archive-org.com » ORG » B » BIOEDGE.ORG

Total: 1811

Choose link from "Titles, links and description words view":

Or switch to "Titles and links view".
  • BioEdge: the latest news and articles about bioethics
    Xavier Symons 21 March 2015 Comments tags 23andme Big Pharma genetic testing It will set up its own pharmaceutical wing to identify new drug targets for both common and rare diseases Should Big Pharma fund bioethics Michael Cook 12 May 2012 Comments tags Big Pharma bioethics conflict of interest Gadfly a person who annoys or criticizes others in order to provoke them into action There is no better word to describe Carl Elliott a University of Minnesota bioethicist who is the profession s most savage critic In his column in the Chronicle of Higher Education this week he took up a favourite theme cosying up to the pharmaceutical industry He complains that too many bioethicists are being funded by Big Pharma which Dr Elliott tends to describe as a Mafia network Should clinical trials be used as marketing exercises Michael Cook 04 September 2010 Comments tags Big Pharma clinical trials informed consent Death in anti psychotic trial raises disturbing questions Search BioEdge Subscribe to BioEdge newsletter Subscribe to BioEdge RSS feed Recent Posts Dutch psychiatric patients may get euthanasia too easily says US study 14 Feb 2016 A Dutch report applies the brakes on completed life euthanasia 13 Feb 2016

    Original URL path: http://www.bioedge.org/bioethics/tag/Big+Pharma (2016-02-18)
    Open archived version from archive

  • BioEdge: Drug giant appoints bioethicist to head compassionate use panel
    model for others in industry and in government to follow In recent years these requests have become more common Patients and their families have applied pressure via social media to drug companies to give them access to experimental treatments The drug companies are reluctant because the drugs are in short supply or unproven and possibly harmful Some states have attempted to short circuit the clinical trial process for these heart rending cases by passing right to try laws It is estimated that the FDA granted about 1800 requests from drug companies to allow compassionate use in the 2014 fiscal year It approved nearly all of them Compassionate use is an attempt to strike a balance between patient autonomy and informed consent On the one hand patients are making their own choices after being informed of the risks On the other hand they may be too sick or may not have the background to understand the risks Often the odds of an experimental treatment working are as low as 10 As a recent article in the New England Journal of Medicine pointed out it may well not be in the interest of patients however sick they may be to have easier access to products that are ineffective and may actually worsen their clinical status Furthermore by diverting resources from clinical trials compassionate use could hold up the approval process and delay the moment when other patients can access the drug Sometimes as in the recent Ebola epidemic the allocation of experimental drugs can affect whole populations and a country s foreign policy Navigating these stormy waters is a job which requires not only medical knowledge but tact and adroit political skills MORE ON THESE TOPICS Arthur Caplan clinical trials compassionate use research ethics This article is published by Michael Cook and

    Original URL path: http://www.bioedge.org/bioethics/drug-giant-appoints-bioethicist-to-head-compassionate-use-panel/11432 (2016-02-18)
    Open archived version from archive

  • BioEdge: Unreported clinical trial data “unethical”
    on ClinicalTrials gov and completed by 2009 found that 23 had not reported any results These unreported trials included nearly 300 000 participants Even where results are released the process of publication can be very protracted Among clinical trials of vaccines against five diseases registered in a variety of databases between 2006 2012 only 29 had been published in a peer reviewed journal by the WHO recommended deadline of 24 months following study completion WHO has recommended that from now on the main findings of every clinical study should be submitted to a peer reviewed journal within 12 months after data collection ends and be published in an open access journal unless there is a specific reason why that s impossible within 24 months It s unethical to conduct clinical research without reporting the results says immunologist Dr Vasee Moorthy author of a paper discussing the rationale behind the WHO s new statement Europe and the United States have already made important regulatory strides to registering trials and making their outcomes public Moorthy says MORE ON THESE TOPICS clinical research clinical trials This article is published by Xavier Symons and BioEdge under a Creative Commons licence You may republish it

    Original URL path: http://www.bioedge.org/bioethics/unreported-clinical-trial-data-unethical/11403 (2016-02-18)
    Open archived version from archive

  • BioEdge: Should medicine leave the gold standard of randomized trials?
    out that randomized trials do not have a long history The first one took place in 1948 and the first instance of describing them as the gold standard dates back to only 1982 While RCTs are clearly useful they argue that ever growing databases provided by electronic medical records and personalised medicine may be eroding their status They describe a rigid insistence on RCTs as medical monotheism the emergence of biomedicine within the monotheistic traditions of Europe and the Middle East imbued medicine with a commitment to universal truths unitary paradigms and a single minded approach to illness and care The idea of a gold standard that there is one best way to do something whether conduct clinical research diagnose a disease or treat a patient emerges from this underlying commitment But in a world where universal truths are fading and governments have abandoned the yoke of a financial gold standards perhaps RCTs need to be dethroned as well MORE ON THESE TOPICS clinical ethics clinical trials randomized clinical trials This article is published by Michael Cook and BioEdge under a Creative Commons licence You may republish it or translate it free of charge with attribution for non commercial purposes

    Original URL path: http://www.bioedge.org/bioethics/should-medicine-leave-the-gold-standard-of-randomized-trials/11398 (2016-02-18)
    Open archived version from archive

  • BioEdge: the latest news and articles about bioethics
    trials Is it an example of medical monotheism Search BioEdge Subscribe to BioEdge newsletter Subscribe to BioEdge RSS feed Recent Posts Dutch psychiatric patients may get euthanasia too easily says US study 14 Feb 2016 A Dutch report applies the brakes on completed life euthanasia 13 Feb 2016 Celebrating 15 years of Dutch euthanasia 13 Feb 2016 Canada s euthanasia courts 13 Feb 2016 IVF audit in Australia 13 Feb

    Original URL path: http://www.bioedge.org/bioethics/tag/randomized+clinical+trials (2016-02-18)
    Open archived version from archive

  • BioEdge: Drug tests in East Germany get “conceded pass”
    the GDR authorities The trials were conducted without the knowledge of the public and although GDR legislation stipulated that patients had to consent to the trials there is no evidence that patients were systematically informed Many different drugs were tested including chemotherapeutic agents insulin heparin anti depressants anti allergy drugs toothpastes and cardiovascular drugs Some documents suggest that some of the trials were carried out without patients having a comprehensive understanding of what the trial involved It is also unclear whether the patients knew that they were participating in trials and were aware of all the risks But even if the patients did not benefit the companies and the government did The companies were able to test new drugs legally while at the same time opening up new markets in the Eastern Bloc and getting test results faster and more cheaply than they could elsewhere The government appears to have earned DM16 5 million from 220 trials between 1983 and 1990 involving more than 14 000 patients and 68 Western companies mainly from West Germany Austria and Switzerland What accounts for the ethical shortcomings of the GDR health system The researchers say the GDR ideology required the subordination of the individual to the interests of the collective a basic precept of Marxism Therefore the rights of the individual were not always fully taken into account This goes against traditional medical ethics where patient autonomy is the primary concern In the GDR decisions were often made for purely ideological reasons State politics followed a socialist collective code of ethics and ethical freedom was non existent a fact that even formerly loyal GDR ethicists openly admit today Medical employees doctors and scientists were expected to subordinate their interests to prioritise tasks of importance to society A truly independent medical opinion was not

    Original URL path: http://www.bioedge.org/bioethics/drug_tests_in_east_germany_get_conceded_pass/11192 (2016-02-18)
    Open archived version from archive

  • BioEdge: Have some American homeless become lab rats?
    companies now typically outsource clinical studies to contract research organizations like South Coast which run trials faster and at lower cost than universities do Their job is simply to follow the instructions of their sponsors This formula is working The contract research industry has grown steadily since the early 1990s and may now generate over 100 billion in annual income according to the Tufts Center for the Study of Drug Development At the top of the heap are corporations like Quintiles which has 28 000 employees and operates in about 100 countries At the other end are private physicians and small companies like South Coast which are often based in strip malls or suburban office parks These companies pay participants for the destitute and mentally ill it is money for jam The main ethical issues here of course are the competence and judgment of the prospective subjects writes Elliott While compensation is not coercive the poor can barely resist the temptation Elliott has been a harsh critic of fellow bioethicists for years regarding many of them as shills for Big Pharma He writes None of the bioethicists or review board managers I spoke to were willing to publicly defend paying mentally ill homeless subjects to take part in clinical trials although most did not seem especially surprised to hear that the practice was occurring But some prominent bioethicists do not see homelessness as a barrier to research The article is confronting and provocative It s well worth reading MORE ON THESE TOPICS clinical trials research ethics This article is published by Michael Cook and BioEdge under a Creative Commons licence You may republish it or translate it free of charge with attribution for non commercial purposes following these guidelines If you teach at a university we ask that your department

    Original URL path: http://www.bioedge.org/bioethics/have_some_american_homeless_become_lab_rats/11082 (2016-02-18)
    Open archived version from archive

  • Compassionate Use Putting drug regulations to the test
    republish it or translate it free of charge with attribution for non commercial purposes following these guidelines If you teach at a university we ask that your department make a donation Commercial media must contact us for permission and fees Some articles on this site are published under different terms Please enable JavaScript to view the comments powered by Disqus comments powered by Disqus Search BioEdge Subscribe to BioEdge newsletter

    Original URL path: http://www.bioedge.org/bioethics/compassionate_use_putting_drug_regulations_to_the_test/11084 (2016-02-18)
    Open archived version from archive



  •