P.Mean: Evaluating private conflicts of interest (created 2008-10-01).

The open source journal PLoS Medicine has an interesting editorial that is worth commenting on.

While the article includes the words "non-financial" in the title, the authors repeatedly refer to private issues.

Imagine you're a peer reviewer who's received a request to referee a paper. The paper reports the results of a study using cell lines derived from an aborted fetus as a diagnostic tool in identifying certain viral infections. You are also a member of a religious organization morally opposed to fetal cell research. In your review, you raise questions about the study's validity and methodology that might undermine the paper's chance of publication.

Imagine you're an editor and you receive a paper from the scientist who supervised your postdoctoral fellowship. It's been a couple of years since you left his lab, but he has supported your career and you have warm feelings toward him; plus you still join your former lab mates occasionally at their monthly pub night. You select sympathetic reviewers and you fight hard for the paper at the editorial meeting.

Their definition of "financial" really means "commercial" because the examples they cite involve corporations (pharmaceutical companies and tobacco companies).

Finally, they use the term "competing interests" rather than "conflict of interest". I'm not sure where this term was used first, but the BMJ in an editorial promoted the term "competing interest" in 1999 for the following reason:

We changed our terminology from "conflict of interest" to "competing interest," arguing that there is nothing wrong with having a competing interest but that there is with not declaring it. Our change of policy has been accompanied by an increase in the number of disclosures, and we hope---like good postmodernists---that this is increasing readers' ability to interpret the discourse. www.bmj.com/cgi/content/full/319/7213/0/a

I prefer the term "conflict of interest" in my writing as it is clearer and more direct language. But I have no problem with using a softer term if it minimizes the non-disclosure of conflicts.

The editors go on to define non-financial competing interests.

Non-financial competing interests (sometimes called ďprivate interestsĒ) can be personal, political, academic, ideological, or religious.

Later they try to define this in more detail.

These interests would include unpaid board, governmental, or committee memberships; political or religious views; and personal relationships such as friendships or family relations, as well as mentoring and adversarial professional interactions. For example, authors should declare if they serve on the editorial board of the journal to which they are submitting or if they have acted as an expert witness in relevant legal proceedings. Reviewers should be expected to declare if they have held grants, co-authored papers, or worked in the same institution with the authors of the study they are reviewing.

Little research has been done on non-financial competing interests, but there are some exceptions.

In a systematic review, Luborsky and colleagues found that a researcher's allegiance to a given school of thought exerted a bias on the study design and outcomes of psychotherapy research comparable to that which has been documented for financial interests.

The reference for this study is

I liked this article, but there are some important points worth adding. There are several other types of non-commercial conflicts of interest beyond the ones discussed in this article.

First, the allegation has been made (though there is no empirical evidence to support this), that federal agencies will tend to financially support and to promote research that are biased towards exaggerating the scope of a problem under the agency's mandate. This will make it easier for the agency to ask for a larger federal budget.

In a criticism of the National Environmental Education Advancement Project (NEEAP), an environmental educational program funded by EPA, Michael Sanera asks

Regardless of the effects of the NEEAP program, the larger issue is this: Should an environmental agency which has a stake in the outcome of environmental policy debates be responsible for environmental education, especially when that environmental education includes a heavy dose of political action training? It would seem only common sense that this situation represents a serious conflict of interest. Does anyone truly expect that the EPA can support a dispassionate, objective, and unbiased educational program which examines both the strengths and weaknesses of the EPAís implementation of the Clean Air or Water Acts or the Superfund program? www.cei.org/gencon/004,02412.cfm

A second potential conflict comes from the dependence on grant money that many researchers have. Often their very jobs depend on getting a number of federal grants. So their goal is to skew the results of one grant to increase the probability of getting a second grant. This has led to the famous comment "There's probably no greater conflict of interest than an NIH grant." Again this represents an allegation so far without any empirical support.

There is a third category known as intellectual conflict of interest. It means a variety of things, but a common element is the belief that one's intellectual persuasions are so set in stone that they cannot make fair and unbiased decisions.

A newsletter article at the U.S. Food and Drug Administration by Jim Morrison raises this issue for FDA reviewers.

However, in our zeal to protect our good name against financial misfeasance, we should not neglect potential conflicts of interest where financial gain is not involved. For example, if a reviewer of a drug belongs to an organization that publicly espouses a point of view for or against that particular drug or its therapeutic class, most people would question the reviewer's ability to perform an unbiased evaluation of that drug. www.fda.gov/cder/pike/Special2002c.htm

A panel discussion on conflict of interest at the American Heart Association raised the same issue, but put a slightly different spin on it.

I also wanted to put on the table another issue, and itís one that I grapple with personally, to a great extent. I run a clinical trial coordinating center. Most of the studies we do are commercially sponsored, so thereís a grant that comes to the institution, not to me personally, to support the clinical trial. When you are during clinical trials supported by industry, even when you donít stand to personally profit from it, there is an intellectual conflict of interest. Youíre invested in it, itís your trial, you helped to design it. It is very, very hard to get yourself and your ego and our persona out of the results of the trial, and itís really important to take a step back and say ďIím going to be proud of this trial, and Iím going to be proud to report this trial whether itís positive, negative, or neutral.Ē av.conferencearchives.com/pdfs/070506/1600_t.pdf

A news story by Jeanne Lenzer on BMJ offers an interesting story about the allegation of intellectual conflict of interest:

Dr Curt Furberg, a member of the FDA's drug safety advisory committee and a prominent authority on drug safety, was told his invitation to participate in FDA hearings on the safety of COX 2 inhibitors had been rescinded. This followed his being quoted in the New York Times on 10 November as saying that a study that he and his colleague performed "showed that Bextra is no different than Vioxx, and Pfizer is trying to suppress that information." [text deleted] Victoria Kao, spokesperson for the FDA, told the BMJ that Dr Furberg's removal was the result of a routine review of all panel members for "financial and intellectual conflicts of interest." www.bmj.com/cgi/content/full/329/7476/1203

Gina Kolata of the New York times also reports on this issue (www.nytimes.com/2004/11/13/politics/13fda.html).

A stark criticism of the concept of intellectual conflict of interest appears on Howard Brody's blog:

Frequently, one hears that there are both financial and intellectual conflicts of interest; somehow this argument is offered as evidence to downplay the importance of the financial conflicts. While intellectual conflicts are important, they can readily be distinguished from financial ones. Financial conflicts of interest are extrinsic to the scientific endeavor, whereas intellectual conflict is the very way science moves forward. Financial conflicts can occur at variable levels Ė some people have them, some people donít Ė and they can be quantified, whereas intellectual conflicts are ubiquitous and not susceptible to quantification in the same way. Moreover, in the context of debate on an advisory committee, for example, it is unlikely that the financial conflict information will naturally emerge, whereas it is likely that any relevant intellectual one will. There are relatively straight-forward methods to alleviate financial conflicts, whereas itís not nearly as clear how one should approach intellectual conflicts. Finally, our legal system has long recognized the distinctions between the two. brodyhooked.blogspot.com/2008/03/more-on-intellectual-conflict-of.html.

Another criticism of this concept of intellectual conflict of interest (though without naming the issue directly) appears in a BMJ article.

At the end of the article is a small note:

Competing interests: SM is a spiritual healer.

In the Rapid Response section of  the webpage for this article, Ron Law notes

A small statement in this article highlights the double standards that pervade the sorry state of allopathic medicine. What medical journal would state: Competing interests: SM is an allopathic medical practitioner.? Although SM may have volunteered spriritual healing as a competing interest, the fact that such a declaration was even considered is a sad double standard. The fact that it was published is even sadder. Either that, or it highlights a higher ethical standard of complementary healthcare practitioners.

So is there a tendency (just to pick on one profession) for surgeons to be biased in favor of surgery? Undoubtedly so, but if we did not allow surgeons to write articles about surgery, then the surgery journals would be quite slim.

There was a recent flurry of opinions about intellectual conflict of interest.

Dellinger and Durbin were harshly critical of another group of researchers.

Drs. Eichacker, Natanson, and Danner accuse the SSC of being biased toward industry, yet fail to acknowledge their own intellectual (academic) bias. This form of bias can be defined as presenting personal, entrenched beliefs as scientific truth in an area where no clear-cut consensus exists. We believe this intellectual bias can be more insidious and damaging than the potential bias arising from affiliations with industry.

In a response, Danniele Poole writes

what defines individuals with strong opinions on the matters they are dealing with, as having an intellectual conflict of interest, is the context, not their opinions alone. Thus, expressing a point of view in a letter to a scientific journal does not represent an intellectual conflict of interest. If it did, no expert (who, by definition, has strong opinions in his field of expertise), should ever be invited to write an editorial or a commentary.

Drs. Dellinger and Poole give a rather lame response to Dr. Poole in my opinion

If this were a simple scientific debate, as Dr. Poole suggests it should be, this group would be supporting or carrying out experimental work in attempt to support (or refute) their bias. Instead they continue to publish letters and editorials, which are not subjected to peer review, advancing their personal political agenda.

I don't know whether Drs. Eichacker et al have a personal political agenda. Neither do Drs. Dellinger and Poole. No one can peer inside the minds of someone else to know their true motivations.

Another Howard Brody blog entry is critical of the perspective of Drs. Dellinger and Poole.

The implicit subtext, as best as I can read it, is that people ("academic intellectuals") who work at NIH, or at universities that believe in avoiding conflicts of interest with industry, are some sort of ivory-tower, goody-two-shoes weirdos. They think they are intellectually superior to the rest of us mere mortals, and the best thing to do with these insufferable twits is to ignore them. By contrast, scientists who jump into bed with industry at the first opportunity are regular people just like us, and are hard-headed, pragmatic realists. Their take on the world is much more reliable. brodyhooked.blogspot.com/2007/12/intellectual-bias-latest-salvo-from.html

The American Council on Science and Health has published a 70 page booklet by Ronald Bailey criticizing "conflict of interest activists," individuals who argue for sharp restrictions on memberships on government scientific advisory boards of individuals with financial ties to industry. Dr. Bailey believes that the adverse effects of commercial conflicts of interest have been vastly overstated. But Dr. Bailey also suggests that non-commercial conflicts cannot be ignored.

People are influenced by all sorts of interests besides money. Why should having once consulted with Pfizer or DuPont disqualify a scientist from serving on a government advisory board or writing a review article in a scientific journal, while being a lifelong member of Greenpeace does not? www.acsh.org/publications/pubid.1687/pub_detail.asp

The concern I have is that promotion of intellectual conflict of interest may be an attempt to minimize the stigma associated with financial conflicts of interest. That's only half good. I do agree that sometimes readers will overreact to a commercial conflict of interest. It is a factor that needs to be evaluated just like whether there was a good control group. If a research study is well designed and carefully reviewed and most of all objective and repeatable, having a commercial conflict of interest should not serve as a disqualifying factor. For borderline situations, though, you can and should take commercial conflicts into account.

Should we take non-commercial conflicts of interest into account? We do have to worry about certain patently obvious cases. You can't be a peer-reviewer for a paper from your own institution. Other than that, I would not encourage discussion of non-commercial conflicts. While the editors at PLoS Medicine are raising some interesting issues for discussion, in my experience, non-commercial conflicts are raised mostly by people who have commercial conflicts to try to cloud the discussion.

Update: August 15, 2011. I published a rapid response to a BMJ article that raised the question: "should the BMJ ... ban editorials and clinical reviews from authors with ties to industry?"

I also found an interesting anecdote in the book, Denialism. How Irrational Thinking Harms hte Planet and Threatens Our Lives, by Michael Specter. He starts off Chapter 2 with the story of Marie McCormick, a pediatrician with a research interest in "high-risk newborns and infant mortality." She was asked to serve on a National Academy of Science panel on vaccine safety.

"McCormick took on the assignment readily, although she was surprised at having been selected. It was not as if she considered vaccine safety unimportant--the issue had preoccupied her for decades. Nevertheless, vaccines were not McCormick's area of expertise and she couldn't help thinking that there must be someone better suited for the job. 'My research has always been on the very premature,' she explained. 'So I was a bit naive about why they wanted me to run that committee.' She soon made a discovery that surprised her: 'I realized that all of us on the committee were selected because we had no prior contact with vaccines, vaccine research, or vaccine policy.'"

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