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SHORT REPORTS |
North East Wales Trust, UK
Correspondence: Dr Rob Poole, Pwll Glas Resource Centre, Pwll Glas Road, Mold, Flintshire CH7 1RA, UK. Tel: +44 (0) 1352 750252; email: eliphaz{at}doctors.org.uk
Declaration of interest T.T. has accepted sponsorship to attend conferences from Janssen-Cilag and Eli Lilly. R.P. has accepted speakers' fees from Lundbeck, Eli Lilly and Pfizer; he has also accepted sponsorship to attend conferences from Wyeth, AstraZeneca and Eli Lilly. No funding was obtained for the present study.
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ABSTRACT |
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 TOP ABSTRACT INTRODUCTIONMETHODRESULTSDISCUSSIONREFERENCES |
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INTRODUCTION |
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TOPABSTRACTINTRODUCTIONMETHODRESULTSDISCUSSIONREFERENCES |
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METHOD |
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TOPABSTRACTINTRODUCTIONMETHODRESULTSDISCUSSIONREFERENCES |
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Outcomes were rated by T.T. He was aware of funding, as this was apparent in the papers. Studies were classified as reporting positive findings if they clearly stated that use of the index drug led to a better clinical outcome or was better tolerated than another treatment. Studies were classified as reporting negative findings if they clearly stated that use of a comparison treatment led to a better outcome or was better tolerated than the index drug or that there was no difference in clinical outcome or tolerability. Where the conclusions in the full text and abstract were equivocal, T.T. made a judgement as to whether the balance of findings was positive or negative.
Papers were included from all psychiatric sub-specialties. Outcome studies were included that compared an index drug with placebo, another drug or a psychological therapy. Studies were excluded if they concerned an index drug that was long established (e.g. tricyclic antidepressants, lithium, older antipsychotics) unless it was being used for a novel indication (e.g. testosterone for resistant depression). Short reports, letters to the editor, editorials, review articles and meta-analyses were excluded.
The authors' relationship with the drug company was determined from declared affiliations and conflicts of interest, or from acknowledgements. Studies were classified as industry-funded if the study was wholly or partly funded by a drug company, including funding in kind (provision of drugs and placebos, or an author who was an employee). Authors were regarded as employees if they worked full time for the company, or declared consultancy positions or shareholdings. Studies were regarded as independently funded if sufficient information was provided to exclude any of these relationships.
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RESULTS |
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TOPABSTRACTINTRODUCTIONMETHODRESULTSDISCUSSIONREFERENCES |
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Of these 190 studies, 33 (17%) were published in the British Journal of Psychiatry, 98 (52%) in the American Journal of Psychiatry and 59 (31%) in the Archives of General Psychiatry. Most studies (157) concerned adults; the remainder concerned elderly people, children, or mothers and babies. Of the 132 studies that were randomised controlled trials, 112 (85%) were industry-funded. In 75% of studies the index drug was an antipsychotic or an antidepressant (Table 1).
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There was a significant difference between journals in reporting of
negative results, the British Journal of Psychiatry being more likely
to report negative findings than the other two (
2=7.99,
d.f.=2, P=0.0184).
Financial relationship with the drug industry
Forty-four studies (23%) were independent. Of the 146 that were
industry-funded, 58 (40%) also received funding from a non-industry source.
Six pharmaceutical companies funded nearly half of all the studies surveyed.
There were 76 industry-authored studies (40%); of these, 64 (84%) had authors
who were employees or shareholders. Seventy studies (37%) were
industry-sponsored.
Outcomes
Positive findings were reported in 152 (80%) studies, whereas 38 (20%)
reported negative findings. Independent studies were more likely to report
negative findings than industry-funded studies. Sixteen (36%) of the 44
independent studies reported negative findings compared with 22 (15%) of the
industry-funded studies. The difference was statistically significant (Yates'
corrected 2=8.3, d.f.=1, P=0.004). Only two (3%) of
the 76 industry-authored studies reported negative findings. The difference
between this group and the independent studies was highly statistically
significant (Yates' corrected 2=22.29, d.f.=1,
P<0.0001). A similar statistically significant difference was
observed in the reporting of negative findings between industry-authored and
industry-sponsored studies (Yates' corrected 2=17.18, d.f.=1,
P<0.0001). There was no significant difference between independent
and industry-sponsored studies in reporting of positive or negative findings
(2=0.44, d.f.=1, P=0.51).
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DISCUSSION |
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TOPABSTRACTINTRODUCTIONMETHODRESULTSDISCUSSIONREFERENCES |
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There are some factors that might have confounded our findings. There were more RCTs among the industry-funded studies. Unlike other investigators, we included all methodologies because the number of independent RCTs in psychiatry is small. It might be that RCTs are intrinsically more likely to produce positive findings. Equally, they might be particularly vulnerable to being abandoned when preliminary findings are not promising (Henry et al, 2005). We did not assess the scientific quality of different studies. It is possible that independent studies tend to be statistically underpowered and that this leads to overreporting of negative findings (Djulbergovic et al, 2000; Procyshyn et al, 2004).
Our findings are unlikely to be solely due to these factors. All previous studies comparing industry-funded RCTs with independent ones have shown that the former are more likely to report positive findings. If industry-funded studies are less likely to be underpowered or methodologically flawed, then one would expect that the reporting of negative findings would be similar in the industry-authored and industry-sponsored groups, whereas actually the sponsored and independent studies were similar. We seem to have found an `all or nothing' effect related to the involvement of a drug company employee.
In conclusion, we have confirmed previous findings that industry-funded studies are less likely to report negative findings. Our novel finding is that this effect appears to be largely or exclusively due to the presence of a company employee among the authorship. This finding requires replication with attention to differences in studies' methodological rigour and statistical power, in order to exclude these as confounding variables.
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REFERENCES |
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Bodenheimer, T. (2000) Uneasy alliance.
Clinical investigators and the pharmaceutical industry. New England
Journal of Medicine, 342, 1539
-1543.
Djulbergovic, B., Lacevic, M., Cantor, A., et al (2000) The uncertainty principle and industry-sponsored research. Lancet, 356, 635 -638.[CrossRef][Medline]
Henry, D. A., Kerridge, I. H., Hill, S. R., et al (2005) Medical specialists and pharmaceutical industry-sponsored research: a survey of the Australian experience. Medical Journal of Australia, 182, 557 -560.[Medline]
Komsaroff, P. A. & Kerridge, I. H. (2002) Ethical issues concerning the relationship between medical practitioners and pharmaceutical industry. Medical Journal of Australia, 176, 118 -121.[Medline]
Lexchin, J., Bero, L. A., Djulbegovic, B., et al
(2003) Pharmaceutical industry sponsorship and research
outcome and quality: systematic review. BMJ,
326, 1167
-1170.
Procyshyn, R. M., Chau, A., Fortin, P., et al (2004) Prevalence and outcomes of pharmaceutical industry-sponsored clinical trials involving clozapine, risperidone or olanzapine. Canadian Journal of Psychiatry, 49, 601 -606.[Medline]
Received for publication March 22, 2006. Revision received February 7, 2007. Accepted for publication February 28, 2007.
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