Thursday, May 30, 2013

Knowing How Bariatric Surgery Causes Weight Loss Can Lead to Beneficial Therapies

Bariatric surgery is an effective approach to weight loss for those dealing with severe obesity. In fact in many cases, bariatric surgery has proven to be more effective in providing long term weight loss than diet, exercise, drugs, or lifestyle modification. However, the surgery can cause trauma and associated complications. Therefore, extensive research is ongoing to develop therapeutic methods that provide bariatric surgical weight loss results without the related trauma and potential complications.

We've believed, for some time, that investigation into how bariatric surgery causes weight loss and other positive changes in the body would be beneficial in helping experts develop multiple therapies for treating obesity.

It is commonly felt that bariatric surgery produces weight loss because the surgery makes physical changes to the body that restrict the amount of food a person wants to eat, or the surgery modifies the intestinal system to allow less calories to be taken in when food is eaten.  But bariatric surgery appears to do more.

Investigators in Sweden have found that bariatric surgery induces modifications in gene expression after the weight loss. The changes occur in at least two genes. These genes are "called PGC-1alpha and PDK4." And these genes play the primary role in glucose control and fat metabolism.

Another study indicates that bariatric surgery changes gut bacteria. The surgery "replaces fattening microbes with slimming ones." And researchers at Massachusetts General Hospital and Harvard University did investigations to determine if the gut changes were the cause or the result of weight loss after bariatric surgery.

In the study, the researchers transferred gut microbiota from obese mice that had undergone bariatric surgery to obese mice that had not had the surgery. And these mice lost weight. (Precautions were taken to insure that the experimental results were accurate.)

But again, while studies like the two mentioned above show that bariatric surgery does have positive  effects, we should not forget that the surgery causes trauma and can cause complications. Still, the studies show how important it is for researchers to investigate bariatric surgery as a way to develop therapies that can lead to beneficial weight loss and other improvements in health without the trauma associated with bariatric surgery.

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Wednesday, May 15, 2013

The Market for Vivus' Obesity Drug Qsymia

Qsymia, a new obesity drug, was approved by the FDA (Food and Drug Administration) in 2012 and is currently on the market. While Qsymia received a good deal of positive press prior to FDA approval, Qsymia's market results, so far, have been less than robust. One of the reasons for poor market results are FDA restrictions initially attached to the drug. When given approval, the drug could be sold only by specific pharmacies via mail-order.

Qsymia is produced by Vivus, a California based company. The drug is a combination of two existing FDA approved drugs. The drugs are Topiramate and Phentermine. Topiramate gained FDA approval in 1996 and is used, mostly, to treat seizures. And Phentermine  was approved in 1959 as a short term (a few weeks or a few months) treatment for obesity.

Concerning the Qsymia restrictions mentioned above, the FDA recently loosened those restrictions. The drug can now also be sold by "certified retail pharmacies." Indeed, as Peter Tam, the president of Vivus stated, "U.S. health regulators' approval to [let Vivus] sell its diet pill Qsymia through retail pharmacies removed 'a major barrier' to the drug's adoption and paved the way for a direct-to-consumer campaign to be launched later this year."

However, while the FDA's easing restrictions will likely help Qsymia in the marketplace, there are other issues hindering Qsymia's market performance. One of the issues is the concern that obesity drugs, in general, have not shown they  have long-term benefits. And many leaders of health care organizations block access to obesity drugs.

Nevertheless, if the drug is easier to purchase, more people will probably use the drug. And with more usage, Qsymia and other obesity drugs will have the opportunity to demonstrate their safety and effectiveness. And with success, more insurers will cover the drugs and more practitioners will prescribe the drug.

Indeed, there is a market for obesity drugs.  According to experts, there are approximately 78,000,000 obese people in the U.S. And if just 500,000 people are prescribed the drug, at $167.00 per month, the yearly sales revenue would be a billion dollars. And in some eyes, that would make the drug a blockbuster

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