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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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    That part is a bit hard to understand for me too. It's evident that the FDA has made a serious new commitment to ME/CFS in this past year, and that they've allowed Ampligen to advance to the point of having an advisory panel review, which is farther than it's ever gotten before. Maybe they wanted to show due diligence in allowing Ampligen an open hearing by the independent experts, even if they kinda suspected what the outcome was going to be. If nothing else, this hearing aired the important issues for the pharma community - the FDA is expressing that they DO feel a sense of urgency about the need to find treatments, and would welcome other sponsors to come forward - Unger said this at the end, in so many words.
     
  2. dannybex

    dannybex Senior Member

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    I too blame Hemispherx and not the FDA. I think Carter and Co assumed that the FDA may have been willing to look at their "new" (old) data, and they were, but they never did the larger and longer study that the FDA requested THREE years ago.
     
    justinreilly, Firestormm and beaker like this.
  3. urbantravels

    urbantravels disjecta membra

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    Yes, this is an independent panel that is formed to make recommendations to the FDA based on an independent review of the evidence. The recommendations are not binding on the FDA, although I do think they are followed in the vast majority of cases.

    Notoriously, there was an FDA review panel in 2009 that called for Vicodin and Percocet to be taken off the market - banned completely - along with other drugs in their class (narcotic pain relievers that also contain acetaminophen.) The reasoning was that acetaminophen can easily cause liver toxicity, so you don't want to routinely throw it in with another drug when it's not necessarily needed.

    However, for some reason the FDA never acted on this recommendation, and Vicodin and Percocet remain on the market. Could have something to do with the enormous market share and profitability of Vicodin...
     
    justinreilly likes this.
  4. SOC

    SOC Senior Member

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    So is the upshot here that no smallish pharmaceutical company is going to get a significant drug past the FDA and we have to get big pharma interested? Heck, that will only take another 10-20 years. :rolleyes:
     
    a2mandel likes this.
  5. Dolphin

    Dolphin Senior Member

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    In the mid-2000s, I heard* that the makers of Imunovir/Isoprinosine started planning a multi-site study of the drug in the US. Then the NICE guidelines came out recommending CBT and GET and this changed their minds against spending all the $ required on a trial.:(

    * Can't remember where I read/heard the latter part but know the trial had been planned.
     
  6. heapsreal

    heapsreal iherb 10% discount code OPA989,

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    Probably have a better chance then ampligen as it already has a good safety profile and its effects can be monitored through Nk function testing and should be alot cheaper and easier to administer then ampligen??
     
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  7. snowathlete

    snowathlete

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    Although I am disappointed, in fairness to the FDA, Hemispherx Biopharma didn't do a good job with their trials and data. It simply was not good enough and the panel clearly were not confident that they could rely on the data being correct. So although I would be happy, as a patient, taking a risk to take this drug, I can understand why a member of the panel without the disease, even after hearing the moving testimonies they heard, didn’t feel able to vote Yes on the drugs approval.

    On a positive note, the message, if true, is that the FDA are keen to find and approve drugs for ME/CFS. The impression I got was that they would even do this if a drug doesn't even look that good, or even that safe, but they need to know where they stand with those facts based on good trials and reliable data. This is the good news.

    I hope this encourages drugs companies to invest in developing drugs for the illness, but my guess is that there just aren't any others even close to be ready, if they even exist at all. The best chance would seem to come from Rituximab, but even a promising drug like that can't get enough funding for trials (that may be to do with patent stuff, I'm not really clear on that, but have read its run out / running out).

    The thing is if you're a drugs company, it's not easy to develop a drug when you don't know the cause of the illness, and when there are sub groupings that you can't tie down. Your starting point is not good because you have to develop a drug that works so well that it is seen to work even when the results are negatively skewed by some subgroups not responding.

    Our best hope still looks to be discovering the pathogenic cause(s) and/or developing solid tests for the disease. Once that is in place, I can see drugs companies investing a lot in developing drugs for the disease, but until then...
     
  8. urbantravels

    urbantravels disjecta membra

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    According to some reports in the financial press, Hemispherx misrepresented the likelihood of Ampligen getting approved in this review, by not disclosing to investors and the public back in June that the FDA had allowed the review based on re-analysis of previous studies, but only while cautioning that "It would be unusual for this type of data to provide adequate evidence of efficacy." The full language of the FDA's message apparently wasn't disclosed until this week's release of background information, and before that HEB was supposedly over-hyping the possibility of approval.
     
  9. Dolphin

    Dolphin Senior Member

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    Yes. Unfortunately drug company is relatively small also, like HEB.
     
  10. heapsreal

    heapsreal iherb 10% discount code OPA989,

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    we just need something to get approved to open the flood gates on other treatments. I dont think immunovir is a 'cure' but it would help certain sub groups and maybe other similar drugs could be approved like interferons used in MS. Maybe we need to support something that is easier to get approved??
     
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  11. user9876

    user9876 Senior Member

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    Has anyone carried out a detailed look at the immune system of those who respond. For example looking at the different types of b cells such as the study that found high numbers of nieve and transitional b cells. Or looking in detail at the NK cells based on the work in Australia.
     
  12. Dolphin

    Dolphin Senior Member

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    I think this study shows an interesting effect, or side effect, of a drug becoming available for CFS

     
    justinreilly and taniaaust1 like this.
  13. jimells

    jimells Senior Member

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    I recall this. Of course, they couldn't possibly recommend simply removing the acetaminophen, because that would've put the drugs in a different class of narcotics, and made these Evil Pain Pills even *more* evil. As I understand it, the main purpose of the acetaminophen is to 'denature' the narcotic by making it dangerous to crush then snort or inject the drug.

    I am feeling particularly bitter today about the way chronic pain patients are left untreated due to the fact that this is the fourth day of an unrelenting migraine attack, and I have zero access to any medication that might help, even though many such drugs are in stock at the pharmacy 12 miles away. :ill:
     
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  14. urbantravels

    urbantravels disjecta membra

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    I was never real clear about why they couldn't just formulate a narcotic with ibuprofen or naproxen or something else that wasn't acetaminophen - could never find reliable info about whether there was some pharmaceutical reason why that wouldn't work.
     
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  15. heapsreal

    heapsreal iherb 10% discount code OPA989,

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    Thats what we would like to see done but again its about research dollars that our illness doesnt get. Im sure a group of us could put our heads together and come up with some good things to research in cfs but its all about dam money. klimas has shown that immunovir helps cfsers improve nk function but i suppose theres no money it approving immunovir??
     
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  16. waiting

    waiting Senior Member

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    So sorry to hear about your migraine, jimells. You've likely already thought of this but is here any chance they deliver? Sometimes they don't advertise this service and sometimes it's free if it's within a certain area.
     
  17. Hope123

    Hope123 Senior Member

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    1) People should not assume that the data that is availabel publicly is ALL the data that is available. FDA can request data from the drug companies but by business laws concerning confidentiality/ patents/ etc., neither FDA nor drug companies are required to release all information to the public. There have been some big scandals in recent years with drug companies witholding data on adverse effects, the drug being approved, and lots of patients being harmed. Some drugs have been pulled off the market or had a big warning label slapped on them because of this.

    As a healthcare professional, I used to get mailings almost every week from pharma about new side effects, indications, warnings, etc. These were from drug companies and required by FDA when something new came up.

    2) One thought is Hemispherix could have looked at who responded to Ampligen and then work backwards to see what, if any, of their blood tests were different from the people who did not respond. I believe they did a fair amount of bloodwork to screen who qualified for the drug initially and to rule out other causes of disease.

    3) An Immunovir study would likely be much les expensive than an Ampligen study. partly because the drug is orally taken, doesn't need a lot of safety monitoring (decades long good safety profile), and is not overly expensive ($100/ month US currently vs. $2,000 or more for Ampligen, not counting infusion cost).
     
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  18. lnester7

    lnester7 Seven

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    Why haven't we seen an study from Imunovir compny??? I am on it, happy so far. It could at least help some.
     
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  19. heapsreal

    heapsreal iherb 10% discount code OPA989,

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    hope,
    that just makes too much sense. All the patients seem to have too much sense lol
     
  20. Dolphin

    Dolphin Senior Member

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    Just did a quick search of some info I had. Here is a sample piece showing they were interested.

    https://listserv.nodak.edu/cgi-bin/wa.exe?A2=ind0410A&L=CO-CURE&P=R1802&I=-3

    Also


    https://listserv.nodak.edu/cgi-bin/wa.exe?A2=ind0511A&L=CO-CURE&P=R2&I=-3

     
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