CONSENT CALENDAR June 13, 2006 L I N D A M A I O Councilmember - PDF document

CONSENT CALENDAR June 13, 2006 L I N D A M A I O Councilmember District 1 TO : Honorable Mayor and Members of the City Council FROM : Councilmembers Linda Maio and Max Anderson SUBJECT : A Brief Presentation to Council on the Off-Label Use of the Drug, Cytotec RECOMMENDATION : That the City Council hear a brief (10-minute) presentation by Maddy Oden on the off-label use of the drug, Cytotec. BACKGROUND : Maddy Oden, a long-time City employee, has asked to make this presentation to Council as part of her foundation’s educational campaign to encourage informed consent regarding the off-label use of the drug Cytotec. Maddy’s daughter, Tatia Oden French, was admitted to an Oakland hospital to deliver her first child in December, 2001. Tatia was in perfect health and the family was looking forward to the delivery of a healthy girl . Against her better judgement, Tatia agreed to have her labor induced, and was administered the drug Cycotec for that purpose. Cytotec is stipualted for the treatment of ulcers, but has been used “off-label” to induce labor. The official description of the drug, Cyctotec, issues the warning that “administration to women who are pregnant can cause abortion, premature birth, or birth defects. Uterine rupture has heen reported when Cytotec was administered in pregant women to induce labor or to induce abortion beyond the eighth week of pregnancy.” In spite of this warning, Cytotec is widely used to induce labor. Although the FDA did not approve Cytotec for use in inducing labor, once the FDA approves a drug to treat specific illnesses a physician may use that drug experimentally for other illnesses. This is what happened in Tatia’s case. Within 10 hours of administration of Cytotec both Tatia Odden French and her child had died. Tatia’s uterus was hyper-stimulated by the drug, causing fetal distress and a ambiotic fluid embolism (AFE) was released causing the death of both mother and child . Subsequent to Tatia and son’s death, Maddy and her family started the Tatia Oden French Foundation. The Foundation’s aim is to significantly reduce the incidence of maternal mortality through education, with the specific focus to acquire informed consent before the drug, Cytotec, and other drugs which are used off label, may be used. 2180 Milvia Street, Berkeley, CA 94704 Tel: 510.981.7110 TDD: 510.981.6903 Fax: 510.981.7199 E-mail: lmaior@ci.berkeley.ca.us

A long list of associations and society’s are on record opposing a bill, introduced recently by Assemblymember Loni Hancock, which recommends informed consent. A list of the opposition is attached. Each has been requested by Councilmembers Maio and Anderson to provide their reasons for opposing informed consent. As these replies arrive they will be disseminated to Council. FINANCIAL IMPLICATIONS : None. CONTACT PERSONS : Councilmember Linda Maio Council District 1 (510) 981-7110 Councilmember Max Anderson Council District 3 (510) 981-7130

Opposition California Medical Association California Neuro Alliance which includes: The ALS Association, American Academy of Neurology, American Stroke Association, Association of California Neurologists, Epilepsy Foundation, Huntington’s Disease Society of American, Hydrocephalus Association, Kennedy’s Disease Association, Myasthenia Gravis Foundation of California, The National Multiple Sclerosis Society, Neuropathy Association, Parkinson’s Institute, The Parkinson’s Association, and United Cerebral Palsy Association-Golden Gate Union of American Physicians and Dentists California Hospital Association Tulare County Medical Society Surgical and Specialties Society California Dermatology Society American Academy of Pediatric, Osteopathic Physicians and Surgeon, California Academy of Family Physicians American College of Obstetricians and Gynecologists Association of Northern California Oncologist Medical Oncology Association of Southern California Planned Parenthood Kaiser Permanente California Psychiatric Association UC Davis Children’s Hospital