If litigation against the pharmaceutical industry has revealed anything over the past two decades, it is that medical research and pharmaceutical marketing have become very difficult to tell apart. As each pharmaceutical scandal has unfolded, a familiar pattern has emerged. A new drug appears on the market and appears to be a stunning success. The clinical trials look excellent; doctors prescribe the drug enthusiastically; it earns billions of dollars in profits. After a few fat years, the problems with the drug begin to emerge: cardiovascular disease, diabetes, pulmonary hypertension, suicidal ideation. During litigation, it becomes apparent that the company has known about the problem for years, but has managed to hide, spin or downplay the risks in its scientific publications, many of which have been produced by ghostwriters working for medical education agencies. Yet so convincing are those publications that, until the litigation, few suspected they did not represent legitimate science.
While ghostwritten articles play a role in this deception, they are only one piece of a much larger problem. That larger problem is the manipulation of medical research for marketing purposes. Medical journals have become, as Lancet editor Richard Horton puts it, ‘information laundering operations for the pharmaceutical industry’.1 This is not simply a matter of recruiting academic opinion leaders to sign ghosted articles. It is the enlistment of medical researchers and journals into an elaborate public relations campaign that begins years before the drug is even launched. With the help of a medical communications team, a pharmaceutical company will prepare the ground for a drug launch with review articles, letters and case reports, all designed to demonstrate how badly the drug is needed and how inadequate the competition is. The company will design clinical trials to show that the drug is safe and effective; if the trials are positive, the company will publish them, and if they are negative, they may hide or bury them. Once the drug is on the market, the company will design clinical trials to fend off competition, to counter potential criticism, or to achieve further regulatory approval for other indications. Once published, these studies will be distributed to doctors by the company sales force. The marketing message will be reinforced by an ongoing communications strategy involving Continuing Medical Education events, conference presentations and satellite symposia, many of which will generate press attention with the help of a public relations firm.
Clinical research has become a competitive, highly profitable, multinational business that, unlike other businesses, is regulated by an honor system. An honor system may have made sense in the old days, when most research was conducted by academic physicians working in universities. But today clinical research takes place almost entirely in the world of business. The biggest business is the pharmaceutical industry, of course, which funds the entire enterprise, but it is not alone. At each step of drug development are smaller businesses whose livelihood depends on speeding a drug along the way to a potential buyer: Contract Research Organizations, subject recruitment firms, publication planners, medical education companies, and commercial Institutional Review Boards. Even medical journals often depend heavily on pharmaceutical companies for advertising revenue and fees for reprints and supplements. Journal editors claim they must trust authors of submitted manuscripts to tell them the truth, but it is naïve to imagine that trust is a sufficient check against the pressures of a multi-billion dollar industry.
Phrases such as ‘ghost authorship’ and ‘honorary authorship’ suggest that the ethical problem is one of deception: hiding the involvement of the actual writer of a scientific article. Yet the problem of ghostwriting would not disappear if the contributions of medical writers were uniformly acknowledged in scientific publications, or even if they were listed as authors. Academic opinion leaders would still get credit for authoring or co-authoring articles to which they did not really contribute in any meaningful way, and pharmaceutical companies would still spin their publications to suit their marketing aims. The only difference would be that the ghostwriters and medical communications companies might become somewhat easier to identify.
Anekwe argues that taking credit for ghostwritten articles is plagiarism and should be subject to policies that deal with plagiarism as a form of research misconduct. He believes that ghost authorship should be taken as seriously as other forms of plagiarism, arguing that it ‘should be frowned upon by the research community in the same way that other types of plagiarism are frowned upon’.2 But ghost authorship actually seems far more serious than other forms of plagiarism, in terms of its purpose, scope, and effects. Plagiarism is typically done in order to further a personal interest, such as passing a class, gaining tenure, or increasing professional stature. It does not capture the magnitude of the strategic enterprise in which pharmaceutical companies are engaged.
The term ‘ghost management’ comes closer. By using the phrase, Sismondo and Doucet convey the fact that ghostwritten articles are part of a broader set of activities through which pharmaceutical companies shape the publication of scientific research from beginning to end. They also understand that the problem with ghosted articles is their part in a larger strategic enterprise. Not all medical research is ethically justified, especially if it places human subjects at risk to serve the marketing goals of a pharmaceutical company. ‘In order to know if published research is ethically justified,’ they write, ‘it is important to ask not only if the results have been published, but also why and how they were published’.3 If a scientific article is published with the strategic intent of marketing a drug, then it is not really scientific communication, but rather public relations.
Public relations is an industry in which, as Habermas explains, ‘the sender of the message hides his business enterprise in the role of someone interested in the public welfare.’4 Pharmaceutical public relations specialists exploit the mechanisms for scientific communication in the same way that conventional public relations specialists exploit outlets for journalism. The purpose of public relations is not to serve the public interest or to represent the truth. The purpose is to manage information in a way that produces an advantage for a client. As Lee Salter writes, ‘A client does not employ a public relations agent to tell the truth, regardless of the personal orientation of the agent. Neither does the client pay a public relations firm to represent the interests of their opponents, let alone to assist the public in weighing up all of the evidence so they can make their own judgment on the situation. A public relations agent who did this would be considered bad.’5 In this sense, the structural logic of pharmaceutical public relations prevents its practitioners from engaging in ethical scientific communication, even if, as individuals, they are well intentioned.
Ethical communication in science and medicine requires rational, critical debate in which all are participating on equal terms, including equal access to all relevant information. The communicators must be committed to honesty in their exchange of ideas and must not conceal private interests and agendas that, if revealed, might alter how others view the substance of what they are saying. Public relations, in contrast, could not be accomplished without some degree of deception. When a pharmaceutical company recruits an academic researcher to become the author of a ghosted article, it takes the perception that academic researchers are people who work in the public interest and uses it to market a product.
Sismondo and Doucet propose a number of well-intentioned remedies for the problem of ghost management, most of which are, to put the case mildly, unrealistic. For example, it is highly unlikely that governments across the world will come together to abolish patents on pharmaceuticals. Nor is it likely that medical journals will collectively refuse to publish industry-sponsored clinical trials. The barrier is not potential damage to the quality of journal submissions, but the fact that the major medical journals are financially dependent on the pharmaceutical industry, which has never been hesitant to throw its weight around. For example, when a 1992 study in The Annals of Internal Medicine pointed out the inaccuracy of drug advertisements in medical journals, a number of pharmaceutical companies simply withdrew their advertising, which cost the journal up to an estimated $1.5 million in lost revenue.6 It is unlikely that journal editors will be willing to take that kind of risk again.
The deeper problem that needs to be addressed, as David Healy has repeatedly pointed out, is the fact that the pharmaceutical industry does not conform to the norms of science. It does not make its raw scientific data available to medical journals or to the public; in fact, it often does not even make its raw data available to the physician-investigators it recruits as collaborators. This kind of secrecy makes it nearly impossible to verify whether a pharmaceutical company is hiding or spinning data until litigation forces the information into the open.
Even forcing raw data into the open would not fix the problem completely, however. Many ghostwritten articles do not involve data. For example, an academic physician might be approached by a medical communications agency to author a ghosted review article, which will masquerade as his or her expert opinion about the current state of a particular therapy or illness. In fact, a fair portion of pharmaceutical public relations does not involve medical journals at all, but a much wider ranger of communication vehicles, such as hospital lectures, conference symposia and CME events. In theory, these communications vehicles are supposed to be independent of industry influence; in practice, they are often funded and managed by industry. Until this funding source is cut off, the potential for influence will remain.
Given the amount of litigation against the pharmaceutical industry in recent years, some of which has resulted in record-breaking penalties, it is surprising that no litigation has been directed towards medical writers, medical communications agencies, or the physicians who sign their names to ghosted articles. Maybe this is because these players are seen as mere instruments in a much larger marketing enterprise, or maybe it is simply that their pockets are not as deep. But if a few high-profile lawsuits were successfully aimed in their direction, it is a good bet that the practice of ghostwriting would come to a sudden halt.