A 69-year-old woman with several medical problems believes that she is allergic to generic medications. She frequently conflicts with her long-time primary care physician, who, as required by the patients insurance coverage, refuses to prescribe brand-name drugs when generic alternatives are available. This conflict inten- sifies to a crisis when the patient develops life-threatening prob- lems and still will not take prescribed generic medications. The presentation of this real case is accompanied by a discussion of the ethical dilemmas of the patients physician, who must weigh the interests of a patient who clings to beliefs that the physician thinks are unfounded against the interests of a just rationing program and the broader population it serves. Ann Intern Med. 2004;141:126-130. www.annals.org For author affiliations, see end of text. See related article on pp 131-136. A 69-year-old woman with diabetes mellitus and supraven- tricular tachycardia believes that she is allergic to generic med- ications. Her primary care physician has cared for her for 12 years. Her medical problems include arthritis, diabetes melli- tus, hypertension, dyspepsia, and depression. She frequently comes to the ofce or the emergency department with symptoms that do not have an apparent physiologic basis. Over the last decade, she has undergone a wide range of diagnostic proce- dures that have not shown clinically signicant abnormalities. A psychiatric consultation 4 years ago led to the conclusion that she had somatization disorder. On the advice of the psychia- trist, the primary care physician sees the patient frequently in the ofce and tries to minimize diagnostic testing and new medications. Three years ago, the patient received a generic preparation of glyburide and developed a rash typical of a drug allergy. The patient concluded that she was allergic to generic medications and refused to ll prescriptions for any generic drug. She could not be convinced that allergy to all generic medications, but not to their brand-name counterparts, was impossible. She refused referral to an allergist, asserting that I know my body. Her physician continued to insist on trials of generic medications when appropriate for her problems and refused to prescribe brand-name drugs when generic alternatives were available, as mandated by her insurance program, the state Medicaid program. She occasionally would agree to try a ge- neric medication. However, she developed diffuse itching within a few minutes of taking the medication and would then discard the rest of the prescribed medication. The patients refusal to take generic drugs became a con- stant focus of her relationship with the primary physician, which had been generally warm and effective. Discussions of this issue added several minutes to most visits. Since their conict about treatment with generic drugs was unresolved, her physician suggested that she might prefer to seek another physician, but she declined. Her physician compromised: When she needed medication for problems that were not po- tentially serious, he would insist on prescribing a generic med- ication and leave it to the patient to decide whether to ll the prescription. She generally left the ofce with the prescription but did not take the medication. When she had a serious problem, the physician would prescribe a brand-name drug, even when an effective generic alternative was available. For example, when he treated her for hypertension, he prescribed an angiotensin-receptor blocker, for which no generic alterna- tives exist, instead of a generic angiotensin-converting enzyme inhibitor. The patient asked the physician to write a letter to Medicaid indicating that she was allergic to generic medica- tions. He refused. This patients fears about using generic medications have led to constant conict between her and her primary care physician. Most physicians have problem patients or difcult patients. Literature on ethical and practical is- sues with such patients and management strategies for dealing with them has increased. Difcult patients are of- ten dened as those who engender a negative reaction from their physicians (13). Estimated prevalence of difcult pa- tients in a primary care panel ranges from 15% to 30% (4, 5). Many of these patients have underlying psychological disease; personality disorders are especially common (5). While most of this literature focuses on the patient, the problem patient does not exist in a vacuum. As this case shows, the adjective difcult actually characterizes the relationship between these patients and their physicians as they address conict, including clinical issues that arise because of the socioeconomic environment of medical practice. The physicianpatient relationship is a complex interplay of personalities. In this case, the physicians rather zealous support for policies aimed at reducing inefciency in health care contribute to the conict in their relation- ship. The conict might not exist except for the state Med- icaid programs limitations on its pharmacy benet. The Medicaid program in Massachusetts does not cover brand- name drugs when generic counterparts are available unless physicians explain in writing why the brand-name drugs are medically necessary. Most states Medicaid programs are struggling to meet their budgets today, partly because the Medicaid programs average annual rate of growth for prescription drugs costs was 19.7% from 1998 to 2002. Forty-eight states report that pharmacy costs were a top reason for Medicaid expenditure growth (6). In this case, the state is therefore taking the perfectly rational step of Academia and Clinic 126 2004 American College of Physicians Downloaded From: http://annals.org/ by Thomas Lee on 09/22/2014 not covering brand-name drugs when equivalent generic drugs are available. One year ago, the patient was hospitalized through the emergency department because of dyspnea and a sensation of chest pressure. She was in supraventricular tachycardia, which responded to a -blocker. She did not have evidence of myo- cardial injury, was discharged symptom-free, and received ge- neric atenolol after a 1-day stay. When she lled her discharge prescription for atenolol, she discovered that her physician had prescribed a generic medication. She did not take the atenolol. Her primary care physician warned her that she was risking her life, and she insisted that he prescribe a brand-name -blocker. He refused, pointing out that the low-cost generic drug was equivalent to the brand-name drug. At this point in the case, the ethical issues have be- come clear. The physician is in a classic conict of interest situation. A conict of interest occurs when the will to achieve certain secondary objectives inappropriately inu- ences progress toward a primary objective (6). In this case, the primary objective is the well-being of the patient. The secondary interest is the cost-effective generic drug policy of the Medicaid program. Twenty years ago, few would have joined the debate about what to do: Most ethicists would have instructed the physician to ignore the requirements of the insurer and simply treat the patient with the more expensive brand- name medication. According to this traditional under- standing of medical ethics, the physicians altruistic com- mitment to the patient would trump the interests of the state. As Pellegrino (7) persuasively stated: Physicians are healers rst, and in this role, nancial incentives and com- modication of health care must be ignored. However, medical ethics has slowly evolved to a dif- ferent view of such issues. Wikler (8) neatly formulated what many others agree is an important evolution in med- ical ethics (8). In the rst stage, ethical behavior was merely a matter of adherence to codes of professional ethics. In the second stage, which marked the birth of bioethics in the 1970s, the focus was the physicianpatient relationship. Ethical behavior is rooted in a personal commitment to an altruistic model of this relationship. In the third stage, bio- ethicists placed the physicianpatient relationship into the larger structure of health care in society. Once medical ethics recognizes the social context of disease and care, it must consider issues of justice, includ- ing the distribution of scarce health care goods. As health care costs have increased, the gap between health care for the wealthy and health care for the poor has widened. Medical ethics in the United States has increasingly recog- nized this disparity as an urgent ethical issue and has re- sponded by incorporating the just distribution of resources into its framework for ethical behavior. Of course, the no- tion of scarcity and rationing as a response is not new. The Health Care and Medical Priorities Commission of Swe- dens Ministry of Health and Social Affairs has noted that rationing is inevitable; rationing has always been part of health care. . . [A]ny rationing scheme must [have] three core principles, all human beings are equally valuable, so- ciety must pay special attentions to the needs of the weak- est and most vulnerable, and cost efciency, all else being equal must prevail (9). Today, growing consensus deals with scarcity, and developing reasonable methods of ra- tioning is an integral part of medical ethics. If one accepts the important role of justice in a frame- work for ethical behavior in health care, the ethical analysis of the present case resolves itself into answering 2 ques- tions: First, is the rationing mechanism just? Second, is the physician taking the right actions to resolve the conict? On the rst question, Emanuel (10) has suggested that at least 3 principles must be considered in allocating health care resources justly: Improving health should be the pri- mary goal, patients should be well-informed, and patients should have the opportunity to consent. Applying the rst principle is perhaps most critical to analyzing this case. Our struggle to apply it emphasizes the difculty that ethicists and physicians face in balancing the twin imperatives of an altruistic physicianpatient relation- ship and just distribution of resources. In this case, the physician would best serve the patients health by provid- ing the brand-name -blocker. However, if we consistently allow patient choice to trump scientically based, reason- ably cost-effective treatment strategies, Medicaid funding will be inadequate to meet the programs responsibilities. A scally compromised Medicaid program might have to deny care for other patients, and the overall health of so- ciety would be ill-served. So, the physician in this case is, in essence, balancing the patients request for a brand-name drug with the need to conserve resources so that the Med- icaid program can serve as many legally entitled patients as possible. The stakes in this case are lower than they would be if the Medicaid program had to deny bone marrow transplantation for a child with a controversial indication, but the nature of the ethical conict is the same. Medical ethics has acknowledged that the conict exists, which is an important advance. However, a principle that leads to easy resolution of individual cases has not been found. A generics-only guideline seems reasonable from a cost-effectiveness perspective. Use of generic drugs, which in most circumstances are exactly like their much more costly brand-name counterparts, is a noncontroversial method of conserving resources. However, we must decide on a case-by-case basis whether rationing by substituting a less costly alternative is just. If the scientic rationale is sound, the rationing mechanism is probably just (11). Bur- ton and colleagues (12) analyzed the ethics of pharmaceu- tical benet management programs. They argued that a limited formulary is a reasonable rationing mechanism and that prohibiting prescription of a brand-name medication is appropriate when a generic equivalent is available. We conclude that insisting that a patient accept a generic drug is a just method to allocate resources. The patients physi- Academia and Clinic Allergic to Generics www.annals.org 20 July 2004 Annals of Internal Medicine Volume 141 Number 2 127 Downloaded From: http://annals.org/ by Thomas Lee on 09/22/2014 cian was acting fairly when he used this principle in his ethical framework for dealing with the patient. The fairness of the allocation principle in this program does not imply that all pharmaceutical benet manage- ment programs are just. Other situations may introduce issues that change the way we ask about the appropriate- ness of limiting access to pharmaceuticals. For example, if the insurer was a for-prot corporation, the physicians were capitated, or physicians received direct nancial re- ward if they adopted a generics-only prescribing policy, physicians conict of interest would be substantially sharper, and we might conclude that they were acting un- ethically because the secondary considerations involved personal gain. Increasing the intensity or immediacy of the incentive for physicians to reduce costs (for example, through stronger nancial incentives) would intensify the conict (13). On the other hand, effective negotiations with pharmaceutical companies might reduce the pro- grams expenses for brand-name drugs and decrease the need for this conict. In this case, we have a public insurer and, at least as far as we know, no nancial pressure on the physician. A Medicaid program, unlike a private insurer, has a relatively clear mandate when it tries to resolve the trade-off between increasing resources for an individual patient and increas- ing the number of patients who can be eligible for cover- age. Simply put, insisting that the patient use a generic drug in this context improves health care. It is a win for society and a no lose for the patient, at least if she takes the drug. We believe that improving health care is paramount. In an earlier era of medical ethics, many ethicists might have argued that the principle of benecence, doing good for patients, might lead a physician to prescribe brand- name drugs for this patient. In the present era, fewer would adopt this viewpoint. We do not think that the principle of benecence entails absolute deferral to the patients wishes. The supporting statement from the Medicine as a Profes- sion Managed Care Ethics Working Group in this issue (14) gives carefully nuanced advice in dealing with insur- ance companies and managed care. We need to consider Emanuels other 2 principles of just allocation (10). First, the requirement for the patient to consent to treatment takes a different form when she is the beneciary of a public program. While the patient clearly controls the choice of a therapeutic intervention, such as whether or not to have surgery or take medication, she cannot really choose medication when the public in- surer adheres to its formulary. Wealthier individuals might opt for a different insurer, which allows greater choice about medications. Most public program recipients do not have this option. The patient in this case study probably has nowhere else to turn for health insurance, and, as an insurer of last resort, Medicaid cannot provide the patient with much choice. Choice is limited in public programs. Rather than assert the patients right to choose between equivalent forms of the same treatment as a safeguard to ensure fair- ness, we must closely scrutinize the scientic rationale of the cost-effectiveness measures that the public program uses. Continuing our analysis by using Emanuels principle of patient consent (10), we note that the physician seems to have been honest and direct in his discussions with the patient. Although the case report is not completely clear on this point, we are reasonably sure that the physician has told the patient that he is insisting on generic atenolol because the Medicaid program itself insists on it. He doesnt have a personal nancial incentive. When physi- cians have to bluff or puff about their nancial incen- tives, the physicianpatient relationship changes for the worse, often irretrievably. These awkward conversations between uncomfortable physician and suspicious patient have brought important ethical questions about certain managed care techniques to public attention (15). If we are going to ration, we must honestly explain our decision making to our patients and respond when they voice their concerns. Presumably, the physician in this case gave an accurate explanation, although research by Pearson and Hyams (16) has suggested that physicians are not always completely honest about efforts to cut costs. They often simply ask the patient to trust them (16). In our analysis of this case, we should ask whether this particular Medicaid program allowed physicians to petition for a waiver from prescribing rules. If it did, the physician could advocate the patients position and still play within the rules. Should he do so? He would have to repress his own convictions about just allocation of resources, but per- haps the opportunity to petition for a waiver is the pro- grams way of afrming that the patients need should come rst in the uncommon instance of an irreconcilable conict. However, programs usually grant these waivers only when the approved medication has a clear contrain- dication. As indicated in the Medicine as a Profession Managed Care Ethics Working Group statement (14), we could not sanction the physician if he lied to get a waiver for this patient (although many patients and some physi- cians might sanction it). Finally, with regard to the conict of interest itself, we note that the physician has addressed the patients needs in a graded fashion in the past. The physician was willing to prescribe brand-name medications when the problem was clinically signicant, insisting on generic drugs only when the problem was relatively clinically insignicant. Essen- tially the physician weighed the best interests of the patient against the interests of the just rationing program. We be- lieve that many would nd this compromise acceptable and that it is a good example of bringing principles of justice and health care rationing to the bedside. Most well- designed Medicaid pharmaceutical benet programs also recognize that problem patients may require compromise and have appeal programs that allow substitution of non- Academia and Clinic Allergic to Generics 128 20 July 2004 Annals of Internal Medicine Volume 141 Number 2 www.annals.org Downloaded From: http://annals.org/ by Thomas Lee on 09/22/2014 generic medications in some circumstances. At this point, medical ethics still seems to give primacy to the physicians duty to advocate for the patient but, in contrast with the past, now requires the physician to try hard to allocate resources justly. One week later, the patient had a heart rate of 160 beats/min at her adult day care program. The nurse called her physician, who directed the nurse to tell the patient to take her atenolol. The patient refused. The nurse suggested that the patient go to another physician, but the patient said, I want him to write the prescription. If he wont and I die, it will be on his head. When the nurse continued to encourage her to switch physicians, the patient said, Ive known him for so many years, and he knows me so well. I dont want to start all over with someone new. At this point, the conicting forces are challenging the physicianpatient relationship. On one side are the pa- tients beliefs about generic drugs. On the other side is the physicians commitment to practice according to guide- lines that ensure just allocation of resources. With the on- set of supraventricular tachycardia in an elderly, diabetic, hypertensive woman, this conict has intensied to a crisis. A generic medication normally produces no decrement in quality, unless the patient will not take it. However, be- cause this patient adamantly refuses to use generic medica- tions, her physicians adherence to Medicaids policy now threatens her health. As medical ethics has evolved in the last part of the 20th century, notions of distributive justice have modied the doctrine of patient autonomy. Still, patient autonomy is, rightly, a potent ethical driver of daily practice. Accord- ing to Burton and colleagues (12), autonomy issues weigh strongly when the ethics of pharmaceutical benet man- agement are reviewed. We normally attempt to respect pa- tients decision making about their use of health care re- sources. Autonomy has limits. We expect patients to be re- sponsible participants in their health care. As Daniels and Sabin (17) pointed out, a reasonably just health care system depends on health care organizations, insurers, physicians, and patients all being accountable for their actions. Pa- tients must use health care resources rationally. If they do not, we cannot simply accede to irrational choices. But, at times, we must be prepared to compromise principles of equity with the needs of an individual patient. Therefore, the physician must reconsider his stance. Although the guideline prohibiting generic drugs is quite rational, the high risk that the patient will harm herself, albeit unintentionally, by not taking generic medications must tip the physician in the direction of prescribing a brand-name medication. In the end, he bows to the pa- tients iron will, perhaps thinking that the Medicaid pro- gram would be harmed if all patients behaved like this woman but realizing that most patients behave more ratio- nally than she. When the nurse called the physician back to report that the patient would not take any medication unless he prescribed it, he relented and prescribed a brand-name, long-acting -blocker. This case study demonstrates the extraordinary intri- cacies of the physicianpatient relationship. Everyone who has been or has treated a patient knows that this relation- ship has nuances. The interdependence, respect, concern, and affection in the physicianpatient relationship con- found the principles that form the basis of a market econ- omy. Here, the patient has been battling with the physician who will not give her brand-name medications, yet she remains extraordinarily committed to that physician be- cause she believes that he has her welfare at heart. From the physicians viewpoint, the duty to provide care tempers all the difculties and frustrations of dealing with an irrational patient. Most relationships between 2 citizens in the liberal state could not tolerate such a sharp division of belief over a fundamental issue. But, the strong ties of the therapeutic alliance, with its acceptance of human frailty, allow the physician to continue to care for the patient and the pa- tient to accept his care. In this situation, the physician makes the appropriate choice. The conict among the patients fundamental right to choose her treatment, her worsening health, and the physicians commitment to practice in a certain way be- came too strong. Perhaps the physician became a utilitarian at the end. He may have realized that the patients wors- ening condition shifted the balance of benet and harm (as averaged across all participants affected by this episode, including himself, the patient, and other Medicaid pa- tients) to net benet for prescribing a brand-name drug. In any case, he heeded his commitment to the patient and prescribed the more expensive medication. We believe that this physician will continue to try to instruct and educate his patient, perhaps to little avail. He will continue to insist on accountable and reasonable be- havior by the patient, but he will relent when necessary. He may guide the patient toward psychiatric help. This case illustrates the increasingly prominent role of distributive justice as a principle of medical ethics. We now expect physicians to balance their obligation to an individ- ual patient with their obligations to all who may need medical care. The accompanying Medicine as a Profession Managed Care Ethics Working Group statement (14) il- lustrates the extent to which this thinking has become part of the mainstream of medical practice. This dual obligation does create challenges, which try our patience and test our patients loyalty to us. Ultimately, the physician and the patient usually resolve the conict and move on together. From Brigham and Womens Hospital, Partners Community Health- care, Harvard Medical School, and Harvard School of Public Health, Boston, Massachusetts. Potential Financial Conflicts of Interest: None disclosed. Academia and Clinic Allergic to Generics www.annals.org 20 July 2004 Annals of Internal Medicine Volume 141 Number 2 129 Downloaded From: http://annals.org/ by Thomas Lee on 09/22/2014 Requests for Single Reprints: Troyen A. Brennan, MD, Brigham and Womens Hospital, 75 Francis Street, Boston, MA 02115; e-mail, tabrennan@partners.org. Current author addresses are available at www.annals.org. References 1. John C, Schwenk TL, Roi LD, Cohen M. Medical care and demographic characteristics of difcult patients. J Fam Pract. 1987;24:607-10. [PMID: 3585264] 2. Groves JE. Taking care of the hateful patient. N Engl J Med. 1978;298:883-7. [PMID: 634331] 3. Lechky O. There are easy ways to deal with difcult patients, MDs say. CMAJ. 1992;146:1793-5. [PMID: 1596817] 4. Hahn SR, Kroenke K, Spitzer RL, Brody D, Williams JB, Linzer M, et al. The difcult patient: prevalence, psychopathology, and functional impairment. J Gen Intern Med. 1996;11:1-8. [PMID: 8691281] 5. Lin EH, Katon W, Von Korff M, Bush T, Lipscomb P, Russo J, et al. Frustrating patients: physician and patient perspectives among distressed high users of medical services. J Gen Intern Med. 1991;6:241-6. [PMID: 2066830] 6. Thompson DF. Understanding nancial conicts of interest. N Engl J Med. 1993;329:573-6. [PMID: 8336759] 7. Pellegrino ED. The commodication of medical and health care: the moral consequences of a paradigm shift from a professional to a market ethic. J Med Philos. 1999;24:243-66. [PMID: 10472814] 8. Wikler D. Presidential address: bioethics and social responsibility. Bioethics. 1997;11:185-92. [PMID: 11654772] 9. Health Care and Medical Priorities Commission. No Easy Choices: The Dif- cult Priorities of Health Care. Swedish Government Ofcial Report. Stock- holm, Sweden: Ministry of Health and Social Affairs; 1993. 10. Emanuel EJ. Justice and managed care. Four principles for the just allocation of health care resources. Hastings Cent Rep. 2000;30:8-16. [PMID: 10862365] 11. Emanuel EJ, Goldman L. Protecting patient welfare in managed care: six safeguards. J Health Polit Policy Law. 1998;23:635-59. [PMID: 9718517] 12. Burton SL, Randel L, Titlow K, Emanuel EJ. The ethics of Pharmaceutical benet management. Health Aff (Millwood). 2001;20:150-63. [PMID: 11558699] 13. Pearson SD, Sabin JE, Emanuel EJ. Ethical guidelines for physician com- pensation based on capitation. N Engl J Med. 1998;339:689-93. [PMID: 9725929] 14. Povar GJ, Blumen H, Daniel J, Daub S, Evans E, Holm RP, et al. Ethics in practice: managed care and the changing health care environment. Medicine as a Profession Managed Care Ethics Working Group statement. Ann Intern Med. 2004;141:131-5. 15. Illingworth P. Blufng, pufng and spinning in managed-care organizations. J Med Philos. 2000;25:62-76. [PMID: 10732876] 16. Pearson SD, Hyams T. Talking about money: how primary care physicians respond to a patients question about nancial incentives. J Gen Intern Med. 2002;17:75-8. [PMID: 11903778] 17. Daniels N, Sabin J. The ethics of accountability in managed care reform. Health Aff (Millwood). 1998;17:50-64. [PMID: 9769571] Academia and Clinic Allergic to Generics 130 20 July 2004 Annals of Internal Medicine Volume 141 Number 2 www.annals.org Downloaded From: http://annals.org/ by Thomas Lee on 09/22/2014 Current Author Addresses: Dr. Brennan: Brigham and Womens Hos- pital, 75 Francis Street, Boston, MA 02115. Dr. Lee: Partners Community Healthcare, Inc., Prudential Tower, 11th Floor, 800 Boylston Street, Boston, MA 02199. W-16 20 July 2004 Annals of Internal Medicine Volume 141 Number 2 www.annals.org Downloaded From: http://annals.org/ by Thomas Lee on 09/22/2014