Papers by Itai Bavli
PLOS DIGITAL HEALTH, 2024
The integration of Artificial Intelligence (AI) into public health has the potential to transform... more The integration of Artificial Intelligence (AI) into public health has the potential to transform the field, influencing healthcare at the population level. AI can aid in disease surveillance, diagnosis, and treatment decisions, impacting how healthcare professionals deliver care. However, it raises critical questions about inputs, values, and biases that must be addressed to ensure its effectiveness. This article investigates the factors influencing the values guiding AI technology and the potential consequences for public health. It outlines four key considerations that should shape discussions regarding the role of AI in the future of public health. These include the potential omission of vital factors due to incomplete data inputs, the challenge of balancing trade-offs in public health decisions, managing conflicting inputs between public health objectives and community preferences, and the importance of acknowledging the values and biases embedded in AI systems, which could influence public health policy-making.
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AI & Society, 2024
Artificial intelligence (AI) technologies in medicine are gradually changing biomedical research ... more Artificial intelligence (AI) technologies in medicine are gradually changing biomedical research and patient care. High expectations and promises from novel AI applications aiming to positively impact society raise new ethical considerations for patients and caregivers who use these technologies. Based on a qualitative content analysis of semi-structured interviews and focus groups with healthcare professionals (HCPs), patients, and family members of patients with Parkinson's Disease (PD), the present study investigates participant views on the comparative benefits and problems of using human versus AI predictive computer vision health monitoring, as well as participants' ethical concerns regarding these technologies. Participants presumed that AI monitoring would enhance information sharing and treatment, but voiced concerns about data ownership, data protection, commercialization of patient data, and privacy at home. They highlighted that privacy issues at home and data security issues are often linked and should be investigated together. Findings may help technologists, HCPs, and policymakers determine how to incorporate stakeholders' intersecting but divergent concerns into developing and implementing AI PD monitoring tools.
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AJOB Empirical Bioethics, 2023
Artificial intelligence (AI) has garnered tremendous attention in health care, and many hope that... more Artificial intelligence (AI) has garnered tremendous attention in health care, and many hope that AI can enhance our health system's ability to care for people with chronic and degenerative conditions, including Parkinson's Disease (PD). This paper reports the themes and lessons derived from a qualitative study with people living with PD, family caregivers, and health care providers regarding the ethical dimensions of using AI to monitor, assess, and predict PD symptoms and progression. Thematic analysis identified ethical concerns at four intersecting levels: personal, interpersonal, professional/institutional, and societal levels. Reflecting on potential benefits of predictive algorithms that can continuously collect and process longitudinal data, participants expressed a desire for more timely, ongoing, and accurate information that could enhance management of day-today fluctuations and facilitate clinical and personal care as their disease progresses. Nonetheless, they voiced concerns about intersecting ethical questions around evolving illness identities, familial and professional care relationships, privacy, and data ownership/governance. The multi-layer analysis provides a helpful way to understand the ethics of using AI in monitoring and managing PD and other chronic/degenerative conditions.
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The Journal of Law, Medicine & Ethics, 2023
Studies of public health decisions that have had harmful effects tend to disagree about what cons... more Studies of public health decisions that have had harmful effects tend to disagree about what constitutes a public health error. Debates exist about whether public health errors must be culpable or not, as well as about what the criteria for judging public health errors should be.
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PLOS ONE, 2023
The pharmaceutical industry's promotion of opioids in North America has been well-documented. Yet... more The pharmaceutical industry's promotion of opioids in North America has been well-documented. Yet despite the clear consequences of improperly classifying pharmaceutical company messaging and frequently permissive approaches that allow the pharmaceutical industry to self-regulate its own advertising, there has been scarce investigation to date of how pharmaceutical industry stakeholders interpret definitions of "advertising." This study explores how variations of "marketing" and "advertising" are strategically framed by the different actors involved in the manufacturing and distribution of pharmaceutical opioids. We employed a framing analysis of industry responses to Health Canada's letter to Canadian manufacturers and distributors of opioids requesting their commitment to voluntarily cease all marketing and advertising of opioids to health care professionals. Our findings highlight companies' continuing efforts to frame their messaging as "information" and "education" rather than "advertising" in ways that serve their interests. This study also calls attention to the industry's continual efforts to promote self-regulation and internal codes of conduct within a highly permissive federal regulatory framework with little concern for violations or serious consequences. While this framing often occurring out of public sight, this study highlights the subtle means through which the industry attempts to frame their promotion strategies away from "marketing". These framing strategies have significant consequences for the pharmaceutical industry's capacity to influence healthcare professionals, patients, and the general public.
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New England Journal of Medicine, 2022
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Clinical Trials, 2022
The marketing and sale of oxycodone (OxyContin) by Purdue Pharma has commanded a great deal of le... more The marketing and sale of oxycodone (OxyContin) by Purdue Pharma has commanded a great deal of legal and policy attention due to the drug's central role in the ongoing overdose crisis. However, little is known about the basis for OxyContin's approval by regulators, such as Health Canada in 1996. Taking advantage of a recently created online database containing information pertaining to the safety and effectiveness of drugs, we conducted a retrospective analysis of Purdue Pharma's submission to Health Canada, including both published and unpublished clinical trials. None of the trials sponsored by Purdue Pharma sought to meaningfully assess the risks of misuse or addiction associated with OxyContin. The trials were short in duration (maximum length was 24 days) and only assessed safety and efficacy of a 12-h dosing interval. Also, the two trial reports that explicitly mentioned (but did not formally evaluate) the risk of misuse were not published, making it unclear how Health Canada concluded that there was no risk of misuse. In our view, these findings underscore the need for transparency of not only of clinical trial data, but also the regulator's interpretation of such data, which is currently lacking in Canada. Furthermore, they call into question why Health Canada's role in precipitating the overdose crisis has not received greater scrutiny, including in the context of recent litigation surrounding OxyContin.
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Perspectives on Science, 2018
A small but growing body of philosophically informed survey work calls into question whether the ... more A small but growing body of philosophically informed survey work calls into question whether the value-free ideal is a dominant viewpoint among scien- tists. However, the survey instruments used in these studies have important limitations. Previous work has also made little headway in developing hypotheses that might predict or explain differing views about the value-free ideal among scientists. In this article, we review previous survey work on this topic, explain limitations of the survey instruments used, describe an improved survey, report results from an initial administration of it that strengthen and refine previous results, and develop two hypotheses that may account for gender effects found in the data. These hypotheses suggest that gender socialization and a greater tendency for female scientists to be aware of sexism in their fields makes them more likely to reject certain aspects of the value-free ideal.
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BMJ, 2020
Key messages
• Public health policies to combat SARS-CoV-2 mostly rely on models designed to pred... more Key messages
• Public health policies to combat SARS-CoV-2 mostly rely on models designed to predict their benefits
• These models often ignore potential harms that arise from these policies
• The short and long term adverse health effects of physical distancing measures, including unnecessary deaths, need to be evaluated and vulnerable populations identified
• Economic effects cannot be separated from health effects, and interventions designed to control covid-19 need to take account of unintended consequences
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Public Health Ethics, 2020
The argument from inductive risk claims that judgments about the moral severity of errors are rel... more The argument from inductive risk claims that judgments about the moral severity of errors are relevant to decisions about what should count as sufficient evidence for accepting claims. While this idea has been explored in connection with evidence required for the approval of pharmaceuticals, the role of inductive risk in the post-approval process has been largely neglected. In this article, we examine the ethics of inductive risk in connection with revisions to the product monograph for OxyContin in Canada, which understates the risks of addiction and abuse associated with this drug. Using the concept of inductive risk, we consider what evidence should have been sufficient for Health Canada (HC) to revise the product monograph for OxyContin. Given the stakes involved, we argue that a less strict standard of evidence would have been appropriate, yet HC in fact took the opposite course, insisting upon a higher standard of evidence than it normally requires. In addition to providing a novel perspective on the opioid crisis in Canada, this article contributes to existing philosophical work by demonstrating that inductive risks in the post-approval stage are important and linked to pre-approval inductive risks.
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Addiction, 2019
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The Israeli Journal of Occupational Therapy , 2019
High rates of addiction, overdose, and death make the opioid epidemic one of the most urgent publ... more High rates of addiction, overdose, and death make the opioid epidemic one of the most urgent public health issues in the United States, with more than 47,000 opioid related deaths in 2017. Evidence from the United States shows that opioid manufacturers' strategies to deceive the medical community about the safety and efficacy of opioids played a pivotal role in the American opioid epidemic. This paper investigates how pharmaceutical promotion practices in the United States influenced health professionals, the regulator and the public, and contributed to the opioid crisis. The study focuses on the approval of OxyContin (an opioid) in 1995 and the aggressive and misleading marketing campaign that followed its approval by its manufacturer, Purdue Pharma. This paper argues that drug companies' strategies to influence the medical community represent a significant public health concern. Identifying the influence of drug companies on the medical community can help prevent similar public health crises.
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American Journal of Public Health , 2019
In July 1973, a study at the University of Chicago linked radiation treatment during childhood to... more In July 1973, a study at the University of Chicago linked radiation treatment during childhood to a variety of diseases, including thyroid cancer. A few months later, a worker at Michael Reese Hospital in Chicago, Illinois found a registry of 5266 former patients who had been treated with radiation dur- ing the 1950s and 1960s. Hospital officials decided to contact these patients and arrange for follow- up medical examinations. Media coverage of the hospital’s campaign had a snowball effect that prompted more medical institutions to follow suit, resulting in the National Cancer Institute (NCI) launching a nationwide campaign to warn the public and medical community about the late health effects of ionizing radiation. This study describes how the single action of a hospital in Chicago and the media attention it attracted led to a national campaign to warn those who underwent radiation treatment during childhood.
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Conference Presentations by Itai Bavli
In January 1996, following the decision of the Food and Drug Administration (FDA), Health Canada ... more In January 1996, following the decision of the Food and Drug Administration (FDA), Health Canada (HC) approved OxyContin (an opioid) for the treatment of chronic pain. HC stated at the time of approval, in the drug’s product monograph (used to inform medical professionals about the safety and appropriate use of the drug), that OxyContin was safe and effective for chronic pain with low abuse potential. However, during the late 1990s and early 2000s, growth in the use of OxyContin was accompanied by widespread reports of addiction, abuse and deaths (GAO, 2003). This prompted the FDA, in 2001, to change the label of OxyContin, strengthening the warning (adding a “black box warning” to the drug packaging) regarding the drug’s abuse liability and risk of addiction. HC, based on available evidence at that time, believed the problem of OxyContin was limited to the United States and decided not to change the product monograph (Sullivan, 2001). Only in 2006, did HC change the OxyContin monograph, strengthening the warning of OxyContin abuse. Drawing on philosophical discussions of inductive risk (Douglas, 2000, 2009; Rudner, 1953), we investigate the ethical obligation of HC to revise and change the original product monograph of OxyContin. We examine how much evidence—and what kind of evidence—should be sufficient for the agency to act.
Evidence shows that Purdue Pharma (manufacturer of OxyContin)—knowing that physicians routinely view drugs monographs to learn about drugs’ efficacy and proper use—used the erroneous information, as it appeared on the monograph, as a principle selling point to influence physicians to increase prescribing (Meier, 2018). By 2001, OxyContin had become the most frequently prescribed narcotic drug in the United States for treating moderate to severe pain (GAO, 2003). A steep increase in opioid prescriptions, with OxyContin at the center of the problem, was the gateway to the opioid epidemic. Many individuals who developed opioid dependency eventually turned to cheaper or more potent street drugs, including heroin or synthetic opioids such as fentanyl. High rates of addiction, overdose, and death make the opioid epidemic one of the most urgent public health issues in the Canada, with nearly 4,000 opioid-related deaths in 2017 (Health Canada, 2018).
We approach the ethics of this issue from the perspective of the argument from inductive risk. According to this argument, value judgments about how bad an error would be in a moral sense are relevant to deciding what should count as sufficient evidence for asserting a claim (Douglas, 2000, 2009; Rudner, 1953). In this case, we argue that a consideration of inductive risks would have supported taking lower quality evidence as sufficient for revising the product monograph. In fact, Health Canada did the opposite, and demanded stronger evidence than it normally requires. Thus, we recommend that inductive risks be explicitly considered in future cases.
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Papers by Itai Bavli
• Public health policies to combat SARS-CoV-2 mostly rely on models designed to predict their benefits
• These models often ignore potential harms that arise from these policies
• The short and long term adverse health effects of physical distancing measures, including unnecessary deaths, need to be evaluated and vulnerable populations identified
• Economic effects cannot be separated from health effects, and interventions designed to control covid-19 need to take account of unintended consequences
Conference Presentations by Itai Bavli
Evidence shows that Purdue Pharma (manufacturer of OxyContin)—knowing that physicians routinely view drugs monographs to learn about drugs’ efficacy and proper use—used the erroneous information, as it appeared on the monograph, as a principle selling point to influence physicians to increase prescribing (Meier, 2018). By 2001, OxyContin had become the most frequently prescribed narcotic drug in the United States for treating moderate to severe pain (GAO, 2003). A steep increase in opioid prescriptions, with OxyContin at the center of the problem, was the gateway to the opioid epidemic. Many individuals who developed opioid dependency eventually turned to cheaper or more potent street drugs, including heroin or synthetic opioids such as fentanyl. High rates of addiction, overdose, and death make the opioid epidemic one of the most urgent public health issues in the Canada, with nearly 4,000 opioid-related deaths in 2017 (Health Canada, 2018).
We approach the ethics of this issue from the perspective of the argument from inductive risk. According to this argument, value judgments about how bad an error would be in a moral sense are relevant to deciding what should count as sufficient evidence for asserting a claim (Douglas, 2000, 2009; Rudner, 1953). In this case, we argue that a consideration of inductive risks would have supported taking lower quality evidence as sufficient for revising the product monograph. In fact, Health Canada did the opposite, and demanded stronger evidence than it normally requires. Thus, we recommend that inductive risks be explicitly considered in future cases.
• Public health policies to combat SARS-CoV-2 mostly rely on models designed to predict their benefits
• These models often ignore potential harms that arise from these policies
• The short and long term adverse health effects of physical distancing measures, including unnecessary deaths, need to be evaluated and vulnerable populations identified
• Economic effects cannot be separated from health effects, and interventions designed to control covid-19 need to take account of unintended consequences
Evidence shows that Purdue Pharma (manufacturer of OxyContin)—knowing that physicians routinely view drugs monographs to learn about drugs’ efficacy and proper use—used the erroneous information, as it appeared on the monograph, as a principle selling point to influence physicians to increase prescribing (Meier, 2018). By 2001, OxyContin had become the most frequently prescribed narcotic drug in the United States for treating moderate to severe pain (GAO, 2003). A steep increase in opioid prescriptions, with OxyContin at the center of the problem, was the gateway to the opioid epidemic. Many individuals who developed opioid dependency eventually turned to cheaper or more potent street drugs, including heroin or synthetic opioids such as fentanyl. High rates of addiction, overdose, and death make the opioid epidemic one of the most urgent public health issues in the Canada, with nearly 4,000 opioid-related deaths in 2017 (Health Canada, 2018).
We approach the ethics of this issue from the perspective of the argument from inductive risk. According to this argument, value judgments about how bad an error would be in a moral sense are relevant to deciding what should count as sufficient evidence for asserting a claim (Douglas, 2000, 2009; Rudner, 1953). In this case, we argue that a consideration of inductive risks would have supported taking lower quality evidence as sufficient for revising the product monograph. In fact, Health Canada did the opposite, and demanded stronger evidence than it normally requires. Thus, we recommend that inductive risks be explicitly considered in future cases.