CDC releases flawed review of ME/CFS treatments for public comment

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On May 16th the U.S. Centers for Disease Control and Prevention (CDC) published a notice of request for public comments on its systematic review draft report for diagnosis and treatment of ME/CFS which will remain open until August 16, 2021

You might not realize it from the above description, but this is the latest milestone in a years-long fight by ME advocates to stop the harm wrought by the PACE trial and other flawed CFS research that has been misused to promote the use of graded exercise therapy (GET) and cognitive behavioral therapy (CBT) as purportedly effective “treatments” for people living with ME. 

#MEAction has been closely monitoring the CDC on this issue, and the contractor who produced the report, the Pacific Northwest Evidence-based Practice Center (EPC) at Oregon Health & Science University. While our full technical response to the draft report will take some time to complete, there are problems that are clear after even an initial review. CDC should never have released this flawed EPC report as it currently stands, and it is so problematic that #MEAction will call not only for its revision, but for CDC to stop its publication.

Read on to find our summary of how we got here, the key take-aways, and what we do about it.

HOW WE GOT HERE: A TIMELINE

2014: Problems with the first EPC evidence review

  • Another federal agency (AHRQ) commissioned EPC to produce an evidence review of ME/CFS treatments, which was published in an academic journal.
  • The EPC report concluded that CBT and GET were effective treatments, based largely on Oxford-criteria CFS studies like the PACE trial, which many ME advocates criticized as inappropriate and methodologically flawed.

2015: Advocates fight for a reanalysis

2016: CBT & GET effectiveness claims downgraded

  • The EPC was forced to issue an addendum reanalyzing the evidence, which downgraded its prior claims and showed GET to be useless and CBT ineffective at treating ME. But EPC still refused to publish this addendum in an academic journal.

2018: #MEAction opposes rehiring EPC for new review

  • CDC announced they would begin ME/CFS treatment guidelines development and attempted to quietly rehire EPC to produce a new evidence review.
  • #MEAction petitioned CDC to not hire EPC contractor because of their prior flawed report and refusal to publish the 2016 reanalysis. CDC proceeded with hiring EPC anyway.

2021: New review reproduces old problems, CDC pauses plans for treatment guidelines

  • CDC releases the EPC draft evidence review for public comment through 8/16/21. 
  • The report reproduces many of the same problems in the 2014 review, showing effectiveness of CBT and GET based on PACE and similar Oxford-criteria studies.
  • CDC announces it will not proceed with developing ME/CFS treatment guidelines until more clinical trial data is available.

5 KEY TAKE-AWAYS

1. EPC consistently reproduces flawed evidence reviews

Remarkably, this latest review repeats the same methodological flaws of basing recommendations for people with ME on CBT and GET studies that have a range of methodological defects, including: subjective outcome measures in unblinded trials, outcome switching, problems tracking harms, and use of Oxford criteria, even though EPC had said that Oxford had a risk of including patients with other fatiguing conditions. Its latest review does not acknowledge the 2016 reanalysis that advocates pushed so hard for, and it does not examine the effectiveness of treatments when Oxford criteria studies are excluded. The 2014 review called for the Oxford criteria to be retired, but the current review does not and it draws conclusions for people with ME based on trials such as PACE with its poor methodology and use of Oxford criteria.

2. CDC without excuse, ignores ME advocates warnings

The CDC went into this latest attempt to develop treatment guidelines having been made fully aware by ME advocates of the problems with EPC’s 2014 review. There is no excuse for CDC putting out yet another flawed report that reproduces all the same problems from the prior evidence review all over again. This yet again demonstrates the failed leadership at  CDC.

3. Good news: CDC puts treatment guidelines on hold

Some people have wondered whether this draft report means that CDC might reimplement CBT and GET as recommendations for ME/CFS treatments, but this systematic evidence review was only an initial step in CDC’s process of developing treatment guidelines. CDC has already announced that they will not pursue developing ME/CFS treatments guidelines at this time. #MEAction wrote to CDC Chronic Viral Disease Branch Chief, Dr. Beth Unger, and she stated:

“…the systematic review provided little new data and the process for guideline development would not be likely to provide an advance over what is currently available from the ME/CFS Clinician Coalition and IACFSME. We will be completing the Systematic Review and will not be proceeding with guideline development until clinical trial data becomes available.”

4. Bad news: publishing flawed review would harm people with ME

This report can still do harm to the ME community, even if the CDC doesn’t use it to develop its own treatment guidelines. If it is published in a peer-reviewed academic journal, as the 2014 review was, it could still be used by other entities to present an erroneous view of ME and promote the continued use of inappropriate CBT and GET “treatments.” There will be no opportunity for community review of the finalized evidence review, so it will be important that CDC hear from us how strongly we oppose any publication of this flawed report, which cannot be resolved through minor revisions.

5. NIH indicted by the lack of evidence to review

Despite all its flaws, this evidence review shows that the NIH has clearly failed in its promise to accelerate ME/CFS research and expedite clinical treatment trials for people living with ME. The CDC says its guidelines cannot proceed without more clinical trial data. #MEAction has repeatedly called on the NIH to expedite clinical treatment trials, but they continue to leave this disease stuck in a decades-long time-warp. Earlier this month we urged Congress to hold the NIH accountable for expediting clinical trials of repurposed drugs used in treating ME/CFS as part of its $1.15 billion research funding for Long COVID. This evidence review’s findings of a lack of progress in treatments for ME/CFS is a stark indictment of the NIH’s inaction and failed leadership.

WHAT WE DO ABOUT IT

#MEAction will be carefully evaluating the entire systematic review draft report and preparing a detailed response to CDC, which we will make available beforehand to anyone who wants to sign-on and support. Join us on Wednesday, June 23rd at 3pm ET for a community town hall. We will share our interim evaluation of the CDC’s draft evidence review and discuss ways we can oppose this report causing further harm to people living with ME.

While anyone can submit a public comment on the draft report, #MEAction will not be mobilizing identical individual comment submissions with the same technical analysis or revision recommendations, as CDC has said it will simply remove any duplicative comments. You will have a chance to review and sign onto #MEAction’s technical comments before we submit them.

As necessary as a technical response is to this flawed evidence review, it is clearly not sufficient to stop the cycle of harm or to force federal agency accountability. For years, advocates have been giving the same fundamental feedback on the methodological flaws and inadequate protocols of these evidence reviews for dealing with an evidence base that has been polluted by PACE and similarly flawed studies, only for CDC to ignore them. #MEAction is committed to equipping our community for activism that channels all of the wisdom and the rage of those who have come before us, and to transform our individual suffering into community power. Together we can hold federal agency leaders accountable and demand our government work for people with ME.

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18 thoughts on “CDC releases flawed review of ME/CFS treatments for public comment”

  1. Nothing of any permanent significance will happen until MEAction is represented by lawyers. Period. End of story. Class action needs to begin NOW while CDC and NIH are already under pressure due to COVID climate. It is the only way to win at negotiation.

    1. As I said, too. I truly do not understand why this route has not been explored/discussed more in the advocacy community. The legal standing IS there. You’d be hard-pressed to find a lawyer who didn’t agree with that, believe me, I’ve done my homework there. But as to actually retaining and using one… where is everyone???
      Accountability from organizations like the NIH seems far more likely to come from a judge than waiting around for Francis Collins to grow a conscience. I believe in advocacy. I DO! Hell, I’d be in Congress myself if I weren’t bedbound. But when empty promises is actually willful negligence, you don’t need a letter, you need a lawyer.

  2. It is unconscionable that this type of treatment for ME/CFS is still being accepted and promoted by the medical community. At the last International ME/CFS conference five years ago in Fort Lauderdale, Dr. Anthony Komaroff still had GET and CBT up on his presentation slides as suggested treatments. I confronted him about it and he sort of brushed it off and said: “Well we don’t really believe that anymore.” I replied, “then why don’t you take it off your slide?”
    There has to be some drastic response from our group to this–something equivalent to the AIDS supporters who confronted Dr. Fauci in person years ago!

  3. I’m so sorry to hear about this latest frustration. Thank you for your endless hard work keeping up the fight 🙏

  4. Everything, EVERYTHING, I come across regarding the NIH regarding ME increases the volume of the voice in my head screaming ” CLASS. ACTION. SIUT! FOR GROSS NEGLIGENCE++!”. The CDC has been far better on the surface as this monstrosity of medical malfeasance percolate but now that it seems to have come alive, we can’t just kill IT, the report… the CDC needs to be lumped in with the NIH regarding the willful neglect of their fundamental duty and purpose. It is ludicrous to believe that if this level of corrupt behavior covered in platitudes were to occur regarding a disease like Parkinson’s or ALS that they wouldn’t find themselves on the ugly side of both class action suits from patients and Katie Porter’s whiteboard at a Congressional hearing they’d been subpoenaed to attend. But because they’ve been so successful in both neglecting AND hiding/smearing our disease, they face no recourse except letter campaigns and a grassroots smattering of semi-bad-ish press.
    If we weren’t all so damn tired, too tired to do more than feel sick, the truth is we have a case. A ‘change how medical research is done in america’ type legal case. But like jocks bullying the kid in a wheelchair, They know we can’t keep up. They know why. What a painful irony… like an abusive relationship. They’re big and strong and know we are too weak to expose the mountains of evidence they don’t even bother to hide… the diplomatic route is within our energy envelope, like a lady’s place is in the kitchen.

    It just.., it reminds me, always, of Congressional testimony Anthony Fauci (who I genuinely respect but have some pointed questions for) gave way back in 1990-ish… essentially, he said “the reason no individual institute of the NIH was stepping up to volunteer to have Chronic Fatigue Syndrome under their umbrella was that NONE of them understood it, it was just a real stumper that one. It was HARD. The whole body was affected, so strange. So no one wants to be responsible for it.”

    I read a paper in a medical journal, a big one but I can’t remember which, about Long Covid a few months ago. Laughed my behind off when I realized that I just read over ten pages that stretched out the sentiment “SOOO many symptoms! Never seen anything like it! Confusing! No idea wtf is going on but horrible, isn’t it?! Not a clue what to do though. Just thought I’d write this paper about how MANY symptoms these people have and reiterate that we have NO CLUE what is happening or why or what to do or… anything. CRAZY TIMES. ”

    I wonder if anyone, any ONE of the people ten, twenty, 30 years ago that made the decision not to care about us has realized now what they’ve done.

  5. Elizabeth Siess

    Worse than useless. This feels personal. Follow the money. Follow the personal connections. There are 17 other review agencies that could have done the work.

    Ron Davis and Francis Collins must have been colleagues at Stanford / Genome Project. What is that relationship like?? Why so little support for OMF??????

    I would keep an eye and ear out for yet another Francis Collins book – maybe something like, ‘How Hope and Prayer Cure Long-Covid: and why ME/CFS is a Failure of Faith’.

    IDK. Just a thought…… Or a hunch??

  6. My cousin is a disability attorney (former DOJ), and she said the only thing we can sue for currently is if an employer fails to make reasonable accommodations for any ME/CFS patient as we are covered by the ADA. She recommended suing as many employers as possible, and once case law starts accumulating then we will be taken more seriously. Perhaps we could go case by case and crowdsource funding for each case? Per my cousin, one case can cost $90k – $120k. Just so you know what we’re up against.

    The reason we don’t have a malpractice case is because doctors, the CDC and NIH can all claim ignorance, because nobody knows for certain what causes this disease, there are no biomarkers, and no approved treatments. Ignorance is not a crime.

    Her recommendations were: 1) Merge charitable organizations so we are one united voice (like American ME Association or something similar); 2) Start suing and accumulating a body of case law; 3) Stay on Congress to pass legislation for ME with dollar values attached. No ‘awareness’ days or committees that make recommendations (that doesn’t result in meaningful change). $$$ does.

    I know we lack money and resources, but if we don’t make litigating a priority it’s going to be much of the same for our community. Nobody seems to pay attention if money is not involved. Just a disability attorney’s 2 cents.

    1. For what I was referring to, a disability lawyer wouldn’t be appropriate. A civil rights non-profit with experience in health and suing the government would. And they cannot claim ignorance. There is a case for pattern-and-practice of discrimination, financial malfeasance and negligence. And honestly, the point of a suit of that type, that scale, is less about winning than it is about discovery (documents etc) and public pressure. No one but us, NO ONE BUT US, knows they’ve done this to us. If done correctly, winning the case wouldn’t matter. Taking it far enough to get on Rachel Maddow and ignite a congressional review of this *specific issue* by Congress would. Public pressure beats advocacy every time.

  7. Gunther De Bock

    A class action lawsuit is the only way we can achieve a tangible result and block corruption within advisory committees.

    Keep in mind that ME action as an organization may not have been given an endless life, knowing that it runs on critically ill people. And the david tullers of this world will probably not be able to devote their time and energy to the ME cause endlessly.

    It is also important that a class action suit happens in the US or the UK because that is where the leading organizations such as the CDC and NICE are located.

    It is best to act while the organization is still strong.

    But I also understand that a lawsuit is an energy and time-consuming matter, not to mention the cost.

    Nevertheless, the momentum is now.

  8. the cdc and fauci in the NIH have ignored and betrayed ME and CFS patients for over 35 years and they will continue doing so. Read http://www.me-ireland.org and take actions to get proper diagnosis and treatments for ME and CFS which have a scientific basis and a medical basis.
    D.

    1. Amy,

      The immediate thing #MEAction is preparing is an official public comment response to this CDC evidence review. CDC is required to follow this public input process and we intend to make full use of it as advocates have done with the previous 2014 public comment period on the AHRQ evidence review. We will continue to use advocacy and activism tools to press the CDC. Now is the time to use the public comment process to our advantage to communicate how upset we are with CDC.

      People have raised various ideas for legal strategies in the above comments. I have had personal discussions with some people about their ideas. But #MEAction is not set up as a legal aid organization and we have not hired lawyers or raised the funds to pursue a legal strategy. For those interested in learning more about what was involved in a successful class action lawsuit in the past I would point to the example of the multi-year campaign to get the CDC to change the definition of AIDS to include women. This was a complex, yet successful action that involved a suit against SSA and direct action against the CDC along with a lot of coalition-building with service providers and even insurers to pressure the CDC. It wasn’t about a single silver-bullet strategy, but about various strategies working together in concert. There were also some very difficult trade-offs between what the class action clients bringing the suit wanted and what activists and outside specialists thought would ultimately be the most impactful. You can find a great case-study of this in Sarah Schulman’s “Let the Record Show: A Political History of ACT UP New York, 1987-1993.” Chapter 7, “Changing the Definition: Women Don’t Get AIDS, We Just Die From It.” Page 227. Any contemplating class action law suits would benefit from familiarizing themselves with this history. ACT UP never sued the government but it designed an inside/outside activism strategy that worked alongside the class action suit to ultimately achieve its desired goal of getting the CDC to change the definition of AIDS to include conditions specific to women.

      Sincerely,

      Ben HsuBorger
      US Advocacy Director
      #MEAction

      1. Thanks very much, Ben, for the response, and for the work MEAction is doing to respond to the CDC.
        I should have worded my question differently – I am aware that MEAction is not a legal aid organization, but I agree with the other commenters that a legal strategy needs to be formed without delay. How can MEAction help facilitate this? The publicity and wide-scale awareness alone would expose the discriminatory practices of the CDC and NIH – no matter the nuances or complexities of a lawsuit. If we don’t act accordingly – especially in the current Covid climate – we need to prepare ourselves for more years of inaction from a governmental entity standpoint.
        Thank you again for your continued advocacy!

  9. This is just off the top of my head – which holds a brain that is swimming through mud… But who sued in the UK over the PACE trial, and got that judge to order an independent review, and the PACE trial thrown out? What can we learn from them? Can we collaborate with them in some way? Are / can their lawyers be licensed in the US? And can we bring pressure to bear from the World Health Organization in some way? Especially now, with Long COVID in the picture world wide.

  10. Thank you MEAction for your relentless perseverance in ALL that you are doing for our community!!! Thank you for your review of, and alerting us to this contracted CDC guidance issue, and issuing a formal response to it. You are appreciated!!

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