Psychotherapy, placebos, and informed consent

Leder G
Journal of Medical Ethics 
Published Online First: 20 August 2020.
doi: 10.1136/medethics-2020-106453

Abstract

Several authors have recently argued that psychotherapy, as it is commonly practiced, is deceptive and undermines patients’ ability to give informed consent to treatment. This ‘deception’ claim is based on the findings that some, and possibly most, of the ameliorative effects in psychotherapeutic interventions are mediated by therapeutic common factors shared by successful treatments (eg, expectancy effects and therapist effects), rather than because of theory-specific techniques. These findings have led to claims that psychotherapy is, at least partly, likely a placebo, and that practitioners of psychotherapy have a duty to ‘go open’ to patients about the role of common factors in therapy (even if this risks negatively affecting the efficacy of treatment); to not ‘go open’ is supposed to unjustly restrict patients’ autonomy. This paper makes two related arguments against the ‘go open’ claim. (1) While therapies ought to provide patients with sufficient information to make informed treatment decisions, informed consent does not require that practitioners ‘go open’ about therapeutic common factors in psychotherapy, and (2) clarity about the mechanisms of change in psychotherapy shows us that the common-factors findings are consistent with, rather than undermining of, the truth of many theory-specific forms of psychotherapy; psychotherapy, as it is commonly practiced, is not deceptive and is not a placebo. The call to ‘go open’ should be resisted and may have serious detrimental effects on patients via the dissemination of a false view about how therapy works.

Conclusion

The ‘go open’ argument is based on a mistaken view about the mechanisms of change in psychotherapy and threatens to harm patients by undermining their ability to make informed treatment decisions. This paper has argued that the prima facie ethical problem raised by the ‘go open’ argument is diffused if we clear up a conceptual confusion about what, exactly, we should be
going open about. Therapists should be open with patients about the differing theories of the mechanisms of change in psychotherapy; this can, but need not involve discussing information
about the therapeutic common factors.

The article is here.

Note from Dr. Gavazzi: Using "deception" is the wrong frame for this issue.  How complete is your informed consent?  Can we ever give "perfect" informed consent?  The answer is likely no.

How Drug Companies Helped Shape a Shifting Biological View of Mental Ilness

Terry Gross
NPR Health Shots
Originally posted May 2, 2019

Here are two excerpts:

On why the antidepressant market is now at a standstill

The huge developments that happen in the story of depression and the antidepressants happens in the late '90s, when a range of different studies increasingly seemed to suggest that these antidepressants — although they're helping a lot of people — when compared to placebo versions of themselves, don't seem to do much better. And that is not because they are not helping people, but because the placebos are also helping people. Simply thinking you're taking Prozac, I guess, can have a powerful effect on your state of depression. In order, though, for a drug to get on the market, it's got to beat the placebo. If it can't beat the placebo, the drug fails.

(cut)

On why pharmaceutical companies are leaving the psychiatric field

Because there have been no new good ideas as to where to look for new, novel biomarkers or targets since the 1960s. The only possible exception is there is now some excitement about ketamine, which targets a different set of biochemical systems. But R&D is very expensive. These drugs are now, mostly, off-patent. ... [The pharmaceutical companies'] efforts to bring on new drugs in that sort of tried-and-true and tested way — with a tinker here and a tinker there — has been running up against mostly unexplained but indubitable problems with the placebo effect.

The info is here.

Are Placebo-Controlled, Relapse Prevention Trials in Schizophrenia Research Still Necessary or Ethical?

Ryan E. Lawrence, Paul S. Appelbaum, Jeffrey A. Lieberman
JAMA Psychiatry. Published online April 10, 2019.
doi:10.1001/jamapsychiatry.2019.0275

Randomized, placebo-controlled trials have been the gold standard for evaluating the safety and efficacy of new psychotropic drugs for more than half a century. Although the US Food and Drug Administration (FDA) does not require placebo-controlled trial data to approve new drugs or marketing indications, they have become the industry standard for psychotropic drug development.

Placebos are controversial. The FDA guidelines state “when a new treatment is tested for a condition for which no effective treatment is known, there is usually no ethical problem with a study comparing the new treatment to placebo.”1 However, “in cases where an available treatment is known to prevent serious harm, such as death or irreversible morbidity, it is generally inappropriate to use a placebo control”. When new antipsychotics are developed for schizophrenia, it can be debated which guideline applies.

From the Conclusion:

We believe the time has come to cease the use of placebo in relapse prevention studies and encourage the use of active comparators that would protect patients from relapse and provide information on the comparative effectiveness of the drugs studied. We recommend that pharmaceutical companies not seek maintenance labeling if it would require placebo-controlled, relapse prevention trials. However, for putative antipsychotics with a novel mechanism of action, placebo-controlled, relapse prevention trials may still be justifiable.

The info is here.

Even psychological placebos have an effect

University of Basel Press Release
Published February 5, 2019

Psychotherapy and placebos are both psychological interventions that not only have comparable effects, but that are also based on very similar mechanisms. Both forms of treatment are heavily influenced by the relationship between patients and those treating them, as well as by the expectations of recovery. Whereas placebo research mostly focuses on a biomedical model – an inert pill is provided with a medical rationale, which produces a corresponding effect – little is known about the effect of placebos provided with a psychological rationale.

“Green is calming”

Placebos can also have effects when specific psychological effects are attributed to them. This is the conclusion that researchers from the Division of Clinical Psychology and Psychotherapy at the University of Basel reached in three independent experiments with 421 healthy participants. The accompanying explanation – the narrative – played a key role when dispensing the placebos, as did the relationship between the researchers and the participants.

The researchers used the color green as the placebo in the video experiments, examining it both with and without a psychological narrative (“green is calming because it activates early conditioned emotional schemata”), as well as in the context of a neutral or a friendly relationship.

After viewing the videos, the participants assessed their subjective condition with questionnaires over several days. The results showed that the placebo had a positive effect on the participants’ well-being when it was prescribed together with a psychological narrative and in the context of a friendly relationship. The observed effect was strongest after administering the placebo but remained evident for up to one week.

Ethical implications

“The observed effects were comparable with those of psychotherapeutic interventions in the same populations,” says principal investigator Professor Jens Gaab. The fact that psychological placebos can have significant effects is not only important for understanding psychological interventions: “It challenges both research and clinical practice to address these mechanisms and effects, as well as their ethical implications.”

The pressor is here

Companies Tout Psychiatric Pharmacogenomic Testing, But Is It Ready for a Store Near You?

Jennifer Abbasi
JAMA Network
Originally posted October 3, 2018

Here is an excerpt:

According to Dan Dowd, PharmD, vice president of medical affairs at Genomind, pharmacists in participating stores can inform customers about the Genecept Assay if they notice a history of psychotropic drug switching or drug-related adverse effects. If the test is administered, a physician’s order is required for the company’s laboratory to process it.

“This certainly is a recipe for selling a whole lot more tests,” Potash said of the approach, adding that patients often feel “desperate” to find a successful treatment. “What percentage of the time selling these tests will result in better patient outcomes remains to be seen.”

Biernacka also had reservations about the in-store model. “Generally, it could be helpful for a pharmacist to tell a patient or their provider that perhaps the patient could benefit from pharmacogenetic testing,” she said. “[B]ut until the tests are more thoroughly assessed, the decision to pursue such an option (and with which test) should be left more to the treating clinician and patient.”

Some physicians said they’ve found pharmacogenomic testing to be useful. Aron Fast, MD, a family physician in Hesston, Kansas, uses GeneSight for patients with depression or anxiety who haven’t improved after trying 2 or 3 antidepressants. Each time, he said, his patients were less depressed or anxious after switching to a new drug based on their genotyping results.

Part of their improvements may stem from expecting the test to help, he acknowledged. The testing “raises confidence in the medication to be prescribed,” Müller explained, which might contribute to a placebo effect. However, Müller emphasized that the placebo effect alone is unlikely to explain lasting improvements in patients with moderate to severe depression. In his psychiatric consulting practice, pharmacogenomic-guided drug changes have led to improvements in patients “sometimes even up to the point where they’re completely remitted,” he said.

The info is here.

Harnessing the Placebo Effect: Exploring the Influence of Physician Characteristics on Placebo Response

Lauren C. Howe, J. Parker Goyer, and Alia J. Crum
Health Psychology, 36(11), 1074-1082.

Abstract

Objective: Research on placebo/nocebo effects suggests that expectations can influence treatment outcomes, but placebo/nocebo effects are not always evident. This research demonstrates that a provider’s social behavior moderates the effect of expectations on physiological outcomes.

Methods: After inducing an allergic reaction in participants through a histamine skin prick test, a health care provider administered a cream with no active ingredients and set either positive expectations (cream will reduce reaction) or negative expectations (cream will increase reaction). The provider demonstrated either high or low warmth, or either high or low competence.

Results: The impact of expectations on allergic response was enhanced when the provider acted both warmer and more competent and negated when the provider acted colder and less competent.

Conclusion: This study suggests that placebo effects should be construed not as a nuisance variable with mysterious impact but instead as a psychological phenomenon that can be understood and harnessed to improve treatment outcomes.

Link to the pdf is here.

Rigorous Study Finds Antidepressants Worsen Long-Term Outcomes

Peter Simons
madinamerica.com
Originally posted

Here is an excerpt:

These results add to a body of research that indicates that antidepressants worsen long-term outcomes. In an article published in 1994, the psychiatrist Giovanni Fava wrote that “Psychotropic drugs actually worsen, at least in some cases, the progression of the illness which they are supposed to treat.” In a 2003 article, he wrote: “A statistical trend suggested that the longer the drug treatment, the higher the likelihood of relapse.”

Previous research has also found that antidepressants are no more effective than placebo for mild-to-moderate depression, and other studies have questioned whether such medications are effective even for severe depression. Concerns have also been raised about the health risks of taking antidepressants—such as a recent study which found that taking antidepressants increases one’s risk of death by 33% (see MIA report).

In fact, studies have demonstrated that as many as 85% of people recover spontaneously from depression. In a recent example, researchers found that only 35% of people who experienced depression had a second episode within 15 years. That means that 65% of people who have a bout of depression are likely never to experience it again.

Critics of previous findings have argued that it is not fair to compare those receiving antidepressants with those who do not. They argue that initial depression severity confounds the results—those with more severe symptoms may be more likely to be treated with antidepressants. Thus, according to some researchers, even if antidepressants worked as well as psychotherapy or receiving no treatment, those treated with antidepressants would still show worse outcomes—because they had more severe symptoms in the first place.

The article is here.

The target article is here.

The Moral and Legal Permissibility of Placebo-Controlled Trials

Mina Henaen
Princeton Journal of Bioethics
Princeton University
Originally posted August 15, 2016

Leaders of research ethics organizations have made placebo-controlled trials illegal whenever placebo groups would not receive currently existing treatment for their ailment, slowing down research for cheaper and more effective treatments. In this essay, I argue that placebo-controlled trials (PCTs) are both morally and legally permissible whenever they provide care that is better than the local standard of care. Contrary to what the anti-PCT often put forth, I argue that researchers conducting PCTs are not exploiting other developing nations, or subjects from these nations, when they conduct their research there. I then show how these researchers are also not especially legally required to provide treatment to their placebo-group subjects. I present some of the benefits of such research to the placebo groups as well and consider the moral impermissibility of making such research illegal.

The article is here.

Disclosure of incidental constituents of psychotherapy as a moral obligation for psychiatrists and psychotherapists

Manuel Trachsel & Jens Gaab
J Med Ethics 2016;0:1–3.
doi:10.1136/medethics-2015-102986

Abstract

Informed consent to medical intervention reflects the moral principle of respect for autonomy and the patient's right to self-determination. In psychotherapy, this includes a requirement to inform the patient about those components of treatment purported to cause the therapeutic effect. This information must encompass positive expectancies of change and placebo-related or incidental constituent therapy effects, which are as important as specific intervention techniques for the efficacy of psychotherapy. There is a risk that informing the patient about possible incidental constituents of therapy may reduce or even completely impede these effects, with negative consequences for overall outcome. However, withholding information about incidental constituents of psychotherapy would effectively represent a paternalistic action at the expense of patient autonomy; whether such paternalism might in certain circumstances be justified forms part of the present discussion.

The article is here.

The Pervasive Problem With Placebos in Psychology

By Walter R. Boot, Daniel J. Simons, Cary Stothart, and Cassie Stutts
doi: 10.1177/1745691613491271
Perspectives on Psychological Science July 2013 vol. 8 no. 4 445-454

Abstract

To draw causal conclusions about the efficacy of a psychological intervention, researchers must compare the treatment condition with a control group that accounts for improvements caused by factors other than the treatment. Using an active control helps to control for the possibility that improvement by the experimental group resulted from a placebo effect. Although active control groups are superior to “no-contact” controls, only when the active control group has the same expectation of improvement as the experimental group can we attribute differential improvements to the potency of the treatment. Despite the need to match expectations between treatment and control groups, almost no psychological interventions do so. This failure to control for expectations is not a minor omission—it is a fundamental design flaw that potentially undermines any causal inference. We illustrate these principles with a detailed example from the video-game-training literature showing how the use of an active control group does not eliminate expectation differences. The problem permeates other interventions as well, including those targeting mental health, cognition, and educational achievement. Fortunately, measuring expectations and adopting alternative experimental designs makes it possible to control for placebo effects, thereby increasing confidence in the causal efficacy of psychological interventions.

The entire article is here.

The potential benefit of the placebo effect in sham-controlled trials: implications for risk-benefit assessments and informed consent

By Remy L Brim and Franklin G Miller
J Med Ethics 2013; 39:703-707 doi:10.1136/medethics-2012-101045

Abstract

There has been considerable debate surrounding the ethics of sham-controlled trials of procedures and interventions. Critics argue that these trials are unethical because participants assigned to the control group have no prospect of benefit from the trial, yet they are exposed to all the risks of the sham intervention. However, the placebo effect associated with sham procedures can often be substantial and has been well documented in the scientific literature. We argue that, in light of the scientific evidence supporting the benefits of sham interventions for pain and Parkinson's disease that stem from the placebo effect, these sham-controlled trials should be considered as offering potential direct benefit to participants. If scientific evidence demonstrates the positive effect of placebo from sham interventions on other conditions, sham-controlled trials of interventions for the treatment of these conditions should be considered to have prospects of benefit as well. This potential benefit should be taken into account by research ethics committees in risk-benefit analyses, and be included in informed consent documents.

The article is here.

Is It Ethical For Doctors To Prescribe Placebo?

By Alice Walton
Forbes
Originally published on March 22, 2013

A new British study out in the journal PLOS ONE is stirring up a lot of debate, as it gives some estimates on the number of doctors who are giving patients placebo to treat their various conditions. It finds that a resounding 97% of the 783 doctors surveyed admitted to giving patients some sort of placebo in their practice. But it would be misleading to say that doctors are giving patients sugar pills or saline injections at the drop of a hat – there are different kinds of placebos, and, as the survey found, doctors have different feelings about when each should be used. Not surprisingly, so does the public.

“Pure” placebos are indeed sugar pills or saline injections with no therapeutic value (aside from that stemming from the psychological effects – more on this later). This “pure” variety was used by about 12% of the general practitioners at some time in their careers. Among these doctors, there were various motivations, including the wish to generate psychological treatment effects, to calm patients, to appease patients’ wish for a treatment, and to treat “non-specific complaints.” Half the doctors only told their patients something vaguely promising, like “this therapy has helped many other patients.” About 25% told their patients that the treatment “promoted self-healing,” and less than 10% revealed that the treatment was actually placebo.

“Impure” placebos, on the other hand, are therapies for which there is no strong evidence that they work for a given problem – for instance, the use of antibiotics to treat a virus, off-label uses of medications, or probiotics for diarrhea. Impure placebos also include lab tests or physical exams that are given simply in order to reassure patients. This type of placebo was much more common, with 97% of doctors reporting their use at least once across their career, and 77% reporting “frequent” use, i.e., at least once per week.

The entire story is here.

The entire study, Placebo Use in the United Kingdom: Results from a National Survey of Primary Care Practitioners, is here.