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Dec 20th: High Noon for Ampligen! FDA Advisory Committee Decides Ampligens fate in live webcast

Discussion in 'General ME/CFS News' started by Cort, Dec 18, 2012.

  1. Nielk

    Nielk

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    As far as #2, I would think that Hemispherx who have had so much at stake, would have done this. My only thought is that they could not find any definitive markers to identify the responders.
  2. heapsreal

    heapsreal iherb 10% discount code OPA989,

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    I think they also need to push approval of antivirals for cfs/me, they have a good idea on how to subgroup these patients. They are already indicated for other illnesses just need to add cfs/me with high viral titres etc.

    These are the things that could stimulate more research into cfs/me. Maybe then big pharma might put more money into ampligen, we just need a spark to get things going?
    justinreilly, taniaaust1 and AFCFS like this.
  3. AFCFS

    AFCFS Senior Member

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    Agreed. I hate to be a wet blanket, but I just see too much the attempts at political maneuvering and a grab at cash. The disease and people seem secondary, and likely exploited. This is not any different than Big Pharma would do, I think in this case with a Little Pharma it was just more exposed. If it were Eli Lilly, it would probably be available in sample packs by now.
    xchocoholic, a2mandel and heapsreal like this.
  4. Hope123

    Hope123 Senior Member

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    Possible, but never assume and we may never know what actually happened. Sometimes the simplest things and idea get lost in the shuffle. Also, from a drug company point of view, the more people they can get the drug approved for (rather than a subgroup), the more $$$ they can make. Drug companies play an important role in medicine but I never underestimate either the depths to which they are willing to go to earn $$$.
    beaker and jimells like this.
  5. Sasha

    Sasha Fine, thank you

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    Under normal circumstances I'd agree with that and that would be the FDA's remit but my understanding was that they would apply less stringent criteria (particularly on efficacy rather than safety) in the case of a serious disease with such spectacular unmet need. I thought the whole point of this 'orphan disease' category was to be realistic about a situation in which a disease has received so little funding that there isn't as much good-quality info to go on and patients are so desperately sick that it should be their choice whether to take a drug.

    Given that the FDA have, over the years, shown themselves so unhappy with the data provided by Hemispherx, I was disappointed that they wouldn't accept evidence from clinicians who've been using Ampligen. RCTs are only important for showing efficacy [as opposed to effect size or other variables] when a clinical effect is too small to detect otherwise and if clinicians have been successful in identifying responsive subgroups and seeing rapid restoration to health of previously very sick, long-term patients in large proportions of those that they treat, that's data that should be taken into account.
    justinreilly, Nielk and a2mandel like this.
  6. Firestormm

    Firestormm Senior Member

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    Just catching up this morning. You got any links to the news stories Urban? Commentary is a bit light on the ground and I'm not paying for WSJ subscription :)

    This would perhaps explain the reaction from the market to the review published earlier this week at least in part. That review was not well received - and back in the Summer - when the price was rising on the hype - Hemispherex were selling their own stock (if memory serves). We were talking about it then. Didn't look good for a company who were saying how confident they were.

    Edit: Did you mean the Street article posted prior to the meeting, perchance? Looks like you might.

  7. heapsreal

    heapsreal iherb 10% discount code OPA989,

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    if amp doesnt get approved does that mean that people wont have access to it under current arrangements, whatever that expensive arrangement is called??
  8. Firestormm

    Firestormm Senior Member

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    Well they were prior to this meeting Heaps. So unless the FDA remove it's experimental/testing status from Ampligen, I can't see why not. Not that I know very much of course.
    heapsreal likes this.
  9. Firestormm

    Firestormm Senior Member

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    Medpage: 20 December 2012: FDA Panel Nixes Hemispherex CFS Drug: http://www.medpagetoday.com/PrimaryCare/SleepDisorders/36569

  10. Firestormm

    Firestormm Senior Member

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    Wall Street Journal. Full article kindly reproduced: http://www.mecfsforums.com/index.php/topic,14500.0/topicseen.html
    Thanks Wildaisy :)
  11. a2mandel

    a2mandel

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    I feel the same way. I am an ampligen patient and the impression all of us had at the site where we infuse (both staff and patients) was that the FDA had agreed that the older data was sufficient
  12. Firestormm

    Firestormm Senior Member

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    Hi Amandel,

    I might be wrong here, but I don't think we heard from the FDA prior to their briefing document published on Tuesday ahead of the meeting; indeed the only positive noises we really heard were from the company and positive analysts.

    It might be that the FDA meeting in February will scale-back their previous demands for a new Trial. It might be that the Advisory committee positives will mean that Ampligen is not taken off the board. I don't think this marks the end. I think HEB will have to look for 'sponsors'/partners and be prepared to open-up and share any future financial benefits.

    That said, they raised $9million in the Summer from sales of their own shares. Quite whether this means they now have a better balance sheet I couldn't possibly say - but HEB have not (yet) said if they are now able to complete a Trial as was previously requested. Maybe they will be able to with this extra cash.

    Rehashing/interpreting old data is not wrong (apparently). What might be considered wrong is the inference in that article above from The Street that HEB knew the FDA were not as happy with things as they led people to believe (or they did not seek to correct the impression of investors and benefitted financially from it). If there is an investigation (I doubt there will be) this could also have an effect.

    It will be interesting (vital) to hear from HEB about what their future plans will be now. Should get more comment later today when America properly wakes up I guess.
  13. Nielk

    Nielk

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    The FDA's final decision has not come down yet. They have till February to decide. They take this decision from the panel into account but, they make their own decision. I have been speaking to someone who is knowledgeable about the FDA procedures and it seems that there are rare occasions when the FDA goes against the advisory panel's decision. Especially when the vote is pretty close. They also look at who voted in what way.
    I don't believe that this will be the case with Ampligen. I think that it's pretty clear that the FDA is not ready to approve it but, it is not over till the fat lady sings...
    justinreilly and Sasha like this.
  14. Firestormm

    Firestormm Senior Member

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    http://blogs.nature.com/news/2012/12/panel-rejects-experimental-chronic-fatigue-syndrome-drug.html
  15. Valentijn

    Valentijn Activity Level: 3

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    Did they show the final tally of votes? How many for and against?
  16. Firestormm

    Firestormm Senior Member

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    WSJ said 8 to 5 against, and Nature above - said 9 to 4 against. Go figure! :) Maybe different votes? I don't know.
  17. xchocoholic

    xchocoholic Senior Member

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    Sorry, I haven't been following this but I have a couple of questions. So far all I've heard is that they don't know why
    Ampligen helps.

    Can you tell me if any of the markers discussed as prevalent in cfs by
    the people who gave these lectures to the fda were tested for by the manufacturers of Ampligen ?

    If so, which markers were positively affected by ampligen ? Which markers were negatively affected ?

    And what marker are used to determine who will benefit from ampligen ?

    And can they explain why these markers were altered by ampligen ?

    Tx .. X
  18. justinreilly

    justinreilly Stop the IoM & P2P! Adopt CCC!

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    If I understand this right, HEB re analyzed the data from its two placebo controlled studdies. They took out everyone who was sick over ten years and on this group, under 10 yrs, the drug was effective but the p value was 0.10 which is deemed not statistically significant, bc it's over 0.5.

    But then there are questions about safety that I wasn't aware of until recently. There is a piece on the NCF site by a patient who says she was in a trial and she and several others dropped out bc of adverse effects, but that they weren't counted as having adverse effects, just shown as being dropouts. The patients says she is still worse than when she started Ampligen 10 years ago.

    http://www.ncf-net.org/forum/2011fall2.htm

    She also talks about HEB threatening to sue CAA if it continued to survey patients who took Ampligen. CAA destroyed the survey documents. This sounds shady to me on the part of HEB.

    Here's another article from the NCF newsletter with quoted letters from a couple of other patients saying similar things about safety.

    http://www.ncf-net.org/forum/ampligeninPink.htm

    The FDA briefing paper and some of the comments of the committee members indicated that HEB hadn't shown safety and had failed to disclose and factor in some instances of adverse events.

    If HEB hasn't really shown safety, then I am less enthusiastic about Ampligen, especially for myself having been sick for 11 years.

    what do you guys think about the safety issue?
    beaker, Hope123 and Valentijn like this.
  19. Nielk

    Nielk

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    I think that the fact that Ampligen could do irreparable damage is very alarming, if true.
  20. john66

    john66 Senior Member

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    I just want to weigh in here from the perspective of the job I used to have selling packaging to the pharma industry. It seemed like a lot of the drugs for AIDS were fast tracked, and lots of the normal and routine data were not given as close scrutiny as other drugs for other diseases. In my local CFS group, we have touched on this. I was hoping this would get approved, not only for helping people, but for putting CFS/ME on the map such as Fibromyalgia drugs like Lyrica did. I'm sure all of this has been said, but I can not help but feel an overwhelming sense of disappointment.
    Wildcat, justinreilly, Nielk and 2 others like this.

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