Only a low number of physicians have disclosed a conflict of interest in journal publications when involved in off-label marketing of pharmaceutical products, according to a study in PLOS Medicine.
Since collaborations between physicians and pharmaceutical companies are essential to medical research, it is expected and necessary for physicians to be forthcoming about those relationships, which may represent a conflict of interest.
In “Conflict of Interest Reporting by Authors Involved in Promotion of Off-Label Drug Use: An Analysis of Journal Disclosures,” the authors found that only one in seven authors identified in complaints alleging illegal off-label marketing had adequately disclosed their conflicts of interest.
“This is a much lower rate of adequate disclosure than has been identified in previous studies,” wrote Aaron S. Kesselheim, Bo Wang, David M. Studdert and Jerry Avorn. “This is a much lower rate of adequate disclosure than has been identified in previous studies.”
Off-label use of drugs is a tricky area for the industry. The companies can’t actually promote off-label uses, but physicians can and since there’s little to no guidance or scientific foundation, patients will often take their doctors’ word. However, off-label prescribing can be incredibly lucrative for drug companies.
“These factors make physicians who are willing to advocate off-label prescribing a valuable commodity to pharmaceutical companies,” the authors wrote. And the government has identified physicians and scientists paid to support off-label uses in lectures and peer-reviewed articles.
In the PLOS study, the authors used a list of physicians and scientists identified by whistleblowers and gathered publications by them to assess the adequacy of disclosures.
“An adequate disclosure was defined as one in which the existence of a financial relationship between the author and defendant manufacturer, as revealed in the complaint, was also stated in the published article,” Kesselheim et al. wrote. “An inadequate disclosure was defined as one in which a personal connection was not mentioned.”
The 39 authors who had financial relationships with pharmaceutical companies in the context of off-label drug marketing wrote a total of 404 related articles and only 15% of these articles had adequate disclosures.
Perhaps more alarmingly, of the 342 articles with inadequate disclosures, 43% had no disclosure, 4% had statements denying any conflicts of interest, 40% had disclosures that did not mention the manufacturer, and 13% had disclosures that mentioned the manufacturer but inadequately conveyed the nature of the relationship between author and manufacturer reported in the complaint.
“The systematic nature of the non-disclosure, and context in which these failures occurred — suspect marketing activities that authors were paid to be a part of — suggest that embarrassment or willful hiding may explain at least some of the missing disclosures,” the authors of the study wrote.