Bioethics: Is there Autonomy in a Pandemic?
By: Samir Kabbabe
Over himself, over his body and mind, the individual is sovereign.
John Stuart Mill
Would you accept a confinement due to the fact of being a COVID-19 suspect case without being offered minimal humane conditions? Would you be willing to receive drugs having a doubtful or marginal benefit but a proven risk of side effects?
THE FOUR BASIC PRINCIPLES OF BIOETHICS
In a broad sense, bioethics deals with ethical conflicts related to life in general, instituting the values and principles that must govern biology-related human actions. Medical bioethics is the discipline concerning the manipulation of the human being biology and nature. There is no medical or public health action eluding the four basic principles of bioethics, such as beneficence, non-maleficence, autonomy and justice.
The beneficence principle is the moral action of medicine to do good, to heal, to eliminate suffering and to foster well-being, and it establishes that actions must offer the maximum possible benefit to the person. Non-maleficence is the duty that actions do not cause harm or entail unnecessary risks, and it implies preventing possible negative effects. The autonomy principle prioritizes the individual as the essential moral component of the medical act, with the rights and dignity that are intrinsic to him as a person, with the ability to deliberate and decide about himself. Justice in bioethics is what determines that the benefits and burdens produced by medical actions are distributed in the most equitable way possible for all those who need them, rejecting any type of discrimination.
Beneficence and autonomy belong to the private domain of individuals, while non-maleficence and justice belong to the public domain and are regulated by legislation; maleficence is punishable by law.
Autonomy is inherent to the person
More than half a century ago, the doctor-patient relationship discarded the verticality in which the doctor ordered and the patient obeyed. The autonomy principle confers horizontality to the doctor-patient relationship, understood as a private interaction of trust and respect between two persons: a professional empowered with knowledge and skills directed toward another person who suffers from a health problem and freely ask for answers and solutions.
A person is a conscious human being who discerns, thinks, feels; who is self-sufficient and free, with the capacity for empowerment and responsible for himself; with a history of experiences making him unique and unrepeatable; who gets along socially and culturally in a specific environment, and who is accountable to others. All persons have dignity, a super-value equivalent to an innate and egalitarian merit conferring them their belonging to the human race, and granting them the same rights as all their equals. We are relational beings submitted to ethics and civility who incorporate in our conduct what benefits others and us. We don’t enjoy unlimited autonomy and freedom: There is no freedom and autonomy without responsibility for our own actions.
Autonomy and dignity confer the patient a personalized identity. Medicine deals with sick people, not with diseases. The defense and development of autonomy and dignity gave rise to other values and rights of the patient such as confidentiality, respect for individuality, truthfulness and transparency of information and informed consent.
The informed consent respects and fosters autonomy
It is up to every competent patient to know their diagnostic assumptions and the nature of their probable illnesses; how they affect their quality and length of life, and the treatment options that might restore their health. Respect for autonomy requires providing the patient with information on diagnostic procedures, on treatment or participation in research tests. Informed consent objectifies the voluntary understanding and acceptance of the procedures the patient could be subject to, with understandable and comprehensive information provided with consideration, without bias or coercion, and that must include the balance of the potential benefits and risks of the procedures.
Informed consent has a high value and benefit. There is nothing better for the success of medical actions than a well-informed and collaborative patient who agrees to comply with medical indications with confidence and conviction, and effectively involved in successive decision-making.
In bioethics, autonomy and the doctrine of informed consent have exceptions when they conflict with other principles. An exceptional situation is the emergency that cannot wait for charitable medical actions because it poses an imminent risk of death or irreversible loss of functions; in this case, the principle of beneficence and the implicit primacy of life over autonomy prevail. Another exception is the case of a disease being a serious threat to public health, such as infectious diseases that can become epidemics.
AUTONOMY IN A EPIDEMIC
What do the doctrines say?
The WHO (World Health Organization), PAHO (Pan American Health Office), the Hastings Center, the Bioethics Committee of the Council of Europe and several medical associations and bioethics committees around the world have issued documents containing standpoints and guidelines, establishing doctrines so that the well-being and rights of individuals and communities are fully respected in times of epidemics. (1, 2, 3, 4)
In epidemics, autonomy can be partially relativized in some aspects, such as the limitation of freedom of movement and the compliance with diagnostic and treatment guidelines, but always guaranteeing minimum human conditions, in line with safety, satisfaction of people needs, in the strict certainty that the actions established by health experts provide proven beneficence and non-maleficence, and in the presumption that the final decisions about which medical interventions to accept belong to the patient.
Freedom of Movement Limitation
Human right restrictions on freedom of movement, which include isolation measures, quarantine, mobility and travel limitations, as well as community measures such as closing of schools, factories and stores or prohibiting meetings, are justified by the ethical value to protect the community, although their efficacy must not be assumed a priori. Restraining measures have negative impacts on individuals, families and communities, as well as significant financial and social consequences, sometimes even devastating and with a greater burden than the disease itself, so decisions must involve different sectors of society and communities.
Historically, during epidemics the imposition of movement restrictions on the population, without clear notifications and without ensuring minimum support conditions for the population, in addition to distrust and contempt, have generated social chaos and violent demonstrations. Restrictions to the freedom of movement must be adjusted when evidences of the pathogen biological behavior and its forms of contagion emerge, together with the real-time impact of the pathogen in different geographies or communities, the safety and protection of essential services’ employees who cannot be demobilized, and the continuous assessment of the social and economic cost-benefit of the restrictive measures, while guaranteeing the minimum conditions so that the population continue to have access to basic services.
Persons affected by the epidemic disease and submitted to isolation or quarantine, besides enjoying the considerations of justice and solidarity due to their vulnerability, require enough information about their diagnosis or epidemiological category (contact, suspicious, probable or confirmed); they also need answers to their expectations and concerns, as well as instructions about what is expected of them so that they can collaborate and get involved in the sanitary care and health strategies.
Human conditions in isolation
Isolation of patients at home should be preferred as long as it is safe and verifiable that remote medical care can be provided and that their basic needs can be met. It is imperative for the patient confined in sanitary facilities to ensure them minimum conditions and satisfy their needs for food, drinking water, clothing, safety, spaces allowing them to move, avoid an overcrowding exposing them to become infected with other diseases, possibilities of communication with their relatives and with the outside world, availability of medicines and the best possible medical care in line with the criteria of justice and the resources available, while protecting their privacy and avoiding social stigmatization of which both the patients may be victims together with their family group.
The right to a timely diagnosis
Every patient has the right to get a documented and timely diagnosis. Epidemiological definitions that classify cases as “contact”, “suspicious” and “probable”, backed by clinical and epidemiological criteria, require to perform safe and immediate confirmatory tests to avoid unnecessary burdens and uncertainties. Faced with the COVID-19 pandemic we are witnessing, the fast diagnostic tests (FDT) to assess antibody levels that have been used must be avoided because they do not detect the disease in its early stages when the virus is replicating and spreading, and thus they cause interpretation errors able of giving rise to false negatives in up to a third of the cases (5). Moreover, they can induce false positives when they merge with other viral infections such as dengue, which is endemic in our country (6, 7). Safe diagnosis tests, such as the RT-PCR (Reverse Transcription Polymerase Chain Reaction), carried out in time, benefit the patient and the rest of the population by favoring strategies to control epidemics. The third part of patients who can be assessed negative by the FDT, although being sick, are affected by the lack of timely medical attention and are potential propagators of the disease. Isolating a person based on an uncertain diagnosis due to a false positive FDT result violates the bioethical principles of autonomy and non-maleficence when followed by restrictive measures.
In those cases where it is impossible to carry out confirmatory tests, as it happens when the health system capacity is exceeded, it is imperative to modify the epidemiological definitions of the cases to speed up medical and health interventions or actions.
Biomedical research in epidemics
In the face of a pandemic, such as that of COVID-19 produced by an emerging pathogen, moral obligations arise in the field of biomedical research to find out as soon as possible the biology, the epidemiological behavior, the nature and natural history of the disease it produces, the implementation of clinical and diagnostic criteria and trials that evaluate screening tests, treatments or preventive measures such as vaccines. The stimulation of biomedical research by means of public and private investments, and the desire to investigate and obtain useful outcomes is also accompanied by moral obligations of international collaboration, sharing of information and the publication of preliminary results if relevant.
The results and progresses of the investigations and their critical assessment by experts must be as precise and transparent as possible, and at the same time they require the participation of independent media and even of social communicators specialized in scientific and biomedical areas. In countries with political models where governments censor and control information and researchers may be subject to punitive measures if they publish results that may be unfavorable to the statements of power, there may be concealment or publication of misleading results undermining the successful management of the pandemic in the rest of the world. There are national and international or supranational organizations that assume responsibility for integrating research results in order to consolidate findings and avoid redundant or useless multiplication of efforts and investments. This is how the WHO, backed by an International Steering Group, created the “Solidarity Essay” (SOLIDARITY) which makes periodic recommendations for different tests being developed.
Researchers require reliable data, as well as resources. In the “Orientation Guide for Managing Ethical Issues in Outbreaks of Infectious Diseases” (1), published by the WHO in 2016, each country is recommended to stimulate research in work lines with value in the face of the epidemic and to incorporate local researchers to participate in the implementation, design, analysis and publication of epidemic-related data and in the progresses of clinical trials. Researchers need data with unified criteria. The lack of methodologically collected and published data, as well as manipulated data, hinders the successful control management of an epidemic.
The biomedical sciences, together with the epidemiological research and the social sciences’ studies, play a fundamental role in reducing morbidity and mortality and in treating the social and economic consequences caused by epidemic outbreaks. Pandemics require collaborative and mutually supportive international efforts. Obligations are not only with people within their own borders, but also with the international community in general, when it comes to diseases easily transmissible beyond borders.
It is the States’ public health governors and managers responsibility to adopt the recommendations of sciences, in light of the knowledge they provide, as well as to implement containment strategies and ensure the robustness of the health system to look after the contingent of patients with quality and safety criteria. Governments have an ethical obligation to ensure the capacity of their health systems to carry out effective epidemic prevention and response efforts.
Autonomy in clinical trials during epidemics
In times of urgency due to epidemics, it may be impossible to meet the usual deadlines for the review of clinical human tests by the institutional bioethics committees, so they tend to be approved in short time periods, but even those must respect the rights and protection of the well-being of the participants, abiding by the same rigorousness of the informed consent and observance of the beneficence, non-maleficence, autonomy and justice principles, at the same time as the studies are guaranteed by their scientific validity and submission to independent revision processes.
When there a significant number of people get sick and die, without effective therapeutic solutions being achieved, it can be perceived that any intervention is better than nothing, but not independently of the risks that they could entail. For tryouts of drugs approved for use in humans, already known and with low potential risks, those responsible for approving the research protocols and the researchers themselves must ensure that there is a reasonable scientific basis to consider that the experimental intervention is likely to be beneficial and effective, that the risks are minimized as reasonably as feasible, that it is possible to solve probable complications, that the design and methodology of the tryouts are rigorous, that there is a careful recording of the results and that there is an independent monitoring of the results.
The very urgency of lacking effective drugs ethically justifies the use of unproven interventions or treatments within the research settings. The WHO has developed the MEURI framework (“monitored emergency use of unregistered and experimental interventions”), where the same above-mentioned criteria of respect for autonomy and informed consent are applied (to be obtained from the patient himself or his legal representative), in addition to confirm that they are for emergency use and that the results are documented and shared in a timely manner with the medical and scientific community in general. Unapproved drugs can only be used in the so-called “compassionate treatments”, within the MEURI framework, as a last measure in the face of an inexorable evolution towards death, and only if there is some reasonable scientific criterion of potential benefit. Within the MEURI framework and for research activities, only pharmacological products manufactured in accordance with good practice should be used.
Treatment and autonomy protocols
Research can turn out promising results of the effectiveness of some drugs in the laboratory and even in animal models, but it is essential to confirm, with rigorous and well-designed clinical tryouts, that they work in humans. National and supranational organizations, such as the WHO, have ruled out the use in hospitalized patients of drugs that were promising in the laboratory and in early clinical tryouts during this COVID-19 pandemic, such as chloroquine and hydroxychloroquine, azithromycin, interferon alfa, and lopinavir/ritonavir.
There are no harmless drugs. It is the responsibility and duty of physicians to know in absolute detail the pharmacology and rationale of their indications, benefits and potential risks. There are numerous tryouts under development with different known drugs, such as famotidine, colchicine and ivermectin, among others. The misuse of a drug is malpractice, it can cause harm and maleficence, which is subject to penalty. It is an axiom in medicine that if a drug does not produce the therapeutic effect for which it is indicated, it can cause unwanted side effects. Hydroxychloroquine, for example, which is still in use in tryouts with out-of-hospital patients, can cause cardiovascular complications in some of them, so a close monitoring is required, as well as resources, to reverse its eventual adverse effects. Ivermectin, which like other drugs has shown effectiveness against the virus in in vitro studies, some 1,000 to 1,200 mg would have to be administered to match the effective dose in humans, when usually in adult humans it does not exceed 16 mg in a single repeatable dose in a week, and the neurotoxic effects of this effective drug against parasites are known.
In times of pandemic, there is enthusiasm in the public to participate in research protocols and receive potential benefits, and this is particularly true when it comes to “prophylactic” treatment protocols. The “Orientation Guide for Managing Ethical Issues in Outbreaks of Infectious Diseases” states that “people who are offered medical interventions for the diagnosis, treatment or prevention of an infectious pathogen should be informed about the risks, benefits and options, just as they would be for other major medical interventions. The final decision, as the same guide says, belongs to the patient.
In an epidemic of an infectious-contagious disease such as COVID-19, the decision to prescribe a treatment scheme (not in the context of a clinical tryout or protocol), with drugs of doubtful or marginal beneficial effect and with potential side effects, without an informed consent, has the potential for maleficence, violates autonomy and violates the principle of justice when imposed on vulnerable populations. The decision belongs to the patient. It is also the right of the patient to accept the recommendations to receive supplements of nutrients such as flavonoids, zinc, vitamin D and C, which in research studies have shown some protective potential against the virus and which, at the recommended doses, do not produce undesirable effects.
Things are very different when autonomy and the informed consent doctrine are relativized if the proposed medical treatment intervention offers a definite and proven benefit and with a high safety profile. Such would be the case, for example, of a patient with meningococcal meningitis, which is highly contagious and has high morbidity and mortality, who refuses to receive the antibiotic that will surely cure her and prevent an epidemic outbreak, or the case of refusing to be vaccinated against measles by an unvaccinated person in a community experiencing an outbreak. In these cases, conviction work is required, respecting the autonomy of the patient, before deciding to impose an effective treatment that certainly will save lives.
There are many pathogens such as the SARS-CoV-2 virus for which there is no effective and proven treatment to this day, although there are clinical tryouts or protocols underway. The population cannot be informed that a treatment for the SARS-CoV-2 virus is already available because none is available. Instead, there is a greater knowledge of the COVID-19 disease which generates a better knowledge concerning how to prevent contagion and greater rationality in the treatment of moderate and severe cases with better modalities of respiratory support and prevention and management of complications that have made it possible to reduce mortality when there are facilities, trained human resources and material resources.
- Guidance for Managing Ethical Issues in Infectious Disease Outbreaks. Geneva: WHO; 2016. https://apps.who.int/iris/bitstream
- Ethical considerations in developing a public health response to pandemic influenza. Geneva: WHO; 2009.
- WHO Guidelines on Ethics in Public Health Surveillance. Washington DC: PAHO; 2017.
- Zika Ethics Consultation: Ethical Guidance on Key Issues Raised by the Outbreak. Washington, DC: PAHO; 2016.
(5) Whitman J, Hiatt J, Mowery C, et al. Test performance evaluation of SARS-CoV-2 serological assays. Preprint. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7273265/
(6) Himadri N, Abinash M, Subatra R, et al. Dengue antibodies can cross-react with SARS-CoV-2 and vice versa-Antibody detection kits can give false-positive results for both viruses in regions where both COVID-19 and Dengue co-exist. Preprint. medRxiv. https://doi.org/10.1101/2020.07.03.20145797.
(7) Lustin Y, Keler S, Kolodny R, et al. Potential antigenic cross-reactivity between SARS-CoV-2 and Dengue viruses. Clinical Infectious Diseases. August14, 2020, https://doi.org/10.1093/cid/ciaa1207.