Fwd: Merck Paid Elsevier to Publish Phony Peer-Review Journal

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ALLIANCE FOR HUMAN RESEARCH PROTECTIONA Catalyst for Public Debate: Promoting Openness, Full Disclosure, andAccountabilityhttp://www.ahrp.org <http://www.ahrp.org/>  FYIDocuments uncovered during the Australian class action lawsuit involving1,000 consumers, against Merck & Co and its Australian subsidiary, MerckSharpe and Dohme, are shocking even to hardened critics of pharmaceuticalindustry corrupt practices. Reports are swirling about Merck's underhandedmarketing scheme evidently cooked up to mislead doctors into prescribing itspotentially fatal drugs--Fosamax (for osteoporosis) and Vioxx (for pain).[1] [2]Merck is reported to have created a fake "peer-reviewed" journal to presentfavorable data that made these drugs look good.  Merck paid Elsevier--one ofthe biggest publishers of medical journals--to publish the phony journal,The Australasian Journal of Bone and Joint Medicine, without disclosing thecompany's sponsorship. Science reports that George Jelinek, an Australian physician and establishedmember of the World Association of Medical Editors, reviewed four issues andtestified at the trial, explained that the "average reader," which in thiscase, would be a physician, could believe the journal to be "genuine" andpeer-reviewed, noting that, "Only close inspection of the journals, alongwith knowledge of medical journals and publishing conventions, enabled me todetermine that the Journal was not, in fact, a peer reviewed medicaljournal, but instead a marketing publication,"Merck also found no trouble hiring academics to sign off as the phonyjournal's "editorial board." Science reports (below) that Peter Brooks, a rheumatologist in Australia,said he didn't recall who asked him to serve on the board, but noted that hewas on Merck's Asian Pacific and international advisory boards from the mid1990s until about 2004, as well as the advisory boards of otherpharmaceutical companies, including Pfizer and Amgen. "You get involved in awhole bunch of things at this level," Brooks said, adding that he had puthis name on "a few advertorials" for pharmaceutical companies about 10 yearsago. So much for the integrity of publishers of medical journals and high profilephysicians!The story was first reported by The Australian, then picked up by TheScientist, Bioethics, and science, engineering cyberspace bloggersReference:1. Jan. 2, 2009 -- After having teeth pulled, 4% of patients in a study whowere taking Fosamax developed a dangerous condition called osteonecrosis ofthe jaw, USC researchers report. None of the tooth extraction patients nottaking Fosamax developed osteonecrosis. The condition, sometimes calledjawbone death, occurs when bone in the jaw fails to heal after a minortrauma. It results in pain, swelling, infection, and exposed bone. See: Fosamax: Higher Risk of Jawbone Death? After Tooth Extraction, FosamaxPatients Have 4% Risk of Jaw Osteonecrosis By Daniel J. DeNoon, WebMD HealthNews, Reviewed by Brunilda Nazario, MDhttp://www.webmd.com/osteoporosis/news/20090101/fosamax-higher-risk-of-jawbone-death2. Merck has already settled thousands of lawsuits in the US over thecardiovascular effects of Vioxx for $4.85 billion, but has made no admissionof guilt.Contact: Vera Hassner Sharavveracare212-595-8974The SCIENTISTMerck published fake journalPosted by Bob Grant30th April 2009 Merck paid an undisclosed sum to Elsevier to produce several volumes of apublication that had the look of a peer-reviewed medical journal, butcontained only reprinted or summarized articles--most of which presenteddata favorable to Merck products--that appeared to act solely as marketingtools with no disclosure of company sponsorship."I've seen no shortage of creativity emanating from the marketingdepartments of drug companies," Peter Lurie, deputy director of the publichealth research group at the consumer advocacy nonprofit Public Citizen,said, after reviewing two issues of the publication obtained by TheScientist. "But even for someone as jaded as me, this is a new wrinkle."The Australasian Journal of Bone and Joint Medicine, which was published byExerpta Medica, a division of scientific publishing juggernaut Elsevier, isnot indexed in the MEDLINE database, and has no website (not even a defunctone). The Scientist obtained two issues of the journal: Volume 2, Issues 1and 2, both dated 2003. The issues contained little in the way ofadvertisements apart from ads for Fosamax, a Merck drug for osteoporosis,and Vioxx. The claim that Merck had created a journal out of whole cloth to serve as amarketing tool was first reported by The Australian about three weeks ago.It came to light in the context of a civil suit filed by Graeme Peterson,who suffered a heart attack in 2003 while on Vioxx, against Merck and itsAustralian subsidiary, Merck, Sharp & Dohme Australia (MSDA).In testimony provided at the trial last week, which was obtained by TheScientist, George Jelinek, an Australian physician and long-time member ofthe World Association of Medical Editors, reviewed four issues of thejournal that were published from 2003-2004. An "average reader" (presumablya doctor) could easily mistake the publication for a "genuine" peer reviewedmedical journal, he said in his testimony. "Only close inspection of thejournals, along with knowledge of medical journals and publishingconventions, enabled me to determine that the Journal was not, in fact, apeer reviewed medical journal, but instead a marketing publication forMSD[A]."He also stated that four of the 21 articles featured in the first issue hereviewed referred to Fosamax. In the second issue, nine of the 29 articlesrelated to Vioxx, and another 12 to Fosamax. All of these articles presentedpositive conclusions regarding the MSDA drugs. "I can understand why apharmaceutical company would collect a number of research papers withresults favourable to their products and make these available to doctors,"Jelinek said at the trial. "This is straightforward marketing."Jelinek also pointed out several "review" articles that only cited one ortwo references. He described one of these articles as "simply a summary ofan already published article," and noted that they were authored by "B & JEditorial.""It appears that 'B & J' (presumably Bone and Joint) refers to the Journal,and B & J editorial presumably to the publishers or owners as there is noeditor of the journal," Jelinek said in his testimony. "This is a subtleattribution, and many readers may not realise that the paper was written bythe owners or publishers of the journal, presuming that is who would writeunder the heading of 'editorial'."Lurie, in examining two of the issues for The Scientist, agreed that oneparticularly strange element of the Australasian Journal of Bone and JointMedicine is that it contains "review" articles that cite just one or tworeferences. "I've never seen anything quite like this," he said. "Reviewsare usually swimming in references." For example, one article onosteoporosis labeled above the title as a "meta-analysis" cites tworeferences -- one itself a meta-analysis. "To the jaundiced eye, [thejournal] might be detected for what it is: marketing," he said. "Manydoctors would fail to identify that and might be influenced by what theyread."Lurie noted that the Australasian Journal of Bone and Joint Medicine is akinto other publishing strategies employed by drug companies; paying forsupplements to existing journals or publishing compilations of originalresearch articles that tend to lack scientific rigor (so-called"throwaways"). "It's kissing cousin to two other tricks that the [drug]companies pull."In response to several questions about the publication posed by TheScientist, an MSDA spokesperson wrote in an email: "MSDA understood thatElsevier envisaged the complimentary publication would draw on the vastresources of Elsevier, publishers of many leading peer-reviewed journalsincluding Lancet, Bone, Joint Bone Spine and others, to deliver novel andtimely full text articles and abstracts to physicians." Many of the articlesappearing in the Australasian Journal of Bone and Joint Medicine were infact reprints or summaries of studies that originally appeared in otherElsevier journals.A spokesperson for Elsevier, however, told The Scientist, "I wish there wasgreater disclosure that it was a sponsored journal." Disclosure of Merck'sfunding of the journal was not mentioned anywhere in the copies of issuesobtained by The Scientist.Elsevier acknowledged that Merck had sponsored the publication, but did notdisclose the amount the drug company paid. In a statement emailed to TheScientist, Elsevier said that the company "does not today consider acompilation of reprinted articles a 'Journal'.""Elsevier acknowledges the concern that the journals in question didn't havethe appropriate disclosures," the statement continued. "It is worth notingthat project in question was produced 6 years ago and disclosure protocolshave evolved since 2003. Elsevier's current disclosure policies meet therigor and requirements of the current publishing environment."The Elsevier spokesperson said the company wasn't aware of how many copiesof the Australasian Journal of Bone and Joint Medicine were produced or howthe publication was distributed in Australia, but noted that "the commonpractice for sponsored journals is that doctors receive them complimentary."The spokesperson added that Elsevier had no plans to look further into thematter.One of the members of Australasian Journal of Bone and Joint Medicine's"Honorary Editorial Board," Peter Brooks, a rheumatologist in Australia,said he didn't recall who asked him to serve on the board, but noted that hewas on Merck's Asian Pacific and international advisory boards from the mid1990s until about 2004, as well as the advisory boards of otherpharmaceutical companies, including Pfizer and Amgen. "You get involved in awhole bunch of things at this level," Brooks said, adding that he had puthis name on "a few advertorials" for pharmaceutical companies about 10 yearsago.As for the Australasian Journal of Bone and Joint Medicine, he said, "If itwould have been put to me that [the journal] was just sort of a throwaway,then I would have said 'no'" to serving on its editorial board. He said hewas never paid for his role, adding that he "didn't ever get [manuscripts]to review or anything like that," while on the board, because the journaldid not accept original manuscripts for review."Having looked at one issue, it actually had some marketing studies," Brookssaid. "It also had papers that were excerpted from other peer-reviewedjournals. I don't think it's fair to say it was totally a marketingjournal."Editor's note (April 30): This story has been updated from a previousversion.# Related stories:Elsevier expands biopharma base [11th March 2008]# Merck's fall from grace [May 2006]~~~~~~~~~~~~~~~~~~~~~~~~~~~http://blog.bioethics.net/2009/05/merck-makes-phony-peerreview-journal/Merck Makes Phony Peer-Review Journal It's a safe guess that somewhere at Merck today someone is goingthrough the meeting minutes of the day that the hair-brained scheme for theAustralasian Journal of Bone and Joint Medicine was launched, and thateveryone who was in the room is now going to be fired. The Scientist has reported that, yes, it's true, Merck cooked up a phony,but real sounding, peer reviewed journal and published favorably lookingdata for its products in them. Merck paid Elsevier to publish such a tome,which neither appears in MEDLINE or has a website, according to TheScientist <http://www.the-scientist.com/templates/trackable/display/blog.jsp?type=blog & o_url=blog/display/55671 & id=55671> .  What's wrong with this is so obvious it doesn't have to be arguedfor. What's sad is that I'm sure many a primary care physician was givenliterature from Merck that said, "As published in Australasian Journal ofBone and Joint Medicine, Fosamax outperforms all other medications...." Saiddoctor, or even the average researcher wouldn't know that the journal isbogus. In fact, knowing that the journal is published by Elsevier gives itcredibility! These kinds of endeavors are not possible without help. One of TheScientist's most notable finds is a Australian rheumatologist named PeterBrooks who served on the "honorary advisory board" of this "journal". Histake: "I don't think it's fair to say it was totally a marketing journal",apparently on the grounds that it had excerpts from peer-reviewed papers.However, in his entire time on the board he never received a single paperfor peer-review, but because he apparently knew the journal did not receiveoriginal submissions of research. This didn't seem to bother him one bit.Such "throwaways" of non-peer reviewed publications and semi-marketingmaterials are commonplace in medicine. But wouldn't that seem odd for anacademic journal? Apparently not. Moreover, Peter Brooks had a pretty laxsense of academic ethics any way: he admitted to having his name put on a"advertorial" for pharma within the last ten years, says The Scientist. An"advertorial"? Again, language unfamiliar to us in the academic publishingworld, but apparently quite familiar to the pharmaceutical publishing scene. It is this attitude within companies like Merck and among doctorsthat allows scandals precisely like this to happen.  While the scandals with Merck and Vioxx are particularly egregious,we know they are not isolated incidents. This one is just particularly so.If physicians would not lend their names or pens to these efforts, andpublishers would not offer their presses, these publications could notexist. What doctors would have as available data would be peer-reviewedresearch and what pharmaceutical companies produce from their marketingdepartments--actual advertisements.  Summer Johnson, PhDFAIR USE NOTICE: This may contain copyrighted (C ) material the use of whichhas not always been specifically authorized by the copyright owner. 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