Introduction
In the last century, average life expectancy in the United States increased by over three decades [1]. This was in large part due to expanded initiatives in health research, which are critical in providing a better understanding of diseases and developing new therapies and treatments. However, this expansion of research and increase in available information means that no single researcher today can validate all possible innovations on his or her own [2]. Nevertheless, health professionals need to understand what treatments are available, as well as their advantages and disadvantages, to make informed decisions when treating patients or creating new health policies. Thus, they rely on shared information from the work of academic peers, such as through highly respected peer-reviewed journals, in ensuring treatment safety [2]. For this reason, it is critical that this system of information-sharing is not only efficient but also reliable. There is an expectation that publications in widely circulated journals have legitimate authors who have the public’s best interests at heart. The ability to make informed decisions after reviewing published data is compromised when the source of the data is misrepresented for the sake of monetary gain. This brings to light some of the issues associated with medical ghostwriting.
Understanding Ghostwriting and Its Prevalence
Medical ghostwriting is the practice of attaching names of legitimate, often well-respected scientists at academic medical centers to articles that have actually been written by marketers within a pharmaceutical industry prior to submission to a scientific journal [3]. In these instances, the designated authors are not the primary producers of the work in question; in fact, in some instances, they may not even have verified the data themselves. Yet they intentionally misrepresent themselves as authors, often in exchange for financial compensation by the company they are representing [3]. The end result is a biased paper, written by a company that will gain from a positive portrayal of its product or a negative portrayal of a competing product. What separates a ghostwritten article from other forms of drug advertising, such as through the media or sales representative visits to physician offices, is that it is presented by a known, credible researcher with no mention of the company they are sponsored by or disclaimer that they are being compensated to publish data. Once the data is published in a medical journal, those reading the paper have no way to distinguish it from an impartial presentation of clinical data.
Ghostwriting is a widespread practice, but more concerning is that it is not entirely certain how widespread it is. Reports suggest that between 11 and 50% of medical articles contain the influence of ghostwriters, but this range remains broad because it is difficult to pinpoint specific examples [4]. Furthermore, it is rare for a single paper on a treatment to be ghostwritten in isolation, as it is often part of a larger ghostwriting campaign involving submission of multiple articles to several journals. Often, ghostwritten papers go unidentified unless specifically examined in independent studies. These are typically long after publication and with specific incentives to do so, such as litigation, when it is too late to reverse the damage. One such example from 2008 involves the drug Rofecoxib, in which it was found that 8% of clinical trial articles and 50% of review articles failed to disclose sponsorship or financial compensation from Merck & Co., the pharmaceutical company behind the drug [5]. The issue is even prevalent in some of the most high-profile publications within the medical industry, including the New England Journal of Medicine and the Journal of the American Medical Association [3]. This pervasiveness is concerning especially when considering some of the risks that ghostwriting presents to vulnerable populations.
Profits at the Expense of Patients
Ghostwriting as a practice continues because it is beneficial to those involved in creating articles. For companies, their product gains attention when it appears that an independent reviewer held in high regard by the scientific community writes about it positively. Favorable portrayals that convince physicians to prescribe the product in question translate to revenue and increased market share for the companies that launch ghostwriting campaigns [4]. Researchers who engage in ghostwriting by attaching their credentials to a previously written paper and claiming authorship also benefit, as they are frequently financially compensated for doing so. Even if they are not compensated, they may benefit by adding their name to a new publication without having to put in the work required to produce it themselves, which improves their reputation within their field and may advance their career [4].
At the same time, it is easy for those who engage in ghostwriting to lose sight of the harm that can occur once their work is published. Undisclosed sponsorship becomes dangerous when academic papers become little more than masked advertising and fail to mention adverse effects associated with a drug or only include data that exaggerates a drug’s positive effects [4]. Because doctors and policymakers rely on these journals for accurate, up-to-date information about the latest available research, these portrayals can ultimately influence decisions that affect patients’ lives. This is evident in the case of the aforementioned Rofecoxib, also known as Vioxx, a pain medication that is now known to double the risk of heart attacks in patients if taken for over eighteen months [6]. However, prior to its launch, pharmaceutical giant Merck launched a massive ghostwriting campaign that resulted in an increase in global sales to $2.5 billion per year in 2003 [5,6]. Despite the fact that in-house scientists at Merck were aware of some of the issues related to the drug, the company hired outside authors to publish papers about the medication’s positive effects in arthritis patients. The most famous of these papers, called the VIGOR study, was published in the renowned New England Journal of Medicine but was later found to contain false data [6]. At least two authors listed on papers discussing Vioxx have since confirmed that their involvement with the data and final product was minimal [4]. Unfortunately, Vioxx is now alleged in over 27,000 lawsuits to have caused sometimes fatal heart-attacks in patients before ultimately being withdrawn from market [6]. Yet this is just one example out of many of the harm that has come from medical ghostwriting. Others include the female hormone replacement therapy Prempro, which has been found to increase risk of breast cancer since being introduced to market, Neurontin, in which articles pushed unsubstantiated off-label uses for neuropathic pain and bipolar disorder, and Zoloft, in which articles downplayed serious side effects [7,8].
Shortcomings in Current Policy
Unlike the ghostwriting of literary works, the ghostwriting of academic literature carries very real consequences in health policy and healthcare delivery because it spreads bias. However, until recently it has not been explicitly addressed within academic research centers, which produce the scientists whose names are willingly used on these ghostwritten papers. Even now, of the top 50 academic medical centers for research within the United States, only 13 ban the practice of ghostwriting. Of these, only 7 medical centers go as far as to clearly define the process of ghostwriting. Yet 26 of these medical centers, the majority, have no published regulations on authorship and ghostwriting [9]. This is a stark contrast to the much harsher penalties levied against researchers who engage in plagiarism, when authors fail to provide credit to others for ideas that are not their own, which frequently include removal from the university. The distinction may be in that unlike with plagiarism, the corporation is a willing party to this deception in authorship, but nevertheless the fact remains that a scientist is taking credit for the writing of others without making substantial contributions of his or her own [3]. In fact, the clear agenda of misrepresenting information to the public may actually cause more tangible harm than plagiarism, which is disturbing considering that ghostwriting is not considered by universities to be a form of research misconduct of the same magnitude.
Despite the best effort of the International Committee of Medical Journal Editors (ICMJE) to develop a code of ethics for publishing medical research that includes disclaiming any conflicts of interest or outside contributions to a piece of writing, the guidelines only offer recommendations and stop short of providing disciplinary action against those who engage in ghostwriting. It is left up to individual journals to decide how to respond to and investigate allegations [4]. Nevertheless, journals are not currently held liable during litigation for allowing misrepresented information to reach the public [6]. Thus, this lack of incentive to enforce individual disciplinary processes creates an unwillingness to police the authorship of articles that is not only a lapse of good science, but threatens the value of these journals to the public. Journals that do not more stringently regulate the content they provide are complicit in adverse effects that may result from mistaken or inaccurately portrayed information.
Moving Forward
Patients who are vulnerable rely on the expertise of their doctors to prescribe the treatments in their best interests. However, a physician’s ability to do so is compromised when they do not have all of the facts surrounding a published study. Although it is important that corporations and researchers have the ability to publish information freely, it is also critical that they be transparent when it comes to the source of information. There is currently a lack of a set of clearly outlined standards and centralized oversight within the biomedical industry when it comes to ghostwriting. Unfortunately, this creates a culture with few consequences and limited accountability. To prevent this, regulations should fall on companies, researchers, and journals collectively. This firstly includes disclosing all sources of funding involved in the production of scientific literature, which allows doctors to understand whether there may be a hidden agenda when making treatment decisions. To prevent additional conflicts of interest, biomedical companies should be prevented from interfering with or influencing scientific literature discussing their product. This may inhibit companies trying to find loopholes in anti-ghostwriting policies from attempting to even influence researchers in the process of compiling an article while technically avoiding the mandate to disclose authorship. Even when influence is disclosed, it may be necessary for a journal to independently verify that data is not deliberately biased or does not completely describe the advantages and disadvantages of a specific product. Furthermore, the penalties for researchers that fail to follow these guidelines should be similar to those for plagiarism, including getting blacklisted from all industry journals or fined, to deter future behavior. Even so, industry self-regulation may not be enough and further legal action may be required, including prosecution for fraud.
The risks of choosing not to disclose all parties involved in the creation of a medical article far outweigh the benefits. Nevertheless, ghostwriting continues to exist due to voluntary participation by those that engage in it, who frequently stand to benefit. But when the health and lives of the public are very much at stake, the responsibility to ensure that data is being accurately presented falls to everyone involved in its publication, from author to editor.
By Arushi Gulati, Viterbi School of Engineering, University of Southern California
About the Author
At the time of writing this paper, Arushi Gulati was a fourth-year student at the University of Southern California, from Los Angeles, CA. She is currently studying biomedical engineering and plans to attend medical school after graduation.
Works Cited
[1] J.P. Bunker et al., “Improving health: measuring effects of medical care,” Milbank Q., vol. 72, no. 2, pp. 225-258, 1994.
[2] Institute of Medicine (US) Committee on Health Research and the Privacy of Health Information, “The Value, Importance, and Oversight of Health Research” in Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, Washington (DC): National Academies Press, 2009.
[3] T.D. Anekwe, “Profits and plagiarism: the case of medical ghostwriting,” Bioethics, vol. 24, no. 6, pp. 267-272, Feb. 2009.
[4] E. Langdon-Neuner, “Medical ghost-writing,” Mens Sansa Monographs., vol. 6, no. 1, pp. 257-266, 2008.
[5] J.S. Ross et al., Guest authorship and ghostwriting in publications related to Rofecoxib: a case study of industry documents from Rofecoxib litigation,” JAMA, vol. 299, no. 15, pp. 1800-1812, Apr. 2008.
[6] D. Singh, “Merck withdraws arthritis drug worldwide,” BMJ, vol. 379, no. 7470, pp. 816, Oct. 2008.
[7] A.J. Fugh-Berman, “The haunting of medical journals: how ghostwriting sold HRT,” PLOS Medicine, Sept. 2010. [Online]. Available: https://doi.org/10.1371/journal.pmed.1000335.
[8] C.S. Landenfield and M.A. Steinman, “The Neurontin legacy — marketing through misinformation and manipulation,” vol. 360, no. 1, pp. 103-108, Jan. 2008.
[9] J.R. Lacasse and J. Leo, “Ghostwriting at elite academic medical centers in the
United States,” PLOS Medicine, vol. 7, no. 2, e1000230, Feb. 2010.