Memorandum by Rethink Severe Mental Illness
(PI 02)
SUMMARY
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.
INTRODUCTION
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: www.rethink.org/research
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.
DRUG INNOVATION
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.
THE CONDUCT
OF MEDICAL
RESEARCH
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.
THE PROVISION
OF DRUG
INFORMATION AND
PROMOTION
Rethink has a publicly available sponsorship
policy (Appendix A) that is also available at: www.rethink.org/news+campaigns/policies.
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—www.rethink.org.
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.
PROFESSIONAL AND
PATIENT EDUCATION
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.
REGULATORY REVIEW
OF DRUG
SAFETY AND
EFFICACY
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.
PRODUCT EVALUATION,
INCLUDING ASSESSMENTS
OF VALUE
FOR MONEY
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.
— Unrepresentative choice of comparator
drugs.
— 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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