| Today, I am going to deal with three pieces | | | | public health response to the obesity crisis. |
| of back-to-back news about the weight loss | | | | |
| market in general and Acomplia in particular. | | | | Which brings me to the specific Acomplia |
| | | | news. Last June, the Berlin social court |
| Decision Resources is one of the world's | | | | classified Acomplia as a "lifestyle" drug. In |
| leading research firms on health care and | | | | doing so, the court was confirming the |
| pharmaceutical issues. In a recent report, it | | | | decision made by the G-BA - a self-regulating |
| confirms that obesity has reached epidemic | | | | body of doctors and health insurers that |
| proportion in seven of the world's major | | | | makes drug recommendations. German law does |
| markets: France, Germany, Great Britain, | | | | not allow the state-run health insurance |
| Italy, Japan, Spain and the United States. | | | | companies to reimburse patients for |
| Given the potential need for effective | | | | non-therapeutic expenditure. There is a |
| treatments, the company predicts that the | | | | prejudice that being overweight is not an |
| market will grow fivefold by 2016 from the | | | | illness requiring treatment but the result of |
| base figures in 2006 where sales are | | | | lifestyle choices by the individual. This |
| estimated at $478 million to $2.7 billion. | | | | month, an appeal against this decision was |
| | | | rejected which leaves Acomplia firmly |
| Given the rate of growth in the incidence of | | | | restricted to the middle and upper classes |
| obesity, Decision Resources predicts that the | | | | who can afford to pay for it, and denies |
| need for safe, effective and well-tolerated | | | | treatment to the poor whose diet may put them |
| medications will be strongest in the US. But, | | | | more at risk of obesity. |
| the experience of Sanofi-Aventis is | | | | |
| instructive. When it applied to the Food and | | | | And back in the US, the latest edition of the |
| Drug Administration (FDA) for the approval of | | | | journal Cell Metabolism is carrying |
| Acomplia, the FDA proved sceptical and | | | | encouraging new animal-study findings that |
| demanded significantly more evidence of the | | | | Acomplia may be useful in blocking the |
| medication's safety. Sanofi-Aventis withdrew | | | | development of alcoholic fatty liver - a |
| the application and will resubmit next year. | | | | major cause of liver disease. Mice treated |
| But this reaction from the FDA has become | | | | with Acomplia did not experience alcohol's |
| more common and it could slow the arrival of | | | | fat-building effects. The researchers |
| all the new medications in this category | | | | speculate that Acomplia could be an effective |
| (Amylin, Arena Pharmaceuticals, Merck and | | | | treatment in humans to reverse the fatty |
| Pfizer all have antiobesity medications in | | | | deposits and so prevent the progression into |
| the development pipeline). | | | | a full liver disease without the need to make |
| | | | the full lifestyle change to give up the |
| So we have an interesting situation | | | | addiction for alcohol (which is often not |
| developing. Looking at the current | | | | possible). They call for full clinical |
| medications in development, they either work | | | | trials. |
| in the same way as Acomplia and so may run | | | | |
| into the same safety concerns, or they rely | | | | How ironic that we should have such good news |
| on injections which are less a convenient | | | | about how effective Acomplia may be at the |
| delivery system. Thus, there are no obvious | | | | same time as the US and German authorities |
| "blockbuster" medications due to appear in | | | | seem so unsympathetic to the antiobesity |
| the US market in the next eight years - a | | | | market's needs. |
| sobering thought for those planning the US | | | | |