| | Informing patients of the risks and benefits of hormone replacement therapy: Nephrologists’ ethical obligationAs consultants, nephrologists are often in a position to observe and diagnose nonrenal illnesses as well as identify potential complications of previously prescribed therapies. The decision to discuss these types of issues with patients can be complicated by the fear of offending the patient’s primary care physician. When such situations pose potential harm to patients, they become ethical issues and the nephrologist’s responsibility to inform patients of potentially harmful exposure is clear. Given recent research findings, the use of hormone replacement therapy by many of the patients referred to nephrologists should be reviewed and discussed with the patient and the referring physician. All potential benefits and harms should be clearly stated.
Patients seen in nephrology practice are generally medically complex and often have multiple medical issues that should be addressed. Treatment with estrogen/progesterone combination products or hormone replacement therapy (HRT) is one such issue that is admittedly a complicated, if not controversial, topic for all concerned, especially for patients. Any thoughtful provider will question what content to offer patients on this topic, and a medical subspecialist might question the appropriateness of offering any opinion at all. This paper will examine the nephrologist’s ethical obligation to advise patients about an issue not typically thought to be directly related to nephrology, in this case, HRT.
Informing patients of the risks/benefits of hormone replacement therapy: nephrologists’ ethical obligations  Case A nephrologist is asked to see a 66-year-old woman for declining glomerular filtration rate (GFR) (50 mL/min) and proteinuria (400 mg/24 h). The presumed cause of her chronic kidney disease is hypertension. Her medical history is significant for 35 years of documented poorly controlled hypertension, a nonhemorrhagic stroke 2 years before today’s visit, and osteopenia. Current medications are a standard estrogen /progesterone combination product (0.625 mg/5 mg), a long-acting nondihydropyridine calcium channel blocker, a low-dose angiotensin-converting enzyme inhibitor, 81 mg of aspirin, and a calcium supplement. When asked about the HRT, the patient responded, “It’s to help my bones and heart.” The nephrologist is familiar with current recommendations on the use of HRT in postmenopausal women and believes HRT is likely contraindicated for this patient. What should the nephrologist’s clinical and ethical response be? To answer that question clinically, one should review recent data in the general medicine literature regarding the use of HRT.1, 2 Current evidence regarding the use of HRT Recently published results from 2 large randomized clinical trials have questioned the decades-old practice of prescribing HRT to women.1, 2 The studies, Heart and Estrogen/Progestin Replacement Study (HERS) and the Women’s Health Initiative (WHI) provided evidence that the risks associated with continuous hormone therapy (combined estrogen and progesterone) outweighed the benefits. In 2002, after the publication of the reports of the HERS and WHI trials, the United States Preventive Services Task Force (USPSTF) issued revised guidelines advising against the use of HRT for the treatment of chronic conditions in postmenopausal women.3 The USPSTF action was based on the following:
•fair to good evidence that HRT does not decrease, and may in fact increase, the incidence of coronary heart disease;
•fair evidence that the risk of stroke is increased with the use of HRT (especially for those with a previous history of stroke);
•good evidence that HRT increases the risk of venous thromboembolism;
•fair evidence that HRT increases the risk of cholecystitis; and
•fair to good evidence that HRT increases the risk of breast cancer.
On the other hand, the USPSTF also concluded that some benefits are associated with HRT based on the following:
•good evidence that HRT increased bone mineral density;
•good evidence that HRT reduced the risk of fracture; and
•fair evidence that HRT might reduce the incidence of colorectal cancer.
On March 2, 2004, the estrogen only arm of the WHI study was stopped because of adverse events associated with estrogen replacement therapy.4 No consensus exists in the medical community on the use of HRT for the treatment of menopausal symptoms that negatively affect quality of life (hot flushes, urogenital disorders, and mood and sleep disturbances). Most clinicians believe the use of estrogen in such instances should be decided on a case-by-case basis and that only short-term estrogen use should be considered.4 Resolving ethical questions Before analyzing the specific ethical dilemma associated with the above case, we should consider the special nature and obligations of the consultant-patient relationship. Professional relationships with patients (or clients) are considered to be fiduciary in nature. “This means that the fiduciary, or physician holds something in trust [safeguards the health of] a patient. [In this model], the physician must act in the best interest of the patient, with the physician subordinating [his or her] self-interest [and the interest of other parties]. Fiduciary relationships are held to higher standards than other types of relationships where it is clear that self-interest is the motive rather than the well being of the client.”5 Clients or patients in a fiduciary relationship are thought to require the protection of this special arrangement because they are exceptionally vulnerable. They are completely reliant upon the specialized knowledge of the professionals for services that preserve important values (health, life, well-being, etc) that cannot be easily protected without the professionals’ expertise. Thus, the nephrologist is ethically obligated to ask the following questions: What is in the best interest of this patient? How may this patient’s health best be safeguarded? Before grappling with the specifics of the nephrologist’s problem, several general guidelines that apply to all ethical dilemmas must be considered. Ethical problems, like clinical problems, require a methodical approach. In the above case, we know that the problem is an ethical one primarily because the nephrologist must decide whether a particular course of action is right or wrong on the basis of moral, not clinical, criteria. With little doubt, the patient would benefit clinically from the recent information about HRT. However, should the nephrologist be the one to provide that information? The next step in ethical problem resolution is to articulate the ethical question. In the above case there are 2 ethical questions, one quite basic and the other more complex: (1) Whose interests should be of highest priority in the clinical encounter? (2) What is the obligation of a medical subspecialist to inform patients of risks/harms associated with their treatment regimen if the regimen in question falls outside the consultant’s medical specialty? The final step is to identify and formulate ethical justification for all possible solutions. Following this step, an appropriate option may then be selected. This process ultimately enables selection of one preferred approach over all other available options. The option that best preserves important ethical principles and provides the greatest depth of justification is selected. This approach is not foreign to medicine. Just as one uses clinical justification to opt for a particular therapeutic approach, ethical justification is used when choosing an approach to an ethical problem. Additionally, if in the above case the nephrologist concludes that information should be offered to the patient, then a decision must be made about how to provide it. Choices Do nothing The nephrologist concludes that considering the benefits of HRT for this patient is not the reason for the nephrology referral, and by advising the patient the nephrologist risks alienating the referring physician. Thus, no action is taken. This approach can be eliminated almost immediately by asking the first ethical question: Whose interest should be primary in the clinical encounter? This approach is obviously the least desirable option, although it is understandable, given time constraints and the risk of offending the referring physician. However, it cannot be justified from either a clinical or an ethical perspective. Doing nothing denies the patient and the referring physician an opportunity to consider improving health outcomes on the basis of new data. This approach also ignores the ethical principle of medical beneficence and does not respect patient autonomy and the right of patients to make decisions for themselves on the basis of the best currently available information. Here, the consultant has potentially beneficial health information that is being withheld for what could be viewed as reasons of self-interest or peer pressure and not for patient benefit. Talk to the patient first The nephrologist concludes that he or she has a duty to immediately offer the patient information about the current HRT recommendations and contact the referring physician afterward either in writing or by telephone. A key factor in considering this option is the strength of the data upon which the duty to inform is based. In this particular case, the data are relatively clear. The nephrologist’s opinion that the patient should not be taking HRT is based upon recent research from 2 large-scale studies. A decision by the consultant to inform the patient is clinically justified given the size of the studies, the conclusions reached by the investigators, and the fact that the data-monitoring boards stopped the studies early because of their concern that HRT increased risk in cases similar to that of the patient. The strength of evidence is sufficient to reassure the consulting nephrologist that the risks of HRT are a source of concern within the scientific community. Thus, discussion of ongoing HRT with the patient’s primary care physician is clearly in the patient’s best interest. Talking to the patient directly is one way to improve the likelihood that the nephrologist’s concern will not be lost among the many competing demands encountered by the referring physician. At least theoretically, no one is more motivated to clarify a treatment plan’s safety and efficacy than the person whom it affects most directly, the patient. Two additional points must be considered concerning the appropriateness of this option. First, patients who are naïve or less knowledgeable need more of the protection inherent in the fiduciary relationship. These patients are at least theoretically more vulnerable. In our case, the patient does not know about the risk associated with continuing HRT. Her health-care providers have the responsibility of making the data available so she can make appropriate use of the information. Second, talking to the patient directly acknowledges and formalizes the fact that the nephrologist’s primary responsibility is to the patient and secondarily to the referring provider and to the nephrologist’s own financial interests. This point should be kept prominently in the foreground of practice for ethical and legal purposes. The ethical justification for the above approach is fairly clear. This proposed option protects and promotes the universal ethical principles of respect for patient autonomy and beneficence.6, 7 The virtues of honesty, integrity, and trustworthiness are preserved, and the appearance of conflict of interest is avoided. These goals are compatible with a quarter of a century of work in biomedical ethics that suggests, “…moral responsibility in medicine ideally should be conceived in terms of fundamental principles, rules, rights, and virtues.”7 Patient autonomy and medical beneficence are 2 of the 4 universal medical/ethical precepts, the preservation of which is certainly desirable. (The other 2 universal principles are just distribution of goods and services and nonmaleficence.6) Contact the referring physician only The nephrologist decides to work through the primary care physician out of respect for the referring physician’s status as the overseer of the patient’s health care and out of concern that the referring physician will be offended by the consultant’s “interfering” in primary care issues. This approach is frequently used by consultants and is possibly more typical of the traditional relationship between the consultant and the referring physician. It demonstrates a more paternalistic view by suggesting that all information about a patient’s health should be funneled through the primary care physician before the information is discussed with the patient. By conveying the information to the referring physician, this approach preserves beneficence, but by failing to speak with the patient, it ignores the principle of patient autonomy. This approach is also less certain to achieve the desired end. It might or might not accomplish the consultant’s goal of conveying information on HRT risk. If the referring physician chooses to ignore the data and not inform the patient, then the nephrologist is left with the dilemma of how to gracefully execute his or her fiduciary duties. This option ultimately ends up being a middle ground approach that may or may not accomplish the goal, and it suggests that the primary obligation of the consulting physician is to the referring physician and not to the patient.
Recommendation and summary  In the example case, the second option is the most appropriate one available to the consultant. The nephrologist should talk to the patient directly and then notify the referring physician of the concern regarding HRT risks. This solution best preserves accepted ethical principles and meets the trust requirement of fiduciary relationships. Any attempt by the consultant to directly stop the HRT is inappropriate because the primary care physician and the patient need to discuss the risks and benefits of HRT thoroughly. The HRT may need to be tapered rather than discontinued. An alternative treatment for osteopenia may need to be prescribed. Additionally, the language used to explain the risk of HRT should be carefully chosen so the patient is not in any way alienated from her physician, but instead may see the collective interaction as an opportunity for all to work together as a team for her benefit. To this end, a physician in 1935 wrote in the New England Journal of Medicine, “You can do harm by the process that is quaintly called telling the truth [or] you can do harm by lying…It [harm] will arise from what you say and what you fail to say. But try to do as little harm as possible, not only in treatment with drugs, or with the knife, but also in treatment with words…expression of sentiments, and emotions.”8 Ethicist and physician Edmund Pelligrino writes that the definition of the end goal of medicine is to promote a right and good healing action for a particular patient.9 In the above case, disclosure of risk is the only action that meets Pelligrino’s requirement. The consulting nephrologist can be comfortable with this sound ethical and clinical decision.
References  1.
1
Women’s Health Initiative Study Group
.
Risks and benefits of estrogen plus progestin in healthy postmenopausal women
(Principal results from the Women’s Health Initiative randomized controlled trial)
.
JAMA
. 2002;288:321–333
.
MEDLINE |
CrossRef
2.
2
Hulley S
, Furberg C
, Barrett-Connor E
, et al.
Noncardiovascular disease outcomes during 6.8 years of hormone therapy
(Heart and Estrogen/progestin Replacement Study follow-up (HERS II))
.
JAMA
. 2002;288:58–66
.
MEDLINE |
CrossRef
3.
3
U.S. Preventive Services Task Force
.
Postmenopausal hormone replacement therapy for primary prevention of chronic conditions
(Recommendations and rationale)
.
Ann Intern Med
. 2002;137:834–839
.
4.
4
Alving B
.
NIH asks participants in Women’s Health Initiative estrogen alone study to stop study pills and begin follow up phase
.
NIH News
. U.S. Dept of Health and Human Services: NHLBI; 2004;
.
5.
5
Lo B
.
Resolving Ethical Dilemmas
(A Guide for Clinicians)
. (ed 2). Philadelphia, PA: Lippincott Williams & Wilkins; 2002;
.
6.
6
Beauchamp TL
, Childress JF
.
Principles of Biomedical Ethics
. (ed 4). New York, NY: Oxford University Press; 2000;
.
7.
7
Beauchamp TL
.
The four principles’ approach
.
In:
Raanan Gillon
editors.
Principles of Health Care Ethics
. New York, NY: John Wiley and Sons; 1994;p. 4
.
8.
8
Henderson JL
.
Physician and patient as a social system
.
N Engl J Med
. 1935;212:823
.
CrossRef
9.
9
Pelligrino E
.
In:
For the Patients Good
. New York, NY: Oxford; 1988;p. 10
.
a Division of Nephrology, University of Virginia Health System, Charlottesville, VA, USA Address correspondence to Lynn R. Noland, PhD, FNP, Division of Nephrology, Box 800133, University of Virginia Health System, Charlottesville, VA 22908
PII: S1548-5595(04)00120-X doi:10.1053/j.ackd.2004.07.007 © 2004 National Kidney Foundation, Inc. Published by Elsevier Inc All rights reserved. | |
|