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?
posted
Done! Thank you for posting :-) Should this also be posted in the Activisim section for more to see? I'm so glad to see movement in the direction of real testing!
Posts: 35 | From North Texas | Registered: Sep 2014
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posted
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!
-------------------- KarlaL Posts: 694 | From New Lebanon, NY | Registered: Dec 2010
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New message from Lymedisease.org, "Have you taken our new survey regarding the FDA's proposed regulation of 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. Our last survey drew over 6,000 responses and was published this year. We need your input now!"
-------------------- KarlaL Posts: 694 | From New Lebanon, NY | Registered: Dec 2010
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Someone (I could not find their name) just posted an extremely wordy and scholarly essay on the CDC attacks on the Advanced Laboratories Lyme culture. I intend to write a simpler summary of this essay, but I have been too busy with the 10,000 signatures campaign over the last few days.
A short summary - evidence from both negative controls, monoclonal and polyclonal antibody testing, and one of the PCR results (DNA sequencing) demonstrate that the study cultures were not contaminated with the European strain B garinii. It is possible that one of the sample's used for PCR was contaminated after being taken from the culture, but this does not negate the rest of the experiment. The CDC's conclusion that the culture was contaminated is not supported by the evidence.
Still, the initial excellent results of the Advanced Laboratories paper need to be validated by independent labs.
KarlaL
Lyme Disease, the Truth: Serious Concerns with the CDC Lyme Culture Assessment
Advanced Laboratory Services (ALS) began offering a badly needed clinical culture for all phases of Lyme disease in 2011. It was the first truly novel Lyme culture developed in over a decade. Its effectiveness could change the entire Lyme disease landscape. The Centers for Disease Control and Prevention ( CDC ) should do everything possible to help validate a potential culture breakthrough with all its implications rather than suppress it with an incomplete scientific analysis. The CDC said they received a number of inquiries regarding the ALS Lyme culture and seemed to have an immediate negative reaction without proper consideration. The Lyme culture has been the “Gold Standard” in Infectious Disease medicine since its inception. The potential value of a valid clinical culture breakthrough is something both sides of the Lyme disease debate would agree on. It would almost immediately change the entire landscape. This is something that should be embraced by everyone involved.
The erratic history of research lab Lyme cultures has led to significant skepticism. A practical and reasonably sensitive Lyme blood culture effective at all three stages of the disease would be the key to solving the current Lyme persistence and chronic Lyme controversies. These controversies have led to much of the acrimony between patients and Lyme researchers and mainstream doctors. Everything possible should be done to solve these controversies given the CDC estimate of 300,000 new cases of Lyme disease occur each year. Many of these people go on to develop chronic conditions which are at the heart of the controversy. This culture truly deserved a complete validation study with direct CDC or NIH involvement since if successful; it would quickly resolve many controversies and hasten a treatment. It makes no sense and shows poor judgement by the CDC to not use the latest microbiology advances to pursue a clinical Lyme culture. Many believe they are avoiding this obvious and low cost strategy because it could be quite embarrassing. There is no place in science for that kind of thinking.
Surprisingly it only received an indirect and incomplete paper assessment with many omissions of fact, logic and evidence by the CDC. The CDC team of Barbara J.B. Johnson, Mark A. Pilgard, and Theresa M. Russell overlooked significant evidence that would have led to a different set of conclusions. When the omitted evidence is considered in an assessment, it indicates the culture is most likely valid. Because of this, the paper study requires a proper re-assessment and JCM re-submission including all the omitted evidence and its implications. It also needs to be reviewed before the FDA makes decisions on how to regulate Laboratory Developed Tests (LDTs) and the ALS Lyme culture in particular. . .
-------------------- KarlaL Posts: 694 | From New Lebanon, NY | Registered: Dec 2010
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Annie C
Frequent Contributor (1K+ posts)
Member # 14
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Done and Up.
-------------------- May God Bless you every day. And Never say never and do not give up no matter what. We need you to help others. Posts: 1288 | From Tetons Wyoming | Registered: Oct 2000
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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.
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This idea expressed in the blog is effectively committing scientific suicide:
" This culture truly deserved a complete validation study with direct CDC or NIH involvement since if successful; it would quickly resolve many controversies and hasten a treatment."
CDC and NIH are NEVER going to validate an excellent Lyme culture test which demonstrates that everything they have said for the past several decades about chronic Lyme has been a lie.
There will be no progress until the coverup is exposed. Elena
-------------------- Justice will be ours. Posts: 786 | From UK | Registered: Oct 2007
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