Lyme disease advocacy organization meets with FDA
Non-profit organization seeks to investigate diagnostic tests for Lyme disease
BOSTON, Oct.26, 2021 (GLOBE NEWSWIRE) – Community-based nonprofit TruthCures met with officials from the Food & Drug Administration (FDA) on Monday, October 18, 2021 to discuss issues with diagnostic testing for the disease notoriously inaccurate Lyme.
Group executive director Laura Hovind and partner Lahra Tillman were joined by Carl Tuttle, a person appointed to New Hampshire Governor John Sununu’s Lyme Disease Commission, and their legal counsel, a former federal prosecutor. Long-time attending physician, published author, and renowned Lyme disease expert Kenneth Liegner, MD participated remotely to demonstrate the shortcomings of the Lyme disease diagnostic method and the damage it causes to patients.
In question, 27 years of diagnostic tests for Lyme disease approved by the FDA. Lyme disease is a bacterial disease caused by the bite of an infected tick. TruthCures says the diagnoses are grossly inadequate because they are designed to detect only a small minority of cases predisposed to developing “Lyme arthritis,” a milder manifestation of the disease. They cited published literature and historical documents from federal meetings that indicate that the sickest cases of Lyme disease are immunocompromised and rarely positive by criteria in place for nearly three decades.
“We are extremely pleased with the response from the FDA so far and are encouraged by how quickly they understood the problem and started to think about the solutions available to them within the regulatory framework,” Tillman said.
In a detailed presentation, the group explained how the financial interests of Lyme disease researchers in patents for the various bacterial components of diagnostic tests and vaccines have been prioritized over public health. They also shared the results of an independent analysis by a diagnostic regulation expert indicating that there may have been irregularities in the process by which Lyme disease diagnostic tests were re-labeled at the end of the tests. 1990s. “We are very concerned that patients were left out of the equation when changes were made to the testing protocol,” Hovind said.
The group has requested the FDA’s help in investigating the manipulated diagnostic protocol and its far-reaching effects, as well as coordinating with other agencies to assess related accepted standards that they claim are inadequate. âAs an official myself, I applaud the efforts of FDA investigators to understand and act on information provided by concerned citizens,â noted Amy Kissinger, board member for TruthCures. “We are confident in their commitment to do the right thing in terms of the regulatory aspect of our claims.”
Hovind added, âOur goal has always been to expose the truth and pave the way for accurate testing so that the millions of people suffering from this devastating disease can get the diagnosis and treatment they need. This development should give them hope that someone is getting to the root of the problem, and change is underway. “
TruthCures is a 501 (c) (3) registered non-profit organization dedicated to restoring a valid case definition for Lyme disease so that everyone affected can be accurately diagnosed and successfully treated. For more information visit realecures.org or send an email to Truthcures.org.
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