Winning Contestants

Posted on September 17, 2012 by Jennie Spotila

Two contests, one that you may have heard of and one that you may not, are active right now with CFS related organizations in the running for cash.

The Chase Community Giving contest on Facebook features two CFS organizations competing for $10,00 or more. Facebook members and Chase customers vote for their favorite charity, and prizes are awarded to organizations receiving the most votes. The contest closes on September 19th, and both Phoenix Rising and the Neuro-Immune Disease Alliance are currently (as of 11am Eastern) at 69 and 148, making them eligible for $10,000 and $20,000 respectively.

The Collaborate|Activate Innovation Challenge is new to me. Sponsored by the pharmaceutical company Sanofi, this contest is looking for proposals teaming two or more non-profit or professional medical advocacy groups “to foster innovation and collaboration to develop solutions that enable people to become more engaged in their health.” The CFIDS Association partnered with a number of organizations to submit two proposals:

  • First, the Association partnered with the National Vulvodynia Association and the TMJ Association to submit a proposal for “Partnering to End Pain,” a web-based system that would connect chronic pain patients with clinical trials across multiple diseases. This is especially relevant for the many CFS patients like me who have also been diagnosed with other overlapping chronic pain conditions.
  • In the second proposal, The CFIDS Association partnered with Genetic Alliance (which hosts the Association’s SolveCFS BioBank), the National Psoriasis Foundation and the Inflammatory Breast Cancer Research Foundation to submit a proposal for “Registries for All Diseases,” a registry using patient-generated information regarding rare diseases to accelerate clinical trials.

Today, it was announced that BOTH proposals were selected to be in the top four proposals out of hundreds received. Along with their partners, the Association will share $25,000 and guidance from a professional mentor to refine each proposal. Then on October 29th, the four groups will present their proposals to an impressive panel of judges, and the winner of $300,000 will be announced on November 15th. The Association is the ONLY nonprofit organization to be represented twice in the top four proposals!

All three of these CFS organizations are raising the profile of our fight against this disease. I’m especially excited about the CFIDS Association’s success because of the panel of judges and sponsorship by a pharmaceutical company. While Chase Giving is, by design, a popularity contest (that has been plagued by problems in the past), the Collaborate|Activate Innovation Challenge is a merit competition. Even if the Association does not place first or second in the final competition, it will benefit from the process of refining their proposals and working with mentors, as well as the exposure to pharmaceutical companies and health organizations. This is a huge and exciting step forward! Through their success in this first round of the competition, the CFIDS Association has helped legitimize the illness for a large new audience. I can’t wait to see what comes out of this competition.

Congratulations to NIDA, Phoenix Rising, and the CFIDS Association for competing in these contests to benefit all patients!

 

 

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Will FDA Step Up?

Posted on September 13, 2012 by Jennie Spotila

The Federal Drug Administration held a conference call today to speak with CFS patients, advocacy groups and other interested parties. This is the first time in the history of this disease that FDA has communicated with the patient community in such a broad and direct way. I was fortunate enough to attend the conference call, and offer this summary of the discussion.

This call happened through the efforts of patients to secure an FDA Stakeholders Meeting. The meeting premise is modeled on a similar process between FDA, HIV patients and others in the 1980s and 1990s. Through sustained communication, FDA and HIV patients came to an understanding of the need for accelerated drug approvals balanced with FDA’s focus on safety and effectiveness. CFS patients and advocates have secured a commitment from Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER), to hold a similar meeting on ME/CFS. The goal of that Stakeholders Meeting is to discuss acceleration of treatments, access to treatments and evaluation of treatments. Understanding the burden of disease from the patient perspective and how to measure those effects are an essential part of developing new therapies.

Today’s call was led by Dr. Sandra Kweder, Deputy Director of the Office of New Drugs within CDER, and she provided some key information:

  • FDA considers CFS to be a serious or life-threatening condition. This means that drug applications can qualify for the Accelerated Approval Process. Accelerated Approval brings drugs to market after shorter clinical trials, and additional studies are done after that approval. This is how many HIV drugs have been approved, as well as drugs for cancer and other conditions.
  • FDA will offer a webinar on “Excellence in Advocacy” in November 2012. The purpose of the webinar is to show advocates how they can speed the development and approval of treatments through engagement of researchers and pharmaceutical companies. I find it a little ironic that FDA will be telling us how to be better advocates, but I think this will be an important session. FDA has been through this process with HIV and other serious conditions; they must have a perspective on what works and what does not.
  • Ampligen will be considered for approval at a public meeting on December 20, 2012. This meeting will feature an FDA panel, as well as public comments from clinicians, patients and others.
  • FDA will hold the 1.5 to 2 day stakeholder meeting in the spring of 2013. This meeting will bring together other federal agencies, researchers, clinicians, pharmaceutical companies and patients. It emerged during the call that a major goal of the meeting will be identifying consensus endpoints. In this context, endpoints are the reliable quantitative measures that will be used in clinical trials to evaluate whether a treatment is working.
  • FDA takes no position on the name issue of ME v. CFS. What they focus on is whether a treatment improves patient condition. They are using the term ME/CFS as a framework for that process but take no position on lumping vs. splitting in defining the illness.
  • There are currently 8 open applications for new drugs to treat CFS. Dr. Teresa Michele stated that many of those applications are for nutritional supplements, with small early trials. FDA expects that agreement on measurable endpoints will speed and increase research into other treatments.

Two issues emerged during the discussion through the comments made by patients on the call. First was the issue of case definition. While FDA insisted that it does not take a position on definition or name, many patients pointed out that case definition shapes research results. It’s been well established that some criteria sweep in people with idiopathic chronic fatigue or depression. In order to evaluate if a drug helps people with ME/CFS, then the case population must be carefully defined. FDA seems to recognize this as an issue, but there was no clarity on what requirements they might make in study design.

The second issue was endpoint measurements: how do we know if a treatment is working? What can be measured in clinical trials to determine effectiveness? In a condition like high blood pressure, it’s clear that the desired endpoint is a lower blood pressure measurement. But in our disease, what can be reliably and quantitatively measured as endpoints? Multiple suggestions were made, including VO2max, natural killer cells, and actimetry data. Debra Waroff offered the “salad” endpoint: whether she is well enough to make a salad. Dr. Kweder seemed to like that measure, as it is a measurement of functional improvement in patients’ lives. Identifying a consensus around endpoints will be a major feature of the 2013 meeting.

Overall, I think this call was very positive. I would have liked to have heard more on FDA’s processes for orphan drugs and accelerated approvals. I also want to know more about how the 2013 meeting is being planned, and how patients can add the most value to that process. But I give FDA a lot of credit for holding today’s conference call and appearing to be so open to our input. If this is a sign of things to come, then I think we can have high expectations for the meeting in 2013.

 

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Testimony Tips

Posted on September 11, 2012 by Jennie Spotila

The CFS Advisory Committee meeting is less than a month away (October 3 and 4), and sign ups for public comment opened last night. At every CFSAC meeting, the public is given the opportunity to offer comments, but you have to register and submit your testimony in advance. I thought it might be helpful to share a few tips that I’ve learned over the last several years of testifying at these meetings. These work for me; your mileage may vary.

Know your audience – You are talking to several groups of people: the voting members of the CFSAC, the ex officio representatives from a number of agencies (such as CDC, NIH and Social Security), and the general public (chiefly patients and advocates). Tailor your comments to one or more of those audiences. I always try to address the voting members of the Committee as my primary target, with the ex officios as a close second. It’s the voting members who have the power to act in the meetings by issuing recommendations to the Secretary; that is their role.

Say something new – The Committee has heard many many illness narratives in which patients talk about their struggles. I believe it is important to keep these stories in the collective face of the CFSAC. But I also think it is important to say something new. Is there a topic that you think has not gotten enough attention? Do you have a unique perspective? For example, we never heard much from young people with the disease until a few meetings ago. Those comments were very effective and grabbed the Committee’s attention, in part because it was something new.

Ask for something concrete – Specificity is much more effective than generalizations, if for no other reason than you can measure progress towards a goal. For example, asking that the government help people with CFS is non specific. Asking that Social Security add CFS to the list of disabling conditions is specific and concrete, and it is easy to assess whether the request has been fulfilled. In the past, I’ve asked that the Committee brief the Secretary of Health and Human Services, that they recommend NIH issue an RFA with $10 million, and that they keep closer track of the Department’s responses to their recommendations. As I said previously, I usually address my comments to the voting members of the Committee since they are the ones who can act in the meetings.

Use emotion strategically – Talking publicly about our experiences with this disease is emotional, and sometimes anger or sadness comes out in testimony. In almost every case, I think this increases our credibility. But I also think it is important to harness our emotions and see them as a strategic element of testimony. If our grief or anger becomes distracting to the audience, it lessens the effectiveness of the message. Think about the point in your comments that are the most emotional for you, and let your emotions show at that point only. Giving public testimony is not just about having our say; it’s about communicating effectively to an audience. Use your emotions to help get your point across.

Protect your privacy – Whether you give comments in person or on the phone, your name and comments become part of the public record unless you specifically request to speak anonymously. The meetings are recorded and video posted online. Your written comments will also be posted to the CFSAC website. Think about what you are saying: are you comfortable with the public knowing details about your medical history? what if your insurance company found your remarks? Make sure you think about this in advance, and tailor your comments to your level of comfort. Alternatively, ask that your comments be kept anonymous.

Follow the rules – The CFSAC has procedures and rules for public testimony. You have to sign up in advance, and your comments are limited to five minutes. There are a number of legitimate complaints about these rules, including the requirement that written comments be submitted prior to confirmation that you have a slot and the disallowing of video comments. But in preparing your own remarks, follow the rules. Otherwise, you risk not being heard at all. The biggest pitfall is the five minute limit. Make sure your comments are five minutes long – you will be cut off if you run over time, and the rest of what you want to say will be lost. In my experience, it takes about five minutes to read 700 words.

Practice practice practice – Do your comments fit within the time limit? Can you read them smoothly? Are you speaking clearly and slowly? Practice. Read your comments aloud, as many times as possible. Even better is to read them to a friend or family member. The more you practice, the better you will sound.

Written comments for this meeting are due September 24th, so I’ll be drafting my remarks this week. I hope you will join me in testifying at a future meeting. Our voices must be heard!

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Imperfect

Posted on September 7, 2012 by Jennie Spotila

I’ve had a craptastic week. Three crash days, including one that involved a three hour “nap.” I don’t understand what triggered these crash days, but I never do. Usually, crash days take me by surprise because whatever activity I’ve been doing just doesn’t seem to be significant enough to cause a crash. My husband is rarely surprised by my crash days; he’s always had a better sense of my limitations.

Last week I made jam and had a doctor’s appointment. We had a family dinner to go to on Sunday, so I did very little on Friday, Saturday and Sunday – I just sat on the couch knitting and watching soccer. The crashing started on Monday, and seemed to get worse through Wednesday. I completely gave in on Wednesday, taking that three hour nap and just spacing out the rest of the time. I had hoped to write several blog posts this week, and maybe work in the garden for a few minutes. I did none of this, and am writing this post from bed.

Through all of this, I have been monitoring my heart rate. With two exceptions, my heart rate was good last week. I generally stayed under 95 beats per minute, and when I did go too high I immediately stopped what I was doing to rest. On both Wednesday and Sunday, I left the house which meant showering, drying my hair, applying makeup. On both days, my heart rate soared as high as 110 beats per minute during the process of getting ready. I took rest breaks (shower, rest, dry hair, rest, get dressed, rest, etc.) to bring my heart rate down, but then it would jump when I moved to the next step in the process. It was frustrating to say the least. On both Wednesday and Sunday, I had several episodes where my heart rate was high and I briefly felt like I might pass out. And on both days, my heart rate stabilized while I was out of the house to around 87 beats per minute.

So were those episodes the cause of these crash days? Was it the high heart rate while I was getting ready? Or was it the near fainting episodes? Both? Or was the crash the result of leaving the house twice? Or that plus making jam? Or none of the above? All of it? This, in a nutshell, is the maddening part of living with CFS. Despite everything I have learned about pacing, despite monitoring my heart rate carefully, I still have crash days. And because life is not a carefully controlled experiment, I don’t know which component or combination of conditions caused the crash days.

I hate crashing. I hate being unable to do simple things like sitting upright to knit, or talking to friends on the phone. I hate being unable to accomplish the things on my modest to do list. I hate the feeling that I am just taking up space and using resources without producing anything or giving something back. And I hate not knowing – after all these years – how to avoid crashing.

Using a heart rate monitor for pacing is an imperfect system. The monitor can’t capture the energy drain of cognitive and emotional activity. And despite my staying within the heart rate limits and breaking activities into pieces for an entire week, just two hours of elevated heart rate was possibly enough to cause three crash days. The heart rate monitor is imperfect, and I am most definitely imperfect in applying that system.

You know what else I hate? Complainy blog posts. I don’t like writing them, and I assume people don’t like reading them. So I will end this on a positive note. A friend called me yesterday from the store to ask what I needed. I couldn’t think of anything, but she insisted. When she dropped off the fruit I asked for, she also brought me flowers for no other reason than that I had a bad week. This friend has struggles of her own, but she took the time to take care of me this way. It turned my whole week around, because now I feel profoundly grateful instead of defeated. It’s the love and support of my family and friends that makes this illness bearable.

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Adapting

Posted on August 31, 2012 by Jennie Spotila

I remember my mother and grandmother canning every year. My grandmother would put up jars of peach halves and applesauce, and my mother made strawberry jam. It always seemed like a silly waste of time to me, since you can buy all those things in a store. But canning is a thing now, and on a whim I decided to try it a couple years ago. One batch of strawberry jam and I was hooked. I can’t explain it, but there is something extraordinarily satisfying about hearing the ping of jars sealing because then you know you’ve done it right.

But canning is a high energy activity. There are several places in the process where you can’t stop for a break. The boiling water in the canner heats up the kitchen. Many recipes require constant stirring. I always dissolved into a puddle on the floor after a canning session. The day I turned 50 pounds of tomatoes into 13 quarts of tomato sauce comes to mind as an example of the insanity.

When I started using the heart rate monitor, canning was one of many hobbies that seemed completely incompatible with this new way of pacing. Certainly my old way of canning is now impossible. But could I adapt the process to be more heart rate friendly? My husband bought a peck of peaches at our local farmer’s market, so I decided to give it a shot. Here’s what happened:

  1. Gather equipment (canner, funnel, tongs) and wash jam jars. Move very slowly so you don’t set of the heart rate monitor.
  2. Sit down for 10 minutes.
  3. Blanch peaches.
  4. Sit down for 5 minutes.
  5. Peel peaches and chop. Mix peaches with lemon juice and hope they won’t turn brown while you rest.
  6. Lie down for 15 minutes.
  7. Drink a large glass of water.
  8. Drag chair over to stove so you can sit while you stir the jam. Make jam.
  9. Wonder how sick women managed to survive on the frontier. Decide that they didn’t.
  10. Remove jars from boiling water. Wonder why no one has invented a better jar lifter that makes you less likely to scald yourself.
  11. Fill jars with jam. Quietly exult that there is one half-jar of jam that will have to be consumed immediately.
  12. Add lids and move jars back to the canner.
  13. Drink a large glass of water. Resist the burning urge to do all the dishes. Lie down for 10 minutes instead.
  14. After jars have boiled for 10 minutes, remove lid and turn off heat. Start the dishes.
  15. After 5 minutes, remove jars from the canner and wait for that lovely PING! as the lids seal. Finish the dishes.
  16. Collapse on the couch.
  17. Test jam on a piece of toast.
  18. Wonder how you got a splatter of jam on the back of your tshirt.
  19. Admire your lovely jars of jam.

Did taking rest breaks make it easier? Yes. My heart rate monitor went off a couple times, but never for very long and the highest it went was 100 beats per minute. I was still exhausted at the end of the process, but I don’t think it was quite as bad as previous canning sessions. That may just be wishful thinking since I don’t have hard data from past years for comparison. My pre-heart rate monitor canning would have taken 1.5 hours. Adding in the rest breaks extended it to 2.25 hours.

I think I’ll pat myself on the back for giving this a try. Rather than assume that this hobby is off limits because of the way I used to do it, I tried to adapt it to my limitations. It’s bittersweet because I was happy to be doing it, but also frustrated that I couldn’t work as fast as I did before. It would be easier if I could recruit help (anyone want to wash my dishes?). And I doubt I’ll be tackling monster projects like 13 quarts of tomato sauce. But I’m really proud of my peach jam, and it will taste better for the effort that went into it.

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Preemptive Rest

Posted on August 28, 2012 by Jennie Spotila

I continue to wear my heart rate monitor every day, and generally listen to its alarm.  When it starts to sound, I sit down (although not instantaneously I will admit). And when I hit the part of the day where it goes off every time I get up or move around, I know I’m done for the day. If I’m lucky, it’s after dinner. But I’ve found that whenever I am really active, the trigger-happy time of day comes earlier. I don’t know for sure, but it seems to me that once I’ve used up whatever energy stores I have, my heart rate rises more easily and stays elevated. A constant alarm is a pretty hard signal to ignore, and if my family is around it’s impossible. One good thing about the alarm: my husband and family are insistent about my listening it. Double edged sword, that, since it’s impossible to get away with overdoing it.

Today, I started the next phase of incorporating my true anaerobic threshold into my daily life: preemptive rest. In his self-help course, Bruce Campbell says that preemptive rest is one of the most important tools for people with CFS. Preemptive rest, or rest to prevent symptoms, is scheduled rest taken regardless of how you feel. By resting before you feel tired, it is possible to reduce symptoms and improve stamina. In the context of the anaerobic threshold, resting before reaching that threshold gives your body a chance to recover from activity before you have gone into “oxygen debt.” In theory, this might increase the sustainable amount of overall activity by rebuilding energy stores before they are depleted.

I’m skeptical. I don’t doubt that the theory has merit. I’m skeptical about my ability to follow through with it. Lying down when I’m not tired seems like a waste. My capacity is so limited, it seems pointless to take a break before I get tired. Along with scheduling preemptive rest, my physical therapist believes that limits on the length of time I spend at any activity will also help. She says that I should take a break after 20 minutes of any activity, but I pushed back on that one. Take a break after 20 minutes on the computer? I can’t get through my email in 20 minutes. I also worry about losing my train of thought. It takes such concentration to write. If I have to take a break every 20 minutes, I’ll have to gear that concentration back up over and over. I would much rather work on a task to completion. I also resist such a regimented approach to getting through the day. Again, my capacity is already so limited that it’s hard to apply even more restrictions to myself.

So we negotiated a compromise. I will take two scheduled rest breaks a day: 20 minutes in the morning and 40 minutes in the afternoon. I will take rest breaks after 20 minutes of physical activity. This means breaking tasks like making dinner into smaller chunks and extending it over more time. And I will take a break after one hour on the computer. I’m tracking my activity, heart rate and symptoms every 30 minutes this week. It’s a laborious pain in the arse, but I don’t think I will stay on track without that kind of record keeping. Otherwise, I’ll just lose track of what I’m doing and how long I’ve been at it.

I took my scheduled rest today, but I did not experience any difference in my stamina or symptoms. It’s only been one day, so it’s impossible to draw any conclusions. I suspect that the benefits from this will only become evident over time, possibly over several weeks. I just hope I have the patience to see it through.

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Another Day, Another Letter

Posted on August 24, 2012 by Jennie Spotila

Last month, I joined six advocates in sending a letter to Assistant Secretary Howard Koh regarding the recent vacancy on the CFSAC and a proposed change to the committee charter. Yesterday, I received the response below. While there are no promises in the letter, I was pleasantly surprised that it was more than a one line acknowledgement. Someone in Dr. Koh’s office read our letter and drafted a response that acknowledged each of the points we made.

One new piece of information: the nominations from 2011 are being reexamined to fill the current vacancy. There is one statement that may give us a window into the type of replacement we will get. Specifically, Dr. Koh says there are current members with multiple areas of expertise which provides some flexibility regarding the charter membership requirements. Does this mean that the new appointee will not be a biomedical researcher?

It’s not much, but it is the most substantive reply to one of my letters that I have ever received from an Assistant Secretary for Health.

Dear Ms. Spotila,

Thank you for your letter regarding the current vacancy in the Chronic Fatigue Syndrome Advisory Committee (CFSAC) membership and the proposed addition of non-voting liaison representatives. I appreciate your interest in this important work.

Due to the recent resignation of a member of the CFSAC, my office is working to identify a new appointee. As stated in your letter, nominees from 2011 are still eligible for selection and are being considered to fill the current vacancy. Of note, the Secretary of the Department of Health and Human Services (HHS) must approve all member appointments to CFSAC.

I also appreciate your attention to the balance of expertise on the committee. In considering nominees, HHS will ensure that the appropriate balance is maintained in accordance with the charter. Also, you mentioned in your letter someone with biomedical research experience is now required to meet the specifications of the charter. However, there are current members with multiple areas of expertise which provides some flexibility regarding requirements for the incoming member.

Your final comments addressed the proposed addition of non-voting members to the committee. While successful precedents for this model exist, I am grateful for your suggestions and will take them into consideration.

Thank you for your attention to these issues as we work toward the mutual goal of addressing chronic fatigue syndrome. Please share this response with your co-signers.

Sincerely yours,

Howard Koh, M.D., M.P.H.

Assistant Secretary for Health

 

 

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Tale of Two Letters

Posted on August 22, 2012 by Jennie Spotila

Advocating for an adequate federal response to CFS usually feels like banging your head against a brick wall. Every once in awhile, you knock out a brick but it feels like so much more because you’ve been banging away for so long. Two recent letters from the US government regarding CFS have given me the it’s-just-a-brick feeling.

Assistant Secretary Koh to the CFSAC

On August 3, Assistant Secretary Howard Koh responded in writing (pdf) to the CFSAC recommendations from its November 2011 meeting. At first, I was appalled by the nine month response time. But then I realized that this is the most substantive written response that the CFSAC has ever received to its recommendations from the Department of Health and Human Services. I applaud Dr. Koh for responding to the CFSAC in a manner similar to his responses to other federal advisory committees, such as the Advisory Committee on Blood Safety and Availability.

The meat of the response is the three page attachment that addresses each of the November 2011 recommendations in turn. There is very little new information here. The CFSAC recommended an RFA for clinical trials, but the letter refers only to the current program announcements and repeats what we already know about the Trans-NIH Working Group. The CFSAC recommended real or virtual Centers of Excellence be formed through an HHS interagency working group, but the letter describes what we already know about the Ad Hoc Working Group. The CFSAC recommended that CFS be classified as a Disease of the Nervous System in the ICD-10-CM, but the letter only summarizes the process of proposals being considered by the Coordination and Maintenance Committee.

The letter does offer a little new information in response to the CFSAC recommendation that the process of transmitting recommendations to the Secretary be clarified. The letter explains that CFSAC recommendations go to the Assistant Secretary for Health (per the charter), who then forwards them to the Secretary and the relevant Operating/Staff divisions. The Assistant Secretary sends the CFSAC a letter acknowledging receipt of the recommendations, and may include any relevant updates. Finally, all information about the recommendations is provided to the Committee’s Designated Federal Officer who then shares that information with the CFSAC. Note that this process does not guarantee a response to the CFSAC from the Secretary, nor does it promise any kind of response to each recommendation. It is entirely possible that a recommendation could go from the Assistant Secretary to the relevant division, and for no information to come from that division to the DFO. This is, in fact, what seems to happen with some frequency.

This letter represents a single brick knocked out of the wall. It’s the most detailed and substantive response the CFSAC has ever received from an Assistant Secretary, but there is very little new information included and no progress to report on the recommendations themselves.

President Barack Obama to Courtney Miller

Now this letter has gotten the CFS community all stirred up! In April 2011, Courtney Miller and her husband, patient Robert Miller, asked President Obama at a town hall meeting what he could do to address the paucity of NIH research funding for the illness. The President promised to look into the matter with NIH. After a great deal of persistent follow up by the Millers, who deserve tremendous credit for their efforts, President Obama responded in writing (pdf).

There is no new information in the letter itself. The President summarizes the state of CFS funding at NIH (which we are well acquainted with), and mentions the State of the Knowledge meeting and the two current program announcements. The President also mentions the DHHS Ad Hoc Working Group that “is working to develop a Department-wide strategy to address the disease.”

But there is one very significant sentence at the end of the letter: “I have asked [Deputy Chief of Staff for Policy Nancy-Ann DeParle] to stay in touch with Dr. Collins at NIH and Dr. Koh at HHS about my interest in their efforts on CFS.” Courtney Miller also reports that according to Deputy Chief of Staff DeParle the President has asked NIH to “elevate the priority” of CFS.

Did the President promise more money? No. Accelerated progress at FDA? No. A national strategic plan crafted with stakeholder input? No. Resolution on the name and definition issues? No. While I understand the excitement this letter has caused among many patients, it is not a game changer. It’s not a solution.

BUT it is progress. When the President tells the Director of NIH to elevate the priority of CFS, that will have some impact. When a White House Deputy Chief of Staff periodically checks in with Assistant Secretary Koh about the President’s interest in their efforts on CFS, you can be pretty sure that Koh will want to have something to report. In my opinion, Presidential and Congressional attention is the only way we will see real change and progress on CFS. This is a step in that direction. (If you would like to thank the President, there is a suggested way to do so here.) It is also critical for the CFS community to recognize that if President Obama loses the election in November, we go back to square one. A new President and new Assistant Secretary will likely have little knowledge of CFS and we’ll have to start all over again.

These letters represent progress, but they are single bricks. If there is a brick wall between us and a cure for CFS, then these letters each represent one brick removed from the wall. In my opinion, the wall has barely been damaged. But this is how we’ll do it: brick by brick.

 

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New Life

Posted on August 15, 2012 by Jennie Spotila

I always wanted kids. When my husband and I got married, we thought three kids sounded like a good plan. Even though I got sick two months after we met, and was still sick when we married less than two years later, we bought a house with a large yard and in a good school district. We wanted a family.

One of my closest friends got pregnant about a month after my wedding. And watching her, I realized that pregnancy is hard. And having an infant is hard. Raising children is hard. According to the newly published CFS/ME Primer for Clinical Practitioners, pregnancy is not contraindicated in women with CFS, and some women may even feel better during pregnancy, perhaps due to increased blood volume. But it goes without saying that having kids is hard on healthy people. It is even more difficult for people with CFS.

So we decided to wait. It was impossible to imagine that I could be sick for longer than two years, or three, four, or five. So my husband and I decided to put off having kids until I felt better, or was at least more stable. Then we thought about how much help we might need, and whether we could afford that help. What kind of parents would we be, given how much we struggle to cope with CFS every day? The years rolled on, and I stayed sick. Eventually, we realized that we would not be able to have children.

This is my biggest loss to CFS. Being a mother was not just part of my plan, it was part of who I was as a person. And it’s not just my loss. My husband will not be a father. It seemed that my parents would not be grandparents. I felt guilty about being the source of this difficulty, and I felt like a failure.

Enter my niece, E. My brother and his wife gave birth to a gorgeous baby girl last week. My parents are, at long last, grandparents. And we have a new life in our family. To hold a baby is a delight, and to watch my brother and his wife become parents is a true gift. Watching them this week has shown me that my husband and I made the right decision. We could never have done this. The energy required to cope with a baby’s physical needs is far beyond my reach, to say nothing of the emotional side of parenting. I’ve been wearing my heart rate monitor while helping to take care of E, and it is abundantly clear that having a baby would have been leagues beyond my physical capacity. This does not make me sad; it gives me peace. Our decision not to have children was painful, but it was the right decision.

E is beautiful and healthy and a blessing in every way. I can’t imagine how we coped without her all these years, and she was definitely worth the wait.

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Free Turkeys

Posted on August 7, 2012 by Jennie Spotila

A keystone of successful efforts to combat complex diseases like CFS has been lacking for thirty years: strategic coordination. Other illnesses, including autism and Alzheimer’s, are now benefiting from coordinated federal strategic plans. In the last year, the Department of Health and Human Services has taken steps in that direction for CFS, but at present this initiative is in a black box and completely inaccessible to those of us who will be most affected by the outcomes of the effort.

In April of 2011, the NIH hosted the long anticipated State of the Knowledge Workshop. Secretary Sebelius sent a letter to the meeting, saying in part, “I want to assure you that several agencies within the Department of Health and Human Services (HHS) are working together with the Chronic Fatigue Syndrome Advisory Committee and advocacy groups to develop interdisciplinary initiatives that will address important aspects of this illness, including improved diagnosis and treatments.” (Letter from Secretary Sebelius, April 7, 2011.)

No details were provided at the Workshop, but a little more information came out at the May 11, 2011 CFSAC meeting. Assistant Secretary Dr. Howard Koh said that there was a “high-level leadership meeting with the Secretary on ME/CFS” in March 2011, and that “they reviewed the status of research, clinical care, education.” According to Dr. Koh, CFSAC ex officio members were at the meeting and that “agency heads of the departments” had met several more times since. (CFSAC Meeting Minutes, May 22, 2011 p. 4)

I saw this as a sign of progress. Advocates, including myself, had repeatedly asked that the Secretary to be personally briefed on CFS and the recommendations of the CFSAC. In my public comment at the May 28, 2009 meeting I said, “Until Secretary Sibelius recognizes CFS as the crisis that you already know that it is – until word comes from the top down that CFS is a fire – I fear nothing will change.” Was this March 2011 high level meaning a sign that things might be changing?

At the November 8, 2011 CFSAC meeting, Dr. Koh announced a new working group formed by the Secretary in an effort to coordinate work on CFS across the Department. “The group will report back to the Secretary an inventory of efforts in the field of CFS going on throughout the department. The group will do its best to coordinate strategies across the department in a more coherent fashion. The group will make its work available on the CFSAC website.” (CFSAC Meeting Minutes, November 8, 2011, p. 17) Dr. Nancy Lee said that the Secretary was asking each agency to send a representative to the working group who has decision making authority, and that she was chairing the working group. (p. 43) The next day, Dr. Lee said:

This is still a work in progress. The process was begun out of the Office of the Secretary. We found out about it after it had been going on for several months and we have been involved in it ever since. There has been a preliminary and currently incomplete inventory of things that various agencies are doing in CFS. There is a table that shows this. There are draft steps to be taken. There will not be a published document. The end result is going to be some strategy steps and some action steps. There is a draft memo that is currently planned to come from one of the Secretary’s four counselors. The memo will be sent to the heads of the DHHS agencies outlining the working group process and asking them to appoint an individual to participate in the group who is sufficiently high level to make decisions on behalf of the agency. If any CFSAC ex officios are chosen as participants, they will have to be high‐level enough to make decisions. This is a process that is anticipated to include just three to five monthly meetings. There then may action steps to continue. Dr. Lee will chair the group. The action steps will be posted on the CFSAC website. (CFSAC Meeting Minutes, November 9, 2011, p. 49)

This announcement was very promising, although there was one thing missing: stakeholder input. As described, this working group was made up of high level agency representatives who would review current efforts and identify strategy steps, but there was no indication that anyone outside the Department would be consulted or involved.

Seven months passed, and we heard an update on the working group at the June 13, 2012 CFSAC meeting. Dr. Koh said that the ad hoc work group has met twice, chaired by Dr. Lee. The participating agencies are NIH National Institutes of Health (NIH), Centers for Disease Control (CDC), Agency for Healthcare Research and Quality (AHRQ), Substance Abuse and Mental Health Services Administration (SAMHSA), Center for Medicare and Medicaid Services (CMS), Food and Drug Administration (FDA), and Administration for Children and Families (ACF). At the two meetings, the agencies “put forward accomplishments and opportunities for the future that would begin new efforts and conversations, identify new activities, and try to do the best we can in a very difficult funding environment.” Two preliminary ideas proposed were to have a national webinar on CFS and establish a patient registry, but the conversations are ongoing. Dr. Koh provided no timeline or additional specifics, although he noted, “Getting all these leaders in the department to come to the same table and establish a common agenda is never easy but these two meetings have been productive and we’re going to have more until we have more deliverables to present to you.”

It sounds promising, and is certainly more high level attention on CFS than we’ve had before. But the slow pace and lack of specifics is a bit troubling. In a joint letter to Secretary Sebelius signed by advocacy groups and individuals, advocates requested a meeting with key Department personnel to discuss the community’s concerns and begin to address key priorities, including stakeholder participation in formulation of a cross-department strategy. In the Department’s response, Dr. Lee said that “HHS has convened an Ad Hoc Workgroup on CFS to develop a Department-wide strategy to address CFS and allow active collaboration among agencies. . . . . The next meeting will be held later this summer and include the opportunity to discuss these issues.”

Given the high interest in the activity of this group, and the stated desire by Drs. Koh and Lee to improve communication with the advocacy community, I believe we are entitled to more specifics about this process. On June 25, I requested additional information from Dr. Nancy Lee about the Working Group, including a list of the individuals serving on the Group and minutes of all the Group’s meetings. On July 17, I received the following reply:

We do not plan to release detailed information on the Ad Hoc HHS CFS Workgroup as it is an internal HHS workgroup. The group has been tasked to identify past agency accomplishments and efforts regarding CFS and identify new opportunities for collaboration and coordination in CFS activities. We have no formal minutes of the past meetings. An outcome of the workgroup will be a report that will be posted on the CFSAC website. Because the workgroup is not yet complete in its fact-finding efforts, and because the final report will need to be reviewed by all participating agencies, it will probably not be posted until 2013. (emphasis added)

This is disappointing, to say the least. It is true that documents containing staff advice, opinion and recommendations can be withheld from the public under FOIA. But Drs. Koh and Lee have repeatedly emphasized the need for greater transparency in the work of the Department. Furthermore, in November 2011 Dr. Lee said that the process would involve three to five monthly meetings. Seven months later, we learn that the group has only met twice and the third meeting is planned for later this summer. The impression given at the November 2011 and June 2012 CFSAC meetings was that this group is moving efficiently, if not swiftly, and that the final product of action items would be posted on the CFSAC website. No one established any timeline publicly, nor promised any deadline. Now we know the truth. No details will be released about the work of this group. There will be no stakeholder participation. The final report will not be posted until some time next year.

This Working Group is being presented to us as evidence that HHS agencies are working together to coordinate efforts in a coherent fashion. Much has been made of the requirement for the agency participants to have decision-making authority. But no one should mistake this effort for a strategic plan such as that produced forAlzheimer’s Disease. That plan, which was mandated by Congress, was drafted with input from thousands of stakeholders, including doctors, policy makers, researchers, and patient advocates.

The HHS Working Group will not produce this sort of plan for us, not even close. What we’ve been promised is a report in 2013 that inventories what is currently being done across HHS, and which will hopefully include new initiatives (possibly the national webinar and patient registry). Dr. Koh’s caution about the budgetary climate is, in my opinion, code for “don’t expect anything new that will cost a lot of money.”

It is a sign of small, incremental progress that the Secretary formed this group and that agency representatives will make some sort of coordinated report. Perhaps we’ll finally see a Surgeon General letter like the CFSAC recommended in May 2007 and October 2009. But it is nonsense for the Department to tell advocates that a meeting to discuss a strategic, coordinated and fully-funded plan is not needed because the Department has already undertaken such an effort. This Working Group will not be producing a strategic plan and is unlikely to bring new funding to the table. I don’t appreciate the “don’t call us, we’ll call you” tone adopted by the Department, either.

It’s a bit like addressing America’s hunger problem by giving out Thanksgiving dinners. The effort is needed, but Thanksgiving is just one meal. No one would turn down a free turkey, but no policy maker or anti-hunger activist would claim that the free turkeys solve hunger in America. At least, they wouldn’t make that claim with a straight face.

In our case, this Working Group’s effort is needed but it won’t solve the problem. This disease causes suffering on an epic scale, and there are a multitude of policy, scientific and medical issues that need to be addressed. Patients and their families have developed significant expertise in many of these issues out of necessity. This expertise should be leveraged to the fullest extent possible in order to produce a coordinated, strategic, and fully-funded plan to address all these issues.

I won’t turn down a free turkey, but I see it for what it is: a gesture that is more symbolism than substance.

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