Reflections from the Front: Conflicts of Interest (Again)

Reflections from the Front: Conflicts of Interest (Again)

Lately a number of high profile stories on conflicts of interest have made headlines. One reported in Nature http://www.nature.com/news/editor-s-move-sparks-backlash-1.10068  relates how Glenn McGee, Editor-in-Chief of the American Journal of Bioethics recently was criticized for his paid position with CellTex Therapeutics in Houston Texas. Is it really okay for the senior editor of one of the world’s most highly quoted ethics journals, theoretically a neutral voice of wisdom, to hold a highly paid position in a controversial, for profit research company? Many bioethicists did not believe it was, and he subsequently resigned from the research position.

Many conflicts of interest are couched in financial terms. I cannot sell goods and services to the company for which I am the purchasing agent. I cannot publish research on pharmaceuticals from companies that I own stock in without disclosing this publicly. I cannot present a medical lecture to a small group of doctors and nurses without disclosure.  In fact, I am not to mention medications by their brand names for fear of creating undue influence on prescribers in the audience.

Some of this seems almost silly, but the underlying question is important. Can I trust this physician, researcher, or author to give me clean information? The most dangerous lie is the near-truth or the half-truth. Blatant lies are easily spotted and named.

Another aspect of this discussion is one I have discussed on this blog earlier. When I, as a treating doctor wear the additional hat of being clinical researcher, how do I keep my loyalties straight? Is this really the best course of action for my patient, or do I believe in the investigational therapy because I have a vested emotional or financial gain at stake?

Closely linked with this bias question is one of coercion. If you trust me as your treating doctor, I may have to say very little positive about the investigational treatment for you to willingly sign on. When you get home and your spouse or children question your decision, in all likelihood you will reply that you trust me, I’ve never let you down, and I wouldn’t recommend this for you if I didn’t believe in it. In fact, by the very nature or a treatment trial, I cannot officially be recommending it to you, nor can I know that it will be helpful. I may hope, speculate, and even believe it will help, but I certainly can’t tell you I know it will help. If I even hint this is true, I am engaging the placebo effect, warping any outcome assessment.

I am only musing, and don’t offer any substantive advice, except to caution that any time we are in a relationship with a vulnerable party our responsibility is greater, and in all doctor-patient relationships this is inherent.  We must be very careful how we say what we say, and to whom we say it.

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Jon Holmlund, M.D.
Jon Holmlund, M.D.
9 years ago

Again (and see also my response to the March 24 post on this subject), I believe it is helpful to frame terms and issues with as much precision as possible.

My current job is as Medical Director for an IRB were we think about and deal with COI matters quite a bit.

Conflict of interest (COI) has been defined as “a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest” (Steinbrook NEJM 360:2160-2163, 2009). Examples of primary interests are welfare of patients (subjects), research integrity, and advancement of medical education. Examples of secondary interests are financial gain, professional advancement, and favors to others.

COI is usually, but not exclusively, financial. Federal regulation defines financial COI as “…a significant financial interest that could directly and significantly affect the design, conduct, or reporting of…research” (42 CFR 50, revised March 2011).

It is clearly a COI for a researcher to have a financial interest sufficiently large to affect his participation in research. Just how much financial interest is too much is not universally agreed upon, but if it exists, it must be “managed” by whatever steps are necessary, including, for example, getting out of the financial relationship withdrawing from the study. Depending on the specific study or financial interest, steps short of that may be sufficient.

It is generally ethical for a physician to also be a clinical researcher. In fact, we need more good, well-trained clinical investigators. Acceptable compensation for such efforts is limited to reimbursement of the coats of actually doing the study. But it is generally agreed that equipoise is required of physician-investigators–they must go into the study “not caring” about the outcome. Issues around equipoise by themselves can be careers for research ethicists.

So is informed consent, one of the pillars of ethical clinical research. Prospective research subjects must get as full and even-handed a discussion of the goals, procedures, risks, and benefits of a research project to inform a voluntary decision on their part to participate or not. Requirements for informed consent are also extensively codified in law and regulation, at least in the West.

Certainly, it is possible for a physician, out of over-enthusiasm or some other non-financial motive–to abuse his Aescaulapian power, creating an undue influence on his patient to participate. To do that is to violate informed consent and compromise the research.

Note, again, as I commented on March 24, that “undue influence” is NOT the same as “coercion.” The latter implies, by definition, a THREAT. If there is no threat, we should not use the word coercion.

These are only brief remarks about COI, but this comment is already too long….

Jon Holmlund, M.D.
Jon Holmlund, M.D.
9 years ago

One more point: FDA is soliciting public comment on how it collects information about financial payments to investigators on clinical trials. The comment period ends May 29, and the link to the FDA’s solicitation includes instructions on how to comment. It’s pretty technical but interested parties may wish to follow this link: https://www.federalregister.gov/articles/2012/03/28/2012-7405/agency-information-collection-activities-proposed-collection-comment-request-financial-disclosure-by?source=govdelivery#h-8