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Medical publishing: a flawed model in dire need of reform
N. Guptaa,...
Corresponding author
nidhigupta@doctors.net.uk

Corresponding author.
, S. Kapurb
a Speciality Trainee ST6, General Adult Community Mental Health Team, Birmingham and Solihull Mental Health NHS Foundation Trust, Birmingham, UK
b Pain Management & Anaesthesia, University Hospital Birmingham, Birmingham, UK
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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">The controversy around a recent paper on Hydroxychloroquine&#44; published-and subsequently retracted-in <span class="elsevierStyleItalic">The Lancet&#44;</span> has refocused attention on medical journals and their publishing practices&#46;<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> This brings to mind the controversy around the 1973 Rosenhan &#46;&#46;&#160;Thud experiment&#46;&#46;&#46;&#46;</p><p id="par0010" class="elsevierStylePara elsevierViewall">In 1973&#44; <span class="elsevierStyleItalic">Science</span> published David Rosenhan&#46;&#46;&#46;s &#46;&#46;&#160;pseudo-patients&#46;&#46;&#46; study &#40;<span class="elsevierStyleItalic">On Being Sane in Insane Places</span>&#41;&#46; Rosenhan&#46;&#46;&#46;s paper stated that 8 sane people &#40;of which Rosenhan himself was one&#41; presented themselves at psychiatric hospitals in the USA&#44; pretending to hear voices saying &#46;&#46;&#160;hollow&#46;&#46;&#46;&#44; &#46;&#46;&#160;empty&#46;&#46;&#46; and &#46;&#46;&#160;thud&#46;&#46;&#46;&#46; They were all admitted&#44; and though all ceased to exhibit any symptoms thereafter&#44; 7 of the 8 were diagnosed with schizophrenia&#46;<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a> Rosenhan&#46;&#46;&#46;s experiment caused an uproar and served to strengthen Thomas Szasz&#46;&#46;&#46;s anti-psychiatry movement&#46; However&#44; recent investigations by the journalist Susannah Cahalan &#40;published in her book <span class="elsevierStyleItalic">The Great pretender</span>&#41; have uncovered serious flaws in the conduct of this research and raised fundamental questions about its veracity&#44; and the unquestioning attitude with which the study was accepted and defended by medical journals&#46;<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">Mainstream media publications-for example&#44; <span class="elsevierStyleItalic">Time</span> or <span class="elsevierStyleItalic">National Geographic-</span>employ paid journalists and editors to commission&#44; write&#44; edit and publish articles&#46; This is expensive&#44; and a major reason why many newspapers and magazines have folded&#46; Now&#44; consider medical publishing&#46; As <span class="elsevierStyleItalic">The Guardian</span> newspaper&#46;&#46;&#46;s medical writer Stephen Buranyi notes&#44; medical journals receive their contributions from authors free of cost&#46; Peer-review is also undertaken <span class="elsevierStyleItalic">pro bono</span> by volunteer medical experts&#46; Moreover&#44; the <span class="elsevierStyleItalic">actual</span> costs of medical research and peer-review are paid for by taxpayers&#44; who fund researchers&#46;&#46;&#46; &#40;salaried&#41; time and resources &#40;research grants&#41;&#46; The publishers then sell the finished product &#40;journals&#44; online access and pay-per-view articles&#41; to the consumer &#40;universities&#44; institutions and individuals&#41;&#46; Medical publishing&#44; therefore&#44; is an industry where producing and processing the raw material are done for free by volunteers and the retailer profits by selling the fruits of others&#46;&#46;&#46; labours&#46;<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a></p><p id="par0020" class="elsevierStylePara elsevierViewall">The scientific publishing industry&#44; in its current avatar&#44; is the brainchild of the press mogul&#44; Robert Maxwell&#46; He nurtured the nascent medical publishing industry in the post-WW2 years&#44; mutating it from a genteel profession into a profitable enterprise&#46; Stephen Buranyi also notes that three major publishers &#40;Elsevier&#44; Springer and Wiley-Blackwell&#41; now control almost 50&#37; of the scientific publishing market worldwide&#46;<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a></p><p id="par0025" class="elsevierStylePara elsevierViewall">The scientific publishing industry exerts a firm control over researchers&#46; The use of <span class="elsevierStyleItalic">Impact Factor</span> &#40;an estimate of how many times a paper published in a particular journal has been cited in other journals&#41; to rank journals has conferred cachet on &#46;&#46;&#160;High impact factor&#46;&#46;&#46; journals &#40;for example&#44; Nature&#44; Lancet&#44; JAMA&#41;&#44; with researchers vying to publish in these journals&#46;<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a></p><p id="par0030" class="elsevierStylePara elsevierViewall">The race to publish &#46;&#46;&#160;significant&#46;&#46;&#46; results has costs&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">Daniele Fanelli&#46;&#46;&#46;s paper &#40;<span class="elsevierStyleItalic">How many scientists fabricate and falsify research&#63;</span>&#41; noted that approximately 2&#37; of scientists own up to &#46;&#46;&#250;<span class="elsevierStyleItalic">having fabricated&#44; falsified or modified data or results at least once</span>&#46;&#46;&#209;&#46; Dr Fanelli also noted around 30&#37; of scientists admitted to &#46;&#46;&#250;<span class="elsevierStyleItalic">changing the design&#44; methodology or results of a study in response to pressures from a funding source</span>&#46;&#46;&#209;&#46;<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a></p><p id="par0040" class="elsevierStylePara elsevierViewall">In 2005&#44; John Ioannidis published a seminal paper titled <span class="elsevierStyleItalic">&#46;&#46;&#160;Why most published research findings are false&#46;&#46;&#46;</span>&#46; In this paper&#44; Ioannidis demonstrated that up to 80 percent of non-randomized studies&#44; 25 percent of randomized trials&#44; and as much as 10 percent of large-scale randomized trials suffer from significant flaws&#46;<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a> As Ioannidis diplomatically put it &#46;&#46;&#250;<span class="elsevierStyleItalic">A third of the most-cited clinical research seems to have replication problems</span>&#46;&#46;&#209;&#46; He opined that publication bias favoured the rapid and prominent publication of &#46;&#46;&#160;positive&#46;&#46;&#46; findings over &#46;&#46;&#160;negative&#46;&#46;&#46; studies and cautioned that &#46;&#46;&#250;<span class="elsevierStyleItalic">evidence from recent trials&#44; no matter how impressive&#44; should be interpreted with caution&#44; when only one trial is available in order to limit premature claims for efficacy</span>&#46;&#46;&#209;&#46;<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">7</span></a></p><p id="par0045" class="elsevierStylePara elsevierViewall">Are there any solutions to this burgeoning problem&#44; then&#63;</p><p id="par0050" class="elsevierStylePara elsevierViewall">One answer possibly lies in <span class="elsevierStyleItalic">Open Access</span> publishing&#44; where researchers pay upfront to have their studies published in online open-access journals&#46; Open access journals then do not have to depend on subscription fees and pharmaceutical advertising to survive&#46; The published research is not hidden behind a &#46;&#46;&#160;paywall&#46;&#46;&#46; and is easily accessible by interested parties worldwide&#44; thereby allowing greater transparency and scrutiny of the research&#46; However&#44; only about 25&#37; of all published papers are currently open access&#44; which is a travesty&#46;<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a></p><p id="par0055" class="elsevierStylePara elsevierViewall">Another solution lies in using sophisticated statistical screening tools to vet studies prior to publication&#46; Dr John Carlisle &#40;Consultant Anaesthetist&#44; Devon&#41; was instrumental in unmasking research fraud propagated on an epic scale by Yoshitaka Fujii&#44; resulting in the retraction of 183 publications&#46; Dr Carlisle pioneered what has come to be known as the <span class="elsevierStyleItalic">Carlisle Method</span>&#58; by testing the randomness of variables such as age&#44; sex&#44; weight&#44; height etc&#46; in a study&#44; Dr Carlisle argues that one can determine whether the distribution of these variables is down to random chance &#40;in a &#46;&#46;&#160;clean&#46;&#46;&#46; study&#41;&#44; or &#46;&#46;&#160;invented&#46;&#46;&#46;&#46; Two major journals &#40;Anaesthesia and NEJM&#41; use the Carlisle method to screen RCTs submitted for publication&#44; and other journals may follow&#46;<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">8</span></a></p><p id="par0060" class="elsevierStylePara elsevierViewall">The gathering momentum for registering all clinical trials &#40;<span class="elsevierStyleItalic">clinicaltrials&#46;gov</span>&#41; and the push for scientists to release their raw data will inexorably lead to greater transparency&#46;</p><p id="par0065" class="elsevierStylePara elsevierViewall">While peer-review is considered the gold standard for medical journals of repute&#44; there are obviously flaws in the system&#46; Dr&#46; Richard Smith&#44; former editor of the British Medical Journal &#40;BMJ&#41;&#44; is of the opinion that peer review is &#46;&#46;&#250;<span class="elsevierStyleItalic">slow&#44; expensive&#44; ineffective&#44; something of a lottery&#44; prone to bias and abuse&#44; and hopeless at spotting errors and fraud</span>&#46;&#46;&#209;&#46;<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">9</span></a> As scientific studies become increasingly complex&#44; it is humanly not possible for reviewers to be able to review all aspects of a paper&#46; Just as the use of plagiarism detection software is now commonplace&#44; perhaps a novel solution may lie in the development of artificial intelligence &#40;AI&#41;-based software that can assist expert reviewers in undertaking sophisticated&#44; multidimensional peer review&#46; While this may sound sacrilegious to traditionalists who regard the peer review process as sacrosanct and inviolate&#44; one could argue that this bastion too needs to be stormed&#46;</p><p id="par0070" class="elsevierStylePara elsevierViewall">In his book&#44; <span class="elsevierStyleItalic">The Trouble with Medical Journals&#44;</span> Dr&#46; Richard Smith also goes on to suggest that the majority of doctors in clinical practice have neither the time nor the inclination to trawl through reams of abstrusely worded medical journals&#44; and that publishers should strive to present research in a succinct&#44; easily digestible format&#46;<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">9</span></a> Those wishing to deep-dive into a particular research paper can then access the full-text on the journal&#46;&#46;&#46;s website&#46; Indeed&#44; the BMJ has been an early adopter of this approach&#44; with some success&#46;</p><p id="par0075" class="elsevierStylePara elsevierViewall">A clamour for change is necessary to force the medical publishing industry to set its house in order and evolve&#46; The status quo is simply unacceptable&#46;</p><p id="par0080" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleItalic">Most people say that it is the intellect that makes a great scientist&#46; They are wrong&#58; it is character</span>&#58; Albert Einstein</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Ethical considerations</span><p id="par0085" class="elsevierStylePara elsevierViewall">Due to the nature of the article&#44; no ethics approval was considered necessary&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Funding</span><p id="par0090" class="elsevierStylePara elsevierViewall">No funding required&#46;</p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Conflict of interest</span><p id="par0095" class="elsevierStylePara elsevierViewall">The authors have no conflict of interest to declare&#46;</p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0030">Author contributions</span><p id="par0100" class="elsevierStylePara elsevierViewall">NG and SK wrote the manuscript&#46; Both the authors contributed to the editing and reviewing of the of the manuscript&#46;</p></span></span>"
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