Physician Autonomy at Issue if Patients Demand Ineffective Treatments
February 1, 2023
A controversial Wisconsin Supreme Court case centers on whether physicians can be legally required to provide ivermectin for COVID-19 if a patient or family requests it.1
“The courts have traditionally not wanted to legislate the practice of medicine. To force a physician to prescribe a treatment that won’t work goes against the very principles of the practice of medicine,” says Gail Van Norman, MD, professor emeritus of anesthesiology and pain medicine at the University of Washington Medicine.
The American Medical Association and the Wisconsin Medical Society asked the court to acknowledge that the standard of care does not require physicians to administer ivermectin to treat COVID-19.2 If they were required to do so, “it forces the doctor to practice against medicine. Many medical ethicists would advise doctors not to prescribe an ineffective drug even if the courts say to do so,” Van Norman asserts.
Regardless of how this case turns out, there are ethical obligations to consider. “Physicians, under the ethics of the profession, are obliged to prescribe therapies with proven efficacy, through scientific studies or substantial clinical evidence, and rational theory supporting the use,” Van Norman says.
In the case of ivermectin, the issue is a patient is asking for a treatment that lacks scientific evidence of efficacy. “Doctors are not legally obliged to prescribe ineffective, substandard drugs just because patients ask for them — and, in fact, are ethically obliged not to do so,” Van Norman warns.
This does not mean patients have no say in what drugs are prescribed for them. Some patients decline a recommended drug, and ask for a different drug. “The patient may, for various reasons, elect to not choose the drug that I recommend, and choose another that is still within the standard of care,” Van Norman says.
Most physicians will not object to that. In that case, “the patient has every right to have their preference not just known, but followed,” Van Norman notes. “The patient is going to live with what the treatment does, and they have the right to make the choice about it.”
However, for ivermectin, the FDA has not approved this drug to treat COVID-19. “The reason it isn’t is that the scientific evidence is not there. Drug companies have not submitted studies that show it’s effective. They might try to produce those studies, but right now we don’t have FDA approval for it,” Van Norman reports.
All drugs can produce side effects and be toxic to varying degrees. “In fact, ivermectin can be pretty toxic,” Van Norman adds.
Nonetheless, an individual still can seek out a physician who will agree to prescribe it — or any medication. “It is not illegal, although it may be unethical, to do so,” Van Norman explains.
The FDA does not regulate the practice of medicine. “It regulates whether drugs can be advertised and marketed for certain things, but not how they are prescribed,” Van Norman says.
In fact, physicians routinely prescribe medications for off-label use. “This can benefit patients in many instances,” Van Norman offers.
For example, metformin is a medication that is approved to treat type 2 diabetes, but it also can help patients lose weight. “If a physician is comfortable with using an off-label treatment, the physician should disclose any additional risks associated with the treatment being off-label,” says Theresa McCruden, JD, director of ethics at Mercy Hospital Forth Smith (AR).
For instance, a patient might request an off-label COVID treatment, unaware there is no clinical evidence suggesting that treatment is any better than a placebo. Patients also should be made aware their insurance is unlikely to cover the drug.
Physicians should base the decision to prescribe a drug off-label on a reasonable expectation that it will help the patient. That can be determined according to the physician’s knowledge of the disease state, the patient’s physiology, and what the drug is known to do. “But it isn’t medically ethical for physicians to simply prescribe a nonsensical treatment out of desperation, or whatever reason,” Van Norman says.
Physicians engaging in this practice likely face professional sanctions by state medical associations and/or malpractice civil lawsuits. How should physicians proceed if a patient asks for substandard treatments; treatments that, in the patient’s particular case, won’t help; or treatments that produce known harms that exceed any benefit they might provide? “Even if a patient asks us to prescribe one of those things, in order to meet professional standards we are not ethically obliged to do any of it,” Van Norman says.
For physicians, such requests are an opportunity to clear up misunderstandings on the risks and benefits of the drugs patients request. “It can open up a conversation and contributes to better patient care,” Van Norman offers.
Physicians should convey understanding that a family objects to standardized treatment, although it is perhaps based on inaccurate information. Also be aware if a family believes the physician is denying what they consider a last hope. “But doctors don’t prescribe ineffective drugs just to make people happy that they tried everything,” Van Norman says. “It’s against medical ethics to prescribe drugs that are ineffective.”
Healthcare providers usually have significant discretion in the care they provide, as long as it does not constitute malpractice, observes Armand H. Matheny Antommaria, MD, PhD, FAAP, HEC-C, director of the Cincinnati Children’s Ethics Center and chair of pediatric ethics. Generally, clinicians can withhold treatments if they believe the risks outweigh the benefits, or the treatments are ineffective. “Patients are generally free to seek a provider who is willing to administer their desired treatment,” Antommaria notes.
In the case of a COVID-19 patient who is critically ill in the ICU, the patient and family would be constrained in their ability find another provider to prescribe the drug. “This power imbalance obligates the providers to more strongly consider the request,” Antommaria notes. “But it still does not obligate them to provide the treatment.”
Additionally, the patient’s critical condition may raise greater concerns about the safety of the proposed treatment. Nonetheless, Antommaria says that in cases like this, providers should seriously and respectfully consider patients’ requests. “Providers should consider allowing treatments to be administered if there is evidence of safety and evidence of ineffectiveness is lacking — in other words, if the treatment is safe and might be effective,” Antommaria says.
If the family finds an outside provider willing to prescribe a drug to a hospitalized patient, there are important implications for the health system. “Systems generally should not be obligated to provide treatment that is ordered by a provider who is not a member of their staff. This would raise substantial issues about the coordination and safety of care,” Antommaria cautions.
For a provider prescribing the drug in this scenario, there are additional legal considerations. “Writing a prescription for a patient who you have not examined would generally be considered unprofessional conduct and raises issues about disciplinary action by the state medical board,” Antommaria warns.
The Wisconsin case touches on foundational ethical principles of autonomy, beneficence, and nonmaleficence, according to McCruden, who suggests clinicians consider several factors. First, patients’ right to demand medical treatments is not an absolute right. Competent patients can make decisions regarding their healthcare. This includes decisions to withhold or withdraw treatments the medical team believes would benefit the patient. “However, the physician ultimately has the right and obligation to ensure the care the patient receives is medically indicated and appropriate for the patient’s condition,” McCruden notes.
Second, physicians must consider carefully if proposed treatments will contribute to the patient’s overall well-being. Previous case law has established physicians are not obligated to provide treatments that, in their view, are harmful, without effect, or medically inappropriate.3 “Physicians can avoid harm by refusing to provide treatments that are not medically indicated and will provide no benefit to the patient,” McCruden offers.
Finally, physicians should listen to the patient’s request with respect, and try to understand the reason for requesting treatment that is not medically indicated. “The ensuing conversation might be an excellent opportunity to educate the patient,” McCruden suggests.
REFERENCES
1. Gahl v. Aurora Health Care, Inc. 2022 WI App. 29 (Wis. Ct. App. 2022)
2. American Medical Association. AMA, WisMed oppose ivermectin as a court-ordered treatment for COVID. Dec. 7, 2022.
3. Causey v. St. Francis Medical Center, 719 So. 2d 1072 (1998).
A controversial Wisconsin Supreme Court case centers on whether physicians can be legally required to provide ivermectin for COVID-19 if a patient or family requests it.
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