I’ll have a lot more thoughts about this week’s CFSAC meeting in Washington, D.C. once I get a chance to watch the videos because I wasn’t well enough to take notes or attend (or closely follow) the entire meeting. But here are a few comments about some profound moments I witnessed that stuck in my head even without notes.
First, let me explain why I have been quite sick since Monday and, therefore, missed parts of the meeting. I signed up for in-person testimony at the CFSAC meeting on May 1st, 2013, on the same day the CFSAC mailing list notified folks that the Federal Register Notice was up online. (The notice itself is dated April 30th, 2013.) The deadline for registering was May 15th. Almost immediately after signing up for my in-person testimony, I received the following confirmation email:
Subject: Registration Notification – Chronic Fatigue Syndrome Advisory Committee (CFSAC) Meeting: Jeannette B.
Date: May 1, 2013 2:40:27 PM PDT
Thank you for your registration.
We look forward to your attendance at the Chronic Fatigue Syndrome Advisory Committee (CFSAC) Meeting being held May 22–23, 2013 at the Hubert H. Humphrey Building in Washington, DC.
Should you have any questions or require additional assistance, please contact CFSACMay2013@seamoncorporation.com.
According to the Federal Register Notice, speakers were to be notified by May 17th, 2013, a Friday, of their assigned speaking time. Moreover, the notice stated, “We will give priority to individuals who have not provided public comment within the previous year.” Since I had never spoken at CFSAC, I figured there would be no issue with my getting a speaking slot. When I didn’t hear anything by the end of business on the 17th, yet had heard that other patients who have testified within the last year and many times before did get an email notifying them of their time slot, I sent an message to the above CFSAC email address inquiring about my time slot. Here it was Friday night and I was going to leave on a $3,000 trip on Monday evening and yet did not know whether I would even get a chance to speak.
The next morning, Saturday, I received a reply in an unsigned email claiming that I had signed up for written testimony only, that the anonymous sender of the reply would check with the CFSAC support team to see if they could fit me in and let me know on Monday. I replied to that email as soon as I woke up on Saturday clarifying that it is absolutely not true that I only signed up for written testimony and that, in fact, I had indicated a preference for speaking on the first day during sign-up. I am 100% certain that I signed up for in-person testimony and the above email proves it. The language, “We look forward to your attendance at the Chronic Fatigue Syndrome Advisory Committee (CFSAC) Meeting being held May 22–23, 2013 at the Hubert H. Humphrey Building in Washington, DC” can hardly be interpreted as “We look forward to reading your written testimony.” Having followed the sign-up instructions perfectly and having received an email basically confirming that I would get to speak, I was stunned. I waited for hours, but didn’t hear back.
Finally, I sent emails to Dr. Nancy Lee, designated federal officer at CFSAC, Dr. Gailen Marshall, chair of the committee and Dr. Howard Koh, assistant secretary for health asking that this be straightened out right away, as I could not possibly wait until Monday with packing given that I would get my Ampligen infusion that morning and then had to rest up for the remainder of the day before leaving that evening. It would seem obvious to everybody who knows anything about ME that patients cannot wait with their packing for a several-days, across-country trip until the day of travel. I wasn’t going to make the exhausting and expensive trip without a confirmed speaking slot and I wasn’t going to waste precious energy on packing and unpacking should it turn out that I would not get to speak.
I received no reply from Dr. Lee or Dr. Koh. Dr. Marshall replied quite graciously on Sunday afternoon; apparently he had been away from his email and, in any event, the decision about who gets to speak falls, according to him, into Dr. Lee’s purview, but he was going to see what he could do. This gave me enough comfort to assume that I would be able to give my testimony in person, so that afternoon I started packing. Long story short, that was way too late and I ended up overdoing and woke up very sick with PENE (PEM) on Monday. I seriously considered canceling the trip, but was hoping that I would feel better on Tuesday or the following days, but that never happened. I had to ask friends to drive me to and from the airport because I was unable to do so myself. The whole trip and time spent in D.C. and even now still, I feel so much sicker than I did a week ago.
Bob Miller made this point in Bethesda last month and proof that he was right was staring me straight in the fact: No matter how often they tell us that they get it, they really have no clue. First of all, notifying participants on a Friday with no way of reaching the people who organize CFSAC, the Seamon Corporation, over the weekend regarding a meeting for which folks will leave on Monday or Tuesday is a recipe for disaster. Also, may I suggest that the confirmation email after sign-up in the future specifically spell out whether somebody is signed up for written testimony only, for testimony via phone or for testimony in person. That way, “misunderstandings” (i.e., mistakes) can be corrected in a timely manner without causing patients any bodily or financial harm. I did not appreciate being made to feel like they were doing me a favor fitting me. There was no apology for what I was put through by being forced to pack way too quickly for what my body can handle and for what ultimately caused a flare-up of my symptoms, merely a “sorry for the confusion.” Unfortunately, the mistake caused a lot more than confusion. It caused a deterioration of my health. There seemed to be no appreciation of, or regret over, that.
In CFSAC’s defense, the issue was ultimately resolved and I did get to speak. And the mistake seems to have been made by the Seamon Corporation, the company that the organization of the meeting is outsourced to. But hiring a third-party to do a government job doesn’t indemnify the government from liability for mistakes made by the third party
Again, these are just some highlights of the meeting for now:
Some people say that Dr. Unger would like to do more for us, but her hands are tied by her boss. I have no way of knowing whether that is true, but she did vote “yes” on one of the four Ampligen questions during the December FDA Advisory Committee. I do see her actively engaged in the conversation and often responding intelligently. Dr. Unger is not a case of not getting it, I don’t think. Having said that, she has a talent for saying things that are absolutely infuriating and/or classic government hot hair.
Two things come to mind from this last meeting. It was reported that she defended inappropriate pictures used for continuing medical education on ME purporting to portray ME patients, pictures that are misleading and outright harmful because they downplay the seriousness of the disease. You know the kind of pictures I am talking about: Employees with well-coiffed hair collapsed into their filing cabinet—whether or not from a hang-over or a serious neuro-immune disease is anybody’s guess, although the latter is unlikely given their well-groomed appearance. Dr. Unger’s rationale for using those types of pictures was said to be an attempt to portray a more positive side of the illness. Come again? What positive side? Have I missed out on the perks of having this crushing illness all these years?
Dr. Unger outdid herself with her comment that the CDC is not endorsing the Canadian case definition because physicians are frightened by its complexity. Wow! I nearly burst out laughing when I heard that. How did these poor physicians make it through medical school? And did Dr. Unger ever consider that getting the point across to medical doctors that ME is a very complex illness is actually a good thing?! It might keep them from harming patients by prescribing the wrong treatment, something that happens every day and damages people’s health irreparably. Maybe those “frightened” physicians are more likely to refer their very sick patients to a specialist who knows how to treat ME properly. And some may even learn a thing or two. Is that too straightforward of a concept for the CDC?
Dr. Maier crossed the border to surreal a couple of times. She kept insisting that the low level of NIH funding for the disease was merely due to the fact that not enough grants were applied for. Yet, we have heard from many (potential) investigators that their ME grant applications are almost always, and pretty much reliably, denied. Dr. Klimas gets one out of eight ME grants approved, which is in stark contrast to her Gulf War Syndrome research work, which gets funded at a much higher rate. And what kind of argument is this anyway: Let’s assume ME researchers submit for a bunch of ME grants that are not of high quality. Are they going to get more money just because of the higher volume of applications? I may be too exhausted from the trip, but this makes absolutely no sense to me.
Later, Dr. Maier delivered an extremely disingenuous “explanation” for why the NIH has not been funding any Ampligen studies: Because Ampligen is under patent and nobody but Hemispherx is legally in a position to study the drug. I felt like I was being talked to like a first-grader. Of course, Ampligen is patented. The patient community’s suggestion has been for the NIH to work with the sponsor, Hemispherx, or get its permission to do the FDA-required trial. Does Dr. Maier really think that the company would turn down NIH money if offered. Now, in all fairness, some strange things have come out of Hemispherx, so maybe it would, unlikely as it is. But how about making the funding of an Ampligen trial by the NIH an option given that the drug will likely disappear without it? That would be a good way of getting advocates of the NIH’s back. Just saying.
Maybe the second most disturbing moment of the meeting (the most disturbing one to be mentioned below) came when Dr. Maier, seemingly in response to something Dr. Fletcher had said (but I need to watch the recordings to make sure I am correct here) that it has been hard for her to be on the committee and that she is sick of being misquoted and then pretty much lost it by saying, “I have worked every freakin’ weekend since February.” I know a thing or two about working every “freakin” day of the year. But I would have never made that point to my clients because, frankly, that would have been unprofessional. Such self-pitying outburst in the face of unending patient suffering—suffering that doesn’t take a break for weekends, that lasts for weeks, months, years, decades—was plain grotesque.
On the second day, Eileen Holderman, the patient representative on the committee, made a very eloquent and passionate, yet professional plea to the committee to stop using the phrase “chronic fatigue,” a point I had made in my testimony a day earlier. It is bad enough to be labeled with “chronic fatigue syndrome,” but “chronic fatigue” is such a crushing insult. Eileen wondered out loud how diabetes patients would feel if one of the symptoms of diabetes, chronic thirst, was taken and turned into the disease name, “chronic thirst syndrome” despite having a number of other serious symptoms, maybe even amputeed limbs. This was a powerful analogy and yet the committee went on to use “chronic fatigue” for the rest of the day, as they had done before. Surreal.
The most troublesome moment started when Dr. Marshall called Eileen “out of order” and Eileen disagreed. I missed the beginning of that interaction, so I don’t know exactly what was going on right then. But Eileen, visibly shook up, proceeded to talk about feeling threatened (together with two other committee members, one of whom is Dr. Fletcher) by lawyers and the designated federal officer (Dr. Lee) and afraid to speak out. She said she felt shut down whenever her viewpoint was inconvenient. It was quite obvious that Eileen was speaking from the heart and that a lot had gone on behind the scenes that we don’t know about. But Eileen did seem genuinely scared.
I don’t know Dr. Marshall, but he seems like a reasonable man who is often on our side. And in his defense, it was towards the end of the meeting and he was rushing to get through the required agenda items. Yet, this exchange was probably not one of his prouder moments, especially since he didn’t call Dr. Maier out during her inappropriate, and clearly out of order, pity party.
I got the strong feeling that there are at least some members on the committee, e.g., Alaine Perry, Dr. Mary Ann Fletcher and Steve Krafchick, who are fighting for us, besides Eileen. I know patients are frustrated with CFSAC and how little it has accomplished over all these years. I imagine that some of the committee members are frustrated, too, by being completely ignored by Secretary Sebelius. So, I would caution against alienating everybody who is genuinely trying to help us. Let’s remember that Dr. Marshall voted for Ampligen all the way. That was huge. Let’s see how things shake out between him, Dr. Lee and Eileen. I hope whatever is going on can be solved amicably to everybody’s satisfaction. But if our patient advocate is being intimidated, then this committee has lost all its integrity.
PS (added May 26th): The more I think about the fact that at least some of the committee members continued to use “chronic fatigue” after having been told by at least two patients during the meeting how derogatory and harmful it is, the more it makes me wonder what the point of it all is. If we can’t even get “our” committee to “go the extra mile” and add on one little word, “syndrome,” then how much hope is there that they are really interested in helping us? How hard is it to use the full name after having just been told that it is a matter of respect and integrity and responsibility?
And here is a radical idea: What if all of our clinician and research experts just started using the term “ME,” as recommended in the recent International Consensus Criteria supported by an “International Consensus Panel consisting of clinicians, researchers, teaching faculty and an independent patient advocate” representing “thirteen countries,” “approximately 400 years of both clinical and teaching experience” as well “hundreds of peer-reviewed publications.” Those folks have diagnosed or treated approximately 50,000 patients with ME!
If they (and we) all just started using it, then the media would follow suit and the many non-experts would as well if for no other reasons than the fact that we live in the age of political correctness. We could solve the “name debate” almost over night. This is how powerful it would be if CFSAC and our experts were putting a little more effort into being disciplined when it comes to the name. This is not rocket science. Imagine how much credibility this patient population could gain almost instantaneously?! Given how much harm the name “CFS” has caused, it is hard to believe that all these smart folks would fail to recognize their responsibility here. Sometimes, somebody has to stick their neck out even if it’s not comfortable. But it’s the right thing to do.
The same really applies to the case definition. We have two sophisticated case definitions, the CCC and the ICC, and yet everybody seems to be insisting on the much more harmful Fukuda or Oxford definitions while fully aware of how much this holds us back and how much real harm it does. All Dr. Unger seems concerned about is to protect physicians from complexity. I think in that spirit, we should stop doing open heart or brain surgeries because, surely, that is very taxing on physicians as well. This all just so grotesque.