Healthy Skepticism Library item: 14878

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Fugh-Berman A, Dodgson SJ.
Ethical considerations of publication planning in the pharmaceutical industry
Open Medicine 2008; 2:(4):
http://www.openmedicine.ca/article/view/118/215

Abstract:

The term “publication planning” can refer to a research group’s organizational timetable and plan. Within the pharmaceutical industry, however, the term describes the finely calibrated process by which clinical trials, commentaries and other articles supporting the efficacy of particular products are written and released into the biomedical literature. This article describes how industry uses publication planning to sway medical and public opinion through the medium of medical journals.

Industry publications describe the utility of publication planning in the following terms: it can “provide essential, appropriate sources for other communications, whether promotional or scientific.”1 It may also “influence regulatory authorities globally” and “influence disease perception and management through citation, discussion, and recommendation.”2

The controlled production and release of pre-clinical studies, clinical trials, reviews and commentaries may begin years before a drug is launched (Fig. 1). Peer-reviewed clinical efficacy studies supporting a new drug or a new indication for a commercially available drug are considered “primary” or “core” publications. According to an industry article, “For a pharma company, getting research published in a peer-reviewed medical journal is like winning a stamp of approval from its most influential audience. It’s an automatic validation unmatched by any other medium.”2 Primary articles “[p]rovide authoritative sources for marketing communications and other promotional materials,” “[s]upport the positioning and selling platform, and coordinate with the overall marketing plan” and “[a]ccelerate the adoption of a new chemical entity or new indication.”1 In other words, they provide the foundation for subsequent “secondary” or “derivative” publications, which include journal advertisements, promotional materials used by sales representatives, and reviews and opinion pieces published in medical journals.

Pharmaceutical companies cannot legally promote a drug before it has been approved by a regulatory authority, nor can they legally promote a marketed drug for off-label use (i.e., for indications other than those approved). However, the US Food and Drug Administration (FDA does not consider articles in the medical literature as promotional. As one industry article states, “Peer-reviewed publications offer pharma companies shelter from often-stormy regulatory waters. FDA views published articles as protected commercial speech so doesn’t regulate their content.”2

For this reason, the generation of subtly persuasive opinion pieces that can be distributed to prescribers in the pages of medical journals is an extremely important component of publication planning. Sponsored articles can be difficult for journal editors and readers to spot. In many cases, the drug that the article is meant to promote is not even mentioned. For example, if a drug is the only treatment for a given condition, articles that review the prevalence, severity or complications of that condition will prepare the market by raising physician awareness of specific issues. Articles that highlight the inconvenience or risks of competing therapies increase receptivity to a new drug that is more convenient or safer (e.g., has once-a-day dosing or is not associated with an adverse effect that may occur with competing drugs).

Reviews and commentaries are the Trojan horses bearing these messages. To ensure that articles are well written and contain suitably subtle marketing messages, a pharmaceutical company may enlist the assistance of a professional medical writer. Such assistance ranges from editing to ghostwriting (i.e., writing contributed by authors who are not acknowledged when the article is published).

Medical writers, who are often scientists or health professionals, are crucial to publication planning. They ensure that manuscripts are scientifically correct, professional, organized, readable, persuasive and submitted on time. Medical writers prepare primary and secondary publications, including clinical trial reports and reviews; they may also prepare meeting materials and abstracts.3 They may work directly for pharmaceutical companies, most often as freelancers, or they may be employed by medical education and communications companies (MECCs), which derive most of their income from pharmaceutical companies.4

A pharmaceutical company may create a publication plan internally or work with a MECC on the plan. The process described here is used to create secondary publications. Typically, a publication plan includes a timeline and lists of articles, grouped under specific messages, with proposed titles and journals to target for submission (Fig. 2). Potential guest authors may also be listed.

Once the topic of an article is chosen, a medical writer generates an outline, which is approved by the sponsoring pharmaceutical company. The writer then researches and writes the paper, incorporating the appropriate marketing message; an experienced writer may be able to communicate messages that align with a sponsor’s marketing objectives even when specific messages are not provided. After the completed article is approved, a guest author, usually an academically affiliated physician, is approached by the sponsor. Guest authors (who may receive payment through a MECC) are generally offered the option to contribute to or amend the article; they usually realize that edits disadvantageous to a sponsoring company’s marketing goals will result in the article not being published – or being published under another physician’s name.5