2024
Tackling the excesses of pharmaceutical marketing and promotion
Gupta R, Ramachandran R, Ross J. Tackling the excesses of pharmaceutical marketing and promotion. The BMJ 2024, 385: e076797. PMID: 38772671, DOI: 10.1136/bmj-2023-076797.Peer-Reviewed Original Research
2023
Medical Product Industry Ties to Patient Advocacy Organizations’ Executive Leadership
Bhat S, Ross J, Ramachandran R. Medical Product Industry Ties to Patient Advocacy Organizations’ Executive Leadership. JAMA Internal Medicine 2023, 183: 1164-1166. PMID: 37603342, PMCID: PMC10442781, DOI: 10.1001/jamainternmed.2023.2842.Peer-Reviewed Original Research
2022
Association Between Payments by Pharmaceutical Manufacturers and Prescribing Behavior in Rheumatology
Duarte-García A, Crowson CS, McCoy RG, Herrin J, Lam V, Putman MS, Ross JS, Matteson EL, Shah ND. Association Between Payments by Pharmaceutical Manufacturers and Prescribing Behavior in Rheumatology. Mayo Clinic Proceedings 2022, 97: 250-260. PMID: 35120693, PMCID: PMC9013005, DOI: 10.1016/j.mayocp.2021.08.026.Peer-Reviewed Original Research
2021
Strengthening the FDA’s Enforcement of ClinicalTrials.gov Reporting Requirements
Ramachandran R, Morten CJ, Ross JS. Strengthening the FDA’s Enforcement of ClinicalTrials.gov Reporting Requirements. JAMA 2021, 326: 2131-2132. PMID: 34766971, DOI: 10.1001/jama.2021.19773.Commentaries, Editorials and LettersMeSH KeywordsActivin Receptors, Type IIAntineoplastic AgentsAxitinibCarcinoma, Renal CellClinical Trials as TopicClinical Trials, Phase II as TopicDrug IndustryHumansImmunoglobulin Fc FragmentsKidney NeoplasmsLaw EnforcementMandatory ReportingNational Institutes of Health (U.S.)Recombinant Fusion ProteinsRegistriesUnited StatesUnited States Food and Drug AdministrationComparison of Duration of Postapproval vs Pivotal Trials for Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval, 2009-2018
Wallach JD, Ramachandran R, Bruckner T, Ross JS. Comparison of Duration of Postapproval vs Pivotal Trials for Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval, 2009-2018. JAMA Network Open 2021, 4: e2133601. PMID: 34751764, PMCID: PMC8579231, DOI: 10.1001/jamanetworkopen.2021.33601.Peer-Reviewed Original ResearchImplementation of 21st Century Cures Act Expanded Access Policies Requirements
Kang S, Chang S, Ross JS, Miller JE. Implementation of 21st Century Cures Act Expanded Access Policies Requirements. Clinical Pharmacology & Therapeutics 2021, 110: 1579-1584. PMID: 34431083, DOI: 10.1002/cpt.2401.Peer-Reviewed Original ResearchTrends in Within-Class Changes in US Average Wholesale Prices for Brand-Name Medications for Common Conditions From 2015 to 2020
Liu P, Dhruva SS, Shah ND, Ross JS. Trends in Within-Class Changes in US Average Wholesale Prices for Brand-Name Medications for Common Conditions From 2015 to 2020. JAMA Network Open 2021, 4: e2035064. PMID: 33481031, PMCID: PMC7823226, DOI: 10.1001/jamanetworkopen.2020.35064.Peer-Reviewed Original Research
2020
Conflicts of Interest Among Authors of Published Cannabidiol Articles, 2014-2019.
Deary EC, Ross JS, Nyhan K, Wallach JD. Conflicts of Interest Among Authors of Published Cannabidiol Articles, 2014-2019. Annals Of Internal Medicine 2020, 172: 769-771. PMID: 32176891, DOI: 10.7326/m19-3650.Peer-Reviewed Original ResearchConfidentiality 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
2019
Digital medicine systems: an evergreening strategy or an advance in medication management?
Egilman AC, Ross JS. Digital medicine systems: an evergreening strategy or an advance in medication management? BMJ Evidence-Based Medicine 2019, 24: 203. PMID: 31754072, DOI: 10.1136/bmjebm-2019-111265.Commentaries, Editorials and LettersSharing of clinical trial data and results reporting practices among large pharmaceutical companies: cross sectional descriptive study and pilot of a tool to improve company practices
Miller J, Ross JS, Wilenzick M, Mello MM. Sharing of clinical trial data and results reporting practices among large pharmaceutical companies: cross sectional descriptive study and pilot of a tool to improve company practices. The BMJ 2019, 366: l4217. PMID: 31292127, PMCID: PMC6614834, DOI: 10.1136/bmj.l4217.Peer-Reviewed Original ResearchConceptsClinical trial dataTrial dataDrug approvalSectional descriptive studyPharmaceutical companiesFDA drug approvalsLarge pharmaceutical companiesClinical trialsDrug levelsNew drug approvalsUS FoodDrug AdministrationNew drug applicationsFDA approvalPatientsNovel drugsDescriptive studyDrug applicationTrialsDrugsExternal investigatorsSharing scoreDrug companiesTrial transparencyStudy measuresAnalysis of Postapproval Clinical Trials of Therapeutics Approved by the US Food and Drug Administration Without Clinical Postmarketing Requirements or Commitments
Skydel JJ, Luxkaranayagam AT, Dhruva SS, Ross JS, Wallach JD. Analysis of Postapproval Clinical Trials of Therapeutics Approved by the US Food and Drug Administration Without Clinical Postmarketing Requirements or Commitments. JAMA Network Open 2019, 2: e193410. PMID: 31074812, PMCID: PMC6512282, DOI: 10.1001/jamanetworkopen.2019.3410.Peer-Reviewed Original ResearchConceptsPostapproval clinical trialsClinical trialsPrimary completion datePostmarketing requirementsNovel therapeuticsDrug AdministrationUS FoodNew indicationsPharmaceutical companiesNew clinical studiesCross-sectional analysisClinical outcomesStudy design elementsPatient populationUnapproved indicationsEfficacy dataClinical studiesStudy completionMAIN OUTCOMEFirst approvalMost trialsTrialsFDATherapeutic approvalsTherapeuticsAssociation of Pharmaceutical Manufacturer Payments to Physicians and Prescribing Dosage of Opioids
Fleischman W, Agrawal S, Gross CP, Ross JS. Association of Pharmaceutical Manufacturer Payments to Physicians and Prescribing Dosage of Opioids. Journal Of General Internal Medicine 2019, 34: 1074-1076. PMID: 31011967, PMCID: PMC6614247, DOI: 10.1007/s11606-019-04897-9.Peer-Reviewed Original ResearchKept in the dark: Scotland rejects “sunshine” legislation
Ross JS. Kept in the dark: Scotland rejects “sunshine” legislation. The BMJ 2019, 364: l1379. PMID: 30926587, DOI: 10.1136/bmj.l1379.Commentaries, Editorials and LettersGeneric 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 roleShortageManufacturersThe Supreme Court's Latest Ruling on Drug Liability and its Implications for Future Failure-to-Warn Litigation
Morten CJ, Kesselheim AS, Ross JS. The Supreme Court's Latest Ruling on Drug Liability and its Implications for Future Failure-to-Warn Litigation. The Journal Of Law, Medicine & Ethics 2019, 47: 783-787. PMID: 31957583, DOI: 10.1177/1073110519897793.Commentaries, Editorials and Letters
2018
Alirocumab’s Price Reduction
Dhruva SS, Ross JS, Desai NR. Alirocumab’s Price Reduction. Circulation 2018, 138: 1502-1504. PMID: 30354510, DOI: 10.1161/circulationaha.118.036069.Commentaries, Editorials and LettersAvailability of Investigational Medicines Through the US Food and Drug Administration’s Expanded Access and Compassionate Use Programs
Puthumana J, Miller JE, Kim J, Ross JS. Availability of Investigational Medicines Through the US Food and Drug Administration’s Expanded Access and Compassionate Use Programs. JAMA Network Open 2018, 1: e180283-e180283. PMID: 30646072, PMCID: PMC6324420, DOI: 10.1001/jamanetworkopen.2018.0283.Peer-Reviewed Original ResearchConceptsCompassionate use programInvestigational medicinesFDA approvalNew drug application submissionAccess programExpanded AccessUS FoodAvailable FDA documentsLife-threatening conditionCross-sectional studyEvidence of safetyProtection of patientsUse programClinical trialsMAIN OUTCOMEDrug AdministrationInfectious diseasesDrug accessClinical development periodsFDA documentsApplication submissionPatientsDiseaseApprovalMonthsThe Impact of Off-Patent Drug Acquisitions on Prices
Gupta R, Henkel A, Forman HP, Ross JS. The Impact of Off-Patent Drug Acquisitions on Prices. Journal Of General Internal Medicine 2018, 33: 1007-1009. PMID: 29687433, PMCID: PMC6025665, DOI: 10.1007/s11606-018-4372-3.Peer-Reviewed Original ResearchAffordability 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