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THOMPSON MED's ASPERCREME: PFIZER DATA SUBMITTED TO SUPPORT CATEGORY I

Executive Summary

THOMPSON MED's ASPERCREME: PFIZER DATA SUBMITTED TO SUPPORT CATEGORY I efficacy status of the product. In a recent letter to FDA, Thompson Medical's New York law firm Davis & Gilbert submitted the results of two 1984 Aspercreme (trolamine salicylate) studies conducted for Pfizer. Davis & Gilbert stated that the documents are confidential materials from the files of Pfizer which were secured under a confidential order of the U.S. Southern District Court of New York in Thompson Medical v. Pfizer. One of the studies requested by Pfizer, conducted by Techni-Med Consultants, Inc., compared three products for efficacy in relieving arthritis pain: a topical 10% trolamine salicylate cream and two placebo tablets; two aspirin tablets and a placebo cream; and placebo tablets and placebo cream. According to a Pfizer document, the preliminary statistical analysis covering the first 23 patients found that "both cream and tablets relieved pain to a greater degree than placebos did, but the difference did not reach the .05 level of statistical significance." Thompson Medical maintained, however, that a May 6, 1984 Pfizer interim memorandum "displays a handwritten notation at the bottom which reads: 'Dr. Clyde (of Clyde Computing Service, the firm conducting the preliminary analysis of data) also projects that if the current trend continues, statistical significance at P=.05 will occur when panel reaches N=60.'" Thompson Medical told FDA: "Pfizer had planned to present to your agency the study results to support its position that Aspercreme (and other trolamine salicylate products) should be put into Category II, thereby effectively removing this competition from the marketplace. After the preliminary report and projection of Dr. Clyde that there would be statistical significance at the .05 level assuming the same trend, Pfizer did not pay for the remaining half of the study and the study was not completed." The second Pfizer commissioned study cited by Thompson Medical was a survey of 5,000 rub and liniment users conducted by Monroe Mendelsohn Research Inc. In the section of the survey on brand loyalty, Thompson Medical said Aspercreme ranked higher than all other tested brands, including Pfizer's Ben-Gay, "which came in second (47%) while Aspercreme topped the group at 60%." In addition, Thompson said "45% of Aspercreme users agreed strongly that Aspercreme is effective to relieve arthritis pain, while less than half as many, or 20%, of Ben-Gay users agreed with the statement as to Ben-Gay. While 53% of the Aspercreme users strongly concurred with the statement that Aspercreme provides long lasting relief for aches and pains, fewer (42%) of Ben-Gay ]users[ were in such agreement as to Ben-Gay." In a separate Oct. 22 submission to FDA, Thompson Medical reported the results of a study by Politino, et al, comparing the efficacy of a 10% trolamine salicylate topical versus placebo in relieving delayed-onset exercise-induced arthralgia/myalgia. The study, involving 83 patients, found that "approximately twice as many subjects in the trolamine salicylate group reported good-to-excellent relief as did those in the control group (39% vs 20%) and conversely, approximately twice as many in the control group reported poor results as did those in trolamine salicylate group (48% vs 23%)," Thompson Medical reported.
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