JAMAby Anne R. Cappola and Garret A.September 24, 2015
The primary interest of the biomedical scientific endeavor is to benefit patients and society. Frequently, this primary interest coincides with secondary interests, most commonly financial in nature, at the interface of the investigator’s relationship with a private sponsor, typically a drug or device company or, increasingly, venture capital firms. Academia and the public have become sensitive to how such a secondary interest might be unduly influential, biasing the interpretation of results, exposing patients to harm, and damaging the reputation of an institution and investigator. This concern has prompted efforts to minimize or “manage” such “conflicts of interest” resulting in a plethora of policies at both the local and national level. Although these policies are often developed in reaction to a limited number of investigators, once introduced, they apply to all. Given the broad array of stakeholders, the diversity of approaches, and the concern that such policies might restrain innovation and delay translation of basic discoveries to clinical benefit, the Institute for Translational Medicine and Therapeutics at the University of Pennsylvania recently convened an international meeting on conflict of interest. Several themes emerged…
Conflicts of Interest:
Dr Cappola
• reports receiving consulting fees from Biomarin, Mannkind Corporation, and Takeda.Dr FitzGerald
• reports being the McNeil Professor of Translational Medicine and Therapeutics, a council member of the American Association for the Advancement of Science, and a member of the National Academy of Medicine biomarker committee;• receiving a stipend for being co-chair of the advisory board for Science Translational Medicine;• grants from the Harrington Family Foundation and Eli Lilly;• consulting fees from Calico and Pfizer, Eli Lilly, Glenmark Pharmaceuticals, and New Haven Pharmaceuticals;• serving as chair for the Burroughs Wellcome Foundation review group on regulatory science awards, the Helmholtz Foundation advisory board for the network of cardiovascular science centers, and the PhD program committee of the Wellcome Trust, a section committee of the Royal Society;• and serving on the advisory boards of the Oklahoma Medical Research Foundation and King’s Health Partners in London. He also serves on the advisory boards of the Clinical and Translational Science Awards held by the University of Connecticut, Harvard, the Medical University of South Carolina, Duke University, and the University of California at San Francisco.Funding/Support:
• This work is supported by a grant [UL1 TR000003] from the National Institutes of Health.
First, the term conflict of interest is pejorative. It is confrontational and presumptive of inappropriate behavior. Rather, the focus should be on the objective, which is to align secondary interests with the primary objective of the endeavor—to benefit patients and society — in a way that minimizes the risk of bias. A better term — indicative of the objective — would be confluence of interest, implying an alignment of primary and secondary interests. In this regard, the individuals and entities liable to bias extend far beyond the investigator and the sponsor; they include departments, research institutes, and universities. The potential for bias also extends to nonprofit funders, such as the National Institutes of Health and foundations, as well as to journals that might, for example, generate advertising revenue from sponsors…
In 1934, Anna Freud wrote the Ego and the Mechanisms of Defense to flesh out her father’s ideas about how the mind gets around unsavory motives. She devoted a whole chapter to intellectualization and rationalization, a favorite of adolescents. Another way to look at it is that there is a cognitive leap in adolescence [Piaget] when the child can finally use formal logic and can think in the same way as his/her parents [stripping them of the power of a superior intellect]. A smart adolescent can justify [rationalize] anything and delights in endless mind games to the consternation of parents through the ages. For a time, it’s a new tool to get what you want, or enter into the power struggle phase of growing up rather than a tool for understanding. And some people never make that latter jump and rationalize their way through life.
From that same book (which I am presently rereading), page 160:
“We are surprised to discover that this fine intellectual performance makes little or no difference to his actual behavior. His empathy into the mental processes of other people does not prevent him from displaying the most outrageous lack of consideration toward those nearest to him.”
Page 162: “The abstract intellectual discussions and speculations in which young people delight are not genuine attempts at solving the tasks set by reality.”
BTW, all of this vindicates my Jack Grubman quote. They are just rewording conflicts of interest as synergies.
It’s great that you are getting thoughts from this paragraph as
well as from our argument made at this time.
Where is the evidence that “such policies might restrain innovation and delay translation of basic discoveries to clinical benefit”? It’s a classic straw-man diversionary tactic. Moreover, nobody is demonizing collaboration with industry per se. Time was, we had an honorable tradition of interacting with industry while retaining our integrity as scientists. That tradition broke down when academic investigators morphed into key opinion leaders who spent most of their time with the marketing departments of corporations – not with the real scientists. After they were outed by Senator Grassley and Paul Thacker, institutional COI policies were strengthened and, yes, they now apply to everybody. As we now survey the aftermath, we should direct our anger to those opportunistic investigators whose ethical tackiness screwed it up for everybody.
The authors and also the editors of JAMA failed the field in this editorial by glossing over the major COI scandals of the past decade. Yes, there is real conflict of interest, and calling it confluence is pure casuistry.
Wonderful revisionist semantics! Conflict of Interest goes from zero to negative whatever. Confluence of Interest goes from zero to positive whatever. Can anyone imagine seeing at the end of a scientific report, “Confluence of Interest: None”?
…“such policies might restrain innovation and delay translation of basic discoveries to clinical benefit”?
Sentences with innovation or translation are suspect. With both? Guaranteed BS…
Is this The Onion version of JAMA?
Unintended side effect: clinical studies of off-patent drugs will be taken more seriously….considering the cost advantage it may be a silver lining..I’d like to see more current studies of MAOIs etc.
Sandra,
It is kind of “onionesque” isn’t it?…
Mickey,
Question for the psychoanalyst. In my rereading of Anna Freud, in that chapter she’s mostly speaking of intellectualism to control the adolescent id. Aren’t these intellectualizations and rationalizations qualitatively different since they are a feeble attempt to ward off the superego which is conscious (assuming the absence of sociopathy)? The only way I see this as suppressing id is if they are so enraged by the criticism they just smother everything with an intellectual blanket. Seems to me most of this is happening at the level of conscious thought.