2023
Early OxyContin Marketing Linked To Long-Term Spread Of Infectious Diseases Associated With Injection Drug Use
Dennett J, Gonsalves G. Early OxyContin Marketing Linked To Long-Term Spread Of Infectious Diseases Associated With Injection Drug Use. Health Affairs 2023, 42: 1081-1090. PMID: 37467441, PMCID: PMC10521060, DOI: 10.1377/hlthaff.2023.00146.Peer-Reviewed Original ResearchConceptsInjection drug useDrug useAdverse long-term outcomesInfectious diseasesReformulation of OxyContinAcute hepatitis ALong-term outcomesOpioid-related overdosesInitial marketingFatal drug overdosesBacterial complicationsHepatitis ADrug overdosesEffects of exposureOpioid epidemicViral infectionGreater burdenIllicit drugsLow exposureComplicationsHigh exposureOverdosesOutcomesDiseaseOxyContin
2021
The Dynamics of Infectious Diseases Associated With Injection Drug Use in Lawrence and Lowell, Massachusetts
Gonsalves GS, Paltiel A, Thornhill T, Iloglu S, DeMaria A, Cranston K, Klevens R, Walensky RP, Warren JL. The Dynamics of Infectious Diseases Associated With Injection Drug Use in Lawrence and Lowell, Massachusetts. Open Forum Infectious Diseases 2021, 8: ofab128. PMID: 34189158, PMCID: PMC8231383, DOI: 10.1093/ofid/ofab128.Peer-Reviewed Original ResearchInjection drug useDrug useHuman immunodeficiency virus (HIV) outbreaksInfectious diseasesSoft tissue infectionsCases of skinPublic health departmentsPoisson regression modelsInfectious complicationsTissue infectionsHIV casesDrainage proceduresFatal overdosesHealth departmentsComplicationsEarly interventionMonthsPotential outbreaksVirus outbreakSentinel SystemDiseaseRegression modelsOutbreakHIVOverdoses
2018
Comparison of treatment effect sizes from pivotal and postapproval trials of novel therapeutics approved by the FDA based on surrogate markers of disease: a meta-epidemiological study
Wallach JD, Ciani O, Pease AM, Gonsalves GS, Krumholz HM, Taylor RS, Ross JS. Comparison of treatment effect sizes from pivotal and postapproval trials of novel therapeutics approved by the FDA based on surrogate markers of disease: a meta-epidemiological study. BMC Medicine 2018, 16: 45. PMID: 29562926, PMCID: PMC5863466, DOI: 10.1186/s12916-018-1023-9.Peer-Reviewed Original ResearchConceptsPostapproval trialsPivotal trialsActual clinical effectSurrogate markerTrial endpointsLarge treatment effectsPrimary endpointNovel therapeuticsNovel drugsTreatment effectsFDA approvalPatient-relevant outcomesMeta-epidemiological studyStandardized mean differenceTreatment effect sizeClinical effectsResultsBetween 2005Odds ratioDrug trialsSame indicationDrug AdministrationEvidence of differencesMean differenceU.S. FoodDisease