Health News Review

The GlaxoSmithKline psychiatric drug Paxil is the topic of the third and final part of a series of unsolicited guest blog submissions by Jonathan Leo, PhD, and Jeffrey Lacasse, PhD.

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Paxil, GlaxoSmithKline, and the University of Pennsylvania

In June of 2012 charges of ghostwriting were made by a University of Pennsylvania Professor over a 2001 paper published in the American Journal of Psychiatry which reported on the use of Paxil in the treatment of manic depressive disorder. The University of Pennsylvania conducted an investigation and concluded that the paper was not ghostwritten.  The committee report concluded that although a medical writer helped write the paper, the listed authors “satisfied all authorship criteria and the publication presented the research findings accurately.”  However, statements that the named authors deserved to be on the byline, or that the paper was accurate, have nothing to do with the issue of ghostwriting.

If everyone agrees that a prominent medical writer wrote an early draft of this paper but was not listed on the byline, shouldn’t this mean the paper was ghostwritten?  One must look closely at Penn Medicine’s logic to see how they conclude that a paper with an invisible author was not considered ghostwritten.  They declare that: “While current Perelman School of Medicine policy and journal practice call for acknowledgment of the assistance of a medical writer, the committee concluded that guidelines in place in 2001 did not.” But again, whether there were policies in place or not is immaterial in determining if the paper was ghostwritten.  In general, policies or laws are put into place to curb existing practices that are seen as harmful.  On the date a policy is enacted the practice is now considered forbidden, but that doesn’t mean that before the policy was enacted the practice never happened. The existence of a policy banning ghostwriting would play a role in determining whether there was a punishment or not, but it wouldn’t play a role in determining if the paper was ghostwritten.  It would have been more accurate for Penn Medicine to acknowledge that the paper was ghostwritten, but that because there were no prohibitions against ghostwriting in 2012 that they weren’t going to pursue the matter.  It will be hard for academic medicine to move forward and curb the practice of ghostwriting if they cannot agree on what constitutes a ghostwritten paper.

Even more problematic is that Penn Medicine has a new policy on ghostwriting that simply calls for mentioning medical writers in the acknowledgment section of the paper.  Why shouldn’t a deserving author be on the byline?  Will undergrads be allowed to abide by the same policy and use paid writers to author their first drafts as long as they thank the “authors” for editorial assistance? (We have discussed the Penn Medicine case extensively in “Medical Ghostwriting: A University-Sanctioned Sleight of Hand?” in Society.)

Paxil, GlaxoSmithKline, and the American Psychiatric Association

The textbook “Recognition and Treatment of Psychiatric Disorders,” was published in 1998 by the American Psychiatric Press (APP) in 1998. The named authors are Charles Nemeroff, current chairman of Psychiatry at the University of Miami, and Alan Schatzberg, former Chairman of Psychiatry at Stanford and former President of the American Psychiatric Association. Documents released as part of discovery in a law suit against GlaxoSmithKline have led to allegations that the textbook involved ghost authors employed by the manufacturer of Paxil. A seemingly damning draft of the book by the medical writers is available on the web. In response to these complaints the APP’s trade journal, Psychiatric Times, defended the textbook’s use of medical writers and declared that they stand behind the authorship line. According to the APP, because Nemeroff and Schatzberg signed-off on the final copy, the article was not ghostwritten. James Scully, Medical Director for the APA, even stated, “The book was reviewed for any potential bias (among other things) by eight independent reviewers, and there was no undue influence on the content from industry or any other outside source.” But his defense of the book does not get at the pertinent question.  It does not matter if the book was reviewed by outside experts.  What matters is: Were there individuals who made significant contributions to the book but are not on the byline?   All the documents released so far in this case, lead to the conclusion that Sally Laden and Diane Coniglio, who are both paid medical writers, deserve to be on the byline which means that the book should be considered ghostwritten.

To defend the book on the grounds that sympathetic reviewers did not find a problem with the book, is not important in determining if the book was ghostwritten, but it does provides a window into the APA’s belief that readers don’t really need to concern themselves with the knowing the true authors of one of their publications.  As long as a publication is given the APA seal of approval that should be enough.  Having eight friends review your paper is a great idea but it has nothing to do with ghostwriting charges.  It does not seem appropriate for an academic organization or an academic publisher to defend the idea that readers do not need to know who writes their publications.

Conclusions

Ghostwriting is neither rare nor insignificant.  Virtually every single blockbuster medication has been tainted by charges of ghostwriting, and some of these medications have had significant negative effects on public health.  Unfortunately, until medical schools and journals make it absolutely clear that the bylines on medical papers should be accurate, readers should realize that the papers they are reading might be written by company employees.  There is no reason that companies and university professors shouldn’t work together.  But when they collaborate on papers just call an author an “author.”

In the examples we have provided the only reason that one can detect the presence of ghosts is because internal company documents have been made publicly available.  For most medical papers this is clearly not the norm, which makes it impossible to know the true prevalence of ghostwritten papers.  Some have suggested that it is close to 100% for clinical trials in certain fields. If the academic community cannot agree on the simple premise that a paper with invisible authors on the byline should be labeled as ghostwritten, then efforts to curb the practice will be difficult.  The most well documented case of a ghostwritten paper is Study 329.  The US Department of Justice (DOJ) recently fined GlaxoSmithKline three billion dollars, in part because of Study 329.   In their complaint about Paxil and the role of Study 329 the DOJ did not mince words: “The United States argues that, among other things, GSK participated in preparing, publishing and distributing a misleading medical journal article that misreported that a clinical trial of Paxil demonstrated efficacy in the treatment of depression in patients under age 18, when the study failed to demonstrate efficacy.” They also note that: “GSK published an article that misstated Paxil’s efficacy and safety for children and adolescents.” Yet, both the journal that published it and the university that employed the lead author still stand by the paper.

We welcome any comments on this piece especially regarding whether the examples we provided should be considered ghostwritten or not.

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Part 1 of the series:  When Should a Medical Paper be Considered Ghostwritten?  Three Easy Steps to Finding Ghost Authors.”

Part 2:  “Ghostwriting & Medtronic’s spinal fusion surgery product”

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Jonathan Leo examines the biological basis of mental disorders such as ADHD, schizophrenia, and clinical depression. Rethinking ADHD: From Brain to Culture, a co-edited volume with psychiatrist Sami Timimi, was released by Palgrave Macmillan in 2009.

Jeff Lacasse has published research on barriers to evidence-based mental health practice, including articles on critical thinking in mental health, clinical treatment of children, and psychiatric medications.

Together they have published several articles on the serotonin theory of depression and ADHD. Over the past several years their articles on ghostwriting have appeared in PLoS Medicine, The Chronicle of Higher Education, and Society.

Their research has been covered in popular media outlets such as The Wall Street Journal, Scientific American, Science,The Chronicle of Higher Education, Fortune, Nature, and the Economist.

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Comments

Irene posted on January 25, 2013 at 6:31 pm

Part of the issue regarding listing professional medical writers in the acknowledgments vs. as authors is that they do not satisfy the criteria for authorship laid out by the International Committee of Medical Journal Editors, to whit: “Authorship credit should be based on 1) substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data; 2) drafting the article or revising it critically for important intellectual content; AND 3) final approval of the version to be published. Authors should meet conditions 1, 2, and 3.” Most often, medical writers have no control over a draft once submitted and thus would not satisfy criterion #3 (or #1, in many cases). In recognition of this phenomenon, the American Medical Writers Association position statement states: “Medical communicators who contribute substantially to the writing or editing of a manuscript should be acknowledged with their permission and with disclosure of any pertinent professional or financial relationships.” The goal is to achieve transparency, so that readers and reviewers can have all available information when evaluating the content. As you might guess, however, there is much resistance to such disclosures, including from the journals themselves.

jonathan leo posted on January 25, 2013 at 7:44 pm

Irene, Your comment is correct and this is part of the problem. Item #3 which you mention above is nothing more than an easy out for medical writers. They can write the first draft of the paper and then simply not sign off on the final copy. Jeff and I have written about this loophole before. Other self-acknowledged medical writers have also pointed out that this is a loophole that lets them keep off the byline – in other words it allows them to ghostwrite. Hopefully ICMJE will close this loophole at some point.

Frances Small posted on January 31, 2013 at 8:04 pm

There should be transparency of the authorship of the article published. It is fraud to have articles ghost written and attributed to the rightful authors and to mislead the public. Whether it was legal before or after does not alter the fact that they know is immoral and unethical. It is too bad that a law that was so obvious had to be written. Greed and only Greed is the motivation behind the ghost written articles.

Dr. Martin Rosenberg posted on February 1, 2013 at 6:16 pm

Frances Small is absolutely correct. When one of my university students places unacknowledged ideas from others in a paper, we call it plagiarism and fail the student.. When unacknowledged “medical writers” employed by drug companies to push their products write articles that are attributed to leading researchers, the people who suffer are members of the public and the medical practitioners who accept doctored results as a justification for prescribing a particular drug. Sometimes people die, but the drug companies and crooked researchers make out like bandits. When someone, such as the Professor at Penn, blows the whistle, the institution attacks and harasses him. This unholy alliance between drug companies and researchers needs to end for the public good.