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Vol. 11, No. 3 · April 2007 · Editor: Martha L. Golar, Esq.
· MAMMAPRINT® -- A BREAST CANCER MOLECULAR PROGNOSTIC TEST · FDA OFFICE OF WOMEN’S HEALTH · PRO BONO TRAINING – NYC BAR ASSOCIATION – CANCER ADVOCACY PROJECT · COURT OFFICERS MAKE GENEROUS CONTRIBUTION TO JALBCA · CALENDAR / CONTACTS JALBCA ANNUAL DINNER AND AWARDS PRESENTATION Wednesday, June 13, 2007 The Water’s Edge Long Island City 6:00 p.m. Cocktails 7:00 p.m. Dinner The Lawyers’ Division of JALBCA invites you to our 2007 Annual Dinner honoring NYU Cancer Center, recipient of the Special Recognition Award, and Barbara A. Ryan and Martha (Mikki) Golar, recipients of the Leadership Achievement Award. Two Co-Presidents will be installed, Hon. Eileen Bransten and Judith Livingston, Esq., together with all newly elected members of the Board of Directors and Advisory Board. Outgoing Co-President, Judge Barbara Panepinto, will be honored. For further information or to RSVP, contact Executive Director Jennifer Fiorentino at (212) 289-9720. MAMMAPRINT® -- A BREAST CANCER MOLECULAR PROGNOSTIC TEST The United States Food and Drug Administration recently announced the first multi-gene expression test to be cleared for marketing. MammaPrint was developed by Agendia, a laboratory based in The Netherlands, as a gene expression profiling test that determines the risk of metastasis and the likelihood of recurrence in breast cancer patients. MammaPrint is a validated molecular-diagnostic test that measures the activity of 70 isolated genes within the original tumor, resulting in information about the likelihood of recurrence within 5 to 10 years of an initial diagnosis. By performing DNA microarray analysis on patients’ tumors, Agendia believes that it has been able to identify a gene expression signature that is a strong predictor of distant metastasis. Tests like MammaPrint, which are capable of measuring gene activity in tumors, are believed to be a powerful tool in helping physicians to better assess the potential outcome of a particular patient’s disease. The results (together with other tests and clinical information such as the size of the tumor, whether it has spread to lymph nodes, whether it has positive or negative hormone receptors, etc.) should also be useful for patients and their physicians in deciding treatment options. For example, it may be helpful in deciding whether a person with early stage breast cancer needs chemotherapy after primary treatment (usually surgery, with or without radiation therapy). Historically, physicians and scientists have relied on clinical parameters such as lymph node status and estrogen receptor status (Er+ and/or Er-) as being the strongest predictors for metastasis. Where breast cancer patients in the same stage of the disease can experience varied treatment responses from one another, MammaPrint technology makes use of DNA microarrays to isolate a breast cancer cell’s gene expression profile. Agendia asserts that it is this individual profile which will more accurately predict disease outcome than its clinical predecessors. The FDA press release on MammaPrint in February 2007 stated that, “Prior to clearance, FDA requested evidence that the MammaPrint had been properly validated for its intended use. Agendia submitted data from a study using tumor samples and clinical data from 302 patients at five European centers. These studies confirmed that the test was useful in predicting time to distant metastasis in women who are under age 61 and in the two earliest stages of the disease (Stage I and Stage II) and who have tumor size equal to or less than five centimeters and no evidence that the cancer has spread to nearby lymph nodes (lymph node negative).” The cost of the MammaPrint technology in the United States is reportedly $3,200. This cost includes the collection, preservation, microarray testing, and genetic analysis of the 70 relevant genes. Author’s Comment: JALBCA attempted to contact Agendia, the developer of the Mammaprint® to inquire as to the current availability of the test in the United States. We were referred to David Bashaw of Ogilvy Public Relations Worldwide, the public relations contact for Agendia in the United States. Per Mr. Bashaw, Mammaprint is not currently available but Agendia intends to make the test available in the United States as soon as possible. Emily Craft, JALBCA’s Susan Solomon Intern, 2006-2007 FDA OFFICE OF WOMEN’S HEALTH The Washington Post reported on February 27, 2007 that the Food and Drug Administration (FDA) had decided to strip $1.2 million out of the $4 million budget of its Office of Women’s Health (OWH). Women’s health advocates believed that this cut may have been the first step toward eliminating the office. The OWH had stood up for scientific research that ultimately led to the approval of the emergency contraceptive Plan B. Because the remaining $2.8 million has already been spent or allocated, the funding cut would have essentially halted further programmatic operations for the balance of the year. In response, a group of senators—Hillary Clinton (D-NY), Barbara Mikulski (D-MD), Patty Murray (D-WA), and Olympia Snowe (R-ME)— wrote a letter to FDA Commissioner Andrew von Eschenbach demanding the agency stop its efforts to defund the office. As a result, the FDA has reversed its decision and has decided to fully fund the OWH. Rep. Carolyn Maloney (D-NY), author of legislation that would make permanent the offices of women’s health within five federal agencies, stated that the threatened FDA budget cut reinforces the pressing need to protect federal offices of women’s health. “As long as offices like this are left hanging by a thread, American women can’t expect the federal government to pay adequate attention to their unique health needs,” said Rep. Maloney. “We cannot allow women’s health research to be ignored as it has been historically. We need legislation to protect the federal offices of women’s health, which are essential to the advancement of women’s health in this country.” Rep . Maloney reintroduced the Women’s Health Office Act (H.R. 1072) earlier in February. This proposed legislation would make the FDA’s Office of Women’s Health and four other federal women’s health offices permanent. The OWH within the FDA, which has not seen a budget increase for several years, ensures that FDA programs are gender sensitive, works to address sex-based disparities in the safety and efficacy of medical products approved by the FDA, monitors progress of women’s health initiatives across the FDA, and partners with other agencies to promote its women’s health programs. Susan Wood, the OWH’s former director, resigned in 2005 over an allegedly politically-motivated delay surrounding the approval of Plan B. Plan B consists of two pills containing a synthetic version of the hormone progestin used in standard birth-control pills, is highly effective in preventing a pregnancy if taken within 72 hours of unprotected intercourse, long before pregnancy tests usually work. The FDA’s approval of Plan B reversed a decision it made three years earlier, prohibiting over-the- counter sales of the drug. Presently, Kathleen Uhl, M.D. is the Director of the OWH and Assistant Commissioner for Women’s Health at FDA. PRO BONO TRAINING – NYC BAR ASSOCIATION – CANCER ADVOCACY PROJECT The Cancer Advocacy Project has scheduled a Pro Bono Training session on Wednesday, May 30, 2007 from 6–9 p.m. The Cancer Advocacy Project assists cancer patients, survivors and family members with free legal services in various areas of law, including employment discrimination, insurance issues, advance directives, wills and public benefits. At this orientation and training, volunteer attorneys will learn an overview of employment related issues concerning the chronically ill including EEOC procedures, an overview of health insurance issues affecting cancer patients and practical application including appeal letters etc. Attorneys who attend the training are expected, within one year, to accept and complete one case. Please contact Director Laura Mosiello at 212-382-4785 or lmosiello@nycbar.org for further information. COURT OFFICERS MAKE GENEROUS CONTRIBUTION TO JALBCA On September 16, 2006, the Court Officers in the Fourth Judicial District held a Charity Golf Outing and decided to contribute the proceeds of the Outing to JALBCA.  Honorary JALBCA President, Chief Judge Kaye (above, left), accepted the contribution in February, at the Court of Appeals Hall. JALBCA is delighted to extend a special note of gratitude to Sergeant Lorraine Copitini, who spearheaded the event (together with Captain Michael Perritt, Major David Joseph, and Executive Assistant Sherry Barnum), and to Fourth District Administrative Judge Vito Caruso. 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 CANCER ADVOCACY PROJECT Association of the Bar of the City of New York 42 West 44th Street NY, NY 10036 www.nycbar.org CancerCare 275 Seventh Avenue NY NY 10001 1-800-813-HOPE (4673) www.cancercare.org SHARE Self-Help for Women with Breast or Ovarian Cancer) 1501 Broadway, 704A New York, NY 11530 www.sharecancersupport.org 212-719-0364
MEMORIAL SLOAN-KETTERING CANCER CENTER Memorial Sloan-Kettering Cancer Center Post-Treatment Resource Program Educational Forums 215 E. 68th Street, Ground Floor New York, NY 10021 212-717-3527 www.mskcc.org/mskcc/html/59513.cfm Bendheim Integrative Medicine Center 1429 First Avenue (at 74th Street New York, NY
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. |
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