Archive for July, 2010

New Analyses Cast Doubt on Fruits, Vegetables, Physical Activity to Control Obesity

July 24th, 2010

July 24, 2010

A review of the relationship between fruit and vegetable intake with adult and childhood obesity casts doubt on how strong is the relationship with weight management. The review was undertaken by TA LeDoux and colleagues from the Department of Pediatrics at the USDA/Agricultural Research Service Childrens’ Nutrition Research Center at Baylor College of Medicine.

They found that, after reviewing 772 studies, increased food and vegetable consumption (in conjunction with other behaviors) contributed to reduced adiposity among overweight or obese adults but no association was shown among children.

While the quality of the studies varied widely, the relationship between high fruit and vegetable consumption and low obesity among “was weak” and among children “unclear.”

The study can be accessed at Relationship of fruit and vegetable intake with ad… [Obes Rev. 2010] – PubMed result

In a separate study, doctors in Plymouth, United Kingdom following 202 children for 7 to 10 years, found that overweight preceded physical inactivity, not the other way around.  As most childhood obesity interventions assume inactivity precedes obesity, this study, if validated, indicates a change in strategy to combat childhood obesity. See Fatness leads to inactivity, but inactivity does n… [Arch Dis Child. 2010] – PubMed result

Stealth Provision Expands Obesity Coverage for Millions

July 21st, 2010

 

On July 19, 2010, The Department of Health and Human Services issued ‘interim final regulations’ requiring  insurers in the group and individual markets  to include preventive services without any cost sharing as part of the the health care reform law signed by President Obama earlier this year. Preventive services include an important, sleeper provision regarding obesity. Here’s how it works.

The law defines “preventive services” as those with an A or B grade recommendation from the U.S. Preventive Services Task Force (USPSTF). The USPSTF has B grade recommendations for intensive behavioral counseling for adults with obesity and for screening and counseling for children. U.S. Preventive Services Task Force Recommendations

Coverage without cost sharing goes into effect on September 23, 2010. Interestingly, the regulations do not provide any limitations on the frequency, intensity or duration of such coverage. This represents a significant new benefit coverage  affecting millions of Americans. Most of the USPSTF recommendations cover screening tests but counseling is covered for tobacco cessation, sexually transmitted infections, dietary counseling for persons with hyperlipidemia and related cardiovascular risk factors, and promote breast-feeding.

I call this a stealth provision because Congress assumed the USPSTF recommendations were screening tests and probably would have rejected this kind of coverage as a listed benefit.

The regulation background information discusses the low level of obesity counseling presently and the benefits to be expected from broader coverage.

Comments can be received for 60 days from July 14, 2010. The proposed regulation can be accessed at Federal Register Contents, Monday, July 19, 2010

FDA Panel Nixes Qnexa

July 16th, 2010

July 16, 2010

I spent three days at the FDA Advisory Committee hearings this week. The first two days were devoted to Avandia for type 2 diabetes. The third day consisted of a review of the anti-0besity medication, Qnexa, made by Vivus Inc.

The committee voted to keep Avandia on the market in spite of long term studies, meta-analyses and observational studies all pointing to an increased risk of heart attacks. And this in a field where there are multiple classes of drugs which enhance glucose control. The evidence was there (in my opinion) but the committee stuck with the drug.

On the other hand, in reviewing Qnexa, the evidence was there that it met the FDA’s requirements for approval. What the committee had was higly speculative fear that it might be approving another phen-fen. (Never mind that Qnexa’s two components – phentermine and topirmate – have been used for decades.) Fear trumped evidence when it comes to obesity products.

Most of the audience at the hearing felt stunned when the vote was announced. Most had expected easy approval as the effectiveness data was very clear and the safety issues were well-addressed, small and mainly speculative. Hopefully, the FDA will look at the company’s two year data in September and approve Qnexa.