IDSA Trying to Influence
FDA On Lab Tests
July 10, 2017
Note to Lyme Treating Health Care Professionals
Perhaps someone might want to share this recent letter, from the IDSA to the FDA, with our preferred labs. I stumbled on it while researching non-related info. It appears IDSA has been actively fighting with the FDA over new proposed regulations currently in draft form.
They've written to about everyone on the planet trying to make changes in this draft, with a steady stream of correspondence from what I can tell. From one of the earlier pieces of correspondence (all from this year) I found this…
QUOTE- "These challenges would likely force laboratories to discontinue developing innovative LDTs and either move toward exclusive use of commercial IVDs or send samples for testing to outside reference laboratories.” [Bottom line- IDSA believes that is a really BAD idea.]
Regarding Paul Auwaerter from Johns Hopkins- if memory serves me, I alerted you to the fact a couple years back that he got on an FDA panel dealing with blood testing. My suspicion, after reading this letter, is he needs back up to support his views and shape new policies? Because of his non-relenting stance that there is no such thing as “chronic Lyme disease”, we are most likely going to be targeted as a result of what is to come.
A quote found elsewhere from Paul Autwaerter is as follows, and what I believe could be a “hint”, as well as problem all around...
“Many hospital laboratories now hide certain microbiology results -- an organism's susceptibility to some broader-spectrum antibiotics, for example -- from culture data reports, in hopes of limiting those antibiotics from being used inappropriately.
Here at Johns Hopkins, for example, our laboratory does not report Western blot bands with its Lyme disease testing results. The report is a simple yes or no; you have a positive result or a negative result, so there is less tendency for misinterpretation.” [Paul Auwaerter, for Medscape Infectious Diseases]
FYI- Paul Auwaerter is also the President-elect for the IDSA, and is on the new panel for developing the next set of IDSA Lyme disease guidelines.
In quotes below… LTD= Laboratory Developed Tests
QUOTE- "Given the importance of this process, IDSA would like to offer its member expertise to serve on FDA’s review panels to classify LDT risk."
QUOTE- "IDSA is well-positioned to collaborate with federal agencies, Congress, and external professional societies to develop a balanced and empirical approach to LDT regulation that does not inhibit management of complex critically ill patients or response to emerging threats, and looks forward to continuing to work with FDA and associated stakeholders on this evolving issue."
Link Here