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

9 tips for anyone newly diagnosed with fibromyalgia

Tired of Your Every Night 2 AM Wake-Up Call?

Muscle Trigger Points and Pressure Pain Sensitivity Maps of the Feet in Women with Fibromyalgia Synd...

The Challenges of Being a Sick Parent

When You Are Frustrated with Healthcare Professionals

How to be Broke and Medicated with Fibromyalgia or ME/CFS

Snooze News – The conundrum of sleep deprivation

How Not to Treat Brain Fog

Massage for Pain: An Evidence Map

Fibromyalgia and Cancer Related Fatigue

 
Print Page
Email Article

Transcript of FDA’s Sep 13 ME/CFS Stakeholder Teleconference

  [ 6 votes ]   [ Discuss This Article ]
www.ProHealth.com • September 19, 2012


On September 13, a group of 50 FDA officials, pharmaceutical developers, and ME/CFS patients & advocates met via a 90-minute telephone conference. It was a big step in the FDA’s plan for hastening development, testing and approval of drugs to treat ME/CFS - a serious disease with 'unmet medical need'.(1)

The FDA.gov page dedicated to sharing information about these activities has now posted the transcript of this discussion (www.fda.gov/downloads/Drugs/NewsEvents/UCM320310.pdf). It includes input from many stakeholders, and is well worth reading.

The meeting was led by Dr. Sandra Kweder, MD, deputy director of the FDA/CDER’s Office of New Drugs. Just a few of the key points she covered in this very interesting meeting are as follows:

• Importantly, Dr. Kweder established that the FDA considers ME/CFS to be in the category of “serious or life threatening diseases.” And that the FDA is committed to making promising drugs available to individuals with such diseases for which there are as yet no approved drugs as quickly as possible via “the rapid development and review of these types of therapy” - a process called ‘the accelerated approval process.’

• Second, Dr. Kweder emphasized it is very important to identify factors that if measured can be considered trial outcome measures. Using HIV just as an example, she noted, what really revolutionized the study of drugs for HIV/AIDS treatment “was finding something to measure in the clinical trials. In that case they had the… fortune or misfortune to be able to identify some marker in the blood that was predictive of the clinical course of the disease. In the beginning it was a type of white blood cell, CDR lymphocytes.”

• As the drug developers further explained, they have learned from experience, “you’ve got to be able to define the condition well… and know where are the rules about studying it. What am I going to have to show in order to get a drug approved.”

• So, respecting the need for measures and rules, said Dr. Kweder, “We are planning to hold a scientific workshop that explores how to identify valid, reliable, quantitative outcome measures to determine if disease symptoms do improve with specific interventions.”

• The workshop, which CDER (Center for Drug Evaluation and Research) plans to host in spring, 2013, will be open to the public and will “explore a multitude of scientific issues about identifying valid, reliable and measurable outcomes to determine if disease symptoms improve with intervention.” As part of this discussion, says Dr. Kweder, “we want to hear from academic experts, from clinical practitioners who are taking care of patients with these conditions, and patients themselves.”

• In the meantime, the FDA will describe the drug review process in detail for the benefit of all viewing the CFSAC meeting in Washington Oct 3 & 4.

• And in mid-November (date to be determined) the FDA will host an Excellence in Advocacy webinar that will “advise patient advocates or advocacy groups on how to come together and develop common themes to… further your mutual goals” with regard to the process of getting drug therapies for ME/CFS approved.

____

1. See a brief report circulated after the Sep 13 telephone conference by Rivka, a patient activist who participated in the meeting. “FDA Pronounces ME/CFS ‘Serious and Life Threatening Disease in Sep 13 Meet.”




Post a Comment

Featured Products From the ProHealth Store
Energy NADH™ 12.5mg FibroSleep™ Optimized Curcumin Longvida®

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


 
NAD+ Ignite with Niagen

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™
Helps the Body Eliminate Excess Calcium and Phosphates
B-12 Extreme™ B-12 Extreme™
The Most Potent Vitamin B-12 on Earth
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
Can Glycine + Amino Acids Be the Secret to Deep, Rejuvenating Sleep? Can Glycine + Amino Acids Be the Secret to Deep, Rejuvenating Sleep?
Probiotic Mint Promotes Healthy Gums & Teeth, Freshens Breath and Whitens Teeth Probiotic Mint Promotes Healthy Gums & Teeth, Freshens Breath and Whitens Teeth
Breaking Through the Mental Fog Breaking Through the Mental Fog

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

· Become a Wholesaler
· Vendor Inquiries
· Affiliate Program
SHOP WITH CONFIDENCE
Credit Card Processing
SUBSCRIBE TO OUR NEWSLETTERS
Get the latest news about Fibromyalgia, M.E/Chronic Fatigue Syndrome, Lyme Disease and Natural Wellness

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

© 2017 ProHealth, Inc. All rights reserved. Pain Tracker App  |  Store  |  Customer Service  |  Guarantee  |  Privacy  |  Contact Us  |  Library  |  RSS  |  Site Map