The growing commercialization of scientific research has raised important concerns about industry bias. According to some evidence, so-called industry bias can affect the integrity of the science as well as the direction of the research agenda. I argue that conceptualizing industry’s influence in scientific research in terms of bias is unhelpful. Insofar as industry sponsorship negatively affects the integrity of the research, it does so through biasing mechanisms that can affect any research independently of the source of funding. Talk about (...) industry bias thus offers no insight into the particular epistemic shortcomings at stake. If the concern is with the negative effects that industry funding can have on the research agenda, conceptualizing this influence as bias obscures the ways in which such impact is problematic and limits our ability to offer solutions that can successfully address the concerns raised by the growing role of private funding in science. (shrink)

Improving surgical interventions is key to improving outcomes. Ensuring the safe and transparent translation of such improvements is essential. Evaluation and governance initiatives, including the IDEAL framework and the Macquarie Surgical Innovation Identification Tool have begun to address this. Yet without a definition of innovation that allows non-surgeons to identify when it is occurring, these initiatives are of limited value. A definition seems elusive, so we undertook a conceptual study of surgical innovation. This indicated common conceptual areas in discussions of (...) innovation, that we categorised alliteratively under the themes of “purpose”, “place”, “process”, “product” and “person”. These conceptual areas are used in varying—sometimes contradictory—ways in different discussions. Highlighting these conceptual areas of surgical innovation may be useful in clarifying what should be reported in registries of innovation. However our wider conclusion was that the term “innovation” carries too much conceptual baggage to inform normative inquiry about surgical practice. Instead, we propose elimination of the term “innovation” from serious discourse aimed at evaluation and regulation of surgery. In our view researchers, philosophers and policy-makers should consider what it is about surgical activity that needs attention and develop robust definitions to identify these areas: for our own focus on transparency and safety, this means finding criteria that can objectively identify certain risk profiles during the development of surgery. (shrink)

Recent professional guidelines published by the General Medical Council instruct physicians in the UK to be honest and open in any financial agreements they have with their patients and third parties. These guidelines are in addition to a European policy addressing disclosure of physician financial interests in the industry. Similarly, In the US, a national open payments program as well as Federal regulations under the Affordable Care Act re-address the issue of disclosure of physician financial interests in America. These new (...) professional and legal changes make us rethink the fiduciary duties of providers working under new organizational and financial schemes, specifically their clinical fidelity and their moral and professional obligations to act in the best interests of patients. The article describes the legal changes providing the background for such proposals and offers a prima facie ethical analysis of these evolving issues. It is argued that although disclosure of conflicting interest may increase trust it may not necessarily be beneficial to patients nor accord with their expectations and needs. Due to the extra burden associated with disclosure as well as its implications on the medical profession and the therapeutic relationship, it should be held that transparency of physician financial interest should not result in mandatory disclosure of such interest by physicians. It could lead, as some initiatives in Europe and the US already demonstrate, to voluntary or mandatory disclosure schemes carried out by the industry itself. Such schemes should be in addition to medical education and the address of the more general phenomenon of physician conflict of interest in ethical codes and ethical training of the parties involved. (shrink)

Patient visits are an important opportunity for general practitioners to discuss the risks of smoking and cessation strategies. In Australia, the guidelines on cessation published by the Royal Australian College of General Practitioners represent a key resource for GPs in this regard. The predominant message of the Guidelines is that pharmacotherapy should be recommended as first-line therapy for smokers expressing an interest in quitting. This, however, ignores established evidence about the success of unassisted quitting. Our analysis of the Guidelines identifies (...) a number of potential conflicts of interest which may have affected the advice provided. These include extensive funding by the pharmaceutical industry of sources cited to support the recommendations, and relations between members of the Guidelines Content Advisory Group and the pharmaceutical industry. Recommendations issued by professional bodies have enormous potential impact upon public health and there is a need for the highest levels of scrutiny and transparency in their development. Information about research cited in guidelines should include funding sources, and developers should be free of obvious conflicts of interest. Smoking remains the leading preventable cause of global mortality. Concerns related to pharmaceutical industry funding of research, scientific integrity and recommendations on smoking cessation by medical advisory groups clearly have implications beyond Australia. (shrink)