Medical Conflicts of Interest and the Glass Houses

June 19, 2009— -- Health care reform is focused on the quality of care, its accessibility and its cost. The debate is heated and likely to intensify in the months to come. It is also loud, so as to drown out debate on a focus for reform far more critical than impending fiscal bankruptcy.

There is debate on the degree to which health care in the United States is ethically bankrupt, and what to do about it. The Institute of Medicine and nearly every other professional organization in the health arena has chimed in. Academic health centers and unaffiliated hospitals are racing to write or expand policy statements on conflicts of interest in regard to clinical activities.

Much of the gnashing of teeth relates to conflictual arrangements between individual practitioners and drug or device manufacturers. Policy is targeting the marketing that seems on the surface to be innocuous: the on-site "detailing" by drug and device representatives, the trinkets and "free meals," the samples that cause one to become more familiar with prescribing the product than with the product's limitations, the sponsored educational programs that engender comfort with the sales personnel if not the product, etc.

All these are easy targets for the race to policies that cleanse the collective conscience of my profession. That's overdue. So, too, is a peer review that decries the feigned or real naiveté on the part of professionals who claim they are above being influenced in such an obvious way. Physicians owe their patients much more than naiveté. The degree to which policy rather than personal ethics is necessary to bring an end to obvious marketing schemes is a reproach to my profession.

But this is all obvious. So the free lunches, the trinkets and other gifts, and the smiling sales representatives with their bags full of samples are banished from many an institution, although not all and not many a private practice. There is much more that affronts moral philosophy:

The Disclosure Dodge: "Industry" is not a curse word. Industry is the fountainhead of jobs that sustain and nurture all of us directly or indirectly. Furthermore, relationship between industry and the professional not employed by industry is not intrinsically wrong, let alone evil. To the contrary, such relationships can enhance the productivity of both parties.

Medical Profession May Be Rife With Conflict of Interest Hazards

The challenge for the independent professional, whether based in the academy, is to guarantee that the relationship does not distort or compromise that professional's primary role as educator, physician, therapist, clergy or whatever. On what can one base such a guarantee? The professional is recruited to the task by an industry that seeks to be advantaged by that professional's expertise and is willing to reward the professional with influence, money or other barter.

The professional is always marching to two drums -- that beating for industrial success and the other for the primary responsibility. I am willing to call a halt to such arrangements whenever there is the possibility that marching to industry's drum can possibly compromise the care of the patient or the education of those involved in that care. The consensus is that the judgment as to any compromise should be passed on to the interested observer -- the reader, the audience, the grant reviewer and the like. This is accomplished by disclosing the potentially compromising relationship on institutional forms, during public presentations, and as appendages to any professional publications.

There is a lot of disclosing going on. The result of a national survey of medical school department chairs was published in the Journal of the American Medical Association last year. Almost two-thirds have a personal relationship with industry as consultant, board member, paid speaker or the like. It is not unusual to see papers in major medical journals where authors disclose relationships with many, many industrial organizations.

Is anyone reassured by all this disclosing? I am not. To the contrary, I look askance at the discloser and at the substance that is being put forth. I am not surprised when paper after paper documents that when the study of a drug or device is industry supported, the result is far more likely to be positive than when the study of the same drug or device is government supported. Disclosure be damned; give me uncompromising ethical behavior.

Health Care Reform May Depend on Physicians' Ethics

In an invited essay in the AMA's Newspaper last year, I argued that no physician should disclose a perceived conflict of interest to his or her patient because if there is such a perception, that physician should defer to a colleague who is not potentially compromised. I feel the same about disclosure in general.

The Institutionalization of Conflict of Interest: The survey of potential conflictual relationships by department chairs mentioned above also asked about the sources of income for their departments. About one in five enjoyed money for equipment and unrestricted funds, one in three clinical departments received support for trainees and the majority of clinical departments received support for "continuing medical education." Interestingly, the chairs themselves felt that the more a chair was involved with industry, the less able the department was to "conduct independent unbiased research."

It's not just at the department level. This is going on at the institutional level where the largesse of industry can buy everything from the emphasis of a new or old department's research to the name of the school. My queasiness peaks when I know that the "CEO" of a large state-supported academic health center is also on the board of a certain major pharmaceutical benefits manager -- which just happens to be the pharmaceutical benefits manager for that state's employee health plan.

Industry Masquerading in Academic Clothing: Very seldom, anymore, are the trials necessary for licensing drugs or devices carried out by the manufacturer. There is an industry devoted to providing that service, the Contract Research Organizations (CROs). I have long railed against this relationship as I consider it inherently conflictual. Science is the exercise of disproving any hypothesis. The CRO is contracted in the hopes it will prove the hypothesis that a particular drug or device is an important contribution. There is no joy in Mudville when the study is negative (see the discussion above about industry-supported vs. government-supported science of this nature). CROs can be very lucrative. Many academic health centers have their own CRO, and many others wish they did. Furthermore, many an "academic physician" is employed for "translational research," which is a euphemism for recruiting patients into trials run by CROs.

Establishing Ethical Standards

There is so much more I need the reader to understand. Those of us who are devoting our lives to the care of the ill need the reader to understand. We need reform that uncompromisingly places the ill patient's and the well person's welfare as the only reason for health care. Today, it is hard to hear, over the din, the voices of the women and men who want nothing more than to serve ethically.

Dr. Nortin Hadler is professor of medicine and microbiology/immunology at the University of North Carolina at Chapel Hill, and an attending rheumatologist at University of North Carolina Hospitals. He is the author of "Worried Sick: A Prescription for Health in an Overtreated America" and "The Last Well Person."