9.4 Drug Company Influence

Some of the risk factors listed in the Clinical Guidelines are based on theories about the cause of schizophrenia that remain unconfirmed. One of these, ‘Season of birth’, is a theory of very doubtful merit. It is based on observations that records in a few countries indicate a slightly higher birth rate for schizophrenics in the late winter/early spring months.[29] Researchers in other countries have not been able to confirm the link,[30] and its use as a diagnostic indicator is highly questionable. The supposed risk season only lasts a few months and, although the rate of schizophrenia in some countries might be slightly higher amongst people born in these months, most of the people who go on to develop the condition later in life are still born outside this period. Similarly, the vast majority of people who are born within this period are obviously not at any risk at all of developing schizophrenia.

These anomalies indicate a certain level of carelessness by the compilers of the Clinical Guidelines. Indeed, both the list of ‘risk factors’ and the list of ‘symptoms and signs’ were not originally devised for the Clinical Guidelines but were adopted without comment from a publication called the Early Psychosis Training Pack.[31] Although the principal authors of the Training Pack were the Director and Assistant Director of EPPIC, the document was produced by Gardiner-Caldwell Communications, a British public relations company which specialises in pharmaceutical marketing. The training pack was funded by an ‘educational grant’ from the pharmaceutical company Janssen-Cilag, which manufactures risperidone, an atypical neuroleptic used for treating schizophrenia.

It may be worth noting that while the Clinical Guidelines were being prepared, Gardiner-Caldwell was publishing a web-based journal entitled Influenza Bulletin[32] for an organisation called the European Scientific Working-Group on Influenza (ESWI). ESWI received funding from a number of pharmaceutical companies, including Solvay Pharma and SmithKline Beecham, both of whom manufacture influenza vaccines. Gardiner-Caldwell appears to have developed a public relations specialty that provides promotional assistance for medical researchers and which, at the same time, also helps to expand the potential markets for their pharmaceutical sponsors. The Early Psychosis Training Pack should be considered in this light, which raises questions as to why the Clinical Guidelines for early psychosis ‘best practice’ in Australia use material from the Training Pack without explanation.

A popular theory among schizophrenia researchers about the season of birth postulates a link between influenza infection of mothers in the second trimester of pregnancy and schizophrenia in offspring. A review of the evidence shows this hypothesis to be doubtful.[33] Still, some psychiatric researchers have called for an influenza vaccination programme for all women of child-bearing age to prevent mental disorders.[34] It is an interesting speculation to consider whether it might have been public relations activity on behalf of influenza vaccine manufacturers that positioned season of birth as a leading risk factor for schizophrenia. The stage is now set for interested parties to argue that influenza vaccination of child-bearing age women is a necessary part of future ‘best practice’ for preventing schizophrenia.

This type of public relations activity on behalf of drug companies does seem to play a role in other early-psychosis research. Most often, the public relations work is on behalf of companies that manufacture the newer neuroleptics. For example a community education programme supporting a new two-step programme for early intervention in first-episode psychosis at the London Health Sciences Centre, London, Ontario, is being sponsored by Zeneca.[35] It involves teaching doctors, parents, school teachers, college teachers and guidance counsellors how to identify the signs and symptoms of early psychosis in young people and where to direct them for psychiatric intervention. Zeneca manufacture quetiapine, an atypical neuroleptic.

The Western Psychiatric Institute and Clinic (WPIC) in Pittsburg, Pennsylvania, is running a Program for Assessment and Care in Early Schizophrenia (PACES).[36] To facilitate this research WPIC educates primary health care suppliers and educational professionals in their catchment area about the early signs of psychosis. Part of the research in conjunction with this programme aims to test the efficacy of three new atypical neuroleptics, with funding provided by the manufacturers of the drugs—Janssen-Cilag, Eli Lilly, and Pfizer.

A recently established programme in the United States aims to increase the awareness of schizophrenia by emphasising the importance of early intervention and detection. ‘The SOS programme—known in full as “SOS—Signs of Schizophrenia: What To Look For, What To Do”—was set up by the National Mental Health Association in conjunction with Janssen Pharmaceutica in the USA’.[37]

In Australia, EPPIC’s preventive treatment centre for young people, PACE, also receives drug company funding from Janssen-Cilag.[38] This may have paid off handsomely for the company. The EPPIC researchers have established a leadership role in early psychosis research and treatment in Australia, as was apparent in the organisation of NEPP and the Clinical Guidelines that emerged from the Project. It may not be coincidental that a half page of the Clinical Guidelines is dedicated to dosage recommendations for using Janssen-Cilag's risperidone in first-episode psychosis.[39] The Clinical Guidelines do not extend these dosage recommendations to include other schizophrenia drugs, and the recommendations for risperidone give the appearance of an official endorsement of the drug.

Drug company involvement is particularly evident in the organisation of early psychosis conferences. For instance, the Second International Conference on Early Psychosis—‘Future Possible’—held in New York in March/April 2000, was sponsored by Pfizer, Lilly, Janssen-Cilag, and AstraZeneca—all manufacturers of new atypical neuroleptics. A similar conference, sponsored by Pfizer, Lilly, Janssen-Cilag and Novartis, was hosted by EPPIC at the Hobart Casino, Tasmania, in September 1998. The foyer of the Hobart conference venue was given a carnival atmosphere by the presence of stalls set up by the drug companies. During intervals between conference sessions, barkers from the drug company stalls competed with one another for the attention of conference delegates, with public relations teams distributing literature, coffee, and various gifts such as pens, tea-towels, writing pads and rubber balls. Sponge-rubber brains from Eli Lilly were very popular.

In the final plenary session of the Hobart conference I asked a question of the assembled delegates: ‘Why are early psychosis programmes taking off now—and why is it happening in Australia—when there does not seem to have been a breakthrough in knowledge about the cause of schizophrenia and Australia does not normally lead the world in mental health initiatives?’ The delegates became animated as they questioned one another for the answer, but none was provided.

There seems to be only one plausible answer to this question: early-psychosis research and intervention programmes are driven by funding and lobbying from the pharmaceutical companies that have recently launched atypical neuroleptics onto the market. The objective of these pharmaceutical companies is to expand the market for the new drugs. The size of the existing market for palliative treatment of the psychotic and post-psychotic stages of schizophrenia is limited by diagnostic conventions. But the size of the market for prophylactic treatment of pre-psychotic schizophrenia is open-ended. Australia figures prominently in this strategy because it is being used as a testing ground for the idea of preventive medicine for schizophrenia. This is in preparation for the introduction of full-scale preventive medicine campaigns in the much larger drug markets of North America and Europe.

[29] R. E. Kendell and W. Adams, ‘Unexplained Fluctuations in the Risk for Schizophrenia By Month and Year of Birth’, pp. 758–63.

[30] C. E. Kim et al., ‘Month of Birth and Schizophrenia in Korea. Sex, Family History and Handedness’, pp. 829-31.

[31] McGorry and Edwards, Early Psychosis Training Pack.

[32] Gardiner-Caldwell Communications, Influenza Bulletin.

[33] Daniel R. Weinberger, ‘From neuropathology to neurodevelopment’, pp. 552–8.

[34] R. Livingston et al., ‘Season of birth and neurodevelopmental disorders: summer birth is associated with dyslexia’, pp. 612–16.

[35] Anonymous, ‘Young Adults Experiencing Psychosis Remain Undiagnosed’, Mental Health Net, accessed August 1996, available on-line at, http:// www. cmhc.com/articles/young.htm

[36] Western Psychiatric Institute and Clinic (WPIC), accessed July 1998, available on-line at, http://brains2.wpic.pitt.edu/paces.html

[37] Anonymous, ‘Early Detection and Intervention in Schizophrenia: The Patient’s Perspective’, p. 4.

[38] Early Psychosis Prevention and Intervention Centre, PACE Background.

[39] National Early Psychosis Project, Australian Clinical Guidelines for Early Psychosis, p. 28.