Last February, six months into its Phase III Lyme disease vaccine trial, Pfizer made headlines for alleged violations of good clinical practice by its trial site contractor, Care Access. The episode led to disenrollment of half the trial participants, with the initial expectation that they would be replaced. Planned enrollment of 18,000 now stands at 6,400 with no apparent intent to increase participation to a level that would ensure meaningful results.
Now details are emerging about transactions between Pfizer and Lyme disease researchers who have a financial interest in maintaining the status quo of Lyme diagnosis and treatment.
My article on TrialSite News (and on this blog) last May detailed the behind-the-scenes antics carried out by SmithKline and government insiders during trials for the original Lyme disease vaccine, LYMErix, in the 1990s. Publicly available records indicate the disease definition was revised, along with the diagnostic criteria, to limit the number of cases that could be diagnosed with "definite" Lyme disease, thereby inflating the appearance of vaccine efficacy.
According to documents from that time, positive Lyme disease diagnosis became contingent upon a robust, genetically-associated immune response to serologic tests, which only a small minority of cases are able to achieve. This standard was represented by serum samples provided to the Centers for Disease Control and Prevention (CDC) by "Academic Reference Center" (ARC) researchers at Yale, Stony Brook, and New York Medical College (NYMC).
I previously reported that one of those ARC researchers, Gary Wormser of NYMC, had been contracted by Pfizer in 2021 to provide samples for "developing Lyme diagnostics for a Lyme vaccine trial." The implication was that again, the disease definition and diagnostic criteria were being manipulated to suit the desired endpoint of the trial, without regard for accuracy or patient welfare.
A newly identified disclosure on the CMS Open Payments Website shows that at least one other researcher has provided similar samples to Pfizer. The disclosure by Harvard for Principal Investigator John A. Branda, colleague of Allen Steere (one of the original ARC researchers), states:
LOW INTERVENTIONAL METHODOLOGY STUDY TO OBTAIN BIOLOGICAL SAMPLES FROM PARTICIPANTS WITH SUSPECTED LYME DISEASE FOR THE PURPOSE OF DEVELOPING CLINICAL DIAGNOSTIC ASSAYS
There are some obvious questions that regulators (not a small, under-resourced patient advocacy organization) should be asking:
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?
Why are the existing standards "good enough" for the general public, but not for this trial?
How will the results obtained through Pfizer's own standards and tests correlate with the the standards and tests used in clinical practice in the U.S. and internationally?
Have the 6,400 participants been made aware that Pfizer is developing its own test to determine vaccine efficacy, instead of using what everyone else uses?
Is Pfizer's diagnostic test considered a "laboratory developed test" (LDT) which would be subject to certain federal regulations?
I've sent an inquiry to ClinicalTrials.gov_Inquiries@pfizer.com but do not expect a response. The answers to the following questions I asked are important to the Lyme community:
Who is the Principal Investigator?
Who are the Data & Safety Monitoring Board (DSMB) members and who is the DSMB lead?
According to CMS Open Payments, Dr. Gary Wormser and Dr. John A. Branda received payments from Pfizer to provide clinical samples “for the purpose of developing clinical diagnostic assays.” Please help the lay person understand why Pfizer needs to develop diagnostic assays rather than using commercially available tests.
What were the criteria for the samples provided and how were they validated? Did any other researchers provide samples for the purpose of developing a diagnostic assay or for any other use in this trial?
If the diagnostic criteria for this trial differ from the CDC’s criteria (https://ndc.services.cdc.gov/case-definitions/lyme-disease-2022/) please describe how they differ, including both clinical and laboratory criteria.
I will update my reporting if I receive a reply.
The CDC admits to nearly half a million American cases of Lyme disease every year, but only around 40,000 are positively diagnosed by the existing criteria. If Pfizer has developed a highly accurate way to diagnose the 400,000 people denied treatment each year due to false negative serology, let's see it. Show us the samples used to validate that assay. Hand over Gary Wormser's "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."
Let's be clear: The 6,400 trial participants (including children as young as five years old) did not sign up to be treated like laboratory mice, or worse. They assumed (perhaps naively) Pfizer would operate ethically and in good faith. Instead, by all appearances, Pfizer is doing whatever is necessary to ensure their product survives phase III trials, instead of their participants. The FDA must immediately pause Clinical Trial NCT05477524 and investigate Pfizer's protocols and procedures.