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ORTHO "EFFICACY WITH ACCURACY" ADS INTRODUCE DELCAP RETIN-A

Executive Summary

ORTHO "EFFICACY WITH ACCURACY" ADS INTRODUCE DELCAP RETIN-A dispensing cap but downplay the product's approved use for severe acne vulgaris. The professional ads highlight "significant clinical improvement" and "less than half the irritation." Nowhere on the multi-color pages of the ad is the approved indication mentioned. It is carried in the brief summary prescribing information as required. The indirect cultivation of the anti-wrinkle use for Retin-A is drawing flak for Ortho. The promotions for the product, for example, were the subject of a Feb. 4 segment on the TV magazine show "60 Minutes." The TV report varied from the usual prescription drug expose in making only tenuous allegations of safety problems from the unapproved use of Retin-A. The criticism of promotional practices stemmed from the view that Ortho is consciously looking the other way to enjoy the expanding unapproved uses for the product. The "60 Minutes" segment questioned Ortho's "public relations campaign" promoting Retin-A's use as a wrinkle treatment. The show concluded by noting that Rep. Weiss (D-N.Y.), chairman of the Human Resources & Intergovernmental Affairs Subcommittee, is taking an interest in Ortho's alleged promotion for unapproved uses. The Weiss subcommittee currently is compiling information to determine whether the publicity that the drug has received from articles published in medical journals and presented at press conferences constitutes an exchange of scientific information or promotion of an unapproved drug. As part of the probe, the subcommittee also is addressing the possibility of conflict of interest for Retin-A researchers who are receiving endowments from Ortho. A recent indicator of the commercial success of Retin-A is a patent suit between the university where the compound was discovered and the company. The Univeristy of Pennsylvania announced Jan. 22 that it is suing Retin-A developer Albert Kligman, MD, for an undisclosed amount. The suit filed in Philadelphia federal court contends that Kligman "breached the University's patent policy and conflict of interest policy by patenting and licensing his anti-wrinkle medication to [J&J] on his own" while he was employed by the university.

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