In the late 1980s #LymeDisease started getting out of control—in terms of both its spread and the government/public health apparatus’s ability to maintain their desired messaging about it.
1/x
#LymeDisease friends, the rollout of Igenex’s new “FDA-cleared!!!” #Lyme test makes my Borrelia-infected blood boil, and it should raise the temperature of yours, too.
I’ve been fighting the battle against bogus diagnostics for many years. This move by @igenexlab is sickening.
First of all, see my rough analysis of their publicly available FDA application data.
To summarize briefly:
• still relying on antibody tests for a disease that causes immunosuppression/immune dysfunction
• it only detects IgG antibodies, which does nothing for the diagnosis of early #LymeDisease
• the data don’t support claims of increased sensitivity
My thoughts on the new “FDA cleared!!!” #idart #LymeDisease test from Igenex:
Note we’re *still* talking antibody tests for a disease that causes immunosuppression/immune dysfunction. AND it only measures IgG (not an early Lyme test).
“The iDart Lyme IgG ImmunoBlot Kit is intended to detect antibodies to LSA and multiple other B. burgdorferi antigens following a ***modified two-tier test methodology.***”
I.e. you still have to take another test to satisfy CDC, IDSA, dumb doctors.
“Positive results from the Dart Lyme IgG ImmunoBlot Kit are supportive evidence for the presence of antibodies and exposure to B. burgdorferi.”
EXPOSURE. They can still tell you (with a straight face) it’s a past infection.
🪡3
Now take a look at all that was known and admitted about #LymeDisease at the time (1986).
• “The spirochete has also been found in deerflies, horseflies and mosquitos.”
• “…birds may serve an important role in
long distance tick dispersal.”
continued…
🪡4
• “As many as two-thirds of the people that become infected by this spirochete are unaware of the tick bite because of the painless bite and the small size (several mm) of the nymphal stage.”
• “A systemic illness ensues due to the lymphatic and hematogenous spread of [Bb]”
🪡5
“The early phase of the illness often consists of the ECM, headache, fatigue, muscle and joint aches, stiff neck and
chills and fever. This phase of the disease may be followed by neurologic, joint or cardiac abnormalities.”
#LymeDisease
US Patent 4,721,617 filed Aug 14, 1986 and assigned Jan 26, 1988: Vaccine Against #LymeDisease
Inventor: Russell C. Johnson
Assignee: Regents of the University of Minnesota
🪡2
Lots to see here.
Firstly, “This invention was made with Government support under Public Health Service Grant AM 34733. The Government has certain rights in this invention.”
#LymeDisease
🪡3
Now take a look at all that was known and admitted about #LymeDisease at the time (1986).
• “The spirochete has also been found in deerflies, horseflies and mosquitos.”
• “…birds may serve an important role in
long distance tick dispersal.”
continued…
Some of the “data” MarDx provided in their IgM Western blot application to the FDA. (MarDx WBs were 1st to be cleared after infamous #Dearborn conference.) A few interesting tidbits in here.
My favorite: For their sensitivity study, MarDx included specimens of physician-diagnosed cases “relative to #LymeDisease case definition.” These undoubtedly would have been pre-screened arthritis samples from the Triangle of Death, Steere/Wormser/Dattwyler. #LymeDisease
I can’t even imagine anyone today getting away with using “physician-diagnosed” samples to validate a #LymeDisease diagnostic device’s sensitivity. The crooks would surely protest. I’ve looked @ a lot of 510Ks & have never seen this before.