The Secret Lives of Big Pharma’s ‘Thought Leaders’
by Carl Elliott / September 12, 2010

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?”
Biederman: “Mm-hmm.”
Lawyer: “What rank are you?”
Biederman: “Full professor.”
Lawyer: “What’s after that?”
Biederman: “God.”
Lawyer: “Did you say God?”
Biederman: “Yeah.”

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 doctorsand 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 The Chronicle of Higher Education 1255 Twenty-Third St, N.W. Washington, D.C. 20037 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.'”

{Carl Elliott is a professor at the Center for Bioethics at the University of Minnesota. This essay is adapted from his book White Coat, Black Hat: Adventures on the Dark Side of Medicine, published this month by Beacon Press.}

New Health Law Will Require Industry To Disclose Payments To Physicians
by Arlene Weintraub / April 26, 2010

Doctors who accept speaking fees, five-star meals and other compensation from pharmaceutical or medical device companies will soon see their names – and the value of the gifts they accept – revealed on the Web, under a new federal law that follows several states in drawing attention to such financial benefits. The experience of one of those states – Vermont – suggests that highlighting the medical industry’s largesse may curb the payments. This month, the attorney general of Vermont – one of three states to require gift disclosures – released data showing that total payments to physicians dropped 13 percent in fiscal 2009 to $2.6 million. The reporting requirement began in 2002. Consumer advocates have complained that industry compensation can affect a doctor’s choice of drugs or treatment and that exposing the doctors will dissuade such behavior. But some consumer groups say that the new law is too narrow in its scope. And it has raised complaints among some doctors, who say the provision will unfairly stain legitimate work they do for industry.

The overall dollar value of gifts to Vermont physicians “has been going down steadily for the last three years,” says Wendy Morgan, chief of the state attorney general’s public protection division. “I think there are more health care providers who won’t accept gifts.” Vermont lawmakers want to make sure of that. Last year they amended the law to ban most gifts outright, including food, which accounted for $800,000 of the 2009 total. The other states with similar legislation, Massachusetts and Minnesota, have also outlawed many forms of corporate gift-giving, although they do allow doctors to accept speaking fees and most product samples. All three states allow research grants. Yet even consumers in those three states will get more detailed information and easier access to the data under the new federal program, which is part of the health overhaul signed into law last month.

Database Will Be Available Sept. 30, 2013
The Physician Payments Sunshine Act requires companies to begin recording any physician payments that are worth more than $10 in 2012 and to report them on March 31, 2013. That includes stock options, research grants, knickknacks, consulting fees and travel to medical conferences at chi-chi hotels. The details will be posted in a searchable database starting Sept. 30, 2013. The measure is based on a bill that was introduced more than two years ago by Sens. Charles Grassley, R-Iowa, and Herb Kohl, D-Wis. The senators believe that physicians who receive benefits from drug and device makers are more inclined to prescribe the priciest products. “We hope this lowers health care costs and strengthens patient-doctor relationships,” says Ashley Glacel, a spokeswoman for the Senate Special Committee on Aging, which spearheaded the original bill. It’s not just states that are reporting physicians who are compensated by life-sciences companies. A growing number of pharmaceutical companies, feeling pressured by lawmakers expressing concerns about medical conflicts of interest, are also listing physician payments on the Internet. Most recently, Pfizer released details of $35 million in payments that it made to doctors in the second half of 2009.

Some industry critics gripe that the federal law has too many loopholes. It only applies to physicians and teaching hospitals, for example. Companies won’t have to report payments they make to nurses, physician assistants, and other medical professionals who might influence which products are prescribed. “If any marketing avenue is not regulated, companies will find a way to exploit it,” predicts Dr. Daniel Carlat, a psychiatrist and associate professor at Tufts Medical School. Carlat was once a speaker for Wyeth but quit over concerns about how to deal with a depression drug’s side effects. “I expect we’ll see a lot more nurse practitioners giving hired-gun talks,” he says. In Vermont, corporate payouts to nurses totaled $288,000 in 2009—almost triple the amount they received the previous year. Some physicians opposed federal and state efforts to limit physician-industry relationships because they fear it will impede innovation.

Complaints From Doctors
“The use of the term ‘sunshine’ has an implicit aura of corruption,” says Dr. Thomas Stossel, a professor of medicine at Harvard. Last year, Stossel co-founded the Association of Clinical Researchers and Educators, which promotes collaboration between physicians and industry to create better products. Stossel has accepted speaking and consulting fees from companies such as Merck and Pfizer, and he says he’s not opposed to his name appearing in corporate disclosures. But he does believe concerns about relationships between companies and doctors have been overblown. “What’s wrong with a company buying me lunch or giving me a tote bag?” he asks. Other physicians acknowledge that donations from industry – even small ones – can create conflicts of interest. “There is extensive literature suggesting that gifts can influence behavior,” says Dr. Robert Steinbrook, adjunct professor of medicine at Dartmouth Medical School. That evidence prompted the National Academy of Science’s Institute of Medicine to issue a report last year endorsing the elimination of all physician-industry relationships that might unduly influence prescribing behavior.

While the new federal law stops short of banning gifts, it does promise to increase the public’s understanding of how companies interact with physicians. Rather than simply listing names and dollar amounts, the federal database will include explanations of what services the physicians provided in return for the payments. And drop-down menus will make it simple for patients to parse the data by name, type of gift received, and other specifics. As a result, “the legislation will allow us to analyze the data in ways that are meaningful,” says Jerome P. Kassirer, a professor at Tufts University School of Medicine and author of “On the Take,” a book about physicians’ financial relationships with companies. That will be especially useful for patients facing hip or knee replacements, or other procedures involving expensive medical devices, Kassirer adds. “They’ll be able to determine whether their doctors are heavily invested in the companies making the devices,” he says.

Research suggests that those details matter to some patients. Kevin P. Weinfurt, an associate professor of psychology and neuroscience at Duke University, has studied how patients participating in clinical trials react to physician disclosures. He found that patients were particularly troubled when doctors owned stock in the companies that were managing the clinical trials. “They felt somehow that this physician could do something in the trial that could make the company a lot of money, which would then make him a lot of money,” Weinfurt says. Industry groups representing pharmaceutical and medical-device makers have supported the federal provisions on physician disclosures. “This knowledge will give the public greater confidence in the nature of the relationships” between companies and physicians, says David Nexon, senior executive vice president of AdvaMed, a trade association of medical device makers. “We have nothing to hide.”

Thought Leadership
by Mitch McCrimmon

Thought leadership is radically different from traditional top-down leadership.
– It can be directed up as well as down or sideways.
– It has nothing to do with position or managing people.
– It is the basis of innovative change.
– It is egalitarian because it can shift rapidly from one person to another.
– It cannot be monopolized. It has nothing to do with climbing a hierarchy.
– It changes how people think, hence no action is necessarily implied.
– Implementation is a separate phase – a managerial undertaking.

What is thought leadership?
Whenever you advocate a new idea to your colleagues or boss, you show thought leadership. It isn’t necessary to have inspirational influencing skills, which is necessary for senior executives because they need to win over the entire organization and beat off their internal competitors for top jobs. Also, to initiate organization-wide change, it helps to be inspirational. But a thought leader focuses on smaller scale changes – ideas for a new product or changes to an existing one. Thought leaders can persuade others using logic, evidence or an actual demonstration of a prototype to win support.

To be a thought leader, you need to immerse yourself in your professional domain and search for new things to say that add value to your organization’s objectives. Traditional, top-down leadership depends on personal credibility or character because such leaders are asking people to join them on a difficult journey and they have a great deal of power over their followers. Hence, we need to trust them. Conversely, the thought leader could have weak interpersonal skills and an indifferent character. They could be loners or eccentrics. All that counts is the credibility of their new idea. This is why we can buy innovations offered by odd creative types who we would not entrust to manage any part of an organization. If you can demonstrate the value of your idea and explain it with conviction, you might not need inspirational influencing skills.

Thought leadership is based on youthful rebelliousness – the willingness to risk group rejection in the pursuit of a better way of doing things. Hence, thought leadership is not a learned skill. Only the content of your discipline or field is learned. Traditional, top-down leadership is portrayed as a collaborative effort between leaders and followers to achieve shared goals. But thought leadership has a more competitive edge. Thought leaders are saying, essentially, that they know of a better product or way of doing things than anyone else in the team or organization. Thought leadership ends when the target audience accepts the idea. It may be that you are using hard evidence to persuade others to avoid dumping a current process for a passing fad. In this case, your leadership does not result in any action taken. This is an important point because it enables us to define leadership as the initiation of new directions and categorize the implementation of new ideas as a managerial activity. This is important because we tend, traditionally, to focus on the PERSON in charge of a group as the leader who may both champion a new direction and implement it. Hence we think that leadership is about managing change. The real value of examining thought leadership is that it helps us to see that there is a critically important distinction between leadership and management. When executives move from championing a new idea to its implementation, therefore, they are switching hats from leadership to management. The bottom line is that leadership is about the initiation of new directions. Implementing them is a managerial undertaking.

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