In response to the Nov. 2010 Regulatory & Legal column ["A question of ethics: When to lie?"] written by Kenneth R. Baker, BS Pharm, JD, this blog discusses the "Placebo Effect."
Editors note: This blog was submitted as a letter to
Drug Topics
in response to a Regulatory & Legal column ["A question of ethics: When to lie?"] written by Kenneth R. Baker, BS Pharm, JD, and published in the Nov. 2010 issue.
We welcome your thoughts on this subject. If you’d like your response posted online, please e-mail it to cphillis@advanstar.com. (Be sure to include your title and city/state.) Drug Topics will post as many responses as possible.
As Richard Kradin stated in his 2008 book, The Placebo Response and Unconscious Healing (2008), current medical practice is “swimming in a sea of placebos and no one is the wiser for it.”1
Did the videos that [Ken Baker’s] students viewed report that over half of all doctors in the United States prescribe placebos?
Time magazine recently quoted a survey of physicians (anonymous) that found that 96% of all doctors in the United States believe that the placebo can be therapeutic. It would be interesting to match up this view so widely held by doctors, if correct, against the views of others in the medical field, such as pharmacists.
Reading your article, I realize that pharmacists have an obligation to make their own ethical decisions related to their patients.
There are at least 4 other ways a doctor can prescribe a placebo in addition to the one depicted in the scenario presented to the class.
The key issue is that the placebo does have a physiological effect on the patient.2 Dr. Fabrizio Benedetti and Dr. Tor Wager have proven through MRI scans that placebo effects can be recorded in brain scan images. Other studies show the placebo response is statistically significant for a wide variety of ailments. So a doctor is ethical in prescribing placebos in one sense.
Daniel Moerman, a medical anthropologist and author of dozens of peer-reviewed articles on the placebo effect, warns that to withhold the prescription of placebos could be considered unethical in one sense, as they can be powerfully therapeutic.3 He particularly warns against prohibiting the use of placebos in clinical trials, in which researchers face the same ethical dilemma as every doctor and pharmacist.
Finally, and most fascinating, there is the newest study led by Dr. Robert Ader (again a peer-reviewed author), which he conducted on patients with psoriasis, mixing placebo prescriptions with the prescription of the specific therapeutic agent.4
Essentially, this groundbreaking study demonstrated that the medication could be reduced by 25% to 50% over an 8-week period, with the same healing results as the full-dosage prescription. The mechanism involved is believed to be the “conditioning response” of the placebo effect. Patients were conditioned with 3 full doses of the medication and then given a placebo on the fourth dosage. This was an important benefit in the study as the real drug agent has toxic side effects.
The design of this clinical study is a stroke of genius and is worth researching. There were actually 3 arms in the randomized controlled study. The results could affect the future of medicine as we learn more about the power of the placebo. The implications of the study could extend into other areas of the immune system and have wide-reaching results.
Robert Speers,MA Psychology, is currently writing the book “ThePowerful Placebo: The Effect of Positive Expectations on Health.” He livesin Boulder, Colo., and can be reached at robert@thepowerfulplacebo.com or303-214-8018.
References
1. Kradin, R. The Placebo Response and the Power of Unconscious Healing. New York: Routledge; 2008.
2. Benedetti, F. Placebo Effects: Understanding the Mechanisms of Health and Disease. New York: Oxford Press; 2009.
3. Moerman, D. Meaning, Medicine, and the Placebo Effect. Boston: Cambridge University Press; 2002.
4. Ader R, Mercurio MG, Walton J. Conditioned pharmacotherapeutic effects: A preliminary study. Psychosom Med. 2010;72(2):192-197.