International Society for History, Philosophy, and Social Studies of Biology

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WEDNESDAY, JULY 8  /  15:30 - 17:00  /  DS-M340
Individual papers
Negative Results, Medical Progress and Adverse Events: Interdisciplinary Insights on Biomedicine

Negative results in biomedicine: The biomedical community's response to the Paxil scandal

Laura Seger (Indiana University Bloomington, United States)

The label “negative” is often applied to experimental results that do not support an investigator’s initial hypothesis--although any undesired result may be termed “negative”--and these results rarely appear in published form outside the field of biomedicine. Biomedical scientists now recognize more than anyone else the importance of negative results because they are driven not just by the epistemic goal to get at the truth. As a community of inquirers according to Helen Longino’s social epistemology, they also share the practical value of preventing harm to patients, and there’s a growing awareness in biomedicine of a direct relationship between the nonpublication of negative results and potential harm. This awareness is due, in part, to community-wide reaction to scandals involving publication bias against, or the outright suppression of, negative biomedical results. In this paper, I describe how certain aspects of the physician-biomedical industry dynamic changed following the Paxil scandal of the early 2000s. Most importantly, major organizations (e.g. U.S. Food & Drug Administration, American Medical Association, European Medicines Agency, World Health Organization, World Medical Association, and the International Committee of Medical Journal Editors) began requiring public registration of all clinical trials, trial results, and adverse events once it came to light that Paxil trial results demonstrating both inefficacy and an increased risk of suicide in adolescents had been purposely suppressed. As a result of this and other similar scandals, which exposed physicians and the biomedical industry to new levels of financial and criminal risk, physicians no longer trust the industry to be honest about the true effect of pharmaceuticals on patients, thus physicians and clinical researchers are beginning to demand access to all results--including negative results--to properly evaluate their prescribed treatments.

The ideal of scientific progress and the DSM

Steeves Demazeux (Université Bordeaux Montaigne, France)

In this presentation, I explore the ways in which the Diagnostic and Statistical Manual of Mental Disorders has been informed by the ideal of scientific progress since the 1980s. My aim is not to evaluate the arguments for or against the scientific nature of the DSM as they have been brought forward and discussed in the public debate for purely promotional or polemical purposes. It is rather to highlight the kind of scientific optimism that has been a driving force in the recent history of the DSM. I argue that while the nature of the scientific ideal of the DSM through its three last editions has remained the same, its effects and its rationale have dramatically changed. Whereas scientific progress required that the DSM-III firmly espouse what I call here a “permanent innovation principle”, it would later paradoxically motivate, in the DSM-IV and especially in the DSM-5, an opposed principle that I call the principle of “prudential conservatism”. I conclude that, while in the past decades the DSM has made an important effort to improve the scientific quality of its revision process, development from the DSM-III to the DSM-5 can hardly be said to have been scientifically progressive.