Conflicts of interest: a review of institutional policy in Australian medical schools

Relationships between the pharmaceutical industry and medical schools have recently been increasingly drawn into the media spotlight because of their ability to create conflicts of interest. Much of this attention is due to evidence that industry relationships can influence the attitudes and behaviours of medical students, with effects persisting beyond graduation. A recent review by the American Medical Student Association (AMSA) of United States medical school policies highlights the lack of policies regarding disclosure and management of conflicts of interest between faculty members and industry.1 Furthermore, some medical schools even rely on industry for a significant portion of their operating budgets.2 This reliance can blur the distinction between the primary motive of universities to facilitate independent education and research and the primary motive of industry to generate profits for its shareholders.

Industry promotes itself and its products to academics, doctors in practice and medical students in a number of ways. These include the provision of gifts, drug samples, honoraria for research and speaking engagements, travel funding and payments for being on advisory boards. Conflicts may also arise from the provision of gifts or discretionary funding from industry to individual institutions.2,3 Medical students have been shown to be vulnerable to these influences, despite the fact that most believe they are personally immune.4,5,6,7,8,9 Indeed, as the attitudes and behaviour formed while in medical school have been shown to persist into professional life,10 it is important both to provide a detailed and balanced education to medical students about these relationships with industry and to protect students (and their future patients) from the sequelae of undue influence by industry.

Medical school policies regulating interaction with the pharmaceutical industry are effective in helping students to maintain a degree of independence from industry bias. Policies can temper a preference for brand-name medications over generics,11 reduce the likelihood of gifts being accepted,12 and lower future interactions with industry, including the receipt of consulting fees.7,12,13 Furthermore, the beneficial influence of these institutional policies on attitudes and behaviour persists after graduation.7 For an overview of recent and current US and Australian conflict-of-interest policy recommendations and regulation, see Box 1. Of particular note, in 2007, the AMSA released the PharmFree Scorecard (http://www.amsascorecard.org), which evaluates medical school policies for their ability to manage potential conflicts of interest.

The purpose of our study was to examine the adequacy of policies at Australian medical schools with respect to declaring and managing potential conflicts of interest with industry.

Permission was obtained from AMSA to use its PharmFree Scorecard as an assessment tool for our survey. In AMSA ’s 2009 survey of the conflict-of-interest policies of 150 US medical schools, the scorecard covered 11 domains (broadly consistent with those identified previously3).

In October 2009, we wrote to the deans of the 20 Australian medical schools, outlining the project and requesting submission of their policies. Following feedback from medical schools, we excluded four domains from our evaluation, as they did not reflect the Australian medical school environment. These domains were pharmaceutical samples, purchasing and formularies, industry sales representatives, and industry funding for trainees.

Consequently, we rated policies across seven domains: gifts, consulting relationships, industry-funded speaking relationships, disclosure, on-campus educational activities, travel to off-campus educational activities, and curriculum. Each domain was scored as follows:

• 3 = model policy

• 2 = good progress towards model policy

• 1 = policy absent or unlikely to have a substantial effect on behaviour.

The application of specific criteria during policy appraisal ensured that domains were scored objectively (Box 2).

Each policy was graded by two assessors, blinded to the institution of origin, applying the unique criteria for each domain. Progress results for each medical school were forwarded to that school for suggested amendments. Any differences in grading were resolved by a third, independent assessor.

The final score for each medical school was calculated as the cumulative score for all domains divided by the total possible score, expressed as a percentage. Domains were not scored if we received formal notification from the school that policy development was in progress. If two or more domains were in progress, the school’s policy was classified as “in process”.

The mean final score in Australia was compared with the mean score from the AMSA 2009 survey, by reanalysing the seven domains included in the Australian survey, using the two-sample t test. Medians were compared using the Wilcoxon rank-sum test.

Grades were assigned using the AMSA grading system: A ≥ 85%, B = 70%–84%, C = 60%–69%, D = 40%–59%, F < 40%, and in process. Non-reporting institutions received a domain score of 1 and a grade of F, in line with the AMSA methods.

Ethics approval was not sought for this study. As medical schools are public institutions that receive federal funding, it was not felt necessary to obtain ethics approval from the schools, as data sought were not of a personal or individual nature. Furthermore, most data were already available on publicly accessible websites. This was consistent with the methods applied by the AMSA. Institutions were advised in writing at the time of request that the results would form the basis of a thesis with the prospect of publication.

Of 20 medical schools surveyed, five reported having two or more policies in development (range, 3–7) and were graded as being in process (Box 3). Data for medical schools graded as being in process were not used in calculating mean scores. Nine medical schools were graded D, and five were graded F (three of which failed to provide any information). James Cook University’s medical school received the highest overall score of 67% and was graded C (Box 4).

Across the seven domains assessed, curriculum received the highest mean score (60%), with seven medical schools achieving the maximum score of 3 (the University of Western Sydney scored 3 in this domain, but was excluded from calculation as it had four policies in process). Curriculum was the only domain in which any medical school scored 3. Gifts received the second highest mean score overall (53%). The domains with the lowest mean scores were on-campus educational activities and travel to off-campus educational activities. Of the 15 medical schools included in our mean domain score calculations, Bond University and James Cook University indicated that they had policies in process for the domain of on-campus educational activities. All other universities received the lowest score of 1 in these two domains.

The domains with the highest mean scores in the 2009 AMSA survey were off-campus educational activities, gifts and consulting relationships (Box 5). The number of perfect scores in 2009 was almost double that in AMSA’s 2008 survey. On-campus educational activities had the fewest perfect scores in AMSA’s 2009 survey — a finding consistent with our results for Australian medical schools.

Compared with the AMSA 2009 results, Australian medical schools performed better in only the curriculum domain (Box 5). The mean final score for Australian institutions was lower than that for US institutions (44% v 58%, P < 0.001; difference in mean scores, 14% [95% CI, 8%–20%]) (Box 6). The Australian median final score was also significantly lower than that for the US institutions (48% v 62%, P = 0.004).

Twenty-five per cent of Australian respondents reported two or more policies in process compared with 18% of AMSA 2009 survey respondents. A similar proportion of institutions in the US (16%) and Australia (15%) did not submit a response to each survey.

Overall, medical schools in the US have more robust policies governing potential conflicts of interest than their Australian counterparts. It is possible that the sequence of surveys stimulated policy improvements seen in US medical schools between 2008 and 2009. In our survey, seven of the 20 Australian medical schools reported policies in development. Furthermore, some schools requested a copy of our findings, suggesting a commitment to enhancing their policies.

A significant number of US medical schools are stand-alone institutions, whereas all Australian medical schools exist under the auspices of a particular university. Consequently, policies governing conflicts of interest at Australian medical schools may reflect general university policy and thus may not address the specific challenges of medical education and research. Consideration should be given to helping Australian medical schools to develop conflict-of-interest policies distinct from their parent university.

Our results indicate a need for improved self-regulation of conflicts of interest by Australian medical schools. Medical schools should continue to recognise their influential position in society, and be aware that their financial relationship with industry is an area in which they should demonstrate leadership in the quest towards the highest possible ethical standards in medical education and research. Failure to take this opportunity may not only compromise the standing of the medical profession in society and the quality of medical research and patient care, but may also lead to the imposition of legislative controls governing disclosure and management of conflicts of interest.