Marc A. Rodwin, Conflicts of Interest, Institutional Corruption, and Pharma: An Agenda for Reform, 40 J.L. Med. & Ethics 511 (2012), Suffolk Univ. Law School Research Paper No. 12-40, available at SSRN.
Since long before his 2011 Oxford University Press book that takes a comparative approach to the problem, Marc Rodwin has been a leading voice in the debate around the pharmaceutical-healthcare industrial complex, and the conflicts of interest that it perpetuates. In his latest contribution in the Journal of Law, Medicine, and Ethics (JLME), Rodwin wisely moves from the language of ethics—which finger-waggingly suggests an individualism of bad guys and good guys—to the language of “institutional corruption.” Rodwin writes that, “in the past, physicians and scholars typically conceived of conflicts of interest as an ethical issue to be resolved according to individual judgment or professional and organizational norms. However, society can mitigate or eliminate conflicts of interest by changing financial and organizational arrangements in medicine.” Larry Lessig has encouraged this sort of move from individuals to institutions in his own work, and in his leadership of the Institutional Corruption Lab at the Edmond J. Safra Center for Ethics at Harvard, where Rodwin is a lab fellow. (Disclosure: I receive support from the Lab too).
Institutional corruption is useful as a lens to understand these problems because it directs us to examine the two-way economy of dependence. To the extent that incentives matter in our world of rational actors, an economy of dependence is an economy of influence. Rodwin notes that the pharmaceutical industry depends on public support in the form of tax subsidies, patent law rules, and other incentives. It is a strange exchange relationship, one where our government gives tax breaks for research and marketing, and even enforce a monopoly, for any new chemical compound invented by a drug company. It does so to the same extent, regardless of whether the new chemical is a cure for cancer or a “me too” drug, which makes no real improvement to clinical care. On the other hand, Rodwin identifies several ways in which the public, physicians, and patients now rely on drug companies. Pharma—not the Food and Drug Administration—sets its own priorities for drug development; designs and conducts the clinical trials that demonstrate safety and efficacy; monitors adverse drug reactions; and finances continuing medical education (CME), medical societies, and journals.
Rodwin gives us a big-picture agenda for reform, in a punchy article that takes full advantage of the short and lightly-footnoted format of JLME, to stay out of the weeds. His self-titled “agenda for reform,” includes everything from changes in patent length (to calibrate with degree of innovation) to new funding for National Institutes of Health research grants to explore drug safety and efficacy, funded by a small tax on drug company sales. Rodwin also revives a proposal from the 1970s, which would have required that drug companies pay for clinical trials that are actually conducted by the FDA, thus minimizing bias (assuming regulatory capture does not just replicate the problem). He argues for expansion of the mandate for disclosure of clinical trial data, to combat the publication bias that currently infects biomedical journals, and repeal of the tax deduction for marketing of pharmaceuticals, given the evidence that it is often inaccurate. He also seeks to tax the healthcare industry to support CME, medical societies, and journals, rather than making them subservient to commercial interests.
What I like about Rodwin’s article is that it is a concentrated indictment of the status quo, paired with an equally efficient proposal for comprehensive reform. In these 10,000 words, Rodwin has delivered the critical yet constructive agenda for reform, which has until now been scattered across hundreds of disparate scholarly reviews, academic books, Congressional hearings, and Office of Inspector General reports. As Rodwin acknowledges, “the details of the reforms suggested in this article need to be worked out, the proposals have limitations, and there are certainly alternative ways to reduce improper dependency on pharmaceutical firms.” Indeed. And, there is much to be said about the political economy of such reforms: I would be the last to suggest that we could levy new taxes on a humongous industry, and tinker with patent law, with a mere stroke of the pen.
But every now and then, it’s nice to have the broad outlines of a comprehensive package of reforms articulated in a single compelling statement. If nothing else, Rodwin has provided us with the regulatory ideal of what a coherent policy might aspire towards.