I submitted the following written comments to the Tick-Borne Disease Working Group, in advance of its June 4 meeting.

If patient interests are not sufficiently represented on the Tick Borne Diseases Working Group (Working Group), then its processes will lack credibility and may harm the Lyme disease patient community.

The legislation establishing the Working Group was included at the request of the Lyme disease community.  Our organization, LymeDisease.org is one of the oldest non-profits serving this community and is the largest communications network in Lyme disease.

We represent the interests of patients with chronic Lyme disease and mobilized over 14,000 patients to contact their legislators to ensure that the Working Group was included as part of the 21^st Century Cures Act.

The need to establish a Working Group was driven in the Lyme disease community by the fact that the interests of patients with chronic Lyme disease have been dismissed and trivialized. The patients and community have been subject to stigma, neglect, discrimination, a lack of research funding, and barriers to access the medical care that they need. (Johnson 2019)

The phrase “nothing about us without us” conveys the urgent need for representation of patients with chronic Lyme disease as it does for other similarly disadvantaged and marginalized groups.

The Working Group is subject to the Federal Advisory Committee Act constraints, which provide for nominations to the committee and for “consideration of a cross-section of those directly affected, interested, and qualified as appropriate to the nature and functions of the advisory committee”. (GSA 2011)

In keeping with the legislative purpose of the Working Group, it is important that patients affected by chronic Lyme disease and their caregivers be meaningfully represented.

The Working Group should not include patients who are merely tokens intended to create the appearance of representation, when the person is either not recognized by the community as having the skills, lived experience, or the ability to be outspoken, knowledgeable and articulate about the issues facing the community.

It is also essential that those representing the interests of the chronic Lyme disease community have the time available to effectively serve and that the community regard them as being capable of providing effective representation.

Who can effectively represent the interests of patients with chronic Lyme disease?

We conducted a survey of over 1,800 patients with chronic Lyme disease to identify the qualifications that patients felt were essential for effective representation of the community on a government panel as well as those that patients would regard as merely token representation. The results of that survey are presented below:

To be a meaningful representative, patients chosen for a panel should: a) have or be a caregiver to a patient with chronic Lyme disease and b) should be an officer or director or someone vetted and approved by a recognized and trusted patient advocacy group (PAG) or someone approved by a PAG.

The latter ensures that they are someone recognized in the community as representing the interests of those with chronic Lyme disease. PAGs are unlikely to give their stamp of approval to someone who lacks the knowledge and ability to hold their own among a group of researchers and to be outspoken about the interests of patients with chronic Lyme disease. Sometimes government panels select patients who are docile and easily managed. These patients cannot effectively represent the interests of patients with chronic Lyme disease.

People who are automatically considered tokens include those who are not a chronic Lyme patient or caregivers or those to whom the community objects. A patient who has only had acute Lyme disease also did not make the grade for most respondents.

LymeDisease.org nominated a number of potential representatives for the Working Group. Most of our nominations were not affiliated with our organization. However, they were members of the community that we felt would have been able to effectively represent the interests of patients with chronic Lyme disease.

Are a sufficient number of patient representatives on the Working Group included for representation to be effective?

It is also important that a sufficient number of patients representing chronic Lyme disease be selected to compensate for the inherent power imbalance between patients and researchers generally.

Patients can have a hard time holding their own in a group of researchers. How outnumbered are the patients? Who is protecting their ability to have an influence? How many patient representatives will there be on this Working Group?

The last Working Group included three patient representatives on the seven public member slots. We believe this number is sufficient, provided that those selected are acknowledged by the community as having the requisite knowledge of the disease and issues affecting those with chronic Lyme disease together with lived experience of chronic Lyme disease and the willingness and ability to be outspoken and articulate in representation of the community interests. This can be assured when patient representatives are nominated by non-profit advocacy organizations who are known and trusted by the community.

Do participants on the Working Group represent industry interests?

Another critical question to ensure proper constitution of the panels is whether people on the panel represent industry interests.  For example, Dr. Robert Smith who sat on the previous TBDWG, has worked for the vaccine industry. Whose interests does he serve when he sits on the TBDWG?  His own? Or those of an industry likely to fund his work?

You might recall that when the last panel was announced, we objected to Dr. Gary Wormser because of his extensive financial conflicts of interest, especially related to Lyme disease diagnostic testing. The central question with conflicts of interests like these are whether “industry stakeholders” are essentially given a seat at the table, when the Working Group is not supposed to reflect industry interests.

Is the legislative purpose of this panel reflected in the new Working Group? 

The TBDWG was included in the 21st Century Cures legislation at the request of patients with chronic Lyme disease. The purpose of the Working Group is to advance the interests of patients with chronic Lyme disease and to include their voices in the discussion of what research to prioritize.

Although the group has the words “tick-borne disease” in its title, and many patients with chronic Lyme disease have co-infections from another tick-borne pathogen, the bill was passed to address the interests of patients with chronic Lyme disease.

Hence, a meaningful question is whether the panel members’ primary focus of interest is in fact Lyme disease. If it is another tick-borne disease, while their information may be generally useful, it will not further the interest of the legislative intent regarding Lyme disease. The interests of researchers in other tick-borne diseases should not usurp or replace those of Lyme disease.

References:

Johnson L. Stigma and Privacy in Lyme Disease [Preprint] 2019. Available from: https://figshare.com/articles/MyLymeData_Stigma_and_Privacy_in_Lyme_Disease_Data_A_project_of_LymeDisease_org_2_11_19_xlsx/7704167

FACA Brochure: https://www.gsa.gov/policy-regulations/policy/federal-advisory-committee-management/advice-and-guidance/the-federal-advisory-committee-act-faca-brochure

U.S. General Services Administration, Federal Advisory Committee Membership Balance Plan: https://www.gsa.gov/cdnstatic/MembershipBalancePlanGuidance-November_2011.pdf

Lorraine Johnson, JD, MBA, is the Chief Executive Officer of LymeDisease.org. You can contact her at lbjohnson@lymedisease.org. On Twitter, follow her @lymepolicywonk.