How to prevent and recognise potential problems

Strategies for identifying and preventing potential problems include the education of trainees and educators about avoiding and managing interactions with the pharmaceutical industry, more transparent disclosure procedures and the harmonisation of conflict of interest policies.

Despite good intentions, industry involvement in medical education can cause unrecognised problems. The educational programme in question was well known for promoting interdisciplinary collaboration and it was recognised with a teaching award. Although the organisers did not believe that the content was influenced by sponsorship and referred to industry financial support as ‘philanthropic’,22 for several years the lectures contained statements that promoted the products being sold by sponsors. A non-faculty lecturer with conflicts of interests was invited to give the lectures when faculty members without conflicts were available. It should not come as a surprise that the students attending these sessions also did not recognise the problematic content since even practising physicians often fail do so.24 The difficulty in recognising problems underlines the need to identify and avoid potentially problematic sessions before they take place. Box 1 provides a decision aid that can be used to document the interaction between topics that may be subject to pharmaceutical industry influence and conflicts of interest. The confluence of a controversial topic involving therapeutics and relevant conflict of interest in this case should have prompted greater attention to this high-risk combination. Note that in this case the content of the course was reportedly reviewed every year by a curriculum committee, yet the problems were not detected or dealt with through this process.

Medical students25 ,26 and physicians24 ,27 are unlikely to believe that their views are biased by their interactions with the pharmaceutical industry, but there is evidence that educational interventions are effective at changing this view.28 ,29 Trainees might be more likely to recognise problematic content if they had a taxonomy for describing the spectrum of such content from a selective presentation of correct information to falsehoods. Both didactic and role playing educational sessions can alert medical students to the effects of marketing on clinical decision-making.29 ,30 For example, an educational session for second- and third-year medical students comprising a session with a former pharmaceutical representative, a faculty debate and online modules increased scepticism about the appropriateness of pharmaceutical company involvement in teaching.29 Such educational sessions can be part of a broader effort to educate trainees about the financial implications of clinical decision-making,31 which may include the subtle implications of gift acceptance32–34 and the price patients pay for direct physician marketing such as the distribution of ‘free’ textbooks.35

In undergraduate medical education, there may not be a simple strategy to ensure that competing interests are fully disclosed,36–39 and this case demonstrates that disclosures are sometimes omitted. One option is to hold information about faculty potential conflicts of interest in a central online repository that is accessible to students. Such a public registry would allow students to determine the conflicts of interest of physicians they meet in clinical settings—there currently is no easy way for students to do this. One medical school already requires public online reporting of conflicts,38 and there is another online database listing payments from certain pharmaceutical companies to physicians.40 These proofs of concept may encourage other institutions to implement registries and perhaps they might be combined into one central public registry. However, it is also important to recognise the limitations and potentially negative consequences of disclosure that may include moral licensing (the belief that biased advice is justifiable because conflicts have been declared) and strategic exaggeration (the tendency to provide more biased advice to overcome expected scepticism resulting from conflict disclosure).41 ,42 The fact that the industry support for the sessions in this case was referred to as ‘unrestricted educational grants’ may make one question the meaningfulness of that term and favour the use of neutral terms such as ‘funding’. If even industry ‘unrestricted educational grants’ are associated with inaccuracies, the complete elimination of industry funding from undergraduate medical education may be necessary.

Discussing problematic cases of industry involvement in medical education may increase awareness and reduce the likelihood of reoccurrences. Indeed, this very case might have been prevented if the organisers had been aware of analogous problems elsewhere. Claims not unlike those made in the lectures and the reference book were the subject of investigations into the marketing of opioids in the USA that resulted in fraud convictions. Three executives at the American manufacturer of long-acting oxycodone pleaded guilty to fraud in 2007.13 The Agreed Statement of Facts in the guilty plea indicates that some company employees decided not to correct the prevalent misperception that oxycodone was less potent than morphine.43 ,44 Also, long-acting oxycodone was touted as having less addiction and abuse potential and being less likely to be diverted compared with other opioid formulations.44 That illegal marketing15 occurred at the same time as both the dramatic increase in opioid prescriptions and the increase in opioid-related mortality in the USA.9 ,10 Opioid prescriptions and opioid-related deaths both also rose in Ontario during the period medical students were exposed to this information in an industry-supported lecture series.11 ,12

This increasing mortality underlines how important it is for trainees and their future patients to be protected from problematic information in undergraduate medical education even as collaborations between universities and industry continue. Yet today the management and monitoring of industry involvement in undergraduate medical education lags behind that in medical research. Policies about industry involvement in undergraduate medical education vary by jurisdiction, do not consistently deal with all important concerns and can be vague. For example, three issues raised by this case are treated differently by current American and Canadian guidelines (table 2).36–39 Hopefully this unevenness will soon be replaced by the sort of consistency demonstrated by the large group of medical journals that recently agreed on a uniform conflict of interest disclosure form for authors.2 The Institute of Medicine has recommended standardised disclosures and bans on speaker bureau membership and industry gift acceptance.39

Existing conflict of interest policies would allow lecture series such as this one to take place at most medical schools. For example, the 10 American medical schools with most stringent conflict of interest policies as rated by the American Medical Student Association in their ‘PharmFree Scorecard’ could all have hosted a lecture series such as the one discussed here as they allow industry sponsorship of medical school lectures and speakers who receive funding from the same companies.6 Box 2 contains a list of questions that can be asked of any institution's conflict of interest policy to determine whether this lecture series would be permitted. Given that the problematic content in this case was not detected for several years, it is plausible that problematic information is being disseminated in other industry-supported teaching sessions at medical schools right now.

What to do when potential problems are identified

It is important for educators to respond appropriately and promptly once a problem has been identified—especially when patient safety is at stake. The response to these educational ‘adverse events’ might be guided by principles used to deal with clinical misadventure45 and include prompt disclosure to those affected as well as corrective measures. Box 3 suggests how these principles might be applied to problematic conflicts of interest in undergraduate medical education. The potential harm to patients related to the presented information in this case can still be mitigated by notifying past students of the problems with the lectures and the reference book that they may still use when making clinical decisions. Medical school conflict of interest policies do not require disclosure of educational misadventure.6 Properly handled problems would serve as positive learning opportunities for both trainees and educators.