2020
Confidentiality Orders and Public Interest in Drug and Medical Device Litigation
Egilman AC, Kesselheim AS, Krumholz HM, Ross JS, Kim J, Kapczynski A. Confidentiality Orders and Public Interest in Drug and Medical Device Litigation. JAMA Internal Medicine 2020, 180: 292-299. PMID: 31657836, DOI: 10.1001/jamainternmed.2019.5161.Commentaries, Editorials and LettersMeSH KeywordsAccess to InformationConfidentialityDisclosureDrug IndustryHumansJurisprudenceLiability, LegalConceptsLegal practicePublic interestMedical device litigationImportant public health informationLegal standardsMedical device manufacturersLitigationSpecial communicationCourtObscure patternsCompany marketingMedical expertsRulesPublic health informationDevice manufacturersPublic healthSuccessful effortsLitigantsPracticePlaintiffsLawsuitsCertain typesInterestAccessDrug Administration
2016
Association between payments from manufacturers of pharmaceuticals to physicians and regional prescribing: cross sectional ecological study
Fleischman W, Agrawal S, King M, Venkatesh AK, Krumholz HM, McKee D, Brown D, Ross JS. Association between payments from manufacturers of pharmaceuticals to physicians and regional prescribing: cross sectional ecological study. The BMJ 2016, 354: i4189. PMID: 27540015, PMCID: PMC4989280, DOI: 10.1136/bmj.i4189.Peer-Reviewed Original ResearchConceptsHospital referral regionsOral anticoagulantsReferral regionsDiabetes drugsDrug classesGreater prescribingMedicare Part D beneficiariesAdditional daysPart D beneficiariesMedicare Part D prescriptionsCross-sectional analysisSectional ecological studyMedicare Part DPart D prescriptionsManufacturers of pharmaceuticalsPrescribingAnticoagulantsPhysiciansDrugsPart DEducational materialsSectional analysisStudy limitationsConsulting feesAssociationDespite Federal Legislation, Shortages Of Drugs Used In Acute Care Settings Remain Persistent And Prolonged
Chen SI, Fox ER, Hall MK, Ross JS, Bucholz EM, Krumholz HM, Venkatesh AK. Despite Federal Legislation, Shortages Of Drugs Used In Acute Care Settings Remain Persistent And Prolonged. Health Affairs 2016, 35: 798-804. PMID: 27140985, PMCID: PMC6712565, DOI: 10.1377/hlthaff.2015.1157.Peer-Reviewed Original ResearchConceptsCare drugsNational drug shortageDrug information servicesDrug shortagesAcute unscheduled careAcute care settingShortage of drugsUtah Drug Information ServiceIll patientsEmergency departmentUnscheduled careDrug Administration SafetyCare settingsAdministration safetyStudy periodDrugsDrug supplyCareEarly evidenceTotal numberPatientsAvailability of Clinical Trial Data From Industry‐Sponsored Cardiovascular Trials
Murugiah K, Ritchie JD, Desai NR, Ross JS, Krumholz HM. Availability of Clinical Trial Data From Industry‐Sponsored Cardiovascular Trials. Journal Of The American Heart Association 2016, 5: e003307. PMID: 27098969, PMCID: PMC4859296, DOI: 10.1161/jaha.116.003307.Peer-Reviewed Original ResearchConceptsIndividual participant-level dataLarge cardiovascular trialsCardiovascular trialsParticipant-level dataClinical trial dataPharmaceutical companiesMajor pharmaceutical companiesIndustry-sponsored clinical trialsInterventional trialsAvailable trialsClinical trialsTrial dataTrialsPatientsSpecific reasons
2013
A historic moment for open science: the Yale University Open Data Access project and medtronic.
Krumholz HM, Ross JS, Gross CP, Emanuel EJ, Hodshon B, Ritchie JD, Low JB, Lehman R. A historic moment for open science: the Yale University Open Data Access project and medtronic. Annals Of Internal Medicine 2013, 158: 910-1. PMID: 23778908, PMCID: PMC5459387, DOI: 10.7326/0003-4819-158-12-201306180-00009.Commentaries, Editorials and LettersUshering in a New Era of Open Science Through Data Sharing: The Wall Must Come Down
Ross JS, Krumholz HM. Ushering in a New Era of Open Science Through Data Sharing: The Wall Must Come Down. JAMA 2013, 309: 1355-1356. PMID: 23508736, DOI: 10.1001/jama.2013.1299.Commentaries, Editorials and Letters
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
Generic Atorvastatin and Health Care Costs
Jackevicius CA, Chou MM, Ross JS, Shah ND, Krumholz HM. Generic Atorvastatin and Health Care Costs. New England Journal Of Medicine 2011, 366: 201-204. PMID: 22149736, PMCID: PMC3319770, DOI: 10.1056/nejmp1113112.Peer-Reviewed Original ResearchPromoting transparency in pharmaceutical industry-sponsored research.
Ross JS, Gross CP, Krumholz HM. Promoting transparency in pharmaceutical industry-sponsored research. American Journal Of Public Health 2011, 102: 72-80. PMID: 22095335, PMCID: PMC3319748, DOI: 10.2105/ajph.2011.300187.Commentaries, Editorials and LettersConceptsClinical trial researchTrial researchIndividual clinical decisionsGuideline recommendationsEvidence-based practiceTRIAL REGISTRATIONSystematic reviewClinical decisionInvestigator contributionsTrial outcomesMedical literaturePublic healthSelective publicationClinical trial data analysisHealthTrial data analysisIndustry-sponsored researchPatientsPhysiciansA Model for Dissemination and Independent Analysis of Industry Data
Krumholz HM, Ross JS. A Model for Dissemination and Independent Analysis of Industry Data. JAMA 2011, 306: 1593-1594. PMID: 21990302, PMCID: PMC3688082, DOI: 10.1001/jama.2011.1459.Commentaries, Editorials and Letters
2010
Conflicts of Interest, Authorship, and Disclosures in Industry-Related Scientific Publications–4
Ross JS, Krumholz HM. Conflicts of Interest, Authorship, and Disclosures in Industry-Related Scientific Publications–4. Mayo Clinic Proceedings 2010, 85: 199-200. PMID: 20118400, PMCID: PMC2813835, DOI: 10.4065/mcp.2009.0744.Commentaries, Editorials and Letters
2009
Pooled Analysis of Rofecoxib Placebo-Controlled Clinical Trial Data: Lessons for Postmarket Pharmaceutical Safety Surveillance
Ross JS, Madigan D, Hill KP, Egilman DS, Wang Y, Krumholz HM. Pooled Analysis of Rofecoxib Placebo-Controlled Clinical Trial Data: Lessons for Postmarket Pharmaceutical Safety Surveillance. JAMA Internal Medicine 2009, 169: 1976-1985. PMID: 19933959, PMCID: PMC2830805, DOI: 10.1001/archinternmed.2009.394.Peer-Reviewed Original ResearchMeSH KeywordsAdverse Drug Reaction Reporting SystemsCardiovascular SystemCyclooxygenase 2 InhibitorsDrug IndustryHumansIncidenceLactonesMyocardial InfarctionRandomized Controlled Trials as TopicRisk AssessmentSafety-Based Drug WithdrawalsSulfonesTime FactorsUnited StatesUnited States Food and Drug AdministrationConceptsPlacebo-controlled trialVoluntary market withdrawalAdverse eventsCardiovascular riskThromboembolic adverse eventsMain outcome measurementsClinical trial dataRofecoxib groupOutcome measurementsTrial dataPlaceboTrial durationSafety surveillanceTrialsMarket withdrawalDeathRiskP-valueSurveillance effortsSubjectsWithdrawalRofecoxibYearsIncidenceDoseTrial Publication after Registration in ClinicalTrials.Gov: A Cross-Sectional Analysis
Ross JS, Mulvey GK, Hines EM, Nissen SE, Krumholz HM. Trial Publication after Registration in ClinicalTrials.Gov: A Cross-Sectional Analysis. PLOS Medicine 2009, 6: e1000144. PMID: 19901971, PMCID: PMC2728480, DOI: 10.1371/journal.pmed.1000144.Peer-Reviewed Original ResearchConceptsOptional data elementsClinical trialsTrial publicationsInternet-based registryCompleteness of registrationCross-sectional analysisSelective publicationPrimary outcomeUS National LibraryReporting TrialsPublication statusTrial resultsPhase ITrialsData elementsSignificant differencesEditors' SummaryEnd dateSystematic protocolClinicalTrialsRelationships with the drug industry: More regulation, greater transparency
Krumholz HM, Ross JS. Relationships with the drug industry: More regulation, greater transparency. The BMJ 2009, 338: b211. PMID: 19193612, DOI: 10.1136/bmj.b211.Commentaries, Editorials and Letters
2008
Updated Estimates of Pharmaceutical Company Payments to Physicians in Vermont
Ross JS, Nazem AG, Lurie P, Lackner JE, Krumholz HM. Updated Estimates of Pharmaceutical Company Payments to Physicians in Vermont. JAMA 2008, 300: 1998-2000. PMID: 18984886, DOI: 10.1001/jama.2008.560.Peer-Reviewed Original ResearchThe ADVANTAGE seeding trial: a review of internal documents.
Hill KP, Ross JS, Egilman DS, Krumholz HM. The ADVANTAGE seeding trial: a review of internal documents. Annals Of Internal Medicine 2008, 149: 251-8. PMID: 18711155, DOI: 10.7326/0003-4819-149-4-200808190-00006.Peer-Reviewed Original ResearchGuest Authorship and Ghostwriting in Publications Related to Rofecoxib: A Case Study of Industry Documents From Rofecoxib Litigation
Ross JS, Hill KP, Egilman DS, Krumholz HM. Guest Authorship and Ghostwriting in Publications Related to Rofecoxib: A Case Study of Industry Documents From Rofecoxib Litigation. JAMA 2008, 299: 1800-1812. PMID: 18413874, DOI: 10.1001/jama.299.15.1800.Peer-Reviewed Original Research
2007
Pharmaceutical Company Payments to Physicians: Early Experiences With Disclosure Laws in Vermont and Minnesota
Ross JS, Lackner JE, Lurie P, Gross CP, Wolfe S, Krumholz HM. Pharmaceutical Company Payments to Physicians: Early Experiences With Disclosure Laws in Vermont and Minnesota. JAMA 2007, 297: 1216-1223. PMID: 17374816, DOI: 10.1001/jama.297.11.1216.Peer-Reviewed Original ResearchWhat have we learnt from Vioxx?
Krumholz HM, Ross JS, Presler AH, Egilman DS. What have we learnt from Vioxx? The BMJ 2007, 334: 120. PMID: 17235089, PMCID: PMC1779871, DOI: 10.1136/bmj.39024.487720.68.Commentaries, Editorials and Letters