Select Committee on Health Minutes of Evidence

Memorandum by Rethink Severe Mental Illness (PI 02)


  Rethink works with people who rely on medicines to help them recover a full and meaningful life from severe mental illness.

  Rethink regularly surveys the views of its members and the people who use its services. This submission is based on those views.

  Rethink works in partnership with a wide range of organisations, including the pharmaceutical industry.

  The pharmaceutical industry is not the only potential source of influence on a charity's work. All forms of fundraising contain inherent potential for influence.

  Financial support from the pharmaceutical industry amounts to 0.47% of Rethink's turnover.

  Medicines are part of a holistic approach to treating severe mental illness but do not offer a cure.

  Increased efforts are needed to develop new medicines with still fewer and less severe side effects, although the hopes of a medicinal "cure" are very remote.

  Public information is essential to encourage and support informed choice.

  Rethink's policy on accepting sponsorship is publicly available.

  We believe that a well publicised public route for patients to contact regulators should be created.

  It is our recommendation that the regulatory process is opened up to include all the stakeholders affected by its decisions.

  Existing methods of evaluating new and existing drug treatments for schizophrenia are generally poor.

  Improved economic health models offering sophisticated measures of quality of life are needed.


  Rethink severe mental illness is a membership-based charity managing nearly 400 services across England and Northern Ireland. We also operate 135 local voluntary support groups. Most of the people who are our members or who use our services are directly affected by severe mental illnesses such as schizophrenia and bi-polar disorder (manic depression) or severe personality disorders. Increasing numbers of people have a "dual-diagnosis" in which a severe mental illness and abuse of street drugs or alcohol present themselves. The majority of the people using our services rely on long-term use of medicines to assist their efforts to recover a full and meaningful life. Rethink severe mental illness was formally known as the National Schizophrenia Fellowship.

  We regularly survey the views of our 7,000 members and the 5,000 people who use our services each day. The findings from these surveys are published as short reports. Relevant titles covering areas of interest to the committee are: A Question of Choice, That's Just Typical, Doesn't it make you sick?, Right from the Start, Just One Per Cent, Who Cares? and Under Pressure. These publications are available at: or in hard-copy form.

  Rethink works in partnership with a wide range of individuals, statutory, voluntary and corporate organisations to provide services, information, advice and support, and to campaign for improvements in the lives of everyone affected by severe mental illness. These partnerships include working with individual pharmaceutical companies and with industry organisations such as the Pharmaceutical Schizophrenia Initiative and the ABPI. We are a member of the Health Coalition Initiative of pharmaceutical companies and voluntary sector organisations that is developing "A Framework Document for Developing Model Agreements or Compacts on Partnerships between Patient Groups and the Pharmaceutical Industry."

  It is important to recognise that, as a voluntary sector organisation, we are reliant on a number of funding sources, including non-pharmaceutical corporate bodies. These non-pharmaceutical corporate bodies also have agendas and reasons for wishing to work with charities that require careful internal scrutiny and external scrutiny.

  Other sources of funding include face-to-face street fundraising, which relies on a charity having a high public profile for success, and funds from grant making bodies which may wish to steer a charity's work in a particular direction.

  The scale and scope of our partnership work with the pharmaceutical industry can be measured in financial terms. Rethink's turnover for 2003-04 was £41.85 million. Rethink's financial support from the pharmaceutical industry in unrestricted income, restricted income and benefits in kind amounted to £196,950 or 0.47% of turnover. Rethink's voluntary income (excluding income from contracts to run services) amounted to £2.77 million. Against this measure, total support from the pharmaceutical industry amounted to 7.11% of voluntary income.

  The views contained in this submission reflect those contained in our survey reports and are based on the views and experiences of our members, the 5,000 people using our services each day and our 1,400 staff.


  There is no "cure" for severe mental illness. A simplistic biological approach to severe mental illness concentrates on chemical imbalances in the brain, which might lead to an equally simplistic view that a drug or combination of drugs could now or may in the future be used to "rebalance" the brain's chemistry and "cure" the illness. Rethink, along with the overwhelming majority of the mental health world, rejects this simplistic view.

  Severe mental illness is the result of a complex interaction between individual genetic make-up, brain structure and chemistry, individual life experiences and the wider environment, including shifting views throughout history of what constitutes "illness." As such, medicines can only ever hope to be one part of a holistic approach that assists people to deal with the symptoms of severe mental illness and one part of a generalised approach to recovering a life that is full and meaningful to the individual.

  There is a perception amongst the public and many professionals that there are essentially two types of medicine—ones that are safe, clean and effective and ones that have severe side-effects and are ineffective. In fact, all medicines have the potential to cause side effects, often severe, on particular individuals and all are less than 100% effective. We all need a more critical and sceptical approach to medicines.

  In broad terms, over the last 50 years, there have only been two "generations" of medicines to deal with schizophrenia and two to deal with the depression and anxiety that are often associated with it. The first generation medicines, while effective in reducing the symptoms of severe mental illness in around 70% of the people using them, are associated with severe and disabling side effects. Second-generation treatments, while being at least as effective, and possibly more effective, in dealing with the symptoms, are associated with fewer and less severe side effects—but they still have a range of side-effects that can, for individuals using them, prove disabling in themselves.

  There is no one single medicine or generation of medicines that is universally effective or that has no side effects. The effectiveness of the medicines routinely used in the treatment of severe mental illness is, like the experience of severe mental illness itself, individual. We believe that informed choice is central to maximising the benefits people can expect from medicines—see Information and Promotion below.

  Rethink believes that new generations of medicines that are more generally effective, more individually tailored and carry still fewer and less severe side effects are urgently required.

  We are encouraged that the pharmaceutical industry is engaged with developing a new generation of medicines and that there is evidence that research into the genome, some of it government supported, may offer novel approaches in the future. However, the investment being made into medicines for the treatment of severe mental illness is wholly inadequate when measured against need and is disproportionately small compared to the investment being made by industry, the government and the voluntary sector into advances into the understanding and treatment of physical illness and disease, such as cancer and cardiac care.


  Rethink does not conduct or participate in medical research. We do not routinely encourage our members or the people who use our services to participate in medical research. We have, infrequently, carried articles in our membership magazine, Your Voice, about medical research being carried out in institutions such as the Institute of Psychiatry, particularly in relation to the use of brain imaging techniques.

  We are in the process of developing our own five-year research strategy. This will establish a research governance structure and a process for involving service users and carers in the development and operation of social research. We do not envisage conducting medical research over the next three years, but intend to be in a position to consider this option at the end of that period.

  We have worked with, and will continue to do so in the future, research organisations whose focus is on the life experiences of people with severe mental illness and their carers—social research.

  Many of the points we raise in Product Evaluation (below) are relevant here too.


  Rethink has a publicly available sponsorship policy (Appendix A) that is also available at: The sponsorship policy begins: "The acceptance and continuation of any sponsorship by Rethink is conditional upon Rethink being satisfied that its name will not be used to promote the efficacy of a particular product, service or event."

  Rethink does not promote any single medicine or class of medicine. We do not believe that medicines by themselves are sufficient for an individual to recover a full and meaningful life. Medicines, as part of a holistic package that address an individual's full set of needs, including accommodation, occupation, finances, family and social inclusion, plays an important role for most people with severe mental illness. We believe in the promotion of informed choice.

  To this end, we produce information for service users, carers and professionals about the range of medicines available. We retain full editorial control of that information. The information is available in a range of formats, including specific medicine information leaflets, pamphlets, packs and books. Some of these are provided free and some require payment. Most are available free on our website—

  In addition, we run a range of seminars, briefings, members' days and conferences each year in which we promote the concept of informed choice. We also speak at conferences and events organised by others, including academic institutions, commercial organisations and the pharmaceutical industry, for which payment to us is sometimes, but not always, made.

  Our most widely distributed publication in this field is Only the Best. The first edition, in a loose-leaf folder format, sold out of its 40,000 print run. A second updated edition in a book format has just been published.

  We accept clearly acknowledged financial support for some of these publications when such support is in line with our Sponsorship policy (Appendix A).

  It is our view that the publication of unbiased information for service users and carers is essential if the concept of informed choice is to become a reality. It is our view that an open and transparent approach in which Rethink retains editorial control and all financial support is clearly acknowledged allows us to produce unbiased information that can be trusted by our members, service users, carers and professionals.

  It is our view that these principles of openness, transparency and editorial independence should underpin the relationship between the pharmaceutical industry and those parts of the voluntary sector that choose to engage with it.


  Mental health is blighted by stigma and discrimination. Professional and patient education plays an important part in combating this, promoting informed choice and enabling service users and carers to become more assertive. Our developing research strategy includes programmes part funded by the pharmaceutical industry to raise awareness of mental health issues and to combat stigma and discrimination amongst specific groups—schoolchildren, police officers and trainee psychiatrists, to date. Again, financial support is acknowledged and Rethink retains full control over the research including its findings and dissemination of those findings.

  We also believe that is important to raise public awareness and counter existing stereotypes that falsely link severe mental illness and violence. Through our media and campaigns volunteer programme, we offer training and support to service users, carers and staff who wish to speak to the media about their experiences or who want to participate in broader Rethink campaigns. The media and campaigns volunteer programme is part-funded by the pharmaceutical industry. Decisions on whether to take part in media interviews or campaign activities are taken by individual members of the scheme, with the support of specialist Rethink staff. Financial support for the scheme does not give the sponsor any right to call on staff, service users or carers to participate in a sponsor's activities. Decisions on whether to take part in this type of activity are taken by individual members of the scheme and with the support of specialist Rethink staff.

  Rethink has been experimenting for the last three years with a national "awareness week" which aims to challenge misconceptions about severe mental illness, raise awareness of the organisation and create fundraising opportunities among members of the public. To date, these "awareness weeks" have been funded from general fundraising activity, but we would consider sponsorship of the week where it was in line with our Sponsorship policy.


  It is our view that much of the media furore surrounding the activities of the pharmaceutical industry stems from a failure in the regulatory process.

  We are concerned that regulators do not, as a matter of course, involve service users and carers and the voluntary sector. Medicines regulation is, perhaps, the last corner of the health world in which the voluntary sector, "patients" and carers fail to find a welcome and a recognition of their value as "experts by experience."

  We believe that regulatory bodies have failed to create open and accessible channels to receive information from "experts by experience." In particular, the "yellow card" warning scheme has been wholly reliant on professional interpretations of patient experience before concerns are even allowed to reach regulators. We believe that a well publicised public route to regulators should be created.

  Commercial confidentiality is too widely used to prevent regulators accessing all the data—published and unpublished—needed to come to reliable decisions on the efficacy and safety of medicines. Academic journals also appear reluctant to publish the results of trials which show that a particular medicine does not work.

  Regulatory reliance on industry bodies and their own experts has created a closed system in which the necessary checks and balances that could be provided by the full involvement of service users ("patients"), carers and others is absent.

  Although we have separate concerns about some aspects of the work of the National Institute for Clinical Excellence, particularly in relation to the implementation of its guidance and guidelines, it does have a comprehensive and inclusive process that allows stakeholders to participate fully in its deliberations.

  It is our recommendation that the regulatory process is opened up to include all the stakeholders affected by its decisions.


  When participating in the National Institute for Clinical Excellence's review of atypical treatments for schizophrenia, it became clear that existing methods of evaluating new and existing drug treatments for schizophrenia are generally poor. Our general criticisms of large numbers of trials revolve around:

    —  Small numbers of participants.

    —  Short length of trials.

    —  High drop out rates.

    —  Unrepresentative choice of comparator drugs.

    —  Funding arrangements.

    —  Lack of transparency of data produced and published.

    —  Lack of rigorous and critical reading of the data by regulators.

  We are aware that the National Institute for Clinical Excellence and other agencies rely heavily on so-called "gold star" randomised control trials (RCTs). It is our experience that RCTs can remove the human experience from the evaluation process. Qualitative evidence, even large amounts of it, can be disregarded. RCTs do not by themselves answer our general criticisms of drug trials above. Indeed, some RCTs score highly on each point of our general criticisms. Our evidence to the NICE review concentrated on the qualitative human experience of using the new (atypical) and old (typical) medicines for the treatment of schizophrenia. It is these human experiences that led us to recommend to NICE not only the ending of postcode prescribing of the new treatments but informed choice for service users in the medicines taken.

  The issue of "value for money" is badly drawn in mental health, where individual life expectancy for people with severe mental illness is 10 years below average, unemployment rates exceed 80% and 12% of the NHS budget is spent in this area. Whether an individual medicine or class of medicines can be said to provide "value for money" should depend less on the concept of an individual reducing demand on NHS services or becoming a tax-payer than on incremental improvements in that individual's quality of life, their degree of social inclusion and their acceptance by and participation in their community.

  Economic models within health that allow for sophisticated value for money measures of improved quality of life are poorly developed. The model of chronic disease management enables some measure of reduced costs to services while the model chosen by NICE in its appraisal of atypical treatments for schizophrenia found overall cost savings, despite higher prescription costs of the new drugs.

  Rethink believes that more sophisticated economic models need to be developed to measure incremental quality of life improvements amongst people with long-term medical conditions.

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