Statistical Review of the Key Lyme Studies Reveals the ‘Wild Conjecture’ Behind the IDSA Guidelines

In a comment to the article, “Study reports flaws in design, analysis, and interpretation of Lyme disease,” Phyllis Mervine elucidates what happened from the depth of her involvement at the NIH at the time of the Klempner clinical trial …

NIH Should Admit They Were Wrong
Phyllis Mervine says:
September 5, 2012 at 7:53 PM

Congratulations to Allison DeLong and her colleagues for showing that the emperor has no clothes. Doctors have long used the IDSA interpretation of the NIH trials as an excuse for medical neglect. Now, hopefully, no more.

When I was on the NIH Advisory Panel for Klempner’s clinical trial, about a decade ago, the other patient representative and I expressed concern that the results, if negative, would be used as an excuse to deny patients care. Phil Baker, NIH Lyme Program Officer at the time, assured us that the trial could do no more than determine that this particular treatment worked, or didn’t work, in this particular subset of patients. Perhaps naively, we believed him. The entire Advisory Panel knew the study design didn’t permit a broad interpretation.

NIH conveniently forgot their promise after the Data Safety and Monitoring Board announced its findings. Within days, NIH published news releases and clinical alerts with this headline: “Chronic Lyme Disease Symptoms Not Helped by Intensive Antibiotic Treatment.” I suggested they substitute “Chronic Lyme Disease Study Shows 3 Months of Antibiotic Treatment Inadequate.” No one responded to my letter.

A few months later the NEJM published the paper in which the authors also leap to the conclusion, “It is unlikely that more prolonged antibiotic therapy or a different combination of antibiotics would result in greater improvement than was observed in this study.” As DeLong points out, there was no evidence for this wild conjecture.

Interestingly, the news release also stated that the investigators found that “the impact of Lyme disease on physical health was at least equal to the disability of patients with congestive heart failure and osteoarthritis.” This contradicts the IDSA claim that chronic Lyme is no more serious than the aches and pains of daily living.

The Klempner study was never designed to settle the question of the efficacy of long-term treatment, yet more than 10 years later it is still being used to deny care to seriously ill people. DeLong proves that the patient advocates were right all along. It’s time for NIH to admit it.

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