The
pharmaceutical industry will need to adapt its R&D efforts to the
requirements of the growing elderly population. In the US it has been predicted
that by 2030, the elderly will represent 20% of
the population and in Europe they may represent a quarter of the
population. The World Health Organization believes that companies need to focus
more on developing patient-centred rather than disease-related measures in
order to satisfy the ‘real’ needs of a global ageing population.
One of the
challenges companies must overcome is that the elderly are under-represented in clinical trials. This means that
the scientific evidence base for many medicines used for the
elderly is rather small, which makes it difficult for physicians to have
confidence in what they prescribe. A number of European geriatricians have gone
as far as to launch a charter against ageism in clinical trials, highlighting
that practical issues in involving elderly in clinical trials are not the only
reason for such observations. Their views are the result of their involvement
in the European-wide PREDICT (Increasing the PaRticipation of the
ElDerly In Clinical Trials) consortium. The consortium members are based in the
Czech Republic, Israel, Italy, Lithuania, the Netherlands, Poland, Romania,
Spain and the United Kingdom and co-ordinated from Medical Economics &
Research Centre Sheffield, UK.
The aim of PREDICT is to investigate reasons for the
exclusion of the elderly in clinical trials and to provide solutions for this
problem. The group published some of its conclusions in a peer-reviewed paper
in the Archives of Internal Medicine, which focused primarily on the
extent of exclusion of older individuals in ongoing clinical trials regarding
heart failure.
The European Medicines Agency (EMA) has also taken account of the
demographic implications of ageing. It has engaged with other regulators,
pharmaceutical companies and organisations representing the interests of
elderly people in Europe in order to improve the current situation. In March
2012 it held a two-day workshop to discuss the EMA’s geriatric
medicines strategy and related activities, so that gaps in the strategy could
be identified. The EMA hopes that a presentation of its strategy in this field
will provide opportunity for the identification of synergy areas between
stakeholders. The Agency has also participated in other initiatives focused on
geriatric medicine. In July 2013, UCL hosted a public engagement workshop, which featured members of the
geriatric community, family carers, professionals from academic research,
industry and regulatory agencies.
Although the
elderly are currently under represented in clinical trials, the ongoing
discussions between stakeholders suggest a more optimistic future. Those behind
PREDICT highlight that an analogous problem occurred in thepaediatric population
but research in this domain has considerably improved and therefore offers an
example of what can be achieved through dedicated efforts focusing on special
populations.
In the EU by
2025 more than 20% of Europeans will be 65 or over, with a
particularly rapid increase in the number of over 80s. A major challenge for European
governments is how to meet the higher demand for healthcare and ensure that
healthcare systems meet the needs of the elderly.
The elderly have markedly different healthcare requirements
to younger age groups but, at present, many services are not ideally tailored
to suit their needs. For example, it has long been known that the elderly use a greater amount of medicines than younger patients.
In a survey by the US National Center for HealthStatistics it was
reported that 80% of the elderly population (adults aged 65 years and older)
took at least one prescription drug in the prior month. The issue of polypharmacy
is a particular concern in the elderly, who compared to younger individuals,
tend to have more disease conditions for which medicines are required.
The European
Commission’s (EC) official position is to actively support Member States
in their efforts to promote healthy ageing through dedicated initiatives to
improve the health of older people. There is a belief that an ageing population in good health will also mean less strain on health
systems and fewer people retiring from work due to ill-health. At present, the European Innovation Partnership on Active and Healthy Ageing
aims to ensure that the average European citizen has two more active and
healthy years to live by 2020. The EC takes the view that ageing is an opportunity
for Europe rather than a hindrance. However, Europe’s continuing economic crisis is creating uncertainty regarding the
plans to improve healthcare for the elderly as governments are reluctant to
invest in new areas. The experience in Greece serves as awarning of what can happen
in the face of economic problems. As a result of the economic meltdown, doctors' wages in the public system
have been cut in line with other government workers, and hospitals are at risk
of being merged and face regular shortages of materials.
The ongoing
economic difficulties in Europe may hinder investment in additional healthcare
services for the elderly since politicians are looking to implement cutbacks.
However, it must be remembered that the elderly also represent a growingproportion of the voting population
and will therefore not accept their long-term healthcare needs being ignored.
