Alumni News
&notes
alumni in print
By Bonita Eaton Enochs, Editor
Risk Evaluation and Mitigation Strategies for U.S. Drug Development
Letters to the Editor that were never published (and some other stuff)
Edward Tabor’73 Regulatory Affairs Professionals Society, 2012
Alex Caemmerer Jr.’47 Trafford Publishing, 2011
Dr. Tabor’s book will help anyone involved in the development and marketing of pharmaceutical and biologic products navigate a new step in the drug development approval process, the Risk Evaluation and Mitigation Strategy, or REMS. Since 2007, the FDA has had the authority to require a REMS as a condition of approval for any product where agency reviewers determine a drug’s benefits would not outweigh the risks without some sort of additional control. As an authoritative resource on REMS requirements, process, and implementation, Dr. Tabor’s book will help predict whether the FDA may require a REMS and offer guidance on how to create a REMS. Dr. Tabor gained experience in government regulation of pharmaceutical and biotechnology products during his 22 years at FDA, including time as a director of two FDA divisions.
Dr. Caemmerer describes himself as an “inveterate letters to the editor writer,” with about 130 letters written to the New York Times and other publications during the past “dozen or so” years. With only a handful of the letters published, he collected the letters into print himself. He has divided the letters into chapters with titles that include psychiatry, psychoanalysis, depression, religion, Catholic bishops and priests, homosexuality, and violence; commentary on the topic introduces the letters in each chapter. The book also includes letters Dr. Caemmerer has written to individuals and essays on changes in American culture over the past few decades.
Listening to Pain: Finding Words, Compassion, and Relief David Biro’91 W.W. Norton & Company, 2011 Originally published in hardcover as “The Language of Pain,” Dr. Biro’s book shows readers how to break through the silent wall of suffering – physical and psychological – that can accompany pain and illness. He draws together compelling stories from patients and insights from some of society’s greatest thinkers, writers, and artists, showing how language can alleviate the loneliness of pain and pave the way for empathy and effective treatment. Dr. Biro, who also has a Ph.D. in literature from Oxford, wrote about his own experience as a patient in his 2000 book, “One Hundred Days: My Unexpected Journey from Doctor to Patient,” which was excerpted in the Winter 2001 issue of P&S. 42 ColumbiaMedicine Fall 2012
Casebook of Interpersonal Psychotherapy John C. Markowitz’82 and Myrna M. Weissman, Editors Oxford University Press, 2012 Dr. Weissman and her late husband, Gerald L. Klerman, M.D., developed interpersonal psychotherapy, a time-limited, diagnosisfocused treatment that helps patients solve interpersonal crises and mobilize social support by helping patients change interpersonal behavior to improve psychosocial functioning. The therapy has been repeatedly tested in randomized trials with such success that it is now included as a leading therapy in treatment guidelines for major depression and eating disorders. This 2012 casebook co-edited by Dr. Weissman and Dr. Markowitz includes in-depth case illustrations by experts for clinicians who use the therapy. Chapters show adaptations of the therapy for patients with particular disorders, such as mood disorders, anxiety disorders, and personality disorders. The book also describes how the therapy can be used in different settings, including group, inpatient, and telephone therapy.