APPENDIX 17
Memorandum by Abbott Laboratories Ltd.
(OB 30)
CONTENTS
1. Executive Summary
2. Implications of obesity
3. Trends in obesity
4. The rise in obesity in recent decades
5. Managing the rise in obesity
6. Institutional structures to deliver an
improvement in obesity management
7. Recommendations for National and Local
strategy
8. References
1. EXECUTIVE
SUMMARY
— Obesity is linked to significant
co-morbidities and is associated with substantial healthcare and
social costs. 2,3
— There has been a significant increase
over the last few decades in the prevalence of obesity and the
overweight population. 3,4
— The recent rise in obesity may be
attributed to changes in physical activity and changes in diet.
— Prevention of obesity and being overweight
is fundamental to managing the epidemic in the longer term, but
it is also important that strategies to treat those already affected
with obesity or prone to becoming obese are not neglected.
— There is increasing awareness of
the potential value of anti-obesity drug therapy as a useful adjunct
for patients who cannot achieve sufficient weight loss through
lifestyle and behavioural modification alone.
— All patients receiving drug therapy
should be reviewed regularly 5
— Reductil (sibutramine) has been shown
to be an effective and well-tolerated treatment for weight loss
and weight maintenance. 12-15
— Reductil has been positively appraised
by the National Institute for Clinical Excellence 6
— Reductil therapy is supported by
"Change for Life", a programme aimed at achieving long-term
change in patient behaviour.
— Clinicians should be encouraged to
adhere to published guidelines for management of patients with
obesity.
2. IMPLICATIONS
OF OBESITY
Evidence suggests that the UK is in the midst
of an obesity epidemic. Obesity is now the major nutritional disorder
confronting Western nations and the World Health Organisation
has declared it the biggest unrecognised public health problem
facing society today. 1
Obesity is one of the root causes of significant
co-morbidities and these co-morbidities are associated with substantial
health care and social costs. The National Audit Office has estimated
that it costs at least £0.5 billion a year in treatment costs
to the NHS, and possibly in excess of £2 billion to the wider
economy. 2 The estimated human cost is 18 million sick days a
year, with 30,000 deaths a year resulting in 40,000 lost years
of working life. 2
Obesity is an important risk factor for chronic
diseases such as hypertension, dyslipidaemia, type 2 diabetes,
cardiovascular disease, obstructive sleep apnoea, musculoskeletal
disorders and some cancers. 3
The personal economic and social costs of obesity
are, however, also significant in terms of reduced quality of
life, lower employment prospects, stigmatisation and poor social
integration. Evidence suggests that, compared with non-obese women,
obese women are less likely to have married, have completed fewer
years of education and have lower household income. 3
3. TRENDS IN
OBESITY
There is a significant global increase in the
prevalence of those who are classified as overweight or obese.
Almost half of the world's population are considered to be overweight
or obese. 4 This problem does not only affect developed countries,
there is now a significant increase in those who are overweight
and obese throughout the developing world. 4
The prevalence has increased by 10-40% in the
majority of European countries in the past 10 years, however the
most dramatic increase has been in the UK, where it has more than
doubled since 1980. 3 Currently, 55% of the UK adult population
is either overweight or obese. 5
In the UK it is estimated that one in five adults
are obese, this number has trebled over the last 20 years. Nearly
two thirds of men and half of women are overweight or obese. In
the UK deaths linked to obesity shorten life by nine years on
average. 2
The prevalence of obesity increases with age,
but of particular concern for the future is the alarming rise
of obesity in children and adolescents. 3 In 1999, the prevalence
of obesity in 15-24 year olds in Europe was reported to be as
high as 8-11%.3 It is imperative that prevention strategies are
targeted at these younger age groups.
Sex, age, race and socio-economic status also
have an impact on weight gain; the lower the social class, the
higher the rate of obesity. 6 Women, older individuals and members
of minority races are more likely to become obese compared with
Afro-Caribbeans and Caucasians. 6
Obesity is an important factor for a number
of chronic diseases that constitute some of the principal causes
of mortality, including heart disease, stroke and some cancers.
It also a major contributing factor to other serious life threatening
conditions such as Type 2 diabetes. 2
An association has been demonstrated between
losing weight and improvements in mortality. In women suffering
from obesity-related conditions and who intentionally tried to
lose weight, there was a decrease in mortality rates of 9% in
cardiovascular disease, 20% in all cause mortality, 37% in cancer,
and 44% in diabetes. 7
4. THE RISE
IN OBESITY
IN RECENT
DECADES
Genetics, the environment and social factors
contribute to the aetiology of obesity.
A genetic predisposition is evident in some
families: children in families where one or more parent is obese
are more likely to become obese themselves. 6
Environmental factors such as changes in overall
levels of physical activity and changes in dietary habits represent
potential environmental factors contributing to obesity.
— Obesity is closely associated with
a sedentary lifestyle; an inverse relationship exists between
body weight and the amount of physical activity. Exercise stimulates
lipolysis, therefore increasing energy expenditure.
— Although the overall amount of food
eaten may not have changed dramatically in the last 20 years,
a decrease in intake of fatty food and an increase in carbohydrate
intake is likely to play a role in the rise of obesity.
5. MANAGING THE
RISE IN
OBESITY
Prevention of obesity and overweight is fundamental
to managing the epidemic in the longer term, but it is also important
to develop strategies to treat those already affected with obesity.
A weight loss of between 5% and 10% of initial body weight significantly
reduces health risks associated with obesity. 5
Effective management of patients with obesity
demands the skill of suitably trained members of a multidisciplinary
team.
Initial management includes a diet and exercise
programme individualised to a patient's lifestyle and physical
needs. Behavioural strategies such as self-monitoring of eating
habits, may be employed to assist adherence to lifestyle changes.
8 Whilst lifestyle interventions are effective for a significant
proportion of obese individuals, long-term outcome is unsatisfactory
with only a limited number of individuals succeeding in maintaining
substantial weight loss. 6,9
There is increasing awareness of the potential
value of anti-obesity drug therapy as a useful adjunct for patients
who cannot achieve sufficient weight loss through lifestyle and
behavioural modification alone. The Royal College of Physicians
(RCP) publish guidance on pharmacotherapy in obesity. 5 Their
guidance emphasises that drugs are effective when used in combination
with changes to diet and lifestyle and increases in physical activity.
This guidance also identifies priority groups for treatment because
of extra health risks; for example patients with type 2 diabetes
or hypertension. 5 These guidelines are a reflection of NICE technology
appraisals for Reductil (sibutramine) and orlistat (Xenical; Roche).
The RCP guidelines state that the newer anti-obesity
drugs (Reductil and orlistat) have demonstrated long-term efficacy.
Long term efficacy has not been demonstrated by the older agents
used to treat obesity (phentermine and diethylpropion). They are
currently licensed for only three months treatment. The RCP guidelines
advocate that these agents should not be used as part of a structured
weight management programme for overweight and obese patients.
5
5.1. Reductil (sibutramine)
The National Institute for Clinical Excellence
(NICE) has positively appraised Reductil therapy for the management
of obesity. 6 Reductil is indicated as adjunctive therapy within
a weight management programme for patients with nutritional obesity
and a BMI =30kg/m2, or =27kg/m2 with other obesity related risk
factors such as type 2 diabetes. 10
Reductil inhibits the reuptake of neurotransmitters
that control food intake (serotonin and noradrenaline). 10 It
therefore helps patients to feel satisfied with smaller portions
of food, so they eat less. Reductil is not an appetite suppressant
and the neurochemical actions of Reductil are distinct from other
centrally acting anti-obesity agents such as dexamphetamine and
fenfluramines. 11
Reductil therapy is associated with initial
weight loss as well as maintenance of weight loss. It has been
demonstrated that 77% of patients treated with Reductil and a
diet and exercise programme achieved medically beneficial weight
loss (=5% of their body weight). 12 Weight loss with Reductil
in combination with diet and exercise, is maintained to 24 months
(Reductil therapy is licensed for a maximum duration of 12 months).
12
Studies in patients with co-morbid conditions
(dyslipidaemia, type 2 diabetes and controlled hypertension) have
confirmed the weight reducing effects of Reductil that have been
seen in patients with uncomplicated obesity.
Improvements in HDL-C and triglycerides as a
result of weight loss with Reductil are at least equal to those
that can be achieved with drug treatment specifically for dyslipidaemia.
13,14
For patients with type-2 diabetes treated with
Reductil, a significant reduction in weight was observed. In addition
to weight loss, HBA1c levels were improved and there were indications
of beneficial changes to lipid profiles. 14 In obese patients
with stabilised hypertension, Reductil has been shown to be an
effective and well-tolerated treatment for weight loss and weight
maintenance. 15
Reductil therapy is supported by "Change
for Life", a 12 month programme aimed at long-term change
in patient behaviour. This programme helps patients build gradual
changes into their lifestyle and supports health care professional
in their follow up of patients receiving Reductil therapy.
5.2 How influential is the media?
The media can have and have had a significant
impact in raising the awareness of obesity amongst the general
public.
However, there is a need to ensure consistent
and accurate reporting on diets, exercise programmes and other
treatments, such as anti-obesity medication. The use of the word
obesity is a term that not many people relate to. The media need
to convey the message that obesity is not just a word that relates
to morbidly obese people, but also to a person who has a body
mass index (BMI) of 30kg/m2, or 27kg/m2 with co-morbidities such
as type 2 diabetes or coronary heart disease (to calculate BMI
you: weight (kg)/height (m)2). A desirable body mass is anything
between 20kg/m2 and 25kg/m2
The media could be best utilised to help communicate
setting realistic weight loss expectations, supporting long-term
behavioural modifications and advising patients that an appropriately
qualified health-care professional is best place to advise on
available pharmacotherapy.
5.3 How coherent is national and local strategy?
The National Audit Office report—"Tackling
Obesity in England", published in February 20012, reported
that there were no national guidelines for health authorities
on how their plans should address obesity.
Whilst the Department of Health has issued National
Service Frameworks for Coronary Heart Disease and for Diabetes,
both of which have links to the prevention and management of obesity,
there is still no clear strategic direction for Strategic Health
Authorities and Primary Care Trusts (PCTs).
Currently there is no strategic guidance for
Local Health Economies (local authorities and NHS organisations).
Without the incentive of a national framework for local organisations,
tackling obesity will not be a local health priority. This is
in contrast with smoking cessation treatment policies, which have
been developed across agency boundaries and are now embedded in
Local Authority Strategic Plans.
At a local level, PCTs allocate responsibilities
to individuals where there are national strategies and performance
measures. For instance, almost every PCT will have someone who
is responsible for the co-ordination of the coronary heart disease
National Service Framework (NSF) or the diabetes NSF. Few PCTs
have a specific named obesity co-ordinator. Therefore, with no
responsibility allocated, co-ordination and implementation of
local obesity strategies for prevention and treatment are less
likely to happen and are left to the few enthusiastic individuals
to champion.
From a clinical perspective, there are useful
and pragmatic treatment guidelines from the National Obesity Forum16,
which many GPs would find useful.
6. INSTITUTIONAL
STRUCTURES TO
DELIVER AN
IMPROVEMENT IN
OBESITY MANAGEMENT
6.1 Role of the Department of Health and the
NHS including that of primary care, hospitals and specialist clinics
Many patients with obesity will be managed entirely
in the primary care setting.
The National Audit Office (NAO) report found
that there was confusion over roles and responsibilities for those
involved in the management of obese patients, and evidence of
a lack of "buy in" by general practitioners for helping
overweight and obese patients to control their weight.
The question of "At what point do overweight
and obese patients become a medical issue?" requires greater
definition. For other established medical conditions, which can
also occur as a result of "lifestyle choice", there
are defined boundaries. For example, high blood pressure and raised
cholesterol levels are clearly defined by accepted physical and
biochemical measures, and these are widely reported in both medical
and lay-press.
This is fundamental to gaining acceptance of
the role of health professionals in the management of obesity
and gives obese and overweight patients guidance on when and how
they should be seeking support from their general practitioner.
The NICE Technology Appraisal for anti-obesity treatments could
be used to establish these medical intervention parameters.
In tandem with criteria for medical management
of obesity, there is a need for appropriate service configuration
and the development of patient care pathways. The management of
obesity requires a service that is accessible to patients and
one which delivers a holistic approach incorporating diet, exercise
and lifestyle modification, interaction of healthcare professionals
who set clear and realistic objectives, along with, where appropriate,
anti-obesity medication.
Most obese patients should be managed in the
primary care setting by a multidisciplinary team.
— Anecdotal evidence suggests that
more specialist weight management clinics are being established
within the primary care setting, often within surgeries and driven
by the practice nurse.
— Specialist clinics in a secondary
care setting are best equipped to manage the more complicated
cases requiring expertise and intervention beyond the scope of
primary care, as accessibility and the ability to have a large
throughput of patients is limited.
Whilst all health services should be tailored
to the needs of the local population and situation, an issue currently
is the lack of national direction on how primary care should be
organised in the most effective way to manage obesity. Equity
and access to obesity management services for patients is highly
variable and at odds with one of the government's primary objectives
for the health service.
6.2 Appropriate institutional structure, budgets
and priorities
The Department of Health has set out the medium
term priorities for the National Health Service in the Priorities
and Planning Framework: 2003-06. It focuses on where the substantial
extra investment needs to be allocated, coupled with the reforms
and improvements required to drive up service standards and capacity.
The onus is on the constituent NHS organisations
to develop coherent Local Delivery Plans with the contribution
of Councils where the department of health has assigned joint
leadership responsibility (eg Mental Health & Older people).
Guidance on pooling responsibilities and intervention budgets
for tackling obesity would provide the necessary impetus to effect
integrated action plans.
The only target reference to addressing the
impact of obesity on key clinical priorities is within the Coronary
Heart Disease area:
— "in primary care, update practice-based-registers
so that patients with CHD and diabetes continue to receive appropriate
advice and treatment in line with NSF standards and by March 2006,
ensure practice-based registers and systematic treatment regimes,
including appropriate advice on diet, physical activity and smoking,
also cover the majority of patients at high risk of CHD, particularly
those with hypertension, diabetes and a BMI >30."
BMI measurement is the only obesity indicator
at present and is often considered as a secondary measure in the
development of patient obesity risk registers.
7. RECOMMENDATIONS
FOR NATIONAL
AND LOCAL
STRATEGY
The recommendations of the NAO on the management
and prevention of obesity should be further implemented.
In particular, for the management of obesity,
there should be greater emphasis placed on supporting primary
care to:
— Identify and help those who would
benefit from active intervention for the management of their obesity
— Train and educate health professionals
to provide a holistic approach to managing obese patients
— Configure and adequately fund services
in primary care to improve access and treatment options for patients
at risk (this may include the setting up of in-surgery provision
for treatment of these patients)
— Help set realistic weight loss goals
and help patients to maintain their motivation to achieve long-term
behavioural change
— Implement and fund cost-effective
interventions (such as pharmacotherapy), as recommended by NICE
8. REFERENCES
1. World Health Organization Consultation
on Obesity, Geneva 1997
2. National Audit Office. Tackling Obesity
in England. HC220 Session 2000-01:15 Feb 2001. Available at www.nao.gov.uk/publications
3. Rossner S. International Journal of Obesity
(2002) 26 Supp4 S2-4
4. Xavier F et al. Obesity Research
Dec 2002 Vol 10 Supp 2
5. "Anti-Obesity Drugs; guidance on
appropriate prescribing and management" available from the
Royal College of Physicians publications department
6. National Institute of Clinical Excellence
technology appraisal of sibutramine. Available at www.nice.org.uk
7. Williamson DF et al. Am J Epidemiol
1995;141(12):1128-1141
8. Fujioka K. Obesity Research (2002) 10
Supp2: 116S-123S
9. Vidal J International Journal of Obesity
(2002) 26 Supp4: S25-28
10. Reductil Summary of Product Characteristics
11. Finer N International Journal of Obesity
(2002) 26 Supp4: S29-33
12. James WPT et al. Lancet 2000;
356: 2119-2125
13. Williams G et al. Obesity Research
2000; 8 Supp1: 90S
14. Fujioka K et al. Diabetes, Obesity
& Metabolism 2000; 2: 175-187
15. McMahon FG et al. Archives of
Internal Medicine 2000; 160: 2185-2197
16. National Obesity Forum guidelines. Available
at www.nationalobesityforum.org.uk
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