Course Authors
Maxwell J. Mehlman, J.D.
Mr. Mehlman reports no commercial conflict of interest.
Estimated course time: 1 hour(s).
Albert Einstein College of Medicine – Montefiore Medical Center designates this enduring material activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
In support of improving patient care, this activity has been planned and implemented by Albert Einstein College of Medicine-Montefiore Medical Center and InterMDnet. Albert Einstein College of Medicine – Montefiore Medical Center is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.
Upon completion of this Cyberounds®, you should be able to:
Describe the ethical/legal issues associated with the withholding of treatment and state-of-the-art AIDS drugs in particular from non-compliant patients
Discuss the legal and ethical conditions under which treatment may be withheld on grounds of patient non-compliance
List the strategies for dealing with non-compliant patients.
Introduction
New highly active antiretroviral therapies ("HAART") provide significant long-term hope for patients with HIV. Unfortunately, treatment regimens are complex, requiring frequent dosing at specific times with numerous pills, some of which must be refrigerated. Failure to maintain the regimen can result in the emergence of drug-resistant viral strains. This has two main consequences: it may compromise the health of the patient and it may permit resistant forms of the virus to be transmitted to other persons who have contact with the patient. Moreover, HAART is expensive, costing approximately $12,000 per year. State medical assistance programs, including Medicaid and ADAPs (AIDS Drug Assistance Programs) cover HAART, but funds are limited, and a number of drug assistance programs have had to be closed to new patients. Non-compliant patients, whose noncompliance may be a complication of mental impairment, homelessness, and/or substance abuse, consume scarce resources that might be better conserved for compliant patients.
May the patient's physician then withhold HAART from non-compliant patients?
The answer seems obvious: "Of course they can."
But it isn't so simple. In the first place, it is not easy to determine which patients are going to be non-compliant. Second, a patient who is non-compliant may become compliant in time for HAART to still be of benefit. Third, we don't know how easy it is to transmit drug-resistant HIV from one person to another; there are no reported cases yet of such transmission. Finally, withholding HAART may land the physician in legal difficulties.
Let's explore some of the issues. Note that I am assuming that there is an existing patient-physician relationship; the discussion would proceed somewhat differently if we were considering whether a physician could or should refuse to enter into a relationship with a non-compliant patient in the first place. I also am assuming that the patient is competent, at least in the sense that they would be allowed to make treatment decisions for themselves based in informed consent. Again, the role of the physician might change dramatically if the patient were found to be incompetent.
Options for Treating the Non-Compliant Patient
A physician facing a non-compliant patient has several options. First, she can prescribe the HAART regimen anyway and hope for, or help the patient to achieve, compliance. But if the physician truly feels that the patient is not going to follow the treatment regimen, then this approach risks the consequences described earlier.
A second option would be for the physician to alert public health officials and ask them to intervene to make sure the patient is compliant. This is done in some places such as New York City in the case of non-compliant persons infected with TB. But currently there is no such public health program for AIDS treatment. Moreover, the HAART regimen is more complex and frequent than the regimen for TB drugs, so that public health intervention would be more difficult and expensive. Finally, TB is more easily transmitted than HIV, and it is clear that drug-resistant TB can be spread from person to person. It is unlikely that public health departments would intervene in the case of non-compliant HIV patients until it was clearer that they presented a real threat to others.
This leaves the physician with two options. She can refuse to treat the patient and terminate the relationship or she can continue the relationship but deny the patient HAART.
How easy would it be to simply end the patient-physician relationship? The "continuous treatment rule" provides that the relationship automatically terminates when further treatment would be "futile." But it is likely that there is something that the physician could do that would benefit an AIDS patient, even one who was non-compliant, so the continuous treatment rule wouldn't apply. In that case, if the physician wanted to end the relationship, she would have to terminate it unilaterally and would be required to give the patient a "reasonable opportunity to obtain care elsewhere." Normally, this means a certain amount of advanced notice, and some information about alternate providers of care. What isn't clear is what this means when, for example, the physician is the only person in the area who specializes in the treatment of AIDS. Even here, the law is unlikely to require the physician to continue to treat the patient indefinitely. The best advice seems to be: the more notice the physician gives the patient and the more help in finding another care giver, the less likely that the physician will be deemed to have acted unreasonably.
What if the physician is willing to continue the relationship, but doesn't feel that the patient would comply with a HAART regime? One option is simply to tell the patient this. For example, the physician could inform the patient that she needed to straighten out her life to the point that she would be likely to be able to comply before HAART would be beneficial. But what if the patient insisted on being given HAART? The physician might try to persuade the patient. But, at some point, the physician might have no alternative but to threaten to end their relationship, allowing the patient to see if she can find another physician who will prescribe the drugs, perhaps because of a different impression of the patient's predicted compliance behavior.
Another option is for the physician not only to withhold HAART, but information about HAART, or, at least, information that would lead the patient to insist on being given HAART. For example, the physician could say merely that there were some other drugs but that they wouldn't benefit the patient. Many patients will know about HAART, so this strategy might not work. But if it would, would it be appropriate?
Generally, withholding information from patients is frowned upon. The only exception in the case of informed consent, for example, is the so-called therapeutic privilege, which allows a physician to withhold information when the information, if imparted, would seriously impair the patient's well-being. But the therapeutic privilege seems to apply when the information itself would harm the patient, not when the information would lead to patient to make life difficult for the physician by insisting on a treatment approach that the physician disagreed with. Furthermore, most scholars insist that the privilege in any event should be interpreted extremely narrowly -- for example, that it only applies if giving the patient the information would so unhinge her as to render her mentally incompetent. Finally, withholding the information might deny the patient the opportunity of seeking a second opinion on the potential benefit or lack of benefit from HAART and on the patient's likelihood of non-compliance. It seems hard to justify depriving a patient of the right to obtain such a second opinion merely because the physician thinks that the treatment is not in the patient's own best interest.
The physician might have a better argument if she withheld the information in order to protect third persons, such as those who might be infected with drug-resistant virus or compliant patients who must rely on public programs with limited funds to be able to obtain the drugs. But the concern about spreading resistant virus would seem to require pretty compelling evidence before withholding information from the patient would be justified. If it is ever appropriate for physicians to ration scarce resources for economic reasons -- which some doubt -- it is not clear that physicians ought to be in the business of denying information to one patient so that another patient can get treatment. (For example, the UK practice of not telling ESRD patients over the age of 55 that dialysis would keep them alive has been widely condemned.)
One final set of issues: Non-compliant AIDS patients most likely are "disabled" within the meaning of the Americans with Disabilities Act (ADA). More importantly, in many instances, the very conditions that render them non-compliant -- such as substance dependence and mental illness -- are themselves disabilities. So, if a physician denies HAART to such a patient, is the physician guilty of discriminating on the basis of the patient's disability?
A "Reasonable Accommodation"
This issue is complex but the law's essential answer is that the physician does not discriminate if she makes a "reasonable accommodation" of the patient's disability. In the case of non-compliant AIDS patients, this might consist of helping the patient to alleviate the conditions that contribute to her non-compliance, such as by providing counseling and referral to social service agencies, helping the patient set up and maintain a workable dosage regimen, storing the medicines, etc. But perhaps, most important, this suggests that the physician ought to reassess the patient's non-compliance frequently. The physician who monitors her patients and prescribes HAART, when a patient has shown that she is ready, will be in a better position both in terms of complying with the ADA and meeting patient needs.