Guest Post: CFSAC Comments of Charmian Proskauer

Posted on June 17, 2014 by Jennie Spotila

Charmian delivered these comments at today’s CFS Advisory Committee meeting. She has kindly given me permission to publish them here in their entirety.

My name is Charmian Proskauer, and I currently serve as President of the Massachusetts CFIDS/ME & FM Association.  However I am testifying as an individual, not as a representative of the Association.

As has been previously pointed out, in October 2012 “CFSAC recommends that you will promptly convene (by 12/31/12 or as soon as possible thereafter) at least one stakeholders’ (Myalgic Encephalomyelitis (ME)/Chronic Fatigue Syndrome (CFS)experts, patients, advocates) workshop  in consultation with CFSAC members to reach a consensus for a case definition useful for research, diagnosis and treatment of ME/CFS beginning with the 2003 Canadian Consensus  Definition for discussion purposes.”

This recommendation appears to have morphed into two separate initiatives, both begun by a government agency without any consultation or input from this Committee or from the patient community – the Institute of Medicine Diagnostic Criteria for ME/CFS activity and NIH’s Pathways to Prevention, or P2P. I would like to talk about both of these.

First, IOM.  Although hundreds, if not several thousands, of ME/CFS patients along with over 50 expert ME/CFS researchers and clinicians, called for the IOM contract to be cancelled, it was not, and the process is going ahead.  However, the IOM process has been open to public input from the beginning, and the committee itself has a healthy representation of acknowledged ME/CFS experts, including some who signed the letter urging the contract to be cancelled.  These experts, as I understand, have the task of reviewing relevant research and clinical literature, and because of their expertise, they can bring to the committee the judgment to separate the good studies from the bad, and the clinical experience to understand the role of various types of treatments that are applied to this illness.  Also the goals that were established in the beginning are still the goals, and they are important ones of recommending a definition of the illness that can be used for making a clinical diagnosis, and developing a plan for education of health care professionals across the board on awareness and diagnosis of the illness.  While patients and advocates are still very concerned about what will be in the final report of this committee, at least there is recognized expertise on the committee and public input in the process.

The same cannot be said for P2P.  This appears to be a closed process within NIH, which over many years has given little serious attention to this very serious illness.  By design, NO members of the panel have any expertise regarding ME/CFS.  The literature review has been contracted out to an outside group, again with no expertise in understanding the context of the ME/CFS literature, good and bad. This outside group is then tasked to prepare a summary report, which will be given to the non-experts on the panel for them to use in their deliberations.  Furthermore, while the original goals of NIH to “conduct an evidence‐based review of the status of ME/CFS research and also convene a dedicated workshop to address the research case definition for ME/CFS” and to create research recommendations made sense, this has since morphed into a different goal which appears to focus on treating “overwhelming fatigue” as a public health problem, and with the treatments of CBT and Graded Exercise Therapy leading the list of treatments!  And this BOGUS process, which by its very setup is not likely to come to any legitimate conclusions about the real disease characterized by Post-Exertional Malaise and Cognitive Dysfunction along with many other physical symptoms, is what will presumably guide NIH in allocating research money (or NOT) for ME/CFS in the foreseeable future!

I therefore urge that the P2P process be suspended, at least until the IOM process has issued its final report and can be taken into account in P2P deliberations, and P2P can address its original goals of creating a research definition for the illness and then addressing research gaps.

Thank you.

 

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Comment for the June 2014 CFS Advisory Committee

Posted on June 17, 2014 by Jennie Spotila

These are the comments I delivered by telephone to the CFS Advisory Committee today. For the record, the operator told me that they were instructed to cut people off precisely at 3 minutes.

Mary Dimmock and I wrote to Dr. Collins about a number of scientific and policy concerns regarding the P2P Workshop, and I ask that NIH and this Committee give these concerns a fair hearing. It doesn’t matter that the P2P process is the same for every disease. The issue is that P2P is not right for THIS disease, for many reasons, not just the makeup of the Panel. These multiple issues are documented in the letter provided to you yesterday, and I think that we deserve the respect of having those concerns considered and addressed.

The danger posed by this fundamentally flawed P2P process is underscored by your discussion about whether an RFA should draw upon the P2P report. I understand the practicality of wanting to align your recommendation with what NIH is doing, and I recognize the tremendous work presented by Dr. Cook yesterday. But we already know that there are flaws and deficiencies in the entire P2P approach, so basing the RFA even partially upon such marred recommendations is risky, to say the least.

The P2P Panel’s primary source of information will be the systematic evidence review. I am not the only one with concerns about this. Last week, the Solve ME/CFS Initiative told NIH that the review search strategy is likely to result in a “grave and substantial error.” Yet this report will shape the non-ME/CFS expert Panel’s knowledge about the disease. ME/CFS expert input will be constrained to less than two days at the Workshop meeting. It is the non-expert Panel that has the power to make decisions, writing their recommendations in 24 hours after the Workshop meeting.

Your recommendation paves the way for an RFA based on the output of that process. You must recognize that by accepting P2P, you have told NIH that you will also accept an RFA based on recommendations written by a group of people with no expert knowledge of ME/CFS and whose primary source of information is a systematic review laden with grave and substantial errors.

My approach to advocacy is moderate, and I don’t like us vs. them thinking, but in this instance I must stand up and say this is scientifically and politically wrong. P2P as it is unfolding for ME/CFS incorporates multiple significant problems. We cannot afford to cross our fingers and hope the P2P output is good, when we already know it is going wrong. As many of you said yesterday, the 2011 State of the Knowledge meeting identified the gaps in research. NIH has what it needs to issue an RFA now. That is what should happen, and NIH should meaningfully engage with all the ME/CFS stakeholders to find the right path forward.

 

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Guest Post: CFSAC Comments of Joe Landson

Posted on June 16, 2014 by Jennie Spotila

Joe Landson delivered these comments at the CFS Advisory Committee meeting today. He has kindly given me permission to post them in their entirety here.

Testimony of Joseph D. Landson

June 2014 Chronic Fatigue Syndrome Advisory Committee

First, credit where credit is due. Thanks to the Social Security Administration (SSA) for its recent revision of ME/CFS disability guidelines. Thanks to the Food and Drug Administration (FDA) for its efforts to ease the approval path for prospective ME/CFS treatments.

So much for the good news; now for the bad. The contradiction in the Pathways to Prevention (P2P) program is so perverted, that only Donald Rumsfeld could appreciate it.

Let me explain. Back in September 2012, a group of patients met with a National Institutes of Health (NIH) official named Dr. Michael Gottesman. Patients asked him why ME/CFS had been largely ignored for over two decades.  Dr. Gottesman replied this was due to a lack of concrete scientific, clinical, medical findings and published papers. In other words, no evidence, no support. The thousands of published journal articles apparently didn’t interest him.

Flash forward to today. Recently, the Agency for Healthcare Research and Quality (AHRQ) revealed the evidence review plan for the NIH’s P2P process for ME/CFS.

But any evidence review begs the question: What evidence is the P2P process reviewing? Is it reviewing the evidence that Dr. Gottesman implied doesn’t exist? In that case Dr. Gottesman seems to have spoken in error. Or, is Dr. Gottesman correct, and there really is no evidence to review? In that case, what on Earth is P2P doing?

If I could ask Donald Rumsfeld, maybe he’d say the purpose of P2P is to find an absence of evidence, a rationale to continue ignoring us. Since we mere patients are almost completely locked out of P2P, who’s to say? We can say what we do see: evidence of absence.

There is an absence of any serious attempt to frame ME/CFS as the systemic biological illness that we experience it to be. There is an absence of any effort to re-imagine a so-called empirical approach in government research, an approach that has demonstrably failed even to measure the illness reliably, let alone do anything to treat it. In P2P, there is an absence of any serious attempt to engage patients in a desperately needed rethinking of the research approach to this illness.

I urge that P2P either be opened up, or discontinued.

 

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P2P Spin

Posted on June 12, 2014 by Jennie Spotila

spinstopsListen carefully to the agency updates at the June 16th CFS Advisory Committee meeting. Updates on the P2P Workshop and systematic evidence review may sound reasonable, but I suspect that hidden within will be some spin-doctoring to deflect our concerns about (and criticisms of) the P2P Workshop. So let’s just get it out of the way right now. Here are some possible spin arguments, and my responses.

The P2P Workshop is responsive to the CFS Advisory Committee recommendation to hold a meeting on case definition.

No, it is not. The recommendation was for a meeting to devise a clinical and research case definition. NIH has said that the P2P Workshop is expressly NOT devising a case definition.

ME/CFS experts are participating in every phase of the P2P Workshop.

Every phase except the one that really matters, and the expert participation is marginal. For example, there are twenty people on the P2P Working Group (that met in January to plan the meeting), but only five of them are ME/CFS experts. The full Working Group only meets once, if it follows the pattern of other P2P meetings. We don’t know how many experts are on the Technical Expert Panel (which helped with the protocol for the evidence review). The experts who will speak at the Workshop? Yeah, we don’t know who they are either. And the group that really matters is the P2P Panel and by design, NO experts whatsoever will be on that Panel. Ask yourself: would you have accepted an IOM committee with no ME/CFS experts on it? Then why is it ok for P2P?

Don’t worry, the P2P Panel of non-ME/CFS experts is just like a jury.

No, actually, it is nothing like a jury. For one thing, juries are selected in public, with both sides of a case having the opportunity to question potential jurors and move for their disqualification. The P2P Panel? Selected by NIH, behind closed doors, with no transparency for how they are screened for bias or preconceptions about ME/CFS. That’s like letting the prosecution choose a jury before anyone walks into the courtroom. Furthermore, this “jury” will make decisions based on an evidence base and field that is controversial, confusing, and laden with bias. No jury would ever be cast adrift in such murky waters without multiple layers of guidance and experts to assist them.

The systematic evidence review is the best methodology out there.

This may be true, although there is certainly controversy over the value of evidence reviews. But the issue is not the methodology. The issue is the study protocol that will be used to apply that methodology.  I’ve already documented the multiple concerns with the protocol, beginning with the failure to ask if the case definitions capture more than one disease. Beyond that, remember that the evidence review is the PRIMARY source of information for the Panel of non-ME/CFS experts. If the review doesn’t ask the right questions, then there is little chance that the Panel will do so at the Workshop.

The P2P Workshop will cover more than the Key Questions as stated in the evidence review protocol.

I’m hearing this already from several sources, and I have three objections. First, the draft agenda documents follow the evidence review questions very closely. And if you compare the key questions and agenda for the P2P Opioid meeting, you will see that they match. Second, even if it is true that the Workshop will cover additional questions – where are those questions? Why is there no transparency about the content of the Workshop? If there are additional topics being covered, then NIH should release that information immediately. Third, if the evidence review does not include some of the questions, then how can the Workshop adequately cover those questions in the absence of the evidence report?

The Workshop will cover ME/CFS, not medically unexplained fatigue.

Then why is the evidence review covering studies on patients with fatigue and no underlying diagnosis? Why does the draft meeting agenda describe the overview section as “Overwhelming fatigue and malaise as a public health problem”?

Our experts and the public will be able to refute anything that goes wrong in the systematic evidence report.

The calendar matters here. The evidence review, conducted and written by a contractor with no ME/CFS expertise, will be published in draft form six weeks prior to the Workshop. At the same time, the contractor will present the evidence review to the P2P Panel (also with no ME/CFS expertise) in a three hour closed door meeting. The two groups of non-experts will discuss the evidence report. Not a single expert will be in the room to point out anything that went wrong with the review. So technically, yes, the public can comment on the draft evidence report. But in reality? The non-expert Panel may never see those comments and even if they do, they will assess the comments after spending three hours discussing the non-expert report with other non-experts.

reality-marketing-no-spinOur experts will be able to provide all the necessary information at the Workshop meeting.

The speakers may have been suggested by the Working Group (only 25% of whom were ME/CFS experts), but the final agenda and speakers are selected by NIH. Each speaker has 20 minutes to talk about their assigned topic. There is time for discussion on the agenda, but we don’t know how it will work. Will the non-expert Panel control discussion with questions? Will there be an open mike that gives experts and patients an opportunity to point out everything that is wrong with the evidence report? We don’t know. Remember, the non-expert Panel takes the evidence report (which they review for 6 weeks) and the Workshop (which lasts 1.5 days and is controlled by NIH), and then they have to turn all that information around and in 24 hours produce a report with recommendations on the future directions of research, case definition, and possibly treatments.

To put this challenge in context, remember the 2011 State of the Knowledge meeting? That was a two day meeting and all the presenters were ME/CFS experts. The summary of research gaps and opportunities was presented by Dr. Suzanne Vernon with the Director of NIH, Dr. Francis Collins, in the room. And what has happened at NIH for ME/CFS research since then? An RFA? Nope. A strategic plan? Nope. Engagement with stakeholders, increase in funding, fair grant review? If a two day meeting of ME/CFS experts that provided input directly to the Director of NIH could not fix any of these problems, then a panel of non-ME/CFS experts using a flawed evidence review and 1.5 days of presentations of experts and non-experts combined will be facing a very steep climb to deliver a strong set of recommendations after 24 hours of discussion.

We should be glad NIH is paying this much attention to ME/CFS.

So any attention is good attention? No. In this case, attention in the form of bad key questions and the framing of the problem as “overwhelming fatigue or malaise” could be very damaging and counter-productive. The conclusions and report of the Panel of non-ME/CFS experts will shape NIH policy. NIH will put a media relations push behind the report. We will be stuck with it for some time to come.

Opposition to P2P is just nay saying and complaining.

As I’ve extensively documented here and in the letter to Dr. Collins, there are legitimate concerns that this process will not produce recommendations that move the field forward with the best of what science can offer. To dismiss these concerns as complaints or negativity is, quite frankly, disrespectful of the advocates who have taken the time to express them. Give my concerns a fair hearing. Then let’s talk about whether the P2P Workshop is the best way to collaborate with the ME/CFS research and clinical community. Anyone who thinks we’re whining or overreacting has not actually read the material submitted to Dr. Collins.

Don’t worry. We’re NIH and we know what we’re doing.

Even the most qualified scientist can get it wrong. Even the purest motivations can lead to mistakes. I’ve written before about the problems of mistrust and disrespect in the ME/CFS landscape. NIH should not tell us to just trust them. NIH should be demonstrating that it is safe and appropriate for us to trust them. Based on what I’ve documented about P2P thus far, they have not done so.

 

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P2P: It’s Not Just Us

Posted on June 10, 2014 by Jennie Spotila

Denied_SignI’ve been asked if it is too late to send an email to Dr. Francis Collins about the P2P Workshop. Definitely NOT! In fact, there is now a super easy way to send that email through a page on ME Advocacy. My thanks to caledonia for making that possible. Please take a minute (literally!) and send your email today.

One of the main reasons I’ve asked Dr. Collins to cancel the P2P Workshop and reexamine the best way to collaborate with the ME/CFS research and clinical community is that NIH has failed to engage stakeholders in a meaningful and substantive way. The P2P Program is simply not designed to do this, and now I’ve got more proof of that from another P2P Workshop.

In September 2014, NIH will host a P2P Workshop on the Role of Opioids in the Treatment of Chronic Pain. Chronic pain is a huge national problem, and there are many issues associated with opioid treatment. So you would think that NIH would have made an effort to involve stakeholders from across the chronic pain community, right?

Apparently not. There was no patient representation on the Working Group for that meeting. Multiple advocacy organizations in the fibromyalgia community had no idea the workshop was even happening, including the National Fibromyalgia and Chronic Pain Association. At least one opioid drug manufacturer was also completely unaware of this Workshop – despite having a regulatory affairs office.

I think what we’re seeing is indicative of NIH’s mindset. Unlike FDA, which has made great strides towards incorporating patients into decision making, NIH is an ivory tower of researchers with limited history of engaging patients and other stakeholders. I think it may not even occur to them that they need to do this.

NIH is not just failing to engage with ME/CFS stakeholders in the P2P process; NIH is failing to engage with ANY stakeholders through P2P. On the one hand, it’s nice to know that it’s not just us. On the other hand, it is very cold comfort.

 

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Twitter Chat

Posted on June 8, 2014 by Jennie Spotila

I will be guest hosting a WEGO Health Twitter chat on Tuesday, June 10th from 3 to 4pm Eastern time. I chose the topic of advocating for yourself when you have a stigmatized chronic disease.

What’s a Twitter chat? Twitter chats are like other chats, but they happen on Twitter. At the appointed time, anyone can follow the chat, and WEGO Health posts a summary or transcript afterwards.

Do I have to join Twitter? You do not have to join Twitter to read the chat. You will have to join if you want to actually participate in the chat.

How do I participate? At 3pm Eastern on June 10th, go to the Tweet chat room and see what people are saying. If you have a Twitter account, you can sign in on the chat page to participate in the conversation. Alternatively, just go to Twitter and read the Tweets tagged #hachat. The Tweet chat room is much easier, trust me.

What is this chat about? I chose the topic of advocating for yourself when you have a stigmatized chronic disease, and we’ll talk about the challenges of doing that in healthcare, family and political settings.

What’s the point? Getting the word out!!! There’s a huge audience out there that does not understand ME/CFS. While WEGO Health asked me to make the discussion questions applicable to more than one disease, I will definitely use ME/CFS as an example during the chat.

I hope you will join me and share your own experiences with this broader audience!

Added June 17, 2014, the transcript to the full chat is now available.

 

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Just In: New CFSAC Members

Posted on June 6, 2014 by Jennie Spotila

New CFSAC members have been announced! Four members have been appointed, along with the announcement of the new chair.

Two members are not new to us, or to CFSAC. Dr. Sue Levine and Dr. Dane Cook have both been given new three year terms. Neither of them was nominated in response to the Federal Register Notice last year, so that means they were hand picked by HHS to continue (this is legal). New to the Committee but well known in the ME/CFS community, Dr. Jose Montoya nominated himself, and has been appointed for a four year term.

Dr. Alisa Koch is a rheumatologist at Eli Lilly, and was nominated by Denise Lopez-Majano. Dr. Koch knows the Lopez-Majano family well, and is familiar with Alexander and Matthew Lopez-Majano’s story. Dr. Koch is somewhat familiar with the IACFS/ME Primer, but has not treated ME/CFS patients. The addition of a rheumatologist to the Committee is interesting, given the emerging evidence that ME/CFS may be an autoimmune or autoinflammatory disease.

Donna Pearson was nominated by the Massachussetts CFIDS/ME & FM Association. I’ve worked with Donna on advocacy projects for the last several years. Donna was a business executive before falling ill with ME/CFS. In my personal opinion, she is smart, organized, and clear-thinking. Donna is very focused on measuring progress and results, and has demonstrated an ability to find consensus among disparate views. The CFSAC roster page makes it look like she was appointed for one day, but I suspect she was given a four year term.

Not on the roster page, but now known in advocacy circles, Dr. Faith Newton will replace Steve Krafchick in July. Dr. Newton is an expert in education, and gave a presentation to CFSAC on providing resources and information to schools and parents. She was nominated by Dr. Gailen Marshall, and appointed for a four year term. Her son has ME/CFS.

The new Chairman of the CFSAC will be Dr. Levine, but word is she will be unable to attend the June meeting so Dr. Lee will act as Chair in her place.

This is an interesting group of new appointees. All but one of the new members are ME/CFS experts, either as clinician, research, patient or parent. This is very very good news. The terms are now staggered such that no more than four terms will expire in any given year. Only two will expire in 2015. The reappointment of Drs. Levine and Cook also gives some continuity to Committee business, especially as they are both chairs of Working Groups. It’s unfortunate that Dr. Levine cannot chair the meeting this month, because I’m looking forward to seeing her leadership style.

 

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A Different CFSAC

Posted on June 5, 2014 by Jennie Spotila

It’s that time again: meaning it is time for another CFS Advisory Committee meeting. Due to the make up day in March, the meetings have fallen very close together. Presumably this spring meeting puts the calendar back on track (but that’s a guess on my part). Key deadlines are upon us, and there are some interesting changes you should also be aware of.

Deadlines You Need to Know

  • The meeting is June 16-17, 2014.
  • If you want to attend in person, you must register by Thursday, June 12th. If you are not a US citizen, the deadline to register was June 5th.
  • If you want to give public testimony in person or over the phone, you must register by Monday, June 9th.
  • According to the Federal Register Notice, if you want to submit written public comments for the record, you must do so by Thursday, June 12th. Be sure to comply with the guidelines on length and file format from the Federal Register Notice.

Many Differences

A number of things will be different about this meeting compared to previous ones:

  • Length – This meeting will be from 12-5pm on June 16th and 9am-5pm on June 17th. This is a switch from the usual two full days for in-person meetings. The Office of Women’s Health was asked about the timing, and OWH stated that the half day on Monday was to avoid requiring everyone to travel on Father’s Day (although presumably some people will still need to do so).

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  • Location – The meeting is in-person (hopefully this is the end of webinars), and it is being held on the first floor of the HHS building in the Great Hall. This has happened only one other time in the history of the Committee: October 2009, immediately after the publication of the XMRV paper in Science. OWH said that the change was made because the usual Room 800 was not available during the month of June.

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  • New Members – As I pointed out in March, there are five (and soon to be six) vacancies on CFSAC. Four terms expired on May 10, and Dr. Dimitrakoff resigned before the March meeting. In theory, at least four new members should be appointed for this meeting. I’ve heard reports that this will be done in time, but failing that, Dr. Nancy Lee will act as chairman of the Committee (in place of Dr. Marshall) and the remaining six members will serve. Dr. Lee has the option of extending terms beyond the scheduled expiration date, but we do not yet know if this has been done or if the new members will be sworn in.

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  • Three Minutes for Public Comment – You might recall that we usually have five minutes for public comment. In December, the time was cut to three minutes because of the compression of the agenda due to the snow day. In March, the three minute limit was retained in order to maintain parity with the people who had their time cut in December. But now, the three minute limit appears to be permanent. I originally wondered if this was a mistake, but the OWH confirmed that Dr. Lee decided to keep the three minute limit. Why? I don’t know.

Agenda, On and Off

You can see the full agenda here. There are a few things to note:

What’s on the agenda?

  • A presentation (and recommendations?) from the Research and Clinician-Scientist Recruitment Working Group. I posted about their work to date in April. Group chair Dr. Dane Cook’s term expired in May, so I do not know if he will attend or has been replaced.

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  • Another intriguing topic is “Future Directions” on day two. This is paired with a presentation on epilepsy as a model for collaborating post-IOM report, so I’m assuming that is the focus of the future direction question. This begs the questions of whether HHS will use an IOM report if they don’t like the answer, and the extent to which anybody will be willing to collaborate with anybody else given the controversies over the IOM contract.

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  • Finally, day two will end with “Open forum” among people in attendance. This sounds like open mic, rather than the submit questions in advance process from the past, but I have no information about how this will actually work. I will be very pleasantly surprised if it really is open forum.

What’s off the agenda?

  • An obvious and glaring omission is any discussion of the P2P Workshop, given that controversy. I am hoping/assuming that NIH and AHRQ will address P2P in their agency reports on day one, but each agency only has 20 minutes and there does not appear to be time set aside for questions.

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  • Another omission is the Education Working Group recommendations from the March meeting. Those recommendations have still not been posted to the CFSAC website. Have they been finalized? Submitted to the Secretary? Is there more work to do here?

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  • And finally, there is nothing about charter renewal on the agenda. The CFSAC charter will expire in September. Is renewal a done deal? Is there room for improvement in the charter? We won’t know unless someone takes it upon him/herself to ask the question.

There’s not much time! So sign up for public comment and send it in. Here’s my post from last year about why getting your comments on the record is so important.

 

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Tell Dr. Collins to Stop P2P

Posted on June 2, 2014 by Jennie Spotila

Denied_SignAs I explain in this previous post, Mary Dimmock and I have sent a letter to Dr. Francis Collins requesting that he cancel the P2P Workshop and reexamine the best way to collaborate with the ME/CFS research and clinical community.

The P2P Workshop will use a panel of non-ME/CFS experts, selected by NIH, to make recommendations on case definition, research direction and possibly treatments. You can read more about P2P and what I’ve discovered through FOIA requests in the posts gathered here.

If you are worried about what P2P could produce . . . if you think this is bad science . . .  if you want to voice your opposition to using non-ME/CFS experts to advise NIH on the direction of ME/CFS research . . . here is your chance.

Fax or email Dr. Francis Collins today and request that he cancel the P2P Workshop.

Use the template I have provided below, or write your own. Fax Dr. Collins at 301-402-2700 or email him at collinsf@mail.nih.gov. It’s simple, but it’s a start.

Please take a few minutes to do this today. If you have questions or comments, post them here or email me at jspotila AT yahoo DOT com.

 

Dear Dr. Collins:

I am writing to request that you cancel the P2P Workshop on ME/CFS . I believe that the P2P Workshop will not advance us towards the much needed ME/CFS research case definition or strategy, for the following reasons:

  1. ME/CFS experts have already pointed a way forward on research and case definition.
  2. The Workshop is examining the wrong disease: the problem of medically unexplained fatigue and not ME/CFS.
  3. NIH has not engaged or involved stakeholders in a substantive way.
  4. The Workshop decision makers are non-ME/CFS experts.
  5. HHS has made numerous contradictory statements about the purpose of the Workshop, so its goal is unclear.

I understand that you were recently provided with extensive documentation of these five points. Dr. Collins, I am not objecting to the P2P Workshop simply to criticize federal efforts to address the challenges of ME/CFS. Careful consideration of these issues raises legitimate concerns about whether the P2P Workshop will produce the good science and sound recommendations we need to advance ME/CFS research.

I hope you will give my concerns a fair hearing, and that you will cancel the P2P Workshop.

Sincerely,

[Your name]

 

 

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Collins: Please Cancel P2P

Posted on June 2, 2014 by Jennie Spotila

Denied_SignLast week, Mary Dimmock and I sent a letter to Dr. Francis Collins, Director of NIH, requesting that he cancel the P2P Workshop on ME/CFS and reexamine how to best collaborate with the ME/CFS research and clinical community.

We offered five reasons why we believe the P2P Workshop is not the right way to move forward:

  1. The Workshop is unnecessary and redundant of other efforts on research and case definition.
  2. The Workshop is examining the problem of medically unexplained fatigue, not ME/CFS.
  3. NIH has not engaged or involved stakeholders in a substantive way.
  4. The Workshop is inappropriate for this disease, particularly because the decision makers are non-ME/CFS experts.
  5. The goal of the Workshop is unclear because HHS has made numerous contradictory statements about its purpose.

You can read the letter below, and that was not the only thing we sent. With attachments and supporting documentation, the package came to 38 pages total. I believe that we have provided ample reasoning and evidence in support of our request to Dr. Collins.

Many people have asked me what they can do to try and stop P2P. I believe this request to Dr. Collins is the first step, and there is a very easy way for you to join in. If you have questions or comments, post them here or email me at jspotila AT yahoo DOT com.

 

Dear Dr. Collins:

We are writing to request that you cancel the Office of Disease Prevention’s Pathways to Prevention Workshop on ME/CFS (“P2P Workshop”). Your immediate action is required to ensure that ME/CFS research and policy is based on the best scientific evidence and processes.

In your April 16, 2014 letter to Representative Zoe Lofgren and colleagues, you said that the P2P Workshop would produce recommendations to move the field forward. We believe that this is not the case, and we offer the following documentation to support our conclusion:

  • The Workshop is unnecessary and redundant given the recommendations of disease experts and other NIH efforts to advance ME/CFS research and clinical care. See Attachment 1.
  • The Workshop has been structured to address the problem of medically unexplained fatigue, and not the disease(s) known as ME/CFS. See Attachment 2.
  • NIH has paid lip service to collecting input from stakeholders, but in reality has not involved them in a meaningful way. See Attachment 3.
  • The P2P Workshop process is inappropriate for this disease, particularly because the decision makers will be non-ME/CFS experts. See Attachment 4.
  • The goal of this Workshop is unclear as a result of numerous contradictory and confusing public statements by HHS about the purpose of the Workshop. See Attachment 5.

Dr. Collins, we are not objecting to the P2P Workshop simply to make a political point or for the sake of criticizing federal efforts to address the challenges of this disease. We are appealing for your help because we know you recognize that ME/CFS is a serious public health issue that needs the best of what science can offer. We sincerely believe that the evidence included with this letter raises genuine concerns that the P2P Workshop does not represent the best of what science can offer, and may very well take us in the opposite direction.

For all of these reasons, we request that you cancel the P2P Workshop. Further, we request that NIH reexamine how to best collaborate with the ME/CFS research and clinical community to achieve the goals of a research definition and strategy. Those who are researching and treating this disease are in the best position to define how to move forward.

We thank you for your consideration of this issue, and we look forward to your reply.

Sincerely,

Jennifer M. Spotila, JD                                              Mary E. Dimmock

 

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