|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Vol. 11, No. 6 · November 2007 · Editor: Martha L. Golar, Esq.
Male Breast Cancer: Learn the Facts Which Can Save Lives DATE: Tuesday, November 27, 2007 TIME: 6:30 - 7:30 P.M. PLACE: Skadden Arps Slate Meagher & Flom Four Times Square (between 6th Ave. & Broadway) SPEAKERS: Deborah Axelrod, M.D., Director of Clinical Breast Services, NYU Cancer Center Baljit Singh, M.D., Pathologist, NYU Cancer Center · Race for the Cure – JALBCA’s Team · JALBCA’S Harlem Mammography Van · JALBCA 2007 Annual Courthouse Alert Kick-Off Reception · FDA Drug Safety Newsletter Fact Sheet · Calendar / Contacts Race for the Cure – JALBCA’s Team More than 50 runners represented JALBCA’s team on September 9, 2007, at the Koman Race for the Cure. Team JALBCA, clad in distinctive green and pink t-shirts, joined thousands of runners in raising money for cancer research and awareness. Thanks go out to team co-captain Emily Ascher for ordering the t-shirts, coordinating with the Koman Foundation and organizing distribution. Also, thank you Chris Pisacane and co-captain Hon. Shirley Kornreich for helping with the distribution of the shirts and numbers and getting the word out.  JALBCA’S Harlem Mammography Van  JALBCA’s Harlem Mammography Van Project, once more, fielded a van providing mammographies to the under-served Harlem Community. The van was located at the Harlem Courthouse and provided services to 30 women on October 22, 2007. Thanks go out to the Association of Secretaries to Supreme Court Justices, New York County, and its president Valerie Qualls and past presidents Lucy Viana and Mary Jenkins, for their hard work in distributing flyers; Camilla Kmiec, Chief of Administration in the Manhattan Management Department of the NewYork City Housing Authority, for arranging to have flyers posted in building lobbies, management offices and community centers; Minda Christensen, Project Coordinator for the American-Italian Cancer Foundation, for duplicating our flyers in English and Spanish; the American-Italian Cancer Foundation for the van; theWomen’s Outreach Network and its Executive Director, Mary Solomon, for coordinating appointments; Patricia Hepburn and Columbia Presbyterian for providing follow-up care for those women whose mammograms indicated such care was necessary; Justice Ruben Martino and Denise Jones for their assistance and cooperation; Kay Murray, who as always coordinated the project with selflessness, hard work and grace; and the Harlem Van Committee – Kay Murray, Mary Jenkins, Shirley Kornreich and Ngozi Okaro – for the planning. The van is scheduled next year for October 23, 2008.JALBCA 2007 Annual Courthouse Alert Kick-Off Reception On Wednesday, September 19, 2007, JALBCA held its cocktail reception to kick-off its 2007 Annual Courthouse Alert. As in recent years, the reception took place at the Appellate Division, Second Department courthouse in Brooklyn. Event co-chairs, Judges Hon. Ellen Spodek and Hon. William C. Thompson spoke, as did JALBCA Co-Presidents Judith Livingston and Hon. Eileen Bransten.  Hon. Shirley Kornreich, Kay Murray, Esq. and members of the Association of Secretaries to Supreme Court Justices, New York County, including its president Valerie Qualls  Co-president Judith Livingston, Hon. William C. Thompson (retired), Hon. Eileen Bransten, Hon. Ellen Spodek  Annual dinner co-chairs from the June 2008 annual dinner- Sandra Katz, Esq. and Cynthia Rubin, Esq.
FDA Drug Safety Newsletter Fact Sheet Contents of Newsletter The FDA reports that it launched its Drug Safety Newsletter in September 2007. This is a source of information for healthcare professionals about the findings of selected post-marketing drug safety reviews from FDA’s Center for Drug Evaluation and Research (CDER). The Newsletter also provides information on important emerging drug safety issues and recently approved new molecular entities (NMEs). An NME is a medication containing an active substance that has never before been approved for marketing in any form in the United States. The FDA intends to publish the Newsletter, produced by CDER’s Safety Policy and Communication Staff, on a quarterly basis. The Newsletter provides post-marketing information to healthcare professionals to enhance communication of new drug safety information, raise awareness of reported adverse events, and stimulate additional adverse event reporting. While the Newsletter is not directed to consumers, patients who are concerned about the products they are taking may want to review it in any event, in addition to consulting their doctor or pharmacist Of course, patients are not advised to change or discontinue therapies prior this consultation. The Newsletter presents data primarily from adverse event reports submitted to FDA’s Adverse Event Reporting System (AERS). The AERS database receives several hundred thousand adverse event and medication error reports every year related to drug safety from manufacturers, healthcare professionals, and the public. The primary value of reviewing AERS data is to identify signals of potential drug safety issues. The FDA advises that some articles in the Newsletter will be based on post-marketing drug safety reviews routinely conducted by FDA’s Office of Surveillance and Epidemiology (OSE), based primarily on adverse event reports from the AERS database. Other articles will be based on reviews of safety information from other sources, e.g., post-marketing clinical or pharmacoepidemiology studies. Articles may focus on a specific drug or class of drugs and may address emerging drug safety issues or safety information that is fully developed. It is also intended that the Newsletter will report on post-marketing findings for a recently approved NME. Post-marketing safety reviews of approved NMEs are carried out at periodic intervals within CDER (Office of Surveillance and Epidemiology, Office of New Drugs, and the Office of Translational Sciences). Adverse Drug Experiences and Adverse Event Reports An adverse drug experience is any adverse event associated with the use of a drug in humans, whether or not considered drug related. It includes the following: (21 CFR 314.80(a)) An adverse event report is a communication to the FDA of an undesirable sign or symptom associated with use of a drug (as required and detailed by 21 CFR 314.80, see also 21 CFR 310.305, 314.98, and 600.80). These reports are logged into AERS. Drug manufacturers are required to report adverse event information to FDA but adverse event reports may also be voluntarily submitted to the FDA directly by healthcare professionals or the general public at www.fda.gov/medwatch/report.htm. The reports are reviewed, safety issues are monitored, and data are periodically analyzed and assessed by CDER. As explained by the FDA, there are inherent limitations to a voluntary reporting system for adverse events associated with the use of a drug. These include, without limitation, underreporting, duplicate reporting, and reporting biases. In addition, it may be that, with respect to a particular report, the reported adverse event(s) may not be causally related to the product(s) that is reported to have been taken. The event may have been related, for example, to the underlying disease being treated, to other medical conditions, or to another product taken at the same time. The FDA advises that the number of cases reported to AERS cannot be used to calculate the incidence rates, to estimate drug risk for a particular product, or to compare risks between products. Calendar / Contacts ADELPHI NY STATEWIDE BREAST CANCER Hotline & Support Program Adelphi University School of Social Work Garden City, NY 11530 www.adelphi.edu/nysbreastcancer/index.html CancerCare 275 Seventh Avenue NY NY 10001 www.cancercare.org 1-800-813-HOPE MEMORIAL SLOAN-KETTERING CANCER CENTER Memorial Sloan-Kettering Cancer Center Post-Treatment Resource Program Educational Forums 1275 York Avenue - Room-M107 NewYork, NY 10021 212-717-3527 www.mskcc.org/mskcc/html/19409.cfm Bendheim Medicine Center 1429 First Avenue (at 74th St.)
SHARE Self-Help for Women with Breast or Ovarian Cancer) 1501 Broadway, 704A New York, NY 11530 www.sharecancersupport.org 212-719-0364 JALBCA does not endorse the content or efficacy of any workshops or programs listed in the Calendar of Events; listings are for informational purposes only, so that our readership is aware of current offerings. |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Home | About | Hotline | Newsletter | Calendar | Contact Mailing List | Membership | Donations | Links |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||