Archive for the ‘Governmental Efforts’ Category

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What's an obese person going to do now?

Friday, October 29th, 2010

It's not surprising to me; the drug Qnexa wasn't approved by the FDA for use in weight loss. Why not? After all it's a combination of low doses of two medications that are already approved. Phentermine was first approved by the FDA in 1959 and for weight loss even, although we're talking short-term use in combination with dieting. The other drug, topiramate, was approved in 1996 for epilepsy and more recently for prevention of migraines.

I hadn't heard of Qnexa when I saw the article in the New York Times yesterday, but today I've had time to look at it's pros and cons and put the risks in perspective.

Qnexa is made by a company called Vivus; their stock went up 28.06% today; I guess that was in anticipation of the medication being approved. When I looked at the company's website, they detail the problem of obesity. It's a major factor in diabetes type 2, high blood pressure, cardiovascular disease and stroke. Some have called it the second leading cause of preventable deaths in America.

Over 400 million people worldwide are obese and it's said to be responible for 9.1% of the annual US healthcare spending; that nearly 150 billion dollars.

And Qnexa has gone through Phase 3 trials on over 4,500 patients with three trials. Its results were impressive; one article mentioned a 14.7% (37 pound) weight loss over a 56-week period. Another controlled trial result said 10.6% compared to 1.7% for those who got placebos.

So why not approve the drug? Well, the answer lies in what pre-clinical and clinical trials do and don't show.

Let's start with Phase Zero through III. Those are conducted with human subjects, initially with tiny doses looking at how the body processes the drug and how it works, progressing to is the drug reasonably safe and tolerable studies with small groups closely observed. Then we go to larger groups for activity and safety and finally to randomized controlled multi-center studies.

At that point the dug may be approved, but, there is Phase IV, post marketing surveillance. That is to detect rare or long-term adverse effects in much larger groups of patients.

Several drugs have been withdrawn or subjected to limited use in Phase IV.  There have been some risks shown in early trials; millions of people would potentially take the drug if it were to be approved. Side effects would conceivably be greater and more serious than smaller studies have shown. Lots of lawsuits could result.

So it's not just the name of the drug being hard to pronounce (who came up with Qnexa?).

I suspect the medication may eventually be approved, but time will tell.

Posted in Governmental Efforts, Obesity | No Comments »

Healthy School Snacks

Friday, October 22nd, 2010

I read an interesting article in the Wall Street Journal yesterday and then perused lots of background information on the Web. The article itself described the challenges of designing a vending machine that could dispense healthier snacks, especially for schools. I had heard that many school districts and even some states were concerned about the obesity epidemic and wanted to quit offering candy bars and sugared sodas. It's not that easy.

One company now offers a vending machine with two major compartments, one for bananas and the other for fresh-cut fruits and veggies. The banana compartment is kept at 57 degrees and the other area at 34 degrees.  They're working on the issue of keeping the fruit, especially the bananas, from getting bruised when it's selected and falls to the delivery area.

The Center for Science in the Public Interest has a website which I found by Googling "Healthy School Snacks." They noted that over a nineteen-year period (1977 to 1996), our kids' calorie consumption from snacks had increased by 120 calories per day. That's roughly equivalent to a ten pound a year weight gain.

They estimated that cost of serving fresh, frozen or canned fruits and veggies would be about 25 cents a day. That's a lot less than their estimates for single-serving bags of potato chips at 69 cents or candy bars at 80 cents.

They gave some suggestions for kid-friendly snacks, including a clever recipe for "Ants on a Log." made by spreading peanut butter on celery sticks and adding raisins.

Then I found the December 2009 Massachusetts Food and Beverage Standards to Promote a Healthier School Environment. They mention the national Action for Healthy Kids (AFHK) initiative (http://www.ActionForHealthyKids.org). That website is well worth looking at, but I concentrated on the Massachusetts plan itself.

A survey done in Massachusetts in 2005 showed over a quarter of students at risk for overweight or already overweight. So state officials and a bevy of advisors were concerned about so-called "competitive foods," which often are high in fats and sugars.  These are sold in vending machines, in school stores or in fundraisers and compete with the well-regulated school lunch and breakfast programs.

Now the state has published a set of well-reasoned guideline for various foods and beverages that might be offered in the schools. The John Stalker Institute website has links for the information.

Take a look, whether you have kids or grandkids in school or not. We need to get behind efforts like this. Adults may be set in their eating habits and reject sound advice; school kids are a captive audience in a sense and their lifetime eating habits can be influenced for their good.

Posted in Governmental Efforts, Healthy eating, our kids and their weight issues | No Comments »

Food Stamps and Obesity

Thursday, October 7th, 2010

In 2004 the state of Minnesota tried, unsuccessfully, to ban the purchase of "junk food" with food stamps. The request was eventually denied by the USDA on rather strange grounds, that it would "perpetuate the myth" that food-stamp users made bad choices in their grocery shopping.

In the meantime the obesity epidemic in the United States rolled on and now, in an article in today's New York Times, I read that the mayor of New York City has asked the federal government for permission to stop food-stamp recipients from purchasing sugared drinks, sodas, of course, being the major culprit in this case.

I'm waiting for the answer, but my bet is the request is denied, although we already, according to the article, ban the use of food stamps to purchase other items that can be health-detrimental, especially cigarettes and alcoholic beverages. The beverage industry will obviously lobby against the plan.  Even the Center for Science in the Public Interest, a non-profit consumer advocacy group with a focus on nutrition and health, food safety, and alcohol policy, suggested we should instead use educational programs to teach food-stamp recipients about the dangers of sugared drinks.

So is Mayor Blomberg in favor of a Big Brother era? He already has lobbied for a state tax on sugared drinks (unsuccessfully), tightened rules on food advertising and brought the city's schools a tougher policy on which food items they can sell.

Yet almost 40% of the kids in NYC's public schools at the K-8th grade level are overweight or obese, with rates still higher in poorer areas of the city. In those same neighborhoods, studies are said to show sugared beverages are consumed at higher rates than in leaner sections of the metro area. Diabetes is twice as prevalent in poor areas of NYC as it is in more affluent ones.

So where do we stop? I totally agree that we're at a crisis point as a society, one fueled by the food industry. I personally deplore the use of food stamps to purchase sugared beverages as much as I do their being used to procure cigarettes and alcohol-containing drinks.  But who gets to decide what our choices are in a free society?

Tough questions without easy answers.

Posted in Governmental Efforts, Healthy eating, Obesity | 3 Comments »

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