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  1. Introduction Russell Ellison, MDChief Medical OfficerVice President, Medical Affairs Roche Laboratories, Inc.

  2. Accutane and Psychiatric Adverse Events • February 1998 • bolded warning in label based on spontaneous reports of psychiatric events with Accutane: ie: an unconfirmed “signal”

  3. Accutane and Psychiatric Adverse Events • February 1998 to June 2000: • pharmacoepidemiological analysis of reports • clinical review of reports of suicides and related events • two retrospective epidemiologic cohorts [UKGPRD, Saskatchewan] • biological and clinical literature review

  4. Accutane and Psychiatric Adverse Events • This evidence does not support a causal association between Accutane and psychiatric events including suicide • Patients with acne, depending on age, gender, and prior history, may be at high risk for a concomitant psychiatric illness

  5. Agenda • IntroductionRussell Ellison, MD Chief Medical Officer, Vice President, Medical Affairs Roche Laboratories, Inc. • Clinical Context for Evaluation of Psychiatric Events and AccutaneDouglas Jacobs, MDAssociate Clinical Professor of Psychiatry Harvard Medical School • Pharmacoepidemiological Evaluation of Spontaneous ReportsRobert C. Nelson, PhDRCN Associates, Inc.

  6. Agenda • Epidemiological Studies and Biological Review John McLane, PhD Director/Medical Science and Safety Roche Laboratories, Inc. • Risk Management Russell Ellison, MD Vice President/Medical Affairs Roche Laboratories, Inc.

  7. Risk Management Options Russell Ellison, MDChief Medical OfficerVice President, Medical Affairs Roche Laboratories, Inc.

  8. Psychiatric Events Risk Management Issues • The evidence does not support a causal association of psychiatric illness with Accutane. Specific information related to possible risk of events beyond known risk factors for disease is lacking. • Patients with severe acne, depending on age, gender, and prior history, may be at high risk for a concomitant psychiatric illness

  9. Psychiatric Events Risk Management Issues • What information to convey, with what desired actions, to be taken by whom and in what circumstances? • e.g.: CME • Psychiatric disease as a concomitant illness: • alert the prescriber to this phenomenon • use the treatment venue as an opportunity for identifying possible problems • applicable to all high risk patients, include Accutane information

  10. Psychiatric Events Risk Management Issues • What information to convey, with what desired actions, to be taken by whom and in what circumstances? • e.g.: Labeling: • Professional: new Accutane data, symptoms, discontinuation, alert to comorbidity in all high risk patients • Patients: Accutane information, alert to symptoms, inform physician of previous history, alert to possibility of psychiatric illness irrespective of acne treatment

  11. Psychiatric Events Risk Management Issues • What information to convey, with what desired actions, to be taken by whom and in what circumstances? • e.g.: Labeling: informed consent • relative strength of causal association compared to other serious adverse events • what to inform patients about, for consent to treatment without a strong statement of cause, or estimates of risk

  12. Psychiatric Events Risk Management Issues • What information to convey, with what desired actions, to be taken by whom and in what circumstances? • e.g.: assessment before and during treatment • simple questionnaires (waiting room) available to identify the possibility of, psychiatric illness but not to confirm or rule out • for all high risk patients (part of dermatological assessment) • potential risk of conflict with time needed for pregnancy prevention in women...compliance?

  13. Psychiatric Events Risk Management Issues • Formal Studies: • Prospective clinical trial: • control group, hypothesis/sample size, blinding • Open cohort studies • matching cohorts unlikely • specificity of question, confidence in the answer • must be prospective

  14. Psychiatric Events Risk Management Issues • Retrospective epidemiologic cohort study: • available databases re: size, specific coding, population definitions • In vitro / in vivo preclinical studies: • specific models for specific psychiatric illness vs general CNS effects

  15. Conclusions • The evidence does not support a causal association between Accutane and psychiatric illness • Additional studies might somewhat clarify but not definitively resolve the issue • Much has been learned about psychiatric disease in acne patients…there is an opportunity to enhance the overall medical impact of the management of all acne patients