Battle Lines

After listening to the IOM public meeting, after reading about what is happening to Karina Hansen and Justina Pelletier, and after poring over comments on blogs, forums, and news articles, there is no doubt in my mind that we are at war.

It is a war being waged against ill children, and against their mothers and fathers, who have been slapped with unverifiable, and outmoded, psychiatric diagnoses in order to strip them of their civil rights.

It is a war against people who suffer from complex, debilitating, expensive illnesses.

It is a war in which our enemies are ignorance, laziness, vested interests, venality, apathy, and lockstep thinking that places institutional welfare above the needs of individuals. 

It is a war against the weak, waged by the strong.

This war has been instigated, and is being perpetuated, by our most powerful health institutions:

• The continued refusal by NIH to fund meaningful research into ME, which essentially hamstrings our ability to initiate trials for treatments,

• The CDC’s 30-year perpetuation of a ridiculous name that allows doctors to dismiss us (as well as anyone else who presents with “fatigue”),

• The DSM’s expansion of “somatoform disorders,” which provides the justification for labeling us as neurotics,

• The possible inclusion of “Bodily Distress Syndrome” in the WHO ICD -11, a move which would effectively reclassify CFS, FM, IBS and other complex illnesses as psychiatric disorders,

• The creation of panels – the IOM and P2P – which are given the unlimited authority to create and disseminate information across the entire spectrum of health care, but which have no expertise, no experience, and no knowledge of the illness they are charged with defining.

In the context of war, these can only be considered onslaughts.

Why are they doing this?

The answer to that question is actually fairly straightforward: money. As a result of the recent economic downturn, cash-strapped governments with extensive social welfare programs, such as national health plans, are cutting back on social services. The same holds true of insurance companies, which, in the US, always put profits first. Medical care is very expensive, which means insurers, whether they are state or private, will seek any means of reducing medical reimbursement – let’s say by reclassifying diseases which are complex, but not well-established in the medical mainstream, as psychological conditions. (The remedies for anxiety disorders – GET, CBT, antidepressants – are much cheaper than Ampligen.)

That’s the macro analysis. On a local level, people who are part of institutions with long-standing positions and policies have a stake in making sure the boat is not rocked. Their advancement within an institution is dependent on their ability to do only those things which are consistent with what has been done before. The primary goal of any institution is to perpetuate itself.

On a micro level, there are a number of people in influential positions (e.g. Simon Wessely) who have a personal stake in defending the status quo, some of whom have reaped substantial benefits (e.g. a knighthood) for doing so.

What should we do?

There are two trains of thought as to how we should proceed:

1) “If you can’t beat ‘em, join ‘em." This is the approach taken by the Let’s Get It Right Group. The idea is to work within the framework of existing power structures. This is called “reform.”

2) “If you can’t join ‘em, beat ‘em.” This is the approach taken by Jeanette Burmeister, and others. The idea is that HHS has repeatedly let us down, and if we work within their rules, they will do so again. This approach is often called “revolution.”

Arguments about the merits, and pitfalls, of each of these approaches – reform vs revolution – have raged since human institutions were formed.

And they rage within our community today, with acrimony on both sides. But must we fight amongst ourselves about the single most effective strategy?

If the institutions – and individuals – waging this war are hammering us with everything they’ve got, why can’t we do the same?

Weaponry

We have a large community, one that provides us with a broad range of talents, expertise, and experience.

Why not make good use of the entire range of what our community has to offer?

• Those who have rapport with government institutions can exert pressure from within. The IOM presentations were a good example of this. Each group’s statement is now part of public record.

• Those who have experience with litigation can place legal pressure from without. Legal pressure is essential for any change in the US. It is the way our entire system works.

• Those who are adept at public pressure can organize demonstrations (May 12 is coming up!) Public demonstrations and events are a great way to gain the attention of the media. And, because this is the 30-year anniversary of the Incline Village outbreak, now is the time.

• Those who can write should take advantage of the huge opportunities available on the Internet. Public comment on news articles is particularly effective, but there are also review sites, emails that can be sent to public officials and representatives, and old-fashioned letters to the editor. (Even if they don’t get published, editors always read these to gauge the interest in certain topics among their readership.)

• The power of social media is something that cannot be denied. When hundreds of people tweeted about the inclusion of “Bodily Distress Syndrome" in the WHO ICD-11, WHO responded with a statement. Even if you can’t get out of bed, you can tweet, you can “like” posts, you can sign petitions.

There is no institution, here or abroad, that is unaware of the power of public outcry.

So, let’s fight back on all fronts. Together.

HealClick.com: New Patient Community Seeks to Turn Patient Sharing into a Tool for Research

Joey Tuan, Beth Mazur, and Cari Allshouse have launched a project to bring ME/CFS sufferers together, and to gather data for future medical research. This is exactly what the community needs - a way to find a "buddy," and a secure means of gathering medical data.

There are only 9 days left to fund this ambitious project. Click HERE to donate.

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Reprinted with the kind permission of HealClick.

By Emily Craven

By the time I was 25, I’d already been sick with Myalgic Encephalomyelitis (M.E.) for four years, had seen nearly two dozen doctors, had to quit my dream job, and moved back in with my parents. One day, on a rare coffee shop excursion, an old friend asked me, “What do you do about an illness with no recognized treatment?”

It was a good question. I explained that I’d been combing patient forums and online message boards. I was slogging through endless posts, weighing anecdotes about treatments relieving or inflaming symptoms, despite having no way to know if the person posting and I reacted similarly to such treatments. “I spend a lot of time banging my head against the Internet,” I told my friend; I truly felt isolated and helpless.

An Ambitious Endeavor

Enter Joey Tuan, Bath Mazur, Cari Allshouse, and their new startup, HealClick.com. The founders set out with two objectives: 1) To make it easier to find relevant patient-shared information, and 2) To use this information to further medical research.

Launched last month, HealClick is a revolutionary free platform that connects patients with chronic illness from all over the world. This hybrid of a social network and an enhanced medical forum uses volunteered symptom and treatment information to match members with similar users, while at the same time building a confidential database to be used for research. It serves over 20 autoimmune, neuroimmune and other poorly understood illnesses. The ultimate goal is to turn amassed patient experiences into research-friendly data that will yield treatment solutions.

“If we can arm ourselves with a database that truly captures our health over time, we can then present M.E. and other poorly understood conditions as problems worth solving to the researchers, backers, and philanthropists that can help us solve them,” says co-founder Joey Tuan.

Since the January 14th launch, 1294 patients have joined HealClick. Combined with the 900-plus beta users who shared their experiences prior to the launch, the site now has over 2200 members. Together they have already generated 2247 treatment reviews.

Finding Our Patient “Doppelgangers” and Getting Answers

HealClick makes it possible to not only get information about your illness directly from other people who have your diagnoses, but also to learn who these people are and what their health and treatment experiences have been like. Using matching technology analogous to dating sites HealClick creates a “similarity score” between patients. It uses each member’s symptoms, diagnoses and treatments to suggest other members that are health-compatible based on their input. In addition, the site boasts a number of traditional social networking features, such as chat, personal messaging and detailed profiles, making it easier for members to get to know each other. There are also innovative variations of social networking features such as the ability to mark a post as “helpful” and to send other members “LUV” (support) for posts and comments. The result is a light-hearted, supportive community that lessens the isolation of being chronically ill.

HealClick also sets itself apart from other patient forums with its ease of use and by serving numerous diagnoses. First, highly-sought treatment reviews are in a dedicated section instead of buried among endless posts. Second, users with over 20 autoimmune and poorly understood illnesses can easily discuss their treatments and coping strategies for common symptoms, such as nausea. This information would typically be scattered across more than 20 separate diagnosis-specific forums. Discussions can also be sorted into categories for one diagnosis only, making it adaptable to the user’s needs.

Building Technology to Collect and Prepare Data for Research

The HealClick team recently launched its Indiegogo crowdfunding campaign in order to develop the components necessary to collect data and make it research-ready. “If we raise just $50,000, we can build a state-of-the-art website to help millions of patients,” Tuan said.

Among the features slated for development are an integrated mobile health tracking app and upgraded servers to sustain HIPAA-level encryption of the patients’ data. The team is also working on refining the matching process through the addition of standardized lab results and natural language processing.

As a patient, I’m very enthusiastic about an easy-to-use tracking app, one which will allow me to daily track my symptoms and treatment by answering a few simple questions. In addition to tracking my own health, the data collected by this app can be anonymized and made available to researchers to identify correlations and patterns over time. The idea that I will be able to contribute data for desperately-needed research from my bed is particularly exciting. Many chronically ill patients together could change the course of research for their conditions simply by clicking on a few answers each day.

Ultimately, HealClick strives to empower patients by designing the tools for them to educate each other and to directly participate in research solutions.

To join: www.HealClick.com

To support the fundraising effort click HERE.

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Emily Craven is a former domestic violence advocate and Reed College graduate. Prior to becoming ill she was an avid traveler and passionate about education. She has severe Myalgic Encephalomyelitis and has been battling the invisible illness since 2002.

IOM Public Meeting, January 27, 2014: Part 2: The CDC Multi-Site Study and P2P

Below is a detailed summary of the second hour of presentations given at the IOM public meeting on January 27, 2014. The two presenters were Elizabeth Unger, who talked about the CDC Multi-site Study, and Susan Maier, who explained the P2P process.

Dr. Unger's presentation of the CDC study demonstrated the flaws that have been apparent in every federally-sponsored study of ME/CFS to date. The instruments used in the study are old stand-bys, and of dubious relevance. The reason they were chosen for this study is that, with one exception (the DePaul questionnaire), they are standard tools of the trade. The problem is that ME/CFS is not a standard illness. (To quote an old adage: You can't fit a round peg into a square hole.)

Several of the questionnaires covered anxiety and depression. The results proved - again - that ME/CFS is neither. Yet, Dr. Unger reported that mental health was fairly normal in ME/CFS patients with a distinct tone of surprise. Conspicuously absent from the CDC's roster was a single objective measurement (e.g. 2-day CPET). 

The IOM panel, particularly those with ME/CFS expertise, asked pertinent questions, most of which Dr. Unger was unable to answer. Dr. Rowe posed the question of whether a sample of patients who had been ill, and treated, for a long time was appropriate for establishing diagnostic criteria. He pointed out that the illness changes over time. (Actually, it is the patients who change. As Dr. Cheney pointed out 20 years ago, our bodies continually adjust to an ongoing disease process.)

Dr. Unger was followed by Susan Maier (Deputy Director of the Office of Research on Women's Health (ORWH)), who gave a presentation that was so laden with jargon and bad syntax that it was nearly impossible to follow. (She compensated for her inability to form a coherent sentence by a great deal of hand waving.) Maier's subject was the Pathways to Prevention (P2P) panel that is being assembled to review research definitions for ME/CFS.

In all respects, the P2P process is even more far-fetched than the IOM's. The members of the panel not only can't be experts in the field of ME/CFS, they can't have anything whatsoever to do with the illness. What's more, they don't even have to be physicians. They can be "highly regarded lawyers, ethicists, methodologists" - and, one presumes, expert butchers, bakers and candlestick makers.

This hodge-podge panel will review material that has been culled (by yet more non-experts using "standard methodology") and listen to presenters, each of whom has exactly 20 minutes to state their case "pro or con." Maier explains that this process is similar to the jury system, with a prosecution and a defense. The jury knows nothing initially, but is educated - over the course of two days - in everything they need to know to make a judgment.

Not only is this the height of absurdity, it is very definitely not the jury model. In our justice system, the defense and prosecution are able to question the jury to discover if they have any prejudices that might influence their decision. With 85% of physicians in the U.S. believing that "CFS" is a mental illness, and the majority of the public probably believing the same, can we really expect this panel to be unbiased? In any event, there is no mechanism for finding out if they are.

And if this were a trial, as Maier proposed, wouldn't the defendants (ME/CFS patients) have the right to face their accuser? Doesn't a jury have to deliberate until they reach a decision - instead of being given a deadline of 24 hours? Wouldn't they have more than two days to hear arguments? Wouldn't the defendants have a say in what constituted evidence?

To employ a more apt judicial metaphor, the P2P panel isn't a jury - it's a kangaroo court.
______________________________ 
This article originally appeared on ProHealth.

Note: You can read summaries HERE of the introductory segment, including Dr. Rick Erdtmann, Director of the Board on the Health of Select Populations, Dr. Ellen Wright Clayton, IOM Committee Chair, and Dr. Nancy Lee, Designated Federal Officer to CFSAC, study sponsor [HHS] representative.

By Erica Verrillo

The second hour of the IOM public meeting held on January 27, 2014 consisted of reports from related federal projects: The CDC Multi-site Clinical Study and the Pathways to Prevention Program (P2P), formerly known as the NIH Evidence-Based Methodology Workshop.

Each of these studies has profound implications for the ME/CFS community. The CDC study provides data that will be used by both committees, as well as researchers and clinicians, and the P2P panel reviews definitions that will be used by researchers.

You can read the meeting agenda HERE.

You can watch the presentations HERE.

You can read information about the committee members HERE.

It is not too late to submit comments to the IOM Committee. Send your comments to: mecfs@nas.edu 

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Elizabeth Unger - Methodology for the CDC Multi-site Clinical Study (18:07) (Video)

Dr. Elizabeth Unger is Chief of the Chronic Viral Diseases Branch (CVDB), Centers for Disease Control (CDC). She began her talk by stating that physicians worldwide recognize an illness that is called CFS or ME, and that there are more similarities than differences in the case definitions for how this illness is described.

Dr. Unger pointed out that the illness is very complex and patients are heterogeneous. The heterogeneity of patients in clinical trials and research studies and in epidemiologic studies can confound results. This may be contributing to the lack of uniform advancement in studies of this illness.

Some of the confounding factors for research have been: severity of illness, duration of illness, co-morbid conditions, medications, and demographics (age, sex, etc.) In Dr. Unger’s opinion, medications have been the least investigated, and could be most problematic for understanding the illness.

Clinicians need a case definition that is as clear and simple as possible so that this illness is recognized and patients get the case they deserve.
When designing the multi-site study, the CDC asked themselves two questions:

1. Is refining or adding criteria going to produce a homogeneous population?
2. What do you do with patients who don’t fit any one definition?

As a starting point for these questions, Dr. Unger quoted Stephen Holgate as saying “To call CFS/ME a single disease greatly underestimates the complexity of the problem” and Dr. Anthony Komaroff as saying, “I suspect that none of these case definitions is likely to describe a very homogenous group of patients."

Because the CDC realized case definition alone was not going to be sufficient, they decided to capitalize on the expertise of clinicians who had the greatest experience treating the illness.

The multi-site study examines standardized data from patients aged 18-70 from seven specialist practices in the U.S. The enrollment criteria relied on clinical expertise rather than on any one case definition. I am using the term “CFS,” but we made it clear to physicians that CFS, ME, post-infectious fatigue, or any of these synonyms or possibly related illnesses, were eligible to participate. The only exclusions were HIV-positive patients, and patients older than age 62 at diagnosis.

Participating Physicians:

• Benjamin Natelson
• Nancy Klimas
• Lucinda Bateman
• Charles Lapp
• Andreas Kogelnik
• Daniel Peterson
• Richard Podell

Stage 1: First Year of Study

Dr. Unger devoted the bulk of her talk to describing Stage I of the study, which was the first year of gathering data obtained by physical examinations, patient questionnaires, and data extracted from medical records (e.g. medical history, medications list, lab tests, family history, infection and immunization history).

Data was gathered from 471 participants who filled out questionnaires either at the time of the clinic visit or in the week before. These included: Patient Health Questionnaire Depression Scale, Generalized Anxiety Disorder 7-Item Scale, Self-Rating Depression Scale, CDC Symptom Inventory (which includes 19 symptoms experienced during the previous month), the Medical Outcomes Study 36-Item short form (which measures quality of life), the Multi-Dimensional Fatigue Inventory-20 (which measures general fatigue, physical fatigue, mental fatigue, reduced motivation and reduced activity), questions from the DePaul symptom inventory, NIH PROMIS forms (pain, fatigue and sleep), sleep questionnaires, and Brief Pain Inventory.

Demographics

The patient population consisted of slightly overweight, middle-aged (48.2) white females with college education. Half were married, and 75% were unemployed, though most did not receive unemployment benefits.

The mean age at diagnosis was 38.4%, with sudden onset reported in 65.4%. Mean duration of “fatigue” was 14.3 years, ranging from 2.5 to 52 years.

Dr. Unger commented that the patient population studied through these specialty clinics was not necessarily representative of the patient population as a whole. Most patients were highly educated and insured, and all had been seen and evaluated by other physicians.

Results

The highest PROMIS scores were in generalized fatigue, physical fatigue, and reduced activity. On the SF-36 mental health was relatively preserved, while vitality was reduced. Functional measures included the mean number of hours for vertical activity (7.5 hours), the mean number of hours for horizontal activity (12.8 hours). The mean days per week in which patients exercised was 3.3.

Overall, 83% of patients reported pain in the previous week. There was a good correlation between PROMIS scores and the Brief Pain Inventory (.75).
The CDC symptom inventory showed the most prominent symptoms to be Post-Exertion Malaise (PEM) and unrefreshing sleep, followed by muscle pain and memory and concentration problems.

In the context of other illnesses, PROMIS scores showed that CFS patients experienced greater fatigue, sleep disturbance, and pain impairment than patients with chronic pelvic pain, spinal cord injury, Muscular Dystrophy, Post-Polio Syndrome, and MS.

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Q&A with Dr. Unger (11:01) (Video)

Question – Nancy Klimas: Have you been able to do an analysis of different case definitions on this data set?

Answer: We have not done that but it is certainly possible. The data is there. That requires a lot of interpretation that we feel will require a lot of dialogue with people, in other words, how to set the criteria for each of the points in the disease criteria.

Question – Nancy Klimas: You have the DePaul symptom inventory on the list. Lenny Jason has an algorithm on an excel spreadsheet that we can use to compare Fukuda to the 2003 Canadian.

Answer: It still requires some interpretation and discussion. The data is there.

Question – Lily Chu: What is the timing and how will the committee receive data? My second question is, I can understand why you are asking clinicians to come up with who fits the CFS diagnosis. Is there any thought given to asking two or three physicians looking at the data if they would agree that this person has CFS? My third question is, you have measures of activity, but other than upright activity, are there any subjective questionnaires of what people do day to day?

Answer: None of these patients were diagnosed by a single physician. They are referrals. I think they [the physicians] are competent in their diagnostic skills.

As for measures of activity, we do not have narrative of what patients do in a given day. But all the questionnaires have time frames. They vary from being vague, others are for two weeks, and the DePaul is for six months. Each has a narrow-minded way in which they are asking questions. This illness defies neat categories. We have to be careful interpreting the data we have.

About logistics – we have the baseline data ready. We can provide the committee with tables and answers.

Question – Dr. Clayton: Did the patients consent to data sharing?

Answer: Patients consented to data sharing within the study. We feel we can release the analyses, but not the raw data, to the IOM.  We feel that’s within informed consent.

Question – Peter Rowe: I have a question about the relevance of prevalence data. You have got patients who have been treated and followed for some length of time. It seems to me it would be problematic to apply those to case definitions. My hope in clinic is that I will have some impact on some patients’ initial CFS symptoms  within a short period of time. So the problem might be that if people have been treated by such an experienced group, some of their symptoms that might be defining symptoms for CFS/ME will be gone by the time you’ve captured the data. How are you approaching that dilemma?

Answer: It is a dilemma. We sort of try to do one step at a time. We are aware of that. I was glad we had 80 patients that were only 2 ½ years from the onset of their illness. In the next phases of the study we have asked physicians to enroll patients earlier on in their disease course. As a last point, we have the intake form which gives a picture of the patients when they first come in, but even there, because this is a referral clinic, this may not be what the illness looked like at first. It’s not only the patients’ response to therapy, but the illness itself changes with time. That is a limitation that we have.

Question – Cynthia Mulrow: I want to understand the representativeness of this sample and what likely spectrum of CFS they might represent. If a large spectrum has not been captured, then it may not be right for us to go overboard using these data to help inform diagnostic criteria.

Answer: We think that it is data that could be used to inform you but we don’t think that absolute decisions can be made solely on the basis of this data. It’s a beginning point. I think that the patients that are in this study should meet the case criteria, whatever the case definition is. That’s not to say others wouldn’t.

The other piece of data in the comparison we have is the data on our population-based surveillance. We use many of the same instruments, so we have a data from those two and we can see how they compare.

This is to me one of the most important steps the field can take is getting some consensus on what are some shared measurements that studies and researchers and clinicians can count on and use, so that we can start making comparisons. One thing we’ve been lacking is measurements of this illness we can use, that’s why I like the PROMIS instrument so much. It compares patients with other patient groups.

Question – Lily Chu: Regarding timing there are studies, and patient anecdotes, indicating that sore throat and flu-like symptoms go down with time and neurologic symptoms go up over time. To Cynthia’s point, there are some epidemiologic studies that suggest that minority and lower socio-economic groups are high risk for CFS and may have more severe cases. This group [CDC study population] is highly educated, has resources to see referrals, etc.

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Susan Maier - NIH Evidence-Based Methodology Workshop (18:27) (Video) 


Dr. Susan Maier is the Deputy Director of the Office of Research on Women's Health (ORWH). She began her presentation by clarifying that the Pathways to Prevention Program (P2P) is a collaboration between NIH Office of Disease Prevention and the Trans-NIH ME/CFS Research Working Group.

The goals of the program are to identify research gaps and methodological scientific weaknesses in a scientific area, to suggest research needs, and to move the field forward through an unbiased and evidence-based assessment of a public health problem.

The P2P Program is for any disease, illness or syndrome that needs a more in-depth understanding, keeping in mind that the goal is to serve the community of researchers.

Timeline

The P2P process was begun in June 2012 when the Trans-NIH ME/CFS Research Working Group and ORWH began formulating a proposal. The Trans-NIH ME/CFS Research Working Group proposal was accepted by the Office of Disease Prevention in December of 2012. The first working group meeting to plan the workshop was held in January 2014. The tentative date for the workshop is December 2014.

Making a Case for ME/CFS

• Necessity – lack of physician recognition, lack of biomarkers, lack of understanding about the scope and range of the illness
• Urgency – there are no FDA-approved treatments
• Public Health Problem – people are sick and there is an unmet need

Working Group Meeting (January 2014)

The working group is composed of experts in the field, patients, advocates, caregivers and Federal partners (e.g. CFSAC, HHS )

They had three tasks.

1. Refine the questions for the evidence review. The evidence review is performed by an evidence-based practice center – this is a contract done through AHRQ (Agency for Healthcare Research and Quality).  
2. Develop the workshop agenda: Topics, speakers and format.
3. Nominate panel members.

Questions considered by the panel

Questions had to be developed and refined, because the questions form the basis for the agenda of the workshop. (Who will speak and on which topics.)

• How do ME and CFS differ?
• What tools will allow us to define subsets across the entire subset of CFS?
• What are the characteristics of patients who respond to specific treatments across the spectrum of CFS?
• What does research on ME/CFS tell us about clinical diagnosis of ME/CFS?
• Have previous research findings shaped current clinical practice or are research and clinical practice completely separate?

Two days will be spent listening to speakers on topics that have been defined by the committee. Speakers are experts in the field - clinicians and researchers – who represent a pro or con position concerning existing case definitions in order to provide a balance. Each speaker will be allotted 20 minutes, followed by a question and answer period.

Nomination of Panel Members

Panel members are highly recognized experts in their areas. These are not experts in ME/CFS, and not necessarily medical doctors or researchers. They may be attorneys, methodologists, ethicists, public representatives – as long as they have no direct connection with CFS. None may be employees of the Federal government.

What happens next?

ODP will set a date for the speakers. Evidence-based practice center will cull the evidence using standard methodology. Every meeting must be approved, so this workshop must be approved by the Federal government. Once the approval has been granted all information will be made public, including speakers and evidence.

The end result is a set of recommendations from the panel based on what they have read and heard. A follow-up (1-9 months later) will then work on how to process the recommendations and put them into practice.

P2P Contacts:

Paris Watson, Senior Advisor, P2P, Office of Disease Prevention (ODP)
watsonpa@mail.nih.gov  prevention@nih.gov

Susan E. Maier, Deputy Director of the Office of Research on Women's Health (ORWH) Susan.Maier@nih.gov

Mariela Shirley, Chair, Trans-NIH ME/CFS Working Group shirelym@od.nih.gov

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Susan E. Maier - Q&A (14:59) (Video) 

Question - Theodore G. Ganiats: At the end there are some recommendations. Are those recommendations for research agenda for the NIH, or are they for practice?

Answer: It has the potential to be both, but our focus is on research that is used for translation into clinical care means we have to focus on “besting the science.”

Question - Theodore G. Ganiats: In the group of panelists, there was nobody from primary care. Given that most patients with this disease, whatever we call it, will be seen I primary case, I think that adding primary care would be important.

Answer: Absolutely.

Question - Lily Chu: On the list of refining questions, it says, “What does research on ME/CFS tell us about clinical diagnosis of ME/CFS?” That seems very similar to the charge of the IOM. How does that work between the NIH and IOM?

My other question is that I’ve been reviewing the P2P website to understand how the process works – you can’t be on the panel if you are a clinician with any experience, or you cannot be a researcher that has published on it? That was concerning to me because this is a complex illness.

One of the requirements for the topics is that it be non-controversial. This is a field that is undergoing a lot of changes. My concern is that there is not going to be anyone with any clinical or research experience on the panel.

My third question is, according to my understanding, the panel writes the document in 24 hours after the workshop?

Answer: The panel receives the evidence report, and any other documentation that is submitted, six weeks before the workshop. At the workshop, the panel will listen to speakers, and speakers will provide additional information that may not be in the evidence report. For example the CDC study may not be published yet. But that information is very important for the panelists.

Yes, the report is written in 24 hours. They do have a day and a half total. That report will be posted on the website for public comment. After 14 days, it will be taken down and the comments will be reviewed. The report will incorporate that content.

There is a link between what the IOM is doing and what we are doing. So, we hope to be able to work with the IOM committee to share the synergy.

About the panel requirements –  the panel members may not be clinicians who see patients with ME/CFS or researchers who study ME/CFS. They could be a clinician that treats pain disorders, or an oncologist that treats patients with cancer-related fatigue, they could be in a research area that has recently gone a case definition review, such as PCOS. They are highly regarded experts in their field, just not in ME/CFS. That content comes from the speakers.

Think about this: It’s a jury model. You have the defense, you have the prosecution. They know the case very well. The jury is sequestered; they don’t know, they don’t know anything. The jury hears the evidence. They make their decisions based on the evidence.

Question - Nancy Klimas: I’m challenged, because I am on both groups. My understanding is that IOM is not able to put anything out until its final report. It would be very difficult to “synergize.” But it can certainly hear, so it’s a one-way direction from P2P. There is so much that would be duplicated, literature reviews and so on, you have this group doing a comprehensive review of the entire literature, obviously that would be something this committee could really value.

The case definition charge itself is difficult. If this group is really focused on a clinical case definition, then the P2P is really focused on a research case definition.

Answer: The goal of the P2P is not to develop a research case definition, but to review it,  review the evidence supporting all case definitions that have been used.

Question - Nancy Klimas: How do you see the one-way direction of this information flow? I am worried about the time lines. When will the Portland group have the evidence from ARHQ?

Answer: The evidence review will be completed roughly six weeks before the workshop. We are “planning” for December 2014.

Question - Nancy Klimas: Might it be possible in order to facilitate this group’s work, to ask that the case definition part be available to this committee sooner than that, because it is too late to be useful on our timeline.

Answer: The two processes are different. Our purpose is different. Our questions will be heavily focused on the research part. That doesn’t mean it won’t be useful for clinical use. Our evidence may not exactly dovetail what you are looking for.

Question - Nancy Klimas: Can those of us who are on both committees have permission to share?

Answer: The content of the meeting is not finalized. All the things we discussed are on sheets of paper and maybe a couple of computer discs. When it’s pulled together, at that point you can share it.

Question - Nancy Klimas: I’m totally confused.

Answer: Paris Watson can give you that specific guidance.

Question - Cynthia Mulrow: My understanding is that protocols for evidence reports are publicly available. Are there ways that we can get access to search strategies that are used in the evidence report tied to specific questions, so that we can peruse those before the final report comes out? My understanding is that these evidence centers develop evidence tables before they finalize the report. Is there a way that our committee can have access to those interim products?

Answer: I don’t know the answer to that. But I can certainly ask.

[Dr. Clayton announces a BREAK.]

IOM Public Meeting: Part 1 - The Process

Below is a detailed summary of the first hour of the IOM public meeting held on January 27, 2014. Even though the agenda was largely focused on bureaucratic process, it is well worth listening to these presentations. 

The underlying tone of the introductory statements was defensive, no doubt due to input from ME/CFS advocates and experts who believe the IOM process to be a waste of time and money, if not outright harmful. There were several references made to the "rigor" of the process, which, in Dr. Clayton's words, made "everything else pale in comparison," and an emphasis on procedure.

There was, however, no mention of specifics. While it was made clear to those listening that many steps would be followed, that these steps would be reviewed and overseen, and that the final product would be examined and re-examined, one crucial question remains unanswered:

If the IOM review is supposed to provide the basis for a new case definition, exactly who determines which material will be read by the committee? Do they plan on reading everything that has ever been published on ME/CFS? If not, how do they intend to cull their material? Dr. Erdtmann mentioned that all "outside" material would be available to the public. Is there "inside" material? If so, what is it?

Unfortunately, we will never know the answer to these questions. This is a "confidential" process, in which members of the public will not have access to the materials, the interim reports, or anything else of substance.
  
While the non-expert members of the committee demonstrated their professionalism by asking appropriate questions, it is clear that they are in over their heads. Given the limitations imposed on most of the committee members by sheer lack of knowledge, it is hard to imagine how they will be able to sort through the vast, contradictory corpus of literature on ME/CFS. They have neither the perspective that long association with patients brings, nor the critical capacity that a thorough understanding of our political history provides.

_______________________

By Erica Verrillo

On January 27, 2014, the Institute of Medicine held a public meeting concerning the IOM’s review of diagnostic criteria for ME/CFS.

The first half of the meeting consisted of presentations by government and IOM representatives. The second half included presentations from patients and patient advocates, as well as public comments.

This article covers the initial presentations, in which the IOM process was described.

• Rick Erdtmann outlined the four steps of the IOM study.
• Ellen Wright Clayton, Committee Chair, welcomed the participants and established the limits of the public session.
• Dr. Nancy C. Lee, representing the sponsor of the study, HHS, talked about some of the background that led up to the IOM review.

You can read the meeting agenda HERE.

You can watch the presentations HERE.

You can read information about the committee members HERE.

It is not too late to submit comments to the IOM Committee. Send your comments to: mecfs@nas.edu 

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Rick Erdtmann – The IOM Process (7:24) (Video)

Dr. Erdtmann is the Director of the Board on the Health of Select Populations, which is in charge of the committee. He outlined the four stages of the IOM study.

1. Define the problem. When this is accomplished, the committee prepares a Contract of Work.
2. Select experts to author the report. The selection of a provisional committee is accomplished through an “extensive search.” The provisional committee is then reviewed to ensure that there is no conflict of interest, and that there is a “proper balance of views.”
3. Gather information based on presentations and research by the committee and staff. Any information from outside sources is listed in files available to the public, but the actual deliberations of the committee are not revealed. A confidential report is then drafted.
4. Peer review process. Volunteer reviewers who roughly match the expertise of the panel are nominated to review the draft. That slate is subject to internal academy review “above and beyond” the purview of the study committee. The reviewers are asked to make critical comments, to clarify errors and offer new insights and suggestions. Reviewer comments are submitted anonymously, and the committee then addresses each comment and modifies the draft. The Report Committee oversees the review process, and ensures that the comments are addressed. Then the report is released to the sponsor and to the public.

________________________

Ellen Wright Clayton, Committee Chair - Introduction to Public Session (4:17) (Video)

Dr. Clayton welcomed the committee and expressed her enthusiasm for the project. She then stated the committee’s task, which is “to evaluate comprehensively the current criteria for the diagnosis for ME/CFS.” Dr. Clayton stressed that the public session was for information gathering only, and that any views expressed by committee members were not to be taken as indicators of the committee’s position. While questions were not allowed from the floor, Dr. Clayton pointed out that “probing questions” would be posed by committee members. After repeating several times that the process of review would be rigorous, Dr. Clayton then introduced the sponsor’s representative. [HHS is the sponsor of the IOM study.]
_________________________

Nancy Lee - Background and Charge to the Committee (15:51) (Video)

Dr. Nancy C. Lee is the Designated Federal Officer for the Chronic Fatigue Syndrome Advisory Committee (CFSAC). Dr. Lee reported that in 2012 CFSAC recommended that HHS convene a workshop to reach a consensus on clinical and research case definitions for ME/CFS. The Secretary of HHS asked IOM to use its consensus process to provide guidance to the broader medical community on how to identify and diagnose ME/CFS in the clinical setting. This includes primary care providers as well as some specialty groups. HHS asked that four specific tasks be addressed. The charge of the IOM committee is to address four specific tasks:

1. Conduct a study to identify the evidence for various diagnostic clinical criteria for ME/CFS using a process with stakeholder input, including practicing physicians and patients.
2. Develop evidence-based clinical diagnostic criteria for ME/CFS for use by clinicians, using a consensus-building methodology.
3. Recommend whether new terminology should be adopted.
4. Develop an outreach strategy to disseminate the definition nationwide to health professionals.

Dr. Lee asked that the committee consider the variety, range and severity of symptoms. “It is also important to distinguish between generalized chronic fatigue with known etiology and unexplained fatigue without associated multi-system illness and the more specific syndrome of myalgic encephalomyeltitis.”

"As you probably know there has been support from advocates, as well as some of the members of this committee, for the Canadian Consensus Criteria of 2003. Criteria should account for different sub-populations, such as children," she said. “The committee may well decide that different criteria are needed for the different entities that fall under the broad umbrella of CFS.”

The third task is to evaluate the terminologies for ME/CFS. These terminologies include but are not limited to: neuro-endocrine immune disorder, myalgic encephalomyelitis, chronic fatigue syndrome, and chronic fatigue immune deficiency syndrome. Different names may be warranted.

“Please know that there are many people – scientists, clinicians, advocates - who believe the name ‘chronic fatigue syndrome’ does harm to patients. I agree.”

Dr. Lee asked that the committee recommend strategies to disseminate these criteria nationwide to patients, and health care professionals. “Pushing out the criteria to a wide audience of health professionals is such a critical need. Whatever the committee develops needs to get into textbooks, widely read journals, and be at the top of a google search.”

Dr. Lee asked the committee to coordinate their efforts with two ongoing efforts: The CDC multi-site study and the NIH Pathways to Prevention (P2P) Program for ME/CFS.

Dr. Lee closed her presentation with the statement that “Patients and providers need help now.”

Dr. Lee Q&A (7:08) (Video)

Question - Dr. Clayton: There are two other efforts that we will hear more about. But I would like to hear from you how these efforts are going to interweave to create a coherent whole.

Answer: A better answer to your question is going to come from my two colleagues. For the CDC, that was designed to gather data to address the issue of what are their symptoms, what are their lab values. So, they are gathering data. The hope is that that information will provide a large body of information.

The other part of the recommendation that we received from CFSAC in 2012 asked for research definitions to be developed. So, the NIH has sort of taken that, and thought about it in different ways. So they are going to develop a research [definition?] going forward, and they are going to provide a thorough review of existing case definitions. So there is going to be some overlap.

Question – Dr. Lily Chu: Patients have had some questions about what type of patients this case definition will apply to. So, I am thinking about a patient coming in to see a typical, average doctor; how do they go about diagnosing CFS? That is my framework. So, I want to make sure that that is the same framework HHS is thinking about.

My second question concerns the different case definitions that are listed - that’s a starting point. But if we have points that we want to add to that case definition to make a new case definition that the panel believes to better represent patients, then that’s what we should be aiming for, not just the existing definitions. Is that right?

Answer: It’s whatever you decide. It could be the existing one, it could be the 2003 [CCC] if you all decide that’s a very good definition. If you decide you like the 2003, or something else but you want to tweak it a little or come up with whole new measures, because the 2003 is eleven years old. So, we defer to the expertise that is assembled around the table; we defer to you.

But, again, to go back to the first point, I am hoping that this will be something that can be taught to many, many providers, so that when they come in they can put it on their differential diagnosis, so they can say this is what people have to they can get on the phone and ask an expert about it. It’s what you do when you don’t see something commonly, but you know you have to make a good diagnosis.

Question – Nancy Klimas: I’m trying to be clear because I actually serve on two panels, the NIH working group and this one as well. This group is looking for a clinical definition – as in the practice of medicine.

Answer: This could be for researchers, but this is also for the doctor or the nurse practitioner or the PA, or other health care providers that somebody walks in and it’s for them to help this person who has this diagnosis that they are not quite sure what it is. Research may come out of this. But this is really for helping patients get the kind of care they need.

Question – Nancy Klimas: In a clinical sense sub-grouping would also be addressed.

Answer: Sub-grouping is good.

Question – Betsy Keller: I have a question about the charge of ultimately creating the set of criteria that will help with the diagnosis. That’s part of the statement of task that you just described to us. Can you explain why HHS stopped there, when you have just acknowledged that it’s very difficult for patients to find providers for the illness? Are there any plans for HHS to provide a website so patients can find qualified providers to treat the disease?

Answer: I think that the government does not endorse specific providers. When we have the report we will hopefully work with the big organizations, but we don’t have the product that we can push out right now. CFSAC has a committee that is looking at educating primary care providers. A lot of that is outside the government.

Question – Betsy Keller: I am concerned about getting this information in some form that is accessible to the patients, because we’re way behind the eight ball.

Answer: Right, and so that’s task four – for you all to help us. We have the advisory committee [CFSAC] that can help us with that as well.

Question – Nancy Klimas: Task three is to address the name. There has been a tremendous amount of public discussion on this that the CFSAC minutes would reflect. In your mind’s eye is there a role for additional public input?

Answer: Absolutely.

Question – Nancy Klimas: In my mind I split it into two things. We’ll hear again and again about the name being harmful. What we need from the committee is constructive advice on how to go forward. Not to spend many hours discussing what is out there, but where do we go from here? And as a committee member, I would welcome public input.

Answer: I think that we really look to the stakeholder advocacy community for suggestions on that task.

Question – Nancy Klimas: I don’t understand the mechanism of how that would happen. Today we have this public testimony, and I am sure it will be very useful. Is there some way to have to input of the public as the process goes on about various elements?

Answer – Carmen Mundaca: We have established an email, and we have delivered comments to you. This email will be open throughout the process, and there is no deadline for submitting. We will have that as a regular means of communication with the public. The email is: mecfs@nas.edu 

Answer – Lily Chu: We are going to talk further about how public input will be gathered and put into the final documents.

Dr. Clayton: I confess that if we get through federal presentations sooner than anticipated that gives us time for public input and I’m not too sad about that.

[End of Part 1]

This article first appeared on ProHealth.

A Year Later - Karina Hansen Still Confined in Mental Ward

A year has gone by and Karina Hansen, a young Danish woman with severe ME, is still confined in a mental ward, where her condition is deteriorating. Her treatments, supervised by psychiatrist Nils Balle Christensen, consist of GET and CBT. A group of concerned patients and advocates, Justice for Karina Hansen (J4KH), has sent a letter to Karina Hansen's guardian asking for a second opinion from Dr. Nigel Speight, a British pediatrician who has been involved in similar cases. (Watch an interview with Dr. Speight HERE.) 

Please scroll down to see what you can do to help.

By J4KH

No one should be stripped of their human rights because they are ill. We have a right to be treated with dignity and respect. We are all vulnerable when we become ill and enter the healthcare system. We must make sure that laws are enforced and human rights are respected for all people.

Karina Hansen is a 25-year-old Danish woman with severe ME (Myalgic Encephalomyelitis). ME is a neuroimmune illness with the defining characteristic of post-exertional malaise or post-exertional neuroimmune exhaustion. It has been coded as a neurological illness (G 93.3) by the World Health Organization since 1969. Cases that are severe can cause a patient to be bedridden and in need of a carefully controlled environment in order to prevent exacerbation of symptoms. Light, noise, and touch can all be physically painful to an ME patient.

Karina has been battling this illness since the age of sixteen with the help of her loving parents. It took seeing different doctors at different institutions to receive the correct diagnosis. After receiving treatment that made her worse, Karina and her parents took steps to prevent this from happening in the future. They hired their own physician and dietician to treat Karina. Her mother, Ketty, was her full-time caregiver. Because of Karina's extreme sensitivity to stimuli such as sound and light, her parents moved into a trailer in their backyard during the day to allow Karina the quiet she needed. Karina hired a lawyer and gave her parents power of attorney to act on her behalf.

Unfortunately, in Denmark ME patients are often labelled as having a functional disorder. The treatment for a functional disorder includes graded exercise therapy (GET), cognitive behavioral therapy (CBT), and possibly anti-depressants. Testing has shown that the bodies of ME patients respond to exercise differently than healthy people. Forcing exercise upon people with this illness can cause a significant worsening of symptoms. Cognitive behavioral therapy can be helpful to some people but only as an adjunct therapy. Treating conditions such as cancer or MS with CBT and GET alone would be considered outrageous, not because they are bad in and of themselves, but because they in no way treat the underlying illness. Treating ME with these therapies is even worse because exercise can actually be detrimental to the patient.

Summary of Karina's experiences prior to her forcible removal

In 2008 Karina was admitted to an arthritis hospital for a two-week treatment that involved GET. At the end of this stay she could only be active an hour a day. She was given the observational diagnosis of ME at this clinic.

At this time Karina and her family did not understand the concept of post-exertional neuroimmune exhaustion and the danger that forced exercise (GET) can have for ME patients. The doctors encouraged it as a way to get better and Karina and her family understandably followed this advice. In 2010, Karina was again pressured into hospitalization and once again her sensitivities to sound and light were not taken into account. During this time a doctor wrote in her journal that Karina had no depressive or psychotic tendencies. Karina and her parents knew that this hospital treatment would be detrimental to her and fought to take her home. The doctors admitted there was absolutely no cause to keep her for psychiatric reasons and she was able to go home. Eleven days later a well-known ME expert examined her and confirmed the diagnosis of ME.

Because of their past experiences, Karina's parents also had another ME expert come in 2011 to confirm the diagnosis and to offer suggestions for testing or treatments that could improve Karina's quality of life. They wanted to ensure that they were doing all they could to properly care for their daughter at home. The ME diagnosis was once again confirmed and further supplements and suggestions were made. At this time in March 2011, a local doctor and medical officer interviewed Karina and found her to be competent to decide her own treatment. Karina explained to them that she did not want CBT or GET and instead chose treatment advice from ME experts. The medical officer wrote an official document in which he accepts Karina's decision to choose her own treatment. With ME being diagnosed multiple times and Karina once again declared mentally competent the family felt secure that all the steps to keep Karina safe had been taken.

In May 2012 Karina had a surprise visit from her GP and another local doctor. The GP had been pressured by the Board of Health to make this visit to evaluate her mental state. Once again Karina was declared mentally competent and could therefore not be forced into unwanted treatment. However, they said they she would have to have a new psychiatric evaluation in a few days. At this time Karina and her parents chose to get her story out to the public in hopes it might protect her. Karina chose pictures that could be used and said she hoped it would help others in her situation.

In May 2012 Karina hired a lawyer and gave her parents power of attorney to make legal and medical decisions for her when she could not. During this time, the Board of Health assigned a psychiatrist to her case and he began contacting Karina's parents asking to visit Karina. Karina is under group 2 in the healthcare system which means she can chose any doctor she wishes and that the government cannot assign her one. She had chosen her own doctors and her family made it clear they did not want this psychiatrist involved in her case. They did not understand why he had any right to be involved in Karina's care.

This psychiatrist continued to insist that he see Karina and pressured them to admit Karina to a hospital, but he would not provide a treatment plan despite written requests by Karina's parents that he do so. The ME Association, Denmark offered to put him in touch with ME experts and have one visit Karina. This psychiatrist refused. In the fall of 2012, Karina's parents stopped all contact with this psychiatrist, but unbeknownst to Karina and her parents, this doctor did not stop his involvement in Karina's case. This doctor wrote to the Ministry for Health and Prevention asking about the right to keep relatives from visiting members in the hospital. He received the reply in a five-page answer that explains that human rights have priority.

Forcible removal and systemic stripping of Karina's patient rights

On February 12, 2013 Karina Hansen was forcibly removed from her bed and relocated to Hammel Neurocenter. A total of five policeman, two doctors, two caseworkers, and a locksmith arrived unannounced to remove one bedridden young woman from her mother's loving care. Ketty Hansen (Karina's mother) was physically held back while her daughter called for her to come help and repeatedly rang her bell (her way of calling for her mother).

The anguish in that moment would be indescribable. What an overwhelming display of force against a bedridden daughter and her mother! Karina used her cell phone to call and text for help. She tried to call her mother who wasn't allowed to answear. She called her sister and father and asked for help. This was an enormous expenditure of energy for someone as sick as Karina. Her adrenaline must have been pumping as she sensed danger.

Later reports showed that during this time the house and its contents, such a supplements, medications, and the food in the refrigerator were photographed. Presumably they were looking for evidence of neglect and, of course, did not find it as Ketty had always received praise for her care of her daughter by doctors who visited her home. Per and Ketty (Karina's parents) took excellent care of Karina. In the aftermath of this visit Per and Ketty found a note on the floor by the door. It said "to Karina's parents. You will be contacted by a head doctor every day at about 10:00 with information about your daughter. You may also contact the place of treatment at this phone number xxx-xxx between 13:30 and 14:30 every day." There was no name or address on the paper. This was the only piece of paper they received that day!

On February 13th Karina called her mother and said "How can I get out of here? I can't take it" and the connection was cut. That was their last contact. They later discovered that Karina made a total of 43 phone calls and sent 7 texts in an attempt to get help before her phone died. Her last call was a call to the police that lasted about 40 seconds. Transcripts have been requested but not provided.

Her family has requested multiple time that her phone be charged for her. The response they received is that Karina must do it herself but she cannot walk to charge it. This shows an extreme callousness to her condition and the extra help Karina needs because of it.

A brief review of the past year

Karina's parents were finally informed that Karina had been taken to a neurocenter for treatment of her "severe condition." They were told that Karina could not have visitors for 14 days and then it would be reevaluated to see if she could have visitors. Although this contradicts what we now know was communicated to this doctor prior to Karina's removal.

This original time period was then extended to 3 weeks because the psychiatrist was on vacation. Then the terms of visitation were that only visitors who supported the treatment given were to be allowed.

During this past year Karina's decision to give her parents power of attorney has been disregarded. She has been appointed a guardian by the state. The guardian did not know Karina or her wishes prior to this. He believes in the treatment Karina is receiving. Conversations in meetings with the caregivers at Hammel Neurocenter have revealed a deep prejudice against ME. One doctor went so far as to call those who believe in ME "imbeciles."

Karina's parents and attorney are fighting this battle in the court system. It is a long, slow, uphill battle. Meanwhile Karina should be afforded the right to the support of her family, the right to change healthcare providers, and the right to have complaints treated in a swift and just manner. She has told them "you are killing me" and she has begged to be allowed to go home, and yet they disregard her.

They have stripped her diagnosis of ME and replaced it with a controversial diagnosis of PAWS (pervasive arousal withdrawal syndrome). Considering Karina has had multiple doctors diagnose her with ME, a second opinion by an ME expert seems to be the correct choice. Karina's parents are asking that Karina's right to a second opinion be enforced. According to the Danish Health Care Act, 2010, a second opinion is allowed if the condition is severe or life-threatening. The Declaration on the Promotion of Patients' Rights in Europe states that all patients should have the possibility of obtaining a second opinion. (2.7)

A well-known ME expert has volunteered his time to see Karina. His travel expenses will be paid by a patient association. This seems a small and easily grantable request in light of this situation. Karina's parents wrote to the guardian asking to allow Karina to take advantage of this opportunity to see an ME expert. The guardian responded saying that he trusts the team at Hammel Neurocenter and that he believes Karina is currently receiving the correct treatment but he said he would bring up their request at the next meeting with the team at Hammel.

What you can do

Please join J4KH in asking that the guardian and the team at Hammel grant Karina this right to a second opinion! We have ways for you to join in listed below.

• Please like Justice for Karina Hansen on Facebook and follow us on twitter at Justice for Karina H @Justice4KarinaH to stay updated.
• Sign the petition to allow Karina to have a second opinion HERE. 
• Lend us the power of your social outreach and join us in a thunderclap for Karina! More information HERE. 
• You can see the open letter written to Karina's guardian by the managers of J4KH HERE. 

Sources:

1. Rynning, E. (2011), Nordic Health Law in a European Context: Welfare State Perspectives on Patient Rights and Biomedicine. Retrieved HERE.
2. Declaration on the Promotion of Patients' Rights in Europe,
3. Crowhurst, G. (2013) Severe ME, UK: Stonebird