Select Committee on Health Written Evidence


APPENDIX 17

Memorandum by the Scottish Association for Mental Health (PI 46)

INTRODUCTION

  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.

IMPACT OF THE DRUG INDUSTRY ON DRUG INNOVATION

  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.

CONDUCT OF MEDICAL RESEARCH

  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[34]. 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 own situation.

  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 original drug.

THE PROVISION OF DRUG INFORMATION AND PROMOTION, AND PROFESSIONAL AND PATIENT EDUCATION

  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 it.

  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.

REGULATORY REVIEW OF DRUG SAFETY AND EFFICACY

  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 their use.

PRODUCT EVALUATION, INCLUDING ASSESSMENTS OF VALUE FOR MONEY

  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


 
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