Historic FDA Stakeholder Meeting on ME/CFS, April 25-26: How To Have Your Say

March 26, 2013

As the FDA Stakeholder Meeting approaches, we explore the various ways that patients can get involved – and offer some suggestions on how to make the most of this unprecedented opportunity.

FDA Logo

On April 25-26, 2013, the United States Food and Drug Administration (FDA) is holding a workshop in Bethesda, MD to discuss how best to facilitate and expedite the development of safe and effective drug therapies to treat signs and symptoms related to CFS and ME. This meeting is expected to attract not only patients and ME/CFS expert clinicians, but also other groups including pharmaceutical companies and the FDA. This is an unprecedented opportunity for us to get the attention and interest of the pharmaceutical industry and to bring a patient perspective to the development and review of drugs for ME/CFS.

Day 1: April 25th

Day 1 of the workshop will give patients the opportunity to share the symptoms and signs that they experience, their experience with treatments and how this disease affects their quality of life. This is being conducted as part of the Patient-Focused Drug Development Initiative, an FDA effort to incorporate the patient experience into the drug approval process by better understanding the patients’ perspective on the severity of their disease and the effectiveness of available treatments. ME/CFS has been chosen as one of the 20 diseases for which such a workshop will be conducted and will be the first of the 20 to go! For a disease like ME/CFS, whose impact is poorly understood by those outside the community, this first day will provide the critical insights needed for discussions on the second day of the FDA workshop, but just as importantly it will also ensure that the drug approval process better incorporates the patient perspective going forward.

Day 2: April 26th

Day 2 will include a scientific workshop on how to best facilitate and expedite the development of safe and effective drug therapies for the signs and symptoms related to ME/CFS. Presentations will include:

  • Lessons learned from previous studies
  • The role of drug repurposing
  • Pathways to expediting drug therapies
  • Appropriate clinical trial design in CFS and ME
  • Outcome measures to assess efficacy
  • Potential valid endpoint measurements of symptom improvement.

The Importance of both Symptoms and Biological Abnormalities

Obviously it is critical that FDA and the pharmaceutical companies understand the symptoms you experience and the impact of those symptoms on your quality of life. But it is just as essential that they also understand the biological abnormalities that are associated with ME/CFS – biological abnormalities that are already being measured through lab tests and other testing. Some examples include:

blue worker on crutches

  • Neurological impairment, seen in symptoms like sleep dysfunction, headaches and sensory disturbances, that can be measured in lab tests like SPECT scans or MRI.
  • Cognitive dysfunction, seen in symptoms like impaired memory and processing speed, that can be measured through various cognitive performance tests.
  • Immunological dysfunction, seen in cytokine abnormalities, high viral titers, RNASE-L abnormality and low natural killer cells.
  • Autonomic dysfunction and orthostatic intolerance, causing symptoms like dizziness, racing heart and feeling sick when standing for long periods, that can be measured by tests like tilt table tests, heart rate and blood pressure monitoring and blood volume.
  • Post exertional malaise and low anaerobic threshold, causing a relapse after mental or physical exertion, documented by cardiopulmonary exercise testing.

By understanding both the symptoms and the related biological pathologies and associated abnormalities, pharmaceutical companies will be in a better position to identify opportunities to subgroup patients and potentially re-purpose existing drugs that might treat ME/CFS. This is especially critical in a disease like ME/CFS – which is too often described simply in terms of “fatigue not improved by rest”, assumed to be due to depression and deconditioning, or thought to be simply another name for chronic fatigue.

Joint Letter to the FDA

To ensure that the pharmaceutical companies understand this biology, a group of ME/CFS organizations and advocates (including Phoenix Rising) submitted a joint letter to the FDA to ask for assurance that a brief overview of the biology and abnormalities of ME/CFS will be summarized right at the beginning of the meeting. The letter that was sent can be found at:

https://dl.dropbox.com/u/89158245/LetterFDAWorkshopMar18.pdf

Information and suggestions for those providing comments

For those who wish to provide comments, either in person at the meeting as part of the panel or ‘open discussion’, or directly to the FDA, the following information will be useful:

  • The suggested topics include:
    • Topic 1: Disease Symptoms and Daily Impacts That Matter Most to Patients
    • Topic 2: Patients’ Perspectives on Current Approaches To Treating CFS and ME

The questions that the FDA is asking on each of these topics are listed at the bottom of this article. You are also given the option to suggest a topic when you register.

Man holding light bulb marked 'IDEA'.

Don’t forget to mention those biological abnormalities!

  • In addition to the questions that the FDA asked, please provide comments about your lab/test abnormalities – linked to symptoms and dysfunction where possible – and indicate how those abnormalities changed as a result of treatment if known. Examples include:
    • Abnormal VO2Max as a result of PENE/PEM
    • Abnormal tilt test as indicative of orthostatic intolerance
    • High inflammatory cytokines indicative of immunological issues
    • Cognitive issues seen in impaired working memory and slow processing speed tested by cognitive performance testing

     

  • Other suggestions:
    • Comments should be concise and to the point. Avoid jargon. Speak about your personal experience and how this disease has affected you.
    • For some people, the term “biomarker” may imply that the biomarker has been “validated”. It is better to use the term “abnormalities” or “test abnormalities” to avoid this confusion.
    • If you’re planning on speaking at the meeting, then given that the time for comments may need to be shortened, it would be good for you to have both a 1-2 minute version and a 3-4 minute version.

How You Can Take Action

Cartoon man in front of crowd holding placardSo what can you do to make sure the FDA and the pharmaceutical companies understand how ME/CFS has affected you and what you have experienced with treatments? There are a number of opportunities for you to participate and to provide comments.

1. Register to attend the meeting and optionally provide comments, or provide comments by proxy

To attend in person, register first-come, first-served at http://mecfsmeeting.eventbrite.com by April 8. You will be asked to provide your name and business, organization, or personal affiliation as applies (e.g. industry, government, patient). When you register, you will need to indicate whether you wish to provide comments. There are three opportunities to present comments at the meeting:

  • You can request to be part of an initial panel discussion on the topics listed below. If you wish to be considered to present comments part of initial panel discussions, you will need to indicate the topic that you wish to address when you register. Then, you will need to send a brief summary of your response to the topic(s) you selected to ME-CFS-Meeting@fda.hhs.gov. The deadline to send the summary of your comments is April 8.  You will be notified before the meeting if you will be on a panel.
  • You can participate in open moderated discussion following the panel discussions on the topics listed below. You do not need to register to provide comments or have prepared testimony for this part of the discussion. A moderator will recognize participants to comment when they raise their hands.
  • You can request to provide comments on other topics as part of the open comment period at the end of the day. If you want to do this, you will need to register as above. In addition, you will need to send a brief summary of your comments for the open public comment session to ME-CFS-Meeting@fda.hhs.gov. The deadline to submit the summary of your comments is April 8.

You can also provide comments by proxy. If you cannot attend but wish to provide comments, you can have a proxy provide them for you. You will need to register to do this.

2. Participate in the FDA meeting remotely

The meeting will also be webcast at http://mecfsmeeting.eventbrite.com.

See http://www.fda.gov/Drugs/NewsEvents/ucm319188.htm for additional information about joining the meeting.

3. Respond to two different surveys that are collecting information for the meeting.

  • Both surveys are collecting information about a) disease symptoms and daily impacts that matter most to patients and b) patient perspectives on current approaches to treating ME/CFS.
    Cartoon man holding clipboard

    Please try to complete both surveys

  • Dr. Leonard Jason and his team and Dr. Lily Chu have created an online survey that uses checkboxes to collect information on symptoms, impact on daily life, treatments being used and the effect of treatments. For those who live outside the U.S., ignore questions about the U.S. region. The link to Dr. Jason’s and Dr. Chu’s survey is here.
  • The CFIDS Association of America (CAA) has taken the questions from the FDA workshop agenda and turned them into an online questionnaire where you can type answers into text boxes. The link to the survey is here.
  • Both surveys are open to everyone no matter where you live. Your responses will be anonymous and confidential.
  • Please try to complete both surveys.
  • Although the surveys may not ask for it specifically, don’t forget to also include comments as above about your lab abnormalities – linked to symptoms and disease dysfunction where possible – and indicate how those abnormalities changed as a result of treatment if known.

 4. Provide comments directly to the FDA now

  • Go here and submit comments now by clicking on the ‘Comment Now!” box in the upper right corner of the page.
  • You can also submit written comments to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Include the docket number, which is “FDA-2012-N-0962-0004”.
  • The Docket is open until August 2, 2013.
  • The FDA is encouraging patients to provide answers to the questions asked in the Federal Register. But again, don’t forget to also include information about the biological abnormalities – linked to symptoms where possible – and indicate how those abnormalities changed as a result of treatment if known. Examples are given above. 

Details on the questions that the FDA would like asked on the two topics

Remember to also provide information on the biological abnormalities associated with these symptoms and the known neurological, immunological and energy production dysfunction and how treatments have affected these biological abnormalities. Examples are given above.

Topic 1: Disease Symptoms and Daily Impacts That Matter Most to Patients

  1. What are the most significant symptoms that you experience resulting from your condition? (Examples may include prolonged exhaustion, confusion, muscle pain, heat or cold intolerance.)
  2. What are the most negative impacts on your daily life that result from your condition and its symptoms? (Examples may include difficulty with specific activities, such as sleeping through the night.)
    1. How does the condition affect your daily life on the best days and worst days?
    2. What changes have you had to make in your life because of your condition?

Topic 2: Patients’ Perspectives on Current Approaches To Treating CFS and ME

  1. What treatments are you currently using to help treat your condition or its symptoms? (Examples may include FDA-approved medicines, over-the- counter products, and other therapies, including non-drug therapies such as activity limitations.)
    1. What specific symptoms do your treatments address?
    2. How has your treatment regimen changed over time and why?
  2. How well does your current treatment regimen treat the most significant symptoms of your disease?
    1. Have these treatments improved your daily life (for example, improving your ability to do specific activities)? Please explain.
    2. How well have these treatments worked for you as your condition has changed over time?
    3. What are the most significant downsides of these treatments (for example, specific side effects)?

Further information

You can get additional information from the following sources:

  • The FDA maintains this webpage that lists information on its efforts regarding ME/CFS.
  • The Federal Register Notice for the April 25-26 FDA workshop can be found here.
  • The FDA has also provided a set of FAQs here about the meeting, which provide additional information.
  • A description of the Patient-Focused Drug Development Initiative can be found here.

Support Phoenix Rising’s Commitment to Effective ME/CFS Advocacy

Phoenix Rising is a registered 501 c.(3) non profit.  We support ME/CFS and NEID patients through rigorous reporting, reliable information, effective advocacy and the provision of online services which empower patients and help them to cope with their isolation.

There are many ways you can help Phoenix Rising to continue its work. You can even donate significant sums, at no cost to yourself, as you shop online! To find out more, visit Phoenix Rising’s Donate page by clicking the button below.

 

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33 comments

{ 33 comments… read them below or add one }

Misfit Toy March 26, 2013 at 11:17 pm

2 hours from me……Hmmm…

Sasha March 27, 2013 at 3:26 am

The joint letter from our advocates and advocacy organisations (including PR) is great:

https://dl.dropbox.com/u/89158245/LetterFDAWorkshopMar18.pdf

I appreciate all the hard work that went into making sure we speak with one voice – we're much more likely to be heard that way.

jimells March 27, 2013 at 10:47 am

On which day will they discuss budgets? Our rulers have decreed that Austerity is the order of the day. Without a real commitment to funding, this is likely just another exercise in CYA.

I liked the letter. Has the FDA responded to it?

Mark March 27, 2013 at 11:59 am
jimells

On which day will they discuss budgets? Our rulers have decreed that Austerity is the order of the day. Without a real commitment to funding, this is likely just another exercise in CYA.

I liked the letter. Has the FDA responded to it?

No response yet as far as I know, though I believe there have been conversations with them to clarify details. I'll post updates here when I hear any news.

SpecialK82 March 27, 2013 at 12:09 pm

Thank you to all who were a part of providing this comprehensive article. I found it very helpful and informative and was pleased to read the joint letter sent to the FDA concerning the confusing case defintions and critieria. I hope that the FDA will agree that the best start to this meeting would be to define what we are all talking about.

The hard work and dedication by our patient population beforehand has increased the odds of a successful meeting I'm sure. Heartfelt thank to all! :thumbsup:

snowathlete March 27, 2013 at 2:18 pm

Thanks for the article, which is really helpful. I think this is one of the most important jobs of PR and other ME/CFS organizations; timely reporting of key informaiton like this in an easily digestable format for patients, so that patients can be aware and respond actively where needed in a coordinated effort. With many patients not well enough to go find out all this stuff on their own, its a critical role.

I agree with the objectives of the letter. I think getting those four points taken aboard by the FDA might be optimistic, but that of course isnt a reason not to make the request and the pressure them for it.

The letter suggests "recognized ME clinician and researcher experts – experts like Drs. Klimas, Rowe, Montoya, Peterson, Chia and Bateman."

To you and me, we know what that means, because we know these doctors take the illness seriously, do not treat it like a psycological illness, and have a lot of experience with the illness. But do the FDA know that is what we mean? And even if they do, will they admit they know what it means and take appropriate steps? My fear (based partly on the fact we already know they havent invited people who they clearly should invite) is that they would invite those people they consider to be "recognized experts" but who we dont want anywhere near the meeting. By the sounds of things there is some dialogue going on between the FDA and the organizations behind the letter, so I expect there is a good chance they will get that message clearly enough.

Mark March 29, 2013 at 12:37 pm

Note that I've just updated the article with some changes and additions to Part 1 of the 'How You Can Take Action' section: some more details on how to make comments in person at the meeting.

medfeb March 29, 2013 at 5:12 pm
jimells

On which day will they discuss budgets? Our rulers have decreed that Austerity is the order of the day. Without a real commitment to funding, this is likely just another exercise in CYA.

I liked the letter. Has the FDA responded to it?

Hi Jimells

We do not have an official response to the letter. The only response that we have is the information posted in the FDA Workshop FAQ which was posted after the letter was sent.

Regarding funding – the meeting is being held by the FDA to gain the attention of the pharmaceutical companies and get them to invest in drug development for the disease. FDA's role in this is regulatory guidance and review/approval, not funding of studies. Typically, the company with the drug funds the trials although I understand that NIH has funded/does some fund clinical trials – especially early ones

Besides for investment by pharma, funding by the government will be important and for that we will need to look to NIH.

medfeb March 29, 2013 at 5:18 pm
snowathlete

Thanks for the article, which is really helpful. I think this is one of the most important jobs of PR and other ME/CFS organizations; timely reporting of key informaiton like this in an easily digestable format for patients, so that patients can be aware and respond actively where needed in a coordinated effort. With many patients not well enough to go find out all this stuff on their own, its a critical role.

I agree with the objectives of the letter. I think getting those four points taken aboard by the FDA might be optimistic, but that of course isnt a reason not to make the request and the pressure them for it.

The letter suggests "recognized ME clinician and researcher experts – experts like Drs. Klimas, Rowe, Montoya, Peterson, Chia and Bateman."

To you and me, we know what that means, because we know these doctors take the illness seriously, do not treat it like a psycological illness, and have a lot of experience with the illness. But do the FDA know that is what we mean? And even if they do, will they admit they know what it means and take appropriate steps? My fear (based partly on the fact we already know they havent invited people who they clearly should invite) is that they would invite those people they consider to be "recognized experts" but who we dont want anywhere near the meeting. By the sounds of things there is some dialogue going on between the FDA and the organizations behind the letter, so I expect there is a good chance they will get that message clearly enough.

The list is not complete yet but some of the experts we listed have been invited –
Lucinda Bateman, Nancy Klimas, José Montoya, Peter Rowe, Christopher Snell.

I expect to see others as they are confirmed on this page:
http://www.fda.gov/Drugs/NewsEvents/ucm319188.htm

snowathlete March 29, 2013 at 5:26 pm
medfeb

The list is not complete yet but some of the experts we listed have been invited -
Lucinda Bateman, Nancy Klimas, José Montoya, Peter Rowe, Christopher Snell.

I expect to see others as they are confirmed on this page:
http://www.fda.gov/Drugs/NewsEvents/ucm319188.htm

Thanks for the update medfeb.
Someone from each of the five labs involved in the Ampligen trials should be invited I think; it seems daft to me that they arent invited, as they know first hand some of the hurdles to getting a drug trial to succeed, what did and didnt work, and so on.

Here is the list of partisipants: http://www.fda.gov/downloads/Drugs/NewsEvents/UCM320307.pdf
I hope they have a big room.

Ember March 29, 2013 at 8:53 pm
snowathlete

Here is the list of partisipants: http://www.fda.gov/downloads/Drugs/NewsEvents/UCM320307.pdf
I hope they have a big room.

This is the speaker list, as of March 20, I believe:

Scientific Drug Development Workshop Confirmed Speakers, Panelists, and Moderators
April 26, 2013
Lucinda Bateman, MD
Lisa Corbin, MD
Lily Chu, MD, MHSH (patient)
Jordan Dimitrakoff, MD, PhD
Nancy Klimas, MD
Dennis Mangan, PhD
Robert Miller (patient)
José Montoya, MD
Bernard Munos, PhD
Peter Rowe, MD
Christopher Snell, PhD
Jennie Spotila, JD (patient)
Elizabeth Unger, MD, PhD
Suzanne Vernon, PhD
Christine Williams, MEd (patient)

The link that you posted is to the ME and CFS Stakeholder Teleconference Participant List (September 13, 2012).

Bob April 1, 2013 at 6:37 pm

I haven't read through all of this (very useful) thread yet, so I may be repeating stuff.
But I just want to post some info relating to using the FDA's online comment form:
http://www.regulations.gov/#!submitComment;D=FDA-2012-N-0962-0004

Please note: it seems that any submitted comments will be made available on their website for public viewing/reading, including any attached documents. I don't think that they publish the commenter's name, so it should be anonymous, as far as I understand. Except the 'Submitter's Representative' details will be made public, when given.

Here are their FAQs, in relation to posting comments, in case helpful:
http://www.regulations.gov/#!faqs;qid=6-2

Their comment form gives details of how to make a submission via snail mail, as follows:

Comments: Submit either electronic or written comments by April 8, 2013, to receive consideration. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document*. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. Electronic or written comments will be accepted after the meeting until August 2, 2013.

* The relevant docket number is:
FDA-2012-N-0962-0004

This is the FDA notice that we are commenting on:
http://www.regulations.gov/#!documentDetail;D=FDA-2012-N-0962-0004

Bob April 1, 2013 at 7:07 pm

Something to note…

The FDA are looking for what they call 'measurable endpoints'.

They are looking for the best way to measure if a treatment has worked or not, in relation to CFS/ME.

The example that they give, for measurable endpoints (these are not ME-specific), is a decrease in blood pressure, or an ability to walk for an increased period of time.

So if anyone has any strong ideas about this, it would be worth submitting them.

I think it's very important that they do not use subjective measures of self-reported 'fatigue' etc., like they used in the PACE Trial, but use objective measures, such as an objectively measured increase in walking ability.

(Sorry if this is repetitive… I still haven't fully read this thread yet.)

Bob April 1, 2013 at 7:09 pm

In relation to Phoenix Rising's (very helpful) Joint Letter to the FDA, I just spotted this in their literature:

There has been conversation regarding the consolidation of ME and CFS in describing the symptom complex. Drug development focuses on quantitative measures of benefit (e.g., symptom improvement), not on the name of the disease. Therefore, for the purpose of drug development, the reference of ME/CFS does not mean that FDA views the two diseases or syndromes as the same.

http://www.regulations.gov/#!documentDetail;D=FDA-2012-N-0962-0001

Ember April 2, 2013 at 3:40 am
medfeb

We do not have an official response to the letter. The only response that we have is the information posted in the FDA Workshop FAQ which was posted after the letter was sent.

In the joint letter to the FDA, its authors write:

For the past twenty-five years, the use of…overly-broad, non-specific definitions has confounded ME research with conflicting results, stalled ME drug development, corrupted prevalence estimates, confused the scientific and medical communities about the nature of ME and severely impacted the quality of care that ME patients receive.

The letter accordingly asks for assurance that “the FDA will encourage researchers and drug sponsors to use disease appropriate clinical trial inclusion criteria, like those seen in the Canadian Consensus Criteria, to avoid the overly broad patient cohorts that have stalled progress in the past.”

The FDA's subsequent statement (FAQS), however, seems biased toward “the continued mixing of ME with unrelated fatiguing conditions:”

At this time, FDA does not endorse any particular disease definition, but does expect that sponsors will define the disease using detailed enrollment criteria for clinical trials that exclude other known causes of fatigue and similar complexes.

Because CFS (Fukuda) explicitly identifies a set of “clinically evaluated, unexplained cases of chronic fatigue,” however, the FDA's own logic, along with the International Consensus Panel's recommendation, should mean that sponsors who define the disease using CFS (Fukuda) for clinical trials will exclude, by definition, cases of ME.

The joint letter also asks for assurance “that the workshop will focus on ME…and not on the vaguely defined, overly broad 'CFS.'” But by using “the terms 'CFS' and 'ME'…interchangeably” and by prevaricating on the subject of disease definitions, the FDA has planned for a workshop that will likely focus on CFS instead, ignoring the distinctive nature of ME. It's like deja vu all over again.

anniekim April 2, 2013 at 7:09 am

Pem/pene is my biggest problem, pain second. I am bedridden. If I remain lying flat, I just have enough energy to read a little, go online a little, have some short conversations. If I go over this at all, ie, crawling to the toilet, walking a couple of steps, the post exertional neuro immune exhaustion kicks in and I am too weak to do anything but lie there staring at the ceiling, with my manageable pain becoming much more severe and unmanageable.

If the mechanisms behind pene/pem could be identified and drugs developed to at least mitigate the pene my quality of life would be improved. I've always felt it's the pene that is the hallmark of this illness

anniekim April 2, 2013 at 7:11 am

Can people outside the US write to the FDA? Thanks

Sasha April 2, 2013 at 7:13 am
anniekim

Can people outside the US write to the FDA? Thanks

I have! Nothing to lose. The drug developers want info about ME – I don't see why it would matter what country the patient is in who provides them with that info.

anniekim April 2, 2013 at 8:08 am
Sasha

I have! Nothing to lose. The drug developers want info about ME – I don't see why it would matter what country the patient is in who provides them with that info.

Ok,thanks Sasha. Will submit a comment. When filling in the basic details, what do I put in for organisation's name which is a required field? Thanks

Sasha April 2, 2013 at 8:11 am
anniekim

Ok,thanks Sasha. Will submit a comment. When filling in the basic details, what do I put in for organisation's name which is a required field? Thanks

It's a long time since I filled that in and I think there's maybe an option like 'patient' or 'customer' or something. Can anyone else remember? Can you post a link to the thing you're looking at? I'm about to go out so perhaps someone else can help. :)

anniekim April 2, 2013 at 8:43 am

Thanks Sasha. I'll just put patient. On my iPad and can't do link

medfeb April 2, 2013 at 2:29 pm
anniekim

Can people outside the US write to the FDA? Thanks

Anniekim
Yes, people outside the U.S. can write to the FDA. You can also answer the two surveys if you havent already. Links are in the article.

Bob April 2, 2013 at 2:53 pm

In case helpful, here are the two surveys…

Dr. Lily Chu and Dr. Leonard Jason:
http://kwiksurveys.com/app/rendersurvey.asp?sid=mnwykzr9g2ae1l5112627

CFIDS Association:
https://www.surveymonkey.com/s/pt-focused-survey

Whit April 5, 2013 at 11:33 pm

Ronald W. Davis, PhD, Professor of Genetics and Biochemistry and Director of the Stanford Genome Technology Center at Stanford, is doing research on CFS. He thinks it would be a good idea for all of us to comment on this federal workshop for CFS and wrote the following for me to send this out. Unfortunately I've been really sick and haven't been able to. But here it is now. If this contradicts something in the above article then go with what PR is suggesting. But maybe this will be good motivation.

There is a public workshop called "Drug Development for Chronic Fatigue Syndrome and Myalgic Encephalomyelitis; Public Workshop" held in Washington DC on April 25 and 26.

http://federalregister.gov/a/2013-05562

Two things they are trying to determine are "the most significant symptoms that you experience resulting from your condition" and "the most negative impacts on your daily life that result from your condition and its symptoms." They expect patients to go to Washington DC to explain their condition, but of course only the least sick could possibly go. However, patients can email or write if it is received by April 8, 2013.

[Whit's note:
Only write about physical symptoms. I know we also suffer from mental symptoms as a result of our physical illness, but do not give them any excuse to write this off as a mental illness. Do not write about emotional symptoms. Tell them about your emotional symptoms by telling them the physical things that cause them, and leave out the emotional aspect. ]

Here is how to make online comments:
Go to:
http://www.regulations.gov
There is a big search box
Type in-
Docket No. FDA-2012-N-0962
Click on "comments" for this current CFS/ME workshop.
Fill in your information and comments.

Submit written comments to:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852
(refer to Docket No. FDA-2012-N-0962 at the beginning of your letter.)

This is an outstanding opportunity to get on the public record the devastating effect of CFS.
Even if nothing happens as a direct result of the on site meeting, the government could not ignore CFS if 100,000 people responded describing the level of their disability. History has shown that the government acts if there is a significant march in Washington DC. But what about a disease so devastating that patients can not get to Washington DC and could not march even if they could get there. An email/written effort might substitute for a march if it is made clear they can not travel or march. If you are really sick, just write what you can. Even writing "I am too sick to write more than this one line" will be beneficial. For those of you that don't trust the government keep in mind there are only two groups that have enough resources to solve CFS; The government and a collection of most of the patients. Things have been so bad, so ignored, for so long, but this is a time when we might really be able to have our voices heard.

It would not be a good thing if this workshop only recorded the responses of people well enough to go there. That would be a false impression of the true effects of this illness. It seems that this might be a window of opportunity to really make our voices heard. Even just to get thousands of responses on the record would provide great citations for people writing grants in the future. There is a rising tide of research now, and we need to do everything we can to provide the impetus for funding. Tell them what it's like. Get your friends, family and doctors to write. Let's motivate them to finally do something about it!

Sasha April 6, 2013 at 3:43 am

Thanks, Whit – I'm sorry you've been so sick.

It's great that your dad took the time to write – we need more like him!

Ember April 6, 2013 at 2:51 pm
Whit

History has shown that the government acts if there is a significant march in Washington DC. But what about a disease so devastating that patients can not get to Washington DC and could not march even if they could get there. An email/written effort might substitute for a march if it is made clear they can not travel or march….

Get your friends, family and doctors to write. Let's motivate them to finally do something about it!

A virtual march on the FDA? Only 88 comments received so far:

Comment Now!
Due Apr 07 2013, at 11:59 PM ET

Nielk April 7, 2013 at 10:12 am

The march of words!

Make your words count.

Ember April 8, 2013 at 2:35 pm

As shown here, 126 comments have been received.

This document shows today as the due date for comments to receive consideration:

Drug Development for Chronic Fatigue Syndrome and Myalgic Encephalomyelitis; Public Workshop
Comment Now!
Due Apr 08, 2013 11:59 PM ET
Notice Posted: 03/11/2013
ID: FDA-2012-N-0962-0004

SpecialK82 April 9, 2013 at 10:05 am

Jennie Spotila explains in her latest blog http://www.occupycfs.com/ that the docket will be open until August 2 to receive comments. Possibly the April 8 deadline was for the comments to be included in this meeting. However, please continue to send your comments in now after April 8 if you haven't done so, I'm sure that these will still be considered in the total count at the end of the day.

Whit April 9, 2013 at 6:36 pm

From OccupyCFS-
"If you want to submit written comments, you have until August 2nd to post comments through the meeting docket. The docket page currently says it will close on April 8th, but FDA has said in the Federal Register and in communication to advocates that the docket will be open until August 2nd."

Can someone else confirm this? It would be good to make sure before sick people spend time writing comments.

Ember April 9, 2013 at 8:33 pm
Whit

Can someone else confirm this? It would be good to make sure before sick people spend time writing comments.

Bob quoted the relevant source earlier:

Comments: Submit either electronic or written comments by April 8, 2013, to receive consideration. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. Electronic or written comments will be accepted after the meeting until August 2, 2013. (emphasis added)

Whit April 9, 2013 at 9:04 pm

Great news! Hopefully we can build up more comments. Since there's more time and I have a tiny bit of energy, I've got some questions about the comment form.

1) It appears the comments are google searchable, and if we use our full name, they may appear in a google search for our name. This may bother some people. But it seems that full name is not required. Do comments have more impact if we give our full name?

2) I had no idea what to put for the "organization name" or "category", and both were required. Forgive me if I've missed explanation of this elsewhere. But it would be good to clarify.

Bob April 10, 2013 at 3:40 am
Whit

Great news! Hopefully we can build up more comments. Since there's more time and I have a tiny bit of energy, I've got some questions about the comment form.

1) It appears the comments are google searchable, and if we use our full name, they may appear in a google search for our name. This may bother some people. But it seems that full name is not required. Do comments have more impact if we give our full name?

My understanding is that all comments, and uploaded documents, may become public both online and in other literature such policy-review documents etc etc.

Here is their privacy notice:
http://www.regulations.gov/#!privacyNotice

In the online form, any part of the form with a 'world' symbol next to it, will be displayed publicly.
So it looks like they will not publish individual names, but will publish the 'Organisation Name' and 'Submitter's Representative' name.

Whit

2) I had no idea what to put for the "organization name" or "category", and both were required. Forgive me if I've missed explanation of this elsewhere. But it would be good to clarify.

I suppose that "ME patient" or "patient" would be appropriate for the organisation name.

For the 'category' list, go to the bottom of the drop-down list, and you'll find 'individual consumer'. I think this looks most appropriate for a patient.

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