<\/p>\n
\nA significant number of papers appearing in peer-reviewed biomedical journals are ghost authored. In 2008, a review of 632 articles published in 6 medical journals with high impact factors showed that 21% had evidence of ghost authorship…<\/div>\n<\/p>\n
The number of industry-sponsored ghost- and guest-authored publications in medical journals is difficult to determine. These publications become visible only during litigation and industry attorneys usually request the courts to seal all documents to prevent additional liability claims. However, some courts have unsealed internal documents showing ghost and guest publications related to 3 widely used products. Guest authorship was documented in 55 articles on sertraline [Zolof], which appeared in biomedical journals with high impact factors between 1998 and 2000… Seven publications on gabapentin [Neurontin], extolling the off-label use of the drug for pain and psychiatric conditions, were traced to a medical communication company.<\/div>\n<\/blockquote>\nIt’s good to see Paxil Study 329 getting its well deserved recognition. Maybe notoriety will finally nudge the JAACAP towards retraction where direct appeals have failed: <\/div>\n\nOccasionally, ghost- and guest-authored studies mislead the health care community and violate public trust. To promote the off-label use of paroxetine [Paxil] for treating depression in adolescents, the manufacturer manipulated clinical trial data to ensure that the drug met efficacy and safety requirements. A publication guest authored by Martin Keller in the Journal of the American Academy of Child and Adolescent Psychiatry<\/em> extolled paroxetine as generally well tolerated and effective for treating major depression in adolescents. Recently, the manufacturer admitted that the Keller paper was part of a fraud and agreed to pay a $3 billion fine for marketing paroxetine and other drugs…<\/div>\n<\/blockquote>\nIn the following, it’s good to see that there are specific moves afoot to put a big damper on guest- and ghost-writing. The minority of us who follow these developments can spot it quickly, but the overwhelming majority of readers don’t seem to know know that they’re reading industry generated propaganda inserted into our literature by our academic colleagues for a price, and that the listed authors may have had nothing at all to do with the design and conduct of the study, its analysis, the writing, or even its conclusions, a shameful misuse of their academic credentials and their universitys’ reputations. It should be grounds for demotion or dismissal in my humble opinion: <\/div>\n\nThe landscape is changing with respect to the publication of industry-sponsored clinical studies. Industry has conceded that the credibility of clinical studies has diminished because of reported ghost and guest authorship and the disclosure of biased or selective results. A working group of industry representatives and biomedical journal editors recently published sweeping recommendations that would enhance the transparency and credibility of industry-sponsored clinical studies [Mayo Clin Proc. 2012 May; 87(5): 424–429. full text on-line<\/a>] [Uniform Requirements for Manuscripts Submitted to Biomedical Journals<\/a>]. One recommendation is that industry should move to a zero tolerance position on ghost and guest authorship. At the present time, only 6 [Amgen<\/font><\/strong>, AstraZeneca<\/font><\/strong>, GlaxoSmithKline<\/font><\/strong>, Johnson & Johnson<\/font><\/strong>, Merck<\/font><\/strong>, and Pfizer<\/font><\/strong>] of the 108 pharmaceutical companies registered in the US have published corporate guidelines and work practices that increase transparency, prevent ghost and guest authorship, as well as abuse of the peer review system. The working group also recommended that guest authors be given full access to study design, the raw data from a study, and the data analyses so that a guest author can attest to study validity. To reduce the underestimation of adverse effects and health risks, the group also recommended that all adverse effects and risks be reported in a transparent and clinically relevant manner…<\/div>\n<\/p>\n
Although the ICMJE, the World Association of Medical Editors, and the Committee on Publication Ethics have declared ghost and guest authorship to be “dishonest and unacceptable,” journal editors have not changed publication paradigms. Only 29% of 324 biomedical journals use, endorse, or adhere to the ICMJE guidelines. Of the 79 journals that compose the Pharmacy Library Core Journal List, only 33% adhere to or endorse the ICMJE authorship guidelines. Listing of authors’ contributions to a study is required by only 9% of 324 biomedical journals and 18% of the core pharmacy journals. Most biomedical journals require identification of the funding sources. However, it is unclear whether industry funding is an in-kind payment from the sponsor or its agents to individuals associated with the subject of the article, funding of future research in the guest author’s laboratory, or both. Few journals require authors to take responsibility for the scientific validity of a study<\/font><\/strong>… <\/div>\n<\/blockquote>\nIn 2000, Dr. Marcia Angell<\/font><\/strong>, then editor of the New England Journal of Medicine wrote a nuclear editorial, Is Academic Medicine for Sale?<\/a> It was stimulated by an article in that issue of the NEJM by Martin Keller et al with 29 authors, many of whom we still know of as the upper level of the KOL\/COI cohort [see has to stop…<\/a>]. It was a valiant effort on Dr. Angell’s part and it would lead her to many other such publications, but unfortunately, the answer to her question remains "yes!"<\/div>\nIn the last month, there have been posts on this blog about ghost-written articles by four of the authors on that paper Dr. Angell was complaining about thirteen years ago [Trivedi, Thase, Rush, Keller] [as it should be…<\/a>, objectively… <\/a>, seroquel: good to the last drop…<\/a>] and another who was reporting on an offshoot of that same old paper promoting data that had been long since retracted [Nemeroff] [has to stop…<\/a>]. Industry funded ghost written articles in major journals remain an every issue problem in spite of some of publicity and progress reported above. <\/p>\n
Zero tolerance seems like the only viable solution and it will have to be enforced by editors, authors, journals, and the universities to be stopped. It’s apparently too lucrative to the guests and their industry sponsors to expect common decency and respect for science to carry the day. Zero tolerance will mean that heads will need to roll, and we aren’t yet in a place to expect that will happen in the near future. The irony is that the last several posts were about a lofty debate in 1990 about the sanctity of clinical trials and evidence based medicine [down the rabbit hole…<\/a>], and here we are only ten years later talking about jury-rigged clinical trials with just-pretend authors… <\/div>\n","protected":false},"excerpt":{"rendered":"Ghost- and Guest-Authored Pharmaceutical Industry-Sponsored Studies: Abuse of Academic Integrity, the Peer Review System, and Public Trust by Dennis K Flaherty, PhD Annals of Pharmacotherapy. 2013 47:1081-1083. [full text on-line] Industry-sponsored ghost- and guest-authored clinical research publications are a continuing problem in medical journals. These communications are written by unacknowledged medical communication companies and submitted […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_bbp_topic_count":0,"_bbp_reply_count":0,"_bbp_total_topic_count":0,"_bbp_total_reply_count":0,"_bbp_voice_count":0,"_bbp_anonymous_reply_count":0,"_bbp_topic_count_hidden":0,"_bbp_reply_count_hidden":0,"_bbp_forum_subforum_count":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-38505","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/38505","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/comments?post=38505"}],"version-history":[{"count":48,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/38505\/revisions"}],"predecessor-version":[{"id":38552,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/38505\/revisions\/38552"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=38505"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=38505"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=38505"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}