Posts Tagged 'Speak Up About ME'

Our ME/CFS Experts Have Spoken on the Case Definition

On September 23, 2013, HHS announced that it has entered into a contract with the Institute of Medicine to begin work to develop “clinical diagnostic criteria” for ME/CFS.

But there’s more.

On the same day, 35 of the leading researchers and clinicians in the field of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) have written an open letter to Health and Human Services Secretary Kathleen Sebelius to announce that they have reached a consensus on adopting the Canadian Consensus Criteria (CCC) as the research and clinical case definition for ME/CFS. They called for HHS to follow their lead by using the CCC as the sole case definition for ME/CFS in all of HHS’s activities related to the disease and strongly urged HHS to abandon its plans to reach out to groups like the Institute of Medicine to develop clinical diagnostic criteria.

Acknowledging that the case definition will be refined as science advances, the authors unambiguously endorsed the Canadian Consensus Criteria as the baseline criteria, stating:

The expert biomedical community will continue to refine and update the case definition as scientific knowledge advances, for example, this may include consideration of the 2011 ME International Consensus Criteria … As leading researchers and clinicians in the field, however, we are in agreement that there is sufficient evidence and experience to adopt the CCC now for research and clinical purposes, and that failure to do so will significantly impede research and harm patient care.”

Just as directly, the authors stated their strong opposition to the IOM initiative, stating:

We strongly urge [HHS] to abandon efforts to reach out to groups such as the Institute of Medicine (IOM) that lack the needed expertise to develop “clinical diagnostic criteria” for ME/CFS. Since the expert ME/CFS scientific and medical community has developed and adopted a case definition for research and clinical purposes, this effort is unnecessary and would waste scarce taxpayer funds that would be much better directed toward funding research on this disease. Worse, this effort threatens to move ME/CFS science backward by engaging non-experts in the development of a case definition for a complex disease about which they are not knowledgeable.”

Wow! Could our experts have spoken any more clearly, loudly and collectively?

More than any other issue, HHS’ decades long failure to adopt a definition that actually reflects our disease has confounded research and forestalled drug development. It has caused doctors to dismiss their patients’ illness or attribute it to depression. It has bred the widespread stigma and misunderstanding that ME/CFS patients face every day. By its actions, HHS has abandoned ME patients to lives of terrible debility and suffering with no treatments, no care and no hope that anything will ever change. In the face of such suffering, some patients have chosen suicide.

Compounding its mistakes, HHS unilaterally entered into a contract with the Institute of Medicine (IOM) to develop clinical diagnostic criteria and has repeatedly stated its intent to use non-experts to define our disease. We need only look to the Gulf War Illness experience with IOM and chronic multisymptom illness to know that this would be disastrous.

But today, thanks to our experts, the time for pretending ME/CFS doesn’t exist is OVER! The time for burying this devastating disease inside of an illegitimate collection of unexplained fatiguing illnesses is OVER! To quote advocate Tom Hennessey, NO MAS!

HHS can no longer claim that there is a lack of consensus amongst disease experts. As with every other disease, it is time for HHS to follow the lead of our disease experts and adopt the CCC for research and clinical purposes. In particular, HHS must now stop wasting taxpayer dollars on misguided efforts that, in the words of the letter authors, “threaten to move ME/CFS science backwards.”

For patients who have suffered through years of studies into ‘false illness beliefs” and maladaptive coping styles, this is finally a way out of the morass, an escape route from all those wasted years. As the authors stated, adopting the CCC will “jump start progress and lead to much more rapid advancement in research and care for ME/CFS patients.” It gives hope that our disease will be treated as the terrible disease that it is and that progress will now come quickly. It gives hope that we will soon rise up from our beds!

This letter is remarkable and historic for the ME/CFS community.

But what does this letter mean in terms of the IOM contract that HHS has just signed? Typically, like most contracts, government contracts have mechanisms built into them to allow the contract to be cancelled when the contract no longer makes sense.

Now that the ME/CFS experts have spoken, the path forward is clear. It does not make sense to waste money and time redefining the disease when the experts have now agreed upon the immediate adoption of the CCC.

We need to send two strong messages to HHS. First, HHS needs to immediately adopt the CCC as the sole definition for ME/CFS as the experts have called for. Second, HHS needs to cancel the IOM contract, which is completely unnecessary, wasteful and a step backwards scientifically.

We need to forcefully engage our congressional leaders on this issue. Further information along with the actions to take with congressional leaders will be provided as soon as possible.

The Sept 23, 2013 open letter from ME/CFS researchers and clinicians to Secretary Sebelius can be found here – http://bit.ly/15npS9B

The Sept 23, 2013 CFSAC announcement on the IOM can be found here – http://bit.ly/18m7XlJ

Thanks to Mary D for this information!

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Make your voice heard – every day! Action Alert

We remember Nancy Lee saying “Nothing about us without us”…

In Chronic Fatigue Syndrome Advisory Committee (CFSAC) discussions Designated Federal Official (DFO)Nancy C. Lee, M.D. has used the phrase “Nothing about us without us” implying that stakeholders should be involved in all things regarding ME/CFS.

But (on Sept 12th) HHS says:

We continue to work on a contract with the Institute of Medicine (IOM) to develop recommendations for clinical diagnostic criteria.  When the contract is finalized, we will provide additional information via the CFSAC listserv and website.  This topic will be included as an agenda item for the November webinar.”

Yet CFSAC members, ME experts and ME stakeholders have been shut out of the HHS/IOM contract development and process.

Sooooo, how exactly is that “Nothing about us without us”? (Just to be clear — the question is in jest.)

Because the reality is that HHS is moving ahead on the IOM contract unilaterally and with total disregard for the overwhelming opposition from the ME community. HHS is undermining the work of ME experts while patients are suffering and dying.”

Take action today(!) and everyday (if you can).

Share widely and encourage others to act!

Tell HHS ENOUGH IS ENOUGH!

Subject line (variations encouraged): Stop the IOM Contract to Redefine ME/CFS

Send (daily) emails (from many people from any country) to:

TO: Kathleen.Sebelius@hhs.gov

CC: howard.koh@hhs.gov , txf2@cdc.gov , Tomfrieden@cdc.gov, Marilyn.Tavenner@cms.hhs.gov , margaret.hamburg@fda.hhs.gov, Mary.Wakefield@hrsa.hhs.gov , collinsf@mail.nih.gov , richard.kronick@hhs.gov , cfsac@hhs.gov , MEACTNOW@yahoo.com

Email templates can be found here:   http://www.occupycfs.com/2013/09/17/insult-meet-injury/#comments

and here:   https://www.facebook.com/events/705280782832088/

(MEACTNOW@yahoo.com is used to tabulate emails sent)

Dear Secretary Sebelius,

I strongly urge the Department to abandon its plan to contract with the Institute of Medicine (IOM) to define its own clinical diagnostic criteria for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).

Researchers and clinicians with years of experience in studying and treating this disease have already created peer-reviewed case definitions – the 2003 Canadian Consensus Criteria (CCC) and the 2011 ME International Consensus Criteria (ME-ICC), which used the CCC as its baseline. These definitions are supported by clinical guidelines for medical practitioners, guidelines also created by experts. These definitions are well regarded by patients, ME doctors, and ME researchers. The CCC has been used both clinically and in research for years.

But rather than adopt these expertly defined disease criteria and the associated medical guidelines, HHS has promoted its own overly broad view of ME that does not require the hallmark symptoms of ME. HHS has questioned these hallmark criteria and misrepresented our disease in its medical education. HHS has even unilaterally reclassified “CFS” to be a subtype of chronic fatigue, in complete opposition to the standards set by the World Health Organization and all other countries that classify this disease as a neurological disease.

Now, HHS is intent on defining its own new criteria for ME using the IOM, an organization whose only effort to define a disease was harshly criticized by Gulf War Illness Advocates for redefining the disease too broadly and for using non-experts to define the disease. HHS has repeatedly stated their intent to use non-experts to define ME. This is a very serious concern for patients who face widespread disbelief every day from the general medical and research community. Adding to these concerns, the description of ME/CFS in the January 2013 IOM report on Gulf War treatments failed to accurately represent ME and listed CBT and GET as treatments, treatments that our experts have said can be harmful.

HHS is progressing the IOM contract unilaterally and with disregard for the overwhelming opposition from the ME community. HHS is undermining the work of our experts while patients are suffering and dying. HHS must stop wasting precious time and dollars. HHS must stop wasting our precious lives.

I strongly urge HHS to abandon its plans to contract with the IOM to define clinical diagnostic criteria for ME/CFS. It is time for HHS to adopt a definition that our experts have created and use that definition to drive an aggressive campaign of fully funded research and to reeducate the medical community.

(sign your name)

Background info for those sending emails   (do not include with email) —— https://dl.dropboxusercontent.com/u/89158245/Action%20Alert%20Sept%2017%20HHS%20on%20IOM.pdf

Deadline fast approaching!

Drug Development for CFS and ME: Public Workshop to be held April 25/26, 2013

 

The registration deadline is fast approaching. Monday April 8th, 2013 (5pm eastern time) is the deadline for:

registration to attend,

registering to view the webcast,

consideration for participation on Day 1 panels,

public comment summaries.

Register here: http://mecfsmeeting.eventbrite.com/#

You can request to be part of a Day 1 panel discussion (topics below)

Suggestions for those providing comments: For those who wish to provide comments, either as part of the panel or as part of the ‘open discussion’, 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 M

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

    • 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.

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 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.

Previously we had heard that public comment by proxy would be allowed. This is no longer the case as apparently there are so many community members who want to provide comment in person that FDA can only schedule those providing comment in person. BUT everyone can submit comments to the docket.

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.

Participate in the FDA meeting remotely

Remember to respond to two different surveys that are collecting information for the meeting.

  • Both surveys are collecting information a) disease symptoms and daily impacts that matter most to patients and b) patient perspectives on current approaches to treating ME/CFS.
  • 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 answer both questionnaires.
  • 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. Examples are given above in #1.

updated post

 

Please note that OccupyCFS has some clarifying info about public comment http://www.occupycfs.com/2013/03/28/clarity-on-comment/ for the FDA April 25/26th meeting as well as lots of background info about the meeting.

 

The following has been slightly revised to reflect information FDA provided as answers to some questions.

On April 25-26, 2013, the FDA is holding a workshop 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 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 will also ensure that the drug approval process better incorporates the patient perspective going forward.

 

Day 2 of the workshop 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:

  • Neurological impairment seen in symptoms like sleep dysfunction, headaches and sensory disturbances and that can be measured in lab tests like SPECT scans or MRI.
  • Cognitive dysfunction seen in symptoms like impaired memory and processing speed and that can be measured through various cognitive performance tests.
  • Immunological dysfunction seen in cytokines abnormalities, high viral titers, RNASE-L abnormality and low natural killer cells.
  • Autonomic dysfunction and orthostatic intolerance causes symptoms like dizziness, racing heart and feeling sick when stand for long periods and 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 that cause a relapse after mental or physical exertion and 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 repurpose 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”, is assumed to be due to depression, deconditioning or is thought to be simply another name for chronic fatigue.

 

To ensure that the pharmaceutical companies understand this biology, a group of ME/CFS organizations and advocates 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 athttps://dl.dropbox.com/u/89158245/LetterFDAWorkshopMar18.pdf

 

Take Action

So 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

Here’s what you need to do:

  • To attend in person, register first-come, first-serve at http://mecfsmeeting.eventbrite.comby 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 that you wish to provide comments as outlined next.

 

  • 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.

 

  • Suggestions for those providing comments: For those who wish to provide comments, either as part of the panel or as part of the ‘open discussion’, 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 M

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

    • 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.
      • 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.
  • 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.

 

  1. Participate in the FDA meeting remotely
  1. Respond to two different surveys that are collecting information for the meeting.
  • Both surveys are collecting information a) disease symptoms and daily impacts that matter most to patients and b) patient perspectives on current approaches to treating ME/CFS.
  • 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 answer both questionnaires.
  • 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. Examples are given above in #1.

 

  1. 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 in above.

 

Get more 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.

 

 

 

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 in #1.

 

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)?

 

Draft agenda posted for the FDA Meeting April 25th and 26th, 2013

The FDA has updated its webpage (http://www.fda.gov/Drugs/NewsEvents/ucm319188.htm) on Drug Development for Myalgic Encephalomyelitis and Chronic Fatigue Syndrome (ME and CFS) to include links to the draft agenda for the April meeting http://www.fda.gov/downloads/Drugs/NewsEvents/UCM344665.pdf as well as to a statement about the purpose of the meeting http://www.fda.gov/downloads/Drugs/NewsEvents/UCM344666.pdf

Registration (first come, first served) is required to attend and you can do that here http://mecfsmeeting.eventbrite.com/# and the meeting will be webcast for those who cannot attend in person. (Link to be provided http://www.fda.gov/Drugs/NewsEvents/ucm319188.htm about one week before the meeting.)

Ms Spotila – author of the Occupy CFS blog – has another very good post http://www.occupycfs.com/2013/03/19/showcase/ about the importance of our voices and what we say at the meeting:

…What we say at the meeting will help us or hurt us. Showing drug developers and FDA that there is a market for new treatments, and telling them which symptoms to target and how to measure improvement, will help us. …

…This is our moment. FDA wants to hear what we have to say about our disease and the need for treatment. We have to get this right. Let’s use this opportunity to teach people about our disease. Let’s show the world what we need, and that we’re willing to participate constructively in the process to get it.  There’s no way to know when (or if) we’ll have this opportunity again. Let’s bring our A game to this showcase event.”

She is right.

Giving careful, measured consideration about the reality of living with ME(cfs) and the reality of the need for treatment will help us. This is not the time to talk about the wrongs that have been done to us…

The FDA has provided questions to help us develop our public comment (deadline 8 April 2013).

The discussion topics on Day I are geared to the patient experience of symptoms, daily impact and perspective on treatment.

Discussion 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, etc.)

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, sleeping through the night, etc.)

a. How does the condition affect your daily life on the best days and worst days?

b. What changes have you had to make in your life because of your condition?

 

Discussion topic 2: Patient perspective on treating CFS and ME

1. What treatments are you currently using to help treat your condition or its symptoms?

(Consider prescription medicines, over-the-counter products and non-drug therapies such as activity limitations).

a. What specific symptoms do your treatments address?

b. 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?

a. How well have these treatments improved your daily life (for example, improving your ability to do specific activities)?

b. How well have these treatments worked for you as your condition has changed over time?

c. What are the most significant downsides of these treatments (for example, specific side effects)?

http://www.fda.gov/downloads/Drugs/NewsEvents/UCM344665.pdf

When asked about the role of caregivers, FDA has responded that the discussion topics will allow for caregivers speaking on behalf of patients who cannot speak for themselves but that the time really is geared to patients. One could assume that FDA would allow a caregiver speaking on behalf of – for instance, a child who, because they got sick during formative years, and has forgotten or never experienced age appropriate normal.

Alternatively, people can register to speak during the open public comment period that follows the discussion topics.

Comments:

Submit either electronic or written comments by April 8, 2013, to receive consideration.

Submit electronic comments to 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 FDA-2012-N-0962-0004. 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. Drug Development for Chronic Fatigue Syndrome and Myalgic Encephalomyelitis; Public Workshop

Document ID: FDA-2012-N-0962-0004 Document Type: Notice
Docket ID: FDA-2012-N-0962  

Electronic or written comments will be accepted after the meeting until August 2, 2013. “

 

 

REMEMBER – if you want to be connected with a mentor to help you craft your public comment, contact us at SpeakUpAboutME -at- gmail -dot- com.

Early/pediatric onset list reminder

People within our community have many different perspectives, and yet those differences pale in comparison to our commitment to move things forward.

We are learning a lot from each other as we engage in interesting and informative discussions. We have many common goals.

As we look forward to 2013 we hope that our community continues to build on our strengths so we can make even greater strides for the benefit everyone affected by ME(CFS).

 

PLEASE SPREAD THE WORD:

Speak Up About ME maintains a list of early/pediatric onset ME/CFS.

If you came down with ME/CFS before age 23, please add your name and illness info to the list*!

Provide

name (let us know if we should use your full name, first name only or a nickname that you provide),

age at onset,

age at diagnosis,

current age,

location (country is sufficient).

Encourage others with early (pediatric) onset ME/CFS to get their onset information listed also.

Send your onset info to: speakupaboutme at gmail dot com.

Public Comments due Thursday, December 6th 2012 for FDA Advisory Committee on Ampligen CALL TO ACTION (updated)

Thursday, 6 December, 2012 is the deadline to submit public comment for the 20 Dec 2012 Arthritis Advisory Committee Meeting!

(2 Dec 2012 – CORRECT EMAIL ADDRESS:   AAC@fda.hhs.gov)

Please spread the word about this – there are only a few days until the deadline. Anyone, anywhere can participate!

If anyone has trouble submitting their comments please email us (see below) – we will do our best to help.

Why is it important for you to send your comments?

For the first time ever, ME/CFS has the chance to get a treatment approved.  Whether you have been on Ampligen or not, whether you wanted to try it or not – once one drug gets approved other drugs will come along and so will additional research dollars.  It will also legitimize the disease in the minds of the medical community and the world.

Why is this public comment just about Ampligen?

Because this particular meeting is part of the process to approve a drug. 

Send in your comments to let the advisory committee know what it is like to have ME/CFS and to tell them that treatment is needed NOW.  

Your comments do not need to be lengthy. Feel free to use the template below. (The template uses CFS because that is how the FDA website http://www.fda.gov/AdvisoryCommittees/Calendar/ucm324972.htm refers to this wretched illness. Using CFS will probably make it easier for those on the committee to follow.)

(The advocacy community will continue to update you about additional significant meetings coming up – including the Stakeholder meeting in the spring, as well as about issues dealing with CDC and NIH…) 

Right now we need to let the Advisory Committee hear us on this issue.

Send in your public comment by THURSDAY DECEMBER 6th, 2012

Send your comments to: AAC@fda.hhs.gov   (this is the correct email address)

Subject line:  Treatment for Chronic Fatigue Syndrome- Ampligen

To The Advisory Committee Reviewing Ampligen:

My name is ___________________…. .

I have had CFS for more than ___ years. 

Before I became ill, I ______________________……. 

My life because of CFS _______________________________________________…….. 

The reality is that CFS is a horribly devastating illness that effects every moment of my life. 

CFS patients need treatments.

We have seen patients do well on Ampligen. We have seen patients’ quality of life improve as a result of Ampligen.

Help us have access to treatments.

Please give the CFS community hope of getting our lives back.

Sincerely,

…………………………

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Remember to send in your public comment by THURSDAY DECEMBER 6th, 2012