August 2008
	Physician Gifts, Regulations and Common Sense It’s that time again. Every so often, a new set of guidelines, rules, regulations or commentary appears on the topic of the legality and ethics of our (i.e., the health care industry’s) interactions with our health care provider stakeholders, and most especially our interactions with physicians. The most recent entry into this stream is a set of guidelines issued by the Pharmaceutical Research and Manufacturers of America (PhRMA) that is scheduled to take effect in January. These guidelines are meant to serve as updates to and clarifications of guidelines issued by PhRMA in 2002. This was pointed out to me by a reader who was kind enough to forward the guidelines to me and ask for my commentary on their impact on pharmaceutical marketing and marketing research. I would like to thank this contributor for taking the time and interest to alert/sensitize me to this issuance, and I encourage each of you to forward topics, articles, etc., on which you would like me to hold forth in one of my monthly publications. That being said, let me note that there is little doubt someone needs to maintain order in the pharmaceutical industry’s interactions with medical professionals, and arguably it is far better for us to police ourselves with voluntary guidelines than to be policed by the federal government, a medical association, etc. I fully applaud the efforts of PhRMA. In this spirit, I truly hope the field these guidelines are designed to regulate will comply with them, and I believe it likely will. As to the guidelines themselves, they are relatively simple and straightforward and contained in the readily available and extremely easy to comprehend guidebook Code on Interactions With Healthcare Professionals. If you have a hard time getting a copy, please contact me and I’ll send it to you. One way or the other, get a copy and read it! I had several reactions to these new guidelines that I’d like to share with you in the spirit of stimulating your own thoughts on the matter. And I hope you will share yours with me for inclusion (with or without attribution, as you wish) in my future writing and speaking ventures. Suffice it to say that this edition of the guidelines is even clearer than the 2002 version in precluding any activity by the field force that is not directly related to the education/training of the medical practitioner or his/her patients. The concept of providing “medically relevant” items, such as stethoscopes, clipboards and even trinkets like pens and coffee mugs of minimal (i.e., less than $100 in value) is now clearly forbidden by the new guidelines, since while they may be involved in the treatment process, formerly a safe harbor in the guidelines, they are not involved in the educational process. Included in the guidelines, it should be noted, is the important distinction that the behavior of our pharmaceutical sales representatives (PSRs) must not only be ethical but also meet the perhaps more stringent test of appearing to be ethical to patients, the press and anyone else who may choose to examine such behavior. Gone are the days when marketing research agencies such as mine often conducted projects to determine whether a physician would prefer to receive a coffee mug or stirrup warmers as a token from PSRs, since neither would be allowed under the new guidelines. Important to consider at this fork in the road, however, are the potential motivations underlying various offerings to physicians, and what we should really be trying to accomplish in establishing and administering such guidelines. First, we need to acknowledge out-and-out cases of bribery, i.e., cash payments for product use, which have indeed been perpetrated by some pharmaceutical companies and device manufacturers. Such payments, usually tied to the use of high-priced medications or devices, are without doubt unethical in nature, and have caused several manufacturers to pay hefty fines and sign consent decrees that they would not engage in such behavior in the future. Such egregious examples of misdeeds should be, and typically are, dealt with summarily once discovered, and are not the focus of the new guidelines. Outside the zone of offering and accepting cash bribes, one must ask oneself what the sponsoring company is trying to accomplish when it leaves a pen, coffee mug or other token item, admittedly unrelated to physician or patient education, with the health care practitioner. Clearly, no one believes that a physician will be “bribed” to use a product by being left with a relatively inexpensive pen imprinted with the product’s name. Rather, conversations with hundreds of PSRs over the years have taught me that such items are distributed for two purposes. The simpler of these is the purported, although no one knows how effective, purpose of “reminding” physicians of the product. While a whole separate article or perhaps even a book could be written on this topic, I will here simply note in passing that much of pharmaceutical marketing is based on the assumption that physicians need to be constantly and assiduously reminded of a product. Most of the sales presentations given by the 90,000 PSRs left in the United States after recent reductions in force are referred to as “reminder” details, since very few new products are being introduced and very little new data is available to present about existing products. Here’s an interesting thought question. Under what circumstances does a physician need to be reminded of a product? It is well known that most physicians use relatively few pharmaceutical products in their practices, with the number 25 often bandied about as constituting the majority of most physicians’ prescribing. What is the likelihood, one might reasonably ask, of the physician forgetting about the existence of any of these products if a pen, coffee mug, etc., is not within view? Not high! Conversely, let us assume that a physician has ignored a new product at its introduction, or worse yet has tried it and found it to be no different from, and perhaps not even as good as, products currently in use in the practice, thus rejecting the product from further use in his/her practice. What is the likelihood that viewing a coffee mug with that product’s name on it gets the physician to give the product further use/consideration? Again, not high! In summary, the benefit to reminding a physician of a product’s existence, an activity hotly pursued by many pharmaceutical marketers, is of highly suspect value, thus rendering the part of the code that precludes our leaving reminder items with physicians relatively benign and untroublesome. The other function that these trinkets serve, PSRs tell us, is much more subtle. In this role, such goodies as pens, mugs, etc., provide the representative with something tangible to hand the physician during the call as a visible sign of appreciation for the doctor’s time and as an indicator of the desire to build a relationship with the doctor. A wise PSR once told me that personal relationships do not sell products, but rather permit the representative to spend enough time with the physician to explain the use and benefits of his/her product(s). Thus, in most cases, physicians who develop relationships and loyalty do so with the representative rather than the company (s)he represents. Most doctors, however, say that such relationships and loyalty only play a role in determining prescribing in the unusual treatment area in which numerous interchangeable products exist. In the more usual case, it is the benefits and risks of a product in comparison to its competitors that cause it to be prescribed, or not. Because of the intangible nature of positive relationships that are caused by pleasing interactions rather than by providing the physician with lavish meals, gasoline, sports equipment, etc., the guidelines are silent on the ethics of developing relationships and loyalty based on anything other than giving the doctor something that costs money. Whether it is ethical for a doctor to prescribe a particular product based on his/her relationship with the representative, loyalty to the company (s)he represents, etc., is not discussed or is not addressed. Considering the relative cost of the representative visit itself versus the pen that might be left behind, this is arguably a significant oversight. In fact, if one were prone, as I am, to be increasingly cynical, one could look at the guidelines’ commentary on meals as an approach designed more to service the appearance of propriety than to provide genuine medical benefit and ethical compliance. More specifically, a loosely translated version of one of the guidelines is that while it is within bounds to provide physicians with “modest by local standards” food if it is incidental to the exchange of information, such meals must occur within the confines of the physician’s office or hospital and under no circumstances down the street from one of these venues. Huh? I believe that if a representative and the physician really want to work as a team in the best interest of the patient’s well-being, and want the opportunity to discuss in some depth the ways in which the PSR’s products can provide such benefits, as well as patient information tools the company makes available to assist the physician in maintaining patient compliance, it could be cogently argued that such a discussion could occur much more meaningfully over a quick dinner at the end of a day than in the middle of the whirlwind atmosphere of the physician’s office in the middle of office hours over an inhaled corned beef sandwich. GfK’s extensive work in the area of sales force effectiveness suggests that the effective representative will be able to form a mutually supportive relationship with a chosen physician under virtually any environmental circumstances, while the ineffective rep will fail to score at the best French restaurant in town. Unlike the reminder items discussed above, where I believe that taking away the pharmaceutical industry’s ability to distribute them in 2009 constitutes no great loss, denying quality interaction time between physicians and their representatives at more leisurely venues such as restaurants and on-their-own-time rounds of golf presents a real potential loss to patients in the area of team building. It also insults physicians based on the apparent belief that a doctor can be prostituted into using a drug (s)he would otherwise not employ by eating a steak dinner at a restaurant while a quality discussion is being conducted. Importantly, by the way, the guidelines speak only to issues involving such interactions between physicians and PSRs, and they exclude interactions with home office marketing staff, key opinion leaders hired as speakers by the pharmaceutical companies, etc. Let me close this diatribe with several quick observations. First, I am deadly serious in supporting the provision of guidelines for ethical interactions between health care manufacturers and health care providers. I am also supportive of doing so on a clear and unambiguous basis, which I believe the revised guidelines accomplish. However, I believe that the new guidelines, as did their predecessors, are better at dealing with perception than reality. That is, while focusing on pens and logoed golf ball distribution, they leave undiscussed the notion that there is an area of endeavor called pharmaceutical marketing, which is, after all is said and done, dedicated to the effort of selling as much of our drug as possible, gaining market share, beating the competition, etc. This is markedly not medical education folks, it’s unabashed promotion, which seems to be OK as long as pens and coffee mugs are not involved. Though pharmaceutical field forces have been cut by an average of 10 percent in recent years, we still have more than 90,000 representatives in the field who are paid a commission based on how much drug they sell. Moreover, these representatives carefully target their calls to busier physicians’ offices where sales potential is greater, calling into question whether less busy physicians are entitled to less information. In summary, I believe that most health care manufacturers are well-intentioned in their efforts to manufacture high quality products and to market them ethically in the best interests of patients, and that the vast majority of physicians would rather shoot themselves than be bought into using a drug that was not optimal for the patient. Therefore, I believe that the 2009 guidelines do a good job in cleaning up our all-important image among patients and the general public, while still leaving untouched our underlying mission to make money for our stockholders by developing, and yes, selling, good drugs. And as a last, unsolicited idea on this topic, I would like to see a respected and honorable group like PhRMA issue a set of guidelines that does not focus on what we as an industry should not be doing in our interactions with health care providers but rather what we should be doing. Health care is increasingly going bankrupt, both domestically and globally, and health care manufacturers and health care providers alike are having a hard time making ends meet. Therefore, while it may be important from a public relations perspective that manufacturers not spend their limited resources on a round of golf for a health care provider, it is even more important to create and communicate ways in which manufacturers and providers can truly partner to make optimal use of our scarce resources to provide quality care to as broad a population as we possibly can while still making a fair return on our time and investment. This will take far more thought than banning coffee mugs, but will make a far greater contribution. And who better to help the industry in making this contribution than those of us in health care marketing research who can study the true needs of our stakeholders and research the best ways to meet them! Richard B. Vanderveer, Ph.D. Group Chief Executive Officer GfK U.S. Healthcare Companies