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Posts Tagged ‘CFIDS Association’

Musical Chairs

December 2nd, 2013 24 comments

circlechairsUnderstanding the CFS Advisory Committee is not limited to what happens in the meetings. The paths that lead members to their seats at the table are very important too. Regular readers of this blog know that I’ve tracked the nomination sources for all the members. I now have new information about how Dr. Gary Kaplan was nominated to the Committee, and it potentially changes the full context of the Committee balance. In fact, I can now show you a very disturbing trend in which nominations seem to be the most successful under Dr. Nancy Lee.

When Dr. Gary Kaplan was appointed to the CFS Advisory Committee last month, he very kindly gave me an interview. I published a profile of him on October 25th.  I asked Dr. Kaplan who had nominated him to the CFSAC, and he told me that he was nominated a year ago by a unnamed patient of his at HHS. I did not include that comment in my profile of Dr. Kaplan because I did not want to risk exposing this person as a patient, if he or she has not gone public about the illness.

I followed up, as I now do with every new member, by filing a Freedom of Information Act request for all letters of nomination submitted in support of Dr. Kaplan. Amazingly, I received a response a month later (the fastest I have EVER received a FOIA response).

The documents reveal that Dr. Kaplan was not nominated by a patient. Dr. Kaplan nominated himself to CFSAC on August 17, 2011. The FOIA letter further states “there are no other nominations submitted on his behalf.”

Now, there’s nothing wrong with nominating yourself to CFSAC. People do it all the time. What frustrates me about this situation is that Dr. Kaplan didn’t simply tell me that this is what he did. I emailed Dr. Kaplan and asked if he would like to comment on the discrepancy. Dr. Kaplan replied:

You are correct I self nominated for the committee. I submitted the application so long ago I forgot the specifics of the process. I was told about the committee and encouraged to submit an application for selection to the advisory board by a patient of mine who works for HHS.

I certainly hope that this was an honest mistake and fuzzy recollection. The sources of CFSAC nomination are a matter of public record, and are an important part of the operation of the Committee.

Tallying the Members

The Federal Advisory Committee Act requires that advisory committees have a balance of views and members. No single source or type of source should dominate appointments. This is why I have been tracking how the members get to the table. With the addition of Dr. Kaplan to CFSAC, the nomination sources break out as follows:

  • Nominated by CFSAC members: Dr. Gailen Marshall and Dr. Adrian Casillas
  • Nominated by CDC: Dr. Lisa Corbin
  • Nominated by The CFIDS Association: Dr. Dane Cook
  • Nominated by PANDORA: Eileen Holderman and Steve Krafchick
  • Nominated by the Miami CFIDS Support & Advocacy Group: Dr. Mary Ann Fletcher
  • Nominated by academic colleague: Dr. Jordan Dimitrikoff
  • Nominated themselves: Dr. Susan Levine, Rebecca Patterson Collier, and Dr. Gary Kaplan

Nominees from advocacy groups (4 combined) and self-nominations (3) predominate. However, five members will depart the committee in 2014: Marshall, Cook, Holderman, Krafchick, and Levine. Look at what that will do to the balance:

  • Nominated by CFSAC members: Dr. Adrian Casillas
  • Nominated by CDC: Dr. Lisa Corbin
  • Nominated by the Miami CFIDS Support & Advocacy Group: Dr. Mary Ann Fletcher
  • Nominated by academic colleague: Dr. Jordan Dimitrikoff
  • Nominated themselves: Rebecca Patterson Collier, and Dr. Gary Kaplan

Self-nominees will dominate, but barely. Nominations for new members were due October 28th, and we will all be watching final selections with great interest.

However, there is a disturbing trend in the recent appointments that may not bode well for those recent nominees. Six appointments have been made since Dr. Nancy Lee became Designated Federal Officer in late 2011. Half of those appointees (Rose, Collier and Kaplan) nominated themselves, which strikes me as very high. All three also live in the DC metro area, which is another odd imbalance. The remaining three (Casillas, Corbin, and Fletcher) each came from a different source: a current member, CDC, and an advocacy group, respectively.

But more disturbing than the nomination sources is the level of ME/CFS specific knowledge these members have brought. Dr. Fletcher is the only person with ME/CFS research experience, and Dr. Kaplan is the only one with ME/CFS specific clinical knowledge. The rest all acknowledged relatively little familiarity with ME/CFS scientific and political issues. For example, Dr. Corbin said at her first meeting that she was not aware there were any alternative definitions to Fukuda. Dr. Casillas admitted that his first meeting made him recall patients who probably did have ME/CFS that he had not recognized at the time.  Only one of the six, Dr. Fletcher, was known to the ME/CFS advocacy community prior to appointment to the Committee.

Coincidence or master plan? The trend of appointing members with no experience with CFSAC and/or little familiarity with ME/CFS is very troubling. If substantial ME/CFS expertise is not appointed to the Committee in 2014, then the FACA requirement of membership balance will likely be violated, to say nothing of the damage that these neophyte members would do to the Committee’s work.

 

 

FAQchecking

November 18th, 2013 19 comments

FAQ ButtonSo We Had Some Questions . . .

For the last few weeks, there’s been a rumor that HHS might actually respond to questions about the Institute of Medicine study. PANDORA urged HHS to address specific questions about the contract during phone calls and emails with HHS officials. The CFIDS Association also “contacted the CFSAC urging them to respond to a myriad of questions,” although they provide no other details about the context of that communication or the questions submitted.

In addition to the efforts of these two organizations, HHS has been buried in a deluge of organized petitions, letters signed by more than two hundred (combined) experts and advocates, and individual emails and letters.

The overall response to this deluge? A brick wall of silence. Since the announcement on September 23rd and the release of the Statement of Work on September 30th, HHS has officially said nothing about it. There have only been individual communications between IOM or HHS employees and advocates. Until now.

On November 15th, an email titled “FAQs Regarding the IOM Contract” went out via the CFSAC listserv. The email has been published in its entirety in a variety of places, but the CFIDS Association posted it first. I encourage you to read the entire document, but here are my standout raising-more-questions-than-answers-FAQ-moments.

TL;DR (Too Long, Didn’t Read?)

  • The IOM study is aimed at the wrong target audience.
  • They think they’re implementing a recommendation but they’re making it worse.
  • They don’t explain why HHS can’t adopt the CCC.
  • They ignore one of PANDORA’s most important questions.
  • They contradict their own written descriptions of the NIH workshop.

But Who Is Answering?

Some people have questioned the authorship of the document (with good reason), specifically whether the CFSAC itself wrote or approved this document. Although the FAQ is not signed, I think we can safely assume that most CFSAC members had nothing to do with it.

How can I be so certain? Because if the CFSAC approved such a document – even if the vote was by email – it would be a violation of the Federal Advisory Committee Act which requires all meetings of the full Committee (electronic or otherwise) to be held in public. Given the Public Citizen smack down of the Committee for a similar violation earlier this year, I think that the CFSAC staff are more careful about these things.

The CFSAC listserv has become an all-purpose communication tool, in part because it is an effective way to get information out to the interested public. Announcements on behalf of other agencies, such as FDA meetings or CDC PCOCA calls, are routinely disseminated this way, although frequently days or even a week after we’ve already found out.

I think it is reasonable to assume that these answers were drafted by Dr. Nancy Lee and her staff, and sent out through the CFSAC listserv without even consulting the full committee. That is, of course, the pattern at the Office of Women’s Health. The entire IOM contract was conceived and developed by HHS staff, with only ONE member of the CFSAC consulted early in the process for input (and told to keep it confidential). I would be very surprised if something as sensitive (and rare) as public statements from HHS about the IOM contract were previewed or approved by the CFSAC itself. This is an HHS staff statement.

The Wrong Target Audience!

clipartdoctorThe first question of the FAQ is “Who is the target audience for the Institute of Medicine (IOM) study?” This was not one of the questions posed by PANDORA, and hasn’t really circulated in advocacy circles, so I’m not sure why this is the first question answered. But the answer is disturbing: the target audience is primary care providers because they don’t know how to diagnose ME/CFS, and patients have to see lots of doctors to finally get the diagnosis.

On the face of it, this seems reasonable. After all, my primary care doctor, and the first two doctors he referred me to, all failed to properly diagnose me.

But my primary care provider can’t diagnose cancer either. He might know I had a malignancy, but he would immediately refer me to an oncology specialist for diagnosis and treatment. My primary care doc can’t definitively diagnose artherosclerosis or rheumatoid arthritis or multiple sclerosis, either. He could suspect any of those diseases, maybe even screen me for them, but then my doctor would refer me to the cardiologist, rheumatologist, or neurologist best suited to diagnose the disease.

Saying that primary care physicians should be able to diagnose ME/CFS rests on two assumptions: that there is no medical specialty better suited to make the diagnosis and treat patients; and that ME/CFS is not so complex a disease that it requires care beyond what a general internist can provide. WRONG and WRONG.

I want primary care providers to know enough about ME/CFS to recognize when someone may need to be carefully evaluated for it, to know what tests might be helpful in screening, and to know which specialists are best suited to make the final diagnosis. A clinical case definition can help with this.

But I absolutely oppose the assumption that all we need is a quick checklist that any general nurse practitioner can use to label someone with ME/CFS and send them on their way to physical therapy. NO.

We Can’t Workshop Because . . . . ?

The October 2012 CFSAC recommendation states that HHS should convene a workshop of ME/CFS experts to reach consensus on a case definition beginning with the 2003 CCC. PANDORA asked why HHS could not convene the workshop and turned to the IOM instead.

In answering, HHS says it relies on professional societies and institutions like the IOM to develop guidelines and recommendations, and then disseminates those guidelines. HHS also says that making a clear distinction between clinical diagnostic criteria and a research definition will improve clinical care and research.

Never mind that the recommendation said that HHS should sponsor a meeting, not create a definition by itself. Never mind that the recommendation said that a single case definition for research, diagnosis and treatment was needed, not separate definitions. So not only has HHS not followed the recommendation, it has still not explained why.

But rest assured! The October 2012 recommendation has been addressed! The FAQ says, “as a direct result of the CFSAC recommendation, HHS’ contract with the IOM requires it to host public meetings and to include in the expert advisory committee ME/CFS experts (which could include members of CFSAC).” No, actually not. This contract only requires one public meeting, and we have no guarantee or information about meeting content.

And did you notice the last part of the sentence? As a direct result of the CFSAC recommendation, the IOM study will include ME/CFS experts which could include members of CFSAC. Several members of the CFSAC roster have been nominated to the IOM panel, including Dr. Levine, Dr. Marshall and Dr. Fletcher (all nominated by PANDORA).

In my opinion, even CFSAC members who are recognized experts in ME/CFS clinical care and research like Drs. Levine and Fletcher should not be on the panel. There has been so much rancor, division, controversy, and disagreement in CFSAC about the case definition recommendation, both publicly and privately, that I believe CFSAC members are biased on the issue. That’s just my personal opinion, but I will oppose the appointment of any current CFSAC member to the panel.

Why Not CCC?

PANDORA asked why HHS could not adopt the 2003 CCC, especially in light of the letter from the 50 experts to Secretary Sebelius. The answer? HHS can disseminate but not endorse guidelines made by nongovernmental groups and besides, the CCC is ten years old. I’m not buying it.

The Institute of Medicine is a nongovernmental group. That’s the POINT. Remember how I pointed out that the government cannot use IOM recommendations if it exerted influence over the development of them?

Yeah, so . . . . the government CAN and DOES both endorse and enact recommendations coming from nongovernmental organizations like IOM. Actually, they do it all the time and not just with IOM.

For example, Dr. Koh recently said that HHS was implementing recommendations from an IOM report on epilepsy that was co-sponsored by federal agencies and non-profit groups. The CDC recommends the American College of Rheumatology’s criteria for diagnosing fibromyalgia, and refers people to the Lyme disease treatment guidelines from the Infectious Disease Society of America.

In all three cases, HHS is endorsing recommendations and guidelines created by nongovernmental groups, not merely disseminating them. I’m sure HHS has its reasons for refusing to adopt the CCC, but those reasons are not the ones offered in this FAQ.

I Could Drive a Truck Through These Holes (if I could still drive)

One of PANDORA’s questions was, “Can the IoM contract be canceled? If not, why not?” The FAQ does not answer the question.

Instead, the FAQ answers a different question: “If the IOM contract is cancelled, will the contract funds go to ME/CFS research?” HHS says, “There is no way for HHS to recover or repurpose these funds.” Fine, but that’s not what we need to know.

First, where did the funding come from? Did it actually come from NIH’s research budget? I assumed the answer to that was no, and that there was never a chance that the money could be used for research regardless of what happened to the IOM contract.

Second, IOM says that HHS and the Social Security Administration funded the study. This FAQ says, “Almost all of the agencies that have efforts involving ME/CFS contributed Fiscal Year (FY) 2013 funds to this study.” Presumably this means HHS agencies, but it still does not tell us which agencies and how much they contributed. I would like to see the full breakdown, and I’m hoping that one of my FOIA requests will provide it.

Another question from PANDORA was completely ignored in the FAQ: “[W]hat guaranteed [sic] can you give that [IOM] won’t come back with something more broad, and thus more harmful, than Fukuda?”

THIS is the question we all want the answer to. In fact, it is arguably the MOST IMPORTANT question of all.

Answer?

*insert sound of crickets chirping here*

The Shifting Sands of NIH

From the very beginning, advocates have been concerned about how multiple case definition efforts would be coordinated. At first, we were worried about the CDC multi-site study and the scope/coordination of the NIH Evidence-based Methodology Workshop (EbMW).

Our concerns were heightened after the announcement of the IOM effort, and alarm bells went off in my head when the Statement of Work said that IOM should coordinate with EbMW “to minimize overlap and maximize synergy. . . [and] assure that relevant information is shared and that key messages are coordinated.”

The FAQ attempts to address this by quoting an unnamed person at NIH:

The expected outcome from the Evidence-based Methodology Workshop for ME/CFS is to identify research gaps in ME/CFS, identify methodological and scientific weaknesses in the ME/CFS field, suggest research needs that will advance the ME/CFS field, and move the field forward through an unbiased, evidence-based assessment of this complex public health issue.

Do you notice what is MISSING from this description of the EbMW? There is nothing in there about a research case definition.

Which is funny, actually, because in a statement on the CFSAC listserv on September 3rd, HHS said “NIH will be convening an Evidence-based Methodology Workshop, which would address the issue of case definitions appropriate for ME/CFS research“. (emphasis added) The same description appeared in the CFSAC listserv announcement on September 23rd.

That phrase – “address the issue of case definitions appropriate for ME/CFS research” – seems to have originated from Dr. Koh’s written statement to the CFSAC in May 2013 describing the EbMW.

Despite all these statements in writing that the EbMW will address the issue of case definitions for ME/CFS research, this FAQ now (presumably) quotes someone (presumably) at NIH as describing the EbMW in a way that does not even mention the case definitions appropriate for ME/CFS research.

Any number of possible explanations come to mind: the EbMW purpose and approach has shifted; Koh’s written statements about the EbMW were wrong; this FAQ is wrong; different people at HHS have different understandings of the EbMW, some or all of which are wrong; this is an attempt to mislead the public; or no one has any idea what they’re doing.

HeadScratchingCartoonI Have Ninety-Nine Questions, And This Answers None of Them

I am becoming accustomed to written statements from HHS that add to the questions I have, rather than actually answering any of them. This FAQ document is just another example. According to the draft agenda for the CFSAC meeting on December 10th, Dr. Lee will discuss the IOM study for 30 minutes. The agenda does not indicate whether the Committee members will be permitted to ask questions or comment.

One can only hope that Dr. Lee’s presentation will clear up the confusion and address the long list of concerns about the contract. This FAQ has not succeeded in doing so.

Denise Lopez-Majano assisted with research for this post.

 

Quizzical

November 12th, 2013 15 comments

Quiz_button

Update November 13, 2013: I have received a response from the CFIDS Association and have updated this post accordingly. Full comment from the Association below. My thanks to Carol Head, CEO of the CFIDS Association for her swift response to the concerns raised in the original blog post.

“You might have ME/CFS.” That’s the result I got on a diagnostic quiz on the CFIDS Association’s  new website. Even apart from that rather ridiculous result – because there is absolutely no doubt that I have ME/CFS – this quiz is extremely problematic. At best, it is inconsistent with the Association’s stated position on the ME/CFS case definition. At worst, it has implications for the Association’s approach to issues like the Institute of Medicine study on ME/CFS and the PCORI Patient-Powered Research Network. Updated: As you will see from the Association’s response, they have corrected the quiz to be consistent with their position on the case definition.

The Association’s new website launched this week with no fanfare or announcement. This has been in the works for many months, and it uses a cleaner and less cluttered design. The quiz “Do I Have ME/CFS?” is prominent in the site navigation and the home page slide show. I took the quiz this week because when I was a Board member, a patient approached me with concerns about a quiz on the old websiteThe new quiz is almost identical to the old one, and my concerns were heightened from the very beginning.

The first question of the test is “Have you felt generally unwell for six months or longer?” UNWELL. As so many of us have said so many times and in so many ways, unwell does not even begin to describe the experience of ME/CFS. The term is not defined in the quiz (the dictionary definitions include “being in poor health” and “undergoing menstruation”), nor does it appear in the case definition papers I examined (Fukuda, CCC, Reeves empirical, or ME-ICC). Why not just ask “Have you been sick for six months or longer?” Why use a vague term like unwell, that (to me, anyway) downplays the significance of our symptoms? To be honest, if I only felt unwell then I would be working. Updated: The updated quiz now asks “Have you experienced at least 6 months of severe physical or mental fatigue that you cannot explain, is not a result of ongoing exertion, is not relieved by rest and substantially reduces your activity levels?” Much more appropriate question that Are you unwell!

The test then progresses through ten more questions, assessing things like reduced tolerance for physical and mental activity, sudden onset, and overlapping conditions. I don’t know who wrote this (or the older) quiz, how it was developed, and whether any attempt has been made to validate it. Question seven asks whether you have had any symptoms from a list of eight, and this is where the underlying case definition shows itself. The list of eight symptoms are the same eight assessed in the Fukuda definition, which requires at least four of them be present for six months along with debilitating fatigue. Because the quiz uses the same list, rather than the symptom clusters used in CCC, I have no doubt that the Association is using the Fukuda definition as the basis for this quiz. Updated: The Association has now updated the quiz to reflect the CCC, rather than Fukuda. See their full response at the end of this post.

This is where the quiz begins to spill over onto policy issues. First of all, the Association’s public position on the IOM study states, “We feel that the Canadian Clinical Consensus* can be optimized as a clinical case definition by applying a standardized methodology of execution, through validation of criteria, and a nationwide dissemination to health professionals.” If the Association believes that the IOM study should optimize the CCC as a clinical case definition, why would they use Fukuda as the basis for the diagnostic quiz? If the CCC is the right starting point, if optimizing it for widespread clinical use is the Association’s goal, then shouldn’t the Association’s own “test” for ME/CFS use the same starting point? This inconsistency makes no sense to me. Updated: As the CEO of the Association explains below, the quiz is now based on the CCC and consistent with the Association’s position on case definition.

However, using Fukuda as the basis of the quiz has deeper implications. You may recall that the Association, along with ten partner organizations, was invited to submit a full application for up to $1 million to build a patient-powered research network. If the Association were to win that grant, would they use Fukuda to identify participants? Since the launch of the SolveCFS BioBank, the Association has responded to questions from the patient community about eligibility criteria, including whether post-exertional malaise (not required under Fukuda) was necessary. The new website for BioBank eligibility simply says, “The SolveCFS BioBank has been built to be a robust resource for ME/CFS research. For this reason it is best that patients have a ME/CFS diagnosis from a healthcare provider. ” No criteria is specified. BioBank participants must complete extensive questionnaires, so information relevant to the various diagnostic criteria can be collected in that way. And one of the unique aspects of the potential PCORI grant is that patients share in the governance of the patient-powered research network. Using Fukuda for this quiz does not mean that the Association believes Fukuda should be used for the BioBank or the PCORI project, but it does at least raise the question. Updated: The quiz is no longer using Fukuda, and other Association activities include opportunities to apply the CCC.

Back to my result: You might have ME/CFS. The results page does not tell me why I received an equivocal answer. Is it because I have sleep apnea? Fukuda excludes me from a CFS diagnosis on that basis. The CCC says, “If a potentially confounding medical condition is under control, then the diagnosis of ME/CFS can be entertained if patients meet the criteria otherwise.” My sleep apnea is perfectly controlled, yet I am still sick. It’s difficult for a short internet quiz to capture this level of complexity, and I doubt the Association’s quiz is intended to do so. Question 11 asks if I’ve seen a healthcare provider for basic lab tests and a physical exam. The question does not ask what the result of that visit was, nor does it list some of the tests that are increasingly used by ME/CFS specialists like two day CPET. Again, I doubt the quiz is intended to deal in that level of specificity.

Which brings me to my fundamental question about the quiz: What’s the point? An eleven question internet quiz cannot diagnose ME/CFS. If someone appears to have ME/CFS according to the quiz, are they more likely to donate to the Association or get involved in Association activities? Is the goal to encourage people to learn more about Association programs? Or is the goal to let someone know that they should see a doctor? If the latter, then this could be accomplished by saying that if a person experiences severe fatigue that reduces her ability to function for six months or more then she should see a doctor, and offer a fact sheet about ME/CFS diagnosis to assist in the conversation with the healthcare provider. Updated: The Association’s comments below offer more explanation of the intended purpose of the quiz, and the new version of the quiz includes appropriate caveats about its limitations and the need to seek adequate medical care.

Internet quizzes are inherently silly, and useless for a complex disease like ME/CFS. So is this a bit of a gimmick that is sloppily inconsistent with the Association’s stated position on the case definition? If so, I hope the issue can be clarified as the alternative explanation of Association support for Fukuda  is difficult to swallow in our current political climate. As you will see from the update below, the Association has updated the quiz to reflect their support for operationalizing the CCC, and have clarified the purpose of the quiz.

Response from Carol Head, CEO of The CFIDS Association, November 13, 2013: 

First, we’ve now updated the quiz on our new SolveCFS.org site so that it is fully in line with CCC. (Note:  It may take a short amount of time to propagate through the web.)  We had always intended to do this and we’re pleased that it’s now done.  I acknowledge that we goofed by missing the update by a couple of days as the new site went live in a “soft launch”. Your blog post pushed our timeline forward.  FYI, as we transitioned a very large amount of content from the old site to the new site (more than a decade’s worth!), we’ve had to prioritize the work.

 Importantly, the quiz is not new; it has been on our site for many years. We gave it more prominence with the new site because it was among the highest trafficked content.  The feedback we have gotten over the years is overwhelmingly positive.

 It is primarily meant for people who are newly sick, not for individuals, like you, who are already deeply knowledgeable about ME/CFS.   It’s designed to be an aid to those exploring ME/CFS online, trying to figure out more about it and hopefully point them toward additional resources to explore further.   While you KNOW you have CFS, many are searching for answers, have no idea what is plaguing them and far too many have doctors unwilling to look toward ME/CFS as a possible diagnosis. While such an elementary tool would not be useful for experienced patients like you, it can be invaluable for someone searching for answers. It can give them some direction, better questions to ask, as they search. Please note that it would be inappropriate to give anyone a definitive “You have ME/CFS diagnosis” online.

 

Convergence

October 10th, 2013 45 comments

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.

 

Directional Signs

August 26th, 2013 7 comments

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.

CFSAC Interviews

August 20th, 2013 Comments off

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).

 

Need to Reality

August 5th, 2013 7 comments

One of the key moments of the April FDA meeting on drug development for ME/CFS was when Bernard Munos said that ME/CFS patients will have to collect and pool their data to attract the interest of big pharma. Many advocates were dismayed by that comment. How can we collect our data? We have no resources. We’re too sick!

Enter PCORI. The Patient Centered Outcomes Research Institute was created by the Affordable Care Act, and is a non-profit organization funded by the federal government. Their budget is huge: $320 million for FY 2013 alone. And they fund research, lots of it. In May 2013, PCORI issued a funding announcement for patient-powered research networks and it could not have come at a better time. Up to $1 million per project is available to help fund data infrastructure to collect and pool electronic data from patients in order to facilitate clinical outcomes research, which is exactly what Munos told us was needed.

Two different ME/CFS projects were proposed, one led by the CFIDS Association and one led by the Open Medicine Institute. In full disclosure, I was one of many advocates consulted by the CFIDS Association in preparing their Letter of Intent, but I have no formal affiliation with the project. Both projects were supported by multiple patient organizations. Neither the CFIDS Association nor OMI were willing to tell me on the record if they were invited to submit a full proposal.

Both organizations already have the beginnings of patient centered research networks. The CFIDS Association has a nascent research network through the SolveCFS BioBank. For the PCORI proposal, the CFIDS Association went big and partnered with Patients Like Me, one of the largest patient-powered research networks in the country. Patients Like Me has almost 10,000 patients in the ME/CFS community on its site, and has the big data expertise to create systems to capture both clinical data/electronic health records and patient reported outcomes. OMI has been building its own online patient data system. They recently received a grant to build a “new personalized medicine infrastructure.

PCORI has set aggressive goals for the projects it funds under this opportunity. During the 18 month period of grant, funded projects must achieve the following: Membership must reach 0.5% of the US population with the condition; patient-reported data must be collected from at least 80% of the participating cohort, patients must be fully involved in network governance, and data must be standardized and suitable for sharing with other infrastructure members.

These patient-powered research networks are not just big databases sitting in server rooms. Patients themselves must be in control of the data and governance of the network. This would be a first in the ME/CFS community: none of the existing biobanks and databases are governed by patients. Traditionally, the non-profits and researchers have determined the features of these databases and how they will be used. But PCORI is requiring direct governance by the network participants themselves. This will be a unique challenge for either proposal. Getting back to the advocates’ reaction to Munos, we’re too sick! So few of us have the capacity to serve on steering committees and boards of directors, and those that have capacity are already involved (often in multiple contexts). A proposal from the Association or OMI will have to think beyond traditional forms of governance in order to collect the input and opinions of the network membership.

Another challenge will be privacy and confidentiality. Patients Like Me pools anonymized data and sells it to partners, and OMI is a for-profit health practice. Participants in either network should pay attention to the consent agreements and understand exactly what will be done with their data. PCORI networks will collect more than just demographic data. Other collected data will include patient-reported outcomes instruments and electronic health records. Managing and protecting the privacy of participants will be one of the challenges for network governance.

So what’s next? Full proposals for PCORI funding are due September 27, 2013 and funding would begin in January 2014. Let’s hope that at least one of the ME/CFS proposals is successful. One million dollars would go a long way towards building what Munos said we needed: a patient-powered network of data that can be shared with researchers and form the basis of treatment trials and biomarker identification. If there is any disease cohort that needs this kind of jumpstart funding, it is the ME/CFS community.

Update August 13, 2013: The CFIDS Association announced on its Facebook page that it has been invited to submit a full application. Dr. Suzanne Vernon said in an email to me, “The CFIDS Association partnered with 10 organizations and were invited to submit a full application to compete for $12 million that will fund 18 patient-powered research networks.  Our full application is due the end of September and organizations are notified of awards in December.  I am hopeful we will have a very competitive application!”

 

Drug and FDA News, May 2013

May 30th, 2013 4 comments

Yesterday, the CFIDS Association formally announced what had been rumored to be on the way: they are preparing to file an Investigational New Drug application. The first step will be a pre-IND meeting with FDA. This kind of meeting is a chance for the Association and its partner, Biovista, to seek FDA’s expertise and guidance in designing the clinical trial. To my knowledge, this is the first formal FDA action on an ME/CFS related potential treatment since the Drug Development Workshop in April. The Association will have to file an IND application before beginning the clinical trial, and FDA has 30 days to review and approve the application. Since this is a drug repositioning trial – meaning that the drug in question is already approved for another purpose – this will probably be a straightforward process. I don’t know what drug is involved, and as a Patient Representative at FDA, I cannot participate in the trial or have other involvement in it or I risk the appearance of a conflict of interest that would preclude me from serving on an Advisory Committee down the road. It is incredibly exciting to see treatment development move forward, and let’s hope more sponsors will follow suit.

There are a few other FDA-related news items to share with you:

  • On June 14th, FDA will hold the next in the series of Patient Focused Drug Development meetings. This meeting will focus on the impact of HIV on daily life and currently available therapies, and patients’ views on issues related to HIV cure research. The format appears to be similar to the ME/CFS meeting, although the questions for patients are more extensive and detailed. The meeting will be webcast, and registration closes June 5th.
  • On June 28th, FDA will hold a PFDD meeting focused on lung cancer. Again, the meeting will be webcast, and registration closes June 19th.
  • Irritable bowel syndrome is an overlapping condition with ME/CFS. The FDA will hold an advisory committee meeting on July 10th to discuss the risk evaluation and mitigation strategies in place for the IBS drug Lotronex. Lotronex is used to treat severe IBS in women, and was withdrawn from the market in 2000 after several deaths and severe complications were reported. The drug was reintroduced in 2002 with more safety restrictions on its use. The purpose of this advisory committee meeting is to consider whether the risk strategy in place assures safe use without placing undue burdens on the patient or health care delivery system.
  • FDA is inviting public comment on two draft industry guidance documents: Expanded Access to Investigational Drugs for Treatment Use – Questions and Answers and Guidance on Charging for Investigational New Drugs – Questions and Answers. Both comment dockets close on July 8, 2013.
  • Finally, ME/CFS patients tend to take numerous prescription medications including pain medications. FDA has posted information on the safe disposal of medications, including certain drugs that should be flushed.

 

Start as You Mean to Go On

April 25th, 2013 11 comments

I’m not sure which way to describe the ME/CFS community reaction to the announcement that Kim McCleary will be leaving the CFIDS Association: that people were so stunned you could hear a pin drop or that the news was the equivalent of a nuclear bomb detonation. Whatever way you describe it, the news is huge.

I worked closely with Kim during my service on the Association’s Board of Directors (2006-2011), and especially during my two years as Chairman. Kim is my friend, and my feelings about her announcement are both personal and professional. Most patients do not know how hard she has worked on their behalf. Kim dedicated herself to our cause, and has made tremendous personal sacrifices in service to that mission. I don’t think there is anyone who knows more about the politics of the disease, and few who understand the research better. In the last few years, she has been instrumental in the transformation of the CFIDS Association into a cutting edge research organization. It’s probably too soon to define her legacy, but she will forever be one of the giants in the battle against ME/CFS.

I know that some in the community will want to rehash various criticisms of Kim and decisions that she made. That’s up to them, but I will not. No one can lead an organization for twenty-two years without there being disagreements and debate. I see little value in revisting them now.

The real issue – and what I believe advocates and patients should be focused on – is where the CFIDS Association goes from here. Can the organization thrive without Kim? The answer is YES. Here’s why the CFIDS Association will continue to succeed:

  • Research – The quality of the Association’s research program is unmatched. Faster Cures has included the Association in TRAIN  – an initiative that encourages innovation in research and venture philanthropy. Strategic funding decisions have led to a 7 to 1 return on investment. For every dollar Association donors have invested in research grants, those researchers have secured an additional $7 in federal grant money. This success is unparalleled. In a recent webinar, Dr. Vernon described the Association’s cutting edge and unmatched patient-centered approach to research and finding treatments for the ME/CFS.
  • Vision – While Kim has been the visionary driver of the Association, the staff and Board are committed to innovation and cutting edge solutions. Suzanne Vernon is a big thinker and is passionate about the Association’s mission. She has recruited new researchers to the field, like Drs. Kathy and Alan Light, Dr. Gordon Broderick, and others. She sees the big picture of the disease, and is always looking for new and innovative ways to attack the problem. The entire staff recently completed a three-year strategic plan, and from what I have heard, Kim’s departure has required adjustments but not fundamental change to that plan. Combining that vision with the expertise of the staff and Scientific Advisory Board means that the Association will not lose step during the transition.
  • Staff – Kim has been the face of the Association, but the staff are some of the unsung heroes of this movement. This is not a 9-to-5-it’s-just-a-job group of people. The staff work harder for less reward than just about anyone else I have ever known. Their dedication, expertise, and persistence has made the Association’s success possible.
  • New Blood – Mark Stone and Leigh Reynolds have joined the staff within the last year, and both bring expertise from working with other disease populations. They have proven themselves in building other organizations with the support of patient communities, and they are bringing those skills to ME/CFS.
  • Profile – The Association is one of the most – if not the most – visible ME/CFS organizations to the outside world. Their proposal took the top prize in the Sanofi challenge. When the XMRV story first broke in 2009, the Board said they wanted the Association to be the source of credible and current news for both the ME/CFS community and others. Both Kim and Suzanne helped raise the profile of our disease by interfacing with new policy makers and influential people, and some of those people now serve on the Association’s SAB.

Kim’s long tenure may have created the impression for some that she was the Association, but that is not the case. The staff, Board, donors, and supporters have always been the lifeblood of the organization, and that has not changed. There is no doubt that Kim’s departure will mean a time of transition for the Association, but the mission and the plan to identify disease-modifying treatment for ME/CFS will go on. Thanks to Kim, the Association is off to a very good start.

 

Two Surveys, Two Opportunities

March 22nd, 2013 2 comments

In addition to all the ways you can participate in and comment on the upcoming FDA Drug Development for ME/CFS Workshop, you can also participate in two surveys that will collect data for presentation at the Workshop.

The CFIDS Association is conducting a survey based on the questions FDA posed in the Federal Register notice for the Workshop. In describing the survey, the Association says:

The survey, designed for people living with ME/CFS and those closest to them, poses open-ended questions to allow respondents to describe the symptoms, daily impacts that matter most, as well as share personal perspectives on treatment. Questions are worded in the same way the FDA has asked them; we’ve supplemented with some some additional questions on the same topics. You can answer with phrases or lists; you do not have to write complete sentences.

All survey responses are anonymous and confidential. We intend to present an analysis of the collective responses at the FDA meeting and at the May 22-23 meeting of the federal CFS Advisory Committee to better inform the federal health agencies about these issues.

The survey will take an estimated 30-60 minutes to complete, and your responses are completely anonymous. Follow this link to begin the survey.

Dr. Lily Chu (who is serving with me on a panel at the Workshop) and Dr. Leonard Jason are also conducting a survey. Lily says:

The main purpose of this survey is to help answer questions the FDA has about ME and CFS symptoms, their impact on people’s daily lives, which treatments patients are using or have tried, and which treatments patients have felt to be effective. Your answers will help teach drug companies about the symptoms/ severity of these illnesses while considering new medications for treatment. I will present the results of this survey at the April FDA meeting.

Instead of asking you to type in answers to each of FDA’s questions, our survey allows you to choose specific answers to questions while allowing space for comments. This may save you some time/ energy typing and also remind you to think about certain symptoms, their impact on your life, and certain treatments. It also allows us to compare your answers to others with ME or CFS.

If you want your answers to be part of the results shared at the FDA meeting, please complete the survey by APRIL 17. The survey will remain open until May 10 though and all responses submitted will be included in our final report to FDA in August.

This survey will take an estimated 30-40 minutes to fill out, and your responses are completely anonymous. Follow this link to begin the survey.

You can participate in both surveys. In fact, I strongly encourage you to participate in both surveys. Each survey needs enough responses to make the data analysis meaningful. You can also participate in the surveys and still submit comments to the FDA. Again, I strongly encourage you to do so. As I said earlier this week, this meeting is a showcase and significant opportunity for the ME/CFS community to teach the FDA and drug developers about our disease. I hope you will invest time and energy over the next few weeks to participate in the surveys and speak directly to the FDA.