I recently wrote a paper on Ghost Authorship for my Bioethics class at the University of New Hampshire. I wanted to post it here because it is probably one of my best papers and I really enjoyed writing it. Let me know what you think! The link below is the PDF version of my paper.
GHOST_ESSAY_2013_FINAL
GHOST AUTHORSHIP IN RESEARCH: A CURSE OR BLESSING?
ABSTRACT
The alluring notion of becoming a prestigious author and the potential for pharmaceutical companies to make billions of dollars, continue to be contributing factors for the publication of ghost-written articles. This places undeserved credibility to these papers and causes readers to perceive them as unbiased articles. The ethical issues associated with ghost authorship can be divided into two distinct theories of ethics: teleological theory and deontological theory. Nevertheless, two positions still exist on ghost authorship – those who condemn the practice and those who condone it. In order to eliminate ghostwriting a three part plan was proposed. The plan would require journals, academic institutions, and government funding agencies, to each implement new policies against ghostwriting. As of the year 2013, the status of ghost authorship is still not where it needs to be and the past few years have seen very few changes in ghostwriting policies across the United States.
INTRODUCTION
Ghostwriting, which involves the practice of writing an article and officially crediting the work to another person, has been around for hundreds of years. Kings and other men of great importance would often dictate to their writers (Fryde 1996). These writers, after revising and editing the original transcription, would sign or initial for these men. Often, these men had no idea what was being written until the work was completed (Fryde 1996). Even Wolfgang Amadeus Mozart, an extremely influential composer of the classical era, was a ghostwriter and would habitually compose work for powerful individuals to make ends meet (Albert 2007). Nowadays, political leaders, executives, and celebrities hire ghostwriters to draft or edit works varying from speeches to magazine articles, and even autobiographies (Rennie & Flanagan 1994). While ghostwriting may be a fitting solution in certain situations, ghost authorship in a research setting is an entirely different story.
In a research setting, whether it is scientific, medical, or ethical, authorship has consistently been a highly sought attribute. Attaining authorship is associated with a plethora of benefits including “…recognition for creativity, peer recognition, better evaluation [and even] financial gains…” (Bavdekar 2012). Ghost authorship, on the other hand, is a phenomenon that involves the exact opposite – giving up authorship. In these situations, individuals who write the articles are not named as authors and are sometimes not even acknowledged. Instead renowned and reputable scientists, who have not participated in the manuscript preparation or the study, are recruited by certain industries to allow their names to be mentioned as authors (Bavdekar 2012). Does this phenomenon, which enables distinguished authors to “bestow underserved credibility upon industry-written papers,” (Bavdekar 2012) compromise the credibility of scientific research and publications or does it serve as a valid public relations and marketing strategy? To answer that question, the ethical issues associated with ghost authorship need to be explored and the underlying rational of the arguments for each position needs to be examined. First, however, let us examine a case study in which guest authorship and ghost writing produced a flood of problems, litigation, and even deaths.
BACKGROUND INFORMATION – A CASE STUDY ON ROFECOXIB
On May 20, 1999 a nonsteroidal anti-inflammatory drug named Rofecoxib, marketed by Merck & Co. to “treat osteoarthritis, acute pain conditions, and dysmenorrhea,” under the brand name Vioxx was approved by the Food and Drug Administration (Karth & Topol 2004). Five years later, in 2004, Merck voluntarily withdrew Rofecoxib from the market in response to concerns about increased risk of heart attacks and strokes (Karth & Topol 2004). However by the time it was discontinued Rofecoxib had already caused an estimated 60,000 deaths (Karth & Topol 2004). The litigation that promptly followed the withdrawal of Rofecoxib and the deaths it caused provided the scientific community with a “unique opportunity to examine guest authorship and ghostwriting” (Ross, Hill, and others 2008). After analyzing over 250 court documents that were obtained during the original litigations against Merck, Ross and his fellow researchers found astonishing results. A daunting 50% (36 of 72) of review articles concerning Rofecoxib “[did not] publish either a disclosure of Merck sponsorship or a disclosure of whether the author had received any financial compensation from the company” (Ross, Hill, and others 2008). The authorship list for these review articles consisted of recruited, external, and academically affiliated investigators (Ross, Hill, and others 2008). While studying the extent of guest authorship and ghostwriting in the case of Rofecoxib, it was found that Merck would first contract medical publishing companies to ghostwrite manuscripts after developing initial marketing plans and then would set out to recruit renowned and reputable scientists to be placed in the first and second authorship positions (Ross, Hill, and others 2008). While not all cases of ghost authorship lead to thousands of deaths, the ethical issues and possible dangers associated with ghostwriting are unquestionable.
ETHICAL ISSUES WITH GHOSTWRITING
While moral values “emanate from our inner convictions [and] provide the substrate that our conscious uses to distinguish right from wrong,” ethical behavior, on the other hand, “implies the adherence to a collection of moral principles that underlie some specific context” (Macrina 2005). In the context of ghost authorship, two separate entities; the original ghost author(s) and the recruited guest author(s), give rise to separate but distinct ethical issues. The issues that ghost authors beget generally regard teleological ethical theories, while guest authors give rise to ethical issues concerning deontological theories (Macrina 2005). Theological theories, often called consequentialist theories, focus on the “consequences of an action [to] determine the morality of that action” (Macrina 2005). In other words the outcome of a specific act, whether good or bad, determines the morality of the initial action. Deontological theories, conversely, do not depend on the “consequences of an action to determine its morality [and are] commonly referred to as duty-based” (Macrina 2005). Immanuel Kant, a German philosopher best known for his deontological theories, advised us to “act in such a way that you always treat humanity, whether in your own person or in the person of any other, never simply as a means, but always at the same time as an end” (Macrina 2005). While this quote more precisely relates to medical ethics, it can be applied to research ethics without much difficulty by replacing ‘humanity’ with ‘research’ and ‘person’ with ‘work’. Essentially, authors would be treating research, whether regarding their own work or the work of others, never simply as means, but at the same time as an end.
When a renowned investigator agrees to be recruited by an industry or pharmaceutical company as a guest author he or she is ultimately violating Kant’s categorical imperative stated in the previous paragraph by using research solely as a means – to become more prestigious or to earn more money. The investigator then fails to simultaneously treat research as an end, or more explicitly as a way to discern the truth while providing both the scientific community and the public with accurate and reliable information. By doing so, the guest author engages in unethical behavior by fundamentally compromising the credibility of scientific research and publications and conceivably placing the health of society at risk. In this case, the investigator is transgressing his or her ‘duty’ to both the public and the scientific community.
The ghostwriter (e.g. the corporation or company creating the original manuscript), per contra, is acting in an unethical manner due to the consequences of his or her actions. In the case of the drug Rofecoxib, Merck, the ghostwriting entity, engaged in unethical behaviors that ultimately led to the death of thousands of people (Ross, Hill, and others 2008). The generally biased and possibly fraudulent research articles on Rofecoxib gained undeserved credibility when “readers [perceived them] as unbiased articles written by [renowned] academicians” (Ross, Hill, and others 2008). This ruse prevents readers from evaluating the impact of bias, and in the case of Rofecoxib, could have been the factor that enabled the Food and Drug Administration to approve its use in 1999. As defined by teleological ethical theories, Merck was unethical by participating in ghostwriting due to the dreadful outcome of Rofecoxib. With that said, if the outcome of Rofecoxib was positive and no adverse effects or deaths were encountered, Merck would still not have acted ethically even if teleologically speaking the opposite was true. This is because not all ethical issues are either teleological or deontological – often both theories can apply. Fraudulently promoting and marketing a possibly harmful drug provided the means to make billions of dollars. The end, or the wellbeing of the patients on Rofecoxib, however, was not fundamentally being met. Even with all the ethical issues that ghost authorship poses – a divide still exists between those that condemn it and those that condone it.
POSITIONS ON GHOST AUTHORSHIP
While ghostwriting and guest authorship are generally viewed by the majority of the scientific community as highly negative practices, only a minority of the top 50 academic institutions in the US have explicitly banned these practices (Ross, Hill, and others 2008). However, in a newsletter published in 2009 by the Office of Research Integrity, an article announced that a prestigious clinical journal, Pharmacotherapy, was adopting new policies on ghost writing and guest authorship. The article stated that ghost authorship, which occurs when commercial entities (e.g. pharmaceutical companies) publish articles without being acknowledged as authors, is an “ethical breach by the authors who created the drafts” (Leedham 2009). The article also explained that guest authorship, e.g. investigators recruited to be primary authors without any intellectual input to the manuscript, is never ethical” (Leedham 2009). Coincidentally, the article directly following this one discussed the importance of institutional authorship policies. This article, which outlines the authorship policies adopted by The Johns Hopkins University School of Medicine, explicitly states that “ghost writing, a practice whereby a commercial entity or its contractor writes an article or manuscript and a scientist is listed as an author, is not permissible” (Garrity & Pudelko 2009). Both of these articles stated that the Rofecoxib controversy played an important role in to the development of these policies (Leedham 2009) (Garrity & Pudelko 2009).
Pharmaceutical companies, on the other hand, believe that ghostwriting is very beneficial and lucrative. In fact they frequently pay renowned authors to appear as contributors to make the research material appear both more legitimate and less biased (Mercola 2011). Although pharmaceutical companies will never openly admit it, they believe that ghost authorship is a perfectly acceptable way to market a drug. Why wouldn’t they? Vioxx alone provided Merck with sales revenue totaling US $2.5 billion in less than five years before being pulled off the market (Karha & Topol 2004). Redux, a diet drug developed by Wyeth-Ayerst, generated over US $255 million before being discontinued (Mercola 2011). In the year 2002 Americans spent over US $200 billion on prescription drugs alone (NOEDB 2008). It would plausible to credit a majority of those profits to the deceptive nature of ghostwriting and guest authors.
Even though the scientific community views ghost authorship as a negative practice, an article published in The Journal of the American Medical Association found that “21% of articles published in 2008 in general medical journals […] had an inappropriate honorary author, and that nearly 80% of articles published in these journals may have had an unnamed important contributor” (Mercola 2011). Unfortunately this means investigators and academicians are still participating in the unethical behavior of ghostwriting and guest authorship. The continued occurrence of ghost and guest authorship is the result of extremely powerful contributing factors that continue to influence both investigators and pharmaceutical companies.
CONTRIBUTING FACTORS – MONEY AND PRESTIGE
While there are many factors that contribute to the continued occurrence of ghost authorship in a research setting, the two most common are the lust for money and the desire to be prestigious and esteemed. Parke-Davis, a pharmaceutical company acquired by Pfizer in 2004, hired a ghostwriting company (MECC) to independently write articles supporting a drug called Neurontin (Mercola 2011). Parke-Davis paid MECC $18,000 per article and MECC paid $1,000 each “to friendly physicians and pharmacists to sign off as authors of the articles” (Mercola 2011). Wyeth-Ayerst paid over $20,000 for ‘friendly’ articles involving Redux and authors received $1,500 for placing their name on the finished papers (Mercola 2011). Thankfully, in 2010, Pfizer was found guilty of illegally promoting uses of Neurontin and was fined more than $140 million for violating U.S. racketeering laws (Mercola 2011).
Authorship of an influential paper also has the potential of “offering cascading material benefits” (Bavdekar 2012). Guest authors on some of these publications can get promoted within their organization, be offered better positions elsewhere, and even secure patents and grants for new projects (Bavdekar 2012). In the academic world authorship is something that is extremely sought after. While this factor usually “spurs scientists to plan and execute research projects and publish them in reputable projects” it can also entice scientists to indulge in “unethical behaviors and crave for authorship even when they do not deserve it” (Bavdekar 2012). These contributing factors, as well as the fact that only a minority of academic institutions explicitly prohibit ghost authorship, are why ghostwriting and guest authors are still common phenomena. While a number of measures have already been taken by various journals to discourage guest authorship, a lot more needs to be accomplished.
RESOLUTION – A THREE PART PLAN
Providing guidance to authors regarding authorship criteria and requiring authors to list their exact contribution in conducting a research project and in preparation and finalization of the manuscript are both example measures that have been taken by journals in an attempt to curb guest authorship (Bavdekar 2012). This alone, however, is not enough. In the following discussion, a three part plan is proposed in an attempt to resolve the issue of ghostwriting and guest authorship once and for all.
Part A: Journals. Rather than just provide guidance to authors about authorship criteria, journals should clearly and explicitly state policy regarding ghost authorship. In addition journals should take a more proactive position on manuscripts found to have been written by ghostwriters. They should notify the authors’ academic institutions and publish a notice that identifies the key players, such as authors and the responsible company or entity, in a ghost-written publication.
Part B: Institutions. Academic institutions should follow in the footsteps of The Johns Hopkins University School of Medicine by having strictly enforced policies deterring faculty members and graduate students from participating in ghostwriting. Serious punitive actions should be taken on those found in violation of these policies.
Part C: Government. A large portion of research funding comes directly from the government. As a matter of fact, there are currently over 26 agencies in the United States government that fund research across the country (Lok 2010). These agencies could potentially withhold funding from academic institutions if these institutions do not have strict policies regarding ghost authorship as described in Part B.
This three part approach should effectively eliminate, or at least greatly reduce, the number of published research articles that contain ghost and guest authors. Pharmaceutical companies, the main protagonists in ghostwriting cases, however, are not discussed in the aforementioned three part plan. The reason behind this is that any policy targeted towards pharmaceutical companies will be strongly disputed. Most of these industries have deep pockets and even deeper connections and any law and or policy that could potentially impact the amount of revenue earned will suffer an unpleasant fate. Since it takes two entities; both ghostwriters and guest authors, to fabricate a fraudulent final product, preventing one or the other from participating in ghost authorship should eliminate the problem. Targeting ghost authors involved with ghost-written literature is a much simpler task than going after the pharmaceutical giants that are developing the articles. While ghost authorship cases have reduced since they first began surfacing in 1996, the status of ghostwriting in 2013 is far from ideal.
STATUS OF GHOST AUTHORSHIP IN 2013
A page titled “The 26 Guidelines at a Glance on Avoiding Plagiarism” found on The Office of Research Integrity website delivers a very brief guide to ethical writing. The most recent addition to these guidelines, Guideline 26, states that “academic or professional ghost authorship in the sciences is ethically unacceptable.” However, none of the ORI newsletters published in 2013 or 2012 mention ghost authorship or ghostwriting in any form. In fact, the word ghost does not even appear once in any of the volumes. Unfortunately, the major government research funding sites such as the National Institute of Health (NIH) and the National Science Foundation (NSF) have yet to address ghost authorship or ratify policies on funding ghost-written manuscripts. In both the grant policy and guidance, and research integrity sections of the NSF and NIH websites, there is nothing pertaining to the unethical practice of ghostwriting. Without strict enforcement against ghost authorship there is no guarantee that the unethical practice of ghostwriting will ever be eliminated. With that said, other than increased awareness on the subject, and the occasional mention of ghost authorship in bioethical textbooks, the status of ghost authorship in 2013 is almost indistinguishable from the status of ghost authorship in preceding years.
SUMMARY
Because of the alluring notion of becoming a prestigious author, and the potential for pharmaceutical companies to make billions of dollars more in revenue, ghost-written articles will continue to be published under the identity of guest authors. This ultimately places undeserved credibility to these papers and causes readers to perceive them as unbiased and honest articles. With that said the ethical issues associated with ghost authorship are very numerous and can generally be divided into two distinct theories of ethics: teleological ethical theories and deontological ethical theories. Nevertheless, two positions still exist on ghost authorship – those who condemn the practice and those who condone it. In order to eliminate ghostwriting and prevent ghost-written material from ever harming the public, such as the Rofecoxib case study, a three part plan was proposed. The plan would require journals, academic institutions, and government funding agencies, to implement new policies against ghostwriting. This three part approach should effectively eliminate, or at least greatly reduce, the number of published research articles that contain ghost and guest authors. As of the year 2013, the status of ghost authorship is still not where it needs to be and the past few years have seen very few changes in ghostwriting policies across the United States.
REFERENCES
Abert, Hermann. 2007. W. A. Mozart. New Haven: Yale University Press.
Bavdekar, Sandeep. 2012. Authorship Issues. Lung India 29: 76-80.
Fryde, Edmund. 1996. Handbook of British Chronology. Royal Historical Society: 25.
Garrity SR, Pudelko J. 2009. The Importance of Institutional Authorship Policies. The Office of Research Integrity Newsletter. Volume 17:3. Page 9.
Karha J, Topol ED. 2004. The Sad Story of Vioxx, and What We Should Learn From It. Cleveland Clinic Journal of Medicine 71:933–934, 936, 934–9.
Leedham, Robert. 2009. Pharmacotherapy Announces New Rules on Ghost and Guest Authorship. The Office of Research Integrity Newsletter. Volume 17:3. Page 8.
Lok, Corie. 2010. Science Funding: Science for the Masses. Nature: 465, 416-418.
Macrina, Francis. 2005. Scientific Integrity – Text and Cases in Responsible Conduct of Research. Third Edition. American Society for Microbiology.
Mercola, Joseph. 2011. Medical Journals Using Ghost Writers. Natural Health Center 11:26.
NOEDB. 2008. 25 Shocking Facts about the Pharmaceutical Industry. Nursing Online Education Database. March 28th 2008.
Rennie D, Flanagin A. 1994. Guests, ghosts, grafters, and the two-sided coin. JAMA 271: 469-471.
Ross JS, Hill KP, Egilman DS, Krumholz HM. 2008. Guest Authorship and Ghostwriting in Publications Related to Rofecoxib. JAMA 299:1800-1812.
Posted in Bioethics, UNH
Tags: Bioethics, Biomedical Science, Essay, Ethics, Ghost Authorship, Ghost Written Articles, Guest Writing, Ramadan, research, Rofecoxib, Samy, science, UNH
