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Vol. 7, No. 1 · January 2003 · Editor: Pamela B. Colker, Esq.
· Expansion of Courthouse Alert · A Special Report on the Staten Island Contingent · JALBCA Joins Komen in New York Race for the Cure · Calendar of Events JALBCA's Seventh Annual Ellen P. Hermanson Memorial Symposium: Why the Cure for Cancer Has Still Eluded Us: Regulatory, Industry, and Legal Considerations  A distinguished panel discussed some of the regulatory, industry and legislative impediments to obtaining Food and Drug Administration ("FDA") new drug approval, and to conducting clinical trials, at the annual Symposium held at the Association of the Bar of the City of New York on November 7, 2002.Karrie Zampini, Director of the Post-Treatment Resource Program at Memorial Sloan-Kettering Cancer Center, described JALBCA's first executive director, Ellen P. Hermanson. Ms. Hermanson was a young journalist who had been an activist in the fight against breast cancer approximately 10 years ago, after she was diagnosed with the disease at the age of 36. Ms. Zampini described how Ms. Hermanson, "helped change the landscape for cancer patients by advocating for herself and others in the fight against this dread disease."  Ms. Zampini presented Chief Judge Judith Kaye with a certificate of appreciation from Memorial Sloan-Kettering's Post Treatment Resource Program, recognizing JALBCA's 10 years of service to the men and women of New York, and leadership in strengthening breast cancer education and advocacy.Roy Reardon, Esq., Co-president of JALBCA , took a moment before introducing the panel to share with the audience his own personal experience with the disease.  Panel members included the following judges and experts: Chief Judge Judith S. Kaye, Associate Justice Sondra Miller, Associate Justice William C. Thompson, Judge Helen A. Freedman, Judge Shirley Kornreich, Larry Norton, M.D., Head, Division of Solid Tumor Oncology, Memorial Sloan-Kettering Cancer Center, Susan Braun, President and CEO, The Susan G. Komen Breast Cancer Foundation, Martin Pavane, Esq., Partner, Cohen, Pontani, Lieberman & Pavane, Esqs., Richard Pazdur, M.D., Director, Division of Oncology Drug Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, and Edward H. Stratemeier, Esq., General Counsel, Aventis Pharmaceuticals.Larry Norton, M.D., gave his annual update on recent developments in the treatment of cancer. Dr. Norton observed that at every period in history, where major changes have occurred, three things have always happened simultaneously. First there must be an understanding of the issue in terms of its basis, "what is its process, what makes it tick?" This becomes a tool for intervention. Second, an appropriate means of intervention must be identified in order to affect the process, allowing for experimentation but also in order to "perturb" the process to yield a positive result. Third, society must endorse the effort as worthwhile and must put human and financial resources behind it. Dr. Norton applied this three-tiered analysis to the process of drug development.  Dr. Norton emphasized that "social will" is expressed in various areas such as laws, compliance, research support, willingness to undergo diagnostic tests and willingness to pay for diagnostic tests. These are areas, he noted, that many members of the Symposium forum and audience were much closer to than he, in the legal, corporate and advocacy communities. He urged the audience to think about the status of our "social will" in this regard -- whether enough resources are being channeled to research efforts and to the FDA, and what attention is being given to the development of protective laws that would allow for the promotion of new and useful products.Dr. Norton described recent advances in the human genome project that have allowed for the identification of various interventions based on a "roadmap" provided by cell DNA. Proteins that are coded by the DNA, that have gone awry, can be identified and intervention can begin with a variety of molecules that can attach to the proteins and prevent these proteins from functioning. Dr. Norton added, "…the promise is extraordinarily exciting and real, to the extent that even the pessimists in my world know clearly that breast cancer, cancer, is going to be eradicated. It's just a matter of when. It's a matter of how fast we can accomplish it." Dr. Norton also spoke of a major discovery in the treatment of chronic myelogenous leukemia, with the development of Gleevec, a molecule that stops an abnormal protein from working, by actually sticking on to the protein, thereby turning off, to an extraordinary degree, the progression of that leukemia. This is significant because the same molecule also attaches onto another protein found in about 70% of GI stromal tumors, an unusual intestinal tumor. This is a classic example of identifying an abnormal component of DNA that generates the abnormal proteins that cause the cells to act abnormally, and perturbing it with medication.  With respect to breast cancer, Dr. Norton revealed that one of the most exciting recent developments in breast cancer treatment has been the discovery and use of aromatase inhibitors. He emphasized that almost all breast cancers need estrogen at some point, in order to thrive. With the use of Tamoxifen, the estrogen "receptor," which allows the cell to respond to estrogen, is blocked. Data has shown that in post-menopausal women or in men with breast cancer who have estrogen receptive tumors, with the administration of Tamoxifen for five years from the time of diagnosis, there has been a dramatic reduction in the incidence of recurrence. Again, we see that the simple perturbation of effecting one molecular pathway, with a targeted molecule involving estrogen, can cure cancer. Dr. Norton added that with the administration of aromatase inhibitors in post-menopausal women, estrogens in the blood can be further lowered by intercepting the enzyme (aromatase) that helps to convert male hormones called androgens (generated by the adrenal glands) into estrogens in other parts of her body. This, he noted, can also affect the growth of breast cancer and actually make the cancer shrink, and prolong survival. Dr. Norton reported that this is only one of the many pathways we have addressed in moving toward a prevention strategy.Judge Kaye asked Dr. Pazdur to describe the FDA's procedures that govern clinical trials. Dr. Pazdur explained that there are basically three phases of clinical trials. Phase I trials are concerned with the safety and toxicity levels of a drug. Phase II involves response rate in screening selected tumor types, and Phase III begins the process of new drug evaluation which compares the new drug to a standard therapy with comparative-based trials. Then the drug is considered for approval and a sponsor, usually a commercial pharmaceutical company, steps in with an application for the drug. Dr. Pazdur explained that during this time the FDA is in constant communication with the company, always with the focus on the assessment of the efficacy of the drug. All clinical data is then reviewed by the FDA, a process that can take anywhere from six to ten months, where it is methodically reconstructed and verified. Dr. Pazdur emphasized the importance of this process, recognizing that it must not be used to prevent the dissemination of effective drugs. The first question to the expert panel was posed by Judge Thompson, who inquired about the existence of a database for those clinical trials that fail, so as to avoid repetition as well as duplication of trials. Dr. Pazdur responded that negative data is hard to come by, as the tendency is not to publish it. He emphasized that the FDA does not regulate the publication of clinical trials but does have a database for the registration of clinical trials, with which pharmaceutical companies are extremely slow to register. Dr. Pazdur then inquired of the panel why the pharmaceutical companies have been reluctant to do so. Mr. Stratemeier explained that the difficulty begins with trying to get the appropriate patient into a specific trial. If a clinical trial is advertised too broadly, many who don't fit the protocol will try to get in. This must be balanced against the need to have a comprehensive publicly available database. Mr. Pavane added that when a clinical trial is held in a number of cancer centers, many people do know about them, but the need for patent protection prevents those trials from being deemed "public." He explained that drug companies interested in securing patent protection can get "method of treatment" protection with patent laws by running a Phase II or Phase III trial. This occurs because patents are given on dosage, regimen (or schedule) but if the trial is published prematurely the right to a patent might be defeated. Dr. Norton asked his fellow panelists about access to pre-clinical unpublished data. He observed that a lot of that information could be extremely valuable because a particular drug may have worked on one cell or on one mouse. Mr. Stratemeier responded by noting that this is a financial issue. Pharmaceutical companies have a profit motive and, therefore, work on the most promising research. Dr. Norton and Mr. Stratemeier observed that the market dictates which drugs are given priority treatment. Judge Kornreich then questioned the panel with a scenario of drug approval in the case of combination therapies, and whether approval could be given without testing each drug of the combination individually. Before answering the question Mr. Pazdur clarified that the role of the FDA is to approve licensing applications. Mr. Pazdur then explained that a randomized study could be conducted in which an allocation of the combination is tested vs. those with the drugs alone. Judge Kornreich 's follow-up question related to end points in clinical trials. She questioned whether tumor size, as an end point in clinical trials, was a subjective kind of end point, and whether survival rate could be more of the gold standard for clinical trials. Mr. Pazdur noted that there are many variables (toxicity of therapy, staging, etc.) that serve as a wide variety of endpoints in the approval of drugs. Judge Freedman, Co-president of JALBCA, raised the question of whether confidentiality agreements or patent laws inhibit rather than promote the development, production and use of good new drugs. She gave an example of two companies, each of which are developing drugs, and one says its drug or agent cannot be used unless a confidentiality agreement is signed. She noted that universities can be the worst offenders because they seek patent protection most quickly. (Mr. Pavane and Mr. Stratemeier explained that universities have sponsored project officers whose function is to gain patent rights for the University.) Mr. Stratemeier noted, however, that this is not an issue that slows down drug development. The difficulty arises with products not yet on the market. One group may have invested hundreds of millions of dollars to bring a product along before it hits the market, while a pharmaceutical company or university may be seeking to recoup as owners of intellectual property. Mr. Pavane reminded us that after a drug hits the market all companies promoting it will benefit from increased sale of the drug. He added that we look to private industry, rather than the federal government, to develop drugs and bring them to market. Judge Miller brought attention to the move afoot to restructure Medicare payments for drugs and drug administration services. She asked how this will affect oncologists and patients, and if this is an area where advocacy is called for. Ms. Braun responded that the way drugs are paid for barely covers the intellectual decisions that are involved with therapy for the patient in addition to the presence of a nurse during treatment, psycho-social aspects and counseling. She noted that the patient advocacy community has been very much against the reduction of payment to practicing medical oncologists. Ms. Braun concluded that there should be a compilation or registry for clinical trials so that there is an understanding of what is available and how to get in. A short question and answer period followed. -- P. C. [back to top] Expansion of Courthouse Alert Every October, in conjunction with National Breast Cancer Awareness Month, JALBCA has conducted a Courthouse Alert in order to promote breast cancer awareness.  With the support of the local chapters of the Women's Bar Association of the State of New York (WBASNY), JALBCA distributes literature and other materials in courthouses throughout the state, and sponsors special events that focus public attention on breast cancer issues. In several counties mobile mammography vans, operated by local health care providers, offer free breast cancer screening examinations, the cost of which is subsidized by the Lawyers Division of JALBCA.Thanks to the generosity of five New York City law firms, JALBCA has expanded its annual October Courthouse Alert to make available free mammograms at locations in Staten Island and Red Hook. Contributing firms are Gair, Gair, Conason, Steigman & Mackauf; Godosky & Gentile, P.C.; Kramer, Dillof, Livingston & Moore; Sullivan Papain Block McGrath & Cannavo, P.C.; and Weitz & Luxenberg. Free mammograms will continue to be offered at locations adjacent to State courthouses in the Bronx, Brooklyn Civic Center, Lower Manhattan and Jamaica, Queens. [back to top] A Special Report on the Staten Island Contingent On October 9, 2002, the latest addition to the Courthouse Alert program was initiated by the Staten Island Women's Bar Association, in conjunction with JALBCA. A ceremony kicked off the event at the Supreme Courthouse, St. George, to commemorate Breast Cancer Awareness Month. The program drew more than 60 court staff, judges, and attorneys, and was chaired by Karen B. Wolff, Court Attorney, Civil Court, Richmond County, Co-chair Staten Island Court House Alert, and Justice Barbara Irolla Panepinto, Supervising Judge of Civil Court, Richmond County, and Assistant Secretary of JALBCA. In attendance for the kickoff ceremony were Hon. Leonard P. Rienzi, Supervising Judge of the Supreme Court, Richmond County; Hon. John Fusco, Surrogate of Richmond County; Hon. Philip Minardo; Hon. Frank Ponterio; Hon. Christopher Mega; Hon. Thomas P. Aliotta; Hon. Eric Vitaliano; Robert Olivari, Deputy Chief Clerk of Supreme Court; Susan Lake, Chief of Staff to Assemblyman John Lavelle; Pamela Tillman , President of the Staten Island Women's Bar Association, as well as Kaye Wilday of the American Cancer Society.  The Women's Bar Association received a Proclamation from Councilman Michael McMahon, declaring October as "Staten Island Women's Bar Association Breast Cancer Alert Month."Barbara O'Brien, Nurse Educator and Board member of the American Cancer Society, Staten Island Region, addressed the group about the importance of early detection by self-examination, mammograms and clinical examinations. Ms. Wolff noted, "As we all know, cancer is a war, and the best weapon we have is knowledge about early detection and screening. The survival rates show that this is not an exercise in futility, but rather a step towards freeing ourselves of this deadly disease." Mammography van services were provided this year on October 10 at the Red Hook Community Court, Brooklyn; on October 30, Queens Family Court; on November 18, New York City Civil Court; on December 16, Brooklyn Supreme Court; in Brooklyn on three separate occasions in October and November, and in both the Bronx Supreme and Housings Court. Appointments for these free mammograms were filled on the days provided. Many, therefore, are taking advantage of the offer of this very important service. [back to top] JALBCA Joins Komen in New York Race for the Cure On Sunday, September 15, 2002, JALBCA marked its ninth year of participation in the Komen New York Race for the Cure. Sporting terrific black t-shirts bearing the JALBCA logo, the team of approximately 45 judges, attorneys, court personnel, family and friends, was an enthusiastic presence in the huge crowd supporting the fight against breast cancer. Team Captains Hon. Shirley Kornreich and Lisa Volpe would like to extend their thanks to all team members for making this occasion so fun and memorable.  The Race for the Cure annually raises millions to support the mission of the Susan G. Komen Breast Cancer Foundation to eradicate breast cancer as a life-threatening disease by advancing research, education, screening and treatment. We invite you to join the JALBCA team next September, for our tenth anniversary of participation in this worthy event. We hope to expand the number of participants to create the largest team yet! Look for announcements of the 2003 race date, and for application information in upcoming JALBCA newsletters.
[back to top] Calendar of Events JALBCA BOARD MEETING AND PROGRAM SCHEDULE Wednesday, February 5, 2003 Can You Eat Your Way to Good Health? Shane Small, Chief Nutritionist, St. Vincent's Comprehensive Cancer Center Click here to print out a PDF flyer for this event and Notice of Annual Meeting, February 5, 2003. Wednesday, March 12, 2003 What Oncologists Consider in Determining Treatment Protocols for Male and Female Breast Cancer Patients Dr. Lynn Ratner, Mount Sinai School of Medicine
THE ASSOCIATION OF THE BAR OF THE CITY OF NEW YORK/JALBCA co-sponsor: THE CANCER-RELATED EMPLOYMENT DISCRIMINATION PROJECT If you have had a cancer-related employment discrimination problem, The Association of the Bar of the City of New York is offering free consultations by phone or in person with experienced employment attorneys to discuss your legal rights. Call Jennifer Kwon at 212.382.6708 for further information or to arrange for an expert consultation, by telephone or in person. MEMORIAL SLOAN-KETTERING POST-TREATMENT RESOURCE PROGRAM Call 212.717.3527 to register for the following programs: CAREER DECISIONS: RETHINKING YOUR WORKLIFE Norma Feldman, CSW, career consultant, will conduct a two-part self-assessment workshop to help redirect your energies and capabilities. Illness may be a turning point in your life. You may reconsider the type of work you are doing, wanting a more meaningful or less stressful career. Identify and focus your talents, abilities and skills into new career options. Pre-registration necessary -- limited space. Call early. Materials forwarded prior to Session I.
YOUNG ADULT SERIES: SURVIVORSHIP 101 For the young adult the cancer experience may create a changed world-view and myriad unfamiliar issues. Our meetings offer information, clarity and support as you negotiate the journey after cancer treatment. Attend one or all of the workshops in this four-part series.
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. [back to top] |
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