Activate Now
ProHealth me-cfs 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

Misdiagnosis on a grand scale?

Myalgic encephalomyelitis, chronic fatigue syndrome: An infectious disease

Repair Damaged Mitochondria and Reduce Fatigue Up to 45%

Are All the "Feel-Good" Pathways Blocked in Fibromyalgia and Chronic Fatigue Syndrome?

Chronic Fatigue Syndrome, Fibromyalgia and Mitchondrial Disorders: A Comparison Plus the MitoQ Trial...

5 Things I've Learned About Chronic Illness Through Mindfulness

An assessment of fatigue in patients with postural orthostatic tachycardia syndrome

Increased Vulnerability to Pattern-Related Visual Stress in Myalgic Encephalomyelitis

Maintenance of Chronic Fatigue Syndrome (CFS) in Young CFS Patients Is Associated with the 5-HTTLPR ...

NIH takes action to bolster research on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

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
Ultra ATP+, Double Strength MitoQ® 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
Free Chronic Fatigue Syndrome and Fibromyalgia Newsletters
Subscribe to
Subscribe Now!
Receive up-to-date ME/CFS, Fibromyalgia & Lyme Disease treatment and research news
 Privacy Guaranteed  |  View Archives

Repair Damaged Mitochondria and Reduce Fatigue Up to 45%

Featured Products

MitoQ® MitoQ®
Powerful Antioxidant Support to Mitochondria
Mitochondria Ignite™ with NT Factor® Mitochondria Ignite™ with NT Factor®
Reduce Fatigue up to 45%
Energy NADH™ 12.5mg Energy NADH™ 12.5mg
Improve Energy & Cognitive Function
Hydroxocobalamin Extreme™ Hydroxocobalamin Extreme™
The B-12 your brain needs for detox & sharpness
Ultra ATP+, Double Strength Ultra ATP+, Double Strength
Get energized with malic acid & magnesium

Natural Remedies

Soothe, Heal and Regulate Your Digestive System with Nutrient-Rich Aloe Vera Soothe, Heal and Regulate Your Digestive System with Nutrient-Rich Aloe Vera
Block food Cravings At Their Molecular Root Block food Cravings At Their Molecular Root
Health Benefits Are Brewing in Green Tea Health Benefits Are Brewing in Green Tea
Olea25 Olive Hydroxytyrosol Hits Astonishing 68,000+ ORAC Antioxidant Value Olea25 Olive Hydroxytyrosol Hits Astonishing 68,000+ ORAC Antioxidant Value
Irritable Bowel Syndrome: Unlocking the Secrets of Peppermint, Acacia and Fennel Irritable Bowel Syndrome: Unlocking the Secrets of Peppermint, Acacia and Fennel

What is Fibromyalgia?
Fibromyalgia Diagnosis
Fibromyalgia Symptoms
Fibromyalgia Causes
Fibromyalgia Treatments
Fibromyalgia Diet
Fibromyalgia Medications
M.E. & CFS
What is M.E./CFS?
M.E./CFS Diagnosis
M.E./CFS Symptoms
M.E./CFS Causes
M.E./CFS Treatments
M.E./CFS Diet
M.E./CFS Medications
What is Lyme Disease?
Lyme Disease Diagnosis
Lyme Disease Symptoms
Lyme Disease Causes
Lyme Disease Treatments
Lyme Disease Diet
Lyme Disease Medications
M.E. & CFS
Lyme Disease
General Health
ProHealth on Facebook  ProHealth on Twitter  ProHealth on Pinterest  ProHealth on Google Plus
Credit Card Processing