ProHealth me-cfs Vitamin and Natural Supplement Store and Health
Log In  |  My Account  |  View Cart  View Your ProHealth Vitamin and Supplement Shopping Cart
800-366-6056  |  Contact Us  |  Help

|
|

Trending News

The Muscle-Brain Connection in ME/CFS Revealed

The Neurobiology of ME/CFS

Simmaron Foundation’s Immunology Workshop: The Forefront of Diagnosing and Treating ME/CFS

P2P: The Question They Will Not Ask

Adrenal Burnout? Naturally Boost Your Energy & Manage Stress

Smartphone app and specialised clinic for chronic fatigue patients

Human herpesvirus 6 and the nervous system

VIDEO: Stuff Healthy People Say to Sick People

Characterization of Natural Killer Cell Phenotypes in Chronic Fatigue Syndrome/Myalgic Encephalomyel...

VIDEO: Dr. Newton Talks About Biomarkers and the Future of ME/CFS Treatment

 
Print Page
Email Article

Ampligen Update: Fight for Approval Slogs On

  [ 10 votes ]   [ Discuss This Article ]
By Charles Lapp, MD • www.ProHealth.com • December 27, 2012


ME/CFS/FM clinical researcher Dr. Charles Lapp directs the Hunter-Hopkins Center in Charlotte, North Carolina. He received FDA approval to administer the experimental intravenous drug Ampligen to ME/CFS patients who could cover the cost 15 years ago, in 1997. Since then he has found that some patients achieve significant improvement on Ampligen, while many others improve. This update is reproduced with kind permission from HHC's December 2012 ME Letter.

*    *    *    *

Ampligen is still struggling for FDA Approval.

Dr. Lapp, Wendy Springs [Dr. Lapp’s infusionist & research coordinator], patient Robert Miller, and Hemispherx consultant Nancy McGrory met in the Summer with key politicians and the Department of Health & Human Services.

The plan was to educate DHHS about Ampligen and our past efforts with the FDA; our goal was to stimulate public hearings and face-to-face meetings with the Food & Drug Administration concerning this one-and-only therapy for CFS/ME.

To that end, DHHS held a public webinar on the subject on September 13, and another on November 15. Details can be found at www.fda.gov/Drugs/NewsEvents/ucm319188.htm .
 
On December 20, stakeholders met with an FDA Advisory Committee. [For background, see “Dec 20: High Noon for Ampligen and Chronic Fatigue Syndrome.”]

In addition to reams of data supplied by Hemispherx Biopharma (the manufacturer of Ampligen), the Advisory Committee heard testimony from researchers, patients, and supporters.

Despite data acquired on over 800 Ampligen patients, the committee voted 9-4 against recommending the drug for commercial approval, citing inadequate information on efficacy and safety in CFS/ME.

They recommended yet another large and prolonged study of Ampligen, which has undergone at least 8 different studies in the past 24 years already!

Stakeholders are infuriated, of course, pointing out that there is no other treatment option currently available for PWCs (people with CFS).

The agency (Food & Drug Administration) uses such advisory committees to obtain expert scientific opinions on a proposed medication, but the agency is not bound by such recommendations. The FDA has a deadline of February 2 to either approve or disapprove Ampligen therapy.

For more details on Ampligen see our website, then click on “Research” and then the “Ampligen” tab.



Please Discuss This Article:   Post a Comment 



[ Be the first to comment on this article ]




 
Free Chronic Fatigue Syndrome and Fibromyalgia Newsletters
Subscribe to
Our FREE
Newsletter
Subscribe Now!
Receive up-to-date ME/CFS & Fibromyalgia treatment and research news
 Privacy Guaranteed  |  View Archives

Immune Support Supplements

Featured Products

Ultra ATP+, Double Strength Ultra ATP+, Double Strength
Get energized with malic acid & magnesium
Hydroxocobalamin Extreme™ Hydroxocobalamin Extreme™
The B-12 your brain needs for detox & sharpness
B-12 Extreme™ B-12 Extreme™
The Most Potent Vitamin B-12 on Earth
Mitochondria Ignite™ with NT Factor® Mitochondria Ignite™ with NT Factor®
Reduce Fatigue up to 45%
Energy NADH™ 12.5mg Energy NADH™ 12.5mg
Improve Energy & Cognitive Function

Natural Remedies

How I Found My Long-Lost Energy How I Found My Long-Lost Energy
Front Line Defense Against Colds & Flu - Support for Healthy Immune System Balance Front Line Defense Against Colds & Flu - Support for Healthy Immune System Balance
Are You Obtaining the Proper Enzymes? Are You Obtaining the Proper Enzymes?
The Most Powerful Natural Antioxidant Discovered to Date - Hydroxytyrosol The Most Powerful Natural Antioxidant Discovered to Date - Hydroxytyrosol
Protecting Our Eyes Against Time-Induced Damage Protecting Our Eyes Against Time-Induced Damage

FIBROMYALGIA RESOURCES
What is Fibromyalgia?
Fibromyalgia 101
Fibromyalgia Symptoms
Fibromyalgia Treatments
| CFS RESOURCES
What is CFS?
ME/CFS 101
ME/CFS Symptoms
ME/CFS Treatments
| FORUMS
Fibromyalgia
ME/CFS
ADVANCED MEDICAL LABS
WHOLESALE  |  AFFILIATES
GUARANTEE
CONTACT US
PRIVACY
RSS
SITE MAP
ProHealth on Facebook  ProHealth on Twitter  ProHealth on Pinterest  ProHealth on Google Plus
Credit Card Processing