PLOS Medicine: Difference between revisions
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{{Infobox journal |
{{Infobox journal |
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| cover = [[File:PLOS Medicine Postcard.JPG|200px]] |
| cover = [[File:PLOS Medicine Postcard.JPG|200px]] |
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| discipline = [[Medicine]] |
| discipline = [[Medicine]] |
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| abbreviation = PLOS Med. |
| abbreviation = PLOS Med. |
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| editor = |
| editor = [[Raffaella Bosurgi]] |
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| publisher = [[Public Library of Science]] |
| publisher = [[Public Library of Science]] |
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| country = |
| country = |
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| history = 2004–present |
| history = 2004–present |
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| frequency = Weekly |
| frequency = Weekly |
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| openaccess = Yes |
| openaccess = Yes |
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| license = [[Creative Commons licenses|Creative Commons Attribution License]] |
| license = [[Creative Commons licenses|Creative Commons Attribution License]] |
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| impact = 10. |
| impact = 10.5 |
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| impact-year = |
| impact-year = 2023 |
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| website = |
| website = https://journals.plos.org/plosmedicine/ |
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| link1 = |
| link1 = https://journals.plos.org/plosmedicine/issue |
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| link1-name = Online access |
| link1-name = Online access |
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| link2= |
| link2 = https://journals.plos.org/plosmedicine/volume |
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| link2-name = Online archive |
| link2-name = Online archive |
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| ISSN = 1549-1277 |
| ISSN = 1549-1277 |
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| OCLC = 54674092 |
| OCLC = 54674092 |
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}} |
}} |
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'''''PLOS Medicine''''' (formerly styled '''''PLoS Medicine''''')<ref>{{cite web |url=http://blogs.plos.org/plos/2012/07/new-plos-look/ |title=New PLOS look |author=David Knutson |date=23 July 2012 |work=PLOS Blog |publisher=Public Library of Science | |
'''''PLOS Medicine''''' (formerly styled '''''PLoS Medicine''''')<ref>{{cite web |url=http://blogs.plos.org/plos/2012/07/new-plos-look/ |title=New PLOS look |author=David Knutson |date=23 July 2012 |work=PLOS Blog |publisher=Public Library of Science |access-date=6 August 2012|archive-url=https://web.archive.org/web/20120801091652/http://blogs.plos.org/plos/2012/07/new-plos-look/ |url-status=live |archive-date=1 August 2012}}</ref> is a [[Peer review|peer-reviewed]] weekly [[medical journal]] covering the full spectrum of the [[medicine|medical sciences]]. It began operation on October 19, 2004, as the second journal of the [[Public Library of Science]] (PLOS), a [[Nonprofit organization|non-profit]] [[open access (publishing)|open access publisher]]. All content in ''PLOS Medicine'' is published under the [[Creative Commons licenses|Creative Commons "by-attribution" license]]. To fund the journal, the publication's [[business model]] requires in most cases that [[Author-pays model|authors pay]] [[publication fees]]. The journal was published online and in a printed format until 2005 and is now only published online. The journal's acting [[editor-in-chief|chief editor]] is Clare Stone, who replaced the previous chief editor, Larry Peiperl, in 2018. |
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== Aims and scope == |
== Aims and scope == |
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The journal's initial aim was to provide an open-access alternative to existing top |
The journal's initial aim was to provide an open-access alternative to existing top-tier journals such as ''[[The New England Journal of Medicine]]'' and ''[[The Lancet]]'' and has concentrated on publishing papers on diseases that take the greatest toll on health globally.<ref name="Prescriptionfor">{{cite journal |title=Prescription for a Healthy Journal |journal=PLOS Medicine |date=1 January 2004 |volume=1 |issue=1 |pages=e22 |doi=10.1371/journal.pmed.0010022 |pmid=17523248 |pmc=523840 |doi-access=free }}</ref> In 2009 the journal reaffirmed its scope and noted that it would use an [[Evidence-based medicine|evidence-based approach]] to give highest priority to studies on diseases and risk factors that cause the greatest burden worldwide.<ref>{{cite journal |title=A Medical Journal for the World's Health Priorities |journal=PLOS Medicine |date=April 2009 |volume=6 |issue=4 |pages=e1000072 |doi=10.1371/journal.pmed.1000072 |pmid=19399159 |author=The PLOS Medicine Editors |pmc=2667639 |doi-access=free }}</ref> |
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From the outset the journal noted that it would not be part of "the cycle of dependency that has formed between journals and the pharmaceutical industry".<ref name="Prescriptionfor" /> The journal does not publish advertisements for pharmaceutical products or medical devices and the journal's open-access license means that it cannot benefit from exclusive reprint sales.<ref name="Prescriptionfor" /> |
From the outset the journal noted that it would not be part of "the cycle of dependency that has formed between journals and the pharmaceutical industry".<ref name="Prescriptionfor" /> The journal does not publish advertisements for pharmaceutical products or medical devices and the journal's open-access license means that it cannot benefit from exclusive reprint sales.<ref name="Prescriptionfor" /> |
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== Abstracting and indexing == |
== Abstracting and indexing == |
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The journal is abstracted and indexed in [[Index Medicus]]/[[MEDLINE]]/[[PubMed]],<ref name=PubMed>{{cite web |url=https://www.ncbi.nlm.nih.gov/nlmcatalog/101231360 |title=PLOS Medicine |work=NLM Catalog |publisher=[[National Center for Biotechnology Information]] | |
The journal is abstracted and indexed in [[Index Medicus]]/[[MEDLINE]]/[[PubMed]],<ref name=PubMed>{{cite web |url=https://www.ncbi.nlm.nih.gov/nlmcatalog/101231360 |title=PLOS Medicine |work=NLM Catalog |publisher=[[National Center for Biotechnology Information]] |access-date=2013-04-18}}</ref> the [[Science Citation Index Expanded]], [[Current Contents]]/Clinical Medicine, and [[BIOSIS Previews]].<ref name=ISI>{{cite web |url=http://ip-science.thomsonreuters.com/mjl/ |title=Master Journal List |publisher=[[Thomson Reuters]] |work=Intellectual Property & Science |access-date=2013-04-18 |archive-date=26 September 2017 |archive-url=https://web.archive.org/web/20170926150543/http://ip-science.thomsonreuters.com/mjl/ |url-status=dead }}</ref> According to the ''[[Journal Citation Reports]]'', the journal had a 2014 [[impact factor]] of 14.429, ranking it 7th out of 153 journals in the category "Medicine, General & Internal".<ref name=WoS>{{cite book |year=2015 |chapter=Journals Ranked by Impact: Medicine, General & Internal |title=2014 Journal Citation Reports |publisher=[[Thomson Reuters]] |edition=Science |series=[[Web of Science]]|title-link=Journal Citation Reports }}</ref> |
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== Notable articles == |
== Notable articles == |
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=== Why Most Published Research Findings Are False (2005) === |
=== Why Most Published Research Findings Are False (2005) === |
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In 2005 PLOS Medicine published an essay by [[John P. A. Ioannidis]] entitled "[[Why Most Published Research Findings Are False]]".<ref>{{cite journal |last=Ioannidis |first=John P. A. |title=Why Most Published Research Findings Are False |journal=PLOS Medicine |date=1 January 2005 |volume=2 |issue=8 |pages=e124 |doi=10.1371/journal.pmed.0020124 |pmid=16060722 |pmc=1182327}}</ref> The essay used a simulation approach to demonstrate that for most study designs and settings it is more likely for a research claim to be false than true due to inherent biases in the way that modern science is conducted. This paper has met much approval, though Goodman and Greenland criticized it in a short comment<ref>{{cite journal |last=Goodman |first=Steven |author2=Greenland, Sander |title=Why Most Published Research Findings Are False: Problems in the Analysis |journal=PLOS Medicine |date=1 January 2007 |volume=4 |issue=4 |pages=e168 |doi=10.1371/journal.pmed.0040168 |pmid=17456002 |pmc=1855693}}</ref> and a longer analysis.<ref>{{cite web |author=Steven Goodman and Sander Greenland |title=Assessing the unreliability of the medical literature: A response to "Why most published research findings are false" |url=http://www.bepress.com/jhubiostat/paper135 |publisher=Johns Hopkins University, Department of Biostatistics |year=2007 |access-date=2013-04-18 |archive-url=https://web.archive.org/web/20120406111748/http://www.bepress.com/jhubiostat/paper135/ |archive-date=2012-04-06 |url-status=dead }}</ref> Ioannidis has answered this critique.<ref>{{cite journal |last=Ioannidis |first=John P. A. |title=Why Most Published Research Findings Are False: Author's Reply to Goodman and Greenland |journal=PLOS Medicine |date=1 January 2007 |volume=4 |issue=6 |pages=e215 |doi=10.1371/journal.pmed.0040215 |pmid=17593900 |pmc=1896210}}</ref> A profile of Ioannidis' work including a discussion of his 2005 paper appeared in the November 2010 issue of ''[[The Atlantic]]''.<ref>{{cite web |last=Freedman |first=David H. |url=https://www.theatlantic.com/magazine/print/2010/11/lworkies-damned-lies-and-medical-science/8269 |title=Lies, Damned Lies, and Medical Science – David H. Freedman |work=[[The Atlantic]] |date=2010-10-04 | |
In 2005 PLOS Medicine published an essay by [[John P. A. Ioannidis]] entitled "[[Why Most Published Research Findings Are False]]".<ref>{{cite journal |last=Ioannidis |first=John P. A. |title=Why Most Published Research Findings Are False |journal=PLOS Medicine |date=1 January 2005 |volume=2 |issue=8 |pages=e124 |doi=10.1371/journal.pmed.0020124 |pmid=16060722 |pmc=1182327 |doi-access=free }}</ref> The essay used a simulation approach to demonstrate that for most study designs and settings it is more likely for a research claim to be false than true due to inherent biases in the way that modern science is conducted. This paper has met much approval, though Goodman and Greenland criticized it in a short comment<ref>{{cite journal |last=Goodman |first=Steven |author2=Greenland, Sander |title=Why Most Published Research Findings Are False: Problems in the Analysis |journal=PLOS Medicine |date=1 January 2007 |volume=4 |issue=4 |pages=e168 |doi=10.1371/journal.pmed.0040168 |pmid=17456002 |pmc=1855693 |doi-access=free }}</ref> and a longer analysis.<ref>{{cite web |author=Steven Goodman and Sander Greenland |title=Assessing the unreliability of the medical literature: A response to "Why most published research findings are false" |url=http://www.bepress.com/jhubiostat/paper135 |publisher=Johns Hopkins University, Department of Biostatistics |year=2007 |access-date=2013-04-18 |archive-url=https://web.archive.org/web/20120406111748/http://www.bepress.com/jhubiostat/paper135/ |archive-date=2012-04-06 |url-status=dead }}</ref> Ioannidis has answered this critique.<ref>{{cite journal |last=Ioannidis |first=John P. A. |title=Why Most Published Research Findings Are False: Author's Reply to Goodman and Greenland |journal=PLOS Medicine |date=1 January 2007 |volume=4 |issue=6 |pages=e215 |doi=10.1371/journal.pmed.0040215 |pmid=17593900 |pmc=1896210 |doi-access=free }}</ref> A profile of Ioannidis' work including a discussion of his 2005 paper appeared in the November 2010 issue of ''[[The Atlantic]]''.<ref>{{cite web |last=Freedman |first=David H. |url=https://www.theatlantic.com/magazine/print/2010/11/lworkies-damned-lies-and-medical-science/8269 |title=Lies, Damned Lies, and Medical Science – David H. Freedman |work=[[The Atlantic]] |date=2010-10-04 |access-date=2013-04-18}}</ref> |
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=== Male Circumcision for Reduction of HIV Infection Risk (2005) === |
=== Male Circumcision for Reduction of HIV Infection Risk (2005) === |
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The first randomized controlled trial to assess the [[Circumcision and HIV|effect of male circumcision on female to male HIV transmission]] was published in 2005 by Bertran Auvert and colleagues in ''PLOS Medicine''.<ref>{{cite journal |last=Auvert |first=Bertran |author2=Taljaard, Dirk |author3=Lagarde, Emmanuel |author4=Sobngwi-Tambekou, Joëlle |author5=Sitta, Rémi |author6= Puren, Adrian |title=Randomized, Controlled Intervention Trial of Male Circumcision for Reduction of HIV Infection Risk: The ANRS 1265 Trial |journal=PLOS Medicine |date=1 January 2005 |volume=2 |issue=11 |pages=e298 |doi=10.1371/journal.pmed.0020298 |pmid=16231970 |pmc=1262556}}</ref> ''[[The Lancet]]'' a leading [[Medical journals|medical journal]] rejected this paper because of [[Medical ethics|ethical]] concerns<ref>{{Cite web|url=http://globalbioethics.blogspot.ie/2012_03_01_archive.html|title=Global bioethics blog: March 2012|website=globalbioethics.blogspot.ie|access-date=2016-04-15}}</ref> around how the trial was conducted before ''PLOS Medicine'' accepted it. The trial was stopped early by the Data and Safety Monitoring Board who advised the investigators to interrupt the trial and offer circumcision to the control group. The trial estimated that male circumcision |
The first randomized controlled trial to assess the [[Circumcision and HIV|effect of male circumcision on female to male HIV transmission]] was published in 2005 by Bertran Auvert and colleagues in ''PLOS Medicine''.<ref>{{cite journal |last=Auvert |first=Bertran |author2=Taljaard, Dirk |author3=Lagarde, Emmanuel |author4=Sobngwi-Tambekou, Joëlle |author5=Sitta, Rémi |author6= Puren, Adrian |title=Randomized, Controlled Intervention Trial of Male Circumcision for Reduction of HIV Infection Risk: The ANRS 1265 Trial |journal=PLOS Medicine |date=1 January 2005 |volume=2 |issue=11 |pages=e298 |doi=10.1371/journal.pmed.0020298 |pmid=16231970 |pmc=1262556 |doi-access=free }}</ref> ''[[The Lancet]]'' a leading [[Medical journals|medical journal]] rejected this paper because of [[Medical ethics|ethical]] concerns<ref>{{Cite web|url=http://globalbioethics.blogspot.ie/2012_03_01_archive.html|title=Global bioethics blog: March 2012|website=globalbioethics.blogspot.ie|access-date=2016-04-15}}</ref> around how the trial was conducted before ''PLOS Medicine'' accepted it. The trial was stopped early by the Data and Safety Monitoring Board who advised the investigators to interrupt the trial and offer circumcision to the control group. The trial estimated that male circumcision protected 60% (95% CI: 32%–76%) for female-to-male HIV transmission. |
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The results of this trial along with two others led to the [[World Health Organization]] (WHO) assessing the evidence for male circumcision to prevent HIV transmission.<ref>{{cite web |url=https://www.who.int/hiv/pub/malecircumcision/research_implications/en/index.html |archive-url=https://web.archive.org/web/20081008073036/http://www.who.int/hiv/pub/malecircumcision/research_implications/en/index.html |url-status=dead |archive-date=8 October 2008 |title=New data on male circumcision and HIV prevention: Policy and programme implications |publisher=WHO}}</ref> The WHO and [[UNAIDS]] subsequently issued recommendations concerning male circumcision and HIV/AIDS<ref>{{cite web |url=https://www.who.int/hiv/mediacentre/news68/en/index.html |archive-url=https://web.archive.org/web/20070413123721/http://www.who.int/hiv/mediacentre/news68/en/index.html |url-status=dead |archive-date=13 April 2007 |title=WHO and UNAIDS announce recommendations from expert consultation on male circumcision for HIV prevention |publisher=WHO |date=2007-03-28 |access-date=2013-04-18}}</ref> including suggestions for government strategic plans, advocacy challenges and exploring the role of new technologies for voluntary medical male circumcision (VMMC) such as [[Prepex]] and other medical devices.<ref>{{cite journal|last1=Sgaier|first1=Sema|last2=Reed|first2=Jason|last3=Thomas|first3=Anne|last4=Njeuhmeli|first4=Emmanuel|title=Achieving the HIV Prevention Impact of Voluntary Medical Male Circumcision: Lessons and Challenges for Managing Programs|journal=PLOS Medicine|volume=11|issue=5|pages=e1001641|doi=10.1371/journal.pmed.1001641|pmid=24800840|pmc=4011573|year=2014 |doi-access=free }}</ref><ref>{{cite journal|last1=Hankins|first1=Catherine|last2=Forsythe|first2=Steven|last3=Njeuhmeli|first3=Emmanuel|title=Voluntary Medical Male Circumcision: An Introduction to the Cost, Impact, and Challenges of Accelerated Scaling Up|journal=PLOS Medicine|volume=8|issue=11|pages=e1001127|doi=10.1371/journal.pmed.1001127|pmid=22140362|year=2011|pmc=3226452 |doi-access=free }}</ref> Several Ministries of Health along with key stakeholders have committed to scaling up VMMC for HIV prevention in Southern and Eastern Africa.<ref>{{cite web |url=https://www.who.int/hiv/pub/strategic_action2012_2016/en/index.html |archive-url=https://web.archive.org/web/20120111093341/http://www.who.int/hiv/pub/strategic_action2012_2016/en/index.html |url-status=dead |archive-date=11 January 2012 |title=Joint strategic action framework to accelerate the scale-up of voluntary medical male circumcision for HIV prevention in Eastern and Southern Africa |publisher=WhHO |date=2011-12-07 |access-date=2013-04-18}}</ref> |
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=== Wyeth Ghostwriting Scandal (2009/2010) === |
=== Wyeth Ghostwriting Scandal (2009/2010) === |
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In July 2009, a United States federal court decision resulted in the release of approximately 1500 documents detailing how articles highlighting specific marketing messages written by unattributed writers, but "authored" by academics, are strategically placed in the medical literature – a practice known as [[Medical ghostwriter|ghostwriting]]. To release these documents, ''PLOS Medicine'', represented by the public interest law firm Public Justice, and ''[[The New York Times]]'', acted as "intervenors" in litigation against menopausal hormone manufacturers by women who developed breast cancer while taking hormones. ''PLOS Medicine'' argued that sealed documents identified during the discovery process for the court case, which demonstrated the practice of ghostwriting, should be made available to the public.<ref>{{cite web |title=Wyeth Ghostwriting Archive |url=http://www.plosmedicine.org/static/ghostwriting |work=PLOS Medicine | |
In July 2009, a United States federal court decision resulted in the release of approximately 1500 documents detailing how articles highlighting specific marketing messages written by unattributed writers, but "authored" by academics, are strategically placed in the medical literature – a practice known as [[Medical ghostwriter|ghostwriting]]. To release these documents, ''PLOS Medicine'', represented by the public interest law firm Public Justice, and ''[[The New York Times]]'', acted as "intervenors" in litigation against menopausal hormone manufacturers by women who developed breast cancer while taking hormones. ''PLOS Medicine'' argued that sealed documents identified during the discovery process for the court case, which demonstrated the practice of ghostwriting, should be made available to the public.<ref>{{cite web |title=Wyeth Ghostwriting Archive |url=http://www.plosmedicine.org/static/ghostwriting |work=PLOS Medicine |access-date=13 April 2013}}</ref><ref>{{cite news |last=Singer |first=Natasha |title=Medical Papers by Ghostwriters Pushed Therapy |url=https://www.nytimes.com/2009/08/05/health/research/05ghost.html |work=The New York Times |date=5 August 2009 |access-date=13 April 2013}}</ref> |
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The documents were initially made publicly available on the ''PLOS Medicine'' website but they are now available as part of the Drug Industry Documents Archive at the [[University of California, San Francisco]].<ref>{{cite web|publisher=Drug Industry Documents Archive|url=http://dida.library.ucsf.edu/abouttheproject.jsp|access-date=18 April 2013|title=About the Project}}</ref> In 2010 ''PLOS Medicine'' published the first academic analysis of the documents by Adriane Fugh-Berman.<ref>{{cite journal |last=Fugh-Berman |first=AJ |title=The haunting of medical journals: how ghostwriting sold "HRT" |journal=PLOS Medicine |date=7 Sep 2010 |volume=7 |issue=9 |pages=e1000335 |doi=10.1371/journal.pmed.1000335 |pmid=20838656 |pmc=2935455 |doi-access=free }}</ref> Her article revealed that the pharmaceutical company [[Wyeth]] used ghostwritten articles to mitigate the perceived risks of breast cancer associated with [[menopausal hormone therapy]] (HT), to defend the unsupported cardiovascular "benefits" of HT, and to promote off-label, unproven uses of HT such as the prevention of [[dementia]], [[Parkinson's disease]], vision problems, and wrinkles. The article was subsequently covered by ''[[The Guardian]]''.<ref>{{cite web |last=Goldacre |first=Ben |title=Medical ghostwriters who build a brand |url=https://www.theguardian.com/commentisfree/2010/sep/18/bad-science-medical-ghostwriters |work=The Guardian|date=Sep 18, 2010 |access-date=18 April 2013}}</ref> |
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=== Tamiflu clinical trial data sharing (2012) === |
=== Tamiflu clinical trial data sharing (2012) === |
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In April 2012 ''PLOS Medicine'' published an article by three researchers who were involved in ongoing updates of a [[Cochrane Collaboration]] review of [[neuraminidase]] inhibitors for treating [[influenza]], describing their experience of trying to gain access to [[clinical study report]]s for the antiviral Tamiflu ([[oseltamivir]]) from the drug's manufacturer [[Hoffmann-La Roche|Roche]].<ref>{{cite journal |last=Doshi |first=P. |author2=Jefferson, T. |author3=Del Mar, C. |title=The imperative to share clinical study reports: recommendations from the Tamiflu experience |journal=PLOS Medicine |year=2012 |volume=9 |issue=4 |pages=e1001201 |doi=10.1371/journal.pmed.1001201 |pmid=22505850 |pmc=3323511}}</ref> The article outlined the need for access to all clinical trial data held by pharmaceutical companies and regulators, and detailed reasons given by Roche for not sharing data on Tamiflu. In a commissioned perspective article published in the same issue of ''PLOS Medicine'', regulators from the [[European Medicines Agency]] (EMA) and other national regulatory bodies outlined a shift in their stance on access to clinical trial data but also highlighted challenges that would need to be overcome.<ref>{{cite journal |last=Eichler |first=H-G. |author2=Abadie, E. |author3=Breckenridge, A. |author4=Leufkens, H. |author5= Rasi, G. |title=Open Clinical Trial Data for All? A View from Regulators |journal=PLOS Medicine |year=2012 |volume=9 |issue=4 |pages=e1001202 |doi=10.1371/journal.pmed.1001202 |pmid=22505851 |pmc=3323505}}</ref><ref>{{cite web|url=http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/04/news_detail_001486.jsp&mid=WC0b01ac058004d5c1 |title=European Medicines Agency – News and Events – European regulators propose way forward for publication of full clinical-trial data |publisher=Ema.europa.eu | |
In April 2012 ''PLOS Medicine'' published an article by three researchers who were involved in ongoing updates of a [[Cochrane Collaboration]] review of [[neuraminidase]] inhibitors for treating [[influenza]], describing their experience of trying to gain access to [[clinical study report]]s for the antiviral Tamiflu ([[oseltamivir]]) from the drug's manufacturer [[Hoffmann-La Roche|Roche]].<ref>{{cite journal |last=Doshi |first=P. |author2=Jefferson, T. |author3=Del Mar, C. |title=The imperative to share clinical study reports: recommendations from the Tamiflu experience |journal=PLOS Medicine |year=2012 |volume=9 |issue=4 |pages=e1001201 |doi=10.1371/journal.pmed.1001201 |pmid=22505850 |pmc=3323511 |doi-access=free }}</ref> The article outlined the need for access to all clinical trial data held by pharmaceutical companies and regulators, and detailed reasons given by Roche for not sharing data on Tamiflu. |
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In a commissioned perspective article published in the same issue of ''PLOS Medicine'', regulators from the [[European Medicines Agency]] (EMA) and other national regulatory bodies outlined a shift in their stance on access to clinical trial data but also highlighted challenges that would need to be overcome.<ref>{{cite journal |last=Eichler |first=H-G. |author2=Abadie, E. |author3=Breckenridge, A. |author4=Leufkens, H. |author5= Rasi, G. |title=Open Clinical Trial Data for All? A View from Regulators |journal=PLOS Medicine |year=2012 |volume=9 |issue=4 |pages=e1001202 |doi=10.1371/journal.pmed.1001202 |pmid=22505851 |pmc=3323505 |doi-access=free }}</ref><ref>{{cite web|url=http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/04/news_detail_001486.jsp&mid=WC0b01ac058004d5c1 |title=European Medicines Agency – News and Events – European regulators propose way forward for publication of full clinical-trial data |publisher=Ema.europa.eu |access-date=2013-04-26}}</ref><ref>{{cite web|date=11 April 2012 |url=http://www.pmlive.com/pharma_news/ema_calls_open_access_clinical_trial_data_tamiflu_concerns_398270 |title=EMA calls for open access to clinical trial data after Tamiflu concerns |publisher=PMLiVE |access-date=2013-04-26}}</ref> The regulators noted, "[w]e consider it neither desirable nor realistic to maintain the status quo of limited availability of regulatory trials data" and concluded, "[w]e welcome debate on these issues, and remain confident that satisfactory solutions can be found to make complete trial data available in a way that will be in the best interest of public health". |
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The article marked a move towards the proactive disclosure of clinical trial data and led to the EMA holding a workshop to establish how this could be done.<ref>{{cite web|url=http://www.ukrio.org/european-medicines-agency-workshop-on-access-to-clinical-trial-data-and-transparency/ |title=European Medicines Agency: Workshop on access to clinical trial data and transparency |publisher=UKRIO |date=2012-12-18 |access-date=2013-04-26}}</ref><ref>{{cite journal |last=Godlee |first=F.|author2=Groves, T. |title=The new BMJ policy on sharing data from drug and device trials |journal=BMJ |year=2012 |volume=345 |pages=e7888 |doi=10.1136/bmj.e7888|pmid=23169872|doi-access=free }}</ref><ref>{{cite web|url=http://www.pmlive.com/pharma_news/roche_offers_compromise_in_tamiflu_data_debate_451786 |title=Roche offers compromise in Tamiflu data debate |publisher=PMLiVE |date=2012-11-26 |access-date=2013-04-26}}</ref> At the workshop Guido Rasi, the EMA's Executive Director, announced "[t]oday represents the first step in delivering our vision. We are not here to decide if we will publish clinical-trial data, only how. We need to do this to rebuild trust and confidence in the whole system".<ref>{{cite web |url=http://www.ema.europa.eu/docs/en_GB/document_library/Report/2012/12/WC500135841.pdf |title=Workshop report: Access to clinical-trial data and transparency |publisher=European Medicines Agency |access-date=14 April 2013}}</ref><ref name="ecancer1">{{cite web|url=http://ecancer.org/news/3670-ema-workshop-reveals-divisions-with-industry.php |title=EMA workshop reveals divisions with industry . ecancer – News |publisher=Ecancer.org |date=2012-12-20 |access-date=2013-04-26}}</ref> ''PLOS Medicine''{{'s}} chief editor, [[Virginia Barbour]], was an invited speaker at the workshop representing the media.<ref name="ecancer1" /><ref>{{cite web |url=http://www.ema.europa.eu/docs/en_GB/document_library/Other/2012/11/WC500134994.pdf |title=Speaker biographies |work=Workshop on clinical-trial data and transparency |publisher=European Medicines Agency |access-date=14 April 2013}}</ref> |
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== References == |
== References == |
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{{Reflist |
{{Reflist}} |
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== External links == |
== External links == |
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* {{Official website| |
* {{Official website|https://journals.plos.org/plosmedicine//}} |
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{{commons category|PLOS Medicine}} |
{{commons category|PLOS Medicine}} |
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[[Category:Creative Commons Attribution-licensed journals]] |
[[Category:Creative Commons Attribution-licensed journals]] |
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[[Category:General medical journals]] |
[[Category:General medical journals]] |
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[[Category: |
[[Category:Academic journals established in 2004]] |
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[[Category:English-language journals]] |
[[Category:English-language journals]] |
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[[Category:Monthly journals]] |
[[Category:Monthly journals]] |
Latest revision as of 04:33, 1 July 2024
Discipline | Medicine |
---|---|
Language | English |
Edited by | Raffaella Bosurgi |
Publication details | |
History | 2004–present |
Publisher | |
Frequency | Weekly |
Yes | |
License | Creative Commons Attribution License |
10.5 (2023) | |
Standard abbreviations | |
ISO 4 | PLOS Med. |
Indexing | |
ISSN | 1549-1277 (print) 1549-1676 (web) |
LCCN | 2004212194 |
OCLC no. | 54674092 |
Links | |
PLOS Medicine (formerly styled PLoS Medicine)[1] is a peer-reviewed weekly medical journal covering the full spectrum of the medical sciences. It began operation on October 19, 2004, as the second journal of the Public Library of Science (PLOS), a non-profit open access publisher. All content in PLOS Medicine is published under the Creative Commons "by-attribution" license. To fund the journal, the publication's business model requires in most cases that authors pay publication fees. The journal was published online and in a printed format until 2005 and is now only published online. The journal's acting chief editor is Clare Stone, who replaced the previous chief editor, Larry Peiperl, in 2018.
Aims and scope
[edit]The journal's initial aim was to provide an open-access alternative to existing top-tier journals such as The New England Journal of Medicine and The Lancet and has concentrated on publishing papers on diseases that take the greatest toll on health globally.[2] In 2009 the journal reaffirmed its scope and noted that it would use an evidence-based approach to give highest priority to studies on diseases and risk factors that cause the greatest burden worldwide.[3]
From the outset the journal noted that it would not be part of "the cycle of dependency that has formed between journals and the pharmaceutical industry".[2] The journal does not publish advertisements for pharmaceutical products or medical devices and the journal's open-access license means that it cannot benefit from exclusive reprint sales.[2]
Abstracting and indexing
[edit]The journal is abstracted and indexed in Index Medicus/MEDLINE/PubMed,[4] the Science Citation Index Expanded, Current Contents/Clinical Medicine, and BIOSIS Previews.[5] According to the Journal Citation Reports, the journal had a 2014 impact factor of 14.429, ranking it 7th out of 153 journals in the category "Medicine, General & Internal".[6]
Notable articles
[edit]Why Most Published Research Findings Are False (2005)
[edit]In 2005 PLOS Medicine published an essay by John P. A. Ioannidis entitled "Why Most Published Research Findings Are False".[7] The essay used a simulation approach to demonstrate that for most study designs and settings it is more likely for a research claim to be false than true due to inherent biases in the way that modern science is conducted. This paper has met much approval, though Goodman and Greenland criticized it in a short comment[8] and a longer analysis.[9] Ioannidis has answered this critique.[10] A profile of Ioannidis' work including a discussion of his 2005 paper appeared in the November 2010 issue of The Atlantic.[11]
Male Circumcision for Reduction of HIV Infection Risk (2005)
[edit]The first randomized controlled trial to assess the effect of male circumcision on female to male HIV transmission was published in 2005 by Bertran Auvert and colleagues in PLOS Medicine.[12] The Lancet a leading medical journal rejected this paper because of ethical concerns[13] around how the trial was conducted before PLOS Medicine accepted it. The trial was stopped early by the Data and Safety Monitoring Board who advised the investigators to interrupt the trial and offer circumcision to the control group. The trial estimated that male circumcision protected 60% (95% CI: 32%–76%) for female-to-male HIV transmission.
The results of this trial along with two others led to the World Health Organization (WHO) assessing the evidence for male circumcision to prevent HIV transmission.[14] The WHO and UNAIDS subsequently issued recommendations concerning male circumcision and HIV/AIDS[15] including suggestions for government strategic plans, advocacy challenges and exploring the role of new technologies for voluntary medical male circumcision (VMMC) such as Prepex and other medical devices.[16][17] Several Ministries of Health along with key stakeholders have committed to scaling up VMMC for HIV prevention in Southern and Eastern Africa.[18]
Wyeth Ghostwriting Scandal (2009/2010)
[edit]In July 2009, a United States federal court decision resulted in the release of approximately 1500 documents detailing how articles highlighting specific marketing messages written by unattributed writers, but "authored" by academics, are strategically placed in the medical literature – a practice known as ghostwriting. To release these documents, PLOS Medicine, represented by the public interest law firm Public Justice, and The New York Times, acted as "intervenors" in litigation against menopausal hormone manufacturers by women who developed breast cancer while taking hormones. PLOS Medicine argued that sealed documents identified during the discovery process for the court case, which demonstrated the practice of ghostwriting, should be made available to the public.[19][20]
The documents were initially made publicly available on the PLOS Medicine website but they are now available as part of the Drug Industry Documents Archive at the University of California, San Francisco.[21] In 2010 PLOS Medicine published the first academic analysis of the documents by Adriane Fugh-Berman.[22] Her article revealed that the pharmaceutical company Wyeth used ghostwritten articles to mitigate the perceived risks of breast cancer associated with menopausal hormone therapy (HT), to defend the unsupported cardiovascular "benefits" of HT, and to promote off-label, unproven uses of HT such as the prevention of dementia, Parkinson's disease, vision problems, and wrinkles. The article was subsequently covered by The Guardian.[23]
Tamiflu clinical trial data sharing (2012)
[edit]In April 2012 PLOS Medicine published an article by three researchers who were involved in ongoing updates of a Cochrane Collaboration review of neuraminidase inhibitors for treating influenza, describing their experience of trying to gain access to clinical study reports for the antiviral Tamiflu (oseltamivir) from the drug's manufacturer Roche.[24] The article outlined the need for access to all clinical trial data held by pharmaceutical companies and regulators, and detailed reasons given by Roche for not sharing data on Tamiflu.
In a commissioned perspective article published in the same issue of PLOS Medicine, regulators from the European Medicines Agency (EMA) and other national regulatory bodies outlined a shift in their stance on access to clinical trial data but also highlighted challenges that would need to be overcome.[25][26][27] The regulators noted, "[w]e consider it neither desirable nor realistic to maintain the status quo of limited availability of regulatory trials data" and concluded, "[w]e welcome debate on these issues, and remain confident that satisfactory solutions can be found to make complete trial data available in a way that will be in the best interest of public health".
The article marked a move towards the proactive disclosure of clinical trial data and led to the EMA holding a workshop to establish how this could be done.[28][29][30] At the workshop Guido Rasi, the EMA's Executive Director, announced "[t]oday represents the first step in delivering our vision. We are not here to decide if we will publish clinical-trial data, only how. We need to do this to rebuild trust and confidence in the whole system".[31][32] PLOS Medicine's chief editor, Virginia Barbour, was an invited speaker at the workshop representing the media.[32][33]
References
[edit]- ^ David Knutson (23 July 2012). "New PLOS look". PLOS Blog. Public Library of Science. Archived from the original on 1 August 2012. Retrieved 6 August 2012.
- ^ a b c "Prescription for a Healthy Journal". PLOS Medicine. 1 (1): e22. 1 January 2004. doi:10.1371/journal.pmed.0010022. PMC 523840. PMID 17523248.
- ^ The PLOS Medicine Editors (April 2009). "A Medical Journal for the World's Health Priorities". PLOS Medicine. 6 (4): e1000072. doi:10.1371/journal.pmed.1000072. PMC 2667639. PMID 19399159.
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has generic name (help) - ^ "PLOS Medicine". NLM Catalog. National Center for Biotechnology Information. Retrieved 18 April 2013.
- ^ "Master Journal List". Intellectual Property & Science. Thomson Reuters. Archived from the original on 26 September 2017. Retrieved 18 April 2013.
- ^ "Journals Ranked by Impact: Medicine, General & Internal". 2014 Journal Citation Reports. Web of Science (Science ed.). Thomson Reuters. 2015.
- ^ Ioannidis, John P. A. (1 January 2005). "Why Most Published Research Findings Are False". PLOS Medicine. 2 (8): e124. doi:10.1371/journal.pmed.0020124. PMC 1182327. PMID 16060722.
- ^ Goodman, Steven; Greenland, Sander (1 January 2007). "Why Most Published Research Findings Are False: Problems in the Analysis". PLOS Medicine. 4 (4): e168. doi:10.1371/journal.pmed.0040168. PMC 1855693. PMID 17456002.
- ^ Steven Goodman and Sander Greenland (2007). "Assessing the unreliability of the medical literature: A response to "Why most published research findings are false"". Johns Hopkins University, Department of Biostatistics. Archived from the original on 6 April 2012. Retrieved 18 April 2013.
- ^ Ioannidis, John P. A. (1 January 2007). "Why Most Published Research Findings Are False: Author's Reply to Goodman and Greenland". PLOS Medicine. 4 (6): e215. doi:10.1371/journal.pmed.0040215. PMC 1896210. PMID 17593900.
- ^ Freedman, David H. (4 October 2010). "Lies, Damned Lies, and Medical Science – David H. Freedman". The Atlantic. Retrieved 18 April 2013.
- ^ Auvert, Bertran; Taljaard, Dirk; Lagarde, Emmanuel; Sobngwi-Tambekou, Joëlle; Sitta, Rémi; Puren, Adrian (1 January 2005). "Randomized, Controlled Intervention Trial of Male Circumcision for Reduction of HIV Infection Risk: The ANRS 1265 Trial". PLOS Medicine. 2 (11): e298. doi:10.1371/journal.pmed.0020298. PMC 1262556. PMID 16231970.
- ^ "Global bioethics blog: March 2012". globalbioethics.blogspot.ie. Retrieved 15 April 2016.
- ^ "New data on male circumcision and HIV prevention: Policy and programme implications". WHO. Archived from the original on 8 October 2008.
- ^ "WHO and UNAIDS announce recommendations from expert consultation on male circumcision for HIV prevention". WHO. 28 March 2007. Archived from the original on 13 April 2007. Retrieved 18 April 2013.
- ^ Sgaier, Sema; Reed, Jason; Thomas, Anne; Njeuhmeli, Emmanuel (2014). "Achieving the HIV Prevention Impact of Voluntary Medical Male Circumcision: Lessons and Challenges for Managing Programs". PLOS Medicine. 11 (5): e1001641. doi:10.1371/journal.pmed.1001641. PMC 4011573. PMID 24800840.
- ^ Hankins, Catherine; Forsythe, Steven; Njeuhmeli, Emmanuel (2011). "Voluntary Medical Male Circumcision: An Introduction to the Cost, Impact, and Challenges of Accelerated Scaling Up". PLOS Medicine. 8 (11): e1001127. doi:10.1371/journal.pmed.1001127. PMC 3226452. PMID 22140362.
- ^ "Joint strategic action framework to accelerate the scale-up of voluntary medical male circumcision for HIV prevention in Eastern and Southern Africa". WhHO. 7 December 2011. Archived from the original on 11 January 2012. Retrieved 18 April 2013.
- ^ "Wyeth Ghostwriting Archive". PLOS Medicine. Retrieved 13 April 2013.
- ^ Singer, Natasha (5 August 2009). "Medical Papers by Ghostwriters Pushed Therapy". The New York Times. Retrieved 13 April 2013.
- ^ "About the Project". Drug Industry Documents Archive. Retrieved 18 April 2013.
- ^ Fugh-Berman, AJ (7 September 2010). "The haunting of medical journals: how ghostwriting sold "HRT"". PLOS Medicine. 7 (9): e1000335. doi:10.1371/journal.pmed.1000335. PMC 2935455. PMID 20838656.
- ^ Goldacre, Ben (18 September 2010). "Medical ghostwriters who build a brand". The Guardian. Retrieved 18 April 2013.
- ^ Doshi, P.; Jefferson, T.; Del Mar, C. (2012). "The imperative to share clinical study reports: recommendations from the Tamiflu experience". PLOS Medicine. 9 (4): e1001201. doi:10.1371/journal.pmed.1001201. PMC 3323511. PMID 22505850.
- ^ Eichler, H-G.; Abadie, E.; Breckenridge, A.; Leufkens, H.; Rasi, G. (2012). "Open Clinical Trial Data for All? A View from Regulators". PLOS Medicine. 9 (4): e1001202. doi:10.1371/journal.pmed.1001202. PMC 3323505. PMID 22505851.
- ^ "European Medicines Agency – News and Events – European regulators propose way forward for publication of full clinical-trial data". Ema.europa.eu. Retrieved 26 April 2013.
- ^ "EMA calls for open access to clinical trial data after Tamiflu concerns". PMLiVE. 11 April 2012. Retrieved 26 April 2013.
- ^ "European Medicines Agency: Workshop on access to clinical trial data and transparency". UKRIO. 18 December 2012. Retrieved 26 April 2013.
- ^ Godlee, F.; Groves, T. (2012). "The new BMJ policy on sharing data from drug and device trials". BMJ. 345: e7888. doi:10.1136/bmj.e7888. PMID 23169872.
- ^ "Roche offers compromise in Tamiflu data debate". PMLiVE. 26 November 2012. Retrieved 26 April 2013.
- ^ "Workshop report: Access to clinical-trial data and transparency" (PDF). European Medicines Agency. Retrieved 14 April 2013.
- ^ a b "EMA workshop reveals divisions with industry . ecancer – News". Ecancer.org. 20 December 2012. Retrieved 26 April 2013.
- ^ "Speaker biographies" (PDF). Workshop on clinical-trial data and transparency. European Medicines Agency. Retrieved 14 April 2013.