Alert to Patients: Act Now! CDC Limiting Your Treatment Options

kidsAll: Share with your social media!
The Lyme Disease Association, Inc. is asking all Lyme patients and their families and friends to send a response to the Washington Post. Tell them in your own words how outraged you are that your treatment options are being cut off, that the Post did nothing to check with the stakeholders of the disease, patients, treating physicians, etc., and how this will affect your health/life. Stick to the topic of the article for your response please. For more details go to https://www.lymediseaseassociation.org/news/1736-cdc-shuts-off-all-prolonged-antibiotic-or-immunoglobulin-therapy-for-lyme-patients and

https://www.lymediseaseassociation.org/blog/1737-who-controls-fake-lyme-disease-news

Go to Washington Post link below, click on comments and post your comment.
https://www.washingtonpost.com/news/to-your-health/wp/2017/06/15/dangerous-unproven-treatments-for-chronic-lyme-disease-cause-are-on-the-rise/?utm_term=.b3638309bf25




CDC Shuts Off All Prolonged Antibiotic or Immunoglobulin Therapy for Lyme Patients

IV pole loJune 16, 2017 – In an MMWR article highlighting several cases of patients diagnosed with Lyme disease who developed complications including death from the treatment, CDC said it does not recommend prolonged antibiotic or immunoglobulin therapy, which it says, lack data supporting effectiveness for chronic Lyme disease. According to the article entitled “Serious Bacterial Infections Acquired During Treatment of Patients Given a Diagnosis of Chronic Lyme Disease — United States”

IV pole loJune 16, 2017 – In an MMWR article highlighting several cases of patients diagnosed with Lyme disease who developed complications including death from the treatment, CDC said it does not recommend prolonged antibiotic or immunoglobulin therapy, which it says, lack data supporting effectiveness for chronic Lyme disease.

According to the article entitled “Serious Bacterial Infections Acquired During Treatment of Patients Given a Diagnosis of Chronic Lyme Disease — United States”:

“These cases highlight the severity and scope of adverse effects that can be caused by the use of unproven treatments for chronic Lyme disease. In addition to the dangers associated with inappropriate antibiotic use, such as selection of antibiotic-resistant bacteria, these treatments can lead to injuries related to unnecessary procedures, bacteremia and resulting metastatic infection, venous thromboses, and missed opportunities to diagnose and treat the actual underlying cause of the patient’s symptoms.”

The CDC told the Lyme Disease Association this morning that this article was provided to inform patients and providers so they can make informed decisions on this issue, since they felt patients were unaware of the dangers associated with IV treatments for Lyme disease–it is for the good of the patient.

See LDA’s Response on the issue: Click here

MMWR article link to complete article https://www.cdc.gov/mmwr/volumes/66/wr/mm6623a3.htm?s_cid=mm6623a3_e




LDA Alert to Lyme/TBD Researchers: Apply for $$ now through CDMRP

cdmrpThe Lyme Disease Association (LDA) is alerting you to the Department of Defense Congressionally Directed Medical Research Program (CDMRP) Program Announcement for FY 2017 CDMRP research grant submissions. The Lyme Disease Association is providing the link to the CDMRP Tick-Borne Disease Research Program. All questions should be addressed to the CDMRP. The FY17 TBDRP Program Announcements can be found here http://cdmrp.army.mil/funding/tbdrp

cdmrpThe Lyme Disease Association (LDA) is alerting you to the Department of Defense Congressionally Directed Medical Research Program (CDMRP) Program Announcement for FY 2017 CDMRP research grant submissions. The Lyme Disease Association is providing the link to the CDMRP Tick-Borne Disease Research Program. All questions should be addressed to the CDMRP. The FY17 TBDRP Program Announcements can be found here http://cdmrp.army.mil/funding/tbdrp

Click here for a list of the FY16 TBD awards.




Attention Lyme Researchers: CDMRP PreAnnouncement for Lyme Research Monies

cdmrpThe Department of Defense Congressionally Directed Medical Research Program (CDMRP) is alerting Lyme & other tick-borne diseases researchers to the potential for anticipated FY17 monies that might become available through the program so that researchers can plan for possible grant submissions. The Lyme Disease Association is providing the link to the CDMRP program. All questions should be addressed to the CDMRP program. http://cdmrp.army.mil/pubs/press/2017/17tbdrppreann

cdmrpThe Department of Defense Congressionally Directed Medical Research Program (CDMRP) is alerting Lyme & other tick-borne diseases researchers to the potential for anticipated FY17 monies that might become available through the program so that researchers can plan for possible grant submissions. The Lyme Disease Association is providing the link to the CDMRP program. All questions should be addressed to the CDMRP program.

http://cdmrp.army.mil/pubs/press/2017/17tbdrppreann




Researchers: Lyme Monies Available from CDMRP

The Congressionally Directed Medical Research Program (CDMRP) has announced funding opportunities under the auspices of the Tick-Borne Diseases Programmatic Panel. $5 million has been appropriated for tick-borne diseases research through the Department of Defense budget for the 2016 (FY16) CDMRP program. Research specifically involving the following areas is being sought:

Pathogenesis:

  • Host-pathogen interactions
  • Human immune response
  • Mechanisms of persistence of Lyme disease
  • New research tools to support studies of pathogenesis

Prevention:

  • Interrupting the natural cycle
  • Personal protection measures
  • Targeted vaccines
  • Post-exposure prophylaxis

Diagnosis:

  • Direct detection of tick-borne pathogens or their products in humans
  • Biomarkers for diagnosis

Treatment:

  • Innovative approaches to treatment
  • Basic studies aimed at safe and effective treatments for the cause of persistent symptoms in Lyme disease
  • Biomarkers of effective prognosis, therapy and cure

Applications addressing persistence and direct detection of Lyme borreliae are highly encouraged.

2016 cdmrp

2016 cdmrp2

 

For further information go to the CDMRP website:

http://cdmrp.army.mil/tbdrp/default.shtml

For CDMRP press release on the funding go to:

http://cdmrp.army.mil/pubs/press/2016/16tbdrppreann.shtml


A detailed description of the funding opportunity, evaluation criteria, and submission requirements can be found in the Program Announcements. The Program Announcements are available electronically for downloading from the Grants.gov website, the CDMRP website (http://cdmrp.army.mil/funding/prgdefault.shtml) and the electronic Biomedical Research Application Portal (eBRAP) (https://eBRAP.org).

All CDMRP funding opportunities, both recently and previously released, are available on the CDMRP website. Listing of all open CDMRP funding opportunities can be obtained on the Grants.gov website by performing a basic search using CFDA Number 12.420.

Submission is a two-step process requiring both (1) pre-application submission through the electronic Biomedical Research Application Portal (eBRAP) (https://eBRAP.org/) and (2) application submission through Grants.gov.  Refer to the General Application Instructions, Section II.A. for registration and submission requirements for eBRAP and Grants.gov.

eBRAP is a multifunctional web-based system that allows PIs to submit their pre-applications electronically through a secure connection, to view and edit the content of their pre-applications and full applications, to receive communications from the CDMRP, and to submit documentation during award negotiations and period of performance.   A key feature of eBRAP is the ability of an organization’s representatives and PIs to view and modify the Grants.gov application submissions associated with them.  eBRAP will validate Grants.gov application files against the specific Program Announcement/Funding Opportunity requirements and discrepancies will be noted in an email to the PI and in the Full Application Files tab in eBRAP.  It is the applicant’s responsibility to review all application components for accuracy as well as ensure proper ordering as specified in this Program Announcement/Funding Opportunity.

For an overview of the submission process, go to: http://cdmrp.army.mil/funding/apply.shtml

For questions: Researchers contact trained staff at the Electronic Biomedical Research Applications Portal (eBRAP) help desk, available Monday through Friday (except Holidays). Standard hours are 8:00 a.m. – 5:00 p.m. eastern standard time (ET).
•E-mail: Help@eBRAP.org
•Phone: (301) 682-550
 
In addition, PIs may want to visit the eBRAP website: https://ebrap.org/ for additional information, such as:



Attention Lyme Groups: Take Action Now!

Signons from Lyme Group Leaders on FDA Test Takeover
The Lyme Disease Association, Inc. (LDA) has formulated a response to FDA to be included in its comment period on its testing Guidance which will affect specialty lab Lyme tests. Therefore, groups who want to support the position taken by the LDA may join in on the letter. LINK TO HISTORY OF FDA GUIDANCE ACTIVITY

 

  • Only the one Lyme group leader authorized by the group can sign onto the letter and must provide valid contact information. All groups welcome. No individuals, sorry. (Individuals see below Group Signon)
  • Signons to the response letter need to be entered on the LDA website form by 12M ET, January 27, 2015.

GROUP SIGNON HERE
All fields below are required, but the letter will contain name of group, contact name, and email only.

Finished

 Letter was submitted with 73 groups signed on.

INDIVIDUALS READ THIS
Any individual who has not yet taken the Lymedisease.org survey on FDA testing takeover, can do so by clicking here.

BRIEF HISTORY: FDA is moving forward in the process of finalizing its new Laboratory Developed Test (LDT) Guidance proposal. The proposal would move LDTs from under the jurisdiction of Clinical Laboratory Improvement Amendment (CLIA) regulated by Medicare & Medicaid Services to under the jurisdiction of the Food & Drug Administration (FDA). The FDA now regulates non-LDT lab tests under “medical devices,” and “approves” or “clears” tests. Non LDTs are tests which are sold to other laboratories while LDTs are generally tests which are developed and used in one lab, commonly called specialty labs.




FDA Moves to Regulate All Lyme Tests

FDA is moving forward in the process of finalizing its new Laboratory Developed Test (LDT) Guidance proposal. The proposal would move LDTs from under the jurisdiction of Clinical Laboratory Improvement Amendment (CLIA) regulated by Medicare & Medicaid Services to under the jurisdiction of the Food & Drug Administration (FDA). The FDA now regulates non-LDT lab tests under “medical devices,” and “approves” or “clears” tests. Non LDTs are tests which are sold to other laboratories while LDTs are generally tests which are developed and used in one lab, commonly called specialty labs.

For the last several months, the LDA has been working a parallel track with other Lyme leaders and on its own to try to understand the implications of such a move for patient access and try to ameliorate any downsides to patients on moving Lyme test under this Guidance.

To that end, the LDA has been on 2 phone calls with FDA officials and other advocates. LDA also contacted a number of Lyme specialty labs about the issue. The LDA made a slide presentation to the FDA’s public workshop on the Guidance on Jan 8-9, 2015, and had a representative available at the 2 day workshop. All presentations at the workshop to the FDA panels were limited to 4 timed minutes and had a category restriction. The LDA and LDo cooperated to present different categories since the speaking time was so limited. CLICK HERE FOR LDA SLIDES Two representatives of IGenex Labs, CA, also presented at the workshop.

The LDA also contacted the offices of Congressman Christopher Smith (NJ), House Lyme Caucus Chair, and Senator Richard Blumenthal (CT), both of whom have worked with LDA on Lyme issues before. Congressman Smith’s office held a meeting with FDA officials to discuss concerns we had raised and continues to follow-up on unsettled issues. Senator Blumenthal wrote a letter to FDA expressing concerns LDA and LDo had voiced on the guidance.

The LDA has also submitted input to the US House of Representatives Energy & Commerce Committee’s 21st Century Cures initiative, specifically “21st Century Cures – A Modernized Framework for Innovative Diagnostic Tests.” CLICK HERE FOR LDA LETTER TO ENERGY & COMMERCE COMMITTEE

Concerns the LDA has are that

1. the peer review process which will be used to categorize tests and risks could be biased. This concern is based on the prior use of “experts” in Lyme disease.

2. the process used for collecting adverse events (MAUDE) currently used by FDA for approved/cleared tests is already flawed− FDA cannot determine which test kits are being reported. Yet under the proposed Guidance, the LDTs would be dumped into the same flawed MAUDE system. That action could put the newly cleared LDTs at a disadvantage, because the LDTs put into the MAUDE system would be subject to greater scrutiny, since FDA would have the ability to more readily act upon the complaints.

3. government agencies have touted that all Lyme tests should be FDA approved, and through our analysis of FDA’s process, we discovered that FDA cannot point to any “approved” Lyme tests; they are all “cleared” which means substantially equivalent to a predicate test–to what test exactly, no one knows, since they cannot point to any original predicate test for Lyme that was not itself also based on substantial equivalence.

4. specialty lab tests will be removed from the market during the review process, citing safety reasons, which can be, e.g., too many positives.

CLICK HERE FOR LDA LETTER TO FDA WITH 73 GROUPS SIGNED ON


2016 UPDATE FROM FDA

FDA DELAYS FINALIZATION OF LAB-DEVELOPED TEST DRAFT GUIDANCE
The FDA announced in November 2016 that it would wait for the new administration and halt the finalization of guidance that would have changed the way laboratory-developed tests are regulated.

http://raps.org/Regulatory-Focus/News/2016/11/18/26218/FDA-Delays-Finalization-of-Lab-Developed-Test-Draft-Regulations/




Important Survey: Proposed Lyme Test Regs

Time Sensitive Survey: The Food & Drug Administration (FDA) is poised to develop new regulations which may affect access to existing tests for Lyme and other tick-borne diseases. Please click on the link to complete a survey being done by LymeDisease.org, an affiliate of the Lyme Disease Association. The information is needed for upcoming meetings with FDA, an immediate response is required. This is very important information needed to help the Lyme Community. Thank you.  
 
Click here to take Survey

Click here for link to more information on the testing issue





From 2013 LDA Conf. to 2014 Peer Review: Ticks in Upper Midwest

At the LDA’s 14th annual Lyme & Tick-Borne Diseases 2013 conference held in St. Paul Minnesota, Ellen Stromdahl, Entomologist, US Army Public Health Command Entomological Sciences Program at Aberdeen Proving Grounds in Maryland, presented US Army Findings in Ticks from the Upper Midwest. Now, the paper of that talk has been published in the peer reviewed journal Parasites & Vectors.

http://www.parasitesandvectors.com/content/7/1/553/abstract




EPA Fall 2014 Newsletter Features LDA

The Environmental Protection Agency’s (EPA) Pesticide Environmental Stewardship Program (PESP), of which the Lyme Disease Association (LDA) is a long time member, features LDA in its Fall 2014 newsletter. PESP is designed to reduce pests, in this case, ticks, and reduce the exposure to ticks with minimal use of pesticides — how Integrated Pest Management (IPM) can be applied to reduce the incidence of potentially debilitating Lyme and other tick-borne diseases. Read about it below.
Click below for pdf of PESPWire Newsletter
2014 PESPWire