The IDSA is accepting comments and letters as they prepare for their open hearing on Lyme disease and the IDSA guidelines this April in Washington D.C. I am sure many are aware of this. At this time I am preparing a model letter which I plan to publish on this BLOG.
One glaring, critical flaw in the IDSA logic is staring me in the face, so in advance of my letter, I have decided to share this one point with my readers.
The IDSA claims that the controlled trials have shown that patients with chronic Lyme or post Lyme do not benefit from prolonged use of antibiotics. They are of course referring to the 3 NIH sponsored studies: Klempner, Krupp and Fallon.
All three studies were designed to look at patients with an established diagnosis of LD who were first treated with IDSA approved courses of antibiotics and yet still complained of various symptoms.
Most of the patients I see with chronic Lyme developed symptoms over a period of years and have never been treated with the IDSA approved Lyme disease regimens or any antibiotics for that matter. These patients are not the subset studied in the 3 NIH sponsored trials.
These studies consider only a small subset of patients identified as having chronic Lyme or post Lyme. The generalization of the findings to all groups of patients with Lyme disease is bad science at the very least.
If one were to study patients who had been previously treated for primary syphilis and then apply the results to heretofore untreated patients with disseminated tertiary syphilis, all would agree that this would be preposterous. In the case of Lyme disease the rules of logic and science apparently do not apply. Not only is the illogical non-science accepted by many well known physicians, but the New England Journal of Medicine agreed to publish an editorial predicated on such nonsensical thinking. One can only conclude that a determined group of individuals, having decided a priori what a particular study would show, twisted, massaged and manipulated the limited data to fit into the "Procrustean bed" of their forgone conclusions. This is not science. Whatever it may be- I have no name for it.
Unfortunately as absurd as this all may seen, the consequences of these machinations has had, and continues to have, a devastating impact on so many suffering patients and the physicians who treat them.
This is not just bad science- it is outside the pale.
6 comments:
Dr,
Could you please comment on the recent finding below regarding manganese transporter?
A manganese transporter, BB0219 (BmtA), is required for virulence by the Lyme disease spirochete, Borrelia burgdorferi
Zhiming Ouyanga, Ming Heb, Tara Omanb, X. Frank Yangb and Michael V. Norgarda,1
+Author Affiliations
aDepartment of Microbiology, University of Texas Southwestern Medical Center, Dallas, TX 75390; and
bDepartment of Microbiology and Immunology, Indiana University School of Medicine, Indianapolis, IN 46202
Communicated by Jonathan W. Uhr, University of Texas Southwestern Medical Center, Dallas, TX, December 19, 2008 (received for review December 4, 2008)
Abstract
Borrelia burgdorferi (Bb), the causative agent of Lyme disease, is transmitted to mammalian hosts through an arthropod (tick) vector. To establish infection, Bb must acquire essential nutrients, including transition metals, from its mammalian and tick hosts. Thus far, no metal transporter has been identified in Bb. Here, we report the identification of the first metal transporter, BmtA (BB0219), in Bb. BmtA-deficient mutants of virulent Bb were readily generated, and the mutants grew slightly slower than wild-type Bb in vitro. However, BmtA mutants were sensitive to the chelating actions of EDTA, suggesting a role for BmtA in metal utilization. Intracellular accumulation of manganese (Mn) was substantially diminished in the bmtA mutant, indicating that BmtA was operative in Mn uptake. Given that BmtA lacks homology to any known Mn transporter, we postulate that BmtA is part of a novel mechanism for Mn acquisition by a bacterial pathogen. BmtA also was essential to the infectious life cycle of Bb in ticks and mammals, thereby qualifying BmtA as a new borrelial virulence factor. In addition, the bmtA mutant was sensitive to treatment with t-butyl hydroperoxide, implying that BmtA, and thus Mn, is important to Bb for detoxifying reactive oxygen species, including those potentially liberated by immune effector cells during the innate immune response. Our discovery of the first molecule involved in metal transport in Bb provides a foundation for further elucidating metal homeostasis in this important human pathogen, which may lead to new strategies for thwarting Lyme disease.
How Evidence-Based Are the Recommendations in Evidence-Based Guidelines?
Finlay A. McAlister1*, Sean van Diepen1, Rajdeep S. Padwal1, Jeffrey A. Johnson2,3, Sumit R. Majumdar1
1 The Division of General Internal Medicine, University of Alberta, Edmonton, Canada, 2 The Institute of Health Economics, University of Alberta, Edmonton, Canada, 3 The School of Public Health, University of Alberta, Edmonton, Canada
Background
Treatment recommendations for the same condition from different guideline bodies often disagree, even when the same randomized controlled trial (RCT) evidence is cited. Guideline appraisal tools focus on methodology and quality of reporting, but not on the nature of the supporting evidence. This study was done to evaluate the quality of the evidence (based on consideration of its internal validity, clinical relevance, and applicability) underlying therapy recommendations in evidence-based clinical practice guidelines.
Methods and Findings
A cross-sectional analysis of cardiovascular risk management recommendations was performed for three different conditions (diabetes mellitus, dyslipidemia, and hypertension) from three pan-national guideline panels (from the United States, Canada, and Europe). Of the 338 treatment recommendations in these nine guidelines, 231 (68%) cited RCT evidence but only 105 (45%) of these RCT-based recommendations were based on high-quality evidence. RCT-based evidence was downgraded most often because of reservations about the applicability of the RCT to the populations specified in the guideline recommendation (64/126 cases, 51%) or because the RCT reported surrogate outcomes (59/126 cases, 47%).
Conclusions
The results of internally valid RCTs may not be applicable to the populations, interventions, or outcomes specified in a guideline recommendation and therefore should not always be assumed to provide high-quality evidence for therapy recommendations.
Free full text article at PLOS Medicine:
http://tinyurl.com/28cqge
The clinical trials involved chronic lyme-- which appears from the IDSA approved acute Lyme disease regimens, Lyme symptoms after 14-21 days of treatment. The clinical trials however used PCR to exclude acutely ill patients. What concerns me is the complete lack of scientific distinction between acute and chronic infection in the IDSA guidelines.
The clinical trials involved chronic lyme-- which appears from the IDSA approved acute Lyme disease regimens, Lyme symptoms after 14-21 days of treatment. The clinical trials however used PCR to exclude acutely ill patients. What concerns me is the complete lack of scientific distinction between acute and chronic infection in the IDSA guidelines.
IDSA's 'NIH' Science -- Due to Big Pharma?
Dear Lyme MD (et al):
Your conclusions and/or inferences about possibly-NIH-inspired IDSA 'logic' in including only "patients with an established diagnosis of LD who were first treated with IDSA approved courses of antibiotics and yet still complained of various symptoms" may correlate to flawed Sloan-Kettering 'logic' in (intentionally) contaminating clinical trials of unpatentable Laetrile/B-17 such that many if not most Sloan-Kettering cancer patients died in the Sloan-Kettering Laetrile/B-17 clinical trials.
Of course, Laetrile/B-17 (not Sloan-Kettering) was then found to be 'unsafe and ineffective.' No one has ever subjected Laetrile/B-17 to an appropriate double-blind clinical trial. Surprise, surprise?
For more info on the very profitable cancer industry's suppression of safe, effective & inexpensive (but not patentable) cancer cures, you may want to check out "The Cancer Syndrome" by Ralph Moss -- and many subsequent Alt.Med & allopathic articles & books.
If you find an expensive, patentable Lyme Disease cure, your real enemy -- which may be 'Big Pharma' -- may then support you. (Your real enemy may NOT be 'Big Brother' -- a ‘scapegoat’?)
For now, thank you very much for your very safe, very effective, and very inexpensive Lyme Disease cures (which are also very unpatentable -- unfortunately or fortunately).
Best regards,
An NIH/FDA/CDC/Big-Pharma Skeptic
P.S. “NIH”? “Not Invented Here,” right? “FDA” & “CDC”? Other Big Pharma ‘captives,’ right? However, don’t get me started. I'd prefer not to be indicted and/or lose my license for serial acronymicide.
These arguments and many others should be incorporated into letters submitted to the IDSA.
The finding of a new virulence factor should be coupled with the argument that: LD represents a new and emerging disease. There is much yet to be learned. Given that the science is far from worked out, it seems premature for the IDSA to issue guidelines related to this disease, especially in light of the divergent views regarding therapy. The IDSA has issued guidelines regarding only a few infectious disease out of hundreds.
This issue can also be incorporated into arguments real the lack of incorporation of basic science data into the guidelines, especially important given that clinical trials have not produced convincing results- understatement.
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