Medical ghostwriters are employed by pharmaceutical companies and medical-device manufacturers to produce apparently independent manuscripts for peer-reviewed journals, conference presentations and other communications. Physicians and other scientists are paid to attach their names to the manuscripts as though they had authored them. The named authors may have had little or no involvement in the research or writing process.
68-594: PLOS Medicine (formerly styled PLoS Medicine ) 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
136-529: A monograph or in the proceedings of an academic conference . If the identities of authors are not revealed to each other, the procedure is called dual-anonymous peer review. Medical peer review may be distinguished in four classifications: Additionally, "medical peer review" has been used by the American Medical Association to refer not only to the process of improving quality and safety in health care organizations, but also to
204-643: 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
272-481: A certain threshold, and effective peer review requires a certain level of expertise. For non-professional writers, peer review feedback may be overlooked, thereby affecting its effectiveness. Elizabeth Ellis Miller, Cameron Mozafari, Justin Lohr and Jessica Enoch state, "While peer review is an integral part of writing classrooms, students often struggle to effectively engage in it." The authors illustrate some reasons for
340-610: A decrease in number of people who reported ghostwriting among professional medical writers. Most pharmaceutical companies have in-house publication managers who may either manage the writing of publications on the company's drugs by a team of in-house medical writers or contract them out to medical communication companies or freelance medical writers. Reprints of the articles can be distributed to doctors in their offices or at medical meetings by drug company representatives in lieu of product brochures. This practice might be illegal if it effectively constitutes advertising or advocating use of
408-557: A fundamental process in academic and professional writing, serving as a systematic means to ensure the quality, effectiveness, and credibility of scholarly work. However, despite its widespread use, it is one of the most scattered, inconsistent, and ambiguous practices associated with writing instruction. Many scholars questioning its effectiveness and specific methodologies. Critics of peer review in classrooms express concerns about its ineffectiveness due to students' lack of practice in giving constructive criticism or their limited expertise in
476-535: A leading medical journal rejected this paper because of ethical concerns 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
544-415: A longitudinal study comparing two groups of students (one majoring in writing and one not) to explore students' perceptions of authority. This research, involving extensive analysis of student texts, concludes that students majoring in non-writing fields tend to undervalue mandatory peer review in class, while those majoring in writing value classmates' comments more. This reflects that peer review feedback has
612-501: A means of critiquing each other's work, peer review is often framed as a way to build connection between students and help develop writers' identity. While widely used in English and composition classrooms, peer review has gained popularity in other disciplines that require writing as part of the curriculum including the social and natural sciences . Peer review in classrooms helps students become more invested in their work, and
680-417: A report on medical ghost writing. The report said, "The Committee was provided with documents from recent lawsuits involving Wyeth’s hormone therapy products. The documents showed that Wyeth hired a medical communications and education company, DesignWrite Inc. (DesignWrite), to draft review articles regarding the breast cancer risk of hormone therapy products and then invited academic researchers to sign on as
748-466: A short comment and a longer analysis. Ioannidis has answered this critique. A profile of Ioannidis' work including a discussion of his 2005 paper appeared in the November 2010 issue of The Atlantic . 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 . The Lancet
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#1732772673621816-448: A time and given an amount of time to present the topic that they have researched. Each speaker may or may not talk about the same topic but each speaker has something to gain or lose which can foster a competitive atmosphere. This approach allows speakers to present in a more personal tone while trying to appeal to the audience while explaining their topic. Peer seminars may be somewhat similar to what conference speakers do, however, there
884-553: A variety of professional organizations representing the drug industry, publishers, and medical societies, and it may violate American laws prohibiting off-label promotion by drug manufacturers as well as anti- kickback provisions within the statutes governing Medicare. Recently, it has attracted scrutiny from the lay press lawmakers the Institute of Medicine , and the National Institutes of Health . as well. It
952-471: A “medical writer” would be an author, but current dialogue on ghostwriting ignores such common-sense interpretations. Listing ghost authors as editorial assistants allows pharmaceutical companies to publish articles with conflicts-of interest that are not transparently reported. Editorial assistants are not mentioned in the abstract, are not indexed in publication databases, are not mentioned in subsequent citations, and are never mentioned in news media accounts of
1020-525: Is a type of engineering review. Technical peer reviews are a well defined review process for finding and fixing defects, conducted by a team of peers with assigned roles. Technical peer reviews are carried out by peers representing areas of life cycle affected by material being reviewed (usually limited to 6 or fewer people). Technical peer reviews are held within development phases, between milestone reviews, on completed products or completed portions of products. The European Union has been using peer review in
1088-479: Is common in the field of health care, where it is usually called clinical peer review . Further, since peer review activity is commonly segmented by clinical discipline, there is also physician peer review, nursing peer review, dentistry peer review, etc. Many other professional fields have some level of peer review process: accounting, law, engineering (e.g., software peer review , technical peer review ), aviation, and even forest fire management. Peer review
1156-594: Is incorporated into the California Health and Safety Code Section 57004. Peer review, or student peer assessment, is the method by which editors and writers work together in hopes of helping the author establish and further flesh out and develop their own writing. Peer review is widely used in secondary and post-secondary education as part of the writing process. This collaborative learning tool involves groups of students reviewing each other's work and providing feedback and suggestions for revision. Rather than
1224-551: Is more time to present their points, and speakers can be interrupted by audience members to provide questions and feedback upon the topic or how well the speaker did in presenting their topic. Professional peer review focuses on the performance of professionals, with a view to improving quality, upholding standards, or providing certification. Peer review in writing is a pivotal component among various peer review mechanisms, often spearheaded by educators and involving student participation, particularly in academic settings. It constitutes
1292-465: Is permitted at some institutions , including the University of Washington School of Medicine , while it is prohibited and considered a particularly pernicious form of plagiarism at others, such as Tufts University School of Medicine and the University of Pennsylvania School of Medicine . Scandals involving prominent physicians researchers have been reported at over a dozen universities in
1360-413: Is still a method used in classrooms to help students young and old learn how to revise. With evolving and changing technology, peer review will develop as well. New tools could help alter the process of peer review. Peer seminar is a method that involves a speaker that presents ideas to an audience that also acts as a "contest". To further elaborate, there are multiple speakers that are called out one at
1428-432: Is that peer review is not just about improving writing but about helping authors achieve their writing vision." Feedback from the majority of non-professional writers during peer review sessions often tends to be superficial, such as simple grammar corrections and questions. This precisely reflects the implication in the conclusion that the focus is only on improving writing skills. Meaningful peer review involves understanding
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#17327726736211496-479: Is the evaluation of work by one or more people with similar competencies as the producers of the work ( peers ). It functions as a form of self-regulation by qualified members of a profession within the relevant field . Peer review methods are used to maintain quality standards, improve performance, and provide credibility. In academia , scholarly peer review is often used to determine an academic paper 's suitability for publication. Peer review can be categorized by
1564-507: Is the only U.S. state to mandate scientific peer review. In 1997, the Governor of California signed into law Senate Bill 1320 (Sher), Chapter 295, statutes of 1997, which mandates that, before any CalEPA Board, Department, or Office adopts a final version of a rule-making, the scientific findings, conclusions, and assumptions on which the proposed rule are based must be submitted for independent external scientific peer review. This requirement
1632-450: Is the process of having a draft version of a researcher's methods and findings reviewed (usually anonymously) by experts (or "peers") in the same field. Peer review is widely used for helping the academic publisher (that is, the editor-in-chief , the editorial board or the program committee ) decide whether the work should be accepted, considered acceptable with revisions, or rejected for official publication in an academic journal ,
1700-551: Is the section of the ICMJE Uniform Requirements laying out guidelines for how potential or actual scientific error and scientific fraud ought to be dealt with. It refers readers to the relevant guidelines from the Committee for Publication Ethics (COPE) - specifically COPE's flowcharts outlining a systematic approach toward scientific error and possible fraud. Medical ghostwriting has been criticized by
1768-399: Is used in education to achieve certain learning objectives, particularly as a tool to reach higher order processes in the affective and cognitive domains as defined by Bloom's taxonomy . This may take a variety of forms, including closely mimicking the scholarly peer review processes used in science and medicine. Scholarly peer review or academic peer review (also known as refereeing)
1836-830: Is voluntary. A list of medical journals which have stated that they follow the Uniform Requirements for Manuscripts Submitted to Biomedical Journals is maintained by the International Committee of Medical Journal Editors. How closely individual medical journals and authors of medical journal articles comply with ICMJE guidelines is a largely self-policed matter. The ICMJE document "Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Publishing and Editorial Issues Related to Publication in Biomedical Journals: Corrections, Retractions and "Expressions of Concern"
1904-587: The Drug Industry Document Archive . It also appears to have occurred in 75% of industry funded trials between 1994 - 1995 approved by the Scientific Ethical Committees for Copenhagen and Frederiksberg. Of the articles published from 1998 to 2000 regarding sertraline , between 18% and 40% were ghost written by Pfizer . A questionnaire using comparable methods in 2005 and 2008 with a 14-28% response rate found
1972-710: The World Health Organization (WHO) assessing the evidence for male circumcision to prevent HIV transmission. The WHO and UNAIDS subsequently issued recommendations concerning male circumcision and HIV/AIDS 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. Several Ministries of Health along with key stakeholders have committed to scaling up VMMC for HIV prevention in Southern and Eastern Africa. In July 2009,
2040-467: The "Open Method of Co-ordination" of policies in the fields of active labour market policy since 1999. In 2004, a program of peer reviews started in social inclusion . Each program sponsors about eight peer review meetings in each year, in which a "host country" lays a given policy or initiative open to examination by half a dozen other countries and the relevant European-level NGOs . These usually meet over two days and include visits to local sites where
2108-871: The Journal of the Royal Society of Medicine. “That’s boring.” This is also particularly evident in university classrooms, where the most common source of writing feedback during student years often comes from teachers, whose comments are often highly valued. Students may become influenced to provide research in line with the professor’s viewpoints, because of the teacher’s position of high authority. The effectiveness of feedback largely stems from its high authority. Benjamin Keating, in his article "A Good Development Thing: A Longitudinal Analysis of Peer Review and Authority in Undergraduate Writing," conducted
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2176-525: The Role of Authors and Contributors" is considered the definitive statement of ethical requirements for how authorship in medical journal articles (the prime forum for medical professional publication) and the degree to which a given writer is deemed to have contributed to the content of a medical journal article are determined. Compliance with the International Committee of Medical Journal Editors' Uniform Requirements for Manuscripts Submitted to Biomedical Journals
2244-541: The United States, however, there have been no reports of any professors being disciplined. Professor Trudo Lemmens of the University of Toronto Faculty of Law argues that ghostwritten papers help protect companies when they are sued in court. Perhaps the most pernicious practice in ghostwriting involves thanking writers for providing “editorial assistance” in the acknowledgments section of the paper instead of
2312-459: The acknowledgments section of the paper instead of listing them on the authorship byline, the problem with simply thanking ghostwriters in the acknowledgements section is clearly illustrated by Study 329 , probably the most notorious ghostwritten paper in the medical literature. The study examined the use of Paxil in adolescents and concluded, “Paroxetine is generally well tolerated and effective for major depression in adolescents.” Several years after
2380-504: The article. In other words, the fact that a pharmaceutical company directly co-authored the paper is concealed from view. That this is seen as acceptable in an era of increased disclosure of conflicts-of-interest is puzzling. While several groups in medicine including the European Medical Writers Association (EMWA) sanction the practice of thanking medical writers for providing “editorial assistance” in
2448-639: The author's work without being acknowledged. The term "ghostwriting" is often used to encompass all three of these practices. The rules for authorship and contribution of the International Committee of Medical Journal Editors (ICMJE, informally known as "the Vancouver Group" from the locale of the group's first meeting, Vancouver, British Columbia, Canada) are a single, universally-respected set of guidelines for describing authorship of and contribution to professional medical publications. The document "International Committee of Medical Journal Editors: Defining
2516-429: The author's writing intent, posing valuable questions and perspectives, and guiding the author to achieve their writing goals. Magda Tigchelaar compares peer review with self-assessment through an experiment that divided students into three groups: self-assessment, peer review, and no review. Across four writing projects, she observed changes in each group, with surprisingly results showing significant improvement only in
2584-652: The authorship byline, which essentially changes the rule of authorship attribution so that ghostwriting is acceptable. Several groups in medicine including the European Medical Writers Association (EMWA) sanction this practice. While the average reader likely interprets “editorial assistance” as help with grammar or improvements to the overall readability of the article, in reality, such “assistants” make major contributions to papers, and would commonsensically be considered co-authors. Tellingly, many medical writers are “editorial assistants” on some scientific papers, but co-authors on others. It would seem obvious that someone employed as
2652-480: The category "Medicine, General & Internal". In 2005 PLOS Medicine published an essay by John P. A. Ioannidis entitled " Why Most Published Research Findings Are False ". 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
2720-431: The classroom environment at large. Understanding how their work is read by a diverse readership before it is graded by the teacher may also help students clarify ideas and understand how to persuasively reach different audience members via their writing. It also gives students professional experience that they might draw on later when asked to review the work of a colleague prior to publication. The process can also bolster
2788-426: The confidence of students on both sides of the process. It has been found that students are more positive than negative when reviewing their classmates' writing. Peer review can help students not get discouraged but rather feel determined to improve their writing. Critics of peer review in classrooms say that it can be ineffective due to students' lack of practice giving constructive criticism, or lack of expertise in
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2856-493: The discovery process for the court case, which demonstrated the practice of ghostwriting, should be made available to the public. 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 . In 2010 PLOS Medicine published the first academic analysis of
2924-434: The documents by Adriane Fugh-Berman. 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
2992-503: The drug for non-approved indications or dosages. Payments to medical ghostwriters may be augmented with consulting contracts, paid trips to teach continuing medical education courses, or grants. The academics or doctors are known as "KOLs" (" Key Opinion Leaders ") or "TLs" ("Thought Leaders"). On June 24, 2010, Senator Charles E. Grassley, Ranking Member of the United States Senate Committee on Finance issued
3060-531: The feedback with either positive or negative attitudes towards the text, resulting in selective or biased feedback and review, further impacting their ability to objectively evaluate the article. It implies that subjective emotions may also affect the effectiveness of peer review feedback. Pamela Bedore and Brian O’Sullivan also hold a skeptical view of peer review in most writing contexts. The authors conclude, based on comparing different forms of peer review after systematic training at two universities, that "the crux
3128-494: The greatest toll on health globally. 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. 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". The journal does not publish advertisements for pharmaceutical products or medical devices and
3196-627: The inefficiency of peer review based on research conducted during peer review sessions in university classrooms: This research demonstrates that besides issues related to expertise, numerous objective factors contribute to students' poor performance in peer review sessions, resulting in feedback from peer reviewers that may not effectively assist authors. Additionally, this study highlights the influence of emotions in peer review sessions, suggesting that both peer reviewers and authors cannot completely eliminate emotions when providing and receiving feedback. This can lead to peer reviewers and authors approaching
3264-629: The journal's open-access license means that it cannot benefit from exclusive reprint sales. The journal is abstracted and indexed in Index Medicus / MEDLINE / PubMed , the Science Citation Index Expanded , Current Contents /Clinical Medicine, and BIOSIS Previews . According to the Journal Citation Reports , the journal had a 2014 impact factor of 14.429, ranking it 7th out of 153 journals in
3332-558: 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. 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
3400-636: 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. The regulators noted, "[w]e consider it neither desirable nor realistic to maintain
3468-576: The paper It is difficult to determine how frequently ghostwriting occurs due to its covert nature. A 2009 New York Times article estimated that 11% of New England Journal of Medicine articles, 8% of JAMA , Lancet and PLoS Medicine articles, 5% of Annals of Internal Medicine articles and 2% of Nature Medicine were ghost written. Between 1998 and 2005 Wyeth had 26 papers promoting hormone replacement therapy (HRT) published in scientific journals. Previously secret internal Wyeth documents providing evidence of this are viewable on
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#17327726736213536-408: The paper was published, court proceedings revealed internal company documents admitting that the study found that Paxil was not any better than placebo on the pre-registered outcome measures, and that the company was concerned about how to manage the negative findings. According to the revised ICMJE Guidelines, Professional medical writers who write papers are not exempt from being listed as authors of
3604-424: The peer review process can be segmented into groups, where students present the papers to be reviewed, while other group members take notes and analyze them. Then, the review scope can be expanded to the entire class. This widens the review sources and further enhances the level of professionalism. With evolving and changing technology, peer review is also expected to evolve. New tools have the potential to transform
3672-441: The peer review process. Mimi Li discusses the effectiveness and feedback of an online peer review software used in their freshman writing class. Unlike traditional peer review methods commonly used in classrooms, the online peer review software offers a plethora of tools for editing articles, along with comprehensive guidance. For instance, it lists numerous questions peer reviewers can ask and allows for various comments to be added to
3740-471: The policy can be seen in operation. The meeting is preceded by the compilation of an expert report on which participating "peer countries" submit comments. The results are published on the web. The United Nations Economic Commission for Europe , through UNECE Environmental Performance Reviews , uses peer review, referred to as "peer learning", to evaluate progress made by its member countries in improving their environmental policies. The State of California
3808-462: The process of rating clinical behavior or compliance with professional society membership standards. The clinical network believes it to be the most ideal method of guaranteeing that distributed exploration is dependable and that any clinical medicines that it advocates are protected and viable for individuals. Thus, the terminology has poor standardization and specificity, particularly as a database search term. In engineering , technical peer review
3876-632: The selected text. Based on observations over the course of a semester, students showed varying degrees of improvement in their writing skills and grades after using the online peer review software. Additionally, they highly praised the technology of online peer review. Medical ghostwriter The American Medical Writers Association speaks about the topic as follows: "Ghost authoring" refers to making substantial contributions without being identified as an author. "Guest authoring" refers to being named as an author without having made substantial contributions. "Ghostwriting" refers to assisting in presenting
3944-579: The self-assessment group. The author's analysis suggests that self-assessment allows individuals to clearly understand the revision goals at each stage, as the author is the most familiar with their own writing. Thus, self-checking naturally follows a systematic and planned approach to revision. In contrast, the effectiveness of peer review is often limited due to the lack of structured feedback, characterized by scattered, meaningless summaries and evaluations that fail to meet author's expectations for revising their work. Stephanie Conner and Jennifer Gray highlight
4012-492: 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. At
4080-473: The type of activity and by the field or profession in which the activity occurs, e.g., medical peer review . It can also be used as a teaching tool to help students improve writing assignments. Henry Oldenburg (1619–1677) was a German-born British philosopher who is seen as the 'father' of modern scientific peer review. It developed over the following centuries with, for example, the journal Nature making it standard practice in 1973. The term "peer review"
4148-442: The value of most students' feedback during peer review. They argue that many peer review sessions fail to meet students' expectations, as students, even as reviewers themselves, feel uncertain about providing constructive feedback due to their lack of confidence in their own writing. The authors further offer numerous improvement strategies across various dimensions, such as course content and specific implementation steps. For instance,
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#17327726736214216-432: 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". PLOS Medicine 's chief editor, Virginia Barbour , was an invited speaker at the workshop representing the media. Peer review Peer review
4284-505: The writer or the editor to get much out of the activity. As a response to these concerns, instructors may provide examples, model peer review with the class, or focus on specific areas of feedback during the peer review process. Instructors may also experiment with in-class peer review vs. peer review as homework, or peer review using technologies afforded by learning management systems online. Students that are older can give better feedback to their peers, getting more out of peer review, but it
4352-616: The writing craft at large. Peer review can be problematic for developmental writers, particularly if students view their writing as inferior to others in the class as they may be unwilling to offer suggestions or ask other writers for help. Peer review can impact a student's opinion of themselves as well as others as sometimes students feel a personal connection to the work they have produced, which can also make them feel reluctant to receive or offer criticism. Teachers using peer review as an assignment can lead to rushed-through feedback by peers, using incorrect praise or criticism, thus not allowing
4420-488: The writing craft overall. Academic peer review has faced considerable criticism, with many studies highlighting inherent issues in the peer review process. The editorial peer review process has been found to be strongly biased against ‘negative studies,’ i.e. studies that do not work. This then biases the information base of medicine. Journals become biased against negative studies when values come into play. “Who wants to read something that doesn’t work?” asks Richard Smith in
4488-538: Was first used in the early 1970s. Since 2017 a monument to peer review is at the Higher School of Economics in Moscow. Professional peer review focuses on the performance of professionals, with a view to improving quality, upholding standards, or providing certification. In academia, peer review is used to inform decisions related to faculty advancement and tenure. A prototype professional peer review process
4556-556: Was recommended in the Ethics of the Physician written by Ishāq ibn ʻAlī al-Ruhāwī (854–931). He stated that a visiting physician had to make duplicate notes of a patient's condition on every visit. When the patient was cured or had died, the notes of the physician were examined by a local medical council of other physicians, who would decide whether the treatment had met the required standards of medical care. Professional peer review
4624-431: Was subsequently covered by The Guardian . 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 . The article outlined
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