Memorandum of the Alzheimer's Society
1. THE INFLUENCE
1.1. The Alzheimer's Society is the UK's
leading care and research charity for people with dementia, their
families and carers.
1.2. Dementia affects over 750,000 people
in the UK alone. The Alzheimer's Society has over 25,000 members
and works through a network of over 250 branches and support groups.
It provides information and support for people with any form of
dementia and their carers through its publications, helplines,
website and local network. It advises professionals, runs quality
care services and campaigns for improved health and social care
and greater public understanding of dementia. The Society funds
an innovative programme of biomedical and social research in the
areas of cause, cure and care.
1.3 Research and drug development by the
pharmaceutical industry has resulted in the licensing of four
drugs which have substantially improved the lives of many people
with dementia and their carers. The Alzheimer's Society shares
some common aspirations with pharmaceutical companiesnamely,
the development and use of drug treatments that can treat the
symptoms of dementia and ultimately cure or prevent the diseases
that cause dementia. However, we believe there are questions to
be asked about the influence that the pharmaceutical industry
has over drug development and access to research data. We have
outlined these below. We also discuss the difficulties in the
relationship between patient organisations and pharmaceutical
2. DRUG INNOVATION
2.1. Pharmaceutical companies are commercially
driven and therefore there exists less incentive for them to develop
or license drug treatments for which there is a limited market.
The cost of clinical trials and submitting a licence application
makes it uneconomical to produce drugs for rarer and more unusual
2.2. A clear example of this is the lack
of licensed drug treatments for non-Alzheimer's dementia. Although
there is some disagreement over the precise numbers, the proportions
of those with different forms of dementia can be broken down as
|Dementia with Lewy bodies||15%
|Fronto-temporal dementia incl. Pick's disease
2.3. The four existing drug treatments used by people with
dementia are licensed only for the treatment of Alzheimer's disease.
Therefore, for 45% of people with dementia there are no licensed
drug treatments. We know that the drug treatments licensed for
Alzheimer's disease are sometimes prescribed for people with other
forms of dementia and that, in many cases, they provide benefit.
The Alzheimer's Society recently conducted the largest ever consumer
survey of people's experience of drug treatments.i It found that
similar proportions of people with vascular dementia (VaD) and
dementia with Lewy bodies (DLB) as those with Alzheimer's disease
felt that the treatments were effective (71% of people with VaD;
79% of people with DLB and 73% of those with Alzheimer's disease
considered treatment effective). Clinical trials also confirm
that dementia drugs are effective for types of dementia other
than Alzheimer's disease.ii,iii,iv,v,vi,vii
2.4. However, the Society was disappointed that the planned
National Institute of Clinical Excellence (Nice) technology appraisals
of drug treatments for non-Alzheimer's dementia have been delayed
because the drug treatments are not licensed for this use. Lack
of Nice guidance creates unnecessary barriers to the provision
of potentially effective drug treatments for people with non-Alzheimer's
dementia. To overcome this, the Society believes that a more flexible
approach should be adopted. While Nice would generally appraise
drugs within their licensed indications, for rare conditions where
there is no incentive for drug companies to apply for a licence,
Nice should carry out appraisals if there is sufficient evidence
about the efficacy of the drug.
2.5. Nice could also be more flexible in their interpretation
of the licensing indications. For example, Nice guidance on drugs
licensed for Alzheimer's disease could be applied to people with
dementia with Lewy bodies. This type of dementia is often called
Lewy body variant of Alzheimer's disease and does not have a separate
classification from Alzheimer's disease in the ICD-10 (International
standard classification of diseases and related health problemstenth
revision). Strictly adhering to the licensing indications for
the dementia drugs means that people with dementia with Lewy bodies
can miss out on potentially beneficial treatment.
2.6. Indeed, the draft scope of the Nice dementia clinical
guideline acknowledges that drug treatments are often used beneficially
outside their licensing indications. The scope states that "where
evidence clearly supports it, recommendations for use outside
the licensed indications may be made in exceptional circumstances."
2.7. The domination of the pharmaceutical industry over
the development of drug treatments for dementia means that there
is an emphasis on searching for new compounds that will be profitable
for the drug company rather than looking at other, less profitable,
types of therapy. For example, aspirin for treating vascular dementia
or the efficacy of vitamins in treating or preventing dementia
have not been fully explored and developed. Moreover, when successful
trials are completed there is often very limited publicity. A
recent example of this is a trial which found vitamin A supplementation
maintains cognitive function.viii
2.8. The Society believes that the pharmaceutical industry's
influence on the innovation of drug treatments can mean that patients
miss out on potential benefits. Public-private partnerships can
be an effective strategy for developing drug treatments for conditions
that do not have a sufficiently large potential market for the
drug companies to otherwise take an interest and should be encouraged.
3. THE PROVISION
3.1. Pharmaceutical companies will be particularly keen
to influence patients, clinicians and patient groups at the time
when a new drug is licensed. It can be difficult for a patient
group to interpret from the promotional literature and claims
of benefit what the new drug will mean for the patients they represent.
3.2. When the drugs for Alzheimer's disease were first
licensed the Alzheimer's Society were praised for being a "voice
of reason" amidst the hype of a cure for Alzheimer's. At
that stage the Society was almost neutral about the drugs as it
was unclear what benefits they would bring. It can be hard to
translate claims of "improvements in quality of life"
into actual benefits that people with dementia and their carers
would experience following initiation of drug treatment.
3.3. It was only when we began to hear reports from people
with dementia and their carers and then conducted our own research
that we were in a position to say that drugs worked for some people.
We were able to say that while they did not work for everybody,
the drugs brought significant benefits for some people and we
could say what these benefits were. This knowledge gave us the
confidence to campaign on behalf of those with dementia for greater
access to drug treatments.
3.4. The Society has lobbied for consumer input into
the development and design of clinical trials. We believe that
this increased involvement would allow consumers to have a better
understanding of the drugs, the benefits and side effects they
bring and whether the drugs are safe.
4. RESTRICTED ACCESS
4.1. The Alzheimer's Society has serious concerns relating
to the influence of the pharmaceutical industry over the publication
of clinical trial data. Data that suggest a company's drug is
less effective, safe or cost effective than another drug for the
same condition pose a risk to the company. This can create pressure
to (1) publish only favourable trials (2) omit negative data from
trials with some positive outcomes. A number of papers discuss
possible publication bias, which can arise from multiple publication
of the results of one clinical trial, selective publication of
positive results and selective reporting of analyses of the data.ix,
x, xi, xii Clear examples of this are evident in the literature
pertaining to the treatment of behavioural symptoms in people
with dementia with atypical antipsychotics. Whilst there are four
published trials indicating efficacy, there are at least a further
three trials which have not been published that failed to demonstrate
significant benefit. Furthermore, only one of the four published
studies mentions the risk of serious adverse cerebrovascular events,
although a meta-analysis by the Committee for the Safety of Medicines
based on source data clearly demonstrated this risk across all
of the trials.
4.2. Prescribing of drug treatments will be guided by
the available evidence. This applies to individual clinicians'
prescribing decisions and local and national guidance, including
Nice guidance. It is vital that the available evidence is accurate
and unbiased. Lack of access to the full range of clinical trial
results can lead to the issuing of incorrect or harmful advice.
4.3. Failure to publish trial results also fails to acknowledge
that people who have agreed to participate in the trial have been
willing to take part because they thought that they would help
to further medical knowledge. It is unlikely that they would have
been willing to participate in the trial had they thought the
results of the trial would never be made available to others.
4.4. The Alzheimer's Society strongly welcomes and supports
the recommendations recently put forward by the Cochrane Collaboration
relating to the prospective registration of randomised clinical
trials. These can found at www.cochrane.org. Prospectively registering
trials would help to reduce duplication of research, allow patients
to find out if there are any relevant trials that are currently
recruiting and help to ensure that the results of all trials are
available and included in systematic reviews.
5. PROFESSIONAL AND
5.1. The Alzheimer's Society has had a policy on working
with pharmaceutical companies for a number of years. It has enabled
the Society to have open and transparent discussions with pharmaceutical
partners in a field that is changing fast. Indeed, the Society
was praised for its transparency in a Which? report which found
that out of 125 patient groups, only twothe Alzheimer's
Society and Diabetes UKhad an accessible and clear policy
on their websites.
5.2. The Alzheimer's Society accepts donations and educational
grants from pharmaceutical companies. The Society's audited income
in the financial year 2002-03 was £27 million. In the last
two financial years (2002-04) donations from the pharmaceutical
industry totalled £68,258. This is expected to represent
just over 0.1% of the Society's income. Donations are only accepted
in accordance with the Society's Guidelines for working with pharmaceutical
companies. (see Annex 1)
5.3. Nevertheless, in spite of our strict guidelines,
public accusations have been made about the Society and our relationships
with pharmaceutical industry. Our role as a trusted and credible
source of independent and reliable information and advice on all
forms of dementia is crucial. We are fiercely independent and
place a high value on maintaining this role. As a result, the
Society will not accept sponsorship from a pharmaceutical company
and their logo must not appear alongside the Alzheimer's Society
5.4. Pharmaceutical companies are strictly regulated
by the industry. The pharmaceutical companies cannot, for example,
promote the drugs for dementia to members of the general public.
The Society is acutely aware of the importance of its role both
as an information provider for people with dementia and their
carers but also as a lobbying organisation that raises the profile
of the need of people affected by dementia and of the treatments
and services required. To put it crudely, patient groups can undertake
promotional activities that pharmaceutical companies cannot. While
we take great care in not doing the pharmaceutical companies'
marketing and lobbying for them, the Society has played a key
role in raising awareness of the available drug treatments, the
need for early diagnosis and highlighting examples of postcode
prescribing. It is important to note that the Society has campaigned
equally vigorously to prevent the use of drugs that do not work
or cause harm. An example of this is the Society's campaign against
the use of neuroleptics/antipsychotic medication for people with
5.5. Despite our caution, the Society has welcomed support
from the pharmaceutical industry. Although we have turned down
many opportunities offered by pharmaceutical companies, there
have been specific strategic alliances which we feel had a positive
benefit for people with dementia and their carers. Most recently
we have been engaged in the development of a funding consortium
involving all the companies that have drugs licensed for the treatment
of dementia. We hope that this way of working will be successful
and enable us to reach more people affected by dementia. This
is a pilot project and will be carefully evaluated in terms of
its success in improving our ability to reach people affected
by dementia, as well as being a viable way of partnership working
for the future. The Society's trustees are closely scrutinising
this pilot project.
6.1. The pharmaceutical industry has developed four drugs
for Alzheimer's disease that have made a huge difference to the
quality of life of many people with dementia and their carers.
However, as outlined above, commercial pressures mean that the
benefits of drug development are available to a restricted group
and that research funded by the pharmaceutical industry lacks
transparency, which has serious implications for evidence based
6.2. Closer working between the pharmaceutical industry
and patient groups would have benefits for both parties in terms
of development of drugs which really meet people's needs. The
Society is eager to find a way of doing this that does not compromise
the independence and reputation of patient organisations.
REFERENCESi Alzheimer's Society,
Drugs for the treatment of Alzheimer's disease: submission to
Nice. 2004. London
ii Small et al, Galantamine in the treatment of cognitive
decline in patients with vascular dementia or Alzheimer's disease
with cerebrovascular disease. CNS-Drugs. 2003; 17(12): 905-14.
iii Erkinjuntti et al, An open-label extension trial
of galantamine in patients with probable vascular dementia and
mixed dementia. Clinical Therapeutics. 2003 Jun; 25(6): 1765-82.
iv Black et al, Efficacy and tolerability of donepezil
in vascular dementia: positive results of a 24-week, multicenter,
international, randomized, placebo-controlled clinical trial.
Stroke. 2003 Oct; 34(10): 2323-30.
v Jarvis and Figgitt, Memantine. Drugs and Aging. 2003; 20(6):
vi McKeith et al, Efficacy of rivastigmine in dementia
with Lewy bodies: a randomised, double-blind, placebo-controlled
international study. Lancet. 2000 Dec 16;356(9247): 2031-6.
vii Edwards et al, Efficacy and safety of galantamine
in patients with dementia with Lewy bodies: a 12-week interim
analysis. Dement Geriatr Cogn Disord. 2004;17 Suppl 1:40-8.
viii Grodstein F, Hee Kang J, Gaziano J M, A large randomized
trial of Beta-carotene supplements and cognitive function. Neurobiology
of Aging. 2004; S2: 54
ix Alzheimer's Society, Drugs for the treatment of Alzheimer's
disease: submission to Nice. 2004. London.
x Melander et al, Evidence b(i)ased medicineselective
reporting from studies sponsored by pharmaceutical industry: review
of studies in new drug applications. BMJ. 2003; 326: 1171.
xi Lexchin J, Pharmaceutical industry sponsorship and research
outcome and quality: systematic review. BMJ. 2003; 326: 1167.
xii Health Which? Money from drugs companies could do patient
groupsand patientsmore harm than good. April 2003