Navigation Links
Physicians Who Treat Obesity Question FDA Rejection of Contrave
Date:2/8/2011

DENVER, Feb. 8, 2011 /PRNewswire/ -- The American Society of Bariatric Physicians (ASBP) is concerned that the FDA recently rejected the weight-loss drug Contrave, contradicting the FDA advisory panel's recommendation for approval.  The rejection of Contrave marks the third weight-loss drug to be rejected by the FDA in the past six months.  The rejection leaves physicians with limited options to address the obesity epidemic, one of the nation's top public health issues.

ASBP's physicians treat obesity and obesity-related co-morbidities on a daily basis and believe the FDA's standards for approving anti-obesity drugs are overly stringent and fail to recognize the health risks associated with carrying extra weight. Current FDA guidelines suggest that for any weight-loss drug to be considered effective it must either  

  1. reduce total body weight after one year by at least five percent more than the placebo group, or  
  2. help at least 35 percent of patients lose at least five percent of their baseline body weight.

In the Phase 3 Clinical Trials, Contrave was shown to induce at least a five percent weight loss in more than 35 percent of patients.  Although Contrave met the benchmark for efficacy, the FDA based its rejection of Contrave on concerns of long-term use and heart problems.  

While ASBP understands and appreciates the cautious manner in which certain anti-obesity drugs are viewed, the FDA seems to lose sight of the many health risks associated with obesity. Obesity-related health risks include diabetes, heart disease, stroke, osteoarthritis, and several types of cancer, to name just a few.  There is ample evidence that obesity is a metabolic abnormality and that pharmacologic interventions can help with weight loss and maintenance, reversing or delaying the development of obesity-related health problems.

Furthermore, the ASBP finds it contradictory that the FDA advisory panel recently recommended lowering the BMI requirement for lap-band surgery without asking for further long-term outcome studies.  Meanwhile, the FDA rejected Contrave and requested the company conduct a study of sufficient size and duration to address the risk of heart attack and stroke. Unfortunately, such studies will likely be costly and require several years to complete, which means that significant time will pass before this drug comes up for approval again.  

The ASBP expects the FDA to consider the demonstrated effectiveness and benefits of weight-loss drugs even if those drugs may carry increased hypothetical risk, because a reduction in obesity leads to a multitude of beneficial effects, which far outweigh minor risks.  

About the ASBP

Founded in 1950, the ASBP is the oldest medical association focused on the education and training of medical professionals treating and managing obese patients and associated diseases. The ASBP is a collaborative organization that provides its members practical information and business tools to implement a successful medical bariatric practice. For more information about the ASBP, visit www.asbp.org.


'/>"/>
SOURCE ASBP
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. 58% of Physicians Support FDA Move to Pull Breast Cancer Indication from Avastin
2. Aprima Electronic Health Record a Top Choice for Colorado Physicians
3. Healthy Advice® Networks Physicians Discuss Patient Adherence Challenges at National Conference
4. Millennium Laboratories to Provide UnitedHealthcares Nationwide Network of Physicians Drug Monitoring and Pain Management Services
5. Consolidated Portland, Maine Healthcare Market Will Hamper Pharmaceutical Reps Access to Physicians
6. Sermo Study Shows 63% of Physicians Would Utilize New Gout Treatments
7. Regado Biosciences, Inc. Presents the First-In-Human Clinical Experience with REG2 at the American College of Chest Physicians (ACCP) Coagulation and Heart Disease Sessions in Vancouver, BC, Canada on November 2, 2010
8. Activity Against Key Drug-Resistant Pathogens is the Most Important Attribute Influencing Surveyed Physicians Antibiotic Selection for Nosocomial Pneumonia in the U.S.
9. MedSolutions Offers Free CME Credit Imaging Safety Webinar for Physicians
10. Emergency Physicians Urge Americans to Take The American Medicine Chest Challenge November 13th
11. Physicians Pharmaceutical Corporation Offers Innovative On-Site Drug Dispensaries
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/11/2017)... -- Hill-Rom Holdings, Inc. ("Hill-Rom") (NYSE: HRC), today provided an ... Puerto Rico , where the company ... Following a comprehensive onsite assessment, ... damage, temporary loss of power and minimal water damage ... operations have resumed, and the company expects to return ...
(Date:10/10/2017)... 2017   West Pharmaceutical Services, Inc. (NYSE: ... drug administration, today shared the results of a study ... the intradermal administration of polio vaccines. The study results ... May 2017 by Dr. Ondrej Mach , Clinical ... Organization (WHO), and recently published in the journal ...
(Date:10/5/2017)...  In response to the nationwide opioid epidemic, ... (AAOMS) released prescribing recommendations that urge ibuprofen – ... a first-line therapy to manage a patient,s acute ... Recognizing the value and importance of the ... Acute and Postoperative Pain Management" stresses that practitioners ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... ... Global Healthcare Management’s 4th Annual Kids Fun Run brought out many kids ... sponsored by Global Healthcare Management’s CEO, Jon Letko, is aimed at getting kids excited ... all ages; it is a non-competitive, non-timed event, which is all about having fun ...
(Date:10/13/2017)... ... ... “The Journey: From the Mountains to the Mission Field”: the story of a ... “The Journey: From the Mountains to the Mission Field” is the creation of published ... all ages and currently teaches a class of ladies at her church, which she ...
(Date:10/12/2017)... ... 2017 , ... Planet Fitness, one of the largest and fastest growing franchisors ... a flagship location in Covington, LA at 401 N. U.S. Highway 190, in January ... Office Depot in the Holiday Square shopping center. Its location allows it to serve ...
(Date:10/12/2017)... ... October 12, 2017 , ... Asante, a ... health care, have expanded their existing home health joint venture through an agreement, ... been operating a joint venture home health company with Asante, delivering clinically integrated ...
(Date:10/12/2017)... , ... October 12, 2017 , ... Leading pediatric oncology ... in Washington, D.C., for the 49th Congress of the International Society of Paediatric ... President of the Center for Cancer and Blood Disorders at Children’s National, ...
Breaking Medicine News(10 mins):