ProHealth fibromyalgia Vitamin and Natural Supplement Store and Health
Log In  |  My Account  |  View Cart  View Your ProHealth Vitamin and Supplement Shopping Cart
800-366-6056  |  Contact Us  |  Help

|
|
|

Trending News

10 "Healthy" Foods That Are NOT Fibro-Friendly

VIDEO: What It Feels Like To Live With Fibro

Fibromyalgia Research Update from Integrated Tissue Dynamics

VIDEO: Treating Fibromyalgia with Oxytocin

The Brain Boosting and Fatigue Fighting B-12

Fibromyalgia, Family and Friends: 8 Ways to Improve Relationships

Sweet Tips for Fibromyalgia Success

Fibromyalgia and Disability Claims

Melatonin Regulates Inflammation Resolution in Fibromyalgia and Other Disorders

Pain Affects Brain Area Associated with Cognitive Function in Fibromyalgia Patients

 
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





Discuss This Article 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
 
Free Chronic Fatigue Syndrome and Fibromyalgia Newsletters
Subscribe to
Our FREE
Newsletter
Subscribe Now!
Receive up-to-date ME/CFS & Fibromyalgia treatment and research news
 Privacy Guaranteed  |  View Archives

Featured Products

B-12 Extreme™ B-12 Extreme™
The Most Potent Vitamin B-12 on Earth
Hydroxocobalamin Extreme™ Hydroxocobalamin Extreme™
The B-12 your brain needs for detox & sharpness
Optimized Curcumin Longvida® by ProHealth Optimized Curcumin Longvida® by ProHealth
Supports Cognition, Memory & Overall Health
Fibro Freedom™ Fibro Freedom™
Soothes, strengthens & revitalizes
Guaifenesin FA™ Guaifenesin FA™
Natural Expectorant Relieves Chest Congestion

Natural Remedies

Research Links Green Tea to Weight Loss Research Links Green Tea to Weight Loss
The Big Blue Fish that Helps Chase the Blues Away The Big Blue Fish that Helps Chase the Blues Away
Dreaming of a Good Night's Sleep? Dreaming of a Good Night's Sleep?
Sleep Like a Baby in Nature's Cradle Sleep Like a Baby in Nature's Cradle
The Brain Boosting and Fatigue Fighting B-12 The Brain Boosting and Fatigue Fighting B-12

FIBROMYALGIA RESOURCES
What is Fibromyalgia?
Fibromyalgia 101
Fibromyalgia Symptoms
Fibromyalgia Treatments
| CFS RESOURCES
What is CFS?
ME/CFS 101
ME/CFS Symptoms
ME/CFS Treatments
| FORUMS
Fibromyalgia
ME/CFS
ADVANCED MEDICAL LABS
WHOLESALE  |  AFFILIATES
GUARANTEE
CONTACT US
PRIVACY
RSS
SITE MAP
ProHealth on Facebook  ProHealth on Twitter  ProHealth on Pinterest  ProHealth on Google Plus
Credit Card Processing