When a drug is licensed for use by a regulatory authority, it is normal for its use to be subject to a quite specific remit. In general terms, this will mean the drug will be licensed for use for a specific condition (or conditions), at a particular dose, to people of a particular age. That does not mean, however, that this will limit how the drug will be used in practice. Doctors are at liberty to use the drug in scenarios that extend beyond those specified in its license – so-called ‘off label’ usage.
Not uncommonly, it seems, a drug company will encourage off-label use by doctors (it extends its market, of course). One way a drug company can do this is to partake in a bit of ‘off-label marketing’. A strategy here might be to court and then pay doctors and scientists to speak and write about off-label uses of a drug.
Ideally, if a doctor or researcher were to write in an academic journal about off-label uses of a drug, then he or she would at least declare any relevant conflicts of interest. That way, readers can better judge whether the author’s opinions might be biased (tainted) through whatever commercial arrangement they have with the drug company that makes the product they are writing about. Some new research suggests that, on the whole, reporting of conflicts of interest here leaves much to be desired .
The study in question started by identifying doctors or researchers who had been reported by other health professionals for (inappropriate) off-label activities. 39 relevant individuals were identified who had gone on to author a (whopping) total of 404 articles about relevant products (drugs with which their appeared to be a conflict of interest) over a 3-year period.
Of these 404 articles:
- 148 had no conflict of interest disclosure at all
- 137 had a conflict of interest disclosure, but failed to mention the relevant drug company by name
- 43 mentioned the relevant drug company by name, but did not disclose the relevant relationship with the author
- 14 had a disclosure erroneously stating ‘no conflicts’
So, of 404 articles, 342 (85 per cent) were deemed to lack adequate disclosure statements.
I’ll leave you with the final paragraph from the article’s authors themselves, which sums things up nicely, I think:
This study documented substantial deficiencies in the adequacy of conflict-of-interest disclosures made by authors who had been paid by pharmaceutical manufacturers. That such failures occurred in relation to off-label marketing schemes is especially troubling. Because off-label use is an area of clinical practice in which opinion is likely to be divided about appropriate care, the views of high-profile “opinion leaders” may exert considerable influence on prescribing practice. Disclosure of financial ties in these situations would give readers an opportunity to weigh the potential for bias. Our findings suggest that approaches to controlling the effects of conflicts of interest that rely on author candidness and variable policing by journals have fallen short of the mark. Readers are left with little choice but to be skeptical.
1. Kesselheim AS, et al. Conflict of Interest Reporting by Authors Involved in Promotion of Off-Label Drug Use: An Analysis of Journal Disclosures. PLoS Med 9(8): e1001280. doi:10.1371/journal.pmed.1001280