Still Waiting, Still Emailing

Posted on September 9, 2013 by Jennie Spotila

I thought I would have an update for you about the case definition efforts at DHHS and the ill-fated (for now) Institute of Medicine contract. I thought that I would have at least a few answers to the questions I sent to the Office of Women’s Health last week. But . . I haven’t heard anything – not from the Office of Women’s Health nor any of the other agencies.

The reasons for the cancellation of the IOM contract are a mystery. A more disturbing mystery is what HHS means when it said it will “continue to explore mechanisms to accomplish this work.” Is IOM still on the table? What do the voting CFSAC members think about this? Will HHS turn to the ME/CFS experts to define the disease?

In thinking about this issue (and waiting for any substantive response), I went back and reviewed some of the CFSAC’s previous discussions about the ME/CFS case definition. And I found the following quotes from Dr. Nancy Lee:

In general, the Federal Government isn’t in the position of telling doctors a case definition. I think a recommendation from CFSAC that the Secretary should tell people to use “X” definition will go nowhere because that’s not what we do. This is a clinical decision that has to come from the clinical community. . .

I’ve been in two or three meetings with the Secretary since I’ve been here. One of them was around this: the idea of a case definition, the need for one, and in addition, the need for a different name for the disease. She basically said that this has to be coming from the medical community. CFS Advisory Committee Minutes, October 4, 2012, p. 37, 38.

If the clinical community must create the case definition, per Dr. Lee’s representation of Secretary Sebelius’s statement, then why was the IOM contract even contemplated? Did the Statement of Work for the contract specify that clinicians and researchers working on ME/CFS should be the majority of the panelists? Usually, the IOM retains complete discretion in the appointment of panel members. Given that the IOM option was developed in secret with no input from the stakeholders, how can we simply trust that the right people would be on the panel?

I’m not a conspiracy theorist, but my trust in this process has fallen through the floor. I am not going to sit at home, twiddle my thumbs, and wait for HHS to enlighten me by answering my reasonable questions. I am going to keep emailing and demanding those answers. I hope you will join me.

What to do: I will email Secretary Sebelius every day this week, and copy the agencies involved. Use these addresses if you would like to join me: Kathleen.Sebelius@hhs.gov and copy the following people: howard.koh@hhs.gov, txf2@cdc.gov, Tomfrieden@cdc.gov, Marilyn.Tavenner@cms.hhs.gov, margaret.hamburg@fda.hhs.gov, Mary.Wakefield@hrsa.hhs.gov, collinsf@mail.nih.gov, richard.kronick@hhs.gov, MEACTNOW@yahoo.com

What to say: There are multiple sample letters circulating in the ME/CFS community, and you may have seen some on Facebook or different forums. This is the email I will be sending. Feel free to adapt my email to fit your own views.

Dear Secretary Sebelius,

Your Department, acting through the Office of the Assistant Secretary, recently published a sole source solicitation for the Institute of Medicine to “develop consensus clinical diagnostic criteria for this disorder.” The request was swiftly cancelled after ME/CFS advocates objected to the backroom secrecy, short response time, and the IOM’s patent lack of experience in creating accurate and meaningful case definitions for diseases. Despite the controversy, it appears that “HHS will continue to explore mechanisms to accomplish this work,” although your Department has refused to clarify what those mechanisms may be.

On October 4, 2012, the Designated Federal Officer of your CFS Advisory Committee characterized your opinion on the development of a clinical case definition for ME/CFS. Dr. Nancy Lee said, “I’ve been in two or three meetings with the Secretary since I’ve been here. One of them was around this: the idea of a case definition, the need for one, and in addition, the need for a different name for the disease. She basically said that this has to be coming from the medical community.” CFS Advisory Committee Minutes, October 4, 2012, p. 38. Your own Advisory Committee recommended that you convene a “stakeholders’ (ME/CFS experts, patients, advocates) workshop in consultation with CFSAC members to reach consensus for a case definition useful for research, diagnosis and treatment of ME/CFS beginning with the 2003 Canadian Consensus Document case definition and its utility for diagnosis and treatment of ME/CFS.” CFS Advisory Committee recommendation, October 2012. Despite all of this, your Department progressed a contract to the IOM with no assurance that the actual clinical and research ME/CFS experts would be the ones staffing the consensus panel, and concealed it from the public until the sole source notice was posted.

I have no confidence that your Department and its agencies will act to protect me or to ensure that I can receive accurate diagnosis and adequate treatment of my disease. Your agencies and personnel have repeatedly ignored the hallmark symptoms of this disease, disregarded the case definitions authored by ME/CFS experts, and resisted meaningful engagement to address the scientific questions that have plagued this disease for decades. This latest episode of your Department issuing and then cancelling a contract with IOM to create a case definition has only increased, rather than allayed, my concerns.

I urge you to consult with the researchers and clinicians who have actually worked on ME/CFS, and not rely on those with no direct experience or whose expertise is limited to overlapping or related conditions. We need transparency, accountability, and direct consultation with the experts, patients and advocates in order to have any hope of moving forward with an accurate case definition for ME/CFS. At present, your Department is only creating barriers to meaningful progress.

Sincerely,

Jennifer Spotila

Feel free to adapt this email to your own views. Many many advocates are working round the clock to get more information, formulate responses, and get help from anyone who can. There will certainly be many more developments in the near future. Stay tuned, and keep emailing!

 

Posted in Advocacy | Tagged , , , , , | 6 Comments

Don’t Stop!

Posted on September 4, 2013 by Jennie Spotila

As of 11:09 Eastern this morning, the sole source contract notice for the IOM case definition was updated to read:

Because of all of the concern from the public surrounding this potential sole source requisition, we have decided to discontinue this request.

I have reached out to multiple sources to confirm whether the contract has been cancelled (or simply suspended), and to determine what happens next. I will keep you posted.

BUT it is very very important that we continue our email action! We need and want a strong, accurate clinical case definition for ME/CFS! This is essential for any of our other efforts to be successful. So tell HHS that we need an case definition process that is inclusive of the ME/CFS experts and stakeholders to solve this problem once and for all.

Please stay tuned for updates as we work with sources and experts to refine our message and find out what HHS plans to do next. I will share updates with you in real time. Keep emailing HHS. YOUR VOICES ARE BEING HEARD. Don’t stop now!!!!

 

Update, September 4, 2013, 5:20 pm: The contract page has been updated again. The new update reads:

This request has been cancelled. However, HHS will continue to explore mechanisms to accomplish this work.

Honestly, I don’t even know how to interpret this. I have renewed my inquiries to get clarification. It seems to me that if HHS is determined to “continue to explore mechanisms,” then we should continue to offer our input into those mechanisms. Keep emailing. I’m hoping we’ll have further clarity from HHS tomorrow, as well as updates from the advocates working on this issue in DC.

 

Posted in Advocacy | Tagged , , , , | 13 Comments

Simple Action

Posted on September 4, 2013 by Jennie Spotila

I am not the only ME/CFS patient worried about what kind of case definition the Institute of Medicine might create for my disease. I don’t have anything against the IOM. To the contrary, I recognize that it is an institution with extraordinary credibility and clout. That’s the problem, actually. If the IOM creates a weak clinical case definition for ME/CFS or worse, supports the psychosocial model of the disease, we are going to be trapped by that mistake for years to come.

Advocates are working together to try and stop this from happening. I am participating as well, and I invite you to join us. All you have to do is send one email every day for a week. Tell HHS that you object to this sole source contract to the IOM without consultation with patients and other stakeholders. The suggested email text can be seen here, and my own email follows below. Feel free to adapt the suggested text (or mine). Send your email to Secretary Sebelius at Kathleen.Sebelius@hhs.gov and copy the following people: howard.koh@hhs.gov; txf2@cdc.gov; Tomfrieden@cdc.gov; Marilyn.Tavenner@cms.hhs.gov; margaret.hamburg@fda.hhs.gov; Mary.Wakefield@hrsa.hhs.gov; collinsf@mail.nih.gov; richard.kronick@hhs.gov; MEACTNOW@yahoo.com

Dear Secretary Sebelius,

I am writing to voice my strong opposition to the HHS proposal to contract with the Institute of Medicine (IOM) to develop “clinical diagnostic criteria for myalgic encephalomyelitis/chronic fatigue syndrome.” I am a member of the ME/CFS community and have witnessed firsthand the devastation of this disease. I am extremely concerned that this planned IOM initiative will gravely harm ME/CFS patients.

I oppose this proposal for the following reasons:

IOM has only been involved in one other study to define a disease, the current effort for Gulf War Illness (GWI), and that process has not been concluded. Advocates and the Research Advisory Committee for GWI (RAC) have criticized the IOM report that redefined GWI as the overly broad chronic multisymptom illness (CMI). They further criticized the misguided focus on psychiatric issues and the failure to staff the IOM panel with GWI experts. Given this and IOM’s inaccurate characterization of CFS in the January 2013 IOM report on treatments for Gulf War Illness patients, we have no confidence that IOM is capable of producing a clinical consensus criteria that defines ME as described by CCC, ME-ICC and most importantly, the patients themselves.

This effort has been progressed in secret, apparently for many months and without consultation with key ME stakeholders, despite the claimed intent of the HHS-IOM initiative to develop a consensus definition. The timing of the announcement before a holiday weekend and the short response time indicate that HHS was not looking for input from the ME experts and ME community.

This IOM initiative does not reflect the October 2012 CFSAC recommendation on the development of a case definition for this disease and in fact is in direct contradiction to that recommendation. CFSAC recommended that a clinical and research case definition be developed in unison, that the effort begin with the Canadian Consensus Criteria and, most importantly, that it be developed by disease experts only.

I strongly urge HHS to abandon its plan for this ill-advised, wasteful, and unscientific initiative.

Sincerely,
Jennifer Spotila

Add your voice to ours, and send one email a day for the next week. It’s simple, and you can make a difference!

Posted in Advocacy | Tagged , , , , | 7 Comments

If You Want Our Support

Posted on September 3, 2013 by Jennie Spotila

A week ago, ME/CFS patients found out about HHS’s plan to sole source a contract to the Institute of Medicine to create a consensus case definition for our disease when the sole source notice was published. Today, the CFS Advisory Committee listserv finally got around to telling us about it. Here’s what they said:

This email is to inform you about HHS’ ongoing efforts to address the 2011 CFSAC recommendation “to reach a consensus for a case definition useful for research, diagnosis and treatment of ME/CFS.”   In response, NIH will be convening an Evidence-based Methodology Workshop, which would address the issue of case definitions appropriate for ME/CFS research, and that HHS was actively pursuing options for a separate effort that would result in a case definition useful for clinicians.  Because the use of and audience for case definitions for research and clinical care are very different, it is important to have separate processes to develop them.

HHS is actively pursuing a contract with the Institute of Medicine (IOM) to convene a consensus committee to develop recommendations for clinical diagnostic criteria for ME/CFS as recommended by CFSAC.  The IOM is unique in the prestige and authority it possesses among U.S. clinicians, researchers and the public. The reports and recommendations released by the IOM are widely accepted and get extensive coverage in both professional and mainstream media. The IOM has a singular reputation as the gold standard for providing biomedical recommendations on difficult, complex and controversial questions in clinical medicine. As the most respected source for medical consensus, the IOM is in a position to bring together experts, the ME/CFS community, and other stakeholders to develop diagnostic criteria for ME/CFS, so that more clinicians can help patients receive the medical care they need and deserve.

Thanks for your support.

Several things strike me as curious about this email, apart from the obvious point that it is a week too late. First, the email refers to the 2011 CFSAC recommendation and not the 2012 recommendation that said a workshop of ME/CFS experts should be convened to consider a definition, starting with the Canadian Consensus Criteria. It’s curious to me that they fail to mention it, particularly since it is one of the Committee’s High Priority Recommendations. Second, the email says the IOM will bring together experts, the community and other stakeholders. Curious, again, because several different sources have suggested to me that this plan to engage the IOM was intentionally concealed from the patient community.

If CFSAC – or more specifically, HHS – wants our support for an IOM process to create a clinical case definition, then they should be willing to address our concerns. I sent the following email to CFSAC with some specific requests:

If the CFSAC Support Team is serious about engaging the ME/CFS community as stakeholders in this process, then I suggest you do the following:

  1. Delay the finalizing and signing of this sole source contract until AFTER the CFS Advisory Committee and the ME/CFS community have had a full and fair opportunity to review the Statement of Work and offer input.
  2. Ensure through the Statement of Work that the IOM will select its consensus committee from ME/CFS researchers, clinicians and advocates, ensuring a full spectrum of opinions are represented.
  3. Tell us when the CFSAC voting and ex officio members were informed of the plan to contract with the IOM, how they were informed, and in what context.
  4. Tell us the cost of this contract, and where the funding is coming from.
  5. Explain how this definition process fits with and is coordinated with the NIH and CDC efforts.

Finally, I note that you may have more success in getting support from the patient community if you inform us of significant developments in a timely fashion – not after we discover the information through other means and mount a response.

Sincerely,

Jennifer Spotila

I will report any response that I receive.

 

Posted in Advocacy, Commentary | Tagged , , , | 5 Comments

Foreshadowing

Posted on September 3, 2013 by Jennie Spotila

The prospect of the Institute of Medicine creating a consensus case definition for ME/CFS scares me. It’s not free-floating anxiety or IOM-hatred. We have a current example of what this IOM contract might mean for ME/CFS and it’s not pretty.

The IOM was recently contracted by the Veterans Administration to create a case definition for Gulf War Illness, which is now being called Chronic Multisystem Illness (about as nonspecific a name as you can get). That process is just getting underway, but it has already come under heavy criticism from GWI advocates.

The chairman of the case definition panel (and former president of the IOM) Dr. Kenneth Shine has said that he can’t recall the last time the IOM was charged with defining a disease. That’s because disease experts usually undertake such a task, not panels populated by non-experts.

In fact, the composition of the GWI panel has been strongly criticized by advocates. Of the sixteen panel members, only Dr. Suzanne Vernon is identified by GWI advocate Anthony Hardie as an expert in GWI research without a bias towards psychological explanations of the illness. The other panel members, including Dr. Fred Freidberg, either have no experience working with GWI or have previously expressed bias towards a psychological explanation. In addition, none appear to have expertise in developing case definitions for other conditions. Hardie writes:

The most striking characteristic of the group selected to be on this committee is how few qualify as experts in the disease. Case definitions are typically developed by committees of experts in the disease in question, using detailed data sources to ascertain objectively which elements best characterize the disease. . . . Assigning this vital task, which will influence all future Gulf War health research, to a committee largely without expertise in the illness, and directing them to carry out the task through a literature review, is without precedent.

If this is the kind of approach the IOM would take in ME/CFS – populating the panel with non-experts or those with a bias towards psychological explanations of the disease – it does not take much imagination to predict what sort of definition would emerge.

The scope of the IOM’s effort to define GWI also gives us some clues. The committee will define Complex Multisystem Illness “as it pertains to the 1990-91 Gulf War Veteran population.” The committee will review “the available scientific and medical literature regarding symptoms for CMI among the 1991 Gulf War Veterans.” They will also hold discussions with researchers and clinicians. You can see the full task list here, although I have been unable to find the actual Statement of Work for this contract. The work will include evaluating existing case definitions, identifying additional areas of research necessary to more adequately develop a case definition, and determining the appropriate terminology to apply to this patient population.

The panel has held two meetings (June and August). A half day public session was held in June, and comments were heard from five Gulf War veterans, four members of the Research Advisory Committee for GWI, and six doctors/researchers with GWI expertise. The remainder of both meetings were closed to the public, with brief summaries posted after the fact. The IOM effort to define GWI is scheduled to take a year, so we will not see the results of their work before May 2014.

In the meantime, HHS is rushing a sole source contract to IOM to create a consensus case definition for ME/CFS. What confidence can anyone have, based on the example of the GWI panel, that this IOM contract will produce a definition that matches the disease we described at the FDA public meeting on ME/CFS symptoms and treatments? If the IOM staffs the ME/CFS panel with non-experts and/or people who have a bias towards the psychological explanation for CFS, we’ll be in trouble. If the IOM does not spend significant time listening to the expert clinicians, researchers and the patients themselves, we’ll be in trouble. It’s hard to have confidence in this sort of process when we see regular jaw-dropping examples of ignorance from federal employees. For example, at the May CFSAC meeting, Dr. Beth Unger of CDC stated that she was not familiar with the work of Dr. Chris Snell on metabolic dysfunction in ME/CFS – despite the fact that they have attended the same meetings where Dr. Snell has presented his work. This is not a confidence builder for ME/CFS patients.

Nothing would make me happier than to be wrong about this. I would love to post a correction after an ME/CFS expert panel is appointed. But based on what the IOM is doing with Gulf War Illness, I am frightened about what a similar process would mean for us. An IOM case definition for ME/CFS will be with us for decades. If they get it wrong, we are in big trouble. I hope I am wrong and that the GWI example does not foreshadow how our disease will be defined. But I am scared, and I think you should be too.

 

Posted in Advocacy, Commentary | Tagged , , , | 10 Comments

IOM On The Case

Posted on August 29, 2013 by Jennie Spotila

No announcement and no fanfare, but it became public this week that the Office of the Assistant Secretary intends to award a sole source contract to the Institute of Medicine to create a consensus clinical definition for ME/CFS. Here’s the specific description of the contract:

The Committee will consider the various existing definitions for chronic fatigue syndrome and develop consensus clinical diagnostic criteria for this disorder. Widely accepted clinical diagnostic criteria and a clear distinction from case definitions for clinical trials and research will aid in advancing clinical care, drug development, and basic and translational research. The Committee will also distinguish between disease subgroups, develop a plan for updating the new criteria, and make recommendations for its implementation.

The Institute of Medicine is an independent non-profit with a great deal of authority, in part because of the independence of their process. The party paying for a report, in this case the government, does not select panel members.

The IOM is currently working on a consensus case definition for Gulf War Illness, and the committee has come under fire from advocates. Dr. Suzanne Vernon of the CFIDS Association is serving on that panel.

We have almost no details, and I have a million questions about it:

  • How much will this process cost?
  • How long will it take?
  • Who will serve on the panel? Will ME/CFS experts be the majority?
  • Will patients have an opportunity to participate? Will that opportunity be more than five minute comments at a public hearing?
  • What can we learn from the Gulf War process, and its advocates?
  • When did OASH decide to go this route?
  • Will NIH still pursue their case definition process? Will the two efforts be duplicative? We know so little about NIH’s process, including these same questions about the panel and timeline.
  • Will anyone from the psychosocial school serve on the panel? What about a patient? What about co-authors from the Canadian and International case definitions?
  • Is the reference to a case definition for ME/CFS a clue as to the intent to treat these as one illness?
  • How will the panel identify subtypes, especially since the published research has proposed so many ways to look at it?

    • Advocates have been banging the case definition drum for YEARS. This has been a subject of great controversy at the CFS Advisory Committee. Many advocates were angry and disappointed that the CFSAC recommendation to hold a workshop on case definition was not followed. So is this the process that will get us where we need to go? We’ll see.

    Posted in Advocacy, Commentary | Tagged , , , , | 5 Comments

    Directional Signs

    Posted on August 26, 2013 by Jennie Spotila

    Last week, the CFIDS Association announced the formation of a Research Advisory Council and its newly appointed members. A close look at the roster reveals some interesting signs about the direction the Association may be headed, and it may surprise you.

    What is the Research Advisory Council?

    In 2011, the Association created a Scientific Advisory Board (pdf) with members from inside and outside the ME/CFS community. The SAB provided informal guidance to the Association’s Board of Directors and staff on issues related to research strategy. It appears that the new Research Advisory Council (RAC) will fill the same role, but the new name reflects the fact that more than scientific expertise is needed. Dr. Suzanne Vernon told me, “We invited people with expertise in regulatory, intellectual property, legal and privacy issues.  Since this required people in addition to scientists, we changed the designation from Scientific Advisory Board to Research Advisory Council (RAC).”

    The RAC will “advise on research matters as it concerns our strategic plan and the roadmap for our 3-year strategy.” Like its predecessor, the RAC is a volunteer advisory group, and it will not evaluate or approve grant proposals. Dr. Vernon said that the RAC will meet 2 to 4 times a year, in addition to individual consultations, and that the first in-person meeting between the RAC, staff and Board of Directors is planned for March 2014 at Banbury/Cold Spring Harbor.

    Some Stay, Some Go

    Six members are departing from the SAB, including prominent clinicians and scientists. Dr. Cindy Bateman and Dr. Nancy Klimas are leading ME/CFS clinicians. Dr. Lin Chang (IBS and gastrointenstinal expert), Dr. Robert Silverman (virologist), and Dr. Vincent Racaniello (virologist) are all prominent in their fields, and brought much needed outside expertise to SAB discussions. Dr. Dimitris Papanicalaou is an endocrinologist who did ME/CFS research before going to Merck Research Laboratories. Their departure means the loss of some important expertise, so I asked Dr. Vernon why these members were departing. Regarding Drs. Bateman and Klimas, she told me, “We will be partnering to conduct clinical trials and we need to be able to work with expert and respected ME/CFS clinicians as our clinical collaborators.  We did not want there to be any possibility of conflict of interest.” While Dr. Silverman and Dr. Racaniello are leading virologists, they “felt they did not have the clinical and regulatory expertise” to advise the Association on the design and execution of clinical trials and a regulatory strategy.

    Six members of the SAB will continue to serve on the RAC: Dr. Italo Biaggioni (expert on the autonomic nervous system); Dr. Gordon Broderick (gene expression and computational models); Russell Bromley (nonprofit strategy consultant); Paul DeStefano (biotech intellectual property attorney); Dr. Roger Dodd (Vice President of Research at the Red Cross); and Kelly Moren (strategic planning consultant).

    New Members

    Six new members of the RAC bring an interesting mix of expertise and perspectives. Several of them are familiar to the ME/CFS community. Dr. Peter Rowe is one of the most highly regarded ME/CFS clinicians, and the leading expert in pediatric ME/CFS. Kim McCleary is well-known to the community, and her appointment to the RAC was announced at the same time as the announcement of her departure as CEO of the Association. Dr. Terry Tyler is the parent of an ME/CFS patient and a current member of the Association’s Board of Directors. These three members represent a cross-section of the ME/CFS world: a clinician, an advocate, and a family member.

    The other three new members come from the pharma world, and this is where things get really interesting. Dr. Vernon told me, “Our research strategy is to bridge the gap between basic and clinical research.  . . .  These 3 RAC members have knowledge and expertise in translational research and what type of regulatory framework is necessary in order to make that translational as effective as possible.”

    The first of theses three new members is Bernard Munos, who may be familiar to some readers. Munos worked inside the pharma industry for years before leaving to reform it from the outside. He has been one of the pioneers in rethinking how drugs should be developed and is a Fellow at Faster Cures. You may remember that he spoke at the FDA’s ME/CFS Drug Development Workshop in April (see the video here). I found Munos’s presentation to be eye-opening, and one of his comments sums it up:

    And the traditional drug R&D model is not really suited to tackle something like CFS. . . . Scientists tend to follow the path of least resistance. I mean it’s smart of them. And so if you have the infrastructure, the tools, the data, that makes it easier and cheaper and faster for them to work on your disease, that’s where they will flock. They follow data for reason that we will talk in a few minutes. So we need data. We already have some, but it’s not enough and it’s not in the right format and it’s not good enough, so we need more and better data. We need tools to go along with that data. We need partners. We need money. And lastly, we need leadership and passion. And I should stress already that we have quite a bit of that already, but we need to maybe connect it a little bit better than it is connected today.

    Given Munos’s prominence in the field and his cutting edge thinking, it is quite a coup for the Association to recruit him as a member of the RAC. In my opinion, this is a strong signal that the Association is thinking creatively about ways to bring treatments to patients faster.

    Another exciting creative signal is the inclusion of  Dr. Tomasz Sablinski on the RAC. Sablinski is another big pharma insider who is trying to push the boundaries from the outside through Transparency Life Sciences. The TLS drug development model is based on crowdsourcing. Researchers, clinicians and patients all provide input on the design of clinical trial protocols in an open source format, and can monitor the progress of the trial and see aggregated data. Remote monitoring is used during the trial to reduce the amount of time patients spend in waiting rooms and office visits. TLS is currently working on MS and Parkinson’s (a protocol for low-dose naltrexone in Crohn’s was discontinued because of intellectual property issues). The trend in clinical trials and drug development is to capture patient input and experience earlier in the process, and having patients participate in actual trial design is revolutionary. I think this is a wonderful perspective to bring to ME/CFS.

    The final new RAC member, Dr. Mark Demitrack of Neuronetics, is a more controversial choice. Demitrack is a psychiatrist and expert in clinical trial design, having led the post-marketing development of Effexor. He also helped shepherd transcranial magnetic stimulation therapy to FDA approval for clinical depression. Earlier in his career, Demitrack conducted research on cortisol levels in CFS and fibromyalgia (abstracts here and here). In 1996, he co-authored Chronic Fatigue Syndrome: An Integrative Approach to Evaluation and Treatment.  I have not read this book, but reviews on Amazon and elsewhere are very negative, and state that the book posits that CFS is caused by depression and stress. In 2005, Demitrack participated in the CFS Computational Challenge meeting co-sponsored by CDC and The CFIDS Association, and gave a presentation on “Clinical Perspectives on Therapeutic Interventions for CFS.” Banbury requires that meeting discussions remain confidential, so there is no report from this meeting. However, in the 2006 issue of Pharmacogenomics where the Computational Challenge papers were published, Demitrack published a paper entitled, “Clinical methodology and its implications for the study of therapeutic interventions for chronic fatigue syndrome: a commentary.” There isn’t space to analyze the article fully here, but Demitrack does seem to have stepped back from a purely psychological theory for ME/CFS and adopted a multi-factoral neuroendocrine view of the illness. The article focuses on the importance of clinical trial design, selection of measurements, homogenous cohorts, and understanding prior treatment response. I asked Dr. Vernon about the significance of appointing a psychiatrist to the RAC and the implications for the Association’s view of the disease. She responded, “Dr. Demitrack is expert in study design, clinical research and regulation.  He understands that the CAA requires a regulatory framework in order to bring safe and effective treatments to ME/CFS patients, the core of our 3-year strategic plan and research strategy.  The CAA does not view ME/CFS as a psychological disorder.” Speaking for myself, I think it will be important to keep an eye on Dr. Demitrack’s views on ME/CFS and the impact he has on the Association’s research strategy.

    Roadmap

    The membership composition of the RAC is a mix of expertise and and perspectives. There is an ME/CFS clinician, an advocate, a family member, an attorney, two ME/CFS researchers, two strategy consultants, a nonprofit research leader, and three pharma experts. Clearly, the Association has stacked the RAC with people who can provide advice on research and regulatory strategy for bringing treatments to patients. Several of the members are recognized as cutting edge thinkers about treatment development. The perspective of an expert clinician and a family member should keep views of patient experiences on the table as well. It’s also an endorsement of the Association’s strategy for prominent people like Bernard Munos and Dr. Sablinski to get on board, as I expect that they both receive plenty of invitations from companies and nonprofits.

    So where is the Association headed? The RAC will provide expert advice on the Association’s research and regulatory strategies.  The PCORI grant, and the partnership with Patients Like Me, would fund a data collection network governed by patients. And the partnership with Biovista will soon begin a clinical trial. These are strong signs of what may be in the 3 year strategic plan mentioned by Dr. Vernon, and the signs point to the development and testing of treatments to get them in the hands of patients as soon as possible.

    Posted in Research | Tagged , , , , , | 7 Comments

    Drug and FDA News, August 2013

    Posted on August 23, 2013 by Jennie Spotila

    Next week, I will be attending the FDA’s Patient Representative Workshop for new patient reps. The meeting is 1.5 days of orientation and discussion, and I am eager to meet my fellow patient representatives. I will report back on the experience and share what I learn.

    Other news from FDA this month:

     

    Posted in Advocacy | Tagged , , , | Comments Off on Drug and FDA News, August 2013

    The Full Ninety

    Posted on August 22, 2013 by Jennie Spotila

    Ninety-one days have passed since the last CFS Advisory Committee meeting. As of the date and time of this post, none of the materials related to the meeting have been posted on the CFSAC website.

    Federal law requires that the Designated Federal Officer ensure that detailed minutes of all public meetings are maintained and available to the public. 5 U.S.C. App. § 10(c). The federal regulations require that the minutes are certified within ninety calendar days of the meeting. 41 C.F.R. § 102-3.165(c). The most recent version of FACA Management Handbook (.doc file) for the Department of Health and Human Service available online states that the minutes should be completed between sixty and ninety days after the meeting.

    Dr. Nancy Lee, the Designated Federal Officer of CFSAC, has failed to comply with these provisions as of the date and time of this post. And it is not only the minutes from the May 2013 CFSAC meeting at issue. We also do not have the presentations or the public testimony from the meeting. We also do not have the “High Priority Recommendations” document approved by the CFSAC at the meeting. You may recall that the content of that document was not posted at the meeting and was not read into the record. I can only make an educated guess as to the precise contents of the document.

    This is not a mere technicality. The purpose of the regulations is to ensure that the public has reasonable access to the work of the advisory committee. Having access to this record is very important. For example, dozens of organizations and advocates requested that the General Counsel investigate the allegations (made on the record at the May meeting) that the DFO had intimidated three voting members of the CFSAC. But we had to produce our own transcript of that part of the meeting, and there is still no official record. All of the presentations and public comment are also inaccessible in print.

    I have no evidence that there is malicious intent behind the failure to comply with these regulations. But it certainly creates the impression that, once again, we are at the bottom of someone’s priority list. With all the professional staff that attend the meeting, I can think of no reason why the minutes and other materials should not be available to us by now.

     Update, August 23, 2013: Some time after close of business August 22nd, the High Priority List (pdf) was finally posted on the CFSAC meetings page. I’ll post an analysis soon. Still no minutes or presentations.

     Update, August 25, 2013: The minutes for the May 2013 meeting have now been posted for day one (pdf) and day two (pdf). Still no presentations, including public comment.

     

    Posted in Advocacy | Tagged , , , | 8 Comments

    CFSAC Interviews

    Posted on August 20, 2013 by Jennie Spotila

    Gabby Klein has written an article for Phoenix Rising that features interviews with CFS Advisory Committee members Dr. Gailen Marshall and Dr. Susan Levine, and non-voting members Dr. Kenneth Friedman, Leigh Reynolds and Dr. Fred Friedberg. It’s an interesting read, including the members’ views on case definition, the CFSAC recommendations, and how patients can advocate more effectively.

    As additional background, you can read my interviews with Dr. Adrian Casillas and Dr. Lisa Corbin, and see who nominated each of the voting members. Stay tuned for more CFSAC coverage, especially as the fall meeting approaches (no date set for that yet).

     

    Posted in Advocacy | Tagged , , , , , | Comments Off on CFSAC Interviews