2019
Generic Drugs in the United States: Policies to Address Pricing and Competition
Gupta R, Shah ND, Ross JS. Generic Drugs in the United States: Policies to Address Pricing and Competition. Clinical Pharmacology & Therapeutics 2019, 105: 329-337. PMID: 30471089, PMCID: PMC6355356, DOI: 10.1002/cpt.1314.Commentaries, Editorials and LettersConceptsPrice increasesDrug pricesPatent drugsGeneric drugsBrand-name manufacturersGeneric drug applicationsGeneric competitionGeneric versionsPricesPolicy solutionsUnited StatesCompetitionPolicySource of concernPrescription drugsCostPricingMarketAgency policiesPolicymakersCompetitorsPast decadeFDA's roleShortageManufacturers
2018
Affordability and availability of off-patent drugs in the United States—the case for importing from abroad: observational study
Gupta R, Bollyky TJ, Cohen M, Ross JS, Kesselheim AS. Affordability and availability of off-patent drugs in the United States—the case for importing from abroad: observational study. The BMJ 2018, 360: k831. PMID: 29555641, PMCID: PMC5858606, DOI: 10.1136/bmj.k831.Peer-Reviewed Original ResearchConceptsOff-patent drugsObservational studyRare diseasePrescription drugsPatent drugsStudy drugTotal Medicaid spendingCardiovascular diseaseOrphan drug designationPsychiatric diseasesDrug AdministrationPatient accessInfectious diseasesDiseaseDrug characteristicsEssential medicinesDrugsGeneric versionsGeneric drugsMedicaid spendingNovel tabletRegulatory agenciesFDAUnited StatesTreatment area
2016
Publication and reporting of clinical trial results: cross sectional analysis across academic medical centers
Chen R, Desai NR, Ross JS, Zhang W, Chau KH, Wayda B, Murugiah K, Lu DY, Mittal A, Krumholz HM. Publication and reporting of clinical trial results: cross sectional analysis across academic medical centers. The BMJ 2016, 352: i637. PMID: 26888209, PMCID: PMC4768882, DOI: 10.1136/bmj.i637.Peer-Reviewed Original ResearchConceptsAcademic medical centerInterventional clinical trialsClinical trialsMedical CenterStudy completionPrimary completion dateClinical trial resultsReporting of resultsSectional analysisInterventional trialsProportion of trialsTrial resultsTrialsMonthsPhase IIManual reviewLead investigatorUnited StatesProportionRate of publicationReportingCompletionPatientsCenter
2014
Impact of the ENHANCE Trial on the use of ezetimibe in the United States and Canada
Lu L, Krumholz HM, Tu JV, Ross JS, Ko DT, Jackevicius CA. Impact of the ENHANCE Trial on the use of ezetimibe in the United States and Canada. American Heart Journal 2014, 167: 683-689. PMID: 24766978, PMCID: PMC4215424, DOI: 10.1016/j.ahj.2014.01.014.Peer-Reviewed Original ResearchConceptsUse of ezetimibeENHANCE trialEzetimibe useProgression of atherosclerosisMain outcome measuresAtherosclerosis regression trialsMonthly numberOutcome measuresRegression trialsEzetimibeIMS HealthCommon evidence baseEvidence baseTrialsUnited StatesUtilization patternsFurther investigationDifferent utilization patternsPopulationDifferent patternsUse trendsAtherosclerosisSimvastatinProgression
2012
Regulatory Review of Novel Therapeutics — Comparison of Three Regulatory Agencies
Downing NS, Aminawung JA, Shah ND, Braunstein JB, Krumholz HM, Ross JS. Regulatory Review of Novel Therapeutics — Comparison of Three Regulatory Agencies. New England Journal Of Medicine 2012, 366: 2284-2293. PMID: 22591257, PMCID: PMC3504361, DOI: 10.1056/nejmsa1200223.Peer-Reviewed Original ResearchConceptsNovel therapeutic agentsEuropean Medicines AgencyHealth CanadaTherapeutic agentsNew therapeutic agentsMedian lengthTherapeutic comparisonsDrug AdministrationMedicines AgencyNew drug applicationsPrescription Drug User Fee ActNovel therapeuticsDrug applicationFDAUnique agentUnited StatesTotal review timeFirst reviewRegulatory agenciesReview timeDaysAgentsReviewRegulatory reviewVast majority
2011
Recent trends in chronic disease, impairment and disability among older adults in the United States
Hung WW, Ross JS, Boockvar KS, Siu AL. Recent trends in chronic disease, impairment and disability among older adults in the United States. BMC Geriatrics 2011, 11: 47. PMID: 21851629, PMCID: PMC3170191, DOI: 10.1186/1471-2318-11-47.Peer-Reviewed Original ResearchConceptsPrevalence of impairmentChronic diseasesOlder adultsDaily livingChronic lung diseaseMore chronic diseasesImpairment of cognitionPrevalence of disabilityOlder U.S. adultsProportion of respondentsIADL disabilityUrinary incontinenceLung diseaseHeart diseasePrevalence trendsInstrumental activitiesU.S. adultsDiseasePrevalenceImpairmentAdultsDisabilityMore diseasesRetirement StudyUnited StatesUse of Fibrates in the United States and Canada
Jackevicius CA, Tu JV, Ross JS, Ko DT, Carreon D, Krumholz HM. Use of Fibrates in the United States and Canada. JAMA 2011, 305: 1217-1224. PMID: 21427374, PMCID: PMC3332101, DOI: 10.1001/jama.2011.353.Peer-Reviewed Original ResearchMeSH KeywordsCanadaCardiovascular DiseasesCohort StudiesCosts and Cost AnalysisDiabetes Mellitus, Type 2Drug CostsDrugs, GenericFenofibrateFibric AcidsHealth ExpendituresHumansHydroxymethylglutaryl-CoA Reductase InhibitorsHypolipidemic AgentsMedical AuditPractice Patterns, Physicians'PrescriptionsUnited StatesConceptsUse of fibratesRole of fibratesObservational cohort studyIMS Health dataFenofibrate useCardiovascular riskCohort studyDiabetes (ACCORD) trialClinical benefitFibratesMonthsPrescriptionUnited StatesPatientsNegative resultsFenofibrateHealth dataCurrent useGeneric formulationPopulationStatinsTherapyTrials
2009
Exposure to Low-Dose Ionizing Radiation from Medical Imaging Procedures
Fazel R, Krumholz HM, Wang Y, Ross JS, Chen J, Ting HH, Shah ND, Nasir K, Einstein AJ, Nallamothu BK. Exposure to Low-Dose Ionizing Radiation from Medical Imaging Procedures. New England Journal Of Medicine 2009, 361: 849-857. PMID: 19710483, PMCID: PMC3707303, DOI: 10.1056/nejmoa0901249.Peer-Reviewed Original ResearchConceptsCumulative effective dosesCumulative effective doseEffective dosesEffective doseMean cumulative effective doseImaging proceduresLow-dose ionizing radiationPopulation-based ratesMedian effective doseOutpatient settingGeneral populationHigh dosesUtilization dataDosesEnrolleesStudy periodRadiation exposureNuclear imagingDoseAnnual effective dosesMedical imaging proceduresUnited StatesExposureHealth care marketYears
2008
Use of Ezetimibe in the United States and Canada
Jackevicius CA, Tu JV, Ross JS, Ko DT, Krumholz HM. Use of Ezetimibe in the United States and Canada. New England Journal Of Medicine 2008, 358: 1819-1828. PMID: 18375999, DOI: 10.1056/nejmsa0801461.Peer-Reviewed Original ResearchConceptsLipid-lowering agentsLow-density lipoprotein cholesterolLipid-lowering guidelinesRatio of prescriptionsUse of ezetimibeTreatment of hyperlipidemiaStatin useCohort studyLipoprotein cholesterolSecondary preventionStatin prescriptionClinical outcomesPrescribing practicesEzetimibeIMS HealthUnited StatesPrescriptionMonthly numberFirst optionDistinct patterns