Update: 03-20-2012A San Francisco Bay Area area physician (
Dr. Raj Patel) with experience administering Ampligen will very shortly be starting open label Ampligen treatment in Los Altos, CA according to Hemispherx Biopharma. The study paperwork has been approved by the IRB board except for minor changes to patient consent wording for California regulations. Hemispherx said the process had been delayed due to the effort of getting a different study ready.
Hemispherx has just published a new study on the beneficial effects of Ampligen.This is good news for persons in the bay area as the medication hasn't been available for over 7 years in this area and preparation for this treatment study has been in the works for almost a year.
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 U.S. 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.htmlhttp://www.cfids-me.org/marys/ampcoda.htmlhttp://www.cfids-me.org/aacfs/ampligen.htmlhttp://theglassmountain.wordpress.com/category/ampligen/https://docs.google.com/spreadsheet/ccc?key=0AllDPaztxjQDdFBkSHRPdkhZblRobzVWUTZUY3JGQ0E&hl=en_US#gid=0Other sites administering the drug under the
FDA approved open label
AMP 511 study include Dr. Peterson in Incline Village, NV,
Dr. Lapp in Charlotte, NC,
Dr. Enlander in NYC, Dr. Klimas in Miami, and
Dr. Bateman's site in Salt Lake City.
* The San Francisco Bay Area physician is a fee-for-service provider. Patients pay the doctor 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.
* The total cost of Ampligen to each participant is approximately $2,500/month.
* The physician estimates it’ll take 18 months for most patients to achieve the full therapeutic and stabilization effects of Ampligen, and they should plan for that timeframe.
Ampligen has a
controversial history, including
refusal of the FDA to approve retail marketing of the drug due to efficacy questions. Also, 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.
While many ME/CFS patients have an interest in Ampligen, the AMP 511 Cost-Recovery treatment protocol requirements are expensive:
*Ampligen is administered from 200mg or 400mg vials. The cost of the Ampligen alone, at the usual therapeutic dose of 400mg twice per week, is $1,200 per month, and is rarely covered by medical insurance. Some patients, however, may require a lesser dose.
*Infusion costs, administrative costs, and testing are extra, are generally not covered by insurance, and will cost approximately $1,300 a month.
Persons interested in Ampligen treatment in the San Francisco Bay Area, and have the resources to pay for the costs involved, contact:
Dr. Raj Patel. Please contact him only if you are seriously interested in participating. Thank you.
This notice is for informational purposes, and is not an offer or guarantee.
Permission granted to repost.
