Memorandum by the Scottish Association
for Mental Health (PI 46)
1. The Scottish Association for Mental Health
(SAMH) is the largest voluntary sector organisation in its field
in Scotland providing accommodation, support, information, training,
employment and day care opportunities for people with mental health
and related problems. In addition, we operate an information service,
offering general mental health information and specialist legal
and benefits advice. SAMH campaigns on a wide range of mental
health issues, and works to challenge the stigma and discrimination
suffered by people who live with mental health problems, influence
policy and improve care services in Scotland.
2. SAMH has a policy of not accepting sponsorship
or grants from the pharmaceutical industry.
3. In April 2004 SAMH published a report
entitled All You Need to Know? A Scottish Survey of People's
Experiences of Psychiatric Drugs. This reported on the results
of a survey conducted with people who had received a new or different
prescription for their mental health problem within the last three
years, together with discussion in four focus groups throughout
Scotland. A total of 756 individual responses were analysed. The
aim of the survey was to supplement information gained from RCTs
by providing user based information on the performance of medicines
and to adopt an inclusive approach to ensure views were sought
from people who are often discounted from RCTs. Overall 61% of
respondents described their drugs as either "helpful"
or "very helpful"this percentage varied according
to the type of drug. For some drugs this figure was nearly 80%.
However, at the same time we found that many experienced unwanted
effects, with 61% experiencing unwanted effects when taking the
drugs, and 42% experienced unwanted effects when stopping. Some
of these unwanted effects were very severe, including suicidal
feelings, sleep deprivation, weight gain, paranoia, incontinence
and sexual difficulties.
4. The pharmaceutical industry has successfully
tested and marketed many drugs, particularly in the last 50 years.
However, the dominance of the industry, particularly in the research
field, has meant that other therapeutic approaches have been neglected.
Some alternatives, such as Cognitive Behavioural Therapy, are
well evidenced by research, but the same cannot be said for nutritional
approaches to mental health problems, psycho-social interventionsand
complimentary therapies many of which are highly rated by service
users. It is not wrong that money is spent on research into pharmaceutical
products, but the sheer amount of resources going into this one
area has led to an imbalance in the range of interventions available.
5. The vast majority of drug trials are
funded by the pharmaceutical industry. SAMH has serious concerns
that the lack of independence of those responsible for conducting
RCTs results in biased information reaching the public domain.
For example, one study has indicated that trials funded by the
pharmaceutical industry are four times more likely to have results
favourable to their own drugs.
SAMH strongly recommends the establishment of an independent body
to perform clinical trials. Funding for this body should come
from fees paid by pharmaceutical companies. Payment of these fees
should be mandatory prior to issuing a drug license. This would
have obvious benefits in terms of rigour, impartiality and credibility.
It is our view that simply trying to force companies to be open
and transparent regarding RCTs, whilst an improvement, would not
be sufficient to ensure full impartiality and accuracy of results.
6. There are clear reasons for the methodological
necessity of testing drugs in controlled environments. However
this sort of evidence is based on establishing efficacy as opposed
to effectiveness. In order to test for effectiveness drugs need
to be tested in more natural settings. This would provide evidence
on the performance of medicines in a more realistic setting and
would provide consumers with information more useful to their
7. There is also a need for more longitudinal
research into the effects of drugs. Most clinical trials are over
a fairly short term, but many people with mental health problems
will take psychiatric drugs for many years of their life.
8. Drug research should also be conducted
using combinations of drugs. In our survey 756 respondents received
1,538 drugs. Often the implications of the interaction between
these drugs is not well known and the additional side effects
that can be caused by them is not well understood. The prescription
of additional drugs to combat side effects is also a cause for
concern as this can sometimes mask the ineffectiveness of the
9. Decision making on prescription of medicines
should be based on full information and informed consent and should
be a joint decision between physician and consumer. Consumers
who are not being given full information are being treated without
their informed consent. Our survey showed that although in many
cases consumers were happy with the input they were offered, some
would have liked to have had more say in the decision. 70% of
respondents were not offered a choice of drug at the time of prescription,
30% did not feel able to ask questions, 20% were either fairly
or very unhappy that their prescription was a joint decision,
and 61% had concerns about their drug after they started taking
10. This needs to be rectified by adequate
training, impartial testing of drugs, the provision of information
to consumers in accessible language, and the establishment and
monitoring of clinical standards which have had meaningful user
influence in their formulation.
11. Consumers are often experts in psychiatric
drugs, especially those who have experienced mental ill health
for prolonged periods of time. More weight needs to be given to
research which reflects the views of those who use the drugs.
12. SAMH recommends the introduction of
good practice guidelines on the prescription of psychiatric drugs
to ensure that each time a new or different psychiatric drug is
prescribed there if a full and frank discussion on all relevant
aspects of the drug.
13. There is a general perception, widely
shared by service users, carers and professionals, that the pharmaceutical
industry spends a lot of money in promoting its products to the
NHS, through the provision of conferences, (with free places and
foreign travel) and other merchandising benefits. Some doctors
have publicly raised concerns eg through the No Free Lunch Campaign.
There needs to be more scrutiny and stricter regulation of the
marketing and merchandising activities of the pharmaceutical sector.
However, health professionals also need to take more responsibility
over their relationship with the pharmaceutical industry.
14. Although we understand changes are in
progress in the system for reporting of side effects it is important
that people are able to report their own side effects directly
to an independent monitor. Systems should be developed to ensure
health professionals take account of these reports.
15. Methods of administering drugs should
also be subject to a high level of scrutiny and should be subject
to constant review. Depot antipsychotics performed badly in our
survey, suggesting the need for greater legal protections surrounding
16. Budgetary considerations should not
prevent consumers from accessing the drugs they find most helpful.
Given the very individual nature of a response to medication a
wide a choice as possible is needed, to ensure that people find
the medication that works best for them. Leaving aside the issue
of fairness, trying to economise by only offering cheaper drugs
probably costs the health service more in the long run, with increased
admission to hospital and/or other demands placed on services
as a result of ill-health.
16 August 2004
34 Richard Smith Foregone Conclusions The Guardian
14 January 2004. Back