American Journal of Bioethics
Summary of the panel discussion, August 12. Available at: who. int/tmediacentre/news/statements/2014/ebola-ethical-reviewsummary/en (accessed 14 January 2015). World Health Organization. 2014b. WHO Meeting of the Scientific and Technical Advisory Committee on Ebola Experimental Interventions—Briefing note. Geneva, November 13. Available at: who. int/medicines/ebola-treatment/scientific_tech_meeting/en/#. VHOOGRkGy40.email (accessed 14 January 2015).
World Health Organization Ebola Response Team. 2014. Ebola virus disease in west Africa—the first 9 months of the epidemic and forward projections. New England Journal of Medicine 371(16): 1481–1495. World Health Organization Ebola Response Team. 2015. West African Ebola epidemic after one year—slowing but not yet under control. New England Journal of Medicine 372(6): 584–587.
Placing and Evaluating Unproven Interventions Within a Clinical Ethical Taxonomy of Treatments for Ebola Virus Disease Nathan G. Allen, Baylor College of Medicine Jennifer S. Blumenthal-Barby, Baylor College of Medicine Laurence B. McCullough, Baylor College of Medicine The target article by Shah, Wendler, and Danis (2015) ends with a call “to determine when it is ethically obligatory, rather than just permissible, to offer unproven interventions to patients.” In the following commentary we attempt to assist in this process by outlining a clinical ethical taxonomy of interventions/treatments in Ebola virus disease (EVD) and discussing how the placement of proven and unproven treatments within this taxonomy affects whether or not they are ethically permissible, obligatory, or impermissible. We also identify an additional constraint that may counsel against providing unproven interventions—the need to ensure sustained excellent infection control. In addition, we describe how patients with potential EVD may form a unique subtype of individuals in regards to the ethics of their care, apart from individuals with and without EVD, when providing proven and unproven therapies. The following taxonomy categorizes treatments based primarily on their degree of clinical effectiveness and outlines the implications for ethical decision making and clinical practice (Table 1). Although the vast majority of current EVD care is in the resource-limited setting, Ebola is a worldwide health threat and this taxonomy is applicable to all health care settings. The provided examples are chosen for convenience and illustrative purposes and are not intended to be exhaustive.
In our taxonomy, interventions already approved for other indications or otherwise available are category B-2. Although we agree that there are some unique features to the use of experimental interventions not needed for use in a research trial, in our taxonomy we do not consider them different than experimental interventions (category B-1) because of their clinical similarity and the additional objections raised by Shah and colleagues to their use. Health care professionals are only ethically obligated to provide treatments in category A. The obligation is dependent on the following: availability of resources, that its provision does not prevent use of a more effective treatment, that it can be provided with sustained and excellent infection control, and that doing so does not put the organization, mission, other patients, or the public at unacceptable risk. Treatments in category B-1 and B-2 are permissible to offer outside of research, but offering them within the context of a research trial is preferable. If treatments are delivered outside of research it should be the result of a preplanned, transparent, and equitable process with clinically and ethically justifiable stopping points. When allocating scarce resources, priority should go to category A treatments, followed by treatments in category B-1 and B-2 that are part of research, followed by treatments in B-1 and B-2 not done as research. It is important to note that many treatments that may be reflexively provided in resource-rich care settings are in category B, not A.
Address correspondence to Nathan G. Allen, Center for Medical Ethics & Health Policy, Baylor College of Medicine, One Baylor Plaza, Suite 301D, Houston, TX 77030, USA. E-mail: [email protected]
50 ajob
April, Volume 15, Number 4, 2015
Ethics of the Ebola Crisis
Table 1. Clinical Ethical Taxonomy of Treatments in Patients with EVD
Group
Clinical ethical classification
Implications for decision making
A
Known to be effective
Obligatory*
Monitor for trends toward ineffectiveness or harm. Perform continuous quality improvement.
B-1
Experimental and novel: new therapies for EVD.
Permissible* but not obligatory
B-2
Experimental for EVD: proven therapies for other conditions but effectiveness for EVD unknown
Permissible* but not obligatory
Preferentially perform as institutional review board (IRB)approved research or at a minimum adhere to WHO requirements for unregistered interventions (World Health Organization 2014) Track and monitor through research or collaborative data sharing to further categorize and establish evidence based protocols
C
Ineffective, harmful, or does not meet “modicum of benefit” test (Brett and McCullough 2012) Cannot be provided without violating quarantine or infection control standards
Impermissible to offer or perform
Rule out unilaterally
Impermissible to offer or perform
Rule out unilaterally
D
Clinical implications
Treatments (not exhaustive) Supportive care, including intravenous fluids, balancing electrolytes, maintaining oxygen status and blood pressure, and treating other infections (Centers for Disease Control and Prevention 2014). Anything that is an “Ebola specific therapy”: ZMapp (Mapp Biopharmaceutical), experimental vaccines and medications.
Resource-intensive advanced therapies (dialysis and mechanical ventilation), other unproven interventions such as bananas CPR (Fins 2014)
Low-yield lab testing, magnetic resonance imaging (MRI)
*Provided resources are available, sustained excellent infection control is in place, and doing so does not create unacceptable risk to self, the organization, or others.
April, Volume 15, Number 4, 2015
ajob 51
American Journal of Bioethics
SUSTAINED EXCELLENT INFECTION CONTROL IS AN IMPORTANT ADDITIONAL CONSIDERATION Shah and colleagues identify provider interest in preserving the integrity of the medical profession and resource limitations as two objections that can counsel against the provision of unproven interventions. An additional important consideration is whether the intervention can be delivered with sustained excellent infection control. This is defined as a reduction of provider risk to an acceptable level and minimization of the spread of the disease. Sustained excellent infection control is ethically important because the high lethality of EVD and lack of effective treatments make it an imminent public health threat in which the containment of the current outbreak and prevention of future spread may be the most important interventions in limiting the total number of fatalities. In addition, the delivery of EVD care is extremely resource taxing, with the potential to both overwhelm local healthcare resources needed to treat other diseases and to reduce the available number of health care personnel if they themselves become infected. Therefore, some treatments, even if they are determined to be physiologically effective, may not be able to be offered if doing so results in too many occupational exposures. To phrase this analysis in epidemiologic terms, if the R0 (the number of people, on average, that one person with the disease will infect) is increased by the provision of a treatment, then the survival advantage it confers in its use must be greater than both the morbidity and mortality related to the additional exposures, as well as the resources lost caring for these new exposures. Because the resources most likely to be lost in this circumstance are the lives, skills, and morale of the limited number of health care professionals combating the EVD epidemic, this calculation is particularly high stakes. For example, if it is found that hemodialysis confers a survival advantage when used in certain patients with EVD but doing so carries excessive exposure risk, then it is ethically inappropriate to deliver. For unproven interventions in particular, these determinations can only be made by rigorous data collection and data sharing, which may be difficult outside of the context of formal research. However, sustained excellent infection control is an essential ethical variable for proven and unproven interventions alike.
PATIENTS WITH POTENTIAL EVD ARE A UNIQUE CATEGORY Patients with potential but not confirmed EVD should be considered separately when determining the ethics of the provision of therapies in EVD. Patients with potential EVD can experience risks similar to both persons with EVD (care delays related to infection control concerns and the rationing of scarce resources) and those without EVD (the risks of the use of unproven therapies for a condition they do not have or will not
52 ajob
be exposed to), as well as unique risks (being quarantined with or without other persons with potential EVD and a delay in treatment for conditions other than EVD, which they may actually have). As such, the probability that a patient presenting with potential EVD in fact has EVD is an ethically important variable that will vary significantly between different treatment settings. In some treatment environments, such as the United States, it is probable that more patients will be evaluated for potential EVD than will be diagnosed with the disease. Even with the development of more rapid diagnostic tests (Reuters Staff 2014), in emergency situations there will still be a delay between presentation and definitive diagnosis in which decisions with an ethical component must be made. Making a unique determination for each patient in regard to the probability of diagnosis, scarcity of resources, and risks/benefits of proven and unproven therapies may be an unreasonable challenge for health care providers. Because these variables are not constant across different health care settings, organizations should work to establish practically workable categories (i.e., low, medium, and high probability) with decision guides or algorithms that can help providers both correctly apply case definitions to sort patients into these categories and to provide them with guidance on which therapies are medically and ethically appropriate to use. Apart from this recommendation, we feel that the provision of treatments required to manage immediate, life-threatening changes in health status should be offered until the diagnosis is determined, balanced against the need to ensure sustained excellent infection control. It is reasonable to assume that some patients will experience care delays or bad outcomes because of the time required to comply with infection control protocols. This is an undesirable but ethically acceptable outcome that balances patient well-being, provider self-risk, and public health considerations. &
REFERENCES Brett, A. S., and L. B. McCullough. 2012. Addressing requests by patients for nonbeneficial interventions. Journal of the American Medical Association 307(2): 149–150. Available at: http://dx.doi. org/10.1001/jama.2011.1999 Centers for Disease Control and Prevention. 2014. Ebola (Ebola virus disease) treatment [as of January 8, 2014]. Available at: http://www.cdc.gov/vhf/ebola/treatment Fins, J. 2014. Responding to Ebola: Questions about resuscitation. Bioethics Forum Blog October 10. Available at: http://www.thehas tingscenter.org/Bioethicsforum/Post.aspx?idD7135&blogidD140 Reuters Staff. 2014. FDA approves Roche Ebola test for emergency use. Reuters, December 29. Available at: http://www.reuters. com/article/2014/12/29/us-health-ebola-roche-idUSKBN0K70TA20141229
April, Volume 15, Number 4, 2015
Ethics of the Ebola Crisis
Shah, S. K., D. Wendler, and M. Danis. 2015. Examining the ethics of clinical use of unproven interventions outside of clinical trials during the Ebola epidemic. American Journal of Bioethics 15(4): 11–16.
World Health Organization. 2014. Ethical considerations for use of unregistered interventions for Ebola viral disease: Report of an advisory panel to WHO. Available at: http://www.who.int/csr/ resources/publications/ebola/ethical-considerations/en/
In Particular Circumstances Attempting Unproven Interventions Is Permissible and Even Obligatory Bruce D. White, Albany Medical College Luke C. Gelinas, Albany Medical College Wayne N. Shelton, Albany Medical College I shall do less whenever I shall believe what I am doing hurts the cause, and I shall do more whenever I shall believe doing more will help the cause. I shall try to correct errors when shown to be errors; and I shall adopt new views so fast as they shall appear to be true views. (Abraham Lincoln, Letter to Horace Greeley, August 22, 1862)
Shah, Wendler, and Danis (2015) consider whether it can be permissible to offer certain types of “unproven” interventions to seriously ill patients. They view unproven treatments as those “with a limited evidence basis to patients outside the context of research” and as those “given without prior testing in humans for safety and/or efficacy” (12). The limited situations they discuss against the backdrop of the Ebola crisis appear unnecessarily to weight arguments against interventions that have not been proven by a relatively high evidence-based standard akin to the double-blinded, randomized controlled trial (RCT) or some other irrefutable benchmark. This overly stringent standard of evaluation risks distorting the more commonly accepted understanding of when interventions are permissible and obligatory. For example, as the authors point out, there appears to be historical precedent for using unproven interventions in some cases, particularly when the patient is dying, and when mainstream or “accepted” treatments are not effective or beneficial. In such situations it seems reasonable that physicians are permitted and even obligated to offer unproven interventions when the risk–benefit ratio assessment undeniably tilts in the patient’s best interests, and the patient’s preferences are respected. However, the evidence on which a responsible physician makes this assessment rarely meets an RCT-like standard or analysis. In many cases, these interventions are contestable and open
to debate, but may still meet the threshold for permissibility. It may be useful here to recall the ethical arguments that HIV–AIDS patients made in the early 1980s when the context for understanding and treating HIV–AIDS was somewhat comparable to Ebola. Those arguments supported offering unproven—yet believed by some to be possibly effective—treatments earlier than would be possible if subjected to RCT-like evaluation and before being “approved” by some authoritative entity or “widely accepted” by physicians. (Fauci 2012) Patients at risk then claimed that a health care delivery system interested in promoting good care for individuals who are seriously ill or dying (beneficence), and in providing better care for the community (justice), should counterbalance provider fears or worries, within reason, about the possible harms from unproven or unapproved treatments (nonmaleficence). Recently, these patient and physician views were dramatically portrayed in the Academy Award-winning Dallas Buyers Club (Borten and Wallack 2013). Such contexts permit and may require physicians to tailor medical interventions and employ modified standards of informed consent in ways that acknowledge the evolving and dynamic nature of situations that do not permit the imprimatur or luxury of knowledge gained from RCTs. Of course, there are professional limits to what interventions are morally permissible for dying patients. Even in situations where the physician determines that there is “nothing to lose” in the care of a dying patient by trying an unproven intervention, the assessment still must—first and foremost—be based on a reasonable belief that more benefit than harm will follow, even if the benefit is marginal. It is this due diligence assessment of available evidence and sound
Address correspondence to Bruce D. White, DO, JD, Professor of Bioethics and Pediatrics, John A. Balint, MD, Chair of Medical Ethics, Alden March Bioethics Institute, Albany Medical College, 47 New Scotland Avenue, MC 153, Albany, NY 12208, USA. E-mail: [email protected]
April, Volume 15, Number 4, 2015
ajob 53
Copyright of American Journal of Bioethics is the property of Routledge and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
Summary of the panel discussion, August 12. Available at: who. int/tmediacentre/news/statements/2014/ebola-ethical-reviewsummary/en (accessed 14 January 2015). World Health Organization. 2014b. WHO Meeting of the Scientific and Technical Advisory Committee on Ebola Experimental Interventions—Briefing note. Geneva, November 13. Available at: who. int/medicines/ebola-treatment/scientific_tech_meeting/en/#. VHOOGRkGy40.email (accessed 14 January 2015).
World Health Organization Ebola Response Team. 2014. Ebola virus disease in west Africa—the first 9 months of the epidemic and forward projections. New England Journal of Medicine 371(16): 1481–1495. World Health Organization Ebola Response Team. 2015. West African Ebola epidemic after one year—slowing but not yet under control. New England Journal of Medicine 372(6): 584–587.
Placing and Evaluating Unproven Interventions Within a Clinical Ethical Taxonomy of Treatments for Ebola Virus Disease Nathan G. Allen, Baylor College of Medicine Jennifer S. Blumenthal-Barby, Baylor College of Medicine Laurence B. McCullough, Baylor College of Medicine The target article by Shah, Wendler, and Danis (2015) ends with a call “to determine when it is ethically obligatory, rather than just permissible, to offer unproven interventions to patients.” In the following commentary we attempt to assist in this process by outlining a clinical ethical taxonomy of interventions/treatments in Ebola virus disease (EVD) and discussing how the placement of proven and unproven treatments within this taxonomy affects whether or not they are ethically permissible, obligatory, or impermissible. We also identify an additional constraint that may counsel against providing unproven interventions—the need to ensure sustained excellent infection control. In addition, we describe how patients with potential EVD may form a unique subtype of individuals in regards to the ethics of their care, apart from individuals with and without EVD, when providing proven and unproven therapies. The following taxonomy categorizes treatments based primarily on their degree of clinical effectiveness and outlines the implications for ethical decision making and clinical practice (Table 1). Although the vast majority of current EVD care is in the resource-limited setting, Ebola is a worldwide health threat and this taxonomy is applicable to all health care settings. The provided examples are chosen for convenience and illustrative purposes and are not intended to be exhaustive.
In our taxonomy, interventions already approved for other indications or otherwise available are category B-2. Although we agree that there are some unique features to the use of experimental interventions not needed for use in a research trial, in our taxonomy we do not consider them different than experimental interventions (category B-1) because of their clinical similarity and the additional objections raised by Shah and colleagues to their use. Health care professionals are only ethically obligated to provide treatments in category A. The obligation is dependent on the following: availability of resources, that its provision does not prevent use of a more effective treatment, that it can be provided with sustained and excellent infection control, and that doing so does not put the organization, mission, other patients, or the public at unacceptable risk. Treatments in category B-1 and B-2 are permissible to offer outside of research, but offering them within the context of a research trial is preferable. If treatments are delivered outside of research it should be the result of a preplanned, transparent, and equitable process with clinically and ethically justifiable stopping points. When allocating scarce resources, priority should go to category A treatments, followed by treatments in category B-1 and B-2 that are part of research, followed by treatments in B-1 and B-2 not done as research. It is important to note that many treatments that may be reflexively provided in resource-rich care settings are in category B, not A.
Address correspondence to Nathan G. Allen, Center for Medical Ethics & Health Policy, Baylor College of Medicine, One Baylor Plaza, Suite 301D, Houston, TX 77030, USA. E-mail: [email protected]
50 ajob
April, Volume 15, Number 4, 2015
Ethics of the Ebola Crisis
Table 1. Clinical Ethical Taxonomy of Treatments in Patients with EVD
Group
Clinical ethical classification
Implications for decision making
A
Known to be effective
Obligatory*
Monitor for trends toward ineffectiveness or harm. Perform continuous quality improvement.
B-1
Experimental and novel: new therapies for EVD.
Permissible* but not obligatory
B-2
Experimental for EVD: proven therapies for other conditions but effectiveness for EVD unknown
Permissible* but not obligatory
Preferentially perform as institutional review board (IRB)approved research or at a minimum adhere to WHO requirements for unregistered interventions (World Health Organization 2014) Track and monitor through research or collaborative data sharing to further categorize and establish evidence based protocols
C
Ineffective, harmful, or does not meet “modicum of benefit” test (Brett and McCullough 2012) Cannot be provided without violating quarantine or infection control standards
Impermissible to offer or perform
Rule out unilaterally
Impermissible to offer or perform
Rule out unilaterally
D
Clinical implications
Treatments (not exhaustive) Supportive care, including intravenous fluids, balancing electrolytes, maintaining oxygen status and blood pressure, and treating other infections (Centers for Disease Control and Prevention 2014). Anything that is an “Ebola specific therapy”: ZMapp (Mapp Biopharmaceutical), experimental vaccines and medications.
Resource-intensive advanced therapies (dialysis and mechanical ventilation), other unproven interventions such as bananas CPR (Fins 2014)
Low-yield lab testing, magnetic resonance imaging (MRI)
*Provided resources are available, sustained excellent infection control is in place, and doing so does not create unacceptable risk to self, the organization, or others.
April, Volume 15, Number 4, 2015
ajob 51
American Journal of Bioethics
SUSTAINED EXCELLENT INFECTION CONTROL IS AN IMPORTANT ADDITIONAL CONSIDERATION Shah and colleagues identify provider interest in preserving the integrity of the medical profession and resource limitations as two objections that can counsel against the provision of unproven interventions. An additional important consideration is whether the intervention can be delivered with sustained excellent infection control. This is defined as a reduction of provider risk to an acceptable level and minimization of the spread of the disease. Sustained excellent infection control is ethically important because the high lethality of EVD and lack of effective treatments make it an imminent public health threat in which the containment of the current outbreak and prevention of future spread may be the most important interventions in limiting the total number of fatalities. In addition, the delivery of EVD care is extremely resource taxing, with the potential to both overwhelm local healthcare resources needed to treat other diseases and to reduce the available number of health care personnel if they themselves become infected. Therefore, some treatments, even if they are determined to be physiologically effective, may not be able to be offered if doing so results in too many occupational exposures. To phrase this analysis in epidemiologic terms, if the R0 (the number of people, on average, that one person with the disease will infect) is increased by the provision of a treatment, then the survival advantage it confers in its use must be greater than both the morbidity and mortality related to the additional exposures, as well as the resources lost caring for these new exposures. Because the resources most likely to be lost in this circumstance are the lives, skills, and morale of the limited number of health care professionals combating the EVD epidemic, this calculation is particularly high stakes. For example, if it is found that hemodialysis confers a survival advantage when used in certain patients with EVD but doing so carries excessive exposure risk, then it is ethically inappropriate to deliver. For unproven interventions in particular, these determinations can only be made by rigorous data collection and data sharing, which may be difficult outside of the context of formal research. However, sustained excellent infection control is an essential ethical variable for proven and unproven interventions alike.
PATIENTS WITH POTENTIAL EVD ARE A UNIQUE CATEGORY Patients with potential but not confirmed EVD should be considered separately when determining the ethics of the provision of therapies in EVD. Patients with potential EVD can experience risks similar to both persons with EVD (care delays related to infection control concerns and the rationing of scarce resources) and those without EVD (the risks of the use of unproven therapies for a condition they do not have or will not
52 ajob
be exposed to), as well as unique risks (being quarantined with or without other persons with potential EVD and a delay in treatment for conditions other than EVD, which they may actually have). As such, the probability that a patient presenting with potential EVD in fact has EVD is an ethically important variable that will vary significantly between different treatment settings. In some treatment environments, such as the United States, it is probable that more patients will be evaluated for potential EVD than will be diagnosed with the disease. Even with the development of more rapid diagnostic tests (Reuters Staff 2014), in emergency situations there will still be a delay between presentation and definitive diagnosis in which decisions with an ethical component must be made. Making a unique determination for each patient in regard to the probability of diagnosis, scarcity of resources, and risks/benefits of proven and unproven therapies may be an unreasonable challenge for health care providers. Because these variables are not constant across different health care settings, organizations should work to establish practically workable categories (i.e., low, medium, and high probability) with decision guides or algorithms that can help providers both correctly apply case definitions to sort patients into these categories and to provide them with guidance on which therapies are medically and ethically appropriate to use. Apart from this recommendation, we feel that the provision of treatments required to manage immediate, life-threatening changes in health status should be offered until the diagnosis is determined, balanced against the need to ensure sustained excellent infection control. It is reasonable to assume that some patients will experience care delays or bad outcomes because of the time required to comply with infection control protocols. This is an undesirable but ethically acceptable outcome that balances patient well-being, provider self-risk, and public health considerations. &
REFERENCES Brett, A. S., and L. B. McCullough. 2012. Addressing requests by patients for nonbeneficial interventions. Journal of the American Medical Association 307(2): 149–150. Available at: http://dx.doi. org/10.1001/jama.2011.1999 Centers for Disease Control and Prevention. 2014. Ebola (Ebola virus disease) treatment [as of January 8, 2014]. Available at: http://www.cdc.gov/vhf/ebola/treatment Fins, J. 2014. Responding to Ebola: Questions about resuscitation. Bioethics Forum Blog October 10. Available at: http://www.thehas tingscenter.org/Bioethicsforum/Post.aspx?idD7135&blogidD140 Reuters Staff. 2014. FDA approves Roche Ebola test for emergency use. Reuters, December 29. Available at: http://www.reuters. com/article/2014/12/29/us-health-ebola-roche-idUSKBN0K70TA20141229
April, Volume 15, Number 4, 2015
Ethics of the Ebola Crisis
Shah, S. K., D. Wendler, and M. Danis. 2015. Examining the ethics of clinical use of unproven interventions outside of clinical trials during the Ebola epidemic. American Journal of Bioethics 15(4): 11–16.
World Health Organization. 2014. Ethical considerations for use of unregistered interventions for Ebola viral disease: Report of an advisory panel to WHO. Available at: http://www.who.int/csr/ resources/publications/ebola/ethical-considerations/en/
In Particular Circumstances Attempting Unproven Interventions Is Permissible and Even Obligatory Bruce D. White, Albany Medical College Luke C. Gelinas, Albany Medical College Wayne N. Shelton, Albany Medical College I shall do less whenever I shall believe what I am doing hurts the cause, and I shall do more whenever I shall believe doing more will help the cause. I shall try to correct errors when shown to be errors; and I shall adopt new views so fast as they shall appear to be true views. (Abraham Lincoln, Letter to Horace Greeley, August 22, 1862)
Shah, Wendler, and Danis (2015) consider whether it can be permissible to offer certain types of “unproven” interventions to seriously ill patients. They view unproven treatments as those “with a limited evidence basis to patients outside the context of research” and as those “given without prior testing in humans for safety and/or efficacy” (12). The limited situations they discuss against the backdrop of the Ebola crisis appear unnecessarily to weight arguments against interventions that have not been proven by a relatively high evidence-based standard akin to the double-blinded, randomized controlled trial (RCT) or some other irrefutable benchmark. This overly stringent standard of evaluation risks distorting the more commonly accepted understanding of when interventions are permissible and obligatory. For example, as the authors point out, there appears to be historical precedent for using unproven interventions in some cases, particularly when the patient is dying, and when mainstream or “accepted” treatments are not effective or beneficial. In such situations it seems reasonable that physicians are permitted and even obligated to offer unproven interventions when the risk–benefit ratio assessment undeniably tilts in the patient’s best interests, and the patient’s preferences are respected. However, the evidence on which a responsible physician makes this assessment rarely meets an RCT-like standard or analysis. In many cases, these interventions are contestable and open
to debate, but may still meet the threshold for permissibility. It may be useful here to recall the ethical arguments that HIV–AIDS patients made in the early 1980s when the context for understanding and treating HIV–AIDS was somewhat comparable to Ebola. Those arguments supported offering unproven—yet believed by some to be possibly effective—treatments earlier than would be possible if subjected to RCT-like evaluation and before being “approved” by some authoritative entity or “widely accepted” by physicians. (Fauci 2012) Patients at risk then claimed that a health care delivery system interested in promoting good care for individuals who are seriously ill or dying (beneficence), and in providing better care for the community (justice), should counterbalance provider fears or worries, within reason, about the possible harms from unproven or unapproved treatments (nonmaleficence). Recently, these patient and physician views were dramatically portrayed in the Academy Award-winning Dallas Buyers Club (Borten and Wallack 2013). Such contexts permit and may require physicians to tailor medical interventions and employ modified standards of informed consent in ways that acknowledge the evolving and dynamic nature of situations that do not permit the imprimatur or luxury of knowledge gained from RCTs. Of course, there are professional limits to what interventions are morally permissible for dying patients. Even in situations where the physician determines that there is “nothing to lose” in the care of a dying patient by trying an unproven intervention, the assessment still must—first and foremost—be based on a reasonable belief that more benefit than harm will follow, even if the benefit is marginal. It is this due diligence assessment of available evidence and sound
Address correspondence to Bruce D. White, DO, JD, Professor of Bioethics and Pediatrics, John A. Balint, MD, Chair of Medical Ethics, Alden March Bioethics Institute, Albany Medical College, 47 New Scotland Avenue, MC 153, Albany, NY 12208, USA. E-mail: [email protected]
April, Volume 15, Number 4, 2015
ajob 53
Copyright of American Journal of Bioethics is the property of Routledge and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
