Off-Label Drug Disclosure Inadequate

Some 85 percent of researchers involved in promoting off-label drug use do not adequately disclose financial conflicts of interest in published articles.

Aug 7, 2012
Hayley Dunning

Directly promoting drugs for purposes outside those approved by the US Food and Drug Administration (FDA), so-called "off-label" use, is illegal for drug companies. However, it is not illegal for physicians and scientists to discuss off-label use with colleagues, deliver lectures, and author peer-reviewed studies. But according to a new study, published today (August 7) in PLoS Medicine, only 15 percent of physicians and scientists involved in such promotion adequately disclosed relevant relationships they maintained with pharmaceutical companies in published studies.

"The major finding is both unsurprising and disturbing," said public health researcher Susan Chimonas of Columbia University, who was not involved in the study, by email. "The current disclosure system is woefully insufficient."

The study, led by physician scientist Aaron Kesselheim of Harvard Medical School, looked at the publications of scientists and physicians named in prosecution cases against drug companies involved in illegal marketing of off-label drugs. Complaints, which were filed with the US Department of Justice by whistleblowers under the US False Claims Act, named scientists and physicians involved in off-label promotion, though they were not punished by the process.

Kesselheim and his colleagues scanned the literature for publications that covered the drug for which the complaint was filed, diagnoses or diseases treated by the drug, or mentioned other medications or alternatives in the same therapeutic class. Of 91 physicians and scientists named in complaints, 39 of them authored a total of 404 related publications. The majority of these authors acted as a paid speaker for the company that had developed and marketed the drug, while others wrote review articles, acted as advisory board members, or received support funds.

However, despite the close ties between the researchers and the drugmakers, only 62 of those 404 related articles (15 percent) had adequate disclosures, with the authors discussing fully the nature of their relationship with the company. The majority of other articles had no disclosure statement at all or had disclosures that did not mention the drug company.

"We were surprised at the relatively low number of adequate disclosures," said Kesselheim. "We were also surprised at the variability of the disclosures, and how some journals seemed to have very clear disclosures where some did not."

Kesselheim said relationships between scientists or physicians and the pharmaceutical industry are becoming more common, and while debates continue about the value of such relationships, every partnership should be disclosed. He advocates for better standardization of disclosure policies between journals and across different types of articles. For example, in the current study, the authors found far less disclosures among commentaries than research articles.

Another troubling trend apparent in the data, Chimonas noted, is that of the individuals identified in whistleblower complaints, most were physicians who did not publish papers.

"We've had anecdotal evidence that companies are increasingly turning to non-academic physicians to serve as paid marketers; academic institutions are putting ethical limits on physicians' relationships with industry, and companies would rather operate outside those limits," wrote Chimonas. "But this study is the first to indicate how strongly companies have already moved in that direction."

The study's authors note that because the FDA offers no clear guidance on off-label drug use, expert opinion can have significant impact on prescribing behavior. Kesselhiem said that physicians need more education about "the importance of disclosure and the need to be forthcoming, and why it matters."

"I would like to see the medical profession, including medical societies and the state boards that license all physicians, doing more to change behavior," Chimonas agreed. "Community docs need guidance (and limits) for relating to industry just as much as academic physicians."

 A. Kesselheim et al., "Conflict of interest reporting by authors involved in promotion of off-label drug use: an analysis of journal disclosures," PLoS Medicine, 9: e1001280, 2012.

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