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| Reprinted with permission from Annals of Improbable Research (AIR) |
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Abstract
Is a single-strength placebo not getting the job done?
Too often, good research about new medicines, research that shows unusually clear-cut results, goes unpublished, and thus unseen. The reason? Journal editors distrust any study in which the placebo effect is "too small."
The problem has a simple solution: rerun the experiment, but instead of giving standard placebos to the control group, instead give them
double-strength placebos (DSPs).
What Is the Placebo Effect?
The placebo effect is the response that a so-called "control group" of patients shows when those patients are treated with placebos, innocuous "pretend" medicine, rather than with real medicine.
Prior Research on Placebos
Scientists have studied a wide variety of placebo issues, and
published reports about what they found.[1,2,3,4,5,6,7,8] Yet prior to
this investigation, no one has published a report on the problem of
minimal placebo response.
The Need to Study Double-Strength Placebos
While certain problems are associated with the use of the double-strength placebo, overall it promises to be a powerful research tool.
Approval of the DSP by the U.S. Food and Drug Administration (FDA) must
of course precede its use. Since its efficacy must be demonstrated in
a proper study, the immediate problem is the choice of a placebo to
give the control group of that study. There is no documentation of
the differing strengths of the placebos that are currently available,
so it would be appropriate to first determine these strengths, and
then select a control placebo that has median effect.
Patient Sensitivity and Safety
There is a more serious problem in studying the efficacy of double-strength placebos. As with any new drug, we must confront the possibility of deleterious effects upon individuals who may exhibit a high level of sensitivity to placebos. [8] Most important, of course, is to find a safe, practical way to identify patients who are acutely allergic to placebos. The public will not tolerate a rash of placebo deaths, nor should it have to.
The expense of safety-testing the placebos can be mitigated by a research setting suggested here.
Special Observation Facility
The subjects of the double-strength placebo study should have the DSPs administered in a specially prepared room, one equipped not with the traditional "one-way mirror," but instead with a large, clear glass window. This is a necessity, because any subjects who noticed a large mirrored opening in a wall would understand that they were being observed, and that might lead to skewed results.
The large glass window should have an ordinary venetian blind on the
observers' side of the glass, with the slats arranged at an angle
permitting optimal light transmission. On the other side of the
glass, there should be a blind of vertical slats, of the type commonly
used on sliding glass patio doors, with the slats arranged at a
suitable angle. For the subjects, this provides a reassuringly
familiar home-like setting. The main advantage of this arrangement,
though, is that with minimal effort and expense, it ensures a
double-blind experiment.
FDA Approval
When the study results are submitted to the Food and Drug
Administration, it is essential to emphasize that approval of
double-strength placebos will be of value only if no required warning
label is required. The reason for this is simple. Even a statement
worded in the most approving way (e.g., "The Surgeon General has
determined that this placebo is harmless despite its potency") may
limit the usefulness of the product.
Technical Note
The molecular structure of the DSP being a merely technical matter, it is beneath the scope of this article.
See article notes.
Frederic N. Firestone is a staff attorney at the Tidewater Legal Aid Society, Virginia Beach, Virginia.
The Placebo Effect - a brief introduction to placebos and how they work. From the American Cancer Society.
Patient Heal Thyself? - an editorial about the placebo effects of antidepressants, with links to the research article and additional commentaries. From the July 11, 1998 issue of New Scientist
Not So Blind, After All - about some potential pitfalls in double-blind experimentation. From the May 1996 issue of Scientific American.
From Placebo to Homeopathy: The Fear of the Irrational - from the September 14, 1998 issue of The Scientist.
Are Placebos Bearing False Witness? - a Chemistry and Industry commentary discusses the effects of placebos.