Survey Establishes Need for ME/CFS Centers of Excellence

Wanted: Patient Participation in Quality of ME/CFS Medical Care Survey

The Chronic Fatigue Syndrome Advisory Committee’s Centers of Excellence Working Group invites the participation of all ME/CFS patients, 18 years of age and older, worldwide, but particularly within the United States, to participate in an online survey the purpose of which is to determine the ease of patient access to ME/CFS Specialists and to assess the quality of medical care received by individuals with ME/CFS from all of their healthcare providers. While it is of primary importance to establish the quality of care received by patients on a country-by-country basis, the intent of this survey is to establish the need for improved care within the United States based upon the quality of their care when compared to that of other illnesses within the United States, and based upon the comparison of their care to that received elsewhere in the world. The more robust the patient participation in this survey, the more significant the data and the more convincing the results drawn from it will be. We are hoping to obtain a minimum of 1,000 respondents in the United States. If you know ME/CFS patients, please encourage their participation. The results of this survey will inform us of the magnitude of need for ME/CFS Centers of Excellence, the services they should provide, and where they should be located.

This online survey is anonymous. Participant identity will not be revealed. Patients will be asked about their experiences with: access to ME/CFS specialists, barriers to access to ME/CFS specialists, the quality of care they have received from ME/CFS specialists, and the quality of care they have received from healthcare providers who are not ME/CFS specialists.

Patients will be asked to provide information, anonymously, about their current living circumstances (such as age, gender, and employment status), their ME/CFS diagnosis, ability to perform tasks of daily living, and illness onset characteristics. Patients will be provided with an opportunity to describe their medical care in their own words.

To access the survey please follow the link: https://redcap.is.depaul.edu/surveys/?s=wGI2stCALK

A Tale of Two Meetings: CFSAC and P2P

Two important meetings are scheduled for early December: CFSAC (CFS Advisory Committee) and P2P (Pathways to Prevention). The CFSAC meeting will be held on December 3-4. The P2P panel will meet on December 9-10. Both will be in Washington, DC and both are available via webcast.

CFSAC was formed in 2003 in order to provide advice and recommendations to the Secretary of Health and Human Services (HHS) through the Assistant Secretary for Health on issues related to ME/CFS. It is currently under the auspices of Office on Women's Health, a division of the Office of Public Health and Science.

In 2010 the committee advised HHS that the name chronic fatigue syndrome should be changed to CFS/ME because the disease wasn't being taken seriously. The idea was that the inclusion of ME might encourage more research into the illness. The CFSAC panel also recommended that a national CFS/ME network of treatment centers be created by HHS, "in order to expand access to care, to develop educational initiatives, and to allow researchers to share data."

Although the recommendations made by CFSAC over the years have been important, they have been ignored, or, even worse, "hijacked." The Federally Designated Officer, Nancy Lee, was considered a large part of the problem, and though she has been replaced is still a major obstacle to making significant progress. 

Of the two meetings, P2P will have the greater impact on the future of ME/CFS, for while CFSAC recommendations have been largely ignored, the P2P's conclusions will have an immediate effect on funding, and on subsequent treatment.

CFSAC is open to public comment. (Please see Jerrold Spinhirne's excellent comment below.)

If you would like to submit a public comment by phone to CFSAC, you must register by Monday, November 24th at 5pm. If you want to submit written comments, these are also due November 24th at 5pm. Registration and instructions for scheduling public comments and submitting public testimony are available at www.blsmeetings.net/cfsac. You can read the full agenda HERE.

If you would like to register to attend the P2P Workshop in person click HERE,

To register for the webcast click HERE

Related posts: The P2P Posts Its Agenda: Are They Kidding?

Advocates to NIH - "Pull the P2P!"

P2P: The Question They Will Not Ask

P2P Invites Input From the Public

The AHRQ Draft Report - Fundamentally and irredeemably flawed
How to Oppose the P2P (Without Chaining Yourself to the White House Fence) 

____________________

My Public Comment for the December 3-4, 2014 CFSAC Meeting

November 9, 2014 at 1:24pm

Comment for the December 2014 CFSAC Meeting by Jerrold Spinhirne, S.E.

Some important quotes regarding the neurological disease myalgic encephalomyelitis (ME) and chronic fatigue syndrome (CFS):

1. Name: Myalgic encephalomyelitis, a name that originated in the 1950s, is the most accurate and appropriate name because it reflects the underlying multi-system pathophysiology of the disease. Our panel strongly recommends that only the name ‘myalgic encephalomyelitis’ be used to identify patients meeting the ICC because distinctive disease entity should have one name. Patients diagnosed using broader or other criteria for CFS or its hybrids (Oxford, Reeves, London, Fukuda, CCC, etc.) should be reassessed with the ICC. Those who fulfill the criteria have ME; those who do not would remain in the more encompassing CFS classification.

2. Remove patients who satisfy the ICC from the broader category of CFS. The purpose of diagnosis is to provide clarity.  The criterial symptoms, such as the distinctive abnormal responses to exertion can differentiate ME patients from those who are depressed or have other fatiguing conditions. Not only is it common sense to extricate ME patients from the assortment of conditions assembled under the CFS umbrella, it is compliant with the WHO classification rule that a disease cannot be classified under more than one rubric....

3. Research on ME: The logical way to advance science is to select a relatively homogeneous patient set that can be studied to identify biopathological mechanisms, biomarkers and disease process specific to that patient set, as well as comparing it to other patient sets.... Research on other fatiguing illnesses, such as cancer and multiple sclerosis (MS), is done on patients who have those diseases. There is a current, urgent need for ME research using patients who actually have ME. [Emphasis added]

– Myalgic Encephalomyelitis – Adult & Paediatric: International Consensus Primer for Medical Practitioners (Carruthers, 2012)

I felt for some time, Keiji, that those who have CFS are at a certain point along a continuum of illness in which fatigue is either the most dominant symptom or the most clearly articulated by virtue of impressions on the part of the patient or physician that such a complaint is important. I predict that fatigue itself will remain the subject of considerable interest, but the notion of a discrete form of fatiguing illness will evaporate. We would, then, be left with Chronic Fatigue that can be distinguished as Idiopathic or Secondary to an identifiable medical or psychiatric disorder. I consider this a desirable outcome. [Emphasis added]

– NIH official Stephen Straus in an undated letter to CDC epidemiologist Keiji Fukuda before the 1994 Fukuda et al. redefinition of chronic fatigue syndrome (Straus, undated)

We propose a conceptual framework to guide the development of studies relevant to the chronic fatigue syndrome. In this framework, in which the chronic fatigue syndrome is considered a subset of prolonged fatigue (>1 month), epidemiologic studies of populations defined by prolonged or chronic fatigue can be used to search for illness patterns consistent with the chronic fatigue syndrome.

Prolonged fatigue is defined as self-reported, persistent fatigue lasting 1 month or longer. Chronic fatigue is defined as self-reported persistent or relapsing fatigue lasting 6 or more consecutive months.

Diagnosis of the chronic fatigue syndrome can be made only after alternative medical and psychiatric causes of chronic fatiguing illness have been excluded. No pathognomonic signs or diagnostic tests for this condition have been validated in scientific studies; moreover, no definitive treatments for it exist.

[N]one of the provisions in these guidelines, especially the definition of idiopathic chronic fatigue and subgroups of the chronic fatigue syndrome, establish new clinical entities. Rather, these definitions were designed to facilitate comparative studies.[Emphasis added]

– Fukuda K, Straus SE, Hickie I et al. Chronic fatigue syndrome: a comprehensive approach to its definition and study. (Fukuda, 1994)

Fatigue is a totally undefinable concept. Fatigue is impossible to measure or quantify. Fatigue is so non-specific that it can be a common element in any acute or chronic disease and many psychiatric diseases. Worse, it redirects the medical and public attention to the totally undefinable fatigue and away from the obvious Central Nervous System changes in these patients. Much worse, it makes fun of a serious illness since most people and most physicians tend to equate fatigue with laziness, work avoidance, something that a bit of effort will chase away. It has turned out to be a damning indictment to all M.E. patients.

– Dr. Byron Hyde in a 2006 speech delivered in London

The recent Stanford brain imaging study (Zeineh, 2014), which found profound brain abnormalities in CFS-labelled subjects, is consistent with the neurological disease myalgic encephalomyelitis (ME) and shows the problem with the continued use the 1994 Fukuda "International" CFS case definition (Fukuda, 1994) to select research subjects for biomedical research. The results can only be applied to an undetermined subset of CFS patients which is never delineated.

The ME IC Primer (Carruthers, 2012), on the other hand, already lists brain abnormalities similar to those found in the Stanford study – white matter abnormalities and reduced regional gray and white matter volume – as associated with the neurological disease ME. ME is a well-described disease entity based on the documented, clinical observation by highly qualified medical doctors of thousands of actual patients with the disease. CFS, as it is currently case defined, is based on a political negotiation made between US Department of Health and Human Services (HHS) bureaucrats and medically unqualified UK psychiatrists in 1994. CFS corresponds to no single clinical entity ever observed in actual patients. In addition to chronic fatigue, the 1988 Holmes definition of CFS required 8 of 11 listed symptoms. The 1991 Oxford definition of CFS required no symptoms other than chronic fatigue. The CDC-assembled 1994 CFS definitional committee diplomatically split the difference and arbitrarily required any 4 of 8 listed self-reported and sketchily described symptoms for a case of CFS.

The Fukuda case definition of CFS is a research concept that is an abstraction. No extensive clinical observation of actual patients was considered. The definition was allegedly only intended as a theoretical framework to assemble research subjects who MIGHT have an identifiable disease. Inexplicably, this abstract research concept was turned verbatim into CFS diagnostic criteria that can still be found in the CDC's "CFS Toolkit" of diagnostic and treatment guidelines today, 20 years later. In other words, doctors are presently diagnosing and treating a research abstraction called CFS, rather than any actual disease – or even any related group of diseases – found in nature. 

The "encephalomyelitis" part of the term ME means inflammation of the brain and spinal chord. Brain inflammation was recently confirmed in ME patients selected using the International Consensus Criteria for ME. (Nakatomi, 2014; Carruthers, 2011) This is completely consistent with the Stanford brain study findings. Dr. E. Donald Acheson in 1959 reviewing 14 outbreaks of infectious disease, by then named myalgic encephalomyelitis, involving thousands of patients stated:

"All the outbreaks shared the following characteristics: (1) headache; (2) myalgia; (3) paresis [muscle weakness, partial paralysis]; (4) symptoms or signs other than paresis suggestive ofdamage to the brain, spinal cord or peripheral nerves; (5) mental symptoms; (6) low or absent fever in most cases; (7) no mortality." [Emphasis added] (Acheson, 1959)

The common symptom of fatigue is not even mentioned in classic descriptions of ME – not because ME patients did not experience and report fatigue, but because fatigue is such a commonly reported symptom that it is not useful for making differential medical diagnoses. The ME International Consensus Criteria (Carruthers, 2011) and IC Primer do not even list self-reported chronic fatigue, or any type of fatigue, as a symptom of ME. Responses to standard fatigue questionnaires are, therefore, of no use for diagnosing ME, or for measuring its severity or improvement. Nevertheless, the concepts of CFS, ME/CFS, and CFS/ME are all based on self-reported fatigue which is only "measurable" by questionnaires – the "instruments" of social science.

Many patients and media reports viewed the Stanford brain study as vindication that CFS is "real." However, by the currently used Fukuda definition, CFS can never be "real." The fatigue must be "unexplained" and "self-reported." The findings of the Stanford brain study are likely to be found as "exclusionary" for CFS by the dogmatic US Centers for Disease Control (CDC) – as they have found all similar physical findings in CFS-labelled research subjects for the past 26 years.

How could brain-scan abnormalities ever be a "biomarker" for the diverse group of patients assembled under the umbrella term CFS? None of the poorly described symptoms that might indicate some neurological involvement – "impaired memory or concentration," "headache of a new type or severity" and "unrefreshing sleep" – in the current "CFS Toolkit" is required for a CFS diagnosis. Abnormal brain scans could never be a biomarker for CFS because an unknown portion of CFS-diagnosed  patients is likely to have no physical brain abnormalities, whatsoever. If the Stanford subjects had been evaluated for ME using the ICC, which requires at least three symptoms indicating neurological impairment, the results could be applied to a specific patient group – the group with the neurological disease ME. Instead, biomedical research using nonspecific CFS-labelled subjects will keep going around in circles as it always has done and always will do.

The fatigue experienced by ME patients is no more "unexplained" than the fatigue experienced by cancer and MS patients. Because the fatigue experienced by ME patients is a bioalarm indicating an underlying disease process and not "unexplained," no patient with ME, strictly speaking, can meet the Fukuda case definition of CFS. The impossibility of a single patient simultaneously meeting both the ICC-ME and Fukuda-CFS case definitions makes the CFS-hybrid terms "ME/CFS" and "CFS/ME" ambiguous and nonsensical.

The CDC has consistently denied any neurological involvement in their conception of CFS. After a quarter century of CFS research, there is still no symptom suggesting any neurological disease or, indeed, the presence of any specific disease, required for a CFS diagnosis or for use as a CFS research subject. The problem is bad faith at the CDC and the rest of the Department of Health and Human Services – not the lack of scientific evidence.

If the CDC, NIH, psychologists, and psychiatrists wish to continue their research of the subjective symptom of chronic fatigue or their search for a distinct chronic fatigue syndrome and its elusive subgroups, they should not do so at the expense of patients with the distinct neurological disease myalgic encephalomyelitis. It is unethical and hypocritical of the CDC and the rest of HHS to keep ME hidden within a hypothetical chronic fatigue syndrome. There is an urgent need for ME, as defined by the ICC, to be officially listed as exclusionary for a CFS diagnosis or for use as a CFS research subject. Just as the presence of CFS subjects without ME confounds ME research, the presence of ME subjects without CFS confounds CFS research. If the CDC is sincere in wishing to research CFS, they should immediately announce that subjects with ME – just as subjects with other fatiguing diseases such as cancer and MS – should be excluded from use as CFS-labelled research subjects.

Copies of the ME IC Primer must be distributed to doctors so they can recognize and rule out ME before making a CFS diagnosis. Doctors must also be educated that in the new US ICD-10-CM, official October 2015, ME is coded for billing and reporting purposes as G93.3 as a neurological disease. CFS and unspecified chronic fatigue are codedtogether as R53.82 as general symptoms.

HHS could actually make itself useful by distributing the ME IC Primer to doctors and medical personnel and informing them how to use the new ICD-10-CM codes. Instead, HHS has chosen to engage in expensive boondoggles such as the unneeded, million-dollar HHS/IOM redefinition of "ME/CFS" or the useless, farcical NIH P2P "ME/CFS" Workshop. Both of these HHS initiatives are set up and stage managed so that they can only cause more confusion, more harm to patient care, and more confounding of research.

References:

Acheson, ED. The clinical syndrome variously called benign myalgic encephalomyelitis,
Iceland disease and epidemic neuromyasthenia. Am J Med 1959; 26(4):569–595.http://www.name-us.org/DefintionsPages/DefinitionsArticles/Acheson1959.pdf

Carruthers BM, van de Sande MI et al. Myalgic encephalomyelitis: International Consensus Criteria. J Intern Med 2011; 270:327–38.

Carruthers BM, van de Sande MI et al. Myalgic Encephalomyelitis – Adult & Paediatric: International Consensus Primer for Medical Practitioners. Published online October 2012.http://www.name-us.org/DefintionsPages/DefinitionsArticles/2012_ICC%20primer.pdf

Fukuda K, Straus SE, Hickie I et al. Chronic fatigue syndrome: a comprehensive approach to its definition and study. Ann Intern Med 1994; 12:953–9.

Nakatomi Y, Mizuno K et al. Neuroinflammation in patients with chronic fatigue syndrome/myalgic encephalomyelitis: An 11C-(R)-PK11195 PET study. J Nucl Med 2014; 55:1–6.

Straus, Stephen. Undated letter on NIH letterhead to Keiji Fukuda quoted and posted online by Craig Maupin in The CFS Report, March 2014 post, CDC AND NIH Officials Discussed "Desirable Outcome" of Seeing A Distinct Illness "Evaporate. ”http://cfidsreport.com/News/14_Chronic_Fatigue_Syndrome_Definition_IOM_Straus.html

Zeineh MM, Kang J, Atlas SW et al. Right arcuate fasciculus abnormality in chronic fatigue syndrome. Radiology 2014; 273(2S). Published online October 29, 2014. 

HHS to ME/CFS Community: We don't care what you think.

Two days ago, Jennie Spotila gave a "(Lack of) Progress Report" on the December CFS Advisory Committee webinar. (See her blog, Occupy CFS.) By all accounts, the event was a disaster.

For those who are not familiar with CFSAC (pronounced "sieve-sack"), it was formed in 2003 to advise the Secretary of the Department of Health and Human Services on issues affecting patients with CFS, such as healthcare, the science and definition of CFS, education and other public health matters related to the disease. During the last ten years, CFSAC has made more than 70 recommendations to the Secretary on important issues, including research funding, Centers of Excellence, provider education, pediatric issues, case definition, and a name change. CFSAC is our community's only direct avenue for communicating with HHS, and therefore occupies a unique, and important, position in terms of influencing federal policy.

Over the past year or so, CFSAC appears to have sunk in a morass of political slime. In January 2012, it violated its public Charter and acted in secret to "narrow down" its list of priorities. (You can read about this sleight of hand HERE.) By making decisions hidden from the public eye, CFSAC not only violated its Charter, it effectively relegated the ME/CFS community to the role of passive recipients, rather than active participants in decisions that will affect us for years to come.

The second nail in CFSAC's coffin came last May when Eileen Holderman reported that she had been threatened with expulsion from the committee by the Designated Federal Official, Nancy Lee, simply for acting as a patient advocate. She said the chair was ‘shutting her down and shutting other people out.’ Most significantly, she stated that "to hijack our recommendation and pretend like it’s being done, that’s wrong.” Mary Ann Fletcher also reported having been threatened with eviction for "expressing her opinion." (Read Mark Berry's article HERE.)

The third (but probably not final) nail was hammered home when December's CFSAC meeting was transformed into a webinar. Claiming "lack of funds," HHS decided to do away with 20 years of face-to-face dialogue, substituting a venue in which participants could not - like Eileen Holderman - report bullying or harassment. Nor could they express the community's ongoing concerns over the IOM contract.

Instead of a meeting, those who signed up for the webinar got dead air, glitches, and "technical difficulties." There was no audio, so people listening on their computers heard nothing for the first 20 minutes, slides went astray, and public comments were not broadcast. As Jennie pointed out, there is no excuse for this kind of mismanagement. Ultimately, the degree to which CFSAC has been completely derailed from its original purpose can only be interpreted as a deliberate act of sabotage.

Jennie sums up the meeting with the following statement:

"This meeting accomplished two things: the public airing of the lack of progress across multiple domains and an exponential increase in frustration in the advocacy community. As many people pointed out yesterday, there is a serious disconnect in communications between HHS and the advocacy community. The decision to go ahead with this meeting was a terrible capstone to the precipitous decline in the HHS-advocacy relationship. Unless, as I said in my written comments, “HHS intends to send the message to the ME/CFS community and to you, CFSAC members, that it does not care what we think, it does not want our input, and it does not intend to do anything beyond or better than what it is already doing.”

If that’s the case, mission accomplished."

Move along, nothing to see here

Jennie Spotila, ME/CFS Advocate, posted this piece on her blog, Occupy CFS, today. (Reprinted with permission) For those who have been wondering whatever happened to the request for an investigation into the intimidation of CFSAC members who sought to represent patient interests, the answer has finally come. And the answer is ... 
_________________________________
Nothing to See Here

By JennieSpotila, Occupy CFS

After more than four months, Assistant Secretary Dr. Howard Koh has finally responded to our request for an investigation into the allegations that Dr. Nancy Lee attempted to intimidate at least two voting members of the CFS Advisory Committee. His response boils down to something along the lines of, “OK people, move along, nothing to see here.” In fact, his letter is so dismissive of the allegations and so vague on what he’s done about it, that it barely qualifies as a response at all.

Quick Review of The Facts

At the May 2013 CFSAC meeting, Eileen Holderman and Dr. Mary Ann Fletcher said that they had been intimidated by Dr. Nancy Lee and threatened with removal from the Committee for expressing their views. They said a third CFSAC member had also been intimidated.

On June 12, 2013, forty-six organizations and advocates wrote to the General Counsel and requested that he investigate the allegations.

On June 21st, the matter was referred to Assistant Secretary Koh. On August 22nd and September 20th, we wrote to Dr. Koh and requested an update on the investigation. We received no response or acknowledgement of our requests.

A Non-Responsive Response

In an letter to Mary Dimmock dated October 31st (but not received by her until November 7th), Dr. Koh finally responded. You can see the full letter here, but I’ll parse the salient points for you:

"The concerns that have been expressed by the members will be taken into consideration as the Committee moves forward in working to accomplish its mission."

This makes no sense at all. Eileen Holderman and Dr. Fletcher did not express “concerns.” A concern is something along the lines of I’m-concerned-that-we-don’t-get-meeting-materials-in-advance. That’s a concern that can be “taken into consideration.” Holderman and Fletcher made allegations of improper conduct by the Designated Federal Officer of the Committee. That’s more than a concern. But Koh doesn’t even acknowledge the nature of the allegations. Nor does he describe what he did to investigate them.

"However, it is important to understand that the Designated Federal Officer for CFSAC, Dr. Nancy C. Lee, has authority to engage in private conversations with individual members of CFSAC."

I am not aware of anyone disputing that Dr. Lee can talk to individual members of CFSAC. The allegations were not about the propriety of Dr. Lee talking to CFSAC members. The allegations were about what she said.  This is what we asked the General Counsel to investigate: Did Dr. Lee tell one or more members of CFSAC that he or she could be removed from the Committee for expressing a point of view? That is the question that must be answered.

"These discussions may be confidential in nature . . ."

Um, okay. As far as I am aware, CFSAC doesn’t deal in matters of national security. They don’t receive confidential corporate documents the way members of FDA advisory committees do. I have no idea what’s so hush hush about it. But even if I accept the proposition that certain discussions are confidential, I hear something a bit ominous in this comment from Dr. Koh. By telling us that those discussions might be confidential, is he saying that Holderman and Fletcher have done something wrong in making their allegations public? Is he actually claiming that they are not permitted to disclose conversations that, at least in their opinion, represent improper behavior by a federal official? Seriously? Is he suggesting that there will be a backlash against any member who speaks out about that kind of behavior? Really?

". . . and also may involve providing information about the rules and regulations of the Federal Advisory Committee Act as they relate to managing CFSAC and the roles and responsibilities of the Committee members."

Permit me to decode this for you.  What this sentence tells me is that Dr. Koh did look into the allegations, although he is completely silent on who he spoke with or what that involved. The sentence also tells me that his conclusion is that Dr. Lee provided information to Holderman and Fletcher (and perhaps the third member too) about the rules and regulations of FACA as it applies to them, and that is the only thing Dr. Lee did.

This simply does not add up. FACA does not state that advisory committee members can be removed for expressing their points of view.  After all, the advisory committee exists for members to do precisely that. Furthermore, FACA requires that advisory committees have a balance of membership and views, so removing a member for expressing a different point of view would unbalance the committee and potentially violate FACA.

Either Fletcher and Holderman are not telling the truth about what Dr. Lee said to them, or Dr. Lee is not telling the truth about what she said to them, or there has been some kind of epic misunderstanding that Koh has failed to identify. And since Koh’s letter gives us no information about whether an investigation was conducted, who was interviewed, and what the findings were, we have no ability to unravel this mess.

"All engaged in this activity should conduct themselves in a manner that is conducive to respectful and candid discussions."

I think this sentence is code for: one or more people are not conducting themselves appropriately and they should knock it off. Of course, the letter does not specify who needs to knock it off. But read between the lines. He has already said that Lee behaved appropriately. So the only people left to knock it off would be the CFSAC members who complained.

Completely Unacceptable

This non-responsive response is unacceptable for so many reasons, it’s hard to know where to begin. We started with seeking advice from multiple sources, including legal, political and advocacy sources. After consultation with a variety of sources, Mary Dimmock has sent a second letter to the General Counsel of HHS. You can read the full letter here, but these are the main points:

• Dr. Koh failed to adequately investigate and resolve the allegations.
• Dr. Koh’s letter contains no evidence or assurance that these allegations are unfounded.
• The failure to resolve the allegations is not at all conducive to respectful and candid discussions.
• Public trust and confidence in the work of the Committee has been undermined and all but destroyed.
• The public cannot trust that Committee members are free to provide honest advice to the Secretary.

The letter then renews our request, that the General Counsel and not Dr. Koh:

"investigate these allegations immediately, and establish whether any voting member of the CFSAC has been intimidated or threatened for expressing their opinions. At a minimum, your response should detail what steps were taken to investigate, your findings on the facts that support or refute the allegations, and what specific corrective action has been taken."

Will it work? I’m not certain. On the one hand, the General Counsel handed us off to Koh before. On the other, Koh’s response is so vague and the issue of public trust so significant, that the General Counsel certainly should step in and do the right thing. I think it’s vitally important to get matters like this on the public record. We are accumulating more and more evidence of a systematic pattern of ignoring our concerns, downplaying the seriousness of the situation, and flat out subversion of good government practices. There are plenty of other people who are interested in this sort of thing, even if the General Counsel isn’t.

It never ceases to amaze me. Do they think we’re stupid? Do they think that hand waving and “These aren’t the droids you’re looking for” Jedi mind tricks actually work? Or are they counting on the media or Congress or the Office of Inspector General* being completely uninterested in what’s going on? We’ll see.

Note: Remember, there is a difference between the Office of the General Counsel (which “supports the development and implementation of the Department’s programs by providing the highest quality legal services”) and the Office of Inspector General (which is “dedicated to combating fraud, waste and abuse and to improving the efficiency of HHS programs.”)

Source: Jennie Spotila, Occupy CFS, Nov 25, 2013

CFS/ME Organizations and Advocates Call for an Immediate Investigation of Threats Made Against CFSAC Committee Members

Eileen Holderman, "I have been intimidated."

On June 12, 2013, twelve ME/CFS patient organizations and 23 patient advocates signed a letter calling for an immediate investigation into threats made against three members of the CFS Advisory Committee (CFSAC). The letter was written in response to events that occurred on the second day of of the CFSAC meeting (May 23rd). During the meeting, patient advocate Eileen Holderman, after repeated attempts on the part of the chair to silence her, stated that she was "afraid." Holderman went on to say, "I have been intimidated, and I’m afraid to speak out but I am going to. I know that there are two other committee members who have also gotten calls." A short time later, researcher Mary Ann Fletcher stated that she had been threatened with eviction from the Committee for expressing her views.

Federal Advisory Committees were established to help the executive branch formulate federal policy. The CFSAC was created to advise the Secretary of Health on issues such as healthcare, the science and definition of CFS, and other issues related to the disease. Over the last decade, CFSAC has made more than 70 recommendations to the Secretary on a number of issues, including research funding, provider education, case definition, and a name change. According to Holderman, the CFSAC has acted on none of them.

Although the CFSAC operates at the behest of the federal government, it has come under fire for violations of the Federal Advisory Committee Act, including acting in secrecy to reduce or reword recommendations made by committee members. (Read about the violations in Jennie Spotila's article HERE.) 

You can read the full text of the letter below. A transcript of the portion of the meeting including Holderman's allegations can be read HERE. You can see video of this portion of the meeting HERE. (Start at 42:12)

June 12, 2013

By postal and electronic mail
William B. Schultz
General Counsel Department of Health and Human Services
200 Independence Avenue SW Room 713-F Washington, DC 20201
William.Schultz@hhs.gov

Dear Mr. Schultz,

On behalf of the undersigned organizations and individuals, I am writing to request your immediate investigation into alleged intimidation of three voting members of the Chronic Fatigue Syndrome Advisory Committee (CFSAC), a Department of Health and Human Services advisory committee housed within the Offrce on Women’s Health. As organizations and advocates serving patients with Chronic Fatigue Syndrome (CFS), we have a longstanding interest in federal policy regarding CFS.

At its most recent public meeting on May 23,2013, voting member Eileen Holderman stated that Dr. Nancy Lee, the Committee’s Designated Federal Officer (DFO), had intimidated her and two others. Voting member Dr. Mary Ann Fletcher stated that she had been threatened with eviction from the Committee for expressing her views. The third member subjected to the alleged intimidation was not identified. We have enclosed a transcript of portion of the meeting during which these allegations were made, and highlighted the allegations on pages 3 and 4.

The independence of the CFSAC and the balance of views among the membership are essential to its advisory role. Threats or intimidation of voting members for expressing their views, particularly by the DFO, would materially impair the CFSAC’s ability to formulate recommendations to the Secretary. Despite the seriousness of these allegations, neither Dr. Lee nor Chairman Dr. Gailen Marshall made any public comment, nor did they promise to look into the allegations or take corrective action.

Therefore, we must ask you to investigate these allegations immediately, and establish whether any voting member of the CFSAC has been intimidated or threatened for expressing their opinions.

Thank you for your prompt attention to this matter.

Sincerely,

Mary Dimmock, for the undersigned organizations and individuals

Patient Organizations
Chronic Fatigue Syndrome, Fibromyalgia and Chemical Sensitivity Coalition of Chicago
CFS/Fibromyalgia Organizations of Georgia, Inc.
MAME (Mothers Against Myalgic Encephalomyelitis)
Massachusetts CFIDS/ME & FM Association
PANDORA (a.k.a. CFS Solutions of West Michigan)
Phoenix Rising
The Fibromyalgia-ME/CFS Support Center, Inc.
Race to Solve CFS
Rocky Mountain CFS/ME and FM Association
Speak Up About ME
The Vermont CFIDS Association, Inc.
Wisconsin ME/CFS Association, Inc. 

Individual Advocates
Rik Carlson, Lori Chapo-Kroger,  R.N., Lily Chu, M.D., Mary Dimmock, Pat Fero, M.E.P.D., Kenneth J. Friedman, Ph.D., Joan Grobstein, M.D., Jean Harrison, Suzan Jackson, Michele Krisko, Denise Lopez-Majano, Billie Moore, Mike Munoz, Matina Nicolson, Donna Pearson, Meghan Shannon, M.S., M.F.T, Nancy Smith, Rivka Solomon, Jennifer  Spotila, J.D., Tamara Staples, Tina Tidmore, Erica Verillo, Charlotte von Salis, J.D.

Originally posted on ProHealth.

"We are not crumbs..."

Mindy Kitei speaking before the CFSAC

Mindy Kitei is a science reporter who has been covering CFS/ME for more than 20 years. Her commitment to people with CFS/ME has been unflagging, and her barbed criticism of the CDC's mishandling of the CFS/ME epidemic has been continual over the course of her career. On May 12, 2011, she delivered this fiery public comment at the CFS Advisory Committee (CFSAC) meeting.

" To the CDC and NIH scientists who have been ... sweeping a world-wide human catastrophe of 17 million people under the carpet, I say to you, 'Have you no sense of decency?'"

Full Text:

My name is Mindy Kitei.  I’m a science reporter who’s covered ME/CFS for twenty years.  Last June, I began my blog, CFS Central, in honor of my friend Nancy Kaiser.

I met Nancy in 1994, while working on an investigative piece for Philadelphia magazine called “The AIDS Drug No One Can Have” about the experimental HIV and ME drug, Ampligen.

Nancy had a severe case of ME. She had multiple seizures every day. When she tried to sit or stand, her blood pressure plummeted; she often crawled instead. She tried many experimental treatments to get well.

Nancy died on June 15, 2008.  I naively thought she’d never succumb to the illness, as if by sheer will she’d keep herself alive.

Three other ME patients whom I interviewed in 1994 have also died of the disease.

Despite its gravity, despite ample evidence that ME is an infectious disease, the government treats it like a joke. The CDC and parts of the NIH have been playing a shell game:  studying patients with simple fatigue or chronic fatigue or depression—but labeling them CFS patients. 

Even when the CDC conducted its XMRV study, it studied the wrong cohort and refused to do an actual replication of the Science study.  It’s just a different kind of shell game from the bogus psychological CFS studies that are the agency’s trademark.

To the CDC and NIH scientists who’ve been doing this ludicrous research for three decades and sweeping a worldwide human catastrophe of 17 million people under the carpet, I say to you:  Have you no sense of decency at long last?

ME patients are suffering from a serious infection— most likely a retrovirus—but are told by charlatans to exercise and have a positive attitude. 

Researchers in government and at universities, as well as the CFIDS Association, admonish desperate patients that taking anti-retroviral drugs is medically indefensible.  When the healthy reprove the sick that they’re impatient and reckless and foolish and need to wait for treatment, I say there is no treatment, and where are the drug trials?  Thirty years and not one approved drug and none in the offing.

ME patients should have the same freedom to try medications that AIDS patients had in the early days.  The AIDS patients became their own advocates because there was no one advocating for them.  The same holds true for ME patients now. Patients are gravely ill, and they have the right to treatment.  To say that they don’t—that’s what is medically indefensible.

The U.S. government conducted the Tuskegee Syphilis Experiment from 1932 to 1972.  The study tracked the progression of untreated syphilis among poor African American men but didn’t tell them they had syphilis. The men got sicker and many died.

In 1997, President Clinton apologized to the remaining Tuskegee men.  Clinton said:  “What was done cannot be undone. But we can end the silence. We can look at you in the eye and finally say on behalf of the American people, what the United States government did was shameful, and I am sorry.”

The United States government has watched ME patients suffer and die for 30 years, and has done nothing, and that is shameful.

In less than a year, more than 125 thousand patients from 108 countries and territories have found my blog, CFS Central.  Patients write to me asking for help every day.  Toward that end, I request a meeting with Kathleen Sebelius, Howard Koh, Francis Collins, Tony Fauci and Thomas Frieden to discuss how to turn this situation around, by funding good studies and finding effective medications.

About funding ME, Dr. Dennis Mangan said during this meeting:  “We’ll use one dollar and try to make two.”   I’m sure Dr. Mangan means well, but it isn’t enough.  As AIDS activist Larry Kramer said years ago about HIV patients:  “We are not crumbs.” After thirty years of neglect, ME needs research parity with HIV. We also need a czar who will oversee ME and report directly to President Obama. 

Finally, we need to enact the ME/CFS Care Act.  Much like the Ryan White Care Act for HIV patients, the ME/CFS Care Act will provide health coverage to needy patients.

In closing, I ask you, Dr. Wanda Jones, to ensure that this meeting occurs.  Dr. Jones, will you help me? 

Visit Mindy Kitei at: http://www.cfscentral.com/