There is no way to sugar coat this. The December 2013 CFSAC webinar was a colossal middle-finger salute to the patient community. Despite the webinar format having been a complete disaster in December, we will be treated to another CFSAC webinar tomorrow; patients can hardly wait, so it seems like a good time to recap.

What was wrong with the December meeting? Well, how much time do you have? This is not a rhetorical question. The sheer number of glitches, the unmistakable indifference exhibited by CFSAC’s Designated Federal Officer (DFO), Dr. Nancy Lee, to the many patient concerns raised in advance and during the meeting, and the mind-boggling degree of incompetence in running and mishandling the meeting will make this a long blog post. It will outrage you. The DFO’s statement that the snags were “extremely sub-optimal” was a massive trivialization. After attending that CFSAC webinar, it was no surprise to me anymore that HHS botched the Obamacare website as badly as it did; it can’t even run an old-fashioned webinar halfway competently. But there was a consolation prize and that was the unintentional and unexpected entertainment value of the meeting. So, make yourself some tea, get comfortable on the couch or in bed and brace yourself for the ride.

The Watered-Down Format for the “Chronically Tired”

The reason we were given for the new “webinar” format was budget constraints due to the Sequester. We were told that all federal advisory committees had been asked to move to the webinar format, though we have yet to be given examples of other committees having done so. But then again, we, the “chronically tired,” are used to the absolute minimum only. Here is a question for everybody: How much money do you think was saved by not having an actual in-person meeting? True, there were no travel or hotel costs for the committee members. However, I bet there were a number of test webinars for the committee members and the IT people before the live webinar to make sure everything would run smoothly. Clearly, the test runs were sorely inadequate, as became painfully evident on December 11, 2013, the day of the meeting. Picture the worst webinar you can possibly imagine and then multiply that by ten. That’s how bad it was.

Also, one could speculate whether the “post-production” cost of synchronizing the audio with the slides and making both available on the CFSAC website aren’t similar to simply putting up the video that is recorded during an in-person meeting and, thus, readily available right after the meeting. Certainly the fact that the audio and slides have not been uploaded to the CFSAC website yet, nearly three months after the meeting, suggests that there is more work than normal involved. If anybody is inspired, maybe a FOIA request inquiring about the alleged cost savings of having two webinars (one in December and one tomorrow) vs. one in-person meeting is in order. Although, unless you can afford to front thousands or tens of thousand of dollars in attorney’s fees for a federal lawsuit, don’t bother because HHS seems to view complying with FOIA as optional, which is why I was forced to file a lawsuit against HHS and NIH in federal court in January of this year.  However, if HHS wants to make the numbers publicly available, I am sure that would be welcomed by the patient community.

Bad Weather: The Missed Opportunity for an Out

The December webinar was cut from two days to one day because of a snowstorm in DC that shut down the federal government. Can’t blame anybody for that. These things happen. But the situation was mishandled entirely. Instead of rescheduling the entire meeting, the already truncated meeting was further shortened to one day.

In the past (until May of last year), CFSAC held two 9 to 5 meetings, a total of 16 hours. By refusing to reschedule the meeting, it got cut to five hours, less than one third of the normal duration of the meeting. Furthermore, the five-minute public-comment slots for the second day were slashed to three minutes.

The weather gave HHS the perfect opportunity to resume the original in-person format. HHS had been given a second chance here to do the right thing. Because the elephant in the room was that the DFO chose to hold this meeting as essentially a teleconference at one of the most critical times in this patient population’s history: the IOM “study” proceeding despite overwhelming protest by experts and patients alike. HHS had a chance to avoid appearing as egregiously disenfranchising patients more and more by returning to a two-day in-person meeting using the weather as an excuse. It did not do so despite the fact that HHS had already rescheduled the meeting once, and this time–in December–it was much more appropriate to do so.  The reason given for the prior rescheduling was the government shutdown. Mind you, the meeting was originally scheduled for November 2013, which was about four weeks after the end of the government shutdown. That should have been plenty of time to proceed with the meeting as planned. Postponing the meeting then, till December, was a lot less justified than it would have been in December.

Tomorrow’s meeting is a make-up meeting for the canceled day in December. Those members of the public who had a speaking slot on the canceled day will get to speak at tomorrow’s meeting. However, what’s most revealing is that, back in December, the speaking slots for the public were initially slated for five minutes and only cut to three minutes when the first meeting day got canceled altogether. Tomorrow’s public-comments slots are for three minutes only as well. Looks like HHS used the bad weather in December as an opportunity to marginalize patients even further.

Video Testimony Without, Wait for it, Video

For the first time, pre-submitted videos were allowed as public comments. However, only the audio portion of those comments was streamed. Of course, the public was not informed of that not-so-small detail before the deadline for the video submission. Not showing the video portion of video comments is so much beyond bizarre that I at first didn’t believe it when I heard it. Which reasonable person in their right mind would assume that the video part of video testimony (!) will be excluded? It was 2013 and even though D.C. is not Silicon Valley, I am sure proper webinars—you know, with audio and video—have been provided by government agencies in the past.

The reason given by HHS: The webinar platform is not compatible with playing videos. Why was this webinar platform chosen again? Patients reported that Seamon Corporation, the company whom many aspects of the running CFSAC meetings is outsourced to, confirmed that HHS had the choice of a playform that allows video streaming. Instead, HHS decided to go with the rudimentary audio-plus-slides-only version. You’d think that reducing the meeting to a webinar is enough of a slap in the face of patients. Not so because HHS basically held a teleconference only, disguised as a webinar.

The CFIDS Association of America Disseminating Official Government Information?

The CFSAC listserv sent an email with the updated agenda for the not-canceled day of the meeting 1.5 hours before the meeting. This was our only official (coming from HHS) indication that the meeting would indeed take place on day two. Interestingly though, the CFIDS Association of America (CAA) was not only informed the previous day that the second day was indeed on, it was also either tasked with notifying the public of official government business or took it upon itself to do so because it published on its Facebook site, at around 5:30pm Pacific, the revised agenda the night before the meeting. See the screen shot below, courtesy of Leela Play. The Facebook post didn’t stay up long; it was deleted fairly quickly, without any explanation, when people started asking questions about whether the CAA is now not even pretending anymore to be separate from the government. But maybe more importantly, does the disseminating of official government information by a non-government agency, before HHS did, constitute a violation of federal law or regulations?

That CAA Facebook post also stated, “As always, ALL are welcome to join in.” This was particularly ironic because until the previous day–when HHS opened up the meeting to everybody without requirimg to register–the meeting was limited to 500 pre-registered participants. Some serious questions were raised by patients whether capping the number of attendees still qualified the as public. Those questions remain even after opening up the meeting to everybody at the last minute, as many people likely did not know about that change, which was buried in a CFSAC listserv message sent the day before the meeting. I know there were patients who did not sign up for the meeting although they were interested because they didn’t want to take a slot away from folks who they considered more actively involved in advocacy than they are. In light of all this, CAA’s cheerleading–“ALL seems particularly tone–deaf, even for  CAA standards.

IOM

After Dr. Koh’s remarks, the DFO talked about the IOM-study process and answered questions. I am not going to go into detail about that part of the meeting. I addressed some of those issues—those relating to the DFO’s threatening emphasizing of the dangers for the community in criticizing the IOM process, namely the likelihood that such criticism would backfire on patients—in a prior blog post, “HHS and the IOM Saga: The Definition of Insanity and a Bad Case of Stockholm Syndrome.” There is much more to say about this part of the meeting, but I will leave that for a future blog post.

Government Intimidation

However, one point cannot go unanswered, as it was disgraceful for a key federal official. I did not live in East Germany for 18 years, see the Berlin Wall fall and become a proud and upstanding U.S. citizen to stand idly by while the U.S. government is trying to suppress free speech and, even worse, attempting to recruit fellow patients to do their handiwork for them.

Here is what I am talking about: The DFO made a strong point to accuse some advocates of “much vitriol and personal attacks in emails and in blogs around the IOM study.” She talked about some unnamed advocates apologizing for “the vitriolic behavior of another advocate” whom she also didn’t name. Maybe the most appalling statement the DFO made was to call for the advocacy community to “call out and reel in,” in the future, those advocates whose comments and opinions she doesn’t approve of.

Ms. Eileen Holderman, the patient advocate on CFSAC, who has reported having been threatened (together with two other CFSAC members) by the DFO, swiftly called out the DFO for indicting the advocacy community with her comments. Dr. Marshall, CFSAC’s Chair, tried to shut Ms. Holderman down citing time constraints, but Ms. Holderman insisted that she “could not let [the DFO’s statement] stand” and the Chair relented by giving her one minute. Ms. Holderman pointed out that most, if not all, of the discourse around the IOM “study” had been civil and constructive and called the DFO’s accusation unfair.

Being one of the advocates who has been vocal about the IOM “study,” I can firmly say that I stand by everything I wrote. I can also say with certainty that I have not seen any vitriolic behavior on the part of other advocates nor have I seen personal attacks on anybody. In fact, the patient community, even those of its members who don’t agree on many issues, seems to be pretty much in agreement that advocates have behaved nothing but professionally. I don’t know if it’s more amusing or disturbing to see government officials whining when their position, competence, expertise, action or anything else related to their official capacity is criticized, especially in a field where patients have been harmed by government agencies for decades, as pointed out by Ms. Holderman. It’s bad enough that the government is not listening to, but, in fact, is harming, patients. But it’s adding insult to injury to be accused of being vitriolic just as a result of appropriately expressing criticism. Not that the ad-hominem-attack charge is a new tactic at all. HHS took a page out of Simon Wessely’s playbook of unsubstantiated death-threat accusations.

Should there be any doubt, advocacy is politics and politics, if it’s to be effective, is not always pretty. Imagine a U.S. president whining about attacks from the other side of the aisle. A pretty ridiculous thought, no? ME patients are fighting for their lives. The kid gloves came off a long time ago, maybe when the CDC misappropriated funds for our disease im the millions in the 1990s? It’s unfortunate that a governmental official would feel the need to abuse the power of her position and the platform it bestows—CFSAC meetings she tightly controls—to call people out who are availing themselves of their First Amendment rights in an entirely reasonable manner, whether it’s due to being overly sensitive or using a tactical ploy.

This should be obvious, but since it’s apparently not, let’s be very clear. If you are a government official and your work is being criticized, even if harshly (with very few exceptions, such as comparisons to Nazi Germany), that is not an inappropriate or personal attack. Everything that has to do with official government business—as opposed to the private life, the appearance, the personal choices, such as religion, etc. of government employees—is most definitely fair game.  The DFO’s comments at the meeting in that regard were quite frankly contemptible and reprehensible and one can only hope that they were not blessed by her superiors. But they were not off-the-cuff statements. Rather, they were clearly prepared well in advance, as the DFO was anxious to read them at the end of the session. Trying to split the patient community by inciting attacks on inconvenient advocates is inexcusable and pretty much as low as it gets.

By the way, I don’t know this for sure, but I have a feeling that those inconvenient advocates might be even more resolved in their will to continue fighting the good fight as a result of the DFO’s shameful comments. If they were easily intimidated, they probably wouldn’t have taken a strong stance on the IOM issue in the first place. Like I said, just a hunch. So, it remains to be seen if this attempt by HHS to quiet some advocates will be successful and if other advocates will be complicit in it.

In that context, you might find the recent articles by Glenn Greenwald, “How Covert Agents Infiltrate the Internet to Manipulate, Deceive, and Destroy Reputations” interesting. Greenwald talks about a number of tactics the government utilizes to disrupt online discourse, such as the use of online trolls with fake personalities who infiltrate online communities as well as attempts to destroy the reputation of advocates.

The Most Incompetently Run “Webinar” in the History of, well, Webinars

Many emails were sent to the DFO on the days before and of the meeting imploring her to reschedule the meeting and pointing out the many problems with the webinar format and the truncating of the meeting to one day. Here and here are my pleas. I don’t know if others were luckier than I was, but none of my emails to he DFO and/or the CFSAC mailbox were replied to, neither before, during or after the meeting.

Others have written about the multiple problems with the webinar format for patients and about the technical glitches, so I will just mention a few examples:

• Many patients cannot afford to spend five hours of cell-phone minutes on a webinar. This patient community is predominantly poor. To borrow from one of Dr. Peterson’s examples, many patients live in their parents’ basement because of their poverty level.
• For the same reason, some patients use a dial-up Internet connection. That means that they can either be on the phone or on the Internet. Since one had to call in for the audio portion of the “webinar” (see below), those patients were not able to follow the slides on their computer screen.
• Again, due to the financial realities for patients, some do not have fancy phones with speakers.  Yet, many patients are too sick to hold a phone up for five hours.
• It wasn’t always clear who was speaking because speakers didn’t always identify themselves.
• It was impossible to follow the text on the screen, as it was quite choppy and patients started complaining about nausea soon after the webinar began.

Many of these problems were pointed out to the DFO via emails after the beginning of the meeting to no avail, despite the fact that they made it impossible for people with disabilities to participate, which raises additional questions regarding the open nature of the meeting.

In order to see the slides on the screen, one had to be in full-screen mode. There were no instructions to that point and patients missed many or all of the slides because of that. That may have just been as well because of the unbelievable IT difficulties in advancing the slides. At some point, it seemed that everybody on the committee was able to advance the slides and since many committee members did so in an attempt to help out, it took minutes to get the situation under control by finally putting Paul, the IT guy, in charge. It was most comical, but understandably seemed quite frustrating to the speaking committee members.

One of the “highlights” of the webinar was the fact that one had to actually call in to get the audio portion of the meeting. So, not only did the “webinar” platform not allow videos, it also didn’t allow audio. Quite the “webinar,” huh?!

This was not explained anywhere in the instructions ahead of time. As a result, I (and many others) missed the first part of the meeting while trying to figure out what was going on by emailing with the Seamon Corporation and the CFSAC mailbox. After I, and probably others, made the DFO aware of this problem via email, the meeting was not halted to send an email from the CFSAC mailbox to everybody and to give people time to connect properly. This would have been especially important because the by far most crucial topic of the meeting, the IOM “study,” was the first agenda item after Assistant Secretary’s, Dr. Koh, short opening remarks.

About 25 minutes into the meeting and after complaining, in an email to the DFO, about the missing sound component, I received an email from Seamon Corporation notifying me of the requirement to dial into the meeting with my phone. There never was a CFSAC listserv announcement to that effect. Although, at some point during the meeting, the meeting website instructions were quietly updated. Below are screen shots showing the before and after.

Before:

After:Seamon Corporation has in the past contacted speakers about their public comments, e.g., to confirm or change the comment time. However, here, where it was probably more crucial than ever because people’s comment time was cut to three minutes at the last minute, no such calls were made. Commenters who might not have checked their emails would have been unaware that they now only had three instead of five minutes for their comments.

The technical difficulties the DFO had trying to call the public-comment speakers resulted in a lot of wasted time during an already extremely short meeting. We had to wait for about a total of 15 minutes for the DFO to call seven patients who had three minutes each to comment and some patients did not use the full three minutes, so that makes a total of less than 21 minutes of comments. I believe nothing else needs to be said here.

There also didn’t seem to be an effective mechanism in place for the Chair to keep track of who on the committee raised their virtual hand first and in what order to allow committee members to speak. There certainly was no accountability for the Chair to be fair and honest in that regard since the public did not actually see in what order the hands went up.

The Chair and the DFO seemed to struggle to figure out how to get the wording for a proposed recommendation drafted by Susan Levine to all committee members for a vote. Put it in a slide? Send it as an attachment to the DFO and the Chair? That’s the problem when you don’t have an in-person meeting. Again, a lot of time was lost just figuring that out at a meeting that was already inadequately short.

Finally, we didn’t get an update from the FDA on the number and types of new drug applications for ME/CFS despite a comment during the last FDA-patient call that such update might be provided at this CFSAC meeting.

CFSAC’s Patient Advocate Ms. Eileen Holderman

The term of our patient representative on CFSAC, Ms. Eileen Holderman, will sadly be up in May of this year. As always, Ms. Holderman was a very strong advocate for us throughout the meeting.

She voiced her concern about the continuing medical education (CME) videos on the CDC website, as the physicians in them used the Fukuda definition as opposed to the more appropriate (because much newer and more sophisticated and accurate) Canadian Consensus Criteria (CCC) and as cardio-pulmonary exercise testing (CPET) wasn’t mentioned in them at all. Dane Cook, another voting CFSAC member, called Ms. Holderman’s criticism armchair quarterbacking and said that it would have been more reasonable for Ms. Holderman to ask for additional videos. I fail to see the logic in that. If a video contains wrong information, especially regarding a mostly misunderstood disease, it would seem appropriate to pull the video altogether instead of being worried about hurting the egos of the physician who participated in the making of the video, which is where  Cook seemed to be coming from. CFSAC member Steve Krafchick on the other hand agreed with Ms. Holderman, citing the emphasis of the CME videos on orthostatic intolerance, their lack of mention of CPET, their use of the Fukuda definition, their lack of mention of the IACFS/ME primer and their reference to the CDC toolkit.

Ms. Holderman later stated her disappointment in the attempt by Dr. Elizabeth Unger of the CDC to rein in Ms. Holderman with respect to her CDC-website review, which has been very extensive over the last three years. According to Ms. Holderman, Dr. Unger informed her in two emails that she was deemed to have overreached in her mission and that such comprehensive review was never envisioned by the agency. It came as no surprise then when Ms. Holderman stated that she felt that, despite some progress having been made with respect to the CDC website, for the most part, change has been resisted by the CDC.

Ms. Holderman further pointed out that addressing the education of health-care providers, the subject of a working group report by Susan Levine, was “putting the cart before the horse,” as logically, we first need a consensus on a case definition. Otherwise, health-care providers are potentially being taught the Oxford or Empirical case definition (both defining the condition of fatigue as opposed to the neuro-immune disease ME/CFS) or the Fukuda definition, which does not require the hallmark symptom of ME/CFS, post-exertional malaise.

In addition, Ms. Holderman objected to the formation of the working groups because those were never voted on by CFSAC and, in her opinion, were imposed on CFSAC by HHS. Her concern is that these working groups undermine the sub-committees, which she sees as very functional.

She also mentioned, but didn’t elaborate, that she wasn’t allowed to be involved in establishing the agenda for the meeting as she had been in the past in her role as a member of CFSAC’s leadership committee.

In her parting comments, Ms. Holderman said that she felt that CFSAC’s recommendations have unfortunately largely been dismissed—no surprise to anybody who has been following CFSAC over the years—and that she is hoping that that will change in the future. She also expressed concern about the leadership committee being in peril and the fact that Assistant Secretary, Dr. Koh, is no longer participating in the leadership-committee meetings. The latter, in particular, certainly is alarming and seems to warrant looking into. Whoever will succeed Ms. Holderman in her role as patient advocate on CFSAC most definitely has some very large shoes to fill.

Other Committee Members

Dr. Ken Friedman, a CFSAC liaison member, reminded everybody of the “institutional reluctance” to allow ME/CFS research, which still seems rampant. He cited several cases of CFS researchers at academic institutions having been discouraged from doing ME/CFS research or having been told that, if they did not cease doing ME/CFS research, their academic positions would be imperiled.

In his parting remarks, Cook, whose term is also almost up, said that he feels that in-person meetings are important and should be implemented again because “people need to be held accountable on a face-to-face basis.”

Even the Chair conceded that webinars are not the best format for CFSAC meetings and that in-person meetings would be preferable. But astonishingly he still, for reasons known only to him, called the December meeting “very professional.” He also made excuses for the mishandling of the meeting by referring to the fact that [they] didn’t anticipate that the meeting would be that problematic. I confess that I find this disingenuous. How do you not notice during the practice runs that you’ve got a big problem? But more importantly, why do you choose the same dysfunctional format for tomorrow’s meeting? What’s the excuse going to be if tomorrow is equally as excruciating?

At some point during the meeting, the DFO apologized and explained the glitches with the fact that the webinar format was new to [them] and the IT people, which begs the question why they chose a format they so obviously couldn’t handle. The attempt to disenfranchise patients backfired painfully for HHS. And this once, patients weren’t the only ones feeling pain.

What to make of it all?

I have rarely seen Facebook and Twitter explode that much in this patient community as it did on that day. Patients could not have felt more disrespected and disenfranchised, which was remarkable given the community’s low expectations in HHS. They were angry and completely exhausted early on during the meeting due to all the confusion and glitches. But then something interesting happened pretty quickly. People, even those who don’t always agree on every issue, bonded. They united. They had a strong voice on social media. And they made the most of this disaster. They used humor to get through it. The material was endless and would have done a Daily Show or Colbert Report segment justice. One of my posts on Facebook that day:

The words of the day: “Can I have the next slide, please? Next slide? Next slide? Hello? Can anybody hear me? Can I have the next slide?”

Somebody else quipped:

Three minutes for comments. Five minutes for Dr. Lee to learn how to throw the switch.

(I’d like to give credit to the person who said that, but can’t remember who it was. If it was you and you feel comfortable being named, please do let me know.)

On a more serious note, the disrespect that HHS has demonstrated with regard to the handling of this meeting is unprecedented and truly astounding. The meeting was run so poorly that patients called for the DFO to be replaced by somebody with more competence and appropriate behavior and less bias towards the ME/CFS community. Of course, Assistant Secretary Koh blew off those requests and complaints with platitudes, just like he had with respect to Ms. Holderman’s report of the DFO’s threat towards her and two other committee members.

The link on the CFSAC website to tomorrow’s meeting, “View the presentations and listen to the webinar,” is not working (see screen shot below), which definitely doesn’t bode well for a successful meeting tomorrow. Yet, the December meeting set the bar so low that it is hard to imagine that it will be worse tomorrow, but I certainly don’t want to jinx anything.