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Court rules that FDA cannot restrict off-label marketing

A federal judge in New York has ruled that the Food and Drug Administration cannot restrict off-label marketing information for an approved drug so long as the information is truthful and not misleading. The judgment was based on the First Amendment—the right to free speech.  
feeds.bmj.com
over 4 years ago
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Guest Post: Agree to disagree? Why not? | Practical Ethics

Pedro Jesus Perez Zafrilla. (University of Valencia) In a previous post on this blog, David Aldridge questions the social convention of ending arguments by “agreeing to disagree.”, arguing that doing so “ends the dialogue at precisely the point where what is really at issue is beginning to emerge” . He also questions the motivations of those who seek to end an argument by offering to "agree to disagree" However, I think agreeing to disagree is a good idea and I will try to argue why. Debating could be characterized by three features: a context of disagreement, open-minded participants, and an expectation that one can rationally convince his/her interlocutor. Then, people who debate do so because they believe that agreement is possible. The achievement of agreement is the aim of  dialogue. Nevertheless, the desire to reach agreement shouldn’t lead us to forget that debate is fruitful only under certain conditions. Some of them include limitations of time and the number of participants, because the decision must be made, or agreement reached, within a reasonable span of time. But there are also other limitations in the debating process. We might begin with the expectation that one can rationally convince one’s interlocutor about the rightness of one’s position but we reach difficulties when incommensurable views are confronted. Some examples are found in debates on taxes, euthanasia or models of education. Here what is morally significant for some persons is not so for others. So, concepts such as “a dignified life” or “quality of education” have different meanings for each side of the debate. Accordingly, the arguments one side presents will not be convincing to the other side. In these cases, the expectation that one can rationally convince one’s interlocutor will generate polarization processes toward antagonist positions (see Haidt, J. “The Emotional Dog and its Rational Tail. A Social Intuitionist approach to Moral judgement”, Psychological Review, 108, 2001, p.823). Even more, each person will think that his/her interlocutor is not morally motivated (Schulz, Kathryn. Being wrong. Adventures in the margin of error. London: Portobello Books, 2010, pp.107-110). In that context, far from achieving agreement, debate leads to disagreement. For that reason, I think the more reasonable option to avoid this turn is to seek points of convergence between the interlocutors, whilst recognising the deep differences that remain between them, as Gutmann and Thompson suggest (Gutmann, A. and Thompson, D. Democracy and disagreement. Cambridge: Harvard University Press, 1996, pp.84-85). However, this recognition of the limitations of the agreement that can be reached doesn’t mean that the dialogue has failed. On the contrary, it is the most suitable way to maintain the effectiveness of dialogue and arrive at agreement. I think so for three reasons: the first is that agreeing to disagree avoids the frustration when our interlocutor doesn’t recognize the rightness of our arguments. Second, and as a consequence of the first, agreeing to disagree enables us to continue recognizing our interlocutor as an open-minded person. Finally, it enables us to set more realistic goals for deliberation. The opposite, blindly trusting the open-mindedness of our interlocutor, as Aldridge argues, seems a to be overly optimistic.. Then, answering to Aldridge’s question about what could motivate an offer to agree to disagree, an appropriate reason to offer to agree to disagree would be an awareness of the limitations that debate has in contexts of deep disagreement.  
blog.practicalethics.ox.ac.uk
over 4 years ago
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Critical Care

The first steps in goal-directed therapy for sepsis are early diagnosis followed by appropriate triage. These steps are usually left to the physician’s judgment, as there is no accepted biomarker available. We aimed to determine biomarker phenotypes that differentiate children with sepsis who require intensive care from those who do not.  
ccforum.com
over 4 years ago
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General =========================================================================

This information is intended for physicians and related personnel, who understand that medical information is often imperfect, and must be interpreted in the context of a patient's clinical data using reasonable medical judgment. This website should not be used as a substitute for the advice of a licensed physician. All information on this website is protected by copyright of PathologyOutlines.com, Inc. Information from third parties may also be protected by copyright. Please contact us at copyrightPathOut@gmail.com with any questions (click here for other contact information).  
pathologyoutlines.com
over 4 years ago
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Critical Care

Community-acquired pneumonia (CAP) requires prompt treatment, but its diagnosis is complex. Improvement of bacterial CAP diagnosis by biomarkers has been evaluated using chest X-ray infiltrate as the CAP gold standard, producing conflicting results. We analyzed the diagnostic accuracy of biomarkers in suspected CAP adults visiting emergency departments for whom CAP diagnosis was established by an adjudication committee which founded its judgment on a systematic multidetector thoracic CT scan.  
ccforum.com
over 4 years ago
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Multiple sclerosis in adults: management | Guidance and guidelines | NICE

The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The application of the recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.  
nice.org.uk
about 4 years ago
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Gallstone disease: diagnosis and initial management | Guidance and guidelines | NICE

The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The application of the recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.  
nice.org.uk
about 4 years ago
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Otitis media with effusion in under 12s: surgery | Guidance and guidelines | NICE

The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The application of the recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.  
nice.org.uk
about 4 years ago
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Rehabilitation after critical illness in adults | Guidance and guidelines | NICE

The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The application of the recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.  
nice.org.uk
about 4 years ago
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Child maltreatment: when to suspect maltreatment in under 18s | Guidance and guidelines | NICE

The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The application of the recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.  
nice.org.uk
about 4 years ago
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Donor milk banks: service operation | Guidance and guidelines | NICE

The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The application of the recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.  
nice.org.uk
about 4 years ago
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Smoking: workplace interventions | Guidance and guidelines | NICE

The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The application of the recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.  
nice.org.uk
about 4 years ago
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Medications for cognitive decline in people with Down syndrome | Cochrane

People with Down syndrome often experience cognitive decline (a deterioration in memory, language, thinking and judgment that are greater than normal age-related changes) at a younger age and in greater numbers than the general population. Various medicines have been shown to improve, or at least slow down the progression of these symptoms in people without Down syndrome.  
cochrane.org
about 4 years ago
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Seven days in medicine: 21-27 November

Medics call on Dublin to change abortion law More than 800 doctors from 44 countries joined a campaign run by Amnesty International to decriminalise abortion in Ireland. In a letter to the Irish government they warned that the current law was putting the lives of women at risk: “[The criminalisation of abortion] impedes and disregards sound medical judgment and can undermine the professional duty of care and confidentiality that doctors bear towards their patients.”  
feeds.bmj.com
about 4 years ago
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Seven days in medicine: 21-27 November

Medics call on Dublin to change abortion law More than 800 doctors from 44 countries joined a campaign run by Amnesty International to decriminalise abortion in Ireland. In a letter to the Irish government they warned that the current law was putting the lives of women at risk: “[The criminalisation of abortion] impedes and disregards sound medical judgment and can undermine the professional duty of care and confidentiality that doctors bear towards their patients.”  
feeds.bmj.com
about 4 years ago
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HITCHEN´S RAZOR

OK, but that hardly addresses the challenge of providing care based on best professional judgement where objective evidence is not available or practical to obtain. The future, from trauma care to cancer care, where “state of the art” is based on a combination of tradition & intuition, rather than double blind prospective trials. While there is tragedy to be discovered in those practices, that is also the starting point for improvements beyond the current state of practice. How does a provider (0r a patient) tell the difference?  
scancrit.com
about 4 years ago
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hs-Troponins Associated With Exercise-Induced Ischemia

High-sensitivity troponin levels pre- and post-stress testing can be a significant predictor of myocardial ischemia and "provide substantial incremental value to clinical judgement," say researchers.  
medscape.com
about 4 years ago
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Net benefit approaches to the evaluation of prediction models, molecular markers, and diagnostic tests

Many decisions in medicine involve trade-offs, such as between diagnosing patients with disease versus unnecessary additional testing for those who are healthy. Net benefit is an increasingly reported decision analytic measure that puts benefits and harms on the same scale. This is achieved by specifying an exchange rate, a clinical judgment of the relative value of benefits (such as detecting a cancer) and harms (such as unnecessary biopsy) associated with models, markers, and tests. The exchange rate can be derived by asking simple questions, such as the maximum number of patients a doctor would recommend for biopsy to find one cancer. As the answers to these sorts of questions are subjective, it is possible to plot net benefit for a range of reasonable exchange rates in a “decision curve.” For clinical prediction models, the exchange rate is related to the probability threshold to determine whether a patient is classified as being positive or negative for a disease. Net benefit is useful for determining whether basing clinical decisions on a model, marker, or test would do more good than harm. This is in contrast to traditional measures such as sensitivity, specificity, or area under the curve, which are statistical abstractions not directly informative about clinical value. Recent years have seen an increase in practical applications of net benefit analysis to research data. This is a welcome development, since decision analytic techniques are of particular value when the purpose of a model, marker, or test is to help doctors make better clinical decisions.  
feeds.bmj.com
almost 4 years ago
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Memories of Robert B. Zajonc - Association for Psychological Science

Robert Zajonc was a consummate scientist, scholar and social science researcher. His was a remarkable life, a life led during a renaissance period of social psychology and he had much to do with its development and flourishing over the latter half of the 20th century. Exposed to all forms of personal suffering during his youth and young adulthood, Bob found his way to America and Ann Arbor after spending much of his formative period in his beloved Poland and France during WWII. These experiences would form the crucible for his professional and personal experiences for the remainder of his life. The facts of his scientific and professional contribution are easily documented — seven distinct scientific lines of inquiry; hundreds of scientific papers, each a seminal contribution; dozens of doctoral students, honorary degrees, scientific awards and medals — the list endless and richly deserved. Robert was also a builder. He served as head of the newly developed social psychology program in psychology at Michigan in the 1970s, Director of the Research Center for Group Dynamics in the 1980s, and Director of the Institute for Social Research in the 1990s. All received Robert’s unique imprint for rigor, quality, and innovation. Bob also played a seminal role in the development of social psychology in Europe, leading to the establishment of the Institute for Social Science Research in Warsaw. Bob was also a father, husband, friend, colleague, and mentor. As chronicled in these remembrances from his first doctoral student, Eugene Burnstein, to Piotr Winkielman, his last student at the University of Michigan, Bob passed along his remarkable scientific judgment and insights that will stand the test of history. But there are others in this list between these two bookend students, distinguished scientists all, Richard Nisbett, Susan Fiske, Mahzarin Banaji, Paula Niedenthal, John Bargh and Richard Moreland who were graduate students, colleagues, co-authors, and deep and abiding friends over the decades.  
psychologicalscience.org
almost 4 years ago
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Tribunal was “unduly lenient” over psychiatrist’s deception, says High Court

The Medical Practitioners Tribunal Service made an error of judgment in finding that the fitness to practise of a psychiatrist who falsified dozens of documents was not impaired, a High Court judge has ruled.  
feeds.bmj.com
almost 4 years ago