Pharmaceutical Controversies and the Performative Value of Uncertainty

McGoey, Linsey

doi:10.1080/09505430902885474

Cited by 69 publications

(49 citation statements)

References 39 publications

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“…The goal was to show that when compared to its competitor, naproxen Vioxx caused fewer gastrointestinal side effects [47]. To the excitement of Merck executives and its shareholders the study data which was presented to Merck's safety board had yielded the results it had hoped for.…”

Section: The Arthritis Relief Miraclementioning

confidence: 99%

“…In September 2004, Merck "graciously" agreed to remove the drug from the market, but not until after it was responsible for between 88,000 -139,000 heart attacks and strokes, 30% -40% of which were fatal. By 2005 the media and Wall Street questioned the company's ability to survive, however reports of the company's' emanate death were premature [47]. [58], and the "mother" of the autoimmune diseases, SLE [57].…”

Section: The Arthritis Relief Miraclementioning

confidence: 99%

“…The submitted trials involved small patient populations with low risk of cardiovascular issues with treatment periods that extended less than 12 months during which time researchers did not collect relevant outcomes to measure cardiovascular problems [47]. But as early as 1999 the company knew there was a problem.…”

Section: The Arthritis Relief Miraclementioning

confidence: 99%

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How Silencing of Dissent in Science Impacts Woman. The Gardasil&reg; Story

Vernon¹

2017

ASM

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The issues of safety and efficacy of certain vaccines remains extremely contentious. The venues for this debate have included periodicals, documentary films, and an ever-increasing number of on-line sites. While debate in science is not only a common occurrence but a fundamental tenet of the scientific community, it only works when divergent opinions can be heard. When those who hold an opposing opinion are denigrated and/or marginalized by those holding the majority opinion such as in the issue of vaccination, where cultural authority for the issue is owned by the profession of medicine, both science and the public lose. What is often forgotten are the benefits derived from the questioning of drug safety that not only extends to the public but to physicians who rely on the truthfulness and accuracy of the information that is being supplied to them by manufactures and government agencies. While most physicians believe they are functioning in their patient's best interest when making vaccine recommendations, these recommendations by in large have become a matter of rote and are made because most physicians have bought into the "vaccines are safe" mantra. What most physicians don't realize is they have unknowingly been recruited by big pharma to assist in shutting down the vaccination debate. This suppression of vaccine opposition even among academics, is becoming more commonplace and will lead down a slippery slope that will silence opposition science, and the dangers that come with this. Those who question vaccine safety have been ostracized, misquoted and even made to appear mentally ill by those who hold the majority opinion on the issue. Physicians who question vaccine safety have had their licenses threatened or have been fired from positions. Tactics such as name calling and the use of terms such as pseudo-science, (even when the evidence being presented is from widely accepted peer-reviewed journals) or "conspiracy theorists" which has the effect of placing those holding the minority opinion in the category of such groups as 9/11 truthers, are not uncommon. Other methods of How to cite this paper:

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Section: The Arthritis Relief Miraclementioning

confidence: 99%

Section: The Arthritis Relief Miraclementioning

confidence: 99%

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How Silencing of Dissent in Science Impacts Woman. The Gardasil&reg; Story

Vernon¹

2017

ASM

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“…Although the GFI suggests that studies should be conducted in marker-negative populations to ensure that a predictive biomarker is wellvalidated and relevant data from non-responders is not overlooked, it fails to place a similar emphasis on those non-responders excluded from empirically enriched trials using EERW designs (FDA, 2012c). As such, even as EERW is being promoted as a means of elucidating the opaque heterogeneity of chronic pain, it nevertheless reproduces an uncertainty about the appropriateness of certain drugs for (un)certain disease conditions that it was supposed to resolve (McGoey, 2009 Issues of heterogeneity of response, labeling and indication and the significance of negative trials results must be situated historically amidst the fraught evidentiary politics of pain medicine in the twenty-first century. Critiques of EBM and RCTs as highly artificial and constrained modes of knowledge production are multiple and familiar (Wahlberg and McGoey, 2007;Epstein, 2008;Will and Moreira, 2010).…”

Section: Heterogeneity Labeling and The 'Empty Promise' Of Personalmentioning

confidence: 99%

“Unsettling circularity”: Clinical trial enrichment and the evidentiary politics of chronic pain

Campbell

King

2017

BioSocieties

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The US Food and Drug Administration's approval of the controversial analgesic Zohydro has drawn attention to its endorsement of so-called 'enrichment strategies' for streamlining clinical trials. Among these is 'enriched enrollment randomized withdrawal' (EERW), a design intended to improve measures of drug efficacy by screening out patients who are non-responsive or suffer adverse effects. EERW has been promoted as a response to the problem of high trial failure rates for drugs that were previously thought to be effective for pain management. This article uses EERW as a window into the evidentiary politics of pain medicine in the twenty-first century, against the backdrop of concerns about prescription opioid abuse. We demonstrate that the reframing of negative trials as 'failed' trials poses a challenge to the evidence hierarchy of evidence-based medicine, and identify several rhetorical strategies used by proponents to normalize EERW by placing it in continuity with routine clinical trial practice and the promise of personalized medicine. Finally, we illustrate how EERW, in the current regulatory context, fails to contribute to the individualization of diagnosis or therapy, and reinforces the perceived gulf between trials for regulatory approval and clinical practice.

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“…In particular, awareness of ignorance or conscious not knowing-the "present absence" of knowledge-has been shown to be a procreative force (Højer 2009). Social studies of science have in this regard especially thought about the importance of not knowing in relation to scientific experiments as a source of validity-as in randomization and blinding-and as a performative tool that may serve particular interests or bolster the authority of those deemed capable of overcoming ambiguity and equipoise, for example, in the context of pharmaceutical industry information politics (e.g., McGoey 2009).…”

Section: The Anthropology Of Unknowingmentioning

confidence: 99%

Public secrets in public health: Knowing not to know while making scientific knowledge

Geissler

2013

American Ethnologist

208

127

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Unknown knowns—or “public secrets”—may play an integral part in publicly funded medical science. In one large transnational field research site in Africa, such unknowing pertains to vital material inequalities across the relations of scientific production. These inequalities are open to experience but remain often unacknowledged in public speech and scientific texts. This silence is not usually achieved by suppressing knowledge but through linguistic convention and differentiation between places and moments of knowing and ignorance. Switching between known and unknown according to situation and interlocutor is an important, largely implicit skill that maintains relations necessary to conduct clinical research—linking bodies, lives, institutions, and technologies across differentials of resources, expertise, and power. Unknowing, then, facilitates research; and it shapes the resulting work and perpetuates the political and economic contradictions that pervade the context and the research endeavor itself. Unknowing thus poses a challenge for conventional anthropological modes of critique and engagement.

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Pharmaceutical Controversies and the Performative Value of Uncertainty

Cited by 69 publications

References 39 publications

How Silencing of Dissent in Science Impacts Woman. The Gardasil&reg; Story

How Silencing of Dissent in Science Impacts Woman. The Gardasil&reg; Story

“Unsettling circularity”: Clinical trial enrichment and the evidentiary politics of chronic pain

Public secrets in public health: Knowing not to know while making scientific knowledge

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Pharmaceutical Controversies and the Performative Value of Uncertainty

Cited by 69 publications

References 39 publications

How Silencing of Dissent in Science Impacts Woman. The Gardasil&amp;reg; Story

How Silencing of Dissent in Science Impacts Woman. The Gardasil&amp;reg; Story

“Unsettling circularity”: Clinical trial enrichment and the evidentiary politics of chronic pain

Public secrets in public health: Knowing not to know while making scientific knowledge

Contact Info

Product

Resources

About

How Silencing of Dissent in Science Impacts Woman. The Gardasil® Story

How Silencing of Dissent in Science Impacts Woman. The Gardasil® Story