Select Committee on Health Written Evidence


Memorandum of the Alzheimer's Society (PI 41)


  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 companies—namely, 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 companies.


  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 diseases.

  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 follows:

Alzheimer's disease 55%
Vascular dementia20%
Dementia with Lewy bodies15%
Fronto-temporal dementia incl. Pick's disease 5%
Other dementias5%

  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 problems—tenth 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.


  3.1.  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.


  4.1.  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 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.


  5.1.  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 two—the Alzheimer's Society and Diabetes UK—had 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 logo.

  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 dementia.

  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 healthcare.

  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): 465-76.

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 medicine—selective 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 groups—and patients—more harm than good. April 2003

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