Posts Tagged 'chronic fatigue syndrome'

(re)Naming ME

There are intense reactions to the name IOM (Systemic Exertion Intolerance Disease, SEID) has proposed for this disease.

It seems that the naming of illnesses is more complex than we would like to believe. Pages 58-59 of the IOM report (http://books.nap.edu/openbook.php?record_id=19012) has Box 3-2 which lists the names submitted to the committee in response to their request for input on the name. Text near Box 3-2 describes the committee’s rationale for SEID.

Astoundingly among the names submitted were “chronic fatigue”, “chronic fatigue syndrome”. Several other submissions included the term “fatigue”. Seriously????

But people are not keen on SEID. In fact it seems that many people are wrapped up in discussions about the name and that the contents of the report seem to be of little interest or concern.

Dr. Lenny Jason has written a blog post about disease names and SEID:

“How disease names can stigmatize

By Leonard A. Jason

  • February 16th 2015

On 10 February 2015, the long awaited report from the Institute of Medicine (IOM) was released regarding a new name — Systemic Exertion Intolerance Disease — and case definition for chronic fatigue syndrome (CFS). Because I was quoted regarding this report in a New York Times article, in part due to having worked on these issues for many years, hundreds of patients contacted me over the next few days.

The reaction from patients was mixed at best, and some of the critical comments include:

  • This new name is an abomination!”
  • Absolutely outrageous and intolerable!”
  • I find it highly offensive and misleading.”
  • It is pathetic, degrading and demeaning.”
  • It is the equivalent of calling Parkinson’s Disease: Systemic Shaking Intolerance Disease.”
  • (It) is a clear invitation to the prejudiced and ignorant to assume ‘wimps’ and ‘lazy bums.’”
  • The word ‘exertion,’ to most people, means something substantial, like lifting something very heavy or running a marathon – not something trivial, like lifting a fork to your mouth or making your way across the hall to the bathroom. Since avoiding substantial exertion is not very difficult, the likelihood that people who are not already knowledgeable will underestimate the challenges of having this disease based on this name seems to me extremely high.”

Several individuals were even more critical in their reactions — suggesting that the Institute of Medicine-initiated name change effort represented another imperialistic US adventure, which began in 1988 when the Centers for Disease Control changed the illness name from myalgic encephalomyelitis (ME) to chronic fatigue syndrome. Patients and advocacy groups from around the world perceived this latest effort to rename their illness as alienating, expansionistic, and exploitive.

Please read the rest of the post here: http://blog.oup.com/2015/02/disease-name-chronic-fatigue-syndrome-me/#sthash.obiMRbIj.dpuf

link to Miriam Tucker’s article Chronic Fatigue Syndrome: Wrong Name, Real Illness

 

http://www.medscape.com/viewarticle/837577_2
“Chronic Fatigue Syndrome: Wrong Name, Real Illness
Miriam E. Tucker
January 08, 2015

Introduction

Sufferers of what has been called chronic fatigue syndrome (CFS) are challenging patients, presenting with complaints of postexertional
malaise, persistent flulike symptoms, unrefreshing sleep, “brain fog,” and often a long list of other symptoms that don’t seem to fit any
recognizable pattern. Some appear ill, but many don’t. And the routine laboratory tests typically come back negative. ….”

http://www.medscape.com/viewarticle/837577_2

We must be heard

Advocates have the opportunity to submit public comment for the Chronic Fatigue Syndrome Advisory Committee (CFSAC) meetings. However, if the committee members do not have access to public comment, they cannot use it to inform the advice and recommendations provided to the Secretary of Health and Human Services which is the purpose of the committee.

For the June 2014 CFSAC meeting, public comment was not provided to committee members so Denise Lopez-Majano sent the following letter to Dr. Nancy Lee, Designated Federal Official (DFO) of the Chronic Fatigue Syndrome Advisory Committee (CFSAC):

Dear Dr. Lee,

I am writing to request that written comment always be provided to CFSAC members (including ex-officios, non-voting liaisons) along with all meeting materials.

It has come to my attention that written public comment was not included in the June 2014 CFSAC committee member’s binders. During the meeting it was indicated that submitted written comment was only available at the back of the meeting room. This means that the unless public comment was also provided orally, it was not accessible to committee members, nor could it be readily referred to by them at other times.

In order for CFSAC to correctly address (among other things) concerns about quality of life, and development and implementation of programs to inform healthcare professionals (as detailed in the CFSAC charter), CFSAC members must be knowledgeable about and aware of the realities patients, caregivers and others regularly face. Public comment often illustrates points that committee members/agencies and others may not be aware of. Therefore it is vital that CFSAC members have ready access to it because public comment helps CFSAC correctly advise and make recommendations to the Secretary about these and other issues.

In addition, some advocates/patients can only provide written public comment. As a result, if their public comment is not provided to committee members, not only is their voice not heard at all, but there is no opportunity for their input to inform CFSAC about matters that can result in CFSAC advice and recommendations to the Secretary.

Just as presentations made to the CFSAC help inform the committee’s advice and recommendations, so too does the public comment provided by stakeholders, who after all, are among those most knowledgeable about life with this horrid illness.

I urge you to ensure that submitted written comment is provided along with all other materials for each meeting.”

If you would like to send a similar email to Dr. Lee, her email address is: nancy dot lee at hhs dot gov

Serious concerns!

Ms. Jennie Spotila has given permission to repost her assessment of the P2P study protocol here in its entirety. (Thank you Ms. Spotila.)

Please post comments on her blog http://www.occupycfs.com/2014/05/02/protocol-for-disaster/

As concerned as we are about IOM, P2P looks far, far worse!

Protocol for Disaster?

May 2nd, 2014 Jennie Spotila Leave a comment Go to comments

disasterThe study protocol for the systematic review of ME/CFS was posted by the Agency for Healthcare and Research Quality yesterday. It’s a recipe for disaster on its own, and within the broader context of the NIH P2P Workshop it’s even worse. Let me show you some of the reasons why.

Remind Me What This Is

The systematic evidence review is the cornerstone of the P2P process. The P2P meeting on ME/CFS will feature a panel of non-ME/CFS experts who will produce a set of recommendations on diagnosis, treatment, and research.

Because the P2P Panel members are not ME/CFS experts, they need background information to do their job. This systematic evidence review done by the Oregon Health & Science University under contract to AHRQ will be that background information. The systematic evidence report will be presented to the Panel in advance of the public P2P meeting, and will be used to establish the structure of the meeting as well.

The systematic review is the foundation. If done correctly, it would be a strong basis for a meaningful workshop. If done poorly, then everything that follows – the workshop and the resulting recommendations – will crumble. Based on the protocol published yesterday, I think “crumble” is putting it mildly.

The Key Questions

You can’t get the right answer if you don’t ask the right questions. (Dr. Beth Collins-Sharp, CFSAC Minutes, May 23, 2013, p. 12)

As I wrote in January, the original draft questions for the evidence review included whether CFS and ME were separate diseases. That question is GONE, my friends. Now the review is only looking at two things:

  • What methods are available to clinicians to diagnose ME/CFS and how do the use of these methods vary by patient subgroups?

  • What are the benefits and harms of therapeutic interventions for patients with ME/CFS and how do they vary by patient subgroups?

These questions are based upon a single and critical assumption: ME and CFS are the same disease. Differences among patient groups represent subtypes, not separate diseases. The first and most important question is whether the ME and CFS case definitions all describe one disease. But they’re not asking that question; they have already decided the answer is yes.

The study protocol and other communications from HHS (including today’s CFSAC listserv message) state that the P2P Working Group refined these study questions. The implication is that since ME/CFS experts and one patient served on the Working Group, we should be satisfied that these questions were appropriately refined. But what I’m piecing together from various sources indicates that the Working Group did not sign off on these questions as stated in the protocol.

Regardless of who drafted these questions, they cannot lead to the right answers because they are not the right questions. And when you examine the protocol of how the evidence review will be conducted, these questions get even worse.

Protocol Problems

The real danger signals come from the description of how this evidence review will be done. The issue is what research will be included and assessed in the review. For example, when asking about diagnostic methods, what definitions will be considered?

This evidence review will include studies using “Fukada [sic], Canadian, International, and others“, and the Oxford definition is listed in the table of definitions on page 2 of the protocol. That’s right, the Oxford definition. Oxford requires only one thing for a CFS diagnosis: six months of fatigue. So studies done on people with long-lasting fatigue are potentially eligible for inclusion in this review.

The description of the population to be covered in the review makes that abundantly clear. For the key question on diagnostic methods, the study population will be: “Symptomatic adults (aged 18 years or older) with fatigue.” There’s not even a time limit there. Three months fatigue? Four? Six? Presence of other symptoms? Nope, fatigue is enough.

There is a specific exclusion: “Patients with other underlying diagnosis,” but which conditions are exclusionary is not specified. So will they exclude studies of patients with depression? Because the Oxford definition does not exclude people with depression and anxiety. We’ve seen this language about excluding people with other underlying diagnosis before – and it results in lumping everyone with medically “unexplained” fatigue into one group. This protocol is set up to result in exactly that. It erases the lines between people with idiopathic chronic fatigue and people with ME, and it puts us all in the same bucket for analysis.

And what about the key question on treatment? What studies will be included there? All of them. CBT, GET, complementary/alternative medicine, and symptom-based medication management. It’s not even restricted to placebo trials; trials with no treatment, usual care, and head-to-head trials are all included.

Let’s do the math. Anyone with unexplained fatigue, diagnosed using Oxford or any other definition, and any form of treatment. This adds up to the PACE trial, and studies like that.

But it’s even worse. The review will look at studies published since January 1988 because that was the year “the first set of clinical criteria defining CFS were published.” (page 6) Again, let’s do the math: everything published on ME prior to 1988 will be excluded.

Finally, notice the stated focus of the review: “This report focuses on the clinical outcomes surrounding the attributes of fatigue, especially post-exertional malaise and persistent fatigue, and its impact on overall function and quality of life because these are unifying features of ME/CFS that impact patients.” (page 2) In other words, PEM = fatigue. And fatigue is a unifying concept in ME/CFS. Did anyone involved in drafting this protocol actually listen to anything we said at last year’s FDA meeting?

Bad Science

Credit: ElodieUnderGlass

Maybe you’re thinking it’s better for this review to cast a broad net. Capture as much science as possible and then examine it to answer the key questions. But that’s not going to help us in this case.

This review will include Oxford studies. It will take studies that only require patients to have fatigue and consider them as equivalent to studies that require PEM (or even just fatigue plus other symptoms). In other words, the review will include studies like PACE, and compare them to studies like the rituximab and antiviral trials, as if both patient cohorts were the same.

That assumption – that patients with fatigue are the same as patients with PEM and cognitive dysfunction – is where this whole thing falls apart. That assumption contaminates the entire evidence base of the study.

In fact, this review protocol makes an assumption about how the Institute of Medicine study will answer the same question. It is possible (though not assured) that IOM will design diagnostic criteria for the disease characterized by PEM and cognitive dysfunction. But this evidence review is based on an entirely different patient population that includes people with just fatigue. The conclusions of this evidence review may or may not apply to the population defined by the IOM. It’s ridiculous!

But it’s the end use that really scares me. Remember that this systematic evidence review report will be provided to that P2P Panel of non-ME/CFS experts. The Panel will not be familiar with the ME/CFS literature before they get this review. And the review will conflate all these definitions and patient populations together as if they are equivalent. I think it’s obvious what conclusion the P2P Panel is likely to draw from this report.

I would love to be wrong about this. I would love for someone to show me how this protocol will result in GOOD science, and how it will give the P2P Panel the right background and foundation for the recommendations they will draft. Please, scientists and policy makers who read this blog – can you show me how this protocol will produce good science? Because I am just not seeing it.

What Do We Do?

This protocol is bad news but it is by no means the last word. Plans are already in motion for how the advocacy community can respond. I will keep you posted as those plans are finalized.

Make no mistake, this evidence review and P2P process are worse than the IOM study. We must respond. We must insist on good science. We must insist that our disease be appropriately defined and studied.

http://www.occupycfs.com/2014/05/02/protocol-for-disaster/

IOM Meeting Monday May 5th

The 3rd meeting for the IOM Diagnostic Criteria for ME/CFS project is Monday May 5th.

Location: National Academies of Science Building 2101 Constitution Ave NW, Washington, DC 20418 (This is a different location than the January meeting.)

Time: 1pm- 5:30pm (the agenda lists the meeting as lasting until 5:30 though the FAQs lists it as ending earlier).

Webcast link: http://www.iom.edu/Activities/Disease/DiagnosisMyalgicEncephalomyelitisChronicFatigueSyndrome/2014-MAY-05.aspx

Agenda link: http://www.iom.edu/~/media/Files/Activity%20Files/Disease/MECFS/Open%20Session%20Agenda_04%2017%2014.pdf

Additional FAQs: http://www.iom.edu/Activities/Disease/DiagnosisMyalgicEncephalomyelitisChronicFatigueSyndrome/2014-MAY-05.aspx

Remember – at any time during the project you can submit comments to the committee. Send comments to: mecfs@nas.edu

It might be worth referencing IOM MECFS Study in the subject line. All comments become part of the Public Access File.

FDA Webinar, chance for Q&A and comments April 23, 2014

FDA is hosting a webinar about the draft guidance document “Guidance for Industry Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis: Developing Drug Products for Treatment”.

Note: the webinar will be close-captioned and there questions/comments can be submitted in real-time using a chat window. (It is safe to assume that personal information should not be submitted as this would then be available for all to see onscreen.)

Public comment on the draft guidance should also be submitted to the docket DOCKET NUMBER: FDA–2014–D–0264 http://www.regulations.gov/#!docketDetail;D=FDA-2014-D-0264 – as it then becomes part of the public record.

FDA’s Guidance Webinar series aims to foster collaboration and transparency in the development of guidance documents through direct outreach to affected stakeholders.” (http://www.fda.gov/Training/GuidanceWebinars/default.htm)

FDA Webinar: Guidance for Industry Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis: Developing Drug Products for Treatment – April 23, 2014

The Office of Medical Policy (OMP) in CDER presents another in a series of webinars on 60-day guidances for industry on Wednesday, April 23, 2014 from 1PM – 2PM EDT. The topic is “CHRONIC FATIGUE SYNDROME”.

Guidance for Industry Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis: Developing Drug Products for Treatment

FR NOTICE

PUBLICATION DATE:  03/11/2014

COMMENTS [DUE] DATE:  05/12/2014

DOCKET NUMBER: FDA–2014–D–0264 http://www.regulations.gov/#!docketDetail;D=FDA-2014-D-0264

SPEAKERS:

Janet Maynard, MD and others

Medical Officer

Division of Pulmonary, Allergy, and Rheumatology Products

Office of New Drugs

CDER/FDA

SUMMARY: This guidance is intended to assist sponsors in the development of drug products for the treatment of chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME). This guidance focuses on specific drug development and trial design issues that are unique to the study of CFS/ME and on the FDA’s current thinking on how effective treatments can be developed for CFS/ME. The points discussed in this guidance may not be applicable to all drug products. The FDA encourages sponsors to design clinical programs that fit their particular needs and to discuss their planned approach with the Division of Pulmonary, Allergy, and Rheumatology Products (DPARP).

For questions concerning the webinar, please contact Marsha Holloman (301-796-0731)

Webinar information on FDA’s Web site: http://www.fda.gov/Training/GuidanceWebinars/default.htm

______________________________________________________________

Guidance Webinar Online-Access Instructions:

To access this webinar, follow the link provided below. Audio will broadcast from your computer speakers.

After following the link, enter as a guest and provide your FULL NAME and organization (i.e. “John Smith – FDA/CBER”). The host will then allow you to enter. If you experience technical difficulties email Jeffery.Rexrode@fda.hhs.gov for assistance. Closed captioning will be provided. Questions/Comments can be submitted live via a Q/A chat window.

Access link: https://collaboration.fda.gov/gfiwebinar

http://www.fda.gov/Training/GuidanceWebinars/ucm392577.htm

Contacting Congressional Representatives – Call to Action

There is an action to push for $7 to $10 million for an RFA (see below for definition) — This would be NIH money specifically to fund ME(cfs) research. (Yes, we need more than that but this request is in line with CFSAC recommendations and the effort is already underway. We can continue to work on getting more.)

1) This link is to a “Dear Colleague” letter and asks Congressional Members to join Reps. Lofgren (San Jose) and Anna Eshoo (Mountain View, Palo Alto) in raising awareness about ME/CFS among Congress. This is important because such letters signal to other politicians what interests some politicians have and are used for “trading favors” when it comes to voting/ supporting certain things. https://dl.dropboxusercontent.com/u/57025850/Dear%20Colleague%202%20-%20letter%20-%20March%202014.pdf

2) This link is to a letter, signed by 11 Congressional Members, that asks Dr. Collins for $7-$10 million to be earmarked for ME/CFS research. (Currently no funds are specifically set aside for ME/CFS research each year.) https://dl.dropboxusercontent.com/u/57025850/Congressional%20letter%20-%20Dr.%20Collins%20-%20March%202014.pdf

What can you do? 

Start by reading the letters.

1) If your Congressional Rep. has signed the letter, contact them and THANK them for their support. Something as simple as “Thank your for your attention to and support of research into the medical condition myalgic encephalomyelitis/ chronic fatigue syndrome (ME/CFS).” They get little positive feedback so everything helps. Please thank Dr. Gutman for starting this at ben.gutman@mail.house.gov. It’s extra good if you’re Rep. Lofgren’s constituent but even if you’re not, that counts too.

 

2) If your Congressional Rep. has NOT signed, contact them and ask them to do so. Remember that peer pressure works on them as it does for other people. Seeing their colleagues sign helps. If your relatives or friends who live outside your area can send it to their Congressional members, that helps as well. More signatures = more power.

Congressional contact info can be found via this link http://www.contactingthecongress.org/).

Before you do call or write, plan out what you want to say.

Tell them (write) you are a constituent (i.e. you vote in their district), tell a bit of your story (perhaps 5 minutes), why research is important to you, and ask the Congress person to read and considering signing both letters. Do not be put off by speaking to staff only and not the Congress person; staff are influential. Remember also, they work for you so don’t be shy!

Online forms for many Congressional offices do not provide for attaching documents . Since you need to attach the Dear Colleague letter and the letter to Dr. Collins it probably is best to call and ask for an email address (unless you already have one).

Let them know that you will follow-up in 2-3 weeks to find out if the Congress(wo)man has signed or not.

Ask them to forward a paper copy of the signed letter to you if possible and report to speakupaboutme AT gmail DOT com who signed – name, state, Congressional district. If they did not sign, remember to politely ask why and post the reason along with the Rep.’s name.

Make a note on your calendar to follow-up in 2-3 weeks.

If they sign please be sure to thank them for doing so.

FYI (and in case they ask)
Congressional Reps who have already signed:
Anna Eshoo (Mountain View, Palo Alto, Saratoga, along the coast)
Zoe Lofgren   (most of San Jose)
Mike Honda (
Sunnyvale, Cupertino, Santa Clara, Fremont, Newark, North San Jose, and Milpitas)
John Garamendi (Sacramento, Fairfield)
Sheila Jackson Lee (Texas, Houston)
Suzan Delbene (King County, Washington)
Eric Swalwell (Los Gatos, Cupertino, San Jose parts)
Scott Peters (San Diego, Poway)
Daniel Lipinski (Chicago suburbs, Illinois)
John Lewis (this is *the* John Lewis, the Civil Rights leader, from Atlanta, GA)
Eleanor Holmes Norton (Washington, DC)

Request for Application (RFA)

An RFA is a formal statement that solicits grant or cooperative agreement applications in a well-defined scientific area to accomplish specific program objectives. An RFA indicates the estimated amount of funds set aside for the competition, the estimated number of awards to be made, whether cost sharing is required, and the application submission date(s). For cooperative agreements, the RFA will describe the responsibilities and obligations of NIH and awardees as well as joint responsibilities and obligations. Applications submitted in response to an RFA are usually reviewed by a Scientific Review Group (SRG) specially convened by the awarding component that issued the RFA.

http://grants.nih.gov/grants/glossary.htm#R11

To contact your member of Congress: http://www.contactingthecongress.org/

https://dl.dropboxusercontent.com/u/57025850/Dear%20Colleague%202%20-%20letter%20-%20March%202014.pdf

https://dl.dropboxusercontent.com/u/57025850/Congressional%20letter%20-%20Dr.%20Collins%20-%20March%202014.pdf

You might consider attaching this for your Congress(wo)man and staff to read:

http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM368806.p