Activate Now
 
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

Acupuncture used in clinical settings reduced symptoms of menopause

Benefits of Coconut Oil Are Undeniable

How Awesome Is Ashwagandha?

CoQ10 supplementation associated with lower pro-inflammatory factors in randomized trial

SURVEY RESULTS: Should Opioids Be Restricted for Chronic Illness?

Clinical trial demonstrates success of low FODMAP diet

Research Demonstrates Superiority of Krill Oil Compared to Fish Oil

Vitamin nicotinamide riboside protects mice from diabetes complications

What’s so Remarkable About Rosemary?

Vitamin-mineral supplement prevents brain cell loss in recent research

 
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
Mitochondria Ignite™ with NT Factor® Vitamin D3 Extreme™ FibroSleep™

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


 
All Natural Deodorants

Featured Products

FibroSleep™ FibroSleep™
The All-in-One Natural Sleep Aid
Mitochondria Ignite™ with NT Factor® Mitochondria Ignite™ with NT Factor®
Reduce Fatigue up to 45%
Ultra EPA  - Fish Oil Ultra EPA - Fish Oil
Ultra concentrated source of essential fish oils
Ultra ATP+, Double Strength Ultra ATP+, Double Strength
Get energized with malic acid & magnesium
Vitamin D3 Extreme™ Vitamin D3 Extreme™
50,000 IU Vitamin D3 - Prescription Strength

Natural Remedies

The Remarkable Benefits of Reishi Medicinal Mushrooms The Remarkable Benefits of Reishi Medicinal Mushrooms
Optimize Your Immune System Naturally: Thymic Protein A Optimize Your Immune System Naturally: Thymic Protein A
Sleep Like a Baby in Nature's Cradle Sleep Like a Baby in Nature's Cradle
Could a B-12 Deficiency Be Causing Your Symptoms? Could a B-12 Deficiency Be Causing Your Symptoms?
Eating Fat is Good... Maybe... Could Be... Sometimes Eating Fat is Good... Maybe... Could Be... Sometimes

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

· Become a Wholesaler

· Affiliate Program
SHOP WITH CONFIDENCE
Credit Card Processing
SUBSCRIBE AND SAVE 15% NOW*
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. Store  |  Customer Service  |  Guarantee  |  Privacy  |  Contact Us  |  Library  |  RSS  |  Site Map