IOM Process Check

Posted on November 4, 2013 by Jennie Spotila

checkmarkControversies continue to swirl around the Institute of Medicine’s study to create a clinical case definition for ME/CFS. I have new information to share, as well as important information about the process IOM uses for its studies. In preparing this article, I corresponded with Jennifer Walsh in the Office of News & Public Information at the Institute of Medicine, and spoke with a number of ME/CFS advocates. The IOM follows the same basic process for every study. This four stage process is described on the IOM website, and is well underway in the ME/CFS study.

First Stage, Complete

In stage 1 of the study, the IOM staff works with the study sponsors to define the formal “statement of task.” For the ME/CFS study, the sponsors are HHS and the Social Security Administration (an error on the IOM webpage originally identified the sponsor as NIH but that has been corrected). The statement of task “defines and bounds the scope of the study, and it serves as the basis for determining the expertise and the balance of perspectives needed on the committee.” This stage has been completed and the statement of task has been posted. This statement of task is distinct from the Statement of Work provided to me by HHS, but uses language pulled directly from that document. Jennifer Walsh told me that stage 1 is complete, and the staff has moved on to stage 2.

Second Stage, Underway

In stage 2 of the study, the committee is selected and approved. Obviously, the composition of the committee is one of the most significant influences on the final outcome, and so great care must be taken at this stage. Committee members are screened for conflicts of interest, defined as:

any financial or other interest which conflicts with the service of the individual because it could significantly impair the individual’s objectivity or could create an unfair competitive advantage for any person or organization. The term “conflict of interest” means something more than individual bias. There must be an interest, ordinarily financial, that could be directly affected by the work of the committee.

It is critically important that we understand this. A point of view or bias is not always a conflict of interest. This is good and bad for us. It’s good because it means that the experts who signed the letter to HHS should not be automatically disqualified for having done so. Their publicly expressed point of view should not, by itself, prevent their appointment to the committee. But it’s bad for us because it means that those who believe ME/CFS is a psychological disorder will also not be automatically disqualified.

At the beginning of committee selection, the IOM solicits nominations from a wide range of sources. IOM sent requests to multiple ME/CFS organizations and individuals. I have confirmed that at least five six organizations and multiple individuals (including myself) submitted nominations to the IOM. PANDORA and Rocky Mountain CFS/ME & FM Association are the only organizations that have released their nomination lists to the public. The CFIDS Association submitted nominations, but told me they would not be releasing their list. The other three organizations have been reticent to state even the fact that they submitted names, let alone release their lists. Given the roasting that PANDORA has experienced for participating in the process, this reluctance is not surprising. For the record, I nominated Dr. Leonard Jason, Dr. Lucinda Bateman, Dr. Peter Rowe, Dr. Chris Snell, and Dr. Lily Chu.

Once nominations are received, the IOM reviews and approves a provisional slate for the committee. That provisional slate is posted on the study website, and the public has 20 days to comment. Jennifer Walsh told me that they plan to post the slate by the end of November/beginning of December. The publication of the list will be announced via a listserv created for this project, and you can sign up for that listserv on the project page. Advocates, be ready. The slate will come out in close proximity to Thanksgiving and the CFSAC meeting on December 10th-11th. Our comments on the slate will need to be prepared and submitted quickly.

At the same time as the public comment period, the IOM will schedule the first committee meeting based on the members’ availability. At least part of that first meeting will be closed to the public, and will include a substantial discussion of potential conflicts of interest. Based on that discussion, background forms, and public comment, the committee slate is finalized and approved.

Third Stage

The third stage of the study process begins at the first meeting (with the provisional committee slate). During this stage, the committee gathers information, deliberates, and drafts their report. Information is gathered through public meetings, submissions from outside parties, reviews of scientific literature, and investigations by members and staff. Efforts are made to gather input from people who have special knowledge of the issue under consideration. The statement of task for this study specifically includes stakeholder input from patients and practicing clinicians.

Walsh told me that the committee and staff will decide how best to engage the public in this study. Public meetings are announced at least 10 days in advance, and webcasts have also been used in other studies. The specifics will be determined by the committee itself. However, Walsh also said that the public can submit outside materials at any time during the study by sending them to mecfs@iom.edu (Updated: IOM asks that we use mecfs@nas.edu). These submissions are subsequently available to the public through the public access folder of the project.

I hope ME/CFS advocates will take advantage of this opportunity. We have produced a number of research papers in the past several years, and I would love to see organizations and individuals do so here as well. We have a lot to say about the case definition, and we should take the time to prepare well-written statements that reference the scientific literature as well as our experiences. I sincerely hope that we will invest the time and energy required to prepare such statements for the committee.

Fourth Stage

In the final stage of an IOM study, the committee’s draft report is reviewed by independent experts with a range of views. Their comments are provided anonymously to the committee, and the committee must address every single comment. The report is then finalized, and any committee member may write a dissenting opinion. The study sponsors (HHS and SSA) do not have an opportunity to suggest changes to the report, and do not see it at any drafting stage. The report is published, and at that time the names and affiliations of the outside reviewers are disclosed.

What We Need to Do

It is important to note that efforts to cancel this study continue. More experts signed on to the letter to HHS on October 26th, increasing the number of signatories to 50. On October 28th, more than 60 advocates sent a letter to HHS in support of those experts. Petitions and letter campaigns continue. In addition, PANDORA submitted a number of questions to Dr. Wanda Jones at HHS, and were told a response would be prepared. Controversy abounds within the advocacy community, and I’ll have more on that soon. But for those who want to follow the IOM study progress and contribute to the process, I suggest the following:

  • Sign up for the study listserv
  • Be ready for the provisional slate announcement at the end of November/beginning of December
  • Submit comments on the provisional slate during the twenty day comment period
  • Begin drafting written submissions to the committee

 

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Go Big or Go Home

Posted on October 31, 2013 by Jennie Spotila

jenbrea

This is Jen Brea after a 12 hour photo shoot for her film, Canary In A Coal Mine. I chose this picture of Jen because I’ve felt that way too. Every ME/CFS patients has felt this way: unable to stand, to lift your head off the floor, to speak. The triggers are different. Some patients might fall into that place after cooking a meal or driving the kids to school or using the computer for a few hours. It’s different for all of us. But we share this common experience that cannot be conveyed by such an inadequate word as “illness,” and that’s why the Canary film is important.

News of the film has spread quickly in the ME/CFS community: a Harvard PhD student disabled by ME/CFS is documenting her experience and the story of this disease through a narrative documentary film. And in my opinion, that is one of the strengths of the project: the storytelling. The visuals from this film are beautiful, and showcase the talents of Kiran Chitanvis. But through all the videos and blog posts, I think it is the story that draws us in.

Brea and Chitanvis created a Kickstarter campaign for the film. The original goal was to raise $50,000 in 30 days – just a quarter of the film’s $200,000 budget. There are a number of factors that define a “good” Kickstarter campaign: materials that show the project will be done professionally; excellent rewards; and publicity beyond Kickstarter that brings new people to the campaign. Brea is doing it all. The videos, stills, website  and narrative released so far are very professionally done. The rewards are great, including behind the scenes access, tickets to the premiere, time with Howard Bloom, or a one-hour shoot of your own story. And through connections and an unbelievable amount of promotional work, the publicity has been greater than I’ve seen for any other ME/CFS creative project.

In just over three days, the $50,000 Kickstarter goal was met. Brea and Chitanvis decided to go big: they stretched the goal to the $200,000 needed for the film AND set a new goal of getting 6,509 people to fund it, which would make it the Kickstarted documentary with the most backers. As of today, with twenty-two days to go, they’ve raised $91,381 from 969 backers.

The attention paid to publicity is really significant. The film’s story has been covered by ABC News and on the TED blog, and many other outlets. In my opinion, this sets Canary apart from other projects. The patient community can’t fund this project by ourselves. In order to truly tell our story to the people who need to hear it – the people who know nothing (or nothing good) about ME/CFS – the film has to reach beyond the ME/CFS community. Brea and Chitvanis are doing that from the start, and support for the Kickstarter from outside our community will help the film ultimately reach that outside audience as well.

And this brings us back to storytelling. What makes people want to support this film is the intimate connection with Brea and others featured in it. It’s the story that pulls you in, and the story that makes you want to do something to help. If that’s true of the Kickstarter, it can be true of the film. And that could be a defining moment. We’ve longed for and dreamed of widespread public attention to the realities of having ME/CFS. Canary In A Coal Mine could deliver.

The film comes at a critical moment in ME/CFS history. Production will begin early next year, and the target completion date is December 2015. Simultaneously, the advocacy community is laboring to make progress across multiple political and scientific fronts. Most notably, the Institute of Medicine is scheduled to release their new clinical case definition of ME/CFS in March of 2015. I would like to believe that the galvanization of our movement is at hand: that our story will be HEARD and SEEN. I would like to believe that change is coming.

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CFSAC Profile: Dr. Gary Kaplan

Posted on October 25, 2013 by Jennie Spotila

Dr_Gary_Kaplan_DOThe CFS Advisory Committee announced via its listserv on October 23, 2013 that Dr. Gary Kaplan has been appointed to the Committee. Kaplan brings an interesting point of view to the Committee, but advocates have reason to be concerned about how well suited he is to the current political landscape. Dr. Kaplan was kind enough to speak with me this week, just as his appointment was being made official.

The Kaplan Center for Integrative Medicine was founded in 1985, making it the oldest integrative medicine practice in the DC area, according to Kaplan. From the inception of the Center, Kaplan’s patients have included people with CFS, fibromyalgia, and chronic pain. Dr. Kaplan is board certified in family medicine, pain management and acupuncture. He is a clinical associate professor of family medicine at Georgetown University’s medical school, and co-directed a grant from NIH to incorporate integrative medicine into the curriculum. Kaplan has also participated in two efforts at NIH’s Consensus Development Program (acupuncture and meditation), which is of interest given that the CDP is currently planning an Evidence Based Methodology Workshop on ME/CFS. With his clinical experience and his work with NIH, Kaplan brings unique expertise and connections to his work with CFSAC.

The Kaplan Center treats patients with CFS and dozens of other diseases. Kaplan describes it as a “buck stops here practice.” But he says that the diversity of symptoms presented by his patients are different manifestations of a unified underlying cause: microglia activation. Microglia are immune cells in the central nervous system, responding to infection and sending powerful signals through cytokines and gene expression. Kaplan says that CFS, fibromyalgia, depression, post-traumatic stress disorder, and other conditions are all neuroinflammatory disease. The multiple labels and categories obscure the origin of disease. Kaplan says that many different triggers can up-regulate microglia cells. The more these cells are activated, the easier they are to activate, and a vicious loop is established in which the microglia are chronically activated resulting in inflammation of the central nervous system.

Kaplan is not the only proponent of this theory. There is evidence of microglia activation in Alzheimer’s, Parkinson’s, and some infections. Microglia activation in ME/CFS is also not a new idea (see page 12 of the report from the 2011 NIH State of the Knowledge Workshop). Kaplan says that microglia activation is a process, not an event. He uses detailed patient histories to identify the origin of the process, whether it is an infection or a traumatic childhood event. Next he focuses on sleep, looking for undiagnosed sleep apnea, narcolepsy, or restless leg syndrome. Kaplan points out that a recent paper suggests that the brain clears neurotoxins during sleep, underscoring the need for good restorative sleep. The next step is adding meditation, and then identifying food allergies and sensitivities. Through it all, Kaplan emphasizes the importance of close involvement and partnership between doctor and patient. Dr. Kaplan’s approach to treating microglia activation in depression and chronic pain will be published in May 2014 in The End of Pain, a book aimed at the consumer audience.

There are signs, however, that Kaplan’s views are very different from those of ME/CFS experts and advocates. For example, Kaplan says myalgic encephalomyelitis is a good descriptive term, but it is too limiting because it does not get to why there is brain inflammation. Kaplan told me that 60% of his patients have psychiatric comorbidities, and he makes no distinction in treating depression or PTSD or CFS or fibromyalgia because he says that all share the neuroinflammatory condition of microglial cell activation. Given that advocates and experts believe the inclusion of depressed patients is one of the major weaknesses of the Fukuda definition, Kaplan’s insistence on seeing both conditions as different manifestations of the same disease process will not be popular.

I asked Dr. Kaplan about the role of exercise, given the recent controversy over exercise testing and the CDC multisite study. Kaplan says that exercise is well-established as down-regulating microglial cells and is essential to treating these conditions. However, he also says that mitochondrial dysfunction and other imbalances could impair patients’ abilities to exercise, and need to be addressed first. Dr. Kaplan says that a patient shouldn’t exercise until the body is ready, and so the approach must be tailored to each individual patient. Once the patient is deemed ready, exercise is an essential part of recovery. In our conversation, Kaplan did not specify how readiness for exercise could be assessed.

Dr. Kaplan told me that he has not followed ME/CFS politics at all. This is a legitimate concern for advocates, given the upheaval caused by the IOM case definition study and the unresolved allegations of intimidation of voting CFSAC members. We know that it takes new CFSAC members time to come up to speed on the numerous issues and substantial history of government efforts (or lack thereof) on ME/CFS. Dr. Kaplan faces a very steep learning curve at a time when multiple controversies require the full attention of the CFSAC.

 

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Don’t Lose Sight of CFSAC

Posted on October 22, 2013 by Jennie Spotila

The IOM controversy and the government shut down have been distracting, but CFS Advisory Committee deadlines are fast approaching. The CFSAC meeting is just three weeks away – November 12-13th – which means that public comment will be due soon, although no deadline has been announced. CFSAC announced via its listserv today that the meeting is postponed to December 10-11th. An agenda and details about public comment will be posted soon. BUT nominations for new CFSAC members are due October 28th, so you have a few more days to submit the required information.

Who Is Leaving?

Six of the eleven voting positions must be filled in 2014. There is one current vacancy, left by Dr. Ann Vincent’s resignation earlier this year. Updated 10/23/13: CFSAC confirmed via its listserv today that Dr. Gary Kaplan has been appointed to fill Dr. Vincent’s seat. Five members will reach the end of their terms in 2014: Dr. Gailen Marshall, Dr. Dane Cook, Dr. Susan Levine, Steve Krafchick, and Eileen Holderman. New nominations should include both researchers and experts in health care delivery, private health care services, and voluntary organizations.

How To Nominate

All the instructions for submitting nominations are contained in the Federal Register Notice. The package must include a letter stating the nominee’s qualifications and willingness to serve, the nominator’s contact information, and the nominee’s CV or resume. Submissions can be sent by email or regular mail, and are due by 5pm on October 28th.

Nominees

I will post names of nominees as I learn about them, and receive permission to post. You can send emails in support of candidates, and I encourage people to do this after a nomination has been made. A majority of the Committee – six of eleven seats – are turning over next year, and we need to do whatever we can to ensure that the new members are familiar with ME/CFS and the issues we’re facing.

The following nominations have been made as of October 25, 2013:

  • Mary Dimmock, nominated by Jennie Spotila
  • Donna Pearson, nominated by Massachusetts CFIDS/ME & FM Association
  • Joe Landson, nominated by Denise Lopez-Majano
  • Dr. Derek Enlander, nominated by Gabby Klein
  • Dr. Leonard Jason, nominated by Dr. Faith Newton
  • Dr. Lily Chu, nominated by herself (with others writing in support)

Gabby mentioned this in the comments, but it bears repeating. You can support any candidate who has been nominated by sending an email to cfsac@hhs.gov. The email doesn’t need to be very long – even just a few sentences in support of a nominee will be read and saved.

 

*Donna Pearson alerted me to this announcement by Dr. Gary Kaplan that he has been appointed to the CFSAC. I’ve asked Dr. Nancy Lee for confirmation, as no announcement has been made on the CFSAC website or listserv. Update: The CFSAC office responded to my inquiry saying that the announcement was posted “prematurely” and that the public would be informed once the appointment process was complete. CFSAC has confirmed 10/23/13 that Dr. Kaplan has been appointed. Interview with Dr. Kaplan coming as soon as I can write it up. Profile posted on 10/25/13.

 

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Exhibit A

Posted on October 17, 2013 by Jennie Spotila

I’ve been very critical of HHS and how they have handled communications and engagement with the ME/CFS patient community, and the fiasco surrounding the Institute of Medicine study is a sinkhole of terrible engagement. But if HHS and/or the IOM want to improve upon past mistakes, I offer Exhibit A: the FDA.

Listen First, Listen Fully

Coincidentally, the Institute of Medicine recently hosted a workshop on Partnering with Patients to improve healthcare. One of the key messages from the workshop was the importance of listening to patients first, and listening to them fully. This is precisely what FDA has done in the last year or so.

First we have the Patient Focused Drug Development meeting on ME/CFS last April. Patients were very specific in their description of symptoms and treatments, but what blew me away was how carefully the FDA employees were listening to us. They asked excellent clarifying questions, took extensive notes, and several commented on how much they learned.

I know some patients were frustrated that this meeting seemed to be such a revelation to the FDA, saying that patient comments at CFS Advisory Committee meetings should have taught them about this disease. But a static five minute slot at a CFSAC meeting is barely adequate to convey one piece of information, let alone the multiple messages we frequently need to communicate. The FDA meeting was interactive, accommodating questions from FDA but also clarifications from the patients and caregivers. The format and the purpose of the meeting facilitated more detailed communication from patients, and the FDA was there to listen. There is simply no comparison between a CFSAC meeting and the PFDD meeting.

How well FDA listened is captured in the first report on the meeting, The Voice of the Patient Report: Chronic Fatigue Syndrome and Myalgic Encephalomyelitis. This report summarizes the comments we made at the meeting, as well as the comments received through the docket. Data from the two surveys conducted prior to the meeting were also considered.

As many patients commented online and to me personally, this report describes our disease. They got it. The report emphasizes the importance of post-exertional malaise, recognizes the seriousness of the disease and its impacts on our lives, and describes the breadth and severity of our cognitive dysfunction. I can’t think of another document produced by the government that does that. If the Institute of Medicine study creates a clinical case definition for ME/CFS that matches this report, then we might be on the right track.

This report will also serve an internal purpose at FDA. On the teleconference FDA held with the ME/CFS community on October 16th, Sara Eggers said that they have already received positive feedback from colleagues at FDA about how helpful the report is to them. During the discussion period, Donna Pearson made the brilliant suggestion that all members of advisory committees considering drugs for ME/CFS receive the report as part of the meeting materials, and Dr. Sandra Kweder immediately acknowledged that as a good suggestion.

But a single report will not stimulate drug development on its own, and FDA does not appear to be sitting still. We learned on the October 16th call that the FDA is drafting a Guidance to Industry document specifically for ME/CFS. Guidance documents capture FDA’s current thinking on a topic, identify specific endpoints or outcome measures that FDA finds valuable for a specific disease, and send a strong signal to industry about the worthiness of a topic or disease. Dr. Janet Maynard (who is replacing Dr. Theresa Michele as FDA ex officio on the CFSAC) said that FDA hopes to publish the draft guidance in spring 2014. This is another good outcome: the public is able to comment on draft guidance documents, and we will have to take full advantage of that opportunity in the spring.

By listening to ME/CFS patients first, and listening fully as demonstrated in the Voices report, FDA sent our community a powerful message: we hear you, we know you are seriously ill, and we want to help. We have responded with respect, while not giving up on the tough questions as demonstrated by multiple advocates on yesterday’s call.

A Thought Experiment

Imagine how different our interactions with the Office of Women’s Health or the other agencies would be if they modeled the FDA’s engagement with us. For example:

  • What if the CDC PCOCA calls answered all questions in real time, rather than selecting from advance submissions through email?
  • What if the NIH held teleconferences with groups and individuals about the planning of the Evidence Based Methodology Workshop, just as FDA did prior to the April meeting?
  • What if the Office of the Assistant Secretary would pay us the courtesy of responding to our multiple inquiries about the allegations of intimidation?
  • What if, instead of pursuing the IOM study in secret, the Office of Women’s Health had considered ideas and concerns from the public on how to address the case definition issue?

FDA is not just paying lip service to listening and then chucking our feedback in the trash. They have stated on multiple occasions (including yesterday) that our feedback has shaped their efforts going forward. We don’t like everything FDA does, and we have no guarantees about what the guidance document will say. But they have demonstrated through their behavior that they are willing to listen, to hear, and to treat us with respect. Imagine if we got that same message from CDC or NIH or the Office of Women’s Health. What if we could actually believe – based on their actions – that they were willing to listen and to take what we say and apply it going forward? Can you imagine?

If HHS wants to improve its relationship with the ME/CFS community, they would do well to see FDA’s engagement as a positive case study. If the Institute of Medicine wants to avoid ending up distrusted and reviled like the Office of Women’s Health, they should look to FDA as one possible path forward. Or the IOM could simply take its own advice and listen first, listen fully.

 

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Which Paddle?

Posted on October 11, 2013 by Jennie Spotila

crossed paddles copyThe IOM study is moving forward, and fast. I can confirm through multiple sources that the IOM has reached out to multiple ME/CFS organizations for nominations to the clinical case definition committee. Those nominations are due today. I can also confirm that the public will be given twenty days to comment on the provisional appointment list, although I do not know when that list will be posted.

So where do we go from here? To borrow yesterday’s analogy, if the canoe is pointed at our goal of the right clinical definition for ME/CFS, how do we coordinate the paddling? I’ve seen great discussion on blogs (including the comments here), forums and by email. I have personally struggled with identifying the right next steps. There are two basic approaches, as I see it.

The first approach is to accept that the IOM study is going forward, and contribute to the process as much as possible. Some people in this camp believe they will be able to meaningfully influence the panel selection and the conduct of the study. Others don’t really believe they will have substantial influence, but see no alternative to engaging constructively. Action from this position includes making nominations to the panel, commenting on those nominations, participating in other opportunities for feedback as they arise, and monitoring the process closely.

The second approach is to continue to oppose the process. People in this camp want the IOM study canceled. Full stop. They believe that not only will we be unable to influence the process, but that the deck is completely stacked against us. Many believe, based on the Gulf War panels and other precedents, that the outcome of the study will be bad. Action from this position includes petitions, contacting Congress, email campaigns, and calls for public protests. (Edited to add: After I published this post, I learned about an excellent and articulate summary of this second approach. It contains the counterarguments to what I say below.)

I did not want the IOM study. I opposed it vigorously, as readers of this blog know. I am very worried about the outcome. I am insulted by how it was created in secret and concealed not just from advocates, but from all but one voting member of the CFSAC. The way HHS has treated the advocacy community, and failed to show the 35 experts even the basic courtesy of an acknowledgement of their letter, is simply outrageous. Given all of that, it sounds like I should be following the second approach, right?

But the problem with the second approach is how to transform my opposition and disgust into successful action. The government can always rescind a contract, but has it ever done so with IOM? Given the relationship between the National Academies (of which IOM is a part) and the government, such a rescission would be a politically loaded action. Petitions, email campaigns and protests are all effective tools, but we need much greater numbers and we have no time. None. The IOM is plowing ahead full speed.

Furthermore, even if we could force the rescission of this contract – what then? I know many advocates believe that the Experts’ Letter calling for immediate adoption of the Canadian Consensus Criteria is the solution. But I heard from a highly placed source at HHS that the government will not accept a definition without their own thorough assessment, if not influence. HHS will want to get its hands on any definition before accepting it, and they will not accept CCC as is. So even if we get the contract rescinded, we will be back where we started except everyone on both sides will be even more pissed off.

I’m between a rock and a hard place, as I contemplate how I should engage in the process. I don’t see much chance of success for either option, frankly. Rescinding the contract is an incredibly steep hill to climb. But I also do not have confidence that I can have meaningful influence over the panel selection or how it does its work. And the third approach – doing nothing – is absolutely not an option for me. I will not retreat to my bed, pull the covers over my head, and wait for it to be over.

For me personally, choosing an approach is a matter of conscience. My personal choice is to follow the first approach. I will monitor the IOM study as closely as I possibly can. I will participate in every opportunity for comment, and I will advocate for this process to be as open and transparent as possible. I will encourage others to do the same. I will approach this study as I do the CFSAC: with skepticism, and with the goal of creating accountability for their actions.

As I said yesterday, there are things I agree with and disagree with on all sides of this issue. I don’t agree with everything in the Experts’ Letter and I don’t agree with everything in the Association’s statements. I find points of agreement and disagreement in every discussion about the IOM study that I have observed or participated in. But my only goal is to follow the course that I believe will lead to the best results for the ME/CFS community. I fully support every advocate’s right to do the same. I do not believe my paddle is better than someone else’s. What I hope for is that regardless of which paddle you choose, you will be willing to work with the other people in the canoe.

 

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Convergence

Posted on October 10, 2013 by Jennie Spotila

In the last two weeks, position statements on the IOM and ME/CFS case definitions have been outnumbered only by rumors and allegations. I’ve had trouble keeping up and I am immersed in this issue. I can’t imagine how challenging it is for patients and advocates to keep track of it all without a scorecard. Fortunately, I think we can boil the statements down to their essentials, and perhaps find the potential for meaningful consensus.

The Statements

Let’s examine the statements in chronological order beginning with September 23rd and the announcement of the HHS contract with the IOM. I include links to the original documents so you can read them for yourself. My summary is my personal understanding and interpretation of the documents. If I’ve gotten anything wrong in my summary, I welcome correction from the statements’ authors.

First up we have the Experts’ Letter to Secretary Sebelius. Released on September 23rd, just hours after the HHS announcement, this letter is unprecedented in ME/CFS advocacy. The bottom line of the letter is 1) immediately adopt the Canadian Consensus Criteria for both clinical care and research; 2) continue to refine and update the CCC as needed; and 3) abandon the IOM effort because they lack the expertise.

Second, PANDORA Org issued a Position Statement on ME/CFS Criteria on September 26th. This seven page document covers more than just the IOM contract, and lays out PANDORA’s thinking on the case definition problem more broadly. For purposes of this post, the bottom line is: 1) the CCC is better than the Fukuda or Oxford definitions, but it’s not sufficient as is; 2) the IOM and the CFSAC do not have sufficient expertise to create a new definition; and 3) PANDORA is ready to help the true experts hold a workshop to create a definition.

Third, Dr. Lily Chu (who did not sign the Experts’ Letter) issued her own letter on September 28th and joined that effort. Dr. Chu is a member of the Board of the IACFS/ME, although this letter is her own position and not the official position of that organization. The bottom line of her letter is: 1) cancel the IOM contract; 2) the CCC needs refinement but is good enough to start using now; and 3) create definitions for clinical care and research through one process use a single definition for clinical care and research. (Lily sent me this clarification, so I’ve updated accordingly)

Fourth, Dr. Bateman published a statement explaining why she was no longer supporting the Experts’ Letter on September 30th. Her statement came after a flurry of rumors that the Association had asked the thirty-five expert signatories to change their position (the Association denies this). The bottom line is: 1) the CCC is the best we have but it is not good enough and needs to be updated; 2) the IOM contract could lead to increased validation and federal funding; and 3) we should actively call for experts on the IOM panel and regroup if the panel falls short.

Fifth, the CFIDS Association issued a statement on October 2nd. The statement includes several paragraphs of background and links to primary documents such as the IOM Statement of Work and the Association’s email to the signatories. The bottom line of the Association’s statement is: 1) the CCC should be optimized for clinical use; 2) the IOM panel should have the best experts and that patients should have a strong voice; and 3) the Association promises strong opposition if the IOM falls short. In a follow-up statement from October 8th, the Association said it believes a positive working relationship with HHS and IOM is necessary in order to secure cooperation for increased funding and other meaningful progress.

Sixth, many advocates continue in their efforts to stop the IOM contract through a variety of means including petitions, letter writing campaigns, and more. I could fill a whole post with links to blog posts and sample letters and forums threads. The bottom line is 1) cancel the IOM contract and 2) immediately adopt CCC.

Seventh, I have to point out that there are other organizations and individuals who have not made public statements. The IACFS/ME has not issued a statement, although several of the members have made their positions clear. A number of prominent researchers and clinicians have not spoken publicly about this either, including Dr. Komaroff, Dr. Rowe, Dr. Kogelnik, Dr. Friedberg, and many of the voting members of the CFS Advisory Committee. I don’t think we can draw any firm conclusions from their silence.

Convergence

What do all these statements have in common?

  1. The Fukuda definition is dead. Not a single statement – including the IOM Statement of Work – says that Fukuda is a reasonable definition. While no one is singing over its grave, everyone has tacitly acknowledged that it is time to move on and do better. This is huge!
  2. The CCC is the place to start. Everyone agrees that CCC should be the starting point for a clinical case definition. The Experts’ Letter, Chu’s letter, and many advocates acknowledge that CCC needs refinement, but advocate for its immediate adoption. PANDORA, Bateman and the CFIDS Association all want to refine and operationalize it prior to adopting it in practice.
  3. The case definition must be written by ME/CFS experts. The HHS Statement of Work does not define “expert” nor does it require a certain number or percentage of them on the IOM panel. However, all of the position statements I’ve reviewed make it clear that the definition must be written by experts, whether on the IOM or another mechanism. Bateman and the CFIDS Association seem optimistic that the IOM panel will have sufficient ME/CFS expertise. PANDORA is the only organization to attempt to define the degree of knowledge that makes an ME/CFS expert. The Experts’ Letter, Chu’s letter, and many advocates do not believe the IOM will appoint sufficient experts to the panel, and support the Experts’ Letter as the solution.

Some advocates, including me, have focused on the strong disagreement between organizations and individuals about the IOM contract. Because there is so much at stake, we all quickly moved into opposing camps based on whether we think the CCC should be adopted as is and whether the IOM will appoint the right experts to its panel. These disagreements remain, but going forward I think focusing on them could be a mistake that will hinder our effectiveness.

Despite our deep divisions over whether the IOM will do right by ME/CFS, I see an opportunity for agreement and mutual reinforcement. We all want a case definition, written and agreed upon by the ME/CFS experts, that accurately describes our disease. We want a definition that operationalizes and improves upon the CCC, rather than starting from scratch. I believe that this may be within our reach. We do not all need to take identical positions or use the same methods to advocate. But we do need to communicate, coordinate, and push common positions forward.

The best analogy I can think of is a canoe. I’ve only been in a canoe a handful of times, but I learned very quickly what happens when you only paddle one side of the canoe: you turn in circles. If you want to move the canoe forward, then you must paddle on both sides. Even better, have a partner sharing your canoe paddle on one side while you paddle on the other. The better you coordinate the paddles, the faster you go.

Our opponents would love nothing better than to see us turning in circles, squabbling over whose turn it is to hold the paddle. I’m not saying we need to join hands and sing Kumbaya. There are things that I disagree with in every statement that I summarized above. This is not about getting my way. This is about results. None of us have a monopoly on the right answer. In fact, I believe that the right answer is more likely to emerge if we pull together. I’m not saying there is no room for dissent. Disagreement is a key part of finding the right answer. I am saying that we are all in the same canoe (even though we wish we weren’t), and we need to start paddling together.

 

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Training Wheels

Posted on October 8, 2013 by Jennie Spotila

When the news about the IOM contract first broke on August 27th, I was at my training for FDA Patient Representatives. Here is my much delayed write-up of that training.

Every year, the FDA Patient Representative Program holds an in-person orientation for the new representatives. With the help of my husband, who drove the car and then pushed my wheelchair around the hotel for two days, I was able to attend this year. Patient representatives are called upon to serve on FDA advisory committees that are considering drug and device applications. I expected a series of dry presentations, but the meeting was much more than that.

“Survivors, fighters and advocates”

photoMy fellow representatives are, in a word, extraordinary. There were many cancer survivors, some of them having beat the disease three or four times. There were patients with multiple sclerosis, Crohn’s disease, Parkinson’s, ALS, alopecia, pulmonary fibrosis, and cardiac disease. There were two parents who have young children with short bowel syndrome and liver damage. I met an extraordinary woman with thalassemia, a rare genetic blood disorder affecting only 1,000 in the United States but many thousands more in other countries. Another woman has mitchondrial myopathy and told me that many patients with that disorder are diagnosed with CFS somewhere along the way.

It was weird to have my disease on my name tag, but I quickly began to see it as a badge of honor. One of the gentlemen with ALS commented that this was “a room full of survivors, fighters and advocates.” Every patient in that room had suffered, and many had looked death in the face. But every single one of us emerged with determination to do something positive. Every patient was there to help their communities. Almost all of us had founded or served on the boards of organizations dedicated to finding answers for our diseases. Many of the patients able to work have made advocacy their careers.

There were several presentations by veteran patient representatives, but the most inspiring was by Matthew Sharp. Matt shared his perspective on HIV/AIDS activism, particularly the evolution of the relationship between activists and FDA. The patient representative program exists because of HIV/AIDS activists, and we have a lot to learn from how they have participated in the drug development process as well.

My one regret about the meeting is that I was not more prepared to introduce myself and ME/CFS. I was one of the first patients to speak during introductions, and I wasn’t sure how much time I could take. I realize now that I assumed most people in the room would know that ME/CFS is a serious disease, but that turned out not to be the case. I had more chances to address it during the meeting and with individual attendees, but I should have had my “this is ME/CFS” elevator speech ready to go, and I missed that opportunity.

The Boring Stuff

There were some technical and mechanical presentations, as I expected. The director of the Office of Health and Constituent Affairs introduced us to the program and to FDA. Over the course of two days, we heard about the drug and device development life cycles, the history of FDA, Medwatch, the orphan drug program and minority health issues. There were key presentations on the extensive conflict of interest clearance process for serving on an advisory committee and how to review the hundreds of pages of information to prepare for a committee meeting.

An key goal of the training was to help us understand the importance of the perspectives we bring to advisory committees and how to contribute to those discussions. Patient representatives are not expected to understand the scientific or statistical minutia of drug applications. Instead, we can bring the instincts, questions, and perspectives of patients and families. Our views are needed on the committees, and we should not be shy about sharing those views. Several representatives talked about the value of asking questions that the scientists wouldn’t think to ask. The bottom line was that we should not feel intimidated by all the scientists and data. FDA wants us there because of our unique perspectives. It was very clear from the FDA employees attending the meeting that they recognize and advocate for the value of patient perspectives at multiple stages in decision making.

What Next?

While some patient reps may be called to serve on advisory committees in the near future, I will probably be waiting a long time. As far as I know, there are no treatments for ME/CFS moving quickly through the pipeline and approaching the final phase of approval. At this time, there is no formal way for me to impact ME/CFS drug development within FDA. I think that the trend is moving towards more participation. For example, the Patient Focused Drug Development meetings are an attempt to capture patient perspectives on specific diseases (ME/CFS included). Within FDA, the need for clearing conflicts of interest are a barrier to swift engagement of patient representatives at meetings with drug developers. But the FDA staff members told us that they are actively pursuing ways to incorporate patient perspectives earlier in the development process.

I was not the only person feeling frustrated about that. Many of the representatives were critical of FDA on this point, and repeatedly asked FDA to be creative in harnessing the expertise of patients. Two of the representatives who attended the meeting have recently created a Facebook group so that we can all stay in touch. The representatives at the meeting had such intelligence and determination that I think we can find ways to harness our collective contributions to achieve practical change. I am certainly committed to doing so.

 

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19

Posted on October 6, 2013 by Jennie Spotila

candleNineteen years ago today, I woke up with a sore throat. I ignored it, as I usually did with pain or illness. I was 26 years old, a “superstar” at my law firm (according to a performance review). I don’t remember if I went to the gym that morning as was my habit, but I got ready for work and walked to the office.

Four hours later, I had a high fever and could barely stand.

My life changed irrevocably that day, although it took me many months to begin to comprehend that. I had to give up my career. Then I gave up walking long distances. Then I gave up my apartment in the city. Then I gave up driving. You get the picture, I’m sure. Usually on this sick-aversary, I would reflect upon the length of time that has passed. In fact, last year, I told the CFS Advisory Committee, “This Saturday is the 18th anniversary of the day I got sick. If I had given birth on October 6, 1994, that child would now be an adult.”

But this year, what weighs upon me is not the passing of nineteen years. It is the burden of this nineteenth year of my illness itself which occupies my thoughts. This year has tested me physically, emotionally, and spiritually. I feel my heart becoming more and more burdened by the suffering of those around me, and by my own suffering too. I have drawn upon reserves of strength that already feel tapped out. My spirit is gasping for breath and longing for just a little bit of rest.

The number nineteen has a positive significance in my religion. The central tenet of the Baha’i Faith is Unity, especially the unity of humanity. The Baha’i Faith draws upon many concepts from Islamic culture (although it is a separate religion). In the Arabic Abjad numeric system, letters correspond to numbers and so each word has a corresponding numeric value. The word vahid means Unity, and the numeric value of vahid is 19. Unity, as a spiritual concept, is not just needed between groups of people, but within families and within oneself. To achieve unity, we need clarity, patience, communication, understanding, and justice. I am struggling to bring those qualities front and center in myself right now because all the trials and difficulties of this nineteenth year have left me in a daze.

I looked a long time for a prayer that I could say today, one that would express my need for strength as well as my belief that there is hope in this life – even after nineteen years of illness, even after a year that has stretched me past my limits. This is deeply personal, but I would like to share that prayer with you today. And if you feel moved to do so, I would be grateful if you could offer up a prayer or good thought for me, too.

O God, my God!  Be Thou not far from me, for tribulation upon tribulation hath gathered about me.  O God, my God!  Leave me not to myself, for the extreme of adversity hath come upon me.  Out of the pure milk, drawn from the breasts of Thy loving-kindness, give me to drink, for my thirst hath utterly consumed me.  Beneath the shadow of the wings of Thy mercy shelter me, for all mine adversaries with one consent have fallen upon me.  Keep me near to the throne of Thy majesty, face to face with the revelation of the signs of Thy glory, for wretchedness hath grievously touched me.  With the fruits of the Tree of Thine Eternity nourish me, for uttermost weakness hath overtaken me.  From the cups of joy, proffered by the hands of Thy tender mercies, feed me, for manifold sorrows have laid mighty hold upon me. With the broidered robe of Thine omnipotent sovereignty attire me, for poverty hath altogether despoiled me.  Lulled by the cooing of the Dove of Thine Eternity, suffer me to sleep, for woes at their blackest have befallen me.  Before the throne of Thy oneness, amid the blaze of the beauty of Thy countenance, cause me to abide, for fear and trembling have violently crushed me. Beneath the ocean of Thy forgiveness, faced with the restlessness of the leviathan of glory, immerse me, for my sins have utterly doomed me.  – Baha’u’llah

 

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The Statement of Work

Posted on September 30, 2013 by Jennie Spotila

I have obtained a copy of the Statement of Work (SOW) for the Institute of Medicine study on clinical diagnostic criteria for ME/CFS. I am making that document available to you in its entirety through this link. I am also offering my interpretation of some of the most significant provisions of that SOW in this post.

But first, I want to state up front how I got this document and what I’ve done with it. There have been a multitude of accusations and allegations swirling in the ME/CFS advocacy community over the last week, and I figure that someone somewhere will question my involvement, so I’ll just get this out of the way right now. I requested the SOW from Dr. Nancy Lee by email on September 24th. Dr. Lee’s office responded on September 25th with a brief variation on the original announcement. On September 27th, I responded to Dr. Lee’s office pointing out that I had requested a copy of the actual SOW document, and I attached a copy of the SOW from the IOM’s study on treatments for Gulf War Illness as an example. I also filed an expedited FOIA request for the document. Finally, at 6:20 pm on September 30th, Dr. Lee’s office sent me the Statement of Work document I link to above and that I discuss in this post. Simultaneously with publishing this blog post, I am also sending an email to a number of advocates giving them the links to the document and this post. Let me be clear: this post contains my opinions and mine alone. I did not share or discuss the SOW with anyone (except my husband) before publishing this post.

We have a number of lawyers, doctors and other professionals in the advocacy community. I hope they will examine the SOW closely and offer their own analysis. I also hope that our expert clinicians and researchers (including the 35 experts who signed the Open Letter) will also scrutinize the document. We need open dialogue among all the factions in the advocacy and scientific community. If there is any hope of salvaging the IOM process and shaping it to meet the needs of ME/CFS patients and their families, then everyone needs to share information and communicate with one another. We won’t all agree, but we can stop slitting each others’ throats.

On to my analysis – again, the full document can be viewed here. I want to focus your attention on five issues: what disease is being studied; the requirements for involving experts; the requirements for stakeholder input; the project timeline; and whether I think this whole thing is good or bad.

This SOW is seeking a single clinical definition for what could be multiple disorders.

The first page of the SOW states, “HHS will request that the IOM develop consensus clinical diagnostic criteria for this disorder.” (emphasis added) The term “ME/CFS” is used throughout the document and is defined on page 2 as follows:

For the purposes of this document ME/CFS shall be used to refer to Myalgic Encephalomyelitis (ME), Chronic Fatigue Syndrome (CFS), Chronic Fatigue and Immune Dysfunction Syndrome (CFIDS), Neuroendocrine Immune Disorder, and other terminologies in use for this illness. (emphasis added)

I submit to you that this statement tells us a great deal. ME and CFS are not two separate diseases in the view of HHS. This is a value judgment that tells IOM that all the entities referred to by those names are really the same thing. Furthermore, all the entities described in the case definitions listed on page two, and the entity(ies) being studied in the CDC multi-site study, are all the same thing. This does not preclude the IOM committee from reaching a different conclusion, but this assumption is a pretty powerful frame for the scope of work.

My experts may not be your experts.

The biggest bone of contention regarding use of the IOM is the open question of how many ME/CFS experts will be involved in the committee. Most advocates, including me, tried to stop this contract because we feared that experts would not comprise the majority of the committee. The CFIDS Association position announced on September 23rd did not oppose the IOM contract as long as the new clinical definition was created by ME/CFS experts. Now that we have the SOW, we can make a better guess about how this will pan out. On page two, the SOW states that the committee shall have expertise in:

  • the pathophysiology, spectrum of disease, and clinical care of ME/CFS;
  • neurology;
  • immunology;
  • pain;
  • rheumatology;
  • infectious disease;
  • cardiology;
  • endocrinology;
  • primary care, nursing, and other healthcare fields;
  • health education;
  • and the patient/family perspective.

I listed the categories on separate lines based on the placement of semi-colons, which is how the sentence would be understood grammatically. I would also like to point out that this list is different from the description of necessary expertise in the HHS announcement about the contract from September 23rd. Missing is the earlier reference to an expert in behavioral health, but the inclusion of “other healthcare fields” could easily be used as justification for including a psychologist or other behavioral expert. Also missing is expertise in epidemiology and developing clinical case definitions. Finally, I have to point out one additional qualification in the SOW: “Individuals with expertise in other multi-symptom, complex disorders or diseases may also be included on the committee.”

The SOW does not define “expertise,” as in how much experience is needed to qualify as an expert in ME/CFS. In their position issued last week, PANDORA said, “we define an ME/CFS clinical expert as a doctor who has primarily provided clinical care to ME/CFS patients for at least 10 years. We define an ME/CFS research expert as someone who primarily researches ME/CFS, particularly ME/CFS researchers who have published on biomarkers and definitions.” (emphasis in original; page 3 of Position Statement on ME/CFS Criteria). This seems like a logical definition to me, but no such definition is included in the SOW.

Another gap is the distribution of expertise among committee members. The SOW specifies that the expert committee should include 12 to 16 people (the HHS announcement said approximately 15). There is no minimum number of experts for any of the categories, including pathophysiology and clinical care of ME/CFS or the patient/family perspective. A literal reading of the SOW does not even preclude one person from claiming both of those areas of expertise. Not only does the SOW not require that a majority of the committee be subject matter experts, it doesn’t even require more than one of them. And I am certain that I am not the only advocate who finds the reference to “expertise in other multi-symptom, complex disorders” to be ominous.

Stakeholder input is mentioned but not defined.

The SOW includes a requirement for stakeholder input, but a careful reading shows that the requirement is not very specific and could be meaningless. The first topic area of the task described on page two states, “Conduct a study to identify the evidence for various diagnostic clinical criteria of ME/CFS using a process with stakeholder input, including practicing clinicians and patients” (emphasis added). On page three, the SOW describes that process with a bit more detail:

During one or more public meetings, the Committee shall consider the testimony of ME/CFS patients, caregivers, and advocacy groups in addition to relevant subject-matter experts such as clinicians, researchers, service providers, and public health officials.

Sound good? Let’s parse this sentence. First, it specifies “one or more public meetings.” That means only one public meeting is required. There are no requirements as to the duration of that meeting or meetings. By comparison, the public meeting for the IOM’s Gulf War Illness definition study lasted five hours. One hour was devoted to discussion from five patients. Six physicians/researchers had a combined 90 minutes to speak. Open public comment was limited to 30 minutes. I have found no evidence that IOM has employed a comment docket for that panel, like FDA did for the April ME/CFS meeting. Under the terms of this ME/CFS SOW, a five hour public meeting with a single hour dedicated to patients would be sufficient. I don’t know whether the IOM will do a better job in our case, but the SOW does not require it.

There are many different groups included in the SOW “stakeholder input.” Testimony will be considered from patients, caregivers, advocacy groups, clinicians, researchers, service providers AND public health officials. Seven categories, each with very different skill sets and goals. The FDA April 25th meeting spent most of the four hours hearing from patients and caregivers, with a few groups and clinicians sprinkled in. Furthermore, the April 25th meeting posed a series of very specific questions to focus discussion on what was most relevant to FDA, and also used a facilitation format to identify high priority common themes.

Finally, this part of the SOW says the committee shall “consider” the stakeholder testimony. It does not tell the committee HOW to consider the input or how much significance and weight it deserves. There is no stated goal for considering that input or answering stakeholder concerns. The SOW is intentionally broad, so the committee will have complete discretion to disregard all the input it receives at one extreme or rely on that input to shape the entire outcome at the other extreme.

There is a timeline but no start date.

Page three of the SOW lists a draft timeline of the project stages, but provides no start date for the clock to begin ticking. If we assume that last week’s HHS announcement is accurate, then the start date was some time in September.  In that case, the 18 month timeline for this project will conclude by March 31, 2015 (that is also the deadline noted on page four of the SOW). You can see the full timeline in the SOW document, but I want to point out a couple important dates that I calculated by assuming work began at the end of September 2013.

  • By December 2013: “Seek committee nominations, assemble committee, begin background research; contact stakeholders” That means nominations to the committee will be due very soon, and we better get ready for that. There is no explanation of how nominations will be collected or what is meant by “contact stakeholders,” including which groups are included or the purpose(s) of the contact.
  • January -March 2014: “Hold first committee meeting; plan workshops – identify topics and potential speakers; identify information needs; develop plans for receiving stakeholder input” The SOW does not explain what the “workshops” will be, and obviously there is no stakeholder input by this point because plans for collecting it are still being formulated.
  • March-July 2014: “Hold second and third committee meetings with workshops; develop report outline and workplan; hold working group conference calls; seek and receive input from stakeholders” Are the workshops for the committee or for the public? Notice that the report is being outlined at the same time as stakeholder input is being received.
  • August-December 2014: “Hold fourth and fifth committee meetings; draft and revise the report; draft recommendations” Presumably stakeholder input has been concluded. Hopefully it will be considered as the recommendations are drafted. Stakeholder input is not mentioned in the timeline after July 2014.

Good Or Bad?

It is important to understand the process that the IOM typically uses in its studies in order to assess whether this SOW is good or bad for us. Detailed information describing that process is available on the IOM website. I highly recommend reviewing that information. A few things stand out to me:

  • The sponsor of a study has no control over the study once the “statement of task” and budget are finalized. I have not been able to determine if the SOW I analyze here is the same as the finalized statement of task referred to by IOM.
  • Panelists serve without pay.
  • Input is gathered in public meetings, but committee deliberations are held in private.
  • Select criteria for committees: “The committee must include experts with the specific expertise and experience needed to address the study’s statement of task. . . . Having the right expertise is not sufficient for success. It is also essential to evaluate the overall composition of the committee in terms of different experiences and perspectives.”

At the risk of repeating myself, I will say again that the caliber and prominence of the Institute of Medicine is well-deserved. The conclusions published by the IOM have an extraordinary influence over whatever topic is at issue. My quarrel is with the study defined in the SOW, not with the IOM itself.

While some people may trust that the IOM will select the “right” panel for the ME/CFS clinical case definition study, it is my opinion that this is based to some degree on hope or optimism. There is nothing in the SOW that requires the committee to have a majority comprised of ME/CFS experts. It is entirely possible that IOM will appoint more experts than non-experts, but there is no proof that this will be the case. It could just as easily swing the other way. For people who insist this committee will have the right make up, please show me the data that supports this certainty.

I am very afraid that the IOM will appoint more non-experts than experts to the committee. I can’t prove that I’m right, but the SOW and the IOM process leaves holes big enough to drive a truck through. I am also deeply concerned that the extent of stakeholder input is left to the discretion of the committee, and it’s possible that there will be little opportunity to for us participate. Again, I hope I’m wrong but the SOW does not mandate much stakeholder participation. I also do not have much hope that we can force the cancellation of this study. The government is more than preoccupied with the shutdown and budget woes, and there is scant political will for Congress to act on our behalf.

So for my part, I am focused on two things regarding the IOM: participation in suggesting nominees for the committee, and closely tracking this study to maximize transparency and accountability. I want to hear more from the 35 experts who signed the open letter to Secretary Sebelius. I want to hear more from the experts who did not sign the letter, for any reason. And I want to hear more from my fellow advocates. Pick apart this SOW. Let’s crowdsource analysis and action.

 

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