ANTI-OBESITY PILL- SAFETY CLEARANCE ON CARD

In a desperate move to arrest the rapid spread of obesity epidemic, there appears to be a concerted move to choose a different approach in the US which is in the forefront when it comes to population with over weight and obesity. Though the major factor responsible for this undesirable development can be attributed to consumption of low quality and high quantity foods by the people, very little progress has been achieved in "persuading" the citizens to eat only healthy food, that too moderately and to be physically active. Industry, especially the Drug manufacturers, cannot be faulted if an opportunity opens up to peddle drugs that can control obesity and this is what is happening in the US. A drug like Qnexa, rejected two years ago, has made a stunning come back and with the likely of approves by the FDA soon, a multi billion industry is going to be spawned. Here is a take on this interesting development. 

"A federal advisory panel on Wednesday overwhelmingly recommended approval of what could become the first new prescription drug to treat obesity in 13 years. The advisory committee to the Food and Drug Administration voted 20 to 2 that the benefits from the weight loss provided by the drug, Qnexa, more than offset the potential risks of heart problems and birth defects. The strongly positive vote, which was not widely expected, represents a stunning comeback for Qnexa and for its developer, the drug company Vivus. In 2010, the same advisory committee, with a somewhat different membership, recommended 10 to 6 against approval, and the F.D.A. then rejected the drug. Some committee members who opposed it last time said they were reassured this time that steps would be taken to minimize the risks, such as by making it hard for pregnant women to get the drug. They also seemed persuaded by the view expressed by Vivus and by some obesity specialists who testified at the hearing that obesity itself causes health problems and that there is a pressing need for treatments. "There is an urgent need for better pharmacologic options for individual patients," said Elaine H. Morrato, an assistant professor at the University of Colorado, Denver, who voted no in 2010 and yes on Wednesday. "I believe that Qnexa demonstrated a meaningful efficacy benefit and that there are consequences to nontreatment of obesity," she said. The F.D.A. is expected to decide whether to approve Qnexa by April 17. It usually follows the recommendations of its outside advisers, but not always. In 2011, it rejected a different obesity drug that had been endorsed by the advisory committee".

It is not clear why the new drug is going to be permitted now, though not much additional data has been provided by the manufacturer regarding its safety. Is it possible that the new members of the advisory committee are influenced by considerations other than consumer safety in gloating over the side effects of this drug reported in some quarters? One consolation is that this new drug will be available only on prescription and will not be accessible to most people easily. Of course one an expect the manufacturer to overwhelm the medical community with sustained promotional programs and the drug may become the most frequently prescribed one within a couple of years. What catastrophe this will bring about in the long run remains to be seen. Now Americans will have the luxury of "having the cake as well as eating it" with no worry about the consequences!

V.H.POTTY
http://vhpotty.blogspot.com/
http://foodtechupdates.blogspot.com