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Physicians' concerns about the Marshall Protocol

Over the years, physicians have voiced various concerns about the Marshall Protocol, concerns ranging from the safety of higher doses of olmesartan (Benicar) to concerns about long-term antibiotic use. The Autoimmunity Research Foundation has assembled articles, well-grounded in scientific research, which address these concerns. Physicians who choose to use and administer the MP do so on the basis of the available evidence.

Concerns about lack of clinical evidence

  1. “There are no well-controlled studies to support the use of the Marshall Protocol for a given indication.” This statement is accurate. At this point, patients and physicians who choose to use and administer the MP do so based on the following evidence:

For some physicians, the above evidence is not sufficiently compelling to warrant automatically starting a patient on the MP without further consideration. Here are some other factors which may play a role in the clinical judgment:

  • evidence for the efficacy of MP versus other available treatment options1
  • patients' expressed preferences and values2
  • orphan drug status – Autoimmunity Research Foundation has won orphan drug status from the FDA for several medications and indications, and is committed to working further with the agency to get the MP approved for a broader range of indications.

Finally, a physician may want to try their patient on a therapeutic probe. While the randomized controlled trial or RCT is widely praised for its validity in identifying the efficacy of a therapy, according to the well-regarded evidence-based medicine textbook produced by JAMA, “clinicians cannot always rely on the results of randomized controlled trials…. In such cases, clinicians can conduct RCTs in individual patients (n-of-1 RCTs).” According to the 2009 edition, in an N-of-1 RCT the patient begins treatment and the subsequent clinical course determines whether treatment is continued.

Concerns about olmesartan (Benicar)

Patients on the Marshall Protocol (MP) take olmesartan (Benicar)–a drug whose actions are fully known–every four to six hours. A substantial body of research supports the use of olmesartan as a part of a curative therapy for chronic disease.

  1. “Higher than typical doses of olmesartan are unsafe.” Ample research supports the fact that olmesartan is one of the safest and has the most gentle side effects profiles of almost any drug on the market. Read more →
  2. “Off-label use of medications is unsafe.” The United States FDA has issued clear Policy Guidance on off-label prescriptions, clearly stating that it is up to the physician's individual judgment to decide whether an off-label drug should be used. Read more →
  3. “Using a hypotensive for patients with low blood pressure is unsafe.” Olmesartan is a weak hypotensive, reducing diastolic pressure by no more than 12 mm Hg in the dosages suggested by the Marshall Protocol guidelines. The NIH has created no medical standards that define low blood pressure, or a range in which low blood pressure is considered dangerous. Symptoms which appear to be caused by hypotension–dizziness, fatigue, lightheadedness–are a result of the disease process and have been shown to resolve as the inflammation resolves, no matter the number of the blood pressure. Read more →

Concerns about antibiotics

  1. “Long-term antibiotic therapy is dangerous and will lead to development of antibiotic-resistant bacteria.” In the the 40 years since the release of minocycline, the primary MP antibiotic, no significant species have been shown to be resistant to it. Minocycline is also one of the few antibiotics that remains active against the bacterial species Methicillin-resistant Staphylococcus aureus (MRSA), despite the fact that it has been prescribed for decades. Read more →

Concerns about vitamin D

Patients on the MP abstain from consumption of vitamin D. Although the secosteroid may currently enjoy a positive reputation in the media, molecular research shows that taking vitamin D exacerbates inflammatory disease.

  1. “Avoiding consumption of vitamin D leads to rickets.” – The majority of cases of rickets occurs among children in developing countries who suffer from severe malnutrition. The disease is cited as a primary reason for consuming vitamin D regularly, even though research has demonstrated that rickets is not caused by vitamin D deficiency, but by hypophosphatemia. Read more →
  2. “Avoiding consumption of vitamin D leads to depression or seasonal affective disorder.” – Light exposure does nothing to resolve an underlying disease state and can actually delay progress for MP patients. MP patients who have completed the treatment have been able to attest to the fact that sunshine is not necessary for good health or happiness. Read more →
  3. “Avoiding consumption of vitamin D leads to cancer.” – A variety of studies has suggested that vitamin D protects against cancer. This seemingly intuitive proposition is supported by neither epidemiological nor molecular evidence. In fact, the very opposite is true. Read more →
  4. “Avoiding consumption of vitamin D leads to osteoporosis.” – While it is conventional wisdom that vitamin D supplementation reverses osteopenia and osteoporosis, a growing body of evidence, both molecular and epidemiological, shows this is not the case. Instead, current research has demonstrated that osteoporosis and osteopenia are often the direct result of infection with the Th1 pathogens, a metagenomic microbiota, which produce inflammatory cytokines and inactivate the Vitamin D Receptor. Read more →

Concerns about light avoidance

  1. “Marshall Protocol patients are forced to wear special NoIR sunglasses–even when they do not need to.” – Only those MP patients who are photosensitive must wear sunglasses. Those who aren't photosensitive (after seeing how the treatment affects them) don't need to wear sunglasses. Read more →
  2. “Latitude studies show that disease is reduced by light exposure.” – Recent studies have compared rates of certain major cancers–most notably breast, colorectal and prostate cancer–to rates of sunlight exposure. This group of research has the liability of being wildly inconsistent. The choice to publish research on a specific latitude gradient may be a better proxy for a researcher's bias. Read more →

Concerns about immunopathology

  1. “A temporary increase in symptoms or laboratory values means the treatment is not working.”Immunopathology is an increase in one's present symptoms of Th1 inflammation or a return of previous Th1 inflammatory symptoms, that is caused by cytokines and endotoxins being released from dying bacteria. Immunopathology is a necessary part of recovery. The amount of immunopathology a patient experiences on the Marshall Protocol (MP) is correlated with disease severity. Patients who are less sick will have comparatively less strong immunopathology. Read more →

Notes and comments

  • CureMyTh1.org references removed during transition to closing that site. — Joyful 01.04.2014

References

1 , 2 Murad MH, Montori VM, Guyatt GH Incorporating patient preferences in evidence-based medicine. JAMA. 2008;300:2483; author reply 2483-4.
Last modified: 01.04.2014
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