Many patients may be surprised to find out that, in fact, the treatment they are taking is not any better than a placebo. Clinicians may think this is no big deal, as long as the person is feeling better and is grateful.

“Clinicians often express that they only care if someone feels better, not so much if it’s due to a meaningful change in pathophysiology as a result of their treatment,” says David Ring, MD, PhD, associate dean for comprehensive care, department of surgery and perioperative care at the University of Texas at Austin Dell Medical School.

To learn more, researchers asked 763 people their beliefs about clinicians’ obligations to inform them as to whether a treatment was proved to outperform placebos.1 Most participants rated it as quite important, regardless of the risk of the treatment. “People do not want to be deceived. And they don’t want information withheld, more so as the risks increase,” says Ring, one of the study’s authors.

Some clinicians remain unconcerned if the patient’s improved outcome is due to the placebo effect or the treatment itself.

“I find that ethically dubious if there is active deception, and I would include leaving a person’s inaccurate ideas uncorrected as a form of active deception,” Ring says. Receiving a placebo could distract people from taking meaningful action to improve their social, mental, and physical health. “We can no longer believe that people are OK with limited or misleading information as long as they feel better. That’s not true,” Ring argues.

Sometimes, the best available evidence is not conclusive on whether a treatment is any better than a placebo. If so, clinicians need to tell patients exactly that, Ring offers.

Clinicians might say, “This is a treatment you might hear about or be offered. It’s important to know that we have no evidence that the potential benefits outweigh the potential harms.”

“Patients only accept unproved or known ineffective treatments when they are feeling unsettled and despairing about their symptoms,” Ring says.

Taking advantage of this vulnerability is unethical. “Resolving to recognize when people seem to be investing inordinate hope on unsupported treatment options leads to some tricky and high-stakes discussions. We should strategize and train for such discussions,” Ring suggests.

In the research setting, early trials often are based on a placebo control arm to determine if a drug works. Researchers are ethically obligated to fully inform people that there is a chance they will receive a placebo. “It’s an added hurdle for researchers seeking to enroll participants, since the volunteers are seeking treatment,” says Gail Van Norman, MD, adjunct professor in the department of bioethics and humanities at the University of Washington.

Some patients ask for a guarantee they will not be in the placebo arm. It is impossible to give it. “If researchers are allowed to pick and choose people who are more likely to respond to a treatment arm, then the study is no longer a randomized study,” Van Norman notes. In the clinical practice setting, the use of placebos happens less often and is more ethically complex. “This is sometimes done because a provider hasn’t been successful with any active treatments, and suspects that there is a psychological issue and no real disease,” Van Norman explains.

Clinicians and nurses involved in placebo treatment often take the view that it is ethically acceptable if it results in patient improvement. “That’s an interesting if. How can you know it’s going to be successful if you have not yet treated them?” Van Norman asks.

Providers think placebos are ethically justifiable if they seem to be producing results; they see the real goal as beneficence. “The trouble is, our goal isn’t beneficence, it’s beneficence achieved through autonomy. When you lie to a patient, you completely obliterate autonomy,” Van Norman says.

Placebo treatment is problematic because it involves some violations of basic ethical principles, such as the obligation to be truthful with patients. “Patients can only make autonomous decisions if they get true information. Deception, in some form, is an aspect of most placebo treatment,” Van Norman observes.

Clinicians may believe that if the patient receives manipulated information, that it is not as bad as lying. “But ethically, manipulated information is trying to get them to make the decision you want them to make,” Van Norman says.

It also is ethically problematic that there is no long-term follow-up on what happens to people treated with placebos. “If they temporarily improve, but they have a devastating outcome later down the road, then your placebo treatment has not been harmless. It’s been extremely harmful,” Van Norman cautions.

REFERENCE

  1. Bandell DLJI, Kortlever JTP, Medina J, et al. How do people feel about the possibility that a treatment might not outperform simulated and inert treatments? J Psychosom Res 2020;131:109965.