No words can truly describe the harm that has come to our family from the insensitivity of the F.D.A. approved two-tests for Lyme disease. I have spoken with a scientist who was present at the Dearborn conference and he confirmed that many of the scientists present at the conference expressed their concerns that while the two-tier test was very specific, the test lacked the sensitivity to be an appropriate diagnostic assay. These scientists only agreed to support the Dearborn criteria if it was only to be used solely for surveillance purposes. It has been recorded on video, that Dr. Paul Lantos and Dr. Paul Auwaerter approached you at the most recent IDSA protest to confirm that even the IDSA agrees with patient advocates that the current recommended tests for Lyme disease are terrible.
So Dr. Mead's and the CDC's recent turn around is obviously not based on any scientific consensus, but politics. The question is, whose politics and why? Who stands to benefit? Since it is not Lyme patients, why does the well-being of Lyme patients matter so little to the CDC?
Fortunately, there is a way for patients who have been harmed by the F.D.A. approved two-tier tests to take action. These harms can include delayed diagnosis, misdiagnose, and improper or no treatment.
Medwatch is the branch of the U.S. Food and Drug Administration (FDA) that receives consumer complaints regarding medications and medical devices. If Medwatch receives enough complaints, the FDA will be forced to investigate this issue.
LYMEPOLICYWONK: Lyme disease testing - the CDC, LabCorp and stories that don't add up
11th September 2014
Dr. Paul Mead of the Centers for Diseases Control and Prevention (CDC) recently stated in the Wall Street Journal that the CDC's recommended two-step process (which requires a positive ELISA test before a Western blot can be given) is accurate and was developed specifically to aid diagnosis of Lyme disease. A stunning assertion given that it directly conflicts with Dr. Mead's previous testimony before the Connecticut Department of Public Health and the Attorney General's office. It is also at odds with the CDC case definition for Lyme disease, which recognizes the validity of a stand-alone Western blot. This turnaround, coupled with LabCorp's recent decision to abandon a stand-alone Western blot, has patients up in arms. And, rightly so. . .
The CDC's blatant rewrite of history only serves to increase public distrust. . .
posted
" Thank you for reporting this event to MedWatch and the U.S. Food and Drug Administration. "
I submitted a complaint. Not sure if this is the right agency. I submitted an issue with a PRODUCT, WB.
-------------------- * Posts: 74 | From Bowie, Maryland | Registered: Aug 2014
| IP: Logged |
poppy
Frequent Contributor (1K+ posts)
Member # 5355
posted
Yes, hermit, I think that is the right category. A test kit is a product.
I'm surprised you got as far as the WB. A negative ELISA stops many before they can go on to the WB.
Posts: 2888 | From USA | Registered: Mar 2004
| IP: Logged |
poppy
Frequent Contributor (1K+ posts)
Member # 5355
posted
Paul Mead speaks with forked tongue. He is also a big liar.
Posts: 2888 | From USA | Registered: Mar 2004
| IP: Logged |
The Lyme Disease Network is a non-profit organization funded by individual donations. If you would like to support the Network and the LymeNet system of Web services, please send your donations to:
The
Lyme Disease Network of New Jersey 907 Pebble Creek Court,
Pennington,
NJ08534USA http://www.lymenet.org/
UBBFriend: Email this page to someone!
Printer-friendly view of this topic