ProHealth health 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

Friendly User's Guide for the Timing of Nutritional Supplements

The Health Benefits of Manuka Honey

Increase Your Magnesium Intake

Vitamin D supplementation could ease IBS symptoms

Top Tips to Boost Your Immunity

11 Amazing Health Benefits of Using Baking Soda

Nicotinamide riboside shows promise for treatment of Alzheimer’s disease

Exercise, calcium, vitamin D, and other factors linked with fewer injurious falls

Vitamin D3 Is a Powerhouse for Your Heart

Curcumin Supplementation May Impart Long-Term Cognitive Benefits

 
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
Vitamin D3 Extreme™ Ultra EPA  - Fish Oil Energy NADH™ 12.5mg


Article Comments



Be the first to comment on this article!

Post a Comment


 
Optimized Curcumin Longvida with Omega-3

Featured Products

Energy NADH™ 12.5mg Energy NADH™ 12.5mg
Improve Energy & Cognitive Function
Mitochondria Ignite™ with NT Factor® Mitochondria Ignite™ with NT Factor®
Reduce Fatigue up to 45%
Ultra ATP+, Double Strength Ultra ATP+, Double Strength
Get Energized with Malic Acid & Magnesium
FibroSleep™ FibroSleep™
The All-in-One Natural Sleep Aid
Optimized Curcumin Longvida® Optimized Curcumin Longvida®
Supports Cognition, Memory & Overall Health

Natural Remedies

Herbal Rescue for High Blood Sugar Herbal Rescue for High Blood Sugar
Running on Empty? Fuel Up with NADH Running on Empty? Fuel Up with NADH
Break Free From Fibromyalgia Break Free From Fibromyalgia
Vital Molecule Increases Cellular Energy and Improves Cognitive Function Vital Molecule Increases Cellular Energy and Improves Cognitive Function
Restoring Gut Health: How to Create a Firewall Against Toxins Entering the Gut Wall Restoring Gut Health: How to Create a Firewall Against Toxins Entering the Gut Wall

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

© 2018 ProHealth, Inc. All rights reserved. Pain Tracker App  |  Store  |  Customer Service  |  Guarantee  |  Privacy  |  Contact Us  |  Library  |  RSS  |  Site Map