Health News Review

Today we publish part one of a three-part guest blog series that came to us in an unsolicited submission.  But because we’ve followed the two authors’ work, we are pleased to accept and pass along their thoughts.  Here is the first of the series by Jonathan Leo, PhD, and Jeffrey Lacasse, Ph.D.

Part One: When Should a Medical Paper be Considered Ghostwritten?  Three Easy Steps to Finding Ghost Authors

One of the hidden secrets of the medical literature is that the named authors on a paper’s byline, particularly in the case of clinical trials, are not necessarily the individuals who wrote the paper.  It is not uncommon for pharmaceutical companies, or medical product manufacturers, to write their own papers and then find university professors to agree to be the named authors of the paper.  The company employees are then invisible to the readers. Presumably, the suggestion that a certain medication or medical product is safe and efficacious will carry more weight if it comes from an unbiased source, often called a Key Opinion Leader (KOL), rather than a company representative. According to Forest Pharmaceutical’s marketing plan for Lexapro, “Bylined articles will allow us to fold Lexapro’s message into articles about depression, anxiety, and comorbidity.”  With ghostwritten papers it is hard to know where to draw the line between science and marketing. Because of its secretive nature, the true extent of this practice is unknown. What will probably surprise much of the general public, and many members of the media, is that the medical community has not called for an outright ban on ghostwriting.  Rather than forbid the practice outright, some in the medical community seem to be trying to develop policies that will allow papers to be published with invisible authors, but that won’t be labeled as “ghostwritten.”

When should a paper be considered ghostwritten? In any other segment of academia, or even in popular literature, this is a fairly straightforward question, answered by simply examining the byline.  If the paper’s byline has an “invisible author” (a ghost), then the paper should be considered ghostwritten.  However, when charges of ghostwriting appear about a medical paper there are all sorts of reasons given why the paper should not be considered ghostwritten. The defenses are endlessly creative and include such notions as: the paper was accurate, the “named” authors signed off on the paper, the paper was peer-reviewed, the person who wrote the first draft is thanked in the acknowledgement section, or… the list goes on.  These defenses are not just espoused by companies but are often put forth by university administrators.  It seems slightly paternalistic to tell the readers of a paper that they shouldn’t bother themselves with concerns about who actually wrote the paper, because higher powers have determined that the paper is accurate, or that the “named” authors have signed off on it, or that the “named” authors are good scientists.  If the second line of a paper –the byline usually follows the title- is not accurate, why should anyone trust the rest of the paper?

In our view there are three simple steps for finding ghosts. Step one is to examine the internal company documents to see who made significant contributions to the paper. Step two is to open up the published paper and see who is on the byline. Step three is to see if the byline has omitted some of those individuals who made significant contributions.  In many cases of ghostwriting there are other issues such as excessive conflicts of interests or the accuracy of the paper, but these are peripheral issues and do not play a role in determining if the paper was ghostwritten.  Also immaterial to the ghostwriting charge is whether the named authors deserve to be on the byline.  Granted, honorary authorship and ghostwriting often go together but they are not the same thing. The named authors might certainly deserve to be on the byline, but the question about ghostwriting concerns unnamed authors – people who should have been on the byline but are not present. Since in most cases the internal company documents about how a paper was developed are not available, the process of detecting ghosts can only be done a limited basis, and is reserved for those cases when court proceedings or Freedom of Information Act Requests have made the documents publicly available.

In the next two days we will highlight papers whose bylines have invisible authors and would seem to qualify as ghostwritten, yet have been defended by certain segments of the medical community as not being ghostwritten. The logic of this is problematic. One case involves a surgical procedure and one case involves a psychiatric medication.  Keep in mind that one does not need to be an expert in spine surgery, or psychotropic drugs, or really much of anything for that matter, to determine if a paper has been ghostwritten.

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Part two: Medtronic’s Infuse spinal fusion surgery product

Part three: Psych drug Paxil – and conclusion

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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

Greg Pawelski posted on January 23, 2013 at 11:51 am

I’m interested in reading all three parts of this blog series. I’m reminded of the findings that were disclosed by the American Society of Hematology of increased death rates among cancer patients taking erythropoiesis-stimulating agents (the anemia drug issue). The analysis was notable for relying on full data on each patient, contributed by the trial sponsors and individual investigators, not on outcome data as published and proselytized by physicians and clinical oncologists moonlighting as Big Pharma’s “Key Opinion Leaders.”

Bruce Lewenstein posted on January 23, 2013 at 1:58 pm

On the question of whether the writer of an article should be an author, I have long enjoyed a quote that appeared in the Chronicle of Higher Education in a profile of Gerald Schatten, the American co-author of the Woo Suk Hwang stem-cell paper that turned out to be fraudulent.

The key phrase is: “If all he did was write the paper, he should not have been named an author.”

“Mr. Schatten’s public modesty has led many American researchers to ask, just what did Mr. Schatten do? Did he do enough to justify authorship of the now-retracted papers? Many believe that he performed some analysis of the data and wrote the paper in English…. If all he did was to write the paper, he should not have been named an author, according to convention. Mr. Bavister, of New Orleans, helped write the 2004 Science paper in English for the Korean group. “That alone does not deserve co-authorship, which is why I’m not a co-author,” he says. The acknowledgments in that paper mention Mr. Bavister’s help.” Guterman, Lila. (2006, 3 February). A Silent Scientist Under Fire, Chronicle of Higher Education, p. 15.

Marilynn Larkin posted on January 28, 2013 at 7:18 pm

Medical ghostwriting seems to be a timeless topic–and, unfortunately, not much has changed over the years. Here’s a link to my Lancet feature (1999) on the topic:

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2805%2975272-7/fulltext

a pdf of the responses:
http://www.thelancet.com/pdfs/journals/lancet/PIIS0140673605766010.pdf

and a link to a Guardian interview (2002):

http://www.guardian.co.uk/uk/2002/feb/07/research.health2

Deborah Collyar posted on February 1, 2013 at 4:41 pm

Thank you for writing and covering this 3-part series on ghostwriting. I am going to alert the Patient Advocates In Research (PAIR) email list, which will certainly generate comments about this troubling topic. Who knows, maybe together we can shine enough public light on this issue that publishers, institutions, and researchers will have to re-evaluate their positions and policies on this ethical dilemma.