April 22, 2012

WHAT THE IDSA WON'T TELL YOU....PT 2


before i get into the meat of today's post, i wanted to highlight a few important issues about the IDSA guidelines on lyme.
  • The IDSA guidelines were written by a panel of 12 Lyme disease researchers and clinicians, and dissenting opinion was ignored in formulating the guidelines [DONTA S, PERS. COMMUN.,2004]
  • The IDSA guidelines do not conform to current standards of evidence based medicine. Many of the IDSA recommendations for diagnosis and treatment of Lyme disease were contingent on the weakest Category III evidence. 
  • The IDSA panel members that wrote the guidelines for diagnosing and treating Lyme disease continue to rigorously defend their stance that "Lyme is hard to get and easy to treat" and that "Chronic Lyme disease does not exist." 
i am continuing my series on what the IDSA won't tell you. i thought it simplest to continue addressing the issues i have with dr auwaerter (who appeared on the dr phil show) and what he has to say about chronic lyme... or more accurately, what he WON'T say about the results of the IDSA studies on Lyme Disease. my friend, Christine H, did the work for me on this post. (thank you Christine!) she wrote in to the dr phil show with an excellent letter that outlines the results of the IDSA clincal studies...ones that dr auwaerter was involved with. yet, he (and the IDSA) continue to report and cite only the parts of the studies that back up their THEORY that Chronic Lyme Disease does not exist. Christine has done a bang up job of shedding light on the truth and with her permission, i am posting her letter on my blog.




Thank you Dr Phil!!

Dr Auwaerter claims that chronic lyme disease does not exist. In his opinion the fact that antibiotic therapy does not improve symptoms provides evidence that chronic Lyme disease is in fact post Lyme disease. Post Lyme disease implies that the Lyme bacteria have been totally eradicated however residual symptoms remain. He uses 4 studies to back up his claims (8).

In regard to the 4 studies that Dr Auwaerter uses to back up the claim that chronic Lyme disease does not exist:


First off, the 4 studies that Dr Auwaerter speaks of (8) involve clinical trials with the antibiotics - ceftriaxone, doxycycline or some combination thereof (1, 2, 3, 4). One of the studies that Dr Auwaerter and the IDSA gang like to cite involves two sets of clinical trials that were undertaken in the late 90’s by Klempner et al. using the antibiotic combinations I have listed previously. 


Klempner et al state that “Persistent symptoms have been reported both in patients who are seropositive for antibodies against B. burgdorferi and in patients who are seronegative. Although the cause of persistent symptoms has not been determined.....” 


The authors conclude that “There were no significant differences between clinical responses of patients who received intravenous and oral antibiotics for 90 days and those of patients who received placebo.” (1) 


These results serve to support a previous study authored in part by Klempner in 1992, in which spirochetes were isolated in 11 out of 12 ceftriaxone treated co-cultures of fibroblast protected spirochetes (5). The authors state that “Fibroblasts were able to protect the spirochete from the action of ceftriaxone in a medium that permits growth of extracellular organisms.” and “the intracellular site would protect the spirochete from the hosts immune system” (5).
These studies authored by Klempner et al have NOT proven the existence of “post” Lyme syndrome as THEORIZED by Dr Aerwarter and the IDSA. Rather, these studies have proven the existence of ceftriaxone-refractory, immune-system-evading, chronic-Lyme disease in the presence of fibroblasts and possibly other human cells. While the 1st study provides evidence of a mechanism of Lyme disease persistence (1), the 2nd study by the same author purports that “the cause of persistent symptoms has not been determined” (5). Did he forget that he authored the previous paper? 


The second study cited by Dr Auwaerter (8) and the IDSA members in order to refute the notion of chronic Lyme disease is authored by one of the Lyme communities own researchers and again involves failed therapy with ceftriaxone. . Dr Fallon et al conducted clinical trials of IV ceftriaxone therapy for Lyme encephalopathy. While the authors did observe measurable improvements in their patients, relapse was common upon antibiotic withdrawal. (3) Again, ceftriaxone treatment failure was observed. Fallon et al concluded that “Treatment strategies that result in sustained cognitive improvement are needed.” 


The STOP-LD Study written by L.B. Krupp et al, the third study cited by Dr Aertwarter (8), adds to the growing proof that ceftriaxone is ineffective for eradicating Lyme disease in humans. This study again assesses the outcome of ceftriaxone therapy in LD patients and reports on the data collected from the patient 6 months later. The only positive finding they report is improvement in fatigue.

And finally the fourth study that Dr Auwaerter refers to (8) is the IDSA Guidelines itself. Because of the IDSA’s tendency to accept expert opinion over high quality factual evidence (6, 7) their recommendations should be considered but not heavily relied upon.


Dattwyler et al compare a 14 day treatment regime to a 28 day regime of ceftriaxone in LD patients (9). Their results were reported as being cured, improved or treatment failure. 76% of the LD patients that received 14 days of ceftriaxone and 70% of the 28 day treatment group were considered to be cured (9). In other words 24 of 100 people treated for 14 days for Lyme disease with ceftriaxone were not cured according to their criteria as were 30 of 100 people treated for 28 days. I sure wouldn’t want to be one of these 54 people that were not cured!! Especially if I had an IDSA approved Dr treating me!! It is kind of odd that in this study there are more people in the 14 day group reporting as cured then in the 28 day group. Either way this is another study that plainly illustrates that ceftriaxone therapy is responsible for several treatment failures.

Ceftriaxone did not improve symptoms in 129 Lyme disease patients in a study conducted by Kaplan, Trevino, Klempner, Weinstein et al. Their final remark “Additional antibiotic therapy was not more beneficial than administering placebo” (10) is somewhat misleading in that to be correct it should have read more like “Additional ceftriaxone therapy was not more beneficial than administering placebo”.


Any Lyme literate Dr or patient for that matter knows that ceftriaxone and doxycycline alone are not curative for Lyme disease. We have already read the studies!! We use antibiotic combos that include cyst/biofilm busting antibiotics such as tinidazole or flagyl and yet I have never seen the IDSA gang do any clinical trials involving these abx in combination with..say doxy. Come on IDSA, get with the program!! You are seriously falling behind here!!

It becomes crystal clear to me that denying all antibiotics in any combination is NOT based on any solid research that Dr Auwaerter, the IDSA gang or any of their supporters have undertaken or presented thus far. This revelation begs the question;
"Exactly how did the IDSA and Dr Auwaerter come to the conclusion that antibiotic use for chronic or pretreated LD is ineffective thus chronic LD does not exist?" 


There are only 2 answers to this question: 
Either they used poor scientific skills to evaluate their research by not considering other antibiotics 
or 
they did truly consider the evidence and decided to try and bend the truth to suit their agenda. 


Either way they don't look very good thru my eyes.


1) Klempner MS, Hu LT, Evans J, et al. Two controlled trials of antibiotic treatment in patients with persistent symptoms and a history of Lyme disease. N Engl J Med 2001; 345:85–92.
2) Wormser GP, Dattwyler RJ, Shapiro ED, et al. The clinical assessment, treatment, and prevention of Lyme disease, human granulocytic anaplasmosis, and babesiosis: clinical practice guidelines by the Infectious Diseases Society of America. Clin Infect Dis 2006; 43: 1089–34.
3) Fallon BA, Keilp JG, Corbera KM, et al. A randomized, placebo-controlled trial of repeated IV antibiotic therapy for Lyme encephalopathy. Neurology 2008; 70: 992–1003
4) Krupp LB, Hyman LG, Grimson R, et al. Study and treatment of post Lyme disease (Stop-LD). A randomized double-masked clinical trial. Neurology 2003; 60: 1923–30.
5) Kostis G, Peacocke M, Klempner MS. Fibroblasts protect the Lyme disease spirochete,Borrelia burgdorferi. From ceftriaxone in vitro. JID 1992:166
6) Khan AB, Khan S, Zimmerman V, Baddour LM, Tleyjeh SM. Quality and Strength of Evidence of the Infectious Diseases Society of America Clinical Practice Guidelines. Evidence in the IDSA Practice Guidelines -CID 2010:51 15 November: 1147
7) Lee DH, MD; Vielemeyer O, MD. Analysis of Overall Level of Evidence Behind Infectious Diseases Society of America Practice Guidelines. Arch Intern Med. 2011;171(1):18-22. doi:10.1001/archinternmed.2010.482
Auwaerter PG. Point: Antibiotic Therapy Is Not the Answer for Patients with Persisting Symptoms Attributable to Lyme disease. Antibiotics for Post–Lyme Disease Syndrome • CID 2007:45 (15 July) • 143
9) Dattwyler RJ, Wormser GP, Rush TJ, et al. A comparison of two treatment regimens of ceftriaxone in late Lyme disease. Wien Klin Wochenschr 2005; 117:393–7
10) Kaplan RF, Trevino RP, Johnson GM, Levy L, Dornbush R, Hu LT, Evans J, Weinstein A, Schmid CH, Klempner MS. Cognitive function in post-treatment Lyme disease Do additional antibiotics help? Neurology. 2003 Jun 24;60(12):1916-22.

1 comment:

Heather said...

Love the footnotes! It really does show this is not just some heated argument -- this is real!!