PLoS Medicine article advocates using legal system to stem ghostwriting
An essay published by PLoS Medicine makes the case that the “guest” authors of ghostwritten articles – typically academic researchers who provide little or no input – in medical journals should be held legally liable for damages or deaths caused by the drug or device that is the subject of articles they sign their names to.
The article points out that ghostwriting “openly infringes academic standards and … contributes to fraud” but that journal editors have been ineffective at putting a stop to it.
We argue that when an injured patient’s physician directly or indirectly relied upon a journal article containing false/manipulated safety and efficacy data, then pursuant to the legal authority outlined above, the authors of that article, including guest authors, are legally liable for patient injuries and could be named as defendants.
Xavier Bosch, Bijan Esfandiari and Leemon McHenry, authors of the PLoS Medicine piece, even endorse the theory that the Racketeer Influenced and Corrupt Organizations Act (RICO) could be used, something that was mentioned in an article last year. Other recourses the authors recommend include the False Claims Act and the Anti-Kickback Statute.
Ghost authorship waning in top journals
Filed under: Health data, Hot Health Headline, Studies
On the academic publishing blog The Scholarly Kitchen, Phil Davis writes about the recent BMJ study indicating that ghost authorship in top medical journals may be on the wane.
The paper’s authors reviewed data from 2008, then compared it to the results of a previous study conducted in 1996. Davis summarizes their findings.
In 2008, self-reports of ghost authorship was 7.9%, down from 11.5% in 1996. In comparison, rates of honorary authorship remained statistically similar over time (17.6% in 2008 versus 19.3% in 1996). Prevalence of honorary authorship in research articles was higher in 2008 than in 1996, but lower for review articles and editorials.
Surprisingly, journals that require authors to detail their contributions showed no difference from journals without such author requirements.
Honorary authorship is the practice of granting authorship to often-powerful individuals (deans and the like) who may not have had a direct role in the study.
While the results may appear encouraging, Davis does provide a cautionary note.
While this study was beautifully and rigorously executed — with a response rate of over 70% — the researchers acknowledge that respondents may not be forthright with reporting inappropriate authorship practices, especially considering the social stigma against ghost authorship. Indeed, a study of members of the American Medical Writers Association and European Medical Writers Association put the incidence of ghostwriting at 42% for 2008, down from 62% in 2005. If the incidence of ghost writing is truly declining, it still has a long way to go.
APA ghostwriting/COI scandal simmers quietly
Filed under: Conflicts of interest, Health journalism, Hot Health Headline
For folks who have had trouble keeping up, MIWatch.org’s Phyllis Vine has pieced together a particularly readable roundup of where the American Psychiatric Association’s Nemeroff/Schatzberg/Glaxo ghostwriting controversy now stands.
Alan Schatzberg (a former APA president) and Charles Nemeroff are, of course, prominent psychiatrists who, in 1999, put their names on the APA-published Recognition and Treatment of Psychiatric Disorders: A Psychopharmacology Handbook for Primary Care. Recent discoveries seem to show that the book, intended to teach primary care physicians about certain new pharmaceuticals, was actually penned by the ghostwriters over at Scientific Therapeutics Inc. Not only that, but the book was bankrolled by an unrestricted grant from the company that’s now GlaxoSmithKline. In other words, it’s double-decker scandal including both ghostwriting and conflicts of interest.
Though the news really hit the mainstream with Duff Wilson’s November 2010 piece in The New York Times, Vine also points out the dogged work of folks like Paul Thacker over at the Project on Government Oversight and others. Work which, Vine writes, has been met by a concerted APA stonewalling effort which appears to continue straight through to the present, despite many unanswered questions.
A MIWatch request to speak to someone about accusations of stonewalling was returned with an email signed by Ron McMillen and rehashing previous statements. His title, “CEO of the APA Office of Publishing Operations” was amended with the word “retired.”
In other words, while the scandal hasn’t gone away, the APA has thus far managed to keep it in a sort of holding pattern, presumably with the hope that it will soon complete its journey to the back burner.
Ghostwritten textbook just ‘tip of the iceberg’
Filed under: Conflicts of interest, Health journalism, Pharmaceuticals
The New York Times‘ Duff Wilson has uncovered what he calls the first ghostwritten book. Published in 1999 under the names of two prominent psychiatrists, “Recognition and Treatment of Psychiatric Disorders: A Psychopharmacology Handbook for Primary Care” coyly mentioned that it was funded by an unrestricted educational grant from the company that is now GlaxoSmithKline.
What it doesn’t mention is that GSK apparently also paid ghostwriters to create the outline and text of the book, then signed off on the final version. Up to this point, ghostwriting had been restricted to journal articles.
A Washington advocacy group called the Project for Government Oversight released documents detailing the relationship on Monday, but Wilson also explains how the Times found their copies:
The documents were separately obtained by The New York Times from the Los Angeles law firm of Baum Hedlund, which received them as part of discovery in lawsuits against the drug company, now known as GlaxoSmithKline, involving Paxil. Leemon B. McHenry, a bioethicist with California State University, Northridge, who consults for the law firm, said many similar documents remain sealed. “This is only the tip of the iceberg,” he said.
Wilson writes that the book was co-published by American Psychiatric Publishing and the American Medical Association. He does not, however, delve deeply into its content or address how it discusses Glaxo’s products.
Scary secrets about ghostwriting in journals
Just in time for Halloween, an anonymous medical ghostwriter spoke to Phil Davis over at the Scholarly Kitchen about the scary world of ghostwriting.
He reveals how much ghostwriters are paid, how the process works, where his work has been published, how to detect ghostwritten material and more.
The Scholarly Kitchen is a blog from the Society for Scholarly Publishing.
(Hat tip to Scott Hensley.)
Did PLoS suffer from COI in ghostwriting article?
Filed under: Conflicts of interest, Health journalism, Hot Health Headline, Pharmaceuticals, Studies
Remember that examination of Wyeth (now Pfizer)’s ghostwriting practices that ran in PLoS Medicine a few weeks back? Well, Pharmalot’s Ed Silverman reports that things got a fair bit weirder, thanks to an accusation from Wyeth/Pfizer that the article’s author suffered from her own undisclosed conflict of interest. The article mentions author Adriane Fugh-Berman was a paid expert witness in the trial against Wyeth through which the documents were exposed, but never discloses that she’s still engaged as such.
Silverman got in touch with Fugh-Berman, who said she would clarify her status.
Things get a bit muddier when company representatives allege that the journal was intentionally using the article fodder for an anti-Pfizer lawsuit. Silverman does a good job of explaining the whole situation.
Related: Say what? Pfizer calls PLoS out on conflict of interest
How ghostwriters sold hormone replacement
Filed under: Health journalism, Hot Health Headline, Studies
Writing in PLoS Medicine, Adriane J. Fugh-Berman, M.D., demonstrates the cynical art of “publication planning” and the use of academic journals as an avenue for unregulated drug promotion by showing, with the help of documents from a major drug manufacturer, how ghostwriting was used to sell hormone replacement therapy.
The documents in question come from the lawsuits against Wyeth over the development of breast cancer during treatment with the hormone replacer Prempro, and were brought to light, according to Fugh-Berman, “when PLoS Medicine and The New York Times intervened in the litigation. Both intervenors successfully argued that ghostwriting undermines public health and that documents proving the practice should be unsealed.”
Fugh-Berman was a paid expert witness in the trial, and thus was familiar with the documents before their release. Her conclusion?
… the pharmaceutical company Wyeth used ghostwritten articles to mitigate the perceived risks of breast cancer associated with HT (menopausal hormone therapy), 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.
According to Fugh-Berman, the effects of this careful campaign seem to have outweighed the preponderance of evidence, at least in the minds of some doctors.
Today, despite definitive scientific data to the contrary, many gynecologists still believe that the benefits of HT outweigh the risks in asymptomatic women. This non-evidence–based perception may be the result of decades of carefully orchestrated corporate influence on medical literature.
Through the course of the article, Fugh-Berman lays out the entire ghostwriting/marketing process, complete with instructive details and damning examples. There’s a lot to take in, but you’ll emerge with a far better understanding of the mundane mechanics that make ghostwriting work.
Related
- Ghostwriting: Journals’ dirty, not-so-little secret
- Wyeth paid university for ghostwritten articles
- Unsealed papers prove Wyeth was behind articles
- Journal editor linked to spinal implant royalties
- How the pharma research ’sausage’ is made
- Archive offers drug industry documents online
- Grassley digs into journal ghostwriting practices
- Grassley compares ghostwriting, plagiarism
- Institute of Medicine prescribes ethics overhaul
Grassley compares ghostwriting, plagiarism
Filed under: Conflicts of interest, Government, Pharmaceuticals, Studies
Sen/ Charles Grassley (R-Iowa) continues his investigation of “medical ghostwriting” with a letter to 10 medical schools asking “what they are doing about professors who put their names on ghostwritten articles in medical journals — and why that practice was any different from plagiarism by students.”
Sen. Charles Grassley
At issue is the practice in which a writer — sometimes paid by a pharmaceutical or other involved company — works on an article intended for publication without being named while a less-involved researcher receives credit.
Journals, medical associations and even pharmaceutical companies have called for an end to the practice but medical schools have been slower to respond.
Grassley has asked the medical schools to explain their policies on ghostwriting and plagiarism, to list complaints and describe investigations into both practices.
Ghostwriting: Journals’ dirty, not-so-little secret
Filed under: Conflicts of interest, Health data, Health journalism, Hot Health Headline, Studies
The New York Times‘ Duff Wilson and Natasha Singer reported the results of a Journal of the American Medical Association study showing that, in an anonymous survey of contributors to six major medical journals, 7.8 percent “acknowledged contributions to their articles by people whose work should have qualified them to be named as authors on the papers but who were not listed.”
Reuters Health’s Brendan Borrell describes the lengths one editor goes to when trying to track down ghostwriters and disclose them in his journal’s articles.
Meanwhile, an editorial in the nonprofit open-access Public Library of Science’s PLoS Medicine calls upon journals to “get serious” in the war against ghostwriting.
Wyeth paid university for ghostwritten articles
Filed under: Health journalism, Hot Health Headline, Public records, Studies
John Fauber and Meg Kissinger of the Milwaukee Journal Sentinel found that Wyeth paid the University of Wisconsin to sponsor “ghostwritten medical education articles that downplayed the risks” of female hormone therapy - one of that company’s most notorious missteps.
Amid mounting concern regarding their safety and shortly before the discovery that Wyeth’s progestin and estrogen products were considered dangerous enough to bring a massive clinical trial screeching to a halt, five ghostwritten articles, paid for by Wyeth, were used in University of Wisconsin continuing medical education materials which promoted the benefits and downplayed the risks of the treatments.
The Wyeth company line is that the articles weren’t bad or misrepresented science, and that the titular authors of the pieces were given “substantial editorial control” over the “scientifically accurate content.”
William Heisel focused on DesignWrite (the ghostwriters behind Wyeth’s pieces) and suggested that reporters check out their own local institutions and ask questions about where money is coming from, ask if the big names of local scientists are helping to hide their dubious connections and to actively question the impartiality of the science itself.
Heisel also put together an entertaining piece regarding just how tickled some researchers are to put their name on ghostwritten work.
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