A New Direction

When I published my blog post last week, “The #CoyneEffect: Is the ME Community Stepping Up or Backing Down?” following my hiatus from advocacy, I did not intend for that to be my return to ME advocacy. I simply felt compelled to make use of this space to express my grave concern about the chilling effect of organizations and individuals with a sizable platform enabling Coyne’s attempted silencing of courageous dissenting voices criticizing the unconscionable neglect of, and misconduct relating to, ME by the federal health agencies. We sorely need those voices to counter potentially harmful government activities. The absence of these voices clearly weakens the community.

I also wanted to set the much-distorted Coyne record straight and to make sure that the efforts to erase the ugly Coyne chapter will not be successful and that there will be no plausible deniability when (not if) Coyne launches his next offensive against the ME community and its patients. Now, my work here is done—ironically and unexpectedly—more effectively due to Coyne’s own comments on my blog. (Though I certainly might feel that I have to respond to new developments in the Coyne matter should they be serious enough.) Educated, trained and experienced in the field of mental health, Coyne has shown himself as somebody who takes pleasure in inflicting harm on people who are very ill and, at least in my case, delighted in taunting and sexual harassment. He made my case for me.

The aggressive bullying of ME patients by an outsider who is not stricken with ME and his seeking to isolate them from the rest of the community after they have dedicated years of their lives to ME advocacy despite being sick is certainly in its own league. However, that does not mean that name calling from within the community is not immensely damaging. Although coming from only a handful, when these personal attacks occur, it is nevertheless counterproductive and destructive. But I do object to classifying civil disagreement as bullying, as has become increasingly popular.

I have no regrets about having gotten involved in ME advocacy—particularly in fighting to hold the Feds accountable for FACA and FOIA violations. My IOM FOIA lawsuit and judgment against HHS and NIH and award of $140,000 in attorneys’ fees, in addition to uncovering revealing correspondence within the agencies and demonstrating their contempt for patient interests, still serves as a deterrent to HHS/NIH stonewalling in future FOIA requests from the community and a reminder that the ME community can effectively assert its legal rights against government wrongdoing. I take comfort in knowing that my advocacy has moved us forward and I am at peace with my decision to take a new direction in my life now.

Though this decision has not come easily to me, it is ultimately not optional. It became clear to me months ago that it was necessary. Serendipitously and unrelated to my stepping back from advocacy, I am very fortunate to have finally found a way to spend more time with my loved ones while still receiving my infusions. It would be hard to be more excited about a new chapter in my life.

On a more mundane subject, I will mostly disconnect from the community on social media in terms of active engagement, so please do not be alarmed if you don’t see me around much. My blog will be maintained indefinitely, though in inactive form. And (never say never) I might even return to advocacy one day if the stars align.

I want to extend heartfelt thanks to those who have collaborated with me over the years. I am in awe of your dedication, integrity and courage. You have led by example and helped me grow into a better and more effective advocate. I wish you the best of luck in continuing the good fight. You will, no doubt, need it. I also want to thank the many who have supported me, cheered me on and believed in me. It has made such a difference.

Before parting, let me please encourage everybody to support advocates they feel speak for them, particularly with respect to government programs that amount to little more than window dressing or worse. Don’t assume your voices of protest don’t carry any weight. They can and often do. Take, for example, the IOM report. Despite containing some useful sound bites, it is dangerously flawed for a number of reasons. For example, not only is the suggested name trivializing and harmful, investigators have also started to use the IOM definition—which was expressly intended to be a clinical definition only—for research purposes, despite the fact that it does not contain any exclusions. Alarmingly, there has been no opposition from any of the IOM committee members to that highly-concerning, though predicable, practice. So far, the IOM definition has been used in research only in combination with other definitions, but that opens the door for the Wesselys of the world to take it one step further by resorting exclusively to IOM and selecting patients for their research who predominantly suffer from a psychological or other physiological condition, as those are not excluded under the IOM definition. It’s a dream come true for the psych cabal. But as seriously flawed as the IOM report is—and it certainly is—it is hard to argue with the fact that the strong ME patient community opposition successfully headed off an even more damaging outcome.

Therefore, please do not bow to the admittedly intense pressure to keep silent. Everybody has a right to voice his or her opinion whether or not it meets with the approval of those promoting the party line. It takes immense courage to stand up for one’s convictions, but deciding to sit on the sidelines instead of speaking up might just tip the scales. For example, there does seem to be a perilous double standard in the community. Fighting PACE is considered imperative and it indeed is. But fighting an NIH study, which has the potential of being more damaging than PACE—for example, having as the lead clinical investigator an ME-as-somatoform-disorder proponent—is all too often aggressively and baselessly labeled being negative, counter-productive or something much more sinister.

Hope is important. But without realism, hope will never materialize into tangible changes. I continue to hold out hope that justice for ME patients will eventually be achieved and that genuine progress and treatment for all is in our future. But remember that it will require holding the Feds’ feet to the fire and not letting them off the hook with improper definition and naming of the disease; woefully inadequate funding; meaningless lip service; bureaucratic corruption and stonewalling; legal violations and dangerously designed studies.

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The #CoyneEffect: Is the ME Community Stepping Up or Backing Down?

I have received a number of messages from members of the community inquiring about my absence from ME advocacy and about my health. I deeply appreciate the concerns and thoughtfulness. James David Chapman recently tweeted:

tweet_chapman

I posted a series of tweets in reply to James, which are reproduced below, because the tweets should be read in succession, as each builds on the prior ones. This, obviously, scratches only the surface of the effects on the community of Coyne’s rampage against ME advocates. But I am not well enough to write a blog post fleshing out the topics of my tweets.

I apologize for the incomplete list of those who have been targeted by Coyne, by public or private attacks or threats or by being aggressively blocked on social media. Louise Reed was one of the targets of Coyne’s vicious cyberbullying who is not mentioned below because I didn’t have enough steam to track down her Twitter handle.

For more background on Coyne’s aggression directed towards the ME community at large and a number of its advocates, please see these two posts on this blog:

Has the “Coyne of the Realm” been devalued?

Standing Up to Coyne and Against Unfair Treatment of ME Advocates

Here are my tweets:

1 2 3 4 5 6 7 8 9 10 11 12 13a 13b 14 15 16 17 18

Tolerating, and thereby emboldening, the ruthless abuse and attempted ostracizing of patients and caregivers by an authority figure can ultimately be more destructive than the abuse itself, especially when it leads to an atmosphere of intimidation and to the sidelining of critical voices one disagrees with; those are much needed, even if inconvenient. Allowing a Wallit and Shorter champion to bulldoze his way through our community, with well-honed bullying tactics, is both short-sided and dangerous.

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Keep an Eye on Your Walitt: NIH Study Poses Dramatic Risk to Long-Term Disability Benefits

Many ME/CFS* sufferers are covered by employer-sponsored long-term disability (“LTD”) policies. These policies almost universally limit LTD benefits to 24 months for disability caused—or even just contributed to—by a mental/nervous disorder. The following language is taken from a current policy issued by a major LTD insurer:

“Once 24 monthly disability benefits have been paid, no further benefits will be payable for any of the following conditions:

  • Anxiety disorders
  • Delusional (paranoid) disorders
  • Depressive disorders
  • Mental illness
  • Somatoform disorders (psychosomatic illness)” [emphasis added]

Another leading disability insurance company defines mental illness as:

“a mental, nervous or emotional disease or disorder of any type.” [emphasis added]

There are variations in the language, but the gist of the mental-health limitation in most LTD policies is the same: a termination of coverage for mental-health conditions after 24 months. Somatic Symptom Disorder as well as other somatoform disorders are listed in the DSM-V and regardless of whether they are expressly mentioned in a policy, any diagnosis of a somatoform disorder will, without a doubt, be classified as falling under the mental/nervous clause.

Disability insurance companies routinely claim that ME/CFS patients are suffering from a mental/nervous disorder despite the fact that the patient’s physician did not diagnose such disorder. Nevertheless, LTD insurers are often successful in their effort to terminate benefits at 24 months by requiring that claimants undergo an “independent” medical exam (“IME”) performed by doctors who are paid by the insurance companies and, nearly without fail—in the case of a CFS diagnosis—find a mental/nervous disorder as a primary cause or at least contributing factor for the disability.

Disabled ME/CFS patients typically suffer disability for their lifetimes, in many cases for decades. Any NIH study, finding or official reference that supports, in any way, the characterization of ME/CFS as a somatoform disorder would be a dramatic boon to disability insurance companies enabling them to limit their payments to disabled ME/CFS patients to 24 months as opposed to the age of 65 (which is the typical age at which LTD benefits terminate for disabilities not caused, or contributed to, by mental/nervous disorders).

The risks regarding disability coverage extend well beyond new claims; current recipients of LTD benefits would not be grandfathered in. Disability policies universally provide for ongoing reviews as to continued eligibility as well as the ability to require an IME or otherwise to review each ongoing claim on a regular basis. Therefore, every ME/CFS patient who has been receiving disability payments beyond 24 months should expect this type of review and likely termination of their benefits should the findings or positions of any HHS agency, such as NIH, suggest a classification of ME/CFS as a somatoform (or other mental/nervous) disorder.

Enter Dr. Brian Walitt, lead clinical investigator for NIH’s intramural study of post-infectious ME/CFS. Walitt is positioned to have a key role—probably the key role—in the study. According to the study’s principal investigator, Dr. Nath, Walitt has been instrumental in the study design. As a member of the small NIH team responsible for the “final assessment of diagnostic validity” (see screen shot below taken from this link to the NIH study website), Walitt will also be involved in the ultimate selection of the 40 ME/CFS patients, one of the most critical aspects of any study. Walitt is a member of that team because he is considered by NIH a “clinical expert” on ME/CFS. His influence will undoubtedly extend to the final conclusions of the study.

(Added 3/30/16: Please see my comment in the comment section below further clarifying Walitt’s central role in the study.)

I discussed at length, in my recent blog post (“Brian Walitt’s Radical Bias: Disorders of Subjective Perception, ME/CFS as Normal Life Experience?”) Walitt’s views (stated only a few months ago) of fibromyalgia not being a medical entity, but merely a normal life experience. Fibromyalgia is, of course, considered to have substantial overlap with ME/CFS and clinicians and researchers who believe fibromyalgia is a somatoform disorder typically believe the same about ME/CFS. Indeed, should there be any doubt, Walitt has been unequivocal in his opinion that chronic fatigue syndrome is a somatoform illness. This is set forth expressly in the 2015 paper, “Chemobrain: A critical review and causal hypothesis of link between cytokines and epigenetic reprogramming associated with chemotherapy,” which he co-authored and which contains the following statement:

“The discordance between the severity of subjective experience and that of objective impairment is the hallmark of somatoform illnesses, such as fibromyalgia and chronic fatigue syndrome.” [emphasis added]

Many patients were incredulous when Walitt flippantly revealed his obvious disdain during NIH’s March 8, 2016 invite-only “ME Advocacy Call” about the study in response to concerns about his bias:

“If chronic fatigue syndrome/myalgic encephalomyelitis is all in your head, it’s only because your head is part of your body.”

Here is Walitt’s quote in full:

“First let me affirm by saying that chronic fatigue syndrome/myalgic encephalomyelitis are a biological disorder. Research has shown that in every system of the body that has been investigated that there have been abnormalities when compared to healthy volunteers. If chronic fatigue syndrome/myalgic encephalomyelitis is all in your head, it’s only because your head is part of your body.” [emphasis added]

As you can see, it is true that Walitt acknowledged that every bodily system of patients has shown abnormalities. But that is entirely consistent with his view that ME/CFS is somatoform, as patients with somatoform disorders are not required to lack physical abnormalities; instead, patients are said to generate thoughts, feelings or behaviors in response to their somatic symptoms that are disproportionate or excessive. Further, Walitt seems to believe that the abnormalities are being created by the patients’ own thoughts and emotions due to some kind of biochemical mechanism. The symptoms themselves do not need to be medically unexplained; they can, in fact, be associated with a biological condition. Saying that one doesn’t believe that symptoms are all in a patient’s head is not irreconcilable with believing that the patient suffers from a somatoform disorder. Therefore, Walitt’s acknowledgement of abnormalities in ME/CFS does not, in any way, negate his apparently strongly-held belief that ME/CFS is a somatoform disorder.

Walitt had to know—in light of the overwhelming criticism directed at him—that it was crucial to pull off a flawless performance during the call and yet, he could not resist making that astonishing remark, which effectively betrayed his assurances of the absence of any bias. Walitt had the perfect opportunity to let us know if he had changed his mind by 180 degrees and no longer considers ME/CFS to be a somatoform disorder, unlikely as it would have been in only a few months. He did not do so.

Given Walitt’s well-documented opinion on CFS as a somatoform illness, there is a high likelihood that the study design, the patient cohort selected for the NIH study, the day-to-day decisions made by the lead clinical investigator and the ultimate conclusions of the study will be affected by Walitt’s clear bias. The very fact that NIH appointed Walitt in the first place, as well as the agency’s in-patients-face failure to remove him from the study after an unprecedented and ongoing outcry from the patient community, is ever so revealing in terms of NIH’s objectives for the study and its recently oft-repeated assertion of a suddenly-found desire to work with patients. It is hard to imagine that NIH could have managed a more perfect middle-finger salute to ME/CFS patients than appointing Walitt as the lead clinical investigator.

As I have said before, this study—in its impact—has the potential of becoming PACE on steroids. In addition to the other dramatic risks posed by the design of the study (which are beyond the scope of this post), thousands of disabled ME/CFS patients could face the sudden loss of most, if not all, of their already modest lifetime income and, as a result, life-threatening poverty that would be impossible to navigate for many in the face of the debilitation caused by their disease—if Walitt continues to remain on the study.

*I am using the term “ME/CFS” because that is what NIH says it is studying. It is beyond the scope of this blog post to discuss the futility of combining the disease, ME, and the social construct and wastebasket diagnosis, CFS.
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Standing Up to Coyne and Against Unfair Treatment of ME Advocates

[Update 5/5/16: For context and background on Ed’s post below, please read my blog post, “Has the “Coyne of the Realm” been devalued?” It describes in detail some of Coyne’s abuse of patients in the ME community, including myself. The mistreatment seems to be ongoing, as he continues to call patients “assholes” and “nut cases” and who knows what else.]

By Edward Burmeister

I am taking the liberty of posting this entry on Jeannette’s blog.

Many of you know that I seldom become involved in ME advocacy. My wife, Jeannette, is typically capable of holding her own. She has been, health permitting, a relentless advocate for ME for several years and has been effective in holding government agencies and officials accountable when their actions or inaction have damaged the ME patient community, and in particular when they have not lived up to their legal responsibilities. It is true that she has strong opinions on how to conduct effective advocacy and states her position assertively, but I can assure you that she makes it a priority to focus on the issues and to stay away from personal ad hominem attacks on other individuals advocating for ME. On the rare occasion when she has made a mistake, she was quick to apologize and set the record straight. Far from being self-promoting, Jeannette has gone out of her way to support and give credit to other patient advocates for their efforts. When her health allows, Jeannette collaborates with other advocates, typically behind the scenes. Among other things, Jeannette’s advocacy efforts seem to have derailed the massive price increase for Ampligen that was scheduled for next month, which according to the Ampligen study coordinator is now not going into effect for the time being.

Jeannette has made sacrifices for the community that go above and beyond. Aside from traveling to Washington, DC on numerous occasions on her own dime, she has paid the travel expenses of other advocates for DC trips. She anonymously paid the Incline Village rent for another patient whom she barely knew, so that that patient could get Ampligen. Not only did she risk having to cover the $139,000 in attorneys’ fees from her FOIA lawsuit herself, she ended up paying about $60,000 in taxes on those fees. In addition, as the plaintiff, she also was not able to bill for the time she herself worked on the lawsuit, which would have totaled additional tens of thousands of dollars. There are many other ways Jeannette has helped patients and the community that few know about. She gives back as much as she can without bragging about her generosity. And while we are financially comfortable, for which we are very grateful (and because of which we would have never thought of asking the community to chip in, for the attorneys’ fees, for example), her financial investment in her own and others’ advocacy has been significant and affected us financially fairly dramatically. (After all, Jeannette is disabled like so many ME patients.) Yet, she has not once talked about that.

The recent incident starting with the Facebook posts of Dr. James Coyne on February 27, 2016, is so outside the realm of reasonable and civil behavior and has affected Jeannette’s health so directly and adversely as to render her physically unable to defend herself at the moment, that I simply cannot stand by and witness this without comment.

Her blog entry, “Has the “Coyne of the Realm” been devalued?” sets forth the facts. I will summarize these briefly, however. It is important to know that Jeannette had been a supporter of Coyne’s efforts on behalf of the ME community and has never stated, publicly or privately, anything that could possibly be viewed as attacking him in any way. She did thoroughly analyze the public interview of Brian Walitt of September 2015 concerning fibromyalgia when she found out that he was to be the lead clinical investigator of the proposed NIH intramural study. She posted a blog entry, “Brian Walitt’s Radical Bias: Disorders of Subjective Perception, ME/CFS as Normal Life Experience?” based on the Walitt interview, expressing her concerns regarding his participation in the NIH study given his stated views concerning fibromyalgia.

Then she tweeted the following to the head of NIH, Francis Collins, with a link to her blog post (22 retweets and 30 likes as of now):

“Not one bit embarrassed that Walitt works for you, hurts very sick patients? What an agency you run!”

Notice that neither Jeannette’s tweet nor her blog post contain any direct or indirect comments on, or criticisms of, Coyne nor would anyone reading these perceive any conceivable attack on Coyne. Coyne would not enter your mind at all. Her tweet was assertive, but completely within the acceptable and reasonable range for advocates who take issue with government actions. One might even consider the tweet reserved given the history of the neglect of ME by NIH. Also bear in mind that Jeannette had filed a FOIA request with NIH to obtain documents concerning the genesis of the IOM study on ME/CFS. She was met with unconscionable obstacles and obfuscations by NIH, requiring her to file a lawsuit, including misrepresentations under penalty of perjury by NIH officials. Only after an arduous legal battle did she obtain the documents to which she and the public were legally entitled. The NIH behavior was so inexcusable that the Judge in the case awarded all her attorneys’ fees (highly unprecedented), totaling $139,000, and specifically called out NIH for its unreasonable conduct in this case.

It is simply not tenable to maintain that her tweet was “abusive.” You may not agree with it or with her tactic of criticizing Walitt or the handling of the proposed study by NIH, but the tweet was absolutely fair game and within acceptable standards of reasonable advocacy. With this background, it was shocking to her, me and most of the community that Coyne stepped in and demanded, in effect, that the patient community condemn Jeannette’s tweet, insist on an apology from the community for the tweet and ostracize advocates like Jeannette, calling her a “sick crazy lawyer,” having a “history of being abusive towards reasonable informed Americans” and posting a “nasty and abusive tweet.” He demanded that the patient community step up and “stop the abusive crazies” or he would stop helping with attempting to obtain documents relating to the PACE trial. When many questioned him on this, he called them names (e.g., “delusional”) and told them to “fuck off.” All of this because Coyne disapproved of Jeannette’s reasonable approach to advocacy.

Please keep in mind that this is coming from a renowned Ph.D. in psychology with a large public following and a recent position of prominence in support of patients with ME.

Coyne is a newcomer to this community and has apparently developed a pattern of labeling long-term advocates with whom he disagrees as divisive and destructive and asking others to ostracize them for simply expressing any views that are inconsistent with his views or approach to advocacy.

I sincerely appreciate, as does Jeannette, the large outpouring of supportive comments from patients in the ME community, public and private. Unfortunately, she has been too sick to thank everybody individually, as she wanted to. As ugly as this has been, Jeannette tells me that a number of new alliances have been formed over this and for that, she’s grateful. We are both especially heartened by the fact that the majority in the community has a functioning moral compass.

Unfortunately, there are a few who have apparently harbored resentment against Jeannette and have taken this opportunity to add to the abuse from Coyne, calling her names, such as “textbook narcissist” with her following of “flying monkeys.” To those few people who thought it fit to pile on in the aftermath of Coyne’s revolting mistreatment of Jeannette by egregiously defaming Jeannette and spreading vile lies about her (some of which are urban legends revived from years ago) and engaging in other character assassination, maybe you want to check in with your conscience because your behavior shines a bright light on your value system and, quite frankly, it’s not flattering. The same goes for those hosting or “liking” such comments.

Jeannette is currently undergoing an intense five-days per week treatment regimen for a medical issue secondary to ME, on top of her infusions. Continuity is crucial for the efficacy of that treatment. That is now in jeopardy due to her decline as a result of Coyne’s verbal and emotional assault. No sick person should be forced to choose between protecting her health and defending her reputation.

It is alarming that some have supported, or at least condoned or downplayed, Coyne’s behavior. Some have suggested that Jeannette somehow brought this on herself, which is not only untrue, but also constitutes shameless and cruel victim blaming. Some have justified it under the greater good theory, in other words, we need Coyne’s advocacy for obtaining the PACE data, so we have to sacrifice a sick patient advocate who has labored for years at great personal cost on behalf of this community and tolerate her abuse by Coyne. Others are saying that they disagree with his language, but basically agree with his sentiment about quieting advocates who don’t toe the party line. I want to be very clear that the foul language, as unacceptable and revealing as it is, is not the main issue here. Had Coyne done what he did—calling sick patients “crazies,” resorting to defamation, trying to coerce a vulnerable patient population into an apology (when he is the one who should apologize) and into shunning advocates for no reason whatsoever—but done it in a more polite manner, it would still have been reprehensible. It’s the substance of what he did much more so than the style in which he did it that is so objectionable. The style does reflect, however, a disturbing aspect of his approach to advocacy. And let’s not forget that this was not just one comment. It was a sustained attack that encompassed many comments and no apology has been made. To those who have suggested that Jeannette back off on this and, in effect, suffer in silence in order that the ME community keep its focus, i.e., the taking down the PACE trial, I respond with two points. First, it was Coyne who launched the unjustified attacks on the community and key advocates. It is up to him to deescalate the situation by apologizing and toning down his rhetoric. Second, silence has facilitated Coyne’s attempt to shut down and ostracize other advocates—Suzy Chapman and Angela Kennedy and presumably others—without any repercussions for Coyne. Someone has to stand up to his bullying tactics. Otherwise, who will be next on the chopping block? Further, is it not possible that his extreme actions in this arena could backfire and give those who oppose his position on the PACE data ammunition to reject his demands?

We are assessing what steps we should take to bring accountability for the described actions against Jeannette, but mainly I wanted to let the community know how strongly I feel about this and how directly it has affected our family. I should add that I have served as the Managing Partner of the Bay Area offices of Baker & McKenzie LLP, the world’s largest law firm, and have never witnessed this type of behavior towards a professional in comparable circumstances, particularly by an individual who, by education and profession, should be compassionate and caring.

By now, Coyne has had plenty of time to issue an apology to the community and the advocates he specifically targeted, including Jeannette. He has not done so. Instead, he stood idly by as further attacks by others, clearly incited by his initial smear campaign against Jeannette, took place. It is clear that he is unrepentant.

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Has the “Coyne of the Realm” been devalued?

[Please also see the follow-up post by my husband, Ed Burmeister, “Standing Up to Coyne and Against Unfair Treatment of ME Advocates.”]

A recent addition to the ME advocacy community, Dr. James Coyne, has been celebrated as a savior of ME patients almost immediately since he joined the conversation just a few months ago by attacking the PACE trial. He has been a very welcome ally. So, it was rather bizarre when Coyne gave the ME community an aggressive ultimatum yesterday, in an apparent attempt to silence patients whom he disagrees with. In this particular case, it was my opinion regarding Walitt’s appointment as lead clinical investigator for the NIH study he took exception with. According to the ultimatum, patients can either “do something about [me]” or he “is out of here.” He posted the following about a tweet of mine addressed to NIH Director Dr. Francis Collins in two Facebook groups, “Invest in ME” and “The ME Alliance:”

He then proceeded to call me a “sick crazy lawyer,” tell another patient to “fuck off,” label another as “delusional,” tell the community that they can “fuck themselves” and throw around f-bombs like they are the new “lol.” He also painted himself as the victim of “abusive crazies,” i.e., dissenting ME patients.

Yet, according to Coyne, I am the trolling and harassing one!

I quote from the above:

fuck yourself

I will demonize a crazy sick lawyer

Apology, my ass

you are delusional

be my fucking guest

Coyne is threatening an “all out war” against the community:

Here is a person who, by his own account, is healthy and obviously extremely high functioning judging by his prolific writing, tweeting, posting, etc.

He, the healthy one, threatens a marginalized, abused, neglected and victimized patient population that has been desperate for his help. Yet, according to Coyne, dissenting patients are the crazies!

I have never seen a member of the ME community that enraged and out of control. Things got so surreal that a number of people wondered whether Coyne’s Facebook account had been hacked. But sadly his Facebook behavior of yesterday is consistent with his recent Twitter conduct.

The irony of the following statement by Coyne is likely lost on nobody.

Illness certainly does not justify bad behavior in public. Nothing does, really. Nevertheless, we witnessed Coyne’s behavior yesterday.

Once again, the community is facing somebody who is asking us to use our inside voices, never mind that hasn’t worked in 30 years. All the while, Coyne is shouting profanities at the top of his lungs, not at the perpetrators, the US government, but at the victims, vulnerable patients who have every right to voice their opinions. Coyne is free to disagree with them, in a civil manner. It’s called discourse. What he exhibited yesterday, however, is called verbal abuse.

Let me assure you that there has not been any bad blood between Coyne and me in the past. Like many other patients, I have been immensely grateful for Coyne’s commitment to fighting PACE and the work he has done on that front. He and I have never had an interaction of any kind other than my liking and sharing a few of his blog and Facebook posts as well as some of his tweets, typically related to PACE.  For all I know, Coyne does not know me, or of me or my past advocacy work, although bizarrely, he Facebook-friended my husband (who is active in ME advocacy only very sporadically) a few months ago.

So, despite the lack of any history here, Coyne proceeded the way he did without the courtesy or the courage to first engage me privately or to at least tag me in his public attacks. This was clearly a calculated hit on a reputable advocate that he felt he could get away with.

According to Coyne, my tweets are not only “quite off the wall” (seriously?), but I am also “quite closed to being corrected.”

How could he possibly know that? As I said, we haven’t had a single exchange, no direct contact whatsoever.

Also note that he posted in two UK groups, possibly because the UK community is not as familiar with my work as US advocates are and I’d likely be an easier target and get less support there, although it hasn’t exactly panned out that way for Coyne. In fact, most patients who commented, regardless of where they are based, are bewildered by Coyne’s tantrum and don’t appreciate his harsh and irrational ultimatum. It seems Coyne miscalculated and the community called his bluff. But still, if one wanted to pit the UK community against the US community, this would be a pretty good way to go about it.

The more patients pushed back, the more Coyne kept repeating that he will just abandon us, unless an apology from the community is forthcoming:

As a matter of background, NIH recently announced an intramural study on post-infectious ME/CFS (their phrase, not mine) as well as the agency’s appointment of Dr. Brian Walitt as the lead clinical investigator. I wrote in detail about a disturbing interview that Walitt gave about fibromyalgia. If you haven’t seen the interview, it’s a must-watch. It will make the hair on your neck stand up. According to Walitt, fibromyalgia is not a disease or illness; instead it is merely a normal way that some people are meant to experience life. Walitt considers a lack of treatment not harmful to patients. Furthermore, in his prior work, Walitt labeled CFS together with fibromyalgia as somatoform and both as disorders of subjective perception, much like the Wessely School. One thing that I fear might get lost in all this Coyne profanity is that he seems to deem Walitt an unproblematic choice for the NIH study. It really does make one wonder where his allegiance truly lies.

Coyne seems to have a huge blind spot when it comes to US ME politics. UK bad, US good:

It’s outside the scope of this blog post to discuss why Coyne’s view of the situations in the UK vs. the US is less than fully informed and much too simplistic. But one only has to look at the CDC website and its continuing medical education material to see that the agency is recommending graded-exercise therapy and cognitive-behavioral therapy, based in part at least on the PACE trial.

I stand unequivocally behind my tweet to Collins. Claptrap like that of Walitt has no place at NIH. Taxpayer money is wasted on Walitt’s salary while quality research is not getting funded. My opinion and that of the vast majority of US patients (and those UK and other patients) who have been closely following the details around the NIH study happens to be that Walitt is an appalling choice for the NIH study. It is an entirely reasonable position—and I’d argue the only reasonable position—that Walitt should not be anywhere near the study. Coyne feels different. In fact, he supports Cort Johnson who supports Walitt.

Do I think Cort’s pro-Walitt piece is indefensible because it downplays the dangers to the community of Walitt’s involvement? Sure. Have I called Cort names because of it? Of course not, because of that whole civilized grown-up thing adults typically do. My tweet was more than appropriate in light of the history of the US health agencies with this disease and in light of NIH’s choosing of Walitt. How can Coyne possibly be the arbiter of what is acceptable in Twitterland given his generous use of profanities?

It’s almost like Coyne is being territorial, the territory being forcefully-stated opinions. They are ok for him—definitely for him—but most certainly not for others, unless they support him; then they are fine, of course.

Can we take a step back and have a little reality check here? Twitter is a place for conversation, a venue to express opinions. Coyne, more than most people you will find on Twitter, expresses strong opinions on a regular basis, which makes this all even more surreal. He hasn’t thought of an attack he doesn’t like to unleash. He is not one to pull many punches. A few months ago, he called a female journalist’s tweet a “bitch comment,” something I naively made excuses for at the time. Let’s face it, we all placed a lot of hope in him and were willing to give him the benefit of the doubt. We were eager to overlook this lapse in judgment that offered a first glimpse of what was to come.

Some of you know that I grew up in East Germany. I am all too familiar with intimidation tactics designed to silence people. Once you’ve experienced the Stasi, you don’t scare easily and you also recognize bullying the moment you see it. Coyne is asking the community to apologize for a tweet—a reasonable one at that—by one person under threat of withdrawing his support for the entire community.

That is outlandish. It is aimed at stifling discourse about issues that are crucial to patients just because certain opinions don’t fit his narrative. Obviously, the entire community is not responsible for what a single advocate says. So, what Coyne is really trying to do is not get an apology—from me or the community—but to get the community to rein me in, just like Dr Nancy Lee, DFO of CFSAC, has unsuccessfully tried before.

Aside from David Tuller, we haven’t had anybody from outside the community stand up for us as forcefully as Coyne. We desperately need the help of outsiders. Many believed he would be the one freeing us from our shackles. Coyne, of course, knows that and is playing on the fears and hopes of patients many of whom have been distraught about Coyne’s behavior and are begging him to stay. He is not budging. Extreme events like this are physically harmful to ME patients. They can cause major crashes and a long-term decline. Either Coyne has not learned even that much about our disease in the last few months or patients are just collateral damage in his quest for complete control.

Coyne seems to think that Collins’ position somehow warrants that he be treated with kid gloves. The opposite is true. Collins is a public persona, a top US health official who needs to be held to the highest standard for the sake of taxpayers and gravely ill patients. His agency together with CDC and other HHS component agencies has been responsible for the abuse and neglect of ME patients. NIH has recently designed a study on ME that reveals the intent to rebrand our disease as a psychosomatic one. And yet, Coyne demands that patients censor and shun other patients for expressing their objection to the study in ways that are not Coyne-approved.

Collins is the head of the world’s largest and most powerful government agency sponsoring biomedical research, but Coyne is acting as though Collins is a delicate flower.

Really? One tweet defines the community’s relationship with NIH? Preposterous. But let’s just say, for argument’s sake, Coyne is right. Why is that a problem? Almost all patients and advocates agree on Walitt. Does Coyne want to gag all of them? Maybe he is hoping that making an example of me will teach others not to have an opinion that differs from his. After all, his attacking the disabled has a devastating effect on the targeted patients’ health and who would want to risk being next? Where will he stop? Or will he? When is the earth scorched enough for him?

But seriously, if agency heads cannot take a bit of heat—especially when they and their predecessors are responsible for a tremendous amount of abuse and neglect of the vulnerable—maybe their appointment was not the best choice. I wonder how Collins feels about being painted by Coyne as somebody who cannot stomach a justified tweet.

I see no need to defend my record. It’s a credibility problem for Coyne, not for me, that he didn’t do his homework. But let me say just this. Sure, I am not a feel-good, kumbaya advocate. My philosophy as an advocate is to hold the Feds’ feet to the fire and exert pressure because playing nice hasn’t worked and people are running out of time. That is how I have successfully called out numerous HHS & Co. legal violations. And that is how I won a federal FOIA lawsuit against NIH and HHS recovering all my attorney’s fees, something practically unheard of in a FOIA case, especially given the amount of legal fees—over $139,000—NIH and HHS had caused me with their recalcitrant and obfuscating behavior. The fact that the Court awarded attorneys’ fees in full is a clear indication of just how unreasonable NIH and HHS acted in that litigation. That conduct included NIH and HHS misrepresenting the facts under penalty of perjury, misstating the law, filing a frivolous summary-judgment motion, disobeying the Court’s order, wrongfully accusing me of lying, everything to avoid complying with the law at the expense of taxpayer money. HHS and NIH directly caused my health to dramatically deteriorate as a result of their deplorable conduct. They acted like bullies towards a disabled ME patient. I have not yet talked very much about the details of the lawsuit, but I am working on it and I can guarantee that patients will be appalled. The Feds used every dirty trick in the book and because of their arrogance, they didn’t in their wildest dreams imagine I would win. Yet, win I did. But hey, according to Coyne, I am just a crazy lawyer.

Quoting from the Court’s attorneys’ fees order:

… the government’s conduct throughout its dispute with Ms. Burmeister was unreasonable. [emphasis added]

Why is Coyne not outraged by how HHS & Co. have violated the law and treated me in that lawsuit? Why does he not take issue with NIH’s decades-long neglect of the community or its upcoming study whose design is beyond redemption? And please spare me the it’s-in-the-past speech. Not only is it unrealistic to think that an agency changes over night, but my lawsuit came to a close just a few months before Collins’ promise of a new era. But then again, Coyne doesn’t “give a fuck” and has his own grievances with NIH:

Is the following possibly why Coyne blew a gasket yesterday?

I have no doubt that he spent many hours on the PACE project, with the help of many patients. And yet, there is just no way he is as invested as any of us patients are. For Coyne, this is intellectual stimulation that provides adoration from many as well as possibly academic glory. For us, this is nothing less than our lives on the lines, vastly different stakes.

I am by no means the first member of the community to be on the receiving end of the rage that seems to have overtaken Coyne recently:

Earlier this week, I noticed his Twitter exchange between Coyne and Rosie Cox whose intelligent and spot-on commentary is a valuable asset to the community:

Patronize and micromanage much?

Angela Kennedy has been another Coyne victim. She was entirely civil in her Twitter exchange with Coyne a few days ago, asking him about his tweets linking to Cort’s blog post about the NIH study (reproduced above):

Instead of answering her question, he kept asking her if she had read Cort’s blog post. And then he sent her the following direct messages:

Wow! The Twitter police in action. In the world of ME advocacy where social media is almost everything, that kind of abusive overreach—seeking to interfere with the online presence of an advocate—can completely sideline somebody. That kind of disproportionate reaction is just vicious. It’s revealing and it’s inexcusable.

I seem to have missed the incident that led to Suzy Chapman—an impeccably accurate and prolific advocate—being blocked by Coyne on Twitter, but I am sensing a trend. I keep thinking how bizarre all of this is. I do feel a bit like I am back in high school and one of the cool (translation: mean) kids is telling others they can’t sit at the cool-kids’ table.

I wonder what Rosie, Angela, Suzy and I—all us *women*—have in common.

Coyne claims that Angela and I have a history of being more abusive with more reasonable people like Julie Rehmeyer.

Angela can speak, and has spoken, for herself and Julie has backed her up:

Coyne’s assertion is plain and simply an untruth as to myself as well. I recently pleaded with Julie to reconsider her plan of interviewing Walitt because I believe that it would give Walitt an opportunity to spin the absurd statements he made in the interview and it’s better to let the interview speak for itself. Julie and I disagreed on strategy. It’s advocacy, for Pete’s sake; there is going to be disagreement. We had a polite Twitter exchange about it. Julie tweeted to me twice that she understood where I am coming from. I am unable to find her second tweet in which she only said, “I hear you,” but here is the other one:

As you can see, Coyne’s description of that exchange as my abusing or attacking Julie is a blatant mischaracterization of what happened.

It has been reported to me that Coyne had a private-message exchange on Facebook on the evening of February 27th with a patient who had been providing him, for months, with amounts of quite rare documentation about UK ME-related matters, including the Lightning Process and the SMILE Trial. The patient relayed to me that, on a number of occasions, the patient urgently messaged Coyne to correct his factually incorrect online statements.

The patient notes that all the exchanges with Coyne up until that time had been perfectly pleasant and straightforward, concentrating on the documents. But on that evening, the messages from Coyne became suddenly abusive.

The patient has graciously given me permission to reproduce Coyne’s verbally abusive private Facebook messages. The first FB PM from Coyne to the patient in that thread appeared to be some kind of ultimatum relating to my Tweet to Francis Collins. The patient feels that Coyne took his anger out on her because he didn’t have the courage to confront me, because both my husband and I and many of our friends are attorneys. Here are some of the Facebook PM exchanges:

Coyne: “This is absolutely unacceptable trolling and harassing of the head of NIH. If something is not done about it, I am withdrawing form the struggle.” [Reproduced Jeanette’s Tweet to Francis Collins]

Patient “Err? I don’t control what Jeanette Burmeister Tweets, or who to. As far as I can see there was one tweet. She is a lawyer who won an FOI case (below)”

[The patient gave links to my blog posts on the NIH and HHS FOIA case.]

Coyne: “I do, when it is to the Head of NIH and I am prepared to tell the patient community collectively to fuck off.”

Patient: “Charming. I have always been civil to you James. As you can see there is definite history between the NIH and Jeanette.”

Coyne: “I don’t give a fuck. If the community cannot do better, they can fuck themselves.”

Patient: “I want you to stop sending me such messages, and to stop swearing in private messages to me. Go take your anger out elsewhere. I don’t tweet. I am too sick to take on another online system. Too many of us are very lucky to be still alive. If my doctors and fellow citizens had had their way in the years of very severe ME, I would be six feet under twice over.”

Patient: “Err – have you sent such messages with swearing to Jeanette Burmeister? Or just to me?

After all – its not as though Jeanette has told Francis Collins what you have just told me – ie if he can’t do better he can fuck himself.

She has been more civil to Francis Collins than you are being to me.”

Coyne: “fuck off, you are wasting my time.”

Patient: “Apologise James. Your communications to me tonight are are appalling and frankly abusive. Have you messaged anyone else with such abusive statements? Or is it just me, who has never been rude or offensive to you.”

Coyne: “I really don’t care what the community thinks, they have totally undermine all my hard work.”

Patient: “Don’t message me again. You have been rude and abusive in these messages beyond the call of anything.

I don’t care how angry you are. You don’t speak to me that way. You are out of order taking out your anger on me about a tweet by Jeanette Burmeister.

I ask you again, have you sent similar messages to Jeanette as well, or anyone else in the ME community tonight – or is it just me you feel free to be verbally abusive to tonight ?”

Coyne: “Let’s not talk to each other no, I didn’t write to her. But you don’t get what I’m saying”

Patient: “So, you decided to take your anger out on me. But you didn’t have the guts to write the same messages to Jeanette, who has a high profile blog and is a lawyer.

I got exactly what you were saying James. you were repeating fuck off in private messages to me.”

I wonder if other patients have received similar messages from him.

It is clear from this exchange that Coyne is seeking to completely control the community around the NIH study.

The problem with relatively new, self-appointed prophets is they don’t have a track record yet, haven’t revealed their agenda yet, have not proven themselves yet. Those things take a while, happen only over time. When people place all their hope in them, and I will admit I did it myself in this case, they risk getting annihilated on a whim, just like Coyne is threatening to do to our community now.

As an outsider who is new to ME advocacy, Coyne can’t be expected to know much about the history of the disease or its politics other than that of PACE. As an academic, however, he ought to know that it is crucial to be aware of one’s limited knowledge. His distressing hissy fit was so gratuitous and really quite unfathomable.

Is Coyne’s outrage even real? I mean is it really possible that somebody would get that angry about one low-to-medium-heat tweet? Or is he looking for an excuse to bail out on us? In other words, does he need a scapegoat to save face because he feels defeated in his fight against PACE? Advocacy gets frustrating. It is not for the faint of heart. I don’t know of many advocates who haven’t considered bowing out. I must say though that this kind of exit has never entered my mind. Or is this a case of uncontrollable rage against an easy target, sick patients who fear his threatened abandonment? It’s clear that we are witnessing control issues here. But does misogyny play a role? Those were all questions that the community has been asking since yesterday. Only Coyne knows the answers and I don’t want to speculate about the source of the ugliness of it all because I believe it will all become clear in short order.

Notice how Coyne set up the “discussion” in a way that if he does drop us as a community, it will look like it’s not due to his frustration over his lack of success with PACE. Rather, he framed it to be my fault or the community’s failure to teach me and advocates like me a lesson. I certainly don’t want to discourage Coyne in his fight against PACE. After all, many sick people have put a lot of their precious health into helping him help us and we urgently do need help. But should he choose to throw in the towel, that is on him entirely and nobody else. I will not be bullied into taking responsibility for his irrational actions—holding the community hostage over a tweet he dislikes—especially not after the indefensible abuse I have already had to take from him.

I really didn’t want to have to write this. But I take my reputation and my health very seriously. Needless to say, this incident has had a major impact on my health and is likely going to interrupt my desperately-needed treatments. I have been quite sick in the last six months and am just now coming out of a severe crash during which, at some point, I had to make an emergency will. Coyne’s behavior is making the community look bad. He’s holding everybody hostage demanding that the community condone his repeated abuse of, and aggression toward, patients in exchange for his staying engaged with PACE. I did not set it up that way. That was all Coyne. If he is willing to deescalate, I will be more than happy to listen.

I consider his vilifying attacks on, and lies about, me personal harassment and worse and plan on taking appropriate steps should they continue. His ultimatum to the community shows a degree of aggression that is unprecedented and highly alarming. Coyne called disabled people “crazies,” is attempting to bully patients into silence, is throwing his weight around with complete and vicious disregard for the wellbeing of seriously ill patients and the fact that his preposterous outburst is making them sicker. There is no room for this behavior in our community. How is somebody like that going to represent the ME community in the outside world? Is he going to walk around telling people who disagree with him to bleep off? Will that be held against the community?

So, yes, an apology is in order indeed—from Coyne to the community and me and everybody else he has abused and attacked.

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Brian Walitt’s Radical Bias: Disorders of Subjective Perception, ME/CFS as Normal Life Experience?

NIH has tapped Dr. Brian Walitt as the lead clinical investigator for its intramural study “Post-Infectious Myalgic Encephalomyopathy/Chronic Fatigue Syndrome.” (For terminology, please see the end of the post.)

Investigators

Walitt_PictureOnly a few months ago—in September 2015—Dr. Walitt gave an interview at a rheumatology conference about his conference presentation on fibromyalgia: “Tilting at Windmills (a rational approach to fibromyalgia).” Rarely have I seen anything less rational than Dr. Walitt’s interview. You simply must watch it because those nine minutes will make you wonder if you mixed up your thyroid meds with some left-over Quaaludes. There is not even a pretense of scientific thinking. The interview illustrates what NIH has in store for us. Watch it, really let it sink it and then tell me that it doesn’t scare the pants off of you. Share it!

Walitt’s claims lack even an inkling of science. In the demeanor of a hokey cult leader, he lays out his horrifying *beliefs* about fibromyalgia. Walitt *believes* that fibromyalgia is not a medical entity (because, you know, he can’t find anything wrong with fibromyalgia patients), that patients’ symptoms are merely part of a normal human existence (because, you know, mind-body connection), that patients are meant to have these symptoms, so that they can learn a lesson (because, you know, hardcore science needs more mindfulness), that it’s perfectly acceptable not to treat patients (because, you know, that will do them no harm and whining to your doctor, or “complaining” as he calls it, is just not very considerate) and that it’s just better for *everybody* that way (because, you know, doctors only have very limited time for each patient and medications don’t work well in fibromyalgia). As a result, Walitt really doesn’t seem to see a point in researching a biological basis for fibromyalgia. If you are wondering why he is doing research at NIH in the first place, don’t! None of this is apparently required to make any sense, except if you take into account that he’s quoting a psychiatrist. According to Walitt, “traditional medical diseases will eventually show themselves objectively.” BUT NOT IF YOU DON’T CONDUCT ANY UNBIASED RESEARCH ON THEM!

In short, according to Walitt, fibromyalgia is not a disease, or an illness; it’s just a story patients tell themselves and others—an incorrect interpretation of their perceptions—that Walitt is here to help interpret. One of his slides claims: “Fibromyalgia is our modern narrative for a range of persistent, distressing, and stereotypical sensory experiences.”

Walitt_What_is_Fibromyalgia

Walitt’s calm, collected and almost pleasant demeanor while presenting the most horrendous theories is chilling. He appears caring and compassionate while seemingly devoted to disappearing fibromyalgia as a medical entity. I say “almost pleasant” because there is something extremely disturbing about Walitt’s delivery in this interview.

Let’s look at what he said exactly:

The most important thing to do is to listen, right? … We can’t restore them to what they think they should be. [not audible] We should bear witness to their difficulties, which is the oldest of the jobs that physicians do. [emphasis added]

Right off the bat, Walitt shows a judgment about the patients’ expectations, disguised as pretend compassion expressed when Walitt stresses the importance of listening. Patients want scientific progress—not witnessing of our suffering—thank you very much.

What Walitt is really saying is, “How dare patients wish not to be sick?!” Never mind that they might be so debilitated that they can hardly do anything and have no quality of life, because they just think they shouldn’t be suffering.

In response to the question of what fibromyalgia is, Walitt said the following:

… fibromyalgia appears to be a way that people experience suffering in their body. Um, both from the way that the bodies are interpreted and the problems of the body, as well as the problems in their lives, as well as how societies tell us how to experience things. All those come together to create a unique experience in different points in time, and right now, that experience, um, is a, one of those experiences is fibromyalgia. Ah. Is it a disease? Or is it a, uh, a normal way that we handle and are supposed to work is still to be determined. But it’s quite possible that the (frowns) tricky way that the brain works, is that we may create symptoms as part of how we’re supposed to operate, as opposed to this representing the system breaking down. [emphasis added]

Instantly, despite the vague delivery, Walitt demarcates his path of normalizing pervasive, extreme, life-altering pain and other symptoms by way of a description that sounds like some religious teaching, definitely not science. According to him, fibromyalgia, while atypical, is—wait for it—normal.

Why conduct any bio-medical research if suffering is just meant to be?

Here is more:

The idea that mind itself is able to create these things and that all experiences are psychosomatic experience. Nothing exists without your brain creating those sensations for you. And the idea that, uh, that process of creation can create these things and is supposed to create things like this, to inform us and to teach us and to guide our behavior, ahem, pushes against the idea that we have free will and that we can do whatever we want and that we should be able to lead the lives that we have always thought we should leave [sic], not the ones that our bodies are restricting us to. Uh, and so accepting those kinds of ideas, ahem, is not so easy, but that might make it a little bit easier on everybody. It might be a more palatable narrative, uh: understanding that people can feel bad for no real fault of their own, uh, because of their circumstances of lives and how brains just work—the way it’s supposed to be, as opposed to being sick. There is a wonderful line from this gentleman, Joel Higgs [sic]: “When people are atypical, society do one of three things: They either medicalize, criminalize or moralize [Smiles]. And so, when we find people with things like fibromyalgia, they are either gonna be sick, bad or weak. And the idea is really to find a fourth way to realize that these atypical things are just a range of normal, that you are not sick, bad or weak, that you are just dealing with the difficulties of just being a human. [emphasis added]

Walitt declares *all* experience psychosomatic, riffs on the educational and spiritual value of symptoms, and applies the work of psychiatrist Joel Nigg to the puzzle of fibromyalgia (though he gets the name wrong).

He suggests that fibromyalgia patients should accept his narrative that their symptoms are part of a normal life, triggered by life’s “difficulties.” Ironically though, instead of medicalizing (definitely not that), criminalizing or moralizing, Walitt psychologizes like it’s nobody’s business. It’s really just his way of saying, “There is nothing wrong with you. So, now pull yourself together and get on with life without continuing to burden the health-care and disability systems.”

Imagine he had said this about cancer patients, that cancer is meant to inform, teach and guide them. Petrifying right? And yet, he said it—about fibromyalgia— unapologetically and entirely comfortably, almost proudly. How can somebody like that possibly be expected to be looking—in an unbiased way—at a disease that is considered closely related to, and overlapping with, fibromyalgia?

Also note that Walitt attaches a thinly-disguised judgment to fibromyalgia patients’ discontent with their “normal” experience of being sick, and thus, contrary to what he says, moralizes plenty. After all, it would be so much easier for everybody—translation: for him and doctors of the same ilk—if patients stopped complaining.

Walitt_Patient_FM

Those complaining middle-aged women really are pesky, aren’t they?

For Walitt, no further research is necessary, because he knows what he knows or so he says. Rather than rising to the challenge of finding answers, his main goal appears to be helping other doctors sink to his level of disbelief, as he explains here:

One of the interesting things about this talk is that people come in with a set of beliefs and a lot those come from what they’ve been taught and what they see on television and what their patients come to their offices with. Sort of these ideas of, you know, fibromyalgia is a disorder of sensitive nerves.

But it’s a narrative that doesn’t seem to be valid and the hope is, and physicians, as they see me talk, often start off using that narrative and believing in the narrative and answering the questions in terms of the narrative, but deep down they know that it’s not true. And by the end, after I say my message, um, they are relieved to hear that deep down their believes are not wrong and that really what may be required is not, uh, saying that fibromyalgia is not real, but finding a new narrative in which to discuss it, one that makes much more sense, uh, to everybody. [emphasis added]

Walitt flat out asserts that fibromyalgia is not a “disorder of sensitive nerves,” presumably based on the fact that his research has failed to bear out such a disorder. No big surprise there because he clearly has his mind made up and isn’t really looking for any biological cause or marker for fibromyalgia.

Basically, Walitt claims that physicians who “believe” in fibromyalgia as a dysfunction of the nervous system have been duped into doing so by their patients and by watching television. (Clearly, he can’t be talking about medical school here since one is unlikely to find any meaningful education about fibromyalgia in med-school curriculums.) Those tortured doctors, he says, feel a huge weight off their shoulders once Walitt enlightens them with his superior knowledge. His “logic” seems to imply that physicians fall victim to political-correctness pressure that prevents them from saying or even thinking what they really believe, which is, of course, congruent with Walitt’s beliefs that fibromyalgia is—while real—not a disease, just a normal life experience.

Rather than pushing for better research to understand, and develop treatment for, the biomedical causes of fibromyalgia, and certainly preferable to feelings of failure that might be uncomfortable to doctors (never mind the patients’ agony), Walitt suggests the following:

Walitt_A_rational_approach_to_tx

Since Walitt believes that not treating fibromyalgia doesn’t harm patients, it only follows that he views biomedical research as unnecessary.

But just how did traditional” diseases become traditional, i.e., understood? By conducting biomedical research. That’s how! And yet, for Walitt, no further research into fibromyalgia is necessary, because his radical theory allows him to sidestep science.

Having declared now that fibromyalgia is normal, though atypical, and having decided not to pursue the development of curative treatment, Walitt suggests patients be told to fend for themselves, as they’ve been doing in the case of CFS for decades. Very tidy:

When you talk to patients with fibromyalgia, uh, and you ask them what they think about it, they can often provide you the answers, about where they should go. Uh. People with highly spiritual feelings and belief that, um, in spiritual forces as, uh, potential ways to heal, uh, should be referred that way. Uh, people who believe in exercise should go that way; people who believe in Eastern philosophies should be referred that way.

Walitt’s round-about way of stressing that fibromyalgia is real betrays what he really thinks:

The experience of fibromyalgia is very much real to the people who have it. The way that we think and feel is based in electricity and biochemistry of our brains. And we don’t really understand how the physicality of that chemistry becomes our thoughts and feelings. And in people with fibromyalgia they clearly feel these ways, and there’s probably a [sic] underlying biology to it, but the idea that that’s an abnormal biology, um, is less clear. The idea that the way that we think and feel should be affected by the goings and comings of our lives and the difficulties we have, um, is something that seems, uh, self-evident, but also’s something that we, uh, like to pretend isn’t true. We’d love it if we could reduce all of these things to a simple pathway. You know science, um, has had all its greatest successes in reducing problems to a single pathway, a single place. And all the, you know, if you take diabetes, understanding the key role of insulin in diabetes. Once that was understood, it transformed the whole illness, and allowed for people to become better.

The problem with things like fibromyalgia and other, uh, disorders that are of the the neurologic systems of the brain, is that the brain seems to have a dual existence. It exists both as a biological construct but it also exists as sort of a psychological construct. And we don’t really understand how the two go together yet. (Smiles) How they play together, how they sing together, how they work together. And so our attempts to alter the biology without understanding the emotional overlay, um, probably leads to a lot of failure. Alright, there are, it it speaks to our lack of understanding how it really works. [emphasis added]

So in two paragraphs, Walitt has gone from being convinced that he knows that fibromyalgia is somatoform, to admitting that he doesn’t really know how it works because, you know, lack of understanding. But rather than being committed to finding answers, creating understanding, expanding the parameters of medicine to address the very real and urgent medical needs of millions of people, he settles—at the expense of patients—for providing only short-term palliative care to his complaining middle-aged female patients.

When he says that fibromyalgia is real to patients, he, of course, means it’s not real to him.

Instead of saying, “we haven’t found the ‘insulin’ for fibromyalgia and need to keep looking,” he bascially says, “It’s really just one of the body’s ways of experiencing suffering.” Bummer, I know.

And the good old standby mind-body connection is always helpful when trying to rationalize the psychologizing of a physiological disease:

… people are not willing to accept the idea that our emotions affect our sensation, right?

And again:

The problem with things like fibromyalgia and other, uh, disorders that are of the the neurologic systems of the brain, is that the brain seems to have a dual existence. It exists both as a biological construct but it also exists as sort of a psychological construct. And we don’t really understand how the two go together yet. (Smiles) How they play together, how they sing together, how they work together. And so our attempts to alter the biology without understanding the emotional overlay, um, probably leads to a lot of failure.” [emphasis added]

The dangers of the mind-body dualism are, of course, always particularly worrisome to Walitt & Co. when it comes to what the likes of him enjoy calling controversial conditions. Actually, according to Walitt, it’s not even a condition; it’s just normal. If only we would finally accept that our mind, and nothing else, is making us sick—scratch that: making us think we are sick—it would be better for *everybody.*

Fibromyalgia might be giving Walitt’s ego trouble because he, as a physician, is unable to help patients due to the limited amount of time a doctor has with his patients and the fact that medications do not work well in fibromyalgia. Hm, what other disease faces these obstacles? I can’t put my finger on it. But luckily, Walitt himself is helping me out. Since at least 2009, Walitt is on record conflating Fibromyalgia and Chronic Fatigue Syndrome as “disorders of subjective perception.” Sure, Walitt is likely to say that our experience is atypical, but what good is that going to do us? ME/CFS patients should be very alarmed by NIH’s choosing of Walitt.

By selecting a lead clinical investigator who has already declared CFS a somatoform disorder, NIH has tipped its hand in a major way, as if the stakes weren’t high enough for the community yet. Given the reputation and reach of the NIH, the weight this study is likely to carry will make PACE appear like a fifth grader’s (attempt at a) science project. In terms of its impact, this is PACE on steroids. Think about that, despite PACE being heavily attacked by journalists and scientists of impeccable reputation in the last few months, it has so far been impossible to get it retracted. Consider the enormous damage PACE has done to the health of so many patients and to the perception of what this disease is. And PACE is a study that, on its face, is devoid of science. How much harder do you think will it be to debunk an NIH study that appears to be looking for biomarkers, but finds that our debilitating symptoms are merely a normal reaction to life? It will be impossible. The stakes are enormous. This study has the potential to sink us for good.

How much more will NIH try to sneak by us? How many times are we supposed to give the agency the benefit of the doubt with this study? They attempted to force the Reeves criteria on us and when patients were petitioning against that, they dropped Reeves for the CDC Grand Rounds presentation without so much as the hint of an explanation as to why Reeves would have even been in the ballpark. They acted like Reeves was never in the picture and yet, I am not at all convinced his criteria are out of the picture. They are forcing the functional-movement-disorder and post-Lyme comparison groups down our throats despite a tremendous outcry about the use of a condition labeled psychogenic (What if FMD patients’ symptoms are caused by an infectious agent or have some other biological basis similar to what they might find in CFS?) as well as a stigmatized illness (Why use Lyme when we really don’t know much about it and the little we do know is disputed?). One of the other study investigators, Dr. Fred Gill, has the most repulsive track record when it comes to CFS. Charlotte von Salis’ piece about him is a must-read. Gill adores the late Straus of NIH, the Wessely School’s PACE and the CDC’s Reeves criteria. NIH might claim that Walitt was an accident, an inadvertent oversight. But two (and who knows how many more) investigators with a glaring bias against our community? That is clearly no coincidence.

And these are just issues patients have been able to glean, partly from the outlandish roll-out of the study (which NIH never apologized for) and NIH’s entirely inappropriate back-channel feeding of information to chosen advocates. There is, without a doubt, a lot going on behind the scenes that we won’t find out about until it’s too late. Replacing the Reeves criteria clearly wouldn’t rectify all that’s wrong with the study. Turns out Reeves may be the least of our worries. Let that sink in.

People are dying—either prematurely because of ME or at their own hand when the suffering becomes unbearable. If they are not dying, they live in agony. There is no room for even the slightest remnants of feel-good drivel or this-is-normal claptrap, let alone for putting somebody with that belief system in the role of the lead clinical investigator. With the reveal of Walitt’s role in the study, we’ve been treated to some inadvertently-shared insights into the structure and aims of the NIH study. Maybe we’ll be able to make enough noise to get Walitt kicked off the study. But don’t hold your breath and, in any event, it doesn’t change the fact that NIH has made its intentions very clear: the rebranding of ME/CFS as a normal life experience.

I’ve included the full transcript below.

Thanks to Ella for assistance in finding a way to translate this mess.

***

(This is not the topic of this post, but note that based on the first slide of Dr. Nath at the CDC Grand Rounds a few days ago, the original post-infectious *CFS* study was turned into a post-infectious *ME/CFS* study. In this post, I am using the terms “ME/CFS” because NIH is using it and “CFS” because Walitt is using it. Unfortunately, it’s beyond the scope of this post to address the issue conflating ME with CFS to which I strongly object.)

NIH_Study_Title_Original

NIH_Study_Title

***

Transcript of interview of Brian Wallit

during the conference “Perspectives in Rheumatic Diseases 2015”

held on September 18-19, 2015 in Las Vegas

(The video of the interview was posted on September 30, 2015 at http://www.familypracticenews.com/specialty-focus/rheumatology/single-article-page/video-fibromyalgia-doesnt-fit-the-disease-model/e913134880916685f3005dac5459ab88.html)

Interviewer: What should we do to try to help patients with fibromyalgia?

Walitt: The most important thing to do is to listen, right? To understand that the experience is valid and not to belittle them, right? It’s also important to be honest with them and explain that the medical system can’t provide the answers that they want. That at best, we can try to help them. We can give them some tools to help deal with the day-to-day struggles of having fibromyalgia. But we can’t just make it go away. We can’t restore them to what they think they should be. [not audible] We should bear witness to their difficulties, which is the oldest of the jobs that physicians do.

(Smiles) One of the interesting things about this talk is that people come in with a set of beliefs and a lot those come from what they’ve been taught and what they see on television and what their patients come to their offices with. Sort of these ideas of, you know, fibromyalgia is a disorder of sensitive nerves.

Slide 1: Patient FM

But it’s a narrative that doesn’t seem to be valid and the hope is, and physicians, as they see me talk, often start off using that narrative and believing in the narrative and answering the questions in terms of the narrative, but deep down they know that it’s not true. And by the end, after I say my message, um, they are relieved to hear that deep down their believes are not wrong and that really what may be required is not, uh, saying that fibromyalgia is not real, but finding a new narrative in which to discuss it, one that makes much more sense, uh, to everybody.

Interviewer: Do we have any idea yet what narrative might be more useful?

Walitt: (Smiles, sights) Ahhhh, that’s a tough question. Um, the problem is that language is so heavily charged. Uh, people are not willing to accept the idea that our emotions affect our sensation, right?

Slide 2: What is Fibromyalgia?

The idea that mind itself is able to create these things and that all experiences are psychosomatic experience. Nothing exists without your brain creating those sensations for you. And the idea that, uh, that process of creation can create these things and is supposed to create things like this, to inform us and to teach us and to guide our behavior, ahem, pushes against the idea that we have free will and that we can do whatever we want and that we should be able to lead the lives that we have always thought we should leave [sic], not the ones that our bodies are restricting us to. Uh, and so accepting those kinds of ideas, ahem, is not so easy, but that might make it a little bit easier on everybody. It might be a more palatable narrative, uh: understanding that people can feel bad for no real fault of their own, uh, because of their circumstances of lives and how brains just work—the way it’s supposed to be, as opposed to being sick. There is a wonderful line from this gentleman, Joel Higgs [sic]: “When people are atypical, society do one of three things: They either medicalize, criminalize or moralize [Smiles]. And so, when we find people with things like fibromyalgia, they are either gonna be sick, bad or weak. And the idea is really to find a fourth way to realize that these atypical things are just a range of normal, that you are not sick, bad or weak, that you are just dealing with the difficulties of just being a human.

Interviewer: Brian, why did you title your talk on fibromayalgia as “Tilting at Windmills?”

Slide 3: Tilting at Windmills (a rational approach to fibromyalgia)

Walitt: Oh, I wanted to invoke Don Quixote’s quest to slay a dragon. Um, fibromyalgia is a very challenging thing for physicians to deal with and the idea that there are easy answers that can be prescribed to one’s patients, um, is kind of a fallacy. And I thought that title would uh bring that out. (Smiles)

Interviewer: What are the difficulties in dealing with fibromyalgia?

Walitt: Well, as physicians, we have a limited amount of time in the office and our training is to use medications, um, to deal with the problems that we see in front of us. And fibromyalgia as a disorder defies all of that. It requires a lot more time and medications do not work very well. And if you try to adhere to how we’ve been trained to treat people, [uh, you’ll inevitably fail.

The experience of fibromyalgia is very much real to the people who have it. The way that we think and feel is based in electricity and biochemistry of our brains. And we don’t really understand how the physicality of that chemistry becomes our thoughts and feelings. And in people with fibromyalgia they clearly feel these ways, and there’s probably a [sic] underlying biology to it, but the idea that that’s an abnormal biology, um, is less clear. The idea that the way that we think and feel should be affected by the goings and comings of our lives and the difficulties we have, um, is something that seems, uh, self-evident, but also’s something that we, uh, like to pretend isn’t true. We’d love it if we could reduce all of these things to a simple pathway. You know science, um, has had all its greatest successes in reducing problems to a single pathway, a single place. And all the, you know, if you take diabetes, understanding the key role of insulin in diabetes. Once that was understood, it transformed the whole illness, and allowed for people to become better.

Slide 4: “Fibromyalgia Controversy”

The problem with things like fibromyalgia and other, uh, disorders that are of the the neurologic systems of the brain, is that the brain seems to have a dual existence. It exists both as a biological construct but it also exists as sort of a psychological construct. And we don’t really understand how the two go together yet. (Smiles) How they play together, how they sing together, how they work together. And so our attempts to alter the biology without understanding the emotional overlay, um, probably leads to a lot of failure. Alright, there are, it it speaks to our lack of understanding how it really works.

Interviewer: What is fibromyalgia?

Walitt: That’s a hard one. Ah, time will tell. Uh, fibromyalgia appears to be a way that people experience suffering in their body. Um, both from the way that the bodies are interpreted and the problems of the body, as well as the problems in their lives, as well as how societies tell us how to experience things. All those come together to create a unique experience in different points in time, and right now, that experience, um, is a, one of those experiences is fibromyalgia. Ah. Is it a disease? Or is it a, uh, a normal way that we handle and are supposed to work is still to be determined. But it’s quite possible that the (frowns) tricky way that the brain works, is that we may create symptoms as part of how we’re supposed to operate, as opposed to this representing the system breaking down.

(fade in and out)

When you talk to patients with fibromyalgia, uh, and you ask them what they think about it, they can often provide you the answers, about where they should go. Uh. People with highly spiritual feelings and belief that, um, in spiritual forces as, uh, potential ways to heal, uh, should be referred that way. Uh, people who believe in exercise should go that way; people who believe in Eastern philosophies should be referred that way. Uh, taking a one size fits all, or using your own judgment of what is legitimate, uh, is often not helpful in treating people with fibromyalgia, because it’s really about what they think is legitimate.

Slide 5: A rational approach to treatment

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Deadline for Comments on Proposed ERISA Disability Regs Fast Approaching: Additional Guidance

We are down to the wire; the deadline for public ERISA (“Employee Retirement Income Security Act”) comments—January 19, 2016—is fast approaching. As of yesterday, the Department of Labor (“DOL”) has received 23 comments in response to its proposed new ERISA long-term disability (“LTD”) regulations. Just to be clear, these proposed regulations relate to disability determinations under employer-sponsored LTD plans, not Social Security disability benefits. I have written about the substance of the DOL proposal and posted instructions for commenting and a sample comment.

Let me supplement what I said in my last post about the substance of the comments. Generic supportive comments along the lines of “I wholeheartedly support the proposed changes” are not as powerful as comments that go somewhat into detail. Don’t get me wrong, I believe if the DOL were to receive a fair number of generally supportive comments, that would definitely help. But ideally, the comments would have some meat to them addressing the specific changes that have been suggested by the DOL.

I realize that this is a potentially intimidating proposition for ME patients, given the cognitive limitations the disease imposes. And the last thing I want to do is discourage anybody from commenting. Therefore, I thought it might be useful for me to break down my analysis from my first ERISA blog post into a list. Try to think about which of the proposed changes would have been helpful to you as you went through the LTD approval process or would be helpful to you if you had to go through it because you currently are, or might in the future be, covered by an LTD plan and then address those points. Remember that the comments will be publicly available, so don’t disclose anything sensitive. Here is a summary list of the most important proposed changes:

1. Claims adjudicators and medical experts may not be hired, compensated, terminated or promoted based on the likelihood of their denying disability benefits or supporting the denial of such benefits.

[Note: This requirement is intended to ensure independence and impartiality of the persons involved in making the decision, which, in turn, is meant to guarantee a full and fair review.]

2. Medical experts may not be hired based on their reputation for outcomes in contested cases rather than based on their expertise.

[Note: This requirement is intended to ensure independence and impartiality of the persons involved in making the decision, which, in turn, is meant to guarantee a full and fair review.]

3. The notice of claim denial must include a discussion of the decision, including the basis of disagreement with a disability determination by the Social Security Administration or a treating doctor.]

[Note: This requirement is intended to aid claimants in understanding why the claim was denied and why the decision is inconsistent with that of the Social Security Administration and/or the treating physician.]

4. The notice of claim denial must include internal rules, guidelines, protocols, standards or similar criteria of the plan that were used to deny the claim.

[Note: This requirement is intended to aid claimants in fully understanding the reason for the denial and in meaningfully assessing the likelihood of success of an appeal.]

5. The notice of claim denial must include a statement that the claimant is entitled to receive—at that stage and not only at the later stage of denial of the appeal—all relevant documentation supporting the denial of the claim.

[Note: This requirement is intended to aid claimants in fully understanding the reason for the denial and in meaningfully assessing the likelihood of success of an appeal.]

6. Claimants must be given the right to review (free of charge), and respond to, new or additional evidence or rationales for denial considered, relied upon or generated during the appeal process and not only after the claim has been denied on appeal. The information would have to be made available as soon as possible and sufficiently in advance of the deadline and the plan would be obligated to consider the claimant’s evidence and written testimony in response to the plan’s new or additional information before making a decision on appeal.

[Note: This requirement is intended to ensure a full and fair review by affording claimants the opportunity to respond to new evidence or rationales during the administrative stage, before going to court.]

7. If the LTD plan has not followed all procedural rules (except in cases of minor errors), a claimant may proceed straight to court without first exhausting all administrative remedies.

[Note: This requirement is intended to allow claimants to proceed to court without exhausting all administrative remedies if the plan’s process fails to satisfy the regulatory minimum standards.]

8. If the LTD plan has not followed all procedural rules, the reviewing court will consider the matter de novo, i.e., the court will give no deference to the plan’s determination and instead set it aside and use its own judgment based on the administrative record.

[Note: De novo is a much more favorable standard for claimants than the usual abuse-of-discretion standard under ERISA, which merely reviews whether the plan’s decision was arbitrary and capricious.]

9. The retroactive rescission (cancellation or discontinuance) of coverage would constitute a so-called adverse-benefits determination regardless of whether the beneficiary/participant is currently receiving benefits. Classification as an adverse-benefits determination is important because it permits the claimant to invoke the ERISA claims-procedure requirements.

[Note: This is a very technical point. It broadens the definition of “adverse-benefits determination.” If the proposed change is adopted, it would, e.g., allow a claimant to invoke the ERISA claims-procedure requirements in case of a claim denial based on the retroactive assertion by the plan that the claimant made a misrepresentation on their application form even if the error was made innocently.]

10. The notice of claim denial must include a prominent one-sentence statement in the relevant foreign language about the availability of language services if the claimant resides in a county where at least 10% of the population are literate only in the same non-English language.

[Note: This requirement only applies in counties that satisfy the 10% hurdle (currently 255 counties) and only with respect to the particular language that is the only one spoken by 10% of the population.]

The proposed change in under 2. would, in my opinion, be the most important one, as many LTD cases are lost by claimants because of the biased opinion of a physician who is in the pocket of the insurance companies. The third proposed change is probably equally crucial. Nevertheless, it is important that the other points be addressed as well or they are more likely to fall victim to the insurance companies’ and employer organizations’ objections. That is not to say that everybody should address all points.

Some of the already submitted comments are likely from the insurance industry and employer organizations, trying to water down the proposed changes by whining about how cumbersome they would be for them. So, let’s rally and get some more comments submitted. I sincerely hope that our advocacy organizations recognize this important opportunity to get involved.

Contrary to what I said in my prior post, I believe now that the easiest and most reliable method of submitting your comments is online at http://www.regulations.gov/#!documentDetail;D=EBSA-2015-0017-0001. Make sure to request an emailed receipt. Please note that “Regulations.gov will undergo scheduled maintenance and as a result the site will be unavailable Monday, January 18, from 8:00 am through 4:00 pm (ET).” If you want to submit your comment during that time, you can email it to e-ORI@dol.gov.

All submissions must include the agency name, Department of Labor, and Regulatory Identifier Number, RIN-1210-AB39.

 

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Proposed ERISA Disability Regs: Instructions and Sample for Public Comments

[Update 1/15/16: additional guidance for your comments here]

Below are instructions on how to submit your comments on the new regulations proposed by the Department of Labor (“DOL”) for long-term disability (“LTD”) benefits under the Employee Retirement Income Security Act (“ERISA”). The DOL asked for comments from the public on these proposed regulations. For details on the proposal, please see my prior blog post.

I am also posting my own comments, as people have asked for a sample. A few words about that. First of all, everybody should feel free to borrow from my submission. Please do not feel like your comments have to sound legalistic; they don’t. They also don’t have to be long or “perfect.” My own comments are far from perfect nor are they exhaustive. I merely picked some of the issues that jumped out at me. It would be helpful if you could include in your comments a few points (or even just one) about how proposed-to-be-changed provisions have negatively affected you personally in your dealings with your LTD carrier and in obtaining LTD benefits, but remember not to include any personally identifiable or confidential business information (see below). Basically, limit your remarks to things you would be comfortable with the whole world knowing about you. It might be useful to take a look at my prior post to decide what points you feel you can meaningfully address.

As a matter of background, the proposed regulations would provide strengthened procedures and safeguards for employees claiming LTD benefits under ERISA. If the proposal is adopted, it would be a game changer for disabled employees covered by ERISA and a big step towards putting a stop to the egregious commonplace wrongful denial of LTD benefits by LTD plans. Many, if not most, ME patients covered by an ERISA plan encounter unconscionable tactics by the powerful disability insurance companies designed to deny employees the benefits they are entitled to, precisely because ERISA has created a framework that overwhelmingly and devastatingly favors said insurance companies. Of course, the ERISA rules affect every LTD claimant regardless of the disabling disease. But ME patients are one of the patient groups that are particularly vulnerable, in part due to the pervasive ignorance, in the medical profession, of the grave disability it can cause. With its proposal, the DOL has put forward a new set of rules that is designed to counteract the unfair advantages insurance companies have had for decades and to provide a better chance for claimants to receive the benefits that are rightfully theirs.

I urge everybody who is able to do so to provide strongly supportive public comments to the DOL. As I have said previously, the DOL is not the big black hole that is HHS, where public comments are ignored or disappeared. The DOL wants to enact this proposal; it merely needs enough public support to justify doing so in light of the fact that they will receive strong pushback from the insurance and employer lobby. I feel quite optimistic that the new regulations will be put in place if we do our part to offset those lobbying efforts.

Instructions for Comment Submissions:

Comments must be in writing and received on or before January 19, 2016.

There are three ways to submit your comments: email, online or regular mail. I personally prefer email because that creates a record of the submission, although, unlike with HHS, the DOL does not have any incentive to make public comments disappear—quite the contrary. And in this case, it looks like the website will provide a receipt after submission. So, if it’s easier for you to submit your comments online or to send a letter, that should work just fine. Just make sure they are received by the deadline of January 19, 2016.

Emaile-ORI@dol.gov (Specify RIN 1210-AB39 in the subject line of the email.)

Online: http://www.regulations.gov/#!documentDetail;D=EBSA-2015-0017-0001 (Click on “Comment Now!”)

Mail: Office of Regulations and Interpretations, Employee Benefits Security Administration, Room N-5655, U.S. Department of Labor, 200 Constitution Avenue NW, Washington, DC 20210, Attention: Claims Procedure Regulation Amendment for Plans Providing Disability Benefits.

All submissions must include the agency name, Department of Labor, and Regulatory Identifier Number, RIN-1210-AB39.

Do not include any personally identifiable or confidential business information that you do not want publicly disclosed because all comments will become part of the public record without any redactions or changes and will be available to the public, without charge, online at http://www.regulations.gov and http://www.dol.gov/ebsa, via search-engine searches and at the Public Disclosure Room, Employee Benefits Security Administration, Suite N-1513, 200 Constitution Avenue NW, Washington, DC 20210.

Important edit just to clarify (Thanks go to Mary Ann Kindel for pointing this out.):  Submissions may be withheld by some agencies if they contain “duplicate or near duplicate examples of a mass-mail campaign.” I do not know if the DOL is one of those agencies, but it is definitely important that your comments be “customized,” as suggested above even if you borrow some ideas or language.

My comments:

Re: RIN 1210-AB39

I am writing to comment on the Proposed Regulations issued by the Department of Labor, Employee Benefits Security Administration on November 18, 2015 (“Proposed Regulations”).

First of all, I want to commend the Department of Labor (“Department”) for this very constructive proposal. I strongly approve of the comment made by the Department in the preamble that “disability claimants deserve protections equally as stringent as those that Congress and the President have put into place for health care claimants under the Affordable Care Act.”

I am presently a disability recipient under an employer-sponsored disability plan governed by the Employee Retirement Income Security Act of 1974 (“ERISA”) and its requirements regarding claims procedures. I can speak first hand to the potential abuses occurring under the current claims-procedure regulations and the urgent need to address these in the Proposed Regulations.

The proposed tightening of the conflict-of-interest rules is particularly welcome. Prohibition against a claims fiduciary (typically the insurance carrier insuring the disability claim under the employer plan) making any decisions regarding hiring, compensation, termination, promotion or similar matters with respect to any individual (such as a claims adjustor or medical expert), based on the likelihood that the individual will support the limitation or denial of disability benefits, should—going forward—help eliminate, or substantially reduce, the documented cases of such behavior by disability insurance carriers, most notably Unum/Provident (see John H. Lanbein, Susan J. Stabile, Bruce A. Wolk, Pension and Employee Benefit Laws at pp. 669-74). The insurance carrier would not be permitted to contract with a medical expert based on the expert’s pattern of denying claims, as is clearly the typical situation today, which I know from my own experience. This will, I hope, add a measure of integrity to independent medical exams (IMEs) used so frequently to contest, and ultimately deny, a disability claim notwithstanding the opinion of the claimant’s doctor.

The proposed amendments to the disclosure requirements should also prove helpful to disability claimants faced with a claim denial based on ill-defined reasons. The requirement to produce a detailed description of the denied decision, including the basis for the plan’s disagreement with the claimant’s treating physician or the Social Security Administration as well as the internal rules, guidelines, protocols, standards or other criteria applied to deny the claim, should prove helpful in appealing denied claims in court.

The other proposed changes are meritorious as well and should be adopted as part of the final regulations. For example, the “de novo” standard of review in cases where the plan has not followed the correct procedures should provide an effective incentive for disability carriers to comply with the relevant rules—an incentive that is unfortunately so desperately needed.

The Proposed Regulations give disability claimants more procedural rights and safeguards to partially offset what is a an unacceptably and unjustifiably uneven playing field at present. I can speak from personal experience that disabled claimants are faced with substantial procedural obstacles put in their way by disability carriers. This is particularly disturbing in light of the diminished capacity of most claimants—due to the limitations imposed by their disability—to get through all the gratuitously cumbersome procedural hurdles and grueling, harassing and irrelevant requirements placed on them by the disability carriers. Given the lack of a jury trial, the prohibition against punitive damages and the potential deferential standard of review of denied claims, these proposed changes are critical to provide at least some fairness to disabled claimants in a process that is heavily structured against them.

For the above reasons, I strongly support adoption of the Proposed Regulations as soon as possible.

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Department of Labor Proposes Lowering Bar for ERISA Disability Claims, Requests Public Comments

[Update 1/15/16: instructions for submitting comments here and additional guidance for your comments here]

I am happy to report a rare positive development for disability claimants, one that is important to get behind. As most of you know, the rules under the Employee Retirement Income Security Act (“ERISA”) regarding employees’ long-term disability (“LTD”) claims are abysmal; the deck is clearly stacked against claimants. It seems, that the U.S. Department of Labor (“DOL”) has taken notice and is attempting to level the playing field somewhat. On Wednesday, November 18, 2015, the DOL published proposed regulations, which, if and when adopted, would provide employees who claim disability benefits under their LTD plan with additional procedural protections and safeguards that would afford some claimants benefits that would otherwise have been improperly denied, as happens all too often. I will discuss the proposal in more detail below, but here is the bottom line: While there still won’t be punitive damages—in my opinion, the most needed change under ERISA—or the right to a jury trial (Neither are in the purview of the DOL, but would require legislative changes to the statute instead.), the proposed changes would impose significant additional restrictions on LTD plans that would make it more difficult for them to improperly deny LTD benefits, which they are so highly motivated to do for obvious financial reasons.

In order for the DOL to move forward with enacting the proposal, it is crucial that it receive comments from the public in support of the proposed changes. Even just a few dozen public comments could tip the scale. If there is no expression of support from the public, that will substantially decrease the likelihood of the proposal being put into place because it is a near certainty that disability carriers and representatives of employer organizations will provide comments opposing these regulations, lobbying to retain the status quo that favors them so heavily. The easiest way to provide comments is by email to e-ORI@dol.gov. Comments have to include “RIN-1210-AB39” (best placed (also) in the subject line) and the agency name, “Department of Labor.” Comments need to be submitted within 60 days. Please note that all comments will be published online without redactions; therefore, do not include any sensitive information.

Unlike HHS and its component agencies, such as CDC and NIH, the DOL seems genuinely interested in effecting desperately-needed change. Citing the “aggressive posture” of LTD insurers and plans, the agency took the initiative to attempt to strengthen the current procedural requirements imposed on LTD plans “[b]ecause of the volume and constancy of litigation in this area….” In fact, the department realized that “disability cases dominate the ERISA litigation landscape today.” Therefore, the DOL “recognized a need to revisit, reexaime, and revise the current regulations in order to ensure that disability benefit claimants receive a fair review of denied claims….,” as “insurers and plans looking to contain disability benefit costs are often motivated to aggressively dispute disability claims.” As opposed to comments sent to HHS or its component agencies, which are completely ignored as a matter of course, comments to the DOL on this matter have a real chance of making a meaningful difference for future claimants and those currently in the claims process. Therefore, in addition to input from individuals, this strikes me as an excellent and unprecedented opportunity for our advocacy organizations to potentially effect some meaningful change. It’s a low-hanging fruit.

As a matter of background, employer-sponsored LTD plans are required, under ERISA, to have in place so-called claims procedures that set forth the process for disabled employees to make claims and appeal the denial of claims under an LTD plan. These requirements have been in place since ERISA was implemented in the mid-1970s. Recently, comparable rules for health plans were strengthened as a result of provisions in the Affordable Care Act (“ACA” or Obamacare, as it has come to be known). What the DOL is proposing with these new disability plan claims procedure rules is to apply many of the stricter ACA health-plan rules to LTD claims.

Note: These proposed regulations do not apply to Social Security disability claims.

Here is a summary of the key aspect of the proposed regulations:

  1. Independence and impartiality—avoiding conflicts of interest.

The proposal explicitly requires that plans ensure—in the interest of a “full and fair review”—that all disability benefit claims are adjudicated in a manner designed to ensure independence and impartiality of the persons involved in making the decision. More specifically, the proposal requires that claims adjudicators and so-called “medical experts” utilized by the plan not be hired, compensated, terminated or promoted based on the likelihood of their denying disability benefits or supporting the denial of such benefits. Tying bonuses for claims adjudicators to the number of denials would not be permissible anymore. Furthermore, the hiring of a medical expert based on his or her reputation for outcomes in contested cases rather than based on his or her expertise would no longer be allowed. I predict that this provision would knock out pretty much every “medical expert” currently engaged regularly by LTD insurance companies because most of them are squarely in the insurance industry’s pocket. This new rule would be much more than an inconvenience for the insurance industry; it could change the game and is, thus, a crucial potential improvement.

  1. Improved disclosure to claimants

Adverse determination of claims would be required to contain a discussion of the decision, including the basis of disagreement with a disability determination by the Social Security Administration or a treating physician. This would constitute a big shift, as LTD benefits are often denied despite the fact that Social-Security benefits have been approved and/or in disregard of the opinion of the treating physician, with no or little explanation of the disagreement. Adverse determination notices would also have to contain the internal rules, guidelines, protocols, standards or similar criteria of the plan that were used to deny the claim. Further, a notice of claim denial would have to contain a statement that the claimant is entitled to receive, at that stage, all relevant documentation supporting denial of the claim. Currently, this is required only at a later stage, upon the denial of benefits on appeal. These new provisions would aid in claimants fully understanding the reason for a denial and meaningfully assessing the likelihood of success of an appeal.

  1. Right to review and respond to new information before final decision is made

Claimants must be given the right to review, free of charge, and respond to new evidence or rationales developed during the appeal process and not only after the claim has been denied on appeal. The evidence would have to be made available as soon as possible and sufficiently in advance of the deadline and the plan would be obligated to consider the claimant’s evidence and written testimony in response to the plan’s new information.

  1. Changes to technical rules regarding the requirement that claimants go through all the plan’s procedural requirements (in legalese, “exhaust administrative remedies”) before taking their claim to court

These changes generally allow a claimant to proceed straight to court without first jumping through more hoops on the administrative level when the plan has not followed all the procedural requirements of the regulations and also provide that the reviewing court consider the matter “de novo” in those cases where the plan has not followed the correct procedures. “De novo” means that the court gives no deference to the plan’s determination denying the claim; instead, it sets aside the plan’s decision and uses its own judgment based on its own review of the evidence. It is a much more favorable standard for claimants than the usual abuse-of-discretion standard under ERISA, which merely reviews whether the plan’s decision was arbitrary and capricious.

  1. Culturally and linguistically appropriate notices

The added language safeguards would require that adverse-benefit determinations include a prominent one-sentence statement in the relevant language about the availability of language services if the claimant resides in a county where at least 10% of the population are literate only in the same non-English language.

 

There are other aspects of the proposed regulations, but those described above are the most significant. Taken together, they should provide ammunition to those whose disability claims have been denied by the insurance carrier administering the applicable LTD plan.

This quote from preamble of the proposal sets out an overview of all the proposed changes:

The major provisions in the proposal largely adopt … provisions that seek to ensure that (1) claims and appeals are adjudicated in a manner designed to ensure independence and impartiality of the persons involved in the making the decisions; (2) benefit denial notices contain a full discussion of why the plan denied the claim and the standards behind the decision; (3) claimants have access to their entire claim file and are allowed to present evidence and testimony during the review process; (4) claimants are notified of and have an opportunity to respond to any new evidence reasonably in advance of an appeal decision; (5) final denials at the appeals stage are not based on new or additional rationales unless claimants first are given notice and a fair opportunity to respond; (6) if plans to do not adhere to all claims processing rules, the claimants is deemed to have exhausted the administrative remedies available under the plan, unless the violation was the result of a minor error and other specified conditions are met; (7) rescissions of coverage are treated as adverse benefit determinations, thereby triggering the plan’s appeals procedures; and (8) notices are written in a culturally and linguistically appropriate manner.

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The Scientifically Challenged UK Media Strikes Back

Reblogging this must-read post by Utting-Wolff Spouts exposing today’s “ethically indefensible” piece by Sarah Knapton, science editor at The Telegraph, about the follow up to the scientifically disturbing PACE trial.

Utting-Wolff Spouts

When I first heard The Telegraph had featured an article concerning a follow-up study of the notorious PACE trial I was inclined to ignore it1. I’ve long become used to the appalling coverage of ME by the British media2 and felt I didn’t need to read any more disinformation disseminated via the Science Media Centre. However, I cracked and had the misfortune to read an article written by Sarah Knapton that is the worst I have seen in the thirty years I have been ill with this disease, which considering the competition is an impressive achievement1.

The article clearly implies ME is a non-illness, the suggestion in the headline that a bit of positivity and exercise could cure sufferers merits no other interpretation. One wonders what spin was put on the latest study by the SMC, as the results of this research bear no similarity…

View original post 1,002 more words

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Holding HHS Accountable for Unrelenting and Unrepentant Legal Violations

Many members of the community have called out HHS for legal violations over the years, such as Dr. Mary Ann Fletcher and Ms. Eileen Holderman confronting Dr. Nancy Lee, DFO of CFSAC, for her attempted intimidation of CFSAC members by threatening to evict them from the committee for voicing their opinion. This was well documented by Jennie Spotila on her blog. Ms. Spotila also uncovered other FACA violations. I successfully sued HHS and NIH in federal court for violating FOIA and the Judge found the agencies’ conduct to be unreasonable to a degree that led him to order both agencies to pay all of my attorneys’ fees, more than $139,000. The award of attorneys’ fees is by no means a given in FOIA cases; it requires a high level of unreasonableness on the government’s part. I explained why HHS again violated FACA regarding CFSAC’s January 2015 comments to the P2P here, here and here. Many advocates have protested these and other legal violations of HHS in formal complaints and public testimony throughout decades.

It’s almost too obvious to make the point, but the government, in our case, HHS, has a mandate to follow the law. The rules exist for important reasons, in the case of FACA, to protect the integrity of the process through transparency and accountability. Similarly, FOIA is meant to facilitate open government. Those are important constructs that, together with other aspects of our legal system, build the foundation of a principled society. They are not just technicalities that can be shoved aside or overlooked whenever it is convenient for the government. To the contrary, they represent rights of the people that are enforceable in court. It seems what we are seeing is a desensitization to legal violations due to the sheer numbers of times HHS has been violating the law, all the while acting as if nothing was wrong. But it is the duty of a citizen, especially an advocate, not to let that cloud one’s judgment and not to let HHS get away with it. A violation is a violation regardless of how many times it has been committed.

However, a few members of our community prefer to turn a blind eye when it comes to HHS’s unlawful conduct. It is possibly understandable, though not excusable, that HHS would downplay the seriousness of its actions or even misstate the law to the public, as Dr. Lee, CFSAC’s DFO, did again just last month at the latest CFSAC meeting in describing HHS’s disclosure obligations under FACA. But why would patients do it?

For a few, the answer seems to be that they are taken aback when they realize that they participated in a process that was unlawful on the part of HHS, such as a FACA violation. Instead of directing their dismay over these violations at HHS, they turn it against those of us who are holding the agency accountable. When somebody has been passionately invested in a project by volunteering a lot of time and effort, it may be natural for the initial knee-jerk reaction to be pushing back upon hearing of HHS’s misconduct. Cognitive dissonance can be quite compelling. And, of course, HHS is relentless in its denial of its violations, never mind that they are obvious. After decades of neglect and abuse by HHS, wanting to believe that things are finally different—that HHS turned over a new leaf and now has the best interest of ME patients in mind—can become a desperate need reinforcing the narrative that nothing is wrong with HHS’s actions. It’s tough to admit to oneself and others that things were not above board when one was led to believe by HHS that they were on sound legal footing and one relied on that. I get that. However, it is asking a bit much of the community to overlook these serious transgressions by HHS just to allow those who were part of the tainted process to retain their comfort level and alleviate any potential guilt. Once a well-reasoned and well-supported analysis of the law has been presented outlining the legal violations by HHS, there is no longer any plausible deniability.

Nevertheless, a shooting of the messenger, which does occur at times when accountability is demanded from HHS for the agency’s illegal actions, is crossing a line. Not only do a few patients and/or advocates praise HHS despite all its egregious violations, make excuses for the agency and presumptuously and patronizingly apologize to the agency or its component agencies for other patients, they also misstate the law publicly to the community thereby enabling HHS to continue their unlawful pattern. They even go as far as to, often publicly, accuse those who try to hold HHS accountable of being conspiracy theorists, making unsupported assumptions, creating unnecessary drama, reporting recklessly and manipulating the community. They question the value of insisting on HHS’s adherence to the law and instead stress the amount of work that went into an HHS project, as if that somehow offsets the violations. They also deny established facts.

This hurts all patients. It is also a double whammy for the many in the community for whom compliance with the law is not negotiable; they witness HHS break the law time and time again and, when they confront the agency, they face unsupportable accusations by others in the community who enabled, condoned, or acquiesced in, the HHS violations and/or are either not familiar with the law or choose to overlook legal violations, seemingly in the interest of a purported greater good.

The greater-good argument is, of course, a slippery slope. To what degree are we supposed to tolerate legal violations? When do they cross over to becoming inexcusable? Who gets to decide? The law exists to remove those grey zones. In our society, the duty to follow the law is not optional nor is it permissible to follow it selectively.

One person has even publicly suggested that it is improper for an advocate who chooses not to participate in a particular process to later criticize such a process. This is absurd. Usually, the reason the advocate chose not to participate in the process (assuming he or she was given an opportunity to do so) is that the process itself was flawed or tainted. Participating would be tantamount to endorsing the flawed process, such as the farcical jury model of the P2P. Only through the looking glass would this lack of participation force silent acceptance on what ultimately turns out to be not only a tainted, but an unlawful process.

It is important in this context that, once a legal violation has been explained in painstaking detail and the facts are not at all in question and are, in actuality, admitted or otherwise proven—as is the case with the FACA violations that occurred with respect to the January 2015 CFSAC recommendation—the accusation that he who uncovers HHS’s unlawful conduct made misrepresentations of the facts or the law can no longer be claimed to be a negligent attack on that person’s reputation; it’s quite intentional.

This is one of those moments when the M.E. community defines itself. Does it want to insist on HHS’s adherence to the law or condone the agency’s manifest legal violations? Some advocates have been fighting, often at great personal cost, to compel legal compliance by HHS. Others have enabled HHS, actively or indirectly, to disregard the law. Asserting that it is important to “work with” HHS or that legal infringements should be overlooked so as to achieve a purported beneficial end result, they downplay the seriousness of, or even defend, activities or processes that are tainted by unlawful HHS conduct. They also, instead of taking issue with HHS’s unlawful pattern, fault those who seek to hold HHS accountable for its legal violations.

It is crucial that those who stand for accountability of HHS under the law and integrity of the governmental process continue to insist on HHS’s compliance with the law. Pursuing legal violations by HHS gives the community unparalleled leverage in its fight against the agency’s recalcitrance, abuse, contempt, neglect, obstruction, distortions, misinformation and failure to fund. Let’s remain firm in our conviction that going along with HHS’s unlawful methods in order to get along is out of the question for our community.

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Yes, CFSAC, there is a FACA violation

“Yes, Virginia, there is a Santa Claus.”–From an 1897 editorial, “Is there a Santa Claus?” of The New York Sun

I was contacted by a member of the Chronic Fatigue Syndrome Advisory Committee (CFSAC) regarding my blog post, “Oops, they did it again! CFSAC violates FACA.” Below is the part of my answer that I think will be of particular interest to the public, as it spells out one of HHS’s recent FACA violations in more detail.

“I want to thank you for your message in response to my blog post, “Oops, they did it again! CFSAC violates FACA”, as it gives me an opportunity to spell out the FACA violation discussed in the second half of my post in more detail in hopes that it will facilitate a deeper understanding of the seriousness of the events surrounding the January 2015 CFSAC P2P comments.

Pursuant to Sections 5(b)(3) and (c) of the Federal Advisory Committee Act (“FACA”), the appointing authority—here, the Department of Health and Human Services (“HHS”)—shall not inappropriately influence the advice and recommendations of the advisory committee—here, the Chronic Fatigue Syndrome Advisory Committee (“CFSAC”). Instead, according to the law, that advice and those recommendations are supposed to be “the result of the advisory committee’s independent judgment.”

Accordingly, the role of a federal advisory committee’s Designated Federal Officer (“DFO”) is to ensure compliance with FACA (ironic, I know), and any other applicable laws and regulations; call, attend, and adjourn committee meetings; approve agendas; maintain required records on costs and membership; ensure efficient operations; maintain records for availability to the public; provide copies of committee reports to the Committee Management Officer for forwarding to the Library of Congress and to provide other support services for the committee. (U.S. General Services Administration, Office of Governmentwide Policy, Committee Management Secretariat; see also 41 C.F.R. §102-3.120 as well as CFSAC’s charter.) Please note that all these functions are purely administrative in nature, such as handling expense reimbursements for committee meetings. The DFO is not supposed to get substantively involved in the advice and recommendations by the advisory committee.

Those federal rules were clearly violated here. I realize that CFSAC’s DFOs break this particular FACA rule (and others) on a regular basis, but that doesn’t lessen the gravity of each violation. For the DFO, Barbara James at the time, to be involved in any substantive way in the comments constituted a violation. For her to be involved in the disturbingly invasive way that she was just makes the violation all the more egregious. I would hope that all CFSAC members find this obvious violation of the law appalling.

There is no doubt that HHS’s behavior was against the law. Beyond that, I did not suggest that the working group did anything unethical or immoral, but the working group certainly caved to HHS pressure and that was inappropriate. The fact that the group did not acquiesce in one instance—the length of the comments—does not excuse giving in on the more substantive issues. Nobody can, in all seriousness, argue that HHS did not exert any pressure on the working group to make changes to the document or did not affect any such changes, regardless of whether all changes were adopted for the final document. HHS’s making, or lobbying for, changes behind the scenes and hiding that very fact from the public is directly contrary to FACA’s purposes of independence and transparency.

Aside from the glaring legal issue, if CFSAC is going to have any credibility, it has to operate independently of the DFO. The integrity of the process is compromised entirely and the committee’s role is usurped if the agency whose contracted work is to be reviewed by the committee is allowed a veto right and, even more so, when that veto right is afforded up front. The working group draft should have gone to the full committee without any edits made by, attempted to be made by, or caused by the involvement of, HHS. The intact document is what represented the “consensus of the Working Group.” Once any kind of pressure is applied by the committee’s authorizing agency, the independence of the committee is not only undermined, it’s obliterated. The entire committee should have had a chance to review the unaltered working group document, discuss it and vote on it at the public meeting. If the DFO, Ms. James at the time, had inappropriately raised any objections to the draft comments at the meeting, the full committee and the public would have witnessed HHS’s improper attempt to influence the draft recommendation and that FACA violation would have become part of the minutes of the meeting.

You argue that it was the right thing to compromise on HHS’s changes to avoid risking that “the P2P panel would never see [the comments].” I disagree. Regardless of the fact that the ends hardly justify unlawful means, CFSAC should have chosen to avoid any appearance of improprieties. The committee could have had an impact without the Secretary. It should have adopted the recommendation without HHS tampering. If the Secretary had not followed the recommendation and not forwarded the committee’s comments to the P2P panel, that would have spoken for itself in a powerful way. Meanwhile, the CFSAC recommendation would have still remained on the record and members of the public could have and would have submitted the recommendation to the P2P panel.

The position that Ms. James got involved “with the best intentions” is both irrelevant and a leap of faith that seems unjustified given the history of the treatment of our disease by HHS, which includes a very long list of wrongdoings and abuses of the community by HHS and which doesn’t bode well at all for even more government censorship or secrecy. For example, during my FOIA lawsuit against HHS and NIH, false statements under penalty of perjury made by agency representatives were not isolated incidents. Other examples include misdirecting congressional funds in the millions by CDC; almost complete refusal to fund research of our disease by the NIH using pretexts and untruths; misinforming the public, media and medical community about our disease by CDC; conducting unscientific studies claiming, e.g., a connection between sexual abuse and our disease by CDC; creating the meaningless social construct and harmful name “CFS;” ridiculing patients by CDC and NIH; creating overly broad definitions by CDC preventing research progress by diluting cohorts; and frequently committing violations of various federal laws. In addition, vigilance and skepticism were clearly called for given HHS’s history of making changes to CFSAC recommendations, which was documented well by Jennie Spotila.

It is alarming that this improper influence by HHS was tolerated at the time given the compelling objections from at least two working group members. Now that these violations have been clearly exposed, any justification of HHS’s unlawful interference can no longer be maintained.”

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Another CFSAC FACA Fail: DFO Misconstrues Law

On Monday, I published a post about CFSAC violating the Federal Advisory Committee Act (“FACA”) by failing to make the the working group’s draft P2P comments available to the public prior to, or at the time of, the January 2015 CFSAC meeting.

Under section 10(b) of FACA, “the records, reports, transcripts, minutes, appendixes, working papers, drafts, studies, agenda, or other documents which were made available to or prepared for or by each advisory committee shall be available for public inspection and copying at a single location in the offices of the advisory committee or the agency to which the advisory committee reports until the advisory committee ceases to exist.” These documents must be made available no later than at the time of the meeting. When HHS had not made the draft comments available to the public for the January meeting, I requested that document, under FACA, after the meeting in a letter to Barbara James, Designated Federal Officer (“DFO”) of CFSAC at the time. I received it in March along with other documents, which is posted and analyzed in my Monday post.

In an apparent attempt to counter my FACA-violation charge, the current DFO, Dr. Nancy Lee, addressed the issue at Tuesday’s meeting:

“We are not required to send these [documents prepared for the meeting] out in advance of the meeting [other than to committee members] because they are pre-decisional. … [W]e are not required to post them on the website because they are pre-decisional.”

Dr. Lee’s excuses for HHS’s failure to comply with FACA fall flat because she is plain wrong regarding the requirements of FACA.

First of all, she seems to combine two arguments. It appears she is saying that HHS is not required to

  • email the relevant documents to the public or post them on the CFSAC website in advance of the meeting nor
  • disclose them at all because they are pre-decisional.

I and numerous other advocates wrote to Ms. James ahead of the meeting in January, saying that “the public should see” the document, which is exactly what FACA requires. I did not ask for the document to be emailed to me nor for it to be posted on the CFSAC website. I also never claimed that the FACA violation was the result of the failure to do so. Yet with her above statements, Dr. Lee falsely insinuated that I did when, in fact, I pointed out a FACA violation resulting from not making the document available to the public at all as required by FACA.

Regarding her second argument, Dr. Lee seems to be confusing the Freedom of Information Act (“FOIA”) and FACA. Under FOIA exemption 5, government agencies may withhold documents that are the product of the “deliberative process in governmental decision-making,” also referred to as “pre-decisional,” the term Dr. Lee used. The relevant FACA-disclosure requirements, however, are as follows:

“… FACA requires disclosure of written advisory committee documents, including predecisional materials, such as drafts, working papers and studies. The disclosure exemption available to agencies under exemption 5 of FOIA for predecisional documents and other privileged materials is narrowly limited in the context of FACA to privileged ‘inter-agency or intra-agency’ documents prepared by an agency and transmitted to an advisory committee.” [emphasis added] (Memorandum Opinion for the Assistant Attorney General Office of Legal Policy dated April 29, 1988)

In other words,

“FOIA Exemption 5 cannot be used to withhold documents reflecting an advisory committee’s internal deliberations.” (Memorandum for Committee Management Officers from James L. Dean, Director, Committee Management Secretariat, dated March 14, 2000)

The rationale is simple:

“Timely access to advisory committee records is an important element of the public access requirements of the Act. Section 10(b) of the Act provides for the contemporaneous availability of advisory committee records that, when taken in conjunction with the ability to attend committee meetings, provide a meaningful opportunity to comprehend fully the work undertaken by the advisory committee.” (see 41 C.F.R. §102-3.170)

CFSAC, as a FACA committee, is not an agency. Therefore, there is no FACA exemption for pre-decisional materials prepared within CFSAC, a sub-committee or a working group for consideration at a CFSAC meeting. Such an exemption would apply only if the materials were prepared by HHS, one of its component agencies or another federal agency.

Lastly, with respect to the working group draft documents that were discussed during the August 18-19, 2015 meeting, Dr. Lee mentioned they were “in the back of the room” and “available for anybody here for review.”

That would not appear to be FACA-compliant either because under Section 10(b) of FACA, the documents “shall be available for public inspection and copying ….” In order to gain access to a CFSAC meeting, one must be pre-registered for the meeting in order to undergo a security check in advance. Without being registered, one is not able to enter the Hubert H. Humphrey Building where the meetings take place. Therefore, “available for anybody here in the room” does not constitute being “available for public inspection” and “available for review” does not satisfy the requirement that it be “available for copying.”

In my last post, I called for a firm commitment from HHS to follow federal laws, such as FACA, going forward. Instead, Dr. Lee misinformed the committee and the public about the legal requirements under the statute, implying that no FACA violation by HHS had occurred. HHS continues to act as though the agency is above the law and it appears that HHS has no intention to be compliant in the future.

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Oops, they did it again! CFSAC violates FACA

This is a post about the violation of federal law by CFSAC yet again. This is also a post about how HHS has controlled CFSAC’s input on the P2P report.

CFSAC violated FACA, the Federal Advisory Committee Act, again. Not that anybody is shocked by that anymore, I know. Just your typical day at the CFSAC office. But wait! There is more. CFSAC’s DFO unduly influenced the committee’s advice to the Secretary. While this probably doesn’t come as a surprise to most either, it is quite revealing as to the mindset of HHS and what M.E. patients can expect from the agency, which is more stonewalling and empty promises. Nothing good has ever come out of that agency for us. I hate to be the bearer of bad news, but it’s not about to change if history as recent as January of this year is any indication.

“How dare I make these claims!” you say? Well, CFSAC admitted to the FACA violation in writing (see below) and I will spell out the overwhelming evidence for the undue influence of CFSAC by HHS in detail below. Here is a link to supporting documents for both, which I received in March 2015 from HHS after I officially requested, under FACA, documents relating to the January 2015 CFSAC meeting.

Of course, the same document-production game was played that HHS enjoys so much with FOIA requests, except, this time, they could not delay as much as they do with FOIA requests (Never mind that it violates federal law.) because I formally requested the documents under FACA and the deadline for bringing a lawsuit based on a FACA violation is very short. There are more technicalities here, but I will spare you the tedious details. I received the documents shortly before the deadline to sue for this recent FACA violation. Part of the documents—crucial parts, i.e., the reference to the line-item numbers for the P2P draft report—are illegible; pages were out of order based on the Bates numbers assigned to them by HHS; and after I sorted them according to the Bates numbers, they were not in chronological order. Maybe to make up for that, I received duplicates of 45 pages. Of course, all of that makes a review that much harder, but based on my FOIA lawsuit experience with HHS and NIH, it’s not only par for the course, it’s by design.

Page numbers I cite refer to document page numbers, not the Bates numbers at the bottom. If you are in the document on your computer, searching for a page is much easier that way. However, if you print the document (It’s long!), the page numbers will be off by one because the cover letter from the DFO does not have a Bates number.

No Access for Public to CFSAC P2P Draft Comments During January Meeting

FACA, the Federal Advisory Committee Act, governs the activities of federal advisory committees. Unlike with, say, the Patriot Act, the title sort of gives it away. Importantly here, it focuses in part on meetings being open to the public. According to section 10(b) of FACA, an agency is generally obligated to make available to the public, before or at the time of the meeting, all materials that were made available to or prepared for or by an advisory committee. The rationale for the obligation to provide contemporaneous availability of advisory committee records under FACA is simple. It is to afford, “when taken in conjunction with the ability to attend committee meetings, […] meaningful opportunity for the public to fully comprehend the work undertaken by the committee.” (41 C.F.R. §102-3.170). Without that opportunity, the meeting isn’t really open to the public. Not providing contemporaneous access to committee records is a FACA violation, a big federal no-no, and that’s what happened with CFSAC in January of this year.

So, “What exactly happened?” you ask. At its December meeting, CFSAC decided to convene an ad hoc working group (“Working Group”) that would provide comments from CFSAC on NIH’s Pathways to Prevention (“P2P”) draft report. The Working Group consisted of the following CFSAC members and ex officios: Dr. Dane Cook, Dr. Mary Ann Fletcher, Dr. Fred Friedberg, Dr. Susan Levine, Dr. Janet Maynard, Donna Pearson and Alaine Perry. The Working Group also included two non-CFSAC members, Claudia Goodell and Charmian Proskauer. That Working Group prepared a draft of the official CFSAC comments on the P2P report and that draft document was the subject of discussion among all CFSAC members at the January 2015 CFSAC meeting. (It was finalized after the meeting and submitted to the Secretary.) FACA was violated when the discussed draft was not made available to the public prior to, or at the time of, the meeting. As a result, patients and other members of the public who listened to the meeting over the phone—the only way for the public to participate—found it impossible to follow along, which essentially turned the meeting into a non-public meeting and that, in turn, means that the CFSAC P2P recommendation to the Secretary was invalid.

There is not much grey zone here. This is about as clear-cut a FACA violation as you will find. If you still don’t believe me, check out page 1 of the linked-to documents. And I quote from a letter written to me by the DFO, Barbara James, dated March 3, 2015, in response to my FACA demands:

“We sincerely apologize that the enclosed Draft Comments discussed during the CFSAC meeting on January 13, 2015, were not provided at the time of that meeting. Thank you for bringing this issue to the attention of HHS, so that HHS can try to prevent this issue in the future.”

And there you have it. Excuse me if I find the I-swear-I-didn’t-know-FACA explanation lacking. Assuming that CFSAC’s DFO was indeed ignorant with respect to FACA, is that really better than a willful violation? I any event, it is an assumption I am not willing to make. The DFO is supported by an assistant whose job it is to know the intricacies of FACA inside and out. This was no oversight.

Also note the lack of a firm commitment to comply going forward. “[T]ry[ing] to prevent [FACA violations] in the future” just isn’t anywhere near good enough.

HHS was fully aware that not providing the draft comments to the public in time for the meeting would make it impossible for the public to follow the meeting. When asked by Ms. Perry about the reason for the artificial three-page limit for the CFSAC comments, the DFO replied that there isn’t an official page limitation (page 305) and then stated the following (page 304):

“The upcoming meeting will be a conference so the committee and the public will not be viewing slides or the document on their computers. Therefore, all changes (edits, new text, etc.) will not be visible to the listening audience or the committee.”

This statement is true only with respect to the public, of course. The committee, on the other hand, did have access to the document, either on their computers or in hard copy format (though not to the changes in real time other than by listening). But what’s important here is that it didn’t bother the DFO one bit that the public would basically be shut out of a meeting that, under federal law, is supposed to be open. Ms. Pearson was also aware of the lack of access to the document to be discussed (p.89):

“Since the public will not have the document, you should suggest up front that they follow along using the P2P’s 389 line Draft Executive Summary if possible. (You might also say that it might probably be difficult for them to follow everything discussed, but that the complete document should be posted on the CFSAC website after going through the correct channels.)”

A cognitively impaired patient population will have difficulty following the discussion of a document it doesn’t have access to? You don’t say! This complete disregard of the duties of a DFO under a federal law is simply inexcusable. Which part of “contemporaneous” is so hard to grasp? What good does a subsequent posting of the finalized document do? None. And “after going to through the correct channels?” Wait, more censorship?

When I threatened legal action in January, I received the linked documents, among them various versions of the draft CFSAC comments. But again, having access to the discussed document after the meeting is not what Congress had in mind when it enacted FACA.

And how about this? In an earlier comment regarding the three-page limit of the document, the DFO offered this justification (page 305):

“… to increase the chances that NIH will actually review and consider our comments.”

This had me quite confused, as the P2P process was supposed to be carried out completely independently from NIH. But I digress.

Keep in mind that CFSAC is required to provide the committee documents without members of the public requesting them. And yet, HHS did not do so despite many patients and advocates expressly asking for it. See the numerous emails from the public in the public-comment section of the linked documents starting at page 150 asking for a copy of the draft comments.

[Edit August 20, 2015: At the CFSAC meeting on Tuesday 18, 2015, the DFO, Dr. Nancy Lee, seemed to try and counter my charge of this FACA violation. I examined her arguments in my new blog post, “Another CFSAC FACA Fail: DFO Misconstrues Law.” Basically, Dr. Lee misinformed the committee and the public on the law.]

Undue Influence by HHS

Regarding the second violation, let’s start with how those P2P comments from CFSAC came about. Please note that I have probably not completely captured the process, as it seems pretty clear that I was not provided with all correspondence regarding the matter, despite the representation by HHS that it had “provided all the documents available under FOIA.” Another blatant misrepresentation.

On December 19, 2014, Ms. Pearson sent a first draft of the CFSAC P2P comments to the Working Group (pp. 277-298). A call among the Working Group members was had on January 5, 2015 to discuss the draft and a revised version was circulated the same day. Three days later, another version was sent to the Working Group members.

Ms. Pearson rejoiced:

“The end is in sight!”

Quite obviously, the Working Group did not expect any substantial additional changes (aside from the ones from CFSAC members who were not part of the Working Group).

Ms. Pearson let the Working Group members know that the document was:

“being carefully reviewed by Barbara James and her staff. They will check for grammar, typos, errors.” They would then “send the document to the full Committee for advance review.” (p. 2)

So far, so good. Grammar and typos, fair enough. Errors, makes sense. Until … all hell broke loose two hours later. Ms. Pearson notified the Working Group as follows (p. 29):

“Barbara James just informed me that the Committee Management Officer for HHS has advised that our document will not be cleared for submission to the Secretary as written. The inclusion of statements that are perceived to be inflammatory, negative or derogatory to HHS or other agencies, the Panel, the Secretary or others will not be accepted.” [emphasis added]

This beyond-belief interference by HHS reminds me a bit of lower-level party officials not allowing the submission to the Politbüro of a report  that will be offensive to the communist party or its leadership. Under FACA, CFSAC is supposed to be independent from its parent agency, HHS. In fact, it is supposed to give advice to HHS, not receive it from HHS just to turn around and forward it to the Secretary. It’s called an “advisory committee!” Get it? If HHS dictates what advice CFSAC can give to the Secretary, then the Secretary is really advising herself through her own agency. Go, taxpayer money!

The Secretary is, of course, free not to implement a CFSAC recommendation. In fact, HHS’s Secretaries have a lot of experience with that; they have made a habit out of ignoring CFSAC. But HHS’s Committee Management Officer or CFSAC’s DFO have no right to refuse to submit a CFSAC recommendation to the Secretary. The draft comments disseminated to the Working Group were about to become a CFSAC recommendation subject to some minor changes by the entire CFSAC before and during the January meeting had the DFO not intervened. To threaten that a committee recommendation will “not be cleared for submission to the Secretary as written” clearly eviscerates CFSAC’s independence.

There was a certain amount of CYA involved here (p. 29):

“Please be aware that Barbara did indicate that we can stand by our original document and/or that one or more of us could submit it directly to the P2P Panel as individuals (not on behalf of the CFSAC). However, it will not be posted on the CFSAC website without the Secretary’s clearance, nor it will be sent to the Panel.”

Another threat, this time that HHS would not post the recommendation on the CFSAC website. HHS must really not have liked those nearly complete draft comments by the Working Group.

So, let’s look at this more closely. Subjectively (“perceived”) inflammatory, negative or derogatory comments will not even be sent to the Secretary? Nothing “negative?” Are these people serious? What is this, the editorial policy of Pravda? If a Secretary’s ego is so fragile that she can’t handle any criticism of anybody (“others”), maybe she’s in the wrong line of work. Patients are suffering day in and day out and the highest-ranking government official in the health department needs to be protected from the truth? Why is it that HHS is so ashamed of the M.E. reality that they have created? If they had done their jobs, shouldn’t they be proud?

But fear not, Ms. Pearson promised an easy fix of the situation. She let the Working Group know that the DFO volunteered to work late into the night to sanitize, I mean revise, the document (page 29). And so the DFO did; she worked all the way till 11:22pm, bless her heart.

This did not go over very well with some of the Working Group members. This is what Dr. Fletcher had to say in reply to the astounding news (p. 31):

“I am certain that our charge as members of the CFSAC was to advise the Secretary of HHS on ways the HHS may better help patients with ME/CFS through research, clinical care and prevention efforts. We were not told to avoid criticism of the HHS or any of its agencies, indeed we were to advise HHS and advise on ways to have an effective programmatic response. The P2P process, which included public response time before finalizing was designed to help set the research agenda for the field. Certainly the CFSAC advisory committee’s response should have weight and be taken into account. The report as it stands is the advise [sic] of this committee to the Secretary and the P2P panel. It should not be edited or changed by the HHS staff.

We thought that we were asked to serve on CFSAC because we had expertise in the field and that HHS wanted our advice. We have worked diligently and professionally in preparing this response, which should be delivered to Secretary and to the P2P panel without further changes or delay. We would hope our comments will be seen and influence the report before it is finalized.”

Brava, Dr. Fletcher!

Ms. Proskauer also took issue:

“Barbara, can you tell us exactly which statements have been flagged as ‘inflammatory, negative or derogatory?’ We should all know, then be given the opportunity to address these as a group. The full Committee has not even had an opportunity to review our work, either to approve or change. It does not seem appropriate to be making changes prior to the full Committee discussion.”

More good points made.

Despite objections being raised, the DFO proceeded to revise the document and, man, it sure must have been in need of some serious revisions— given the massive amount of changes that were made— despite all the time and effort the Working Group had invested and despite the fact that the draft was basically final. In the process of being reviewed and revised by HHS, entire paragraphs were deleted. In order to get a feel for the extent of the revisions that were made after HHS got involved, take a look at the redlines starting on p. 33 and on page 359. Some language was revised in such a way as to change its meaning completely. The redlines don’t always seem to properly track the changes that were made because the deletions and additions don’t match up in some places. Some changes didn’t make it into the final document. The important point is the extent of HHS’s involvement and the nature of the resulting or attempted changes. The comments were supposed to come from CFSAC, not HHS itself.

As you go through the versions and email correspondence, please keep in mind that there are, in all likelihood, many emails missing. Some emails are referenced, but were not provided. Not a single email critical of the HHS draft was provided to me. It is simply not credible that there were none. There is no way that there was not more fallout from the vast changes made after HHS got involved. Some Working Group members did not chime in at all if one were to believe the file I received is complete. Obviously, there is a lot more related correspondence out there that we don’t have access to. Are we to believe that somebody as principled and outspoken as Dr. Fletcher, for example, would not have objected to the heavy-handedly edited Working Group draft? The correspondence that was sent to me was clearly cherry-picked and the critical voices were left out. Dr. Cook called the revised document “improved” (p. 84). Seriously? The document was gutted! With friends like that, who needs HHS? Dr. Sue Levine simply said, “I think the document is fine.” And off it went to the entire committee, sent by the DFO. A few more changes were made in response to requests by the full committee. And voila, a CFSAC recommendation that was quite different from what the Working Group had signed off on was created. It can be found on the CFSAC website.

Below are a few examples of changes that seemed to have occurred after HHS got involved. There are many more. Underlined parts were added. Struck-through parts were deleted.

“Although dedicated researchers have identified parameters for defining ME/CFS, those parameters have not been universally adopted by the CDC and HHS. As a result, studies of ME/CFS are fraught with methodological problems, preventing a clear understanding of who is affected by the disease.” (p. 10)

“The dissemination of diagnostic and therapeutic recommendations should focus on primary care providers and all other health care providers dealing with symptoms specific to this disease, including but not limited to cardiologists, endocrinologists, neurologists, rheumatologists, psychiatrists, clinical immunologists, internal medicine and pediatrics, and infectious disease specialists.” (p.15) (emphasis added)

Earlier in the Draft, you asked whether or not ME/CFS is a spectrum disease. We believe the better question is the one originally published by the PzP Working Group and then discarded due to lack of research studies and evidence. “Are ME and CFS separate diseases or do they fall on a spectrum of one disease?” To take that original question further, have the terms CFS and ME/CFS been broadened, intentionally or otherwise, to encompass far more conditions than the disease identified as Myalgic Encephalomyelitis by the World Health Organization? ” (p. 18)

Researchers, advocates and the CFSAC have recommended use of the Canadian Consensus Criteria to define the illness until further research warrants modification. The failure to do so, along with the failure to adequately fund large scale studies aimed at identifying objective biomarkers, has opened the door to no fewer than eight (8) definitions over the years.” (p. 35)

The dearth of funding and reluctance of the HHS to collaborate with the broader stakeholder community has negatively impacted scientific progress in every way.” (p. 36)

“…estimated $5 million, which is far below diseases of less consequence and lower prevalence…” (p. 36)

Clinicians and others who do not think that ME/CFS is a disease in its own right simply have no read the literature and are thus uninformed.” (p. 40)

Yet the NIH and other agencies use a lack of information regarding ME/CFS to justify the failure to adequately fund additional research. In a response to this Committee’s request for an RFA in 2014, the National Institutes of Health replied “Unfortunately there remains a lack of definitive evidence regarding the etiology, diagnosis, and treatment for ME/CFS. As such, issuing a Request for Applications (RFA) would not be an effective strategy as RFAs generally encourage a narrowly defined research area that addresses more specific gaps in scientific knowledge.” Regarding the lack of a consistent set of criteria, the CFSAC has frequently recommended the universal adoption of the 2003 Canadian Consensus Criteria (CCC), requiring the key symptom of post exertional malaise.” (p. 40)

It is important to acknowledge that a majority of experts in the field have agreed upon parameters for defining ME/CFS. In a letter to the Secretary of Health and Human Services dates September 13, 2013, more than 50 of the world’s experts stated that they support the adoption of the 2003 Canadian Consensus Criteria and urged the HHS to adopt the CCC as the single case definition for all Department activities, both research and clinical uses. The NIH acknowledged their status as experts when responding to a CFSAC request for a data and biobank sharing platform in 2014: “The pool of ME/CFS researchers is small (e.g., the advocacy field identifies a group of 50 ME/CFS clinicians and scientists world-wide considered expert in this area of research.)… Thus, developing and maintaining a unique ME/CFS database is cost prohibitive in light of the small number of ME/CFS researchers…” However, the request of these experts to adopt the 2003 Canadian Consensus Definition has not been recognized or supported by the CDC and HHS agencies.” (p. 40)

“... we consider the PACE Trial to be “fruits of the poisonous tree.” (p. 43)

There is research and evidence for post-exertional malaise in ME/CFS and neurocognitive symptoms have been demonstrated for decades in this patient population. Much of the literature regarding ME/CFS was excluded from the Evidence Review.” (p. 45)

“[T]he failure to lack of universally accepted adopt the parameters identified by dedicated researchers has stifled progress.” (p. 45)

“There exists a plethora of is published objective data about ME/CFS and the disease itself is not subjective in nature.” (p. 45)

Additionally, rather than holding yet another workshop or conference, strong commitment from the Department of Health and Human Services is needed to follow the lead of experts in the field and fund the research that is so desperately needed.” (p. 46)

The Department of Health and Human Services HHS should follow the lead of stakeholders and national and international experts to adopt a universal consensus-based case definition and to help advance the field.” (p. 46)

For decades the burden of communication has fallen almost entirely on patients who must often educate themselves in order to receive a correct diagnosis, and then must educate family, friends, employers and healthcare providers.Many patients, especially those who are better educated and have more financial resources, are (by necessity) actively involved in their own care, while others are too sick to participate or do the research required to find physicians who can help.” (p. 50)

The DFO delivered her vast edits with the following comments (p. 358):

“I tried to keep as much of the working group’s language as possible.”

Could have fooled me. And not just me. Even Ms. Pearson, who was spearheading the Working Group effort and worked very closely with the DFO, noted (p. 62):

“We will need to communicate thoroughly and effectively with the members of the Working Group. There are so many modifications this document [sic] that they will consider the revisions to be disrespectful of their expertise and unappreciative of their contributions.”

When Ms. Pearson sent the heavily revised document to the Working Group, she did so saying (p. 88):

“PS If you are interested in seeing Barbara’s ‘red ink’ version, I will send it under separate cover. However, you’ll probably see all the deletions and changes and get confused, disheartened, and angry. So I just ask that you check out the revised document with a fresh eye first, then go through the marked up version to see specifically what is [sic] missing and/or changed.”

These two quotes are ever so revealing. It is quite obvious from that language that there was an awareness that the extent of the changes was excessive and problematic.

Remember, the document was just about to go to from the Working Group, which had basically completed its work, to the entire committee for their review when the DFO, Barbara James, took over. (The remainder of the committee later ended up making only minor changes to the document, as those committee members with the most interest in the subject had likely volunteered to be members of the Working Group and had already provided their input.) The only changes that the DFO and her team were going to make were with respect to grammar, typos and errors. Yeah, right.

I noticed that Dr. Levine raised the necessity of separating ME from CFS twice, but no responses to her have been produced. Here are Dr. Levine’s remarks:

“I wonder if any of you care to address the ambiguity of using the combined term ‘ME/CFS’ and the need to tear these apart as representing possibly 2 separate illnesses.” (p. 300).

“Personally, I feel that even though it’s mentioned several times, that it’s crucial that we distinguish ‘ME’ as a separate illness or what we now understand to include ‘post exertional malaise’ from other types of fatigue.” (p. 313)

Finally, Ms. Pearson sent an email around to the Working Group copying and pasting “complimentary emails.” Emails by Working Group members that were critical of the process are obviously missing from the production (see above), but HHS was making sure to send along those messages containing praise, pitting different corners of the patient community against each other:

“Although no one told me their remarks were confidential, it might be best to keep them within out group, just in case.” (pp. 345-347)

Just in case of what? In case of a FOIA request, in which case the identities cannot be legally redacted? Although assuming that HHS would bother with legalities is a stretch. Silly me. Some of the messages are easily attributed to their authors as it is. Let’s see, which advocate uses random initial caps, just for example? Of course, I noticed the mea-culpa message (p. 346):

“I thought Jeannette Burmeister was on to something with her legal case and that it was all well thought out. My sincere apology!” (p. 346)

I respect somebody who is able to admit they were wrong. Except I was indeed on to something and it was indeed all well thought out. No good deed goes unpunished.

So, am I going to get an apology now? No worries; my ego is not that fragile or needy. What really is called for is an apology by HHS to the entire M.E. community and, more importantly, a firm commitment to follow FACA and other federal rules in the future.

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CFSAC Comments August 2015: Ampligen Price Increase on Shaky Ground

I looked into the Ampligen issue–the exorbitant 267% price increase by Hemispherx–some more. Here is one thing that patients who are currently enrolled in the trial can do. They can contact Schulman Associates, the Institutional Review Board (IRB) for this trial at: Schulman Associates Institutional Review Board, Inc., 4445 Lake Forest Drive, Suite 300, Cincinnati, Ohio, fax: 866.377.3359. The IRB was “established to help protect the rights of research subjects” and encourages trial participants to write to the IRB “[i]f [they] have any questions about [their] rights as a research subject, and/or concerns or complaints regarding this research study….”

I also sent a follow-up message to FDA’s Dr. Woodcock with additional information regarding the distressing new price for Ampligen. I submitted that message together with my message to Dr. Woodcock from two days ago as official comments for the CFSAC meeting next week urging CFSAC, especially its FDA ex officios, to follow up with Dr. Woodcok. My CFSAC comments are reproduced below. (My new message to Dr. Woodcock starts under “August 13, 2015 Letter.”)

CFSAC Meeting August 18th-19th, 2015

Public Comments by Jeannette Burmeister

Submitted on August 13, 2015

I would like to urge CFSAC, particularly its FDA ex officio members, Drs. Maynard and Hall, to follow up with Dr. Woodcock regarding Hemispherx’s enormous price increase for Ampligen. Since FDA has regulatory authority over cost-recovery programs such as the Ampligen trial, I am asking that FDA exercise its authority to audit the justification of the new price and to re-assess its authorization of the increased price.

Below are two letters I sent to Dr. Woodcock on August 11, 2015 and today (August 13, 2015) with more details about the situation, which is dire and urgent.

August 11, 2015 Letter:

You can read my August 11 letter at 267% Price Increase for Ampligen.

August 13, 2015 Letter:

Dear Dr. Woodcock,

As a follow-up to my letter of August 11, 2015 regarding the enormous price increase for Ampligen by Hemispherx Biopharma, Inc. (“HEB”), I wish to raise a few additional issues.

As you know, FDA may allow drug companies to recover certain costs for investigational drugs in accordance with 21 C.F.R. 312.8, as it has done in the case of HEB and Ampligen. In order for a drug manufacturer, a so-called sponsor, to charge for certain costs for a drug undergoing clinical investigation, certain requirements have to be met.

In accordance with 21 C.F.R. 321.8(d)(1), a sponsor may recover only the direct costs of making its investigational drug available, not the indirect costs. The regulations further provide:

“Direct costs are costs incurred by a sponsor that can be specifically and exclusively attributed to providing the drug for the investigational use for which FDA has authorized cost recovery.“

“Indirect costs include costs incurred primarily to produce the drug for commercial sale (e.g., costs for facilities and equipment used to manufacture the supply of investigational drug, but that are primarily intended to produce large quantities of drug for eventual commercial sale) and research and development, administrative, labor, or others costs that would be incurred even if the clinical trial or treatment use for which charging is authorized did not occur.”

In March of this year, Hemispherx announced the completion of an $8 million facility-enhancement project in New Brunswick, N.J. to allow for a higher-capacity manufacturing process for both Ampligen and the company’s other drug, Alferon N. In the same month, HEB announced plans to commence distribution of Ampligen in Australia and New Zealand. This week, HEB announced that it was getting ready to supply Ampligen to patients in Europe and Turkey. As Australia, New Zealand, Europe and Turkey are currently completely untapped markets for Ampligen, it seems likely that the upgrades to the New Brunswick facility were made in anticipation of commercially selling the drug in these large new distribution areas, especially given the timing; the completion of the enhanced facility nearly coincided with the announcement regarding Australia and New Zealand and was followed, only a few months later, by the announcement with respect to Europe and Turkey. HEB will need to produce Ampligen in much larger quantities now in order to satisfy the demand in the new markets and with its upgraded facility will have the capacity to do so. In addition, HEB, by its own admission, is still actively and diligently pursuing FDA approval in the U.S. If it is successful with that endeavor, the new facility will be used to produce large quantities of Ampligen for commercial sale in the U.S. Consequently, the facility-enhancement project is likely an indirect cost and not recoverable under FDA regulations. Therefore, should HEB have included it in the cost justification for the price increase in the U.S. market, that would constitute an improper cost calculation and, given the magnitude of the project, even if depreciated or amortized, it alone may account for the Ampligen price increase.

Moreover, HEB has incurred manufacturing costs for the study of Ampligen treatment of other indications, e.g., Ebola, HPV, HIV, hepatitis and influenza. Were the costs for those efforts included in the cost justification for the open-label-trial price increase?

I also want to make you aware of the fact that the documentation that patients had to sign in order to enter the trial makes the express representation that the charge for the drug is “expected to be $2,100 for the first eight (8) weeks and $2,400 for each additional eight (8) week period.” Obviously, modest, justifiable price increases are to be expected and not objectionable. Dramatic increases—certainly those in the ballpark of 267% (an increase of $26,000 per year, from $15,600 to $41,600)—are not; they are inconsistent with the terms on which patients agreed to participate in the trial. In an FDA-regulated trial, such seeming price gouging ought to be impermissible, especially given the concerns as to the cost calculation and the representations made to the participants in the trial, many, if not most, of whom have made substantial personal sacrifices, financial and other, to participate and have also, over all these years made contributions, often at a price to their health, to HEB’s FDA-approval efforts for Ampligen by frequently completing extensive paperwork, undergoing large blood draws, performing stress tests twice a year, traveling to D.C. to testify in support of the approval of the drug, etc.

These and potentially other concerns raise serious questions as to whether the tremendous price increase for Ampligen was implemented properly and is otherwise permissible. Since FDA has regulatory authority over cost-recovery programs such as this one, I am asking again that FDA exercise its authority to audit the justification of the new price and to re-assess its authorization of the increased price. I do not purport to speak for anybody other than myself, but please be aware that the situation is a top priority for many in the patient population.

Sincerely,

Jeannette Burmeister

cc:

Dr. Stephen Ostroff, FDA Acting Commissioner (via email)

Nancy McGrory, Hemispherx Patient Advocate (via email)

Schulman Associates Institutional Review Boards (via fax)

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267% Price Increase for Ampligen

[Please see here for my follow-up letter to Dr. Woodcock.]

I just sent the following message regarding Hemispherx’s extraordinary 267% price increase for Ampligen to Dr. Janet Woodcock, the FDA’s Director of the Center for Drug Evaluation and Research:

Dear Dr. Woodcock,

I am writing to you regarding a matter of grave concern for the patients in Hemispherx Biopharma, Inc.’s (“HEB”) AMP-511 open-label clinical trial for Ampligen, a drug highly effective for many ME (or as the FDA calls it “ME/CFS”) patients. I have testified at the Ampligen Advisory Committee meeting and other federal committee meetings in favor of FDA approval of the drug and I remain convinced that this drug should be approved by the FDA without further delay because many patients would benefit from it and because there are no other FDA-approved pharmaceutical interventions for ME.

I have been a study participant for over three years. Last night, I learned through ME Action’s blog (http://www.meaction.net/2015/08/10/ampligen-price-increases-substantially-available-soon-in-europe/) that the price of the drug will go up 267%, from $15,600 to $41,600 per year, effective immediately as of July 24, 2015. Because it has not been approved by the FDA, the cost of the drug is currently not covered by private insurance or Medicare/Medicaid. Patients pay the entire cost out of pocket. Nevertheless, I have not received any notification from HEB of this extraordinary price increase.

HEB seems to claim that the price increase is necessitated by their increased cost in providing the drug to trial participants and that the increase has been verified by an accounting firm. However, accounting firms can avail themselves of a number of different methods to establish cost. For example, I understand that HEB recently expanded its facilities. Was the cost of this expansion, which would be a sunk cost at this point, included in the cost justification for the price increase either through depreciation or amortization? Moreover, HEB’s position itself is apparently contradictory as to the basic fact whether the new price includes merely manufacturing cost or also the cost of continued research and FDA-approval efforts. These points are merely illustrative of the various types of cost that may or may not have been included in the price-increase justification. It just does not seem probable that HEB’s cost increased that dramatically over night. A gradual increase seems much more plausible and would have been much easier to absorb for patients.

As you know, there are only four Ampligen trial sites in the country. Patients move and either leave their families behind or uproot them, either buy and sell houses or rent second homes, give up or change jobs, mortgage their houses, enroll their kids in new schools, etc. in order to relocate to a trial site and, in doing so, incur substantial long-term expenses far beyond just the price of the drug and the related infusion/physician’s cost. At the very least, HEB could have informed study participants of the fact that it is considering an increase at the time when it hired the accounting firm. The entire process from hiring the firm to the firm’s completed report typically takes time. That would have at least provided patients some advance notice. Some patients have very recently invested in relocating to a trial site just to find out now that they will not be able to afford the drug at the new price.

To be completely blindsided, not only without any advance warning, which was entirely feasible, but without any notification from HEB whatsoever upon effectiveness of the increase—more than two and a half weeks ago—is inexcusable and I would like to confirm with you that HEB followed any applicable federal rules both with respect to the magnitude of the price increase and the lack of notice.

I am looking forward to your response. Obviously, the matter is of utmost urgency, as many trial participants will be unable to afford the new price and will have to re-plan their lives without the drug. Most importantly, suddenly being cut off from a potent drug that patients’ immune systems have come to rely on might very well put the health of the current trial participants at risk.

Sincerely,

Jeannette Burmeister

cc:

Dr. Stephen Ostroff, FDA Acting Commissioner

Nancy McGrory, Hemispherx Patient Advocate

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Hip Surgery and ME: Society Has It Wrong

I am proud to share a note that my husband, Ed Burmeister, wrote last week. He initially posted it on Facebook only where it received a lot of attention and was shared more than 250 times. It really resonated with the community.

Therefore, I talked him into allowing me to post it here as well. I am blessed to have such a supportive and loving spouse.

Last Wednesday, I had a complete hip replacement.  It was a short procedure (1-1/2hours). No general anesthesia required.  I was out of bed the day of surgery and home after two days.  On Monday, I started driving again and really could have done so on Saturday already. Yesterday, I returned to work. I was comfortably working away, largely free of pain.  I walk without a limp and with no assistance and am pretty much unrestricted in my activities. I never needed narcotic painkillers after the surgery.  Ibuprofen does the trick.

Well-wishing family, friends and colleagues sent cards, flowers and gift baskets.  These were all nice to receive and I appreciated them. There have also been numerous and repeated inquiries about my progress. Just a lot of thoughtfulness all week.

Contrast this with the way Jeannette and her fellow ME patients are viewed and treated by the same cohorts.  Their disease, myalgic encephalomyelitis, is many multiple times worse than what I went through and it is ongoing, in Jeannette’s case for over nine years now. Many others have been sick much longer, some for decades. ME patients will most likely be sick for life and they are typically getting worse, as ME is often progressive.

Most activities that others don’t think twice about are impossible for Jeannette. She cannot stand for more than just a few minutes. She cannot walk more than just a few blocks. Sometimes, she cannot walk one block. Her debilitation goes far beyond the effects on her mobility and reaches into every corner of our lives. She is never comfortable, not even for a few minutes. It is always just a matter of degree of the relentless misery. Jeannette’s only contact to the outside world, besides the infusion room, is Facebook. But her presence on social media is frequently judged by some (what her friend Dave, also an ME patient, calls) normal-health people. It is estimated that about 25% of ME patients are sicker than Jeannette, some to a point that is unimaginable to everybody who has not been around those who are near death.

Jeannette is unable to leave the house on most days, and then generally only to receive thrice-weekly infusions, and spends most of her time lying down. Even sitting is impossible for extended periods. If she ignores her limits, it comes at a big price in the form of feeling considerably worse. Last Wednesday, the day of my surgery, Jeannette had no choice but to sit in the hospital waiting room for hours. There was no way to elevate her legs, which would have helped somewhat. Her only alternative was to lie on the floor, which she has done at the airport and other places in the past, but couldn’t risk in a hospital due to her being immunocompromised. At the end of the day, she was at least as impaired as I was having just come out of major surgery. The next day, she was too sick to visit me in the hospital, for which she beat herself up. She wanted nothing more than to be there next to me in the recliner the hospital staff had kindly moved into my room to accommodate her disability. But she couldn’t. That day, she didn’t eat, she could hardly move or talk. It was her payback for the sin of being there for me on my day of surgery.

It breaks my heart to see what Jeannette and other ME patients go through every day of their lives due to being this sick. But something else is almost more intolerable and that is how society treats them.

The thing is, when she is able to go out to the doctor or for an occasional meal with me, Jeannette often looks normal, often fantastic actually, despite being quite sick because she rests up for her outings in order to be able to make them and she probably also operates on a fair amount of adrenaline when she does leave the house for which she pays dearly. There are times when her appearance matches her debilitation and she looks like death warmed over, but at those times, she is usually too sick to leave the house. Nobody sees it. When others see her on those better days, they simply cannot seem to take in the degree of suffering she endures on an ongoing basis.  It is as if, despite her achievements, she has no credibility with society, which makes split-second assumptions about her health merely due to her particular diagnosis and what people think they know about it, which typically has very little to do with reality. At best, her disability is ignored. At worst, she isn’t believed. Hence, she does not receive flowers or gift baskets or cards wishing her well. Much worse, she does not receive the consideration and understanding that even a modest comprehension of her disease should provide.

I think it is as hard on her as the suffering from the disease to have to endure this constant indifference and complete lack of understanding by those around her. The absence of any validation of the degree of her disability and of any consideration for her special needs is, in and of itself, debilitating and robs Jeannette’s soul of the nourishment and support she so desperately needs.

The determination with which society refuses to acknowledge the severity of ME would be hard for me to believe if I didn’t witness it almost daily. A week after major surgery, I am multiple degrees less sick than Jeannette is almost every day, but–except for her fellow patients from whom she fortunately draws a lot of strength–nobody around her knows it. Worse, it seems that people don’t want to know it.

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Behavioral Health: Undue Influence by NIH on IOM ME/CFS Study

This coming Tuesday is the day of the unveiling of the IOM report on a new clinical case definition and new name for ME/CFS commissioned by HHS for $1 million. Although HHS did everything in their power to lobby for the IOM, the report lacks in credibility in ways too numerous to list here. So, let me focus on one, the strong appearance of undue influence by NIH on the IOM resulting in the inclusion of behavioral-health specialists on the IOM ME/CFS committee.

NIH’s Insistence on Including Behavioral Health

Many of you may remember HHS’s touting of the IOM as an institution that provides objective and independent advice. That does not jibe with the charge by Steven Coughlin, PhD, MPH, adjunct professor of epidemiology at Emory University in Atlanta, and others, that the IOM was influenced in rendering past Gulf War Illness reports by the sponsoring agency, the VA, to include “speakers … to brief the [GWI] IOM committee [presenting] the view that the illness may be psychiatric, although science long ago discredited that position.”

And yet, the exact same thing seems to have happened here with respect to the IOM committee for ME/CFS. NIH demanded that behavioral-health specialists be included as panel members and the IOM obliged without even an iota of resistance. This is how we ended up with two psychologists on the IOM panel, Dr. Cleeland and Dr. Alegria. Of interest is, e.g., that Dr. Alegria has co-authored a paper that classifies CFS as a neurasthenia spectrum disorder.

Hard not to feel like the IOM’s claim of independence is nothing but a PR stunt, huh? It does make sense; after all, the IOM relies heavily on federal-government money for its operations. It’s difficult to imagine any real independence—independence that goes beyond lip service— when a financial dependence exists. No wonder then that there was not a sliver of doubt on the part of NIH that the IOM would “accept” the ME/CFS contract, as NIH-internal correspondence reveals:

I’m sure they want the business.

Seriously?

Speaking of business, the total estimated cost for the meetings—based on the conference approval request by Dr. Lee to Dr. Koh— is $237,533. Since the committee members are not compensated beyond their expenses (included in the cost), does that mean that the IOM’s profit was over $762,000? That’s taxpayer money! Moreover, it looks like HHS budgeted (see approval request) and paid for seven meetings, but only five took place. It would follow that the IOM’s cost was actually lower than estimated and the IOM’s profit even higher. In any event, it would be quite the profit margin, especially when you consider that HHS’s initial total estimate for the ME/CFS “study” was $750,000 and that the IOM Gulf War Illness case-definition report from just last year cost “only” $850,000. Inflation really kills you, doesn’t it?

But anyway, if it’s business, why not get what you really want when you have all the bargaining power. In the case of NIH, that was, among other things, to include the psych lobby. And so they did and here is how.

On August 19, 2013, NIH provided a Statement of Work/Request for Proposal (SOW/RFP) to the IOM, which you can find here. The SOW/RFP contained the following language under “Task Description” with respect to the committee membership:

This Committee shall have expertise in areas necessary to address the topic areas identified below, including expertise in the pathophysiology, spectrum of disease, and clinical care of ME/CFS; neurology; immunology; pain; rheumatology; infectious disease; cardiology; endocrinology; primary care, nursing, and other healthcare fields; health education; and the patient/family perspective.

Note that ME/CFS experts were included. Based on the SOW/RFP, the IOM submitted to the NIH the first version of their Technical Proposal on August 23, 2013. All drafts of that document have been claimed exempt under FOIA, so I do not have a copy of those. On August 30, 2013, NIH sent an email to the IOM in reply with “issues and concerns.” Here is one of the additions NIH requested IOM to make to the proposal:

Prerequisite that committee expertise include ME/CFS and behavioral science

Well, since ME/CFS expertise was most likely already part of the proposal (as the IOM was working off NIH’s SOW/RFP, see above), the only specialty NIH added was behavioral science. Whoever drafted the SOW/RFP, probably somebody in the Office of Women’s Health at HHS (Take a guess!), dropped the ball and didn’t include behavioral-health specialists. Well—sarcasm alert—NIH “fixed” that. Could there still be any doubts about NIH’s agenda when it comes to our disease?

As a result, the IOM complied with NIH’s demands by submitting a revised proposal with the following language that, wouldn’t you know it, includes behavioral health (see NIH email of September 10, 2013):

 The committee will include approximately 15 members with expertise in the following areas: epidemiology; clinical medicine/primary care and other health care fields particularly with expertise in ME/CFS including behavioral health, neurology, rheumatology, immunology, pain, infectious disease, cardiology, endocrinology, and scientists and physicians with experience in developing clinical case definitions.

But that was still not good enough for NIH. The agency wrote to the IOM on September 10, 2013 with the following not too subtle “proposed” change:

The committee will include approximately 15 members with expertise in the following areas: epidemiology; clinical medicine/primary care and other health care fields particularly with expertise in ME/CFS including neurology, rheumatology, immunology, pain, infectious disease, behavioral health, cardiology, endocrinology, and scientists and physicians with experience in developing clinical case definitions.

See what NIH were trying to do here? They were trying to bury “behavioral health” in the middle of the sentence, most likely in hopes that those brain-fogged patients won’t notice. That’s the entirety of this change request with respect to this particular sentence: change the order of specialties to move behavioral health, so it wouldn’t be the first specialty after “ME/CFS including ….” Wouldn’t want to be too obvious, would they?

And voila’, IOM’s final technical proposal of September 12, 2013 linked to here says (under “Work Plan, Expertise”) exactly what NIH “proposed.” It’s a miracle! The IOM apparently operates based on an atypical definition of “independent.”

All About Appearances

Dr. Lee’s conference approval request (under “Location”) makes it very clear that HHS’s only real concern is not for actual independence. Instead it’s all about the appearance of independence.

As an unbiased convener, it is important that these meetings do not appear to be led or influenced by HHS. Holding the meetings in the IOM facilities … will reduce the appearance of bias or influence by HHS….

P2P Release

The release date of the NIH’s P2P report—the result of the research equivalent of the IOM “study”— is top secret (woot, woot), but one would probably not be too far off guessing that it will follow shortly on the heels of the IOM announcement, in a well-orchestrated HHS attempt of a one-two knock-out punch. The duplication of efforts by HHS (IOM) and NIH (P2P) culminating in near-simultaneous publications is just one building block for the HHS absurdity we’ve been witnessing for over 30 years and that is climaxing right now.

Early Release of IOM Report

Another of the many mind-boggling snippets about the IOM report is the fact that it is not due, under the task order, until March 22. In other words, it will be released almost six weeks early. Ask yourself when anything government-related has ever been completed early. The IOM contract itself had no time to spare to fall within 2013 fiscal year; otherwise, HHS would have had to bid farewell to almost one million dollars (something I will address in a future post). HHS’s farcical IOM project has not gone according to plan thanks to enormous opposition by experts, patients and advocates. So, it only makes sense that HHS is pushing out the IOM report as soon as possible in a desperate attempt to put a lid on future opposition.

IOM Studied an Oxymoron

But at the end of the day, nothing should come as a surprise here. The fact that the IOM had no qualms taking on “studying” an oxymoron, i.e., the combination of two not only completely different, but also exclusionary medical entities—ME and CFS—makes it hard for the organization whose reputation has been taking numerous beatings recently to escape obvious questions about its scientific rigor. But I guess those IOM overhead costs have to be paid somehow, so something had to give and in this case, it was independence and science.

Note added 2/9/15, 10:15am PST: I received the documents discussed, and linked to, above as a result of my FOIA lawsuit against HHS and NIH. I am continuing to work my way through them. Meanwhile, get this: HHS and NIH are still not in full compliance with the Judge’s order for document production, more than three months after the full production was due.

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FACA Request: Did HHS Orchestrate CFSAC’s P2P Comments?

Today, I filed a request with Barbara James, DFO of CFSAC, under the Federal Advisory Committee Act (FACA) regarding the January 13, 2015 CFSAC meeting and CFSAC’s P2P comments. My letter, which in addition to requesting immediate access to various documents relating to the meeting and comments, shows that FACA was clearly violated by HHS in connection with the last CFSAC meeting, is reproduced below. My last blog post reproducing correspondence with Ms. James gives context for my request.

The public’s P2P comments were due on January, 16, 2015, three days after the CFSAC meeting. Doesn’t it strike anybody as peculiar that the DFO (and CFSAC) was so confident that the Secretary would sign off on the comments on such short notice? After all, CFSAC recommendations have, for years, largely been ignored by the various Secretaries who either haven’t replied to them at all or taken months or years to do so, typically rejecting them.

HHS has never had ME patients’ best interest at heart and it certainly hasn’t with their recent duplicative IOM and P2P initiatives, which have been cloaked in secrecy; been pushed through with the speed of light; been directly opposite to the October 2012 CFSAC recommendation, the letter of the 50 ME/CFS experts to Secretary Sebelius recommending the adoption of the Canadian Consensus Criteria and the letter of 171 advocates to Secretary Sebelius supporting our experts; been excluding both experts and patients from participation in the IOM and P2P efforts in any meaningful way; been designed as unscientific from the start; been wasting taxpayer money when our disease otherwise hardly receives any and been just absurd. Just as an example, two words: jury model! And yet, the Secretary was expected by the DFO (and the committee) to approve the CFSAC P2P comments on the spot, which is not only unprecedented for this patient population, but must have invoked emergency-type procedures. The fact that HHS is so highly interested in having CFSAC provide official comments to the P2P speaks for itself because HHS has made it very clear throughout the entire P2P process that what’s best for patients is not only at the very bottom of the agency’s list; it didn’t even make the list.

The contrast between usual CFSAC business and the handling of the P2P comments is so stark that it compels the question as to whether CFSAC is merely being used by HHS to legitimize the P2P farce. It is certainly curious that CFSAC’s P2P advice to the Secretary seems to have been heavily influenced—when the committee, by law, is supposed to be independent from the parent agency—by HHS through extensive edits made to the P2P Working Group comments. Talk about circular! Was CFSAC’s advice to HHS’s Secretary basically being orchestrated, in large part, by HHS itself?

Via Email: Barbara.James@hhs.gov

January 17, 2015

Re: Request for Records Relating to January 13, 2015 CFSAC Meeting

Dear Ms. James,

I am a patient advocate for Myalgic Encephalomyelitis. I am writing to request disclosure of documents relating to the January 13, 2015 CFSAC meeting (“Meeting”) pursuant to Section 10(b) of the Federal Advisory Committee Act (“FACA”). This section of FACA provides as follows:

“Subject to section 552 of title 5, United States Code, the records, reports, transcripts, minutes, appendixes, working papers, drafts, studies, agenda, or other documents which were made available to or prepared for or by each advisory committee shall be available for public inspection and copying at a single location in the offices of the advisory committee or the agency to which the advisory committee reports until the advisory committee ceases to exist.” [emphasis added]

I hereby request that all documents falling under Section 10(b) of FACA relating to the Meeting be made available immediately. Without limiting the scope of this request, I particularly request that the proposed comments regarding NIH’s ME/CFS Pathways to Prevention (“P2P”) program prepared by the ad hoc CFSAC P2P Working Group and made available by the Working Group to the entire committee for discussion at the Meeting be provided, along with earlier drafts of the proposed comments by the Working Group, whether or not sent to the entire committee, working papers and revisions of the proposed comments, including, without limitation, those suggested and/or requested in writing or verbally by Ms. James, HHS’s Designated Federal Officer for CFSAC, or other HHS personnel, contractor or representative (collectively, “HHS”), whether or not incorporated into the proposed comments by the CFSAC P2P Working Group provided to the full committee and/or discussed at the Meeting and/or sent to Secretary Burwell (collectively, the “Proposed Comments”). My request includes all emails and other correspondence between and/or among CFSAC members (voting members, ex officio members liaison representatives, and/or P2P Working Group members, collectively, “CFSAC members”)), the DFO or HHS relating to the Proposed Comments and the Meeting. I am also requesting all emails from and to patients, advocates and other stakeholders sent to or by Ms. James, HHS or any CFSAC Member requesting or otherwise regarding the Proposed Comments and/or regarding the Meeting.

Please note that government agencies may not require members of the public or other interested parties to file FOIA requests for non-exempt advisory-committee records. (41 C.F.R. §102-3.170). Although records covered by FOIA exemptions may generally be withheld, please note that, in accordance with the Memorandum for Committee Management Officers from James L. Dean, Director, Committee Management Secretariat, dated March 14, 2000 (“Memorandum”), “FOIA Exemption 5 cannot be used to withhold documents reflecting an advisory committee’s internal deliberations” (see also Preamble to final rule under 41 C.F.R. Parts101-6 and 102-3, Federal Register, Vol. 66, No. 139, p. 37731 (July 19, 2001); opinion of the Office of Legal Counsel, U.S. Department of Justice, 12 Op. O.L.C. 73, April 29, 1988, entitled “Disclosure of Advisory Committee Deliberative Materials.”). [emphasis added] Further, as noted in Food Chemical News v. Department of Health and Human Services, 980 F.2nd 1468 (D.C. Cir. 1992), the Court of Appeals for the D.C. Circuit held that:

“… under section 10(b) of FACA an agency is generally obligated to make available for public inspection and copying all materials that were made available to or prepared for or by an advisory committee. Except with respect to those materials that the agency reasonably claims to be exempt from disclosure pursuant to FOIA, a member of the public need not request disclosure in order for FACA 10(b) materials to be made available. Thus, whenever practicable, all 10(b) materials must be available for public inspection and copying before or on the date of the advisory committee meeting to which they apply.” [emphasis added]

Accordingly, pursuant to the Memorandum, “… agencies may not delay making available non-exempt records to interested parties under FOIA procedures as an administrative convenience, or for other reasons.” The Memorandum further states that “[g]iven the plain and unambiguous language contained in section 10(b) of FACA, coupled with controlling case law and DOJ’s FOIA guidance, [the Director, Committee Management Secretariat is] encouraging each Committee Management Officer (CMO) to assure the maximum timely availability of covered advisory committee records.”

To the best of my knowledge, none of the materials requested above, not even the version of the Proposed Comments discussed at the Meeting, were made available to the public before, or on the date of, the meeting in direct violation of FACA section 10(b) and, to my knowledge, have still not been made available. This calls into question whether the Meeting itself qualified as a public meeting since the public was denied access to the key document and background material considered at the Meeting, preventing the required “meaningful opportunity for the public to fully comprehend the work undertaken by the committee.” (see 41 C.F.R. §102-3.170)

The requested documents, once received, will be published on my blog, “Thoughts about M.E.,” to allow the public a full understanding of the circumstances surrounding the Proposed Comments.

This is my third written request with respect to some of the requested material.

Please respond immediately to advise me as to when you will provide me with access to the requested documents. Otherwise, I will promptly pursue legal avenues to enforce FACA compliance.

Sincerely,

Jeannette K. Burmeister

(Attorney at Law)

Attachment:

Memorandum for Committee Management Officers from James L. Dean, Director, Committee Management Secretariat, dated March 14, 2000

Cc:

Sylvia Burwell, Secretary for Health and Human Services (Sylvia.Burwell@hhs.gov)

William B. Schultz, General Counsel of HHS (William.Schultz@hhs.gov)

Director, Committee Management Secretariat, General Services Administration (cms@gsa.gov)

Olga Nelson, Committee Management Officer, Office of the Assistant Secretary for Health, Department of Health and Human Services (olga.nelson@hhs.gov)

CFSAC Voting Members (via CFSAC mailbox: cfsac@hhs.gov):

Susan Levine, M.D. Chair

Adrian M. Casillas, M.D.

Rebecca Patterson Collier, R.N., CCM

Dane B. Cook, Ph.D.

Lisa W. Corbin, M.D.

Mary Ann Fletcher, Ph.D.

Gary E. Kaplan, D.O.

Alisa E. Koch, M.D.

Jose G. Montoya, M.D.

Faith Newton, Ed.D

Donna M. Pearson

CFSAC Ex Offiicio Members:

Jennifer E. Moore, Ph.D., R.N., AHRQ (jennifer.moore@ahrq.hhs.gov)

Ermias Belay, M.D., CDC (eeb8@cdc.gov)

Elizabeth Unger, M.D., Ph.D., CDC (eunger@cdc.gov)

Alaine Perry, M.P.H., CMS (Alaine.Perry@cms.hhs.gov)

Janet W. Maynard, M.D., FDA (janet.maynard@fda.hhs.gov)

Keith Hull, M.D., Ph.D., FDA (keith.hull@fda.hhs.gov)

Deborah Willis-Fillinger, M.D., HRSA (dwillis-fillinger@hrsa.gov)

Mariela C. Shirley, Ph.D., NIH (Shirleym@od.nih.gov)

Susan E. Maier, Ph.D., NIH (Susan Maier maiers@od.nih.gov)

Cheryl A. Williams, SSA (Cheryl.Williams@ssa.gov)

Amanda Wulf, SSA (Amanda.wulf@ssa.gov)

Bcc:

Susan Levine, M.D.

Charmian Proskauer

Claudia Goodell (to be sent once email address obtained)

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January 2015 CFSAC Comments: More HHS Disregard for the Law?

Yesterday, I sent the following email to Ms. James, DFO of CFSAC:

Dear Ms. James,

I heard that the CFSAC P2P Working Group had prepared a document for official submission regarding P2P to be discussed at the upcoming CFSAC meeting and that this report was heavily edited by HHS before being sent to the full committee. Is that true? If it is, then I believe the public should see both the original Working Group document prior to HHS’s editing and the document that went to the full committee.

I look forward to your reply.

Sincerely,

Jeannette Burmeister

Ms. James replied as followed:

The draft comments, which will be finalized during tomorrow’s meeting, will be posted to the CFSAC website after the Secretary has signed off on them.

I answered Ms. James with the following email:

Dear Ms. James,

Thank you for your reply. I am afraid, however, that it was not responsive to my question.

So, let me ask again: Was the document that the CFSAC P2P Working Group had prepared as draft comments to be discussed at the CFSAC meeting and, once finalized, to be submitted as official CFSAC P2P comments edited by HHS before being sent to the entire committee? If so, would you please make both versions of the document available.

CFSAC patient representative, Donna Pearson, sent an email to several patients who had asked similar questions, in which she gave her view of the events surrounding the P2P Working Group document and the edits made to that document by HHS. Therefore, I am also requesting that all emails between the Working Group and HHS staff concerning the Working Group document and the HHS edits thereto be made available, so that the public can fully understand what occurred.

I am looking forward to your responsive reply.

Sincerely,

Jeannette Burmeister

Just to clarify, my request includes all emails among the Working Group members on the subject.

The HHS actions regarding potentially heavily editing the Working Group document raise serious concerns with respect to the independence of he committee and the lack of transparency. These and other related actions will be investigated to determine any potential violations of FACA and other federal laws and regulations, including a potential violation of the requirement to make documents to be discussed at the meeting available to the public in advance.

Thank you.

PS: Dr. Susan Levine, Chair of CFSAC, and Donna Pearson, CFSAC’s P2P Working Group Chair, were copied on my correspondence with Ms. James.

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