Mary Dimmock had a comment slot for Tuesday, and like all the other Tuesday slots hers was unilaterally cancelled when Dr. Lee decided to dispense with the first day of the meeting.
did not receive a public comment slot. I’m happy to publish her comments in their entirety.
Good afternoon. Thank you for giving me time to speak today.
I will address just two of the many issues that ME patients face – HHS’ failure to focus on the disease the patients actually have and HHS’ failure to effectively engage the ME community.
At the last CFSAC, Dr. Unger questioned the nature of post-exertional malaise. She also questioned its significance as a hallmark symptom, rhetorically asking “If a patient doesn’t have [PEM], wouldn’t you still manage them as a “CFS” patient?”
When I heard that, I wanted to scream. That single exchange highlights what is so rotten with HHS policy toward ME. From its earliest response in 1984 to its actions today, HHS has either utterly misunderstood or willfully ignored the neuroimmune disease with its hallmark PEM that patients actually have.
Instead, HHS has wasted decades and countless millions fixated on studying medically unexplained fatiguing illnesses under the rubric of “CFS”, a man-made clinical entity that in reality is an unscientific hodgepodge of biologically unrelated conditions. A black hole guaranteed to insure that any disease in the CFS grip will remain forever medically unexplained and mistreated.
Now HHS wants us to take a leap of faith that their IOM contract will fix the chaos that HHS definitions have caused.
To which I ask one simple question. What disease are these new criteria going to describe? The disease that the Canadian Consensus Criteria describes? Or will the new criteria describe the range of diverse medically unexplained fatiguing conditions encompassed by CFS criteria.
According to Dr. Lee and IOM’s Kate Meck, no decision has been made on this fundamental question yet. That is stunning. This is a million dollar contract and the panel has already been named. Who will make this decision and on what basis? Will the panel still be the appropriate one once the decision is made? But I was much more concerned when in response to my question, Dr. Lee never said that this new criteria was intended to specifically describe ME. Instead, she emphasized establishing ME as a subgroup of the broader CFS or maybe ME as part of a spectrum of CFS illnesses. She also said that for the sake of primary care physicians, it was better to start broad and define subgroups.
Are you kidding me? Where is the scientific proof that this collection of medically unexplained fatiguing conditions called CFS is a valid clinical entity to begin with? Where is the scientific justification to treat ME as a subgroup of this bogus entity? How many more papers does Dr. Jason need to publish to convince you that this is scientific lunacy?
HHS needs to listen to the experts, to the patients and to the evidence. HHS needs to explicitly and immediately acknowledge that the disease described by the Canadian with its hallmark PEM is completely separate from the broader collection of medically unexplained fatiguing illnesses. HHS needs to put up a black box warning against exercise for these patients as suggested at the last CFSAC. HHS needs to follow the lead of experts and point clinicians to the CCC. And HHS needs to require that all NIH funded research incorporate the CCC.
But HHS won’t do that. Which brings me to my second point – HHS’ failure to engage the ME community as key stakeholders.
Case in point – the IOM contract. A microcosm of failed engagement. We all know where the disease experts and patients stand on the definition and what the CFSAC recommendation said. So what does HHS do? It ignores all of that and instead unilaterally defines its own initiatives to create its own criteria for some vaguely defined and non-specific condition. Using non-experts. Spending 18 months and 1 million dollars redoing what the experts have already done and recommended. You even had the temerity to reject the Canadian Consensus Criteria because it doesn’t incorporate evidence since 2003 while you steadfastly refuse to accept this same evidence when it comes to PEM and CPET.
Other examples of failed engagement? Take Dr. Koh’s disingenuous and off-point response to the ME community’s request to investigate allegations of intimidation of CFSAC members by the designated federal official.
Or patients being told they can’t see the NIH research plan because the plan might change. What? All plans change. That’s the nature of plans. It’s not an excuse for withholding the plans from those most affected.
Or HHS’ decision to reclassify CFS in the ICD-10-CM to be a subtype of the symptom of chronic fatigue despite recommendations from the CFSAC, the IACFS/ME and patient organizations and advocates against it. Despite the fact that the change is against standards set by the World Health Organization, which classifies CFS as neurological.
This CFSAC meeting? Let’s be real. This change isn’t about cost savings. It’s about stakeholder avoidance.
And on and on and on. Blow off responses. Minimal information. No transparency. One-way communication. Utter disregard for this community. We are often told “Nothing about me without me.” But HHS’ real modus operandi is “Everything about ME without ME.”
Patients are very angry. For thirty years, HHS has willfully refused to make a serious, urgent commitment to the specific disease that patients have – in fact has utterly obscured the existence of the disease described by the Canadian Consensus Criteria to the point that doctors do not even think its real. HHS has willfully refused to engage the very people most affected by its actions. And HHS has made it clear it has no intention of changing.
It is insanity for us to continue to have faith in HHS’ actions.