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

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

Do You Have These Fibromyalgia Symptoms of Systemic Dysfunction?

Fibromyalgia – The Savella Story

Meet Devin Starlanyl: Fibromyalgia and Chronic Myofascial Pain Expert

Which Infection Causes CFS & Fibromyalgia?

The "Mind Diet" Reduces the Risk Of Alzheimer’s Dementia. Might It Also Help the Brain Fog Found Wit...

Need Help with Pain Management? There's an App for That

Simplifying Nutritional Support in CFS & Fibromyalgia

6 Reasons Why Trigger Point Injections Aren't Helping Your Fibromyalgia

How Multiple Chronic Illnesses Shaped One Woman Into a Patient Advocate

VIDEO: Fibromyalgia & Your Stress-Coping Savings Account

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 



Please Discuss This Article:   Post a Comment 

[ Be the first to comment on this article ]

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

Vitamins and Supplements for Fibromyalgia Support

Featured Products

Fibro Freedom™ Fibro Freedom™
Soothes, strengthens & revitalizes
Hydroxocobalamin Extreme™ Hydroxocobalamin Extreme™
The B-12 your brain needs for detox & sharpness
Guaifenesin FA™ Guaifenesin FA™
Natural Expectorant Relieves Chest Congestion
Energy NADH™ 12.5mg Energy NADH™ 12.5mg
Improve Energy & Cognitive Function
Optimized Curcumin Longvida® Optimized Curcumin Longvida®
Supports Cognition, Memory & Overall Health

Natural Remedies

IBS, Crohn’s Disease, Colitis, and Other Digestive Disorders IBS, Crohn’s Disease, Colitis, and Other Digestive Disorders
Ubiquinol - A More Advanced Form of the Energy Producing Nutrient CoQ-10 Ubiquinol - A More Advanced Form of the Energy Producing Nutrient CoQ-10
SAD? Coping with Seasonal Affective Disorder
Prepare Yourself for Cold & Flu Season
Research Links Green Tea to Weight Loss Research Links Green Tea to Weight Loss

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