Ethics and industry-sponsored research

Barry Koehler misunderstands the nature and purpose of our proposed oversight mechanisms.1 It is actually less complicated and bureaucratic to standardize the principles and basic contractual mechanisms governing university–industry relations than to have a Babel of options confronting researchers, universities and industry. Administration of the rules would of course remain local, but there would be both accountability and appeal mechanisms to ensure consistency, transparency and disinterested adjudication of conflicts. It's a bit like medicare: the principles are established for all, but the operations are highly decentralized. As for costs, even a budget of $2 million per year for the oversight office would amount to less than a tenth of one percent of the industry's taxpayer- subsidized annual marketing expenditures. It is thus highly affordable without “adding to the cost of bringing new therapeutic agents to patients.”

Joseph Pater and colleagues essentially maintain that the status quo works and that exceptions are truly anomalous. This view flies in the face of the literature we cited, documenting frequent and in some cases systematic conflicts of interest, bias and restraints on freedom to publish. That the editors of 12 of the world's leading medical journals — including CMAJ — have recently introduced publication policies to discourage this behaviour reflects widespread recognition that there is a serious and growing problem.2

Pater and colleagues place their faith in “educational initiatives and appropriate leadership from existing professional and funding bodies” and reject our more concrete proposals. This seems naive in view of the extraordinarily powerful economic pressures at work. Researchers, and their corporate sponsors, sometimes behave badly because it pays. If there is to be an effective speed limit one must post signs, pay to monitor behaviour and penalize transgressors. Nothing in our proposed rules should slow down trials; indeed, standardization should diminish the upfront time required to negotiate terms and conditions.

Olli Miettinen correctly reminds us that interactions with pharmaceutical companies are only one potential threat to scientific integrity, others being intrinsic to the academy itself. However, both the literature and the response by journal editors indicate that pharmaceutical companies are currently the large and growing threat.