They want ta' legislate the moonThey want ta' legislate the womb
They wanna legislate all the things they hate
They want ta' legislate this tune
Hmm, Whatever happened to Grant Lee Buffalo? Ahh, they broke up in 1999 (thank you Wikipedia) - that explains why they've been quiet.
Anyhow, that brings us to today's topic - should we legislate what are essentially medical issue? Connecticut thinks so. In July last year House Bill 6200 passed through the Connecticut House of Representatives by unanimous approval (137 for, 0 against). What does this bill do? It protect Connecticut licensed Lyme treating physicians from prosecution by the State of Connecticut Medical Examining Board solely on the basis of a clinical diagnosis and /or for treatment of long-term Lyme disease - thus allowing them to provide long term antibiotic treatment for people with chronic lyme disease (and also sufferers from Post-Lyme disease syndrome).
Sounds reasonable? Except that in patients who have non-specific symptoms after being treated for Lyme disease, and no evidence of active infection (so called Post-Lyme disease syndrome or PLDS), studies have shown that more antibiotic therapy is not helpful and can be dangerous.
Read this report from the National Institute of Allergy and Infectious Disease (part of NIH). Read this letter regarding the bill sent by the Infectious Disease society of America.
I write on behalf of the Infectious Diseases Society of America (IDSA) to urge you to oppose the enactment of Connecticut House Bill No. 5625, which sanctions the use of long-term antibiotic therapy to treat Lyme disease and would protect physicians, who administer such therapies, from disciplinary action. In urging your opposition to this legislation, our primary concern is to ensure the best quality in patient care and to protect the public’s health and safety. To this end, we believe it is critically important that you be fully apprised of the widespread consensus within the medical and scientific community about the appropriate treatment of Lyme disease, as well as the medical community’s concerns about unproven, potentially harmful treatments for so called “chronic” Lyme disease that are advocated by a small group of physicians.
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Carefully designed and conducted studies of Lyme disease treatments have failed to demonstrate benefit from prolonged antibiotic therapy. Rather, these studies have demonstrated that there is no difference in the measured improvement between patients receiving placebo and patients treated with antibiotics.
Furthermore, the scientific evidence that long-term antibiotic therapy may be dangerous, leading to potentially fatal infections in the bloodstream as a result of intravenous treatment. Far from improving the patient’s quality of life, prolonged antibiotic therapy may actually increase the patient’s suffering. Also, although the bacteria that causes Lyme disease does not acquire resistance to antibiotics, long-term antibiotic exposure can lead to drug-resistance among other microorganisms, creating “superbugs” that cannot be treated with currently available drugs.
I think we can expect to see more bills like this. It is the government's job to protect us from those who offer false hope and possibly dangerous 'cures' not to enable them.
4 comments:
Please, please can I urge you to do your research in an UNBIASED manner and you will see the facts for yourself.
The scientific evidence for Chronic Lyme disease and the PERSISTENCE of the COMPLEX Borrelia Spirochete is DETAILED and VAST, unlike that of the IDSA and their devoted followers viewpoint, that this bacteria is "hard to catch and easy to cure". Please see http://www.lymeinfo.net/medical/LDPersist.pdf for 70 studies which show the persistence of the bacteria.
You may also like to look at a study titled "Rapidly progressive frontal-type dementia associated with Lyme disease" which demonstrates a tragic case of a gentleman diagnosed with Dementia after being treated with a course of antibiotics for Lyme Disease. He showed improvement whilst on antibiotics but relapsed when the antibiotics were stopped. He was institutionalised for the psychiatric condition but soon died. The authors of this study concluded that "Lyme disease must be considered even in cases with purely psychiatric presentation, and prolonged antibiotic therapy may be necessary"
The NIAID link you cite which rejects the existence of Chronic Lyme Disease cites numerous flawed and corrupt articles and trials to support its stance.
Taken from the above mentioned link - “Because of the confusion in how the term CLD is employed, experts in this field do not support its use (New Eng. J. Med. 2008; 357:1422-30).”
In response to this quoted NEJM article, “A Critical Appraisal of "Chronic Lyme Disease"”, I will please refer you to the following learned responses and ILADS press release:
1. ‘Chronic Lyme Disease and the "Axis of Evil"’ authored by Raphael B. Stricker and Lorraine Johnson, published on PubMed and on Medscape Today on 02/02/2009. This paraphrases the term, “Axis of Evil,” as a self-derogatory slur in the face of the disparaging and dismissive remarks in the New England Journal of Medicine and provides a substantial body of references and evidence.
2. ‘Responding to a New England Journal of Medicine Critical Appraisal of “Chronic Lyme Disease”’ authored by Dr. Joseph Jemsek and published on Lymemed. This paper is ‘an attempt to highlight the most glaring incongruities and perplexing logic flows contained within what is considered a shameful and politically-motivated article.’
3. ‘ILADS Members Question Motives of New England Journal of Medicine Article on Lyme Disease Treatment’, a press release published by International Lyme and Associated Diseases Society on 02 October, 2007.
(Cont. in next comment)
(Cont) Personal observations on this article - There are deliberate strategies employed to confuse and obfuscate. There is no science; just an attempt to rubbish contrary medical opinions:
The following extract demeans and belittles and denies the suffering, - in many cases extreme - discomfort and disabling pain experienced by sufferers. It is shameful: “Despite resolution of the objective manifestations of infection after antibiotic treatment, a minority of patients have fatigue, musculoskeletal pain, difficulties with concentration or short-term memory, or all of these symptoms. In this article, we refer to these usually mild and self-limiting subjective symptoms as "post–Lyme disease symptoms," and if they last longer than 6 months, we call them "post–Lyme disease syndrome."
The following is cited as grounds for not using long term antibiotics in treating Lyme: “Antibiotic therapy can cause considerable harm to patients treated for chronic Lyme disease or post–Lyme disease symptoms. Life-threatening anaphylaxis and biliary complications requiring cholecystectomy have occurred after ceftriaxone administration. Candidemia from infection of an intravenous catheter has resulted in death.” Are the authors excluding these same morbid outcomes for like therapies and protocols employed in other conditions such as TB or meningitis? Are they actually suggesting these potentially serious and fatal outcomes are specific to Lyme?
Furthermore: “In a single-center trial conducted by Krupp et al., 55 patients with severe fatigue (as measured by an 11-item questionnaire) after treatment of well-documented Lyme disease underwent randomization to receive ceftriaxone or an identical-appearing placebo for 28 days. The investigators reported a reduction in scores for fatigue severity in the ceftriaxone group that exceeded the reduction in the placebo group by 13 percentage points.” Also: “In light of the risk of serious adverse events in their study, Krupp et al. concluded that "repeated courses of antibiotic treatment are not indicated for persistent symptoms following Lyme disease, including those related to fatigue and cognitive dysfunction.” It is noteworthy that rejection of use is based not on lack of efficacy, for this is proven, but on possible harm resulting from potential side-effects!
It is also stated that: “Eligibility criteria for two controlled trials stipulated that symptoms must be severe enough to interfere with the patient's ability to function.”
Can this really be the case, that only patients presenting severe and therefore long-term symptoms were selected? These, necessarily would be the least likely to show a favourable response from a course of the antibiotics as described. With Lyme disease patients presenting such a severity of symptoms, a much more rigorous protocol would be indicated.
In addition: “The central question is not whether a few spirochetes might persist after antibiotic treatment, but whether clinical disease can be attributed to their presence.” Therefore, it is concluded that, if they are present, it is mistaken to attribute any presenting symptoms to them? This calls into question the whole basis of the study which affirmed Lyme disease as a clinical condition in the first place. What they are saying is that when Willy Burgdorfer MD, PhD discovered these bacteria to be present, he was mistaken in attributing this to the clinical disease that was presenting! Further confusion and obfuscation!
The article criticises “the unproven and very improbable assumption that chronic B. burgdorferi infection can occur in the absence of antibodies against B. burgdorferi” In other words, if antibodies are not present then there is no evidence of infection. In contrasting contradiction, it is also stated that, “Indeed, the strategies used by B. burgdorferi” permit them to “adapt to the vertebrate host and evade host defenses”!
(Cont. in next comment)
(Cont) There are further contradicting statements and incongruities: The article gives an objective summation and offers the criticism that the method of diagnosis is extraordinary in that, “The diagnosis of chronic Lyme disease and its treatment differ substantively from the diagnosis and treatment of recognized infectious diseases.” In other words, the methodology should be identical. The authors then appear to affirm that, actually, the Borrelia bacteria behaves differently, inferring the necessity of a different methodology: “The lack of convincing evidence for the persistence of B. burgdorferi in treated patients is not surprising. The failure of treatment for bacterial infections typically occurs as a result of pathogens that either have or acquire resistance to antibiotics, difficulties in achieving sufficient concentrations of antibiotic at sites of infection, or impaired host-defense mechanisms. None of these factors are generally applicable to infection with B. burgdorferi.”
Referring back to the NIAID link you cite -
“In an effort to address the confusion regarding appropriate therapy, NIAID has funded three placebo-controlled clinical trials on the efficacy of prolonged antibiotic therapy for the treatment of PLDS. The published results were subjected to rigorous statistical, editorial and scientific peer review.”
These trials have been demonstrated to be grossly flawed. The first trial (ref. New Eng. J. Med. 345:85-92, 2001) funded by NIAID is overseen by Dr Klempner, an IDSA Lyme disease guideline panel member and author, who is already predisposed toward the viewpoint that long-term antibiotic therapy is not effective for this condition.
The second clinical trial (ref: Neurology 2003;60:1923-1930) is overseen by Dr Krupp, a collaborator in authorship of other studies written by IDSA Lyme disease panellists.
The third clinical trial (ref: Neurology 2008;70:992-1003, A randomized, placebo-controlled trial of repeated IV antibiotic therapy for Lyme encephalopathy) is authored by B. A. Fallon, MD, J. G. Keilp, PhD, K. M. Corbera, MD, E. Petkova, PhD, C. B. Britton, MD, E. Dwyer, MD, I. Slavov, PhD, J. Cheng, MD, PhD, J. Dobkin, MD, D. R. Nelson, PhD and H. A. Sackeim, PhD. I quote from this:
“Conclusion: IV ceftriaxone therapy results in short-term cognitive improvement for patients with post treatment Lyme encephalopathy, but relapse in cognition occurs after the antibiotic is discontinued. Treatment strategies that result in sustained cognitive improvement are needed.”
It is significant that the first two trials funded by NIAID are not undertaken by independent authors but by people who have bias and conflicts of interest. It is noteworthy that NIAID somehow interpret the quoted conclusion in the third trial to infer the inefficacy of the treatment when it is clearly stated that, once the treatment was withdrawn, the symptoms returned.
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(Cont) The Klempner trial ("Two controlled trials of antibiotic treatment in patients with persistent symptoms and a history of Lyme disease. New England Journal of Medicine, June 12, 2001") is used persistently to support the IDSA stance that "long-term antibiotics are not beneficial in treating Lyme disease", BUT has been trashed by an independent research group (amongst others) as being flawed and "bad science".
Various organisations are often cited to substantiate the IDSA guidelines, namely the CDC, ALDF and EUCALB - when those very organisations actually hold no independent viewpoint at all but merely voice and duplicate that of the IDSA Lyme disease panel. Different organisations are being cited to give the appearance of wider and more authoritative backing from different, independent sources when the membership of these organisations actually contains the very same people amongst their number and, therefore, disqualify them as an independent source. There is no corroborating evidence from varying authoritative points of reference, then, to support this view promulgated by IDSA; there is, in fact, only one point of reference – the guidelines as set out by the IDSA Lyme disease panel, which is currently under investigation for GROSS conflicts of interest!
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