Thursday, June 28, 2012


Yesterday, the US FDA approved the drug BELVIQ / Lorcaserin, by US Arena Pharmaceuticals, for the treatment of Obesity.
It is true the the whole developing world is attacked by this epidermic called obesity. WHO is advising the whole world to fight obesity, thereby hoping to arrest Diabetes, hypertension and cardiovascular disease ( CAD and stroke ). This is correct. Because of the " hurry, curry, lazy" culture in our country, we too have seen an alarming rise in obesity, especially childhood obesity, in Malaysia. I blame it on the MacDonald diet of fast food, high carbs, sodas, coupled with little exercise ( instant remotes, escalators, lifts to each floor, couch potato ).  Last night, I heard CNBC interview Mr Skinner, the out going MacDonald CEO, who boldly declared that whatever regulations that government can put on the public about "unhealthy " diets, MacDonald will have a way of campaigning against it. Such is the power of big corporations and their advertisement and promotional machinery.
Anyway, back to BELVIQ. The pharmacological name is Lorcaserin, and it is a serotogenic agent, meaning that it acts at specific serotonin receptors in the brain, mainly around the hippothalamus area. There at the satietic site, it suppresses appetite, so that eating a little makes you full. Actually, this drug was submitted for approval in 2009 and rejected, because of safety and efficacy concerns. They re-submitted with new 1 year data, and approved it yesterday. It does cause patient to lose an average of 5% body weight over the treatment period and weight lost seemed to be maintain over at least 2 years.
I am concerned about the safety aspect. All the clinical trials done were short term, from weeks to 2 years follow up. The reported side effects are nausea, dizziness and headache. However, the issue may not be so simple. Of course, we are biase because we have seen what happened to the other serotogenic agent - the Phen-Fen issue and also what happened to rimanobant, the other centrally acting agent. Both these agents approved, subsequently cause valvular heart disease and deaths and had to be withdrawn. I am afraid to suggest that Belviq, may end up with the same problem as Rimanobant, as they both stimulate the anorexic center and suppress the satiety center in the hippothallamus. I am afraid of depressions, suicides and also sudden cardiac death with Belviq. It is true that so far, we have not seen it. I think the largest study is about 3,000+ patients. When it is widely used, I am afraid that these side effects may appear. It is also on record that when Arena Pharma first applied for approval in 2009, FDA had some safety concern about the possibility of associated tumours, but this were subsequently forgotten ( no mention ), in the current approval.
Well US FDA has approved Belviq for use to treat obesity in patients with BMI > 30 or in patients  with BMI > 27 plus one important coronary risk factor like hypertension and diabetes.
Basically, the best way to lose weight is diet and exercise, but this is also the difficult, disciplined way, and the younger generation may not be too fond of this. A pill is a short-cut.

No comments: