Background to Risk due to Toxicity
David Woolley, Adam Woolley in Practical Toxicology, 2017
Risk usually has a comparative element that needs to be considered in any assessment, most simply as a risk/benefit analysis. When considering a chemical that has been developed for a particular purpose, the advantages of its use should be considered as well as the disadvantages. This is also true when looking at chemicals that have been used for many years but then are shown to be associated with toxicity. Replacement of a toxic chemical with an essentially unknown substitute is not necessarily better, as long-term experience with the substitute can show different hazards that may also be undesirable. Thus, benzene was replaced by toluene in the 1970s, when it was found that benzene is a carcinogen; long-term experience with toluene has demonstrated a number of chronic effects including neurological deficits that include central nervous system (CNS) depression, peripheral neuropathy, encephalopathy, and optic neuropathy together with a variety of other toxicities (Dart 2004).
Conclusion
Sheila A.M. McLean, Sarah Elliston in Regulating Pre-Implantation Genetic Diagnosis, 2012
Here also, questions of safety and quality inevitably arise. It is of course impossible to state with any certainty that new procedures carry no risk, and even if some risks are found to exist, what is at issue is a risk–benefit analysis. While proponents of the precautionary principle would point to the lack of evidence as requiring a cautious approach, a liberal account would prioritise reproductive liberty unless and until evidence of harm is found. How a risk– benefit analysis is calculated will, of course, depend on which interests and concerns are prioritised. This, in turn, as we have seen in relation to making public policy, will depend on many factors, including the personal morality of legislators and regulators and their views as to what is, and is not, acceptable or important.
Healthcare Politics
Kant Patel, Mark Rushefsky in Healthcare Politics and Policy in America, 2019
The field of economics offers several analytic tools that can be useful in health policymaking/decision-making as well as evaluation of health programs to determine its impact, effectiveness, and efficiency. Some of these tools include the following: cost–benefit analysis in the healthcare field can provide an analysis of expenditure of health resources relative to benefits. Such analysis can help determine whether the cost of a given program can be justified compared to the benefit it provides. It can also help in setting priorities when decisions or choices must be made in the face of limited resources. Risk–benefit analysis can allow policymakers to weigh the potential for undesirable outcomes and side-effects against the potential positive outcome of a policy/program or a medical treatment. Cost-effectiveness analysis involves comparing several different intervention strategies using common units of costs and benefits. The Center for Disease Control and Prevention (CDC) utilizes cost analysis, economic evaluation, regulatory and budget impact analysis, and health impact assessment in public health programs (“Public Health Economics and Methods” n.d.). Almost all state governments conduct cost–benefit analysis but the quality and impact of such analysis vary. At the federal level, the use of cost–benefit analysis is required in many federal agencies particularly with respect to regulatory decision-making (White and Silloway 2016).
A Teen With Cerebral Palsy and Intellectual Disability and the Hysterectomy Question
Published in The American Journal of Bioethics, 2018
Julia's condition as described in the case is perplexing. Despite daily morphine and ibuprofen to treat orthopedic pain, she still has intense dysmenorrhea monthly. Her treating physician believes all medical interventions have been exhausted. Has there been consultation with physiatrists, pain specialists, or palliative care specialists? Is there another reason for the pain? Given that the surgeon thinks that there is only a 50/50 chance of eliminating the pain with a hysterectomy, is it worth the risk of putting Julia through an abdominal hysterectomy (since a vaginal hysterectomy was considered too risky)? Julia's mother has the impression that a hysterectomy could shorten Julia's life, but that even if this happened, it would be justified if it improved the quality of her life. This risk–benefit analysis is in question.
Immune checkpoint inhibition in early-stage triple-negative breast cancer
Published in Expert Review of Anticancer Therapy, 2022
Revati Varma, Matthew Wright, Jame Abraham, Megan Kruse
In this setting, neoadjuvant pembrolizumab is administered over 24 weeks at 200 mg every 3 weeks for eight doses or 400 mg every 6 weeks for four doses IV for 30 minutes. The pembrolizumab is given with concurrent NACT consisting of paclitaxel and carboplatin followed by an anthracycline and cyclophosphamide. Similarly, irrespective of pCR status, adjuvant pembrolizumab is administered for up to 27 weeks at 200 mg every 3 weeks for nine doses or 400 mg every 6 weeks for five doses IV over 30 minutes. In clinical practice, pembrolizumab is recommended for eligible patients with early-stage TNBC that is considered high-risk, meaning that the tumor is at least 2 cm in size or at least N1 nodal stage. Eligible patients include those who do not have relative contraindications to immunotherapy such as a poorly controlled autoimmune disorder, immunodeficiency or immunosuppression. Despite limited evidence, those with impaired or dysregulated immune function are suspected to be at increased risk of developing significant irAEs and/or be intolerant of immune checkpoint inhibitors thus use of pembrolizumab in this population must be done with caution. There also may be concern that underlying immune dysregulation can impair the efficacy of immune checkpoint inhibitors. Patients with well controlled autoimmune conditions have been found to safely tolerate immune checkpoint inhibitors. Ultimately, as with any medical decision, a risk-benefit analysis is required for each individual patient along with shared-decision making.
Days of Future Past: Reply to Open Peer Commentaries on “Revising, Correcting, and Transferring Genes”
Published in The American Journal of Bioethics, 2020
I am also not convinced that every ethical concern needs to be explicitly stated or the framework will be reductive, as Weber et al. (2020) argue. The framework presented in the paper is explicitly not supposed to reduce all ethical issues to risk/benefit analysis, as the long discussion of incorporating concerns about downstream social effects in the penultimate section is supposed to highlight. But the fact that it could be read this way is concerning, when you consider that such frameworks are not just tools for good-faith efforts to ensure responsible use. If the framework presented in this paper allowed for ignoring larger ethical issues in favor of a reductive risk/benefit-style consequentialism about clinical applications, that would significantly reduce its value. The bigger problem is not that, as Weber et al. put it, the framework seems to assume “the biomedical model of the person”, but rather that a too-economical framework may create an opening in normative space for a reductive treatment of the ethics of gene editing.
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