2022
Renewing the Call for Reforms to Medical Device Safety—The Case of Penumbra
Kadakia KT, Beckman AL, Ross JS, Krumholz HM. Renewing the Call for Reforms to Medical Device Safety—The Case of Penumbra. JAMA Internal Medicine 2022, 182: 59-65. PMID: 34842892, DOI: 10.1001/jamainternmed.2021.6626.Commentaries, Editorials and LettersConceptsReperfusion catheterClinical evidenceClass IPenumbra reperfusion catheterSingle-arm trialUser Facility Device Experience (MAUDE) databaseAdverse event reportsPostmarket surveillanceHealth policy makersMedical device reportsPenumbra deviceClinical evaluationPatient deathDevice safetyMedicine recommendationsAnimal dataCatheterFDA databaseFDA medical device regulationsClinical literatureSmall sample sizeDevice reportsEvent reportsPublic healthExperience database
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 LettersConceptsLegal practicePublic interestMedical device litigationImportant public health informationLegal standardsMedical device manufacturersLitigationSpecial communicationCourtObscure patternsCompany marketingMedical expertsRulesPublic health informationDevice manufacturersPublic healthSuccessful effortsLitigantsPracticePlaintiffsLawsuitsCertain typesInterestAccessDrug Administration
2017
Blueprint for Transparency at the U.S. Food and Drug Administration: Recommendations to Advance the Development of Safe and Effective Medical Products
Sharfstein J, Miller J, Davis A, Ross J, McCarthy M, Smith B, Chaudhry A, Alexander G, Kesselheim A. Blueprint for Transparency at the U.S. Food and Drug Administration: Recommendations to Advance the Development of Safe and Effective Medical Products. The Journal Of Law, Medicine & Ethics 2017, 45: 7-23. DOI: 10.1177/1073110517750615.Commentaries, Editorials and LettersYale Law SchoolEffective medical productsSuch medical productsMedical productsJohn Arnold FoundationLaw schoolsCongressional authorizationDevelopment of SafeYale Medical SchoolFDA practiceCongressional actionRegulatory statusRegulatory processesTransparencyPolicy constraintsJohns Hopkins Bloomberg SchoolPractical recommendationsPublicPublic healthTask ForceSpecific recommendationsRecommendationsPracticeBlueprintAuthorization
2014
Inconsistencies among European Union Pharmaceutical Regulator Safety Communications: A Cross-Country Comparison
Zeitoun JD, Lefèvre JH, Downing N, Bergeron H, Ross JS. Inconsistencies among European Union Pharmaceutical Regulator Safety Communications: A Cross-Country Comparison. PLOS ONE 2014, 9: e109100. PMID: 25333986, PMCID: PMC4204813, DOI: 10.1371/journal.pone.0109100.Peer-Reviewed Original Research
2011
Promoting 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 researchPatientsPhysiciansAdherence of Pharmaceutical Advertisements in Medical Journals to FDA Guidelines and Content for Safe Prescribing
Korenstein D, Keyhani S, Mendelson A, Ross JS. Adherence of Pharmaceutical Advertisements in Medical Journals to FDA Guidelines and Content for Safe Prescribing. PLOS ONE 2011, 6: e23336. PMID: 21858076, PMCID: PMC3157354, DOI: 10.1371/journal.pone.0023336.Peer-Reviewed Original ResearchConceptsSafe prescribingPharmaceutical advertisementsCross-sectional analysisFDA guidelinesAdherence ratesCounter medicationsMedian 2Inclusion criteriaDisease awarenessCurrent FDA guidelinesDrug AdministrationPrescribingPharmaceutical advertisingSerious riskUnique advertisementsAdherenceDrug namesPublic healthStudy limitationsEfficacy informationGuideline itemsMedical journalsGuidelinesFDARisk