Winds of change: growing demands for transparency in the relationship between doctors and the pharmaceutical industry

These vary from pens and notepads to sponsored travel and accommodation for attending national and international meetings. The impact of receipt of even small gifts has been emphasised.6 Drawing from social science research, Brennan and colleagues commented on the general human impulse to “reciprocate” for even small gifts, and that those receiving such gifts are often unable to remain objective as they “reweigh information and choices in light of the gift”. Further, they stated that “. . . the expectation of reciprocity may be the primary motive for gift-giving”.6

These are senior doctors (usually academics) whose opinions are considered influential in determining both diagnostic and therapeutic practice. Undoubtedly, significant resources are lavished on this group, and those targeted by Senator Grassley’s inquiries would be considered within this category. Furthermore, in media reports on new medications in which such a “key opinion leader” was cited, half of such experts had financial ties to industry, and in only a third of these cases were those ties acknowledged.7

There has been recent concern about the apparently common practice of “ghost writing”. A damning exposé of this practice used documentation from legal proceedings concerning the anti-inflammatory agent rofecoxib to provide the hitherto best-documented case history of the relationship between the pharmaceutical industry, medical publishing companies and academic clinicians.8 This report described pharmaceutical company employees working either independently or in collaboration with medical publishing companies in preparing manuscripts on clinical trials, and subsequently recruiting external academically affiliated investigators to be the publication “authors”. These recruited academic authors were frequently given first or second authorship positions. For scientific review articles, similar processes were documented, with the academic recruits frequently being the sole authors and, moreover, being offered honoraria for their participation. While industry financial support was acknowledged in most of the clinical trial reports, this was reported in only half of the review articles. As discussed by the authors of the report, it is unlikely that such practices differ from those of other companies and other products.8

In 2008, the Association of American Medical Colleges (AAMC) released a formal report on industry funding of medical education.9 This thoughtful and robust report began with an acknowledgement of the appropriateness of a partnership with industry, yet also the need to manage this: “The fault lies not only with industry; the acceptance, indeed the expectation of such financial incentives by academic professionals and their institutions has encouraged these practices.”9

This report recommended clarity about the extent to which interactions with industry are prohibited, and commended the necessity for educational programs on the relationship with industry for students, trainees and teaching faculty. It proscribed receipt of gifts, cautioned on the distribution of samples, and restricted access of pharmaceutical representatives. Strikingly, the report strongly discouraged the involvement of faculty in industry speakers bureaus, and proscribed accepting payment for attendance at industry-sponsored meetings and acceptance of gifts at such events. Furthermore, it stated that industry-supplied food and meals should be considered as gifts and therefore not be accepted. Acceptance of travel funds was proscribed, as was allowing written or oral presentations to be ghost written. Those involved in decisions about purchases of pharmaceuticals or devices were required to declare all conflicts of interest.9

What has been the impact of this report (and others) on clinician behaviour in the US? A recent commentary described a surprisingly widespread acceptance of these major shifts in practice.10 Contrary to the fears of many, no significant movement of academic faculty out of those medical colleges with strong conflict-of-interest policies was observed.10

In Australia, the umbrella industry representative body, Medicines Australia, published the 15th edition of its code of conduct in 2007.11 For the first time, and under the direction of the Australian Competition Tribunal, this code detailed mandated website disclosure of all industry-sponsored educational and marketing activities in Australia and the associated costs (http://www.medicinesaustralia.com.au/pages/page136.asp), although, at this stage, not disclosure of the names of clinicians receiving remuneration. This would appear to be the first national mandated detailing of such activities, and has revealed that about 30 000 such events occur each year, involving at least 800 000 attendances and costing about $60 million per annum, of which the hospitality cost (food, beverages, travel and accommodation) is about $32 million.