“Yes, Virginia, there is a Santa Claus.”–From an 1897 editorial, “Is there a Santa Claus?” of The New York Sun
I was contacted by a member of the Chronic Fatigue Syndrome Advisory Committee (CFSAC) regarding my blog post, “Oops, they did it again! CFSAC violates FACA.” Below is the part of my answer that I think will be of particular interest to the public, as it spells out one of HHS’s recent FACA violations in more detail.
“I want to thank you for your message in response to my blog post, “Oops, they did it again! CFSAC violates FACA”, as it gives me an opportunity to spell out the FACA violation discussed in the second half of my post in more detail in hopes that it will facilitate a deeper understanding of the seriousness of the events surrounding the January 2015 CFSAC P2P comments.
Pursuant to Sections 5(b)(3) and (c) of the Federal Advisory Committee Act (“FACA”), the appointing authority—here, the Department of Health and Human Services (“HHS”)—shall not inappropriately influence the advice and recommendations of the advisory committee—here, the Chronic Fatigue Syndrome Advisory Committee (“CFSAC”). Instead, according to the law, that advice and those recommendations are supposed to be “the result of the advisory committee’s independent judgment.”
Accordingly, the role of a federal advisory committee’s Designated Federal Officer (“DFO”) is to ensure compliance with FACA (ironic, I know), and any other applicable laws and regulations; call, attend, and adjourn committee meetings; approve agendas; maintain required records on costs and membership; ensure efficient operations; maintain records for availability to the public; provide copies of committee reports to the Committee Management Officer for forwarding to the Library of Congress and to provide other support services for the committee. (U.S. General Services Administration, Office of Governmentwide Policy, Committee Management Secretariat; see also 41 C.F.R. §102-3.120 as well as CFSAC’s charter.) Please note that all these functions are purely administrative in nature, such as handling expense reimbursements for committee meetings. The DFO is not supposed to get substantively involved in the advice and recommendations by the advisory committee.
Those federal rules were clearly violated here. I realize that CFSAC’s DFOs break this particular FACA rule (and others) on a regular basis, but that doesn’t lessen the gravity of each violation. For the DFO, Barbara James at the time, to be involved in any substantive way in the comments constituted a violation. For her to be involved in the disturbingly invasive way that she was just makes the violation all the more egregious. I would hope that all CFSAC members find this obvious violation of the law appalling.
There is no doubt that HHS’s behavior was against the law. Beyond that, I did not suggest that the working group did anything unethical or immoral, but the working group certainly caved to HHS pressure and that was inappropriate. The fact that the group did not acquiesce in one instance—the length of the comments—does not excuse giving in on the more substantive issues. Nobody can, in all seriousness, argue that HHS did not exert any pressure on the working group to make changes to the document or did not affect any such changes, regardless of whether all changes were adopted for the final document. HHS’s making, or lobbying for, changes behind the scenes and hiding that very fact from the public is directly contrary to FACA’s purposes of independence and transparency.
Aside from the glaring legal issue, if CFSAC is going to have any credibility, it has to operate independently of the DFO. The integrity of the process is compromised entirely and the committee’s role is usurped if the agency whose contracted work is to be reviewed by the committee is allowed a veto right and, even more so, when that veto right is afforded up front. The working group draft should have gone to the full committee without any edits made by, attempted to be made by, or caused by the involvement of, HHS. The intact document is what represented the “consensus of the Working Group.” Once any kind of pressure is applied by the committee’s authorizing agency, the independence of the committee is not only undermined, it’s obliterated. The entire committee should have had a chance to review the unaltered working group document, discuss it and vote on it at the public meeting. If the DFO, Ms. James at the time, had inappropriately raised any objections to the draft comments at the meeting, the full committee and the public would have witnessed HHS’s improper attempt to influence the draft recommendation and that FACA violation would have become part of the minutes of the meeting.
You argue that it was the right thing to compromise on HHS’s changes to avoid risking that “the P2P panel would never see [the comments].” I disagree. Regardless of the fact that the ends hardly justify unlawful means, CFSAC should have chosen to avoid any appearance of improprieties. The committee could have had an impact without the Secretary. It should have adopted the recommendation without HHS tampering. If the Secretary had not followed the recommendation and not forwarded the committee’s comments to the P2P panel, that would have spoken for itself in a powerful way. Meanwhile, the CFSAC recommendation would have still remained on the record and members of the public could have and would have submitted the recommendation to the P2P panel.
The position that Ms. James got involved “with the best intentions” is both irrelevant and a leap of faith that seems unjustified given the history of the treatment of our disease by HHS, which includes a very long list of wrongdoings and abuses of the community by HHS and which doesn’t bode well at all for even more government censorship or secrecy. For example, during my FOIA lawsuit against HHS and NIH, false statements under penalty of perjury made by agency representatives were not isolated incidents. Other examples include misdirecting congressional funds in the millions by CDC; almost complete refusal to fund research of our disease by the NIH using pretexts and untruths; misinforming the public, media and medical community about our disease by CDC; conducting unscientific studies claiming, e.g., a connection between sexual abuse and our disease by CDC; creating the meaningless social construct and harmful name “CFS;” ridiculing patients by CDC and NIH; creating overly broad definitions by CDC preventing research progress by diluting cohorts; and frequently committing violations of various federal laws. In addition, vigilance and skepticism were clearly called for given HHS’s history of making changes to CFSAC recommendations, which was documented well by Jennie Spotila.
It is alarming that this improper influence by HHS was tolerated at the time given the compelling objections from at least two working group members. Now that these violations have been clearly exposed, any justification of HHS’s unlawful interference can no longer be maintained.”
Thoughts About M.E. 
Thank you very much, Jeannette. 🙂
Well done, Jeanette. This is clear and compelling. Thank you!
Have you talked to the ACLU?
The ACLU might not be the right body to take interest in this. But there are definitely other avenues to pursue this further.
True, they might not be, but they defend citizen’s rights against the tyrrany & misbehavior of government… They may know at least a further direction to go…
God bless you, I don’t know how you do it.
Jeanette the work you are doing for the me community is unbelievable and exceptional for one am most grateful to you.
with your outstanding legal prowess you are perfectly positioned and qualified to stand guard and ensure our tights aren’t perpetually trampled on.
the scornful approach that the nih and it’s subsidiaries, have had towards patients with ME, is appalling shameful and wicked
thank you so much for your amazing advocacy. Unfortunately you are dealing with people who are congenitally incapable of being truthful and decent towards patients with this ghastly illness
Bravo Jeannette
This is brilliant, Jeannette. Thank you
Thanks for this additional clarity, Jeannette. Indeed, the law matters. I can’t imagine anyone arguing otherwise.
I know. I used to think we are all on the same page when it comes to the law. Imagine my surprise.
thank you so much, jeannette
Thank you so much, Jeannette–the ‘HITS’ just keep coming. Such disrespect for the law and for patients — and the CFSAC supposed to stand up for the rights of pwM.E. — don’t bother because CFSAC caves to the beat of the drum of the violations following the lead of the DFO, no less — CFSAC is, therefore, not doing the intended job and not authentically representing M.E. patients. WHAT a farce!! What a SCAM!!
Good for you, Jeannette, always forging ahead strongly and courageously for the benefit of all ME/CFS sufferers.
One point I’d like to make as well: When it’s said that CFSAC documents have to be made available “to the public,” what is the definition of “the public”? Many people with ME/CFS can’t travel to D.C. to read and/or copy the documents. Many of us are not physically able to do so.
So, as members of “the public,” aren’t we, those most affected, supposed to be granted access to read these materials? We should.
Then the government agency/committee should make them available to us online somewhere, so that we, as “concerned members of the public,” can read them.
This is important. If there is a way to raise this amidst all of these other legal points, I suggest it be added.
If I had the energy, I’d make a case for this as someone who is homebound 90-95% of the time with this disease.
Thanks for everything you do in waging battle for the benefit of all ME/CFS sufferers.
This is a great question!
FACA provides that documents be made available “at a single location in the offices of the advisory committee or the agency to which the advisory committee reports.” However, FACA was enacted in 1972, long before the Internet. The spirit of the law–to allow for public oversight of advisory committees–together with the fact that HHS avails itself heavily of the Internet in order to deny the community in-person meetings and merely holding webinars provides for a very strong argument that FACA is to be interpreted to require HHS to make the documents available online no later than at the beginning of a meeting. This has not been tested in court, as far as I know, but maybe it’s time.
Regardless of whether a legal challenge would succeed, HHS surely has a moral obligation to do so given the level of disability and poverty of the community. But it is clear that HHS is stonewalling all the way. The DFO, Dr. Lee, made it very clear at the last meeting (https://thoughtsaboutme.com/2015/08/20/another-cfsac-faca-fail-dfo-misconstrues-law/) that HHS feels no obligation to do the right thing here. The name of the game for HHS always has been, and still is, to hide the ball as much as possible. I mean how long would it take to post a document online? A minute? Two? The self-righteous refusal to do so shows the deeply rooted contempt and disregard HHS feels for ME patients.
I think it is important for patients to continue keeping the pressure on regarding this point, as it clearly shows how unjustified and callous HHS’s actions are. There is just no excuse.
And new laws have been enacted since 1972 on behalf of the disabled, such as the Americans with Disabilities Act and the transparency laws passed under the current administration. I believe the federal law generally requires electronic access to federal data, where it exists in electronic format, anyway – 501c compliant maybe? I also think a Congressional inquiry is appropriate into these shenanigans.
It was Kathy D. here who raised the question about documents being made available to “the public,” especially those of us with ME/CFS.
I agree with everything you say about HHS, which has disregarded our disease and us for years. The agency has to have its feet put to the fire, so to speak, on all of these issues as you are doing.
And all of us with this disease have to keep the pressure on — yes! A thousand times, yes!
I think we should call and email HHS about the “documents being made available to the public” issue. Most of us can’t travel ot D.C.
The governmental agencies won’t do anything without a fight. This was proven when you had to sue under the FOIA for documents.
I wish we could do a class action lawsuit on all of these issues against HHS, NIH, etc.
Pingback: Holding HHS Accountable for Unrelenting and Unrepentant Legal Violations | Thoughts About M.E.
Thank you so much Jeannette for holding them all accountable. You wouldn’t think patients would have to fight so hard to get HHS, NIH and CFSAC to do their jobs. But thanks to you at least they’re on notice that they can’t get away with it as easily as they thought they could.