Information from drug companies and opinion leaders

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Abstract
The ALLHAT study The second example is the different approach chosen by pharmaceutical companies and some opinion leaders in the scientific discussion in peer reviewed journals5 6 and in the rejection of the ALLHAT study's results published in national journals targeted at prescribers and cardiologists.7 8 This double standard represents a predefined strategy aimed at challenging unwelcome results.11 ALLHAT had immediate responses in the Journal of Hypertension, whose editors asked specialists to discuss its methodological strengths and weaknesses.5 The invited commentaries substantially praised the strengths, identifying only minor weaknesses.11–14 Full scale attacks directed at the design, analysis, and interpretation of ALLHAT appeared instead in the journal of the Italian Society of Hypertension (Ipertensione & Prevenzione Cardiovascolare)7 and in a weekly medical magazine.8 According to the Italian editorial, the drawbacks of ALLHAT were a lack of previous experience in research trials in most centres, the short duration of the study, the lack of a washout period before randomisation, and the unusual combination of drugs associated with the experimental ones. The editorial also implied that the ALLHAT investigators had their own competing interests since a priority for the public institutions that funded ALLHAT (National Institutes of Health in the United States) is keeping the costs of care low.7 In the other article the major flaws in ALLHAT were listed as the ineffectiveness of monotherapy (actually 55% of patients were well controlled with monotherapy; the need to add a second drug, which could have favoured chlortalidone; the fact that 90% of the population was already treated with antihypertensive drugs (doesn't this happen in almost all hypertension trials?); that heart failure was not a prespecified end point (it was, and a totally validated one too); and that follow up was too short to show differences that could become important with long term treatments (ALLHAT has one of the longest follow ups among hypertension trials). In its conclusion the article says that ALLHAT's results should not be applied to Italian or European clinical practice, given the countries' low percentage of black patients (who benefit most from a thiazide diuretic treatment).8 Interestingly, in ALLHAT's main report, a subgroup analysis indicated that results did not change according to race.4 However, none of these arguments was present in the letters to the editors published by JAMA a few months after the ALLHAT report.6 These two cases underscore the need for a common set of rules if pharmaceutical companies and opinion leaders want to save their credibility. Firstly, pharmaceutical companies need to agree to collaborate on an explicitly prioritised research agenda where questions related to care are more relevant than drug specific issues. Secondly, a transparent code of conduct against publication bias or selective suppression of information should be developed. Since only a minority of randomised controlled trials gets published, a registry of ongoing studies following the example of the US National Cancer Institute's physician data query database (www.nci.nih.gov/cancer_information/pdq/) is warranted, together with disclosure of investigators' competing interests and their roles in the design, conduct, analysis, and interpretation of the study. Finally, both pharmaceutical companies and opinion leaders should recognise their ethical duty to avoid speaking two different languages—the scientific one in peer reviewed journals and the language stuffed with personal opinions when they speak directly to practitioners or policy makers.