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Vol. 9, No. 6 · December 2005 · Editor: Martha L. Golar, Esq.
“Cases and Controversies in Cancer Care” DATE: January 17, 2006 TIME: 6:30 P.M. PLACE: Skadden Arps Slate Meagher & Flom Four Times Square (between 6th Avenue & Broadway) New York, NY GUEST SPEAKER: Randye Retkin, Esq. Director of the LegalHealth program of the New York Legal Assistance Group (NYLAG) NYLAG is a nonprofit legal group that provides free civil legal services to low-income, at-risk populations. LegalHealth presently works in conjunction with 11 hospitals and 10 community organizations across the New York City area, including CancerCare, SHARE, Beth Israel Medical Center, Maimonides Hematology/Oncology Clinic, and the Ralph Lauren Center for Cancer Care and Prevention. · Race for the Cure · Annual Courthouse Alert Project -- Kick-Off Reception · Tenth Annual Ellen P. Hermanson Memorial Symposium · Calendar of Events Race for the Cure  JALBCA, thanks to Emily Ascher and Justice Shirley Werner Kornreich, the team captains, once again fielded a team in the Komen Race for the Cure. More than fifty JALBCA supporters, arrayed in ultra-hip brown and pink tee-shirts, finished the race. Many thanks to all the team members and people who supported them, especially Sandra Lespinasse and Robin Shears. Annual Courthouse Alert Project -- Kick-Off Reception
The President of the Women’s Bar Association of the State of New York (WBASNY), Andrea Phoenix, also attended the reception in support of the project. Past Presidents of WBASNY, Marjorie Lesch and Joan McNichol, also attended the event. WBASNY chapters throughout the State of New York help to implement the Courthouse Alert, particularly outside New York City, where WBASNY members arrange for distribution of breast cancer-related literature at courthouses, speaker events and other activities, as part of the educational and outreach effort. During Fall 2005, JALBCA will sponsor two mammogram vans in every borough except Queens, which will have one van, as part of its Courthouse Alert program. The vans travel to courthouses citywide to provide free mammograms for those who are uninsured or underinsured. The provider also distributes information about breast cancer. Special thanks to Kay Murray, Mary Jenkins and Lucy Viana for their hard work in organizing the Harlem mammography van. Tenth Annual Ellen P. Hermanson Memorial Symposium On October 11, 2005, JALBCA sponsored the Tenth Annual Ellen P. Hermanson Memorial Symposium. The program was titled “The Promise of Herceptin and Clinical Research: Moving New Therapies Into Practice.” As in past years, the Hon. Judith S. Kaye moderated the program. The panel of judges this year included Hon. Barbara Irolla Panepinto, Hon. Sondra Miller, Hon. Ellen M. Spodek and Hon. Shirley Werner Kornreich. The panel of experts included Jill C. Alvarez, Esq. (of Epstein Becker & Green), Pamela K. Klein, M.D. (of Genentech, Inc.), Larry Norton, M.D. (of Memorial Sloan-Kettering Cancer Center, “MSKCC”), Marvin B. Pavane, Esq. (of Cohen, Pontani, Lieberman & Pavane) and Jo Anne Zujewski, M.D. (of the National Institutes of Health). The program, as always, began with Dr. Norton’s update on the status of breast cancer research. He noted two major developments. First, he spoke to the accuracy of digital mammography versus traditional film mammography. Digital mammography provides the great advantages of easy storage and ability to send images instantly anywhere in the world for consultations or comparisons. Further, this newer technology has been shown by studies to be just as accurate as film for purposes of diagnosis, and one recent study suggested that it is superior for women with dense breasts. In light of these results, Dr. Norton reported that MSKCC has decided to offer solely digital mammograms.  Annual Symposium Panel The second development cited by Dr. Norton was a randomized clinical trial evaluating the effects of a low-fat diet on breast cancer patients. This trial intimated that a low-fat diet may indeed have some protective effect, particularly for women with tumors that are estrogen-receptor negative. Dr. Norton then discussed two drugs that have generated a lot of attention, i.e., Evastin and Herceptin. Evastin works by neutralizing a chemical signal secreted by cancer cells that triggers the growth of new blood vessels. Thus, it essentially starves a tumor by curtailing its blood supply. He explained that a recent clinical trial demonstrated that the combination of Evastin and Taxol can be very effective in slowing tumor growth. While the difference in results attributable to Evastin is small, he emphasized that the trial established a “proof of principle” that this type of drug can work. The second drug he discussed, Herceptin, was the direct subject of the Symposium. Herceptin is a monoclonal antibody (which is a product of bioengineering) manufactured by Genentech, Inc. It binds to a protein called HER-2, found on the surface of some normal cells, and plays a role in how cell growth is regulated. In certain types of breast cancer, HER-2 is “over-exposed,” and is associated with a more aggressive type of cancer. It is known that, in cases of metastatic breast cancer, approximately 20% - 30% of tumors produce excess amounts of HER-2. This protein has been described as a type of antenna on a cell, receiving signals to increase proliferation of cancer cells, making “HER-2 positive” breast cancer tumors much more formidable. Herceptin is designed to block the antenna, essentially blocking one more pathway by which cancer progresses. A study involving Herceptin, which began in the year 2000 and actually involved two large randomized clinical trials, involved patients with HER-2 positive invasive breast cancer, in early stage. It was stopped approximately two years ahead of schedule, due to promising data indicating impressive results in treatment of certain types of breast cancer. As was later discussed by the panelists, Dr. Norton noted that this trial perfectly illustrates the ethical dilemmas involved in drug research. Small clinical trials need to be repeated -- possibly several times -- to produce reliable results, a process that can take many years. The Herceptin trial, however, involved thousands of patients in multiple locations, in order to yield quicker results.  Pictured left to right: Barbara A. Ryan, Esq., Co-chair Annual Symposium, Toni Ann Gagliardi, JALBCA's Susan R. Solomon Intern, Hon. Sondra Miller, Hon, Judith S. Kaye, Mikki Golar, Esq., Co-chair Annual Symposium. Dr. Norton explained that the early termination of the Herceptin trial was essentially demanded by medical ethics, i.e., those patients in a randomized trial who had received only the standard treatment, but not the experimental drug being tested, should not have to wait to reap the benefits of Herceptin. However, there are more subtle factors, not directly relevant to patient protection, that may possibly influence the early stopping of a trial. These factors are described in literature criticizing the early stopping rules generally: (1) clinical investigators protecting themselves against a public perception that they are not protecting the patient and, therefore, protecting themselves against criticism that they acted unethically; (2) concern that competitors may report a positive study first; and (3) concern that the industry sponsor will not support a trial if a later clinical trial end point is used as an early stopping criterion. An earlier end point, for example, is “progression-free survival” and a later end point would be “overall survival.”
After Dr. Norton’s presentation, the panel discussion commenced, with the judges posing tough questions to the panelists. The panel discussed perceived problems with the drug-approval process at the FDA (e.g., too much bureaucracy, not enough funding), the role of data safety and monitoring boards (also known as data monitoring committees) which monitor interim data in clinical trials in order to ensure the safety of the participating subjects, and the need for consumer education. The experts seemed to agree that with regard to the early stopping of a clinical trial, the decision always comes down to a risk/benefit analysis, and presently, there is no national dialogue on how to balance the risks against the benefits. There seemed to be unanimity that such a dialogue is sorely needed. Calendar of Events SHARE (Self-Help for Women with Breast or Ovarian Cancer) 1501 Broadway, Ste. 704A New York, NY www.sharecancersupport.org Call 212.719.0364 for further information Ongoing Metastatic Cancer Group A daytime group in which women with metastatic breast or recurrent ovarian cancer meet with others having a similar experience. The group is facilitated by a psychotherapist who is also a SHARE participant. This is not a drop-in group. Registration is required.
MEMORIAL SLOAN-KETTERING CANCER CENTER Post-Treatment Resource Program Educational Forums 1275 York Avenue, Room M107 New York, NY 10021 www.mskcc.org Call 212.717.3527 to register for the following program: Autologous Stem Cell Transplant: Transitions
ADELPHI NY STATEWIDE BREAST CANCER Hotline & Support Program Adelphi University School of Social Work Garden City, NY 11530 www.adelphi.edu/nysbreastcancer 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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