drug

Weight-loss pharmaceutical that caused tumors in animal studies approved for Lazy America

Wednesday, July 04, 2012 by: J. D. Heyes
Tags: weight loss, drug, FDA

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Delicious
(NaturalNews) Perhaps the only thing worse than a population not motivated to cut the size of its collective waistline is approving a "weight-loss" medication that may cause cancer.

A sick joke, right? Wrong.

For the first time in 13 years (thank Big Pharma and Big Lawsuits), the U.S. government has approved a weight-loss medication. The Food and Drug Administration has given the go-ahead to Arena Pharmaceutical, of Zofingen, Switzerland, to manufacture Belviq, a drug which, according to reports, can be utilized by overweight or obese adults with at least one of those conditions.

In clinical trials, the BBC reported, the drug achieved only "modest" results, helping folks lose an average of about five percent of body weight. To put that in perspective, someone who weighed 225 pounds (but maybe should only weigh about 170) only lost about 11 pounds.

But here's the rub: Not only does the drug appear to only minimally affect obesity, it's potentially deadly as well. It was rejected by the FDA in 2010 because officials were concerned about tumors that had developed in animals tested with the drug.

However, somehow after the San Diego-based Big Pharma resubmitted its application with more information, the FDA suddenly found "little risk of tumors in humans using the drug," the BBC reported. Now, the medication is expected to launch in 2013.

What the drug does - and doesn't - do

According to published information regarding Belviq, the drug ostensibly works by blocking appetite signals in the brain, and it's supposed to make patients feel like they're fuller on less food. It's recommended for obese patients with a body mass index (BMI) of 30 or greater ("normal" BMIs change with age and differ by sex, but generally BMI for men should be 20-26 and women 19-25, for comparison's sake).

The drug can also be prescribed to people with a BMI of 27 or more if they've got another medical condition such as type 2 diabetes, high blood pressure or elevated (bad) cholesterol. It is not recommended for women who are nursing.

While the approval process may be a little dicey, there is a clear market for the pill (though we'll always recommend diet and exercise at NaturalNews as the best way to fight your own personal battle of the bulge). More than one-third of the U.S. population is obese, and that has led to a resultant dramatic rise in the occurrence of other medical conditions, as well as a huge spike in healthcare costs.

"Obesity threatens the overall well being of patients and is a major public health concern," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a statement. "The approval of this drug, used responsibly in combination with a healthy diet and lifestyle, provides a treatment option for Americans who are obese or are overweight and have at least one weight-related comorbid condition."

The tumor risk seems to be all but forgotten by the FDA.

Short leash for Arena

The last time a major diet drug was on the market - the so-called Fen-Phen combo of fenfluramine and dexfenfluramine - was pulled in 1997 after it was linked to heart valve damage.

"When used at the approved dose of 10 milligrams twice a day, Belviq does not appear to" cause the same kind of damage, the FDA said.

To its credit, the agency is putting Belviq - and its manufacturer - on a short leash.

Arena "will be required to conduct six post-marketing studies, including a long-term cardiovascular outcomes trial to assess the effect of Belviq on the risk for major adverse cardiac events such as heart attack and stroke," the agency said.

But honestly, it's almost possible to lose five percent of body weight just getting off the couch regularly and walking through the average house. While that's an exaggeration, just think of what walking three-to-four times a week, for 30 minutes at a time, would do for you.

We're betting much better than five percent. And you'd be drug-free.

Sources:

http://www.bbc.co.uk/news/world-us-canada-18620860

http://www.halls.md/body-mass-index/bmirefs.htm

http://www.cbsnews.com

http://www.fda.gov

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