Drivers of the opioid crisis: An appraisal of financial conflicts of interest in clinical practice guideline panels at the peak of opioid prescribing

Spithoff, Sheryl; Leece, Pamela; Sullivan, Frank; Persaud, Nav; Belesiotis, Peter; Steiner, Liane

doi:10.1371/journal.pone.0227045

Cited by 37 publications

(35 citation statements)

References 65 publications

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“…It is very likely that pain experts were genuinely interested in minimizing pain. However, opioid‐related payments from pharma may have influenced decisions of some experts and societies 53,67,94 …”

Section: Category II Organizations: Important Influencersmentioning

confidence: 99%

The iatrogenic opioid crisis: An example of ‘institutional corruption of pharmaceuticals’?

Makhinson

Seshia

Young

et al. 2021

Evaluation Clinical Practice

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Rationale Prescribed opioids are major contributors to the international public health opioid crisis. Such widespread iatrogenic harms usually result from collective decision failures of healthcare organizations rather than solely of individual organizations or professionals. Findings from a system‐wide safety analysis of the iatrogenic opioid crisis that includes roles of pertinent healthcare organizations may help avoid or mitigate similar future iatrogenic consequences. In this retrospective exploratory study, we report such an analysis. Methods The study population encompassed the entire age spectrum and included those in whom opioids prescribed for chronic pain (unrelated to malignancy) were associated with death or morbidity. Root cause analysis, incorporating recent suggestions for improvement, was used to identify possible contributory factors from the literature. Based on their mandated roles and potential influences to prevent or mitigate the iatrogenic crisis, relevant organizations were grouped and stratified from most to least influential. Results The analysis identified a chain of multiple interrelated causal factors within and between organizations. The most influential organizations were pharmaceutical, political, and drug regulatory; next: experts and their related societies, and publications. Less influential: accreditation, professional licensing and regulatory, academic and healthcare funding bodies. Collectively, their views and decisions influenced prescribing practices of frontline healthcare professionals and advocacy groups. Financial associations between pharmaceutical and most other organizations/groups were common. Ultimately, patients were adversely affected. There was a complex association with psychosocial variables. Limitations The analysis suggests associations not causality. Conclusion The iatrogenic crisis has multiple intricately linked roots. The major catalyst: pervasive pharma‐linked financial conflicts of interest (CoIs) involving most other healthcare organizations. These extensive financial CoIs were likely triggers for a cascade of erroneous decisions and actions that adversely affected patients. The actions and decisions of pharma ranged from unethical to illegal. The iatrogenic opioid crisis may exemplify ‘institutional corruption of pharmaceuticals’.

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Section: Category II Organizations: Important Influencersmentioning

confidence: 99%

The iatrogenic opioid crisis: An example of ‘institutional corruption of pharmaceuticals’?

Makhinson

Seshia

Young

et al. 2021

Evaluation Clinical Practice

View full text Add to dashboard Cite

show abstract

“…Weak opioids (e.g., tramadol, codeine) are recommended for mild to moderate pain, and for severe pain, strong opioids (e.g., morphine, fentanyl) [ 3 ]. Advocacy for pain control, advertisement of efficacy of opioids for chronic pain based on low level evidence, and aggressive prescription practices by physicians resulted in an increased use of opioids for cancer and non-cancer related pain [ 4 – 6 ].…”

Section: Introductionmentioning

confidence: 99%

Increased risk of adverse events in non-cancer patients with chronic and high-dose opioid use—A health insurance claims analysis

Burgstaller¹,

Held²,

Signorell³

et al. 2020

PLoS ONE

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Background Chronic and high dose opioid use may result in adverse events. We analyzed the risk associated with chronic and high dose opioid prescription in a Swiss population. Methods Using insurance claims data covering one-sixth of the Swiss population, we analyzed recurrent opioid prescriptions (≥2 opioid claims with at least 1 strong opioid claim) between 2006 and 2014. We calculated the cumulative dose in milligrams morphine equivalents (MED) and treatment duration. Excluded were single opioid claims, opioid use that was cancer treatment related, and opioid use in substitution programs. We assessed the association between the duration of opioid use, prescribed opioid dose, and benzodiazepine use with emergency department (ED) visits, urogenital and pulmonary infections, acute care hospitalization, and death at the end of the episode. Results In 63,642 recurrent opioid prescription episodes (acute 38%, subacute 7%, chronic 25.8%, very chronic (>360 days) episodes 29%) 18,336 ED visits, 30,209 infections, 19,375 hospitalizations, and 9,662 deaths occurred. The maximum daily MED dose was <20 mg in 15.8%, 20−<50 mg in 16.6%, 50−<100 mg in 21.6%, and ≥100 mg in 46%. Compared to acute episodes (<90 days), episode duration was an independent predictor of ED visits (chronic OR 1.09 (95% CI 1.03–1.15), very chronic (>360 days) OR 1.76 (1.67–1.86)) for adverse effects; infections (chronic OR 1.74 (1.66–1.82), very chronic 4.16 (3.95–4.37)), and hospitalization (chronic: OR 1.22 (1.16–1.29), very chronic OR 1.82 (1.73–1.93)). The risk of death decreased over time (very chronic OR 0.46 (0.43–0.50)). A dose dependent increased risk was observed for ED visits, hospitalization, and death (≥100mg daily MED OR 1.21 (1.13–1.29), OR 1.29 (1.21–1.38), and OR 1.67, 1.50–1.85, respectively). A concomitant use of benzodiazepines increased the odds for ED visits by 46% (OR 1.46, 1.41–1.52), infections by 44% (OR 1.44, 1.41–1.52), hospitalization by 12% (OR 1.12, 1.07–1.1), and death by 45% (OR 1.45, 1.37–1.53). Conclusion The length of opioid use and higher prescribed morphine equivalent dose were independently associated with an increased risk for ED visits and hospitalizations. The risk for infections, ED visits, hospitalizations, and death also increased with concomitant benzodiazepine use.

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Section: Discussionmentioning

confidence: 99%

“…23 Similarly, guidelines for opioid prescribing for chronic noncancer pain from 2007 to 2013 were at risk of bias because of pervasive COIs with the pharmaceutical industry and the paucity of mechanisms to address bias. 24 KDIGO states that it makes every effort to avoid any actual or reasonably perceived COI that may arise as a result of an outside relationship or a personal, professional, or business interest of a panelist. All panelists are required to complete, sign, and submit a disclosure and attestation form showing all such relationships that may be perceived as or are actually a COI.…”

Section: Discussionmentioning

confidence: 99%

Self-reported Financial Conflict of Interest in Nephrology Clinical Practice Guidelines

Chengappa

Herrmann

Poonacha

2021

Kidney International Reports

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Introduction There is ongoing controversy concerning the potential influence of industry and financial conflict of interest (FCOI) in the development of clinical practice guidelines (CPG). The influence of industry in renal guideline development has been discussed in the past with emphasis on the National Kidney foundation (NKF) and Kidney and Dialysis Outcomes Quality Initiative guidelines. In this study we evaluate the self-reported FCOI among guideline panel members in Kidney Disease: Improving Global Outcomes (KDIGO) CPGs. Methods We examined 10 of the most recent KDIGO CPGs developed between 2009 and 2018. Using disclosure lists, we catalogued FCOIs for panelists for each individual CPG. The categories were Advisor/Consultant, Honoraria, Travel Stipend, Grant/Research Support, Speaker, Equity Interest, Employee, Board of Trustees, Royalties, Advisory Board, Employment, Ownership, Data Monitoring Committee, Expert Testimony, and Development of Education Materials. We also reviewed FCOIs for members of evidence review team (ERT). We also catalogued the company involved in each disclosure. One conflict describes 1 instance of participation of an individual in 1 category in each guideline. “Company” describes a commercial, industry, or institute affiliation reported in each episode. Results One hundred two (66.4%) of the total 151 panelists reported FCOI. A total of 662 conflicts were disclosed. Being a consultant or advisor was the most common category. One hundred fifty-one companies were associated with FCOI disclosure. One company was most frequently reported, involving 60 (9%) of 662 conflicts. Of the 52 members in the ERT, there was 1 instance of FCOI. Conclusion FCOI is prevalent in KDIGO guidelines with almost two thirds of the panelists self-reporting FCOI. The evidence review team had only 1 instance of FCOI.

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Drivers of the opioid crisis: An appraisal of financial conflicts of interest in clinical practice guideline panels at the peak of opioid prescribing

Cited by 37 publications

References 65 publications

The iatrogenic opioid crisis: An example of ‘institutional corruption of pharmaceuticals’?

The iatrogenic opioid crisis: An example of ‘institutional corruption of pharmaceuticals’?

Increased risk of adverse events in non-cancer patients with chronic and high-dose opioid use—A health insurance claims analysis

Self-reported Financial Conflict of Interest in Nephrology Clinical Practice Guidelines

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