In the early 1970s, a group of medical researchers decided to study an unusual question. How would a medical audience respond to a lecture that was completely devoid of content, yet delivered with authority by a convincing phony? To find out, the authors hired a distinguished-looking actor and gave him the name Dr. Myron L. Fox. They fabricated an impressive CV for Dr. Fox and billed him as an expert in mathematics and human behavior. Finally, they provided him with a fake lecture composed largely of impressive-sounding gibberish, and had him deliver the lecture wearing a white coat to three medical audiences under the title "Mathematical Game Theory as Applied to Physician Education." At the end of the lecture, the audience members filled out a questionnaire.
The responses were overwhelmingly positive. The audience members described Dr. Fox as "extremely articulate" and "captivating." One said he delivered "a very dramatic presentation." After one lecture, 90 percent of the audience members said they had found the lecture by Dr. Fox "stimulating." Over all, almost every member of every audience loved Dr. Fox's lecture, despite the fact that, as the authors write, it was delivered by an actor "programmed to teach charismatically and nonsubstantively on a topic about which he knew nothing."
It is tempting to imagine that the Dr. Fox study reveals a deep flaw in the structure of medicine—for example, that health-care workers are too trusting of authority, or that Continuing Medical Education (CME) lectures are a sham. But what the study actually reveals may be something closer to the opposite. If medicine were simple and transparent, pretending to be a medical expert would be very difficult. An audience could spot incompetence right away. Pretending to be a medical expert is possible precisely because medical knowledge is so specialized and opaque. These days an ordinary doctor can no more expect to understand the intricacies of specialized medical research than the driveway mechanic who tinkered with his Volkswagen in 1962 can expect to fully understand the complex, computerized automobiles on the road today. Those who have tried to sit through a medical lecture in a field other than their own will secretly admit that they could have been fooled by Dr. Fox as well.
Since the 1950s, marketers have been taken with the idea that when it comes to spreading the word about unfamiliar products or ideas, some people are far more important than others. The phrase "opinion leader" was made familiar by the sociologists Paul Lazarsfeld and Elihu Katz in their 1955 book, Personal Influence, where they used the term to explain the way that media messages were filtered and spread by personal, face-to-face contact with influential people. It is not hard to see why marketers liked this idea. Mass-media advertising can be expensive. What if there were a way to avoid the masses and simply concentrate on the special people? Today the pharmaceutical industry uses the terms "thought leader" or "key opinion leader"—KOL for short—to refer to influential physicians, often academic researchers, who are especially effective at transmitting messages to their peers. Pharmaceutical companies hire KOL's to consult for them, to give lectures, to conduct clinical trials, and occasionally to make presentations on their behalf at regulatory meetings or hearings.
The KOL is a combination of celebrity spokesperson, neighborhood gossip, and the popular kid in high school. KOL's do not exactly endorse drugs, at least not in ways that are too obvious, but their opinions can be used to market them—sometimes by word of mouth, but more often by quasi-academic activities, such as grand-rounds lectures, sponsored symposia, or articles in medical journals (which may be ghostwritten by hired medical writers). While pharmaceutical companies seek out high-status KOL's with impressive academic appointments, status is only one determinant of a KOL's influence. Just as important is the fact that a KOL is, at least in theory, independent. Medical audiences trusted Dr. Fox partly because he played the part of an expert so convincingly: white coat, gray hair, and a complicated lecture, delivered with authority. But they also trusted him because they had no reason not to trust him. Dr. Fox was not selling a product or pitching an idea. The very implausibility of his charade is part of what made it so persuasive. Dr. Fox appeared to be impartial.
It is not hard to see why pharmaceutical companies would like to have a Dr. Fox speaking on their behalf. Most marketers would like to have a convincing, influential, and apparently independent expert who will deliver the text that they give him. The more interesting question is: Why do so many academic physicians want to be Dr. Fox?
"It strokes your narcissism," says Erick Turner, a psychiatrist at the Oregon Health and Science University. There is the money, of course, which is no small matter. Some high-level KOL's make more money consulting for the pharmaceutical industry than they get from their academic institutions. But the real appeal of being a KOL is that of being acknowledged as important. That feeling of importance comes not so much from the pharmaceutical companies themselves, but from associating with other academic luminaries that the companies have recruited. Academic physicians talk about the experience of being a KOL the way others might talk about being admitted to a selective fraternity or an exclusive New York dance club. No longer are you standing outside the rope trying to catch the doorman's eye, waiting hungrily to be admitted. You are one of the chosen. "You get to hobnob with these mega-thought leaders and these aspiring thought leaders," Turner says. "They make you feel like you're special."
Turner is a former drug reviewer for the Food and Drug Administration. He worked at the FDA for three years, after six years as a fellow at the National Institute of Mental Health. In 2003, after taking an academic position at Oregon, he began giving talks on behalf of pharmaceutical companies—Eli Lilly, AstraZeneca, and Bristol-Myers Squibb. "I left the FDA, and I felt kind of frustrated that I had all this knowledge about how clinical trials work, and I felt there wasn't much of anything I could do with it," he says. "It felt like a demotion going from bossing big pharma around, where you tell them to jump and they ask how high, and then suddenly you are way on the other end of the food chain. You're begging to be a site investigator, and they say, 'Nah, I don't think so. You might have trouble recruiting,' or 'Your IRB is too slow.'"
Actually doing clinical trials for drug companies is often boring and mechanical, Turner says. But if you are involved with the rollout of a company's new drug, you are really in on the action. "The first thing they do is ferry you to a really nice hotel. And sometimes they pick you up in a limo, and you feel very important, and they have really, really good food. And they make you sign a confidentiality agreement and say you need to sign this if you want to get paid." The meetings Turner attended featured what he calls the "mega-thought leaders," the recognized leaders in the field, who gave presentations to a group of people like him—the second-tier "little thought leaders." ("It was kind of like the farm team," he says.) The companies will also offer these aspiring thought leaders media training and advice on public speaking. "They give you slides that you will probably be speaking from, and you'll be in a room with about a dozen other people," Turner says. "You get up there, and you have your pointer, and then you stand off to the side when you're done. And the facilitator will say, 'So what did you think of his voice? What did you think of his body language? Did he project well?'"
It is an article of faith among pharmaceutical executives that KOL's are a critical part of any marketing plan. According to a 2004 study of the 15 largest pharmaceutical companies, the industry spends just under a third of its total marketing expenditures on KOL's. So important are KOL's that new businesses have emerged solely to recruit, train, and manage them. The reason they are so important is their role in managing the discourse around a given product. Equal parts scientific study, commercial hype, and academic buzz, this discourse will begin years before a drug or device is brought onto the market, and will usually continue at least until the patent expires. If a company can manage the discourse effectively, it can establish the desperate need for its drug, spin clinical-trial results to its advantage, downplay the side effects of a drug, neutralize its critics, and play up the drug's off-label uses. (Drug companies are prohibited from promoting a drug for conditions other than the ones for which the FDA has approved it, but because these off-label uses are often highly profitable, many companies have found creative ways of getting around the prohibition.) Virtually all physicians are on the receiving end of this communication, but only a relatively few deliver it. If the industry can influence those few, then it can also influence the rest.
Naturally, some lower-level pharmaceutical employees resent the KOL's they are expected to flatter and serve. A medical writer I spoke with compares thought leadership to a cult, or maybe the priesthood. "At meetings they get big fancy badges, like generals with their medals," he says. Michael Oldani, an assistant professor of medical anthropology at the University of Wisconsin at Whitewater, worked for nine years as a drug rep for Pfizer before beginning his academic career. Once he flew in a surgeon KOL from Texas to talk about an antibiotic at a German restaurant in Milwaukee. Unfortunately, the restaurant seated them in the basement, which was sweltering hot. "It's a sweat pit down there!" Oldani said to the manager, but there was no other place for them to go. The evening was a disaster. "A lady passed out into her strudel, face down," says Oldani. "And it's an emergency, with an ambulance, and picture me: I'm like, 'Christ, just throw some water on her and get her outside! She's ruining this program!'" The surgeon's talk was fragmented and disorganized, and when it finally ended, at 10 p.m., Oldani was ready to go home and sleep. But to Oldani's astonishment, the surgeon was not finished. "He tells me he needs some kind of alcohol to clean his mouse pad. And I'm like, 'Really? I was just going to drop you off.' We drove around town for like an hour and a half until we finally found an all-night Walgreen's."
Perhaps the most remarkable recent exchange with a KOL emerged in an investigation of Joseph Biederman, a child psychiatrist at Harvard University. In a lawsuit against Johnson & Johnson, Biederman was accused of promising positive research results to the company in exchange for funding. A hint of Biederman's self-opinion emerged in a deposition, where a lawyer asked him about his academic ranking.
Biederman: "To move in the ranks from one rank, for example, at Harvard, there is instructor, from instructor you move to assistant professor, from assistant professor you move to associate professor, from associate professor you move to full professor."
Lawyer: "Full professor?"
Lawyer: "What rank are you?"
Biederman: "Full professor."
Lawyer: "What's after that?"
Lawyer: "Did you say God?"
The status of being a KOL carries a certain irony. It is a hunger for status that motivates many academic physicians to work for industry, yet in order to preserve their status, those physicians must also cultivate the perception of independence. If Dr. Fox were unmasked as an actor, merely reading his lines, nobody would pay any attention. And of course, most academics do not especially like to think of themselves as figures like Dr. Fox. As Erick Turner asks, "Is it worth it, feeling like you are a robot, just speaking from a prefab slide set?"
For the past several years, Sen. Charles E. Grassley of Iowa, the ranking minority member of the Senate Finance Committee, has made it his mission to investigate and expose the conflicts of interest generated when KOL's work for the pharmaceutical and medical-device industries. His investigations have targeted prominent academic physicians at Harvard, Stanford, Emory, Wisconsin, and Minnesota, among other universities. Last year, in a little-noticed section of the health-care-reform legislation, Congress passed the Physician Payments Sunshine Act, which will require drug and device companies to disclose payments to doctors and teaching hospitals to the Department of Health and Human Services. Disclosure of conflicts is widely seen as a "win-win" solution to the KOL problem. Doctors get to keep accepting industry money; the drug companies get to keep giving it; and anyone else who might be affected can be reassured by the knowledge that the transactions are no longer secret.
Mere disclosure is unlikely to fix the problem, however. Minnesota, where some of the most egregious offenses have occurred, has had a similar "sunshine law" since the mid-90s, to little effect. What is more, empirical research in psychology suggests that, contrary to conventional wisdom, people who disclose their conflicts of interest make judgments that are more biased, not less. If the aim of disclosure is to shame KOL's into giving up their industry relationships, it is based on a faulty premise; the most prominent KOL's often announce their industry relationships with something close to pride. And why shouldn't they? If the very reason scholars work with industry is the status confirmed by the relationship, then asking KOL's to reveal their industry ties is not much different from asking them to reveal their honors and prizes.
Universities could easily clean up the problem, simply by banning or capping industry payments to faculty members, but that is unlikely to happen. Not just because academic physicians would object, but also because many high-level university administrators have lucrative corporate relationships of their own. (For instance, the president of the University of Michigan sits on the Board of Directors of Johnson & Johnson, while the president of Brown University sat on the boards of Pfizer and Goldman Sachs.) As universities have come to look more like businesses, competing for funding and prestige in a consumer marketplace, industry relationships have become a lucrative perk of many university jobs.
David Healy, a psychiatrist at Cardiff University, in Wales, and a prominent industry critic, worked for many years as a KOL before his industry relationships began to go sour. Healy says he was never impressed with the intellectual accomplishments of KOL's: "If you look at the opinion leaders, the guys in the field are not stellar geniuses. The field moves forward by virtue of the fact that people cooperate. It's not that anybody has a particularly brilliant insight, or that these guys are really awfully bright, but the opinion leaders who work with pharma are actually the least bright. These guys get made by industry. They get money, they get status, and they knew they wouldn't be anything if it weren't for this."
My brother Hal, a psychiatrist at Wake Forest University, used to work as a KOL for GlaxoSmithKline. The event that drove him away from the business came one day when he was giving a lunch lecture at a local primary-care clinic. To his irritation, none of the doctors in attendance paid any attention to the lecture. They were answering pages, talking loudly with one another, helping themselves to the lunch that Glaxo had brought in—anything, it seemed, to avoid listening to him talk. Eventually Hal got so frustrated that he cut the lecture short. As he was packing up his laptop to leave, however, the Glaxo rep asked him a favor. The director of the clinic had been unable to attend the lecture. Would Hal mind sticking around a few more minutes to say hello? Reluctantly, Hal agreed, and the rep took him to a small room adjoining the clinic, where he said they would wait until the director appeared.
"There was a line on the floor," Hal says. He had never seen such a thing before. "The rep told me that we weren't supposed to step past that line unless a doctor said it was okay." They stood behind the line, waiting patiently. After a few minutes, the director walked down the hall toward them. "I sort of looked at him hoping to make eye contact and speak, but he wouldn't even look at us," Hal says. "This rep just stood there with a big smile on his face, and the doctor stopped in front of the treatment room five feet away from us, and stood there for several minutes reading a chart. Then he walked away into the treatment room like we were not even there."
Hal calls this his moment of understanding, after which he never gave another industry-funded talk. Up to that point, he had imagined himself as a high-powered academic physician bringing the latest university research to doctors out in the community. Standing next to the drug rep, however, Hal understood how the community of doctors saw him. To them, Hal was a drug-company shill. "I was literally standing in the drug-rep spot begging for a minute of this doctor's time, like a cocker spaniel begging for a leftover piece of meat from the table," he says. It was no wonder the doctors saw little difference between Hal and the rep. "It was like I had become a psychiatric call boy," he says. "I might as well have just said, 'Hi, I'm Hal. The company sent me to make sure you all have a good time.'"