The Paroxetine 352 Bipolar Study Revisited: Deconstruction of Corporate and Academic Misconduct

Medical ghostwriting is the practice in which pharmaceutical companies engage an outside writer to draft a manuscript submitted for publication in the names of “honorary authors,” typically academic key opinion leaders. Using newly-posted documents from paroxetine litigation, we show how the use of ghostwriters and key opinion leaders contributed to the publication of a medical journal article containing manipulated outcome data to favor the proprietary medication. The article was ghostwritten and managed by SmithKline Beecham, now GlaxoSmithKline (GSK) and Scientific Therapeutics Information, Inc. without acknowledging their contribution in the published article. The named authors with financial ties to GSK, had little or no direct involvement in the paroxetine 352 bipolar trial results and most had not reviewed any of the manuscript drafts. The manuscript was originally rejected by peer review; however, its ultimate acceptance to the American Journal of Psychiatry was facilitated by the journal editor who also had financial ties to GSK. Thus, GSK was able to take an under-powered and non-informative trial with negative results and present it as a positive marketing vehicle for off-label promotion of paroxetine for bipolar depression. In addition to the commercial spin of paroxetine efficacy, important protocol-designated safety data were unreported that may have shown paroxetine to produce potentially harmful adverse events

Evaluation of an exercise field test using heart rate monitors to assess cardiorespiratory fitness and heart rate recovery in an asymptomatic population.

PurposeMeasures of cardiorespiratory fitness (CRF) and heart rate recovery (HRR) can improve risk stratification for cardiovascular disease, but these measurements are rarely made in asymptomatic individuals due to cost. An exercise field test (EFT) to assess CRF and HRR would be an inexpensive method for cardiovascular disease risk assessment in large populations. This study assessed 1) the predictive accuracy of a 12-minute run/walk EFT for estimating CRF ([Formula: see text]) and 2) the accuracy of HRR measured after an EFT using a heart rate monitor (HRM) in an asymptomatic population.MethodsFifty subjects (48% women) ages 18-45 years completed a symptom-limited exercise tolerance test (ETT) (Bruce protocol) and an EFT on separate days. During the ETT, [Formula: see text] was measured by a metabolic cart, and heart rate was measured continuously by a HRM and a metabolic cart.ResultsEFT distance and sex independently predicted[Formula: see text]. The average absolute difference between observed and predicted [Formula: see text] was 0.26 ± 3.27 ml·kg-1·min-1 for our model compared to 7.55 ± 3.64 ml·kg-1·min-1 for the Cooper model. HRM HRR data were equivalent to respective metabolic cart values during the ETT. HRR at 1 minute post-exercise during ETT compared to the EFT had a moderate correlation (r=0.75, p<0.001).ConclusionA more accurate model to estimate CRF from a 12-minute run/walk EFT was developed, and HRR can be measured using a HRM in an asymptomatic population outside of clinical settings

Gesture Recognition in Robotic Surgery: a Review

OBJECTIVE: Surgical activity recognition is a fundamental step in computer-assisted interventions. This paper reviews the state-of-the-art in methods for automatic recognition of fine-grained gestures in robotic surgery focusing on recent data-driven approaches and outlines the open questions and future research directions. METHODS: An article search was performed on 5 bibliographic databases with combinations of the following search terms: robotic, robot-assisted, JIGSAWS, surgery, surgical, gesture, fine-grained, surgeme, action, trajectory, segmentation, recognition, parsing. Selected articles were classified based on the level of supervision required for training and divided into different groups representing major frameworks for time series analysis and data modelling. RESULTS: A total of 52 articles were reviewed. The research field is showing rapid expansion, with the majority of articles published in the last 4 years. Deep-learning-based temporal models with discriminative feature extraction and multi-modal data integration have demonstrated promising results on small surgical datasets. Currently, unsupervised methods perform significantly less well than the supervised approaches. CONCLUSION: The development of large and diverse open-source datasets of annotated demonstrations is essential for development and validation of robust solutions for surgical gesture recognition. While new strategies for discriminative feature extraction and knowledge transfer, or unsupervised and semi-supervised approaches, can mitigate the need for data and labels, they have not yet been demonstrated to achieve comparable performance. Important future research directions include detection and forecast of gesture-specific errors and anomalies. SIGNIFICANCE: This paper is a comprehensive and structured analysis of surgical gesture recognition methods aiming to summarize the status of this rapidly evolving field

On the Cognition of States of Affairs

The theory of speech acts put forward by Adolf Reinach in his "The A Priori Foundations of the Civil Law" of 1913 rests on a systematic account of the ontological structures associated with various different sorts of language use. One of the most original features of Reinach's account lies in hIs demonstration of how the ontological structure of, say, an action of promising or of commanding, may be modified in different ways, yielding different sorts of non-standard instances of the corresponding speech act varieties. The present paper is an attempt to apply this idea of standard and modified instances of ontological structures to the realm of judgement and cognition, and thereby to develop a Reinachian theory of how intentionality is mediated through language in acts of thinking and speaking

Ariel - Volume 5 Number 6

Editors J.D. Kanofsky Mark Dembert Entertainment Robert Breckenridge Joe Conti Gary Kaskey Photographer Scot Kastner Overseas Editor Mike Sinason Circulation Jay Amsterdam Humorist Jim McCann Staff Ken Jaffe Bob Sklaroff Janet Welsh Dave Jacoby Phil Nimoityn Frank Chervane

Left-Handed W Bosons at the LHC

The production of W bosons in association with jets is an important background to new physics at the LHC. Events in which the W carries large transverse momentum and decays leptonically lead to large missing energy and are of particular importance. We show that the left-handed nature of the W coupling, combined with valence quark domination at a pp machine, leads to a large left-handed polarization for both W^+ and W^- bosons at large transverse momenta. The polarization fractions are very stable with respect to QCD corrections. The leptonic decay of the W bosons translates the common left-handed polarization into a strong asymmetry in transverse momentum distributions between positrons and electrons, and between neutrinos and anti-neutrinos (missing transverse energy). Such asymmetries may provide an effective experimental handle on separating W + jets from top quark production, which exhibits very little asymmetry due to C invariance, and from various types of new physics.Comment: 32 pages, revtex, 17 figures, 3 tables, v2 minor corrections to ME+PS results, no changes to conclusions, added reference

Change over time in brain serotonin transporter binding in major depression: effects of therapy measured with [(123) I]-ADAM SPECT.

Several studies have reported low brain serotonin transporter (SERT) binding in individuals with major depression. We hypothesized that the SERT standardized uptake ratio (SUR) values using [(123) I]-ADAM single photon emission computed tomography would increase in depressed subjects who responded to cognitive behavior therapy (CBT) compared to CBT nonresponders. [(123) I]-ADAM scans were acquired before and after 12 weeks of CBT from 20 depressed subjects and on two occasions 12 weeks apart from 10 nondepressed, healthy volunteers. The primary outcome measure was change over time in SUR values in the midbrain, medial temporal lobe, and basal ganglia regions. Depressed subjects demonstrated low pretreatment mean SUR values that significantly increased over time in the midbrain (P = .011), right medial temporal lobe (P = .008), and left medial temporal lobe (P = .000) regions. Treatment responders showed a significant increase over time in SUR values in left medial temporal lobe (P = .029) and right medial temporal lobe (P = .007) regions. Partial and nonresponder subjects also showed a significant increase over time in SUR values in the left medial temporal region (P = .040) (vs. healthy volunteers), but to a lesser degree. The findings suggest that low pretreatment SERT binding may increase over time in some depressed individuals who experience symptom improvement