arrow19 Comments
  1. Cort Johnson
    Mar 07 - 8:13 am

    Dr Peterson has not been invited? Besides Ampligen he has more experience with antivirals than anyone (except for Dr. Lerner) and he treats a more distinct population which has NK cell dysfunction…That’s unbelievable….

  2. Lars
    Mar 07 - 10:18 am

    Bob,
    Support you a 100%, but I do think it is a strategic mistake to focus solely on Ampligen, as it is highly unlikely that the FDA will reverse its ruling. The hope lies in applying pressure for new federally funded RCT´s of promising drugs

  3. Anita
    Mar 07 - 10:47 am

    It is not about Ampligen only, but the truth of the matter is that Ampligen is a good starting place for A DRUG OF ANY KIND to be approved for ME/CFS. There are no other drugs in the pipeline for any of us. The year that AZT was approved, there were NINE other drugs approved that same years BECAUSE of the fact that having even one drug approved for a disease makes other pharmaceutical companies take notice and start TRYING to find other therapies. Sure there are only a few people on Ampligen right now, but that subset can be used to teach the FDA why and how it works. This is an *opportunity* to stand up and fight for treatments as patients with this horrible disease. it’s time!

  4. Caroline
    Mar 07 - 10:54 am

    I have similar feelings. No question a progress with Ampligen is crucial. But at the same time there are other drugs like e.g. Rituxan which look very promising but lack funding for clinical trials. The OMI for example is still trying to raise funds for a Rituxan trial, this could be supported by the government / FDA and be promoted at the workshop as well.

    Despite of that I appreciate the advocacy of you, Bob, very, very much – thank you for doing all this for the community!! Will send an e-mail, thanks for the template.

  5. Enid
    Mar 07 - 2:12 pm

    Nothing approved for ME/CFS yet – why not – it’s been going on long enough. Best wishes Bob in your hard fight.

  6. Gregory G Cutler DVM
    Mar 07 - 3:06 pm

    While I will write emails and attempt to make phone calls I think it would be equally important to try to get our respective representatives to put pressure on those involved in the “workshop” to actually make progress in the production of drug development for our disease.
    I think it would be important to first find out what/who are their criteria for inclusion in the workshop. If they feel they have already dealt with the Ampligen issue beyond their necessary scientific evaluation (and I believe that’s the case) then why waste precious time beating a dead horse? They have put the ball back in Biospherx’s court to do due diligence- it’s now their job!
    I think it’s important to have some but not too much patient representation and maybe Robert and one other would be great!
    I could debate using Dr. Petersen as again we’re getting involved with the whole Ampligen issue which I think may not be anything but a spring board and not a main issue of this meeting. An argument could very easily be made for Dr. Klimas as she is much more Academic and surely knows how to work the system and get NIH grants etc.,. She would be my first pick and I have no experience with either.
    I think this whole Workshop could be a tremendous opportunity but needs to be pressured heavily!

    Greg

  7. Celeste Cooper
    Mar 07 - 3:31 pm

    I used Bob’s letter with such valuable information. Changed it around a bit so if they only read the first sentence of each paragraph it will say something different. I have posted it in my FB notes, and sent it of course.

    The response from the HHS was the usual, nothing like the one Senator Reid got, but I think Bob is sure proof that persistence counts. It only takes a minute. I hope everyone will follow through.

    TY again for all you do to spread the word. In healing and hope, Celeste

  8. Kristina
    Mar 07 - 5:34 pm

    So who has been invited to the workshop? Maybe we need to find that out.

  9. Bob Miller
    Mar 07 - 8:44 pm

    Kristina,

    FDA is not telling anyone who they are inviting or even what the agenda is. They claimed this would be a transparent process and that patients would have input. We have heard of patients already being invited to be representatives, over a week ago, so much for transparency and the same with clinicians.

    As for this meeting, it was to be on treatments and drug development. So does it not make sense to have the top ME/CFS treating experts in the same room at the same time??? FDA will say as NIH has, we want new blood, well the new blood leaves when their funding dries up…And our experts remain…They are truly committed…

    We shall see what FDA offers up come April.But for now they should hear from the patients…

    Thanks to All,

    Bob Miller

    • Kristina
      Mar 08 - 1:40 pm

      Thanks for the reply Bob. I’m just wondering here….. as I understand both Hemispherx and the FDA said that they would be open to meeting together and working towards getting Ampligen through the approval process. And that meeting should absolutely happen.

      Would the time at the FDA Stakeholder meeting be better spent then on other more general topics that will of course include Ampligen but also other drugs, the approval process in general, setting up new subcommittees to meet more regularly and so on?

      Always appreciate what you do for the patient population!

  10. Mark Hansen
    Mar 08 - 11:21 am

    What if there is not and never will be a “drug” to treat ME / CFS with? That is, what if what is required is a stress free environment, a massive dietary change, a tailored nutritional therapy and substantial lifestyle changes? If the ANS (autonomic nervous system) is at the root of this, it would seem that such an approach would seem more likely to have comprehensive long term benefit than just dealing with separate pieces of the puzzle…immune, gut, POTS…etc. Treating the genesis of all of our symptoms will be the only reasonable approach, as opposed to masking the individual symptoms.

  11. Roland
    Mar 10 - 2:05 pm

    That the FDA is not inviting Bob and Dr. Peterson clearly shows that up to highest levels the FDA is not willing to listen to and work with the patients. And this despite all the emails, phone calls, petition, testimonies, hunger strike and intervention by senator Reid.

    Of course we need to do another email action and it will probably force them to invite Bob and Dr. Peterson but it will not change their attitude and without a change in attitude there will be no willingness to approve Ampligen and to do other important steps. The stakeholder meeting in April, the stakeholder conference call in September 2012 and all the CFSACs are just there to pretend as if they would care – but they do not care.

    So one question is what is their motivation for not wanting to help us? Approving Ampligen would make heroes out of the FDA, they could proudly say that they are doing all to help patients. But now they are rightfully accused that they do not want the patients to get better.

    And the next question is how can we achieve that the highest levels are changing their policy with real actions and not just with planning another meeting. How can we achieve real big public and political pressure on the FDA. A few articles on local TV and newspapers, emails or a meeting of senator Reid with Sebelius is obviously not enough.

    The opinion was posted that Ampligen should not be a major topic of the meeting because the FDA will not reverse their decision. But all possible drugs will face the same difficulties as Ampligen is facing. No drug will meet FDA’s current expectation on safety and efficacy because CFS is such a complex disease and because of the difficulties in enrollment criteria and endpoints. Therefore the Ampligen data has to be used to discuss this. For example Hemispherx stated that FDA’s analysis resulted in a p-value of 0,1. One outcome of the meeting must be whether this p-value is acceptable for the only drug for CFS.

  12. Deborah Ann
    Mar 11 - 6:38 pm

    I cannot get email to Seblius anymore. >>>>>

    “Sorry, we were unable to deliver your message to the following address.

    :
    Remote host said: 550 #5.1.0 Address rejected. [RCPT_TO] ”

    ( what does this mean?) I keep trying to email her and I get the above response.
    Other email recipients designated in the header…are they meeting their intended designation?

    Ampligen team? You getting my daily emails?

    Anyone else feeling ‘rejected’?

    “MAILER-DAEMON@yahoo.com”

  13. Bob Miller
    Mar 11 - 6:51 pm

    Deborah Ann, checking this now, I have not had trouble, nor has anyone else told me this.

    Bob Miller

  14. Deborah Ann
    Mar 11 - 6:54 pm

    Ok, after 3 DAYS OF DAEMONS, I now have a ty from her in my inbox. Must be that Sebelius fans are ..swamping the servers.

    • Bob Miller
      Mar 11 - 6:57 pm

      That is a Good Thing!!! Thanks to all sending the Emails, as of this afternoon, No invitation had been sent.

      Bob Miller

  15. Deborah Ann
    Mar 11 - 6:55 pm

    ty Bob; might be just my problem ~ hopefully resolved

  16. Linda Bright
    Mar 12 - 4:52 pm

    If we do get envited, Please suggest having in a hotel with conference room to cutdown on the walking distance and the chaos of bus pick- up, waiting for, be dropped off at the wrong. Ect. The timing of patient attendance must be planned with our patient disabilities in mind. I attended the last NIH meeting beginning at 0800 and ending at 430p. X 3 days. I was in remission when I arrived and in total collapse by the end. I could probably attend every afternoon, but not three days in a row. I volunteer my time to work with the program planner by phone to plan a conference PWCFS can gain the most from without causing a crash an relapse for the patients. NIH is not a good place forMe/CFS patients to tackle.

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