The challenge of institutionalised complicity: Researching the pharmaceutical industry in the era of impact and engagement.

The pharmaceutical industry plays a central role in the production of the drugs we use to treat most illnesses. It is immensely powerful and has received sustained attention from sociologists of health and illness, who have provided a critique of its influence and sometimes unethical behaviour. However, in recent years, funders are increasingly expecting researchers to engage and collaborate with stakeholders, including industry. This raises important questions about the institutionalisation of complicity and the different forms this might take. This article asks: How can sociologists engage with the pharmaceutical industry in a positive and constructive manner, whilst remaining independent, principled and critical? It will draw on my experience of establishing a major project on high-priced drugs for rare diseases and the literature on collaboration, stakeholder engagement and responsible research to propose a methodological framework to address this challenge. This is based on six PRIMES: (normative) Principles, Reflection and Independence, (field) Mapping, (careful) Engagement and Strategic intervention that have broad applications to many other areas of contemporary social science research.

Valomaciclovir versus valacyclovir for the treatment of acute herpes zoster in immunocompetent adults: a randomized, double-blind, active-controlled trial.

Herpes zoster is a common infectious disease that can result in significant acute and chronic morbidity. The safety and efficacy of once-daily oral valomaciclovir (EPB-348) was evaluated for non-inferiority to 3-times daily valacyclovir, an approved therapy. In this study, 373 immunocompetent adults with onset of a herpes zoster rash within the preceding 72 hr were randomly assigned to receive one of four treatments for 7 days: (1) EPB-348 1,000 mg once-daily; (2) EPB-348 2,000 mg once-daily; (3) EPB-348 3,000 mg once-daily; or (4) valacyclovir 1,000 mg 3-times daily. A 20% margin was the reference for non-inferiority assessment. For the primary efficacy measure of time to complete crusting of the zoster rash by Day 28, non-inferiority criteria were met for once-daily EPB-348 2,000 mg and once-daily EPB-348 3,000 mg compared to 3-times daily valacyclovir. Additionally, EPB-348 3,000 mg significantly shortened the time to complete rash crusting by Day 28 compared to valacyclovir. For secondary efficacy measures, non-inferiority was achieved for the EPB-348 1,000 and 2,000 mg groups compared to the valacyclovir group for time to rash resolution by Day 28. No EPB-348 group was non-inferior to valacyclovir for time to cessation of new lesion formation or time to cessation of pain by Day 120, though no significant differences occurred between treatment groups. Nausea, headache, and vomiting were the most common adverse events. Based on these results, additional studies are warranted to define further EPB-348's potential as an effective and safe therapy for acute herpes zoster.

Flaws in the U.S. Food and Drug Administration's rationale for supporting the development and approval of BiDil as a treatment for heart failure only in black patients.

The U.S. Food and Drug Administration's (FDA) rationale for supporting the development and approval of BiDil (a combination of hydralazine hydrochloride and isosorbide dinitrate; H-I) for heart failure specifically in black patients was based on under-powered, post hoc subgroup analyses of two relatively old trials (V-HeFT I and II), which were further complicated by substantial covariate imbalances between racial groups. Indeed, the only statistically significant difference observed between black and white patients was found without any adjustment for potential confounders in samples that were unlikely to have been adequately randomized. Meanwhile, because the accepted baseline therapy for heart failure has substantially improved since these trials took place, their results cannot be combined with data from the more recent trial (A-HeFT) amongst black patients alone. There is therefore little scientific evidence to support the approval of BiDil only for use in black patients, and the FDA's rationale fails to consider the ethical consequences of recognizing racial categories as valid markers of innate biological difference, and permitting the development of group-specific therapies that are subject to commercial incentives rather than scientific evidence or therapeutic imperatives. This paper reviews the limitations in the scientific evidence used to support the approval of BiDil only for use in black patients; calls for further analysis of the V-HeFT I and II data which might clarify whether responses to H-I vary by race; and evaluates the consequences of commercial incentives to develop racialized medicines. We recommend that the FDA revise the procedures they use to examine applications for race-based therapies to ensure that these are based on robust scientific claims and do not undermine the aims of the 1992 Revitalization Act.

Genotyping the future: scientists' expectations about race/ ethnicity after BiDil.

The ongoing debate about the FDA approval of BiDil in 2005 demonstrates how the first racially/ethnically licensed drug is entangled in both Utopian and dystopian future visions about the continued saliency of race/ethnicity in science and medicine. Drawing on the sociology of expectations, this paper analyzes how scientists in the field of pharmacogenetics are constructing certain visions of the future with respect to the use of social categories of race/ethnicity and the impact of high-throughput genotyping technologies that promise to transform scientific practices.

Putting pharmacogenetics into practice.

Genetics is slowly explaining variations in drug response, but applying this knowledge depends on implementation of a host of policies that provide long-term support to the field, from translational research and regulation to professional education.

Commercial development of stem cell technology: lessons from the past, strategies for the future.

This paper presents historical and contemporary survey data on the commercial development of stem cell technology from the 1990s to the present day. We describe the first wave of industrial investment in hematopoietic stem cells during the 1990s and contrast this with the more recent expansion of the sector. In particular, we explore the cell types used, diseases targeted and business models adopted by firms. We conclude, by arguing that the commercial prospects for stem cell technologies remain highly uncertain and that innovative public policies should be adopted to prevent 'market failure'.

Pigmented villonodular synovitis of the temporomandibular joint: a report of two cases.

Pigmented villonodular synovitis is a benign but locally destructive disease that originates in the synovial membranes of the joints. It is a proliferative disorder of unknown etiology, and it is usually monarthric. Approximately 80% of cases involve the knee; the hip, ankle, foot, hand, elbow, and shoulder account for most other cases. Pigmented villonodular synovitis in the temporomandibular joint is rare. When it does occur, its features include preauricular swelling, trismus, and symptoms of temporomandibular joint dysfunction. It can be diagnosed by a combination of the history, clinical examination, characteristic radiologic findings, and fine-needle aspiration or biopsy results. Wide local excision, including the involved bone, and a total synovectomy are advocated because the lesion can recur if it is not adequately excised. We report two new cases of pigmented villonodular synovitis of the temporomandibular joint, and we review the literature on this subject.

Schwannoma of the epiglottis: first report of a case.

Schwannomas of the larynx are rare. Most of the few such reports in the literature have described schwannomas that occurred in the aryepiglottic fold or the true vocal folds. In this article, we report what we believe is the first case of a schwannoma arising from the epiglottis.