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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. urbantravels

    urbantravels disjecta membra

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    Shades of PACE!
  2. urbantravels

    urbantravels disjecta membra

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    Justin, I've read the whole post at that link and I don't see any mention of patients dropping out due to adverse effects that weren't reported as such in the studies. Was that mentioned in some earlier post by the same person, perhaps?
  3. Hope123

    Hope123 Senior Member

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    I haven't read those links and the FDA briefing document is long. However, I skimmed some sections of the adverse effects chapters and the reviewers write exactly what concerns they had. FDA panel felt Hemispherix did not accurately count the number of people adversely affected nor rate the severity of their reaction accurately. There were definitely discrepancies.
    beaker likes this.
  4. Hope123

    Hope123 Senior Member

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    There were multiple questions put to the FDA panel. So it depends on which questions they're writing the vote about.

    Question by question and vote:
    http://news.yahoo.com/fda-advisory-committee-makes-recommendations-195759063.html

    The one person who did not vote was not an "abstainer"; this person was a designated non-voting member ahead of time so that the total number of voters was 13.
    Firestormm likes this.
  5. Hope123

    Hope123 Senior Member

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    If you go to the link "Ampligen in the Pink", it's there.

    justinreilly likes this.
  6. lnester7

    lnester7 Seven

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    All I can say is that I have heard EVERYTHING can send people worse than how they started, I read people from Imunovir, LDN, Mb12..... So in this disease is not unique to Ampligen, Everything we try can or get us worse, or same, or better.
    WillowJ, heapsreal, vli and 1 other person like this.
  7. Hope123

    Hope123 Senior Member

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    It is difficult to predict how any one individual will react to a drug since there are such things as idiosyncratic reactions and they include death. However, when I make a choice about what drug to take myself or, in prior work, give to someone else, I do rely on the probability of reaction by looking at how the drug has perform in groups of people. And a lot of people here do that as well.

    The safety data on Ampligen is based on 200-300 people tops and is spotty at that (unclear or ?deceptive reporting by the company, only following patients for a few months, etc.) whereas Immunovir has decades long safety data I believe in the thousands and similarly, LDN has been used in hundreds of thousands of people in higher doses than CFS for reversing the effects of opiods for a long time ( in fact, I've used it in this way on patients before) and in lower doses in other diseases as well. So although the data is not necessarily in people with CFS, I am more reassured about those medications than Ampligen.

    The prevalence and severity of side effects should also be noted. A 1% chance of a side effect is different than a 20% chance and being permanently worsened by a drug is different than having mild stomach issues for a few days.
    WillowJ, beaker, justinreilly and 2 others like this.
  8. Firestormm

    Firestormm Senior Member

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    Company Press Release:

    Nielk likes this.
  9. Firestormm

    Firestormm Senior Member

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    24 December 2012: Class Action Launched against HEB for non-disclosure:

    Nielk likes this.
  10. Nielk

    Nielk

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    Firestormm - Do you think that Hemispherx knowingly mislead the public?
  11. urbantravels

    urbantravels disjecta membra

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    It's interesting that the lawsuit (at least according to this report) does not reference the Dec 20 recommendation by the committee to reject Ampligen, but rather the release of all the damning pre-meeting information on Dec 18, which caused the stock price to plunge in advance of the committee meeting.

    The information released on Dec 18 continues to make me wonder: Why did the FDA let things advance to the stage of having the committee meeting if they already thought the information HEB was giving them was so bad, & thus probably thought the rejection would be a foregone conclusion? I suppose there is value in having everything brought out into the open in a public meeting; a lot about the disease and its burdens was aired to a (potentially) new audience, and the FDA got the chance to give assurances that they do consider the disease serious, and do want to work with drug sponsors, which is important for both patients and the drug companies to know. But I don't really understand enough about how the FDA works to do more than guess.
    Nielk likes this.
  12. CallieAndToby

    CallieAndToby Senior Member

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    I can't take immunovir or LDN b/c of violent reactions, so I'm pretty much screwed. I'm going downhill fast and have already spent months and months being bedridden.

    I know 5 people who were in the ampligen trials, all said it was hell the first 6-12 months, but all improved by 80%, one said his POTS disappeared, and one guy said his CFS went away. One of these people I speak of was completely bedridden for 15 years and now is able to work. Sucks we don't really have many treatment options. Imm. and LDN don't help everybody either so what are the rest of us supposed to do??
  13. CallieAndToby

    CallieAndToby Senior Member

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    I'd like to try antivirals, haven't been prescribed them yet but have no other options left. Would love to see more research into them yes. I feel like time is running out for people though, I have friends who have been sick for 20 years and they are completely bedridden and in such states of depression, how much more can they take?
  14. Firestormm

    Firestormm Senior Member

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    Probably not, Nielk. I don't think the company said as much as they could but then I haven't been following all the goings on as closely as some clearly have. This is what seems to be a bunch of investors suing the company presumably because they have either lost money or seen their 'faith' and investment value tumble. It does smack of 'double-dealing' when the company themselves capitalised on the speculation back in the Summer to raise $8million when the stock hit $1. That kind of thing never sits well with investors who have now seen the stock sit at around 0.27 cents but it's not illegal on the face of it. It's capitalism at it's 'finest' :)

    Was asking elsewhere just how serious this class action might be. I mean it's not like the SEC have gotten involved. So is it really all that serious? I don't know. I do know that America doesn't hold back from pursuing legal redress for, well, just about everything :) If something was 'withheld knowingly' then surely the regulator would be involved?

    What will come of this I don't know. Doesn't look to good for investors though. Which way with HEB go know? A new clinical trial? Will they use the money they raised? Or will that money be needed to settle this class action? Perhaps the details of the action will reveal the amount of damages they are seeking. But whether or not it will be successful - or is even reasonable and not 'sour grapes' - I really couldn't say at this point.
    Nielk likes this.
  15. WillowJ

    WillowJ Senior Member

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    because instead of potentially harming the liver, these drugs can potentially harm the kidneys. There is some kind of meme that Tylenol is the safest pain medicine but I have never understood the merit to it. However I haven't checked the adverse report figures.
  16. WillowJ

    WillowJ Senior Member

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    This is OT for this thread but I can answer that.

    Different meaning of 'market'. The comment that the markets don't like uncertainty isn't meant to refer to the stock market, much less short selling or selling on the margin. It's meant to refer to the market broadly, as in Adam Smith's market (everything that is for sale or trade everywhere) with the supply/demand stuff.

    This is the market where about half the businesses share comes from small businesses who by definition don't have (and probably aren't even thinking of) shares of stock; most of them are S corps and P corps (i.e. the are owned by a Single person/family, or by a Partnership of say, two or three persons [for example, siblings or close friends who launched a business together] and even some left still using their SSN for a TIN (Taxpayer Identification Number; i.e. they never incorporated or formed an LLC or any such at all, they are just Joe Bloe doing business as Joe's Towing)... they pay taxes at individual rates, I assume because they represent costs/risks borne by individuals; however the 'profits', if the business I used to work at was any indication of the norm, exist mostly on paper and any in liquid form are put back into the company in the form of bonuses, equipment costs, the next project, and the like, and yes, many do have employees; we aren't, by and large, talking about hobbyists, which collectively don't take up much market share). I don't know what percent of large businesses (which is where the C corps would be, which pay tax at the Corporate rate) are publicly traded.

    So for the 'don't like uncertainty' bit, this comment relates to companies with employees, for the most part, acting in stable ways, not about paper/electronic representations of shares being bought and sold in the most unstable ways available.

    In this case, yes, I agree, and this is my former job. Hiring or expanding is not going to happen when it's not known what the new rules and taxes are going to be. It's necessary to be able to predict. Because one has to plan ahead by years, to do anything. And one needs to know there's a good chance it can work. Otherwise one is putting at undue risk not only the resources (and good name) of one's self and one's own retirement and the care of one's family -- but also putting at undue risk the jobs and well-being of the people one employs. They would have put a lot of time and effort and often loyalty into the company. And it's not worth risking putting them out of work, just to try something that isn't well thought out. Or that there is a lack of information for. Certainly some companies do things that wreck the company and their employee's lives (temporarily, anyway--hopefully not permanently), and they get a lot of press. But I think it isn't the norm. Most companies would generally rather stick around--and keep people employed. So they'll usually wait until they hear what they need to know, to evaluate whether it's going to work or not.

    That's why not knowing things, or short-term/expiring tax cuts, etc., doesn't help the economy (or not much). Because anything that's temporary or unknown, cannot help the long-range planning.
    Little Bluestem and Marco like this.
  17. Nielk

    Nielk

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    From what I hear, it is not unusual for these litigation firms to sue publicly traded companies. This is pretty common here in the States. I also thought that what can they sue for already. Hemispherx doesn't seem to have money but I was told that companies have insurance for such things.
    Firestormm likes this.
  18. liquid sky

    liquid sky Senior Member

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    I know where you are coming from, Callie. I was hoping they would give some kind of provisional approval to Ampligen. It is obvious that it DOES help a subset of patients. They were there to testify. People are running out of options and out of time. This disease in its worst is sheer hell. Give the patients all the data and let them make a decision based on what they are experiencing. To just never approve anything in decades is brutal.
    CallieAndToby likes this.
  19. CallieAndToby

    CallieAndToby Senior Member

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    Exactly. Couldn't agree more. I feel really bad for the folks who have been sick 20+ years.
    WillowJ likes this.
  20. Firestormm

    Firestormm Senior Member

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    ahimsa and Nielk like this.

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