Documents uncovered during the Australian class action lawsuit involving 1,000 consumers, against Merck & Co and its Australian subsidiary, Merck Sharpe and Dohme, are shocking even to hardened critics of pharmaceutical industry corrupt practices. Reports are swirling about Merck’s underhanded marketing scheme evidently cooked up to mislead doctors into prescribing its potentially fatal drugs–Fosamax (for osteoporosis) and Vioxx (for pain).  
Merck is reported to have created a fake "peer-reviewed" journal to present favorable data that made these drugs look good. Merck paid Elsevier–one of the biggest publishers of medical journals–to publish the phony journal, The Australasian Journal of Bone and Joint Medicine, without disclosing the company’s sponsorhip.
Science reports that George Jelinek, an Australian physician and established member of the World Association of Medical Editors, reviewed four issues and testified at the trial, explained that the "average reader," which in this case, would be a physician, could believe the journal to be "genuine" and peer-reviewed, noting that, "Only close inspection of the journals, along with knowledge of medical journals and publishing conventions, enabled me to determine that the Journal was not, in fact, a peer reviewed medical journal, but instead a marketing publication,"
Merck also found no trouble hiring academics to sign off as the phony journal’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 he was on Merck’s Asian Pacific and international advisory boards from the mid 1990s until about 2004, as well as the advisory boards of other pharmaceutical companies, including Pfizer and Amgen. "You get involved in a whole bunch of things at this level," Brooks said, adding that he had put his name on "a few advertorials" for pharmaceutical companies about 10 years ago.
So much for the integrity of publishers of medical journals and high profile physicians!
The story was first reported by The Australian, then picked up by The Scientist, Bioethics, and science, engineering cyberspace bloggers
1. Jan. 2, 2009 — After having teeth pulled, 4% of patients in a study who were taking Fosamax developed a dangerous condition called osteonecrosis of the jaw, USC researchers report. None of the tooth extraction patients not taking Fosamax developed osteonecrosis. The condition, sometimes called jawbone death, occurs when bone in the jaw fails to heal after a minor trauma. It results in pain, swelling, infection, and exposed bone.
See: Fosamax: Higher Risk of Jawbone Death? After Tooth Extraction, Fosamax Patients Have 4% Risk of Jaw Osteonecrosis By Daniel J. DeNoon, WebMD Health News, Reviewed by Brunilda Nazario, MD http://www.webmd.com/osteoporosis/news/20090101/fosamax-higher-risk-of-jawbone-death
2. Merck has already settled thousands of lawsuits in the US over the cardiovascular effects of Vioxx for $4.85 billion, but has made no admission of guilt.
Posted by Vera Sharav
Merck published fake journal
Posted by Bob Grant
30th April 2009
Merck paid an undisclosed sum to Elsevier to produce several volumes of a publication that had the look of a peer-reviewed medical journal, but contained only reprinted or summarized articles–most of which presented data favorable to Merck products–that appeared to act solely as marketing tools with no disclosure of company sponsorship.
"I’ve seen no shortage of creativity emanating from the marketing departments of drug companies," Peter Lurie, deputy director of the public health research group at the consumer advocacy nonprofit Public Citizen, said, after reviewing two issues of the publication obtained by The Scientist. "But even for someone as jaded as me, this is a new wrinkle."
The Australasian Journal of Bone and Joint Medicine, which was published by Exerpta Medica, a division of scientific publishing juggernaut Elsevier, is not indexed in the MEDLINE database, and has no website (not even a defunct one). The Scientist obtained two issues of the journal: Volume 2, Issues 1 and 2, both dated 2003. The issues contained little in the way of advertisements 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 a marketing 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 its Australian subsidiary, Merck, Sharp & Dohme Australia (MSDA).
In testimony provided at the trial last week, which was obtained by The Scientist, George Jelinek, an Australian physician and long-time member of the World Association of Medical Editors, reviewed four issues of the journal that were published from 2003-2004. An "average reader" (presumably a doctor) could easily mistake the publication for a "genuine" peer reviewed medical journal, he said in his testimony. "Only close inspection of the journals, along with knowledge of medical journals and publishing conventions, enabled me to determine that the Journal was not, in fact, a peer reviewed medical journal, but instead a marketing publication for MSD[A]."
He also stated that four of the 21 articles featured in the first issue he reviewed referred to Fosamax. In the second issue, nine of the 29 articles related to Vioxx, and another 12 to Fosamax. All of these articles presented positive conclusions regarding the MSDA drugs. "I can understand why a pharmaceutical company would collect a number of research papers with results 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 or two references. He described one of these articles as "simply a summary of an already published article," and noted that they were authored by "B&J Editorial."
"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 no editor of the journal," Jelinek said in his testimony. "This is a subtle attribution, and many readers may not realise that the paper was written by the owners or publishers of the journal, presuming that is who would write under the heading of ‘editorial’."
Lurie, in examining two of the issues for The Scientist, agreed that one particularly strange element of the Australasian Journal of Bone and Joint Medicine is that it contains "review" articles that cite just one or two references. "I’ve never seen anything quite like this," he said. "Reviews are usually swimming in references." For example, one article on osteoporosis labeled above the title as a "meta-analysis" cites two references — one itself a meta-analysis. "To the jaundiced eye, [the journal] might be detected for what it is: marketing," he said. "Many doctors would fail to identify that and might be influenced by what they read."
Lurie noted that the Australasian Journal of Bone and Joint Medicine is akin to other publishing strategies employed by drug companies; paying for supplements to existing journals or publishing compilations of original research 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 The Scientist, an MSDA spokesperson wrote in an email: "MSDA understood that Elsevier envisaged the complimentary publication would draw on the vast resources of Elsevier, publishers of many leading peer-reviewed journals including Lancet, Bone, Joint Bone Spine and others, to deliver novel and timely full text articles and abstracts to physicians." Many of the articles appearing in the Australasian Journal of Bone and Joint Medicine were in fact reprints or summaries of studies that originally appeared in other Elsevier journals.
A spokesperson for Elsevier, however, told The Scientist, "I wish there was greater disclosure that it was a sponsored journal." Disclosure of Merck’s funding of the journal was not mentioned anywhere in the copies of issues obtained by The Scientist.
Elsevier acknowledged that Merck had sponsored the publication, but did not disclose the amount the drug company paid. In a statement emailed to The Scientist, Elsevier said that the company "does not today consider a compilation of reprinted articles a ‘Journal’."
"Elsevier acknowledges the concern that the journals in question didn’t have the appropriate disclosures," the statement continued. "It is worth noting that project in question was produced 6 years ago and disclosure protocols have evolved since 2003. Elsevier’s current disclosure policies meet the rigor and requirements of the current publishing environment."
The Elsevier spokesperson said the company wasn’t aware of how many copies of the Australasian Journal of Bone and Joint Medicine were produced or how the publication was distributed in Australia, but noted that "the common practice for sponsored journals is that doctors receive them complimentary." The spokesperson added that Elsevier had no plans to look further into the matter.
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 he was on Merck’s Asian Pacific and international advisory boards from the mid 1990s until about 2004, as well as the advisory boards of other pharmaceutical companies, including Pfizer and Amgen. "You get involved in a whole bunch of things at this level," Brooks said, adding that he had put his name on "a few advertorials" for pharmaceutical companies about 10 years ago.
As for the Australasian Journal of Bone and Joint Medicine, he said, "If it would 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 he was 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 journal did not accept original manuscripts for review.
"Having looked at one issue, it actually had some marketing studies," Brooks said. "It also had papers that were excerpted from other peer-reviewed journals. I don’t think it’s fair to say it was totally a marketing journal."
Editor’s note (April 30): This story has been updated from a previous version.
# Related stories:Elsevier expands biopharma base [11th March 2008]
# Merck’s fall from grace [May 2006]
Merck Makes Phony Peer-Review Journal
It’s a safe guess that somewhere at Merck today someone is going through the meeting minutes of the day that the hair-brained scheme for the Australasian Journal of Bone and Joint Medicine was launched, and that everyone 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 looking data for its products in them. Merck paid Elsevier to publish such a tome, which neither appears in MEDLINE or has a website, according to The Scientist
What’s wrong with this is so obvious it doesn’t have to be argued for. What’s sad is that I’m sure many a primary care physician was given literature from Merck that said, "As published in Australasian Journal of Bone and Joint Medicine, Fosamax outperforms all other medications…." Said doctor, or even the average researcher wouldn’t know that the journal is bogus. In fact, knowing that the journal is published by Elsevier gives it credibility!
These kinds of endeavors are not possible without help. One of The Scientist’s most notable finds is a Australian rheumatologist named Peter Brooks who served on the "honorary advisory board" of this "journal". His take: "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 paper for peer-review, but because he apparently knew the journal did not receive original submissions of research. This didn’t seem to bother him one bit. Such "throwaways" of non-peer reviewed publications and semi-marketing materials are commonplace in medicine. But wouldn’t that seem odd for an academic journal? Apparently not. Moreover, Peter Brooks had a pretty lax sense 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 publishing world, but apparently quite familiar to the pharmaceutical publishing scene.
It is this attitude within companies like Merck and among doctors that 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, and publishers would not offer their presses, these publications could not exist. What doctors would have as available data would be peer-reviewed research and what pharmaceutical companies produce from their marketing departments–actual advertisements.
Summer Johnson, PhD
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