Activate Now
ProHealth fibromyalgia 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

Aromatherapy Diffusers For Fibromyalgia Support

An Interview with Ken McKim: Educating the public about chronic illness

Repair Damaged Mitochondria and Reduce Fatigue Up to 45%

Fibromyalgia and Food: Things You Need to Know This Holiday Season

Dr. Teitelbaum's 3 Steps to Fibromyalgia Pain Relief - Part 1: Understanding Fibromyalgia Pain

Cellular Havoc: Zeroing In On The Sleep Problems in Fibromyalgia?

Are All the "Feel-Good" Pathways Blocked in Fibromyalgia and Chronic Fatigue Syndrome?

Chronic Fatigue Syndrome, Fibromyalgia and Mitchondrial Disorders: A Comparison Plus the MitoQ Trial...

Amazing Fibromyalgia Health Benefits from a Tiny Superfood - Including Recipe Ideas!

5 Things I've Learned About Chronic Illness Through Mindfulness

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
Hydroxocobalamin Extreme™ Guaifenesin FA™ Energy NADH™ 12.5mg

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

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

Repair Damaged Mitochondria and Reduce Fatigue Up to 45%

Featured Products

B-12 Extreme™ B-12 Extreme™
The Most Potent Vitamin B-12 on Earth
Optimized Curcumin Longvida® Optimized Curcumin Longvida®
Supports Cognition, Memory & Overall Health
FibroSleep™ FibroSleep™
The All-in-One Natural Sleep Aid
Energy NADH™ 12.5mg Energy NADH™ 12.5mg
Improve Energy & Cognitive Function
Fibro Freedom™ Fibro Freedom™
Soothes, strengthens & revitalizes

Natural Remedies

Fighting Fatigue with Ground-breaking French Oak Wood Extract Fighting Fatigue with Ground-breaking French Oak Wood Extract
Magnesium: An Essential Supplement for ME/CFS Magnesium: An Essential Supplement for ME/CFS
D-ficient? Health Risks You Need to Know About D-ficient? Health Risks You Need to Know About
Milk Thistle: Trusted Support for Health & Healing in a Toxic World Milk Thistle: Trusted Support for Health & Healing in a Toxic World
Green Coffee Extract: Unique Obesity Intervention Green Coffee Extract: Unique Obesity Intervention

What is Fibromyalgia?
Fibromyalgia Diagnosis
Fibromyalgia Symptoms
Fibromyalgia Causes
Fibromyalgia Treatments
Fibromyalgia Diet
Fibromyalgia Medications
M.E. & CFS
What is M.E./CFS?
M.E./CFS Diagnosis
M.E./CFS Symptoms
M.E./CFS Causes
M.E./CFS Treatments
M.E./CFS Diet
M.E./CFS Medications
What is Lyme Disease?
Lyme Disease Diagnosis
Lyme Disease Symptoms
Lyme Disease Causes
Lyme Disease Treatments
Lyme Disease Diet
Lyme Disease Medications
M.E. & CFS
Lyme Disease
General Health
ProHealth on Facebook  ProHealth on Twitter  ProHealth on Pinterest  ProHealth on Google Plus
Credit Card Processing