Conflicts of Interest and the Pharmaceutical Industry

CONFLICTS OF INTEREST AND THE PHARMACEUTICAL INDUSTRY

A conflict of interest occurs when an individual’s private goals are inconsistent with that person’s official respon-sibilities. The interrelationship between scientists, physi-cians, and researchers and the pharmaceutical industry has given rise to a variety of well-publicized cases rais-ing concerns about conflicts of interest.

Researchers and drug companies are interdepend-ent. The pharmaceutical industry depends on scientists and clinicians for research, development, and marketing. Conversely, the medical profession depends on research that is largely financed by the pharmaceutical industry. While this interdependence often benefits industry, re-search, and patient care, conflicts of interest may arise in two main areas: (1) drug research and development and (2) clinical education and product marketing.

Drug Research and Development

Pharmacology, unlike some other basic science disci-plines, has a unique status when it comes to potential conflicts of interest. The pharmaceutical industry com-bines a desire for discovery and development with profit-motivated marketing and sales goals. Although scientists and physicians share the desire for drug dis-covery and development and are motivated by the de-sire to contribute to scientific advancement and im-proved patient care, pharmaceutical companies are simultaneously under strong commercial pressures. Pharmaceutical companies are therefore willing to offer financial incentives to physician–researchers who con-duct studies, recruit patients, or are helpful in product development and testing. In some cases, this financial support may compromise professional judgment in con-ducting, analyzing, or reporting research.

For example, often a pharmaceutical company will contract with a private physician to recruit patients into a drug study. While this arrangement frequently offers patients access to treatment that might otherwise be un-available, the potential conflict may ultimately result in lack of objectivity in study design, data interpretation, and dissemination of research results. For example, a 1986 study in the Journal of General Internal Medicine found a statistically significant relationship between drug company funding and outcomes favoring a new therapy.

In addition, this kind of arrangement places the physician in a dual role as a clinician–researcher, with sometimes competing obligations to the drug company and the patient. The doctor assumes a position of re-sponsibility to the company while simultaneously main-taining the usual duties to protect and benefit his or her patients. The physician’s role as patient advocate can easily be compromised, since physicians also have a po-tentially competing interest in enrolling patients in the trial. In fact, patients may mistakenly believe that when their personal family physician suggests they enroll as a subject in a study, the doctor is suggesting enrollment because it is in that specific patient’s interest to partici-pate. However, the enrollment offer probably has little to do with that particular patient’s care and more to do with the physician’s desire to enroll subjects.

At minimum, the principles of autonomy and benef-icence require that patients be told the source of fund-ing for sponsored studies in which they are invited to enroll and advised of any potential conflicts between the physician’s research interests and treatment recom-mendations.

Although disclosure to patients is important, pa-tients are generally ill suited to assess how a potential conflict of interest actually affects their treatment. In addition to disclosure to patients, we need rigorous re-porting requirements for those engaged in drug studies.

Institutions should implement clear policies, and pro-fessional guidelines should be developed, to prohibit re-lationships that place patient care secondary to financial gain.

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 prof-its. As the gatekeepers for all prescription drugs, physi-cians have the power to determine which drugs will compete successfully in the marketplace, making doc-tors the logical targets for marketing efforts by pharma-ceutical firms. In fact, pharmaceutical companies spend more than $11 billion each year on promotion and mar-keting. Between $8,000 and $13,000 is spent annually on each physician. However, many company-sponsored arrangements may conflict with the physician’s respon-sibility to act in the best interest of the patient. A vol-untary code has recently been adopted by the Pharma-ceutical 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 com-panies have generous programs for providing their products free of charge to those who cannot afford them. However, free samples provided by drug compa-nies directly to physicians’ offices should be used cau-tiously, 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 pre-sumably 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 appro-priately and sometimes cannot accurately determine whether it is therapeutically effective. Thus, the patient is entitled to be protected by the physician, whose pri-mary 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 med-ical journals and direct to consumer advertising in the popular media, pharmaceutical company sales repre-sentatives frequently visit physicians. Although thesalesperson’s goal is clearly to promote sales, often these visits take the form of “education” for busy clini-cians. Company representatives present “educational” information, provide meals, and may give gifts or incen-tives to the doctor. Although such visits may keep clini-cians informed about current products, they may also precipitate conflicts of interest. Gifts of more than to-ken value, trips to resort areas for “educational” pro-grams with little scientific merit, and cash incentives for prescribing a drug or having it added to a hospital for-mulary 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 impro-priety. 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 care-ful to avoid impropriety and should receive specific in-struction about the ethically appropriate scope and lim-its of interactions with drug company representatives.

The area of continuing medical education is simi-larly mired with controversy, as “educational” meetings may be simply soft sells at company expense to encour-age physicians to prescribe one company’s product over a competitor’s. While some industry-sponsored educa-tion provides a good opportunity for unbiased scientific exchange, such as when a drug company underwrites the cost of an educational program but places no re-strictions on topics discussed or speakers chosen, too of-ten “education” is a euphemism for marketing. To be considered legitimate, a conference or meeting must be primarily dedicated to scientific and educational activi-ties, and the main incentive for bringing attendees to-gether must be to further broad knowledge.

In addition, physicians may be invited to serve as a drug company “consultant.” These “consultants” are in-vited to a company-sponsored symposium, which is sometimes nothing more than a sales pitch for that com-pany’s products with little real interaction or consul-tancy. While consultants who provide genuine services may receive reasonable compensation and accept reim-bursement for travel expenses, token consulting or ad-visory arrangements cannot be used to justify compen-sating 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 allow-ing the pharmaceutical company to influence the data they present, the means of presenting it, or the out-comes drawn. When companies financially support con-ferences or lectures other than their own, the organizers of the conference should maintain control over the top-ics and speakers selected. If a speaker wishes to men-tion 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 sup-ported 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 in-vitations 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 educa-tional. In addition, industry sponsorship should be noted in any publication reporting study results. Finally, both attendees and speakers should demand that finan-cial sponsorship be revealed before registration and that financial relationships between speakers and the promoter be plainly stated. In short, to ensure objectiv-ity 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 ques-tions are useful to assess the ethics of an arrangement between pharmaceutical company and researcher– clinician. First, would it be embarrassing for the clini-cian if the public knew about the financial arrange-ment? 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 uncom-fortable discussing the remuneration with patient re-cruits 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 fi-nancial 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?