Lyme disease patient-advocacy organization TruthCures has called for the immediate suspension of Pfizer's phase III Lyme vaccine trial, known as "VALOR".
In a September 21, 2023 letter to the Food & Drug Administration Center for Biologics Evaluation and Research (FDA-CBER) and its director, Peter Marks, M.D., PhD., the nonprofit states as a primary reason for its complaint, "There is no accurate diagnostic test to determine if subjects in the placebo arm get Lyme disease at a higher rate than subjects in the vaccinated study arm," putting volunteers at significant risk of contracting the disease without an ability to diagnose it.
The letter goes on to detail manipulation of the diagnostic standard during trials for the previous Lyme disease vaccine, LYMErix, in the 1990s and how TruthCures previously presented proof of these events to FDA investigators. The letter questions recent payments from Pfizer to prominent researchers and institutions involved in the prior events.
According to the Centers for Medicare and Medicaid Services (CMS) Open Payments Website, in 2022 Pfizer paid New York Medical College (NYMC) $156,000.00 and The General Hospital Corporation (parent of Massachusetts General Hospital) $71,019.96 for biological samples intended for development of a diagnostic test for Pfizer's trial. TruthCures points out the current circumstances' similarity to the manipulation that transpired decades ago.
TruthCures contacted Dr. Gary Wormser of NYMC for comment prior to publishing an article on TrialSite News last May. Dr. Wormser stated in an email (emphasis his):
I HAD SOMETHING TOTALLY UNIQUE THAT THEY NEEDED, I HAD CULTURED PATIENT ISOLATES OF BORRELIA BURGDORFERI THAT WE HAVE SAVED AND HAVE BEEN EVALUATING GENETICALLY OVER MANY YEARS.
The complaint continues, "Given the genetic association of positive serology with the less severe disease outcomes among a minority of Lyme infections, Pfizer’s solicitation of genetically evaluated samples warrants serious investigation and the immediate suspension of its VALOR trial."
TruthCures poses a litany of questions to FDA-CBER, including, "Why is Pfizer developing its own assay rather than using the standards and tests that were developed for the previous, nearly identical, Lyme vaccine, and that have been in use for 29 years?"
The complaint further states, "For decades, Lyme experts and authorities have emphasized the need for more accurate tests, yet none have been developed or commercialized. Current initiatives include the LymeX Diagnostic Prize, a public-private partnership led by the Department of Health & Human Services (HHS) to identify an innovative new approach to diagnosing Lyme disease. Are we to believe that Pfizer has suddenly developed an accurate Lyme diagnostic since purchasing some magical samples from prominent Lyme researchers with extensive conflicts of interest?"
In closing, TruthCures demands, "The FDA must immediately suspend Clinical Trial NCT05477524 and initiate a full investigation. We expect a response to this letter within 30 days."
See TruthCures' letter here: