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The CSI:OPIOIDS project is a research study initiated to investigate the clinical contexts surrounding suicides and suicide attempts that occur after transitions in prescription opioid therapy for long-term pain.
The study was inspired by personal observations and anecdotal evidence of patients experiencing severe distress and, in some cases, death by suicide, following efforts to reduce or stop their long-term opioid prescriptions.
what is csi opioids??
This interview introduces CSI: Opioids, a research project by the University of Alabama at Birmingham focused on understanding suicides that occur following changes to prescription opioid pain medication.
“…as an investigator i also think it’s really important for us to understand when things are going very badly in the process of health care that we think is supposed to help people what’s that about we have to figure out we have to ask about that and sometimes badly included patients who actually killed themselves or attempted to commit attempted to die by suicide so csi opioids is a descriptive study..”
Inspired by personal observations and a database of hundreds of deaths compiled by Anne Fuqua, the study aims to move beyond simple cause-and-effect by exploring the complex factors and context surrounding these tragedies through a descriptive approach, similar to investigating airplane crashes.
The current phase involves a survey for grieving families and survivors to gauge willingness to participate in more in-depth future research like psychological autopsies, ultimately seeking to inform healthcare practices and prevent future losses.
“…I both observed personally and received countless letters from patients who are in extreme distress as efforts were made to reduce or stop prescription opioids that they had been receiving and sometimes they wrote me letters or actually saw patients just deteriorate right before my eyes and the question was since other people were also having good outcomes from reductions at the very same time what’s going on with these terrible situations where people are being harmed …”
DR. STEFAN G. KERTESZ TO THE FDA,
This document is a formal letter from Dr. Stefan G. Kertesz to the FDA, urging them to improve their communication regarding opioid risks.
Dr. Stefan Kertesz,MD Profile | University of Alabama at Birmingham
BACKGROUND
Dr. Kertesz, a professor and researcher with extensive experience in addiction and pain medicine, highlights two main areas for improvement: providing more accurate information on the actual risks of new opioid use disorder and overdose and, crucially, better informing the public and healthcare providers about the significant, sometimes delayed risks associated with reducing or discontinuing prescribed opioids.
He emphasizes the importance of addressing the mistreatment of long-term pain patients, including the elevated risk of suicide, particularly for those forced to change prescribers.
Dr. Kertesz urges the FDA to take immediate action to update its communication and guidance based on the latest scientific evidence, particularly concerning the real risks of OUD and the significant, often delayed, harms associated with opioid reduction and prescriber transitions for long-term pain patients.
He emphasizes the need for science-based care to mitigate the ongoing pattern of patient mistreatment.
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Here is a detailed briefing document reviewing the main themes and most important ideas or facts from the provided interview excerpts regarding the CSI:OPIOIDS project:
Briefing Document: Clinical Contexts of Suicide following Opioid Transitions (CSI:OPIOIDS)
Date: October 26, 2023 (Based on interview context of speaking 2 months after a November 2nd launch date, placing the interview around early January 2022, but presenting the briefing in the present.)
Source: Excerpts from an interview with Dr. Allison Varley (Researcher, UAB and Birmingham VA Medical Center), Dr. Stefan Kertesz (Physician Researcher), and Ann Fuqua (Registered Nurse and Recruitment Coordinator) about the CSI:OPIOIDS project.
Project Overview:
The CSI:OPIOIDS project is a research study initiated to investigate the clinical contexts surrounding suicides and suicide attempts that occur after transitions in prescription opioid therapy for long-term pain.
The study was inspired by personal observations and anecdotal evidence of patients experiencing severe distress and, in some cases, death by suicide, following efforts to reduce or stop their long-term opioid prescriptions.
Main Themes:
- Observational Evidence of Harm: The project stems from observing and receiving accounts of patients experiencing significant deterioration and even death by suicide during opioid transitions, contrasting with positive outcomes experienced by others undergoing similar changes. This highlights a critical need to understand when and why these negative outcomes occur.
- The Ethical Imperative to Study Harm: Dr. Kertesz emphasizes the ethical importance of investigating when healthcare interventions, intended to help, result in severe harm, including suicide. He states, “I think at an ethical-ish level I’m just concerned about it but as an investigator I also think it’s really important for us to understand when things are going very badly in the process of health care that we think is supposed to help people what’s that about.”
- Ann Fuqua’s Role and the Genesis of the Project: Ann Fuqua’s personal experience of losing a friend to a myocardial infarction four days after rapid opioid taper, coupled with her subsequent collection of hundreds of documented deaths (including a significant number of suicides) following opioid transitions, was the primary catalyst for the project. Her “list” served as foundational evidence of the scale of the problem. Dr. Cortez found her through Twitter, recognizing the importance of studying the losses Ann had documented.
- Focus on Understanding “How and Why” Bad Things Happen: The study is not designed to prove a simple cause-and-effect relationship (i.e., that opioid tapers cause suicide). Instead, it aims to provide a detailed, descriptive, and qualitative understanding of the circumstances, patient characteristics, and healthcare processes present when these tragic outcomes occur. This approach is likened to airplane crash investigations, which aim to understand the confluence of factors leading to a disaster rather than identifying a single cause.
- Two-Phase Study Design: The project is structured in two phases. Phase one is a pilot study using a survey to assess the willingness of bereaved families and survivors to engage with researchers and gather initial information about the deaths. Phase two, contingent on the success of phase one and securing funding, will involve more in-depth psychological autopsies, detailed interviews with survivors, and medical record reviews conducted by a multidisciplinary team of experts.
- Respect for Survivor Privacy and Consent: The researchers prioritized an ethical recruitment strategy, deciding against directly using Ann Fuqua’s privately collected data without explicit consent. They set up a system where survivors could voluntarily engage with the research team, acknowledging the vulnerability of individuals grieving and posting information online. Dr. Cortez states, “we wouldn’t assume that we have consent just because they reported a loss on facebook or something like that and I think that’s like the only fair way to do this because people post on facebook and they may think something is… not publicly accessible or not when they’re grieving”.
- Current Status (Phase One): As of the interview date (approximately early January 2022), the phase one survey had been open for about two months. They had received hundreds of visits to the website, several dozen people starting the survey, and 27 completed surveys. This was considered a positive start.
- Eligibility and Participation: The phase one survey is open to adults (19+ in Alabama, and adults from any US state or territory) who believe they have lost someone close to them by suicide after a change in pain medication (starting, stopping, increasing, or decreasing). Participation is voluntary, not compensated, and data is stored securely and confidentially. The survey can be completed online or by telephone and takes 10-15 minutes.
- Addressing Uncertainty in Cause of Death: The study is designed to accommodate situations where the medical examiner’s ruling differs from the family’s belief about the cause of death (e.g., ruled accidental, but family believes it was suicide). The survey allows respondents to describe what they know and their level of confidence, and the research team, including suicide experts, are familiar with the complexities of determining intent.
- Limitations and Future Aspirations (Studying Non-Fatal Distress): The researchers acknowledge the critical need to study individuals experiencing profound distress and suicidal ideation related to opioid transitions who have not died by suicide. However, they currently lack the ethical framework and resources to safely conduct research with this highly vulnerable population. They hope that the current study will pave the way for future research addressing these “very dire situations,” encouraged by receiving emails from individuals in distress.
- Motivation for Participation: Ann Fuqua highlights that participating in the study is a way for grieving families to contribute to preventing future tragedies. She says, “participating in this study is one of the most important things that they can do to help ensure that no one else down the line has to suffer as they have and that we can stop these needless tragic deaths.”
Most Important Ideas or Facts:
- The CSI:OPIOIDS project was inspired by the observed increase in severe distress and suicides among patients undergoing prescription opioid transitions for long-term pain.
- Ann Fuqua’s informal collection of hundreds of deaths provided compelling initial evidence of the problem.
- The study is descriptive and qualitative, seeking to understand the context and factors surrounding these deaths, not to prove a simple cause-and-effect.
- Phase one involves a voluntary survey for bereaved families and survivors to gauge willingness to participate in research and gather initial data.
- The study prioritizes ethical data collection and respect for survivor consent.
- The research team includes experts in suicide research, pain care, and health systems implementation.
- The study is open to adults in the US who believe a loved one died by suicide after an opioid pain medication change, regardless of the official cause of death ruling.
- The researchers recognize the urgent need to study individuals in distress who have not died by suicide but currently face ethical challenges in designing such research.
- The ultimate goal is to use the findings to inform healthcare providers, regulators, and policymakers on how to prevent these tragic outcomes.
Quotes from Original Sources:
- Dr. Kertesz : “…sometimes badly included patients who actually killed themselves or attempted to commit attempted to die by suicide so csi opioids is a descriptive study…”
- Dr. Kertesz: “…in my view when we undertake a change to health care with the goal of helping people if the patient winds up dead by suicide at the end of that that is not a successful change to their health care…”
- Dr. Kertesz: “…we wouldn’t assume that we have consent just because they reported a loss on facebook or something like that and I think that’s like the only fair way to do this…”
- Dr. Kertesz: “…what we’re asking is when the bad thing happens how and why does it happen…”
- Dr. Kertesz: “…ultimately when you study a selected set of cases where something terrible has happened the kind of insight you get is descriptive and qualitative it tells us about how and why bad things happen…”
- Ann Fuqua: “…participating in this study is one of the most important things that they can do to help ensure that no one else down the line has to suffer as they have and that we can stop these needless tragic deaths.”
ALL THESE PHYSICIAN SEEN BELOW ARE CLASSIFIED AS CRIMINALS BY THE DEA AND UNITED STATES DEPARTMENT OF JUSTICE
