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

The Crucial Role CoQ10 Plays in Fibromyalgia and ME/CFS

Meditation, Cortisol, and Fibromyalgia

The Exercise Intolerance in POTS, ME/CFS and Fibromyalgia Explained?

Will a Gluten-free Diet "Fix" Fibromyalgia?

The Twins: Fibromyalgia / PTSD

#ISpeakForPain Blitz

5 Ways That I Reduce Stress During Tough Times

VIDEO: Medical Marijuana Use of Fibromyalgia Patients

Move More: How I Actually Started Exercising with a Chronic Condition

Integrative medicine for chronic pain: A cohort study using a process-outcome design in the context ...

 
Print Page
Email Article

All FDA Drug Approvals Not Created Equal

  [ 7 votes ]   [ 1 Comment ]
www.ProHealth.com • January 26, 2014


All FDA Drug Approvals Not Created Equal
Press Release: Eurekalert, Jan 21, 2014
 
Many patients and physicians assume that the safety and effectiveness of newly approved drugs is well understood by the federal Food and Drug Administration (FDA) —but a new study by researchers at Yale School of Medicine shows that the clinical trials used by the FDA to approve new drugs between 2005 and 2012 vary widely in their thoroughness.
 
Published in the Jan. 22/29 issue of JAMA, the study is the first systematic analysis of the standard used by the FDA in making drug approval decisions.
 
"We found that during the study period, more than one-third of the drugs were approved on the basis of a single trial, without replication, and many other trials were small, short, and focused on lab values, or some other surrogate metric of effect, rather than clinical endpoints like death," said first author and Yale School of Medicine student Nicholas S. Downing, who conducted the study with senior author Joseph Ross, M.D., and colleagues at the Yale Center for Outcomes Research & Evaluation (CORE).
 
Downing and the team evaluated the strength of clinical trial evidence supporting FDA approval decisions for new drugs by characterizing key features of efficacy trials, such as trial size, design duration, and end points. They used publicly available FDA documents to identify 188 novel therapeutic agents for seven years. These medical review documents summarized in great detail the rationale behind FDA approvals.
 
"Based on our analysis, some drugs are approved on the basis of large, high-quality clinical trials, while others are approved based on results of smaller trials," said Ross, assistant professor of internal medicine at Yale School of Medicine. "There was a lack of uniformity in the level of evidence the FDA used."
 
He added: "We also found that only 40% of drug approvals involved a clinical trial that compared a new drug to existing treatment offerings. This is an important step for determining whether the new drug is a better option than existing, older drugs."
 
Downing said survey data shows that patients expect drugs approved by the FDA to be both safe and effective. "Based on our study of the data, we can't be certain that this expectation is necessarily justified, given the quantity and quality of the variability we saw in the drug approval process," he said.
 

Other authors on the study include Jenerius A. Aminawung, M.D., Nilay D. Shah, and Harlan M. Krumholz, M.D. The study was funded in part by the Pew Charitable Trusts.

Citation:Nicholas S. Downing, Jenerius A. Aminawung, Nilay D. Shah, Harlan M. Krumholz, Joseph S. Ross. Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012. JAMA doi: 10.1001/jama.2013.282034





Post a Comment

Featured Products From the ProHealth Store
Optimized Curcumin Longvida® Fibro Freedom™ B-12 Extreme™

Looking for Vitamins, Herbs and Supplements?
Search the ProHealth Store for Hundreds of Natural Health Products


Article Comments Post a Comment

The Inequality runs deep...
Posted by: WilliamAkai
Jan 26, 2014
The most crucial thing that's "not equal" about the FDA is its prevalent pandering to big corporate interests above public health interests (google/bing "Tougher Supplement Regulation: A Necessity Or Politics? by Rolf Hefti").
Reply Reply
 
Natural Pain Relief Supplements

Featured Products

Fibro Freedom™ Fibro Freedom™
Soothes, Strengthens & Revitalizes
FibroSleep™ FibroSleep™
The All-in-One Natural Sleep Aid
B-12 Extreme™ B-12 Extreme™
The Most Potent Vitamin B-12 on Earth
Optimized Curcumin Longvida® Optimized Curcumin Longvida®
Supports Cognition, Memory & Overall Health
Hydroxocobalamin Extreme™ Hydroxocobalamin Extreme™
The B-12 Your Brain Needs for Detox & Sharpness

Natural Remedies

Red Yeast Rice - Natural Option for Supporting Healthy Cholesterol Red Yeast Rice - Natural Option for Supporting Healthy Cholesterol
The Surprising Benefits of Probiotics - What You Didn't Know The Surprising Benefits of Probiotics - What You Didn't Know
Stop Bacteria With Nature's Antibiotics Stop Bacteria With Nature's Antibiotics
Front Line Defense Against Colds & Flu - Support for Healthy Immune System Balance Front Line Defense Against Colds & Flu - Support for Healthy Immune System Balance
Could a B-12 Deficiency Be Causing Your Symptoms? Could a B-12 Deficiency Be Causing Your Symptoms?

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 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. Pain Tracker App  |  Store  |  Customer Service  |  Guarantee  |  Privacy  |  Contact Us  |  Library  |  RSS  |  Site Map