Link to post- https://www.linkedin.com/pulse/sunshine-law-faca-ever-see-sun-tbdwg-kristina-bauer/

Will the Sunshine Law and FACA ever see the sun in the TBDWG?

Published on April 10, 2018

Instructor and President at Yoga Synergy Spa

The Tick-Borne Disease Working Group (TBDWG) is governed by a number of laws including the Federal Advisory Committee Act (FACA). FACA assures that ‘the Congress and the public are kept informed with respect to the number, purpose, membership, activities and cost of advisory committees’.

The Sunshine law requires public meetings, deliberations, and the sharing of documents to be open to the public so we have a chance to participate in the following meetings.

However, during the December 2017 public meeting, the Designated Federal Officer to the TBDWG made a series of promises regarding transparency that have, for the most part, not been met. The point of the committee is to appease the public in many cases related to Lyme disease.

RESPONSE- The "point of the committee is" NOT "to appease the public in many cases related to Lyme disease." It has a stickly outlined structural foundation and specific goals, as stated publicly below. Source

QUOTE- "The Working Group will provide expertise and review all efforts within the Department of Health and Human Services related to all tick-borne diseases, to help ensure interagency coordination and minimize overlap, and to examine research priorities.

The Working Group shall have the following responsibilities:

(A) Not later than two years after the date of enactment of the authorizing legislation, develop or update a summary of:

(1) ongoing tick-borne disease research, including research related to causes, prevention,

treatment, surveillance, diagnosis, diagnostics, duration of illness, and intervention for

individuals with tick-borne diseases;

(2) advances made pursuant to such research;

(3) federal activities related to tick-borne diseases, including:

(a) epidemiological activities related to tick-borne diseases; and

(b) basic, clinical, and translational tick-borne disease research related to the pathogenesis,

prevention, diagnosis, and treatment of tick-borne diseases.

(4) gaps in tick-borne disease research described in clause 3b;

(5) the Working Group's meetings; and the comments received by the Working Group.

(B) Make recommendations to the Secretary regarding any appropriate changes or improvements

to such activities and research; and

(C) Solicit input from States, localities, and non-governmental entities, including organizations

representing patients, health care providers, researchers, and industry regarding scientific

advances, research questions, surveillance activities, and emerging strains in species of

pathogenic organisms."

CONTINUED RESPONSE- No where does it say this working group must "appease the public" or even bow to their demands. If anyone would like a committee to do something different than this one was designed and ordered to do by way of an official Congressional Act and Codes of Regulations, then get one of your own. This is not the time, place or audience to be complaining to or about any structural changes wanted by a handful of non-professionals tossing themselves into the political arena.

The subcommittee members are doing their jobs and are not going to suddenly stop and cow-tow to your unsubstaniated complaints because you happen to want something different.

In the Lyme community there has always been a divide created by those who have an uncontrolable desire to crush what others are working on at any given time. These same people continue to try to disrupt others work rather than focusing on what they can do to HELP our situation. They need to stop impeding progress and making the Community as a whole appear insane.

We find this unacceptable in that we need action now, especially in making sure all committee and subcommittee meetings are transparent and members held accountable. This is the very framework of what work will transpire on our behalf.

CFR Part 1003 details the implementation of the government in the Sunshine Act; this law further details transparency and accountability requirements. [2]

Under the Sunshine Act:

A meeting or portion of a meeting may be closed and information pertaining to a meeting withheld —for specified reasons found under the law under— only by vote of a majority of members. This is not happening AT ALL!

RESPONSE- The Code of Federal Regulations (CFR) was implemnented to cover many different scenarios, not just a disagreement in the greater Lyme Community between the IDSA/CDC and patient groups. EXAMPLES- Protecting witnesses' names in a discussion of drug enforcement policies, protecting undercover officers identities and locations when discussing potential terroristic acts against the USA and foreign countries, etc.

And again, the applicable code does not require committee members to share their every day activities step by step with the public.

No 15 days notice of subcommittee meeting, no observing the subcommittee discussions, no access to how they made their decisions. No transparency. We need to make sure the efforts made by the TBDWG are not rewritten or overridden by anyone. If literature is not kept open in what the subcommittees write, it can be rewritten.

RESPONSE- The subcommittee members report to the committee members, not to the Secretary. Subcommittee members work is a contribution, not a final plan or anything that is set in stone. Their contributions are designed to be researched, edited and if they warrant, be placed in a final draft by the Committee members.

QUOTE- "In carrying out its function, the Working Group may establish subcommittees..." There actually can be Committees with NO subcommittee members. Our "side" finally has a seat at the table- a number of them, doctors and strong community leaders- and now is their chance to help all of us get our concerns considered.

So what are these people doing that keep telling you what to do? What is their goal? What is their motivation? Can they possibly think it is helpful to keep pushing YOU to harass the ONLY people who have a chance of helping us?

This violates FACA and Sunshine because their is no reason like a threat to national security for these meetings to be held in secret.

RESPONSE- According to the CFR there doesn't have to be a threat. They have every right to keep on working without reporting every single conversation they have and every little contribution they've made to the public. This is "standard procedure" and it falls under the CFR.

The set-up here has even allowed for public input. So, if you have suggestions that are in line with their mission, you are free to share them and they will be recorded. However, the repeated, petty, half-witted responses you are being told to submit and the harassment and nonsense that goes with it won't be seen by most and will be a waste of your time and energy.

The subcommittee members aren't even allowed to communicate among other subcommittee members, per former TBDWG committee chair, Karen Vanderhoof-Forschner, per a public social media feed.

RESPONSE- In my opinion, Karen Forschner has a lot of practice and a long history in causing behind the scenes disruptions in the Lyme community that have set us back. This is why most groups and advocates who have been working hard and well together for you for many years prefer not to, or will not, work with her or those she is currently asociated with anymore.

In fact, when threatened with exposure, or just in trying to be more visable in the Community, those who are undermining our efforts will lie and/or accuse those who have been enduring these never ending assaults of causing the same problems they've been known to instigate.

Example- Susan Green states...

Source- FB post located here, by...

Susan Green April 6 at 11:37pm

RESPONSE- Read the introduction to the page regarding a 2012 Maryland bill, SB 891, located here. Susan Green is attempting to put the bad deeds done by her group on the backs of others who had nothing to do with the attempts she has accused them of doing.

She also publicly stated on social media that her work was being redone and turned in as hers when it wasn't. She stepped down for these reasons of unethical behavior, is a successful attorney and felt she had an ethical obligation to remove herself.

RESPONSE- Karen Forschner and all other subcommittee members are suppose to provide drafts and collections of information for the Working Group. They do not have the ability, per the CFR (Code of Federal Regulations), to have their research or submissions be the "final word".

QUOTE- "These subcommittees were established to assist the Working Group with the development of the report to Congress and the HHS Secretary as required by the 21st Century Cures Act." Source

That's why it is called a "working GROUP", not a Karen Forschner free-for-all or whatever-I-say-goes committee. Imagine what it would be like if someone on the "other side" of this debate were to be allowed say what ever they wanted and it be the "final word". And since, unlike Karen Forschner and Susan Green, the subcommittee members can't be the final word... are THEY quitting because of that? No.

Our patient goals for the TBDWG would be to support access to all treatment options, recognition of persistent infection/co-infections, the need for direct detection tests and other tests technologies, and clinical diagnosis over the 2-tiered serology tests. These ladies, as do many other advocates like myself are VERY skeptical that any Lyme vaccine (using current vaccine technology) could be helpful vs quite harmful. It's scientifically impossible to ever vaccinate against a B cell issue!

RESPONSE- If that is the way YOU feel, write a respectful letter and submit it for consideration. That's exactly what I (and others) did and our letters were considered and then posted publicly. THAT is the proper way to have your opinions heard.

What is the point of a committee to explore new possibilities if federal agency representatives on that committee are required by law to uphold the old dogma? That sounds like a law that needs to change, as it hamstrings any committee trying to find new solutions for the better good of this desperate patient group.

RESPONSE- Fine! If you want the laws changed to suit you just go thru the proper channels like everyone else must do and work for that change. It apears you don't understand that the TBD working group does NOT have the ability to correct, fix, ignore or change the laws because you or anyone else would like them changed to suit your views. Changing laws is an entirely different subject and the task shouldn't be dumped by Lyme patients in the TBD working groups' lap to address when they are unable to make such changes. It just doesn't make sense.

YOUR CALL TO ACTION:

Email the following people instead of the black-hole tickbornedisease@hhs.gov email account.

RESPONSE- As we've seen happen, "the black-hole" only exists for those intending to disrupt the procedures, not for those who adhere to the Code of Federal Regulations when sending in their submissions.

Dr. Brett Giroir = brett.giroir@hhs.gov

Assistant Secretary for Health = ash@hhs.gov

Chief of Staff = valerie.huber@hhs.gov

Chief Medical = vanila.singh@hhs.gov

You're welcome to cut and paste this brief concern below to the above email addresses. Emails to these Senior officials are LOGGED and NUMBERED, kept on record and generate a response.

We will continue to make sure the TBDWG's actions are transparent, they are held accountable under these laws, and made public for a fair and balanced final report.

RESPONSE- Excuse me. You haven't "made sure" yet that what you want is being handled per your desire, or that anything beyond what is required has been made transparent, so you can't "continue" to do something you haven't done. In fact, you've failed to get seriously ill patients concerns and views on the record by pulling these stunts.

So, for those who keep pushing people to blindly go out and "do something".... please don't keep promising sick patients you or they will accomplish what you all together can not do, and don't ask patients to continue to waste their precious time doing your dirty work for you (attempting to disrupt the work of others who are working on their behalf).

If anyone would like to send the TBD working group a letter with your thoughts, simply write it out (respectively) and send it to the email address they provided-tickbornedisease@hhs.gov

Thank you for your help in holding these people responsible for the future health of our children.

Kristina Bauer, Lyme Advocate and Mom of 4 Gestational Lyme Babies

KristinaBauer7@icloud.com

-------------------------------------------------------

Dear (name),

I am writing because because I have several concerns regarding ongoing problems with the federal working group (the “TBDWG” committee) at the U.S. Department of Health & Human Services (HHS).

It is our understanding Wolitski has not attended the required proper FACA training. The TBDWG is scheduled to provide Congress a Report in December 2018.

RESPONSE- At the very least please use some respect and address him as "Mr. or Mister". Do you have any proof that Mr. Wolitski hasn't had the FACA training or is this just another attempt to discredit the working group by tossing out a handful of wet noodles to see what will stick? If he hasn't had the training, is it required? If it is required, how will it affect his performance IF he hasn't had it?

o Wolitski is having the writing of this report performed by six subcommittees behind closed doors, whose sessions are not open to the general public.

When the Constitution was written it didn't have the entire country, who would be affected by it, sitting there watching it being written. In fact, the Constitutional Convention was conducted under an oath of secrecy, so a newspaper printing of it 2 days later was the first time that Americans—“We the People”—saw the Constitution. Everyone may not think so, but I personally feel that was a good and an important document.

A handful of people had a chance to make needed changes for the Lyme Community, and instead QUIT and are now part of the bashing club that's attacking those remaining. What's wrong with these people? You'll notice even with the Constitution the subcommittee members made "important contributions"- at least those who didn't walk out on us.

QUOTE- "The Constitution was the result of months of passionate, thoughtful deliberation among delegates. Many others besides James Madison made important contributions, particularly those who served on the Committee of Detail, which included Oliver Ellsworth, Nathaniel Gorham, Edmund Randolph, John Rutledge, and James Wilson; and those on the Committee of Style, which included Alexander Hamilton, William Johnson, Rufus King, and Gouverneur Morris. Other notable delegates included Benjamin Franklin and George Washington (who served as president of the convention)." Source

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

o FACA rules require public access to materials used by federal employees in preparation for these open full meetings of the TBDWG; importantly,

o These subcommittees are very much part and parcel to Wolitski’s preparation for the full TBDWG meetings; therefore,

§ FACA requires the public have access to these subcommittees to provide citizens a chance to prepare for the full TBDWG meetings.

o By having these six subcommittees private, the public cannot properly prepare for these full TBDWG meetings – it’s unjust, unfair, against FACA, because being so designed, it naturally blocks public preparation; for example,

o The public does not become aware of the six subcommittees’ discourse until the day of the full TBDWG meeting and then we only see the final products and have had no chance to prepare our thoughts and contributions – it is then too late to participate.

RESPONSE- That's the sorry way the cookie crumbles. If you'd like a different design for another committee, get the laws changed and have one. Kicking the system in already in place only hinders our progress and wastes time and energy.

o More than 1,000 public contributions submitted to email tickbornedisease@hhs.gov are not being used by the subcommittees – also stifling public participation. There have been a handful posted publicly and is a far cry from what still needs to be posted on the TBDWG website of HHS.

We need 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 TBDWG subcommittee members.

RESPONSE- That's not the way it works. When in Rome, do as the Romans do or get out of town.

Please have this access made available, under law, so that we can properly prepare for full meetings of the TBDWG.

Respectfully,

Your name

Cc: brett.giroir@hhs.gov; Valerie.huber@hhs.gov; vanila.singh@hhs.gov; tickbornedisease@hhs.gov