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Accelerating Treatments for ME/CFS: A Call to Action for the FDA

Discussion in 'Action Alerts and Advocacy' started by Cort, Apr 25, 2012.

  1. Cort

    Cort Phoenix Rising Founder

    Messages:
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    Raleigh, NC
    For decades, ME/CFS (Myalgic Encephalomyelitis/Chronic Fatigue Syndrome) has devastated the lives of patients and our loved ones, leaving us with an alarmingly low quality of life. Today, ME/CFS affects the lives of more than 1 million Americans of both sexes and all ages at an annual cost of at least $21 billion in direct costs and lost productivity.

    As patients and loved ones, we have suffered too long with too little research, a disbelieving medical community and no approved drug treatment specifically for ME/CFS.

    This has to change! We know that we need many things, such as more money for research. But right now, an important branch of the FDA is up for reauthorization and legislation is being put forth to accelerate drugs for chronic illnesses. We want to capitalize on this opportunity by calling on the FDA to hold a Stakeholder meeting to discuss approval of ME/CFS treatments.

    Stakeholders Meeting FDA officials have stated theyre committed to bringing stakeholders together to overcome the challenges drugs face.

    We request they honor that commitment and hold a stakeholders meeting to find an expedited path forward for drugs for chronic fatigue syndrome. The FDA has a process called accelerated approval which allows companies to market drugs for serious illnesses with unmet needs which have proven to be safe before all their effectiveness data is in. We believe drugs under consideration by the FDA for ME/CFS should be given this status.

    A Special Case Chronic fatigue syndrome is probably the only large disorder in the US without a single medical treatment approved for it. Dr. Woodcock at the FDA has said she is committed to examining treatments for the chronically ill where few or no treatments exist.

    Benlystras recent approval for lupus may lend some hope. The first drug approved for the disease in over 50 years, Benlystra failed to significantly surpass the effects of placebo after 76 weeks in a clinical study and only 35% of the study participants responded, yet the FDA, citing the lack of treatment options and the effectiveness of the drug in a subset of patients, gave it the go ahead. Ampligen, the only drug currently under review at the FDA, has been shown to be effective (see PlosOne study) and hundreds of patients over the past ten years have shown that its safe.

    We need the FDA to hear from as many people as possible to ensure that the Stakeholder meeting happens. Please write and/or call before May 2, 2012 to request the stakeholder meeting. Please ask your families and friends to send letters on your behalf. And please use Facebook, Twitter, etc. to get the word out for ACTION NOW!

    A Template for the letter along with Email addresses and other details are below.

    Instructions for the email

    1. Use the attached template for the letter to Secretary Sebelius/Dr. Hamburg and other officials

    We ask that you follow this template as closely as possible as that will strengthen our request.

    Personalizing the email:The template has space for you to add 2-3 brief sentences about your personal story or information at the end of the second paragraph.

    a. Simply replace the personal story in the template with your own story, adding details like how long you have been ill and how ME/CFS has affected your life, work, finances, etc.

    If you do add a personal story, please try to keep the overall email length to less than 1 page because it will be more likely to be read. If you want to go more in-depth with personal stories, we ask that you send a separate email as a follow-up after our action is done.

    b. If you do not wish to personalize, just remove the personal story from your letter.

    Sending the letter:When your letter is ready:

    a. Cut and paste your letter directly into the body of your email. Please do not attach as a separate document as it may not get through email systems and is less likely to be read.

    b. Add the email addresses by cutting and pasting the following list of emails directly into the To box. The one email message will go to all addressees at one time.

    2. Email addresses


    Kathleen.Sebelius@hhs.gov , margaret.hamburg@fda.hhs.gov, janet.woodcock@fda.hhs.gov , Nancy.Lee@hhs.gov , howard.koh@hhs.gov , brian_ahlberg@harkin.senate.gov, Alex_Stern@mikulski.senate.gov , jeff.carroll@mail.house.gov , monica.volante@mail.house.gov , Annie_Walden-Newman@murray.senate.gov , mecfsaction@yahoo.com

    The following addresses are included as the contacts for the corresponding legislative leader

    Senator Mikulski (Alex_Stern@mikulski.senate.gov), Congressman Pallone (jeff.carroll@mail.house.gov), Congressman Pitts (monica.volante@mail.house.gov), Senator Murray (Annie_Walden-Newman@murray.senate.gov)

    The Mecfsaction@yahoo.com address is included to allow us to track the number of letters sent.

    3. Contact your senator or congressman


    You may wish to send a letter (or forward this one) to your senator or congressman as well, especially if they are involved in the Health, Education, Labor and Pension Committee or on the House Appropriations Committee, which has a subcommittee for Health.

    If you do not have an email address for your senator or congressman, you can use the following links to access the contact forms for those from your state.



    These representatives sit on committees that are particularly influential:

    Subcommittee on Children and Families


    Democrats by Rank


    Republicans by Rank


    Subcommittee on Primary Health and Aging

    Democrats by Rank


    Republicans


    Sample Email Letter

    From: John Smith May 25, 2012

    To: Secretary Kathleen Sebelius, Department of Health and Human Services

    Dr. Margaret Hamburg, FDA Commissioner

    Cc: Dr. Janet Woodcock, Office of New Drugs, FDA, Dr. Nancy Lee, Director Office of Womens Health, Dr. Howard Koh, Assistant Secretary of Health, Chairman Tom Harkin, Health, Education, Labor, and Pensions, Senator Barbara Mikulski (D-MD), Senator Patty Murray (D-WA), Congressman Frank Pallone (D-NJ), Congressman Joseph Pitts (R-PA),

    Subject: Chronic Fatigue Syndrome: Request for Stakeholder Meeting


    I am John Smith and I write to you to request that the FDA hold a Stakeholder meeting to discuss treatments opportunities for Chronic Fatigue Syndrome (also called Myalgic Encephalomyelitis or ME/CFS), a debilitating disease that affects more than one million Americans of both sexes and all ages.

    For decades, ME/CFS has obliterated the lives of patients and their families, leaving them with a pitiful quality of life, no hope of treatment and a medical community ill prepared to care for them. Compounding the personal devastation is the effect on our countrys economic well-being; ME/CFS drains our workforce and costs our economy more than $21 billion annually. In spite of all this, little has been done to address our situation.

    My son is one of those millions with ME/CFS who have been left to rot. His life was cut down by ME/CFS at age 22 and if nothing changes, he will be very sick for the rest of his life, never able to work and more likely to die prematurely.

    I am aware of the FDAs role in assessing the benefit-risk of new drugs on a case by case basis and in shaping the future of medical breakthroughs by bringing stakeholders together to identify and overcome challenges. Yet, ME/CFS patients continue to suffer terribly while ME/CFS as a disease has been moved through six different divisions at the FDA and the only treatment for ME/CFS has been stuck in the FDA process for over a decade.

    ME/CFS demands real and significant action today. I request that FDA hold a Stakeholder meeting, including Dr.Woodcock, Dr. Lee, expert ME/CFS clinicians, patients, product sponsor and other key stakeholders, to explore opportunities to accelerate approval of treatments. Approval of a drug is critical to changing the face of this disease.

    Robert Miller, a ME/CFS patient/advocate, will contact you in two weeks to confirm scheduling of this meeting.

    As patients and family, we cannot allow our lives to be destroyed any longer. This meeting must happen to advance science for all ME/CFS patients!

    Sincerely,

    John Smith
    Waterford, Ct 06385
    860-123-4567
    justinreilly likes this.
  2. taniaaust1

    taniaaust1 Senior Member

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    Sth Australia
    I assume only Americans mean anything as far as this goes?

    If anyone knows of anyone out there who really wants to be more involved in advocacy and this letter but isnt capable of getting brain together to put it together and email it out (I get very frustrated when I cant do such things, leaving me at times having to be one of the unheard).

    Feel welcome to pm me with your name and any details you'd like to go into it, and I can currently put your info in the right places and email it on your behalf.

    (I'd like to see more of the unheard being heard from. I can put on it Im doing it for one too unwell to even advocate without help)
    justinreilly and Googsta like this.
  3. justinreilly

    justinreilly Stop the IoM & P2P! Adopt CCC!

    Messages:
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    NYC (& RI)
    Great! Thanks to John Smith, Robert Miller and Cort for this very important initiative! I have emailed mine.

    I'd like to request a change to the text: I believe that Ampligen has been in the FDA process since 1990 (Osler's Web p. 371); so I suggest the last sentence of the fourth paragraph be changed to read:
    "Yet, ME/CFS patients continue to suffer terribly while ME/CFS as a disease has been moved through six different divisions at the FDA and the only treatment for ME/CFS has been stuck in the FDA process for over two decades."
    ggingues likes this.
  4. ggingues

    ggingues $10 gift code at iHerb GAS343 of $40

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    Concord, NH
    So is this a daily thing? I think I posted it on some other thread, not sure if I got a response? Found this thread first and not my comment, so here I am again asking.

    GG

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