PLOS Medicine

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Aims and scope

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

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

Why Most Published Research Findings Are False (2005)

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)

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)

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)

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]

Related Research Articles

In published academic research, publication bias occurs when the outcome of an experiment or research study biases the decision to publish or otherwise distribute it. Publishing only results that show a significant finding disturbs the balance of findings in favor of positive results. The study of publication bias is an important topic in metascience.

<span class="mw-page-title-main">David Healy (psychiatrist)</span> Irish-born pharmacologist

David HealyFRCPsych, a professor of psychiatry at Bangor University in the United Kingdom, is a psychiatrist, psychopharmacologist, scientist and author. His main areas of research are the contribution of antidepressants to suicide, conflict of interest between pharmaceutical companies and academic medicine, and the history of pharmacology. Healy has written more than 150 peer-reviewed articles, 200 other articles, and 20 books, including The Antidepressant Era, The Creation of Psychopharmacology, The Psychopharmacologists Volumes 1–3, Let Them Eat Prozac and Mania: A Short History of Bipolar Disorder.

<span class="mw-page-title-main">Oseltamivir</span> Antiviral medication used against influenza A and influenza B

Oseltamivir, sold under the brand name Tamiflu, is an antiviral medication used to treat and prevent influenza A and influenza B, viruses that cause the flu. Many medical organizations recommend it in people who have complications or are at high risk of complications within 48 hours of first symptoms of infection. They recommend it to prevent infection in those at high risk, but not the general population. The Centers for Disease Control and Prevention (CDC) recommends that clinicians use their discretion to treat those at lower risk who present within 48 hours of first symptoms of infection. It is taken by mouth, either as a pill or liquid.

Male circumcision reduces the risk of human immunodeficiency virus (HIV) transmission from HIV positive women to men in high risk populations.

<span class="mw-page-title-main">Joep Lange</span> Dutch clinical researcher (1954–2014)

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<span class="mw-page-title-main">Circumcision</span> Removal of the human foreskin

Circumcision is a procedure that removes the foreskin from the human penis. In the most common form of the operation, the foreskin is extended with forceps, then a circumcision device may be placed, after which the foreskin is excised. Topical or locally injected anesthesia is generally used to reduce pain and physiologic stress. Circumcision is generally electively performed, most commonly done as a form of preventive healthcare, as a religious obligation, or as a cultural practice. It is also an option for cases of phimosis, other pathologies that do not resolve with other treatments, and chronic urinary tract infections (UTIs). The procedure is contraindicated in cases of certain genital structure abnormalities or poor general health.

<span class="mw-page-title-main">Prevalence of circumcision</span> Overview of international circumcision rates

The prevalence of circumcision is the percentage of males in a given population who have been circumcised, with the procedure most commonly being performed as a part of preventive healthcare, a religious obligation, or cultural practice.

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<span class="mw-page-title-main">John Ioannidis</span> American scientist (born 1965)

John P. A. Ioannidis is a Greek-American physician-scientist, writer and Stanford University professor who has made contributions to evidence-based medicine, epidemiology, and clinical research. Ioannidis studies scientific research itself, meta-research primarily in clinical medicine and the social sciences.

<span class="mw-page-title-main">Irving Kirsch</span> Medical researcher

Irving Kirsch is an American psychologist and academic. He is the Associate Director of the Program in Placebo Studies and a lecturer in medicine at the Harvard Medical School and Beth Israel Deaconess Medical Center. He is also professor emeritus of psychology at the Universities of Hull and Plymouth in the United Kingdom, and the University of Connecticut in the United States. Kirsch is a leading researcher within the field of placebo studies who is noted for his work on placebo effects, antidepressants, expectancy, and hypnosis. He is the originator of response expectancy theory, and his analyses of clinical trials of antidepressants have influenced official treatment guidelines in the United Kingdom. He is the author of the 2009 book The Emperor's New Drugs, which argued most antidepressant medication is effective primarily due to placebo effects.

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<span class="mw-page-title-main">Elioda Tumwesigye</span> Ugandan politician

Elioda Tumwesigye is a Ugandan politician, physician, and epidemiologist who has served as minister of science, technology and innovation in the cabinet of Uganda since June 2016. From March 2015 until June 2016, he served as the minister of health.

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References

  1. ↑ 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.
  2. 1 2 3 The PLOS Medicine Editors (1 January 2004). "Prescription for a Healthy Journal". PLOS Medicine. 1 (1): e22. doi: 10.1371/journal.pmed.0010022 . PMC   523840 . PMID   17523248.{{cite journal}}: |author= has generic name (help)
  3. ↑ 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.{{cite journal}}: |author= has generic name (help)
  4. ↑ "PLOS Medicine". NLM Catalog. National Center for Biotechnology Information . Retrieved 18 April 2013.
  5. ↑ "Master Journal List". Intellectual Property & Science. Thomson Reuters. Archived from the original on 26 September 2017. Retrieved 18 April 2013.
  6. ↑ "Journals Ranked by Impact: Medicine, General & Internal". 2014 Journal Citation Reports. Web of Science (Science ed.). Thomson Reuters. 2015.
  7. ↑ 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.
  8. ↑ 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.
  9. ↑ 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.
  10. ↑ 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.
  11. ↑ Freedman, David H. (4 October 2010). "Lies, Damned Lies, and Medical Science – David H. Freedman". The Atlantic . Retrieved 18 April 2013.
  12. ↑ 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.
  13. ↑ "Global bioethics blog: March 2012". globalbioethics.blogspot.ie. Retrieved 15 April 2016.
  14. ↑ "New data on male circumcision and HIV prevention: Policy and programme implications". WHO. Archived from the original on 8 October 2008.
  15. ↑ "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.
  16. ↑ 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.
  17. ↑ 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.
  18. ↑ "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.
  19. ↑ "Wyeth Ghostwriting Archive". PLOS Medicine. Retrieved 13 April 2013.
  20. ↑ Singer, Natasha (5 August 2009). "Medical Papers by Ghostwriters Pushed Therapy". The New York Times. Retrieved 13 April 2013.
  21. ↑ "About the Project". Drug Industry Documents Archive. Retrieved 18 April 2013.
  22. ↑ 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.
  23. ↑ Goldacre, Ben (18 September 2010). "Medical ghostwriters who build a brand". The Guardian. Retrieved 18 April 2013.
  24. ↑ 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.
  25. ↑ 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.
  26. ↑ "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.
  27. ↑ "EMA calls for open access to clinical trial data after Tamiflu concerns". PMLiVE. 11 April 2012. Retrieved 26 April 2013.
  28. ↑ "European Medicines Agency: Workshop on access to clinical trial data and transparency". UKRIO. 18 December 2012. Retrieved 26 April 2013.
  29. ↑ 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.
  30. ↑ "Roche offers compromise in Tamiflu data debate". PMLiVE. 26 November 2012. Retrieved 26 April 2013.
  31. ↑ "Workshop report: Access to clinical-trial data and transparency" (PDF). European Medicines Agency. Retrieved 14 April 2013.
  32. 1 2 "EMA workshop reveals divisions with industry . ecancer – News". Ecancer.org. 20 December 2012. Retrieved 26 April 2013.
  33. ↑ "Speaker biographies" (PDF). Workshop on clinical-trial data and transparency. European Medicines Agency. Retrieved 14 April 2013.
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