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Perhaps you have read the recent article in the New York Times about the U.S. Government (specifically the U.S. Department of Health & Human Services) warning the pharmaceutical industry that they must not offer any financial incentives to any health care professional that would entice them to prescribe or recommend their products. (1,2) A laudable goal, but extremely difficult to execute. According to the author, the government has informed the manufacturers that currently employed marketing practices may contravene federal fraud and abuse laws. New standards have apparently been developed in an attempt to address this complex issue. These new standards raise the thorny issue of health care professionals and competing interests, otherwise known as "conflict of interest" (COI).
What is a COI? According to Michael McDonald, Director, Centre for Applied Ethics, University of British Columbia, a COI can be defined as a situation in which a person, such as a public official, an employee, or a professional, has a private or personal interest sufficient to appear to influence the objective exercise of his or her official duties. (3) A COI generally involves the abuse of the trust people have in professionals and tends to not only injure the relationship with a particular client or employer, but also damages the profession. There are 3 key elements to a COI: 1) a private or personal interest (e.g. financial benefit); 2) an official duty (i.e. duties you have because you have an office, or act in an official capacity and involves obligations to clients, employers or others that exceed private or personal interests and; 3) an interference with the objective and independent judgment that professionals are expected to provide. An "apparent" COI arises when a reasonable person would think that the professional's judgment is likely to be compromised, whereas a "potential" COI involves a situation that may develop into an actual COI. An "actual" COI exists when professional judgment concerning a primary interest has been unduly influenced by a secondary interest. (3)
Some general examples of financial relationships that can lead to an apparent COI would include investments, consultation work, research funding, support to organize an educational program, conference travel support, speaking honorariums and gifts. "Influence peddling" or the soliciting of benefits in exchange for using your influence to unfairly advance the interests of a particular party, and use of confidential information for the purchase of products (e.g. drug stocks) based upon knowledge gained through confidential information represent two forms of a COI that are, unfortunately, all too common.
Consider these hypothetical scenarios:
While hypothetical, these scenarios are actually based upon descriptions of events that have reported in the literature, personal communication or experience. Every one of them represents a potential COI. Check out www.nofreelunch.org if you are interested in more examples and literature citations.
Gifts and other financial "sweeteners" constitute to another form of EBM, namely "Entrée-Based Medicine". These enticements trigger the "reciprocity rule" or the inherent social obligation to reciprocate when an unsolicited gift is received. (4) When a gift is accepted, a relationship and obligation is implicit. These enticements influence behaviour either directly or, similar to tobacco, on a secondhand basis. And, of course, these gifts cost money, and patients will eventually have to pay the bill. Finally, gifts can erode professional values and damage the public image. Not surprisingly, patients tend to feel that gifts to physicians are more influential and more inappropriate than do physicians themselves. (5)
Wazana recently published the results of an unfunded study in which he conducted a literature search to characterize the relationship between physicians and the pharmaceutical industry. (6) He identified 539 studies that met his search terms, of which 29 were deemed "relevant" in that they contained quantitative data and were published in a peer-reviewed journal. In summary, he found that interactions with industry were generally endorsed; the average frequency of encounter was 4/month; interactions resulted in increased formulary requests and prescribing changes; continuing education programs sponsored by industry preferentially highlighted sponsor products and resulted in attendees increased prescribing of sponsor drug; gifts positively influenced attitude towards sponsor. Unfortunately, he also determined that there are no published studies using patient outcome measures to determine the ultimate impact of this relationship.
Hospital pharmacists are being placed in a potential COI position more often than ever before. No doubt this relates directly to the significant and increasing influence and involvement we have in direct patient care, formulary management, patient education, education of other health care professionals, and drug-related research. As our responsibilities increase, so to does our risk for a COI. The ACP-ASIM recently released a position paper on physician-pharmaceutical industry relations. (7) They state that "…physicians frequently do not recognize that their decisions have been affected by commercial gifts and services and in fact deny industry's influence…research, however, shows a strong correlation between receiving industry benefits and favoring their products…". Why should we expect anything different of hospital pharmacists?
In contrast, the 2001 Canadian Society of Hospital Pharmacists guidelines for the relationship between health care facility pharmacists and the pharmaceutical industry simply state that "…the relationship between pharmacists and the industry can be beneficial to both parties…" and that the "…lines of communication should be kept open in a spirit of cooperation and coordination…". (8) Nowhere in the preface and scope of this position paper does it state that pharmacists must retain an arm's length relationship with industry to ensure objectivity. Perhaps an amendment is in order?
How do you determine if you are in position of a potential COI? Start by asking yourself some simple questions. Has the definition been met? Has your objectivity been compromised? Would relevant others (employer, clients, colleagues, or the general public) trust your judgment if they knew you were in this situation? Would you identify your involvement on your CV? Would you let your mother know?
What should you do if you find yourself in position of COI (potential, actual)? First off, recognize that it takes skill and good judgment to recognize a COI as private and personal interests can cloud objectivity. (3) It is often easier to recognize when others are in a conflict, than when you are. Experts generally recommend that you start by talking to a trusted colleague or friend when in doubt. It's also a good idea for you to re-familiarize yourself with existing professional guidelines, even if they are often somewhat dilute in nature. As soon as you recognize that you are in (or are headed for) a potential or actual COI situation, the right (i.e., ethical) thing to do is to get out of the situation, or, if you can't, make it known to all affected parties your private interest and preserve the trust essential to professional objectivity. (3)
According to recent Gallop polls, pharmacists are currently in a position that is envied by all other professionals. Over the past decade or more, we have been the top rated professional for honesty and ethics. (9) In fact, the public consistently rates the pharmacy profession higher than the medical profession. This is not something that we should take lightly, rather it is something we should work hard to preserve. While I suspect that the public was thinking about their often-visited community pharmacists, rather than hospital pharmacists when completing these surveys, I think it would be safe to extrapolate the results to our profession as a whole. When compared to community pharmacists, institutional practitioners are actually uniquely situated to function as bioethical watchdogs. Institutional pharmacists are typically salaried public servants and their income is not dependent on sale of drug products. In fact, they routinely work towards reducing drug use in their practice setting and control the availability of drugs through the use of selective formularies, prescribing guidelines and restrictions and intensive continuing education. Let's recognize the trust the public has already placed in us and consider ourselves as bioethical watchdogs. In doing so, think carefully about your actions. Take your expanding professional responsibilities seriously and remember who you work for. Be "untouchable" and do the "right thing". Continue to be a profession that the public can rely on for objective and independent drug therapy expertise.
In summary, my hat goes off to the U.S. Department of Health & Human Services for their timely warning. Perhaps they should also be reminding the health care professionals that they should not accept these enticements. "With regards to my own status, I must admit to placing myself in a position of potential COI on a few occasions during my 24 years of practice, most of these occurring early in my career when ignorance was bliss. However, I now accept that, being human, I too am vulnerable to influence. Considering this inherent fallibility, I have taken actions, wherever possible, to minimize any apparent, potential or actual conflict of interest. I'm not on any industry advisory boards, not a paid industry consultant, don't speak at drug company events, nor have I financial interest in the sales of any drug product. How clean is your slate?
J. Jewesson, PhD FCSHP
Publishing Co-Editor, Journal of Informed Pharmacotherapy
J Inform Pharmacother 2002;11:1.
This editorial is based upon a presentation given by Dr. Jewesson at the August 12, 2002 Canadian Society of Hospital Pharmacists Annual General Meeting, Vancouver BC, Canada.
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This view is commendable, albeit most difficult to follow. As a physician on the pharmacy committee of a large community hospital, I can tell you that our pharmacists use cost saving rather than evidence-based results in product acquisition. Is that any better or more ethical?
Gary Witman MD
Physician, Good Samaritan Medical Center
Once again I applaud Dr. Jewesson for a refreshing and courageous editorial. The issue of conflict of interest (COI) is an important one and has huge consequences, both in costs to the health care system as well the cost to the professional integrity of the individuals involved. If there ever was a belief that, by virtue of our professional training, pharmacists and other health professionals somehow acquired a sense of ethical conduct, that belief has been severely challenged. The “conscience” was once described to me as a three cornered wheel that spins in our heads. When we are first exposed to a moral or ethical dilemma, the corners cut in and hurt as they spin. This is the “pang of conscience” and, hopefully, we make the ethical decision, the wheel stops spinning and it stops hurting. But if we fail to heed the warning, take the unethical road and allow the corners to chafe continuously, the sharp corners eventually wear down and it doesn’t hurt as much anymore. I believe that the temptations thrown at us every day from Big Pharma have worn the corners down permanently in many health professionals and the constant barrage of bribes and gimmes don’t ever register as unethical.
I find it interesting that, while many hospitals have incorporated disclosure statements into their formulary application process that force physicians to disclose their ties to drug industry when applying for formulary status for a drug, the same disclosure requirement is not applied to the pharmacists involved in the same formulary process. Are we pharmacists somehow immune to the solicitations of the drug industry or morally superior to physicians so that disclosure is unnecessary? Somehow I don’t think so.
It is a sad commentary on our profession, and maybe on society in general, that many individuals do not perceive their actions as unethical or in potential COI. Pharmacists, especially those in a direct position of influence on drug utilization such as a Clinical Specialists or DUE pharmacists, must not only maintain absolute objectivity and impartiality, but they must be perceived to be acting objectively and impartially. It is not good enough to say one is impervious to commercial influence, and that that free round of golf or dinner or other gimme has no effect on one’s behavior. We must all realize that those freebies are paid for by someone - the consumer or the taxpayer – and that by accepting them, an implicit obligation to the donor (i.e. drug company) has been established. One becomes tainted from the moment they accept the gift.
So who is at fault for the current ethical dilemma? Pharmacists and physicians point the finger at drug industry for offering bribes and resorting to influence-peddling, while the drug companies complain that they are forced into this behavior because physicians and pharmacists expect it - in fact demand it. In fact both are true and we are all (bribers and bribees alike) somewhat to blame. The problem is so ubiquitous and entrenched, that it is difficult for most people to distinguish ethical boundaries as they pertain to their relationship with the drug industry. Where do you draw the line? Is it OK to have a drug rep buy you lunch, or even a cup of coffee? Or is the line drawn at a round of golf, or a dinner or a hockey game or …? In my view, the line can be drawn in only one place, and that is to refuse all gifts from the drug industry including that cup of coffee. Once you move the line anywhere else, it becomes arbitrary, and it is just as easy to equate a $100 hockey ticket or a $60 round of golf with a $2 cup if coffee as it is a $1000 all expenses paid weekend at the You-Name-it Fishing Lodge. The ACP-ASIM guidelines states “It is not just lavish amenities that are in question. The acceptance of even small gifts can affect clinical judgment and heighten the perception (as well as the reality) of a conflict of interest” I have little faith that voluntary guidelines for the relationship between health care professionals and the pharmaceutical industry such as those set by the ACP-ASIM and CSHP will be the answer. Unless we all take COI seriously and actively and continuously monitor our behavior with the pharmaceutical industry for potential COI, the only alternative, I fear, is government legislation mandating an arms-length relationship with the industry. We have to do much better than we are doing now. We must be continuously vigilant of the threats to our professionalism and independent judgment with respect to the care of our patients and the exercising of our official duties. We must not let the corners of our conscience wear down.
Richmond, British Columbia, Canada
Copyright © 2002 by the Journal of Informed Pharmacotherapy. All rights reserved.