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

10 Fibro-Friendly Foods with a Bonus: Beautiful Skin

Fight Back! Win the War Being Waged Against Your Immune System

Studies Show that Magnesium L-threonate Improves Brain Plasticity, Leading to Direct and Significant...

Clary Sage Oil May Be Pricey, but Its Benefits Are Priceless

Component of red wine, grapes can help to reduce inflammation, study finds

Poly MVA: A Novel Therapy for Increasing Energy, Repairing DNA, and Promoting Overall Health

Pumpkin Pie Turmeric Breakfast Smoothie - Vegan + Gluten-Free

Vitamin D supplementation extends life in mouse model of Huntington's disease

Omega-3 fatty acid stops known trigger of lupus

Conquer Your Email Inbox, Increase Productivity and Reduce Stress

Print Page
Email Article

All FDA Drug Approvals Not Created Equal

  [ 7 votes ]   [ 1 Comment ] • 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
Vitamin D3 Extreme™ Ultra ATP+, Double Strength FibroSleep™

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

FibroSleep™ FibroSleep™
The All-in-One Natural Sleep Aid
Optimized Curcumin Longvida® Optimized Curcumin Longvida®
Supports Cognition, Memory & Overall Health
Ultra ATP+, Double Strength Ultra ATP+, Double Strength
Get energized with malic acid & magnesium
Mitochondria Ignite™ with NT Factor® Mitochondria Ignite™ with NT Factor®
Reduce Fatigue up to 45%
Vitamin D3 Extreme™ Vitamin D3 Extreme™
50,000 IU Vitamin D3 - Prescription Strength

Natural Remedies

Relief for Dry, Itchy Skin Caused by Fibromyalgia Relief for Dry, Itchy Skin Caused by Fibromyalgia
Strontium - The Missing Mineral for Strong Bones Strontium - The Missing Mineral for Strong Bones
Quercetin: Natural Support for Allergy & Inflammation Relief and More Quercetin: Natural Support for Allergy & Inflammation Relief and More
Vitamin K-2 – A Key Player in Cardiovascular and Bone Health Vitamin K-2 – A Key Player in Cardiovascular and Bone Health
SAD? Coping with Seasonal Affective Disorder SAD? Coping with Seasonal Affective Disorder

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

· Become a Wholesaler
· Vendor Inquiries
· Affiliate Program
Credit Card Processing
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