Newcastle Symposium on the Goals of Ageing Research
24th-25th April 2001 International Centre for Life Times Square, Newcastle
Session 2. Implications for Healthcare
Session 2.1
Session 2.2 Discussion Points
Contents of Session 2
Chair: Professor Rose Anne Kenny

Paper 2.1: Research on Ageing - Julian C. Hughes

Paper 2.2: Drug Development in an Ageing World - Gary Ford

Points from Discussions
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Implications for Healthcare
Paper 2.1
Research on Ageing: Implications for Healthcare
Julian C. Hughes
Healthcare is often measured in terms of efficiency and effectiveness. In this paper I shall argue
that there is also an ethical imperative for healthcare. To understand the implications of ageing
research for healthcare, therefore, we must consider not only efficiency and effectiveness, but the
ethical imperative too.
I shall start by considering efficiency and I shall use the notion of ‘intermediate care’ as my
example. ‘Intermediate care’ has recently become something of a buzz phrase in the care of the
elderly: it is the strategic aim of services up and down the country; it is the way to obtain money
for development. It has recently been defined (and its importance emphasized) in the National
Service Framework for Older People:
‘A short period (normally no longer than six weeks) of intensive rehabilitation and treatment
to enable patients to return home following hospitalisation, or to prevent admission to long
term residential care; or intensive care at home to prevent unnecessary hospital admission’.
(1)
One thing to note about this definition is that care is not intermediate in terms of place: it is
intermediate in terms of intensity, where hospitals are presumed to be places of high intensity
care (e.g. intensive care, coronary care, etc.) and home is normally associated with low intensity
care. Intermediate care is between the two. It might be provided on a hospital site (but without
intensive medical and nursing input), or it might be provided at home (by increasing the intensity
of the input from medical and allied professions); or it might be provided in the community in,
for instance, a social service’s establishment, again with increased input from medical, nursing,
physiotherapy, occupational therapy, speech and language therapy. These will be ‘intermediate
care facilities’, which I should like to call, facetiously and atavistically, ‘cottage hospitals’.
So what will the effects of ageing research be on intermediate care? It rather depends on what
ageing research achieves. If ageing research merely increases the length of life, i.e. the quantity,
then the need for intermediate care will go up. There will be more frail elderly people at home
and more in the hospitals and a greater need to find somewhere for them to go that is neither the
one nor the other. (This is whether we regard intermediate care positively, as an attempt to
discourage dependency, foster independence, and get people as close to home as possible; or
whether we regard the enthusiasm for intermediate care negatively as simply a way to stop
spending money on expensive acute hospital beds.) If ageing research merely increases the
quantity of life it looks straightforwardly as if things will be just as they are now, but worse.
More interestingly, what if ageing research improves the quality of life for the elderly? This
becomes more speculative, but if the effect is that there is less morbidity, then there will be less
need for the diagnostic and therapeutic skills of the intensity found in a hospital. People will
spend more time able to live independently at home, should they so wish. There might then be a
decreased need for rehabilitation, but perhaps a greater need for palliation, when the question is
not cure (the province of hospital medicine), but care. This is interesting because it suggests that
the care in ‘intermediate care’ will need to be in no sense ‘intermediate’. (2) This seeming oddity
in our use of words points to the extent to which we have accepted that ‘care’ is to be thought of
in a technological and scientific manner. Home has no medical technology, hospitals are full of
it; intermediate care is somewhere between the two. Of course, we are also talking about skill
and training, but the same holds true: the paradigm suggests that skill and training in hospitals
are greater than they are at home and intermediate care will be between the two. By implication,
‘care’ is linked to technology and science, skill and training.
There is the interesting possibility, however, that ageing research, by emphasizing the care in
‘intermediate care’, might sever the link between care on the one hand, and technology, science,
skill and training on the other. Rather than a ‘step down’ (to use the present parlance) in the level
of care, as people move from the technological and scientific atmosphere of hospitals towards
home, they might expect the level of care to ‘step up’. But this is a reversal of the paradigm: as
you move away from hospital the care increases. The ambiguity lurks in the use of the word
‘care’: caring for someone might need a good deal of expertise and technology (if they are in a
coma say); caring about a person is quite different. If ageing research decreases the need for
hospital care, it might increase the need for intermediate care in the form of palliative care, but in
so doing it might help to emphasize the need to care about the elderly, not just to care for them.
Ageing research might help to clarify the need for a human face to the cottage hospital. (3)
What, then, about effectiveness? My example here will be the antidementia drugs. As will be
known, the National Institute for Clinical Excellence has recently pronounced that these drugs
(the cholinesterase inhibitors) ‘… should be made available in the NHS as one component of the
management of those people with mild and moderate Alzheimer’s disease …’. (4) What will be
the impact of ageing research on the effectiveness of our treatment of the dementias? Well,
without further ado, it seems quite likely that ageing research, from the point of view of
effectiveness, will be beneficial. Even if vaccines to destroy amyloid plaques in the brain do not
come to fruition, it seems likely that our increasing knowledge of the genetics and
pathophysiology of Alzheimer’s disease will increase our ability to treat such disorders. All in
all, therefore, the implications of ageing research for healthcare (in terms of efficiency and
effectiveness) are good - unless all we get is quantity and not quality of life - if not very good.
I must insert an important caveat. If ageing research is to have the sort of beneficial effects I
have described, its fruits need to be delivered to the shop floor. I hope it is not disloyal to point
out that, whilst in the Institute for Ageing and Health here in Newcastle there is some of the most
impressive research in the world going on, in the Centre for the Health of the Elderly (the clinical
part of the same building) we sometimes simply do not have enough nurses. (I do not in any way
suggest this is unique to Newcastle!) Delivering good quality healthcare requires more than just
good quality research: it also requires the right social, economic and political circumstances.
Efficiency and effectiveness, however, are not the only parameters in town. Healthcare is also a
matter of ethics: the ethical imperative. It is imperative for two reasons. First, because issues of
right and wrong occur ubiquitously as part and parcel of clinical practice. Many clinical
decisions are, at the same time, ethical decisions (e.g. whether to treat someone, whether to
perform the next investigation, how frank to be with them). Secondly, the ethical imperative of
healthcare is imperative because matters of value (in contradistinction to matters of fact) are
implicit in many of the concepts used in clinical practice. I can demonstrate this point by asking
what we are aiming at in healthcare. The answer is clearly ‘health’, but it is notoriously difficult
to define health. I do not wish to enter the thorny debate concerning health and disease: health as
the absence of disease, disease as dysfunction, or disease understood in terms of illness and
health as a complete state of well-being and the absence of illness. (5) But I do wish to stress that
health and illness are notions that involve values. The ethical imperative in healthcare involves
the recognition of values.
Talk of values - values which are deeply embedded at a conceptual level in the very meaning of
what it is to be healthy and what it is to be ill - should make our consideration of healthcare less
facile. From the point of view of efficiency, what is required is not just efficiency, but efficiency
that enhances those aspects of life that are important to human beings. Not just caring for old
people (the factual, science-based side of medicine), but caring about them (which involves
engagement with values and the humanistic aspects of medical practice) in an environment that
makes this care evident: my atavistic impression of the cottage hospital perhaps. We also want
healthcare to be effective, but again there are values at stake: will life with improved cognitive
function be worthwhile? Will there be real opportunities for us as older people to flourish in our
individual ways even if we are well?
Having accepted that ageing research will have an impact on healthcare, we are left with a
further question: how will ageing research be affected by and how will it affect the implicit and
explicit values of healthcare in the elderly? Will ageing research reflect the values of older
people? Or will it reflect societal concerns? How do we know what these values are? Will it be
the values of researchers, funding authorities, drug companies or governments that count?
Research into palliative care in dementia, into quality of life in old age, into the quality of care in
residential and nursing homes, or into the use of psychotherapy in old age, these sort of research
projects are not as sexy as research into genes and neuroscience, but they can tell us directly
about what is important in old age. Such research might seem soft, but it is closer, perhaps, to the
concerns of older people and their carers than some more "scientific" research. So there is
certainly a question concerning the setting of priorities in ageing research.
If we take a broad view of health, then ageing research, to inform healthcare, must be broadly
based. I suggest that ageing research must involve ethical research, that is research into the
ethical issues that surround ageing; but also more conceptual research, philosophical research
even, into the nature of the issues themselves. The distinction, for instance, between normal and
abnormal ageing is not solely a matter for science to determine. We shall need qualitative
research, as well as quantitative, backed up by clear thinking about the concepts and values
involved. The ethical imperative in healthcare, therefore, should encourage ageing research, if it
is to have a broad impact, to look at meaning and value in old age. This will involve the whole
context within which healthcare is provided: the economic, social and political context. It should
also focus our attention on the individuals themselves, the older people who need to be cared for,
but also cared about.
References:
1. Department of Health. (2001). National Service Framework for Older People. London:
Department of Health. p 156.
2. Cf. Grimley Evans, J. and Tallis, R. C. (2001). A new beginning for care for elderly
people? British Medical Journal, 322: 807-808.
3. My atavistic talk of the ‘cottage hospital’ elicited some opposition in the symposium on
the grounds (a) that cottage hospitals were not all good; and (b) that intermediate care, as
the definition shows, can involve care at home and need not involve other facilities or
institutions. My use of the notion of ‘cottage hospital’, however, is intended to be
redolent of old fashioned standards of care which many people feel, rightly or wrongly, to
be missing in today’s culture of efficiency and effectiveness. Betjeman’s cottage hospital
nurses, with "inflexible nurses’ feet", might have been intimidating, but at least they were
probably nursing and not managing the budgets! The rallying cry, ‘Save our Cottage
Hospital!’, might not have been altogether rational, but is more immediately appealing
than ‘Save our Intermediate Care Facility!’. As for intermediate care at home, since we
have the notion of ‘Hospital at Home’, why not the notion of ‘Cottage Hospital at
Home’?
4. National Institute for Clinical Excellence. (2001). Guidance on the Use of Donepezil,
Rivastigmine and Galantamine for the Treatment of Alzheimer’s Disease. National
Health Service. p 1.
5. National Institute for Clinical Excellence. (2001). Guidance on the Use of Donepezil,
Rivastigmine and Galantamine for the Treatment of Alzheimer’s Disease. National
Health Service. p 1.
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Implications for Healthcare
Paper 2.2
Drug Development in an Ageing World
Gary Ford
"The successful development of more than nine thousand new drugs in the last twenty five years
has saved countless lives and relieved millions of victims of acute and chronic illnesses. These
new drugs present greater hazards as well as greater potential benefits than ever before – for they
are widely used, they are often very potent and they are promoted by aggressive sales campaigns
that may tend to overstate their merits and fail to indicate the risks involved in their use."
President J F Kennedy, 1962
"As my journey through the pharmaceutical jungle progressed, I came to realise that, by
comparison with the reality, the story was as tame as a holiday postcard."
The Constant Gardener, John Le Carre, 2000
The pharmaceutical industry has had great success in the last 50 years in delivering effective
drugs to the developed world, but they are still viewed by some as immoral organisations without
a social conscience motivated only by profit. Recent discussion of the industries pricing and
patent protection of HIV drugs for the developing world illustrates some of these concerns, with
GSK said by some to stand for Global Serial Killer rather than GlaxoSmithKline. These slogans
whilst attractive are not helpful in engendering long-term desirable change in drug development.
It is also important to distinguish between the morals and attitudes of scientists and clinicians
within the industry and the morals of an organisation acting within a highly regulated capitalist
global economy where share holder profit is the primary aim of the organisation.
In this talk I want to raise for discussion the issue of how the gerontology/geriatrics research
community, health services and older people themselves should influence the development and
marketing of drugs by the pharmaceutical industry. My perspective comes as someone who has
been interested in drug development for more than 20 years, and has had and continues to have
extensive interactions with the industry.
I want to first mention three items of background information relevant to the discussion. The first
is that older people in the developed world now receive the majority of prescribed drug therapy,
and the trends indicate there will be further increases. The proportion of total prescriptions
received by older people in the UK increased from 39% to 45% between 1985 and 1995 with a
further remarkable increase to 50% three years later in 1998. Demographic changes and
increasing evidence of the benefits of drug therapy In older people will lead to further increases
in the volume of prescribing to older people such that by 2020 around two thirds of all drugs
prescribed in the UK are likely to be to the older population.
The second is that drug expenditure is accounting for an increased proportion of health services
expenditure, in the developed world, with an increase in the UK from 9% to 13% in the last 10
years. Current valuations of global pharmaceutical company research budgets and anticipated
returns on investment indicate that the financial community anticipates continuing real increases
in global drug expenditure.
The third is the major changes occurring in the structure of the pharmaceutical industry.
Significant changes are occurring in the structure of the pharmaceutical industry. Historically
there were many small pharmaceutical industries, often with a strong national base and culture,
such as Wellcome prior to the merger with Glaxo, or part of larger agro-chemical companies,
such as ICI prior to the separation of Zeneca. Considerable consolidation has occurred and is
predicted to take place in the industry, the most recent example being the GlaxoSmithKline
merger. Most industry observers believe the industry will ultimately consist of 4 or 5 large
pharma companies primarily focused on phase III trials and marketing. A new model of small
biotechnology companies (who develop new chemical entities) and contract research
organisations (who undertake clinical trials) supporting the large pharmaceutical companies
appears to be evolving; the "virtual" drug company. The pharmaceutical industry may also
become increasingly involved in the marketing of other health care interventions with drug
therapy as part of a managed care package. Traditional pharmaceutical companies could also
become more involved in the marketing of alternative and "complementary" therapies, such as
nutriceuticals.
Pharmaceutical research and marketing is a much more globally focused activity than was the
case 25 years ago. These changes present a number of challenges to individual countries and the
regulatory bodies. The ability of companies to shift their research base to the most attractive
economic base, and threats to move research away from countries who block marketing of
specific products (e.g.: Glaxo Wellcome’s response last year to the initial judgement by NICE on
relenza) may influence regulatory decision making and governmental controls on marketing.
The pharmaceutical industry has only partially recognised the specific challenges surrounding
drug development for the older population. A number of small initiatives were mounted in the
late eighties to develop skills in this area. However the majority of pharmaceutical companies
appear to have no specific expertise or research strategies addressing the broader issues of drug
development and drug use in older people. The main reason I believe lies in the focus on drug
development of specific disease conditions, to the neglect of a broader consideration of the
overall health needs of individuals or the community. The structure of scientific investigation of
drugs leads inevitably to the exclusion of many older patients and the recruitment of a pure
disease population with a focus on measuring disease specific outcomes.
Fries exposition that interventions in middle aged and older people should compress disability
mortality curves has become accepted as a key philosophy in academic gerontology and
geriatrics ("Adding life to years"). These considerations suggest trials of interventions should
either look at long-term outcomes of disability or at least model the likely effects on lifetime
disability. In contrast approaches to drug development have focused around short-term outcomes
of treatment, particularly mortality, rather than the long-term health of target populations.
The mapping of the human genome and improvements in screening of drugs for biological
activity has resulted in a large excess of new chemical entities suitable for drug development.
Thus choosing the drugs and drug targets for further clinical development has become a major
issue in pharmaceutical industry R&D. The market economy dictates that decisions about which
drugs are developed is decided independently by individual pharmaceutical companies, albeit
after discussion with key opinion leaders in health care. Drug development is now increasingly
driven by market considerations. Hence the major research programmes into obesity. Because of
the marketing perspective it is highly likely that pharmaceutical companies would wish to
advertise life extending anti-ageing drugs", and indeed some herbal/complimentary companies
do so already. Even if it is accepted that marketing perspective have an important role there are
problems. Perspectives are often based on historical experience and the potential of drug
treatments to change market need, and general management of patients, is often not recognised
by health care professionals and the industry. The extensive prescription of acid suppressant
drugs was not anticipated by most observers because peptic ulceration and oesophagitis were
considered diseases requiring surgical treatment.
Regulatory bodies have in essence a yes/no veto role after completion of clinical trials but no
involvement in the decision making strategic development. The internationalisation of drug
regulation needs to be considered. The FDA and EMEA are now the two international bodies
with significant influence on licensing of drugs but not research strategy in relating to the choice
of targets or treatment population (except in only minor ways, such as some data being required
in older people). There are recent encouraging examples of how the medical community can
influence research strategy. The development of the Meningitec vaccine occurred after pressure
from public health bodies. There has been concern about the lack of studies examining drug
efficacy and safety in children. The recent decision by the FDA to extend patent life of drugs in
the adult population for products where data on drug efficacy and safety has been obtained in
children, has led to companies investing in obtaining such data.
I suggest that older people, health services and the gerontology/geriatrics community need to
develop a framework to discuss desirable drug interventions, to move away from responding to
developments only after licensing and to create a forum for active dialogue with the
pharmaceutical industry. The dialogue we have now is unfortunately often driven by single
disease interest groups such as Alzheimer’s or MS patient groups. Academia probably exerts
more influence than generally believed through research identifying disease pathophysiology and
methodologies that allow testing of drug efficacy.
Since industry now operates as multinational companies, international and national networks
would need to be established to exert influence. Regulatory bodies need to review the influence
of their current structure and processes on involvement of older patients in clinical trials, perhaps
by seeking data on the effects of drug interventions on healthy life span and lifetime disability.
If we want to avoid the development of drugs advertised as anti-ageing, we should be cautious in
establishing an environment where human ageing targets and biomarkers are used as measures of
drug outcome, and ensure the used of disease (problematic for the reasons discussed earlier) or
more general functional outcomes. The pharmaceutical industry and developed world should
consider their ethical responsibility, and role in providing drugs to older people in developing
countries, and with governments of the developed world decide how the regulatory and market
economy support rather than conspire against appropriate drug development. We need to use the
market to direct appropriate drug development at a much earlier stage, and not only after drug
licensing. Finally society and older people themselves need to consider more explicitly their
desires and wishes with respect to the appropriate level of resource allocation to drug
development and health care expenditure in relation to other competing activities such as
housing, community infrastructure, and education, all of which have large potential health
benefits. Which brings me to the most difficult point, cost effectiveness. How do we decide the
appropriate allocation of resources to older people within a community? Even more troubling is
how does the academic community facilitate redistribution of health care resources away from
the developed world to the developing world?
Finally any controls and interventions need to be structured to not inadvertently kill the
pharmaceutical goose that has laid so many golden eggs (drugs).
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Implications For Health Care
Discussion Points from Session 2:

There is research to suggest that the use of information technology may lead to the more
effective use of drugs. It might be that drug costs will go up, but there is the potential for
overall health costs to come down.

Pharmacogenetics might allow more focused and effective prescribing, but it will be
extremely expensive and the costs will need to be re-allocated in some way. In addition,
such advances in medical knowledge will impose a burden of technical information on
medical school syllabuses and on doctors. There is tension between this high-tech and
expensive side of medicine and the humanities-based aspects. Against this concern,
however, it is possible to be sceptical about pharmacogenetics being able to help with
complex problems such as hypertension.

Efficiency and effectiveness tends to focus on health care, but in terms of social care
what people need is time to make decisions. Intermediate care should not be solely about
place, but about time for convalescence. A separate worry about intermediate care is that
it simply might be second-rate medical care for older people. One aspect of this might be
that hospitals nowadays do not allow enough time for people to talk. Hospitals used to
allow more social life in which, for instance, the ancillary staff played an important staff.

If we suggest that the health care needs of older people are distinct from those of other
groups, then we will find ourselves in an ethical, political and sociological debate
concerning the needs of older people over against (for instance) the needs of children. In
this debate it often seems that children win out.

There is a tension between societal needs and individual needs. Given that decisions are
politically driven and given that the agenda is often set by the pharmaceutical industry,
societal wants and individual needs must be inserted into the decision-making process
earlier.

The increase in the use of drugs in the elderly might be a result of the focus in modern
medicine on the diagnostic and treatment side of health care. Against this, there is an
increasing tendency for quality of care issues to be considered in the evaluation of drug
treatments. Certainly in primary care the main issue is often not "the diagnosis" but "the
problem".

A good example of the factual or scientific sign of medical practice coming together with
the human/value side is seen in the increasing role of the community pharmacist who
both attends to the technical and factual business of checking tablets and possible
interactions, but also might personally deliver dosette boxes to allow older people to
remain supported in the community.

The National Service framework for older people puts a heavy emphasis on rooting out
ageism. The basic tenant is that age does not determine where a person’s needs are best
met. The notion of "the person" is a way of uniting the science side and the humanistic
side of medical practice.

If ageing is not seen as a disease then there is no need to regulate drugs that affect ageing.
Drugs that reduce cholesterol, for instance, could be seen (as long as they are safe) as in
no greater need of regulation than wrinkle cream. But this opens the possibility of real
resources being diverted away from health care to the benefit of the pharmaceutical
industry.

Numerical decisions have to be made in all sorts of areas of human endeavour (e.g.
education). The quality of health care and the quality of these other areas often go
together. The problem of the dichotomy between facts and values probably reflects
deeper social forces and values, although this does not negate the responsibility of
individuals to try to be aware of values in the context of health care.

There is a need for older people themselves to be engaged in qualitative research. This
goes beyond consulting. For instance, Better Government for Older People engaged older
people in designing a house and the same process will be used to consider intermediate
care, which at present is viewed with some suspicion. Since there is to be so much
investment in intermediate care it seems sensible for this to reflect the views of older
people.

The concept of an intermediate care facility (as opposed to a cottage hospital) might be a
more honest use of language, lacking as it does the tincture of benign civility. There is a
point to be made about the professionalisation of care. Whilst we generally wish to have
good quality communication with health care professionals, we do not normally wish to
develop close personal relationships with them. The natural instinct to care about people
needs to be demonstrated within the professional business of caring for them.

Given that in the market place simple solutions (such as drugs) are favoured for complex
problems as opposed to complicated solutions (such as intermediate care), how can we
keep both the scientific knowledge and the requirements of broader public policy both in
view?

Hypertension provides a useful model for discussion. There is a continuum and blood
pressures which require treatment are judged in terms of the relative risk posed.
However, this does not tell us what is "normal". For what is normal in our society is not
necessarily in other countries. In fact, the normal (by which we mean average) blood
pressure in other countries is considerably lower than that which is counted normal in
Britain. Social change, therefore, might be more significant than tinkering with drugs.
The social also comes in when we think about cost-effectiveness. Actually no money is
saved by treating blood pressure, but our society has decided that it is worthwhile to treat
blood pressure in order to save the morbidity and mortality associated with strokes and
heart disease. It may be that in the future dementia will be added to this list. We have to
beware of medicalising what might be considered as normal age-related changes in our
society.

Intermediate care might after all meet a need. It might be more positive to think in terms
of the needs of older people, rather than in terms of the needs of those providing care.
Intermediate care also involves intensive care at home, rather than care in some other
building. The thrust of the National Service Framework for Older People is for patientcentred care, a single point of entry with a single assessment, with integration between
Social Services and healthcare and joint management structures. This sort of model is
seen to some extent in a new nurse-led unit in Newcastle which allows more time, more
individual care, with lower technology, all of which is aimed at understanding and
meeting the persons real needs.

The move towards qualitative research that includes older people as participants is
reflected in the broader move from representative to participative democracy. Similarly,
on the global scale, the tendency for the developed world to use developing countries for
their research has been replaced by a greater emphasis on participative and democratic
research.
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Ageing pages constructed by Andrew J. Palmer Jan 2002