Is there a path forward for FDA approval of new obesity drugs?
An important artcile was published September 8th, 2011 on the topic of the challenges of FDA approval for new obesity drugs in the United States in the journal Current Opinion in Endocrinology, Diabetes and Obesity. Written by Obesity PPM's Chief Health Policy Officer Morgan Downey, researcher and scientific leader, Dr. Arya Sharma, and clinical leader at the Geisinger Obesity Institute, Dr. Chris Still, the paper is titled "Is there a path for approval of an antiobesity drug: what did the Sibutramine Cardiovascular Outcomes Trial find?" Click here to download the PDF.
Purpose of review
Obesity continues to increase in prevalence in the USA and throughout the world. It is clearly a major contributor to morbidity and mortality. Unfortunately, effective prevention strategies are few. As a contributor to cardiovascular disease, obesity is an important treatment objective. However, before approval, all drugs must meet safety and efficacy concerns of the US Food and Drug Administration.
Recent findings
Since July 2010, the Food and Drug Administration’s Endocrine and Metabolic Advisory Committee has reviewed three new drug applications and one previously approved drug for the treatment of obesity. This review examines in detail the Advisory Committee’sconsideration of the risk–benefit equation of the four drugs with a concentration on sibutramine and its key study, Sibutramine Cardiovascular Outcomes Trial.
Summary
Future development of drugs for the treatment of obesity will be dependent on whetherthey can survive review for safety and effectiveness. The Food and Drug Administrationcontinues to be highly concerned with proposed obesity drugs increasingcardiovascular or any risks and may require changes to clinical research protocols.KeywordsFood and Drug Administration approval, obesity, weight loss medications
Unspoken: The Childhood Sexual Abuse – Obesity Connection
For the past week, shocking news has come out of Penn State University of alleged child sexual abuse by a former football defensive coach, Jerry Sandusky. The scandal has taken down the university’s president and its famed head coach, Joe Paterno. The school’s credit rating has been downgraded; federal and state agencies are investigating.
Most of us react to such news with a sickening feeling of the psychological trauma the victims of such abuse, in this case including a 10 year old boy, must endure. Less well researched is the connection between child sexual abuse and adult diseases including mortality.
In 1998, Felitti et al. published a paper on the relationship of childhood abuse and household dysfunction to the leading causes of death in adults. Their study included children who were exposed to psychological, physical or sexual abuse, violence against the mother, living with household members who were substance abusers, mentally ill or suicidal or ever imprisoned. They founded a graded relationship between the number of categories of childhood exposure and adult health risk behaviors.
Is the Obesity Epidemic Leveling Off? Don’t be Too Sure.
Recently, CDC epidemiologists published an article in the Journal of the American Medical Association to the effect that there was not a significant change over the past 12 years in the nation’s obesity rate of 35.5% for adult men and 35.8% for adult women. Many, but not all, media reports interpreted this as meaning the obesity epidemic was leveling off. But is that really the case? Let’s look behind the headlines.
First, let’s keep in mind that, even if BMI is highly correlated with body fatness, it still misses a lot of groups for whom the BMI is a crude indicator of body fatness or excess adipose tissue.
Second, obesity prevalence should not be judged by making the BMI of 30 the sole criteria. This is better explained if you look at the “etables” accompanying the article. These breakdown the categories by age and gender and graphically plot the changes in BMI from 1988 to 2010. While each graph is slightly different, they basically all show three trends: the population at normal weight is declining, the population with a BMI of 30 is getting even heavier and the BMI level for 90% of each subgroup is progressively increasing. Bottom line: fewer Americans are at a normal weight and the overweight and obese subgroups are gaining weight.
OAC & Obesity PPM Joint Press Release
Obesity Action Coalition (OAC ) Partners with Obesity PPM on Online Educational Initiative to Increase the Understanding of the Complexity of Obesity
For Immediate Release
December 28th, 2011
For More Information:
James Zervios
Director of Communications
(800) 717-3117
This email address is being protected from spambots. You need JavaScript enabled to view it.
Tampa, Fla. – In February 2012, the OAC and Obesity PPM will launch a long-term online educational initiative to increase understanding of the complexity of obesity and its many causes. The disease of obesity impacts individuals physically, emotionally, economically and socially. This initiative will look at various factors both controllable and uncontrollable by individuals affected by obesity.
Running throughout 2012 and 2013, the initiative will take a three-pronged approach: a 14-part series of publicly available webinars, articles addressing aspects of Obesity PPM’s Twelve Pillars® model, and social media enriching the public dialogue about each event topic. The first live, online event will take place in late January 2012.
