CFSAC Testimony of Matthew Lazell-Fairman

Posted on June 21, 2012 by Jennie Spotila

Matthew Lazell-Fairman delivered these comments to the CFS Advisory Committee at its June 14, 2012 meeting. He has kindly given me permission to publish them here.

To those responsible for health policy on ME/CFS, I need you to listen and fully absorb just how terrible and serious this disease really is.

I never imagined, before becoming sick, that an illness could so completely redefine my life. Instilled with the inspirational ideal of the disabled who rise above their limitations to achieve great heights – the runner who tragically loses a leg, but is soon running again with assistive technology – I imagined that disabilities were obstacles that could be overcome, at least to some degree. Like the characters in a Horatio Alger story, one had only to pull oneself together and rise above the obstacle. It was to my horror, then, to become sick with ME/CFS, an illness that I could not rise above, an illness that wrecks both body and mind, rendering victims living shells of their former physical and intellectual selves and leaving them forever to languish on the margins of an unaware and uncaring society. Just as we reserve a special place in our collective imagination for horrifying illnesses, like ALS, that trap the minds of victims in a progressively unresponsive physical form, so too must we reserve a place for ME/CFS, which traps patients in an altogether different, though equally horrifying, prison.

No description can do justice to the experience of this illness. To those with only healthy points of reference, ME/CFS can only be described as feeling at all times like you have just finished running a marathon, while extremely hung over and severely sick with the flu, after having not slept in at least three days. And even the slightest exertion – brushing teeth, showering, reading the newspaper, washing dishes – amplifies that feeling to more unbearable levels, to the point that the only thing you can do to not feel worse is to lie on your back, face-up in a dark room. And the longer you are sick, the more ragged and worn out you feel. Like a brake pad wearing against its metal drum, you feel your very being grinding away, week-after-week, month-after-month, year-after-year. To recite symptoms or state that ME/CFS is comparable to late-stage AIDS, congestive heart failure, and multiple sclerosis does not begin to convey the severity of this illness. The harsh, soul-crushing reality of an incurable illness that strait-jackets the bodies and minds of its victims is lost in translation.

I cannot express how abrupt was the change from vibrant life to pallid sickness. I graduated from Connecticut College Phi Beta Kappa and Summa Cum Laude, after winning awards in my final years for outstanding achievement and writing a 275-page honors thesis on the evolution of wartime repression in America. After college, I backpacked across Asia for five months, traveling alone for two and a half months through an unstable part of western China, India, and Southeast Asia.  During that trip, I went SCUBA diving in Bali, climbed mountains in Tibet, road a motorcycle through northern Thailand, found myself targeted by “gem smuggling” scam artists in India, and once rode a train so packed that I was forced to stand for 17 hours of a 25-hour journey. I also met the woman who has become my wife. A life of joy and promise lay in front of me.

Today, the sense of boundless opportunity is gone, replaced by never-ending sickness that totally dictates the boundaries of my life. Only two years later, sick with ME/CFS, I am unable to work, am largely housebound, cannot read or write for more than a few minutes without developing headaches and becoming confused, and cannot sustain any significant physical or mental exertion without suffering a severe crash. On days when I crash, I am often so sick that I cannot even leave on the TV, as the light and noise aggravate my symptoms. On those days, being too sick to do anything at all, I just lie in bed, lightheaded and zoned out, with my head aching, my eyes burning like fire, my muscles sore and weak, and exhausted to a degree the healthy have never known, yet unable to sleep. My every experience of reality is mediated by pain and incomprehensible fatigue, from the moment of waking till the moment of sleep.

My life now is very limited. I manage, filling my days to the extent possible with the things I enjoy that I am still able to do, which are few. But my reality is nonetheless a struggle. Not just to overlook the harsh reality of physical suffering that never departs or to come to grips with watching all my peers surpass me, while I grow physically weaker and my mind dulls, but to attempt to find meaning in a life so severely circumscribed. Had I only lost an arm or a leg, I could still enjoy my old Sunday ritual of drinking coffee, reading the newspaper, and listening through my stacks of vinyl records, which now gather dust. Had I only lost my hearing or my sight, I could spend my time advocating, or at least find the right words to express my travails. I might even still pursue a career in academia. But, with constant pain and fatigue and being unable to spend more than a few minutes reading or writing before becoming confused and unable to find needed words, those possibilities are off-limits for me. My only hope is that they will not always be so.

I am not one of the most severely afflicted. Yet, it should at least be clear from my experience that ME/CFS is one of the most severe illnesses in America today. This illness is not the “Yuppie Flu,” as popularly imagined. Nor is it “all in my head,” as our uneducated medical community too often believes. Rather, it is a serious, life-robbing illness that is so torturous and difficult to bear that some choose suicide to escape it. It is beyond travesty, then, that ME/CFS receives such an outrageously small sum of taxpayer funds for research, while other illnesses of similar severity (and generally smaller patient populations) receive hundreds of millions and even billions of dollars for research. When this illness is one day solved, it will no doubt be obvious to all, as it is to the doctors, patients, and advocates here today, that those we trusted as stewards of the public health were too busy, too inattentive, too locked into erroneous, outmoded preconceptions to realize how vastly they were failing to meet the trust we put in them.

More than any moment in the past, this moment is the time for change. The Norwegian government has already issued a formal apology for decades of neglect and utter disregard. It is time for the United States government to follow suit and to embrace this illness with a seriousness and vigor that characterized the fight against HIV/AIDS. For that to happen, public officials responsible for ME/CFS must take seriously the trust implicit in their position, for it is their moral responsibility to break down the doors that we sick patients cannot reach, to give form to the outrage we patients, doctors, and advocates feel by savagely working the message to Secretary Sebelius that this illness cannot justly be ignored.

Let me just say one last thing: The most frustrating thing about living a life of such horrible suffering is that the only thing standing in the way of a cure are the people here at the NIH, the CDC, and the FDA, who have never taken this illness seriously. How many more of these meetings will we have to listen to civil servants pass the buck?

 

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CFSAC Takeaways

Posted on June 18, 2012 by Jennie Spotila

I won’t attempt a comprehensive writeup of the recent CFS Advisory Committee meeting. This meeting was one of the most thoroughly covered: on Twitter (#CFSAC), real-time reports from Phoenix Rising, and a writeup by Tina Tidmore. Instead, I offer comments on what I took away from the meeting, good and bad.

Positives

  • Video! The live videocast was restored for this meeting, although Dr. Nancy Lee said that it was not clear how long the committee would retain the budgetary resources to provide this level of access. She also did not provide any figures on the number of people logged in, which Dr. Wanda Jones did at past meetings, so we have no way to know if video access increased remote participation in the meeting.
  • CDC – I was pleasantly surprised that CDC had some progress to report. The website has been partially revised as of May 16, 2012, and work will continue (which is good since many objections remain), including the addition of a section on pediatric ME/CFS. CDC has begun enrolling patients in a seven site clinical study in which expert clinicians will identify ME/CFS patients and collect mass amounts of data that CDC will analyze to identify key features of the illness. I wish there had been more discussion of the study design, especially since CFSAC members seemed confused about it. CDC also posted a new CME course on Medscape and 4,600 doctors have completed the course in about three months. Two additional modules are in development.
  • FDA – The FDA ex officio reported that there are eight active Investigational New Drug Applications currently in review. She could say no more than that, and commented that it had been extraordinarily difficult to get permission to say even that much.
  • Engagement – The ex officio members were more engaged in the discussions than they were a few years. They tried to help the committee understand what is possible (or not) on issues like the IACFS/ME Primer, and also offered perspective on discussions like how to pursue revising the case definition. Engagement by and information from the ex officios is a good thing, and I hope the committee will rely on them as a resource.
  • Best Line of the Meeting – In my opinion, the best statement of the meeting was made by Matthew Lopez-Majano during the panel discussion with two adolescent patients and a parent. A CFSAC member asked the panel what they felt was most important for new doctors to know about the illness. Matthew responded, “Have an open mind. There is no diagnostic test for this. You only have our word.” Love that!

Disappointing

  • NIH – Dr. Susan Maier reported that FY2011 expenditures on ME/CFS at NIH totaled $6.3 million, although she did not provide a full list of those grants or even the general categories of the studies. She also reported that the Trans-NIH ME/CFS Working Group took the priorities identified in the State of the Knowledge Meeting and turned it into a list of actionable items. Why did it take 14 months just to develop a list of action items? It was disappointing that no member of the CFSAC asked that question on the record.
  • IACFS/ME Primer – There was a great deal of discussion about the new IACFS/ME Primer for Clinical Practioners, with Dr. Gailen Marshall and Steve Krafchick pushing for endorsement and distribution of the Primer by DHHS. But it was clear from the outset of the discussion that multiple members of the Committee had not read the Primer at all, even on the second day of the meeting. The discussion was circular, and frustrating to watch. Several ex officios tried to offer input on what DHHS could and could not do with the Primer. Overall, this was a disappointing discussion that would have been easily improved if members had been briefed in advance and if the IACFS/ME had been able to participate. A final recommendation was made, “That the Secretary should authorize the appropriate person within HHS to work with IACFS/ME to make the primer widely available, particularly to primary care providers.” I fear this may be so nonspecific as to be useless. It might have been better for Mr. Krafchick to withdraw his motion until IACFS/ME could participate in the discussion.
  • Case Definition – The case definitions of ME/CFS have long plagued researchers, clinicians, and patients. Dr. Lee attempted to facilitate a strategic planning discussion for the committee to come up with a plan of action to arrive at a new consensus definition. This is another topic that would have benefited greatly from advance preparation by the members. I’ve run strategic planning discussions and they are HARD, but if everyone at the table does not have the same grasp of even the most basic issues, the discussion is rarely productive. For example, one of the new members asked what were the problems with the current definition. I don’t fault her for asking, but this is a fundamental issue that was planned for the agenda! How could the committee staff failed to have brief members in advance? I applaud the committee for attempting it, but they flailed around for an hour and the only action item identified was for the conversation to continue and Dr. Lee may make assignments to subcommittees.  Another sign of the extremely poor preparation was that the committee already made a recommendation on this issue in October 2009 but not one person mentioned this during the discussion. Did anyone bother to look? Recommendation: Multiple case definitions currently are used for CFS. The CFSAC rejects the empirical case definition and the terminology of “chronic un-wellness”, both of which are endorsed by the CDC, and recommends that DHHS recognize a need for and commit to support a national effort to arrive at a consensus definition of CFS that is accurate, standardized, and reflective of the true disease. Response: Yes; The CDC uses the 1994 International Research Case definition. The term “chronic unwellness” is not a CFS case definition component and is not used as such by the CDC. I might also note that this is another example of the kind of non-responses I highlighted in my own testimony.
  • Recommendations – In addition to the recommendation on the Primer, the committee passed three other recommendations. Two of them related to links to be placed on the CFSAC website, and the discussion around those dragged on for at least 20 minutes while voting members were leaving and the quorum was dropping away. The last was a recommendation that HHS partner with CFSAC and the Dept of Education to educate educators and school nurses on ME/CFS affecting children and adolescents. This was the ONLY recommendation on pediatric issues, despite the fact that most of the first day’s session was spent on pediatric ME/CFS.

What the . . . ?

  • Preparation – As I mentioned above, there were several times in the meeting where it was clear that some members were inadequately prepared for the discussion. Mr. Krafchick and Marti Bond (Office on Women’s Health) had an exchange regarding the materials provided to committee members. Marti Bond said the agenda was emailed to members two weeks prior to the meeting, but that the materials binder was provided upon arrival. In the past, apparently, they have mailed the materials to members who then failed to bring the binders to the meeting. This required running additional copies of the materials. *sigh* Adequate advance preparation is essential if these meetings are to be productive. Why not email the key documents (like the Primer, a memo explaining case definition issues, and the Recommendations Progress Chart) to members in advance and provide the full hard copy binder upon their arrival?
  • Feedback – At the November 2011 meeting, the committee asked the Secretary to clarify the process of transmitting recommendations and receiving feedback. Dr. Lee stated that the ex officios had collaborated on a white paper describing the process and capturing feedback from the Secretary. She stated that the memo is in clearance and she hoped to provide it to the committee very soon. Unfortunately, she made this announcement at 4:50pm on the second day. It would have been really nice to know this information at the beginning of the meeting. I would have edited my own comments to incorporate that information.
  • Commitment – After the lunch break on the second day, Dr. Lee made remarks about the commitment of everyone at the table. Phoenix Rising captured the comments (not sure if this is verbatim quote): “I want everyone to know we are committed to this topic. Some people have worked for many years. We have several of our government members personally affected by ME. We are very committed to this, or we wouldn’t be here.” What precipitated these comments? Was it the public comment session that preceded the lunch break? My comments were critical of the committee and HHS, but I did not question anyone’s personal commitment. Matthew Fairman made a comment about public officials passing the buck and that there has been a violation of the public trust. But comments like these have been made before at other meetings. Dr. Lee’s comments sounded defensive, but I don’t know if she was speaking for herself or for other members who had concerns. The whole episode was quite puzzling to me.
  • Dr. Koh – Assistant Secretary Dr. Howard Koh attends a small portion (~30 minutes) of each CFSAC meeting (unlike his predecessors who usually did not attend at all). In introducing Dr. Koh, Dr. Gailen Marshall said, “There is no stronger advocate for people with this illness.” Uh, what?? Given the other people at the table, in the room, on the phone, Dr. Koh is the strongest advocate? Is that in some secret behind the scenes way that is completely invisible to the public? I know I would very much appreciate hearing what Dr. Koh is doing to advocate for me and all the other patients. But what killed me about Dr. Koh’s brief appearance at the meeting is that when he opened the floor to questions from the committee members, NO ONE SAID ANYTHING. Seriously? The Assistant Secretary just invited questions and YOU DON’T HAVE ONE? I can think of five questions just off the top of my head. 1) Dr. Koh, will you commit to changing the name to ME/CFS? 2) Dr. Koh, how many briefings on ME/CFS have you had with the Secretary, when and for how long? 3) Dr. Koh, may we have your personal assurance that you will respond to each of the committee’s 65 recommendations prior to our next meeting? 4) Dr. Koh, what have the Secretary and Dr. Francis Collins discussed regarding the level of NIH funding for ME/CFS research? 5) Dr. Koh, when will you meet with us in person to discuss each of our recommendations? I just could not believe that everyone let that opportunity slip right on by. Maybe members should keep an index card with a question on it in case they get another chance with Dr. Koh.

Overall, I think this meeting was no better and no worse than every other CFSAC meeting I have observed. The ME/CFS advocacy community must continue to build on the foundation we have, and do everything possible to secure accountability from both the committee and DHHS. I’ll be posting more articles about the CFSAC in the coming months, and I hope this will help the community coordinate its information and approach to the committee.

 

 

 

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XMRumorsV

Posted on June 15, 2012 by Jennie Spotila

Rumors about the Lipkin study are flying fast and furious these days. We’ve been hearing for months that the study results would be made public this year, but “news” of specific dates has kicked things into a frenzy.

In April, a rumor circulated that the results would be published on April 30.  Dr. Mikovits was quoted as clarifying that her own part of the study would be done by April 30th, and Dr. Lipkin said something similar.

On June 1, Dr. Dan Peterson spoke at the Invest in ME conference in London. He told the audience that the Lipkin study would be published on June 30th. This statement was repeated on Twitter by journalist Jorgen Jelstad (@DeBortgjemte), kicking up much excitement. The good thing about that, though, was that Lipkin’s lab (@CII722) was able to respond directly. On June 4th, Lipkin* the CII tweeted:

The XMRV study will NOT be published on June 30. Rumors associated with this release date are false.

We have begun composing the manuscript/compiling the data. Follow @CII722 for updates. Cheers!

In response to a direct question about why the date had been pushed back, Lipkin the CII tweeted: “June 30th was an estimated date. It was never definitive.”

Just eleven days later, the rumor kicked up again. Science Insider, in an article about the dropping of criminal charges against Dr. Mikovits, reported that the results “are expected to be revealed in a few weeks.”

A similar statement was made at the CFS Advisory Committee meeting on the same day. Dr. Nancy Lee** (DFO of the committee), Dr. Gailen Marshall (chairman of the committee), and Dr. Ermias Belay (ex officio from CDC) said that a white paper with the results would be published within a few weeks. I then had the following exchange with Dr. Lipkin the CII on Twitter:

@knittahknits: It was reported at the #CFSACmeeting that the XMRV results will be published as a white paper in a few weeks. Can you confirm?

@CII722: Another false rumor. XMRV paper will be peer-reviewed. Will announce on Twitter when it is submitted/accepted/published.

I’m not surprised that these rumors are circulating, nor am I troubled by Dr. Lipkin’s the CII’s responses. What DOES trouble me is the source of the rumors. Dr. Peterson provided samples for the study. Drs. Lee and Belay are federal employees. I assume that all three were quite confident in the information that they have since they made such public statements about it. They all have to know the effect such statements would have on the community, and none of them are irresponsible rumor mongers.

So who is telling these people that the results will be published in a few weeks?

*Update 12:25pm – The Center for Infection & Immunity contacted me via Twitter after this post was published to clarify:”Hi! 2 corrections. Our Twitter is run by the CII’s science writer, not Dr. Lipkin. More accurate to say “the CII tweeted” & “CII’s response” so I have updated the post accordingly.

**Update 6:14 pm – I emailed Dr. Lee about this and regarding the timing of the results she responded, “I do not know when the XMRV results will be released.  I too have heard conflicting information. It will happen when it happens.  I must have patience.”

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“Keep Track. Keep Asking.”

Posted on June 14, 2012 by Jennie Spotila

This is the public comment I delivered by telephone to the CFS Advisory Committee today.

Thank you to Cort Johnson for representing me at the speaker’s table, since I am too ill to be with you in person. I am not an invisible sufferer.

Actions speak louder than words. Unfortunately, most of what we hear from the Department of Health and Human Services is words. Words and empty promises.

Despite all the effort you have invested in making recommendations to the Secretary, there is very little action to report. HHS updates the Recommendations Progress Chart for this Committee twice a year, and I assume that you examine each version closely. This Chart is the only public metric for progress at HHS, and it is disappointing to say the least.  In the last twenty months only three of your recommendations have been marked with updated responses, and many of the recommendations marked complete have not actually been accomplished as you intended.

I compared the Progress Charts dated October 2010, March 2011, and December 2011, which is the most recent version I have. Each chart was updated to add the new recommendations from your meetings, bringing the total number to 65. Apart from that, the progress reports were as follows:

Regarding your recommendation that AHRQ’s expected review of CFS for the State of the Knowledge meeting should be widely communicated, the March 2011 progress chart stated that NIH is in discussions with AHRQ regarding the review. But as you are aware, no AHRQ review was completed in time for the State of the Knowledge meeting or since. No progress there.

Regarding your recommendation that several agencies collaborate on developing a demonstration project focused on more effective care for people with CFS, the March 2011 progress chart stated that additional knowledge of causes, care coordination, and treatment for CFS is needed before this can be undertaken. No progress there.

Regarding your recommendation that HHS engage the expertise of the CFSAC to advance policy and agency responses to ME/CFS, the December 2011 progress chart stated that several members helped plan the SoK meeting and review the CDC website. It’s better than nothing, I will admit, but I don’t believe that meeting planning and website content review is where you can add the most value to the policy and agency responses to ME/CFS.

That’s it. Three progress updates over a period of twenty months, and those updates were No, No, and Ongoing.

Furthermore, I direct your attention to items like your 2006 recommendation that NIH issue an RFA with specific funding attached. That recommendation is marked Yes/Complete, and the note states that two Program Announcements were issued in 2008. But we know that Program Announcements do not have dedicated funding attached, and no RFA has been issued by NIH in six years. Despite that significant discrepancy between your recommendation and what has been done, this is reported to you as accomplished.

What are we to conclude from this? We always hear nice promises at these meetings. There is always the illusion that real progress is being made, that things are beginning to change. But to me, the lack of progress on your recommendations – and the lack of accountability at HHS for ignoring your recommendations – is the true barometer of where we are. Committee members, don’t mistake these updates for real progress.  To borrow from Dr. Grobstein’s comments yesterday, “Keep track. Keep asking.”

Actions speak louder than words. In our case, inaction speaks louder still.

Fourteen months ago, Dr. Frances Collins announced that the Secretary had directed that CFS be given “special attention.” Is this what special attention looks like? Maybe it’s just me, but I am not seeing much difference between the special attention we are allegedly receiving now and the lack of special attention we had before. I am thrilled CDC is revising some of its materials, but that is not enough. Meeting with patient groups is not enough. I signed the Joint Letter from advocates and groups because HHS must undertake a strategic, coordinated, and fully-funded effort to address the critical priorities for adequate ME/CFS research, treatment and provider education.

I call on HHS to put an end to this perpetuation of the status quo cloaked in words and promises. Do something real. Act on this Committee’s recommendations. We need answers. We deserve action.

 

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CFSAC Comments from Dr. Lily Chu

Posted on June 13, 2012 by Jennie Spotila

Dr. Lily Chu submitted these written comments to the CFS Advisory Committee for its June 2012 meeting. She has kindly given me permission to publish them here.

Dear Sirs and Mesdames,

Thank you for this opportunity to address official and ex-officio members of CFSAC.

In the early 1990s, it was a habit of mine to watch the newsmagazine show “20/20” every Friday. One evening, the show was about Dr. Jack Kevorkian and the controversy over physician-assisted suicide; as a pre-medical student, I was interested in anything medically related and  paid extra attention.  I learned that one of the persons he assisted was Judith Curren, a nurse affected by fibromyalgia and chronic fatigue syndrome (CFS), who had suffered from severe pain and other symptom prior to her death.  Later on, as a medical student and then a physician working with elderly patients, I remembered the case because of the ethical situation but not because of CFS.

Now, however, what stands out to me is that Ms. Curren suffered from CFS and was affected enough that she chose death over life. When I first encountered this illness six years ago, one of the first persons I spoke to was a good friend who also happened to be an excellent physician.  She told me she had taken care of a very sick man in his 30s with CFS, so sick that a short car ride to her office was hardly tolerated.  Not long after she had changed medical practices, she heard he had passed away.  She was particularly upset because she did not think people could die from this illness. It was a revelation to me too and I put it down to a rare incident.  However, since that time, I have known two young people personally that have passed away within the last year and have heard/ read of many others (1- 5) yet outside of the patient community and a few ME/CFS researchers and clinicians, the fact that people do die from ME/CFS is hardly acknowledged anywhere and rarely investigated.

My intention is not to cause anxiety, fear, or alarm – many people with CFS continue to live years to decades, albeit at much reduced function/ quality compared to their lives pre-CFS – but rather to encourage governmental agencies and researchers to take this illness seriously and urgently examine areas of ME/CFS that have been neglected.

1) Study the effects of  ME/CFS long-term through cross-sectional and longitudinal studies.

A few studies have looked at the effects of ME/ CFS superficially in people who have lived with this for more than a decade but there are practically no longitudinal studies beyond a few years. Just 2 weeks ago, Chang et al., utilizing a large national cancer registry and a case-control design, showed that there was a statistically significant increased risk of non-Hodgkin’s lymphoma in people with CFS over the age of 65. (6)  Since Paul Levine’s studies in the mid-1990s, this increased risk has been theorized to exist but there was no follow-up until recently. (7)

Furthermore, Chang or other researchers should consider replicating the study in a younger population.  In 2006, Jason et. al. studied a list of ME/CFS deaths and concluded that 20% of the deaths were not only related to cancer but that the cancer deaths occurred 15 years earlier on average than cancer deaths in the population (48 vs. 72). (8) Thus, Chang et al., confining their study to those over the age of 65, would have missed any findings from this younger group.

2) Encourage researchers to include homebound and bedbound subjects in their studies.

There have been no studies on how many or what percentage of US ME/CFS patients are homebound or bedbound but using figures from British studies, at least 25% of patients fall into this category. (9) Having done home visits in the past for the elderly, I know that this type of population is particularly vulnerable – they are some of the sickest patients yet receive the least amount of care. This is further compounded by the fact that these ME/CFS patients rarely show up in emergency rooms or hospitals, as very sick patients with other illnesses do, and thus continue to stay invisible to the medical/ scientific community. Part of this is that patients feel these places have very little to offer them but the other part is that medical staff may not believe that they could be so sick and not take patients’ symptoms seriously nor treat them appropriately.

Furthermore, there are only two studies that have been published including this population, both based in the UK. (10, 11) Yet, treatment goals and suggestions are routinely made for this group originating from clinic-based studies, which often involve less severely affected patients. In other areas of medicine, such as diabetes or hypertension, treatment suggestions, such as what should be the initial first drug of choice, are made based partly on severity of illness and goals may change based on the individual, not a one-size-fits-all paradigm. (12, 13) Why can’t the same concept be applied to ME/CFS?  At the same time, symptoms these patients DO suffer from including uncontrolled pain, inability to sit up without passing out, light/ noise sensitivity, difficulty swallowing/ eating, and severe cognitive dysfunction are neither studied nor treated appropriately to the best of medicine’s current ability. Thus, it is not surprising that many of the deaths I am aware of occurred in this group,  because of suffering/ despair/ hopelessness and/ or underlying biological processes the scientific/ medical community has yet to understand.

Over the last 2 decades, technology has advanced to the point where some tests and procedures that were once confined to the clinic or hospital are now able to be done during home visits. Aside from researchers visiting subjects, blood tests, certain x-rays, ultrasounds, and other portable diagnostic testing should be explored in investigating this group.

3) Consider autopsy and tissue sample studies and communicate with clinicians/ researchers involved in these studies.

Autopsy studies are a valuable method of gaining insight into the pathophysiology of illnesses.  In 2005, Sophie Mirza, a 32-year old woman from the United Kingdom, died of ME/CFS after having been bedridden for 6 years.  Before her death, Ms. Mirza was subjected to healthcare professionals who thought her illness was entirely psychological and who tried to have her placed in a psychiatric hospital. A preliminary autopsy revealed ME/CFS to be the main cause of death and the neuropathologist involved, Dr. Dominic O’Donovan, stated:

“the spinal chord [sic] looked normal but…4 out of 5 dorsal root ganglia were abnormal and showed disease. [I was unable] to find exactly what had caused this but the result was dorsal root ganglionitis – an inflammation.”

“dorsal root ganglionitis is a pathological condition….psychiatrists were baffled by her illness but… “It lies more in the realms of neurology than psychiatry, in my opinion.” (3)

Since then, Dr. O’Donovan and Dr. Abhijit Chaudhuri have performed at least 3 other autopsies with each individual consistently showing evidence of inflammation of the dorsal root ganglion and/or degenerative changes in the spinal cord or brain. (14, 15) Such inflammation may explain some of the severe pain and other neurologic symptoms some patients suffer from. They, along with other groups in the UK are currently working on establishing a post-mortem ME/CFS tissue bank to continue to study these unfortunate incidents systematically. (16)

In the United States, as far as I know, no such study is ongoing or has been proposed although I am aware that the CFIDS Association of America, Dr. Dan Peterson’s group, as well as possibly the Whittemore-Peterson Institute may have some tissue samples and have thought about this topic. I suggest that government officials and researchers communicate with these groups as well with Drs. O’Donovan and Chaudhuri.

Finally, it has been brought to my attention that governmental officials would not allow submission of photographs or short videos involving homebound/ bedbound people as a means of testimony although videos have been allowed in the past. (17)  Photographs and videos allow officials, researchers, clinicians, and the public a glimpse of the bedrooms that severely ill people are confined to for years to decades in a way that words on a page or a voice on the telephone do not. Would this not add to the picture of the illness the government needs to formulate an appropriate response to this illness? Are people afraid of seeing the truth?  I suggest officials see the film “Voices from the Shadows,” about severely ill ME/CFS patients, which is now available online and won the Audience Favorite award at the Mill Valley Film Festival in November of 2011. (18)

If some of what I have written sounds familiar, it is because some of the same ideas have been suggested in the past. Please take action on these issues soon. I hope to never hear about another preventable death nor to attend another funeral due to ME/CFS. Thank you for your attention.

Sincerely,

Lily Chu, MD, MSHS

 

References

1. ME/CFS Memorial. Blue Ribbon Campaign for ME/CFS. http://www.blueribboncampaignforme.org/ME_CFS_Memorial.html. Accessed June 2012.

2. Casey Fero ME-CFS Tissue and Blood Bank. Wisconsin ME/CFS Association, Inc. http://www.wicfs-me.org/casey_fero_blood_blank.htm. Accessed June 2012.

3. The story of Sophia and ME.  Invest in ME. http://www.investinme.org/Article-050%20Sophia%20Wilson%2001.htm.  Accessed June 2012.

4. Emily Collingridge, 1981-2012: such a short life, such a huge legacy. The ME Association.  http://www.meassociation.org.uk/?p=10880. Accessed June 2012.

5. Alison Hunter Memorial Foundation. http://www.ahmf.org/smh040502.html Accessed June  2012.

6. Chang CM, Warren JL, Engels, EA. (2012), Chronic fatigue syndrome and subsequent risk of cancer among elderly US adults. Cancer. doi: 10.1002/cncr.27612

7.  Levine PH, Pilkington D, Strickland P. Chronic fatigue syndrome and cancer. Journal of Chronic Fatigue Syndrome, 2000, Vol. 7, No. 1 : Pages 29-38

8.  Jason LA, Corradi K, Gress S, Williams D, Torres-Harding S. Causes of death among patients with chronic fatigue syndrome. Health Care Women Int. 2006 Aug; 27(7): 615-26.

9.  The 25% ME Group. http://www.25megroup.org/home.html Accessed June 2012.

10.  Wiborg JF, van der Werf S, Prins JB, Bleijenberg G. Being homebound with chronic fatigue syndrome: A multidimensional comparison with outpatients. Psychiatry Res. 2010 May 15; 177 (1-2): 246-9. Epub 2010 Mar 5.

11.  Wearden AJ, Riste J, Dowrick C, et al. Fatigue Intervention by Nurses Evaluation – the FINE Trial. A randomised controlled trial of nurse led self-help treatment for patients in primary care with chronic fatigue syndrome: study protocol. [ISRCTN74156610]. BMC Med. 2006 Apr 7; 4:9.

12. Standard in medical care of diabetes – 2012. American Diabetes Association. http://care.diabetesjournals.org/content/35/Supplement 1/S11.full. Accessed June 2012.

13. JNC7 Express. The seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of Hypertension. http://www.nhlbi.nih.gov/guidelines/hypertension/express.pdf. Accessed June 2012.

14.  Inflammation in chronic fatigue. The Naked Scientists, http://www.thenakedscientists.com/HTML/content/interviews/interview/2099/. Accessed June 2012.

15. O’Donovan DG. Pathology of chronic fatigue syndrome: pilot study of four autopsy cases. http://www.bond.edu.au/prod ext/groups/public/@pub-burcs gen/documents/genericwebdocument/bd3 016859.pdf. Accessed June 2012.

16.  Lacerda EM, Nacul L, Pheby D, Shepherd C, Spencer P. Exploring the feasibility of establishing a disease-specific post-mortem tissue bank in the UK: a case study in ME/CFS. J Clin Pathol. 2010 Nov; 63(11): 1032-4. Epub 2010 Oct 5.

17.  Testimony of Laurel Bertrand to Chronic Fatigue Syndrome Advisory Committee, October 30, 2009, http://www.hhs.gov/advcomcfs/meetings/presentations/bertrand1009.html. Accessed June 2012.

18.  Voices from the Shadows. Directed by Josh Biggs and Natalie Boulton. http://mubi.com/films/voices-from-the-shadows. Accessed June 2012.

 

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Watch This!

Posted on June 11, 2012 by Jennie Spotila

There is something very simple, and very important, that you can do: Watch the CFS Advisory Committee meeting on June 13th and 14th.

Why does it matter? In 2009, the CFSAC began videocasting its meetings. Viewership for the meetings was usually around 800 people, and the CFS community began paying a great deal more attention to the committee’s proceedings. Then in November 2011, videocasting was dropped as “too expensive” and only phone-in access was offered. Participation dropped to approximately 200 people. CFS advocates lambasted the Department of Health and Human Services for dropping video access. We pointed out how essential video was for patients, many of whom are too sick to attend in person and too sick to hold a phone to their ears for 8 hours a day. I found it very difficult to follow the discussion at the meeting because I could not see the speakers, those speakers did not identify themselves, and the presentations were not made available until after the meeting.

But we were heard!!!! Videocasting has been restored for this week’s meeting, and here’s where you come in. If only 200 people watch this meeting, DHHS could make the case that videocasting does not increase patient participation. So let’s make sure we have high participation! Here are the instructions for joining the meeting:

On June 13-14, 2012, the meeting will provide a live video stream at www.hhs.gov/live and be available by audio (listen only) at 1-888-677-1834.  Passcode: CFSAC 2012

PLEASE log in and watch the meeting. Even if you have no interest. Even if you are too sick. Log in with your computer and let it run all day. DHHS will be paying close attention to the viewership numbers. Show them that we are paying attention!

UPDATE: Link fixed for live streaming of meeting.

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CFSAC Basic Facts

Posted on June 8, 2012 by Jennie Spotila

The first 2012 meeting of the CFS Advisory Committee is June 13-14th. While the patient community focuses on the opportunity for public comment, I think it is also important to understand how the committee functions. We have to understand the context of committee operations in order to assess its success.

Federal advisory committees derive their authority from one of three sources. First, Congress can create advisory committees through legislation, as they did with the Advisory Council on Alzheimer’s Research, Care, and Services. These committees have a statutory mandate to provide advice, usually in the context of a specific task like consulting with the Department of Health and Human Services on a long range plan for addressing treatment and care issues for Alzheimer’s patients and their families. Second, the President can create an advisory committee, as was done with the Presidential Commission for the Study of Bioethical Issues. Finally, a Department Secretary can create an advisory committee and this is the case with the CFS Advisory Committee.

Advisory committees are governed by the Federal Advisory Committee Act (FACA) and its associated regulations, which set forth all types of rules for the operation of committees. These include the requirements for charters, record keeping, public access, and more. There is pending legislation in Congress that would revise the FACA, but it seems unlikely to pass.

The CFS Advisory Committee has both a charter and a set of by-laws. The charter must be renewed every two years, and the current charter will expire on September 5th of this year. Some years, renewal has required advocacy efforts to secure, but that does not seem to have been the case in more recent years. The purpose of CFSAC is advise the Secretary of DHHS on issues related to CFS, specifically:

(1) the current state of knowledge and research and the relevant gaps in knowledge and research about the epidemiology, etiologies, biomarkers and risk factors relating to CFS, and identifying potential opportunities in these areas; (2) impact and implications of current and proposed diagnosis and treatment methods for CFS; (3) development and implementation of programs to inform the public, health care professionals, and the biomedical academic and research communities about CFS advances; and (4) partnering to improve-the quality of life of CFS patients.

The CFSAC does not advise the Secretary directly. The committee’s recommendations are conveyed through the Assistant Secretary for Health, Dr. Howard Koh. Sometimes the person in the Assistant Secretary role has attended portions of CFSAC meetings, as is the case with Dr. Koh, but others have not interfaced with the committee at all. The DHHS employee most visible is the Designated Federal Officer (DFO) for the committee, Dr. Nancy Lee. The DFO is responsible for the operation of the committee, and has extraordinary influence over how well the committee does its job. Dr. Lee’s predecessor in this role, Dr. Wanda Jones, helped the CFSAC make great strides through live webcasting of the meetings, ensuring the committee’s recommendations were actually conveyed to the Assistant Secretary, and providing more transparency about the status of the recommendations.

Membership of the CFSAC falls into two categories, ex officio and external appointees. There are seven ex officio members representing agencies within DHHS. These members are non-voting, but attend each meeting and provide updates on their agencies’ activities on CFS. The seven represented agencies are the Agency for Healthcare Research and Quality (AHRQ), Centers for Disease Control and Prevention (CDC), Centers for Medicare and Medicaid Services (CMS), Food and Drug Administration (FDA), Health Resources and Services Administration (HRSA), National Institutes of Health (NIH), and Social Security Administration (SSA).

There are eleven external members of the CFSAC, appointed by the Secretary of DHHS or her designee. Nominations are invited from the general public, but the selection process itself is not public. Seven members “shall be biomedical research scientists with demonstrated expertise in biomedical research applicable to CFS” and four members “shall be individuals with expertise in health care delivery, private health care services or insurers, or voluntary organizations concerned with the problems of individuals with CFS.” The full roster of the committee is posted on the CFSAC website, including the expiration dates of the appointed members’ terms.

The committee meets two times per year in Washington, DC. Usually, the meetings are two days long, and cover a range of topics. There is always time for public comment, although people do have to sign up in advance. The webcasting has made it possible for hundreds of people to observe these meetings, and I have found it quite instructive. The agenda for next week’s meeting has been posted, and the meeting will take place on June 13th and 14th. You do not have to sign up in advance to be able to watch the meeting online, and I hope you will be able to do so. DHHS does track the number of people watching these meetings. The last meeting in October 2011 was not videocast, and this attracted significant criticism from the community. A large audience will show DHHS that it’s important to us and worth the expense for them.

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Abstract Risk

Posted on June 6, 2012 by Jennie Spotila

I posted about the cancer and CFS study last week based on the abstract only. Now I have a copy of the full paper, and there is much more to discuss. Dr. Suzanne Vernon also wrote about the study, so you might want to check out her analysis too. I expressed concerns about two aspects of the study: whether the subjects actually had CFS and whether the odds ratio represented a significant risk of cancer. Reading the full paper, my concerns were justified.

Case Selection

The study began with the selection of 1.2 million cancer cases from the SEER cancer registry. These cases were all first cancers in people aged 66 to 99 between 1992 and 2005. Cases had to have Medicare coverage for at least 13 months prior to diagnosis with cancer, and people with HMO coverage were excluded. Controls (100,000) were selected at random from the Medicare database and matched by gender, age, and location to the cancer cases. Both the cancer cases and controls were then evaluated for CFS in the Medicare database.

The presence of CFS was evaluated based on the database only. No confirmation of the diagnosis was attempted. More importantly, two codes were counted as CFS. The CFS code (780.1) was introduced in 1998. For older cases, this study used the code for neurasthenia (300.5). Neurasthenia is a topic unto itself, but its definition should give you pause:

a condition that is characterized especially by physical and mental exhaustion usually with accompanying symptoms (as headaches, insomnia, and irritability), is believed to result from psychological factors (as depression or emotional stress or conflict), and is sometimes considered similar to or identical with chronic fatigue syndrome

In this study, the authors used two definitions of CFS. The first group was diagnosed with CFS or neurasthenia beginning in 1991, and the second group was diagnosed only with CFS after 1998. Neurasthenia is not the same as CFS, and is much more likely to be applied to people with chronic fatigue and other vague symptoms. Such a diagnosis is not the same as the 1994 Fukuda definition of CFS. And it should be quite obvious to readers that neither the neurasthenia nor the CFS diagnoses were made using anything like the Canadian Consensus Criteria.

The authors did attempt to apply stringent requirements to the CFS groups. The diagnosis had to be documented in at least 1 hospital claim or by at least two outpatient claims that were 30 days apart. They also did not consider CFS diagnoses made during the year prior to the diagnosis of cancer to avoid the possibility that undiagnosed cancer was the source of fatigue. Despite these conditions, the authors acknowledge, “We were unable to assess whether CFS was correctly diagnosed by physicians and reported in Medicare claims.” This is a major weakness of the study. The authors point to their overall prevalence rate of 0.5% as being consistent with community-based studies like Dr. Leonard Jason’s. But Dr. Jason’s study was not limited to diagnosed cases. If we assume that only 25% (a generous number) of CFS cases are diagnosed, then the prevalence rate of this population would be 2%. That’s a prevalence number approaching that of the CDC’s empiric definition, and we know that definition is highly likely to capture patients with depression and other sources of fatigue.

Based on all of this, I have little confidence that the prevalence rate and CFS case selection in this study is accurate. It would be very interesting to pull the CFS cases and use chart review to attempt to confirm the diagnosis.

Actual Cancer Risk

This study found higher odds that certain cancer cases had CFS (compared to controls) in non-Hodkin’s lymphoma, pancreatic and kidney cancers. The study found lower odds that cases of breast and oral cavity/pharynx cancers would have CFS compared to controls. However, the only association that held up after multiple comparison adjustment was non-Hodgkin’s lymphoma. Even when the neurasthenia cases are excluded, the odds ratio holds up (Table 2 of paper). This study was also able to examine sub-types of non-Hodgkin’s lymphoma, and three subtypes were significantly associated with CFS/neurasthenia: diffuse large B cell lymphoma, marginal zone lymphoma, and B cell non-Hodgkin’s lymphoma not otherwise specified.

There are more than a dozen subtypes of non-Hodgkin’s lymphoma, but interestingly the first two subtypes associated with CFS have a median age at diagnosis of 65 to 70 years of age. The authors note the significant limitation of their study, “because our study was limited to people aged 66 years and older, our results may not be generalizable to younger (nonelderly) populations.” The authors also note that neither CFS nor neurasthenia was associated with cancer overall. Only the odds ratio with non-Hodgkin’s lymphoma held up in the study.

The actual numbers should be noted. According to Table 2 in the paper, 500 controls had CFS/neurasthenia (.5% of 100,000). Of the almost 1.2 million cancer cases, 5,885 had CFS/neurasthenia (.5% of 1,176,950). Of the 57,632 cases with non-Hodgkin’s lymphoma, 403 people had CFS/neurasthenia. While this is probably the biggest statistical study of CFS and cancer, the actual numbers of cases are still quite small. Even so, the hypothesis that chronic immune activation or infection could play a role in the association of CFS and non-Hodgkin’s lymphoma is supported by this study. As the authors note, “Our study results support continued efforts to understand the biology of CFS.”

Abstract vs. Paper

The hype in the CFS community when this study was released can be summarized as “Ack! People with CFS have a higher risk of non-Hodgkin’s lymphoma!” Here is yet another illustration of the absolute peril of relying upon paper abstracts and media spin. The paper explicitly refuses to make such a claim:

We would also caution further against any direct interpretation or application of our results in a clinical setting. We could not estimate the absolute risk of NHL associated with CFS, but the risk is likely too small to affect the clinical management of patients with CFS.

Everyone got that? This paper does not say that people with CFS have a higher absolute risk of non-Hodgkin’s lymphoma. This paper did find some interesting statistical associations that should be investigated further, especially given the role of immune activation in CFS. But that’s all the paper found.

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Cancer Risk

Posted on June 1, 2012 by Jennie Spotila

A study published online today found that CFS patients have a higher risk of developing certain kinds of cancer. I cannot get full access to the study (curse you, paywall!), so this post is based only on the abstract.

The study used the Medicare database to identify 1.2 million cancer cases and 100,000 controls between the ages of 66 and 99 years old. CFS was identified using linked Medicare claims at a prevalence in both groups of 0.5%. The association of CFS with cancer was calculated using odds ratio. An odds ratio is the ratio of the odds of an event occurring in the first group to the odds of it occurring in the second group. If the odds ratio is greater than one, then the condition or event is more likely to occur in the first group; an odds ratio of less than one, then the condition is less likely to occur in the first group.

The study reported the following odds ratios for cancer: non-Hodgkin’s lymphoma 1.29; pancreas 1.25; kidney 1.27; breast 0.85; and oral cavity and pharynx 0.70.  It is very important to note that only the non-Hodgkin’s lymphoma odds ratio withstood multiple comparison adjustment, which is why the study only draws a conclusion about the association of non-Hodgkin’s lymphoma with CFS. The study concludes that, “Chronic immune activation or an infection associated with CFS may play a role in explaining the increased risk of NHL.”

This is scary stuff. An increased association with or higher risk of cancer in people with CFS has long been reported by Dr. Dan Peterson and others. But based on reading the abstract, I have some serious questions about this study.

First, CFS was identified in these cohorts based on linked Medicare claims. That means that a doctor had to code the patient as having CFS. We know that CFS is under-diagnosed, with only 20% or fewer cases actually receiving a diagnosis. In this study, 0.5% of the cohorts had been coded as having CFS. But that prevalence of 0.5% is higher than the prevalence rate found by Leonard Jason’s community-based study. Jason’s study found a prevalence of 0.42%. That is not consistent with the maxim that CFS is under-diagnosed. Furthermore, there is no information provided about how CFS was diagnosed in these patients. It seems highly likely to me that an unknown number of these cases are actually cases of chronic fatigue, and not CFS.

Second, odds ratio is not the same thing as relative risk. By way of example, let’s assume that 90 out of 100 sixth grade boys laugh at fart jokes, but only 20 of 100 sixth grade girls laugh at fart jokes. The odds of a boy laughing at a fart joke are 9:1. The odds of a girl laughing at a fart joke are 1:4, or 0.25:1. The odds ratio is calculated 9/0.25, or an odds ratio of 36. But this does not mean that boys are 36 times more likely to laugh at fart jokes than girls. The relative position is calculated 90/20, or boys being 4.5 times more likely to laugh at fart jokes than girls. That’s still a huge disparity, but it’s nowhere near the odds ratio of 36.

In this study, the odds ratios are very small: 1.29 in non-Hodgkin’s lymphoma cases. And this number tells us nothing about the relative risk of a CFS patient developing non-Hodgkin’s lymphoma. Based on these numbers alone, and the uncertainty about how accurately CFS was diagnosed in any of these cases, I’m not sure this paper should be sending any of us to push the panic button.

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Raising the Limit

Posted on May 29, 2012 by Jennie Spotila

I feel like I am getting close to baseline, the state I was in prior to the exercise testing. It’s taken almost seven weeks, and in that time I have left my house a total of seven times – 5 doctor appointments and 2 social outings in my wheelchair. It has been a hard slog back to normalcy, and I’m getting close.

I’ve been wearing a heart rate monitor for 18 days, and have the alarm set to go off when I go over 95 beats per minute. It does not take much to put me over that line. I’ve been so frustrated that it goes off when I climb a flight of stairs or laugh or walk through my yard. But that alarm has forced me to pace much more than I normally would. I am walking slower. I’m making different choices about what I try to accomplish in the house. And that alarm has stopped me from doing things I would normally have pushed to do, like weeding for even 5 minutes or planting flowers in the yard. I have done far far less than I was inclined to do.

Has it made any difference in my symptoms? Perhaps. I have not had a crash day since strapping on the monitor. But my fatigue, pain, and cognitive symptoms all persist. Nothing is off the charts, but none of it is gone, either. On the other hand, I have been coming back to baseline and I think it makes sense to attribute that progress to the careful pacing forced by the monitor.

Today I raised the limit on my heart rate monitor to 105 beats per minute. This was my anaerobic threshold on the first day of the exercise tests. Now that I am feeling closer to normal, I thought it made sense to experiment with the higher limit. If I can sustain that without crashing, perhaps it will be a sign of progress. So far today, I have been able to climb the stairs and water some plants in the yard without setting off the monitor for more than a couple of beats.

The anaerobic threshold is not the only barrier I am trying to avoid. There is what I am calling the crazy threshold (CT) to manage as well. The crazy threshold is that point at which I can’t take being isolated in this house for another minute. The past few days have been ok. My husband was home for most of the holiday weekend instead of running in several directions at once. We went out for ice cream at the dairy right by the house. And my parents came for a visit too. I’ve had enough human interaction that I don’t feel perilously close to the CT.

This week, I am in self-imposed seclusion and house arrest. We have a wonderful family event to attend on Saturday that will also involve a car trip. It will be a big outlay of energy, and I cannot WILL NOT miss it. I don’t think I will be resentful of the heart rate monitor if careful pacing gets me to and through this family celebration without a crash. Too much to hope for? We’ll see.

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