A dangerous trend is emerging: forcing doctors to provide unproven medications to COVID-19 patients. This could have repercussions on oncology.
In addition to or instead of standard-of-care therapies, cancer patients sometimes request complementary (therapies used in conjunction with standard cancer treatment) and alternative (non-standard treatments used in place of standard) medical treatments. standard anticancer treatment). , despite limited evidence of their effectiveness. Some examples of complementary and alternative therapies include mind/body practices (such as meditation and yoga); biology-based practices (such as dietary and herbal supplements and cannabis); manipulative and body-based practices (such as massage, chiropractic, 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 address the ethical and legal issues posed by patients’ requests to include complementary and alternative medicine in their cancer treatment plan.
Govind Persad, JD, Ph.D.
The appeal of complementary and alternative medicine
Despite research showing that cancer patients who use only alternative therapies instead of standard cancer treatments have much higher mortality rates, nearly 40% of Americans surveyed by ASCO believe that cancer can be cured through only alternative medicine.2 Cancer is a disease that constitutes particularly fertile ground for requests for complementary and alternative medicine from patients. For some cancers, existing treatments may not offer high expectations for cure or survival over several years, making complementary and alternative medicine therapies particularly attractive to patients. And cancer treatments generally carry heavy 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, posing few ethical and legal concerns. These interventions, even when they have not been proven to benefit patients, are unlikely to directly interfere with cancer treatments or pose other risks of medical harm.
Nearly 40% of Americans surveyed by ASCO believe that cancer can be cured using alternative medicine alone.
—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 have greater potential for conflict. Some potential conflicts involve interactions between these biologically active drugs and standard cancer therapies, which may interfere with the effectiveness of cancer therapies, and patients’ refusal to undergo surgery, radiation, chemotherapy, or other traditional treatments because that they believe that complementary and alternative medicine therapies alone will do it. heal them.
Although competent adults always have the ethical and legal right to refuse recommended treatments, clinicians can often work with patients to offer information that can alleviate these conflicts. For example, oncologists can 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 circumvent medical decisions
On time, cancer patients have been more aggressive in pressuring clinicians to offer complementary and alternative medicine, including in hospital settings. Patients and their family members sometimes even demanded that specific medications be provided to them. Before the COVID-19 pandemic, these requests generally failed, with a landmark 1979 ruling establishing that there is no right of access to unproven cancer treatments.3
More recent “right to try” legislation allows patients to request only unapproved interventions that have undergone Phase I clinical trials. It does not require pharmaceutical manufacturers, hospitals or doctors to offer these interventions to patients.
However, during the COVID-19 pandemic, some judges have been willing to force hospitals to provide coronavirus patients with unproven COVID-19 medications. For example, at the request of a spouse, an Ohio court required a hospital to provide a patient with ivermectin, a drug unproven in the treatment of COVID-19, for 3 weeks, before another judge cancels the injunction requiring treatment.4
In another case, an Illinois judge did not require a hospital to provide a patient with unproven coronavirus medications, but he did require the hospital to allow a board-certified doctor — if it wants one – to do it.4 Although almost all doctors asked to provide the drug refused, the patient’s doctor eventually agreed and administered the treatment, which reportedly caused a harmful side effect. At the same time, other courts have refused to require hospitals to provide these drugs or to allow others to do so.
Although this trend has not yet translated – at least in reported court cases – into legal requests for cancer patients to receive unproven anticancer drugs or other interventions, it is worth oncologists being aware of this general movement. Existing decisions that have been unfavorable to hospitals do not constitute binding national or state precedent, so courts remain free to reject these claims. Legal advisors should be aware of more favorable decisions that do 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 result in legal dispute. Working with patients to understand why they may want certain treatments, ensuring they feel heard, and offering potential options can be helpful in preventing legal disagreements.
Working with patients to understand why they may want certain treatments, ensuring they feel heard, and offering potential options can be helpful in preventing legal disagreements.
—Govind Persad, JD, PhD
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Right of clinicians to refuse requests
Ethically, the objections Claims for unproven treatment fall into two categories. Some objections are based on concerns about risks to other patients or hospital staff. For example, some treatments may pose risks of contamination, damage to equipment, or affect the patient in a way that results in stressful situations for staff and the hospital. Other objections are based on the conscience rights of clinicians: if a doctor believes that an intervention would be unethical, he or she generally has the right to withdraw from the case.
A desirable alternative that could reduce the risk of legal disputes is the availability of more clinical trials to test cancer treatments that are not currently the standard of care, including complementary and alternative therapies. In other medical settings, such as the response to the COVID-19 pandemic, some investigational treatments, such as hydroxychloroquine, convalescent plasma, and fluvoxamine, have been tested in randomized trials. These trials have provided an access point for those who want them and have allowed society to investigate them to determine if they are truly effective.
Of course, clinical research trials are only an appropriate use of research resources when they can be expected to provide socially useful knowledge. If it is already known that a treatment is ineffective or dangerous, a clinical trial may not be an appropriate option.
Dr Persad is an assistant professor at the Sturm College of Law at the University of Denver and a bioethics fellow at the Greenwall Foundation.
DISCLOSURE: Dr Persad received a grant from the Greenwall Foundation and personal fees from the World Health Organization.
THE REFERENCES
1. National Cancer Institute: Complementary and Alternative Medicine. Available at www.cancer.gov/about-cancer/treatment/cam. Accessed August 15, 2022.
2. Harris Poll: 2018 ASCO Cancer Opinion 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 US 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 yield 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 The column is intended to provide general information on 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 lawyer.
Disclaimer: This commentary represents the views of the author and does not necessarily reflect the views of ASCO or The ASCO post.
The contents of this article have not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and do not necessarily reflect the ideas and opinions of ASCO®.
