consulting Senior Advisor - US Government, United Nations, non-profits, corporate social responsibility programs

April 4, 2018 Jenna Luché-Thayer

To: Dr. Brett Giroir, Assistant Secretary for Health, US Department of Health and Human Services (HHS)

cc: Valerie Huber, M.Ed, Chief of Staff, Office of the Assistant Secretary of Health, HHS,

Vanila M. Singh, MD, MACM, Chief Medical Officer for the Office of the Assistant Secretary for Health, HHS

Subject: Lack of Transparency Regarding Tick-Borne Disease Working Group

.....................................................................................................................................

Dear Dr. Brett Giroir,

My name is Jenna Luché-Thayer, I am a former Senior Advisor to the US Government and the United Nations and currently assisting institutions and communities to build a humane and rights-based patient-centered response to the global borreliosis pandemic.

My advocacy efforts include addressing Lyme patients’ concerns regarding the management or facilitation of the Tick-Borne Disease Working Group (TBDWG) by US Department of Health and Human Services (HHS) and the Designated Federal officer (DFO) Richard Wolitski.

My advocacy efforts are informed by over three decades of policy and grassroots experience in 42 countries where I worked on governance, transparency, accountability, human rights and political representation of marginalized groups. I have served on four federal working groups that were governed by Federal Advisory Committee Act (FACA) and numerous domestic and international fora that required meaningful engagement with the public and stakeholder groups affected by the topics under consideration.

I am also part of an extended network of patient advocates united in addressing these concerns. I share the Lyme patients’ concerns regarding the lack of transparency and accountability that appears to be a significant management challenge for the HHS team facilitating the TBDWG.

For example, to date, HHS staff responsible for facilitating the TBDWG have been unable to meet HHS promises regarding the distribution of the more than one thousand public comments to the TBDWG and Subcommittees. These public comments were sent in good faith to the TBDWG general email account.

Furthermore, there have been many hundreds of questions submitted to the general email account that have gone unanswered and/or have received polite responses that contained no answers to the posed questions.

Is it true that Dr. Richard Wolitski has not attended the FACA training necessary to take on this role of federal working group DFO? I ask because it appears that DFO Wolitski is not adhering to the rules of the FACA and has structurally embedded interference and obstruction to the required public discourse.

The TBDWG is scheduled to provide Congress a Report in December 2018

· Wolitski is having the writing of this Report performed by six Subcommittees behind closed doors, whose sessions are not open to the general public

· A sizable amount of discourse is occurring among emails, also not publicly available

These six Subcommittees are structured to provide the full group (TBDWG) with their final draft Congressional Report sections during very short, public one or two-day meetings. FACA rules require public access to materials used by federal employees in preparation for these open public meetings of the TBDWG such as:

· Subcommittee notes

· More than 1,000 public contributions submitted to email tickbornedisease@hhs.gov are not being used by the Subcommittees – also stifling public participation

· These public comments have not been posted on the HHS website as promised during the December 2017 TBDWG public meetings

We have been told Wolitski received permission from HHS attorneys to operate this way. However, we believe the attorneys were misled in order to obtain approval.

During the December 2017 public meetings, Wolitski described the Subcommittees as being the groups of experts to provide the core material, including information content and recommendations, that will be used by the voting members on the TBDWG for the Report to Congress. In this case, Wolitski appears to have conflated the ‘need for public participation’ in the Subcommittees with the ‘public need for access’ to the Subcommittees’ discourse. These are two separate objectives and this conflation has resulted in a full obstruction of public access the Subcommittees’ discourse.

These Subcommittees are very much part and parcel to Wolitski’s preparation for the public TBDWG meetings. According to the December 2017 TBDWG public meeting, it was the role of the Subcommittees to review and assess all HHS and Department of Defense publications related to tick-borne diseases.

FACA requires the public have access to these Subcommittees to provide citizens a chance to prepare for the full TBDWG meetings. However, the public has no idea how many Subcommittee meetings have taken place and whether or not the Subcommittees have been able to implement this aspect of the TBDWG legal charter. Furthermore, the public has no idea what literature, if any, has been reviewed and what been omitted from consideration.

For example, a draft of a Report on congenital Lyme, co-authored by CDC official Alison F. Hinckley, is in the pipeline for publication. Advocates requested this Report on congenital Lyme be shared with the Subcommittee on Access to Care Services and Support to Patients, there was no response or indication this request was honored.

There has been no account of the Subcommittees’ progress in nearly five months’ time.

By making these six Subcommittees private, the public cannot properly prepare for the public TBDWG meetings. From my experience, all this is very poor form, poor management, against FACA rules, shows indifference regarding public stakeholder groups and a clear lack of judgement with regards to the political optics.

Furthermore, there have been reports that a few individuals in the TBDWG core group and Subcommittees have tried to inhibit advocacy efforts to address these concerns.

The structural impediments to public access appear to be by design and effectively obstruct public preparation in a high-stakes Report for the Lyme patient community, including their families, friends, caretakers, medical providers, and the general public at risk for diseases that may disable, bankrupt, and kill.

For example, in the current roll-out, the public does not become aware of the six Subcommittees’ discourse until the day of the full TBDWG meeting. This set up ensures the public has no chance to prepare their thoughts and contributions prior to the public meeting.

Is it the intention of HHS to have the public sit like stooges and passively accept in silence whatever content of the Subcommittee Reports are shared during the May 2018 ‘call-in’ and ‘in-person’ public meetings?

If the December 2017 meeting is any indication of the planned May 14-15, 2018 public meeting, the public will be given ‘the opportunity’ to speak. However, the format of the December 2017 meeting did not provide interactive spaces for direct questions and answers between the public and the TBDWG, or the public and HHS.

Additionally, a strong ‘down talking’ tone by some representatives of HHS and selected speakers were noticed by attendees. One of the chosen facilitators, an AIDS activist, used the ‘victim playbook’ to describe the Lyme patient community and focused on ‘describing their feelings’ rather than the reality of their experience, such as being denied treatment options that meet internationally accepted standards.

This facilitator, Wolitski and the Vice Chair of the TBDWG indicated the TBDWG (and Subcommittees) are the ‘experts with the superior knowledge assembled to aid the patient community’. This scripted scenario was being played out in a room where many of the attendees have advanced degrees and significant CVs. This ‘victim-rescuer paradigm’ is off-putting; it also lacks strategic merit with regards to public participation.

HHS needs to recognize that their audience are not primarily sick patients; they are not even an audience. They are public stakeholders with whom they are supposed to co-create a Report that may possibly impact the lives of millions of persons. These stakeholders are experienced, knowledgeable and capable citizens who know their rights and demand full and respectful parity in all discourse on this subject matter.

We require public access to these Subcommittee meetings and similarly, we need public FACA-required access to all Wolitski’s preparation materials, which would necessarily include all emails from all HHS staff associated with the TBDWG, including those to/from HHS staff, management officials, and the Subcommittee members. Please have this access made available so that we can properly prepare for the May 2018 TBDWG public meetings.

In addition to these issues regarding tone, transparency, accountability and FACA, there are other issues. The promise of ‘a fair and balanced’ representation is not apparent given the majority of the participants in the TBDWG and its six Subcommittees have clear ties (such as being federal employees, grantees etc.) to federal agencies promoting ‘anti-patient’ Lyme opinions that ignore or directly attack patient priorities.

Lyme patients share three core concerns and priorities:

1. Current serology tests are unreliable, leaving many undiagnosed and untreated. Diagnostic tests need be improved to capture early and late infection and presence of pathogens in seronegative persons.

2. In the absence of reliable tests, clinical diagnosis is sufficient to begin treatment with antibiotics.

3. Many Lyme patients have symptoms and complications from ongoing and persistent infection. These symptoms and complications can be debilitating, disabling and lead to death. Treatment options for these symptoms and complications should include those that have been vetted through internationally accepted standards for clinical practice guidelines. This would mean that long term antimicrobial treatments are part of the options available to patients.

The anti-patient views opine that:

1. Current serology tests are reliable and should be used to reconfirm clinical diagnosis. Treatments should begin when results of recommended serology tests are both positive.

2. There is lack of evidence of persistent infection and therefore no long-term treatment options are necessary for Lyme patients.

Should the final Report reflect the status quo as found in the anti-patient views above, we will all know that this process had no good will or intentions.

In closing, I ask you to step in and assure that FACA is upheld and public stakeholders, including the patient community, are recognized as partners and treated with respect going forward in this process of governance. Addressing these serious issues in the facilitation of this process will better ensure an outcome that is both humane and reality based.

Thank you for your time and consideration of these critical matters. I understand this correspondence will be logged in and numbered. I would like this correspondence to be included with my full name, and all other personal and professional information contained, in the Public Comments.

Faithfully,

Jenna Luché-Thayer

Jenna Luché-Thayer. 33 years working globally on the rights of the marginalized. Former Senior Advisor to US government and UN. Founder, Global Network on Institutional Discrimination™ - Holding institutions accountable for political and scientific solutions. Founder and Director, Ad Hoc Committee for Health Equity in ICD11 Borreliosis Codes. Email - jennaluche@gmail.com

2nd Link Here- https://www.linkedin.com/pulse/why-certain-lyme-advocates-claiming-advance-patient-quo-luche-thayer

Why are certain Lyme advocates claiming to advance the Lyme patient agenda with actions that maintain the status quo?

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