The FDA has recently proposed regulating Lyme diagnostic tests. This survey will be used by LymeDisease.org in its meetings with the FDA to show how this decision will impact patients.
IMPACT ON LYME PATIENTS
The types of lab tests the FDA wants to regulate include tests manufactured by the specialty labs that patients and doctors rely on for accurate tick-borne disease diagnosis. Note: Current FDA-approved tests are shown to miss more than 50% of Lyme disease cases.
THE AMERICAN MEDICAL ASSOCIATION SAYS "NO" TO NEW FDA REGULATIONS
These proposed changes are widely criticized. The AMA believes new regs will result in patients "losing access to timely life-saving diagnostic services and hinder advancements in the practice of medicine." What do you think?
Done. Although a couple of the questions were not phrased in a way that I could answer for my case.
Posted by KarlaL (Member # 29631) on :
Lymedisease.org: Have you taken our survey yet? The FDA has proposed regulating Lyme lab tests. We need your views on this very important topic. This is extremely time sensitive so please respond quickly! We will use this information to assess patient views and to inform our meetings with the FDA. We need your input now!
Posted by elara (Member # 41819) on :
The reason the FDA is pushing forward with regulating LDTs and especially Lyme tets not FDA approved, is because 5 US Senators who normally support Lyme patients read the CDC MMWR that used the infamous Johnson Assessment of the Sapi/ALS culture. One key letter written and signed by the Senators was:
It specifically pressured the fDA and based it on the MMWR. Various people have described problems with the CDC Johnson Assessment but nobody discovered Johnson omitted key DNA evidence which if mentioned would have altered the basis of her conclusions.
Not only did she leave off critical 16S gene evidence in NCBI that indicated Bb, she failed to perform a standard contamination entry analysis which would have implicated the PCR testing or third party sequencing done in Alabama.
Had she incorporated ALL the evidence and performed the contamination entry analysis, the totality of the evidence would have shown only the PCR amplicons were partially contaminated and the culture was not contaminated and looked good. There was no legitimate evidence supporting the culture results were not good.
This is a new revelation that needs to find its way to the media, the 5 Senators, the FDA comments, and the CDC. The complete story is documented here. Please find ways to notify the media and write the Senators since they cannot appreciate basing their views on a study that left off evidence. In science, leaving off evidence knowingly or for any other reason invalidates an analysis or Assessment by itself.
Lymedisease.org reports that 6000+ Lyme patients have taken our FDA survey! Thank you!
Surveys are one way for patient opinions to be heard. The FDA wants to change its regulations regarding available Lyme tests in the United States–and we’re sharing your views on the subject. Click here for more information and to take our survey.