N40GL
12-07-2004, 12:52 PM
The Need for Double-Strength Placebos
by Frederic N. Firestone, Ph.D., J.D.
Virginia Beach, Virginia
Proper labeling will be an important issue when double-strength placebos reach the market
Too often, good research about new medicines—research that shows unusually clear-cut results—goes unpublished, and thus unseen.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: re-run 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 offers promises to be a powerful research tool. Approval of the DSP by the US 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 to 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.
References
1. "Placebos: relative merits of H2O and H2SO4," A. Amoamasamat, Journal of Patheohomic Medicine, vol. 2, 1989, pp. 6-14.
2. "Polished gravel as a placebo: some technical problems," A. Amoamasamat, Western Medical Repository, vol. 8, 1990, pp. 46-47.
3. "Why diabetics react strangely to many placebos," A. Amoamasamat, Molasses and Sugar Quarterly, vol. 23, 1991, pp. 56-60.
4. "LSD: a reason to avoid its use as a placebo," A. Amoamasamat, Cactus Times, vol. 1, pp. 1-84.
5. "When the placebo suppository is more effective than the therapeutic agent: a suggestion to practitioners," A. Amoamasamat, Tips for Managed Care, vol. 3, 1993, pp. 8-9.
6. "Patients who are displeased by placebos: a terminological mystery," A. Amoamasamat, Journal of Medical Linguistics, vol. 88, 1994, pp. 5-22.
7. "Forged prescriptions for placebos: a crime with mitigating circumstances? in A. Miss, ed., The Wrong is Ended But the Felony Lingers On, A. Amoamasamat, New York, Paris, and Casablanca: Who’s Publishing, 1996.
8. "Overly sensitive users of placebos: a statistical analysis of post-mortem examinations," A. Amoamasamat, unpublished, 1997. Was available from the author prior to his recent replication of the study. The author’s widow does not respond to requests for copies.
Notes
i. The author completed this article at the fishing facility of Virginia Beach, where it was immediately subjected to pier review.
ii. The problems involved in using two-way mirrors, three-way mirrors, etc., will be addressed in a separate publication, as will the problems related to using zero-way mirrors.
by Frederic N. Firestone, Ph.D., J.D.
Virginia Beach, Virginia
Proper labeling will be an important issue when double-strength placebos reach the market
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: re-run 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 offers promises to be a powerful research tool. Approval of the DSP by the US 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 to 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.
References
1. "Placebos: relative merits of H2O and H2SO4," A. Amoamasamat, Journal of Patheohomic Medicine, vol. 2, 1989, pp. 6-14.
2. "Polished gravel as a placebo: some technical problems," A. Amoamasamat, Western Medical Repository, vol. 8, 1990, pp. 46-47.
3. "Why diabetics react strangely to many placebos," A. Amoamasamat, Molasses and Sugar Quarterly, vol. 23, 1991, pp. 56-60.
4. "LSD: a reason to avoid its use as a placebo," A. Amoamasamat, Cactus Times, vol. 1, pp. 1-84.
5. "When the placebo suppository is more effective than the therapeutic agent: a suggestion to practitioners," A. Amoamasamat, Tips for Managed Care, vol. 3, 1993, pp. 8-9.
6. "Patients who are displeased by placebos: a terminological mystery," A. Amoamasamat, Journal of Medical Linguistics, vol. 88, 1994, pp. 5-22.
7. "Forged prescriptions for placebos: a crime with mitigating circumstances? in A. Miss, ed., The Wrong is Ended But the Felony Lingers On, A. Amoamasamat, New York, Paris, and Casablanca: Who’s Publishing, 1996.
8. "Overly sensitive users of placebos: a statistical analysis of post-mortem examinations," A. Amoamasamat, unpublished, 1997. Was available from the author prior to his recent replication of the study. The author’s widow does not respond to requests for copies.
Notes
i. The author completed this article at the fishing facility of Virginia Beach, where it was immediately subjected to pier review.
ii. The problems involved in using two-way mirrors, three-way mirrors, etc., will be addressed in a separate publication, as will the problems related to using zero-way mirrors.