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PEPTIC ULCER TREATMENT GUIDELINE DEFINITION OF PLACEBO

Executive Summary

PEPTIC ULCER TREATMENT GUIDELINE DEFINITION OF PLACEBO should be clarified to distinguish between "no drug whatsoever" and active compounds such as antacids, FDA's Gastrointestinal Drugs Advisory Cmte. suggested during its March 22 review of draft guidelines for the clinical evaluation of antiulcer drugs. Summarizing cmte. consensus, Chairman Eugene Schiff, MD, University of Miami School of Medicine, stated that the guidelines should "have a better definition of placebo" so that "it is clear what we are talking about." Commenting on ulcer trials where patients on active drug and placebo were allowed to take antacids concomitantly, Bristol-Myers' Sheldon Schwartz, MD, said that if the word placebo is used "it ought to really mean placebo -- no drug whatsoever, not a phony antacid -- I mean it would really have to have no chemical value." Schwartz added: "Once you start to talk . . . about something which has healing powers in and of itself, proven in the medical database, then you have to say that that is a partial treatment category and it is no longer placebo." FDA Cardio-Renal Drugs Div. Acting Director Raymond Lipicky, MD, stated that if a clinical trial were properly controlled, other variables, such as antacid use, should not bias results. "I would argue that the design of a trial, if it is double-blind and treatments are randomized and populations are large enough so that one doesn't have to worry about whether the randomization worked . . . that basically the assumption is that all variables are being controlled . . . and that, indeed, one is simply looking at the effects of pill one versus pill two," Lipicky remarked. Commenting on the use of a placebo without concomitant therapies, Lipicky questioned "whether you can use those results for any predictive purposes because you have done [the study] in such an artificial way and in such a limited population that is defined so explicitly that you have no ability to generalize." Schiff explained that the cmte.'s discussion focused on treatment of duodenal ulcers "because there are going to be some connotations in terms of placebo trials in gastric ulcer that wouldn't be applied to duodenal ulcer." Schiff added that "there appears to be no risk, [i.e.] increase in complications related to the doudenal ulcer specifically, in treating patients with a placebo in a controlled, carefully monitored setting." SmithKline representative Brian Dickson, MD, commented that while many Investigational Review Boards consider true placebo studies unethical, SmithKline does placebo controlled studies "and I don't think there is much risk in the acute." He added that "it is different story, perhaps, when you are doing maintenance studies over one and two [years], and perhaps longer." Roche representative Dirk Enthoven, MD, asked whether a patient who heals at two or four weeks during a four or six week trial should be dropped from the study or continued on drug therapy throughout the entire period. Cmte. member Janet Elashoff, MD, UCLA, said: "There is the ideal from the statistical point of view and there is the practice. Most studies have taken people off and it has been a reasonably accepted practice. I prefer not to see it from a statistical point of view. From a clinical point of view, it doesn't mimic practice either way." In further discussion, the cmte. agreed to revise the guidelines to recommend consideration of serial endoscopies, "particularly when assessing a new type of drug where we don't know the healing rate," Schiff said.
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