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

Alcohol intolerance in CFS - gives us a clue as to the mechanisms of fatigue

Simplifying Nutritional Support in CFS & Fibromyalgia

Need Help with Pain Management? There's an App for That

How Walking to Bathroom Can Be Harder Than Running a Marathon: A Doctor’s ME/CFS Case Study

Ask the Doctor: Is CFS an onset to fibromyalgia? What is the difference?

How Multiple Chronic Illnesses Shaped One Woman Into a Patient Advocate

Fighting Fatigue with Ground-breaking French Oak Wood Extract

Is Your Body Your Friend and Healing Ally?

Breathing Techniques for a Better Night’s Sleep

On the Path: Dan Moricoli's Remarkable Chronic Fatigue Syndrome Recovery Story

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

Please 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
Subscribe Now!
Receive up-to-date ME/CFS, Fibromyalgia & Lyme Disease treatment and research news
 Privacy Guaranteed  |  View Archives

Vitamins and Supplements for ME/CFS Support

Featured Products

MitoQ® MitoQ®
Powerful Antioxidant Support to Mitochondria
Hydroxocobalamin Extreme™ Hydroxocobalamin Extreme™
The B-12 your brain needs for detox & sharpness
Energy NADH™ 12.5mg Energy NADH™ 12.5mg
Improve Energy & Cognitive Function
B-12 Extreme™ B-12 Extreme™
The Most Potent Vitamin B-12 on Earth
Ultra ATP+, Double Strength Ultra ATP+, Double Strength
Get energized with malic acid & magnesium

Natural Remedies

Breaking Through the Mental Fog Breaking Through the Mental Fog
Aching Muscles? Top 10 Nutrients to Take Back Your Life Aching Muscles? Top 10 Nutrients to Take Back Your Life
Natural Support for Mood, Sleep and Mental Focus? L-theanine Natural Support for Mood, Sleep and Mental Focus? L-theanine
The Brain Boosting and Fatigue Fighting B-12 The Brain Boosting and Fatigue Fighting B-12
Herbal Inflammation Management for Whole Body Health Herbal Inflammation Management for Whole Body Health

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