Invest in ME Conference 12: First Class in Every Way
OverTheHills wraps up our series of articles on this year's 12th Invest in ME International Conference (IIMEC12) in London with some reflections on her experience as a patient attending the conference for the first time.
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FDA To Discuss NADH for ME/CFS at May 8 Meeting

Discussion in 'General ME/CFS News' started by Gemini, May 8, 2017.

  1. Gemini

    Gemini Senior Member

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  2. Gemini

    Gemini Senior Member

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    May 8-9, 2017 Meeting of the Pharmacy Compounding Advisory Committee (PCAC) - Webcast Information

    The Center for Drug Evaluation and Research (CDER) plans to provide a free of charge, live webcast of the May 8-9, 2017, meeting of the Pharmacy Compounding Advisory Committee.

    The webcast will not display until the meeting begins at approximately 8:30 a.m. EST on May 8-9, 2017.

    Webcasts of advisory committee meetings provided by CDER have limited capacity. Once capacity of the webcast is reached, no additional individuals will have access to the webcast unless others have exited the webcast. If an individual signs off from the webcast, CDER cannot guarantee that this person will be able to sign back on if capacity has been reached.

    The meeting webcast can be accessed at the following web address:

    https://collaboration.fda.gov/pcac0517/

    Note: At the access page, please sign in as a guest. No password is required.
     
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  3. keenly

    keenly Senior Member

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    NOT good news.

    FDA is owned by Big Pharma. They need to stay away.
     
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  4. RogerBlack

    RogerBlack Senior Member

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    My understanding is that this would make it possible for licenced pharmacists to use NADH in pills they make.
    It doesn't have any other regulatory impact - is this correct?

    https://www.fda.gov/AdvisoryCommitt...acyCompoundingAdvisoryCommittee/ucm553365.htm - page 54 'the agency is against including NADH on the list'. (for several reasons including lack of proven efficacy and chemical instability if you simply add it to a capsule along with other stuff)

    There is also a proposal for Q10, which is similarly recommended against.
     
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  5. Skippa

    Skippa Anti-BS

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    Should I go and buy some NADH? CAN I go and buy some NADH?
     
  6. RogerBlack

    RogerBlack Senior Member

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    My understanding (please correct me if I'm wrong) is that this has precisely zero effect on anyones practices at the moment.
    It does not prohibit supplements with the compound in question.
    It doesn't do anything to change clinical trials, or the approval for them.

    It means that if a doctor wanted to prescribe (for example) NADH+Q10+Kryptonite in one pill, they could ask their compounding pharmacy to make some up, and they could, without issue.

    At the moment, the compounding pharmacy cannot do this, and the patient would need to take them in separate pills. (or pills found as supplements)
    http://www.pccarx.com/what-is-compounding
     
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  7. Gemini

    Gemini Senior Member

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    Some of my takeaways from the meeting's one-hour "NADH for ME/CFS" segment:

    The Advisory Committee's decision does not impact the ability to make/buy NADH supplements.

    Fagron, a pharmaceutical compounding company, put forth the proposal.

    The Advisory Committee, in an unanimous 9-0 vote, upheld the FDA's position against the proposal.

    Cited reasons for the rejection-- more studies of the use of NADH in ME/CFS are needed along with more information about its safety and stability.

    CDC's Dr. Unger, a member of the Committee, pointed out that some ME/CFS clinicians are currently using NADH in
    conjunction with other supplements.
     
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  8. HowToEscape?

    HowToEscape? Senior Member

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    Sure, I'd rather buy my stuff from scam artists who have 27 different company names used to package 'health and nutrition supplements' made from bulk supplies sourced from China.

    How about some Ayurvedic magic meds with natural Earth sourced lead? Ayurevedic lead is good for you, it has polarizing energy. Or maybe a Hulda Clark Zapper. That cures everything, but teh evil FDA doesn't want you to know!!!!
     
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  9. RogerBlack

    RogerBlack Senior Member

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    Quite.
    https://www.alibaba.com/product-detail/high-quality-natural-fermentation-coenzyme-q10_524398846.html - as one example.
    This is one kilogram of Q10.
    Compared with https://www.naturesbest.co.uk/co-q10-200mg-p730/

    $300/kg, vs $1200/kg.
    The tests in the first one appear legit, and if they are performed on every batch, with attention to what the impurities actually are, are a reasonable first step. How many US based small companies will verify those tests, when doing that costs several hundred dollars.
    How many might go to a cheaper supplier offering 'cosmetic grade'.

    Are the impurities harmless antioxidants, or fungal toxins from improperly treated and monitored bioreactor contamination.

    The unregulated supplements industry is great, in that it can provide access to things that are simply unavailable conventionally.
    But it's got major issues.
     
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