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Meg Mangin R.N.
Research Team (on leave)
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Posted: Sun Sep 18th, 2005 21:37 |
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When will a blinded study be done of the Marshall Protocol?
A large cohort of Marshall Protocol patients with a variety of Th1 inflammatory diseases, supervised by their personal physicians, are reporting, via the Internet, dramatic improvement in their health. This unorthodox method of conducting a trial of a novel treatment protocol, has prompted some doctors to ask when a standard randomized, double-blind, placebo-controlled study will be done to 'prove' the efficacy of the Marshall Protocol.
Dr. Marshall's response follows:
I spoke recently with staff from the FDA regarding exactly how one could conduct blinded trials of a curative therapy for a deadly disease, and we decided, preliminarily, that the risk/reward ratio was so low that it would probably not be ethical to blind any such trial (under FDA guidance ICH E-10).
The relevant guidance says "where an available treatment is known to prevent serious harm, such as death or irreversible morbidity in the study population, it is generally inappropriate to use a placebo control."
http://www.fda.gov/cder/guidance/4155fnl.htm
There is a copy of the Internationally harmonized document from Health Canada at URL
http://tinyurl.com/89gc9
See also the discussion at
http://answers.google.com/answers/threadview?id=474362
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Dr Marshall wrote: I 'saw' the bacteria in sarc several years ago, in the Nilsson photos, the Cantwell photos, and of course the Wirostko TEM photos. From those images I learnt exactly how the pathogens work, how they weave their evil on the phagocyte, and upon the immune system.
So it is of little interest to me for every patient to be tested with a microscope to see 'bacteria.' I can observe the effects of the bacteria on a patient, in their bloodwork. The manifestations are clear, and I don't need to look through a microscope.
Dr Andy Wright and Dr Bela Boszik have been looking down microscopes, however, so that even the physicians from Missouri can be satiated now
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Sir Alexander Fleming's discovery of the bacteria killing power of penicillin was never put to a controlled double-blind study, nor a peer-review in some journal. It worked! It was used! It saved countless lives.
If mankind waits for a controlled, double-blind study for a positive answer to every inquiry or medical thought, or the approval of a team of (un)knowledgeable "peers" in a journal article, mankind is going to continue to suffer grossly. Modern medicine has hit a "wall" with this belief that everything must be answered with a controlled, double-blind study, or be approved in a "peer" reviewed journal....in other words, have a definitive answer before starting out on a treatment. The new idea comes from someone that is more "learned" on that particular problem/solution that the "peer reviewers" or he would not have deduced the new answer. This modern day phenomena of so great a belief that a controlled double-blind placebo test of new ideas, or, the approval in some journal of a peer review is necessary is putting a stop to new discoveries.
George Howell
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Satire of Evidenced-Based Medicine
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