Lyme Disease Association, Inc.

Transcription

1 Lyme Disease, Inc. PO Box 1438, Jackson, New Jersey (Fax) July 7, 2014 Fred Upton, Chairman Henry A. Waxman, Ranking Member Energy & Commerce Committee Energy & Commerce Committee 2125 RHOB 2322A RHOB Washington, DC Washington, DC Dear Mr. Chairman, Ranking Member, and Committee Members, The following letter articulates the position of the Lyme Disease, Inc. (LDA), other Lyme and tick-borne diseases groups and groups with high exposure to Lyme across the country signing onto this letter regarding the Energy & Commerce Health Subcommittee Lyme bill markup. We do not want the Amendment in the Nature of a Substitute to H.R to advance and we do want the original HR 4701 to advance. We have also included the provisos necessary for an acceptable Lyme disease bill. Below we explain fully the nature of our concerns and the history of the operations of agencies in general regarding Lyme. Appendix I, attached, elaborates on provisions of Lyme legislation identified and deemed necessary by signers. Amendment in the Nature of a Substitute Introduced June 19 (hereafter, Substitute 4701) Substitute HR 4701 was introduced in the Health Subcommittee on 6/19/14, days after the conference call with the agencies and with a half hour notice to the Subcommittee. It is a harmful bill, which we and dozens of Lyme groups across the country vehemently oppose. We are extremely concerned that the Subcommittee passed it without any consultation with Lyme stakeholders, such as patients/advocates/physicians. Substitute 4701 codifies the existing systems within HHS which have been so harmful to patients and treating physicians and have subjected researchers to systemic biases that have been detrimental to scientific progress. The bill makes a mockery of transparency, accountability and stakeholder input. (See details in attachment). One of the major reasons for having a bill for Lyme is to provide for broader input into the development of the federal tick-borne diseases (TBD) agenda and to give affected stakeholders a seat at the table. Substitute 4701 institutionalizes an internal HHS working group composed only of HHS employees; no patients, advocates, private physicians or non-federal researchers will be working group members. Substitute 4701 contains language stating the internal HHS working group will consult with at least one member of these various- constituencies. This is not the same as having a seat at the table, provides no structure for obtaining broader input from outside stakeholders, and is unacceptable. The internal working group addressed in Substitute 4701 is not eligible for the Federal Advisory Committee Act (FACA). The working group would not be subject to reasonable standards of transparency and could continue its business outside of public view with only a non-representative group of non-federal individuals. The working group could keep all papers, records and minutes of meetings secret. There are no requirements or provisions for public access to information. This situation is unacceptable. Page 1 of 12

2 The Substitute 4701 provides for a public meeting before the issuance of each report submitted to Congress only one public meeting within two years of passage and then only one public meeting every five years when the report to Congress is updated. There is no language on the public s ability to provide input during the meeting, much less any language encouraging agencies to obtain public input on any activities or strategies. The timing of the public meeting is before the report to Congress, indicating that it would likely be an after-the-fact exercise conducted after agency deliberative processes and the execution of agency programs. This situation is not acceptable. Providing five-year reports to Congress in no way supplants the need for transparency and accountability throughout the process. How many in Congress will read the five-year reports, and how will they properly evaluate the contents if there has not been transparency and accountability in the development of agency strategies and execution of agency programs over the reporting period. Meaningful participation and access to information by stakeholders must be included in the bill. It seems clear that a primary goal of Substitute 4701 passed by the Subcommittee was to avoid applicability of the FACA. Substitute 4701 changed from establishing a committee with public representatives to memorializing in statute one which only contains government members. Based on bipartisan concerns of Congress with transparency and accountability, we are more than a little chagrined that the Subcommittee would engage in efforts to avoid FACA applicability. When Mr. Waxman introduced the Federal Advisory Committee Transparency Act of 2001, he was quoted as saying, The intent of Congress was that all proceedings of advisory committees be open to the public. Regrettably this legislation is necessary to ensure that the Social Security Commission, as well as other advisory groups (emphasis added by us) do not continue on a course of secrecy. There is no good reason why the public should not have access to those meetings. It is time to lift the veil of secrecy. Three years later, in 2004, Mr. Waxman authored a Government Reform minority staff report on secrecy in the [then Bush] Administration. One of Mr. Waxman s specific concerns was the [Bush] Administration s efforts to avoid FACA applicability, writing, The Administration has carefully structured the way it solicits advice from private entities to avoid establishing an advisory committee subject to FACA. Mr. Waxman was further critical that in other cases the Administration established groups of government employees that work extremely closely with outside entities to gather and channel advice to government agencies in ways that were in violation of FACA. These practices Mr. Waxman indicates he abhorred in the past, are the same ones that have stifled Lyme disease research for decades. Preference for HR 4701 as Introduced (hereafter Original HR 4701) We prefer the Committee move Original HR 4701 as introduced on 5/24/14, by Mr. Gibson, with Representatives Courtney, Peterson, Smith (NJ), Wolf, and Barletta. It meets the requirements of the Lyme community and focuses on the extremely detrimental problems which call for Congressional action. It is a bill with a substantive purpose, unlike Substitute 4701, the purpose of which seems to be to placate the agencies rather than address a serious epidemic. Original HR 4701 meets the requirements of establishing a working group under FACA, requiring open and transparent meetings, with balanced membership representing a diversity of viewpoints including at least one each of Lyme patients/families and Lyme group representatives, researchers, and treating physicians. It contains a meaningful public hearing to seek public input on the development of a scientific framework within 60 days and annually thereafter. It also provides for development of a scientific framework for each identified vector-borne disease (VBD) and provides for a robust process to include a comprehensive literature review including both acute and chronic disease, the identification of research questions, and recommendations for advancing research. It does not have bells and whistles; what the bill describes is the operation of good government conducted in a transparent manner, with a reasonable level of participation by public stakeholders. We do not believe that anyone could sincerely point to any provision in Original HR 4701 and show that it would not improve current government operations. We are thus at a loss as to why the whole Subcommittee decided without objection - to gut the bill. The opportunity to correct this situation now lies with the full Committee. Please provide us Page 2 of 12

3 with a letter of your intentions no later than July 15, to help govern our final actions on this bill, and we prefer to know what your intentions are before we take further actions regarding the potential passage of a Lyme bill. Thank you Sincerely, Patricia V. Smith, President@LymeDisease.org CC: Energy & Commerce Committee Members. HR 4701 Co-sponsors ENC: Attachment I Necessary Provisions of Lyme Legislation Identified by Lyme s *Please note that the below signups were collected from a groups only signup over an approximate three-day period during the July 4 th holiday. Alabama Lyme Disease American Lyme Arizona Lyme Disease Arklatex Lyme Disease And Prevention & Support Kevin Wolfe President Montgomery AL Kevin@alabamalymedisease.org Antoinette Grewal Director West Hills CA LILATI@aol.com Larry S. Levy Chair Scottsdale AZ Larry@valuepro.netbox.com Annette Sharp Founder Texarkana TX annette.sharp@yahoo.com Beasley & Associates, Inc. Marcia L. Beasley Chair of Board Floral City FL abeasley001@tampabay.rr.com Bergen Bowmen, Inc. JOANN MILLS Secretary Ridgefield Park NJ jmills8860@gmail.com Brookfield/Wolfeboro NH support group Jeff Dugas Supporter Brookfield NH dugasp@myfairpoint.net Can Do With Lyme Christina Murphy Founder New Market MD candowithlyme2@gmail.com Central Maryland Lyme Disease Robin Wolfenden Co-Coordinator Westminster MD AfterTheBite@gmail.com Central Mass Lyme Foundation Michele Miller Founder Worcester MA CentralMassLyme@gmail.com Change.org petition Calling for a Congressional Investigation Of the CDC, IDSA and ALDF Carl Tuttle Petition Organizer (22,285 Signatures) Hudson NH runagain@comcast.net Charles A Thomas Bldrs Dawn M Thomas Vice President Greensboro MD dawn.elaine.416@gmail.com Chico Lyme Shelly Mariposa Facilitator Chico CA shellymariposamarketing@gmail.com Clarksville Lyme Support Holly Peterson Co-Leader Oak Grove KY adamnholly830@bellsouth.net Dan Volpe Dan Volpe President West Hollywood CA drvolpe@gmail.com Eastern CT Chapter, Lyme Disease Assoc. Kimberlee Pappa Chapter Chair North Branford CO pappak1@owls.southernct.edu Fairfax Lyme Jane Ferris, Ph.D. Facilitator Fairfax CA drjaneferris@gmail.com Family Connections Center For Counseling Sandra K. Berenbaum, LCSW, BCD Owner Southbury CT familyccc@aol.com Florida Lyme Lucy Barnes Director Floral City FL AfterTheBite@gmail.com Florida Lyme Advocacy Florida Lyme Disease Founder of Harrisburg Lyme Fox Valley Wellness Center Lori Hoerl Melissa Bell Linda E. Olley Steven Meress MD Founder and Director Board Member R.N., Director At Large, Harrisburg Lyme Fernandina Beach Jacksonville Beach FL captlorisandy@gmail.com FL FLDA@comcast.net Mechanicsburg PA lymelady70@gmail.com President Fond du Lac WI smeress@foxvalleywellness.com Page 3 of 12

4 Gear Up for Lyme Andy Holzman Race Director Arlington VT Georgia Lyme Mindy Abel Co-Founder Cumming GA Georgia Lyme Disease Greater Manchester Lyme Disease Harford County Lyme Disease, Inc. Healing with Lymes Health Associates Medical Houston Lyme/TBDs support group Hudson Valley Lyme Disease Assoc. Illinois Lyme Indiana Lyme Connect IndianaLyme Liz Schmitz President Peachtree City GA David Hunter Facilitator Bedford NH Jean Galbreath President Street MD Courtenay Wentworth stark dr GRAHAM NC William Mora M.D. Sacramento CA Teresa Lucher Founder/Leader Houston TX Jill Auerbach Chairperson Poughkeepsie NY Joan M. Sullivan Susan Coleman Morse Dan Lentz Illinois Lyme Moderator Elmhurst IL Founder Bloomington IN IndianaLyme Moderator Jane Marke, MD Jane Marke, MD MD New York NY Kenneth B. Liegner, M.D. Kenneth B. Liegner, M.D. Physician caring for Persons with Lyme & TBDs Whitestown IN Pawling NY Kentuckiana Lyme Disease Tondia Burrows Co founder Louisville KY KENTUCKYINDIANA LYME SUPPORT PAMI BOARD MEMBER LOUISVILLE KY GROUP L.A. Lymie Ann-Marie O'Shaughnessy founder Moorpark CA Lancaster County Lyme Rita Rhoads CRNP Bart PA Las Vegas Lyme Disease Rene Rothstein President Las Vegas NV Lehigh Valley Lyme Support Cathy Gumlock Facilitator Easton PA Lexi 's Lyme Team Angel Emrey Oppose ht4701 Athens TN living lyme Kris Martindale stop this bill while Lyme patients die. Bandon OR Lovey On Lyme Marvina Lodge President Cusseta GA Lyme Action Network Christina T. Fisk President Kattskill Bay NY Lyme Action PA Donna Falcone Online/Social Media Coordinator Clarks Summit PA Lyme Aid - Santa Rosa Karen Miller Facilitator Healdsburg CA hbgkaren@sonic.net Lyme Alliance of the Berkshires Karla Lehtonen Leader New Lebanon NY karla@taconic.net Lyme of Grand Rapids, MN Martie Jacobson President Hill City MN mlj@2z.net Lyme of Greater Corresponding Kathy White Kansas City Secretary Overland Park KS Lymefight@aol.com Lyme Awareness Lyme Disease Of Southeastern Pennsylvania, Inc. Stefanie Manning Douglas W. Fearn Digital Billboard Coordinator Brandon SD Stefanie.manning@gmail.com President/Chairman Pocopson PA dwfearn@dwfearn.com Lyme Disease, Inc. Patricia V. Smith President Jackson NJ President@Lymediseaseassociation.org Lyme Disease, RI Chapter Lyme Disease Christian Prayer Julie Merolla LICSW, ACSW Debora Scatuccio Chair Warwick RI Jumerol@yahoo.com Mrs. Jackson NJ dscatucc@optonline.net Page 4 of 12

5 Lyme Disease Education & s of Maryland Lyme Disease Eugene Oregon Lucy Barnes Director Centreville MD AfterTheBite@gmail.com Deb Elder Administrator & Leader Eugene OR DGDEB.ELDER@GMAIL.COM Lyme Disease in WA. State Dan Boeholt Spokesperson Aberdeen WA geodan2@comcast.net Lyme Disease Network Of Middle Tennessee Lyme Disease Network of New Jersey Norma Engelhardt Coordinator Nashville TN riverboats@comcast.net Bill Stolow President East Brunswick NJ bstolow@lyme.net Lyme Disease Subcommittee Pamela Brown State Representative Nashua NH pam.brown@leg.state.nh.us Lyme Disease Eastern Panhandle WV Kelly Edmonds Moderator Shepherdstown WV kellyknits@comcast.net Lyme Illuminati Ginger Savely Dr. Washington DC Lymedc@gmail.com Lyme loonies David Skidmore Artist Brooklyn NY skidz57@yahoo.com Lyme Memes For Education Brianna Cooper Ms. Olympia WA Briaboo2008@aol.com Lyme Network Laura Grimshaw patient Northbrook IL anadema@aol.com Lyme Research Alliance Debbie Siciliano Co-President Stamford CT debbiesis@yahoo.com Lyme Research Initiative Sherrill Franklin Ms. West Grove PA sfranklin56@comcast.net Lyme Cape Cod Scoot Caseau Co-chair Hyannis MA flhx59@yahoo.com Lyme Support Network Susan Pribyl Vice-president Ingleside IL lymeaide@comcast.net Lyme Support Network Kimberly Frank President Ingleside IL lymeaide@comcast.net Lyme Support Wyoming Suzanne Morlock Coordinator Wilson WY lyme@suzannemorlock.com LYME411 Nancy Bourassa Founder Laconia NH info@lyme411.org LymeDisease.org Phyllis Mervine President Chico CA pmervine@lymedisease.org LymeQuest NJ Jeannine Phillips Chairperson East Brunswick NJ NeBrunswickLyme@comcast.net Madison Area Lyme Support Della Haugen Lyme Support Founder/Leader Madison WI djhphoto10@yahoo.com Maine Lyme Disease.org David Mulqueeney Mr. Scarborough ME davemulqueeney@yahoo.com MaineLyme Constance "Happy" President Hampden ME cdickeyrn@midmaine.com Dickey RN Massachusetts Lyme Legislative Task Force Michelle Treseler Newton MA michelle.treseler@gmail.com Megan Taylor Megan Taylor Dr Denver CO cougressk@yahoo.com Mid Columbia Lyme Disease Elaine Walker Leader Hood River OR ecckwalk@yahoo.com Mid-Shore Lyme Disease Linda Reilly President St. Michaels MD lcreilly1@gmail.com Mid-South Lyme Disease Karen Angotti co-founder Eads TN fkangotti@aol.com MIDHUDSON LYME DISEASE SUPPORT GROUP RACHEL DILDILIAN CO-FACILITATOR HYDE PARK NY BENAGUM@AOL.COM Minnesota Lyme Laurie Gross Lyme Support New Brighton MN lauries.rhythm@comcast.net Educator Minnesota Lyme Mark Thompson President Hugo MN m.thompson@visi.com Minnesota Lyme - Maple Grove Minnesota Lyme Brainerd Chapter Lorrie Link support group Mediator Maple Grove MN l2link@comcast.net Tania Melby Vice President Pequot Lakes MN dare2dream@tds.net Minnesota Lyme David Bradee Member Eden Prairie MN david.bradee@gmail.com Missouri Lyme/Masters' Disease Carol Ellingsen Coordinator Everton MO skywagon180@centurytel.net MLA BRAINERD CHAPTER Judy Dwire President PEQUOT Lakes MN jdwhiskey@tds.net Morgan Taylor Morgan Taylor Morgan Taylor Austin TX morgan.taylor@ttu.edu Page 5 of 12

6 New Jersey Lyme ONline J. Phillips Moderator East Brunswick NJ New Mexico Lyme Disease Support Diane J. Marie HR 4701 Albuquerque NM New Paltz Lyme Beverly Cain Leader Gardiner NY New York City Lyme Disease Newtown Lyme Disease Task Force Ellen Lubarsky Leader New York NY Maggie Schaefer/ Kim Harrison co chairs Newtown CT Northwest Indiana Lyme Bonnie Sparks Member Demotte IN Northwest Indiana Lyme Jennifer Robertson Member Griffith IN PA Lyme Resource Network, Director, Social Amy Tiehel Delco Region Media Ridley Park PA People who help Tick borne patients Dave Dornfeld physican Boynton beach FL Personal Chair, Loudoun Samuel Shor, County MD, FACP Lyme Commission Reston VA Physician Dr. Gina Piazza DO, an ILADS physician Williamsville NY Portland Lyme David Johnson Facilitator Sherwood OR Professional Medical Services Of Naples James Schaller, MD, MAR, DABPN President Naples FL ProHealth Erica Lehman MD Los Angeles CA Providence Rotary Lyme Awareness Rex G Carr, MD Ridgefield Lyme Disease Task Force Sacramento Lyme Disease Cynthia Leonard Rex G Carr, MD Chair and Cofounder Physical Medicine And Rehabilitation Jamestown RI cynthiaeleonard@gmail.com Hanover NH rcarrmd@comcast.net Karen Gaudian Co Founder Ridgefield CT crtn@aol.com Dorothy Leland leader Davis CA saclyme@gmail.com San Francisco Lyme Disease Diana Rocha Founder, Leader San Francisco CA sf_lyme@yahoo.com SF SEAL - San Francisco Support, Robin Krop facilitator San Francisco CA sf_seal@sbcglobal.net Education & Advocacy for Lyme Sierra Foothills Lyme Support Christine Ryland co-facilitator Meadow Vista CA cryland@gmail.com South Central PA Lyme Forum Barry & Diana Holtry Founders Shippensburg PA scentralpalymeforum@yahoo.com South Shore Lyme Support Helen Brown Chairperson Whitman MA southshorelyme@gmail.com Southeast Lyme Disease Southwestern Vermont Lyme Disease Virignia Anez Director Miami FL virginia@supernets.net Rev. Claire L. North, MSS, MFA Founder/President Manchester VT revclairenorth@mac.com St. Cloud Area Lyme Nicole Koll Founder/Leader Sartell MN nicole.koll@hotmail.com St. Louis Park Lyme Disease St. Louis Park Lyme Disease Sturbridge Lyme Awareness of MA (slam) Suffern NY Lyme/Co-Infections Leslie Johnson Mary Ann Ryken Griffin, MD Co creator of support St. Louis Park MN slplymegroup@gmail.com MD Minneapolis MN lymeawaydoc@yahoo.com Trish Mccleary Co founder Sturbridge MA s.l.a.m@msn.com Vicki Ann Hollister Member Port Crane NY vhollyann@aol.com Taos Lyme Rebecca Hall Organizer TAOS NM ranchitos@taosnet.com TBD Cindi DuMond Camillus NY Crsplash@twcny.rr.com Tennessee Lyme Network Shelley Brown Founder Memphis TN Sruthbrown@gmail.com Texas Lyme Disease Patricia Ricks Secretary, Board of Directors Corona del Mar CA Pat.Ricks@txlda.com Page 6 of 12

7 The Charles E. Holman Morgellons Disease Foundation Gwen Simmons, RN RN LAKELAND TN The Mayday Project Allison Caruana Vice President Windermere FL The Serano, Inc. Joel Spinhirne President Hood River OR Through Challenge and Lyme David R Thomas Proprietor Sayre PA darith1lymee@gmail.com Tick Borne Disease Alliance David Roth Co-Chairman New York NY roth@blackstone.com Tick-Borne Infections Council Of North Carolina, Inc. (TIC- NC) Susan Walser President Pittsboro NC susan@tic-nc.org Ticked-Off Donna Castle Founder Groton MA 1450 Dcastlemom@gmail.com Twin city Lyme Support Vicki koecher Facilitator Mpls MN vicki.koecher@gmail.com United Bowhunters of NJ John Erndl President Jackson NJ J.erndl@ubnj.org Utah Lyme Disease Alliance Vermont Lyme Action Committee Jenny Jones President/ Spokesperson/ Co founder Alpine UT Imahulamama@yahoo.com Jackson Whelan Member Pittsford VT jw@jacksonwhelan.com VermontLyme.Org Bern Rose Moderator Barre VT dulcimeralive@gmail.com Virginia Lyme Lucy Barnes Director Centreville MD AfterTheBite@gmail.com Virginia Yahoo Lyme List Rolf Taylor Moderator Annandale VA rolf.taylor@yahoo.com VT Lyme Action COMMITTEE Jackson Whelan Member Pittsford VT jw@jacksonwhelan.com Walker area Cynthia Dainsbeg Lyme patient advocate Laporte MN cdainsberg@ymail.com Washington Lyme group Sheryl Ellis Ms Tacoma WA Sheryl_darlene123@yahoo.com Western Wisconsin Lyme Action Wilton Lyme Disease Support Marina Andrews Founder Luck WI inluckfarm@lakeland.ws Yvonne Bokhour C-Founder Westport CT yvonne@bokhour.com Winona Lyme Shan Devine Founder Winona MN Winonalyme@yahoo.com Wisconsin Lyme Network Kristin Collins President, Medical Liaison WAUKESHA WI collins.kristin@att.net Wisconsin Lyme Support at Yahoo Mike Nickel Moderator Kronenwetter WI miken@tds.net Wisconsin Lyme Support Network Alicia Cashman Sun Prairie WI acashman@charter.net Women's Lyme Disease Laura Lower Administrator Mollenhauer Gwynedd PA LKC75@aol.com Wyoming Lyme Support Suzanne Morlock coordinator Wilson WY lyme@suzannemorlock.com York Lyme Disease Support Robert Stibitz Co-Chair York PA yorkpalyme@yahoo.com Carolyn Brooks, MD ILADS Physician Amherst MA cbr55555@aol.com Page 7 of 12

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9 ATTACHMENT I A. Necessary Provisions of Lyme Legislation Identified by Lyme s 1. FACA Compliance: A Working /Advisory Committee Must Fall Under FACA. In August 2013, NIH released a 162-page report describing the 144 NIH Advisory Committees and 6 HHS Advisory Committees Managed by NIH Staff. NIH defined an advisory committee as any committee, board, commission, council, conference, panel, task force, or other similar group, or any subcommittee or other subgroup thereof, which is established by statute, or established or utilized by the President or any agency official for the purpose of obtaining advice or recommendations on issues or policies which are within the scope of his or her responsibilities. Noting its role as the steward of medical and behavioral research for the Nation, NIH describes its mission as science in the pursuit of fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life and reduce the burdens of illness and disability. NIH ties its mission and programmatic goals to advisory committees: The NIH draws advice from scientists actively engaged in research and non-scientific (public) members with an active interest in the mission or health program areas of a specific Institute or center to serve on federal advisory committees. These members provide the broad perspective that is essential to balanced and effective programs. [Emphasis added]. It is necessary that any tick-borne diseases (TBD) working group fall under The Federal Advisory Committee Act (FACA) because the central problem requiring a legislative remedy is that one outside entity has exerted undue influence over agency policy. Over two decades, a small group of influential individuals in a powerful medical society have been able to control the dialogue regarding Lyme disease and have had almost exclusive input into setting agency agendas and policy-making. NIAID relies extensively on the advice of outside entities regarding Lyme and other TBD, and simply seems to want their activities to remain private and exclusionary. Notwithstanding the state-of-the-science conference that Congress requested in 2010, individuals with differing viewpoints have been largely shut out. This not only causes serious harm to patients and to physicians who only want to do what they have been trained to do, but also seriously impedes the progression of the science and the development of clinical tools. One researcher with more than three decades of experience with infectious diseases called the situation with Lyme unique. These are the circumstances that justify establishing a tick-borne diseases advisory committee and such action is aligned with the rationale behind FACA. In passing FACA in 1972, Congress wanted to bring some order to an out-of-control process that often functioned behind closed doors and which many believed did not sufficiently represent the public interest. Advisory Committees often are useful in helping the government manage and solve complex or divisive issues and in bringing together divergent opinions. Under FACA, federal officials have access to information and advice on a broad range of issues, and public stakeholders have an opportunity for input at the table. Mr. Waxman s Government Reform Minority Staff Report during the Bush Administration (see cover letter) provides a summary of FACA. In 1972, Congress adopted the [FACA] to govern how the Executive branch obtains advice from groups of advisors outside the federal government. FACA sets out rules for the operation of advisory bodies such as boards, task forces, and commissions to promote the good government values of openness, accountability, and a balance of viewpoints. The goal of FACA is to prevent secret advisory bodies from exercising a hidden influence on government policy. FACA applies to any advisory group that is established or used by a federal agency and has at least one member that is not a federal employee. The membership of a group subject to FACA must be fairly balanced in terms of the points of view represented and the functions to be performed. Generally, FACA requires that advisory committees announce their meetings, hold their meetings in public, take minutes of the meetings, and Page 9 of 12

10 provide the opportunity for divergent viewpoints to be represented. The public must be given access to the minutes as well as other records, reports, and transcripts. We recognize that advisory committees should only be created and maintained when clearly justified, and agencies, in many cases, would rather not have to deal with them; yet HHS and/or the President and/or Congress have determined there was a need and created 250+ advisory committees in HHS. Tick-borne diseases could be the poster child of why the principals of FACA are necessary. 2. Seat at the table: Working Established by the Bill Must Include Non-Government Employees, Representing Diversity of Viewpoints, & Categories of Individuals at the Table Must Be Identified in Bill A small group of selected individuals has a long history of private meetings and collaborations during which they deliberately excluded the concerns of a broad range of Lyme stakeholders. Numerous researchers at prestigious medical centers and research institutions have opinions differing from the dogma of the Infectious Diseases Society of America (IDSA). Those researchers voices deserve to be heard. Treating physicians also have a great deal to contribute to the process by their experiences in diagnosing and treating patients over a period of years and, for some, decades of real life experience with important issues, such as, the existence of Lyme and other TBD in non-endemic areas, how well laboratory diagnostics have performed and supplemental tests that were helpful, diagnosing and treating co-infections, how often and for what patients treatments were successful/unsuccessful. They should have a voice. In addition, the advisory committee should include patients and/or family members and non-profit organizations dedicated to TBD We now have such a long history of agencies failing to address the concerns of patients that these stakeholders need to be heard in a substantive and meaningful way, not in some perfunctory venue. Some non-profit tick-borne disease organizations have been in existence for decades and have worked closely in various situations with extensive networks of researchers. They are in many ways clearinghouses of information and are links among patients, physicians, and researchers. Other disease advisory committees include patients and/or their advocates. Six of the members of the National Allergy and Infectious Diseases Advisory Council are appointed from the general public, as are six members of the AIDS Council, including patients and their advocates. Autism and muscular dystrophy have HHS advisory councils managed by NIH, both with at least 1/3 of its members from the public. The Autism Interagency Committee includes at least one parent and advocacy organizations play a major role even heading up subcommittees. The Muscular Dystrophy Interagency Committee includes a broad cross section of persons affected with muscular dystrophies, including parents or legal guardians. As noted above, FACA requires committee membership to be fairly balanced in terms of the points of view represented and the functions to be performed. There is even a requirement for discretionary advisory committees to develop a Membership Balance Plan, which is also strongly recommended for mandatory (statutory) committees. Congress considered this to be an important provision to foster good government. An important note: On multiple occasions, IDSA has written to members of Congress objecting to past legislative efforts to create a Lyme disease or TBD advisory committee, making misleading statements, such as We cannot support non-evidence based public health policy decision-making [that previously proposed legislation] would institutionalize. Those legislative efforts would have added non-federal members to a committee including both scientific experts and individuals with other types of expertise. Other HHS/NIH committees are quite capable of separating scientific from non-scientific information. Regarding an advisory committee s ability to dictate federal decision-making, as long ago as 1955, DOJ issued an opinion that created guidelines for any valid advisory committee, including that a committee must be purely advisory, with government officials determining the actions to be taken on the committee s recommendations. In 1972, FACA codified those provisions. We believe that with over 150 advisory committees, NIH staff are very aware of their advisory nature, although reportedly some NIH officials have echoed misleading statements that the agency would be told what to do. Many of IDSA s other statements in letters to Congress deserve close scrutiny. Page 10 of 12

11 3. General Public Input Meeting: A Public Meeting Must be Held Within 180 Days and at Least Biannually Thereafter and Provide for Input from the Public. In addition to routine meetings convened of the advisory committee, a public meeting designed specifically to solicit public input must be convened within six months of passage and then convened at least biannually thereafter. Meetings that are open to the public do not always provide for public input. It is important to have a meeting as early as feasible to seek input from the public. The goal is to have a public meeting at the front-end of the deliberative process rather than to be simply reporting back to the public on what agencies have already done. B. Our Views on the Legislative Process We don t believe it is possible to develop or evaluate good legislation without understanding what the actual problems are that require fixing. What is needed in a Tick-Borne Diseases bill are provisions that will provide real transparency and accountability not to provide lip service to those attributes which are or should be lynchpins of federal government programs. If the Committee is willing to set real transparency and accountability as goals of the bill, we can move forward. If the Committee is willing to accept that there may be serious problems causing substantial harm to patients that require congressional oversight and attention to at least get us on a path to fixing the problems, then, again, we can move forward. This is not a hollow exercise for the Lyme community to get a Lyme bill; or to get something, and it is not about egos or someone wanting to get a seat on an advisory body or about any particular member of Congress. It is about promoting the best science and freeing science from entrenched biases, and it is about protecting the interests of patients and their caregivers. We understand the time constraints of Members of Congress and the far too many competing demands, particularly committees with jurisdiction for public health programs. Members of Congress who have an interest in Lyme and other TBD and who spent time to learn about the issues have expended great efforts trying to share information with their colleagues. We are extremely appreciative of those efforts. We also are thankful that almost all members have refrained from dismissing or denigrating Lyme patients, advocates and the many top-notch researchers who have no agenda other than following the best science. In addition to working with our congressional representatives who have become champions, many advocates and researchers have made trips to the Capitol on many occasions. Still, Lyme advocacy organizations are truly grassroots and/or research organizations, which do not have lobbying shops. As an example, one Lyme organization spends an average of 97% of its budget on programs and has an extensive resume of research it has funded published in peerreviewed journals among many other accomplishments. We are at a competitive disadvantage to large disease organizations, some of whom have large offices in DC and multimillion dollar government affairs budgets. The IDSA, while not a disease association, spent $900,000 on lobbying in We are aware that the IDSA, has written to Congress on multiple occasions claiming that there is nearly unanimous or widespread consensus among the medical and scientific community regarding Lyme disease. But that is simply not an accurate portrayal. An unbalanced conference call, as occurred days before the Health Subcommittee s mark-up, will not provide Congress the information and insight it would need to identify and understand what the problems are that legislation needs to address. We understand that a couple of days before the amendment in the nature of a substitute was introduced in the Subcommittee, committee staff had a conference call with HHS and possibly other unknown researchers. Although it is a critically important issue, when we asked the committee for the names of researchers on the call, they told us it is private information. We understand that Congress has a right to private meetings in certain circumstances, and in some cases, privacy is a prerequisite to obtaining information. However, we were very much concerned in this case because private meetings with HHS agencies, the IDSA, and sometimes other hand-picked parties who shared the same views have led to the exclusion of valid and credible viewpoints and biased decisions. It would be a sad irony for us that the same type of biased communications that has been so commonplace and so detrimental, were also given unbalanced weight in considering legislation. Congress has a long history, under Republicans and Democrats alike, of investigating Page 11 of 12

12 inappropriate biases exercised by Federal agencies in the execution of their programs; we doubt that in any of those cases would they be satisfied with talking only to agency officials and their closest allies. We would like to see the concerns of the Lyme community and that includes scientists and researchers as well as well informed advocates and patients given some diligent consideration. C. What Legislation Can be Passed in a Short Period of Time? With where we stand now and the information people have, what is the legislation that would not hurt but would be expected to help the Lyme community and could responsibly be put forward in a short period of time? It seems the only answer would be legislation applying well-vetted principals of good government, such as establishing a FACA-compliant advisory board, although it may also include other provisions. Congress should not insert itself at this time into the science on tick-borne diseases, and there is no need for Congress to take sides regarding the science. What we have described are broken processes, which lack transparency and accountability and do not allow for adequate participation by stakeholders. FACA has already been vetted there were numerous rounds of hearings and numerous bills were scrutinized and massaged before passage of FACA. It is about open government. It is about good government. It doesn t matter what the issue is. Outside of national security issues and classified information, FACA should be applicable. Thankfully, every disease program at NIH does not need an advisory committee because every disease program at NIH is not broken. Unfortunately, there is a need for Congress to step in and apply the processes of open government to tick-borne diseases. It is a fact that outside advisors are going to be used extensively at HHS; Congress took great care to try to ensure that the process was not abused for any agency in the federal government. With the extreme pressure from the IDSA, HHS has been reluctant to allow such normal practices with Lyme disease. There is no good government reason to exempt them from the requirements of conducting their business in open and transparent processes and listening to a diversity of viewpoints from credible sources which NIH in its Advisory Committee report described as essential. For the immediate future, we do not see NIAID agreeing to change, rather they can be expected to vigorously defend the status quo. Without judging the science itself, you have an opportunity to take actions to establish an environment which fosters good decision-making to achieve the best science outcomes. Page 12 of 12