Rest In Power, CFSAC

image credit: D. Fiorito

The Chronic Fatigue Syndrome Advisory Committee (CFSAC) is dead. Both the website and the email listserv made the announcement on September 6th: “The charter for the Chronic Fatigue Syndrome Advisory Committee expired on September 5, 2018.”

A sudden death under unusual circumstances necessitates an autopsy.

One of the major aspects of my advocacy career has been CFSAC-watch. I believe that the end of CFSAC is a significant blow to the ME community, but I also know that we can overcome this damage. I have many more words to say, but in this post I will address:

  • Who knew the charter was at risk
  • Why the committee may have been killed
  • Why this matters
  • What happens next
  • Statements from nine twelve committee members (voting/non-voting) (updated September 7th at 6pm)

Who Knew The Charter Was At Risk?

CFSAC was a federal advisory committee created at the discretion of the Secretary of Health and Human Services (in the U.S.). A charter is required under federal law for such a committee, and the maximum length of a charter is two years. CFSAC’s charter has been renewed every two years as required since its inception in 2002. Sometimes, effort was required from advocates and organizations to secure the renewal, but it has always been renewed.

This year, it was perfectly reasonable to assume the charter would be renewed as a matter of course. All the signs pointed in that direction.

At the June 20, 2018 meeting, Admiral Brett Giroir (Assistant Secretary for Health) spoke to the committee and said:

Your role is really critically important because we need the outside input, the outside expertise, the outside perspective . . . And you certainly have my full support and everyone here knows that if I can do anything to support the functions or the deliberations of this committee, I’m here to serve. (emphasis added)

The same day, Ms. Nicole Green (Acting Director for the Office on Women’s Health), seemed to make a commitment to renewal when she said:

I would like to provide you with a quick update on the CFSAC Charter which currently expires in September. . . We have already started the process to consider the charter status and we’ll finalize that as soon as possible. . . In March we posted a federal register notice to fill these last remaining vacancies and I am happy to report that we received a number of applicants. My office is committed to keeping this process moving. (emphasis added)

I have also learned that members of CFSAC did not know the Charter was at risk. Dr. Faith Newton, Chair of the Committee, told me, “I had no idea that this [charter expiration] was even a possibility or under consideration.” (see below for the full text of statements from members). The Committee was preparing for its meeting in December, and the working groups were actively meeting as recently as the last few weeks. Everything seemed to be humming along fine, and then BOOM. It’s over.

Was the public intentionally misled in June, or did something change? Neither Ms. Greene nor Commander Gustavo Ceinos (the Designated Federal Officer of the Committee) have responded to my request for comment. Updated: I received a comment from an HHS representative at 5:02 pm, September 7th. The full text is in the final section of this post.

Why Was the Committee Killed?

All signs were pointing to another routine renewal. So why was the Committee terminated instead?

It seems highly unlikely to be budget related. According to the Charter, the combined cost of expenses and staff support was only $196,192 per year. It also seems highly unlikely that there was difficulty filling the six empty voting slots, since Ms. Greene said they received a number of applications in April.

There is no evidence of a general house-cleaning of advisory committees. An anonymous advocate looked at the other advisory committees operated within the Office of the Assistant Secretary, and it appears that CFSAC is the first one to be terminated under the current administration.

Trying to figure out why the Committee was killed is speculative. Was it because the Committee was moving in a more substantive and cross-agency direction? Were the nominations submitted in April overwhelmingly displeasing to HHS, and they killed the Committee rather than fill the slots? Was it an active or passive lack of interest from the higher levels of HHS? Did they think we would not object to this decision?

There is simply no justifiable reason to terminate CFSAC at this point in time. That leaves two possibilities: either HHS could not be bothered, or HHS wanted to kill the Committee because it was problematic for them.

Added September 7th after initial publication: According to Jill Wasserman in the Office of Women’s Health:

HHS leadership reviewed the Chronic Fatigue Syndrome Advisory Committee (CFSAC) charter, duties and accomplishments as is required by the GSA and in the context of the FACA provisions. The Department feels that the committee accomplished the duties outlined in its charter, and its original mission has been amplified and disseminated throughout many agencies within HHS and across government. (emphasis added; full statement in the final section of this post)

This is trash. What is finished, such that the agencies can now operate on autopilot? Most of CFSAC’s recommendations have not been implemented. The Committee’s working groups were midstream in preparing recommendations for the next meeting. Neither CDC nor NIH knew in advance that the Committee was being terminated. The assertion that it was time for CFSAC to take a bow and exit stage right is absolute, unadulterated garbage.

Why Does Killing CFSAC Matter?

The death of CFSAC is very bad for the ME community. Advocate Mary Dimmock was blunt:

I’m beyond livid with the whole stinking mess. The sudden dissolution of CFSAC is symbolic of the insufficient commitment, leadership, and sense of urgency needed to rapidly advance the field and relieve the suffering of more than a million Americans.

Here is what HHS has taken from the ME community:

  1. Transparency. Representatives from the many agencies had to report in public on what they were doing about ME.
  2. Focus. CFSAC was the only government entity with the sole focus of ME/CFS.
  3. Influence. Pressure from the CFSAC members led to the CDC reexamining its website and medical education. CFSAC forced the issue of diagnostic criteria, and also consistently pressured NIH to do more.
  4. Representation. CFSAC was the primary vehicle for the public to talk back to the federal agencies, both through public comment and through the experts serving on the Committee.
  5. Coordination. CFSAC brought together representatives from multiple agencies (and more recently, other departments).
  6. Labor. People with ME dedicated hundreds (perhaps thousands) of hours to support the work of CFSAC. We have offered public comment, sometimes from bed. We have served on working groups. We have invested our precious energy to make CFSAC better.

Terri Wilder, an activist living with ME who also represented #MEAction on CFSAC, summarized it very well:

As frustrating as the process may feel at times CFSAC is one of the very few spaces that the community has a seat at the table with key stakeholders. This is a HUGE loss to the community. I’m very disappointed that the current Secretary does not see the value in our community or recognize the challenges we face in scientific discovery and receiving expert clinical care while living in a world full of stigma.

I have worked on CFSAC issues for years. As far as I know, I’m the first advocate to openly track who nominated each member of CFSAC (also here and some FOIA requests are still pending). When I discovered CFSAC had violated the Federal Advisory Committee Act in 2012, I reached out to Public Citizen and got their help in solving the problem. I found another violation in 2014, and went directly to HHS about it. Perhaps more than any other advocate, I have documented a very long and very specific list of problems with CFSAC over the years.

So listen when I tell you: we need a federal advisory committee dedicated to ME. Full stop. The work of this committee is an essential part of requiring the federal government to help people with ME.

What Happens Next?

The ME community cannot be silenced.

The Solve ME/CFS Initiative has launched an easy way for people to write to their members of Congress and ask for a Congressional advisory committee. (see below for a long comment from SMCI)

#MEAction said, “What we’re fighting for is nothing less than our voice as a community — our lives as a community — and we refuse to be erased.” #MEAction is holding a protest in front of HHS office in DC on Friday, September 14th. Please join or share this event with anyone who could show up. For those who can’t be there in person to protest, you can protest through social media.

I say again: the ME community cannot be silenced. #HearMEnowHHS

Full Reactions from Members and Representatives

I reached out to the members of CFSAC and asked for their comments on the termination of the Committee. I decided to print every comment I received, in full. It is worth taking the time to read them.

Voting Members of CFSAC

Dr. Faith Newton, Chair of CFSAC, told me:

I was shocked and surprised to learn that the CFSAC charter had not been renewed.  I had no idea that this was even a possibility or under consideration.  I am looking into if and how we can support the continuation of the working groups or integrate them into what the federal agencies are already doing given their mission.  Please understand that I personally do not view the revocation of this Charter as any reason whatever to give up on the policy based gains we have begun making; it is instead both a challenge and an opportunity for all of us to pursue new organizational structures and locate additional support to continue this critical work. (emphasis added)

Dr. Cindy Bateman said:

The email notice I received today that the CFSAC Charter was not renewed took me completely by surprise. I was Chair of the Medical Education Working Group actively working on critical issues related to ICD coding and facilitation of physician education. We had a newly formed Suicide Ideation Working Group pulling together resources for patients in need. Amrit Shahzad led an active Clinical Trials and Treatment Working Group exploring paths to ME/CFS treatments. I’m afraid the important investments and recommendations by these groups will be lost. While I am optimistic about progress within the NIH regarding funding and promotion of scientific research related to ME/CFS, these agencies are not involved in these important issues addressed by the Working Groups of CFSAC. I’m very sad to see it come to such an abrupt end. An important voice has been silenced.

Dr. Gudrun Lange told me:

It is a real shame that this happened and a huge step backwards to further knowledge about ME/CFS and the well-being of our patients.  I am very disappointed that this action was taken!

Dr. Amrit Shahzad spoke on behalf of CFSAC’s Clinical Trials and Treatment Working Group:

The announcement of CFSAC termination came as a shock to the Clinical Trials and Treatment working group. The recommendation to form this working group was made at the CFSAC meeting in December 2017 with the mandate to engage the biopharmaceutical industry and to identify effective ways of promoting drug development in ME/CFS. In the few months we’ve had to work together as a team, we feel tangible progress was made. With the unexpected non-renewal of the CFSAC charter, we stand to lose the hard-earned progress made by our and other working groups. This morning, the members of the Clinical Trials and Treatment Working Group have reaffirmed their commitment to the objectives; we will strive to continue our work as a team despite absence of CFSAC’s formal structure.  Beth Unger relayed CDC’s firm intention to remain committed to continuing to work with us and other stakeholders to advance knowledge about this devastating illness and improve the lives of those living with ME/CFS. We are hoping support from other agencies as well. The ME/CFS community is tough and resilient and will persevere.

Dr. Alisa Koch (updated since initial publication): I would say I am very sorry to see this go as I think we have done a lot of good for patients.

Dr. Jose Montoya did not respond to my request for comment. Donna Pearson declined to comment.

Federal Members of CFSAC

Dr. Beth Unger of CDC sent me the following statement:

Staff in CDC’s Chronic Viral Diseases Branch, which includes the myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) program, were recently made aware of the decision by the U.S. Department of Health and Human Services not to renew the charter of the Chronic Fatigue Syndrome Advisory Committee (CFSAC).

During the past several years, CDC experts have used many different ways to engage with ME/CFS stakeholders, including people who have ME/CFS and their loved ones. We remain committed to continuing to work with our partners to advance knowledge about this devastating illness and to educate the public and clinicians about ME/CFS through our website, patient-centered calls, continuing education and other means. For specific questions on the CFSAC decision, please reach out to HHS’s Office of the Assistant Secretary of Health.

Dr. Vicky Whittemore, NIH’s representative on CFSAC, said:

The CFSAC is an HHS committee. Even though the CFSAC charter was not renewed, NIH is committed to research on ME/CFS. Over the past few years we have ramped up our efforts on ME/CFS significantly, including reinvigorating the Trans-NIH ME/CFS Working Group, doubling research funding for this disease, launching a clinical trial at the NIH Clinical Center to closely examine the clinical and biological characteristics of post-infectious ME/CFS, establishing three Collaborative Research Centers (CRCs) and a Data Management and Coordinating Center focused on ME/CFS, and collaborating with the CDC to develop Common Data Elements for ME/CFS. NIH also hosts regular telebriefings with the ME/CFS community to provide updates on our activities and answer questions. The National Institute of Neurological Disorders and Stroke, which is the lead institute for the Trans-NIH ME/CFS Working Group, has recently formed a working group of its advisory council to provide scientific guidance on how best to advance ME/CFS research at NIH. The working group includes basic scientists, clinicians, federal partners, advocates, and individuals with ME/CFS. For questions regarding the CFSAC charter, please contact the Office of the Assistant Secretary for Health.

Both Dr. Unger and Dr. Whittemore referred me to the Office of the Assistant Secretary. However, I will point out again that neither Nicole Greene nor Commander Ceinos responded to my request for comment.

Updated: I received the following comment from Jill Wasserman in the Office of Women’s Health at 5:02 pm, September 7th:

On behalf of an HHS spokesperson and in response to your questions about the expiration of the HHS Chronic Fatigue Syndrome Advisory Committee charter:

We wanted to reassure the community that the expiration date was on our radar and, in fact, the necessary processes had begun. These statements you quote describe our due diligence to begin the process for consideration of the charter’s renewal/expiration and concurrently prepare for potential renewal.

To put the decision in context: The committee, which has been in existence since 2002, is a discretionary committee under the Federal Advisory Committee Act (FACA). A discretionary committee is established under the authority of the HHS Secretary and its establishment and termination are under the legal discretion of the Secretary.

The General Services Administration (GSA) mandates that one of the Secretary’s responsibilities under FACA is a regular review to continue or terminate a committee housed under his/her agency.  Also, the FACA and related policies are clear that the Committees are intended to be short-term and time-limited.

HHS leadership reviewed the Chronic Fatigue Syndrome Advisory Committee (CFSAC) charter, duties and accomplishments as is required by the GSA and in the context of the FACA provisions. The Department feels that the committee accomplished the duties outlined in its charter, and its original mission has been amplified and disseminated throughout many agencies within HHS and across government.

During its unusually long tenure, the CFSAC advised the Secretary of Health and Human Services on a number of issues related to myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). The committee and ex-officio members ably fulfilled the duties in the charter, which included advising and making recommendations on strategies to inform public and health care professionals about advances related to the disease, and strategies to ensure that input from individuals with ME/CFS and caregivers was incorporated into Departmental research now being conducted by NIH and CDC.

Agencies will continue to work with advocates to support the critical research necessary to discover the causes and treatments for this disease.

The agency ex-officio representatives have already received copies of the June recommendations for consideration in their future work. The recommendations will be compiled per usual and posted on the website for archiving.

Do you have any additional comment?

The Secretary, on behalf of the entire Department of Health and Human Services, wishes to thank the committee and its many members who served so diligently over the years for their hard work and dedicated service. He also wishes to thank members of the public and the advocate community for their participation on various work groups, as well as for their support and dedication to this cause. HHS remains committed to working with stakeholders to support the critical research necessary to discover the causes and treatments for this disabling disease.

Non-Voting Liaison Representatives

#MEAction issued strong words and launched a protest.

Charmian Proskauer spoke on on behalf of the Massachusetts ME/CFS & FM Association:

The Massachusetts ME/CFS & FM Association has long strongly supported and actively participated in the work of the Chronic Fatigue Syndrome Advisory Committee. In recent years there have been significant changes giving patients and advocates more voice and more opportunities to help create positive outcomes.

We were shocked and deeply dismayed to learn of its abrupt termination and will work actively with other advocates to call on congress to establish a permanent ME/CFS Federal Advisory Committee through congressional action. We will also petition the Office of Women’s Health to re-charter CFSAC immediately so that the momentum we have built and the projects we have begun with our federal agency partners are not interrupted.

Courtney Miller of Simmaron Research has not yet responded with a comment.  (updated) said:

CFSAC is immensely important as the sole mechanism for engagement between disease experts, patients and our federal health agencies. It contributed to a recent turning point in federal recognition and research, following publication of the Institute of Medicine and Pathways to Prevention studies. Until yesterday, I represented Simmaron Research on CFSAC, working collaboratively with members and advocates on the Treatment Trial Working Group. For a disease with no diagnostic test and no FDA-approved treatment, the Secretary’s decision to disband CFSAC is a jarring setback for all of our work to treat ME/CFS patients with respect and the federal commitment we deserve. CFSAC’s work is by no means done.

After SMCI launched their call to action last night, I asked a few questions and indicated my commitment to publish comments in full. Emily Taylor responded as follows:

JS: When did you learn the CFSAC charter was in jeopardy?

ET: Like the members of the committee and the public, we were blindsided by the announcement yesterday. It was our first notice that CFSAC would not be renewed.

JS: What actions, if any, did SMCI take to advocate for renewal of the charter?

ET: Prior to this announcement, we were troubled by many of the actions of the committee. We saw “red flags” such as the failure to approve new members, delayed responses to meeting scheduling questions, and other areas of concern. We repeatedly expressed these concerns to the DFO and other ex-officios. SMCI regularly inquired of HHS staff and the DFO about the future of the committee, but never received any response that indicated to us that it was the agency’s intention to shut down the committee.

JS: Will you ask Congress to add the creation of a new committee to specific legislation? If so, will you append it to something like a healthcare bill? Or will it be ME-specific legislation, whether an authorization bill or some other bill?

ET: There are several avenues of approach (just as you describe) and we are open to pursuing all statutory and agency-based solutions. At the same time, we recognize that advocacy work is complex and constantly shifting as the political winds blow. And we are not doing this alone. We are so proud to be working with #MEAction and others in the ME/CFS community and making every effort to work in synergy, best leveraging our precious energy and resources for results.

I would describe our approach as strategic, yet flexible and opportunistic. Our priority and first choice strategy is stand-alone ME/CFS legislation which addresses the needs of ME/CFS beyond just the Federal Advisory Committee, but also creates additional grant programs and funding for ME/CFS research and education. If we are unable to accomplish that, attaching language to another bill that creates a committee and grant programs (with funding!) is a strong second choice strategy. Ultimately, we are results driven. If another opportunity or avenue becomes available to secure funding, investment, and a new committee for ME/CFS, we will pursue it if we can.

JS: Will that call to action go to each signer’s member of Congress? Will it go to any other recipients?

ET: SMCI’s congressional messaging system is a one-click activism tool which sends messages directly to the user’s member(s) of congress, linking directly into the Capitol’s digital messaging system. SMCI retains a record that the message was sent – but no other person receives a copy except the user, if they choose. It is a great system (especially for those who are unwell) to easily and quickly participate in advocacy.

For those with additional energy, the “thank you” redirect page which you see immediately upon completing the action, contains a step-by-step walkthrough for additional ways for folks to continue their efforts.

JS: What is your measure of success for this initiative?

ET: Like all of SMCI’s actions, we measure multiple levels of success. One of my mentors in Washington DC taught me that any action should create success and forward progress, even if it fails, so that no effort is wasted. Even failed short-term goals put your effort in a better long-term position. I bring that strategic thinking to all SMCI’s advocacy work.

In the short-term, increasing the visibility of this issue will help bolster existing/ongoing efforts and ideally combine with those efforts into a larger comprehensive ME/CFS action. In the middle-term, I expect this issue to bring new allies and champions to the table, help us build a broader coalition of support in congress, and *fingers crossed* push our joint-effort with #MEAction to hold a hearing in the House about ME/CFS across the finish line. In the long-term, I would measure the success of this action by the creation of a new, better, federal advisory committee for ME/CFS, an opportunity for the ME/CFS community to participate in re-writing a new charter for the committee, and creating a legislative vehicle through which we can execute our other strategic goals (like increased research funding, medical education, and more!).

JS: What specifics do you envision for such legislation, such as which agency will be responsible for operating the committee and what the committee’s specific charge should be?

ET: At this stage, it’s a bit premature to outline such specifics since the legislative language which will go through my [sic] versions and compromises before finalization. Broadly speaking, committees like this are generally housed in HHS and depending on the language of the statute can be inside or outside Federal Advisory Committee Act (FACA) standards. Ideally, I would like to include legislative direction regarding committee responsibilities, reporting, membership, and length of committee existence.

JS: Any other comments you would like to make?

ET: On a personal note, I am really hopeful and encouraged. I know this work can be so frustrating at times, especially when something unexpected, like the disbanding of CFSAC, happens. But, these setbacks can be opportunities in disguise. I am so proud of the advocacy work for ME/CFS these past two years and I want to send a special “shout out” to the ME/CFS Advocacy community. Thank you to our friends at #MEAction, USAWG, and the hundreds of independent advocates, patients, and loved-ones who have participated and fought with us.

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24 Responses to Rest In Power, CFSAC

  1. Joey H. says:

    My stomach is in knots.

    To be fair, this might be the single most honest statement HHS has ever made concerning their feelings about people with ME.

  2. JP says:

    Thanks Jennie, for quickly pulling together the interviews, and laying out the sparse facts regarding the abrupt ending, or the Committee’s RIP.

    Even though the event leaves many questions in my mind, and feelings of victimization, my logical mind aligns more with the SMCI statements. If we ALL rise up, and show our strengths in numbers, this could be an “opportunity in disguise” to make further improvements, gain more awareness, and garner more support.

  3. Rivka says:

    Contacting my members of congress now!
    – rivka

  4. Eileen Kelly says:

    Keep up the good work! Thank you!

  5. jimells says:

    Just a vague idea… would the CFSAC members consider calling a press conference to announce the charter non-renewal? Are there any health reporters that would bother to attend?

    This is the second time our advisory committee has been killed. The original “CFSCC” was established in 1999 and had its last meeting in June 2000. The recently deceased “CFSAC” first meeting was Sept 2003.

    A topic of the first “CFSAC” meeting was, in a cruel twist of the bureaucratic knife, the 2003 termination of the three original Cooperative Research Centers. The meeting minutes include the cryptic notation “the centers not be re-bid because they are located in Section 39, which was disbanded.”

    • Emily says:

      Can you tell us how/why they were willing to start the first CFSAC? Did it have anything to do with the misappropriated funds? ( my memory is so terrible these days) If so I think that would be a strong case for precedent that oversight is necessary.

      Jennie, thanks so much for this work.

  6. Bazia says:

    Thanks for all this info.
    I’m all for seeing this as an opportunity!
    I’ve already contacted my representatives.

  7. Kathryn Stephens says:

    I have always questioned why the CFSAC members did not request a personal meeting with the head or undersecretary of HHS. If this is not the time to do this, I don’t know when would be better. So few recommendations taken into consideration, or approved; so little honest concern for patients who have just about killed themselves to travel and be in attendance at meetings; and so little funding for such a devastating disease: all of these should make us not so surprised at this ignoble ending.

    Maybe we could talk NINDS into having the next advisory committee? If ME is truly in their baliwick, maybe they should get the funding for a committee and they should be the Institute at NIH to spread awareness, recommend policy to other government agencies, and recruit researcher and educators. They might be able to do a better job of it than ORWH or the CDC.

    FYI: I see another patient/advocates name and email in the blanks required to post a comment. Mine may be there next?

  8. Debbie Iverson says:

    Jennie, from the bottom of my heart, thank you. I can’t imagine where we’d be without your advocacy and extreme dedication.

  9. Terri says:

    If they think the committee accomplished the duties outlined in its charter they are delusional. How have we accomplished these “duties” when hardly any of the recommendations were accepted! #shame

  10. I may die before this disease is solved. That’s a horrible thought.

  11. Lisa Petrison says:

    Thank you for looking into this and summarizing the information here.

    Do most recognized diseases have advisory committees? I would be interested in knowing which other ones do vs. do not have them.

    I agree that writing to Senators and Representatives is a good idea, and I did that myself last night. Solve ME/CFS’s setup took me only a minute or two to complete.

    Hopefully many other people will take action in contacting their own elected officials, even if they cannot join an in-person protest.

    This is all very disturbing and suspicious.

    • Jennie Spotila says:

      Very few diseases have dedicated advisory committees, and many of those were created by Congress. CFSAC was pretty unique, which makes its loss even worse.

  12. Scott says:

    Given the reality of ME in America, it boils down to one of two explanations:

    Incompetence or corruption.

    Follow the money. What government or corporate entity / industry will benefit, or have their benefits protected, by the dissolution of the committee?

  13. Janet Flynt says:

    Thank you so much for the well-researched
    and much needed clarification. Emily’s experience is well-heeded.
    Use the change to create more awareness and
    new opportunities.

    The last meeting of the Trans-NIH wg
    discussed expanding membership to outside
    the NIH. Maybe Dr. Koroshetz has additional
    clarification. Also the current private organizations have
    joined our voices and can continue to move the CFSAC
    activities forward. For me, one challenge is to get private
    funding to accomplish this.

    • MS says:

      It is always good to get private funding but recognize that private funding — especially at the basic sciences level — is dwarfed by federal funding. Most private funders are a) reluctant to fund areas where the basic science is not well worked out yet and b) for which they don’t see a financial return on their investment. There are some funds which have social instead of financial goals (e.g. private foundations, nonprofits) but private money is often profit-driven.

      Also — and I say this as a researcher — federal funds have less restrictions than private funding. In fact, I was warned about private funding by several mentors as a young researcher because I was getting flyers from private funders. My mentors were dynamic people who knew how to work the system to get their work funded and were hardly traditional/ orthodox. One was in high demand and regularly consulted for private companies. However, they told me to watch out for restrictions (about how much I could ask for, the content of my work, who I could work with, who I would need to vet my work before publication, etc.) and rules.

  14. Liz Burlingame says:

    Jennie, Incredible reporting! Incredible. I have one question — I seem to recall that the current administration shut down the HIV/AIDS Action Committee at the end of 2017. Is CFSAC the second committee to be silenced?

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