Contrary to popular political opinion, neither population ageing nor new medicines have been the main drivers of rising health and social care spending in recent decades. As life expectancy has grown because death rates from events like strokes and heart attacks have fallen, so age specific disability rates have also fallen. In essence, the events and diseases that can kill you young can also take your independence early. As their incidence falls and life expectancy goes up, the age when people start to need more costly forms of care tends to rise in parallel.
With drug treatments, total costs have also stayed surprisingly stable in richer countries, at around 15% as a proportion of all health spending. As expensive new products arrive so older ones lose intellectual property protection and become low price generic therapies. The costs of human labour, by contrast, rise over time as people become more educated and their expectations naturally grow.
However, some conditions, including dementias such as Alzheimers Disease and eye disorders like macular degeneration, have long seemed directly linked with ageing. Their observed prevalence has increased more or less in line with the average ages of populations across the world, albeit Japan, the major nation with the longest recorded life expectancy, claims the world’s lowest age standardised dementia rate. Some may question such observations, but there is evidence that in countries like the UK the average age of dementia onset has shifted backwards in recent decades.
Globally, there are currently a little over 40 million people living with dementia. This total could increase to some140 million by 2050 without better prevention and more effective treatments. It is this reality which led the G8 to make its recent pledge to foster the development of effective new therapies by 2025.
A deliverable promise?
Given the inherent riskiness of medicines development, it is uncertain that this challenging political timetable will be met. Major companies like J&J, Pfizer and Lilly have spent billions of dollars/Euros in seeking to build on the fundamental research conducted in Universities and other publicly and charitably funded institutions in order to provide better treatments, but so far with little practical success.
Some fear we are no nearer to effective new preventive therapies than when the aberrant amyloid beta protein build up that is a core aspect of Alzheimer’s disease and features to varying degrees in some other degenerative neurological conditions was first identified over a century ago. The fact that in the past governments and health care funders have on occasions seemed intent on reducing outlays on dementia treatments like the cholinesterase inhibitors to a bare minimum when they were still under patent could be taken as a warning to avoid risking further funds in such difficult fields.
Any investment area characterised by a need for sustained long term research and uncertain returns is in truth unlikely to be judged attractive by either public or private institutional decision makers with serious money to spend. However, this is no reason to lose faith that the challenge of reducing the burdens imposed by dementia and allied disorders can and will ultimately be met.
Recent research has, for example, shown that in perhaps up to 30 per cent of cases the life style and allied factors that protect against vascular diseases and allied conditions like type 2 diabetes and certain cancers can also prevent, or at least delay, the onset of dementias. Stopping smoking, using anti-hypertensives and statins to minimise vascular disease risks, exercising and avoiding obesity in middle life are all desirable. They can also help prevent other conditions, ranging from rheumatic disorders to macular degeneration.
But life style changes alone, even when combined with using today’s medicines in an optimal manner, will not be enough to prevent the majority of dementia cases from arising. If this end is to be achieved, developing better preventive treatments is vital. The good news is that provided investment is continued in not only investigating further in understanding the genetics of dementia and established concepts such as the amyloid and Tau protein hypotheses for Alzheimer’s disease, but also in exploring ideas like whether or not failures in the brain’s waste disposal mechanisms are involved, then in time definitive therapies for conditions like Alzheimer’s disease will certainly emerge. (It is interesting to note that the brain and the eyes are the only organs that lack direct links with the lymph system, the body’s ‘main drainage facility’.)
Combining good social and biomedical science in helping to improve the care of people who are currently at risk from dementia is part of the solution for which ‘great and good’ bodies such as the World Dementia Council (set up in the wake of the G8 initiative) must press. Yet if promoting innovation is a key goal, all stakeholders must also, as the Global Action on Dementia initiative has recognised, seek to ensure that the commercial incentives for investing in high risk long term biomedical research are genuinely adequate.
‘Once off’ special prizes and similar initiatives may be of some limited value when intellectual property right facilitated investment processes are in danger of failing. But at present much public policy debate on this topic is sadly confused. For me there can be no substitute for ensuring that the potential for financial return provided by patents and allied provisions such as regulatory data protection is sufficient for meeting twenty first century bio-scientific investment needs.
The discovery and development time needed for better Alzheimer’s therapies is likely to exceed the duration of existing medicine intellectual property rights (IPRs). I believe that we are already at the point where extensions in the duration of the IPRs available to successful innovators in areas like neurological disease treatment are urgently required, along with guarantees of globally appropriate approaches to ensuring access. This last is vital, of course. Yet assuring access can only become a primary priority after the innovations humanity is seeking have been marketed. If the G8 initiative on dementia leads to real progress in IPR reform then it will truly be able to claim success.
Emeritus Professor of Pharmaceutical and Public Health Policy