Game Changer: Previous Studies on Chronic Lyme Disease Flawed

Game Changer: Previous Studies on Chronic Lyme Disease Flawed

For years, insurance has been withholding treatment for chronic Lyme disease (or even re-treatment after a short course of antibiotics doesn’t work) based on four studies that were conducted in 2001.

Two of the most influential were conducted by Mark Klempner, PhD and published in the New England Journal of Science: “Two controlled trials of antibiotic treatment in patients with persistent symptoms and a history of Lyme disease” New England Journal of Medicine, 2001. 345(2):85-92. Klempner, M. S., Hu, L. T., Evans, J., Schmid, C. H., Johnson, G. M., Trevino, R. P., Norton, D., Levy, L., Wall, D., McCall, J., Kosinski, M., Weinstein, A.]   See studies here. 

Note: Dr. Klempner was soon thereafter hired as Associate Editor of New England Journal of Health.  Hmmm

The IDSA (Infectious Disease Society of America), AMA (American Medical Association), NIH (National Institute of Health) and the CDC (Center for Disease Control) – the four most powerful organizations in America having to do with defining disease behavior, spread, diagnosis, treatment, public policy and insurance rules and regulations – all used Dr. Klempners conclusions to determine their response to the growing epidemic of Lyme disease.  The raced and irresponsible conclusion (my words) whose validity is now called into question stated:

“Although we used both conventional and hypertonic culture mediums to isolate B. burgdorferi in base-line samples of cerebrospinal fluid and blood and used PCR to detect B. burgdorferi DNA in base-line samples of blood and cerebrospinal fluid as well as samples of blood collected during treatment, we did not find evidence of persistent infection with B. burgdorferi in these patients. There was no evidence of B. burgdorferi in a total of more than 700 different blood and cerebrospinal fluid samples from the 129 patients in these studies.”


“In summary, patients with chronic musculoskeletal pain, neurocognitive symptoms, or both that persist after antibiotic treatment for well-documented Lyme disease have considerable impairment in their health-related quality of life. The patients enrolled in these studies did not have evidence of persistent infection by B. burgdorferi, as judged on the basis of the available microbiologic and molecular methods of detection. 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.”

The third trial was published in 2003 by Dr. Krupp from SUNY at Stony Brook, “Study and treatment of post Lyme disease (STOP-LD): a randomized double masked clinical trial.” Gaudino EA, Coyle PK, Krupp LB. concluded that:

“Despite symptom overlap, patients with PLS show greater cognitive deficits than patients with CFS compared with healthy controls. This is particularly apparent among patients with PLS who lack premorbid psychiatric illness.”  See study here.

The last of the four studies, by Fallon et al., had a very small sample size. It found hints of some benefits from retreatment but nothing definitive either positively or negatively.

According to “Infectious Disease Today” Allison DeLong, (picture credit to Brown University) a biostatistician at Brown University’s Center for Statistical Sciences and lead author of the study published online Aug. 19, 2012, in Contemporary Clinical Trials, said the four studies do not prove that retreatment does not work. That questionable interpretation, however, has led doctors to forgo treatment and insurance companies to withhold reimbursement.

Ms. DeLong was motivated to evaluate the studies that have had such a profound effect on Lyme sufferers everywhere, when a personal friend began to feel better after a second round of antibiotics.  According to Klempner’s study her friend should not have felt any different, but Allison wasn’t buying that.

Working with some colleagues; a statistics graduate student Barbara Blossom of Colorado State University, Dr. Elizabeth Maloney of Wyoming, Minn., and Dr. Steven Phillips of Greenwich Hospital in Connecticut, DeLong set out to see if these studies were strong enough to base the IDSA guidelines on with suspicions that proper medical practices were not followed carefully, especially given the problems the medical community has with testing for an accurate diagnosis.

Additionally, the authors became concerned that their results were tainted by too many subjects realizing that they were receiving real treatment instead of the placebo. The measure of fatigue is subjective and could be influenced by that realization.

But DeLong found that the subjects weren’t likely to have realized anything. Here’s why: If the members of each group have a blindly optimistic seven in 10 chance of believing that they received real medicine, then the people who really were would be right seven out of 10 times and the people receiving the placebo would only be right 3 out of 10 times. The people receiving the medicine would seem like they had discovered their status, but in reality they were only making a lucky, optimistic guess. Read the full story here.

Finding an accurate diagnosis for Lyme disease is necessary to refute or prove that antibiotics are necessary.  Thankfully, as of August1, 2012 such a test is available through Advanced Labs (see

The Serano Group discredit the studies for some other reasons, “…typically, research not demonstrating anything is hard to get published. But due to political and commercial pressures to promote a distorted Lyme disease agenda, this study was rushed to press and continues to be cited as important evidence that persisting Lyme borreliosis does not exist and should not be treated.”  Read the full article here.

Well, more and more the evidence is shifting public thought and proving what Lyme-literate and “compassionate open-minded” doctors have known all along…we aren’t making up these horrible symptoms – we have chronic Lyme disease.

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2 Responses to Game Changer: Previous Studies on Chronic Lyme Disease Flawed

  1. susan robbins says:

    We are committed to establishing a foundation for lyme research/support: prevention and cure. If they could get public support for research for AIDS, we can certainly do it for lyme, a growing epidemic of which most of the country is not aware;; they know not how many children are being infected on a daily basis. There is a DVD about how they did it for AIDS. We must follow their example. Please direct us. We know we have to get support of people with “influence”: the media, celebrities (Hollywood, sports), people with means. Please help guide us.

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