Clinical Education and Product Marketing

The second area for ethical concern is clinical education and product marketing. The line between "education" and marketing is frequently a blurry one, and it is often difficult to separate a company's desire to educate physicians about products that may genuinely enhance patient care from the company's desire to increase profits. As the gatekeepers for all prescription drugs, physicians have the power to determine which drugs will compete successfully in the marketplace, making doctors the logical targets for marketing efforts by pharmaceutical firms. In fact, pharmaceutical companies spend more than $11 billion each year on promotion and marketing. Between $8,000 and $13,000 is spent annually on each physician. However, many company-sponsored arrangements may conflict with the physician's responsibility to act in the best interest of the patient. A voluntary code has recently been adopted by the Pharmaceutical Research and Manufacturers of America which establishes guidelines for relationships between the pharmaceutical industry and health care professionals.

Ultimately, prescribing practices are the main source of concern, as physicians may be induced to prescribe some products rather than others based on factors other than therapeutic effectiveness or cost. Many drug companies have generous programs for providing their products free of charge to those who cannot afford them. However, free samples provided by drug companies directly to physicians' offices should be used cautiously, and the choice of drugs should be made on the basis of medical indications, not sample availability. While samples supplied to physicians' offices to be given to patients may enable a patient to try a drug for a few weeks to be sure it is tolerated, they also serve to get patients started on a particular product which presumably will have to be continued and paid for by the patient or a third-party payer. The patient, as a health care consumer, is not in a position to assess the need for a certain drug or decide whether it is prescribed appropriately and sometimes cannot accurately determine whether it is therapeutically effective. Thus, the patient is entitled to be protected by the physician, whose primary role is that of patient advocate as dictated by the principles of beneficence and nonmaleficence.

Product marketing presents other ethical issues as well. In addition to direct product advertising in medical journals and direct to consumer advertising in the popular media, pharmaceutical company sales representatives frequently visit physicians. Although the salesperson's goal is clearly to promote sales, often these visits take the form of "education" for busy clinicians. Company representatives present "educational" information, provide meals, and may give gifts or incentives to the doctor. Although such visits may keep clinicians informed about current products, they may also precipitate conflicts of interest. Gifts of more than token value, trips to resort areas for "educational" programs with little scientific merit, and cash incentives for prescribing a drug or having it added to a hospital formulary all are cause for concern. The line between a gift and a bribe is not a sharp one, and clinicians and drug company employees should strive to avoid any impropriety. The American Medical Association has stated in its Current Opinions that gifts should primarily benefit patients and should not be of substantial value. While textbooks, modest meals, and educational or work-related gifts, such as notepads or textbooks, may be appropriate, cash payments are not appropriate. Physicians should not accept gifts from companies if the gift might compromise or appear to compromise the physician's objectivity. A helpful criterion suggested by the American College of Physicians when considering the ethical appropriateness of a particular interaction between a physician and drug company is to ask whether one would be willing to have the arrangement generally known. If not, the action falls outside the realm of ethical acceptability and should be avoided.

Medical students and residents are not exempt from the influence of drug companies. Many students and residents are offered gifts of educational books or equipment or are invited to attend company-sponsored events. Young professionals need to be extremely careful to avoid impropriety and should receive specific instruction about the ethically appropriate scope and limits of interactions with drug company representatives.

The area of continuing medical education is similarly mired with controversy, as "educational" meetings may be simply soft sells at company expense to encourage physicians to prescribe one company's product over a competitor's. While some industry-sponsored education provides a good opportunity for unbiased scientific exchange, such as when a drug company underwrites the cost of an educational program but places no restrictions on topics discussed or speakers chosen, too often "education" is a euphemism for marketing. To be considered legitimate, a conference or meeting must be primarily dedicated to scientific and educational activities, and the main incentive for bringing attendees together must be to further broad knowledge.

In addition, physicians may be invited to serve as a drug company "consultant." These "consultants" are invited to a company-sponsored symposium, which is sometimes nothing more than a sales pitch for that company's products with little real interaction or consultancy. While consultants who provide genuine services may receive reasonable compensation and accept reimbursement for travel expenses, token consulting or advisory arrangements cannot be used to justify compensating physicians.

Speakers at company-sponsored events who are drawn from the professional community should subject their presentation to the same level of scientific rigor as they would apply to a presentation at a professional meeting. In particular, they should refrain from allowing the pharmaceutical company to influence the data they present, the means of presenting it, or the outcomes drawn. When companies financially support conferences or lectures other than their own, the organizers of the conference should maintain control over the topics and speakers selected. If a speaker wishes to mention a specific product, he or she should be sure to avoid any appearance of impropriety by comparing it fairly and completely with competing products. Researchers and clinicians who are invited to conduct studies supported by drug companies and present their data at company-sponsored educational events should take special care to conduct the study meticulously, analyze the data rigorously, and present the data as objectively as possible. Speakers should avoid accepting lecture invitations to events at which the drug company pays the audience to attend and should object if the company's marketing representatives conduct sales activities, such as distributing samples or brochures about a specific product, when an event has been promoted as educational. In addition, industry sponsorship should be noted in any publication reporting study results. Finally, both attendees and speakers should demand that financial sponsorship be revealed before registration and that financial relationships between speakers and the promoter be plainly stated. In short, to ensure objectivity and eliminate any appearance of conflict of interest, doctors should get their information primarily from professional peer-reviewed journals and not rely solely on material provided by drug companies.

In addition to these general guidelines, three questions are useful to assess the ethics of an arrangement between pharmaceutical company and researcher-clinician. First, would it be embarrassing for the clinician if the public knew about the financial arrangement? Arrangements that would cause embarrassment or lead others to suspect a conflict of interest should be avoided. Second, can the physician reveal the financial arrangements to patients whom the clinician invites to participate in the study? If the physician feels uncomfortable discussing the remuneration with patient recruits because of the appearance of a conflict of interest, the physician should not participate. Third, would the clinician pursue the same treatment strategy if there were no financial incentive? If the physician would likely choose another treatment were it not for the financial rewards from the drug company, the physician should reconsider offering enrollment for the patient. Finally, do any professional codes, institutional policies, or other guidelines preclude participation?

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