ProHealth me-cfs Vitamin and Natural Supplement Store and Health
Home  |  Log In  |  My Account  |  View Cart  View Your ProHealth Vitamin and Supplement Shopping Cart
800-366-6056  |  Contact Us  |  Help
Facebook Google Plus
Fibromyalgia  Chronic Fatigue Syndrome & M.E.  Lyme Disease  Natural Wellness  Supplement News  Forums  Our Story
Store     Brands   |   A-Z Index   |   Best Sellers   |   New Products   |   Deals & Specials   |   Under $10   |   SmartSavings Club

Trending News

When Retreat Means Advance: A Recovered Chronic Fatigue Syndrome/Fibromyalgia Patient Looks Back

Creating Intimacy Through Mindful Touch When You Live with Chronic Illness

VIDEO: How does your brain respond to pain?

4 Ways to Give Back When You’re Chronically Ill

Factors Associated with Increased Risk for Clinical Insomnia in Patients with Chronic Neck Pain.

10 Fibro-Friendly Foods with a Bonus: Beautiful Skin

Fight Back! Win the War Being Waged Against Your Immune System

Millions Missing Day of Protest Draws Attention to Plight of ME/CFS Patients All Over the Globe

An Illness Denied for Decades Is Exposed - Lighting Up a Hidden World: CFS and ME

SURVEY RESULTS: Weight Management & Chronic Illness

Print Page
Email Article

Ampligen Update: Fight for Approval Slogs On

  [ 10 votes ]   [ Discuss This Article ]
By Charles Lapp, MD • • 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 .
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.

Post a Comment

Featured Products From the ProHealth Store
Energy NADH™ 12.5mg B-12 Extreme™ Mitochondria Ignite™ with NT Factor®

Looking for Vitamins, Herbs and Supplements?
Search the ProHealth Store for Hundreds of Natural Health Products

Article Comments

Be the first to comment on this article!

Post a Comment

Natural Pain Relief Supplements

Featured Products

Ultra ATP+, Double Strength Ultra ATP+, Double Strength
Get energized with malic acid & magnesium
Mitochondria Ignite™ with NT Factor® Mitochondria Ignite™ with NT Factor®
Reduce Fatigue up to 45%
Hydroxocobalamin Extreme™ Hydroxocobalamin Extreme™
The B-12 Your Brain Needs for Detox & Sharpness
MitoQ® MitoQ®
Powerful Antioxidant Support to Mitochondria
Energy NADH™ 12.5mg Energy NADH™ 12.5mg
Improve Energy & Cognitive Function

Natural Remedies

The New Dual Activation Pain Relief Cream The New Dual Activation Pain Relief Cream
Strengthen Cell Function with Energy-Boosting Niagen Strengthen Cell Function with Energy-Boosting Niagen
Optimize Your Immune System Naturally: Thymic Protein A Optimize Your Immune System Naturally: Thymic Protein A
Rejuvenating the Brain - How PQQ Helps Power Up Mental Processing Rejuvenating the Brain - How PQQ Helps Power Up Mental Processing
Guarding Against the Dangers of Vitamin D Deficiency Guarding Against the Dangers of Vitamin D Deficiency

ProHealth, Inc.
555 Maple Ave
Carpinteria, CA 93013
(800) 366-6056  |  Email

· Become a Wholesaler
· Vendor Inquiries
· Affiliate Program
Credit Card Processing
Be the first to know about new products, special discounts and the latest health news. *New subscribers only

CONNECT WITH US ProHealth on Facebook  ProHealth on Twitter  ProHealth on Pinterest  ProHealth on Google Plus

© 2016 ProHealth, Inc. All rights reserved. Pain Tracker App  |  Store  |  Customer Service  |  Guarantee  |  Privacy  |  Contact Us  |  Library  |  RSS  |  Site Map