Are self-regulation and declaration of conflict of interest still the benchmark for relationships between physicians and industry?

In an editorial in 2001, the Editor of the Medical Journal of Australia (MJA) found “a pressing need for an open inquiry and the formulation of national guidelines” to confront conflicts of interest in research organisations.1 A subsequent editorial in 2002 tackled the issue of conflicts of interest in the formulation of clinical practice guidelines.2 Articles by others echoed the Editor’s concerns.3,4

Despite reaffirming many of the same concerns, another editorial in 2004 concluded that the aim of the MJA was “not to exclude anyone with a potential conflict of interest from publishing or reviewing — to do so would disqualify virtually everyone (including editors)”.5 In the light of increasing public and professional scrutiny of these issues, does this response still meet the “ultimate goal ... to promote transparency, reduce bias, and maintain public trust in what we publish”?5

When clinical opinion leaders declare the receipt of financial or professional benefits in exchange for providing advice to a pharmaceutical company, but are then expected to give objective, unbiased interpretations of their industry-sponsored research or area of expertise in reviews, editorials or treatment guidelines, then a potential conflict, or duality, of interest exists. This does not imply wrongdoing, but it does create serious doubts.

We contend that leaving the interpretation of these declarations of potential conflicts of interest to consumers of these articles may be unnecessarily difficult, and that such transparency alone may not erase the doubts that are inevitably created. Others go further in suggesting that transparency may facilitate the creation of biased information because people may not sufficiently discount the influence of the declaration, and advisors may therefore feel licensed to exaggerate their position.6 Does our diverse medical community7 just “trust” the integrity and judgement of all authors or, conversely, should we dismiss all research findings and conclusions as biased when potential conflict of interest exists? As objective as authors with potential conflicts of interest try to be, can they fully negate the subconscious obligation for reciprocation that exists when gifts or other benefits are offered and accepted?8 Self-regulation has rarely been shown to work effectively in any enterprise, be it politics or business reporting, as shown by Enron, HIH and many other examples.

Potential conflicts of interest are common in our field of clinical cancer research,9,10 with complex financial relationships and conflicts of interest that may exist between the pharmaceutical industry and individual physicians,9,11-14 academic institutions7-9,11-15 and consumers,16-18 and the potentially adverse effect that these relationships can have on individual patient care and public health. One author has gone as far as saying that, “We are compromising our integrity and the safety of research subjects, while engaging in unethical research practices and undermining ethical standards of research”.19

Several studies in oncology have found a positive association between pharmaceutical industry sponsorship and the reporting of positive outcomes (even if not clinically significant),20,21 manipulation of clinical trials,22 hiding of “preliminary data sets”19 and leaking of preliminary results to the investment industry by clinical researchers.23 All such activities cast doubt on the trial results and the judgements involved in producing guidelines, when potential conflicts of interest are declared.24 The best evidence-based guidelines are only as good as the quality of both the evidence and the evaluators.

In an editorial published in the MJA in 2006, Tattersall and Kerridge observed:

However, does this always occur? For example, in the annually published analysis of significant clinical advances in oncology — as expert and ethical as each author of this document no doubt is, are there no alternative authors without conflicts of interest to take the place of the 10 authors (of the 20 overall) with declared potential financial conflicts, involving up to 13 different companies for one of them, and including ownership of shares of companies whose products they are charged with independently analysing?26 Are there no alternatives for the expert Committee on Safety of Medicines, which advises the regulatory agency on new drug approvals in the United Kingdom, than 23 of the 29 committee members with potential financial conflicts of interest, including an association with at least five companies for 13 members, at least 10 companies for another four, and at least 20 companies for three?27

Regardless of the integrity of clinicians, such payments may be perceived as bribes or payments for favours received or expected.28 The head of the Australian Competition and Consumer Commission (ACCC) views financial conflicts of interest as “grubby issues that act as an unpleasant stain on the professionalism and good name of Australia’s medical practitioners ...”29 Professor Martin Tattersall, a leading Australian oncologist, has been quoted as saying that the “issue of buying the key opinion leaders is so overt these days”.30 In addition, concern about the profound influence of pharmaceutical companies on doctors is no longer confined to the developed world, as an alarming report from British organisation Consumers International reveals.31 A former Editor of the New England Journal of Medicine (NEJM), Dr Jerome Kassirer, believes that these problems reflect the values of a rapacious society and a widespread decline in ethical standards, and are creating a fully justified loss of trust in the medical profession.32

Evidence-based data on the extent and impact on many integral parts of public health of potential conflicts of interest, particularly financial ones, have reached a new high point in 2008. As far back as 1970, the UK Department of Health first proposed that expert advisers to regulatory agencies suspend all conflicts of interest during their time in office.33 However, over 30 years later, the industry’s scientific experts continue to have extensive conflicts of interest while providing their advice.27 We are conscious of the disturbing fact that the NEJM, which can currently claim to have the most stringent policy of the general medical journals for restricting and declaring potential conflicts of interest of authors, had to reverse its 12-year policy of precluding anyone with financial ties to industry from writing editorials or review articles in 2002 — simply because it couldn’t find enough authors with no financial ties. As the Editor of the BMJ commented in a recent editorial:

With recent increased public scrutiny, it is timely to review editorial and other policies.