Gratitude

Posted on November 20, 2012 by Jennie Spotila

We celebrate Thanksgiving in the United States on Thursday, and you may have seen the 30 days of gratitude meme on social media this month. I decided to share my gratitude in one post, and focus on aspects of my life with CFS. So here goes: 30 things I am grateful for in my CFS life.

  1. To say I am grateful for my husband is so inadequate. We met only two months before I got sick, and he has stayed with me through it all. I don’t think I would have made it this far without his support. I am blessed.

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  2. I am grateful that I was diagnosed after only 6 months of illness. Most people with CFS are not diagnosed at all, and even those who are diagnosed often spend years going from doctor to doctor before finding one knowledgeable enough. Early diagnosis made such a difference in my life because it confirmed for me that I was not crazy and made it possible to pursue disability benefits.

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  3. I am so grateful that I made the investment this year to have exercise testing. It was terribly hard, but I learned some very valuable information, and it is changing how I cope with the illness.

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  4. I work with only a few healthcare providers, but they all believe in CFS. When I have needed to consult a new doctor, I’ve always dreaded the CFS part of the conversation because I don’t want to deal with the dismissal and disbelief that are so common. So far, I have been very fortunate.

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  5. Some days it is hard to remember, but I am very grateful that I am not more disabled and ill than I am. There are patients who cannot get out of bed at all, or who deal with more severe symptoms than me in many ways. I am grateful for the capacity I have, even though that changes day to day.

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  6. Despite the slow pace of getting treatments and diagnostic markers for CFS, there are many researchers working on this disease. I am grateful to every single one of them, and have had the privilege of thanking some of them in person.

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  7. I am extremely fortunate to have disability benefits, and I am grateful to the attorneys who have helped me with that. Without those benefits, I would have spent the early years of my illness living with my parents. Things have not always been easy financially, but without my benefits it would have been much harder. I wish I didn’t need them, as I would much rather work, but I am grateful that safety net is there.

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  8. I am grateful to the doctors around the country who specialize in treating CFS patients. I have met only a few of them, but they are some of the most compassionate people I know. In more than one meeting, I have seen clinicians check on the patients in the room (including me) and try to help them. Most of us cannot see these specialists on a regular basis, but they help us all through their participation in research and in building a clinical knowledge base.

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  9. I am grateful for the understanding and support of my family. So many patients must contend with disbelief from spouses, parents, children and other relatives. My family gets it. Actually, it’s pretty funny to be at a family gathering and listen to the chorus of voices telling me to sit down when my heart rate monitor starts beeping.

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  10. I am deeply grateful to all the patients who advocate on CFS issues. I know how hard it is to do this while being sick. I have seen the toll it takes on people, and appreciate the sacrifices they make to help advance the cause. I cannot list everyone here (although that is a list that should be compiled), so I’ll give a global shout out to all of you.

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  11. I am grateful for my house. Many patients have to rely on family or are homeless because they cannot work and support themselves. Having a house gives me the luxury of space, a yard, and solitude – all of which help me cope with this illness that keeps me housebound.

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  12. As much as I hate it sometimes, I am grateful for my heart rate monitor. It gives me immediate feedback and warns me when I am pushing too hard. I hate the message, not the messenger.

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  13. I am grateful for my friends. I met some through my husband, some through the patient community. Some of them I know only from phone calls, email or Twitter. There is no substitute for the support of good friends, and the way they make me laugh is good medicine.

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  14. I am grateful for the internet. It is hard to imagine how isolated I would be without email, Twitter, or Facebook.

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  15. My brain does not work as well or as long as it used to, but I am grateful that I’ve retained enough cognitive function to write this blog, to read scientific papers, and to participate in advocacy. I wish I could do this 10 hours a day or more like I used to, but something is better than nothing.

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  16. I am grateful for my dog, Grif. He is my constant companion, and makes me laugh every day. He forgives me for not being able to take him for walks, and will play fetch even when I have to throw the toy from bed.

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  17. I am grateful for Laura Hillenbrand. She has proven it is possible to write great books despite being severely ill with CFS. She is one of my role models (and is also funny as hell).

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  18. I am grateful for my wheelchair. Without it, I could not travel or go to the movies (or a concert). I don’t do those things often, but I would not have the option at all without that wheelchair.

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  19. There are healthy people who have stepped up to the plate and are advocating on behalf of CFS patients. I am deeply grateful every day for their commitment, engagement and service. I have had the privilege of working with some of them, so a special shout out to Mary Dimmock, Denise Lopez-Majano, Kim McCleary and Suzanne Vernon.

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  20. Sometimes, I’m grateful to drink a cup of hot tea and watch the birds outside. I am not the kind of person who slips into quiet moments with mindfulness and ease, but I am grateful when I can.

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  21. To all the healthy caregivers, including my own, thank you. I know parents and spouses of CFS patients who could knock your socks off with the depth of their love and determination.

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  22. I am grateful for the new friend I made this year. She routinely emails and says “I’m going to the store. Send me your list.” She is a constant source of support and humor, and has a mean brownie recipe.

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  23. I know I am critical of the CFS Advisory Committee, but I am grateful the Committee exists and especially grateful to everyone who serves on that Committee. The public policy arena of CFS would be a barren and desolate place without that Committee as a vehicle for information and recommendations.

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  24. I have a few friends from “before” who have stuck with me. They are fierce. It takes a special person to stick with a friend even when her whole life and outlook changes. I am eternally grateful to these women.

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  25. I am grateful for the open access science movement. I need to be able to read research papers myself, and it is so frustrating when a paper I need is behind a paywall. I appreciate everyone who tries to make science more available to people like me who do not have access to a science library.

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  26. I am grateful for my house cleaners, and grateful that I can afford house cleaners. Clutter and mess and dirt drive me completely nuts, and I’m lucky to be able to foist part of that work onto other people.

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  27. I am thankful for my health insurance. Without it, I don’t know how we would manage to pay for the healthcare I need.

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  28. I am grateful for the pain medications that keep my pain under control most of the time. We have spent years trying to find the right combination of medications that I can tolerate and that provide enough relief to keep my pain bearable.

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  29. I am grateful that I learned how to knit and that most days I am able to do it. People joke that they knit so they don’t kill people, but I have found that knitting really does help me manage my pain and frustration, and relieves my boredom.

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  30. I am so grateful for my local library, and especially the online request system. If the book is in our county library system, I can get it without ever having to leave the house.

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  31. BONUS: When I started this blog, I wasn’t sure if anyone would read it. But here you are, and I am grateful to all of you. I appreciate all of your comments and emails. I appreciate that you share my posts on Twitter and Facebook, or link to my posts from your own blogs. I’ll try to keep writing things that are interesting to you or speak to you in some way.

 

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FDA Webinar on Advocacy

Posted on November 16, 2012 by Jennie Spotila

Yesterday, the FDA hosted a webinar for the ME/CFS community on “Working Together for Change.” Their stated goal was to show what has been successful for patient groups in the past in working with FDA and other entities. The slides and recording of the meeting will be available on the FDA website, and I will update this post with that link when it becomes available.

Dr. Sandra Kweder, Deputy Director of the Office of New Drugs (Center for Drug Evaluation and Research, FDA) opened the meeting with a presentation similar to the one she gave at the CFS Advisory Committee meeting on October 3, 2012. She reviewed the history of the FDA and the role of CDER in ensuring that only safe and effective drugs are marketed to the public. Dr. Kweder explained the review process and the unique challenges of evaluating drugs for conditions that do not have objective measures of disease state or signs. She suggested that ME/CFS advocates could learn from the process other disease groups have followed in addressing those challenges, such as irritable bowel syndrome, functional dyspepsia, depression, and fibromyalgia. Dr. Kweder’s advice included: partnering with organizations and centers equipped to conduct trials; recognize that a research definition is for research; filling in the gaps and remember that the science matters; and to be creative in learning from other groups.

I saw a lot of chatter during and after the meeting expressing frustration that this presentation was so similar to the CFSAC presentation. Neither slide deck is available, but the presentations did seem very similar to me. However, there were almost certainly participants in yesterday’s webinar who did not see the CFSAC meeting. Dr. Kweder provided essential background on what FDA does and does not do, and it is crucial for all advocates to understand this. I think it is reasonable to spend some time at these meetings making sure everyone has some shared basic knowledge.

Richard Klein from FDA’s Office of Special Health Issues provided an overview of the ways FDA seeks inputs from patients. He reviewed the history of how this process has evolved, particularly since the HIV/AIDS crisis of the 1980s. FDA uses several mechanisms in this process, including the Patient Representative Program which places patient representatives on advisory committees reviewing drug applications. Mr. Klein emphasized several things advocates should understand about FDA:

  • FDA works within a tight regulatory framework that restricts what the agency can and cannot do
  • FDA can guide sponsors of drug development but cannot direct drug research and development
  • FDA provides assistance but has no direct control over drug development
  • FDA must follow strict confidentiality rules
  • FDA is only one piece of a larger puzzle that includes researchers, industry, and Congress
  • FDA has a strict oversight role and that is its only role

Mary Dwight, Vice President of Government Affairs with the Cystic Fibrosis Foundation gave a presentation on the path that the Foundation pioneered in working with FDA. Cystic fibrosis is a rare genetic disease affecting approximately 30,000 patients. In 1955, the life expectancy for a child with cystic fibrosis was 5 years; today the life expectancy is to the 40s and beyond. This drastic change is the result of a successful drug development process, and the Foundation has played a critical role in that process. Ms. Dwight explained how the Foundation achieved this remarkable success:

  • Good science about the disease was essential, including the discovery of the cystic fibrosis gene by Dr. Francis Collins (now Director of NIH) in 1989.
  • Drug developers were reluctant to invest, so the Foundation provided venture philanthropy to spur investment. Drug developers also needed data and expertise, so the Foundation stepped up there as well.
  • They created a patient registry and Foundation-accredited care centers. This enabled them to connect the drug developers with the patients for clinical trials.
  • They created a national therapeutic network, coordinated from one central location, to provide best practices in study design, standardized research procedures and expert advice on correct outcome measures. They also assemble scientific consortia to foster communication and collaboration among researchers.
  • The Foundation sees FDA as a partner to talk about patient data, but that it is the patients’ job to bring the data to the table. FDA only evaluates data, it does not collect the data.

Ms. Dwight also said that as science and treatments have evolved, their approach has evolved too. She recommended that if the ME/CFS community does nothing else, it should collect natural history and group data for the patient population.

Pat Furlong of the Parent Project Muscular Dystrophy started her presentation by saying that ten years ago the Duchenne community was where the CFS community is now. Duchenne is a progressive and fatal genetic disorder affecting boys, with approximately 20,000 new cases per year. She said that stakeholders (patients, researchers, regulators, etc) interact with non-living parts of the system (regulations, etc) in an ecosystem of drug development. Ms. Furlong said that they modeled their process on the work of the Cystic Fibrosis Foundation, and started with a patient registry. While there is still no treatment for Duchenne, there are now drugs in the pipeline. She categorized the elements of a successful program:

  • Clinical infrastructure – patient registry; identify endpoints; research networks
  • Advocacy – increased money from NIH, DOD and CDC; direct engagement of regulators
  • Education – patients; drug developers; clinical trials; management of expectations (because this is a lengthy process)

Ms. Furlong said that her organization’s Board created a policy statement on its goals for FDA advocacy. They’ve held two meetings with CDER to discuss the policy and what data FDA needs. They are working with a consulting firm to develop and publish a risk-benefit framework for rare diseases, and are developing a parent survey on risk tolerance.

Participants had an opportunity to ask questions of the panel. Patricia Carter, myself, Marly Silverman, Courtney Miller, and Hillary Johnson made statements or asked questions. Steve Morin of the Office of Special Health Issues also invited people to submit questions since we ran out of time.

Overall, I found this webinar to be very informative, and not a little daunting. The CFS community is a long way from accomplishing what the Cystic Fibrosis and Duchenne communities have done. However, there are steps being made in the right direction. FDA will hold a meeting next year to address the issues of endpoints and outcome measures in CFS. The CFIDS Association is competing for prize money to fund patient registry projects. Several organizations, including the Chronic Fatigue Initiative and the CFIDS Association have established biobanks. CFI’s Bank will house 200 patient and 200 control samples; the Association’s Biobank has enrolled more than 500 patients and controls. One of the Association’s grants this year was to a pharmaceutical company to screen approved drugs for applicability in CFS. Finally, on December 20th, the FDA will hold an advisory committee meeting on Ampligen, the only new drug currently in the pipeline for CFS.

The main takeaway from the webinar was this: patients, advocacy groups, researchers, industry, NIH, CDC, FDA, legislators and policymakers must all cooperate to help make treatment for CFS a reality. As Mary Dwight said, forced collaboration among the players is essential but the patient is the only player who participates in every step of the process and is the only one with a holistic view of the disease. We must be at the table at each stage in the process.

 

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In Concert

Posted on November 14, 2012 by Jennie Spotila

I went to a concert on Saturday night. I know, right? Given how sick I have been, and how much I have struggled after outings, a concert sounds pretty crazy. In fact, I haven’t been to a concert in many years.

My first date with my husband was the Cranberries concert at The Tower Theater in 1994. We only dated two months before I got sick, but in that time we saw the Soup Dragons, Youssou N’Dour, and Stone Temple Pilots (give me a break, it was 1994!!!). Over the years, we’ve purchased and wasted tickets to more concerts than I can count. I’ve made it to a few, but more often than not I’ve been too sick to go. Concerts are a nightmare to people with CFS: it’s at night (sometimes very late); it’s loud; it’s crowded. Sensory overload is part of the package, on top of the physical effort of just getting there. Even on the few occasions I was able to make it to a show, I had to deal with terrible relapses afterwards. I always ended up wondering if a two hour concert was worth two or three weeks of recovery. After awhile, I gave up trying.

So why now? I am a huge fan of the Carolina Chocolate Drops, and seeing them in concert has been on my “Bucket List” for several years. This was more to me than just another concert. I love – no, LOVE – their music and what they are doing as a band. The Chocolate Drops are rescuing black string band and fiddle music and updating it for a new generation. This music is pure; the happy songs are joyful, and the sad songs are honest. These are songs about life: life is hard but take joy where you can find it, even in something as simple as cornbread and butter beans. Their music makes me think of family, leisurely afternoons on the porch, simple food, laughter, and sweet tea. The only Southern things about me are the fact that I was born in Arkansas and my years-long search for the perfect biscuit recipe, but this music touches my heart in a way I can’t fully express. Watch a few of their performances (try this one, this one and this one), and see if you don’t feel the same.

Still, my ability to go to a concert is a crapshoot at best and carries the steep price of weeks of illness afterwards. Seeing the Chocolate Drops in concert always seemed out of reach because their concerts were in the city, or had an opening act, or were too far away. Then an appearance in Reading, Pennsylvania showed up on their schedule and I started to plan. The distance was doable; there was no opening act; the theater is small; there was wheelchair seating. I cleared the decks for preemptive rest, giving up three other events in October to save the energy for this. The week prior to the concert, I restrained myself from doing just about everything. Even so, I felt shaky and weak on the day of the concert and probably would have stayed home if it was anyone besides the Chocolate Drops.

We sat in the first row, which meant we could see how the band members coordinated with each other throughout the concert. This is a talented group of musicians, each of them playing multiple instruments. They played a number of songs that are not on any of their albums, and talked about the history of the music they play – black string band, Piedmont fiddling, and the minstrel legacy. I was mesmerized by the bones, and despite a demonstration I still don’t understand how they get such complicated sounds just from knocking them together. The entire evening was magical from start to finish. My Mom, mindful of my limitations, pointed out we could leave early but the only way to get me to do that would have been to drag me out.

And then it happened, as I figured it would. During their performance of Leaving Eden, the magnitude of the experience crashed over me like a wave. That song makes me tear up on a good day: “I can’t tell my daughters all the things I’m scared of. But I am not afraid of that bright glory up above. Dying’s just another way to leave the ones you love.” I thought about the sacrifices I had made just to be there and share this experience with my family. I thought about the price I would pay afterwards. I had fantasized about this concert during long days of being bedridden, with no assurance that I would be able to fulfill this dream. I would have wept right there in the theater, but I bit back the tears so that my husband and parents would not be concerned. I let that music pass over me and through me. Sometimes, especially during the worst times, I am afraid. I feel like CFS will never get better, there will never be a treatment, and every crash could be my last: the one from which I will never recover. Those are long and lonely hours, and it is easy (perhaps natural) to forget that everyone at some point experiences the same level of suffering. This music reminds me that I am not alone; it tells me that I can carry on. This is soul-full music.

For a few hours on Saturday, I was paroled from the prison of my illness. I laughed, sang, clapped, and tapped my feet to some of my favorite songs. I felt triumphant in overcoming my disability and finding a way to achieve this dream. Thank you, Carolina Chocolate Drops, for your music and for sharing that moment with me.

 

 

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CFSAC Testimony of Dr. Joan Grobstein

Posted on November 8, 2012 by Jennie Spotila

Dr. Joan Grobstein delivered these comments to the CFS Advisory Committee at its October 3-4, 2012 meeting. She has kindly given me permission to publish them here.

Hello.  I’m Dr. Joan Grobstein.  I’m a physician.

My topic is responsibility.

Recently we’ve seen accomplished scientists honestly and courageously admit that their original findings about XMRV were mistaken.  They took responsibility for an error.  At its best, this is how science works:  form a hypothesis, test the hypothesis, revise the hypothesis.  We would like to see the same honesty and courage from scientists at CDC about the empiric definition.  The hypothesis that the empiric definition defines the same disease as either Fukuda or the Canadian definitions has been tested and found to be wrong.  Scientists at CDC must take responsibility for this error.  The original paper on XMRV in ME/CFS patients has been retracted. CDC should retract all papers using the empiric definition or, at least, rename them to indicate that they are studies of Idiopathic Chronic Fatigue and major depression, not ME or CFS.

NIH must also take responsibility:  fund studies that will clarify the definition controversy, as it did with XMRV.  Because we saw money appear quickly to study XMRV, we know that funds are available.  It’s clear that CDC’s new study about the definition is unlikely to be impartial.  They are vigorously defending their position.  During a recent phone contact with patients Dr. Unger said CDC could be “lumpers one day and splitters the next”.  This is a remarkably unscientific statement.  The scientific method demands that we rigorously define the conditions of our investigations.  Without understanding this, how can Dr. Unger be trusted to undo the harm to ME and CFS patients that the definitional conflict has caused?  Leaders at CDC must take responsibility and ensure that science done at CDC is impeccable.  There are biomarkers for Canadian-defined ME/CFS patients.  Does CDC wish to conceal that these biomarkers are not found in empiric-defined CFS patients?

Turning now to the responsibilities of the voting members of CFSAC, its staff, and its ex officio members, we’re all aware that very few recommendations made by this Committee have been implemented.

For example, CFSAC made three specific revenue-neutral recommendations  which have been ignored.  The first, from 2009, condemned the use of the empiric definition.  Despite this recommendation, CDC continues to publish studies using the empiric.  The second recommended removing the Toolkit from the CDC website.   The third recommended making IACFS/ME’s Primer widely available.  These last two recommendation were made 4 months ago.  Today, the Toolkit remains on the CDC website.  Meanwhile, CFSAC’s own website has a new link to the Toolkit and no link to the Primer.

Who’s responsible for the lack of action?  Committee members have fulfilled their responsibilities.  It says on the website they “asked” that these three things be done.  On the contrary, they are experts, and, as such, they made recommendations to the Secretary.  Yet neither the ex officio members nor the staff have apparently worked on implementation.  Dr. Koh’s comments gave no indication that he is aware of the importance of these recommendations.  In a letter to advocates explaining his refusal to meet, Dr. Koh said, “CFSAC provides a mechanism to ensure stakeholders are engaged and have the opportunities to offer input.”  Instead, it appears that CFSAC provides a mechanism to ensure stakeholders are contained and have opportunities to offer input that will be ignored.  So what is the point of CFSAC?  If it cannot accomplish these small, high impact tasks how can it accomplish what we really need:  significantly increased funding for research, better education and improved clinical care?  CFSAC costs $235,000 annually.  That sum could fund a study of natural killer cell function in Canadian-defined patients, or create a mechanism to identify an undiagnosed low-income patient, or educate a few more physicians.  I’m a taxpayer.  I’m concerned that we’re spending almost a quarter of a million dollars each year on a committee whose recommendations are routinely ignored by DHHS.

Here’s a suggestion.  Ask ex officio members to take responsibility.  Ask staff members to assign each recommendation to the agency or agencies with responsibility for implementing that recommendation.  Ask each ex officio member to report on activities to implement each recommendation at every meeting.  If nothing is happening ask for explanations from higher levels within the agencies.

We need to see progress.

 

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Hurricane Drunk

Posted on November 6, 2012 by Jennie Spotila

No walls can keep me protected
No sleep, nothing in between me and the rain
And you can’t save me now
I’m in the grip of a hurricane
I’m gonna blow myself away
(Florence + the Machine)

 

Hurricane Sandy made a beeline for my house. At least, that’s how I felt. We stocked up on food and water, assembled all the flashlights and batteries, and charged up the emergency radio. My husband flood-proofed the basement and and set up a mattress in the room farthest from all the big trees. We have a gas stove, so we knew we would be able to cook. We were ready.

And I was a mess. First, I stopped paying attention to the news because it upset me so much. Then I worked on a blog post to distract myself until my brain stopped working. Then I rushed to cook things before the power went out. And finally, I fell asleep on the couch while my husband monitored the basement and our power and the trees.

I’ve never experienced so much anxiety before a storm. Part of it was all the hype from the tv and social media. And part of it was legitimate given the scope of the storm and its aftermath. But I was acutely conscious that much of my anxiety was fueled by my powerlessness. What would I do if a tree fell on the house? How would I cope in a noisy shelter? What if we lost power for a week? What if the basement flooded? My journey into pacing has made me painfully aware of just how disabled I am. I no longer hold any illusions about my capacity to do physical work, or to handle stress, or to live outside the normal routine. I do not have capacity for those things. I feel like a prisoner in my home, and the prospect of damage to that home was simply overwhelming and deeply frightening to me.

Thankfully – miraculously – we were fine. We never lost power. The neighbor’s enormous tree fell away from the houses. Our basement did not get wet. Our families were not quite so fortunate. One disabled relative had to evacuate to a hotel for a week while her home was without power. Other relatives lost power when a tree fell on a neighbor’s garage, taking out two utility poles. And a family cottage at the Jersey shore was in the direct path of the storm, and flooded. There are months of paperwork, cleanup and repairs ahead to cope with that. But all of us are safe, and that is the most important thing.

The storm aftermath highlighted the extent of my impotence. My husband moved the disabled relative to the hotel. My husband spent a full day helping to clean out the flooded cottage. Me? I emailed the lawn service to ask them to clean up the leaves and branches in the yard. I was incapable of doing anything else. No one expected anything of me, except me. I watched our family work hard to cope and recover, and my contribution was to answer the door on Halloween.

This Makes. Me. Crazy. And sad, and useless, and powerless, and angry, and afraid, and dependent, and resentful. Why is this my life? How can I endure existing but not being of use? I’m not an elderly woman who has raised her family and contributed to society over many years. I imagine that it is easier to rest and let others do for you, after you have done for them over the years. But I am in the prime years of my life, trapped in a body that just gives out on me after the smallest physical tasks. I sat here, feeling like the hurricane was aimed at a bullseye on my back, and there was not a single damn thing I could do about it.

But I also know I am blessed and protected. The havoc that Sandy wreaked on millions of others is heartbreaking. Others are living the worst case scenario that I feared, and here I sit. Safe. But powerless to help anyone.

 

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Puzzle Pieces

Posted on October 30, 2012 by Jennie Spotila

Let’s play a game. Imagine you have a large puzzle that makes an Impressionist picture of a colorful cottage-style garden. You can put it together as long as you have the picture on the box. First you assemble the lower left corner, all lavender and yellow flowers. Another section of red roses sits somewhere in the middle. Near the upper right corner is a section of white and gray paving stones, and you also put together an area of green herbs although you are not sure where it goes yet. This puzzle will take a lot of time to solve, but with the finished image on the box you know that you’ll put it together eventually.

Now imagine the box is gone. All you have is a white/gray blob, and lavender/yellow section, the red rose section and another green blob. The rest of the pieces are all mixed up together, and while you can separate out some edge pieces and consolidate others by color, without the box you cannot even be certain what the final picture should look like. It’s frustrating, isn’t it, to have all those pieces on the table and not see how it fits together or even know for certain that you have all the pieces. That’s the feeling I got reading the American Family Physician’s article on Chronic Fatigue Syndrome: Diagnosis and Treatment. I dissected the AAFP patient information sheet on CFS in a recent post, but now I think it’s important to examine this review article by the same authors. The article attempts to present a finished picture of CFS for family practitioners, but so many pieces are missing that the paper bears little resemblance to the CFS I live with.

Generally Speaking

“Chronic Fatigue Syndrome: Diagnosis and Treatment” by Dr. Joseph Yancey and Dr. Sarah Thomas gives an overview of CFS for family physicians. They review the Oxford and Fukuda criteria, the basic lab workup recommended by CDC, and a list of exclusionary conditions. In a section on etiology of CFS, the authors quickly cover the immune system, genetics, psychosocial, adrenal system, and sleep/nutrition. Finally, the treatment section focuses on cognitive behavioral therapy (they say it works), graded exercise therapy (this works too), nonpharmacological (nothing really helps) and pharmacological treatments (these don’t work either).

In the authors’ defense, there are significant space limitations in the American Family Practitioner journal: 1,500 to 1,800 words in the case of clinical review articles like this one. There is no way to include all the information about CFS that family doctors need in such a limited space. It also appears that neither Yancey nor Thomas are CFS experts, based on the very limited information I could find online. I emailed Dr. Yancey, the corresponding author for the paper, on October 24th with a few questions but to date I have not received a response.

Method Madness

Drs. Yancey and Thomas describe their research methods as follows:

A PubMed search was completed using the MeSH term chronic fatigue syndrome. The search included randomized controlled trials and clinical trials in English from the past 10 years. We also searched the Cochrane database, Essential Evidence Plus, the National Institutes for Health and Clinical Excellence guidelines, and the Centers for Disease Control and Prevention Web site. Search date: August 26, 2011.

This methodology accounts for some of the missing pieces. First, anything published after August 26, 2011 was not captured in the search. That includes the IACFS/ME Primer, NCI’s paper on the risk of cancer among elderly CFS patients, the ME-ICC criteria, and the Rituximab trial. But before we forgive the authors’ oversight of these papers based on the date of their literature search, consider a curiosity I found in the paper references. The authors cite one paper published after August 26, 2011: The FITNET trial of internet based CBT for adolescents with CFS is included as reference Number 27. Does that strike you as odd? If the authors truly limited themselves to the references found on August 26, 2011 then this paper should not be included. Furthermore, of all the papers published after August 2011 to include in a review of CFS treatment and diagnosis, why was a CBT paper the one cherry-picked by the authors?

Even within the boundaries of the search methodology, the authors missed some papers that would have been helpful in their overview sketch of CFS. I attempted to recreate the authors’ search in PubMed, and found more than 1,300 clinical study papers alone. These include all of the letters critical of the PACE study and Tom Kindlon’s many letters and papers on the potential harms and inaccuracies in CBT/GET studies. Other important papers such as the spinal fluid proteome by Schutzer, et al., the differential gene expression post-exercise paper from Light, et al., and the cytokine network modeling by Broderick, et al. were captured in the PubMed search but did not make it into this review paper.

Finally, there are several seminal papers that are not returned in the PubMed search. The Journal of Chronic Fatigue Syndrome published the Canadian Consensus Criteria by Caruthers, et al., in 2003. This case definition is gaining broad acceptance among policy makers and researchers, but it does not show up in a PubMed search because the journal was never indexed in Medline. Another example is the Van Ness, et al. study showing the significance of two-day exercise testing in differentiating CFS patients from controls. This is a critical paper, suggesting a possible diagnostic test (albeit an extremely unpleasant one) for CFS. But because the journal was never indexed, these papers do not show up in a PubMed search and so non-experts like Yancey and Thomas never see them.

Cognitive Bias

I do not know what Dr. Yancey and Dr. Thomas believe about CFS, including whether they believe the illness is primarily psychological in origin. After reading this paper, however, I fear this may be the case. I can best illustrate this through examples.

In the opening paragraph of the article, the authors say “CFS is often mentally and emotionally debilitating, and persons with this diagnosis are twice as likely to be unemployed as persons with fatigue who do not meet formal criteria for CFS.” What about physically debilitating? If the authors recognized the physical disability experienced by many CFS patients, and the physical suffering of all of us, wouldn’t they mention it in this paragraph? This simple omission is a very subtle way to communicate that people with CFS are not physically ill.

There is a brief discussion of the case definition in the paper. According to the authors, the 1988 CDC definition focused on physical symptoms, and the 1991 Oxford definition “emphasize mental fatigue over physical symptoms.” But the criteria, printed as Table 1 in the article, require fatigue to be “severe, disabling, and affects physical and mental functioning.” I’m no fan of the Oxford definition, but even I can see the requirement of physical disability. Again, Yancey and Thomas gloss right over the fact that CFS has serious, physical symptoms.

In discussing the biopsychosocial model of CFS etiology, the authors say: “CFS is often associated with depression, which has led many physicians to believe that CFS is a purely psychosomatic illness. Evidence supporting this conclusion is lacking.” Fair enough. But then they say, “Strong evidence suggests that childhood trauma increases the risk of CFS by as much as sixfold.” Sigh. I covered this in my dissection of the patient information sheet. Childhood trauma may have physical systemic affects, but I am not aware of any evidence showing that CFS patients have higher rates of trauma compared to patients with other illnesses like MS or lupus or diabetes or cancer. In my opinion, it is misleading to single out childhood trauma as a risk factor for CFS in the absence of such evidence.

The authors devote space and attention to CBT and GET studies, and this is understandable given the fact that CBT and GET treatments have received the most study in CFS. CBT “can help persons with CFS recognize how their fears of activity lead to behaviors that ultimately cause them to feel more fatigued and disabled.” It is true that CBT can help patients correct activity avoidance behavior, but in my experience this is a very small minority of patients. Even the CDC, target of so much criticism, does not describe CBT this way. The CDC says: “CBT can be useful by helping them pace themselves and avoid the push-crash cycle in which a person does too much, crashes, rests, starts to feel a little better, and then does too much once again.” This is a more appropriate description of CBT that acknowledges the importance of self-management and the prevalence of the push-crash cycle, as opposed to the activity avoidance highlighted by Yancey and Thomas.

Graded exercise therapy is very controversial for CFS patients, mainly because traditional GET uses a scheduled increase process as opposed to a patient-driven increase process based on symptoms. Not surprisingly, this issue is not discussed in the paper. The authors do mention that a heart rate monitor can be used to avoid overexertion during exercise, but there is no mention of the body of evidence on CFS exercise testing and pacing methods. They even cite a study that suggests improvements in GET do not correlate with increases in exercise capacity, suggesting that GET may actually work by “decreasing symptom-focusing behavior in persons with CFS.” Pacing, the only behavioral technique that truly helps CFS patients, is not mentioned by name, although the authors do say:

Patients should be encouraged to take rest periods as necessary, and to practice relaxation techniques. Although there is no evidence these modalities are effective, they are unlikely to be harmful and may be helpful.

Neither CBT nor GET is curative because it does not target the underlying mechanism of illness. CBT is not curative for cancer or heart disease either, for the same reason. Drawing the conclusion that these therapies are not curative because of the patient is a fallacy, but this is the conclusion that Yancey and Thomas suggest:

Despite the positive results of CBT and graded exercise therapy, the effects are usually moderate and rarely lead to resolution of CFS. Patients with poor social adjustment, a strong belief in an organic cause for fatigue, or some sort of sickness benefit (i.e. financial incentive) tend to have worse responses to therapy. Unlike with many other illnesses, membership in a CFS support group was associated with worse outcomes.

The study cited by the authors in support of these statements is this one from 2002. That study points out its own limitations: it uses the Oxford definition, lost 17% of the patients to follow-up, and did not actually measure the exercise capacity of the patients. But this is the kind of evidence that is sufficient for Yancey and Thomas.

The overall tone, selective quotation, and reference choices give me the impression that the authors believe CFS to be a psychological condition, at least in part. I do not know this for a fact, but if I read only this article about CFS and nothing else, I would believe that it is an emotional problem. It’s not just the amount of space devoted to the psychosocial research. The authors focus on the psychological elements to the exclusion of discussion of physical disability, post-exertional malaise, and the well-documented physiological findings in this illness.

Missing Pieces

There are huge gaps in this paper. Orthostatic intolerance, an issue for most CFS patients, is not mentioned at all. Post-exertional malaise is not explained, and no CFS exercise studies are referenced. The importance of medications and other treatments in managing sleep and pain issues is ignored, and pain is barely discussed at all.

This article illustrates a few pieces of the puzzle, mainly CBT, GET and the psychosocial model of CFS. A family physician reading only this article would not be able to separate chronic fatigue from CFS patients, and would understand almost nothing about the complexity of CFS. I found the tone to be generally hopeless: try therapy and exercise but it probably won’t help you much. Maybe a motivated physician would visit the CDC website (and this illustrates the importance of fixing problems in those materials).

No one will be able to assemble the CFS puzzle using the pieces in this article. Too much evidence is ignored, too much emphasis is placed on the psychosocial pieces, and there is very little information about how to manage the other symptoms of the illness. I know the full picture exists and I can identify the gaps. But a family physician who does not have the picture of the box will not recognize all that is missing and will never be able to assemble the pieces in a way that will help CFS patients.

I fear that doctors will rely on this article to provide the same kind of advice I received from doctors in 1994: keep going to the gym, staying in bed is the worst thing you can do, get some counseling, there is nothing else we can do to help you. This bad advice and hopelessness did not help me, and may have even hurt me by keeping me much more active than my body could tolerate. It was years before I found and received adequate care for pain, sleep, and orthostatic intolerance, and even more years before I found expert help for pacing and activity management. This article will do nothing to change the way doctors treat CFS, and will reinforce the destructive pattern already in place.

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Patient Focused Drug Development

Posted on October 25, 2012 by Jennie Spotila

The FDA hosted a public meeting this morning to discuss the Patient Focused Drug Development (PFDD) initiative. The meeting was available via webcast, and a transcript will be published on the FDA website. CFS is on the list of candidate diseases to be included in this process, so the meeting was of great relevance to us as patients and advocates.

The goal of the Patient Focused Drug Development Initiative is to create a more systematic way for FDA to collect and use patient perspectives on the burden of disease and the risk/benefit ratio of treatments. While patient input is used in a variety of ways in the drug approval process, it is not as systematic and comprehensive as is needed. Dr. Janet Woodcock, the director of FDA’s Center for Drug Evaluation and Research, explained that FDA wants to understand patients’ perspectives on the burden of illness, how it affects daily life, how treatments affect those symptoms and outcomes, and what degree of risk is acceptable for the benefits. Every patient has a different experience of disease burden and tolerance for risk, so collecting single patient input on these questions may not capture the full spectrum of patient experience. The selection of twenty conditions (from the proposed list of thirty-nine) is intended to be a pilot program to help the FDA figure out how best to collect this input more generally.

Dr. Teresa Mullin, Director of the Office of Planning and Informatics, explained that making a determination of the balance between treatment risk and benefit requires an analysis of the condition and the current treatment options. Patients can speak to the clinical manifestations of the condition that have the most significant impact on them, as well as other aspects of the condition that affect daily life. Patients can also speak to how those impacts change with disease progression, and share their own experiences of the current standard of care and all treatments being used (including non-pharmacological treatments). While many of these issues have been considered and discussed from the clinicians’ point of view, it is very common for patients to have a very different view of the symptoms they feel most affect daily life or how well treatments work (or not) over time. Dr. Mullin said that the objective of this PFDD process is to create a systematic way to collect broad patient input and capture it in a usable and useful format to be used by review panels when considering products for approval.

In discussing why the FDA selected the thirty-nine candidate diseases, Dr. John Jenkins, Director of the Office of New Drugs, said that collective patient community input was essential throughout the approval process from the oversight of trials through post-approval safety issues. He pointed out that the patient perspective is very different from that of consumer safety advocates. For example, patients with asthma have a very different risk tolerance with inhaler medications compared to safety advocates who do not have asthma. Several division directors explained why their divisions had proposed specific diseases, including Dr. Theresa Michele from the Division of Pulmonary, Allergy and Rheumatology Products. Dr. Michelle is also FDA’s ex officio representative to the CFS Advisory Committee, and she spoke about the severity of CFS and why her division recommended its inclusion in the PFDD process.

Most of the remaining time of the meeting was devoted to hearing public comment. In an attempt to give everyone time to speak, comments were limited to two minutes but this was not enforced by the meeting moderator. Patients and advocates representing diverse conditions spoke about why their disease should be part of this process, including Alpha-1 antitrypsin deficiency, alopecia, ALS, Alzheimer’s, amyloidosis, arthritis, angioedema, Batten disease, blood cancers, brain tumors, dystonia, gastroparesis, hereditary cancers, inflammatory bowel disorders, interstitial cystitis, kidney diseases, lung diseases, melanoma, migraine,  muscular dystrophy (including Duchenne), and narcolepsy. Four members of our CFS community spoke: Mary Dimmock, Joe Landson, Amy Squires, and Mary Schweitzer.

Several things struck me during all the public testimony. First, I found it heart-breaking to listen to so much suffering. Dealing with CFS, we sometimes have blinders on and I think we forget how many other millions of people are suffering from poorly understood diseases with no treatment and no help. One man with ALS said he would celebrate if he had some of the other diagnoses on the proposed disease list, and did not understand why ALS was missing from the list. A woman with gastroparesis described her suffering in brutal detail, and drew a parallel between her experience and having the stomach flu every day. How many times have we CFS patients described our illness as having the worst influenza every day? It quickly became clear that for all the advances in medical care, there are too many diseases and too many patients and too many families suffering.

Second, a number of advocates pointed out that by selecting individual diseases, FDA had caused a “disease war,” in which groups were competing to get on the list. As an alternative, they proposed hosting PFDD meetings on body systems (lungs, nervous system, immune system, etc) or other factors (such as severity or availability of treatments). They reasoned that the combination approach would allow more diseases to be represented and capture more diverse patient input.

My personal opinion is that this would be a mistake. This is intended to be a pilot process to collect input that will be useful to drug review panels. I do not believe that a systems approach will collect the level of detail on CFS or other illnesses that is necessary for reviewers. How can a meeting on gastointestinal disorders capture a sufficient level of detail on patients with Crohn’s disease and gastropareisis that can be used in the drug approval process for a treatment for only one condition? And what about diseases like CFS and amyloidosis that do not have a single body system “home”? I believe FDA needs to drill down to a fine level of detail in collecting and understanding patient perspectives, so I hope they will not start combining conditions in an effort to cram more disease groups into these meetings.

Your input is necessary now! The public docket to submit comments on the disease list closes on November 1st. If you can, please write to FDA and give your perspective on how CFS meets the following criteria:

  • Disease areas that are chronic, symptomatic, or affect functioning and activities of daily living;
  • Disease areas that reflect a range of severity;
  • Disease areas for which aspects of the disease are not formally captured in clinical trials;
  • Disease areas that have a severe impact on identifiable subpopulations (such as children or the elderly);
  • Disease areas that represent a broad range in terms of size of the affected population
  • Disease areas for which there are currently no therapies or very few therapies, or the available therapies do not directly affect how a patient feels, functions, or survives.

FDA will take several months to review the collected input and decide upon the first twelve diseases for PFDD meetings in 2013 through 2015.

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Mary Dimmock’s Comments to the FDA

Posted on October 25, 2012 by Jennie Spotila

Mary Dimmock presented a shortened version of these comments at the FDA meeting today on the Patient Focused Drug Development initiative. She has kindly given me permission to post her comments in full here.

My name is Mary Dimmock and I am a member of a national alliance of patient organizations and patient advocates representing patients with Chronic Fatigue Syndrome, also known as myalgic encephalomyelitis or ME/CFS.

The popular misconception is that ME/CFS is chronic tiredness due to deconditioning, depression or poor diet. That is what I thought until my energetic, smart, adventurous 23 year old son was struck down by ME/CFS after contracting Giardia while backpacking across Asia. Overnight, he went from academic excellence and scaling mountains to being unable to work, seldom able to leave the house and too often unable to do more than lay on his side in a dark room, in constant pain.

He is not alone. One million Americans of all ages, races and socioeconomic groups and 17 million people worldwide have been struck down overnight by this complex, multi-system disease that causes significant immune and neuroendocrine abnormalities; brain dysfunction and neurocognitive defects; cardiovascular and autonomic disturbances and abnormalities in energy production including mitochondrial dysfunction. As a result, patients suffer devastating functional impairment that results from the profound exhaustion, unrefreshing sleep, joint and muscle pain and cognitive problems that include difficulty thinking, slower processing speed and impairment of memory. These symptoms are exacerbated after even minimal mental or physical activity and can result in a relapse called post-exertional neuroimmune exhaustion that can last hours, days, or weeks. For some, even minimal activities like talking to a friend on the phone for a few minutes, taking a bath or making a meal for themselves can cause post-exertional neuroimmune exhaustion.

The CDC has said that ME/CFS can be as disabling as multiple sclerosis, lupus, rheumatoid arthritis, heart disease, end-stage renal disease… and similar chronic conditions.”  Patients can be sick for decades and many have been sick since outbreaks in the mid-1980s. Twenty-five percent of patients are bed-bound, house-bound or wheel-chair bound. Ten percent of patients are pediatric, some as young as 5. The inability to attend school, play with friends or even participate in family activities during their developmental years has a particularly harsh and lifelong effect on children. Overall recovery is rare and one study found that patients are more likely to die prematurely from cancer, heart disease or suicide.

And yet, today, there are no treatments for ME/CFS that are capable of even minimally improving patient functionality of changing the long-term outcome of the disease. There is only one ‘disease modifying’ drug being progressed through the FDA review process. The lack of agreement on definition, endpoints and how to measure treatment outcomes has impeded drug development. The drugs that are used provide only very limited relief for specific symptoms like pain but have little impact on the overall level of functioning. There are a small handful of experts nationwide who will prescribe antivirals or immune modulators to try to change the course of the disease but most doctors are unwilling to prescribe such drugs. Some of this reluctance is because they do not recognize that for patients, the disease severity warrants the risk.

The resultant reality for many patients is that they will spend every one of the rest of their days in pain, disability and isolation, functionally so limited that they are unable to work, care for their families or even sometimes take care of themselves.

It is time that we peeled back the misunderstanding and looked closely at the severity of this disease, the dramatic loss of functionality that these patients experience and the total lack of approved treatments. It is time we looked at how these patients would view the benefit-risk of a drug that would give them back even a small portion of their lives.

Please include ME/CFS for the one million Americans who suffer from this terrible disease. Please do this for all those sons and daughters who are not yet sick so that they never have to experience the nightmare that my son lives every single day.

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FDA Input Sought

Posted on October 20, 2012 by Jennie Spotila

As part of its commitment under the recently approved Prescription Drug User Fee Act (PDUFA V), the FDA will be conducting an initiative, called the patient-focused drug development initiative, to provide for a more systematic approach to obtain the patient’s perspective on the disease severity and the currently available treatments. The intent is to ensure a thorough understanding of the severity of the treated condition and the adequacy of the existing treatment options.

This initiative will be conducted for each of 20 different disease areas over a period of 5 years. The FDA has nominated an initial list of 39 diseases, including ME/CFS, using the following criteria:

  • Disease areas that are chronic, symptomatic, or affect functioning and activities of daily living;
  • Disease areas that reflect a range of severity;
  • Disease areas for which aspects of the disease are not formally captured in clinical trials;
  • Disease areas that have a severe impact on identifiable subpopulations (such as children or the elderly);
  • Disease areas that represent a broad range in terms of size of the affected population
  • Disease areas for which there are currently no therapies or very few therapies, or the available therapies do not directly affect how a patient feels, functions, or survives.

The next step in the process is for the FDA to gather public input between now and November 1st on which of disease areas should be selected for inclusion in this initiative. Additional disease areas may also be nominated during this time.

Note that initiative is in addition to the ME/CFS FDA stakeholder meeting that Dr. Woodcock, Director of the Center for Drug Evaluation and Research at the FDA, has already committed to.

How can you help:  For ME/CFS, this is an excellent opportunity to help the FDA better understand how ME/CFS affects the patients. Your support is essential to ensure that ME/CFS is one of the 20 selected diseases.

Please send your comments in by November 1 to ensure that the FDA understands why ME/CFS should be selected as one of the 20 diseases.  

Comments can be submitted electronically, or by regular mail to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Make sure you include the docket number (FDA-2012-N-0967).

Further information on the patient focused drug development initiative and the list of 39 diseases initially nominated can be found here.


 

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This. Is. Why.

Posted on October 17, 2012 by Jennie Spotila

I’m on the verge of tearing my hair out, and I suspect I’m not the only one. The American Academy of Family Physicians published a review article about CFS (paywall) on Monday, accompanied by a patient information sheet. From the very first sentence, this information sheet is a disaster. It packages harmful misinformation for family doctors to share with patients. Let’s take a look:

Chronic fatigue syndrome (CFS) is a disorder that causes you to be very tired.

NO! No it does not! A person with sleep apnea is tired. A nursing mother is tired. A perfectly healthy person studying for the bar exam is tired (ask me how I know). CFS does not make me tired. CFS causes prostration, a medical term that means a collapse from complete physical or mental exhaustion. Using the word “tired” is not only medically inaccurate, it falsely minimizes the severity of my disease and my experience.

People with CFS may have other symptoms, such as poor sleep, trouble with remembering things, pain, sore throat, tender lymph nodes, or headaches.

Can you spot what’s missing? Post-exertional malaise! The generally accepted hallmark symptom of this disease is not on the list. It is the first symptom on the Fukuda criteria list of accompanying symptoms. But it’s not listed here and not explained to the patient.

Not everyone with CFS has all of these symptoms.

I know hundreds of CFS patients. Every single one of us has experienced these symptoms for extended periods of time, if not daily, over the course of years. While it is technically correct that the Fukuda criteria do not require all of those symptoms, it is an oversimplification to simply say we don’t have all the symptoms. And of course all the other symptoms and overlapping conditions are not mentioned at all.

Childhood trauma (for example, physical or sexual abuse) may raise the risk of getting it.

I am aware of two studies that showed a higher prevalence of childhood trauma among CFS cases compared to healthy controls (this one and this one). Here’s the problem: childhood trauma may raise the risk of many disorders later in life. Without comparing the prevalence rate of trauma among other illness groups, there is no way to know if the association with CFS is unique. Are there studies comparing the incidence of childhood trauma among people who develop multiple sclerosis, rheumatoid arthritis, cancer, hepatitis, heart disease or  . . . oh, that’s right. Doing that kind of study in those illnesses might be offensive because those illnesses are real. But we can do those studies in CFS with no problem.

Two treatments can help with CFS: cognitive behavior therapy (CBT) and graded exercise therapy. With CBT, a therapist teaches you about how your thinking affects how you feel and act. With graded exercise therapy, you slowly increase your physical activity, which hopefully increases your function.

You know where this is going, right? Setting aside the arguments about whether CBT and GET studies actually show a benefit, and setting aside how this sort of statement plays right into the mental illness meme, let’s talk about GET. Will GET increase CFS patients’ functional ability? Maybe some patients, but it should be pursued with extreme caution and prejudice. As the work of the Pacific Fatigue Lab and my own exercise testing results show, the energy metabolism systems of CFS patients are severely impaired. We do not make or use energy, or recover from activity, the way other people (including other illness groups) do. Graded exercise must be undertaken very carefully because it takes very little activity to push a patient into a severe crash.

I shudder to think about how family doctors will use this information sheet, and what it will do to the patients who receive it. What is truly remarkable about it is that it bears only a passing resemblance to the full review article and the AAFP’s patient education page on CFS. But this watered down, oversimplified summary of misinformation about CFS will undoubtedly be used, and it is likely to make things worse for patients, not better.

So does anyone – journalists, doctors, policymakers, or other observers – wonder why the CFS Advisory Committee and patient advocates have been begging CDC to fully revise its website and remove the harmful content that filtered into this information sheet?

This is why.

Does anyone wonder why the CFSAC  recommended that the CDC remove its Toolkit from the CDC website?

This is why.

Does anyone wonder why an alliance of organizations and patients wrote a lengthy and heavily referenced position paper in support of that recommendation?

This is why.

Does anyone wonder why there was such vigorous disagreement at the CFSAC meeting about whether professional societies like the AAFP should be invited to participate in revising the CFS case definition?

THIS. IS. WHY.

 

 

Update November 2, 2012: Author Toni Bernhard published a great article about the AAFP patient information sheet.

Update October 31, 2012: I’ve also published a detailed analysis of the AAFP review article on CFS.

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