Commentary
Time to End Free Drug Samples
Timothy Craig Allen, MD, JD.


Keywords: Drug samples; costs; inappropriate prescribing

Published: 10 January 2013 Cite as: Craig TA. Time To End Free Drug Samples. Bull Health L Policy. 2012;1(2).

Introduction
Pharmaceutical manufacturers are highly regulated, and must meet a plethora of governmental and nongovernmental guidelines and rules, some of which were enacted to address manufacturer improprieties regarding drug sales. Yet pharmaceutical manufacturers continue to use, and indeed increasingly utilize, extreme pharmaceutical marketing tactics that often incorporate deceptive methods or biased information.
1 Further, pharmaceutical sales teams are typically an aggressive sort, and have been likened to soldiers going to war, stopping at nothing to prevail.1

Free drug samples are big business. The value of free drug samples dwarfs the value of other pharmaceutical manufacturer gifts to physicians.
2 One study found that up to 94% of physicians have some pharmaceutical manufacturer relationship, and between 78-92% receive free drug samples.3 No matter what they are told by pharmaceutical manufacturer sales teams, physicians should clearly understand that “[d]rug samples are gifts from pharmaceutical representatives. Acceptance of the sample establishes an implicit relationship with the gift giver that involves vague but real obligations. Any gift, even those of small monetary value or those that benefit patients, creates a relationship of reciprocity that affects treatment decisions.”3-6 Yet, whereas gifts to physicians have come under increasing scrutiny and control,3 free drug samples have been left relatively unexamined, and only a few academic centers have banned free drug samples altogether.7

Free drug samples undoubtedly provide some benefit to some patients, including some of those who are most in need.
1,3,8,9 Despite free drug samples being considered physician gifts, they have been protected from increased social scrutiny by the assumption that they provide various societal benefits, the most important of which is drug access to needy patients. Other protective benefits that have been deemed to allow for reduced free drug sample scrutiny include allowing patients to try a medication and receive immediate therapeutic benefit without the delay of filling a prescription or costly commitment, and providing valuable manufacturers’ educational material for the benefit of the physician and patient.1,3,8,9

The social cost of free drug samples heavily outweighs these benefits, however. Rather than the expected benefit of providing a medication instantly without costly commitment, studies have shown that free drug samples instead typically persuade patients to pursue, and become dependent on, only brand name drugs without regard to their cost or efficacy, actually resulting in significant long-term social cost rather than short-term savings.
1,10 In addition, instead of the expected result of providing socially useful educational material for the benefit of the physician and the patient, the “educational material” is frequently merely biased marketing boilerplate, which may contain incomplete or incorrect information, including the suppression of unfavorable research results.1 As this material is typically labeled as “product information” or “educational material” rather than “advertisement” or “promotional material,” the provision of this information is ethically questionable. This misinformation could be so serious as to ultimately lead to patient death.1

Providing medication to the truly needy remains an extremely important endeavor. Physicians, as many others, believe that the most important function of free drug samples is providing for the needy.
3,11,12 Unfortunately, even this important social benefit is overwhelmed by the negative consequences of free drug samples. Research has shown that overall, needy patients actually are less likely to receive free drug samples than others, including insured patients.1,3,13-15 Perhaps worse, physician abuse of free drug samples is pervasive, with studies showing that almost all physicians give free drug samples to family and friends, and use the samples themselves; that one third of all free drug samples are being consumed by physicians, their families, and their friends; and that one fourth of all medications taken by residents are free drug samples.2,3,16-19 Physician utilization of free drug samples as direct gifts to themselves, their families, and their friends is ethically unsound. In addition, the increased patients’ feelings of gratitude and loyalty to the physician who provides the free drug samples constitutes an indirect but real pharmaceutical gift to the physician, for which the physician is also beholden to the pharmaceutical manufacturer.2 Ultimately, it is evident from numerous studies that “free drug samples serve as a marketing tool, not as a safety net”15 for needy patients.

For a physician, putting one’s own interest ahead of the patient’s best interest by accepting a pharmaceutical bribe violates the physician’s duty to the patient, diminishes the physician-patient relationship, and erodes patient trust.
1 Such is often the case in free drug sample situations where additional pharmaceutical incentives are involved. Yet physicians need not have any intent to benefit or deceive. Studies have shown that good, well-intended physicians often are not even aware that their objectivity has been compromised in their use of free drug samples.1,3,4,6,11,20-31 As difficult as it is for the experienced physician to avoid the ethical landmines of free drug samples, in the training realm, where physicians develop life-long behaviors and formalize their ethical boundaries, inexperienced medical students and residents are exceptionally vulnerable to pharmaceutical manufacturers’ marketing maneuvers.1,3,32

In an environment of health care that is increasingly monitored, free drug samples stand out as an obvious exception, as they are typically incompletely monitored, if monitored at all, in clinics and hospitals. The increasing stress on an already overburdened health care system makes it unreasonable to assume that free drug samples will be monitored any more appropriately in the future, either in the clinic or hospital setting.
33 Such lack of monitoring increases the risk of any number of negative consequences, from medication errors to outright theft.

Authors, after damning indictments of the whole free drug sample mess, nonetheless have stopped short of demanding an end to free drug samples.
1,3,9 Instead, they recommend the institution of additional safeguards as a remedy,1 or propose half measures such as increased physician education or better managing pharmaceutical manufacturer sales representative contact.3,9 But there is no historical evidence “additional safeguards” or tepid half measures will, on top of the morass of already existing guidelines and rules, have any impact on reforming the pharmaceutical industry, and it is unreasonable to think they would. The minor benefits of free drug samples alone cannot be their salvation. Free drug samples must end.

Ending free drug samples will not be to the detriment of needy patients. Alternative ways to assist the bona fide needy will arise to fill the vacuum left by the end of free drug samples. Drug sample vouchers may provide significant benefit without presenting physicians with ethical challenges.
3 Pharmaceutical manufacturers themselves will undoubtedly participate in this endeavor, outside the realm of the physician clinic or hospital. Indeed, they already are. “If you cannot afford you medication, [pharmaceutical manufacturer] may be able to help” has already made a place for itself in popular jargon. Further, because the current benefit to needy patients has been exaggerated, real measures to provide medications to the truly needy are likely to provide significantly more benefit, both in terms of cost and efficacy, than the current system of free drug sample distribution that involves the prescribing physician.

In a free, economically unrestricted,
laissez-faire world, free drug samples would be appropriately unregulated. However, in the current, artificial, government-burdened, regulation-laden environment of health care, the carve-out for free drug samples, ostensibly in the name of benefiting needy patients, does not pass ethical muster. Free drug samples have proven themselves to be no different from other forms of pharmaceutical manufacturer marketing.8 Numerous studies have shown that the real but meager benefits of free drug samples are overwhelmed by the social costs, including the insidious erosion of patient trust. Half measures such as increased regulation and physician education have failed and there is no evidence adding new measures would be of any benefit. It is time to end free drug samples.

Author(s)
Timothy Craig Allen, MD, JD, is Professor and Chair, Department of Pathology and Laboratory Medicine, University of Texas Medical Center, Tyler, TX.

Correspondence:
Professor Timothy Craig Allen, 11937 U.S. 271,
Tyler, TX 75708
Email: timallenmdjd@gmail.com

References (Bluebook)

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