Trial By Error: The CDC’s Pathetic Response to Reuters

By David Tuller, DrPH

The recent Reuters article about the illness, or cluster of illnesses, variously called CFS, ME, CFS/ME and ME/CFS was problematic for many reasons. One of them was the information included from the US Centers for Disease Control and Prevention. In explaining why the CDC dropped its longstanding recommendations for cognitive behavior therapy and graded exercise therapy, Dr Elizabeth Unger, chief of the chronic viral diseases branch, repeated the tired trope that the agency believed people had “misinterpreted” what it meant.

It is long past time for the CDC to drop this unconvincing claim. As a public health agency, it has a responsibility to acknowledge when it has made mistakes, as it has in this case, rather than advancing absurd arguments to cover its tracks.

Let’s review the history. Prior to the summer of 2017, the CDC removed its continuing medical education module on the illness, which included references to PACE. Although the agency left recommendations for CBT and GET in place on the website, it positioned them as generic management strategies. This was clearly nonsense–a face-saving way of not admitting error. For one thing, the agency does not routinely recommend CBT and GET as generic management strategies for other chronic illnesses. For another, the CME module had linked the treatment recommendations directly to PACE; only after the module was removed were CBT and GET deemed to be generic management strategies.

When the CDC removed the recommendations themselves two years ago, it did so quietly. The change became public after I noticed it mentioned on an advocacy forum and then questioned the agency. At that point, I received a statement explaining that the recommendations had been removed because people had expressed “confusion” about what the agency meant by CBT and GET. Apparently Dr Unger conveyed a similar message to Kate Kelland, the Reuters reporter.

Note to Dr Unger: No one who knows anything about this field misinterpreted what the CDC meant in recommending CBT and GET as treatments. By pushing this untenable argument, you make yourself and the agency look ridiculous. Please just acknowledge that the CDC got it wrong in endorsing PACE and the CBT/GET paradigm in the first place.

As clearly explained in the 2011 PACE paper in The Lancet and other publications, the two treatments were based on the unproven theory that patients’ persistent symptoms were perpetuated by deconditioning. This deconditioning was itself, per the theory, caused by sedentary behavior arising from unhelpful beliefs about having a physical illness that could be exacerbated by excess activity. The goal of the treatments was to reverse these unhelpful beliefs and the attendant deconditioning through a mix of psychological and behavioral strategies.

Yet PACE was an open label trial that relied on subjective outcomes—a study design that generates an unknown amount of bias. The trial also used a broad definition for the illness that has been shown to identify many people who don’t actually have it. Moreover, the study’s reported success on the subjective measures was possible only because of dramatic changes to the methods of assessing these outcomes. Finally, in PACE, the objective outcomes all failed to match the subjective reports—a failure downplayed by the investigators and their enablers.

The CDC has adopted the new definition of the disease presented in a 2015 report from the US Institute of Medicine, now the National Academy of Medicine. The 2015 report found that the illness is associated with neurological, immunological and energy metabolism impairments that cannot be attributed to the effects of deconditioning. According to the new definition, the cardinal symptom is not fatigue per se but “exertion intolerance”—the tendency to suffer relapses after minimal activity, often called “post-exertional malaise.”

And if exertion intolerance is the cardinal symptom, then a program of steadily increasing exercise like GET would clearly be contra-indicated. So would the form of CBT used in PACE, which was designed to alleviate patients of the supposedly unhelpful beliefs about their illness that purportedly kept them from engaging in activity.

For years, the CDC—the country’s lead public health agency–placed its faith in PACE. Yet the study was riddled with methodological anomalies that first-year epidemiology students can spot. In PACE, for example, participants could be “recovered” or “within normal range” on key outcome thresholds at baseline, before any treatment at all—a feature that should have disqualified any trial from getting published. These problems were immediately evident to patients. Why did the CDC fail to notice?

The CDC has evaded answering this question by pretending that readers “misinterpreted” its advice rather than admitting that agency officials themselves screwed up big time. And the CDC’s refusal to provide an honest accounting—to state that it removed the CBT and GET recommendations because the science it had previously cited could not in fact be defended—is disturbing. This abdication of responsibility allows biased and misguided reporters like Kelland to suggest, without evidence beyond the speculations of PACE defenders, that the agency acted under pressure and intimidation from science-illiterate patients.

The CDC’s statements and actions matter because other medical institutions and public health agencies follow its cues. As soon as the agency removed the CBT and GET recommendations in 2017, it should have launched a serious outreach effort to alert medical providers of the change. That it did not helps explain why major centers like the Mayo Clinic have continued to push ME/CFS patients toward psychotherapy and exercise-based treatments despite the lack of quality evidence to support their use. (The CDC has recently updated its website material for medical professionals, but it has still done far too little to counter the potential damage from its past recommendations.)

Given the history, I suppose it is not surprising that the CDC and Dr Unger continue to disappoint in this domain. But it is nonetheless very, very dispiriting. Even after all this time, they appear unable to act in ways deserving of their leadership roles.

Comments on this entry are closed.

  • Bill Clayton 25 March 2019, 12:30 pm

    Thanks for this David. Many within the ME Community would love to write letters on this subject but just the thought of trying to put one together exhausts us, so your support is appreciated as always. I always shake my head when I read the deconditioning theory. I was running marathons then hit with ME. Going from extremely fit to unable to walk is a bit more than deconditioning I would suggest !

  • Anil van der Zee 25 March 2019, 12:36 pm

    This statement was also mentioned by a Dutch program called the Monitor in the Netherlands. This was in 2018…

    “That is why we send an email to Elizabeth Unger: Because not mentioning the therapies also means that the CDC discourages their use? And on what basis?

    Unger replies: “Feedback from ME / CFS patients and their loved ones showed that those terms can be confusing to the public and sometimes misinterpreted by doctors who are not familiar with ME / CFS. They were also sometimes misinterpreted as healing treatment that has not been shown to be for the majority of patients.”

    https://www.google.com/amp/s/demonitor.kro-ncrv.nl/amp/artikelen/vs-schrapt-aanbevolen-behandeling-mecvs-na-klachten-patienten

  • Gabby Klein 25 March 2019, 12:42 pm

    You state: “For years, the CDC—the country’s lead public health agency–placed its faith in PACE.” it’s true that CDC used PACE findings to continue to push GET & CBT, But, CDC actually prompted these harmful therapies years before PACE trial was published.

    They unveiled their toolkit in 2006 and disseminated it via CDC website, hard copies which were mailed out to tens of thousands of physicians and with their Continuing education initiatives.

  • Wendy Boutilier 25 March 2019, 12:56 pm

    The CDC, NICE, Health Canada several other countries believed this pseudoscience and are all responsible for the harm brought to the patients no one would listen to. They have built careers out of PACE, changed the name of a debilitating disease so many times we will soon need a 2nd alphabet and one was bestowed a knighthood. These arrogant psycho babblers did everything in their power to stigmatize the vulnerable who were too sick to live, resulting in suicide and even that was twisted around to suit the agenda. All of these countries owe an apology to every one of us, our families, and our friends. CDC released a lame excuse and others stayed silent. All are culpable for this travesty of medical negligence that has been going on for decades.

  • jimells 25 March 2019, 1:00 pm

    “[CDC] has a responsibility to acknowledge when it has made mistakes”

    It’s not a mistake when it’s on purpose. NIH and CDC continue to dismiss and abuse us with a policy of deliberate indifference. Many M.E. patients are disabled. We have been denied the benefits of NIH medical research. We have been subjected to discrimination by government agencies and society at large, as a result of CDC and NIH actions. Those actions and refusals-to-act are violations of Section 504 of the Rehabilitation Act, which states in part:

    “No otherwise qualified individual with a disability in the United States … shall, solely by reason of her or his disability, be excluded from the participation in, be denied the benefits of, or be subjected to discrimination under any program or activity receiving federal financial assistance or under any program or activity conducted by any Executive agency…”

    The Americans With Disabilities Act exempts the federal government. But the government forgot to exempt itself from the Rehabilitation Act. Parents of autistic children regularly use Section 504 to force local and state governments to design and implement suitable education plans. So far I have not found a case where Section 504 was cited, successfully or otherwise, in a complaint against the federal government, but I have not looked very hard. The county law library is only ten miles away, but it might as well be a thousand.

    Thirty years of phone calls, letters, lobbying, demonstrations, etc. have had little effect. It’s well past time to try another approach. Perhaps we can take these agencies to court and force them to do their jobs.

  • Allison Haynes May 25 March 2019, 2:15 pm

    Thank-you David for directly addressing the CDC. They most definitely “got it wrong” but it goes much further than a mistake or series of mistakes.
    They have been maligning people with M.E., and refusing to do proper research, since they refused to investigate the 1980’s outbreaks, calling them “hysteria” (really, CDC ????). This agency whose job is clearly stated (Centers for Disease Control) completely abdicated its responsibility when faced with a severely disabling contagious disease.
    The CDC’s Stephen Straus decided in 1988 that this illness (which already had the WHO name M.E. and WHO code 93.3 under Neurological diseases) should instead be called “CFS” and should disappear into the category of “fatigue”. I’m sure you know this & have seen Straus’s letter describing this as a “desirable outcome”. This process of “redefining”/disappearing M.E. into a wide category of vague fatigue is still going on today, as I’m sure you’re aware.

    The CDC must be held responsible for their actions or lack thereof. They must admit their wrongdoing. It’s a tall order, but with millions ill and new patients appearing all the time, it’s the only way to handle this properly.

    Please keep writing ! I and so many pwme are incredibly grateful for the attention your work is getting.

  • jimells 25 March 2019, 3:12 pm

    >>Straus’s letter describing this as a “desirable outcome”.

    The letter, which was obtained using FOIA, can be found here:
    http://www.cfidsreport.com/News/14_Chronic_Fatigue_Syndrome_Definition_IOM_Straus.html

  • Laura C 25 March 2019, 5:16 pm

    Thank you, David, for continuing to help #PwME, as so many of us are too sick to advocate for ourselves. <3

  • Lisa Petrison 26 March 2019, 7:16 am

    I continue to think that the Reuters’ article goal of keeping ME/CFS perceived to be a psychological disease and Kate Kelland’s Monsanto ties are connected.

    Here is an interesting article by “Glyphosate Girl,” who has been closely covering the recent Monsanto trials, for instance.

    It’s revolutionary enough that glyphosate is now understood to be a cause of non-Hodgkins lymphoma (a disease with a strong history of being linked to ME/CFS), but if it were seen to be a risk factor for getting ME/CFS itself, then that would be even more of a death knell for Monsanto and Bayer than what we are seeing happening now.

    This is really getting interesting, I think.

    Thanks much for your tenaciousness in working to get to the root of what is going on with this situation, Dr. Tuller.

    https://glyphosategirl.com/?p=1206&fbclid=IwAR0pUjsxMdFE5tX5-8ngd8MDNcnY8IabnegPYU66sstTlt4NL2n16l62y4s

  • Carol Broadbent 26 March 2019, 12:21 pm

    David, thank you for highlighting the absurdity of the CDC’s position and the lack of leadership on this particular topic. Your writing is consistently spot-on, focused and clear. I’m always appreciative of your voice and support. Long overdue expressing my thanks. On behalf of the many gravely ill sufferers of ME/CFS, like my 24-year-old daughter, thank you.

  • Rivka 26 March 2019, 12:40 pm

    Great piece, David!!

    The CDC won’t admit it made a “mistake.” Because then it opens itself up to lawsuits.

    I do agree with those above who say we should pursue this as a lawsuit and in the courts.

  • Lene Christianse. 26 March 2019, 3:52 pm

    Thank you, David. I always enjoy reading your articles.

  • Robert Jacobs 29 March 2019, 9:14 am

    Fabulous summary of one of the many disturbing and harmful events in the history of ME. Since CBT and GET are still being recommended and used by many providers for ME, perhaps it is time to pursue legal action. There are simply too many PWME at risk. Thank you for the clarity and persistence of your coverage of this medical nightmare.