On what basis did Health Canada approve OxyContin in 1996? A retrospective analysis of regulatory data.

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we conducted a retrospective analysis of Purdue Pharma's submission to Health Canada, including both published and unpublished clinical trials.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.

Michael Reese Hospital and the Campaign to Warn the US Public of the Long-Term Health Effects of Ionizing Radiation, 1973-1977.

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 during 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.

Key considerations in the adoption of Artificial Intelligence in public health.

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.

When Public Health Goes Wrong: Toward a New Concept of Public Health Error.

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.

Multi-Level Ethical Considerations of Artificial Intelligence Health Monitoring for People Living with Parkinson's Disease.

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-to-day 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.

Pharmaceutical company responses to Canadian opioid advertising restrictions: A framing analysis.

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.