Inadequate representation of the elderly in clinical trials
While the elderly account for high drug consumption, they remain underrepresented in clinical trials. 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 people in clinical trials are not the only reason for such observations. These views are the result of
their involvement in the European-wide PREDICT consortium for "Increasing the Participation of the Elderly In Clinical Trials"
(6). Coordinated from the Medical Economics & Research Centre, Sheffield, UK, the PREDICT initiative began in February 2008
and has received support from the EU and FP7 Health research (the Seventh Framework Programme of the EU for the funding of
research and technological development in Europe). The aim of PREDICT is to investigate reasons for the exclusion of the elderly
in clinical trials and to provide solutions for this problem. Those behind PREDICT highlight that an analogous problem occurred
in the paediatric population, but research in this domain has considerably improved and therefore offers an example of what
can be achieved.
Several key European geriatricians state that they have often found themselves in a situation where they were unable to offer
patients the best course of treatment with the weight of scientific evidence behind them because of insufficient evidence
from clinical trials (6). The group has also carried out extensive reviews of medical literature for conditions prevalent
in elderly people to back their opinions. In 2010, PREDICT researchers reported findings from interviews with health professionals
in nine countries, as well as from more than 50 focus groups with elderly people and their carers. More recently, it published
some of its conclusions in a peer-reviewed paper in the Archives of Internal Medicine, focusing primarily on the extent of exclusion of older individuals in ongoing clinical trials regarding heart failure (7).
The EMA has also taken account of the demographic implications of ageing. In October 2011, it issued an invitation for expressions
of interest in an EMA workshop on medicines for older people (8). The provisional dates stated for the workshop are March
22–23, 2012. The workshop will feature a presentation and discussion of the EMA geriatric medicines strategy and related activities,
so that gaps in the strategy can 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. It will also seek input on the regulatory mechanisms
it is developing to boost geriatric medicine. The sessions currently planned focus on themes that match the EC's European
Year of Active Ageing initiative, namely healthy ageing and medicines, demonstrating safety and efficacy in the older population,
geriatric pharmacovigilance, and the role of regulatory agencies in providing information to the older population.
Opportunities for the pharmaceutical industry
For the pharmaceutical industry, a renewed focus on the elderly population offers a tremendous research and commercial opportunity.
The work of the PREDICT group and the EMA should also help companies to trial their drugs in this underserved section of the
population.
It is predicted that the Alzheimer's disease drug market will nearly triple over the next 10 years, increasing from €4 billion
in 2010 to €10.6 billion in 2020 in the major markets of the US, France, Germany, Italy, Spain, the UK and Japan (9). At present
the market is dominated by symptomatic therapies that only provide modest effects on cognitive and functional decline but
there is a need for more effective drugs. To date, governments have been unwilling to fund expensive new therapies. For example,
the UK's National Institute for Clinical Excellence (NICE) caused considerable patient anger in 2007 when it ruled that Aricept
and similar drugs should be restricted to people whose dementia had progressed from mild to the moderate, but has not yet
reached severe (10). The pharmaceutical industry must find natural allies among patient organisations and clinicians who are
dissatisfied with the availability of treatments for elderly section of the population. If governments have publicly stated
that they will back initiatives to improve healthcare for the elderly, then their commitment to reimbursing new therapies
will be expected.
Companies are aware that pricing will remain important and in the US market, which is becoming more cost conscious, many firms
are attempting to become more proactive. For example, Pfizer recently signed a five-year agreement with the US healthcare
insurer Humana to investigate treatment costs for the elderly in chronic pain, cardiovascular disease and Alzheimer's disease.
The two companies will look at products in relation to healthcare resources and reducing costs (11). The Pharmaceutical Research
and Manufacturers of America (PhRMA) industry body has highlighted the cost of failing to treat chronic diseases, estimated
it to be as much as 75 cents of every dollar spent on healthcare in the US (12).
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