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often referred to as KOLs, are valuable to the credibility of the manuscript and therefore essential to the whole project of publication planning. To leave analysis and writing to authors, though, will often result in a manuscript that does not serve the company’s interests. One experienced planner addressing colleagues at a 2011 conference jokingly illustrates the point, waving an imaginary manuscript in the air:
“What is this? They’re promoting the competitor!” Another calmly affirms that “the approach of having an industry-authored [industry-written] first draft is a good one.” Moreover, as depicted by planners, authors typically make few substantial contributions to the manuscripts they author, are slow to respond, and miss dead- lines. Some expect prominence in authorship order and even try to violate ethical practices, for example, by trying to remove acknowledgment of medical writers.
While the planners complain about deadbeat authors, they create the conditions for those deadbeats. According to one speaker’s estimate, 50% of companies show only the penultimate manuscript to authors, to solicit their input. It is likely that authors will have little to add to a well-crafted manuscript essentially ready for publication. That becomes especially likely if authors are given tight deadlines.
According to one whistle-blowing medical researcher, part of the problem he faced was that he received abstracts only after they were submitted (and accepted) for meetings and received manuscripts only days before the planners’ deadlines for journal submission. The orderly and efficient rollout of presentations and papers means that authors are likely to contribute little.
To produce a manuscript, planners must coordinate work by multiple parties they do not want to become authors, such as company statisticians, company and agency researchers, and medical writers. Perhaps some of these would meet authorship criteria, or perhaps no single person would, because the ICMJE maintains a concept of authorship that does not easily apply to cases of corporate production of manu- scripts. On the whole, research as managed by publication planners is hard to fit into the ICMJE’s framework, although it directly opposes the implicit ethical stance adopted by those criteria.
In this largely unseen process, pharmaceutical companies initiate and fund the planning, research, analysis, writing, and the placing of papers, and typically main- tain control of data throughout. In the corporate production of knowledge, medical writers, authors, planners, company scientists and statisticians all play roles, with the end goal of supporting the marketing of products.
Industry-Sponsored Dissemination of Medical Knowledge
Publications address many audiences, but to pharmaceutical companies the most important audiences are generally made up of prescribing physicians. Simply by being published, articles may reach some physicians and researchers who influence physicians. But companies do not rely on this route and distribute their preferred knowledge directly to physicians by sales representatives, key opinion leaders (described below), and occasionally by direct mailings—the pharmaceutical com- pany Merck is reported to have bought 900,000 copies of a New England Journal of Medicine article reporting a large trial of Vioxx (Smith 2006), an amount that sug- gests at least some mass mailings.
At the ground level, pharmaceutical sales representatives use reprints of publica- tions for promotional purposes. Addressing an audience of publication planners at a large conference, a former sales representative, now an industry consultant, gives a bit of a pep talk: “Folks, they’re dying for your work, by the way. Field reps are dying every day for more of your work. You know that, right? Because that’s what doctors are going to see.” In the course of discussing legal developments around interactions between companies and physicians, she indicates how articles create opportunities for conversations. She imagines a situation in which she is not permit- ted to discuss science suggesting the off-label use (i.e., use not sanctioned by regu- lators) of drugs:
Those of you who’ve been a sales rep know how difficult that would be. First reprint I’ve gotten now in three years, and I’ve got it gripped, I’ve got it in my hand .… So now I’m now in an office and I’ve got this reprint and I think ‘Hi doc, good to see you today. By the way, and one more thing, here’s this reprint. Goodbye.’
This, she indicates, would be uncomfortable, unusual, and unproductive. For sales representatives, distributing reprint of scientific article is an opportunity to initiate discussions. Those discussions will invariably be of the article, but also about how to use its information—setting up possible prescriptions and sales.
Of course, pharmaceutical sales representatives do much more than transmit knowledge. Providing information about drugs is only one component of their jobs.
Sales reps also provide samples, as gifts and to get physicians used to prescribing their products. Where these haven’t been made illegal, they provide other, larger, gifts to physicians (see Oldani 2004). Perhaps most commonly, they provide friend- ship (e.g., Fugh-Berman and Ahari 2007). Ultimately, though, it is the fact that sales reps provide information, whether in the form of scientific reprints or product infor- mation sheets, that legitimizes their presence in physicians’ offices. The transmis- sion of medical knowledge is what allows sales reps to make their pitches, offer their friendship, and convince physicians to prescribe specific drugs.
But while sales representatives might be prominent vectors for the distribution of knowledge, their sales role makes them suspect. According to another former phar- maceutical sales representative, “[t]here are a lot of physicians who don’t believe what we as drug representatives say. If we have a KOL stand in front of them and say the same thing, they believe it” (Moynihan 2008). For this reason it is worth taking a detailed look at key opinion leaders.
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Key Opinion Leaders
I would give them all the information that I wanted them to talk about. I would give them the slides. They would go through specific training programs on what to say, what not to say, how to answer to specific questions, so that it would be beneficial to my company.—
Former sales representative (quoted in Moynihan 2008: 1402)
The term “key opinion leader” descends from work on structures of influence in such domains as politics, fashion, culture, and medicine, by the sociologist Paul Lazarsfeld and his students (e.g., Katz and Lazarsfeld 1955). As the term itself sug- gests, pharmaceutical companies engage key opinion leaders (normally “KOLs”) primarily to influence others, to lead opinions in the directions that the companies prefer: KOLs are key mediators between pharmaceutical companies and physicians.
For this reason, relations between the companies and KOLs are ideally, from the point of view of the companies, part of general “KOL management” (a standard phrase) plans.
There are different kinds of KOLs. High up in the ranks of prestige, and paid accordingly, are researcher KOLs. These are usually academics with significant research profiles, whose value to pharmaceutical companies might stem from any number of activities. As discussed already, they might be engaged by publication planners to serve as authors on medical journal articles stemming from company- led research. In addition, they might contribute to research by recruiting patients for trials, by responding to invitations to conduct trials on specific topics, or by initiating their own trials. They might be consulted on any of medical, marketing, or research issues. And finally, researcher KOLs are often paid to speak to other researchers, patient groups, or to physicians at continuing medical education ses- sions, with the eventual goal of increasing sales. One speaker at a 2012 meeting on KOLs, enthusing about a new approach to network analysis, says, “So it’s really very, very interesting and starts to give us the tool and the power to be able to actually look at these network maps and start to think about the implication in terms of the things that we are doing commercially.” A marketing firm writes in overview: “Interacting with qualified investigators, physicians experienced in regulatory reviews, well-known and respected speakers, and highly published authors will help to efficiently manage tasks within the critical path of the product and disseminate the message of the product to the end prescribing audience”
(InsiteResearch 2008).
These well-known physicians and researchers are not usually hired simply to present a company’s script but are chosen and/or brought on board with care.
Independent agencies identify KOLs who could serve the pharmaceutical compa- nies’ needs and may design communication plans for companies to build relation- ships and knowledge with their prospective collaborators. The KOLs are nurtured through seminars, close contact, advisory boards, and publications.
Hegemony of Knowledge and Pharmaceutical Industry Strategy
At lower levels of prestige, but equally valuable to pharmaceutical companies, are ordinary physicians, either general practitioners or specialists, who are paid to speak to other physicians. They become part of the “speakers bureaus” for particular drugs and give talks in clinics over lunchtime or after dinner, with other physicians assembled by sales representative around a buffet lunch or a pleasant dinner (Reid and Herder 2013). More occasionally, they may speak at community events, again organized by sales representatives. In this context, KOLs effectively become sales- people, as well as conveyors of scientific information: according to a Merck study, the return on investment from KOL-led meetings with physicians was almost dou- ble the return on meetings led by sales reps (Hensley and Martinez 2005). It is common for drug companies to measure prescriptions before and after KOLs’
talks—companies buy prescription data from health information services compa- nies, which buy it from pharmacies—and they expect an increase (Moynihan 2008).
One marketer speaking at a 2012 conference on KOLs essentially defined promo- tion in these terms: “you have a key opinion leader engagement with a group of doctors, and you measure sales before and after the engagement.”
KOLs do more than sell, though. Both physician and researcher KOLs, but espe- cially the latter, may be engaged for larger marketing activities, paving the way for later sales efforts. For example, they may be engaged first to learn about and then speak on diseases, rather than drugs:
Another common objective…is to educate the marketplace and drive awareness of a par- ticular disease state, mechanism of action, or existing treatment alternatives. A goal within this objective may be to successfully engage with key opinion leaders by completing a set number of advisory boards. (CampbellAlliance 2011)
Marketing involves a full range of activities with the goal of coordinating products, distribution networks, and demand (e.g., Applbaum 2004). With this in mind, phar- maceutical companies might not only want to communicate with physicians and others about their products but also to create awareness of new opportunities and approaches and interest in and concern about particular conditions and to introduce fears about alternatives. For all of such goals, KOLs are excellent conduits.
The marketing company InsiteResearch (2008) argues that the term “KOL man- agement” is the right one for interactions with KOLs. Drawing on a dictionary defi- nition, the company argues that, in general, management should involve “handling, direction, and control,” precisely what is needed to make KOLs effective. Thus a speakers bureau program begins with a training session, to ensure that speakers are well versed in the positive aspects of the product and able to speak effectively about them. For example, Wave Healthcare claims on its website:
It’s vital that advocates are able to communicate and influence colleagues with clarity and conviction. To ensure speakers are at the top of their game, we have developed a communi- cation skills programme for clinicians. (Wave Healthcare 2011)
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Another such firm, KnowledgePoint360, which owns Physicians World Speakers Bureau, offers programs for training speakers, and its promotional material appears to treat KOLs and employees in the same terms: “Whether it is for external resources, such as speakers, or internal staff, including sales representatives and medical sci- ence liaisons, a robust training program is critical to the long-term success of any pharmaceutical, biotech, or medical device company” (KnowledgePoint360 2010;
see also Carlat 2007). Pharmaceutical companies work with physicians to make them “product champions” and pay them generously for their lectures (Moynihan 2008).
Typically, physician KOLs are nominated by sales representatives, who have a sense of their abilities. Sales reps will know “what’s their stage presence?” argued one company employee making a presentation at a 2014 conference on speakers bureaus. They will also know if “he looks good in a tie,” suggested another pharma- ceutical company manager at the same conference—who quickly disavowed that kind of recommendation, because it doesn’t relate to the KOL’s knowledge or com- munication skill and so might be looked at askance by regulators.
Though physician KOLs’ main role is to communicate facts and views to other physicians, with the goal of increasing sales, pharmaceutical companies might sometimes recognize the value of having speakers who are also customers. One company manager, addressing the audience at a 2011 KOL management confer- ence, raises the specter of an investigation of a speakers bureau program: “When you say ‘I need 700 to 1000 speakers in this activity’, the questions [that are] going to get pushed back to you in investigations are, ‘Why do you need so many? How many is each speaker going to do? Why did you need a thousand?’” His concern here is that investigators will conclude that speakers’ fees are inducements to pre- scribe or payments to receive (rather than transmit) advertising messages. That would constitute illegal marketing.
After physician KOLs have been trained, they become part of a speakers bureau for a company and wait to be offered engagements. As already mentioned, sales representatives handle all of the details: transportation is arranged, the time and place are set, invitations are sent and resent, and the equipment is set up and the food laid out. All that the KOL has to do is to make the presentation. Most of the time, that is straightforward. In the USA, speakers are not permitted to adjust the prepack- aged PowerPoint slides or to deviate from their scripts when doing what are known as promotional talks, the bulk of the engagements. Says one psychiatrist, who earns large sums in speaking fees:
So if I am doing a promotional program for a company, I have to use the slide deck that they provide me—I am not allowed to alter it in any way and every word in that slide deck is basically reviewed by their own internal counsel… .
Hegemony of Knowledge and Pharmaceutical Industry Strategy
In addition to the slides and the scripts, answers to standard questions also are scripted, and speakers are trained not to answer any questions in ways that might either be illegal or run against company interests.
The KOLs are sometimes aware that they are being used by pharmaceutical com- panies, though they find ways to defend their actions. One endocrinologist inter- viewed is quite critical of the industry and especially of its role in promotional talks, though he gives them regularly. “The reason for giving the promotional talks is to help the company sell its drug—I mean that’s basically—that’s what a promotional talk is.” A hospital-based hematologist echoes this point but manages to find educa- tional value despite the problems. “The honest answer is that promotional talks are not really for educating so—and I give plenty of promotional talks—… but some speakers are better than others at bending it into an educational talk.” The value of their work in terms of education is echoed by others. Every single one of the KOLs interviewed for this project invoke education as a reason for speaking on behalf of companies, even when they are doing purely promotional speaking. In interviews, KOLs take pride in their teaching, and teaching is how they frame even promotional talks. “I am educating fellow physicians. I spend my day educating patients, I spend some of my evenings educating fellow physicians,” explains one.
But in this context, it is the pharmaceutical companies’ preferred messages that are being communicated. As we have already seen, pharmaceutical companies pro- duce large quantities of data, shaped and arranged to support their interests. When KOLs serve as authors on company manuscripts, they give their weight to the estab- lishment of that knowledge in the medical community as a whole. But pharmaceuti- cal companies are not content to let that knowledge sit in medical journals, where it does little good. While there are senses in which KOLs are providing something like education, often involving scientific information, the education they are providing has been shaped and created by the companies for which they are working. KOLs do distribute knowledge.
If done correctly, then, KOL management will spread knowledge, change opin- ions, and change prescribing habits—which will generate a good return on compa- nies’ investment.
Orchestration of Continuing Medical Education
Based on my very direct experience, quite frankly, the CME lectures which everybody espouses as being appropriate interaction for the best, can be the most biased presentations of any you’ll ever see given—and you don’t ever trace back the funding for the CME group to the couple of companies giving the vast majority of the money to one of those speakers
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bureaus. So while CMEs are given a veneer of legitimacy they actually can be very danger- ous to the public educational experience.—Interviewed clinical researcher (oncologist) KOL
In many jurisdictions, physicians must take continuing medical education (CME) courses to maintain accreditation. CME is supposed to be independent of corporate interests—sponsors are not allowed to control the content of courses. For pharma- ceutical companies, this is the best kind of marketing: directed at receptive audi- ences that need to educate themselves and provided by sources that the audiences have reasons to trust.
The independent agencies that organize most of these courses are allowed to provide organization, pay for speakers, help speakers prepare their talks, and pro- vide entertainment for participants. In 2012, commercial support for CME (includ- ing advertising and related income) in the USA accounted for roughly 40% of income for accredited CME providers, a considerable reduction from a few years earlier (Accreditation Council for Continuing Medical Education 2012).
Accredited CME providers are subject to regulation, the most important aspect of which is that sponsors like pharmaceutical companies may not control the content of courses. In the USA, pharmaceutical companies may provide funding for CME, may provide organization, pay for KOL speakers, help them prepare their talks, and provide entertainment for participants. In some cases, even fully independent orga- nizations may invite them to influence content: for example, one letter by a Canadian medical organization soliciting funds for a CME conference stated that “major sponsors will be given the opportunity to nominate participants to represent indus- try’s interest and to participate actively in the conference” (Brody 2007: 208). But in theory, the company must allow speakers complete freedom when it comes to the actual content.
Yet, for pharmaceutical companies, it is only a modest challenge to align KOLs with their own interests when it comes to CME. If the above measures of support are not enough, companies have further systems and methods of orchestrating CMEs indirectly. If sponsors have chosen their speakers well, supported the research of these speakers, and given them templates and slides for their talks, the courses will convey preferred messages.
The companies attempt to carefully manage their KOLs, their promotional talks, and their contributions to CME. At the very least, those talks tend to strongly endorse the sponsor’s products. As one medical education and communication company advertised: “Medical education is a powerful tool that can deliver your message to key audiences, and get those audiences to take action that benefits your product”
(quoted in Angell 2004: 139). Both promotional and CME talks, then, are part of pharmaceutical companies’ promotional campaigns. Any education their talks pro- vide and any health benefits that result from it have to be understood as shaped by the sponsoring companies’ interests. According to an industry education specialist, the ideal for CME is “control—leaving nothing to chance” (Bohdanowicz 2009).
Hegemony of Knowledge and Pharmaceutical Industry Strategy