Wednesday, September 15, 2010

The Secret Lives


Pharma's Thought Leaders

Carl Elliott is at it again:
(from the Chronicle of Higher Education)

... 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..."

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. 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.

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).

Most marketers would like to have a convincing, influential, and apparently independent expert who will deliver the text that they give him.

"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. 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. "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.

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."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. "

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.

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. 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.

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. 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.

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: "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. 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."

And so it goes...

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