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. 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. 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.
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:
- You are on a federal committee and charged with determining whether a drug is a “breakthrough medication” for the purpose of national drug pricing. You are also a paid consultant for the patentee of this product.
- You accept an invitation to attend an all expenses paid 3-day continuing education event in Lisbon, Portugal. The agenda will focus on the management of hepatitis include a 1-hour seminar each day, followed by an extensive social events agenda. Your spouse is invited. You will be expected to participate in the creation of “clinical practice guidelines” for hepatitis. A company who holds the patent on one of the competing drugs will sponsor the entire program.
- You attend a small group industry-sponsored dinner talk at a swank location, and receive a token gift of an expensive pen emblazoned with a product name. You were invited as you are considered to be a local opinion leader. You carry this coveted pen to rounds the next day and show it to your colleagues, including your new pharmacy residents.
- As the pharmacy director of a large hospital, you give permission for pharmaceutical reps to join the health care team at bedside, to review medical charts and discuss medication choices. In turn, your department will receive some expensive computer/projector equipment.
- As the pharmacy director of a large hospital, you agree to meet 3 reps this week to discuss new products. The first will be at 0745hrs on your way to work. You’ll meet at the EZ Fill gas station and she’ll pay for the fill up while talking to you about her new drug. The second will be at a Mr. Lube outlet on the way home tomorrow. He will pick up the tab for the oil change in exchange for your time. The third will be at the local Ho Lee Chow take out restaurant. The rep will pay for the order and pitch her product while you wait.
- You are contacted by a marketing group to complete a telephone survey. It will require 20 minutes of your time and the questions relate to lipid formulation amphotericin B prescribing in your hospital. You will receive $200 for your participation and will be contacted at work mid morning.
- You have acted as a principal investigator for an industry-sponsored drug bioequivalence trial. Preliminary results do not favour the sponsor’s drug. The sponsor isn’t happy. They inform you that they now believe the study methodology was flawed and do not wish the data to be published. They also inform you that you will receive the full grant funds promised.
- You are invited by a well known journal to write a review paper on a new drug class. The journal will pay you $1000 for your effort. You learn that the supplement is sponsored by a drug company and that they will be scrutinizing and approving the content before publication. You have a financial relationship with several of the patentees of these products. They have paid your speaker honorariums in the recent past.
- You sign a contract with a drug company to undertake research on their new drug. The contract contains a 3-year gag clause to prevent unauthorized release of any findings. Your hospital did not scrutinize the contract before signing.
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. 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.
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. 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. 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”. 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. 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.
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. 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?
Peter J. Jewesson, PhD FCSHP
Publishing Co-Editor, Journal of Informed Pharmacotherapy