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ME / CFS P a t i e n t s: C a l l t o A c t !

Discussion in 'Action Alerts and Advocacy' started by BobM, Jun 24, 2013.

  1. BobM

    BobM

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    ME / CFS P a t i e n t s : C a l l t o A c t !

    Attention ME/CFS patient community,



    We the "FDA Team" are asking you to send the message below to the FDA and to listed members of Congress.



    The recent patient-focused drug development meeting held by the FDA was a start - but only a start. The FDA stated that their goal was to support treatments for the chronically ill, particularly where there is a drug deficit, yet the meeting fell short of meeting that goal. Bob Miller and others on our team are continuing communication at the top level, including with Dr. Janet Woodcock, Director of the Center for Drug Development and Research at the FDA. We have informed her that your messages will be sent to one of her staff members, David Banks PhD, of Special Health Issues.

    We want them to hear from you, family and friends. This keeps critical channels of communication open.

    NUMBERS COUNT!



    AIDS patients demanded one thing: "Treatment," and they got it! We must demand the same.



    Please email the following to David Banks and myself Bob Miller. (I am monitoring how many emails are sent with other FDA team members.) Also, we ask you to Cc others in the Department of Health and Human Services and congressional staff members so they can influence the FDA.



    Just copy and paste, please add your name and address or email information at the end. (As always, this is just a suggested template for your convenience):



    To:David.Banks@fda.hhs.gov, 511bobmiller42@gmail.com



    Cc:howard.koh@hhs.gov, Sara_Mabry@casey.senate.gov, Karen_Wade@hagan.senate.gov, Eamonn_Hart@blumenthal.senate.gov, Carolyn_gluck@reid.senate.gov

    monica.volante@mail.house.gov, robb.walton@mail.house.gov, rebekah.armstrong@mail.house.gov, eric.fox@mail.house.gov, christopher.Stewart@mail.house.gov, ryan.mcBride@mail.house.gov



    Subject: ME/CFS Treatments



    Dear Dr. Woodcock:



    Over 1 million Americans and their families continue to suffer with ME/CFS. Patients have no options as there are no FDA-approved treatments. One drug has been stuck in the pipeline for two decades (Ampligen), and there are no others likely to be reviewed for years to come. The recent patient-focused drug development meeting fell short. By the end of this year, FDA must convene a follow-up meeting to engage pharmaceutical and biotech companies to assist the FDA in establishing a regulatory pathway for drug approval.



    The meeting held on April 25th and 26th opened the FDA's eyes to the severity of our condition and the enormous Unmet Medical Need. FDA has the power and the authority to waive traditional regulations when healthcare demands, particularly when the disease is serious/life-threatening, as ME/CFS clearly is. We need access to treatments NOW. Please act now for us! Don't stop the progress; let's keep it going. We cannot wait another decade for relief. People are suffering and dying; they are invisible to you, but they are dying.



    Thank you,

    "Place Your Name Here":

    "Place Address and/or Email Here"

    - - - End of your email message - - -


    The FDA Team includes: Robert Miller, ME/CFS patient / activist - Courtney Miller, patient caregiver (FDA Team supporter)Lori Chapo Kroger, patient and president of PANDORAOrg. Pat LaRosa, patient /advocate Billie Moore, parent of patient lost to ME/CFS & patient advocate
    Cort Johnson, patient and principal of Health Rising
  2. SpecialK82

    SpecialK82 Senior Member

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    Bob,

    Thanks to the team for putting together this action. I have a couple of questions.

    I'm not clear what specifically the letter is requesting? Is it the follow-up meeting to meet with pharma and biotech companies? I couldn't tell if that is what we are asking for or if you all are just referring to a meeting that is already planned?

    If so, can we, as the patient community come up with a plan to get more pharma to the table? I couldn't see how many reps showed up at the first FDA meeting (as they were off camera) but I didn't get the idea that they were packing the room. I realize that the FDA will probably have to pique their interest initially, but can we strategize with the FDA on how to get maximum turnout?

    Secondly, can we ask for periodic meetings with the FDA to ensure that the ball does keep moving?

    Thirdly, as I understand from the FDA when Ampligen approval was denied, they explained that they had questions (discrepencies) that have not been adequately explained by Hemispherx. Is Hemispherx planning to do so and if so, will it be done publicly?

    Fourthly, as I understand the White House contact that your wife had been given by President Obama is no longer in that position. I'm hoping that by now you have been given an alternative contact. Could you update us on where that stands and wondering if this isn't an excellent time to push the President (Kathleen Sebeilous' boss) again?

    Thank you and the team as always, for fighting on the front lines for all of us.
  3. BobM

    BobM

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    Hi SpecialK,
    There is no follow-up meeting set as of yet and the only thing to be suggested from the ME/CFS - FDA Stakeholder Workshop is to produce a report. We do not need a report, we are asking for a follow-up meeting with the FDA where they would specifically invite pharma and biotech companies. We had made that request for the first meeting, but the FDA told us pharma would attend, just because FDA arranged the meeting. And as you stated Pharma did not pack the room.

    As for your 2nd question, we have had continued contact with FDA and hope to get an agreement to have follow-up meetings. But it is key to have patient support along with support from our Representatives in D.C.

    3rd, After the ME/CFS - FDA workshop, FDA admitted they had for the first time truly understood the severity of ME/CFS. Had they had the proper understanding re: ME/CFS prior to ruling on Ampligen, perhaps the outcome would have been different, if you recall the vote was a denial 8 to 5 . As for Hemispherx making public comments, it is a catch 22. If they discuss Ampligen openly, they can be fined, if FDA decides the company is somehow promoting Ampligen. Hemispherx and the FDA need to determine how to move forward for the patients best interest.

    4th, Making a new contact at the White House is like starting over from the very begining. It takes time and lots of energy. But we are working on it.

    Hope this helps,
    Thanks for your interest,
    Bob Miller
  4. SpecialK82

    SpecialK82 Senior Member

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    Thank you Bob for clarification on this call to action, I will be sure to send a letter. Can we push for anything on the drug re-purposing front at the same time? I would think even getting a couple sleep meds or anti-seizure meds like Klonopin approved for ME/CFS would help establish this illness to disbelieving physicians.

    Sorry to hear that a new White House contact is starting from stratch - that's very dissappointing.
  5. SpecialK82

    SpecialK82 Senior Member

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    Hmmm..... I just read Jennie Spolita's blog today and she is suggesting some issues with the content of the letter. . http://www.occupycfs.com/

    Are there any comments from the patient advocate letter-writers? Just trying to understand how we can best make a difference.

    Thanks!
    Firestormm and Nielk like this.
  6. Firestormm

    Firestormm Guest

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    You might also like to have a read of Nielk's review of the FDA Drug Development meeting, which featured Melissa Robb from the FDA. She spoke about the pathways to approval and about the 'serious' status afforded ME.

    The article can be read here of course. Thanks for drawing attention to Jenny's article I hadn't seen that since Cort's blog was posted.
    SpecialK82 likes this.
  7. Nielk

    Nielk

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    I really wish the "FDA team" would have consulted with Jennie Spotila before taking any action. We are lucky in that we have her designated by the FDA as a patient FDA representative. With her guidance, we might have come up with a more effective and accurate response.

    I share the frustrations of others with the inactions or passed mis-actions of the FDA but, we have to be smart in the way that we proceed. Even though many feel that the FDA meeting has fallen short, I feel that a lot has been accomplished. It seems that they are finally understanding the severity and the unmet need of this illness.

    As Melissa Rob explained, there are different avenues for a drug to get approval from the FDA in an easier and faster way. She went into detail as to how these reviews need to be submitted. “the goal is to expedite the review process and get the drug to market quicker.”

    To be honest, besides Ampligen which I agree has been a disaster, there has not been any other drug to come up for review at the FDA for treatment of ME/CFS.

    The challenge is more to the pharmaceutical companies to come up with possible treatments. Is it a function of the FDA to attract pharmaceuticals to initiate interest?


    WillowJ and Firestormm like this.
  8. WillowJ

    WillowJ Senior Member

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    (sorry about the bright blue text. I had to change the grey to see it once I'd quoted it.)

    I think it is the job of all the relevant federal agencies, because the situation we are in now comes from their past failures. So they should take some initiative to fix things. But practically, I am not sure what else FDA can do just at the moment. Putting us on the list of diseases having Stakeholder Meetings immediately (in the pilot program) was big. I do not know if they write white papers or anything like that.

    The document they are making from the meeting should help because then we won't have to start all over from scratch every time there is a new meeting or a new change in personnel (as we do at CFSAC). And it will be another reference, another official government document that should end up saying, hey, this is serious. Also it should include scientific info like tests that can be run and some of which are potential biomarkers and clinical trials endpoints. Which should interest pharma.

    Maybe one thing we can ask is that they make a press release when they publish it.

    I think another thing we could ask for is that they bring in experts to educate the Arthritis Review Panel. Dr. Enlander, Dr. Klimas, Dr. Fletcher, Dr. Chia, Dr. Montoya, Dr. Kogelnik, Staci Stevens and Dr. Snell, Kathy and Alan Light, Dr. Jason, and so forth. Possibly, as they are doing that make a conference DVD from this and turn it into a CME for physicians.

    So this way next time Ampligen or anything else comes before the panel, they will know the benefit:risk decision should look like a benefit:risk decision for myasthenia gravis, not for skin tags.
    Mark and SpecialK82 like this.
  9. Firestormm

    Firestormm Guest

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    Not sure if this was a rhetorical question, Nielk; but I think the FDA are doing what they can to make research and investment in this area i.e. our condition - as attractive as possible to pharma. Hell, they are doing far more now than they have done in the past. And yeah, it might not be enough - or attracting pharma fast enough - for some people; but darn having helped with that aspect of the conference: seeing how ME has been raised in terms of profile etc. I'd say they are proceeding in the right direction.

    My concern when Health Rising published that letter - and with the letter itself - was really that 'we' didn't have our good intentions and frustrations misinterpreted as, well, what Jennie says in her article. Although she's done it far more knowledgeably that I could have hoped to. Seemed to me, my concern, was that we've just had a two-day FDA conference and barely have the transcripts been published and we're already kicking over the ant-hill.

    The FDA can't 'force' pharma to get involved and no matter what some people think - based on personal experience - of Ampligen; the FDA can't approve it because they are told to. The same will apply to Rituximab for that matter. I know we want action now - but I was uncomfortable with that letter. And as Jennie has highlighted - we surely need to be correct in what is said as well as giving some care towards how we say it and how what is said can be perceived by those who at the end of the day, are trying to help.

    As an aside - perhaps - I was chillin' last night watching a favourite movie of mine, The American President with Michael Douglas and Annette Benning (am such a romantic softy at heart :)) - anyway; he says something about 'politics being perception' and I think it's true and worth bearing in mind. Not that they haven't or didn't - but the perception now being discussed is perhaps not the perception intended by the authors? Anyway...
    Nielk likes this.
  10. Nielk

    Nielk

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    Jennie Spotila, the ME/CFS patient representative at FDA explains in her article the importance of having the FDA produce A Guidance Report.

    This guidance to industry was proposed by a few people at the FDA meeting in April.

    I am concerned that the letter drafted in this thread does not give the FDA any positive feedback for what they have done for us at their meeting in April. It is true that in the past, they have had a horrible record with us (Ampligen) but, they seem to be changing and we need to acknowledge that. Change does not happen overnight. (even if we wanted this for the past 20 years)
    WillowJ and SpecialK82 like this.
  11. SpecialK82

    SpecialK82 Senior Member

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    I completely agree. The FDA has really stepped up to the plate recently, and I think that we should always praise the accomplishments in our correspondence so that we come across as reasonable and logical. We let the other agencies know that the FDA has raised the bar at the past CFSAC meeting, hoping that they too will step up.

    And of course the FDA could do more, there always should be some pressure on forward movement. The patient advocates who wrote this letter apparently have been in contact with (or had meetings with??) the FDA after the Stakeholders meeting. It's very difficult for those of us on the outside of those conversations to make heads or tails of what is really going on without understanding what has been discussed.

    Again, I'm hoping that one of the letter-writers might enlighten us a bit if possible......
  12. JohnnyD

    JohnnyD Senior Member

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    Two of the letter writers, Cort Johnson and Bob Miller, are having a constructive dialog with Jennie on Jennie's site... in the Comments section. If you are having trouble getting on Jennie's blog I've found entering the url as: "occupycfs.com" and not "www.occupycfs.com" helps, for some reason.
    SpecialK82 likes this.
  13. Nielk

    Nielk

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    Since we, ME/CFS patients, have been asked to write (copy) the above letter and to send it out to members of the government, I wish they would take the time to explain the background of this letter.

    Bob says that he has been working with the FDA for the past two years. I wish he would tell us what has been going on and where we are standing.

    I appreciate all the work that patient advocates like Bob have been doing in our behalf. I just can't follow blindly, without truly understanding what the issues are.
  14. WillowJ

    WillowJ Senior Member

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    I agree with this. I thought there were a lot of positive things to come out of the meeting and my sense is that most patients have been surprised but pleased about how things went. Plus, as has been mentioned, there are still outcomes pending.

    Of course we need everything yesterday, last year, 30 years ago. But we can't change the past: we can only go on from here. Government agencies have limits to how speedy they can be. They cannot give us a drug overnight.

    And for once, somebody in the government is doing something right. We should acknowledge this.

    And then suggest some specific stuff for what's next, to make sure they keep moving forward and remember the urgency of our situation.
    Valentijn likes this.
  15. WillowJ

    WillowJ Senior Member

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    what I forgot to say the other day is that the Millers have been putting a lot of effort into moving things forward and this is very much appreciated!
    Nielk likes this.

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