When I was on the NIH Advisory Panel for Klempner’s clinical trial, the other patient representative and I expressed concern that the results, if negative, would be over-interpreted and used as an excuse to deny care. NIAID Lyme Program Officer Phil Baker 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. The study design didn’t permit broader interpretation. We believed him.

NIAID conveniently forgot this after the Data Safety and Monitoring Board announced its findings. Within days news releases and clinical alerts from NIH and NIAID posted this headline on their websites, which is still there today: “Chronic Lyme Disease Symptoms Not Helped by Intensive Antibiotic Treatment.” Within months the NEJM published the paper in which the authors also leap to the conclusion that “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.”

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 runs counter to the IDSA claim that chronic Lyme is no more serious than the aches and pains of daily living.

The Klempner study was not designed to settle the question of the efficacy of long-term treatment, yet more than a decade later it is still being used to deny care to seriously ill people. In 2001, I suggested NIH substitute "Chronic Lyme Disease Study Shows 3 Months of Antibiotic Treatment Inadequate" for their headline.  No one responded to my letter.