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#but have no regard for methodology or curiosity or. well. ethics.
dragonomatopoeia · 2 years
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the thing that really gets me about conspiracy theories is how they sort of gesture at science as this monolithic conclusion without competing hypotheses or process of discovery. they're always so CERTAIN about the absolute correct reading of the situation and put forth that there is One reason for everything and that one reason is usually very racist
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hd99-solutions · 3 months
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Discovering the Best Astro Numerologist in India
Sanjivv Gandhi is a shining example of knowledge and expertise in the mystical sciences, where astrology and numerology intersect. His in-depth knowledge of these ancient disciplines, as well as his ability to provide precise insights, have earned him the title of best astro numerologist in India. This blog delves into Sanjivv Gandhi's life, accomplishments, and distinct approach, highlighting why he is a revered figure in the field of astro-numerology.
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The Journey of Sanjivv Gandhi: Best Astro Numerologist in India
Sanjivv Gandhi's interest in astrology and numerology started at a young age. Growing up in a family that valued spiritual wisdom and traditional sciences, he was exposed to the fundamentals of these disciplines from an early age. His natural curiosity and dedication compelled him to delve deeper, studying various texts and learning from renowned gurus. His unwavering pursuit of knowledge led him to become a master of astro-numerology.
Expertise in Astro-Numerology
Astro-numerology is a sophisticated combination of astrology and numerology that examines the positions and movements of celestial bodies alongside numerical patterns. Sanjivv Gandhi excels at this intricate practice, providing clients with comprehensive analyses that take into account both astrological charts and numerological influences. His expertise enables him to provide accurate predictions and effective solutions for a wide range of issues, including personal relationships, health, and career and financial success.
Unique Approach and Methodology
Sanjivv Gandhi's unique approach distinguishes him as the best astro numerologist in India. He combines traditional techniques with modern insights to ensure that his methods are both time-tested and relevant to today's needs. His consultations are known for their depth and clarity, with clients receiving actionable advice and a clear understanding of their circumstances.
Holistic Analysis: Sanjivv Gandhi's readings are extensive, covering many aspects of a person's life. He considers the big picture, combining astrological charts, numerological patterns, and individual circumstances to provide comprehensive guidance. 
Personalized Solutions: Recognizing that each individual is unique, he tailors his advice and solutions to his clients' specific needs and challenges. His recommendations, whether they involve gemstones, mantras, or specific actions, are intended to produce tangible results.
Ethical Practices: Integrity and ethics are at the heart of Sanjivv Gandhi's work. He believes in empowering his clients with knowledge and never uses fear-based strategies. His goal is to guide and support others in making informed decisions about their lives.
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Achievements and Recognition
Sanjivv Gandhi's contributions to astronumerology have received widespread recognition. He has been featured in several prestigious publications and has received numerous awards for his efforts. His clients include not only people from all walks of life, but also celebrities, business magnates, and political figures who seek his advice on critical decisions.
Awards and Honors: Sanjivv Gandhi has received numerous awards for his outstanding contributions to astrology and numerology. These awards recognize his dedication and expertise in the field.
Media Presence: He is frequently invited to share his thoughts on television shows, radio programs, and in print. His predictions and analyses are highly regarded, establishing him as a credible voice in the community.
Global Reach: Although Sanjivv Gandhi is based in India, his reputation spans the globe. He provides consultations to clients all over the world, using technology to bridge distances and provide his expert advice.
Client Testimonials
Sanjivv Gandhi's clients' satisfaction and success are the true testaments to his expertise. Here are some testimonials highlighting his impact:
- Rajesh M: "Sanjivv Gandhi's reading changed my life. His observations were spot on, and the solutions he suggested resulted in immediate improvements. He is the best astro numerologist in India."
- Priya S: "I was blown away by Sanjivv Gandhi's predictions. His advice has been invaluable in helping me navigate my professional and personal lives."
- Anita K: "Sanjivv Gandhi's approach is both compassionate and insightful." He helped me understand the difficulties I was facing and offered practical solutions that made a significant difference."
Conclusion
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Sanjivv Gandhi stands out in the ever-changing world of astrology and numerology for his extensive knowledge, ethical practices, and dedication to his clients. His ability to combine traditional wisdom with modern relevance distinguishes him as a unique and valuable guide for those seeking clarity and direction in their lives. As the best astro numerologist in India, Sanjivv Gandhi continues to illuminate the paths of many, helping them navigate the complexities of life with confidence and insight.
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Part II: Disability Right Movement
Role of Psychology
Crethar and Ratts (2008) define social justice as a multidimensional methodology in which mental health providers attempt to concurrently encourage personal growth and the mutually decent through speak to obstacles correlated to both individual and distributive justice. The counselor or psychologist empowers the client or group to stand up for their beliefs in a healthy manner. Crethar and Ratts (2008) suggest that when they entrust their client, they base the empower around four principles: equity, access, participation, and harmony. Equity is the appropriate dissemination of resources. The Key is the everyone has access to these resources. Participation is that everyone is part of the decision-making process. Lastly, harmony is the best possible outcome for the community.
Kinderman (2013) states that psychologists should speak out against social injustices. Psychologists study human behavior, which makes them a great way to speak out for the injustices in the world. Social change primarily comes from groups and leaders (Louis, Mavor, La Macchia, & Amiot, 2014). Leadership is in a position of power to change injustice in a group quickly; however, some are unwilling to step up and be the voice for change. For the psychologist, social change could go against their code of ethics. Lack of leadership would pose a dilemma for the psychologist to choose between belief or principle of ethics. Kinderman (2013) suggest that psychologist should help other understand human behavior to shape social change.
Ethnic Inequalities on the Psychological Well-Being
People with disabilities are more likely to have lower education, low socioeconomic status, and be unemployed. Psychological well-being is already common in most cases when someone has a disability. According to Chang et al. (2014), disability was one of two factors responsible for depression rates. A person with either suffers from a mental or physical disability is at a higher risk for depression. A disabled person could be discriminated against because of limited resources. Resources may be diverted away from a person with a disability because they are considered to have a reduced quality of life and toward a person with a so-called better chance of having a good quality of life.
Analysis of any Concerns Regarding Ethnic Inequality
Disability can also affect a person’s relationships. According to Wasserman (2016), people that are married are generally happier than unmarried people. Disability can make it difficult for a person to find friendship or love. The disability is seen as creating an awkward degree of inequality and difference. Wasserman (2016) suggests that non-disabled people could think a relationship with a disabled person might be unfulfilling. Relationships are complicated for most people without disabilities. Relationships are viewed as more complex with people with disabilities because of society’s view on people with disabilities. Relationships are only one aspect of inequality that people with a disability experience. They also experience inequality in education, health care, and employment. People with disabilities understand their limitations and will not apply for the job they cannot perform. Some non-disabled people will judge a person by their disability instead of focusing on their qualifications. Society needs to focus on the person in front of us instead of the disability. Lastly, we can recognize a person’s limitations but understand they are far more capable than their disability.
Analysis of the Role of Psychology
Social psychology is a way to tie the individual to social change; however, social psychology is usually based on how individuals view others. Psychology has not had much influence on social change. Historical sociologists have been the first for social change. According to De la Sablonnière (2017), over 70 years ago, social change came up in psychological literature; however, only a few psychologists have to take on social change. Intersectionality is obtaining arise in consideration in psychology. The theory or framework comes from the work of Black feminist scholar-activists and its emphasis on interlocking systems of oppression and the necessity to effort regarding structural-level alterations to stimulate social justice and impartiality (Rosenthal, 2016). Modern curiosity in intersectionality in psychology gives a chance to lure mental health providers’ devotion to structural-level problems and make public integrity and fairness more crucial in psychology (Rosenthal, 2016). Psychologists have learned many subjects of social justice such as prejudice, discrimination, conformity, and numerous subfields around these matters in psychology. The American Psychological Association (2017) code of ethics needs psychologists to uphold all society’s rights, regardless of the stage of life, sex, gender identity, race, background, national origin, belief, sexual orientation, disability, language, or financial status. The code pushes psychologists to become mindful of these features and circumvent bias and unwarranted practices. Hays et al. (2010) suggest that group work is a way to assist in empowering clients at an individual and systemic level. Hays et al. (2010) believe in increasing attention to social justice problems using education, training, supervision, practice, and research. Promoting change within a group could help shed light on the oppression or discrimination of people with disabilities. Psychology could empower people to stand up for equal rights to promote positive change.
An explanation of the relevance of this topic to the field of psychology and the role and responsibilities of psychology concerning the issue
Individuals with a disability have experienced some shame in the world. Non-disabled people are unsure of how to handle a person’s physical or mental impairment. Psychology explore the data about physical or psychological impairment and way to treat the impairment. The field of psychology’s responsibilities should be to support and discover where the hitches are and try to shed light on the issue with the group, legislature, and community to increase the quality of life for those with disabilities.
The American Psychological Association (2013) defines clinical psychology as “a clinical discipline that involves the provision of diagnostic, assessment, treatment plan, treatment, prevention, and consultative services to patients of the emergency room, inpatient units, and clinics of hospitals.” The American Psychological Association (2013) says Clinical psychology combines “science, theory, and practice to understand, forecast and alleviate maladjustment, disabilities, and discomfort as well as to promote human adaptation, adjustment, and personal development.” Psychology concentrates on the intellectual, emotional, biological, psychological, social, and behavioral characteristics of a human role in diverse societies and at all socioeconomic levels.
Publishing Site and Reasoning
For this blog, I am choosing to launch it on the blog site Tumblr. Tumblr is a place where people of different backgrounds and points of view can express themselves, discover themselves, and find new perspectives. It is where your interests connect you with your people. This platform is very user-friendly and has been available since 2007. Using Tumblr, I can reach academics that are casually looking for more psychology-related content and a younger audience that may find comfort in reading information on disabilities and ways social change can be implemented for this social problem. Tumblr is an excellent platform to help facilitate an academic conversation because Tumblr is easily accessible and can be seen from any smart device.
References
American Psychological Association. (2017). Ethical Principles of Psychologists and Code of Conduct. Retrieved from http://www.apa.org/ethics/code/
American Psychological Association. (2013). Guidelines for psychological practice in health care delivery systems. Retrieved from http://www.apa.org/pubs/journals/features/deliverysystems.pdf
Chang, T. E., Weiss, A. P., Marques, L., Baer, L., Vogeli, C., Trinh, N. T., … Yeung, A. S. (2014). Race/Ethnicity and Other Social Determinants of Psychological Well-being and Functioning in Mental Health Clinics. Journal of Health Care for the Poor and Underserved, 25(3), 1418-1431. doi:10.1353/hpu.2014.0138
Crethar, H. C., & Ratts, M. J. (2008). Why social justice is a counseling concern. Counseling Today. Retrieved from https://www.txca.org/images/tca/Template/TXCSJ/Why_social_justice_is_a_counseling _concern.pdf
De la Sablonnière, R. (2017). Toward a Psychology of Social Change: A Typology of Social Change. Frontiers in Psychology, 8. doi:10.3389/fpsyg.2017.00397
Hays, D. G., Arredondo, P., Gladding, S. T., & Toporek, R. L. (2010). Integrating Social Justice in Group Work: The Next Decade. The Journal for Specialists in Group Work, 35(2), 177-206. doi:10.1080/01933921003706022
Kinderman, P. (2013). The role of the psychologist in social change. International Journal of Social Psychiatry, 60(4), 403-405. doi:10.1177/0020764013491741
Louis, W. R., Mavor, K. I., La Macchia, S. T., & Amiot, C. E. (2014). Social justice and psychology: What is, and what should be. Journal of Theoretical and Philosophical Psychology, 34(1), 14-27. doi:10.1037/a0033033
Rosenthal, L. (2016). Incorporating intersectionality into psychology: An opportunity to promote social justice and equity. American Psychologist, 71(6), 474-485.
Wasserman, D. (2016). Disability: Health, Well-Being, and Personal Relationships (Stanford Encyclopedia of Philosophy). Retrieved from https://plato.stanford.edu/entries/disability-health/
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queernuck · 7 years
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Language and Archaeology
In The Discourse on Language, Foucault evokes the notion of the madman in a fashion that is conspicuously similar to the figuration of the schizophrenic in Deleuze and Guattari, as a means not only of expanding his discussion of language, but moreover on linking it to a sort of concept of intelligibility and psychoanalytic as well as psychiatric control as relayed from the mad, the standards-of-madness and anticipating in part the means by which an appropriation of the mad, of the schizophrenic, has been conducted by neocolonial apparatuses of intelligibility, the psychopathological pseudoscience that Foucault describes when attempting to lay out the means by which one arrives an archeology, an archeologos of sorts, when engaging with discursive structures, knowledges of the past and knowledges-of-knowledges, the means by which Foucault lays out a series of claims and possibilities without quite adopting any for-himself, a contrast to the later schizophrenia of a Žižek text but sharing a common affinity all of the same. 
The Discourse on Language is published here as an appendix to The Archaeology of Knowledge and while the two are not identical in their focus, the relationship between the two is unmistakable and to consider this œuvre is a sort of mischievous rabattement both against and with Foucault’s texts, such that one applies the methods (or indeed, anti-methods, preclusion of methods) within the text to itself, a containment of the discursive in order to draw out artifacts of Foucault’s own writing. He speaks of the divide between truth and falsity in designation: the divide itself is clear enough, and to contend against this is to effectively contend against the wrong question regarding these statuses. True and false are not reconcilable, they cannot be collapsed into each other, except as a horizontal juxtaposition, but the question is not if they are able to become-same. Rather, the question is if their difference matters, if there is a meaningful distinction between the two beyond a lack of contemporaneity. Foucault points to the structure of the Penal Code as originally being a “theory of Right” that was then developed as part of a medically, sociologically, scientifically realized theory of existence far greater than the mere prescribing of an ideal good, instead thematized into a larger structuralism of what must be necessary in order to allow this good. It was not an ethics, but rather a totalizing scientific ontology. In Discourse Foucault makes a note that opens up the field of critique for such thoughts, in discussing that the totality of “truth” is not in fact the entirety of the medical, or the botanical, or the scientific field but in fact that error, falsity, frameworks of the incorrect provide a meaningful part of knowledge that is far more than mere historical curiosity.
This, then, leads us to the archaeological. Foucault is not speaking of the discipline of historio-geological activity, although that certainly can be understood as archaeological in some sense. Rather, Foucault is referring to a larger process by which one reckons knowledges, that one finds in a historicism of knowledge that continually reclaims and divests, that shifts in order to create new disciplines that are inevitably ontologically collapsed into an always-already true, that are effectively known as being the continual truth of that which is spoken of within their knowledges. This is part of a larger structure of critique for Foucault, and to understand Archaeology of Knowledge without likening it to his other critical texts, a process that he ironically enough critiques as the conceptual œuvre, is remiss simply because these texts are important as examples of this methodological turn, as a means of realizing archaeological possibilities. In Discipline and Punish Foucault’s main focus is not upon the changing legal structures that prescribed certain punishments, but rather on the desiring-machines that were at work in carrying out the punishment and moreover the flows with which they dealt. For the drawing and quartering of a treasonous assassin, there was a realization that as Foucault describes the structure of law was in effect an extension of the sovereign, that the law was in fact the body of the sovereign extended, a concept that would be developed by Deleuze and Guattari in the “despotic body” and that still resonates when discussing the ideological posturing of neocolonial violence, how one reacts to the encounter of the colonized and the colonizer in the imperial soldier dying in combat. In the case of the despotic body of law, one’s body was punished in response to the violation of law specifically because violating law was not merely an offense against another, but in fact a violence against the body of the sovereign. Violence against the sovereign themselves was the absolute singularity of violence: not only against the extended body, but the body itself, the most profound act of violence possible within these contexts. Given the ideology of divine ordination, it was in effect not only an attack on the state as body, the sovereign as state, but the sovereign in itself as ordination of God. Thus, in response the body was to be punished with greater and greater intensity depending on the severity to which the body of the sovereign was subjected by the violation of law, with regicide being the most absolute violation possible.
While this discussion is interesting, and certainly influences how the late capitalist prison has in fact become structured by a larger societal realization of the panopticon as part of a larger hyperrealism, a sort of state-of-affairs where being surveilled is assumed rather than worried, a sort of acceptance and moreover embracement of the schizophrenic paranoia that many held in the past, the archaeological consists specifically in the means by which Foucault describes discourses such as “psychopathology” as developing out of discourses of the past and moreover out of discursive structures internal to these discourses such that there is never a recourse to incorrectness except in recognition of a supposed-past, that one cannot recognize the incorrect except in recognizing a new structure of correctness. Thus, the medical preserves its old skeletons: the psychopathological does away with the psychoanalytic as it has no meaningful connection to the body as a realized neurological object, it is too philosophical, too ethical, too analytic to meaningfully fit the structure of clinical psychology as a development of clinical medicine. Clinical medicine, in turn, is only recently evolved as a science: it only acts as scientific as a sort of accessory to the larger medical apparatus of knowledge, is a collecting of disparate and anti-scientific encounters predicated on singular and unrepeated phenomenon, and can only be appropriated under the structure of “clinical trial” in a sort of juridical turn of language. 
The psychopathological that Foucault describes is, specifically, a site of control in that it is developed out of a certain medical apparatus appropriating discourses of psychology developed as the psychiatric, rather than the psychoanalytic, precluding the opportunity for development of frameworks such as schizoanalysis, instead understanding the psychological as medical and moreover the psychiatric as a sort of medicalization of treating the psychological. The body is seen as constructing and developing the psychological, rather than as being developed by it, such that the word is in fact ancillary to the questioning and structuring of the body, rather than foundational to it. This in turn leads to a structuring of traumatic experience as singular, a defiance of a structuralism of trauma except as a sort of collected experience, similar to other rates of disease rather than as a specific process that is intentionally cultivated by the structures of violence in question. That the body is presented with conditions where one is more likely to develop certain diseases, that these can be traced back to conditions of poverty, commonalities of environment that are described as this or that disease, leads to a concept that trauma is the same, that moreover trauma can be structured as disease rather than part of a structural realization of the Oedipal, a creation of a traumatic subject that may in turn be influenced to retraumatize others, that is part of a repetition of intergenerational and colonial trauma predicated on a structure of repetition and rabattement. 
Studies of First Nations children have indicated that a stronger component of cultural education (language especially) within their schools is effective in reducing suicide rates, rates of traumatic experience, and that it indicates stronger communities. In itself, this seems to point to a single, simple means of realizing this good, that means being language education, perhaps expanded to a sort of specialized curricula applicable to these schools, but it does not indicate the way in which this good is in fact part of a realization of a larger structure that ameliorates the intensity of colonial violence, that in effect resists some of the Oedipal violence of traumatic experience. These schools, in implementing this specific curricula, would be found wanting given the current structure of pedagogy, the “banking model” that Freire describes as foundational to both the ideology of pedagogy and its structural formation. That leftist thought is not immune to this is important, archaeologically speaking; when Badiou describes Maoist criticism of Stalinist fetishization of the city at the expense of the peasant, one finds the roots of Freire’s understanding of the possible consciousness of the peasant, that in fact it is within their own words, within a realization of commonality and community against the structure of empire that one finds the means of dealing with traumatic violence, the dispossession of peasant life. That the peasant has, in turn, been increasingly made obsolete as a distinction due to the neoliberal structuring of the sweatshop and the factory farm is in fact a response in part to the effectiveness of this realization, a realization that peasants are not without the consciousness that even some Marxists assumed they would lack. Instead, one finds that the Maoist development, the Maoist and radical turn of pedagogy, allows for a profound depth of this realization. The community is not to be doubted, but rather merely underdeveloped intentionally through an imperial pedagogy as part of a sort of colonial structuring of the cultural as an artifact, an archaeologism of the cultural. Conversely, in many ways there are structures within Filipino culture that have developed into their own apparatuses of ensuring intergenerational trauma, an ideology of the intergenerational relationship that relies upon continual retraumatization and violence both to ensure the traumatic experience and to punish a realization of this trauma as inflicted rather than necessary, as a colonial apparatus of control rather than being a part of an untouched Filipino culture is itself part of an archeological structure, whereby one may realize the way in which concepts of culturality are used in order to create the intergenerational gap that must then be closed within the Oedipal structure by the realization of a certain traumatic experience. Reinflicting trauma as a means of colonial control, even in neocolonial terms, is inherited by American colonial power over the Philippines and continued even in Filipino-American lives, subjectivities.
Archaeology is, at its core, realizing these developments, not merely a discourse of knowledges but moreover a structure that operates within the sort of spaces that Deleuze and Guattari describe as geological. These two concepts anticipate a certain meaning given that the geologic as a knowledge in fact is necessary for the archaeological in traditional uses of both words, and that the conceptual framework of Deleuze and Guattari’s geological immanence, the transition between planes of immanence that sees the change of knowledges realized on a sort of geological timescale, a time that is different from the scientific usage of such a term but evocative of the means by which these exceed normal experiential understandings of time, of change, is important to realizing Foucault’s understanding of the archaeological. The geological forms over millions of years, but the archaeological deals in decades, sometimes structurally intermingled and collapsed due to the geological structuring of the matrix that surrounds them, but specifically defiant of time as a measure regardless of their supposed demarcation through time. For Foucault, the archaeological component of knowledge lies in discussing the means by which one passes from the recording of a history, of an event, the structure of book or œuvre into contemporary practice, the way in which one finds authorship or lack-thereof as indicative of a knowledge. Foucault notes that, for a great deal of time, the scientificity of a book was in fact reliant upon its authorship, while in turn that of a play, or of a poem, was in fact in defiance of such thoughts. The reversal of this, the absolute positivism that is given to scientific knowledges through the document, and the realization of poeticism not as document but as book, gives way to a development of reading such that one can discuss the changing field of knowledges that Foucault wishes to develop.
Foucault evokes Borges in saying that “play” evokes not merely a commentary, but rather a word-for-word repetition of a text that is absent, a sort of simulacra of a text that is the commentary, the remove being that which many would ascribe to the deconstructive act as measure. The means by which this act is realized relies specifically upon this distancing of reading from the text, the repetition and realization of a “text” as an object but moreover the remove itself being part of the commentary, that the read, the hunt that Derrida’s deconstruction presents, is instead preserved as the original and text-of-origin and that one finds later the deconstructive reading, the commentary, the means by which one has dissected the text. This process of commentary-as-text is repeated again and again, eventually creating not only an original continuity but a later œuvre that can be observed: the creation of Newtonian physics as a conceptual structure, or Euclidean geometry, or even the Cartesian plane. The way in which these concepts are given a certain historicism, are structured as providing a sort of truth-beyond-truth, a logical necessity, and then located in the historical is part of creating the scientific as a process of discovery that produces knowledge that may not be the same, but is overwhelmingly similar, that deals with questions not of origin, but of uncovering. Foucault critiques this process specifically in that it requires an investment in the ideological turn whereby the scientific is held as a sort of rationality beyond reproach, that there is a sort of metaphysical truth to the scientific that may be grasped, or at least reached toward, all while denying this as a model of transcendental knowledge. The scientific specifically relies upon the notion that models may always be refined, that their lack of exactness is due not to failure, but to their overwhelming success and the means by which their success is realized.
The means by which this, in turn, is linked to a scientism of the phenomenal and the phenomenological that results is part of an apparatus whereby the phenomenological is ascribed to an embodied appropriation of concepts of transcendence such that the phenomenological is not able to be truly “monist” in the conventional sense but instead made up of fields, of atomic and subatomic, physical or ancillary to the physical even below thresholds of discernibility. Even the instantaneous linkage of the quantum cannot be realized as providing a means of realizing the rhizomal: the schizophrenic has come to dominate the socius everywhere except the scientific, which perseveres in arboreality, unable to realize its own Oedipal content. The arboreal structure of the medical, the scientific, is specifically predicated upon recent ideological turns of what knowledges can constitute scientific truth, scientificity, how one can in fact meaningfully grasp the scientific as part of creating a recourse to the relativism of the postmodern while still allowing the social phantasmic to expand along the plane of postmodernist schizophrenic affinity, the schizophrenia of late capitalist existence. 
Foucauldian archaeology specifically anticipates this process, this separation and refusal, in order to create a means by which knowledges can be assessed both on their own and in relation to knowledges they hold as flawed, as part of a genealogical structuring of knowledges that are referred to in present critiques. The means by which this allows for a sort of anti-historical tracing of knowledge, of the ideological investment behind the knowledges that structure encounter, that structure the language constitutive of the phenomenological, is useful for postcolonial thought specifically in describing how the neocolonial has appropriated so many discursive formations of the precolonial and repeated them in a sort of neocolonial framework, under the apparently-schizophrenic but moreover as a mere naming of the schizophrenic: the means by which one sees a theory of shamanism, a sort of nomadic experience appropriated by colonial terminologies in order to liken it to the West or to enter into an Orientalist fetishization of it is in fact part of the larger appropriation of knowledges that Foucault discusses. The archaeology that Foucault engages in allows for a continual structuring and restructuring of the known as well as the unknown in order to create fields of knowledge anew, to effectively take that which is unknowable and not only make it thinkable, not only make it known, but to eventually make it necessary. This, as enacted through the linguistic, through the structuring of language that thematizes and constitutes much of Foucault’s archaeological analysis, constitutes the means by which the historical is in fact created actively.
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mhsn033 · 4 years
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Coronavirus doctor’s diary: How gardening could help in the fight against obesity
Image copyright Getty Photography
Being chubby puts you at bigger chance of fundamental sickness or loss of life from Covid-19, consultants negate – and now contemporary anti-weight problems methods were launched spherical the UK. In Bradford, community schemes to advertise wholesome lifestyles offers a contemporary methodology to the difficulty. Dr John Wright of the city’s Royal Infirmary explains why radical pondering is mandatory.
Our whole concentration on Covid-19 has concealed one other international pandemic that has been extra insidious but distinguished extra inferior: weight problems. Early in the pandemic, we spotted frequent patterns in our sickest Covid-19 sufferers – they were extra at chance of bask in diabetes and heart disease and, severely, to be obese. As the radical coronavirus makes a non permanent retreat in the UK, weight problems has become a spotlight of consideration no longer ethical for the NHS but furthermore the high minister as he role-gadgets weight reduction for the nation.
The Covid-19 therapies that we are discovering by map of our analysis trials are making crucial, though minute, enhancements in survival. Alternatively, prevention is considerably higher than medication, and if we’re going to offer protection to our electorate then we desire to no longer greatest give a enhance to our public health prevention measures to stop transmission in the short length of time, but furthermore decrease their chance from ruin from an infection by tackling weight problems in the longer length of time.
Front line diary
Image copyright Tom Lawton
Prof John Wright, a doctor and epidemiologist, is head of the Bradford Institute for Neatly being Study, and a worn of cholera, HIV and Ebola epidemics in sub-Saharan Africa. He is penning this diary for BBC News and recording from the clinical institution wards for BBC Radio.
Snoop on the subsequent episode of The NHS Front Line on BBC Sounds or the BBC World Service
Or be taught the earlier online diary entry: Will vaccine sceptics assemble trials a headache?
At the clinical institution, we bask in got been tracking the lives of 16,000 teens from delivery as section of the Born in Bradford accomplishing to attain how the advanced interaction between our genes, lifestyles and atmosphere affects our later chance of physical and psychological ill health. It is love an infinite Child of Our Time see, but with the particular scientists from internationally working collectively to solve the clues. The accomplishing has proven that our chance of weight problems begins very early in existence and is severely high for teens of South Asian heritage. The path of breadcrumbs as to why South Asians bask in twice to four instances the danger of diabetes and heart disease leads support to delivery.
As these Bradford teens grow up, they face very various futures in the event that they dwell in Ilkley, undoubtedly a number of the richest places in the country, or Manningham, undoubtedly a number of the poorest. If they are rising up in interior-city Manningham then they’ll be surrounded by meals swamps of snappy-meals outlets, and meals deserts of wholesome alternate solutions. Unlucky-quality houses lack ethical kitchens to put collectively wholesome meals. The roads are too busy and unhealthy to cycle or even stroll to varsity. Lack of parks and gardens hinder active play. Junk meals promoting infects young minds and sorrowful-quality meals is all that some families can bask in sufficient money.
Our efforts to deal with weight problems are depressingly futile and the girth of the sphere’s inhabitants continues to amplify. We point of curiosity too usually on blaming folk for base alternate solutions rather than addressing the wider, interacting and advanced stipulations that lead to weight problems. There is no longer any longer this kind of thing as a straightforward behaviour change advice identical handy-washing or social distancing, no straightforward medication such as dexamethasone or remdesivir to dispense.
Dr Mathew Mathai has labored in the paediatric diabetes clinic at St Luke’s Clinic in Bradford for over a decade. When he first started, he says, teens with kind 2 diabetes were unparalleled at the clinic – now there are 18 at anybody time.
His clinic has been held with regards to for the length of the pandemic and he’ll soon be seeing his sufferers all yet again, with a ethical different to weigh them and be taught the manner social distancing restrictions bask in affected them.
“This will perhaps even be surely though-provoking to detect what lockdown has performed: for some it has been a precious length to imagine command. And others bask in gone the many map and so that they’ve been for your total time, staring at TV and eating extra,” he says.
Image caption Bradford paediatric dietitian Alison Woodhead serving to to obvious junk meals from a fridge with Maryam, 14
Much of the work his clinic does is ready motivation – and Dr Matai is enthusiastic to enlist folk in the community who will support with that.
One such individual is Tahira Amin, a registered dietitian, who changed into once on maternity whisk away when she realised extra would possibly even be performed regionally to support make stronger fitness, health and the total surely feel of the interior-city home spherical Lister Mill in Bradford.
“I wished to acquire pleasure from my being pregnant but peaceful fundamental a obtain 22 situation and investigated what I also can attain in the build folk,” she says. She’d already been excited by a programme to coach fencing to Muslim young girls folks and girls and now she had an thought for one other accomplishing – to advertise ethical health by taking over allotments and turning derelict land into a community garden.
Amin believes that assembly others in an outside, active atmosphere is a bigger solution to acquire out about wholesome lifestyles than sitting spherical in a college room. “We can grow meals, obtain out about diet and vitamin and obtain command that the truth is helps in the fight against weight problems,” she says,
Sofia Rashid lives nearby and is pleased with the changes, severely because it’s made it so distinguished much less difficult for her seven-one year-ancient disabled daughter to navigate her walker by map of the greener spaces.
“We have all sorted the fraction and helped grow issues. The total girls folks here are serving to and we were out strolling by map of lockdown – it changed into once encouraging to bask in any individual excited by health,” she says.
Rashid says the response to Amin’s accomplishing has been unbelievable. “She’s furthermore instructing us about wholesome eating and she or he’s area up a cycling neighborhood so a pair of of us are planning to recede bikes for the first time,” Rashid says. “Closing weekend we had a avenue neat-up the build your total girls of the home got collectively, it changed into once folk of all ages.”
Dr Mathai is joyful it’s native schemes love this which is ready to assemble a valid disagreement, severely for teens who need support navigating the array of takeaway alternate solutions on offer in the city.
“This is no longer any longer a clinical recount, it is a social and community recount that desires to be addressed,” he says. “It desires to be native parks, authorities and products and services taking the lead, with doctors there to crimson meat up that community-driven methodology.”
In Bradford we are constructing on our work in Born in Bradford to build the sphere’s first “Metropolis Collaboratory” that recognises that we desire a radically various methodology to battling weight problems. It brings collectively coverage makers, communities, faculties, city planners, transport consultants, and researchers to support carry out and test whole system approaches that can act all a number of the most reasonable ways by map of every recount of the city to put lives.
Our native and national response to Covid-19 has proven what is possible with frequent motive and collective endeavour. Let us put the same vigour and dedication to tackling the many pandemic.
Discover @docjohnwright and radio producer @SueM1tchell on Twitter
You would possibly well also merely furthermore be drawn to…
Image caption Arleth Avila has been earmarked for gastric surgical operation in Colorado
As a side-carry out of the upward thrust in childhood weight problems, an increasing quantity of teens are being identified with kind 2 diabetes – severely, in some UK cities, in the Asian community. Will the NHS build in mind an methodology now being tried in the US, and offer these teens bariatric surgical operation?
Could per chance bask in to peaceful teens with kind 2 diabetes be offered a gastric op?
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lauramalchowblog · 4 years
Text
Equipoise and Its Problems
By MICHEL ACCAD, MD
I recently participated in a debate opposing me to Professor Adam Cifu on the topic of “Evidence-based medicine in the age of COVID.” The debate took place on an episode of Dr. Chadi Nabhan’s Outspoken Oncology podcast. Dr. Saurabh Jha was the moderator and he did a great job keeping us on point and asking for important clarifications when needed. It was a fun and cordial moment and I found it intellectually fruitful. You can listen to it here or on any podcast platform. The discussion strengthened my conviction that the central issue about EBM is the conflation of the role of the physician with that of the clinical scientist.
That conflation was quite apparent in a recent online editorial published by Robert Yeh and colleagues on the topic of equipoise during the COVID-19 pandemic. Yeh at al. are accomplished academic cardiologists and outcomes researchers (Yeh was a guest on The Accad and Koka Report a couple of years ago).
I’ll get to their editorial in a moment, but equipoise is a term that I became aware of only in the last few years, mainly from mentions on MedTwitter. From those mentions I developed an intuitive sense of what equipoise must mean: a mental state of uncertainty about a treatment that prompts the medical community to seek a more definitive answer by way of a randomized controlled trial. For example, one might say “I’m not sure if hydroxychloroquine works to prevent or treat COVID-19.  Based on the existing collective experience, there is equipoise about it.  We need a clinical trial.”
That seems reasonably straightforward, but the editorial by Yeh et al. piqued my curiosity so I decided to look into the origin of the term and its introduction in the medical literature.
“Theoretical” equipoise
It turns out that the term equipoise (“equal weight”) was introduced into the domain of clinical research in 1974 by Charles Fried in a textbook on research ethics.
Fried asserted that there should be an “indifference requirement” when an investigation compares two treatments.  If the investigator has reason to believe that one treatment arm of a clinical experiment is inferior to the other(s), then that arm should be eliminated or the trial cannot ethically proceed. The idea was not original to Fried. Other ethicists, such as Lawrence Shaw and Thomas Chalmers, had previously postulated that requirement but without giving it a specific name.
At any rate, Fried’s term remained in relative obscurity until it was put in the title of a special article in the New England Journal of Medicine in 1987. In “Equipoise and the Ethics of Clinical Research,” Benjamin Freedman described equipoise as a state of “genuine uncertainty” in the conduct of clinical trials, but he offered additional clarity about the meaning of the term in this context.
In his article, Freedman cautioned against what he termed “theoretical equipoise,” i.e., a too strict and too abstract understanding of the indifference requirement. According to this stringent interpretation, a researcher can ethically proceed with an experiment only if a “50-50” indifference regarding the treatment arms exists. Any time he or she has reason to believe that one arm may be better than the other, then the experiment cannot ethically proceed further.
This possibility was vividly on my mind a few weeks ago when comments made privately by investigators at the University of Chicago, one of the sites of a multi-site trial of Gilead’s antiviral Remdesivir, were leaked to STAT News.
The UC physicians commented during their internal meeting that the hospital course and length of stay of Remdesivir-treated COVID patients seemed to them to be much improved as compared to what was being reported about hospitalized patients from China, Lombardy, or other centers with severe mortality rates. This “good news” about Remdesivir spread like wildfire, causing Gilead’s stiock to shoot up. But many were quick to dismiss it as just a rumor or a biased impression, especially given that that trial had no concurrent randomized control group for comparison.
Still, the information seemed important, so I conducted a survey among physicians on Twitter about how this piece of news should affect enrollment in the other, ongoing randomized controlled trials of Remdesivir.  What should prospective patients or currently enrolled patients be told?
Interestingly the answer to my survey showed…equipoise
In other words, 50% of those surveyed did not think that the additional information had relevance to the conduct of on-going randomized control trials, even though the information was not available at the time the trials were approved or when they were beginning to enroll patients.
But according to Freedman, research ethicists from the 1970s and 1980s clearly thought that this kind of information not only could have relevance for the conduct of trials but could theoretically jeopardize the entire research enterprise.
Freedman mentioned other ways that equipoise can be “disturbed.” Not only can any new experience with a treatment outside of the experimental study tilt the balance one way or another, but once a trial is begun, any accumulated knowledge in the course of the trial can also sway the judgment of physicians in favor or against the treatment. If, say, among the first 12 enrollees of a 100-patient trial the outcomes seem better with treatment A compared to treatment B, shouldn’t patient #13 and beyond be at least made aware of that fact?
Freedman mentioned some solutions that ethicists had previously proposed to deal with this thorny problem.  One of them is actually already part of clinical trial methodology: the blinding of the investigators. In the course of a trial, accrued outcomes are not analyzed by the physicians involved in the care of patients but by an independent data monitoring committee.  That way, the clinicians are kept from being biased by the data as it accumulates.
But Freedman rightly pointed out that, from an ethical standpoint, blinding clinicians is like sticking their heads in the sand:
If interim results would disturb equipoise, the investigators are obliged to gather and use that information. Their agreement to remain in ignorance of preliminary results would, by definition, be an unethical agreement, just as a failure to call up the laboratory to find out a patient’s test results is unethical.
Clearly, equipoise highlights the tension between the therapeutic aims of medicine and the scientific aims of research.
Other proposals have been suggested. One of them, advanced by Paul Meier, was to stipulate that participation in clinical trials is commensurate with the everyday risks of not always getting one’s best choices in life.  Trial subjects, therefore, should not necessarily expect to get the best care possible.
Another idea, proposed by Arthur Schaefer, was to let patients be the judge of whether equipoise is present or not, a form of “shared decision-making” but only sillier than the one currently in vogue.  A third one—at the opposite end of the autonomy spectrum—was to simply conscript patients into participating in clinical trials.  Ethics be damned!
“Clinical equipoise”
Freedman wisely considered these proposals to be “counsels of desperation.” The problem, according to Freedman, was that understanding equipoise in the theoretical sense of holding the 2 treatment arms exactly balanced is “conceptually odd and ethically irrelevant.”  Such an understanding of equipoise is so “highly sensitive to the vagaries of the individual investigator’s attention and perception” as to make the concept “overwhelmingly fragile.”  Equipoise is liable to be overthrown even on a “hunch” or a personal bias.”
Besides, the “theoretical equipoise” could only apply to very “clean” and one-dimensional hypothesis testing of the type “Is A superior to B in producing outcome X.”   In reality, Freedman asserted, clinical research is always conducted with a plurality of outcomes in mind.  Not only are benefits tallied, but various side-effects as well.  In such a situation, theoretical equipoise is impossible to maintain or even hold to begin with.  It’s an irrelevant mental abstraction.
Instead, he offers the concept of “clinical equipoise” which he defined as the uncertainty that arises not when a particular physician cannot decide the superiority of one treatment over another, but more broadly when the “clinical community” is divided and when there is “an honest, professional disagreement among expert clinicians about the preferred treatment.”
Clearly, clinical equipoise as stipulated by Freedman is much less liable to be disturbed than the original concept.  So long as there is disagreement among a sufficiently large number of colleagues or clinicians, equipoise can be said to exist, and a clinical trial can be justified on ethical grounds:
…clinical equipoise places the emphasis in informing the patient on the honest disagreement among expert clinicians. The fact that the investigator has a “treatment preference,” if he or she does, could be disclosed; indeed, if the preference is a decided one, and based on something more than a hunch, it could be ethically mandatory to disclose it. At the same time, it would be emphasized that this preference is not shared by others.
Freedman’s proposal has some prima facie reasonableness.  Medicine is a collegial enterprise.  Rare is the physician who holds opinions in isolation, without the influence or agreement of others.  In my debate with Dr. Cifu I remarked that if the community of intensivists remains divided on the question of the benefit of early versus delayed intubation for severe COVID-19, then they may agree to conduct a clinical trial and would be justified in doing so.  It would indeed be ethical and realistic to tell a patient “look, I believe that treatment A can help people like you, but other doctors disagree or are concerned that the risks outweigh the potential benefits and that’s why we think people like you should enroll in a trial.”
Enters EBM
Freedman’s concept of clinical equipoise would be all well-and-good if modern medicine were built on a sound moral and epistemological foundation. But Freedman made his proposal in 1987, only a year before David Eddy coined the term “evidence-based” and just a couple of years before Sackett et al. articulated the principles of EBM that would become the new dogma of academic medicine.
The EBM takeover of medicine has changed the concept of equipoise in the opposite way to that which Freedman feared. If, in the early days, “theoretical equipoise” was conceivably too fragile and under the constant threat of the whims of the hunches and preferences of individual clinicians, equipoise in the age of EBM has become unassailable.
After all, it is the central dogma of EBM that there is no firm knowledge about a treatment unless the evidence comes from a well-conducted, randomized, blinded clinical trial. If there is no randomized controlled trial, there is no substantive knowledge. As long as EBM reigns, the demand for equipoise is self-fulfilling.
If a new treatment is being to be tried or an old treatment repurposed for a new set of circumstances, the default position that any clinician must hold is the agnostic one, no matter what the prior experience is up to that point:  “There is no proof!”  Otherwise, one practices out of the bounds of evidence-based medicine.  With such a default position, it can be unethical for a physician to treat a patient outside of a clinical trial, a claim that’s been made repeatedly by EBM champions in the course of the COVID pandemic.
Equipoise for all?
But pandemics are not friendly to equipoise. In the age of COVID-19, patients, clinicians, scientists, and even politicians are restless and ready to pounce at the first bit of hopeful news, even if that news is questionable: “We cannot wait for perfect data!” is the motto of the day.
It’s against that tendency to spring into frenzied action during a pandemic that Yeh et al. made their plea in their editorial blog entitled “Equipoise on Covid-19 therapeutics.”
Here, Yeh and colleagues stress the valid point that a pandemic is precisely not a time to send caution to the wind. They rightly warn that an “exuberant embrace of untested treatments may lead to toxicities” and also delay the discovery of effective therapies. They lament that this is taking place because equipoise has not been “maintained.”
But having just read Freedman’s article, I cannot help but think that Yeh et al. may have also sent his cautionary distinction on equipoise to the wind. For, in framing their discussion of equipoise, these authors are not so careful to distinguish the individual practicing doctor from the trialist, let alone the individual clinical scientist from the “community of clinicians.”
Consider the following passages:
Traditional pathways for evaluating new treatments through randomized trials hinge on establishing and maintaining equipoise at a broad public health level, but also at the bedside where wrenching decisions are made in real-time.
Or:
Equipoise—that is, whether physicians making bedside decisions genuinely maintain uncertainty regarding whether a given option is helpful or harmful—can erode rapidly for several reasons.
In both of these sentences one gets the sense that the authors do not view equipoise as a condition necessary to allow a researcher to engage in experimental medicine, i.e., the way Freedman and his predecessors had initially conceived of it. For Freedman and for the ethicists, it’s the trialists’ job to decide if equipoise is either present or not in order to proceed with the experiment.
Instead, for Yeh et al. (and for many contemporary clinician-scientists, no doubt), equipoise is a sort of “epistemic virtue” that both scientists and practicing doctors must cultivate and “maintain” until a clinical trial can ultimately adjudicate the value of a particular treatment. Repeatedly in their article the authors speak of the difficulty of “preserving” equipoise in the age of COVID.
Furthermore, they lump the bedside clinician with the trialist. And that conflation is not benign if we consider the coercive policy proposals they recommend: “stewardship committees” to restrict the use of certain treatments outside of clinical trials:
The coronavirus era demands immediate design and adoption of institutional policies, shaped by clear national guidance, to preserve equipoise and allow focused randomized trials to enroll and yield data as quickly as possible….A model for such policies might be the way in which many hospitals strictly limit access to certain antibiotics, requiring approval from a specialist stewardship committee prior to release from pharmacy.
Also:
We also call for widespread commitment among clinicians to restrict use of purported coronavirus treatments outside of clinical trial. This must be paired with a reduction of barriers for pooling patient-level data to maximize knowledge generation and, in doing so, honour the selflessness of patients or families who agree to participate (emphasis mine).
Yeh et al. may rightly consider patients who enroll in trials to be selfless, but they should be mindful that if participation in a trial is the only possible way to access a promising treatment, then those patients may very well be acting out of justified self-interest.
Clear thinking is the way forward
As Yeh and colleagues mention in their article, there is an inherent tension between doctoring and experimenting. But we must deal with this tension with clear thinking, not by muddling ethical and epistemological concerns.
One approach may be to toss out the idea of equipoise altogether.
A few years ago, Franklin Miller and Steven Joffe proposed doing just that in the pages of the New England Journal of Medicine. They raised reasonable objections to Freedman’s concept of clinical equipoise arguing, for example, that there is no objective way to determine if equipoise is present. What does it mean that a sufficient number of clinicians should disagree on the value of a treatment? Instead, Miller and Joffe justified the conduct of clinical trials on the basis of their socioeconomic benefits, arguing that population-level considerations trump any right a patient may have to a new treatment, especially if it is a costly one.
I disagree with Miller’s and Joffe’s severe utilitarianism. For one thing, it has no strong philosophical or moral justification. Utilitarianism is just a preference. For another, the same arguments that they have raised against equipoise can be raised against their own economic arguments. When is a treatment costly enough to warrant that it be made available only after vetting by an experimental trial? Who decides? And what if an old but still costly treatment was not vetted by a clinical trial? Should it be taken away from patients until a trial is conducted? Also, Miller and Joffe seem to have given little thought or consideration to understanding why treatments are costly to begin with.
Like Yeh and colleagues, I think that equipoise is a helpful concept that should not be abandoned. But the way out of the dilemma is precisely to remain mindful that physicians and clinical scientists have distinct primary aims.  The aim of the physician is to bring about health in a particular patient. That of the clinical scientist is to bring about some general knowledge that will help physicians.  It is to the scientist that equipoise pertains. The fact that the physician and the clinical scientist share the same playpen, or that one and the same person may have a dual role, should not obscure that they each have a radically different task at hand.
Michel Accad is a cardiologist based in San Francisco and host of the podcast, The Accad & Koka Report. This post originally appeared on The Accad & Koka Report here.
Equipoise and Its Problems published first on https://venabeahan.tumblr.com
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kristinsimmons · 4 years
Text
Equipoise and Its Problems
By MICHEL ACCAD, MD
I recently participated in a debate opposing me to Professor Adam Cifu on the topic of “Evidence-based medicine in the age of COVID.” The debate took place on an episode of Dr. Chadi Nabhan’s Outspoken Oncology podcast. Dr. Saurabh Jha was the moderator and he did a great job keeping us on point and asking for important clarifications when needed. It was a fun and cordial moment and I found it intellectually fruitful. You can listen to it here or on any podcast platform. The discussion strengthened my conviction that the central issue about EBM is the conflation of the role of the physician with that of the clinical scientist.
That conflation was quite apparent in a recent online editorial published by Robert Yeh and colleagues on the topic of equipoise during the COVID-19 pandemic. Yeh at al. are accomplished academic cardiologists and outcomes researchers (Yeh was a guest on The Accad and Koka Report a couple of years ago).
I’ll get to their editorial in a moment, but equipoise is a term that I became aware of only in the last few years, mainly from mentions on MedTwitter. From those mentions I developed an intuitive sense of what equipoise must mean: a mental state of uncertainty about a treatment that prompts the medical community to seek a more definitive answer by way of a randomized controlled trial. For example, one might say “I’m not sure if hydroxychloroquine works to prevent or treat COVID-19.  Based on the existing collective experience, there is equipoise about it.  We need a clinical trial.”
That seems reasonably straightforward, but the editorial by Yeh et al. piqued my curiosity so I decided to look into the origin of the term and its introduction in the medical literature.
“Theoretical” equipoise
It turns out that the term equipoise (“equal weight”) was introduced into the domain of clinical research in 1974 by Charles Fried in a textbook on research ethics.
Fried asserted that there should be an “indifference requirement” when an investigation compares two treatments.  If the investigator has reason to believe that one treatment arm of a clinical experiment is inferior to the other(s), then that arm should be eliminated or the trial cannot ethically proceed. The idea was not original to Fried. Other ethicists, such as Lawrence Shaw and Thomas Chalmers, had previously postulated that requirement but without giving it a specific name.
At any rate, Fried’s term remained in relative obscurity until it was put in the title of a special article in the New England Journal of Medicine in 1987. In “Equipoise and the Ethics of Clinical Research,” Benjamin Freedman described equipoise as a state of “genuine uncertainty” in the conduct of clinical trials, but he offered additional clarity about the meaning of the term in this context.
In his article, Freedman cautioned against what he termed “theoretical equipoise,” i.e., a too strict and too abstract understanding of the indifference requirement. According to this stringent interpretation, a researcher can ethically proceed with an experiment only if a “50-50” indifference regarding the treatment arms exists. Any time he or she has reason to believe that one arm may be better than the other, then the experiment cannot ethically proceed further.
This possibility was vividly on my mind a few weeks ago when comments made privately by investigators at the University of Chicago, one of the sites of a multi-site trial of Gilead’s antiviral Remdesivir, were leaked to STAT News.
The UC physicians commented during their internal meeting that the hospital course and length of stay of Remdesivir-treated COVID patients seemed to them to be much improved as compared to what was being reported about hospitalized patients from China, Lombardy, or other centers with severe mortality rates. This “good news” about Remdesivir spread like wildfire, causing Gilead’s stiock to shoot up. But many were quick to dismiss it as just a rumor or a biased impression, especially given that that trial had no concurrent randomized control group for comparison.
Still, the information seemed important, so I conducted a survey among physicians on Twitter about how this piece of news should affect enrollment in the other, ongoing randomized controlled trials of Remdesivir.  What should prospective patients or currently enrolled patients be told?
Interestingly the answer to my survey showed…equipoise
In other words, 50% of those surveyed did not think that the additional information had relevance to the conduct of on-going randomized control trials, even though the information was not available at the time the trials were approved or when they were beginning to enroll patients.
But according to Freedman, research ethicists from the 1970s and 1980s clearly thought that this kind of information not only could have relevance for the conduct of trials but could theoretically jeopardize the entire research enterprise.
Freedman mentioned other ways that equipoise can be “disturbed.” Not only can any new experience with a treatment outside of the experimental study tilt the balance one way or another, but once a trial is begun, any accumulated knowledge in the course of the trial can also sway the judgment of physicians in favor or against the treatment. If, say, among the first 12 enrollees of a 100-patient trial the outcomes seem better with treatment A compared to treatment B, shouldn’t patient #13 and beyond be at least made aware of that fact?
Freedman mentioned some solutions that ethicists had previously proposed to deal with this thorny problem.  One of them is actually already part of clinical trial methodology: the blinding of the investigators. In the course of a trial, accrued outcomes are not analyzed by the physicians involved in the care of patients but by an independent data monitoring committee.  That way, the clinicians are kept from being biased by the data as it accumulates.
But Freedman rightly pointed out that, from an ethical standpoint, blinding clinicians is like sticking their heads in the sand:
If interim results would disturb equipoise, the investigators are obliged to gather and use that information. Their agreement to remain in ignorance of preliminary results would, by definition, be an unethical agreement, just as a failure to call up the laboratory to find out a patient’s test results is unethical.
Clearly, equipoise highlights the tension between the therapeutic aims of medicine and the scientific aims of research.
Other proposals have been suggested. One of them, advanced by Paul Meier, was to stipulate that participation in clinical trials is commensurate with the everyday risks of not always getting one’s best choices in life.  Trial subjects, therefore, should not necessarily expect to get the best care possible.
Another idea, proposed by Arthur Schaefer, was to let patients be the judge of whether equipoise is present or not, a form of “shared decision-making” but only sillier than the one currently in vogue.  A third one—at the opposite end of the autonomy spectrum—was to simply conscript patients into participating in clinical trials.  Ethics be damned!
“Clinical equipoise”
Freedman wisely considered these proposals to be “counsels of desperation.” The problem, according to Freedman, was that understanding equipoise in the theoretical sense of holding the 2 treatment arms exactly balanced is “conceptually odd and ethically irrelevant.”  Such an understanding of equipoise is so “highly sensitive to the vagaries of the individual investigator’s attention and perception” as to make the concept “overwhelmingly fragile.”  Equipoise is liable to be overthrown even on a “hunch” or a personal bias.”
Besides, the “theoretical equipoise” could only apply to very “clean” and one-dimensional hypothesis testing of the type “Is A superior to B in producing outcome X.”   In reality, Freedman asserted, clinical research is always conducted with a plurality of outcomes in mind.  Not only are benefits tallied, but various side-effects as well.  In such a situation, theoretical equipoise is impossible to maintain or even hold to begin with.  It’s an irrelevant mental abstraction.
Instead, he offers the concept of “clinical equipoise” which he defined as the uncertainty that arises not when a particular physician cannot decide the superiority of one treatment over another, but more broadly when the “clinical community” is divided and when there is “an honest, professional disagreement among expert clinicians about the preferred treatment.”
Clearly, clinical equipoise as stipulated by Freedman is much less liable to be disturbed than the original concept.  So long as there is disagreement among a sufficiently large number of colleagues or clinicians, equipoise can be said to exist, and a clinical trial can be justified on ethical grounds:
…clinical equipoise places the emphasis in informing the patient on the honest disagreement among expert clinicians. The fact that the investigator has a “treatment preference,” if he or she does, could be disclosed; indeed, if the preference is a decided one, and based on something more than a hunch, it could be ethically mandatory to disclose it. At the same time, it would be emphasized that this preference is not shared by others.
Freedman’s proposal has some prima facie reasonableness.  Medicine is a collegial enterprise.  Rare is the physician who holds opinions in isolation, without the influence or agreement of others.  In my debate with Dr. Cifu I remarked that if the community of intensivists remains divided on the question of the benefit of early versus delayed intubation for severe COVID-19, then they may agree to conduct a clinical trial and would be justified in doing so.  It would indeed be ethical and realistic to tell a patient “look, I believe that treatment A can help people like you, but other doctors disagree or are concerned that the risks outweigh the potential benefits and that’s why we think people like you should enroll in a trial.”
Enters EBM
Freedman’s concept of clinical equipoise would be all well-and-good if modern medicine were built on a sound moral and epistemological foundation. But Freedman made his proposal in 1987, only a year before David Eddy coined the term “evidence-based” and just a couple of years before Sackett et al. articulated the principles of EBM that would become the new dogma of academic medicine.
The EBM takeover of medicine has changed the concept of equipoise in the opposite way to that which Freedman feared. If, in the early days, “theoretical equipoise” was conceivably too fragile and under the constant threat of the whims of the hunches and preferences of individual clinicians, equipoise in the age of EBM has become unassailable.
After all, it is the central dogma of EBM that there is no firm knowledge about a treatment unless the evidence comes from a well-conducted, randomized, blinded clinical trial. If there is no randomized controlled trial, there is no substantive knowledge. As long as EBM reigns, the demand for equipoise is self-fulfilling.
If a new treatment is being to be tried or an old treatment repurposed for a new set of circumstances, the default position that any clinician must hold is the agnostic one, no matter what the prior experience is up to that point:  “There is no proof!”  Otherwise, one practices out of the bounds of evidence-based medicine.  With such a default position, it can be unethical for a physician to treat a patient outside of a clinical trial, a claim that’s been made repeatedly by EBM champions in the course of the COVID pandemic.
Equipoise for all?
But pandemics are not friendly to equipoise. In the age of COVID-19, patients, clinicians, scientists, and even politicians are restless and ready to pounce at the first bit of hopeful news, even if that news is questionable: “We cannot wait for perfect data!” is the motto of the day.
It’s against that tendency to spring into frenzied action during a pandemic that Yeh et al. made their plea in their editorial blog entitled “Equipoise on Covid-19 therapeutics.”
Here, Yeh and colleagues stress the valid point that a pandemic is precisely not a time to send caution to the wind. They rightly warn that an “exuberant embrace of untested treatments may lead to toxicities” and also delay the discovery of effective therapies. They lament that this is taking place because equipoise has not been “maintained.”
But having just read Freedman’s article, I cannot help but think that Yeh et al. may have also sent his cautionary distinction on equipoise to the wind. For, in framing their discussion of equipoise, these authors are not so careful to distinguish the individual practicing doctor from the trialist, let alone the individual clinical scientist from the “community of clinicians.”
Consider the following passages:
Traditional pathways for evaluating new treatments through randomized trials hinge on establishing and maintaining equipoise at a broad public health level, but also at the bedside where wrenching decisions are made in real-time.
Or:
Equipoise—that is, whether physicians making bedside decisions genuinely maintain uncertainty regarding whether a given option is helpful or harmful—can erode rapidly for several reasons.
In both of these sentences one gets the sense that the authors do not view equipoise as a condition necessary to allow a researcher to engage in experimental medicine, i.e., the way Freedman and his predecessors had initially conceived of it. For Freedman and for the ethicists, it’s the trialists’ job to decide if equipoise is either present or not in order to proceed with the experiment.
Instead, for Yeh et al. (and for many contemporary clinician-scientists, no doubt), equipoise is a sort of “epistemic virtue” that both scientists and practicing doctors must cultivate and “maintain” until a clinical trial can ultimately adjudicate the value of a particular treatment. Repeatedly in their article the authors speak of the difficulty of “preserving” equipoise in the age of COVID.
Furthermore, they lump the bedside clinician with the trialist. And that conflation is not benign if we consider the coercive policy proposals they recommend: “stewardship committees” to restrict the use of certain treatments outside of clinical trials:
The coronavirus era demands immediate design and adoption of institutional policies, shaped by clear national guidance, to preserve equipoise and allow focused randomized trials to enroll and yield data as quickly as possible….A model for such policies might be the way in which many hospitals strictly limit access to certain antibiotics, requiring approval from a specialist stewardship committee prior to release from pharmacy.
Also:
We also call for widespread commitment among clinicians to restrict use of purported coronavirus treatments outside of clinical trial. This must be paired with a reduction of barriers for pooling patient-level data to maximize knowledge generation and, in doing so, honour the selflessness of patients or families who agree to participate (emphasis mine).
Yeh et al. may rightly consider patients who enroll in trials to be selfless, but they should be mindful that if participation in a trial is the only possible way to access a promising treatment, then those patients may very well be acting out of justified self-interest.
Clear thinking is the way forward
As Yeh and colleagues mention in their article, there is an inherent tension between doctoring and experimenting. But we must deal with this tension with clear thinking, not by muddling ethical and epistemological concerns.
One approach may be to toss out the idea of equipoise altogether.
A few years ago, Franklin Miller and Steven Joffe proposed doing just that in the pages of the New England Journal of Medicine. They raised reasonable objections to Freedman’s concept of clinical equipoise arguing, for example, that there is no objective way to determine if equipoise is present. What does it mean that a sufficient number of clinicians should disagree on the value of a treatment? Instead, Miller and Joffe justified the conduct of clinical trials on the basis of their socioeconomic benefits, arguing that population-level considerations trump any right a patient may have to a new treatment, especially if it is a costly one.
I disagree with Miller’s and Joffe’s severe utilitarianism. For one thing, it has no strong philosophical or moral justification. Utilitarianism is just a preference. For another, the same arguments that they have raised against equipoise can be raised against their own economic arguments. When is a treatment costly enough to warrant that it be made available only after vetting by an experimental trial? Who decides? And what if an old but still costly treatment was not vetted by a clinical trial? Should it be taken away from patients until a trial is conducted? Also, Miller and Joffe seem to have given little thought or consideration to understanding why treatments are costly to begin with.
Like Yeh and colleagues, I think that equipoise is a helpful concept that should not be abandoned. But the way out of the dilemma is precisely to remain mindful that physicians and clinical scientists have distinct primary aims.  The aim of the physician is to bring about health in a particular patient. That of the clinical scientist is to bring about some general knowledge that will help physicians.  It is to the scientist that equipoise pertains. The fact that the physician and the clinical scientist share the same playpen, or that one and the same person may have a dual role, should not obscure that they each have a radically different task at hand.
Michel Accad is a cardiologist based in San Francisco and host of the podcast, The Accad & Koka Report. This post originally appeared on The Accad & Koka Report here.
Equipoise and Its Problems published first on https://wittooth.tumblr.com/
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nest-raider · 6 years
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Five Common Myths About SEO 2019
The particular search engine optimization (SEO) is usually an important design feature associated with the website that enables the particular spider or robot to effortlessly access it, thereby increasing the visibility on the internet. If you speak about search ranking in SEARCH ENGINE OPTIMIZATION, you're talking about the placement of your content on lookup results pages (SERPs). Kent Lewis, Creator, and President of Anvil, the performance-based firm based out associated with Portland, says that in 2019 voice search and Amazon research can be a lot more notable than they were in 2018. Google Search Console (Webmaster tools) is one of the particular SEO basics. If you need to find out how We actually do it, visit Post Czar to get a free gift plus details of the way i use write-up marketing and SEOcious to acquire top Google listings. It really is geared towards SEO professionals (in-house and agency), marketing managers, and company owners. 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swissforextrading · 6 years
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Empathy vs. the Machines
We recently welcomed two experts to Pier 17 for an informal conversation about the implications of new technology on ethics and empathy: Dr. Jodi Halpern, MD, PhD, is the UC Berkeley Professor of Bioethics and Medical Humanities, and Jonathon Keats is the principal artist behind Mental Work, whom The Atlantic has called a “multimedia philosopher-prophet.” Together, they explored how empathy can broaden the conversation around the impacts of tech and science — part of our SciComm Studio series inspired by the Mental Work showroom, and our continuing work exploring the emergent future of intelligent machines. We’ve condensed that conversation into key highlights below. On Philosophy Keats: I’ve chosen the job title ‘experimental philosopher’ because I don’t know exactly what it means. I decided to study philosophy because  I wanted to do what I imagined philosophy to be as a child — going around being a pest. When I learned that isn’t really what academic philosophy is about, I chose to do philosophy on my own terms. I wanted to have conversations that weren’t limited to five other people with the same specialization, and I wanted to ask open-ended questions. The one mechanism I smuggled out of academia is the thought experiment. Essentially, it’s a way to coerce your opponent into agreeing with you by luring them into an absurd position. The coercion didn’t make much sense in my case, because coercion isn’t exactly open-ended, so I decided to take ‘thought experiment’ literally. I decided to see if I could undertake experiments out in the world, where I didn’t have a conclusion in mind. Instead the idea was to create absurdist alternate realities that people could experience together, in which everyone would be sufficiently disoriented to reconsider their opinions. Every project I’ve done has, in one way or another, engaged that methodology. ‘Experimental philosopher’ is a very old job title actually, dating back many centuries to before the advent of professional philosophy. I’m motivated by curiosity, in ways that don’t allow me to focus on a single subject, but to mix them in irresponsible and mutually enlightening ways. Halpern: I think we’re incredibly aligned! I also came to philosophy — I’m a psychiatrist, and studied philosophy of mind. My whole life has been about studying empathy. I was really shocked, in medical school, at how doctors were detached from the feelings of their patients. I became very interested in detachment, and took on every skill I could to attack the idea that you had to be detached. I studied the role of emotions in the beliefs we hold, and how to understand each other person’s distinct world and developed a model of engaged curiosity. Philosophy & Technology Halpern: Before modern science, before Descartes and the earliest sketches of the modern scientific method, in ancient philosophy, science and philosophy were sort of the same thing.  Regarding our topic, both asked how one person could understand another person’s mind. Both took engaged curiosity to be central. In Aristotle, there’s this parable of a man staring at the stars and being so absorbed that he fell into a well.  His curiosity was a motivation in and of itself. Today, research often has to be so immediately practical — to get grants and so on — that we lose touch with what science originally was. Keats: To me, science has become much more operational. It seems that science can benefit from considering why we’re undertaking the investigations that we are, and one way we can do so is by exploring alternatives — positing possible worlds. And what I say about science is also applicable to technology. Mental Work, specifically, is about exploring what might happen if we were to become cyborg. We’ve already allowed machines into our lives in so many ways without much thought; perhaps by taking a leap into the future and imagining how the future might manifest, we might be able to ask what kinds of technology we might want. Defining Empathy Halpern: In the clinical context, empathy is about certain moments of genuinely therapeutic interactions. Traditionally, it’s about being “understood.” I’m a bit critical of too narrow a definition of understanding, but there’s something transformational about being understood in a richer sense. What’s therapeutic about it — so far, this is my view — depends upon one person experiencing and internalizing another’s engaged curiosity. There are limits. Doctors always say “I know how you feel,” and that’s a bad thing to say because you don’t really know how other people feel. Each person is a world unto themselves. You can’t get all of the particulars of their individual experience.   Keats: For me, empathy is related to theory of mind: The ability to appreciate that you can’t know what someone else is experiencing, and that what you are experiencing  may not be identical to what someone else is experiencing. This is one of the great political challenges of our time. We seem to be losing whatever empathy we may once have had, and what’s coming into the world in place of empathy is xenophobia — an inability to appreciate how someone else might think, an inability to value what you can’t know. I’m investigating these questions in a new project called Intergalactic Omniphonics. Half a millennium ago, there was a Copernican revolution in the sciences that not only changed astronomy, but also taught us that we can run an experiment on Earth that can tell us about the entire universe. More generally, Copernicanism teaches us that there’s nothing special about where we are in space or time. But there had never been an equivalent revolution in culture. By ‘Copernican’, I’m referring to the act of decentering — where you don’t see yourself, your tribe, or your nation as the center of everything. To explore that idea, I’m making musical instruments that are potentially accessible to anyone in the universe — including aliens from other galaxies — and challenging our assumptions of what music is: the sensory, cognitive, and experiential assumptions we make as humans. What if you don’t have ears? What if we use gamma rays instead of sound? I’ve even invented a cello that modulates gravitational waves. Bridging divides is not about saying “I know how you feel,” but having an experience together. That’s the essence of empathy. Art & Philosophy Keats: I believe that philosophy and science — like most every discipline — have moved toward greater and greater specialization. That’s completely understandable and legitimate at one level: as you build knowledge, you get to a stage where any given individual isn’t going to be versed in all of it. The arts are the exception to this rule. Everything and anything can be art now. That can be detrimental, but also opens up enormous potential to explore any topic using any methodology. Art is a space that facilitates philosophy as philosophy needs to be done. The freedom given by the art world needs to be taken as a challenge to pursue curiosity in the most encompassing and inviting ways possible. Empathy vs. the Machines Halpern: We ask, can we empathize with machines, and can machines empathize with us? We can empathize with machines, yes. We can make a very simple stick figure that evokes empathy. There’s no question. But can they have empathy for us? I have two hours on YouTube on this question. Right now, we obviously don’t have AI, but in principle? I don’t rule it out. But the real question for me isn’t whether we can create therapeutic relationships with machines, but should we? AI psychotherapy, for example. The problem for me is if this machine-human interaction replaces transformational empathy between two human beings. There should be a co-vulnerability, a co-mortality. So now some people have heard my work and want to create a mortal AI! Keats: Can a machine be empathetic? Can an animal or any other organism? I think it relates to the issue of humans treating humans as special and privileged. Being open to the possibility of an empathetic machine can induce us to question our own self-importance. There’s also the matter of how machines can make people more empathetic to other people — machines as a mediators of relationships. In the past, I’ve often been inspired by philosophical instruments, mechanisms that can be used to confront complex ideas through interaction with a physical object. For instance, philosophical instruments were an inspiration for Mental Work. Ideally, what happens with a philosophical instrument is that people confront ideas together, leading to a relationship or conversation that can be generative of empathy through co-exploration of who we are. Technology & Empathy Halpern: Descartes, from the beginning, was really a technologist. There was this idea that the purpose of engineering science was to design solutions to problems. When it comes to ethics, experts often focus too much on utilitarian questions, which are focused on outcomes–the catastrophic, unintended consequences. But for most people, ethics is more about our rights and duties to each other. Not just the outcome, but how we treat each other along the way. We don’t have to wait 5 years to see what happens. We can look at how it changes the way we treat each other right now. A professor at Yale spoke to me, and said, you know, you could foresee this recent use of social media to silo people politically— the companies said the internet would make the world more socially connected, and this would  bring people together and end tribalism. Well, the same was said about the telegraph and the radio. Each time we thought we finally had a tool to unite people across differences, but we didn’t ask the right questions. Both technologies actually worsened tribalism, helping stir up conflicts that lead to world wars.  We keep making the same mistakes, imbuing technology with magical powers to change how we treat each other. Keats: Mental Work was inspired in part by my wariness about the Industrial Revolution, and how society took up industrialization without thinking through the consequences. Arguably we’re now on the verge of a Cognitive Revolution. In the Industrial Revolution, the machine could do what the body could do, but more powerfully and quickly. We’re approaching an era where the human mind may likewise be challenged by AI and rising computational power. So how do we navigate change and prepare for the future in a way that is as informed as possible? I want to make the connection between the Industrial Revolution and the Cognitive Revolution explicit with Mental Work. We can avoid the worst and most obvious mistakes by fabricating possible worlds to experience together — foundations for reflecting on where we’re going before we get there. We can negotiate the future we want, rather than settling on the one arrived at by default. Keep up to date with ideas, insights and events by signing up for our monthly newsletter.  --- Mental Work installation photo by Astra Brinkmann for swissnex San Francisco. https://nextrends.swissnexsanfrancisco.org/empathy-vs-the-machines/ (Source of the original content)
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kristinsimmons · 4 years
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Equipoise and Its Problems
By MICHEL ACCAD, MD
I recently participated in a debate opposing me to Professor Adam Cifu on the topic of “Evidence-based medicine in the age of COVID.” The debate took place on an episode of Dr. Chadi Nabhan’s Outspoken Oncology podcast. Dr. Saurabh Jha was the moderator and he did a great job keeping us on point and asking for important clarifications when needed. It was a fun and cordial moment and I found it intellectually fruitful. You can listen to it here or on any podcast platform. The discussion strengthened my conviction that the central issue about EBM is the conflation of the role of the physician with that of the clinical scientist.
That conflation was quite apparent in a recent online editorial published by Robert Yeh and colleagues on the topic of equipoise during the COVID-19 pandemic. Yeh at al. are accomplished academic cardiologists and outcomes researchers (Yeh was a guest on The Accad and Koka Report a couple of years ago).
I’ll get to their editorial in a moment, but equipoise is a term that I became aware of only in the last few years, mainly from mentions on MedTwitter. From those mentions I developed an intuitive sense of what equipoise must mean: a mental state of uncertainty about a treatment that prompts the medical community to seek a more definitive answer by way of a randomized controlled trial. For example, one might say “I’m not sure if hydroxychloroquine works to prevent or treat COVID-19.  Based on the existing collective experience, there is equipoise about it.  We need a clinical trial.”
That seems reasonably straightforward, but the editorial by Yeh et al. piqued my curiosity so I decided to look into the origin of the term and its introduction in the medical literature.
“Theoretical” equipoise
It turns out that the term equipoise (“equal weight”) was introduced into the domain of clinical research in 1974 by Charles Fried in a textbook on research ethics.
Fried asserted that there should be an “indifference requirement” when an investigation compares two treatments.  If the investigator has reason to believe that one treatment arm of a clinical experiment is inferior to the other(s), then that arm should be eliminated or the trial cannot ethically proceed. The idea was not original to Fried. Other ethicists, such as Lawrence Shaw and Thomas Chalmers, had previously postulated that requirement but without giving it a specific name.
At any rate, Fried’s term remained in relative obscurity until it was put in the title of a special article in the New England Journal of Medicine in 1987. In “Equipoise and the Ethics of Clinical Research,” Benjamin Freedman described equipoise as a state of “genuine uncertainty” in the conduct of clinical trials, but he offered additional clarity about the meaning of the term in this context.
In his article, Freedman cautioned against what he termed “theoretical equipoise,” i.e., a too strict and too abstract understanding of the indifference requirement. According to this stringent interpretation, a researcher can ethically proceed with an experiment only if a “50-50” indifference regarding the treatment arms exists. Any time he or she has reason to believe that one arm may be better than the other, then the experiment cannot ethically proceed further.
This possibility was vividly on my mind a few weeks ago when comments made privately by investigators at the University of Chicago, one of the sites of a multi-site trial of Gilead’s antiviral Remdesivir, were leaked to STAT News.
The UC physicians commented during their internal meeting that the hospital course and length of stay of Remdesivir-treated COVID patients seemed to them to be much improved as compared to what was being reported about hospitalized patients from China, Lombardy, or other centers with severe mortality rates. This “good news” about Remdesivir spread like wildfire, causing Gilead’s stiock to shoot up. But many were quick to dismiss it as just a rumor or a biased impression, especially given that that trial had no concurrent randomized control group for comparison.
Still, the information seemed important, so I conducted a survey among physicians on Twitter about how this piece of news should affect enrollment in the other, ongoing randomized controlled trials of Remdesivir.  What should prospective patients or currently enrolled patients be told?
Interestingly the answer to my survey showed…equipoise
In other words, 50% of those surveyed did not think that the additional information had relevance to the conduct of on-going randomized control trials, even though the information was not available at the time the trials were approved or when they were beginning to enroll patients.
But according to Freedman, research ethicists from the 1970s and 1980s clearly thought that this kind of information not only could have relevance for the conduct of trials but could theoretically jeopardize the entire research enterprise.
Freedman mentioned other ways that equipoise can be “disturbed.” Not only can any new experience with a treatment outside of the experimental study tilt the balance one way or another, but once a trial is begun, any accumulated knowledge in the course of the trial can also sway the judgment of physicians in favor or against the treatment. If, say, among the first 12 enrollees of a 100-patient trial the outcomes seem better with treatment A compared to treatment B, shouldn’t patient #13 and beyond be at least made aware of that fact?
Freedman mentioned some solutions that ethicists had previously proposed to deal with this thorny problem.  One of them is actually already part of clinical trial methodology: the blinding of the investigators. In the course of a trial, accrued outcomes are not analyzed by the physicians involved in the care of patients but by an independent data monitoring committee.  That way, the clinicians are kept from being biased by the data as it accumulates.
But Freedman rightly pointed out that, from an ethical standpoint, blinding clinicians is like sticking their heads in the sand:
If interim results would disturb equipoise, the investigators are obliged to gather and use that information. Their agreement to remain in ignorance of preliminary results would, by definition, be an unethical agreement, just as a failure to call up the laboratory to find out a patient’s test results is unethical.
Clearly, equipoise highlights the tension between the therapeutic aims of medicine and the scientific aims of research.
Other proposals have been suggested. One of them, advanced by Paul Meier, was to stipulate that participation in clinical trials is commensurate with the everyday risks of not always getting one’s best choices in life.  Trial subjects, therefore, should not necessarily expect to get the best care possible.
Another idea, proposed by Arthur Schaefer, was to let patients be the judge of whether equipoise is present or not, a form of “shared decision-making” but only sillier than the one currently in vogue.  A third one—at the opposite end of the autonomy spectrum—was to simply conscript patients into participating in clinical trials.  Ethics be damned!
“Clinical equipoise”
Freedman wisely considered these proposals to be “counsels of desperation.” The problem, according to Freedman, was that understanding equipoise in the theoretical sense of holding the 2 treatment arms exactly balanced is “conceptually odd and ethically irrelevant.”  Such an understanding of equipoise is so “highly sensitive to the vagaries of the individual investigator’s attention and perception” as to make the concept “overwhelmingly fragile.”  Equipoise is liable to be overthrown even on a “hunch” or a personal bias.”
Besides, the “theoretical equipoise” could only apply to very “clean” and one-dimensional hypothesis testing of the type “Is A superior to B in producing outcome X.”   In reality, Freedman asserted, clinical research is always conducted with a plurality of outcomes in mind.  Not only are benefits tallied, but various side-effects as well.  In such a situation, theoretical equipoise is impossible to maintain or even hold to begin with.  It’s an irrelevant mental abstraction.
Instead, he offers the concept of “clinical equipoise” which he defined as the uncertainty that arises not when a particular physician cannot decide the superiority of one treatment over another, but more broadly when the “clinical community” is divided and when there is “an honest, professional disagreement among expert clinicians about the preferred treatment.”
Clearly, clinical equipoise as stipulated by Freedman is much less liable to be disturbed than the original concept.  So long as there is disagreement among a sufficiently large number of colleagues or clinicians, equipoise can be said to exist, and a clinical trial can be justified on ethical grounds:
…clinical equipoise places the emphasis in informing the patient on the honest disagreement among expert clinicians. The fact that the investigator has a “treatment preference,” if he or she does, could be disclosed; indeed, if the preference is a decided one, and based on something more than a hunch, it could be ethically mandatory to disclose it. At the same time, it would be emphasized that this preference is not shared by others.
Freedman’s proposal has some prima facie reasonableness.  Medicine is a collegial enterprise.  Rare is the physician who holds opinions in isolation, without the influence or agreement of others.  In my debate with Dr. Cifu I remarked that if the community of intensivists remains divided on the question of the benefit of early versus delayed intubation for severe COVID-19, then they may agree to conduct a clinical trial and would be justified in doing so.  It would indeed be ethical and realistic to tell a patient “look, I believe that treatment A can help people like you, but other doctors disagree or are concerned that the risks outweigh the potential benefits and that’s why we think people like you should enroll in a trial.”
Enters EBM
Freedman’s concept of clinical equipoise would be all well-and-good if modern medicine were built on a sound moral and epistemological foundation. But Freedman made his proposal in 1987, only a year before David Eddy coined the term “evidence-based” and just a couple of years before Sackett et al. articulated the principles of EBM that would become the new dogma of academic medicine.
The EBM takeover of medicine has changed the concept of equipoise in the opposite way to that which Freedman feared. If, in the early days, “theoretical equipoise” was conceivably too fragile and under the constant threat of the whims of the hunches and preferences of individual clinicians, equipoise in the age of EBM has become unassailable.
After all, it is the central dogma of EBM that there is no firm knowledge about a treatment unless the evidence comes from a well-conducted, randomized, blinded clinical trial. If there is no randomized controlled trial, there is no substantive knowledge. As long as EBM reigns, the demand for equipoise is self-fulfilling.
If a new treatment is being to be tried or an old treatment repurposed for a new set of circumstances, the default position that any clinician must hold is the agnostic one, no matter what the prior experience is up to that point:  “There is no proof!”  Otherwise, one practices out of the bounds of evidence-based medicine.  With such a default position, it can be unethical for a physician to treat a patient outside of a clinical trial, a claim that’s been made repeatedly by EBM champions in the course of the COVID pandemic.
Equipoise for all?
But pandemics are not friendly to equipoise. In the age of COVID-19, patients, clinicians, scientists, and even politicians are restless and ready to pounce at the first bit of hopeful news, even if that news is questionable: “We cannot wait for perfect data!” is the motto of the day.
It’s against that tendency to spring into frenzied action during a pandemic that Yeh et al. made their plea in their editorial blog entitled “Equipoise on Covid-19 therapeutics.”
Here, Yeh and colleagues stress the valid point that a pandemic is precisely not a time to send caution to the wind. They rightly warn that an “exuberant embrace of untested treatments may lead to toxicities” and also delay the discovery of effective therapies. They lament that this is taking place because equipoise has not been “maintained.”
But having just read Freedman’s article, I cannot help but think that Yeh et al. may have also sent his cautionary distinction on equipoise to the wind. For, in framing their discussion of equipoise, these authors are not so careful to distinguish the individual practicing doctor from the trialist, let alone the individual clinical scientist from the “community of clinicians.”
Consider the following passages:
Traditional pathways for evaluating new treatments through randomized trials hinge on establishing and maintaining equipoise at a broad public health level, but also at the bedside where wrenching decisions are made in real-time.
Or:
Equipoise—that is, whether physicians making bedside decisions genuinely maintain uncertainty regarding whether a given option is helpful or harmful—can erode rapidly for several reasons.
In both of these sentences one gets the sense that the authors do not view equipoise as a condition necessary to allow a researcher to engage in experimental medicine, i.e., the way Freedman and his predecessors had initially conceived of it. For Freedman and for the ethicists, it’s the trialists’ job to decide if equipoise is either present or not in order to proceed with the experiment.
Instead, for Yeh et al. (and for many contemporary clinician-scientists, no doubt), equipoise is a sort of “epistemic virtue” that both scientists and practicing doctors must cultivate and “maintain” until a clinical trial can ultimately adjudicate the value of a particular treatment. Repeatedly in their article the authors speak of the difficulty of “preserving” equipoise in the age of COVID.
Furthermore, they lump the bedside clinician with the trialist. And that conflation is not benign if we consider the coercive policy proposals they recommend: “stewardship committees” to restrict the use of certain treatments outside of clinical trials:
The coronavirus era demands immediate design and adoption of institutional policies, shaped by clear national guidance, to preserve equipoise and allow focused randomized trials to enroll and yield data as quickly as possible….A model for such policies might be the way in which many hospitals strictly limit access to certain antibiotics, requiring approval from a specialist stewardship committee prior to release from pharmacy.
Also:
We also call for widespread commitment among clinicians to restrict use of purported coronavirus treatments outside of clinical trial. This must be paired with a reduction of barriers for pooling patient-level data to maximize knowledge generation and, in doing so, honour the selflessness of patients or families who agree to participate (emphasis mine).
Yeh et al. may rightly consider patients who enroll in trials to be selfless, but they should be mindful that if participation in a trial is the only possible way to access a promising treatment, then those patients may very well be acting out of justified self-interest.
Clear thinking is the way forward
As Yeh and colleagues mention in their article, there is an inherent tension between doctoring and experimenting. But we must deal with this tension with clear thinking, not by muddling ethical and epistemological concerns.
One approach may be to toss out the idea of equipoise altogether.
A few years ago, Franklin Miller and Steven Joffe proposed doing just that in the pages of the New England Journal of Medicine. They raised reasonable objections to Freedman’s concept of clinical equipoise arguing, for example, that there is no objective way to determine if equipoise is present. What does it mean that a sufficient number of clinicians should disagree on the value of a treatment? Instead, Miller and Joffe justified the conduct of clinical trials on the basis of their socioeconomic benefits, arguing that population-level considerations trump any right a patient may have to a new treatment, especially if it is a costly one.
I disagree with Miller’s and Joffe’s severe utilitarianism. For one thing, it has no strong philosophical or moral justification. Utilitarianism is just a preference. For another, the same arguments that they have raised against equipoise can be raised against their own economic arguments. When is a treatment costly enough to warrant that it be made available only after vetting by an experimental trial? Who decides? And what if an old but still costly treatment was not vetted by a clinical trial? Should it be taken away from patients until a trial is conducted? Also, Miller and Joffe seem to have given little thought or consideration to understanding why treatments are costly to begin with.
Like Yeh and colleagues, I think that equipoise is a helpful concept that should not be abandoned. But the way out of the dilemma is precisely to remain mindful that physicians and clinical scientists have distinct primary aims.  The aim of the physician is to bring about health in a particular patient. That of the clinical scientist is to bring about some general knowledge that will help physicians.  It is to the scientist that equipoise pertains. The fact that the physician and the clinical scientist share the same playpen, or that one and the same person may have a dual role, should not obscure that they each have a radically different task at hand.
Michel Accad is a cardiologist based in San Francisco and host of the podcast, The Accad & Koka Report. This post originally appeared on The Accad & Koka Report here.
Equipoise and Its Problems published first on https://wittooth.tumblr.com/
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