{"id":"https://openalex.org/W1994074491","doi":"https://doi.org/10.1136/bmj.h1500","title":"Commentary: Will 20th century patient safeguards be reversed in the 21st century?","display_name":"Commentary: Will 20th century patient safeguards be reversed in the 21st century?","publication_year":2015,"publication_date":"2015-03-25","ids":{"openalex":"https://openalex.org/W1994074491","doi":"https://doi.org/10.1136/bmj.h1500","mag":"1994074491","pmid":"https://pubmed.ncbi.nlm.nih.gov/25814537"},"language":"en","primary_location":{"id":"doi:10.1136/bmj.h1500","doi":"https://doi.org/10.1136/bmj.h1500","is_oa":false,"landing_page_url":"https://doi.org/10.1136/bmj.h1500","pdf_url":null,"source":{"id":"https://openalex.org/S4393917726","display_name":"BMJ","issn_l":"1756-1833","issn":["1756-1833"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","dongbi-a","doyens","jufo-2","ki-jl-3","medline","norway-2","poland-200","russia-white-list-1","vabb-shw"],"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"BMJ","raw_type":"journal-article"},"volume":null,"type":"editorial","indexed_in":["crossref","pubmed"],"open_access":{"is_oa":false,"oa_status":"closed","oa_url":null,"any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5047954147","display_name":"Gregg Gonsalves","orcid":"https://orcid.org/0000-0002-5789-9841","observed_orcids":["https://orcid.org/0000-0002-5789-9841"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"G. Gonsalves","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"last","author":{"id":null,"display_name":"D. Zuckerman","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":true,"raw_author_name":"D. Zuckerman","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]}],"institutions":[],"countries_distinct_count":0,"institutions_distinct_count":0,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":null,"has_fulltext":false,"cited_by_count":17,"citation_normalized_percentile":null,"cited_by_percentile_year":null,"biblio":{"volume":"350","issue":"mar25 7","first_page":"h1500","last_page":"h1500"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T13417","display_name":"Biomedical Ethics and Regulation","score":0.37720000743865967,"subfield":{"id":"https://openalex.org/subfields/2737","display_name":"Physiology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T13417","display_name":"Biomedical Ethics and Regulation","score":0.37720000743865967,"subfield":{"id":"https://openalex.org/subfields/2737","display_name":"Physiology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T14396","display_name":"Healthcare Regulation","score":0.33079999685287476,"subfield":{"id":"https://openalex.org/subfields/3605","display_name":"Health Information Management"},"field":{"id":"https://openalex.org/fields/36","display_name":"Health Professions"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T11649","display_name":"Pharmaceutical industry and healthcare","score":0.13979999721050262,"subfield":{"id":"https://openalex.org/subfields/3004","display_name":"Pharmacology"},"field":{"id":"https://openalex.org/fields/30","display_name":"Pharmacology, Toxicology and Pharmaceutics"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/fda-drug-approval-process","display_name":"FDA drug approval process","score":0.6909999847412109},{"id":"https://openalex.org/keywords/drug-safety","display_name":"drug safety","score":0.5590000152587891},{"id":"https://openalex.org/keywords/hiv-aids-activism","display_name":"AIDS activism","score":0.5730000138282776},{"id":"https://openalex.org/keywords/accelerated-approval","display_name":"accelerated approval","score":0.828000009059906},{"id":"https://openalex.org/keywords/expanded-access-program","display_name":"expanded access program","score":0.9279999732971191},{"id":"https://openalex.org/keywords/thalidomide","display_name":"thalidomide","score":0.8190000057220459},{"id":"https://openalex.org/keywords/dalkon-shield","display_name":"Dalkon Shield","score":0.8180000185966492},{"id":"https://openalex.org/keywords/vaccine-contamination","display_name":"vaccine contamination","score":0.6010000109672546},{"id":"https://openalex.org/keywords/patient-safety","display_name":"patient safety","score":0.3959999978542328},{"id":"https://openalex.org/keywords/drug-regulation-reform","display_name":"drug regulation reform","score":0.48500001430511475}],"concepts":[{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.6458548903465271},{"id":"https://openalex.org/C3018890749","wikidata":"https://www.wikidata.org/wiki/Q204711","display_name":"Food and drug administration","level":2,"score":0.5907480716705322},{"id":"https://openalex.org/C2780900520","wikidata":"https://www.wikidata.org/wiki/Q100268981","display_name":"Denial","level":2,"score":0.5546867251396179},{"id":"https://openalex.org/C2775832928","wikidata":"https://www.wikidata.org/wiki/Q407954","display_name":"Expanded access","level":2,"score":0.5139040946960449},{"id":"https://openalex.org/C3013748606","wikidata":"https://www.wikidata.org/wiki/Q15787","display_name":"Human immunodeficiency virus (HIV)","level":2,"score":0.46864813566207886},{"id":"https://openalex.org/C512399662","wikidata":"https://www.wikidata.org/wiki/Q3505712","display_name":"Family medicine","level":1,"score":0.39718854427337646},{"id":"https://openalex.org/C199539241","wikidata":"https://www.wikidata.org/wiki/Q7748","display_name":"Law","level":1,"score":0.3384714126586914},{"id":"https://openalex.org/C17744445","wikidata":"https://www.wikidata.org/wiki/Q36442","display_name":"Political science","level":0,"score":0.33137959241867065},{"id":"https://openalex.org/C545542383","wikidata":"https://www.wikidata.org/wiki/Q2751242","display_name":"Medical emergency","level":1,"score":0.29837456345558167},{"id":"https://openalex.org/C15744967","wikidata":"https://www.wikidata.org/wiki/Q9418","display_name":"Psychology","level":0,"score":0.12210428714752197},{"id":"https://openalex.org/C142724271","wikidata":"https://www.wikidata.org/wiki/Q7208","display_name":"Pathology","level":1,"score":0.10628587007522583},{"id":"https://openalex.org/C11171543","wikidata":"https://www.wikidata.org/wiki/Q41630","display_name":"Psychoanalysis","level":1,"score":0.0}],"mesh":[{"descriptor_ui":"D000163","descriptor_name":"Acquired Immunodeficiency Syndrome","qualifier_ui":"Q000188","qualifier_name":"drug therapy","is_major_topic":false},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D014481","descriptor_name":"United States","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D014486","descriptor_name":"United States Food and Drug Administration","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D015658","descriptor_name":"HIV Infections","qualifier_ui":"Q000188","qualifier_name":"drug therapy","is_major_topic":false},{"descriptor_ui":"D049673","descriptor_name":"History, 20th Century","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D049674","descriptor_name":"History, 21st Century","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D055553","descriptor_name":"Prescription Drugs","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":true},{"descriptor_ui":"D055808","descriptor_name":"Drug Discovery","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":false},{"descriptor_ui":"D061214","descriptor_name":"Patient Safety","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true}],"locations_count":2,"locations":[{"id":"doi:10.1136/bmj.h1500","doi":"https://doi.org/10.1136/bmj.h1500","is_oa":false,"landing_page_url":"https://doi.org/10.1136/bmj.h1500","pdf_url":null,"source":{"id":"https://openalex.org/S4393917726","display_name":"BMJ","issn_l":"1756-1833","issn":["1756-1833"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","dongbi-a","doyens","jufo-2","ki-jl-3","medline","norway-2","poland-200","russia-white-list-1","vabb-shw"],"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"BMJ","raw_type":"journal-article"},{"id":"pmid:25814537","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/25814537","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"BMJ (Clinical research ed.)","raw_type":"Historical Article"}],"best_oa_location":null,"sustainable_development_goals":[{"display_name":"Good health and well-being","score":0.8560000061988831,"id":"https://metadata.un.org/sdg/3"}],"study_designs":[],"awards":[],"funders":[],"has_content":{"grobid_xml":false,"pdf":false},"content_urls":null,"referenced_works_count":5,"referenced_works":["https://openalex.org/W1530825044","https://openalex.org/W2097833714","https://openalex.org/W2130434619","https://openalex.org/W2146628582","https://openalex.org/W2147671322"],"related_works":["https://openalex.org/W4297337636","https://openalex.org/W4410534346","https://openalex.org/W4239186455","https://openalex.org/W7037883448","https://openalex.org/W4296626517","https://openalex.org/W1933462502","https://openalex.org/W2906483764","https://openalex.org/W2477836930","https://openalex.org/W1994689960","https://openalex.org/W205869769"],"abstract_inverted_index":{"Most":[0],"physicians":[1],"and":[2,10,21,58,81,83,149,161,171,179,195],"patients":[3],"assume":[4],"that":[5,41,100,206],"medications":[6],"are":[7],"proved":[8],"safe":[9],"effective.":[11],"This":[12],"hasn\u2019t":[13],"always":[14],"been":[15],"the":[16,38,51,78,87,93,102,110,112,117,130,141,177],"case.":[17],"The":[18],"US":[19],"Food":[20],"Drug":[22],"Administration":[23],"was":[24],"born":[25],"out":[26,173],"of":[27,30,35,40,54],"a":[28,63],"series":[29],"20th":[31],"century":[32],"tragedies:":[33],"contamination":[34],"vaccines":[36],"at":[37,168],"turn":[39],"century;":[42],"dangerous":[43],"substances":[44],"found":[45],"in":[46,50,60,67,77,92],"commonly":[47],"sold":[48],"medicines":[49],"1900s;":[52],"deaths":[53,84],"over":[55],"100":[56],"children":[57],"adults":[59],"1937":[61],"from":[62,122],"sulfa":[64],"drug":[65,143,159,193],"dissolved":[66],"diethylene":[68],"glycol":[69],"(antifreeze);":[70],"extensive":[71],"birth":[72],"defects":[73],"caused":[74,85],"by":[75,86],"thalidomide":[76],"early":[79],"1960s;":[80],"infertility":[82],"Dalkon":[88],"Shield":[89],"intrauterine":[90],"device":[91],"1970s.1":[94],"Those":[95],"tragedies":[96],"all":[97],"inspired":[98],"laws":[99],"strengthened":[101],"criteria":[103],"used":[104],"to":[105,116,151,174],"allow":[106],"medical":[107],"products":[108],"on":[109],"market.\n\nSubsequently,":[111],"first":[113],"effective":[114],"challenge":[115],"FDA\u2019s":[118,142],"growing":[119],"authority":[120],"came":[121],"an":[123],"unlikely":[124],"source:":[125],"people":[126,133],"with":[127,134],"HIV/AIDS.":[128],"In":[129],"1980s,":[131],"as":[132,146],"AIDS":[135,154],"faced":[136],"certain":[137],"death,":[138],"they":[139],"criticized":[140],"approval":[144,160,194,208],"process":[145],"too":[147],"slow":[148],"unresponsive":[150],"their":[152],"needs.":[153],"activists":[155,202],"pressed":[156],"for":[157,191,199],"expedited":[158],"making":[162],"experimental":[163,200],"therapies":[164],"widely":[165],"available,":[166],"demonstrating":[167],"FDA":[169,175,187],"headquarters,":[170],"speaking":[172],"officials,":[176],"media,":[178],"Congress.":[180],"They":[181],"were":[182],"remarkably":[183],"successful,":[184],"helping":[185],"shape":[186],"reforms,":[188],"including":[189],"pathways":[190],"accelerated":[192],"expanded":[196],"access":[197],"programs":[198],"medicines.\n\nAIDS":[201],"quickly":[203],"learnt,":[204],"however,":[205],"speedier":[207],"\u2026":[209]},"counts_by_year":[{"year":2023,"cited_by_count":1},{"year":2022,"cited_by_count":1},{"year":2019,"cited_by_count":2},{"year":2018,"cited_by_count":3},{"year":2017,"cited_by_count":4},{"year":2016,"cited_by_count":3},{"year":2015,"cited_by_count":3}],"updated_date":"2026-10-31T12:09:11.096373","created_date":"2016-06-24T00:00:00"}
