of rotation-elimination diet based upon test results. Which protocol is used is based upon specific criteria which determine which approach is indicated, then a conult with the patient to see which method is most likely to produce compliance (since no test or dietary plan is any better than the patients willingness to adhere to it).[This message has been edited by Mike NoLomotil (edited 08-18-2000).]


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## flux (Dec 13, 1998)

Oops, I apologize for misreading patient for patent. Perhaps I had too much beer!









> quotethough, once a patients get their treatment plan and follow it, of course, the way the protocol works has been revealed. It cannot be done without test results to base it on, however).


Anyway, it doesn't sound all that logical to say it's proprietary when it will ultimately be revealed (plus are the administrators going to be given NDAs?) and the connection between that and the "test" results doesn't fit. Of course, I don't believe that any of this is useful for anything.


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## Mike NoLomotil (Jun 6, 2000)

Naw, no NDA's. They never remember to sign papers anyway. Cannot give the treatment without revealing the methodology nor logic. The doctors and dieticians receive the protocols as an implementation tool for therapeutic use of the test results to implement as they see fit. Without the test results the (1) protocol won't work anyway.


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## eric (Jul 8, 1999)

Mike, I am slightly perturb you posted what seems to be an advertisement for the people you work for on this section. If the papers were published I might not be so bothered about this. Also, you mention gastro problems as a whole and never define IBS itself and I think that needs to happen for an IBS BB. I realize you beleive in your work and that is commendable and this is really not for an arguement, but better understanding on my part. I do beleive food plays a part in IBS, but for different reasons perhaps then you do.I just need to know in simple terms how this helps IBS.If we could start from the beginging that would be great, I walk into your clinic and then what?------------------ http://www.ibshealth.com/


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## Guest (Aug 18, 2000)

WOW, talk about ego's. I for one enjoy new information. I don't know if I beleive or not but it is nice to hear that work is being done in the IBS area. ------------------ http://www.digestioninfo.com


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## SteveE (Jan 7, 1999)

I understand your point, kwilim, but I think the debate is over whether or not this "work" as you call is really productive work that will lead to real benefits for IBS OR is it "work" intended to simply line some pockets at the expense of those of us who suffer from IBS. And while I can't honestly which it is for certain at this point, I think the debate is useful and important."When I'm working on a problem, I never think about beauty. I think only how to solve the problem. But when I have finished, if the solution is not beautiful, I know it is wrong." -Richard Buckminster Fuller


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## JeanG (Oct 20, 1999)

The debate is also whether this "unpublished" abstract belongs here or in the Products section, or Discussion forum.JeanG


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## Guest (Aug 18, 2000)

SteveE - I completely understand your thoughts about questionable products and services. Unfortunately the only way I know of for a person with IBS to improve is to try new approaches. I for one will never understand what will help each person with IBS. Everyone is so different. Look at Rose, she has been trying forever to find something to help her. I have just read that she found a product sold thru a Multi Level Marketing company that has helped her. I am sure glad for her. If she had not continued searching she would not have found relief. Another group are finding relief from just eating bread. I know how difficult it is to continue, so many things hurt instead of help or do nothing. You get your hopes up, pay money for something and it doesn't help. It is easy to get to the point of being afraid to try new things because nothing ever helps. My wife is another example, she found a digestive enzyme from a multi level marketing company that helped her the most. I guess what I am saying is that help can come from the most craziest of places. If we don't read about things, how are we going to find help. My thoughts are if a product, service or remedy is not going to hurt someone lets let it be talked about instead of calling it snake oil. Who knows, it could help someone. JeanG - As to the debate about an unpublished abstract belonging, why shouldn't it. Here is the name and information about this forum "News, Research and AbstractsPost any news, research or abstracts to this forum." To me this thread is appropriate. As for belonging, lets change to the issues that you have a part in. Do all those threads promoting services and products apply to the main board? Maybe they should be in either this forum or the product section. If someone who does not have a financial interest or who is not aligned with that financial interest post about their experience with that product that's OK, but for someone to continue to post time and time again about the product that they have a financial interest in and then continue to bump those posts or the people aligned with them bump those posts in the main discussion bulletin board in my opinion is wrong? ------------------ http://www.digestioninfo.com


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## Mike NoLomotil (Jun 6, 2000)

I posted an abstract of published paper from a peer reviewed journal from (2) doctors not affiliated with Signet Diagnostic Laboratory. They performed tests to determine of the MRT method, which is used by physicians with the LEAP Dietary protocols, performed as claimed. Their conclusion was that it did. I did not even post the whole paper. It is on the Signet website where the detractors of this new test literally demanded I post it instead of offering to send it to people.----------------------------------------I posted the abstract of a clinical report that another doctor did on patients with chronic disgetive problems, which if you read the patient selection clearly includes symptoms of IBS. It was not restricted to those symptoms as there are other gastric problems that are non-IBS which can be caused by food or chemical sensitivity. This doctor felt he wanted to evaluate that too. Over 80 patients were included in this group and the results were 85% of the patients symptoms improved in the initial 30 days. Based upon the responses again today, either the data are believed to be faked, or over 80 patients demonstrated placebo effects and Dr. pardell intentionally seeks to obscure that. Or something. -----------------------------------------I fail to see how disseminating this info is "advertising" for me, but is "a really good post" when it is someone else. Especially hypnotherapy. TThe discussion board is being constantly posted with hypnotherpay promotion, with links that lead directly to hypnotherapy products for sale no more than 2 clicks removed. There are many documents which could be posted which question the claims of hypnotherapy. To you see me pounding anybody about this and with those documents? What is the rationale that hypnotherpay advertising with articles and links in threads on the discussion board is OK but an independent doctors findings on food sensitivity is not OK here? I guess I am a little perturbed now too. So what does all this accomplish for the patients we are supposed to be here to help if we are truly interested in that?-----------------------------------------The articles Signet and Dr. Pasula self-published in trade journals are not here, but I said are available in hard copy for the interested. I can have them posted in a day if I want, but I do not do this so as not to be "accused of advertising" by disseminating valid, useful information that an effective means of causal identification and removal has been discovered and is in clinical use. ------------------------------------------It is somehow a source of consternation that the findings of the research and clinical evaluations of doctors performed in the development of MRT and the clinical use of the test results in removing foods and additives in the diet makes peoples gastrointestinal symptoms feel better. Apparently this is because the results run contrary to what have become "belief systems". Belief systems and clinical trials and technical demonstrations often conflict as new therapeutic modalities are developed. This is the nature of the advancement of medicine. This is not new to me or anyone else in the field, nor should it be to anyone here who is in healthcare or as closely associated with it as many of us are.I fail to see anything inappropriate about posting these abstracts here. If one chooses to ignore the results, fine.If one chooses to persist in branding me and the doctors I work with as mercenaries, and suggest we fake data and rip off sick people, fine. This is an opinion, not a fact.I have to go now and babysit my kids, bandits in training. I get a lot of questions by e-mail about the testing, the dietary programs, how it works, what are the criteria etc. and useful information that can help sick people is exchanged. If someone would like to ask me a question about the testing or the therapy, feel free and I will answer it this weekend when I get a chance.I have already posted all the credentials of all the doctors, all the consultants, all the investigotors, and a list of all the doctors using the method so far.Anything else one would like to ask is, as always, open to discussion.----------------------------------------Have a good weekend.Mike[This message has been edited by Mike NoLomotil (edited 08-18-2000).][This message has been edited by Mike NoLomotil (edited 08-18-2000).]


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## eric (Jul 8, 1999)

Mike,I walk in the door and...? I am just asking you to walk me through this testing.I am in agreement with you on some food issues and some gastro problems. The one I am curious about is IBS, if the study was a scientific clinical study using eighty IBS patients and they were 80% better and the study was published. Hell, I would be posting it.I read the full abstract and they included." Patients with a prior history of organic bowel disease were not excluded" that would not be IBSers, so do you know how many were just IBSers and what improvement they showed?------------------ http://www.ibshealth.com/


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## Mike NoLomotil (Jun 6, 2000)

ERICMaybe it was ME "walking in the door" and getting "I am slightly perturbed at you for posting what appears to be an advertisemsnt..." HUH?After I just read another 5,000 word tome on hypnotherapy on the discussion board, some of which was about acid secretion (?) and some of which showed symptom regression rates significantly inferior to dietary changes based on MRT testing, followed up with the link that leads to a webiste product-specific on the home page to selling hypnotherpay tapes.And I did not bust any gonads over either issue. As I never do. Oh and "...this belongs on the Product Board (dead zone) or Discussion Board". If I posted it there I would be ripped for advertising on the Discusion board. So I put Dr. Pardells findings here and...???? And he does not work for me. he is an independent practitioner of preventive medicine. He does LEAP in his practice like allthe other docs and dieticisn do. He was one of the doctors that helped develop the treatment protocols.I know these findings conflict with what some beliefs are. I understand that. I just ask the same professional courtesy and objectivity be granted that I try to extend to others.So, do you see that MAYBE that was what I got when I walked in the room?--------------------------The baby will not let me work...she is all over me like white on basmati. I will be thrilled to answer those questions tomorrow.I do not mind one bit ever being questioned on technique, therapy, outcomes, method, selection, anything objective. Grill me to death. That I expect. But ask for and get an answer first thats all.----------------ALSO---------------------So there is no further confusion, I do not "work for these people". I am one of the owner group of Signet Diagnostic Corporation. I coordinated the whole clincial development side, raising the money to get the R&D done, and oversee the company. Dr P ran the technology development and the laboratory side. So I am not a hired mercenary. I am a Self-employed mercenary. We paid for this research and developement with our own money and borrowed money. No grants. No tax subsidies. No nothing. I put my money where my mouth is on this technology. So did Dr. P and our partners (as I said before, many of whom are former patients who got relief from their food and chemical sensitivities of many types).I am sure that other people with therapeutic methods touted here on this board and on the in-thread links that are posted on the discussion board did the same thing. I do not know what the problem is with that. So I sometimes have difficulty figuring out how one is able to discern that some are "great posts" and some are "totally inappropriate advertising".


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## Guest (Aug 19, 2000)

Isn't it interesting how some people can treat their causes one way and other peoples causes another way.------------------ http://www.digestioninfo.com


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## eric (Jul 8, 1999)

Mike, there is 15 years of solid scientific research into hypnotherapy and IBS and all the research I have posted on this are published findings. Funny thing is almost all the top Gastro doctors studying IBS recommend it as an effective tool. Also,the studies for the most part have been duplicated by independent sources with pretty much the same results.I will await your answers to my questions when you have some time. ------------------ http://www.ibshealth.com/


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## Guest (Aug 19, 2000)

Eric,If one compares the amount of published information in medical journals concerning the efficacy of hypnotherapy vs. the MRT test in treating IBS, there's no comparison at all; hypnotherapy wins hands down. Some examples:---------------------------------------------Scand J Gastroenterol Suppl 1999;230:49-51 Hypnotherapy in the treatment of irritable bowel syndrome: methods and results in Amsterdam. Vidakovic-Vukic M Sint Lucas Andreas Ziekenhuis, Dept. of Internal Medicine, Amsterdam, The Netherlands.BACKGROUND: Irritable bowel syndrome (IBS) is frequently observed, but its etiology and pathogenesis are still unknown. However, it is clear that individual perception plays an important part in pathogenesis (hypersensitive, hyperreactive gut). There is no easy medical treatment of IBS. However, in recent years, hypnotherapy (HT) has been shown to be successful in the treatment of IBS. METHODS: Recently we started treating IBS patients using hypnotherapy. All our patients remained symptomatic, despite medical therapy. We applied the gut-targeted method, adding to it the view that the therapy should be tailored to the individual, in accordance with each person's unique representational style. RESULTS: So far, 27 patients have been treated, with good results, comparable to results elsewhere. Of these patients two stopped the therapy prematurely, and one remained symptomatic. All other patients experienced clear improvement: pain and flatulence was reduced or completely disappeared, and bowel habits normalized. CONCLUSION: Based on data from the literature and supported by our own experience, we conclude that hypnotherapy is a valuable addition to the conventional treatment of IBS. To improve our knowledge of sensitivity to hypnotherapy, further research is necessary to recognize cases with more hypersensitivity and those dominated by hypervigilance. More generally, we need a theoretical model of hypnotherapy as applied to treating physiological disorders.---------------------------------------------Appl Psychophysiol Biofeedback 1998 Dec;23(4):219-32 The treatment of irritable bowel syndrome with hypnotherapy. Galovski TE, Blanchard EB University of Albany, State University of New York, New York, USA.Previous research from the United Kingdom has shown hypnotherapy to be effective in the treatment of irritable bowel syndrome (IBS). The current study provides a systematic replication of this work in the United States. Six matched pairs of IBS patients were randomly assigned to either a gut-directed hypnotherapy (n = 6) or to a symptom monitoring wait-list control condition (n = 6) in a multiple baseline across subjects design. Those assigned to the control condition were later crossed over to the treatment condition. Subjects were matched on concurrent psychiatric diagnoses, susceptibility to hypnosis, and various demographic features. On a composite measure of primary IBS symptoms, treatment was superior (p = .016) to symptom monitoring. Results from the entire treated sample (n = 11; one subject was removed from analysis) indicate that the individual symptoms of abdominal pain, constipation, and flatulence improved significantly. State and trait anxiety scores were also seen to decrease significantly. Results at the 2-month follow-up point indicated good maintenance of treatment gains. No significant correlation was found between initial susceptibility to hypnosis and treatment gain. A positive relationship was found between the incidence of psychiatric diagnosis and overall level of improvement.Publication Types: Clinical trial ---------------------------------------------: Eur J Gastroenterol Hepatol 1996 Jun;8(6):525-9 Use of hypnotherapy in gastrointestinal disorders. Francis CY, Houghton LA Department of Medicine, University Hospital of South Manchester, UK.Medical history is full of anecdotal reports on the use of hypnosis in the treatment of gastrointestinal and other disorders. Unfortunately, much of the work published to date consists mainly of short case reports or involves small numbers of patients. They have, however, all broadly given the same message: that patients symptoms improve and they cope better with their condition after hypnotherapy. More recently, controlled trials have shown that patients with severe refractory irritable bowel syndrome or relapsing duodenal ulcer disease respond well to hypnotherapy. This article aims to give an overview of the areas in gastroenterology where hypnotherapy has been applied, discussing in particular what progress has been made in the area of irritable bowel syndrome.Publication Types: Review Review, tutorial ---------------------------------------------Aliment Pharmacol Ther 1996 Feb;10(1):91-5 Symptomatology, quality of life and economic features of irritable bowel syndrome--the effect of hypnotherapy. Houghton LA, Heyman DJ, Whorwell PJ Department of Medicine, University Hospital of South Manchester, UK.AIMS: The purposes of this study were to quantify the effects of severe irritable bowel syndrome on quality of life and economic functioning, and to assess the impact of hypnotherapy on these features. METHODS: A validated quality of life questionnaire including questions on symptoms, employment and health seeking behaviour was administered to 25 patients treated with hypnotherapy (aged 25-55 years; four male) and to 25 control irritable bowel syndrome patients of comparable severity (aged 21-58 years; two male). Visual analogue scales were used and scores derived to assess the patients' symptoms and satisfaction with each aspect of life. RESULTS: Patients treated with hypnotherapy reported less severe abdominal pain (P < 0.0001), bloating (P < 0.02), bowel habit (P < 0.0001), nausea (P < 0.05), flatulence (P < 0.05), urinary symptoms (P < 0.01), lethargy (P < 0.01), backache (P = 0.05) and dyspareunia (P = 0.05) compared with control patients. Quality of life, such as psychic well being (P < 0.0001), mood (P < 0.001), locus of control (P < 0.05), physical well being (P < 0.001) and work attitude (P < 0.001) were also favourably influenced by hypnotherapy. For those patients in employment, more of the controls were likely to take time off work (79% vs. 32%; p = 0.02) and visit their general practitioner ( 58% vs. 21%; P = 0.056) than those treated with hypnotherapy. Three of four hypnotherapy patients out of work prior to treatment resumed employment compared with none of the six in the control group. CONCLUSION: This study has shown that in addition to relieving the symptoms of irritable bowel syndrome, hypnotherapy profoundly improves the patients' quality of life and reduces absenteeism from work. It therefore appears that, despite being relatively expensive to provide, it could well be a good long-term investment.---------------------------------------------: Br J Hosp Med 1991 Jan;45(1):27-9 Use of hypnotherapy in gastrointestinal disease. Whorwell PJ University Hospital of South Manchester, West Didsbury.Recent controlled studies in the field of gastroenterology have shown that hypnotherapy is unequivocally beneficial in conditions such as irritable bowel syndrome and peptic ulceration. There is also some evidence for influence on certain physiological functions. Further research should help to define more clearly the role of this controversial form of therapy.Publication Types: Clinical trial Randomized controlled trial ---------------------------------------------Gut 1990 Aug;31(8):896-8 Changes in rectal sensitivity after hypnotherapy in patients with irritable bowel syndrome. Prior A, Colgan SM, Whorwell PJ Department of Medicine, University Hospital of South Manchester.Fifteen patients with the irritable bowel syndrome were studied to assess the effect of hypnotherapy on anorectal physiology. In comparison with a control group of 15 patients who received no hypnotherapy significant changes in rectal sensitivity were found in patients with diarrhoea-predominant irritable bowel syndrome both after a course of hypnotherapy and during a session of hypnosis (p less than 0.05). Although patient numbers were small, a trend towards normalisation of rectal sensitivity was also observed in patients with constipation-predominant irritable bowel syndrome. No changes in rectal compliance or distension-induced motor activity occurred in either subgroup nor were any changes in somatic pain thresholds observed. The results suggest that symptomatic improvement in irritable bowel syndrome after hypnotherapy may in part be due to changes in visceral sensitivity.---------------------------------------------: Lancet 1989 Feb 25;1(8635):424-5 Individual and group hypnotherapy in treatment of refractory irritable bowel syndrome. Harvey RF, Hinton RA, Gunary RM, Barry RE Gastroenterology Unit, Frenchay Hospital, Bristol.33 patients with refractory irritable bowel syndrome were treated with four 40-minute sessions of hypnotherapy over 7 weeks. 20 improved, 11 of whom lost almost all their symptoms. Short-term improvement was maintained for 3 months without further formal treatment. Hypnotherapy in groups of up to 8 patients was as effective as individual therapy.Publication Types: Clinical trial Randomized controlled trial ---------------------------------------------: Gut 1987 Apr;28(4):423-5 Hypnotherapy in severe irritable bowel syndrome: further experience. Whorwell PJ, Prior A, Colgan SM Fifteen patients with severe intractable irritable bowel syndrome previously reported as successfully treated with hypnotherapy, have now been followed up for a mean duration of 18 months. All patients remain in remission although two have experienced a single relapse overcome by an additional session of hypnotherapy. Experience with a further 35 patients is reported giving a total group of 50. This group was divided into classical cases, atypical cases and cases exhibiting significant psychopathology. The response rates were 95%, 43%, and 60% respectively. Patients over the age of 50 years responded very poorly (25%) whereas those below the age of 50 with classical irritable bowel syndrome exhibited a 100% response rate. This study confirms the successful effect of hypnotherapy in a larger series of patients with irritable bowel syndrome and defines some subgroup variations.---------------------------------------------Lancet 1984 Dec 1;2(8414):1232-4 Controlled trial of hypnotherapy in the treatment of severe refractory irritable-bowel syndrome. Whorwell PJ, Prior A, Faragher EB 30 patients with severe refractory irritable-bowel syndrome were randomly allocated to treatment with either hypnotherapy or psychotherapy and placebo. The psychotherapy patients showed a small but significant improvement in abdominal pain, abdominal distension, and general well-being but not in bowel habit. The hypnotherapy patients showed a dramatic improvement in all features, the difference between the two groups being highly significant. In the hypnotherapy group no relapses were recorded during the 3-month follow-up period, and no substitution symptoms were observed.Publication Types: Clinical trial Randomized controlled trial ---------------------------------------------Note that most of these were published in major peer-reviewed journals, such as The Lancet, Gut and the European Journal of Gastroenterology and Hepatology. This is in sharp contrast to current MRT test publications, which consist of abstracts and short articles in obscure journals with small circulations. Is more research into the use of hypnotherapy to treat IBS needed?Yes, but if I had $495.00 to spend (the cost of an MRT test; $895.00 for the "home care" package) and I could spend it on either hypnotherapy or the MRT test, I'd choose hypnotherapy, no questions asked...


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## Guest (Aug 19, 2000)

We have been through this many times in the past. I do believe that all of us are trying to help people find relief for their IBS, I truly do. What really happens is that all of us come out looking like a bunch of babies bickering with each other. The problem has always been the unfairness in that Hypnotherapy continues to be promoted even though there are few people suggesting it, and then everyone else that has a financial interest in a different product are viciously attacked, Why? Many people just want to hear about what helps, isn't this a good goal. Look at the health care professionals, don't they get paid? I just feel that everything needs to be equal and I always feel so strongly that I always speak up and make a fool out of myself, SORRY ------------------ http://www.digestioninfo.com


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## Guest (Aug 19, 2000)

Mike,You said above (somewhere) "...either the data are believed to be faked, or over 80 patients demonstrated placebo effects and Dr. pardell intentionally seeks to obscure that...".Although it may be "insinuated" by some of the things that some folks are saying (or perceived as such by you), I honestly don't think anyone is actually asserting that the data is "faked", or that your Doctors are intentionally obscuring placebo results. That seems to be a little too far out on the "conspiracy" spectrum to be believable for me. If you folks were actually doing things like that, I'd be inclined to see you all as downright "evil", and I don't think that's the case.Nevertheless, I do think that what a lot of people are wondering about is, "How can this LEAP thing be so guaranteed, proven, and effective and NOT be broadcast on the nightly news (or otherwise be universally recognized) as "THE" cure for IBS". I mean, really, if this stuff is as good as you say it is, it would be a momentous and historic milestone in the annals of medicine. Or at least that's the logic that most of us have in our minds when we look at your claims.So, I'm wondering if the "disconnect" in all this, and maybe one of the differences between LEAP and Hypnosis, is that LEAP isn't as proven or recognized as Hypnosis yet, and NOT that your data is false or otherwise a sham. You just don't have enough of it yet.Or, and this is a possibility that I'm sure you don't like thinking about, maybe you guys, as well intentioned as you might be, are just headed down a mistaken path and you're plain...wrong...in your methods, conclusions, etc. Obviously you wouldn't continue on with your efforts if you thought so, but you must admit it is a possibility.And finally, the third possibility is that you are in fact a bunch of cheats, liars, and frauds. I myself don't think that is the case, but the natural skepticism of an experienced IBSer always includes that possibility somewhere on the chart.If your method and treatment is "righteous", then sooner or later it will in fact be on the nightly news, and you'll be a saint. If not, I suspect it will suffer the fate of most fads, and dissappear.I think some have already made up their minds on this, but I myself would like to see further discussion and reports on it before rendering a personal judgement one way or the other. Admittedly, I'm on the skeptical side and was very impressed with Guy's analysis over on the discussion board where this all started with flux's snake oil thread, but I'm still on the fence.Please consider this in good faith and a civil tone, albeit from a skeptic.BJP.S. to ALL: I don't know if this thread, in the "News, Research and Abstracts" Forum is the right place to put my post, but it is in response to something Mike said here, so I can't put it anywhere else. Maybe this can be carried over to the discussion forum if it gets too off topic for this one.


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## Mike NoLomotil (Jun 6, 2000)

I have not been here for a day or so, as there are some things I have to do sometimes...job and kids and defending my honr from accusations of being a hardened criminal on the DISCUSSION Board...so I just checked here and see there are some more posts...I am supposed to get a notice when a post hits, but my e-mail is screwed up. Sorry.I have to go back and read everything to remember who wants what or says what...so I will try to do that today if not tomorrow AM for sure.--------------------------BRIEF TO ERIC:--------------------------I recommend hypnotherapy and/or cognitive behavioral therapy as an important adjunct in the tx of IBS. I personally do not doubt the veracity of any of your research, clincial outcomes, posts or Mike001's "tapes" therapeutic benefits. But if anectdotal data from me is "fraud" then it must be "fraud" from everyone...no? Not that you saud that, but it is a blunt and valid point.If one modality is held to a certain standard of "burden of proof" in a public forum, but that same standard appears to not apply in some minds to the modality one prefers, this reflects that what we have is "selective thinking"...that is focusing on that which agrees with our belief system to the exclusion of things which do not, and the placement of a higher burden of proof upon that which is not within our personal belief system.The effectiveness of hypnotherapy is within my belief system (if not the claimed mechanism...I think that remains conjecture) but I could care less what the actual mechanism of producing the outcomes is. If the clinical outcome is relief for the patient from symptoms then it is a worthwhile investment if no physical harm can come.I hope that is clear...I also feel that the same standards of what constitutes self-promotion should also be applied across the board and they are clearly not.I ask that consideration at a professional level from the professional people. That is also all I ask.I find nothing intrinsically wrong with what you do or how you do it if people are helped. I do not appreciate implication or outright slanderous postings of fraud being made against myself and the doctors doing this, based upon material which is no better or worse than other material which is considered "great post". So if I become testy at times...well I am human too, after all, not.....as church lady would say....SATAN!!! he would delight in threads such as these...and others which people must endure to weed-out the information.----------------------------I will go back over the thread after I get some things done and see what questions I did not answer and gladly answer them ALL in due course.---------------------------Mike


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## Mike NoLomotil (Jun 6, 2000)

This was posted on another thread where people think we are headed down a mistaken path, but ill-intentioned as opposed to good intentioned (I apprecaiet the benefit of the doubt...but understand we are not talking about laymen...we are talkign about reaerch being done by an IMMUNOLOGIST and other well-respected and VERY EXPERIENCED Board Certified Specialists...they are old enough to be MY father some of them...they have been studying this their whole lives). NOBODY is goign to lead Jonathan Brostoff down a mistaken path. he has seen more patients as an immunologist, pathologist, investigator and educator than most docs see in a lifetime.But who knows him personally, eh?In the meantime please take a moment to consider the following:------------------------------------------------------------------------------------------REPOST FROM DISCUSSION BOARD THREAD ON SNAKE OIL:So having taken the night off, I think the only additional thing I can offer to the thread on the subject of imaginary food sensitivity, gut irritation, immune reactions (inflammatory mediators) etc. is a very brief summary showing the trail of this fictitious and imaginary work and findings from 2000 back to 1982 (farther than I thought) wherein Qualified Investigators TOTALLY UNRELATED AND UNKNOWN TO DR. PASULAS GROUP AND DIRECT-CONSULTING PHYSICIANS AND DIETICIANS WORK IN THIS FIELD repeatedly have implicated food in the etiology of the disease. Specifically finding "red flags" all over the place of inflammatory mediator abnormalities, but lacking the technology which would produce a REAL-TIME determination of active reaction to specific foods or additives, except as selected in small oral-challenge diets (100-150 was just not practical for oral challenge).Again, this is a very brief "representative selection" and Only from doctors doing work TOTALLY SEPARATE from ANYBODY involved with Dr. P. MRT, LEAP, Dr. P's prior-art, or anybody using it so as to avoid any further postings of the findings of the guilty parties.These papers also demonstrate that work on food intolerance and the etiology and pathogenesis of gut hyperreactivity is not restricted to journals that nobody reads, or obscure and irreputable references or investigators. Again, I am only posting the abstracts of a portion of the work for the sake of the already excessive size of this thread.----------------------------------------LANCET: NOVEMBER 1982----------------------------------------FOOD INTOLERANCE: A MAJOR FACTOR IN THE PATHOGENISIS OF IRRITABLE BOWEL SYNDROME. Jones VA, McLaughlan P, Shorthouse M, Workman E, Hunter JO Specific foods were found to provoke symptoms of irritable bowel syndrome (IBS) in 14 of 21 patients. In 6 patients who were challenged double blind the food intolerance was confirmed. No difference was detected in changes in plasma glucose, histamine, immune complexes, haematocrit, eosinophil count, or breath hydrogen excretion produced after challenge or control foods. Rectal prostaglandin E2 (PGE2), however, increased significantly, and in a further 5 patients rectal PGE2 correlated with wet faecal weight. Food intolerance associated with prostaglandin production is an important factor in the pathogenesis of IBS.---------------------------------------------ANNALS OF ALLERGY AUGUST 1983---------------------------------------------PROSTAGLANDINS IN THE PATHOGENISIS OF FOOD INTOLERANCELessof MH, Anderson JA, Youlten LJ Prostaglandins appear to have cytoprotective effects in the upper bowel and are released in increased amounts in patients with abnormal peristalsis and diarrhea. Drugs which interfere with prostaglandin (PG) synthesis often prevent the symptoms of food intolerance and have been reported as improving food-related symptoms in the irritable bowel syndrome.(NOTE ON FINDINGS OF THE STUDY NOT INCLUDED IN THE ABSTRACT: Prostaglandin E2 levels were found to be significantly elevated in 10 of 17 patients with cyclic D-C IBS. The investigators also stated that certain findings point to the additional separate involvement of other mediators of the Arachadonic Acid Cycle...these include the inflammatory leukotrines LTB4,LTC4,LTD4,LTE4)--------------------------------------------SCANDINAVIAN JOURNAL OF GASTROENTEROLOGY:SUPPLEMENT 1985--------------------------------------------FOOD INTOLERANCE. Lessof MH Food intolerant symptoms can have various causes, including enzyme deficiencies (of lactase or aldehyde dehydrogenase) and pharmacological effects (e.g., caffeine, salicylates). The irritable bowel syndrome can also be associated with intolerance to specific foods in some cases, but the mechanism is unclear. Immunological causes are less common but may explain the small bowel mucosal changes associated with gluten enteropathy, as well as the childhood enteropathy provoked by cow's milk or, rarely, by other foods. Food allergy of the more immediate and classical type is associated with reactions both within and outside the gastrointestinal tract. Where these include urticaria, asthma and eczema, immunoglobulin E antibodies are often demonstrable by skin or radioallergosorbent tests, but pseudo-allergic reactions can produce a similar clinical picture. Diagnosis of food intolerance depends on withdrawing the food concerned and assessing the response to a blind challenge. Objective ways of detecting subclinical reactions are also useful, including the detection of a mediator response involving prostaglandins, histamine or serotonin.--------------------------------------------GASTROENTEROLOGY CLIN. NORTH AMER.: JUNE 1991---------------------------------------------NEW DIRECTIONS IN THE IRRITABLE BOWEL SYNDROMEBailey LD Jr, Stewart WR Jr, McCallum RW The irritable bowel syndrome (IBS) is an umbrella for the diagnosis of heterogeneous conditions that are awaiting better identification of specific manometric causes. This article focuses on the concept that future therapy for IBS will rely on identification of subgroups and in turn tailor the specific therapeutic approaches to an appreciation of the pathophysiology and symptom predominance of these subgroups. Future therapies will rely on the following principles: (1) prokinetic agents to coordinate upper gastrointestinal and colonic motility as well as improve the propulsive nature of colonic contractions; (2) gastrointestinal hormone agonists such as erythromycin and antagonists such as sandostatin and cholecystokinin antagonists; (3) spasmolytic therapy incorporating calcium channel blocking and anticholinergic agents; (4) inhibition of ovulatory cycle changes in circulating concentrations of gonadal hormones in women, who tend to dominate the IBS population; (5) incorporation of concepts relating to the role of subtypes of 5-hydroxytryptamine receptors in control of neural and myogenic function; (6) reassessment of food intolerance and sensitivity; (7) incorporation of concepts relating to psychologic profiles and psychologic treatment approaches. IBS is a rich and fertile area for application of the exciting new pharmacologic advances relating to gastrointestinal smooth-muscle and neural innervation of the gut. Improvement in the understanding and treatment of IBS will be one of the major accomplishments of this decade.---------------------------------------------CANADIAN JOURN.OF GASTROENTEROLOGY:MARCH 1999---------------------------------------------EFFECTS OF INFLAMMATORY MEDIATORS ON GUT SENSITIVITYBueno L, Fioramonti J Department of Pharmacology, INRA, Toulouse, France. lbueno###toulouse.inra.frOver the past decade, attention has been paid to the role of visceral sensitivity in the pathophysiology of functional bowel disorders, especially irritable bowel syndrome, and visceral hypersensitivity is the most widely accepted mechanism responsible for both motor alterations and abdominal pain. Inflammatory mediators sensitize primary afferents, especially C-fibre polymodal nociceptors, favouring the recruitment of silent nociceptors that give rise to secondary spinal sensitization. After local tissue injury, the release of chemical mediators such as potassium ions, ATP, bradykinin and prostaglandin E2 directly activate nerve endings and indirectly trigger the release of algesic mediators such as histamine, 5-hydroxytryptamine and nerve growth factor from other cells, which, in turn, stimulate proximal afferent nerve endings and silent nociceptors. Among the intermediary structures activated by inflammatory mediators and susceptible to the release of proalgesic substances, mast cells and platelets play a crucial role; however, immunocytes such as macrophages and neutrophils or sympathetic nerve terminals are also candidates. Moreover, events likely to activate synthesis of mediators by mast cells, such as stress and septic shock, also trigger colonic hypersensitivity. Prolonged visceral hyperalgesia may also depend on spinal sensitization. A number of substances are candidates to play a role at the spinal cord level in mediating painful and nonpainful sensations. Among them, substance P, dynorphins and glutamate play a pivotal role in postsynaptic sensitization, particularly during and after gut inflammation. Finally, despite the complexity of the relationship between inflammatory mediators and gut hypersensitivity, numerous results **strongly suggest that alteration of neuroimmune communications at the gut level may trigger a series of events that give rise to chronic changes in visceral sensitivity**.-------------------------------------------AMERICAN JOURN.OF GASTROENTEROLOGY: JAN 2000-------------------------------------------RISK FACTORS FOR IRRITABLE BOWEL SYNDROME:ROLE OF ANALGESICS AND FOOD SENSITIVITIES Locke GR 3rd, Zinsmeister AR, Talley NJ, Fett SL, Melton LJ Division of Gastroenterology and Internal Medicine, Mayo Clinic and Mayo Foundation, Rochester, Minnesota 55905, USA.OBJECTIVE: Symptoms of irritable bowel syndrome (IBS) are reported by 10% of the general population; however, evaluation of traditional risk factors has not provided any insight into the pathogenesis of this condition. The objective of this study was to identify additional risk factors for irritable bowel syndrome. METHODS: A valid self-report questionnaire that records the gastrointestinal (GI) symptoms required for a diagnosis of IBS, self-reported measures of potential risk factors, and a psychosomatic symptom checklist was mailed to an age-and gender-stratified random sample of Olmsted County, Minnesota residents aged 30-64 yr. A logistic regression model that adjusted for age, gender, and psychosomatic symptom score was used to identify factors significantly associated with IBS. RESULTS: A total of 643 (72%) of 892 eligible subjects returned the survey. IBS symptoms were reported by 12% of the respondents. IBS was significantly associated with use of analgesics (acetaminophen, aspirin, or nonaspirin nonsteroidal antiinflammatory drugs) for reasons other than IBS, reporting a food allergy or sensitivity, and ratings of somatic symptoms. No association was detected for age, gender, body mass index, smoking history, alcohol use, educational level, exposure to pets in the household, or water supply. **Among subjects reporting the use of just one type of analgesic, IBS was associated with acetaminophen but not aspirin or nonaspirin nonsteroidal antiinflammatory drugs used alone. The odds of having IBS were higher among subjects reporting more reasons for taking analgesics and intolerance to a higher number of foods.CONCLUSIONS: IBS is significantly associated with analgesic use. However, this is confounded by other somatic pain complaints. IBS symptoms are associated with the reporting of many food allergies or sensitivities. The role of food-induced symptoms in IBS requires further investigation.----------------------------------------------------------------------------------------As the Mayo Clinic suggests, further investigation as required is continuing.Actually, to me the most interesting finding in their survey was the association between acetominophen use and IBS (but not the other analgesics).Why? As a final note before I go off to other things for the weekend, an analysis of all the MRT tests run since the test method was finalized and implemented for the frequency of acetaminophen reactivity is interesting. The test database accessed includes over 1300 patients with symptomologic sets (well discussed previously) of food intolerance, sensitivity, delayed-allergy of "bestozich"..what EVER someone wants to call what is not "true allergy" as we have established at length.33% of all the tests came back test-positive for reaction to acetaminophen. Does acetaminophen use predispose people, or produce a rebound hypersensitivity reaction which can elicit symptoms in the gut and elesewhere? Now that is an interesting hypothesis set forth by the Mayo Clinic boys as one of the (2) things most closely associated with IBS...food intolerance being the other.------------------------------------------Looking back at the other charlatans around the world investigating this area of etiology and treatment over the past 3 decades, I feel that I am in good company and will continue to remain a proponent.------------------------------------------Have a very fine d-free and c-free Sunday everybody.MNL------------------------------------------Again, if any questions have been unanswered in this thread (ie: Eric) I will get to them ASAP>-------------------------------------------PS: I have no idea what this "win or lose" mentality is.When we reduce therapeutic modalities to "who wins and who loses", an integrative approach to therapy is avoided and the only one who loses is the patient.[This message has been edited by Mike NoLomotil (edited 08-20-2000).]


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## Mike NoLomotil (Jun 6, 2000)

ERIC:I think that the first question you asked, on a quick backup read was about "what happens in your clinic" or a step-by-step.We do not operate any clinics. LEAP was developed in a beta medical clinic until the technologya and protocols were perfected and ready for clinical use by doctors and dieticians. The beta-clinic physical plant was closed...it was for R&D. There is a list of soem of the doctors using the method so far in their practices on the webiste. I do not know if it is the most current I have to check, New users of LEAP in their practices begin and we have to update the list.So the thing is the patient experiecne is like any othe rpatient experience. The doctor examining a patient determines that the patient exhibits the symptoms associated with potential food or additive intolerance based on specific history and physical exam, ruling out other causes. If he thinks testing is indicated he does orders it as it is alot easier to send a blood sample than do 150 serial open challenges for individual foods and additives. So it comes to the laboratory, it is anlyzed and the results returned to the doctor with a patient-support package for him to use.When he getes the test results back he reviews them with the patient like any test results then institutes the treatment protocol appropriate for that patient. It is just another modality that the doctor uses in his/her practice.Dr. Pardell's practice in Hollywood Florida has now adopted the "name" that was used in the beta clinci for foods ensitivity treatment associated with his practice (Oxford Nutritional Center). This is becasue he is a very strong beleiver due to the results he gets, and is a good clincian who wishes to participate in any new protocols or new adjuncts when they need to be evaluated. So does Dr. Gilderman at Unversity Medical Research and Medical center.They are preparing to evaluate an adjunct product clinically which show promise of being an effective adjunct to the treatment of all symptoms of food and chemicals sensitivity...not just the iBS symptom set.Among the many questions I get e-mailed, one person wanted to understand exactly what the deal was with the dietary protocols...how critical are they to the successful remission of symptoms etc. This may be part of your question.I have posted a portion of my answer to him in hopes it will help aswer your questions. If not let me know and I will amplify tomorrow--------------------------------------------------------------------------------------...To answer your question as to whether the "LEAP dietary management program is critical to achieving success based on the [test] results....":Actually, no it is not always critical. Depends on the patient. The dietary protocols we developed are based upon the overall needs of changing peoples behavior as well as getting the fastest response possible AND the highest adherence rate so the lowest possible recidivism rate is achieved. No test ever solved anything. They are tools which are used to help manage a disease in one way or the other. Some patients will absolutely NOT get any benefit from the money they invest in a test if they do not follow the treatment. EXAMPLE: Positive path report for squamous cell? Cancer. Need surgery and chemo. The test did nothing except identify a need. If the patient does not comply no results with be obtained.So with the current state of the art in the management of disease-states linked to diet, as a clinician or therapist (dietician) you are already dealing right out of the box with a probable failure when you start looking at telling people they have to stop eating something. The palate is the greatest source of human pleasure. It is reliable, instantaneous and, unlike a lover, is always there when you want it. Feed it, be happy, relaxed, contented, sooth yourself with the look, feel, taste, texture, of the fooda..feel the endorphins, serotonin, etc.So with many people you have to contrive something that will produce some good results fast, otherwise their ATTACHMENTS to the pleasures of the palate and the foods therein will overcome their DESIRE TO GET BETTER and the program will fail because they will recidivise. And who (patient) is going to take personal responsibilty? Few. They will say your test sucks and the doctor sucks and the diet sucks and you ripped them off. And in a way you did because you gave them something to do that you should KNOW that their fundamental human nature is going to resist, cheat, backslide and thus cause them to probably fail. So if you do not develop a program that addresses these issues effectively, all you did was try to sell them a test. Some ï¿½Labsï¿½ do this all the time, either by accident or by design or by sheer lack of therapeutic foresight. Nothing hacks me off more than to see someone pushing a test, then give the patient a pamphlet to read and send them on their way basically with the admonition "Go and sin no more, brother!". So the therapist must gain the confidence of the patient fast. This is the main objective of such things as having a special protocol for complicated cases. Get some fast results so the credibility of the doctor and dietician are enhanced, and thus the patient motivation is maintained. AND they are more likely to do what you ask because they will think ï¿½I'll be damned. That part worked. OK! Whats next?". For people who have to learn self-discipline about diet when they have none, you must create contrived experiences. These are "things to do" designed to increase the patients involvement in their eating patterns, increase the probability of the patient following orders, helping the patient in becoming more aware of their diet and lifestyle, and learning from that awareness to take charge of it. And there must be rules of participation, such that if they do not fill out those weekly reports, and dietary logs, or symptom surveys the doctor will not treat them anymore for being a ï¿½bad patientï¿½...and there is no refund (HomeCare) for patients who do not follow doctors orders. The patient must experience a direct-investment in the process or she will not value it highly.So the LEAP protocols are more than a special diet...one of them is a plain old ordinary rotation-elimination diet (for simple cases- patients who show they are strongly self-directed and committed to managing themselves). The "proprietary protocol" (Antigen Cleansing Diet) incorporates a test-based 'clinical trick' we learned which gets faster initial results, plus some extra work for the patients to do to get them into a behavior-modification mode. If you are going to give someone a test, it must do what you claim and it must be able to be used in a way that is therapeutically useful, so it must incorporate whatever strategies are shown necessary to maximize the chance of a successful outcome.Until someone develops a product which will stop the hypersensitivity reactions in the first place before they occur, what you are left with is either avoidance, or pharmacotherapy after the fact to block the neurogenic consequences, or cognitive and hypnotherapy to reduce your responsiveness to the reactions or all of the above. Each element, especially dietary restrictions, must be more carefully considered with many patients than just GO AND DO.In summary, there have been patients who did NOT go through 3,4,5 6 counselling sessions to get relief. They took the test, got their results, got their training materials and an explanation of how to incorporate the results into an elimination-rotation diet and went ahead and damn well did it on their own. But not everybody can do that...many have to be 'brought along". It is up to the dietician or other designated person to evaluate what is the best course for each patient based upon behavioral issues more than the test results.Many IBS victims who have already taken charge of their diet to some degree(eliminated additives, not afraid to take responsibility for cooking their own food, not afraid to read a book or read a label and do it already, Type A take-charge personalities, etc) and MOST IMPORTANT OF ALL have a SUPPORT SYSTEM at home...people who will help them and encourage them and not try to knock-them off track (to keep their co-dependent relationships alive); people who are not threatened when an IBS family member or spouse or friend victim takes charge of themselves. Someone who will say "No Gracie, do not eat that steak...eat your chicken. It Bothers you there on my plate? OK I will eat the chicken and turnip too honey, just like you today. We are in this together." This is a must for all but the strongest and most self-directed patients, as opposed to "Aw, go on, one bite won't hurt...what do those people know anyway.".THAT kind of support and understanding is worth all the dieticianï¿½s hours in the world. Probably more.----------------------------------


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## Mike NoLomotil (Jun 6, 2000)

Quote with Question:---------------------------------------Nevertheless, I do think that what a lot of people are wondering about is, "How can this LEAP thing be so guaranteed, proven, and effective and NOT be broadcast on the nightly news (or otherwise be universally recognized) as "THE" cure for IBS". I mean, really, if this stuff is as good as you say it is, it would be a momentous and historic milestone in the annals of medicine. Or at least that's the logic that most of us have in our minds when we look at your claims.-----------------------------------------people think this as an natural extension of not understanding exactly how the medical system works in the US...as regards R&D funding, development, promotion of discoveries, cost recovery, and funding.To simplify a complex situation, the breakthroughs you see on the nightly news are there becaseu there is either university-based funding or pharmaceutical based funding behind them. These represent huge dollars if you look into it (I can post the data later if you like) being invested and in the case of pharmaceuticals they are serviced by a tax-subsidy system that allows not only the write-off of monies spent on R&D BUT the deductability of marekting dollars in the billions. This is why they are the most profitable industry in the US and it drives the medical machine.Private R&D firms run on private funds. There are "rounds" of funding usually done via private plavements under Reg D, Section 504,505,506 etc depending upon specific criteria. Or a venture capital group msut be pursuaded to provide funds in exchange for equity...or a technology transfer must be accomplished at some point with a strategic partner with the resources to take things to the next step. In short, private firms developing new medical technologies are not subsidized by the tax system and the nature of this makes their discoveries much more difficult to get promoted. At each step aolong the way you must raise funds for the next step. So in simple terms (which is really more than I should be discussing but if I see that if I do not folks will not understand why I do not have the same impact as Searle)...this technology has been through (3) rounds of funding...start up...investigatory....development. We now must go to round 4 (I am actively engaged in it) so that you will end up seeing it all over the place. The nIH funded IBS study being applied for by Nova University on LEAP in IBS is the independent portion of round 4...that will get a large prospective study when it is done slapped-up in a major journal BECAUSE the NIH funded it and NOVA UNIVERSITY and Dr. Sandberg DID it. he other part is the internal or operational fourth round of funding. There is a specific strategy being pursued by a large investment banking firm whose medical division is extremely excited about this technology and began active owrk on Phase 4 about (2) months ago. what the strategies are would eb inapprorpriate for me to discuss. But there is no bank vault to go to, we are not 30% of the annual media income for network TV and syndicated publications etc. thus demanding and receiving "show time" on the nightly news. One must consider how the system works.MNL


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## Guest (Aug 21, 2000)

Mike,That's a detailed explanation to my question and I appreciate the thought and time that went into it...but what does it matter if you're SmithKlineBeacham or Joe Blow? - if you build a better mousetrap, the world will recognize it.Really, are you saying that funding is PREVENTING the recognition that your plan works? That just doesn't seem to make sense to me. If "funding" were necessary for recognition, then I suspect a lot of discoveries, in any field, would still be waiting to be recognized.Now I can understand that funding is necessary to GET THERE - to the point that you produce something noteworthy, so I can see your problems from that perspective. But once you arrive, and your method/invention/system (or whatever the case may be) is established, then recognition follows whether your bank account is big or not. That is...if the result does in fact work.Don't misunderstand, I'm not challenging your integrity or making any assertion that your LEAP thing doesn't work. I'm just still wondering why it hasn't been recognized BY THE ESTABLISHED MEDICAL COMMUNITY if it does work, and your answer about funding for recognition doesn't get me there.Now I understand that referring to the ESTABLISHED MEDICAL COMMUNITY is a slippery slope, and recognition by that group does not necessarily mean automatic validity (so don't diss me for any reference to the Merck Manual here!), but it might help when you can report the results of the NOVA study or present a testimonial from a well recognized IBS organization (e.g. IFFGD or UNC Center for Functional GI & Motility Disorders). Perhaps that time will come, but again, the recognition itself would not seem to depend on any funding for that recognition. Build it and they will come - guaranteed!BJ


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## Mike NoLomotil (Jun 6, 2000)

Hi Bob.Sorry, but the fact is that in the real medical world, the world does Not beat a path to your door when you invent a better moustrap until they hear that it is there.The ways and means to that, each step of the way require, access to large amounts of money. Otherwise word travels slowly (see the LEAP physician list...it is growing but based upon one at a time presentatins, not 600 per day by 1200 reps in the field who are taking lunch trays and free samples to the doc's offices to get past the gatekeepers...if you don't buy the staff lunch, so you cna see the doc while they eat, you do not even get a audience). and $500,000 for a subsidized conference..every WEEK!. Have you seen any of the info about how the pharmaceutical industry, research and promotion works? I will post it for you tomorrow if you want. I gotta run, as a matter of fact, to one of those funding-related meetings. You must have a good investment banker to shop you around, then VC's who will listen. You have to cut through HUNDREDS of offering cirdulars and Business Plans thet get weekly...most of which go right down the cirular file and die.Especially the past few years when medical technology as an investment vehicle for institutional capital has been as attractive as ExLAx to a D-Type.Medicine and technical development and advancement runs on a Massive Cash Machine...and for the most part the publicly traded companies turn their own crank. Every one else fishes.For the little guys, you sell first yourright hand, then your arm, then the other one, then your shirt, to Venture Capital funds or private Angel Investors, or limited private placements to accredited investors until you buy claw your way up with the claw you borrowed money to buy. And stripped your own assets to sharpen. This is real. It is not dog-eat-dog it is lion eats dog. This how it has been since I entered the field 30 years ago. It has just reached a mind boggling stuation in The New Millenium!Build it and nobody comes unless you throw a big party. Amd pay the cab fair round trip and put on a good feed.You die in silence. Fact. If I had a buck for every new thing that I have seen that was good that did not get developed for lack of funding, or died in beta-testing because marketing dollars were yileding better in widget funds, you and I would not be doing this right now. I would just fly over to your place, our we would be out on the boat fishing. For marlin.CU Later....gotta go sell my right hand now.MIke[This message has been edited by Mike NoLomotil (edited 08-22-2000).]


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## Mike NoLomotil (Jun 6, 2000)

For those who have read the threads on LEAP and the LEAP Test and dietary modification programs (this one as well as that found under "...NEW PATENT..." on the PRODUCT board) and who wish to read the case of Lisa from the Nevada Digestive Disease Association who entered the LEAP program in Early August 2000 for IBS, CROHNS, and FIBROMYALGIA she has posted her reports on the program on the AMERICAS DOCTOR DIGESTIVE DISEASE CONDITIONS Forum. (www.americasdoctor.com). There is a separate thread in the Digestive Disease Forum which the members of this Board may find interesting, and discussion provoking.


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## Mike NoLomotil (Jun 6, 2000)

LISA's LEAP Report can be read on this BB thread: http://www.ibsgroup.org/ubb/Forum1/HTML/013431.html


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