Navigation Links
Physicians Who Treat Obesity Question FDA Rejection of Contrave

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

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:
(Date:6/26/2016)... DUBLIN , June 27, 2016 Jazz ... the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act ... proposed acquisition of Celator Pharmaceuticals, Inc. ("Celator"; Nasdaq: ... 11:59 p.m. (Eastern Daylight Time). As previously ... entered into a definitive merger agreement under which Jazz ...
(Date:6/24/2016)... June 24, 2016  Consumers have taken a ... have placed more emphasis on patient outcomes. ... programs in the pharmaceutical industry have evolved beyond ... pharmaceutical companies are focusing on becoming more patient-oriented ... products and services that improve health. ...
(Date:6/24/2016)... 24, 2016   Bay Area Lyme Foundation ... Dean Center for Tick Borne Illness , Harvard ... MIT Hacking Medicine, University of California, Berkeley, and ... the five finalists of Lyme Innovation , ... than 100 scientists, clinicians, researchers, entrepreneurs, and investors ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... June 26, 2016 , ... PawPaws brand pet supplements ... was developed to enhance the health of felines. The formula is all-natural and is ... herbs in the PawPaws Cat Kidney Support Supplement Soft Chews are Astragalus ...
(Date:6/25/2016)... ... June 25, 2016 , ... The temporary closing of Bruton Memorial Library on June 21 ... brings up a new, often overlooked aspect of head lice: the parasite’s ability to live ... not a common occurrence, but a necessary one in the event that lice have simply ...
(Date:6/25/2016)... ... June 25, 2016 , ... On Friday, June 10, Van Mitchell, Secretary ... Work award to iHire in recognition of their exemplary accomplishments in worksite health promotion. ... Maryland Workplace Health & Wellness Symposium at the BWI Marriott in Linthicum Heights. iHire ...
(Date:6/24/2016)... ... ... Marcy was in a crisis. Her son James, eight, was out of control. Prone to ... , “When something upset him, he couldn’t control his emotions,” remembers Marcy. “If there ... my other children and say he was going to kill them. If we were ...
(Date:6/24/2016)... Rhinebeck, NY (PRWEB) , ... June 24, 2016 , ... Topical BioMedics, Inc, makers of ... of companies that call for a minimum wage raise to $12 an hour by 2020 ... wage. This will restore the lost value of the minimum wage, assure the wage floor ...
Breaking Medicine News(10 mins):