Ask the Expert: Ethics and Professionalism

The dilemma that physicians face in assessing the value of a new medication is to determine whether its efficacy or safety is superior to that of existing medications and whether the higher cost and less extensive clinical experience associated with a proprietary drug can be justified in preference to a cheaper generic alternative. This process will include a review of research studies, acquisition of clinical experience, and review of regulatory actions. It also requires an assessment of the physician's and patient's values, including the relative importance of efficacy, safety, cost, convenience, certainty, and hope. As expert consultants and care providers, physicians have an obligation to be well informed, experienced, current, and judicious. Information from industry has the potential to both help and hinder the achievement of these goals but cannot be allowed to replace or derail the physician's own activities.

Pharmaceutical representatives visit individual physicians to encourage their use of specific medications. Standard marketing practices include the provision of information regarding the indications, proper use, and major side effects of the medication, accompanied by motivational materials or activities to get the physician's attention, engender positive feelings, highlight favorable aspects of the drug, and stimulate a change in the physician's behavior.

Information may take the form of peer-reviewed publications favorable to the medication, proprietary information highlighting the drug's efficacy and safety data, and updates on FDA actions regarding the drug. Each of these must be approved by the FDA for marketing distribution. Although the selection of information for formal presentation is far from unbiased, the sources tend to be of high caliber, making the information valid, but incomplete (1).

Less formal information may also be shared, including anecdotes from other physicians, patterns of prescription in the community, and the formulary status of the medication at the physician's or other practice sites. This information is not reviewed by the FDA and may or may not be accurate.

Certain types of information may not be shared by marketing representatives, including use of the medication for indications not approved by the FDA, use of doses outside the approved range, or use of the medication in unapproved populations (“off-label use”). Discussion of competitors' drugs are limited to FDA indications and doses as well.

Common motivational practices include the presentation of gifts, provision of free samples or vouchers, and development of a personal relationship with the physician. Marketing meetings are often coupled with meals, either delivered to the physician's practice site or provided to groups of physicians at a restaurant. These may include a contract speaker, either a local person with some degree of expertise in the field or a nationally known speaker with an established reputation in the area.

Physicians should be motivated by a desire to obtain accurate and useful information that will enhance the quality of their practice and should try to minimize other factors. Pharmaceutical representatives are excellent sources of information on current actions of the FDA regarding their drugs, such as a newly approved indication or recently issued warning. In fact, it is unlikely that physicians will encounter such information from other sources. Data on efficacy and safety, whether from a reprinted peer-reviewed publication or from proprietary sources may also be of interest, but should serve merely as a starting point from which the physician will search for additional information. It is appropriate for the physician to be influenced by this process; in fact it would be poor practice not to be.

Physicians should take pains not to be swayed by motivational factors. The beginning of wisdom in this area is frank recognition that meals, pens, and sticky pads have an impact even on the most objective and entrenched practitioners (2). At a minimum, the American Medical Association guidelines (3) should be followed, as they are by most pharmaceutical companies. A better approach would be the simple avoidance of these incentives. Visiting experts or “opinion leaders,” who are on contract as part of the drug company's speakers bureau, should be viewed in the same way as other marketing representatives.

The use of samples and vouchers is more equivocal (4). They serve the useful purpose of encouraging the physician to gain experience in the use of a new drug and may be the only means by which some patients can obtain the medication. They have been criticized as encouraging the use of more expensive drugs when less expensive alternatives are available. There is no clear consensus on this issue. It is recommended that physicians consider the role of these items carefully and examine objectively the consequences for their practice, often in conjunction with a peer outside the practice.

Dr. S answers Ms. D's personal inquiries politely, but unenthusiastically, and quickly redirects the conversation to ask about the latest FDA actions regarding Ms. D's drug. She accepts and looks over the peer-reviewed papers Ms. D presents her and listens to the marketing presentation highlighting the favorable aspects of the drug. She requests a copy of the package insert so that she can review safety data in more detail. She chooses not to accept the pens and sticky pads. Although she does not usually attend promotional dinner programs, she recognizes the name of the national speaker and agrees to attend the program. She accepts the samples of the short-acting formulation of the drug, knowing that two of her patients depend on them for their supply but turns down samples of the long-acting formulation, which does not appear to have enough benefits to offset the increased cost.

When she and her husband attend the dinner program, they pay for his meal. She asks several questions of the speaker both during and after the presentation. Later, she conducts a brief literature search from her office on the issues covered. She discusses her findings with her colleague in the office, asking for his opinion and its basis. A few days later, she agrees to an appointment with a pharmaceutical representative from another company to discuss an alternative drug in direct competition with Ms. D's product. Satisfied that the new indication for the drug is legitimate, she begins prescribing it for appropriate patients.