ALDF article fails to mention flaws in Lyme disease trials
In his article "Is It Possible to Make a Correct Diagnosis of Lyme Disease on Symptoms Alone?" published in the American Journal of Medicine, Dr. Phillip J. Baker, executive director of the American Lyme Disease Foundation (ALDF) cites five Lyme disease trials to support the organization's position that extended antibiotics are not useful in the treatment of Lyme disease.  Unfortunately, Dr. Baker fails to mention several flaws with those clinical trials.
Dr. Baker, director of the American Lyme Disease Foundation, who was responsible for overseeing The National Institute of Allergy and Infectious Diseases’ (NIAID) Lyme disease program, wrote in his article, “The results of 5 placebo-controlled clinical trials on the efﬁcacy of extended antibiotic therapy for the treatment of post-Lyme disease symptoms provided no evidence of a persistent infection by culture and/or other laboratory tests, and showed no signiﬁcant lessening of symptoms, which one would expect to occur if symptoms were caused by a persistent infection.”¹
Unfortunately, Dr. Baker fails to mention that these trials, sponsored by the National Institutes of Health (NIH), were rife with flaws. They were small, under-powered and typically enrolled the sickest Lyme disease patients, who had already failed other treatments.
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The largest study included only 70 subjects. The smallest enrolled 37. The subjects had been ill an average of 4.7 to 9 years in 3 of the 5 studies. And their quality of life and functioning was already poor. The Berende trial subjects had been ill for 2 years on average and also presented with a poor quality of life.
Finally, Dr. Baker has not considered the poor reliability of the culture or laboratory test for Lyme disease in identifying whether a persistent infection has cleared.
Editor’s Note: Lyme disease treatment should not be based on results from flawed clinical trials.
- Baker PJ. Is It Possible to Make a Correct Diagnosis of Lyme Disease on Symptoms Alone? Review of Key Issues and Public Health Implications. Am J Med. 2019.