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Today the BMJ published a re-analysis of the data in Study 329. The results of this study, funded by GlaxoSmithKline were first published in 2001 in the prestigious Journal of the American Academy of Child and Adolescent Psychiatry. That article claimed that the antidepressant paroxetine is safe and efficacious in the treatment of adolescent depression, leading to its widespread use across the globe. Subsequent investigation, culminating in today’s publication in the BMJ, shows that paroxetine is no more effective than placebo in treating depression in adolescents, but is much more harmful. The authors, led by Australian child psychiatrist Jon Jureidini, have gone to extraordinary lengths to secure access to and then reanalyse the original data, some 77,000 pages of it. Their forensic analysis shows just how the original paper managed to ‘prove’ the safety and efficacy of paroxetine – by using end points not specified in the original protocol and by coding away and ignoring side-effects. The full chronicle of the investigation of Study 329 can be found here. The website and articles are well worth a close examination.
In my view, this publication and expose is a ‘game changer’ for research ethics as it shows the perils of data secrecy and the way that it is well nigh impossible to challenge the results of randomised controlled trials without access to the original protocol and the data. And this raises a fundamental question for research ethics: How can it be ethical to approve research and enroll patients unless there is a guarantee of open access to the protocol and data? Without such a guarantee, we risk patients serving as little more than fodder for the marketing machinery of the pharmaceutical industry as trial results are manipulated and skewed to economic imperatives. Psychological Causes The brain plays an important role in levitra pills online trigging an erection, which releases certain neurotransmitters during sexual excitement. This totally tends to ruin a man s life at the age of 40 and shop levitra 70 are known to experience episodes of poor erections at some point of time. Besides, some lubricants that are formulated with desensitizing ingredients are also considered as natural aphrodisiacs which have been used since ancient days. women viagra For women, they can only tell you that they are going through canada viagra prescription a problem but cannot come in and show you the problem. We often justify enrolling patients in research on the grounds of the potential contribution to future knowledge – the research will help guide treatment for future patients, even if some of the trial patients receive placebo. This justification dissolves in the absence of guaranteed open access to data and protocol.
This research is both heartening and deeply dismaying. Heartening because it shows that it is possible for a small number of extremely motivated people (with an enormous amount of effort) to call to account research misconduct, and provide a clear recipe for avoiding future problems of this nature. It is dismaying because the ground has shifted in terms of losing (more/all) confidence in clinical research; and in the knowledge that there will never be enough motivated people to do all of the necessary reanalyses should investigators (both commercially and publicly funded) open up their data. This expose has cast a long shadow over all research findings.
However, a phoenix might rise from the ashes. The restoration of Study 329 could be a trigger to demand that open access become the new norm. Human research ethics committees (institutional review boards) could demand open access as a requirement for ethics approval. Only such a proposal might restore confidence in the clinical research enterprise, and thereby ensure that when patients enroll in research for the greater good, there is some chance of that good coming to pass.
CALL FOR PAPERS
Submissions to this issue are limited to 5,000 words. The deadline is October 1, 2015.
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Susan Dwyer (University of Maryland):
What do bioethicists do? According to a recent Boston Globe op-ed by the Harvard cognitive psychologist Steven Pinker, they needlessly get in the way of saving and improving human lives by throwing up ethical red tape and slowing the speed At this point the flow of blood resumes as http://www.donssite.com/truckphoto/Picture-of-Blue-peterbilt-stepdeck-Fergus-Truck-Show-2011.htm levitra on line normal and is no longer concentrated in the genital area. It can be examined at different level that comprises psychology and medical reason. buy cheap tadalafil Once taken, its effect can prevail from buy cheap cialis 5 to 6 hours. There are many online store usa but if you want to get branded canadian cialis generic more info here for you then you should make practice of the drugs of cialis, purchase cialis & donssite.com openly. of research, and in so doing, they undermine their right to call themselves ethicists at all.
Read on at Aljazeera America. You can also listen to her discuss this — as well the need to consider race, class, and gender in medical research — at The Majority Report.
Guest Post by Julieta Arosteguy (FLACSO)
In August of last year, after teaching my first and only bioethics class of the semester, I was fired from my teaching position at the National University of San Martín (Argentina). I was told by the program’s officials that the reasons for my dismissal were my atheist, feminist, and pro-abortion views.
Before I was fired, I had taught bioethics for four years as an Adjunct Professor at the Childcare and Parenting Program (Puericultura y Crianza) of the National University of San Martín. Every year, I got excellent evaluations from my students.
The semester before I was fired, however, I discussed for the first time the “F.,A.L.” ruling of the Argentinean Supreme Court. In 2012, the Supreme Court decided on a case of abortion for the first time in its history. In the “F.,A.L.” ruling, the Supreme Court interpreted the criminal law that prohibits abortion, stating that access to abortion should be considered a right for all women when the pregnancy presents some risk for the woman’s life or health, or when the pregnancy is the result of sexual abuse. The Court ordered that all obstacles that prevent access to safe, legal abortions be removed. (You may find the decision here.)
Teaching the “F.,A.L.” ruling and Argentinean law on abortion in a program dedicated to women’s reproductive health care was my contribution to removing obstacles for the access to safe and legal abortion. As I found out the following semester, FUNDALAM, the NGO in charge of the program, closely linked to the Catholic “Opus Dei” group, was not pleased with my decision.
However, firing a person for her religious and political views is illegal in Argentina, and I took the case to court. Although the case is not yet settled, I was granted a cautionary order that mandates my restitution. The judicial order was issued in December last year, but neither FUNDULAM nor the University of San Martin has complied with it. Continue reading
So, a few days ago, this happened:
Supermodel Natalia Vodianova has ignited a firestorm of discussion about the rights of the disabled in her native Russia after her autistic sister was kicked out of a Nizhny Novgorod cafe by the owner, who allegedly accused her of scaring customers away.
In an August 12 Facebook post, Vodianova wrote that her 27-year-old sister Oksana, who has been diagnosed with autism and cerebral palsy, and Oksana’s caretaker stopped at the cafe the previous day to seek respite from the heat.
After the caretaker ordered a snack for Oksana, Vodianova wrote, the owner of the cafe approached the two women and told them: “Why don’t you leave? You’re scaring away all of our customers. Go get medical help for you and your child. And then go out in public.”
In response to Vodianova’s mother’s attempts to intervene,
a security guard threatened to “call the crazy house” and “lock you in the cellar” if the two women did not leave the premises….After her mother left the cafe with Oksana and the caretaker, they were confronted by police who told them they were being “detained for minor hooliganism…”
If purchase levitra you have erectile problem that stops you from making love, it is time to see doctor. Risk factors If you are going through premature ejaculation then there are a number of cipla cialis risk factors that can affect your ability to attain an erection. -Treatments for chemotherapy’s other side effects, such as nausea medication, can also cause leg pain. As a viagra from uk its goal is to provide all its customers best support and assistance with respect to question regarding delivery, services, and products. People first develop metabolic syndrome and this eventually develops into diabetes. viagra overnight So the federal Investigative Committee opened an investigation. Hands were wrung. Horrified-sounding words were spoken. Fine. But this does not ameliorate two terrible facts about Russia, and its treatment of disabled individuals:
1. Disabled individuals (and especially disabled children) have been excluded, isolated, and otherwise denied their full human rights before, and during, the communist regime: http://dsq-sds.org/article/view/936/1111
2. Disabled individuals (and especially disabled children) are not doing much better in post-communist Russia: http://www.rferl.mobi/a/26584457.html
The truth is this: Official policies allow for (or, at best, ignore) widespread abuse of the disabled, including physical and psychological threats and public humiliation. And for too long a time, the Russian public largely went along with the abuse; tapping into some of the darker aspects of Russian society, some enjoyed the ugly, oppressive displays. One can only hope that now, with the presence of social media that thus far has, at least in part, managed to evade even Putin’s iron grip on information, these displays are obscured neither by the iron curtain nor by the quiet approval of the locals, changing the situation for those most affected by this national disgrace. Sunlight being the best disinfectant and all….
CALL FOR PAPER PROPOSALS
Series Title: Moral Psychology of Emotions
Series Editor: Mark Alfano
Publisher: Rowman & Littlefield International
Volume: The Moral Psychology of Regret
Volume Editor: Anna Gotlib
Proposals are sought for chapters in a volume entitled The Moral Psychology of Regret, which is a part of a new series, entitled Moral Psychology of the Emotions (Rowman & Littlefield International) with Mark Alfano as series editor. Anna Gotlib will be serving as the editor of the Regret volume, the proposed publication date for which is late 2017.
A few words of what the general series is about from the Rowman & Littlefield International page:
How do our emotions influence our other mental states (perceptions, beliefs, motivations, intentions) and our behaviour? How are they influenced by our other mental states, our environments, and our cultures? What is the moral value of a particular emotion in a particular context? This series explores the causes, consequences, and value of the emotions from an interdisciplinary perspective. Emotions are diverse, with components at various levels (biological, neural, psychological, social), so each book in this series is devoted to a distinct emotion. This focus allows the author and reader to delve into a specific mental state, rather than trying to sum up emotions en masse. Authors approach a particular emotion from their own disciplinary angle (e.g., conceptual analysis, feminist philosophy, critical race theory, phenomenology, social psychology, personality psychology, neuroscience) while connecting with other fields. In so doing, they build a mosaic for each emotion, evaluating both its nature and its moral properties. Each volume will approach a particular emotion from multiple angles, with novel contributions both from philosophers employing a variety of methods and working in a variety of traditions and from philosophically-savvy scientists developing models in personality psychology, social psychology, neuroscience, and other fields.
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The particular volume on regret, as I interpret it, construes the emotion as broadly as possible. Topics might include (but are in no way limited to): regret related to loss; the rationality, functionality, and motivational force of regret; regret’s influence on our present and future decision-making; the phenomenological experiences of regret; the relationship of regret, moral luck, and virtue; the distinctions between shame and regret; gender, race, and regret; professional regret; and everything in between. I hope to bring together a group of theorists who will add something new, and perhaps unusual, to the discourses of moral psychology by addressing an emotion that has not been sufficiently discussed. I very much hope that you can be a part of this project, and look forward to your response.
Submission Details
Proposals should be about 250-300 words (with each chapter 8,000-9,000 words). Authors should also include a CV, and if possible, indicate any written/other work related to the subject of regret. Please email your abstract and CV to: agotlib@brooklyn.cuny.edu
Deadlines
Abstracts due: December 2015
Selection of abstracts and proposal writing: January 2016
First drafts due: January 2017
Publication: late 2017
Rukmini Callimachi of the New York Times reporting from Northern Iraq, in conversation with PBS’s Judy Woodruff:
The horrors that these women are — were forced to endure really challenged the imagination. What they talk about is how systematic the rape was and how they tried to, you know, protest and they tried to ask the fighters, why are you doing this to me? And everything was cloaked in a religious justification.
They told them, you are infidels. You are unbelievers.
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The Yazidis, of course, are not Muslim. They believe in seven angels and are therefore considered polytheists by ISIS. And the fighters explained to them that, because of your lack of faith, the Koran gives us the right to rape you, and whatever we do to you is not only justified in scripture; it is considered virtuous.
Watch the interview or read the transcript here. I really don’t even know what to say.
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