More than 40 primary studies, and three recent systematic reviews and meta-analyses, have shown a clear association between pharmaceutical industry funding of clinical trials and pro-industry results. Industry sponsorship biases published scientific research in favour of the sponsors, a result of the strong interest commercial sponsors have in obtaining favourable results.Three proposed remedies to this problem are widely agreed upon among those concerned with the level of sponsorship bias: financial disclosure, reporting standards and trial registries. This paper argues that all (...) of these remedies either fail to address the mechanisms by which pharmaceutical companies’ sponsorship leads to biased results—design bias, multiple trials with predictable outcomes, fraud, rhetorical effects and publication bias—or else only inadequately address those mechanisms. As a result, the policies normally proposed for dealing with sponsorship bias are unable to eliminate it. Only completely separating public clinical research from pharmaceutical industry funding can eliminate sponsorship bias. (shrink)

It is argued that neoliberal political ideology has redefined the regulatory state to have greater convergence of interests and goals with the pharmaceutical industry than previously, particularly regarding acceleration and cost reduction of drug development and regulatory review. Consequently, the pharmaceutical industry has been permitted to set the agenda about how shorter term and cheaper alternative carcinogenicity testing systems are investigated for validity. The authors contend that, with the tacit approval of the neoliberal regulatory state, the commercial interests of the (...) pharmaceutical industry framed the process and interpretation of validating these new test systems, thereby influencing what counts as knowledge about the carcinogenic status of new pharmaceuticals. While such alternative tests were occasioned by “molecularization,” the framing of their validation was not determined by technoscientific logic or a lack of standards of validation, but by the sociopolitical goals of the controlling institutions. Indeed, a different validation process could have been conducted had the priority been to develop carcinogenicity testing in the interests of public-health protection. While the resulting validation indicated that the short-term alternative tests posed small risks to the commercial interests of pharmaceutical firms, they provided little reassurance that patients would not be exposed to greater risks than before from undetected carcinogens. (shrink)

No discussion of academic freedom, research integrity, and patient safety could begin with a more disquieting pair of case studies than those of Nancy Olivieri and David Healy. The cumulative impact of the Olivieri and Healy affairs has caused serious self examination within the biomedical research community. The first part of the essay analyses these recent academic scandals. The two case studies are then placed in their historical context—that context being the transformation of the norms of science through increasingly close (...) ties between research universities and the corporate world. After a literature survey of the ways in which corporate sponsorship has biased the results of clinical drug trials, two different strategies to mitigate this problem are identified and assessed: a regulatory approach, which focuses on managing risks associated with industry funding of university research, and a more radical approach, the sequestration thesis, which counsels the outright elimination of corporate sponsorship. The reformist approach is criticised and the radical approach defended. (shrink)

We all know that doctors accept gifts from drug companies, ranging from pens and coffee mugs to free vacations at luxurious resorts. But as the former Editor-in-Chief of The New England Journal of Medicine reveals in this shocking expose, these innocuous-seeming gifts are just the tip of an iceberg that is distorting the practice of medicine and jeopardizing the health of millions of Americans today. In On the Take, Dr. Jerome Kassirer offers an unsettling look at the pervasive payoffs that (...) physicians take from big drug companies and other medical suppliers, arguing that the billion-dollar onslaught of industry money has deflected many physicians' moral compasses and directly impacted the everyday care we receive from the doctors and institutions we trust most. Underscored by countless chilling untold stories, the book illuminates the financial connections between the wealthy companies that make drugs and the doctors who prescribe them. Kassirer details the shocking extent of these financial enticements and explains how they encourage bias, promote dangerously misleading medical information, raise the cost of medical care, and breed distrust. Among the questionable practices he describes are: the disturbing number of senior academic physicians who have financial arrangements with drug companies; the unregulated "front" organizations that advocate certain drugs; the creation of biased medical education materials by the drug companies themselves; and the use of financially conflicted physicians to write clinical practice guidelines or to testify before the FDA in support of a particular drug. A brilliant diagnosis of an epidemic of greed, On the Take offers insight into how we can cure the medical profession and restore our trust in doctors and hospitals. (shrink)

The heart of the matter -- The evolution of the French medicine -- Coping with physicians' conflicts of interest in France -- The rise of a protected medical market : the United States before 1950 -- The commercial transformation : the United States, 1950-1980 -- The logic of medical markets : the United States, 1980 to the present -- Coping with physicians' conflicts of interest in the United States -- The evolution of Japanese medicine -- Coping with physicians' conflicts of (...) interest in Japan -- Reforms -- Professionalism reconsidered. (shrink)

The disclosure policies of scientific journals now require that investigators provide information about financial interests relevant to their research. The main goals of these policies are to prevent bias from occurring, to help identify bias when it occurs, and to avoid the appearance of bias. We argue here that such policies do little to help achieve these goals, and we suggest more effective alternatives.