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Executive Summary

ACCUTANE "PREGNANCY PREVENTION" SURVEY HAS ENROLLED OVER 12,000 WOMEN since its January start. The survey, which is being conducted for Roche by the Slone Epidemiology Unit at Boston University's School of Public Health, is currently enrolling approximately 700 women per week, according to Roche. Female patients are enrolled in the program through one of two mechanisms: a form supplied by the physician when the prescription is written; or a form supplied in the new product packages, introduced this May. Patients are given a $10 inducement for participating in the survey. The survey is part of Roche's Pregnancy Prevention Program, which includes blister packs, educational programs, patient information brochures, and other services that aid the physician in patient selection and counseling. Roche implemented the program shortly after an April 29, 1988 advisory committee review of pregnancy exposures and birth defects associated with the drug ("The Pink Sheet" May 2, 1988 p. 14). The study is designed to assess a number of factors, including: the rate of pregnancy among users; awareness of the teratogenic risks; history of prior acne therapy; pregnancy outcome among users who become pregnant; risk factors for the occurrance of pregnancy; and impact of the survey on compliance with prescribing guidelines. Survey participants are randomly assigned to either telephone or mail follow-up. Both groups will be contacted approximately six months after discontinuation of therapy for pregnancy information. Those in the telephone arm will also be contacted "several times during treatment to obtain detailed additional information related to their prior acne therapy, level of awareness of Accutane's hazards, physician contacts, and pregnancy prevention practices while using Accutane," the protocol notes. The teratogenic risk of Accutane thereapy was the subject of a number of "letters to the editor" in the Sept. 14 issue of the New England Journal of Medicine that were written in response to an April article. Health Research Group, in one of the letters, criticized the Slone survey as inadequate for assessing pregnancy exposures or risks because enrollment is voluntary. In response, Slone noted that "if the sample proves to be representative of female isotretinoin users, estimates of pregnancy rates are likely to be valid." The group is attempting to address that issue by comparing characteristics of survey participants to Accutane users in Medicaid and HMO data bases. Among Roche's other recent efforts at limiting misuse and pregnancy exposures with Accutane is an ad campaign that appears to be the antithesis of traditional promotions. The ad, which has been running for the last year, highlights that Accutane is "CONTRAINDICATED" (with bold red letters) unless patients meet certain criteria that is detailed in small print. The ad, which has a sister promotion targeted specifically to dermatologists, has received two awards: one from Modern Medicine, and one (the Hagen award) from the Journal of the American Medical Association. Roche just began running a new ad that focuses on the results of a survey of 110 physicians that found that 22% of potential female Accutane users did not qualify for use under the company's guidelines.

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