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 | | NO ‘SILVER BULLET’ CURE FOR OBESITY EPIDEMIC | | | Datamonitor | | 21/01/2008 | | | The obesity epidemic is sweeping the globe and it seems no country is immune. The United States is regarded as the most obese nation in the western world, with one in three adults classified as clinically obese. However, the UK is not far behind. By 2015, almost 16 million Britons over the age of 20 are forecast to be obese – about the current population of the Netherlands. While anti-obesity drugs are available, the growth in their use is not mirroring the growth in the obese population because they are not reimbursed by governmental health bodies, most of whom consider obesity a ‘lifestyle’ disease. While some believe obesity is a bigger public health threat than climate change, according to a report by independent market analyst Datamonitor, the anti-obesity drug development pipeline is unlikely to produce a pharmacological ‘silver bullet’.
Obese present huge financial burden
Because of the high risk and large number of co-morbidities related with obesity, such as heart disease, stroke and diabetes, a population with a high rate of obesity represents a huge financial burden for governmental health services. Obesity is defined in most countries as someone with a body mass index (BMI) of 30 or more. The World Health Organisation (WHO) estimate there to be at least 400m clinically obese people worldwide and the rapidly expanding epidemic shows no signs of slowing, says Datamonitor cardiovascular analyst Evguenia Rossikhina. “Few European countries have rates of obesity below 10% and prevalence rates, particularly among women, have risen to more than 20% in countries such as the UK and Germany.
“The most rapid increase has been observed in England, where obesity rates have risen three-fold from 1980 to 2001,” she says.
Simply speaking, the huge rise in obesity is down to the over consumption of calories and inadequate physical activity. In practise, this is due to the increasingly sedentary nature of life in western societies, where people have become increasingly dependent on motorized modes of transport and children are less likely to engage in energy-expending activities, preferring passive pastimes like watching television instead. In addition, the increase in fast food and convenience food consumption has risen due to the hectic lifestyle led by people nowadays. This is especially obvious in Japan, as the increasing westernization of diet has led to a sharp increase in the prevalence of obesity.
However, while there are drugs on the market designed to combat obesity, the use of these drugs has not increased in line with the rise in prevalence of the disease. This is in some measure because those currently on the market are associated with unpleasant side effects. It is also due to a perceived lack of efficacy, in some part at least due to inflated expectations of weight loss on the part of the patients and unwillingness to change their lifestyle, Ms. Rossikhina says. “Patients that are motivated to lose weight usually comply with treatment. However, problems commonly occur in maintaining the weight loss and behavior modification essential to keep the excess weight off.
“Key opinion leaders spoken to by Datamonitor suggested that if patient expectations are managed and physicians take time to explain the ways to increase the tolerability of the drugs to the patient, they are less likely to give up the drug after a few months without having achieved any meaningful results,” she says.
Lack of reimbursement a key factor
However, the biggest barrier to widespread up-take is the lack of reimbursement. With the exception of the UK and Spain, obesity drug sales in Europe have declined in recent years, despite there being more obese people now than ever before. Despite the massive patient potential for the treatment of obesity across Europe, the size of the markets have been restricted by the lack of reimbursement and the failure to categorize obesity as a disease rather than a lifestyle condition, Ms. Rossikhina says. “Conversely, the UK anti-obesity market has expanded significantly over the period of the last four years, representing 17% of the total global market. This steady growth is due to the reimbursement practices in the UK.
“While it is common in Europe not to acknowledge obesity as a disease and to classify anti-obesity medication as ‘lifestyle drugs’, and consequently not reimburse the use of such drugs, in the UK the patient only needs to pay the standard prescription charge for obesity medication, “ she says.
Total sales in the US anti-obesity drug market declined significantly in the period from 2002 to 2005, in part due to the bad publicity surrounding Meridia in 2002 (which was withdrawn temporarily from the Italian market over long term concerns regarding its cardiovascular safety) which had a knock-on effect on other drugs. The drop in sales can also be attributed to the high discontinuation rates that characterize obesity treatment, an issue further confounded by the fact that patients are paying for the expensive medication themselves, and therefore are a lot more likely to quit in the absence of dramatic weight loss.
Thus, the most critical issue for the rapid medical acceptance and commercial success of approved obesity products is reimbursement by payers, as patients are unwilling to pay out of their own pocket for therapy. Eighty five percent or more of US health plans currently do not reimburse obesity products, but the US still accounts for 52% of anti-obesity drug sales in the seven major markets. While the medical community’s view of obesity is evolving to where obesity is viewed as more than a lifestyle disease, payers may be less willing to change their views and reimburse for a product that will be chronically used.
Roche and Abbot currently lead the way
Currently the leading anti-obesity drugs are Roche’s Xenical and Abbot’s Meridia/Reductil, which Datamonitor forecast will earn $228m and $124m in the 7MM respectively in 2007. New drugs coming to market will have to show superior efficacy to those currently available, most likely to the point of having a demonstrable impact on other cardiovascular risk factors and co-morbidities such as diabetes, to have a chance at reimbursement, which must be viewed as the ‘holy grail’ for anti-obesity drug producers.
To this end, Sanofi-Aventis has put in a lot of effort into proving that Acomplia (rimonabant) combats multiple risk factors of cardiovascular disease and ameliorates existing conditions. Recently Sanofi-Aventis announced that it aims to submit Acomplia for worldwide approval in 2009 as a treatment for type 2 diabetes. If approval is granted, Acomplia may also be granted reimbursement, at least in diabetic obese patients.
Compounding the issues with the currently marketed anti-obesity medications, the anti-obesity drug development pipeline doesn’t hold any outstanding candidates either. Of the 42 different products in development in 2006, only nine were in Phase III clinical trials. Highlighting the difficulties manufacturers of marketed drugs and those still in development face finding safe, tolerable and efficacious obesity treatments, there are 38 different mechanisms of action amongst the 42 drugs in development. This reflects both the complexity of the disease and the high number of feasible targets to combat extra weight. It also indicates that the mechanisms of action of currently marketed products result in unsatisfactory weight loss, Ms. Rossikhina says. “The pipeline is rich in Phase I and II candidates, but only 12% are in Phase III development.
“Invariably, there is a lot of attrition in late stage development, with a large number of discontinuations of compounds. In the five years previous to 2007 56 anti-obesity agents were discontinued,” she says.
A number of the products in development also target diabetes, or the prevention of diabetes, which, if the products make it to the market, should help them to secure reimbursement. However, Datamonitor has not identified any products in development that will provide a significant improvement on those currently available, Ms. Rossikhina says. “In the absence of a highly effective pharmacological cure, and barring a huge sea change in society’s attitude towards diet and physical activity, governmental and societal initiatives seem to be the only thing standing in the way of the continual expansion of the first great epidemic of the 21st century.
“An especially worrying trend is that prior to the current generation, obesity has been something that largely developed in adult life. However, we are now seeing children that are essentially growing up obese, promising a huge burden for national health services and tax payers for years to come, with no immediate prospect of a ‘silver bullet’ cure.” | |
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