A signature theme of my new book Unaccountable is a staggering decline in trust in an array of institutions: banks, Congress, the media, you name it, since the 1970s. But in one area, trust has grown. Nearly 70 percent of Americans polled late last year thought their doctors rated high or very high for honesty and integrity. That's 22 points higher than the clergy. (If you're a lobbyist, don't bother looking.)
Do doctors deserve that trust? Perhaps not entirely, according to ProPublica, the New York Times, and my own analysis in Unaccountable. Pharmaceutical companies engage in direct lobbying of lawmakers, but the focus of my book is the newer, unconventional, and typically more insidious path to influence, in areas that extend far beyond health to nearly every important policy area. Big Pharma's path is through painstakingly chosen and highly paid-and-perked doctors and researchers.
An elite few who take large sums from Big Pharma very likely sway decision making by countless other physicians, who might not even know they are getting a choreographed, yet subtle, sell-job. But even when these elite few can be named, it's not clear whether they can be shamed: disclosure alone can often be a mere "performance" of accountability.
ProPublica, which has been covering the story for years in its Dollars for Docs series, began examining a government database that went live last week, as mandated by the 2010 Physician Payment Sunshine Act. ProPublica found that from August to December 2013, drug and device makers channelled $3.5 billion to more than a half million medical professionals and around 1,360 teaching hospitals.
At least $350 million was earmarked for speaking and consulting gigs. Ethicists looking at the issue told the New York Times that they focus closely on speaking and consulting because "these relationships can influence prescribing behavior and negatively affect patients, especially when such ties are lucrative."
Another statistic stands out. Of the 32,000 doctors or researchers named in the database as having received Big Pharma money, the average took in less than $2,000. It was a tiny group of just 130 who earned more than $100,000. Time Magazine flagged a super-elite within that subset: 18 doctors who accepted more than a million dollars each from top drug and device companies.
Some of these medical professionals may well be what the industry calls Key Opinion Leaders or KOLs, which have proliferated nearly worldwide since the end of the Cold War. (Google KOLs, and you'll find a whole cottage industry that will help drug and device makers identify the best medical "thought leaders.")
Often these experts are high-status physicians or medical researchers who sport impressive credentials; they may be affiliated with top medical schools, journals, and professional associations. KOLs often garner more in industry consulting fees than from their "day job." And yet it is that day-job image as an incorruptible, oath-taking doctor or researcher that lends them weight. The job of these opinion leaders is to convince fellow professionals that a particular company's product is most effective. "The KOL is a combination of celebrity spokesperson, neighborhood gossip, and the popular kid in high school," observed Carl Elliott, University of Minnesota bioethics ethics professor, in the Chronicle of Higher Education.
The physician who sits on the board of a major journal or a medical specialty association can act as a gatekeeper for the narrative. Your physician hears the talk, reads the journal, all the while listening to the "authority"--the KOL.
Elliott argues:
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 ... 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.
KOLs can also help "create" conditions that require medication. A case in point is female sexual dysfunction. Philosopher and sociologist Sergio Sismondo studies the industry and found that KOLs:
acted as mediators between pharmaceutical companies, the FDA, physicians, and potential consumers. They held industry-sponsored workshops and wrote position papers that solidified female sexual dysfunction as an illness, thereby positioning themselves as the very experts to whom the FDA would turn for advice on drug submissions and to whom the media would turn for interviews and information.
Sociologists Piotr Ozierański and Lawrence King note that relying on KOLs may be necessary for those drug and device companies that lack personal ties to policymakers and therefore are less able to push their products through direct lobbying. KOLs, they say, also serve as a convenient buffer between drug companies and decision makers, thus structuring in deniability.
Still, these opinion leaders do not explicitly endorse specific drugs, "at least not in ways that are too obvious," Elliot writes:
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).
And KOLs rely on their flexible identities, affiliations and fuzzy boundaries to help cloud the obvious associations. Now that the database can name some of them, KOLs will need that ambiguity more than ever to help them deny that industry ties impact their professional opinions.
A key theme of Unaccountable is how top players in arenas from finance and foreign policy to energy and health care use the appearance of independence and impartiality to achieve their overlapping and conflicted agendas. And for KOLs and Big Pharma, appearances are vital.
But won't the new database shatter that? Not so fast. Sometimes disclosure is simply a "performance" of transparency, which, as I write in Unaccountable, is distressingly common in venues far beyond the pharmaceutical business. According to Carl Elliott:
Disclosure ... is widely seen as a 'win-win' solution... 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.
Another area to watch out for is whether KOLs and that elite group of big-earners mentioned in the Times are driven underground by the database and choose to operate informally, under-the-radar. That is what seems to have happened in the lobbying business: when lobbying laws were tightened in 2007, many lobbyists found ways around it and decided not to register at all.
Sismondo argues that the Sunshine Act risks clouding the bigger, darker picture:
Transparency alone is not adequate to address the situation...Instead, we should be addressing the larger issue of the "institutional corruption" of medicine; namely, that the pharmaceutical industry has a disproportionate influence on medical opinion, which weakens medicine's ability to promote individual and public health in ways that are independent of the industry.
Corruption, by the way, that is entirely legal. Bitter pill, indeed.