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

ME/CFS Patients Demand FDA Bring Pharma and Clinical Experts to the Table

  [ 4 votes ]   [ Discuss This Article ]
By PANDORA • • October 11, 2013

ME/CFS Patients Demand FDA Bring Pharma and Clinical Experts to the Table

Press release: GRAND RAPIDS, Mich., Oct. 10, 2013 /PRNewswire-USNewswire

PANDORA Org and many ME/CFS patients will participate in the FDA Chronic Fatigue Syndrome and Myalgic Encephalomyelitis (CFS and ME) Stakeholder teleconference on October 16 from 1:30 p.m.–3 p.m. EDT.  PANDORA Org's goal is to motivate the FDA to bring pharmaceutical and biotech companies to the table in a second workshop.  

"There are no FDA-approved therapies for this devastating disease, and patients need access to treatments now," said Lori Chapo-Kroger, RN, president and CEO of PANDORA Org. "Now that the FDA has a better understanding of the disease impact, as shown by their Patient Voice Report of their April meeting with patients, they need to open the drug development door wider so patients can find some relief from their suffering. To make this happen, the FDA needs to include the pharmaceutical companies and ME/CFS clinical experts in a workshop focused on developing outcome measures, what they failed to do in April."

In a September 2012 Report to the President on Propelling Innovation in Drug Discovery, Development, and Evaluation, President Barack Obama's Council of Advisors on Science and Technology states that the FDA should expand the scope of acceptable endpoints used to approve drugs for serious or life-threatening diseases with unmet needs.

"Certainly, this goal should be applied to drug development for ME/CFS, which the FDA classifies as a serious or life-threatening disease with unmet needs," said Chapo-Kroger.

The drug that has progressed furthest in the drug approval process is Ampligen, which has been in trials for decades. Rituximab is also showing promise in trials of ME/CFS patients. "The researchers and clinical experts involved in these studies are some of the top ME/CFS experts in the world and have the experience to know what outcome measures are best for ME/CFS drug trials," said Chapo-Kroger. "Leaving them out of an outcome measures discussion is a mistake and a tragedy for our patient community who are fighting to survive every day." 

After the background remarks, the FDA will open the teleconference discussion for public comments on the following three topics:

Feedback from the ME/CFS public workshop that was held April 25-26.

Current projects related to drug development in ME/CFS.

Potential methods to catalyze ME/CFS drug development.

The FDA's Patient-Focused Drug Development initiative is a commitment under the fifth authorization of the Prescription Drug User Fee Act (PDUFA V) that aims to more systematically gather patients' perspectives on their condition and available therapies to treat their condition.

The announcement of the October 16 teleconference can be found HERE.

Registration for the FDA call will be open until October 11, 2013. For more details, please go HERE

The September 2012 report to the president can be found HERE.


PANDORA Org is a national nonprofit organization seeking to alleviate the suffering caused by neuro-endocrine-immune diseases (NEIDs), including ME/CFS, Fibromyalgia, chronic Lyme disease and Gulf War illnesses. For more information visit:

For More Information Contact

Lori Chapo-Kroger 



Post a Comment

Featured Products From the ProHealth Store
B-12 Extreme™ Ultra ATP+, Double Strength 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

Natural Pain Relief Supplements

Featured Products

Hydroxocobalamin Extreme™ Hydroxocobalamin Extreme™
The B-12 Your Brain Needs for Detox & Sharpness
MitoQ® MitoQ®
Powerful Antioxidant Support to Mitochondria
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
Ultra ATP+, Double Strength Ultra ATP+, Double Strength
Get energized with malic acid & magnesium

Natural Remedies

Ubiquinol - A More Advanced Form of the Energy Producing Nutrient CoQ-10 Ubiquinol - A More Advanced Form of the Energy Producing Nutrient CoQ-10
Fighting Fatigue with Ground-breaking French Oak Wood Extract Fighting Fatigue with Ground-breaking French Oak Wood Extract
Safely Burn Away Body Fat Safely Burn Away Body Fat
Are You Obtaining the Proper Enzymes? Are You Obtaining the Proper Enzymes?
Aches and Pains? A Simple Solution You'll Love Aches and Pains? A Simple Solution You'll Love

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