From the $80 hamburger to managing conflicts of interest with the pharmaceutical industry

Hidden in full view?

Our personal opinions and interactions with the industry have evolved over time. During the 1980s and 1990s AD engaged with drug companies as a paid consultant and speaker at symposiums and advisory board meetings. The endeavour was intellectually and financially rewarding, and to him the conflict of interest seemed manageable. This changed in the late 1990s when he embarked on a programme of research that led to some of the earliest reports documenting how the drug industry influences the interpretation of medical evidence and guidelines.12 Since that time he has had no relationships with industry. Moreover, he now “sees” industry influence in almost all facets of patient care, medical education, clinical research, and even certification exams (in which the correct answers are based on pharmaceutical funded guidelines).

CB was a postgraduate resident in the early to mid 2000s. During that era he enjoyed pizza and sandwiches at regular noon-time seminars, without thinking about who paid for lunch, and regularly attended departmental journal clubs at the city’s most exclusive restaurants. (He and his fellow trainees could not believe there was such a thing as an $80 hamburger.) Towards the end of his clinical training he began to feel uncomfortable with some of these industry interactions (including meeting an industry representative in a clinic room at the cancer hospital to be “gifted” an expensive textbook). However, it was not until a series of conversations with his mentor during his transition from trainee to faculty that he made a conscious decision to have no industry relationships.

This decision was relatively straightforward for CB, who was beginning to have his own concerns about the industry’s role in shaping physicians’ opinions. He also benefited from another major role model, the renowned oncologist Ian Tannock, who shared concerns about physician-industry relationships. Tannock, who had written an influential textbook, was appalled when he learnt that his book had been gifted by industry representatives to second year oncology trainees in CB’s programme. Tannock subsequently spoke to the trainees about the importance of boundaries and the next year gifted his book to CB’s entire class.

The industry cultivates key opinion leaders to promote its products in diverse settings.3 Many (but not all) advisory board meetings are an extension of these efforts. These interactions are less about giving physicians a chance to provide useful advice to the industry and more about companies cultivating personal relationships and goodwill among thought leaders who will influence physicians’ behaviour when those leaders write editorials and guidelines and speak at meetings. Likewise, the role of many investigators in practice changing clinical trials is often limited to enrolling patients (a valuable contribution) or lending their name and prestige to the ultimate publication without actually doing the work of an author (a dubious practice). Editorialists with financial conflicts of interest are more likely to endorse therapies with uncertain clinical benefit.14 Many members of drug and device regulatory approval committees have financial ties to industry.56 There is evidence to indicate that these relationships may influence regulatory decision making.78 A substantial proportion of regulators ultimately change careers and work for the industry.9

None so blind

In our experience in Canada many trainees today do not see any potential problems with industry relationships. They have observed the behaviour of their teachers and mentors and learnt that thought leaders serve on industry advisory boards, participate in guideline writing committees funded by industry, give lectures sponsored by industry (sometimes embarking on a “tour” of several locations in a short period after attending a society meeting), and receive industry funding for research. These activities normalise the behaviour and in some ways make it seem desirable as a mark of stature. Recently one of us was shocked during a teaching seminar with senior trainees when it became apparent that all of them expected industry to pay for their travel to annual meetings. One trainee even asked, “If a drug company doesn’t pay for me to attend the annual meeting, who will?”

Such beliefs are pervasive and powerful. AD has advised dozens of junior faculty members to consider “branding” themselves as having no industry conflicts, but the pull towards industry is so strong that few have taken this advice. When starting an academic career, junior physicians are constantly looking for opportunities to advance their career and to network with key leaders in their field. Dinners with senior faculty (paid for by industry) or joining an advisory board, often including travel to a nice location, a large cheque, and instantaneous networking opportunities with the most senior people in the field, are therefore very enticing.

But these relationships matter and so come at a cost. Published research consistently finds that physicians with even apparently trivial industry relationships exhibit biased behaviour.10 Most key opinion leaders and their audiences may not realise that they are part of a coordinated and sophisticated effort by industry to shape the views of other physicians and influence practice. Drug company efforts are deliberate, purposeful, and effective: they pay people whose opinions they are seeking to affect.

Transparency not enough

Physicians starting their career need to decide how to choose to interact with industry. In some areas of healthcare, interactions with industry are necessary; for example, government grants generally do not fund clinical trials of new drugs. Most clinical trialists therefore need to learn how to manage the risk of bias by setting limits in the relationship, such as by taking ownership over writing the manuscript, ensuring full access to study data, pushing back against “spin” of the study results, and being careful to present results and current management recommendations at lectures, rather than marketing a specific drug. To protect their perceived integrity they must also determine how payments from industry flow to them and their institutions. Although it is important that these investigators recognise the potential for bias, we see these research interactions as very different from relationships with industry that are not required to succeed in academic medicine.

Unnecessary interactions include going to industry sponsored dinners, serving on advisory boards or speaker bureaus, and attending or participating in continuing medical education (CME) events sponsored by industry. While the content of journal editorials and presentations at major conferences may be more protected from bias, the message at industry sponsored CME events, such as satellite symposiums at society meetings (which pay the society and the speaker a substantial amount of money), are generally highly managed by industry. Pharmaceutical companies should be in the business of drug discovery and manufacturing and do not belong in CME at any level (including payments to professional societies).

Given that relationships between industry and thought leaders are pervasive, and the evidence is consistent that these relationships are associated with biased positions, who should be delivering CME, writing editorials, and shaping practice guidelines? Disclosing financial conflicts of interest is now commonplace and, if complete, enables identification of potential bias. However, transparency in itself is not a solution. Results of research in behavioural economics indicate that disclosure does not reduce conflicts of interest and can make the situation worse.11 The only way to be truly unbiased is to have no conflicts.

Conflicts arising from industry involvement are not the only potential source of bias.12 Others include being a practitioner who makes most of his or her income from the intervention being studied, being an author of a clinical trial that showed the treatment to be effective and thus being “anchored” to that result, and being a consultant to payers (such as public or private insurers) who include cost savings as an important objective. Thus we acknowledge that bias is not a completely black and white issue.

Next generation

In our first conversation on this topic nearly two decades ago AD said, “One day the world will wake up and understand this problem. When that happens, the real thought leaders will be those with no industry relationships. Consider this as you start your independent career and position yourself to be the rare person in your specialty with no conflicts. You will then be the one invited to lead trials and write guidelines, editorials, and opinion pieces.”

We have revisited this topic sporadically since that first conversation. In recent years it has surfaced primarily when CB has been offered interesting research opportunities involving financial support from the industry. Each time AD has asked CB, “What exactly would motivate you to accept this offer? Is the opportunity really core to your mission? Will it give you the opportunity to achieve something truly important to you or your patients?” Thus far the answer has been “no” and the advice given (and action taken) has been to decline. We urge the next generation of physicians to consider such questions each time they contemplate similar opportunities that come with potential conflicts of interest. We say they should avoid all unnecessary industry interactions and engage only in those that represent an opportunity to advance a research study or clinical programme about which they are truly passionate.

We are not suggesting that academic physicians with industry relationships deliver substandard clinical care or are incapable of producing first class and principled research. Nor do we wish to demonise physicians who accept offers that create conflicts of interest—their behaviour doesn’t make them bad people. Rather, we encourage junior faculty always to consider carefully their decision to engage with industry and to think about when it becomes worthwhile to change their disclosure slide from “None” to “Some.” At some point in the future, that careful consideration may pay off when the world recognises them as a new kind of key opinion leader.