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

 




LDA Featured Member in EPA Newsletter

2014 PESPWire    

2014 PESPWire2

2014 PESPWire3




LDA Presents Lyme & TBDs to EPA

On September 18, 2014, Lyme Disease Association President Pat Smith presented a 1.5 hour PowerPoint presentation entitled Lyme & Other Tick-Borne Diseases: A National Overview & The Role of LDA to the Environmental Protection Agency Biopesticides & Pollution Prevention Division in Arlington, VA. The presentation was done in person, and through a webinar and call in. Question and answer followed, and education materials were distributed by LDA Board member Richard Smith. 

Ms. Smith discussed her organization’s role in Lyme disease prevention and provided an overview of Lyme and other tick-borne diseases with an emphasis on research and prevention. The LDA has been a long time partner in the EPA’s Pesticide Environmental Stewardship Program (PESP) a program designed to reduce risks from pests, in particular, ticks, thereby reducing risks of tick-borne diseases with minimal use of pesticides. This goal is to be achieved by developing tools to be used in schools and for people who have access to public lands for outdoor uses.

LDA helped in the PESP to form the Network to Reduce LD in Children & High Risk Groups. LDA also helped to plan and organize the EPA Conference in 2011 in Virginia, Promoting Community Integrated Pest Management (IPM) to Prevent Tick-Borne Diseases. Pat also co-chaired with CDC, a conference session: Public Outreach Strategies to Reach Targeted Populations. Ms. Smith also co-authored the article from the Network which appeared in the National Association of School Nurses (NASN) March 2010 Journal, You Can Make a Difference to a Child by Reducing Risk of Lyme Disease.

 

2014 PatSmith EPAPictured L to R: Raderrio Wilkins, Agriculture IPM and Biopesticides Demonstration Grants Lead, Environmental Stewardship Branch, US EPA Office of Pesticide Programs; Richard Smith, LDA Board Member; Pat Smith, LDA President; Frank Ellis, Chief, Environmental Stewardship Branch, Office of Pesticide Programs  U.S. Environmental Protection Agency, Washington, DC 

 




LDA Speaks Out: CDC/Advocates Meeting & “No Lyme In The South”

I think it is time to clarify some of the issues surrounding both the Lyme advocate meeting held at CDC in Ft. Collins CO, June 2013 and the “no Lyme disease in the South” controversy. In early 2013, I wrote to the Centers for Disease Control & Prevention (CDC) and presented the objections of the Lyme Disease Association (LDA) to the CDC’s website statement that Lyme does not occur nationwide. I asked for all the pertinent data used to support that statement. The goals of LDA in this context are that threats of disease be realistically assessed and that patients not be condemned to unnecessary suffering because they are denied the opportunity for early diagnosis and safe and efficacious treatments. I am sure everyone agrees that patients and physicians have the right to the best, most up-to-date data and science.

CDC’s initial response included this rationale: (1) the distribution information on the tick vectors of Lyme disease and specifically that Ixodes scapularis is limited in distribution to the eastern and upper mid-western regions of the U.S. and Ix. pacificus to the west coast, (2) that it is well-established from the literature that Ix. scapularis ticks in the southern U.S. [GA, FL, AL, MS, etc] do not typically bite humans, especially the nymphal stages that are most important for transmission of B. burgdorferi and (3) the relatively small numbers of Lyme disease cases reported from states where Ix. scapularis and/or Ix. pacificus are not present can almost entirely be shown to be travel-related cases that were not acquired locally, hence the use of the term “does not occur” nationwide.

CDC said that LDA could have an opportunity to further discuss this issue if we disagreed, which we did. In conjunction with CDC’s “no Lyme in areas such as the South and central states,” I suggested that the flawed surveillance system is heavily weighted against disease even being reported there: “I think discussions on the failures of Lyme surveillance and how that impacts upon patient diagnosis and treatment, research dollars, health care spending, need to happen, and since I like to assume we are all working for the same goal, I would like to propose that we do what it takes to begin that discussion in an open and transparent way, with all at the table to provide and review available evidence. Many lives & dollars could be saved by such a move.”

LDA then requested all supportive documentation from CDC showing that reported cases in other states were almost entirely travel related. CDC admitted they did not have that data nor could they direct us to any entity which had such information. They sent a box of peer-reviewed literature supporting the remainder of their “no Lyme in the South and central states position” such as geographic distribution of Ixodes ticks and the “ticks in the South rarely bite humans” literature, which LDA then began to analyze.

In the meantime, CDC contacted LDA and suggested a meeting at CDC Ft. Collins with Lyme leaders from various geographic regions. Several groups were invited by the CDC and many of the Vector-Borne Disease Division personnel were at the table, as well as a representative from CDC Atlanta, when the meeting was convened on June 11, 2013. Seven groups including LDA attended, and 3 organizations did not attend in person but by speaker phone for a 2 hour portion of the all day event ─ unfortunately, they were only able to hear a small portion of the whole day’s proceedings─ a day packed with meetings, discussions, lab tours, and an informal dinner with all attendees.

In the group presentation section, I gave the allowed 10 minute PowerPoint which provided factual data that placed the CDC “no Lyme in the South and Central states” argument in serious jeopardy. The papers which CDC cited contained very old data, some citing journals decades old, some of which did not even support what was touted, and many did not contain current statistics from states they place in the no/doubtful Lyme category, some used maps of projected deer tick populations that current research had long since proven were out of date. Notwithstanding claims to the contrary, according to researchers, physicians, and tick-bite victims in the South, deer ticks are certainly biting people. No one questioned my presentation then or in the subsequent 3+ months.

I have since read all the speculation on the net and in newspapers about what did or did not occur or what was/was not accomplished at this meeting. I am not sure anyone would be naïve enough to think that government Lyme policies would be immediately changed as a result of this one meeting, if so, they certainly set their expectations too high. Perhaps some people feel that there is not any reason to meet with CDC anyway, with the rationale that we can get what we want without meeting with them. I have been involved now in Lyme work for almost 30 years as an advocate. As frustrating and absolutely exasperating as it has been and may continue to be, I can tell you that the major federal public health agencies need to be part of the solution in order to achieve more than very fragmented, partial successes in our battle against Lyme & other tick-borne diseases.

What needs to be recognized by all is that two agencies under the US Department of Health & Human Services (HHS), the CDC and the National Institutes of Health (NIH), are the ones designated by Congress with responsibility to oversee disease areas which most impact Lyme patients. They are the ones who set policies, receive grant funds to distribute, and in general, are “in charge of” diseases. To complicate the chain of command with Lyme, the CDC in Ft. Collins, CO is the home to the Vector-Borne Diseases Division which handles Lyme and other tick-borne diseases and which is under the direction of CDC Atlanta, GA, which is under US Department of Health & Human Services (HHS). Therefore, for something to be accomplished with Lyme, one chain goes from CDC in Colorado to CDC in Georgia, and, if it is perceived to possibly overlap another agency’s jurisdiction, on to HHS in DC. HHS is part of the executive branch and overseen by the Executive Office of the President. With any “non-political” disease, this process is not an easy one, but with one as complex as Lyme, in such a contentious climate, you can be sure substantive decision-making is going up the chain of command and changes to policy will be well vetted and time consuming.

This meeting was like the first meeting at a negotiations table, parties get to meet each other face-to-face. They get to hear positions discussed at the same table, and in our case, we had a lengthy session where each person could discuss what they did not like about what the “other side” was doing in the “Lyme wars.” That helped people to see real people behind the issues; it put a face on the disease. There was passion, disagreement, and intelligent discussion of the science and of the lives affected. There was no shouting or disrespect. A list of attendee-suggested future actions was created─ the CDC said it would set up some of the meetings we felt were most important, and it has since reiterated they will proceed with that agenda. We did have a late August conference call with CDC regarding the materials released by CDC at the Boston Lyme disease conference regarding confirmation that Lyme cases are indeed ten times more prevalent than reported surveillance case numbers indicate. That fact was not a surprise to any of us advocates who for many years have used a “Lyme is underreported by a factor of ten” qualifier based upon past CDC remarks that Lyme was that vastly underreported for surveillance purposes.

My position is that this CDC-advocates’ meeting was successful, as opposing parties met, talked, presented their programs and issues, interacted on a personal level, and CDC has committed to moving forward with some of the items placed on the “wish list” of the advocates. I know there are good people on both sides who would like to see the Lyme disease issue resolved. Like everywhere else in life, unfortunately, there are others who would like to keep the pot stirred and do not want the two sides to try to find common ground.

Speaking for LDA, we will try to continue to work with the agencies in government that have responsibility for dealing with Lyme, but we will also continue to speak out using science and statistics to promote policies which support the current realities of tick-borne diseases and to overturn policies supported by obsolete data and/or specious analyses which continue to hurt Lyme patients and physicians, e.g.., CDC’s “no Lyme in the South,” a policy which delays diagnosis and treatment, skewers surveillance, and suppresses relevant research. Dr Kerry Clark’s recent research on southern Lyme, partially funded by LDA, is a step in that direction, and rather than “contradicting” other older research, I think it shines new light on areas on which other researchers have feared to tread lest they be mired in the political morass of Lyme disease—where researchers may be told “don’t go there or you may never publish again.” Dr. Clark’s research postulates there may be additional factors besides those considered by CDC to explain the cases of Lyme in the South, factors that might help explain the fact that the FL Dept. of Health indicates that 30% of Lyme cases from 1999-2008 occurred in state, not from travel.

I am sure that many of you, like me, have been extremely frustrated by reading in countless studies from the ’80s through today recommendations for further studies to move the field forward– studies which far too often were not pursued. To facilitate forward progress, it would be productive and responsible for CDC and other agencies to refrain from reflexively repeating statements and positions based on fragmentary and often outdated data. It is time to formulate policies based on current and convincing data and support research using cutting edge techniques which can provide the answers we all need to stop the spread and devastation of Lyme disease, not only nationwide, but also worldwide.

Pat Signature

LDA President

 




Dept. of Defense Health Board Meeting

LDA submitted “Diagnosis and Treatment fo Lyme & Other Tick-Borne Diseases in the Military Health System” at the Defense Health Board Meeting, Sept 4-5, 2008.

click here for pdf




LDA Co-Chairs EPA Lyme Conf. Session

March 30 -31, 2011, Arlington, VA – The Environmental Protection Agency (EPA) Environmental Stewardship Branch Lyme Network, of which LDA is a founding member, held a 2-day Lyme disease prevention conference, “Promoting Community Integrated Pest Management (IPM) to Prevent Tick-Borne Diseases.” LDA President, Pat Smith, and Emily Zielinski-Gutierrez, Centers for Disease Control and Prevention (CDC), co-chaired a session: Public Outreach Strategies to Reach Targeted Populations. Pat Smith helped obtain the speakers for the session, co-chaired it, and presented a Powerpoint on Lyme’s spread and the LDA’s work in combating that spread across the country. She also answered questions. LDA provided its Lyme brochures at the conference and was available to answer questions throughout. The conference was sold out, more than 146 attendees, many of whom were professionals in tick management, although the public was invited, and a free online webinar had 180 signed up to hear the conference and ask questions.

2011-EPA-Conf Smith BlanchardEnvironmental Protection Agency, Arlington, VA

March 31, 2011 Community Integrated Pest Management for Preventing Tick-Borne Diseases Conference

(L) Pat Smith, President, Lyme Disease Association, and (M) Emily Zielinski-Gutierrez, Centers for Disease Control and Prevention, Co-Moderators of the Public Outreach Strategies session with (R) Diane Blanchard, Co-President, Time For Lyme, Panel Member.

 

 

Environmental Protection Agency (EPA) – Lyme Disease Association (LDA) 

 

Agenda Highlights

  • Protecting Children in Schools and Outdoor Environment
  • Creating Institutional Structures for Community Level IPM
  • Role of Landscape Planning in Tick Management
  • Public Outreach Strategies to Reach Targeted Population
  • Protecting Oudoor Workers Exposed to Ticks
  • Population-Based Prevention Strategies
  • Research Strategies
  • Summary of Research Needs and Knowledge Gaps

 

 2011-EPA Conf

Click here for program summary

National Conference Website