Where can I find statistics about the Marshall Protocol?
Statistical report
Unfortunately, we don't have the resources to report statistics formally at this time. All the information to start the Marshall Protocol is available online to anyone. No one is required to officially sign up, log in to the websites or update us on their progress. And we don't have the resources to contact people on a regular basis to obtain statistical data. That's what grant money would allow us to do and we have applied for several grants.
Some members have voluntarily sent medical records, just as members volunteer their lab tests results. Dr. Marshall keeps basic patient information charted but it is not yet compiled. The success of SarcInfo.com and marshallprotocol.com, along with all our projects and research, has strained our limited resources.
Our best guess at the total number on the Marshall Protocol is over 5000. Some people consider themselves in remission, even though that is poorly defined. Many have reported dramatic improvements and most have reported some improvement. There are so many variables that compiling statistics will be a difficult task.
Response rate
The Marshall Protocol has a 95+% response rate. This statistic means that almost everyone who tries the MP has an immediate symptomatic reaction to the Benicar blockade and/or the addition of low dose every other day minocycline that is indicative of reduction of 1,25-D, hormonal adjustment or immunopathology. As folks progress on the MP, they will experience periodic symptom exacerbation and eventual symptom resolution.
Recovery rate
We use the term recovery to mean improvement in symptoms. Since this takes some time for many, this is the reason why the estimated recovery rate is lower than the response rate. See the Karolinska Poster.
Success is defined a bit differently by each individual. The reference to 40-50% success reflects the fact that many in our cohort have yet to complete treatment. We believe the MP has the potential to be 100% successful when followed correctly for a long enough time.
The Marshall Protocol, although clearly effective, is still a work in progress, an informal study and a careful clinical experiment. It is unprecedented in medical history and because it is unique, we are unable to follow the standard 'rules of reporting'. MP patients and doctors accept that because they know it is the only way we can proceed.
Research data
"We really don't need any more research data. Remember that the NIH uses a figure of 10% improvement as their threshold for a therapy to be useful. There is no way that any study of MP participants could ever get down to that low a level of improvement, and thus we really have an overwhelming amount of scientifically valid data right now, even if you compensate for vagaries in the way it has been accumulated."
..Trevor..
Is the data anecdotal?
I would not accept the use of the term "anecdotal" to describe our collection of data during this trial. We have conducted an Internet-based, open-label, observational, adaptive, phase 2 community-based trial, and we believe we have done it with as much rigor as is applied in any clinical trial. See What can medical research learn from the open source software movement?
Below is a diagram that we used when we met with the FDA last April, and cemented our ongoing relationships with them. Maybe there is something on the diagram that will help fill in the missing links for you.
Our collection of data is in accordance with the guidance from the Oxford Center for Evidence Based Medicine, as enshrined in the paper: When are randomised trials unnecessary? Picking signal from noise.
I would ask you to get the full text and work through it, as it will clarify the all the methodology related issues in your mind.
Finally, only history will record how well we have carried out this study. If, as has been suggested, we have failed to properly assess treatment failures and dropouts, that will become obvious as time goes by. I studied statistical design of experiments as an undergraduate circa 1972, then again in medicine ca. 1980 at Sir Charles Gairdner Hospital and again in 1983 as a Visiting Scientist at the Dept of Surgery, Hospital for Sick Children (Toronto). I hope that this study will stand as testament to the thoroughness of my training, and the quality of my mentors.
But this study is a joint effort, and many have contibuted to its success. In this vein you should note that Meg Mangin serves on a Data Safety and Monitoring Board at the NIH, and last year (2006)also served as a panel member at an NIH "State of the Science" symposium.
..Trevor..
Disease statistics
How many subjects on the MP have Sarc, Lyme, Cfids, etc.
Karolinska Conference
There are also some statistics as of May 2006 on the Karolinska Poster.
Look at the upper right hand chart that has faces. You will see Sarcoidosis numbers and conservative count of response.
Click the picture of bacteria to watch the Realvideo.
Page 2 shows molecular modeling of different vitamin D's.
Page 3 explains why the focus on secosteroid D and the problem with Koch's postulate in the Era of the Genome.
You may print out this poster for your doctor.
See also The Karolinska Conference was a success
Many of the patients reported on in the Karolinska presentation were still quite early in the MP (many were actually on it considerably less than 18 months). All patients were in phase two and three and most had been on the MP for anywhere from 6 to 22 months. ~Joyce Waterhouse, Ph.D
The patient community needs to understand, that the 40%+ 'success rate' cited in my (Karolinska) presentation was regarded as exceptionally good by 'conventional medicine', where a 10% rate is regarded as 'success'. Only we ourselves have selected the objective of 100% success.
..Trevor..
Clinical trials
Please review the paper "When are randomized trials unnecessary? Picking signal from noise"
You will need detail in the the full-text, which you can get from your medical library. This review was written by staff from the Center for Evidence Based Medicine, Oxford University, and it sets out the criteria to be followed when the evidence base is overwhelming, as it is in our study.
Paradigm shifts often defy numerical quantification, as in the examples given in that paper (the introduction of Penicillin, Cardiac Pacemakers, ether, blood transfusions, etc). In our study nearly everybody slowly recovers their health. Those who don't have the fortitude to stay with the regimen fail, of course, but virtually nobody else does. Quantification (numbers) therefore become subjective, as is discussed in that paper. It comes down to the meaning of the words used in definitions - "recovery," "speed" and etc. These will all be eclipsed by history, as was true in the innovations cited in that paper.
We have demonstrated the existence of a totally new Microbiota in man. This Microbiota is responsible for nearly all chronic disease, and is also a major determinant in the processes of aging. That concept defies quantification. Read some more, and let your mind understand what is happening here. You are seeing the process of history unfold. You cannot squash that process into the confines of past pragma and study methodologies, new methodologies have to be developed to encompass the vast scope of our work.
..Trevor.
3/08 "We have been in close contact with NIH since 2003. Both Belinda and I spoke with Director Steve Groft NIH/ORD just a couple of weeks ago, and were told there is still no money available for Sarcoidosis. Unfortunately, NIH is still relying upon the brains of the American pulmonologists, I am afraid. I was not consulted about, nor was I asked to peer-review, these studies.
What you are seeing is the failure of Medicine to deal with the intellectual challenge of Molecular and Genomic Biology. While Biology is producing a wealth of information about how the body actually works, at the level of individual molecules, Clinical Medicine is still struggling to deal with decades-old concepts at the level of the cell, approximately 100,000 times larger, and similarly less complex.
The people who suffer are the patients, of course. But NIH does not care about them. I have been told that they have to only focus on advancing the science. I have been told that if NIH worried about the well-being of the patients who are currently ill, then the researchers' work-quality would suffer.
As for the studies (new NIH studies) themselves, they will produce nothing useful. At a time when we have laid out the entire pathogenesis, from precisely how the intraphagocytic microbiota evades the immune system to the manner in which the disease processes subvert the hormonal systems, NIH is not only looking in the wrong place for the wrong pathogens, they are using assay techniques which don't work either." ..Trevor..
April 2008
It is a Phase 2 trial, and has been running since early 2002. It is not in the Clinical trials.gov database, as they are only interested in Phase 3 trials. There will probably never be a phase 3 trial because Phase 2 has been so successful that it is hardly ethical to ask patients to wait 5 years for Phase 3 results on a 'no-brainer' like this. In this case a placebo arm would certainly be inethical.
If you don't understand trial design, you might be able to glean a little more understanding from these Evidence Based guidelines in the UK BMJ:
http://www.bmj.com/cgi/content/full/334/7589/349
In any case, our trial is no longer actively recruiting.
..Trevor..
ps: on the FDA website you will find the Foundation's designations for sarcoidosis listed in this document: http://www.fda.gov/orphan/designat/alldes.rtf
June 13, 2008
If you look at our 2006 LAX DVDs you will find that Susan explains how she recovered from Chronic Lyme to the point that she is able to run a small farmyard at age 72. There are also many other recovered Lyme patients who have posted their success story at: http://www.marshallprotocol.com/forum2/7287.html
You need to understand that each one of those success stories is a real live, human being, whom you can identify. How many of your Doc's patients can you contact to check out their treatment effectiveness?
After your Doctor gives me some standards of comparison, then we can talk statistics. I just want to see a few Lyme pts whom your Doctor has cured after three years. Then we can start discussing statistics.
I am not trying to be difficult, it is just that Medicine is being so stupid these days. We have described the molecular biology of the disease process, we have shown proof of concept for that biology, and yet physicians whose own performance is best described as a "house of playing cards" try to persuade themselves that there is an option to our science.
Well, there isn't any option for patients with Borreliosis who want to recover their health, there is no effective treatment for comparison. So why are we even trying to talk statistics? How many patients on your Doc's treatment plans give it up because it doesn't work or doesn't help? How many patients have died in his/her care?
Our study is entirely open, and all of our 360 professional members can see the cohort progress, and they know that dying (because of the MP) is not something that they see... But once again, statistics should be comparing this rate against a control population - and that is an unpalatable concept indeed for most LLMDs...
As for when the MP will be finished, I suggest you read this thread very carefully and ask yourself what your goals really are - to stop taking relatively innocuous drugs, or to live a long, healthy life...
http://www.marshallprotocol.com/forum39/12139.html
Yes, we are getting aggressive on these issues, I am tired of dealing with physicians living in glass houses who throw stones...
..Trevor..
Aug 13, 2008
1. What number of people are currently on MP broken down by disease diagnosis?
Thousands. Most don't report to us. Those who are, or have been, reporting members of this cohort number 1015. They all have Th1 disease.
2. What number of individuals (by disease diagnosis) are reporting significant improvement?
More than 16%
3. What number of individuals have finished MP and are leading a normal life?
A large proportion of them. How many do you see posting with significant problems?
Cocoa,
1. If you think that there is an alternative therapy which can offer you the same prospect, or better prospects, than the MP then please embrace it. We will dutifully mark you down on the study results as "lost to followup."
2. 16% is around the level at which a new drug is declared a success by the FDA. A physician considers a new drug a success if he gives it to 10 people, and it significantly improves the outcome of one. Read the literature (particularly the BMJ) -- this low rate is fully documented...
3. About half the cohort went well into Phase 2/3 and then stopped reporting. Many pop up again, and we bump into others at conferences, etc. Some have failed. That is the nature of clinical research.
4. The MP has a 100% response rate. Or close to it. Everybody who gets Immunopathology is carrying the metagenomic microbiota. What you decide to do from that point is your choice. We offer you help based on hundreds of folk we have guided before you, including ourselves. We get no salaries, we are all volunteers. This whole effort will one day cease. It may be tomorrow, or it may be in several years time. We are already suffering from study-burnout as myself, and the other fully recovered early adopters, realize they have better things to do with their lives than post on a message board, debating the efficacy of a therapy which works, and for which there is no viable alternative
..Trevor..
Related FAQs:
When will clinical trial results of the MP be published in a pubmed indexed journal?
When will a blinded study be done of the Marshall Protocol?
Last edited on Fri Aug 15th, 2008 00:03 by Foundation Staff
|
