The influence of the pharmaceutical Industry:
Health Policy, research, prescribing practice and patient use
Submission by Critical Psychiatry Network
The Critical Psychiatry Network is a group of practising Consultant Psychiatrists based in the British Isles, who are critical of orthodox beliefs in psychiatry, especially the importance attached to biological interpretations of distress. The Network first met in Bradford in January 1999, and seeks to influence thinking and practice in the mental health field. We are sceptical about the validity of the medical model of mental illness. We disagree with the emphasis placed on biological research and treatments. We do not seek to justify psychiatric practice by postulating brain pathology as the basis for mental illness. We believe that the practice of psychiatry must recognise the primacy of social, cultural, economic and political contexts. We welcome the Health Committee’s inquiry into the influence of the pharmaceutical industry in the NHS. It is timely given the widespread public and professional concerns.
The factual basis upon which our evidence rests is that the great majority of common psychiatric conditions (such as depression or psychosis) are unlike other medical disorders in that there is no evidence to support the view that these conditions are caused by underlying disturbances in brain function. Psychiatric conditions are not medical condition like liver or kidney failure, both of which have identifiable pathological causes that predict treatment response and outcome. This has a number of consequences:
We must emphasise that we are not against the use of medication in psychiatry. We use it daily in our work. Our view is that there has to be a more rational basis for the use of medication than is currently the case, one that is free of commercial pressure and interest, and more honest about the limitations and potential harm that medication can cause.
1. Drug Innovations
Our view is that commercial rather than clinical or scientific demands are becoming the dominant driving force for ‘innovation’, thus the popularity of cheaper "me too" options, and the promotion of new ‘disease concepts’ to allow the re-badging of old products to expand markets without major development costs 2. An example of the latter is the granting of a product licence for the use of Fluoxetine for the treatment of ‘premenstrual dysphoric disorder’, a disorder constructed to create a new niche for the drug as its patent was about to expire. Other examples include social anxiety disorder and post-traumatic stress disorder.
2. The conduct of medical research
Perhaps more so than any branch of medicine, psychiatry is open to the influence of external interests, including the pharmaceutical industry. This can be seen in the influence that the industry has on the design, conduct and reporting of psychiatric research, which all serve to promote the sponsor’s drug in the most favourable light.5,6 This has major implications for the design, conduct and interpretation of scientific studies of the efficacy of drugs in psychiatric conditions. There are high levels of media and public concern specifically about the influence of commercial interest on scientific knowledge, specifically in relation to side effects of the SSRI class of drugs.
3. Provision of drug information and promotion
We are deeply concerned about the influence of pharmaceutical company representatives in shaping the opinions of mental health professionals through promoting their companies’ products. We believe that they have an inordinately powerful influence in this respect. Their work represents the triumph of the science of marketing over the marketing of science. We believe that the health service and general public needs to be better informed about the modus operandi of pharmaceutical company representatives.
We believe that the interests of the public would be better served in this respect if Trusts had clear policies dealing with the relationships between clinical staff and representatives. For this reason we have recently undertaken an audit of all 83 mental health trusts in England by letter addressed to each Trust’s chief executive. At the time of writing the response rate is 73%. The figures for the 61 respondents are as follows:
Have a policy in place
Considering a policy
The Health Committee will no doubt be aware of growing trend to introduce nurse prescribing in the NHS. We broadly welcome this development, but we believe that it makes the introduction of clear policies regarding contact with pharmaceutical company representatives even more important. It is known that representatives ‘groom’ community psychiatric and ward nursing staff, especially when psychiatrists working closely with these nursing colleagues will not see representatives. Our view is that very close scrutiny must be made of the possible influence that representatives may have upon nursing colleagues in this respect. There must be very tight policies governing the type of preparations to be prescribed by nursing staff, particularly with regard to new drugs. All Trusts must have agreed policies that specify what is and what is not acceptable in terms of the relationship between clinicians and representatives.
For these reasons, our view is that pharmacists working in the NHS, especially specialist pharmacists working in mental health, are a more appropriate source of impartial advice about pharmacotherapy for people with mental health problems. Mental health specialist pharmacists have a thorough understanding of the mode of action, effectiveness, risks and side effects of psychotropic medication. Although their sources of information are culled from the industry, they are (or should be) removed from the immediate commercial interests that drive the work of company representatives. They are thus better placed to appraise the claims made for the effectiveness of different drugs.
We are also deeply concerned about the growing trend for direct to consumer advertising, not out of the need to protect professional interest, but because it is in the interests of the pharmaceutical companies to shape the way the public understands emotional distress in order to market their products. We cannot overstate the power and influence of the pharmaceutical industry in alliance with influential elites (like psychiatrists) in this respect.
4. Professional and patient education
Biological explanations of mental disorder dominate contemporary psychiatry,7 despite the absence of convincing evidence that conditions such as depression and schizophrenia have a biological basis. The education of psychiatrists continues to stress the importance of concepts such as schizophrenia, despite the overwhelming evidence that the concept is seriously flawed.8 In our view one of the main reasons for this is that it serves the interests of the pharmaceutical industry.
We draw your attention to an important paradox here. Government policy in the health service has rightly attached particular importance to social and contextual factors,9 and the democratic ideals of greater public involvement in the health service. This is of particular importance in psychiatry, where many service users feel alienated and excluded from society,10 especially those from our Black and Minority Ethnic communities.11 Despite this, the education and training of psychiatrists, arguably the single most powerful and influential group of professionals in mental health services, is dominated by biological accounts 6 that are incapable of responding to the social, cultural and political realities of many patients’ lives.
5. Regulatory review of drug safety and efficacy
6. Product evaluation, including assessments of value for money
Economic evaluations often use measures derived from value judgements, so it is very important that the researchers are impartial. Economic evaluations funded by drug companies show their own products favourably.12 The National Institute for Clinical Excellence (NICE) does not appear to take into account the source of funding of research studies that it cites in evidence for the efficacy of drugs in producing its guidelines.
Recommendations for Action
We believe the following actions are necessary 2 :
Dr. Philip Thomas
For and on behalf of Critical Psychiatry Network
Monday, 16 August 2004
Bracken, P. & Thomas, P. (2001) Postpsychiatry: A new direction for mental health. British Medical Journal, 322:724-727.
2Moncrieff, J., Hopker, S. & Thomas, P. (2002) The pharmaceutical industry and disease mongering. British Medical Journal. 325, 216.
3Moncrieff, J., Hopker, S. & Thomas, P. (2004) Psychiatry and the Pharmaecuetical Industry: Who pays the piper? [In press] Psychiatric Bulletin, July 2004.
4Thomas, P. & Cahill, A. (2004) Compulsion and psychiatry—the role of advance statements. British Medical Journal, 329:122–3
5Safer DJ (2002) Design and reporting modifications in industry sponsored comparative psychopharmacology trials. Journal of Nervous and Mental Disease, 190, 583-592.
6Melander H, Ahlqvist-Rastad J, Meijer G, Beerman B (2003) Evidence b(I)ased medicine- selective reporting from studies sponsored by the pharmaceutical industry: review of studies in new drug applications. British Medical Journal 326, 1171-1173.
7Moncrieff J, Crawford M (2001) British psychiatry in the twentieth century- observations from a psychiatric journal. Social Science and Medicine, 53, 349-356.
8See, for example, Bentall, R. (2003) Madness Explained: Psychosis and human nature. London, Allen Lane.
9HMSO (2000) The NHS Plan: A Plan for Investment, A Plan for Reform. Cm 4818-I, London, HMSO
10Sayce L (2000) From Psychiatric Patient to Citizen: Overcoming Discrimination and Social Exclusion. Macmillan Press: London.
11P. Walls and S.P. Sashidharan (2003) Real Voices - Survey findings from a series of community consultation events involving Black and Minority Ethnic groups in England. Report prepared for the Department of Health September 2003
12Baker C.B., Johnsrud M.T., Crimson M.L. et al (2003) Quantitative analysis of sponsorship bias in economic studies of antidepressants. British Journal of Psychiatry 183, 498-506