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Recent eLetters

Displaying 1-10 letters out of 432 published

  1. Teaching medical students rational prescribing and improving opportunities for doctors to appraise new treatments enhances rational prescribing

    Greater transparency and regulatory oversight in disclosing gifts and payments to physicians from drug and medical device companies could well reduce their influence on a doctor's prescribing habits and medical management recommendations. The threat of a very public loss of professional reputation among peers and patients is likely to discourage a physician accepting drug and medical device company generosity. However, a more positive, potentially more effective and formative approach would be include in medical school ethics curricula the psychology of gifting and the adverse influence on clinical practice exerted by pharmaceutical company incentives and honoraria. Instead of policing behavior to stop physicians raiding Big Pharma's cookie jar, we should intensively caution our medical students about inappropriate ties with pharmaceutical industry. The latter could form the basis of a career-long ethical approach towards refusing undue gifts and payments.

    Careful scrutiny of drug-company sponsored clinical trials could lead doctors to the conclusion that exciting but expensive new treatments are not superior to reliable old work horses. Sponsored studies may ignore comparisons with long-established effective drugs (there's little income in established patent-expired drugs. By aggressively marketing their newest products, drug companies would have physicians believe otherwise.

    If only doctors had the time at work (preferably paid and without clinical obligation) and the necessary skills to assess the methodological robustness of a study, decipher its findings and apply its conclusions to patients. Such favourable conditions are rarely available outside the journal club, postgraduate training, teaching hospital and medical school.

    If health executives really care about research bearing relevance to patient care in ambulatory and community practice, they need to fund doctors to train in appraising the quality of what they read and pay them for the time spent keeping up to date. Better informed doctors are likely to deliver better care and dividends in improved care will likely outgrow remuneration to doctors.

    Burgeoning health-care evidence needs to be efficiently delivered to doctors caring for patients in digestible allotments that will not prove overwhelming. This involves communicating information relevant to their clinical practice or specialty, in a format and schedule compatible with achieving balance in a doctor's work and personal life.

    Paying doctors for non-clinical time to learn about the latest evidence is a good start. Even if one has not assessed the original studies, investigation and treatment summaries updated with newly emerging clinical research provides a short-hand way for ensuring patients receive the best of care, but requires commensurate time to absorb.

    Conflict of Interest:

    None declared

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  2. The use of placebos in Ebola treatment trials

    The argument for substantial benefit conferred by the placebo effect in treatment trials has been around for a while. Clinical triallists do not deny that inactive sugar pills and IV medications or sham surgery have some quantifiable benefit when compared with doing nothing at all. Patients who consent to participate in treatment studies tend to be more motivated and confident that they will get better than those who refuse to be enrolled, despite only having a one in two chance of receiving a potentially beneficial therapy. Randomised controlled trials attempt to discern whether new therapies result in a clinically relevant benefit (improved survival, reduced symptoms) in addition to that conferred by the human mind's empowerment to enhance immunological and psychological defences from participation in studies. Furthermore the awareness of being closely observed and monitored for clinical progress or deterioration is an incentive for patients to do better (the Hawthorne effect, aiming to gain approval from investigators and other participants), regardless of whether a study subject receive the tested or inactive treatment.

    Ebola haemorrhagic fever, with its high case fatality risk, has no reliably proven effective single drug or immune treatment. Although several repatriated adults in advanced health systems have survived with novel immune therapy, it could well have been the excellent critical care and fluid resuscitation that were responsible for their recovery. The latter would almost certainly not be available on a day to day basis in the impoverished West African countries where EHF trials would be conducted. In addition to placebo comparisons, the study of advanced fluid resuscitation, immunomodulators and vaccines in vulnerable people who cannot afford such treatments even if they were found to work remains ethically challenging.

    Conflict of Interest:

    None declared

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  3. Is it ethical for scarce research funding to be diverted to overzealous policing of low risk observational studies?

    To the Editor:

    A substantial proportion of medical research funding in advanced health economies are diverted to the overzealous policing of low risk observational studies.

    As we plea and wait for the resumption of competitive funding to the research endeavour so necessary to maintaining Australia's global stature as a science and innovation based economy, the haemorrhage could be stemmed re- allocating scarce resources from the non-productive and demoralising barrier imposed by the layer of administration and bureaucracy that sits on top of, and suffocates, original scientific research.

    I faced months of delays to starting low risk studies that aim to record current clinical care practices to establish a baseline from which improvements could be identified and assessed further. This included "behind the scenes" observation of acute pain management and sedation protocols that aim to calm the acutely agitated. Neither study influenced clinician behaviour or treatment as would have been occurred during routine care. Both had already been declared to being above reproach by reputable regulatory and oversight bodies in Melbourne Australia.

    I had to expend numerous hours of tortuous negotiation of a maze of needlessly imposed complexity mandated by my local hospital ethics and governance committee. National Ethics Application Forms and numerous other documents had to be identically filled in with my hospital's mast head and be re-submitted to await much-delayed adjudication.

    Researchers should contest the resource- and labour-intensive bureaucratisation of research oversight that confers no additional protection to participants in low risk obervational research in the advanced economies, including Australia's.

    Australia's gutting of science research funding has at least served to highlight dispiriting barriers posed by administrative processes that are wasteful withut conferring additional benefit or participant protection.

    Conflict of Interest:

    None declared

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  4. A very difficult area

    A very difficult area indeed. My view is that that, once you have decided to stop fluids and/or nutrition, then the patient will certainly die. Whether or not they will suffer whilst starving, or dehydrating, is unclear. However, prolonging life in such cases extends suffering for relatives, staff, and possibly/probably the patient.

    A lethal injection at this point is surely more humane than extending life and, thus, extending suffering. As a profession doctors should surely see a 'good' death as a part of the care we should be providing. I can see nothing good about allowing someone to starve to death, because we feel that taking an active step, is a step too far. We have already decided that they are going to die. Why not provide the quickest and most painless death possible?

    Conflict of Interest:

    A relative is in this situation

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  5. The best argument against the organ market still awaits refutation

    Critics of a regulated market in organs have correctly focussed on its inability to protect the vendor from coercion and exploitation. However, they have consistently failed to realise that coercion and exploitation are not immanent in this market. Rather, they are immanent in the need to even consider selling ones organs (free people do not engage in such considerations). In other words, the critics have failed to acknowledge that a regulated market in organs should, at least theoretically, be able to protect the vendor from coercion and exploitation that might occur within the sphere of exchange, but it cannot protect the vendor, not even theoretically, from coercion and exploitation that occur universally outside this sphere. Even worse, its ethical guise would only serve to conceal and reinforce them.

    In this light, criticism of any organ market could make sense only if it were part of the greater struggle against the oppressive social conditions that have made it a viable option to begin with. This anti- market argument still awaits refutation.

    Conflict of Interest:

    None declared

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  6. Authorship for the grant winners and postgraduates

    Dear Sir,

    The article was well read and understood. I would like to draw the attention of readers to the current reality, of having grant winners who are not the authors even though their hypothesis and proposal writing has contributed significantly and scientifically towards achieving the grant/funds, followed by processing of the entire scientific/social projects based on the proposed hypothesis. Authorship is considered to be reserved only for persons who have been receiving primary credit and have been holding a primary responsibility for published work (experimental data or data from other means like literature review, meta-analysis etc) (APA Publication manual, 2001). International Committee of Medical Journal Editors (ICMJE, 1997) has formulated regulations for scientific writing and ethical regulations in publishing/ maintaining the quality of scientific writing globally. These regulations are currently acceptable all over the world, in its original form or these regulations have been modified by respective countries, institutes, departments, units and research groups as per need of the time, space, funding and legislations.

    According to the ICMJE, the authorship credit should be defined/ based on meeting all four of the following conditions:

    1) Substantial contribution to the study includes: i. Conception and design, (e.g. Co-investigator, consultant or research support staff who have intellectually contributed to the grant proposal) OR ii. Clinical or methodological support throughout the implementation of the study (generally through participation in regular team meetings) OR iii. Analysis and interpretation of data

    AND

    2) Provide important intellectual contribution towards the conceptualization or writing and reviewing multiple drafts of the article or abstract in a timely fashion.

    AND

    3) Final approval of the version to be published (or may waive final approval at a point where no more substantial changes are to be made).

    AND

    4) Are prepared to take public responsibility for the paper.

    Keeping in view the above mentioned conditions, There are a variety of formal strategies of weighting the contributions of co-authors (Digiusto, 1993). For instance, issues where students are considered as co author or/ and student as grant holders still need a lot of discussion and regulation as per consensus of the entire group to be agreed upon. Many countries (for example, Malaysia) now allows a Phd or MSc student to be a Principle investigator to hold the grant, where supervisors and the seniors still have the final say as to whether student can be the first author/ coauthor even though he/she is holding a grant as a grant winner. Another important issue in this aspect is the biased authorship privilege, which is abducted from the articles written by the students as main authors. This is done for the sake of either maintaining the keep performance index (KPI) of the university or for personal professional benefits to improve the CV of supervisor or any of the members of the research group. Still it could be legal though it is not ethical. The issues regarding the ghost authors taking privilege from the grant winners is another area to be discussed. I will suggest that there is a need to compile a meta analysis of all such studies to be discussed strategically and conclusively with reference to ICMJE and as per my opinion that a single article can't bring in any necessary change without consulting the ICMJE.

    References:

    American Psychological Association. (2001). Publication Manual of the American Psychological Association (5th ed.). Washington, DC: Author.

    Diguiusto, E. (1993). Equity in authorship: A strategy for assigning credit when publishing. Social Science and Medicine, 38(1), 55-58.

    Conflict of Interest:

    None declared

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  7. Re:Suicide tourism may not change the courts but the courts could alter suicide tourism

    The term 'suicide tourism' was first coined by the media for obvious reasons. Is it necessary to use such a repugnant term though. When used to refer to a group collectively this insult can can be glossed over- in a way it could not without causing anger if referring to an individual who takes the harrowing decision to go abroad for an assisted death. To refer to the increased number of people 'from England' (presumably Wales is still included )as being 'outsourced'(ref responses) like a commodity, is dehumanising. However strong opinions may be the right of people to be treated with respect and dignity is paramount, not their usefulness to support an argument.

    Conflict of Interest:

    I support the right of individuals to decide when to die but have no competing interests

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  8. Re "Advance consent, critical interests and dementia research"

    Formulating the desire to consent in advance to research as a critical interest is a valuable addition to the literature on consent to research by incapacitated individuals. As Dr. Buller notes, much attention has been paid to these concerns in the literature and many states have enacted statutes protecting human research subjects. States vary in how thoroughly they treat the topic, with some carefully defining who may provide proxy consent to research under what circumstances, while others provide virtually no guidance on proxy consent. What is interesting to note given Dr. Buller's article, though, is that proxy- focused approaches using human subjects research laws fall short of providing health care recipients the ability to affirmatively assert their right to consent to research--to express their critical interest in research participation in a legally binding format.

    Dr. Buller notes that advance research directives have not gained wide support, yet documenting one's consent to research in advance is arguably the most patient/participant-centered and empowering way to document one's critical interest in participating in research. A relatively recent change in Virginia's Health Care Decisions Act warrants attention on this point. Virginia appears to be the only state that has codified the possibility of advance consent to research and has included consent to research explicitly among the powers of a designated health care agent. Some states, such as California, note in human subjects research laws that an agent may consent to research if such power has been granted in an advance directive, but the separate statutory language concerning advance directives does not make any mention of including preferences and instructions regarding research in advance directives.

    In contrast, Virginia explicitly authorizes consent to research in an advance directive (Va. Code s 54.1-2983.1. http://leg1.state.va.us/cgi- bin/legp504.exe?000+cod+54.1-2983.1) and also includes the power to consent to research among the agent's powers on the model form (Va. Code s 54.1-2984. http://leg1.state.va.us/cgi-bin/legp504.exe?000+cod+54.1-2984; see also the "Integrated AD Form" http://www.virginiaadvancedirectives.org/option-1--integrated-ad.html). Moreover, recognizing that people may feel differently about research depending on whether it may offer a direct benefit to them or not, the power to consent is described in two separate provisions so that people may opt to choose both, one, or neither. As with any other "default powers" in a Virginia form, the two powers may certainly be struck through, and users of the form are made aware of this at the beginning of the list of powers.

    Virginia has well-developed human subjects research laws, as well, which can control when no advance directive is available. Nonetheless, the right to consent to research as a critical interest can be best exercised through affirmative documentation in an advance directive, rather than through a proxy's inferences about a patient's desire to take part in research after he or she has lost capacity. Virginia has recognized the importance of providing mechanisms for people to consent in advance to research and incorporates research provisions directly into its Health Care Decisions Act.

    Conflict of Interest:

    None declared

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  9. Suicide tourism may not change the courts but the courts could alter suicide tourism

    Sir,

    I have no argument with Charles Foster's tortuously argued claim that suicide tourism has not led to a change in prosecutorial policy, although I am far more exercised by the potential for change in the latter influencing requirement for the former. Nor do I disagree with his admission that it is intellectually dishonest for us to allow Swiss clinics to siphon off our sufferings and responsibility, except to add that it's also immoral of us to do so.

    Where I take issue with him is with his blithe statement that allowing the status quo to continue "is likely to do less harm overall than introducing any conceivable assisted suicide law into England."

    The conceivable law now in question is Lord Falconer's Assisted Dying Bill and this provides for safeguards and transparency that have been long and carefully considered, are modelled on laws in Oregon operating successfully for seventeen years, are certainly more comprehensive than those pertaining in Switzerland; and are our own. As such, they aim to address the unnecessary, inevitable suffering resulting from the necessity to travel - and be able to travel - to die in alien surroundings. Yes, Dr. Foster, this is a moral as well as an intellectual challenge.

    Sincerely,

    Dr Richard clubb

    Conflict of Interest:

    HPAD member

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  10. Does the pragmatic model undermine the importance of the ethical obligations involved in information process? A defence of continuous genetic counselling for research participants.

    Hallowell et al. advocate an interesting pragmatic approach to the disclosure of genetic information in research settings. Furthermore, they present a useful framework which explicitly addresses advantages and disadvantages linked to different feedback policies researchers could pursue (Hallowell et al. 2014, table 1).

    We agree with the authors that the feedback of findings from whole- genome sequencing (WGS) or whole-exome sequencing (WES) technologies cannot be considered as automated processes of data disclosure. Since we have to take into account the research participant's autonomy as well as the prevention of possible harms related to the disclosure of genetic information, feedback policies have to be carefully chosen and thought over.

    In its evaluation of feedback policies, the authors state that no feedback undermines participant autonomy (policy A) and choosing their feedback option maximizes it (policy E) (Hallowell et al. 2014, table 1). However, more freedom to choose feedback options is not necessarily related to a more autonomous choice of the participant. It could be argued against Hallowell et al. that if in the information platforms suggested by Kaye et al. (2012) research participants were responsible to select on their own what level of research participation they consent to and which results they would access, this would not necessarily represent a more autonomous decision. This one-dimensional view of autonomy undermines the importance of intelligible communicative information transmission (Manson and O'Neill 2007) an essential and ethically demanded dimension of research participants' autonomous decision making (Eyal 2012).

    As an alternative to Hallowell et al. interpretation of autonomy, Manson and O'Neill (2007) suggest an agency-based approach that is based on informational and communicative obligations between the parties of counsellors and patients in a clinical context that could be extended to the process of information disclosure in genetic research. Assuming that the researcher's interest does not primarily focus on the information submission to the participants but on the generation of scientific knowledge, the agency-based approach between counsellor and participant could provide a better framework for assuring intelligible communicative information for the research participant. Autonomy should not refer only to more options to choose from, but also to an enhanced comprehension of information on possible harms and benefits of WGS/WES technologies.

    Hallowell et al. state that feedback of genetic findings goes hand in hand with extensive resources consumed due to the information costs arising in the communication process. Nonetheless, it can be objected that information costs should not exceed the normal information costs of a clinical setting. E.g. after receiving the research results and counselling the participant, the counsellor may initiate a personalized genetic test in order to correctly approve the general finding in the participant's personal context. Thus, the counsellor who stays in close contact with the participant is responsible for the information disclosure and information revealing is part of the counsellor-participant relationship. The counsellor therefore can be considered as the link between research (research results are usually published in journals or data bases) and the participant.

    Furthermore, it would be incorrect to consider researchers and sponsors as the only responsible agents for the costs of informational and communicative obligations. As it occurs with other ethical requirements in research settings such as post-trial obligations of access to beneficial information and interventions (WMA 2013 paragraphs 26 and 34, Mastroleo 2014), other agents -e.g. host country governments- have interests in and bear responsibility for the participants' health needs. So, following commonly held principles for conducting human health research, it could be argued that in advance of a clinical trial, sponsors, researchers and governments (among other agents) should make provisions and bear the economic costs of continuous genetic counselling for participants who may need it.

    Finally, besides discussing obligations of researchers towards participants and pointing out the numerous problems arising in this case (information costs, data quality, communication restrictions etc.), we should also focus on the communication process between counsellor and research participant as well as the counsellor's obligations towards potential participants prior to the participation in research projects. If we are taking seriously ethical obligation of genetic information process towards research participants, the consequences of data revealing should be discussed before samples are collected. Moreover, data disclosure should be a continuous process underlying the "nature" of genetic information: research on genetic data is an ongoing process; ideally it should be moderated by a counsellor to grant research participants truly informed and autonomous decisions.

    References

    Eyal, N. (2012). "Informed Consent", The Stanford Encyclopedia of Philosophy (Fall 2012 Edition), Edward N. Zalta (ed.), http://plato.stanford.edu/entries/informed-consent/#VolCon

    Hallowell, N., Hall, A., Alberg, C., Zimmern, R. (2014). "Revealing the results of whole-genome sequencing and whole-exome sequencing in research and clinical investigations: some ethical issues". JME; 0:1-5.

    WMA Declaration of Helsinki (2013). "Ethical Principles for Medical Research Involving Human Subjects.", http://www.wma.net/en/30publications/10policies/b3/

    Kaye, J., Curren, L., Anderson, N. (2012). From patients to partners: participant-centric initiatives in biomedical research. Nat Rev Genet; 3: 371-6.

    Manson, N., O'Neill, O. (2007). Rethinking informed consent in bioethics. Cambridge University Press, New York.

    Mastroleo, I. (2014). "Consideraciones sobre las obligaciones posinvestigaci?n en la Declaraci?n de Helsinki 2013." Revista de bio?tica y derecho; 31: 51-65, http://revistes.ub.edu/index.php/RBD/article/view/10438

    Acknowledgments

    We would like to thank Prof. Mertelsmann for helpful comments on this letter.

    Contributors

    Both authors were involved in the drafting and writing of this piece. Both authors approved the final version of the manuscript and are accountable for all aspects included in it.

    Conflict of Interest:

    None declared

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