#LymeDisease diagnostic tests were designed to detect cases of *late Lyme arthritis*, a condition associated with certain genetics and which usually manifests as a single arthritic knee. This is the visual CDC uses ⤵️ 
People who have the genetic makeup for susceptibility to *late #Lyme arthritis* tend to produce a strong antibody response to #LymeDisease infection, but it builds over time. That’s why CDC & IDSA say “don’t test in the first 3 weeks.”
According to CDC & IDSA, #LymeDisease is *defined* by this small subset of people who are able to test positive by serology (antibody tests).
It should be the other way around: Define the disease, then establish testing that accurately diagnoses >95% of cases meeting criteria.
It should be the other way around: Define the disease, then establish testing that accurately diagnoses >95% of cases meeting criteria.
BUT
#LymeDisease testing was notoriously inaccurate in the early 1990s. That was problematic for vaccine development. How could a vax be proven effective if cases of #Lyme couldn’t be accurately diagnosed?
#LymeDisease testing was notoriously inaccurate in the early 1990s. That was problematic for vaccine development. How could a vax be proven effective if cases of #Lyme couldn’t be accurately diagnosed?
The CDC said *late #Lyme arthritis* cases produced positive serologic tests, contrary to how #LymeDisease was defined at that time.
Allen Steere published that only *late #Lyme arthritis* cases showed a high rate of antibody reactivity. This report also discusses the genetic association of high antibodies with arthritis.
#LymeDisease
#LymeDisease
Allen Steere was in charge of #LYMErix trials for SmithKline (GSK). He was instrumental in *changing the definition* of #LymeDisease to clear a path for the trials.
The new definition included ONLY *late #Lyme arthritis* cases and not those known to be sicker but seronegative.
The new definition included ONLY *late #Lyme arthritis* cases and not those known to be sicker but seronegative.
This worked great because
a) they knew serologic tests would be highly accurate for this small subset (about 15% of all cases) as long as they waited a few weeks, so it could be claimed that the tests were accurate for how #LymeDisease was defined,
AND…
a) they knew serologic tests would be highly accurate for this small subset (about 15% of all cases) as long as they waited a few weeks, so it could be claimed that the tests were accurate for how #LymeDisease was defined,
AND…
b) using this #LymeDisease testing methodology in #LYMErix trials would still miss many of the *late #Lyme arthritis* cases if tested early, thereby making the vaccine look even more effective!
Even if #LYMErix was a total failure (IT WAS!!!), no more than 6% of cases could get diagnosed in the first few weeks after a tick bite.
Serology is 40% sensitive for the 15% *late #Lyme arthritis* cases in the first few weeks: .40 x .15 = .06 or 6%.
Serology is 40% sensitive for the 15% *late #Lyme arthritis* cases in the first few weeks: .40 x .15 = .06 or 6%.
That makes for some fantastical #LymeDisease vaccine trial data!
…And a whole lot of victims going undiagnosed because this new disease definition & diagnostic standard that exclude the sickest/majority of true cases, were embedded into FDA’s requirements.
…And a whole lot of victims going undiagnosed because this new disease definition & diagnostic standard that exclude the sickest/majority of true cases, were embedded into FDA’s requirements.
All #LymeDisease tests cleared through the #FDA 510(k) pathway since 1995 #daisychain back to the tests that were manipulated for #LYMErix trials. None are valid. All must be recalled.
• • •
Missing some Tweet in this thread? You can try to
force a refresh
