Countering Hesitancy and Misinformation on Side Effects to Complete the Course of COVID Vaccination

It has been well-documented that concerns about side effects prevent many from soliciting immunization. And family medicine providers play a key role in addressing concerns about COVID vaccines. However, there are few documented examples of the decision-making process regarding second shots after the emergence of a concerning and previously unknown side effect. Therefore, we present a case where a primary care provider and patient worked together to analyze real-time adverse event data on post-vaccination shingles to decide whether to receive the second dose

Meta-analysis of heterogeneity

Meta-analyses Applying a Food and Drug Administration (FDA) method for opioid measurement dilemmas, we used meta-analytic techniques to quantify how much heterogeneity would have been observed across hypothetical state-comparison studies, each applying one of the 4 variants on the same sample (fixed effects). In preliminary analyses, Florida generally had higher opioid use than California, presumably due to an older population, scope of practice legislation and other factors

Overview of Evaluating ADFs in the Community

Dr. Nabarun Dasgupta presents as the invited Guest Speaker at the US Food and Drug Administration Advisory Committee on the 10 year evaluation of OxyContin reformulation. Epidemiologic considerations on evaluation of abuse deterrent formulations are presented. Presented June 10, 2020 at the Joint Meeting of the Drug Safety and Risk Management Advisory Committee (DSARM) and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) https://www.fda.gov/advisory-committees/advisory-committee-calendar/september-10-11-2020-joint-meeting-drug-safety-and-risk-management-advisory-committee-and-anestheti

Days’ Supply Assignment for Opioid Analgesics - Code and Jupyter Notebook

Code and output to accompany paper in Journal of Pharmacy Practic

Ghost in the Machine: The Emotional Gravity of Conducting Mortality Research

There is no abstract associated with this publication

The Case for Product-Specific Surveillance

There is no abstract associated with this publication

Analysis of Naloxone Buyers Club Data

Analytic code in Stata MP v17 for manuscript. Community naloxone distribution is an evidence-based overdose prevention strategy. The naloxone Buyers Club is comprised of 113 harm reduction programs in 40 states. The Buyers Club facilitated purchases of 3.7 million doses between 2017 and 2020. Only half received federal funding, necessitating mutual aid redistribution. To improve naloxone access, prescription-only designation should be reconsidered

Re-Analysis of X:BOT using Public Access Data Files

We had been developing new statistical theories and methods to address differential dropouts during trial enrollment, as part of a dissertation project at the University of North Carolina Gillings School of Global Public Health, in the Department of Biostatistics (Elizableth Ajazi, Committee Chair: Todd Schwartz, Advisor: Steve Marshall). The applied example we been working on uses recent publicly released data files from NIDA-CTN-0051 (ClinicalTrials.gov NCT02032433). The primary study report was published in The Lancet on January 27, 2018, entitled "Comparative effectiveness of extended-release naltrexone versus buprenorphine-naloxone for opioid relapse prevention (X:BOT): a multicentre, open-label, randomised controlled trial" by Lee et al. We were able to replicate the findings for the primary endpoints on efficacy. However, our attempt to replicate the primary safety outcome, overdose, failed. Suspecting we were not replicating the study properly, we examined the adverse event data meticulously. To our surprise we found more patients with overdose in the public file than in the published report