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San Francisco Bay Area Ampligen study (AMP 511) approved

Discussion in 'Active Clinical Studies' started by Doogle, Aug 11, 2012.

  1. Doogle

    Doogle Senior Member

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    The San Francisco Bay Area area practice of physician (Dr. Raj Patel) has been IRB approved and has started baseline testing patients for the FDA open label Ampligen treatment study protocol (AMP 511).. Dr. Patel stated Ampligen can be started within a few weeks after a patient's baseline test results are OKed by Hemispherx Biopharma. He is the only physician in the SF Bay Area presently approved to administer Ampiigen. Persons interested in participating in the treatment study at his office in Los Altos, CA, and have the resources to pay for the costs involved (see below), contact: Dr. Raj Patel.

    AMP 511 Cost-Recovery treatment protocol requirements are expensive:

    * The total cost of Ampligen to a participant is approximately $2,500/month.

    * Ampligen is administered from 200mg or 400mg vials. The cost of the Ampligen alone, at the maximum therapeutic dose of 400mg twice per week, is $2,400 per 8 weeks, and is rarely covered by medical insurance. Some patients may require the lesser 200mg dose which is less expensive.

    * IV Infusion costs, administrative costs, and testing are extra and estimated at $2,000 per 8 weeks and are generally not covered by insurance.

    * Dr. Patel estimates it will take 18 months for most patients to achieve the full therapeutic and stabilization effects of Ampligen, and they should plan for that timeframe.

    Hemispherx has published a new study on the beneficial effects of Ampligen. According to the Hunter-Hopkins Center, Ampligen an experimental drug manufactured by Hemispherx Biopharma, is an anti-viral and immune modulator used to treat CFS. In a 1990-1992 placebo controlled study, approximately 80% of 45 CFS patients improved, and 50% improved significantly. A similar study in Belgium reported similar results. Several hundred persons have been treated with Ampligen, and thousands of doses of have been administered safely. Patient experiences with Ampligen can be read at:
    http://ampligen-treatment.blogspot.com/2010/01/my-ampligen-treatment-begins.html
    http://www.cfids-me.org/marys/ampcoda.html
    http://www.cfids-me.org/aacfs/ampligen.html
    http://theglassmountain.wordpress.com/category/ampligen/
    https://docs.google.com/spreadsheet...FBkSHRPdkhZblRobzVWUTZUY3JGQ0E&hl=en_US#gid=0

    * Dr. Patel has five years experience administering Ampligen. He is a fee-for-service provider. Patients pay the office directly for services at the time services are rendered, and submit his/her own claims to insurance.

    * Before being enrolled in the treatment protocol, patients will be tested for biomarkers to determine the likely response to Ampligen.

    * After a patient is determined appropriate for the study, they must remit a $1,000 deposit to the physician, for paperwork to be started.

    * Patients withdrawing during the paperwork period will forfeit their deposit. Patients who continue will have the $1,000 applied to their cost of Ampligen administration.

    Ampligen has a controversial history, including refusal of the FDA to approve retail marketing of the drug due to efficacy questions. Some patients state they've become worse on the drug. However, Ampligen has been clearly beneficial for a subset of ME/CFS patients. Some of the clinical factors that may identify these patients are:

    * Acute Viral Onset
    * 2-5A Synthetase/RNase L Up Regulation
    * Depressed Natural Killer Cell Cytotoxicity
    * Persistent Herpes Virus Infections (EBV, HHV-6, CMV, etc)

    Ampligen often initially causes dose dependent flu-like symptoms that can be significant. This has contributed to patient reports of Ampligen's adverse effects. These are not the only health risks from Ampligen. Titrating the Ampligen dose may help minimize side effects. Ampligen is administered intravenously twice per week, so people with fragile veins may have difficulty with infusions. IV ports are sometimes installed.

    Ampligen is administered under an experimental drug treatment protocol, and may be discontinued at any time without penalty by the participant, the FDA, the manufacturer, or the study principal investigator (usually the administering doctor). Before a person enrolls in the drug treatment protocol, the risks will be explained, and participants must sign a consent form. Persons that improve and consequently stop Ampligen for an extended period may eventually relapse after a unpredictable length of time. Some patients restart Ampligen if they start to relapse.

    Other sites administering the open label AMP 511 treatment study protocol include Dr. Peterson in Incline Village, NV, Dr. Lapp in Charlotte, NC, Dr. Enlander in NYC, Dr. Klimas in Miami, and Dr. Bateman in Salt Lake City.

    This notice is for informational purposes, and is not an offer or guarantee.
    Permission granted to repost.
     
  2. Valentijn

    Valentijn Activity Level: 3

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    So that works out to $63,000 for the recommended 18 months.

    ...

    :eek:
     
    ggingues likes this.
  3. ggingues

    ggingues $10 gift code at iHerb GAS343 of $40

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    Sounds like chump change, LOL. Hopefully this will lead to a more affordable drug for most, and changes in the medical system to cover the costs, for people who are not wealthy, which is most of us!

    GG

    PS Thanks to the pioneers!
     
    Xandoff likes this.
  4. Doogle

    Doogle Senior Member

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    For 18 months I get the equation: 18 mo * $4400/8 wk * 4.34812 wk/1 mo = $43,046.39. Still a staggering amount of money but I wanted to get the figure correct.
     
  5. vli

    vli

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    Tomorrow I will start wk 26 of my Ampligen treatment, and i would love to hear from anybody who will participate in this study and will be happy to answer any questions on PM.
     
  6. lnester7

    lnester7 Seven

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    VLI, How are you doing on it? I am doing the baby version (imunovir) so I am interested in your experience.
     
  7. Valentijn

    Valentijn Activity Level: 3

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    Whoops, you're right. No idea how I came up with $63,000. Brain melting down?
     
  8. NotAllInMyHead

    NotAllInMyHead

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    I wanted to add a comment re the costs, which depend on the dose one is on. In Incline Village, many patients are on less than 200mg. The costs for the drug mentioned above assumes the use of two 200 mg bottles (200mg bottle is the only way this drug is "packaged"). If one is on 200 mg or less, the drug cost is cut in half ($7,800 per year plus infusion costs). Again, still lots of money, but not nearly the astronomical numbers that I sometimes see people mention online. The problem is that one will not know what dose is needed beforehand, as it varies widely among patients.
     
    Doogle likes this.
  9. vli

    vli

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    hi there,

    i'm just gonna be really lazy and paste in a reply i wrote to Laurel on fb:

    hi Laurel,

    I'm sorry i know i haven't updated my blog, at all. If you don't mind, I'm just gonna say i feel i have a better view of things now at the near-six months mark than i would've back in may or june. I think my improvements are seen in my overall (just a little) increased confidence that Amp will work, though to what greatest possible extent I don't know. I think I'm having less PEM, more energy, more stamina if I push it (it sounds weird but i mean if required, i've more room to push), would prolly say i feel i'm at 50% of my pre-illness state of function. Sorry haven't done a new Karnofsky score so can't say but guessing i'd prolly have increased by 10 points! My parents are now prepared for me being here for 1.5 yrs and maybe even 2 yrs. Not very scientific but hope that makes up for my lack of blogging (I'm finding that, unlike Sophie C who's a way better blogger than me, day-to-day emotional events that happen that are outside my control prevent me from writing abt Amp accurately, because i'm feeling crappy due to misunderstandings or conflicts w/ other ppl that're also taxing my body). I'll write a post end of Aug/beginning of Sep--my family're here and i feel crazy!

    V
     

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