24 October 2013

Pharma Payola

Having written about 'pharma payola' I was interested to see ''You're Not Just a Paid Monkey Reading Slides:' How Key Opinion Leaders Explain and Justify Their Work' (Edmond J. Safra Working Papers, No. 26) by Sergio Sismondo, which comments
Key Opinion Leaders (KOLs) are physicians and researchers hired or engaged by pharmaceutical companies, often to speak to audiences of other physicians. This paper provides some background information on the structures of pharmaceutical company influence on and control over KOLs, and then focuses on KOLs’ explanations and justifications of their paid work for the companies. Among their important justifications are ones in terms of the educational value of the talks they give, and the benefits gained by patients; these are buttressed by claims about the integrity of the speakers. However, KOLs rarely address larger issues to do with the influence that pharmaceutical companies have on medical knowledge, issues not addressed by the KOLs’ integrity.
Sismondo argues that
Key Opinion Leaders play important parts in pharmaceutical companies’ marketing strategies, alongside medical science liaisons, sales representatives, scientific research and publications, advertising, and other elements. As that short list suggests, pharmaceutical marketing is centered on the movement of information, mostly forms of medical science. 
KOLs are important information conduits. “There are a lot of physicians who don’t believe what we as drug representatives say,” says Kimberly Elliott, the former sales representative. “If we have a KOL stand in front of them and say the same thing, they believe it.” Clearly representatives of the pharmaceutical industry believe that KOLs can do commercially useful work under the guise of science and/or medical experience, keeping company interests in the background as they present scientific evidence for (and against) the drugs on which they are speaking. There may be more at stake than belief, too: KOLs may be serving as models for other physicians to emulate, leading not just opinions but behavior. 
As we have seen, KOLs and the data they present are carefully managed. Physician KOLs are trained to explain specific scientific data, and then make presentations with company slide sets; in the process they are co-opted into promotional plans. Researcher KOLs may be brought into a company’s ambit in other ways, such as through advisory boards and consultancies, with research funds for commercially valuable projects, and with authorship on company articles. By definition, good management impinges on KOLs’ actual independence, though they may not always be aware of it—as we’ve seen, KOLs vigorously insist that they are not paid shills, paid stooges or paid monkeys, even though they are paid. When they are justifying their work as paid speakers, KOLs’ sense of independence or integrity is crucial. They can focus on the fact that they believe what they say, that they see it as warranted, regulated, and useful. If they can speak with conviction, they don’t consider any of the relationships that they might have with the sponsoring company to be relevant. There is no possibility of interested science, and no possibility that the careful deployment of science can support commercial over patient interests. KOLs can cheerfully take the money, status, and perks that pharmaceutical companies offer, secure in the belief that they are acting in the interests of education and health. 
There are at least three ways in which KOLs’ sense of their own integrity fails to address important politico-epistemic issues. First, as I have just mentioned, pharmaceutical companies go to some lengths to gain some control over the actions, habits, beliefs, and loyalties of KOLs with whom they engage. Thus KOLs may be misled in their sense of integrity, since they are not fully independent. When they give promotional talks in particular, they are tightly controlled, and it is only by portraying the sources of control as stemming from regulatory demands—such as the demands of the FDA—that they can insist on their full integrity. 
Second, even if those companies did almost nothing to co-opt KOLs, there would be lingering issues about conflict of interest. Take Dr. R, who earned more than $200,000 in speaker’s fees in 2009. He is concerned about the ethics of this, but defends his actions in terms of good science. “There is always the potential that somehow I’m getting in under the radar and then springing this very subtle and very pernicious sales message. . . . I’m listening to myself every time I speak, and I have to ask myself the question: ‘Is what I’m saying truthful?’” The massive conflicts of interest that Dr. R has, stemming from his substantial income from speaking engagements, would affect not only the likelihood of his giving a sales message in his talks, but also the likelihood that he would not recognize it and the likelihood that he would answer his own question about truthfulness affirmatively. Conflict of interest has powerful effects, in medicine as much as anywhere else. 
Third, and most importantly, personal integrity does not address central issues in the political economy of medical knowledge. When pharmaceutical companies pay KOLs to be conduits of information, it is the companies’ preferred information being circulated. Pharmaceutical industry funding makes up roughly half of the funding for clinical trials, and sponsors a majority of the new trials initiated each year. Clinical trials represent the most generally valued forms of medical science. The industry produces a significant portion of the scientific literature on in-patent prescription drugs, with as many as 40 percent of the articles on recently approved drugs in the more prestigious medical journals having been ghost managed for companies. Publication planners are involved in the creation of those articles, and also in the choice of KOLs to serve as authors and the choice of journals to which to submit them.  Companies’ interests can thus be expected to influence a myriad of legitimate choices in the design, implementation, analysis, description, and publication of clinical trials. We can reasonably expect, and there is abundant evidence, that the industry makes those choices to support its commercial interests.42 Even if companies are not completely coherent actors, they are coherent enough in their goals that choices in all the different stages of research and communication can point in the same direction. The result is still recognizably medical science, but it is science serving very particular and clear interests. 
This continues with the communication of medical science in the field, where, as we have seen, pharmaceutical companies hire KOLs to give PowerPoint presentations where every slide is company-prepared and mandatory, and where there is a script that must be followed. It continues into CME, where pharmaceutical companies contract with medical education companies to produce courses that serve their interests, using physicians who have been vetted and prepared as instructors. When they give talks, KOLs contribute to the enormous influence that the pharmaceutical industry has on medical knowledge. What they communicate will often be sound medical science, and thus will not often challenge their senses of integrity; nevertheless, it will be science chosen to help sell a product. 
Research, education, and marketing, then, are often fused. When a physician learns about conditions and treatments, she is often learning results created by agents of pharmaceutical companies and transmitted by other agents of those companies. In the end, it matters little what KOLs think they are doing, how honest they are, or how much they believe what they say. They are, inevitably and inescapably, part of large- scale, commercially driven efforts to shape the medical knowledge that physicians have and apply in practice.