Ghost Authorship is widespread in industry-sponsored research

Ghost authorship is the omission of the name of someone who contributed to a scientific paper from that paper's list of authors. Sometimes this can be because what the individual contributed is not considered critical to the creation of that paper. Sometimes this can be because the inclusion of that author's name would cast suspicion on the validity of the work.

Gotzsche et al, publishing in PLoS Medicine, conducted a study of industry initiated trials conducted in Denmark in 1994 and 1995. They found that ghost authorship was incredibly widespread. In the 44 industry-initiated trials, 33 had examples of ghost authorship. In most cases (31) the ghost authorship was for statisticians working for the company who had participated in data compilation and analysis.

Commenting on the widespread nature of the practice the study's authors had this to say:

We take issue with this widespread practice of not including statisticians as authors for reports of randomised trials. Multicentre trials are often complex and generate large datasets, and the trials we reviewed were no exception...Furthermore, the statistical report is a fundamental part of the research that has a crucial influence on what is written in the publication. Omission of a company statistician, usually also from the acknowledgment section, deprives readers of a key insight into the role of the company, although it is sometimes evident that reports of industry-sponsored trials contain sophisticated statistical analyses that are beyond the capabilities of the authors...We cannot exclude the possibility that data analyses in some of the trials, and corresponding sections in protocols, were performed by company employees who were named authors but not statisticians, but it is unlikely since the pharmaceutical corporations usually have strong departments of statistics...We believe it is wrong to deny a person who has contributed substantially (e.g., by performing the statistical analyses and by writing the statistical report) the opportunity to comment on the paper and finally approve of it, thereby fulfilling all three criteria for authors defined by the International Committee of Medical Journal Editors. (Citations removed. Emphasis mine.)

The widespread nature of this abuse begs the question about whether we need a better system for reporting participation in scientific papers. Elizabeth Wager, speaking about this article and also in PLoS Medicine, comments that differing systems -- such as a contributorship system -- have been suggested before and should be reconsidered now:

The question of whether writers merit authorship if they are involved only at the publication stage of a study has not been resolved. Guidelines from the European Medical Writers Association state that such writers usually do not qualify for authorship although their role should be acknowledged...The ICMJE criteria state that all authors should have made a substantial contribution not only to developing the manuscript but also to other aspects such as collecting, analysing, or interpreting the data...It could be argued that the act of drafting a manuscript always involves an element of interpretation, yet many writers feel they do not fulfil the overarching principle that authors should be able to take public responsibility for the study.

However, the role of statisticians is slightly clearer. The ICMJE criteria state that involvement in data analysis (or study design) and contribution to the manuscript is a qualification for authorship. Gotzsche and colleagues highlight what they call the "widespread practice of not including statisticians as authors for reports of randomised trials" and note that this "deprives readers of a key insight into the role of the company." They urge editors to change from the traditional system of simply listing authors' names to listing individuals' specific contributions to research projects. Such a "contributorship" system was proposed almost ten years ago...and has been endorsed by the ICMJE..., yet it has not been widely adopted outside the largest general medical journals.

Listing contributions has many advantages. It makes it easier for editors to detect ghost authors (if key roles such as data analysis or drafting a manuscript are missing from the list) and guest authors (who are listed despite having made little or no contribution to the study or publication). (Citations removed.)

Regardless of what we decide to do, it is important to recognize how shockingly widespread this practice is becoming. I am not saying that these trials are necessarily biased, but it is certainly possible that they are.

The statisticians involved may have cooked the books, and none of us would be the wiser because we have no idea who they are. In a practical sense, scientific accountability is derived from reputation. You have a history of being accurate and doing good work, so that people believe you in the future. This system does not allow for anonymous contribution.

At the very minimum, editors need to become very aggressive about attribution and finding out every last person who contributed to a paper. At the maximum, a contributorship system where each figure and analysis is enumerated by the person who performed it might be even better. This would have the added benefit of discouraging data falsification because you would really know who performed every step in the process. You would not even be able to hide behind the fig leaf of your superiors.

Hat-tip: BMJ.

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This idea of contributorship is raised in a corporate setting but I think if it were really done as said - to the figure level - it would turn academic papers on their ear. People would see that main authors of papers in many fields did nothing but get the grants and look things over. In fact this idea might actually reduce accountability because issues would be pushed down to the least powerful person. Now at least the big names on the paper have to take responsibility for it - all.

I didn't know what to think of this article when it came out.

On the one hand, they do show incorrect attribution, but it was almost always a statistician who was left out. Very few times was it someone involved in the design or collection of the data. It almost seems minor, like the statisticians are considered merely technical staff, and I can almost understand it.

While they should be reporting everyone involved more dutifully, I suspect this paper missed the mark. I believe the amount of "ghost-written" papers is very high and is probably impossible to properly measure. People I know in the NIH who are involved in clinical trials say that they can always smell these papers because of the inevitable drug-company lingo that sneaks into the text. For instance, the use of the expression "study-drug" rather than the name of the actual chemical compound.

The detection of this kind of ghost-writing, in which the drug companies provide papers, written-in-full, to authors with established reputations, is a challenge. They tend to be reviews, commentaries, and meta-analyses that rely on aggregation of data and use of the author's reputation to direct a field into pursuing the drug companies interests. Unless one were to carefully interview lots of well-established scientists, it's unlikely it could be uncovered, and the parties involved have no interest in being helpful in such an investigation.

To follow on quitter's remarks, I refer you to a nice commentary (free PDF) by Georgetown's Adriane Fugh-Berman on her personal experience in being approached by a drug company to be a ghost-author of an already-prepared draft.

That's a beautiful reference you got there Abel. Pretty much confirmation of everything I've heard from the NIH people who have had similar experiences.

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The Human Injury of Lost Objectivity

If I were to rate the corruptive tactics performed by big pharmaceutical companies, the intentional corruption of implementing fabricated and unreliable results of clinical trials by pharmaceutical companies by hired third parties who manipulate these trials they sponsor because of their power to control others involved in such trials that is largely absent of regulation would be at the top of the list, and likely the most damaging to the requirement of authenticity and, more importantly, assuring the safety of the public health, as I understand that this does in fact occur.

Decades ago, clinical trials were conducted at academic settings that focused on the acquisition of knowledge and the completely objective discoveries of meds. Then, in 1980, the Bayh-Dole Act was created, which allowed for such places to profit off of their discoveries that were performed for pharmaceutical companies in the past. This resulted in the creation of for-profit research trial sites, called Contract Research Organizations, which is often composed of community research sites with questionable investigators possibly void of necessary research experience or quality regarding their research purpose and ability. Since they are for- profit, with some CROs making billions of dollars a year. The trials conducted at such places are sponsored by pharmaceutical companies that control and manipulate all aspects of the trial being conducted involving their med being studied in the trial. This coercion is done by various methods of deception in subtle and tacit methods. As a result, research in this manner has been transformed into a method of marketing, which includes altered results of the trial to favor the sponsors med. Their activities are absent of true or applied regulation, and therefore have the autonomy to create whatever they want to benefit what may be a collusive relationship between the site and the sponsor.
Further disturbing is that once the creation of the trials is completed, they are then written by ghostwriters often, although no one seems to know how often. These people are not identified and acknowledged by the sponsor, and may not be trained in clinical research overall, as they are simply freelance writers, as one does not need research training or certification in order to perform this function. Rarely do trial ghostwriters question their instructions about their assignment, which is clearly deceptive and undocumented by the sponsor. Also, these hired mystery writers are known to make about 100 grand a year. This activity removes accountability and authenticity of the possibly fabricated clinical trial even further. The corruptive act is finally completed by the sponsor hiring an author to be placed on the trial that likely had no involvement with the trial, and, along with others, was paid by the sponsor for doing this deceptive act.
To have the trial published, the sponsor pays a journal to do this in various ways, I understand, such as purchasing thousands of reprints of their study from the journal. Again, how often this process is performed is unknown, yet frequent enough to create hundreds of such false writers and research sites to support the pharmaceutical industry.

So benefits of meds studied in such a malicious way potentially can harm patients and their treatment options and safety risks. The purchased reprints are distributed to the sponsors sales force to share the content with prescribers which may lack validity.

Such misconduct discussed so far impedes research and the scientific method with frightening ethical and harmful concerns, if in fact true based on reports by others. If so, our health care treatment with meds is now undetermined in large part with such corruptive situations, as well as the possible absence of objectivity that has been intentionally eliminated. Trust in the scientific method in this type of activity illustrated in this article is absent. More now than ever, meds are removed from the market are given black box warnings. Now I understand why this may be occurring.

Transparency and disclosure needs to happen with the pharmaceutical industry for reasons such as this as well as many others, in order to correct what we have historically relied upon for conclusive proof, which is the scientific method. More importantly, research should not be conducted in a way that the sponsor can interfere in such ways described in this article, requiring independent sites with no involvement with the drug maker. And clearly, regulation has to be enforced not selectively, but in a complete fashion regarding such matters. Public awareness would be a catalyst for this to occur, after initially experiencing a state of total disbelief that such operations actually are conducted by such people, of course. We can no longer be dependent on others for our optimal health. Knowledge is power, and is also possibly a lifesaver.

Ethics and Science need to shake hands. . Richard Cabot

Dan Abshear