Qnexa’s Second At-Bat

February 17th, 2012 No comments »

Interest is rising as Vivus Inc.’s next date with the Food and Drug Administration draws near. The Endorinologic and Metabolic Drug Advisory Committee meeting on February 22, 2012 will reconsider whether to approve Qnexa, which is a combination of phentermine and topiramate. Both drugs are already approved by the FDA and are available as generics.  The FDA has put out their briefing materials, as well as that from Vivus on their website. Endocrinologic and Metabolic Drugs Advisory Committee > Briefing Information for the February 22, 2012 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee

The materials indicate that the Advisory Committee will be debating how to mitigate the exposure by women of childbearing potential to half of the Qnexa compound, topiramate.

Media interest is reflected in a front page story by Andrew Pollack in the New York Times. Diet Treatment, Already in Use, to Get F.D.A. Review – NYTimes.com

Son of Fen Implicated in French Deaths

February 11th, 2012 No comments »

A French study has determined that a fenfluramine-deritative drug, half of the Fen-Phen combination, may be responsible for   3,100  hospitalizations and   1,300 deaths. Estimate of deaths due to valvular insufficiency attributable to the use of benfluorex in France – Fournier – 2012 – Pharmacoepidemiology and Drug Safety – Wiley Online Library  The authors  believe these figures are likely underestimations.

FDA Sets Hearing on Cardiovascular Aspects of Obesity Drugs

February 9th, 2012 No comments »

The Food and Drug Administration (FDA) has announced two days of hearings on the role of cardiovascular assessment in the preapproval and postapproval settings for drugs and biologics developed for the treatment of obesity, March 28 and 29th, 2012 Advisory Committee Calendar > March 28-29, 2012: Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement

Michelle Obama Changing Military Food Choices

February 9th, 2012 No comments »

Reuters has reported that Michelle Obama will join in an announcement of new nutrition standards for the armed forces 1,100 dining facilities. Over a quarter of eligible 17-24 year olds are too overweight to join the military. Once in, members of the military are gaining too much weight. Department of Defense officials describe this as a “national security problem.” The military spends about $4.65 billion on food services each year and an estimated $1.1 billion on medical care associated with excess weight and obesity. http://www.reuters.com/article/idUSL2E8D90AO20120209

The military’s struggle with obesity has always been an interesting one. It is probably the largest sub-group in the US population with a high number of young people and a culture most supportive of physical activity. In addition, exceeding the different services’ weight standards can result in loss of a career. So, with all that, one would think it would have it’s weight problem pretty well under control. Yet, it isn’t which is probably due to the fact that it is not as isolated from the rest of society. In addition, the physical work of soldiers and sailors have given way to more and more technologically based skills.  Nonetheless, fighting wars, repeated deployments and family issues drives up stress. Obesity rates of US soldiers has doubled since the start of the Iraq war. Families are also affected. Tens of thousands of spouses have had bariatric surgery costing $363 million over ten years. Military spent $363million on WEIGHT-LOSS surgery for obese soldiers’ wives over last ten years | Mail Online One spouse reported becoming depressed and engaging in emotional eating and finally losing 118 pounds.

The future problems for military recruitment are very serious. John Cawley and JC Maclean have calculated that from 1959-2008 the percentage of the population ineligible for service more than doubled for men and tripled for women. They estimate that a 1% rise in weight and body fat would further reduce eligibility by over 850,000 men and 1.3 million women. Unfit for service: the implications of rising ob… [Health Econ. 2011] – PubMed – NCBI

Orexigen and FDA Agree on New Study

February 6th, 2012 No comments »

Orexigen Therapeutics Inc. has announced that it has reached agreement with the Food and Drug Administration on a new protocol to test for adverse cardiac events for it obesity-fighting compound, Contrave. Orexigen Therapeutics, Inc. – Press Release

How Blame Gets in the Way

February 5th, 2012 No comments »

Recommended reading. Sara Sklaroff has written an eloquent essay on what it means to live with type 2 diabetes. On Our Own: Why We Who Struggle To Live With Diabetes Could Use A Helping Hand

Arena to Get Second Shot at Approval

February 2nd, 2012 No comments »

Arena Pharmaceuticals Inc. (and its partner Esai Inc.) have announced that they have been informed by the Food and Drug Administration that an Advisory Committee meeting will be held in the second quarter on their weight loss drug candidate, lorcaserin.  Arena Pharmaceuticals Receives Notice from FDA of Advisory Committee Meeting for Lorcaserin (NASDAQ:ARNA)  Arena is expected to produce information on efficacy and tumor development with their drug.

Competitive Food Sales in Schools Not Affect Obesity

February 2nd, 2012 No comments »

Most US middle and high schools sell soft drinks, candy and chips to their students. These practices have been widely criticized as contributing to childhood and adolescent obesity. However, a new study followed  approximately 19,450 children from fifth to eight grade. Researchers found the children’s weight gain was not associated with the introduction or the duration of exposure to competitive foods. This did not vary by gender, race/ethnicity or family socioeconomic status. Possible explanations are that children’s food preferences and dietary patterns are firmly established before adolescence. Also, schools are highly structured whereas home life may have more opportunities for snacking. http://www.asanet.org/images/journals/docs/pdf/soe/Jan12SOEFeature.pdf.