Ethical issues in psychopharmacology.

California State University, Northridge, Department of Philosophy, 18111 Nordhoff Street, Northridge, California 91330-8253, USA.
Journal of Medical Ethics (Impact Factor: 1.69). 08/2006; 32(7):405-10. DOI: 10.1136/jme.2005.013185
Source: PubMed

ABSTRACT The marketing of selective serotonin reuptake inhibitors in the psychopharmacological industry presents a serious moral problem for the corporate model of medicine. In this paper I examine ethical issues relating to the efficacy and safety of these drugs. Pharmaceutical companies have a moral obligation to disclose all information in their possession bearing on the true risks and benefits of their drugs. Only then can patients make fully informed decisions about their treatment.

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    ABSTRACT: To assess the efficacy and safety of the selective oxytocin receptor antagonist epelsiban in the treatment of premature ejaculation (PE). Double-blind, randomized, parallel-group, placebo-controlled, stopwatch-monitored, phase 2, multicenter study (GSK557296; NCT01021553) conducted in men (N = 77) 18-55 years of age, with PE defined as per International Society for Sexual Medicine consensus definition. Patients provided informed consent prior to a 4-week un-medicated run-in to determine baseline intravaginal ejaculatory latency times (IELT) recorded in an electronic diary. Patients needed to make a minimum of four intercourse attempts and have a mean IELT <65 seconds to be considered for randomization. Men with moderate-to-severe erectile dysfunction were excluded from the study. Eligible patients were randomized to placebo, epelsiban 50 mg, or 150 mg, taken 1 hour before sexual activity. Active treatment IELT times were recorded in an electronic diary, along with subjective measures of intercourse satisfaction, over an 8-week treatment period. The Modified Index of Premature Ejaculation and International Index of Erectile Function were completed at study visits. Stopwatch timed IELT recordings and a modified version of the patient-reported outcome questionnaire the IPE were used in this study to determine the effect of epelsiban when taken orally prior to intercourse in subjects diagnosed with PE. The baseline (mean) IELT for patients pretreatment was (0.52, 0.63, and 0.59 minutes) for placebo, epelsiban 50 mg and 150 mg, respectively. On-treatment, average geometric least squares means of the median IELT values (mean) were slightly higher in the 50 mg and 150 mg groups (0.72 and 0.69 minutes), respectively, vs. the placebo group (0.62 minutes). Headache was the most common adverse event, and rates were similar across all groups. Epelsiban 50 mg and 150 mg were well tolerated, but did not result in a clinically or statistically significant change in IELT in men with PE, compared with placebo. Shinghal R, Barnes A, Mahar KM, Stier B, Giancaterino L, Condreay LD, Black L, and McCallum SW. Safety and efficacy of epelsiban in the treatment of men with premature ejaculation: A randomized, double-blind, placebo-controlled, fixed-dose study. J Sex Med **;**:**-**.
    Journal of Sexual Medicine 08/2013; 10(10). DOI:10.1111/jsm.12272 · 3.15 Impact Factor
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    ABSTRACT: This essay examines the effects of commercialization on education with particular focus on corporatization of academic research. This trend results from a business model of education, which I identify as profit‐based inquiry. I contrast profit‐based inquiry with Nicholas Maxwell's conception of wisdom‐based inquiry and conclude that the business model fails to achieve enduring value and results in a promotional or ideological emphasis rather than one that stresses the importance of critical rationalism. In order to make my case for this failure, I focus attention on the current state of commercialization in research of medicines.
    London Review of Education 07/2007; 5(2):131-142. DOI:10.1080/14748460701440665
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    ABSTRACT: Reporting guidelines (e.g. CONSORT) have been developed as tools to improve quality and reduce bias in reporting research findings. Trial registration has been recommended for countering selective publication. The International Committee of Medical Journal Editors (ICMJE) encourages the implementation of reporting guidelines and trial registration as uniform requirements (URM). For the last two decades, however, biased reporting and insufficient registration of clinical trials has been identified in several literature reviews and other investigations. No study has so far investigated the extent to which author instructions in psychiatry journals encourage following reporting guidelines and trial registration. Psychiatry Journals were identified from the 2011 Journal Citation Report. Information given in the author instructions and during the submission procedure of all journals was assessed on whether major reporting guidelines, trial registration and the ICMJE's URM in general were mentioned and adherence recommended. We included 123 psychiatry journals (English and German language) in our analysis. A minority recommend or require 1) following the URM (21%), 2) adherence to reporting guidelines such as CONSORT, PRISMA, STROBE (23%, 7%, 4%), or 3) registration of clinical trials (34%). The subsample of the top-10 psychiatry journals (ranked by impact factor) provided much better but still improvable rates. For example, 70% of the top-10 psychiatry journals do not ask for the specific trial registration number. Under the assumption that better reported and better registered clinical research that does not lack substantial information will improve the understanding, credibility, and unbiased translation of clinical research findings, several stakeholders including readers (physicians, patients), authors, reviewers, and editors might benefit from improved author instructions in psychiatry journals. A first step of improvement would consist in requiring adherence to the broadly accepted reporting guidelines and to trial registration.
    PLoS ONE 10/2013; 8(10):e75995. DOI:10.1371/journal.pone.0075995 · 3.53 Impact Factor


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