A dangerous trend is emerging to force physicians to provide unproven drugs to patients with COVID-19. It could spill over into oncology.
Posted: 10/31/2022 12:39:00 PM
In addition to, or instead of, receiving therapies that are the standard of care, patients with cancer sometimes request to receive complementary (therapies used in conjunction with standard cancer treatment) and alternative (nonstandard treatments used in place of standard cancer treatment) medical treatments, despite limited evidence of their efficacy. Some examples of complementary and alternative therapies include mind/body practices (such as meditation and yoga); biologically based practices (such as dietary and herbal supplements and cannabis); manipulative and body-based practices (such as massage, chiropractic therapy, and reflexology); biofield therapy (such as Reiki and therapeutic touch); and treatments from traditional medical systems (such as ayurvedic or traditional Chinese medicine).1
In this column, I discuss the ethical and legal issues presented by patient requests to include complementary and alternative medicine in their cancer treatment plan.
Govind Persad, JD, PhD
The Allure of Complementary and Alternative Medicine
Despite research showing that patients with cancer who solely use alternative therapies instead of standard cancer treatments have much higher mortality rates, nearly 40% of Americans surveyed by ASCO believe cancer can be cured solely through alternative medicine.2 Cancer is a disease that poses particularly fertile ground for complementary and alternative medicine requests from patients. For some cancers, existing treatments may not offer high expectations of cure or multiyear survival, making complementary and alternative medicine therapies particularly attractive to patients. And treatments for cancer usually carry burdensome side effects that patients want to avoid, including financial toxicity.
Some complementary methods, such as prayer, spirituality, and mind/body practices, can easily coexist with recommended cancer interventions, presenting few ethical and legal problems. These interventions, even when they have not been proven to benefit patients, are unlikely to interfere directly with cancer treatments or present other risks of medical harm.
Nearly 40% of Americans surveyed by ASCO believe cancer can be cured solely through alternative medicine.
— Govind Persad, JD, PhD
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Other complementary and alternative treatments, such as dietary supplements and herbal medicines, can also often coexist with recommended cancer interventions, but they present greater potential for conflict. Some potential conflicts involve interactions between these biologically active medicines and standard cancer therapies, which may interfere with the effectiveness of cancer therapies, and patient refusal to receive surgery, radiation, chemotherapy, or other traditional treatment because they believe complementary and alternative medicine therapies alone will cure them.
Although competent adults always have the ethical and legal right to refuse recommended treatments, often clinicians can work with patients to offer information that may mitigate these conflicts. For example, oncologists may suggest complementary practices that do not pose a risk of harmful drug interactions and that help patients cope with the side effects of cancer and its treatment, including nausea, pain, and fatigue.
A Dangerous Legal Trend to Override Medical Decisions
At times, patients with cancer have been more aggressive in pressing clinicians to provide complementary and alternative medicine, including in hospital settings. Patients and family members have occasionally even demanded that specific medicines be provided to them. Prior to the COVID-19 pandemic, these requests were typically unsuccessful, with a landmark 1979 decision establishing there is no right to access unproven cancer treatments.3
More recent “right-to-try” legislation permits patients to request only unapproved interventions that have completed phase I clinical trials. It does not require pharmaceutical manufacturers, hospitals, or doctors to provide those interventions to patients.
However, during the COVID-19 pandemic, some judges have been willing to force hospitals to provide patients infected with the coronavirus with unproven COVID-19 drugs. For example, at a spouse’s request, a court in Ohio required a hospital to provide a patient with ivermectin, an unproven drug in the treatment of COVID-19, for 3 weeks, before a different judge overruled the injunction requiring treatment.4
In another case, a judge in Illinois did not require a hospital to provide unproven coronavirus drugs to a patient, but it did require the hospital to allow a board-certified doctor—if willing—to do so.4 Although almost all doctors who were asked to provide the drug refused, the patient’s doctor ultimately agreed and administered the treatment, reportedly causing a harmful side effect. Meanwhile, other courts have refused to require hospitals to provide these drugs or to require them to allow others to do so.
Although this trend has not yet—at least in reported legal cases—spilled over into the legal demands of patients with cancer to receive unproven cancer drugs or other interventions, it is worthwhile for oncologists to be aware of this general movement. The existing decisions that have gone against hospitals are not binding national or statewide precedents, so courts remain free to deny these requests. Legal counsel should be aware of more favorable decisions that did not require the provision of unproven drugs and be able to provide them as part of their legal arguments.
Ideally, however, these conflicts should not reach the point of a legal dispute. Working with patients to understand the reasons why they may want certain treatments, ensuring they feel heard, and offering potential options may be helpful in forestalling legal disagreements.
Working with patients to understand the reasons why they may want certain treatments, ensuring they feel heard, and offering potential options may be helpful in forestalling legal disagreements.
— Govind Persad, JD, PhD
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Clinicians’ Right to Refuse Requests
Ethically, objections to requests for unproven treatment fall into two categories. Some objections are based on concerns about the risks to other patients or hospital staff. For example, some treatments may present risks of causing contamination or damaging equipment or affecting the patient in a way that leads to stressful situations for the staff and the hospital. Other objections are based on clinicians’ right of conscience: If a physician believes an intervention would be unethical to provide, he or she typically has the right to withdraw from the case.
A desirable alternative that may reduce the risk of legal disputes is the availability of more clinical trials to test treatments for cancer that are not currently the standard of care, including complementary and alternative therapies. In other medical contexts, such as the COVID-19 pandemic response, some experimental treatments, such as hydroxychloroquine, convalescent plasma, and fluvoxamine, have been tested in randomized trials. These trials have provided a point of access for those who desire them and have allowed society to investigate them to determine whether they are, in fact, effective.
Of course, clinical research trials are only an appropriate use of research resources when they can be expected to provide socially valuable knowledge. If a treatment is already well known to be inefficacious or dangerous, a trial may not be an appropriate option.
Dr. Persad is Assistant Professor at the University of Denver Sturm College of Law and Greenwall Foundation Faculty Scholar in Bioethics.
DISCLOSURE: Dr. Persad has received grant funding from the Greenwall Foundation and personal fees from the World Health Organization.
1. National Cancer Institute: Complementary and Alternative Medicine. Available at www.cancer.gov/about-cancer/treatment/cam. Accessed August 15, 2022.
2. The Harris Poll: ASCO 2018 Cancer Opinions Survey. October 2018. Available at www.asco.org/sites/new-www.asco.org/files/content-files/research-and-progress/documents/2018-NCOS-Results.pdf. Accessed August 15, 2022.
3. United States v Rutherford, 442 U.S. 544 (1979). Available at https://caselaw.findlaw.com/us-supreme-court/442/544.html. Accessed August 15, 2022.
4. Tompkins A: Can a COVID patient force a hospital to administer ivermectin? Lawsuits in nine states offer different results. Poynter. October 1, 2021. Available at https://www.poynter.org/reporting-editing/2021/can-a-covid-patient-force-a-hospital-to-administer-ivermectin-lawsuits-in-nine-states-offer-different-results/. Accessed August 15, 2022.
Editor’s Note: The Law and Ethics in Oncology column is meant to provide general information about legal topics, not legal advice. The law is complex, varying from state to state, and each factual situation is different. Readers are advised to seek advice from their own attorney.
Disclaimer: This commentary represents the views of the author and may not necessarily reflect the views of ASCO or The ASCO Post.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.