EILEEN HOLDERMAN:
Good afternoon. My name is Eileen Holderman. I’m an advocate. I apologize for not having any formal presentation. I have some notes, so I’m going to “wing it.” But I’ve been living this IOM thing for quite some time since November 2012 when CFSAC made a recommendation. We’ll get to that in a moment. But I’m here today to state my opposition to the IOM HHS contract, and I’m calling for the cancelation of the contract.
The majority of stakeholders oppose the contract for many reasons, and it’s evidenced by the letter and call campaigns, twitter campaigns, the congressional calls an meetings, the two petitions, the demonstration, the media interviews, legal actions, Freedom of Information Acts, the advocates’ letters signed by 171 advocates, and the ME/CFS expert letter. Fifty ME/CFS experts, researchers and clinicians, got together—they wrote a letter and they sent it and mailed it to Secretary Sebelius , and in that letter they said:
“We, the experts have developed a definition, the Canadian Consensus Criteria, to describe ME/CFS. We’re using it, we’ve been using it, we’re committed to refining it. Now we want the government to use it.”
Simple as that. Why waste a million dollars on a contract, especially when this disease gets only five million, and as Dr. Klimas said eloquently, less than male pattern baldness. And that’s a fact. That money could go toward biomedical research. Why waste 18 months to do a study when we already have a good consensus criteria, and then years more to roll that out and “mis-educate” doctors and healthcare professionals with what may be a worse definition than Fukuda and worse name than “Chronic Fatigue Syndrome”? And it’s no reflection off the people on this panel because I do have tremendous respect for all of you as an individual, but when HHS sets up a poor study design, you guys can do only so good as what they dictate. And I know that CDC does this all the time by inviting experts to participate on their website, on the C and E courses, but then when they dictate the terms of it and say that you can only teach doctors by using the Fukuda definition, which is 20 years old, outdated, erroneous—doesn’t have the hallmark symptom of PEM—and is used for research only, then you’re really not educating doctors; you’re mis-educating them.
So what is so upsetting to the patient community is that in November 2012, CFSAC—and I’m a member of that committee—we made a recommendation, and I helped craft the language of it, that recommendation, and we wanted to convene a workshop with only ME/CFS experts, meaning researchers, clinicians and patients, to reach a consensus on a research and clinical case definition, starting with the Canadian Consensus Criteria. We basically wanted to just endorse that criteria. And what happened after that was outrageous because in our subcommittees, contention at the highest level.
I chair one of the subcommittees, and I don’t want to get into the ugly realities of what was going on behind the scenes; but it was so ugly that anyone who spoke out, and I was one of them, got calls from the government. And we were intimidated, and we were threatened with eviction off the committee, and there is an ongoing investigation about it. It directly relates to the case definition recommendation we made. We are the experts making the recommendation, and the government is not taking our
recommendation. They’re hijacking it, making it their own, and not using all experts like we asked, drawing it out. They’re going to do the same thing that VA-IOM did to Gulf War by redefining—by giving them a new name, “Chronic Multisymptom Illness,” by saying the best clinical practices for that disease is CBT, GET and antidepressants. And that study that came out in January was very alarming because it had a section on ME/CFS, and in that section it said the same clinical practices, GET, CBT and antidepressants, would be used for ME/CFS. So we don’t know how this new panel could possibly contradict the earlier findings of the IOM study. I simply don’t know how that would work.
It also troubles me that CDC and NIH will be participating in this, and there is a contradiction because on one hand, IOM says once the sponsor finishes, they’ll have no further contact. On the other hand, HHS says there will be continual meetings with NIH and CDC to give them information. And I’ve been very vocal about the flaws in both of those studies. I’m not going to get into them today, other than to say that for 30 years we waited for biomedical research for this brutal neuroimmune disease with an infectious component; and instead, we are getting now three initiatives at the same time. Talk about redundant and waste of money! To come up with case definitions. We’ve already got one It’s the Canadian Consensus Criteria. Our 50 ME/CFS experts have said “We’ve got it. Let’s use it. Let’s use the money instead for biomedical research, education and treatment for the over one million Americans and 17 million worldwide suffering from this serious neuroimmune disease, Myalgic Encephalomyelitis.
So, I’m part of the patient advocacy movement that is going to continue to push the envelope and ask for the cancelation of the contract, and let’s get on with the serious business of studying and treating this disease. Thanks.
ELLEN WRIGHT CLAYTON:
I do want to clarify one point: there will be no contact between the committee members and HHS at any point from now on until the end of the study. The contact between the staff is only to show that they’re doing work so that is…uh…you know…just to give progress reports, but it will in no way go to the substance of what the committee is talking about. There will be no contact between the committee and HHS till the end of the study. I just want to be very, very clear about that.
Thank you very much for your comments. And I…uh…and I’m…uh…very grateful to hear them.
