Janine Wedel - Unaccountable - How Elite Power Brokers Corrupt Our Finances, Freedom, and Security

KOLs can be (unpaid) authors of manuscripts that are “ghost-managed.” 60Here’s Sismondo:

These are manuscripts for which pharmaceutical companies control or shape multiple steps in the research, analysis, writing, and publication. Pharmaceutical companies not only fund clinical trials, they also routinely design and shape them, typically employing contract research organizations to run those trials. By combining and splitting datasets, the companies propose multiple manuscripts derived from a study or group of studies. Hired medical writers produce first drafts and edit papers, which publication planners expertly shepherd through the publication process. Because of the commercial importance of having the right sort of author and of keeping companies’ interests in the background, KOLs serve as the nominal authors of manuscripts. It can then appear as if respected independent researchers, rather than coordinated corporate teams, led the research and analysis. KOL authorship increases the perceived credibility of an article while hiding key features of the research process. For example, even though an array of employees and contractors—company statisticians and researchers, reviewers from multiple departments, medical writers, and publication planners—often contribute more to the research and the articles than the nominal authors do, they are only rarely acknowledged in journal publications.

Made for Deniability

As in the other arenas we’ve explored, appearances are vital; the performance of independence and impartiality is integral to players’ success. The same is true with KOLs. Both the industry and the opinion leader himself must maintain the patina of independence. Elliott observes that, for pharmaceutical companies, it’s “just as important . . . that a KOL is, at least in theory, independent” as are his status and credentials. 61Of course, these opinion leaders’ flexible identities do not augur well for impartiality. Yet, at the same time, displaying independence is the key to their influence and deniability.

In other work, Ozierański and co-author sociologist Lawrence King point to several dimensions of this issue, showing how informality and deniability are plaited into the process, especially in the field of drug reimbursement. They note that relying on KOLs may be necessary for drug companies that lack personal ties to policymakers and therefore are unable to push their products through direct lobbying. They further observe that using KOLs to endorse products is a convenient way of building a buffer between a drug company and decisionmakers, thus structuring in deniability. This is especially important in relation to contentious issues, as it minimizes the likelihood that the company will be caught red-handed. (The authors cite an example of a drug company using a PR agency which in turn uses its own KOLs. 62) Finally, generating pressure through KOLs reduces the need to use formal channels, say, to provide hard evidence for the efficacy and safety of a drug or medical product. Those, of course, would be subject to accountability mechanisms. In other words, it is far more convenient to use a KOL as a messenger than to make a formal offer that potentially could be scrutinized. 63Informality is the handmaiden of deniability.

The Limits of Transparency

Transparency is widely seen as a panacea for rooting out corruption and ensuring accountability. But is it? Transparency relies on the idea that making activities visible will deter them from happening in the first place. Yet even when the facts are clear and known, transparency can be of limited use.

As with American economists who are now subject to a non-binding code of ethics, whether transparency has any effect remains to be seen. In 2010, the U.S. Congress enacted the Physician Payment Sunshine Act, which requires “drug and device companies to disclose payments to doctors and teaching hospitals to the Department of Health and Human Services.” 64The legislation followed Senate investigations that “targeted prominent academic physicians at Harvard, Stanford, Emory, Wisconsin, and Minnesota, among other universities.” 65

The Sunshine Act was implemented in 2013, and the government is slated to launch its own searchable website. Before that, ProPublica had set up a searchable database using information from voluntary disclosures; 66from its website anyone with a computer can look up their physician to see if he or she has received pharmaceutical or medical-device dollars. 67

What has been the result so far? The passage of the legislation may have forced companies to issue public reports on payments to physicians. ProPublica reported in 2014 that many top pharmaceutical companies had drastically cut their budgets for physician speaking engagements ahead of the disclosure rules taking effect. 68ProPublica suggests several possibilities for the pullback. One explanation relates to companies’ cyclical needs: drug patents were expiring and doctors are needed more for speaking at the beginning of a new drug’s life cycle. Another possibility is that the latest crop of approved drugs were specialty drugs that didn’t necessarily require many physicians to rally on their behalf. And yes, a third reason could be that the threat of disclosure is taking them out of the game.

It’s too early to fully assess this, of course. But there are indications that disclosure might be more of a performance, without having the intended effect. According to Elliott, 69

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.

What has happened to shame? As Ozierański explains: “It’s difficult to name and shame such high-status professionals because even if it’s clear that they have been involved in ethically dubious activities, they enjoy so much peer support and prestige.” 70

With sanctions less than effective, the upshot is that accountability to the public is weakened by the use of KOLs. Trading on the reputation of the impartial scientist can’t help but violate the public trust. As Sismondo argues, 71

. . . we should be addressing the larger issue of the “institutional corruption” 72of 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.

UNIVERSITIES, LENDING LEGITIMACY

Shame and institutional sanction are sometimes in short supply in the home base of the academic—the university itself. Many universities now have institutes or think-tank–like entities that engage in shadow lobbying and, in the process, help support academics. These entities can use the university’s impartial image to make a policy or a cause look like a scholarly conclusion, often downplaying or disguising the source of their funding.

One such place that has faced criticism is the Mercatus Center at my own university, George Mason. As the Wall Street Journal put it, “When it comes to business regulation in Washington, Mercatus, Latin for market, has become the most important think tank you’ve never heard of.” 73

The Charles Koch Foundation has donated some $30 million to George Mason; in Jane Mayer’s investigation into Koch-funded political activities for the New Yorker , she writes this of Mercatus founder, former economics professor at George Mason, and current Koch Industries executive Richard Fink: “He said that grant-makers should use think tanks and political-action groups to convert intellectual raw materials into policy ‘products.’” 74