WMA should not retreat on use of placebos

Editor—I do not think that patients should remain untreated when a proved effective treatment is available, and I was pleased by the new clause 29 in the revised Declaration of Helsinki. I am dismayed that the World Medical Association is retreating from this position.¹

The association's first condition for the use of placebo in research trials to be ethically acceptable—“Where for compelling and scientifically sound methodological reasons its use was necessary to determine the efficacy or safety of a prophylactic, diagnostic, or therapeutic method”—is so vague that it could be used to justify any trial using a placebo. For example, to show efficacy we could say that we must have untreated patients. But under the new Declaration of Helsinki, which bans placebo controls when there is an effective treatment, mere efficacy is not enough. It is relative efficacy that is important.

The second condition—“Where a prophylactic, diagnostic, or therapeutic method was being investigated for a minor condition and the patients who received placebo would not be subject to any additional risk of serious or irreversible harm”—suggests that unless the patient might die it is quite acceptable to let him or her suffer. Thus we could use placebos for eczema, for example, and let the patients scratch. I think that patients have a right to be treated. They go to doctors to have their problems alleviated, not to be guinea pigs.

If the reason for back pedalling is the criticism that in developing countries the best established treatment may be too expensive, this is not addressed at all. “Too expensive” is not a scientifically sound methodological reason. We justify trials too small to provide an answer to the question if an adequate trial were too expensive. The relevant clause of the declaration states that “The benefits, risks, burdens and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic, and therapeutic methods.” Inserting the word “available” after “current” would be sufficient to meet the objection of developing countries. If a treatment is too expensive it is not available.