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