<i>Academic Emergency Medicine</i> Can Print Pharmaceutical Advertising While Not Compromising Its Mission or Its Integrity

Editor’s Introduction: The two commentaries that follow resulted from a vigorous debate among the members of this journal’s editorial board regarding whether or not paid commercial advertising from the pharmacy and medical device industries should be accepted and printed in our journal. The order in which they are presented was determined by a coin flip by the editor-in-chief. The two papers are attempts to clarify and provide background for further debate on this complex issue. This was a collaborative effort: there was continuous feedback between the two writing groups, and authors are listed alphabetically, but the participants held their view points with a significant degree of passion, appropriate for the importance of the topic. While the journal has no official practice banning advertisements by drug and device manufacturers, a combination of a very conservative posture toward the concept of such advertising and the general state of medical advertising in general (due to budgets being adversely affected by economic conditions) have resulted in no such industry advertising for the past several years. At issue is whether the journal should begin to more aggressively pursue advertising revenue or formalize a ban. The interested reader is also referred to the following article from the August issue of AEM: “A review of the federal guidelines that inform and influence relationships between physicians and industry.”1 A moderated online discussion board is available on the SAEM web site at http://www.saem.org/aemforum for those wishing to participate in further debate of the issues. David C. Cone, MD Editor-in-Chief, Academic Emergency Medicine Recently, the editorial board of Academic Emergency Medicine (AEM) has debated whether AEM should begin to accept and print paid advertising from the pharmaceutical and medical device industries (to which we will refer as “industry”). Advantages and disadvantages exist for modifying the current and long-standing AEM practice, which actually does not derive from any written policy of the journal. Dr. Chisholm and co-authors have argued against industry advertising.1 In not accepting industry advertising, AEM is currently the “outlier” among other American emergency medicine journals. Indeed, a large number of respected journals, such as the Journal of the American Medical Association (JAMA), Science, and the New England Journal of Medicine all print such paid advertising. On behalf of our opinion group, we assert that AEM should change its practice, allow appropriate industry advertisements, and benefit the Society for Academic Emergency Medicine. These actions would compromise neither the mission nor the integrity of the journal. We believe that a change of advertising policy will benefit AEM and its readers. We will develop three main themes, which include: How advertising can appear in a biomedical journal, while independence between the journal’s academic contents and the advertising which appears can be maintained. How advertising facilitates improved awareness of new pharmaceuticals and products, a desirable outcome. How advertising revenue could encourage new publishing initiatives by AEM, through an increase in its revenue base. We concede that caution is prudent regarding industry advertising. Direct-to-consumer industry advertising, which is protected by the First Amendment, frequently misleads. Some authorities have suggested that such advertising encourages patients and doctors to use or prescribe medications inappropriately, while driving drug spending upward.2,3 The Food and Drug Administration has “...warned 14 major pharmaceutical companies about brief Internet ads that accompany searches on Google and other search engines, saying the ads were misleading because they didn’t include risk information.”4 However, our commentary does not address direct-to-consumer advertising. Several medical organizations have addressed the problems that can ensue if there is undue influence by industry upon medical education and medical practice. The Institute of Medicine (IOM)5 and the American Medical Association (AMA)6 have appealed to physicians and physician groups to distance, but not isolate themselves from industry. This issue has recently been revisited within JAMA.7 The Department of Health of the State of Massachusetts has mandated an end to the practice of providing even small gifts, such as pens and Post-It notes.8 Physicians affiliated with Harvard University “may no longer accept gifts and meals from drug and device firms….”9 The American Psychiatric Association has ended industry-financed seminars at its annual meeting.10 These and other similar actions, which cannot all be enumerated individually here, operationalize recommendations from the IOM5 and the Association of American Medical Colleges (AAMC)11 regarding gifts to individuals and other practices that have become viewed as conflicts of interest in medical education and practice. However, the list of pitfalls discussed at length in these reports5,11did not include print advertising in medical journals. Delineation of the potential for real or apparent conflicts of interest when an academic medical or scientific journal accepts paid advertisements can help guide the establishment of prudent policies to govern this practice. Without our stipulating the specific terms of such a policy, AEM can be informed by the policies of other academic and practice societies. The AAMC has stated that interactions between academic medicine and industry must “…serve to enhance the health of the public,”“…be transparent,”“…reflect high standards of medical professionalism that reach beyond applicable laws and regulations,”“…involve reciprocal communications…,” and “…support and enable the free exchange of information in appropriate settings in a manner adherent to applicable law and consistent with the standards of medical professionalism.”11 Toward that end, the AAMC has advocated an “arm’s length” approach to, rather than an elimination of, accepting of industry advertising and money. This approach neither eliminates advertising entirely, nor compromises organizational independence or integrity.11 The AAMC report suggested implementing a “filter” between the organizations providing funds and the recipients of these funds, such that the existence or a perception of undue influence can be avoided. With a proper filter, industry advertising can be permitted while avoiding the unacceptable consequences of direct-to-consumer marketing. A foundation, or an operating process, could be established within the Society to govern the receipt of advertising revenue, if the leadership determined that such a filter would be required. Whether through such a filter or via another mechanism, advertisers would not be permitted to influence any decisions regarding the awarding of grants, nor the publication schedule for papers. Specific policies to guide advertising in AEM, without the need for any foundation to act as a filter, need not be derived de novo. JAMA, and it parent organization the AMA, have developed an advertising policy that maintains independence between advertising and published scientific content. This policy was most recently revised by the AMA in November 2007.6 All AMA journals accept pharmaceutical advertising under this policy, without creating the illusion or perception of endorsement by the AMA. This AMA policy, which has been periodically revised after the Sunbeam product endorsement issues that arose in 1998,12 addresses not only pharmaceutical advertising, but also equipment, instruments, and devices; food products; dietary supplements; books; insurance coverage; continuing medical education programs; and miscellaneous products and services. Others have detailed prudent strategies for guiding the printing of medical industry advertisements in academic publications. Rothman et al.7 cite five underlying principles and premises that can favor and guide reasonable advertising policies. These include: “…pharmaceutical and medical device industries make important contributions to medical progress.” “…research demonstrates the power of gifts to bias physicians’ choices.” “…education must be carefully distinguished from marketing.” “…individual as well as Professional Medical Associations’ (PMAs) organizational ties to industry take a variety of forms, so the guidelines for PMAs must reckon with each of them.” “…PMAs must set their own agendas and priorities and remain faithful to them.” Rothman et al.7 then make a series of recommendations that address these principles and premises. These recommendations are included within the following topical areas: “General Budget Support from Industry,” which advocates that “PMAs should work toward a complete ban on pharmaceutical and medical device industry funding ($0), except for income from journal advertising and exhibit hall fees.” (italics added). In other words, Rothman et al. specifically exempt advertising from their concerns regarding pharmaceutical and medical device industry support of PMAs. Further, it is stated that “All funds from industry should be truly unrestricted…”, which is a restatement of the general principle that advertisers cannot be permitted to influence journal publication decisions, publication schedules, grant awards, and the like. “Industry Support of Publications,” which states: “Just as it is acceptable for PMAs to derive revenue from industry for exhibit hall displays at scientific meetings, revenue from industry advertising in PMA journals can be acceptable when the advertising is clearly identified as such (italics added).” Some journals separate advertisements from the scientific and editorial content (both in print and in online publications) so that readers can choose to ignore the advertisements or can remove the print advertisements from the journal. However, PMA journals must have policies governing journal-based advertising to ensure that scientific and editorial integrity is maintained, by prohibiting editorial decisions to be based on the likelihood of generating advertising revenue, and by prohibiting advertising placement to be based on upcoming journal content. Interactions between AEM and its advertisers also should be consistent with additional standards that may be established in the future to assure that exchanges of information are evidence-based and free of bias. Any such interactions must be “unrestricted”; there can be no real or implied “quid pro quo” expectations on the part of advertisers. Advertising has a legitimate function to assist informing the medical community of the existence of new diagnostic aids and therapies for diseases that burden our patients. Advertising can appropriately publicize products and services to the readership of AEM. With the pace of medical innovation in academia and industry, advertising in our journal could more quickly make physicians aware of new pharmaceutical products, which may be initially more well known by practitioners of other specialties. With this information, physicians then can examine the evidence for these new products, discuss them with their peers, and then consult credible sources of evidence, such as original journal articles, and read and evaluate them for potential bias. Physicians would thus be able to make informed decisions regarding the clinical usefulness of these products to their medical practice. Industry advertising shows logical promise to facilitate shortening of the second translational gap, or “T-2”: the gap between the availability of new therapies and their broad implementation in medical practice.13 Studies detailing many pharmaceutical therapies were first published long before their broad acceptance by the medical community and before any expectation of awareness by the emergency medical community. An example that is pervasive is the role of anti-Helicobacter therapy for acute gastritis. The role of Helicobacter was first verbally reported by Warren and Marshall at a conference in 1982 and reported in writing in 1983.14 This advance led to medication regimens, but their widespread use did not occur until the mid-1990s. Now, as emergency physicians, we know that we can refer patients with suspected gastritis to gastroenterologists for possible anti-Helicobacter therapy, but we would not have been likely to have acquired this knowledge through our own peer-reviewed journals. Advertising is one way to facilitate the diffusion of knowledge. It would be consistent with our goals to permit advertising, to help increase physician awareness of new therapeutics and diagnostics and thus facilitate shortening of T-2.13 Indeed, AEM recently published proceedings of the 2007 consensus conference regarding the development of a research agenda for knowledge translation, which included a session specifically devoted to implementation of evidence-based clinical algorithms.15 An algorithm may include (as is the case for cardiac thrombolytic agents, Group IIbIIIa Inhibitors, or new combinations of medications to treat Helicobacter pylori) or exclude (as is exemplified by the use of radiographs by the Ottawa Ankle Rules) therapeutic or diagnostic aids. When the issue is one of inclusion of new agents, advertising can clearly facilitate T-2. The costs of publication of AEM are significant, budgeted for 2009 at $535,000, spread across our membership of approximately 5,600. Industry advertising could assist AEM to expand in ways that are now financially prohibitive and alleviate a financial burden to the membership of the Society, while potentially educating the journal readership of new industry products. We advocate a sensible position, which would permit our society and our journal to accept pharmaceutical advertisements, while compromising neither our mission nor our integrity. It is time to change our journal’s practice and permit such advertising. We assert that limited industry advertising could serve positive educational and financial values of sufficient importance to compel a change from AEM’s current “no industry advertising” practice. Academia and industry have a commensal relationship. Academia is in the business of creating new science through cutting-edge research and then disseminating this information via peer-reviewed scientific publications. Shaywitz and Stossel point out that, “…the goal of medical research is not to publish papers, but to develop new treatments for people suffering from disease.”16 When viewed as a means of publicity and not as a means of endorsement, with transparency of interaction and with a lack of any quid pro quo, pharmaceutical advertising represents a legitimate function for our journal and extends and enhances the underlying goal of medical research. Maintaining unnecessary barriers between academia and industry only serves to prolong the gap between the availability and the widespread implementation of new and useful medical “tools.”13 Adoption of the policies and principles advocated by Rothman et al.7 to govern industry advertising in AEM would provide intelligent guidance to permit our society to take a measured and balanced step forward, in a manner that maintains the ethical high ground, while permitting the financial benefits of advertising that will accrue.

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