Please see the following letter addressed to the Tick Borne Disease Working Group. “Antibody detection for the purpose of diagnosing Lyme disease has been and continues to be an epic failure” Anyone wishing to contact the Lyme Disease Working Group can send an email to: tickbornedisease@hhs.gov Letter to the Tick Borne Disease Working Group: --------- Original Message ---------- From: Carl Tuttle runagain@comcast.net To: "Tick-Borne Disease Working Group (OS/OASH)" tickbornedisease@hhs.gov Cc: Date: January 31, 2018 at 10:28 AM Subject: PCR DNA amplification followed by Sanger sequencing To the TBD Working Group, The TBD Working Group was charged to implement part of the 21st Century Cures Act. Under Subtitle B--Advancing Precision Medicine, President Obama clearly expressed the intention of the law that the Precision Medicine Initiative is to address disease prevention, diagnosis and treatment via implementing initiative based nucleic acid technology by putting a double helix DNA molecule model next to him when he spoke January 30, 2015. (See Sec. 2011 below) The Tick-Borne Disease Working Group was formed under Subtitle F--Facilitating Collaborative Research. Might I remind the Working Group that the Subcommittee must adhere to the spirit of this Public Law and that the intention of the Congress did not specify advancing an antibody Precision Medicine Initiative. Congress knows we are in a genetic medicine era, practicing precision medicine based on accurate analysis of genetic data of the host and pathogens. Western Blot (serology) promoted by the CDC is not the image on the left of the President! (See attached picture) Antibody detection for the purpose of diagnosing Lyme disease has been and continues to be an epic failure as it could take 4-6 weeks to develop detectible antibodies after a tick bite which is absolutely unacceptable. From the Centers for Disease Control: The AMD Program (Advanced Molecular Detection) https://www.cdc.gov/amd/basics/amd-initiative.html Excerpt: “Public health experts need the right tools at the right time to protect Americans from microbes that are growing more fierce and moving faster than ever among us.” [But not for Lyme disease!!!] _______________________________ PCR DNA amplification followed by Sanger sequencing is the classic textbook technology for molecular diagnosis. A national proficiency testing program for Sanger sequencing-based diagnostics for the early detection of Lyme disease has been sabotaged by the Centers for Disease control as described in the 57 million dollar claim against the CDC: $57 million claim against the CDC on Lyme test: https://www.change.org/p/the-us-senate-calling-for-a-congressional-investigation-of-the-cdc-idsa-and-aldf/u/20864023 It’s time to recognize that the roadblock to resolving the Lyme disease crisis here in the United States IS the CDC. My purpose here is to remind members of the Committee that their job is to prevent a small group of people from sabotaging the intent of the Public Law. Excerpts from the Whitehouse Archives on the 21st Century Cures Act https://obamawhitehouse.archives.gov/node/333101 Public Law No: 114-255 (12/13/2016) (This measure has not been amended since the House agreed to the Senate amendment with amendment on November 30, 2016. The summary of that version is repeated here.) 21st Century Cures Act TITLE II--DISCOVERY Subtitle A--National Institutes of Health Reauthorization (Sec. 2001) This bill amends the Public Health Service Act to reauthorize the NIH through FY2020. (Sec. 2002) The NIH must support prize competitions to fund areas of biomedical science that could realize significant advancements or improve health outcomes. Subtitle B--Advancing Precision Medicine (Sec. 2011) HHS is encouraged to carry out a Precision Medicine Initiative to address disease prevention, diagnosis, and treatment. In implementing the initiative, HHS must implement secure data sharing and ensure inclusion of a broad range of participants. Subtitle F--Facilitating Collaborative Research (Sec. 2061) The CDC must: (1) enhance and expand infrastructure and activities to track the epidemiology of neurological diseases, (2) incorporate obtained information into a National Neurological Conditions Surveillance System, and (3) ensure that the system facilitates further research on neurological diseases. (Sec. 2062) HHS must: (1) continue to conduct or support research on vector-borne diseases, (2) establish the Tick-Borne Disease Working Group to review HHS efforts regarding tick-borne diseases. Respectfully submitted, -Carl Tuttle Lyme Endemic Hudson, NH