But they're often willing to lend their name because drug company studies are often large high quality clinical trials that get published in great journals, and this goes on the academics resume. Documents were found describing Merck employees working either independently or in collaboration with medical publishing companies to prepare manuscripts and subsequently recruiting external academically affiliated investigators to be authors. Merck could actually put this whole set of opinions and perspectives out in the medical literature with it having the stamp of coming from an academic institution, when it really came from the drug company marketing people.
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In this next module, we’re going to discuss authorship. My main advice on authorship is to think about the authorship before you write the paper. Especially, if you’re the person drafting the paper. Think about who is going to get authorship. Think about what the order will be. Run that by people and establish that early on in the process so that everybody’s on the same page. So that nobody feels slighted later on. There are two questions that you have to answer with authorship. First of all, who gets authorship? Who are you going to include as an author on your paper? The main criterion here is that if you are an author listed on the paper, then you are taking public responsiblity for its content. That’s a high bar. It means that if later, the paper is found to have a problem. If it’s found to have fraud, if it’s retracted. You are responsible. You are liable for those transgressions. And that is going to reflect badly on you. So if you are not the primary author of the paper, before you except co-authorship ask yourself the question as to whether you want to take that level of responsibility. Do you really understand the ins and outs of the paper well enough? And if you’re the one writing the paper and trying to decide on authors, keep in mind that most people don’t want to be included on your paper unless they have been fully involved. For example, sometimes I give students, or colleagues, a little help on statistics, or editing, or something. And then they might come back to me and say, do you want to be an author on the paper? And I don’t want to be an author on that paper, because I haven’t been sufficiently involved with its content to feel that I can take public responsibility. I think junior people feel this obligation to include every senior person that they’ve ever talked to about the article. But keep in mind that most people don’t want to be on your paper unless they can take public responsibility for its content. So they’re not going to be offended if you don’t offer them authorship. You can always put them in the acknowledgment section as I’ll talk about it a minute. And then of course there’s the issue of order, what order with the authors appear in? In general, of course, order implies the authors’ relative contributions. The first author is usually the person who wrote up the draft of the paper, might have been the person who collected all the data, often a graduate student, or a junior person. And the last position is usually the senior author, the head of the lab or research team, or the senior person who oversaw the research. That’s a position of stature as well. Sometimes you’ll have dual first authors, if maybe two graduate students worked on it together equally. In between the first and last positions, you should put everyone else in their order of their contributions. If it’s not clear if the rest of the authors contributed equally without much differentiation, you could consider putting them in alphabetical order or even reverse alphabetical order. And sometimes you get these large working groups now with lots and lots of people, international collaborations. Those large working groups can be cited as a group because they often comprise hundreds of authors. As I mentioned, papers have an acknowledgements section. That’s where you are going to cite any funding sources. So if you’re a graduate student who is on a certain fellowship, make sure you cite your funding source there. If it was a grant funded study, you’re going to mention the grant there. This is also a good place to acknowledge people who you don’t feel merit authorship, and who probably don’t want to be authors on the paper, but maybe they gave you some materials, or they offered some statistical consulting or some other advice. It’s a way to acknowledge those people without making them take on the role of author. I also want to mention the ethical issues of ghost authorship and guest authorship. This is a hot button particularly in the medical literature. It’s been written about in the New York Times and its had some pretty profound influence on the medical literature. It’s important that you are aware of these practices. Obviously they are to be avoided when it comes to authorship. A ghost author is a professional writer who usually a company hires to draft a manuscript. At the end of the day the writer is not listed as an author on the manuscript though they may have written the whole paper. Hence the term, ghost authorship. Now, there’s nothing wrong with professional writers being involved in the writing process. Scientists can certainly use the help of writers, but it’s the lack of transparency that’s suspect here. The ghost writer is likely a paid gun for the drug company, but this is completely hidden. The related type of authorship is guest authorship, or sometimes called honorary authorship. This is when a company does a study, analyzes the data, draws their conclusions, drafts the paper, then they call or email an academic researcher at a prestigious university and invite them to be an author, often the first author on the paper. That academic researcher certainly can’t take public responsibility for the study. But they’re often willing to lend their name because drug company studies are often large high quality clinical trials that get published in great journals, and this goes on the academics resume. The drug company meanwhile gets to bolster their papers credibility by leading researchers to believe that an outside independent unbiased expert was a driving force in the study. Obviously, this is misleading if in fact the academic was only minimally involved and is simply lending their name, and their institution’s name to the paper. It’s unclear how common these types of unethical authorship practices are in the literature. And journals have now cracked down on this so hopefully the prevalence is decreasing. But a study in the British Medical Journal in 2011 that surveyed top medical journals found evidence of honorary or guest authorship in 17.6% of papers. And evidence of ghost authorship in 7.6% of papers. So at least in 2011, this practice was fairly pervasive. If you’re interested in learning more about this, the medical community learned a lot about this practice because of litigation surrounding the drug Vioxx. Merck was being sued over the drug Vioxx, which was to found to increase the risk of heart attacks. Because of the court trials, internal company documents entered the public domain. And there’s a fascinating article in JAMA from 2008, where some researchers systematically reviewed 250 court documents related to published clinical trial and published review papers. What they found was pretty shocking. The researchers reviewed emails and other documents related to 24 clinical trial papers that Merck was involved with. Here’s what they dug up, straight from the results section. Documents were found describing Merck employees working either independently or in collaboration with medical publishing companies to prepare manuscripts and subsequently recruiting external academically affiliated investigators to be authors. Recruited authors were frequently placed in the first and second positions of the authorship list. The use of guest or honorary authorship was an accepted practice at Merck apparently. They also looked at 72 review papers that the company was involved in publishing. They found, documents were found describing Merck marketing employees developing plans for manuscripts, contracting with medical publishing companies to ghostwrite manuscripts, and recruiting external, academically affiliated investigators to be authors. Recruited authors were commonly the sole author on the manuscript and offered honoraria for their participation. Only half of the review articles even disclosed that Merck had sponsored those papers. That’s quite insidious and you can see that this could have profound impact on the medical literature. Merck could actually put this whole set of opinions and perspectives out in the medical literature with it having the stamp of coming from an academic institution, when it really came from the drug company marketing people. You can see why this has been such a hot issue. And just to give you an idea, this is an actual internal company email that was made public during the court trial. It shows you how blatant this practice is. The company writes to the potential guest author, I would like to invite you to be an author on the abstract and manuscript for this study. We are currently preparing both for submission before the end of this year. Could you please let me know if you would be interested in authorship on both the abstract and manuscript, one of the two planned publications, or none? In making your decision, you may want to take into consideration that the results of this study were negative at first glance. Basically, the company is giving out authorship like a gift. And they’re allowing the researcher to choose whether or not they want to accept this gift based on how the study results happened to come out. Clearly the author being invited here has no basis for taking public responsibility for the content of these articles. Obviously this researcher was not heavily involved in the analysis, because the analysis is already done, or the writing of the paper, it’s already being drafted. This is a clear case of guest authorship. And the trial turned up many emails like this that made it obvious as to what was going on. Again, it’s a fascinating topic, it’s been widely written about. I’m giving you some references here, if you’d like to read more, about these unethical authorship practices. There’s some interesting articles in the New York Times that are worth your time to read.
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