Over at the Milwaukee Journal Sentinel and MedPage Today, John Fauber updates Side Effects, his long-running investigation into conflicts of interest, with coverage of a Senate inquiry which Fauber’s work helped inspire.
The Senate investigation, led by the familiar bipartisan duo of Max Baucus and Chuck Grassley (2,315-page PDF | press release), involved the review of about 5,000 pages of documents from medical device maker Medtronic (a frequent subject of Fauber’s reporting) over the course of 16 months.
Fauber, who is uniquely qualified to do so, summarized the report’s key findings:
Medtronic marketing employees were secretly involved in drafting and editing favorable medical journal articles about the company’s lucrative back surgery product while the company paid millions to the surgeons whose names lent weight to the studies, documents from a U.S. Senate investigation reveal.
The company’s undisclosed manipulation of information about its genetically engineered spine surgery product, Infuse, included overstating its benefits and downplaying concerns about serious complications.
Over the course of 15 years, Medtronic paid $210 million to a group of 13 doctors and two corporations linked to doctors, including more than $34 million to University of Wisconsin orthopedic surgeon Thomas Zdeblick, who co-authored a series of papers about the product.
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.
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.
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.
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.