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Reaching full and open disclosure for universities, medical schools and doctors

Most surveyed patients said they’d have more confidence in their doctor’s decisions with full disclosure of competing interests. AAP Image/Alan Porritt

TRANSPARENCY AND MEDICINE – A series examining issues from ethics to the evidence in evidence-based medicine, the influence of medical journals to the role of Big Pharma in our present and future health.

Today Martin Tattersall discusses ways to reach full disclosure in the medical world.

The prevalence of outside interests of academic researchers, educators and clinicians, and their under-reporting to employers and patients are high.

Links between the medical profession and drug and device manufacturers are widespread, but public disclosure of these links in Australia is largely absent.

Universities, state departments of health, the National Health and Medical Research Council (NHMRC) and hospitals have developed policies to inform confidential declaration of real or potential conflicts of interest (COI) by their employees. But how often declarations of COI are made and how they are managed is not known.

Professional bodies have developed position statements or guidelines informing their members about managing relationships with industry (such as the Australian Medical Association (AMA) and the Royal Australasian College of Physicians), but there is no documentation of their effects on members’ behaviour.

Reaching full disclosure

In 2009, the Sydney Medical School established a committee to facilitate the disclosure and management of external interests by senior staff employed by the school. The primary role of the committee was to raise awareness of the importance of disclosure of external interests within the meaning of the University’s conflict-of-interest policy. It also sought to evaluate disclosures made by staff in accordance with the policy.

The dean of medicine requested all staff either disclose external interests or confirm that they had no disclosures to make annually. These disclosures are maintained in a confidential register.

The committee evaluates each disclosure of interest in accordance with the policy in consultation with the staff member making the disclosure and their supervisor. It determines whether:

  • there’s a material external interest that has the potential to create a conflict; and

  • a conflict of interest could have or could appear to have the capacity to influence the conduct of the staff member, regardless of whether or not it has actually done so. And, if so, whether the conflict of interest can be eliminated or how it can be managed.

Since the committee was established, declarations of outside interests have been made by over 90% of relevant university employees, of whom approximately 30% have declared an actual, potential or perceived conflict of interest. A management plan has been developed for individuals with conflicts.

This experience indicates the willingness of medical school academic staff to declare their outside interests confidentially, and to develop a management plan guided by the external interest committee and their supervisor.

Medical students

A report in the Medical Journal of Australia last year examined the adequacy of policies at Australian medical schools for managing potential conflicts of interest with the pharmaceutical industry.

A “Pharmfree” scorecard developed by the American Medical Students Association (AMSA) was used, and the results for Australian medical schools were compared with US schools. Australian medical schools had a lower mean score overall (44% compared with 58%), and they performed better in only the curriculum domain.

A notable feature of the scoring system was that the disclosure score was highest for the declaration being on a “publicly available website and/or disclose to patients when such a relationship might represent an apparent conflict of interest.”

Most medical practitioners interact frequently with the pharmaceutical industry. A survey of general practitioners in Australia found that pharmaceutical representatives visited them on average six times a month in 2001. Another Australian survey reported that 41% of medical specialists had participated in industry-sponsored research in the previous 12 months.

What about the patients?

It’s frequently argued that it’s in doctors’ and industry’s best interest for their interactions to be openly declared. But little is known about the views of patients on doctor-industry relationships.

A 2009 survey of 906 patients attending three general practices in metropolitan Sydney showed that patients were concerned about the effects of interactions between doctors and the pharmaceutical industry.

Most patients (76%) were not aware of their doctor’s outside interests, but agreed that knowing about them would aid in their treatment decision making. They noted that disclosure of interests would increase their confidence in their doctor’s decisions.

Most agreed that disclosure of competing interests by doctors is important, believing it would help patients make informed decisions (78%). Nearly half the patients thought their doctor was not unduly influenced by pharmaceutical company interactions, but 77% of these patients still felt it was important for their doctor to disclose interactions.

Most patients would like their doctor to disclose competing interests verbally during the course of a consultation (78%), by clearly displaying it on the wall of the consultation room (67%), or in a printed document (62%).

And most said they would have more confidence in their doctor’s decisions with full disclosure of competing interests.

The study indicates that patients want to know about their doctor’s competing interest, and provides reassurance that the information is unlikely to undermine patients’ trust in their doctor. Still, few doctors currently disclose their outside interests to their employer or to their patients.

The way forward may be legislation such as the US Sunshine Act, which requires pharmaceutical companies to disclose the names of doctors receiving financial benefits from industry on a public website.

And there are positive noises being made in several quarters. Four large pharmaceutical companies have suggested to the industry body’s code of conduct review that all companies should declare payments to doctors. The Australia and New Zealand Association of Medical Deans is apparently reviewing institutional policies relating to conflicts of interest. But it’s not known whether they’re considering making declarations publicly available.

The impact of open disclosure on interactions between researchers and doctors and the sponsors of pharmaceutical products and on public perceptions of health professionals is a legitimate subject for future research.

This is the twelfth part of Transparency and Medicine. You can read previous instalments by clicking the links below:

Part One: Power and duty: is the social contract in medicine still relevant?

Part Two: Big debts in small packages – the dangers of pens and post-it notes

Part Three: Show and tell: conflicts of interest undeclared for clinical guidelines

Part Four: Eminence or evidence? The ethics of using untested treatments

Part Five: Don’t show me the money: the dangers of non-financial conflicts

Part Six: Ghosts in the machine: better definition of author may stem bias

Part Seven: Clearing the air: why more retractions are good for science

Part Eight: Pharma’s influence over published clinical evidence

Part Nine: Insight into how pharma manipulates research evidence: a case study

Part Ten: Why data from published trials should be made public

Part Eleven: Open disclosure: why doctors should be honest about errors

Part Thirteen: Ethics of accepting suppliers’ gifts in the business v medical world

Part Fourteen: Conflicts of interest in guideline development: the NHMRC responds

Part Fifteen: Consumer input in Medicines Australia’s code of conduct review

An unidentified reader has asked the disclosure statement for this article note that Professor Tattersall was the chairman of the Australian Drug Evaluation Committee (ADEC) from 1997 to 2008. The information was always part of Professor Tattersall’s profile and the disclosure has been amended.

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