468 e-Letters

  • A conceptual mistake in the definition of access in post-trial access implementation discussion?

    Paul et al. (2018) “Implementing post-trial access plans for HIV prevention research” present a much-needed discussion on the implementation of post-trial access plans. Here, I just want to signal a mistake on the conceptual definition of access, to an otherwise flawless paper.

    If I am correct, the mistake would be related to the formulation of the following question:

    "it the responsibility of researchers and sponsors only to ensure that all participants have access to effective preventive therapies, or does that responsibility extend further, to ensuring that participants actually receive them?" (Paul et al 2018:4)

    I believe that "to ensure that participants have access to an intervention" is logically equivalent to "ensuring that participants actually receive an intervention". The MRCT Center's framework on post-trial responsibility defines access as “[…] the ability, right or permission of an individual to use an object or asset, and implies the removal of barriers to allow such use” (MRCT Center 2017:76). If a person does not actually receive an effective preventive therapy, she does not have the ability to use it. Therefor she has no access. Hence, distinguishing between the above expressions is conceptual mistake.

    Instead, what I believe that the authors wanted to discuss is how much sponsors and researchers need to do to ensure access to an investigational intervention. In fact, irrespective of the abo...

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  • Unconvincing claims in this article

    On p.5 the authors comment on the use of mindfulness exercises as "a tool to relieve suffering
    and increase functioning". They claim that "This goes against common epistemic values" where these epistemic values are described as "the sort of values that lead one to accept uncomfortable truths, and to be honest, even brutally honest, with oneself."
    As far as I can see there is no argument given for that claim, and what is more, it seems to go precisely contrary to the purpose of mindfulness exercises in that these are intended to enable one to be honest with oneself and face uncomfortable truths (e.g.: "... we cultivate acceptance by taking each moment as it comes and being with it fully, as it is [...] receptive and open to whatever we are feeling, thinking, or seeing". [Kabat-Zinn, Full catastrophe living, p.28f: https://books.google.at/books?id=fIuNDtnb2ZkC]). Mindfulness is to a large extent a tool to enable one be "honest, even brutally honest, with oneself".

    There is a number of other strange claims in this article, I will mention only one: "Suppose an atheist was having trouble coping emotionally with a natural disaster in which there were many casualties. They might object to imagining the people who died in the disaster frolicking in heaven, even if doing so would help them cope. They do not believe in heaven, thus the imaginati...

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  • Lessons learnt from the past: “Conscientious objection” to abortion in Chile will lead to widespread disobedience of the new law

    Authors Montero and Villarroel discuss problems that might arise from “conscientious objection” (CO) to the new law in Chile that legalized abortion in cases of life endangerment of the woman, fatal fetal abnormality, and rape. (“A critical review of conscientious objection and decriminalisation of abortion in Chile”, Jan 6). The law provides the “right” to exercise CO, with the only caveat that health institutions are required to immediately refer patients to non-objecting practitioners. We share the authors’ concerns that conscientious objection may prove be quite widespread in Chile with the new law. In fact, we argue it will create serious, widespread problems for access to safe and legal abortion, despite the referral requirement.

    Of course, in a Catholic-dominated country like Chile with a total abortion ban, the new law represents a major advance, and it will undoubtedly help many women. We appreciate the challenges and hard work to get the law passed and acknowledge it may have been difficult to do so without CO as a political compromise. Unfortunately, last-minute lobbying by Catholic hospitals resulted in a court’s expansion of the CO clause in the law, giving the “right” of CO to not just doctors, but also support workers and even institutions (when only individuals can have a conscience). This law will be very difficult to reverse and women will suffer the consequences.[1]

    The authors rightly recognize the difference between conscientious object...

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  • I'm so glad I practice in the UK, not USA!

    I was intrigued to read this article about US practice relating to consent and minors.

    Intrigued; and very pleased that I practice in the UK, where this was agreed, very sensibly, years ago.

    The UK law permits a minor to consent to treatment, as long as they are capable of understanding the issues involved. And for vaccination, the issues (when you leave out the non-science-based scary stuff) are usually straightforward.

    This means that vaccinating adolescents against HPV is straightforward - a few simple questions to establish that they understand what the vaccines for, and have an acceptable understanding of the almost-negligible risks involved, and you can vaccinate them, without requiring parental consent and with the full support of healthcare systems and the courts.

    The ludicrous situation in the USA where some parents can prevent their children from accessing vaccines at the right time (before sexual debut), when the children themselves have a clearer understanding of the issues than their parents and want to be vaccinated is now, thankfully, a largely historical issue here.

  • If..

    The article by Brennan [1], which has just been drawn to my attention, only exists in hypothetically perfect world in which medical evidence is always clear cut and bureaucracies beyond fallibility, bias, corruption or perhaps even scrutiny - it hinges like a lot of ethical investigations round the word "if". You could agree "y" if "x" (though I am not sure whether in this case it would be a libertarian argument as opposed to just an argument) but we do not have flawless bureaucracies making perfect decisions based on immutable scientific laws. Of course, a crucial argument relating to political liberty is just that bureaucracies are inevitably imperfect.

    While we could explore and criticize the basis of many such decisions (and despite huge institutional pressures many criticisms of vaccine products lie within mainstream scientific debate, for instance issues regarding influenza vaccination, HPV, aluminum adjuvants, mercury preservatives etc.) we are simply not talking about a branch of science which admits of such certainties. Nor are we dealing with just a few products. The US mandated schedule has perhaps dozens of products already, with hundreds in the pipeline which depend for their commercial viability on being licensed and mandated in their turn. Brennan does not engage with the problem that is not about one or two instances (for instance MMR vaccine is often cited) but an indefinitely large number products which could become c...

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  • The libertarian case reconsidered

    Jason Brennan presents a justification for mandatory vaccination policy from a libertarian perspective. I reevaluate Brennan’s argument, focusing on the applicability and potential limit of the clean hands principle he proposed. I argue that the clean hands principle cannot tell us how to weight the degrees of risk of different collectively harmful activities; therefore, we could not distinguish the relative significance of coercive interventions that aim at stopping different kinds of collectively harmful activities. Using secondhand smoke prevention as an analogous policy example, I illustrate that many behaviors that suffice the five conditions could be qualified as collectively harmful activities. These activities are hence subject to coercive policies that are justified by the clean hands principle, including those obviously infringe individual rights and civil liberties and contradict with libertarianism. For libertarians, this implication of the clean hands principle might not be too comfortable to accept.

    Main Text
    Using David Gauthier’s strategy, Jason Brennan demonstrates that even starting with a theory “with strongly individualist and antigovernment premises” such as libertarianism, mandatory vaccination is justifiable (p.37).1 Drawing on one of his own works, Brennan argues that the clean hands principle requires a person not to participate in collectively harmful activities, and that libertarians should accept governments’ coercive...

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  • compromise

    Indeed FGA type 1 and 2 would not rob me and so many like me who want to follow our religious rights and adhere to harmless procedures as well which are surely less invasive than male circumcision. Its would not make me feel harrassed by western oppression of allowing the afflent consenting woman undertake the same procedure while condemning me of mine. Since FGA type 1 n 2 are harmless they are on the rise as cosmetic surgeries, so why should my choice of doing it for religious purpose become harmful to be banned. Yes severe forms shouldn't be allowed but surely type 1 or 2 as alternatives can reduce severe forms from happening. Medicalization and strict protocols can be framed to ensure safety from FGA type 1 n 2 procedures as well.

  • When comparing risk vs risk we have to define the perspective first

    A non-vaccinator is not the culprit for the existence of immunosuppressed persons. Hence, we must use overall and not conditionals probabilities here and pass to the population level. Let’s assume that the prevalence of immunosuppressed persons is 4/10.000 and that measles attack rate is 2/10.000 for the population. Then the probability to observe an immunosuppressed person that gets infected by measles is very low, say 4/10.000 * 2/10.000 = 8 * 10^(-8). The probability to get an encephalitis from measles vaccine is 1 * 10^(-6) and hence more probable.
    Risk vs Risk is always problematic and should be avoided.

  • Response to "In Defence of Governance: Ethics Review and Social Research"

    Recently we conducted a study that identified an “ethics ecosystem” that, as a form of research governance, ensures that common ethical principles are operationalised by a number of actors within this ecosystem. This ethics ecosystem includes researchers, research ethics committee members, research institutions, publishing houses and Editors, and external Associations [1, 2].

    In their paper ‘In defence of governance: ethics review and social research’, Sheehan et al [3] attempt to find a strong ethical answer for the need for such levels of ethical governance at the ethical review level for the social sciences. In doing this, the authors respond to a number of hypothetical claims against the need for such a review governance system. They then create their case that society has a stake in social research because of its link to enquiry, and in turn, human flourishing. They explain that because individual members of society will reasonably disagree about this ‘stake’, i.e., what specific research enquiry should proceed through ethical review to further human flourishing, this needs to be settled via a ‘fair process’ governance (i.e., a committee style) model.

    While this paper is certainly a comprehensive and interesting analysis highlighting many of the discussions in this area, the authors fail to sufficiently link their final argument to ‘enquiry’.

    We believe we can provide a better defense for an ethical review framework. This can be achieved by...

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  • Best interests in early Prolonged Disorders of Consciousness: different balances

    Professor Wade’s article is an excellent overview of how to apply best interests to decision making in prolonged Disorders of Consciousness (PDoC) and should be mandatory reading for all health professionals caring for individuals with brain injuries1. However it fails, as does the Royal College of Physicians PDoC guidance, to adequately emphasise the vastly different balances when comparing withdrawal or withholding of clinically assisted artificial nutrition and hydration versus far more invasive and burdensome treatments.

    A significant proportion of patients in a PDOC are only alive because they were subjected to the very invasive life sustaining treatment that modern medicine can inflict. The existence of the clinical entity of PDoC could arguably be seen as a failure of prognostication and best interests decisions during the acute phase of a catastrophic brain injury; continuing invasive treatment that is arguably either ‘futile’, not in the patients best interests or be so invasive and prolonged to be disproportionate to the likely outcome2. However prognostication can be a difficult and uncertain at this stage.

    In our institution we admit up to 70 patients per annum who have sustained an out of hospital cardiac arrest and the majority of these survive long enough to need to assessment of neurological prognosis. At 72 hours, if the patient remain neurologically obtunded, we use multi-modal assessment to assess the likely outcome according to internation...

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