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Vol. 7, No. 5 · December 2003 · Editor: Martha L. Golar, Esq.
FROM SCIENCE TO MARKET” DATE: Tuesday, January 20, 2004 TIME: 6:30 P.M. PLACE: Skadden Arps Slate Meagher & Flom Four Times Square, 37th Floor (between 6th Avenue & Broadway) New York, NY GUEST SPEAKER: Elma S. Hawkins, Ph.D., MBA, Vice Chairman of Antigenics Antigenics is a New York-based company that develops healthcare products for a wide range of cancers, infectious diseases, and autoimmune disorders (including Oncophage and AG-858, personalized cancer vaccines based on Antigenics’ heat shock protein technology, which are designed to reprogram the immune system to target cancer cells while leaving healthy cells unaffected). · Current News Items · JALBCA’S Annual October Symposium · Calendar of Events · Adelphi NY Statewide Breast Cancer Hotline & Support Program · Courthouse Alert Current News items Letrozole Trial – Use of Aromatase Inhibitor After Five Years of Tamoxifen Therapy In November 2003, the New England Journal of Medicine (NEJM) reported the successful results of a randomized trial of letrozole in post-menopausal women who had undergone five years of tamoxifen therapy for early-stage breast cancer. This was a double-blind, placebo-controlled trial involving 5187 enrolled women. Letrozole is an aromatase inhibitor (sold as Femara by Novartis) which works by suppressing estrogen production. It is already known that in hormone-dependent breast cancer, five years of postoperative tamoxifen therapy will prolong disease-free and overall survival. Another trial also revealed that women who continued to receive tamoxifen therapy after five years had worse outcomes than women in whom it was discontinued at five years and, accordingly, the National Cancer Institutes (NCI) has recommended that, outside of a clinical trial, tamoxifen treatment should be limited to five years. The results from this letrozole trial indicate that five years of letrozole therapy, following the five years of tamoxifen, significantly improves disease-free survival. Disease-free survival—the primary end point for the study—was defined as the time from randomization to the recurrence of the primary disease (in the breast, chest wall, or nodal or metastatic sites) or the development of a new primary breast cancer in the contralateral breast. After the first interim analysis of the trial results, the independent data and safety monitoring committee recommended, in the interest of patient care, that the study be terminated early and the trial results be revealed to participants. As for side effects, hot flashes, arthritis, arthralgia, and myalgia were more common in the letrozole group than in the placebo group, but were “generally low-grade.” Vaginal bleeding was more common in the placebo group. There was also a trend toward a higher rate of reports of newly diagnosed osteoporosis in the letrozole group. The authors of the NEJM article indicated that until the long-term effects of letrozole on bone metabolism are known, they recommend that women receiving long-term letrozole therapy take calcium and vitamin D according to the guidelines for the prevention of osteoporosis, and that their physicians consider monitoring their bone mineral density. They also noted that the trial results do not apply to pre-menopausal women, since therapy with aromatase inhibitors alone does not suppress estrogen production sufficiently in women who are still ovulating. There are other trials underway which are designed to compare aromatase inhibitors with tamoxifen as adjuvant therapy for the first five years after diagnosis or to study aromatase inhibitors used in sequence with tamoxifen. The NEJM article reported that preliminary results from the Arimidex, Tamoxifen, Alone or in Combination (ATAC) trial show that disease-free survival is longer with anastrozole (also known as Arimidex, manufactured by AstraZeneca) than with tamoxifen. Arimidex and Femara are two aromatase agents that are approved by the FDA for treatment of hormone-positive breast cancer. It was noted, however, that tamoxifen is still considered an acceptable standard of care. Rising Cases of Large Tumors On November 18, 2003, The Wall Street Journal reported that a small increase was reported during the 1990s in the proportion of women with newly diagnosed breast cancer who have large tumors. The increase was found in white women. The analysis was prepared by the American Cancer Society based on the NCI’s Surveillance, Epidemiology and End Results program, a database of cancer incidence and survival data that covers about 14% of the U.S. population. Experts have speculated that this increase in large tumors may be the result of obesity and hormone-replacement therapy and it occurred during a time when the discovery of small tumors also rose sharply, which is attributed to increased mammography. Large tumors are apparently about twice as common in black women, which is explained by less access to high-quality screening, particularly for poor women. However, overall breast cancer survival is improving. Antidepressants Used for Hot Flashes May Affect Cancer Treatment New research suggests that antidepressants in a class called selective serotonin reuptake inhibitors (SSRIs), often used to treat hot flashes, reportedly may reduce the effectiveness of tamoxifen. Tamoxifen (sold by AstraZeneca under the brand name Nolvadex and also available generically) causes hot flashes as a side effect in up to 80% of patients who take the drug. The report of the study—which included only 12 women—was published in the December 3 issue of the Journal of the National Cancer Institute and the study’s senior author is Dr. David Flockhart, director of the Division of Clinical Pharmacology at the Indiana University School of Medicine. Study results suggests that tamoxifen’s metabolism, and possibly its effectiveness, can be modified by the genetic makeup of the person taking the drug and by the use of these antidepressants prescribed to reduce tamoxifen-related hot flashes. In the specific study, the SSRI paroxetine, made by GlaxoSmithKline under the brand name Paxil, was tested. The drug is known to interfere with the enzyme that breaks down tamoxifen into chemical agents, or metabolites, and particularly the metabolite called endoxifen. With lower amounts of this metabolite in the blood, this means that lower levels of tamoxifen were available in the bloodstream. Dr. Flockhart explained that paroxetine (and certain other antidepressants), as well as tamoxifen, are metabolized through a shared pathway. Presumably patients will now want to balance the benefits and risks of taking these antidepressants. JALBCA’S Annual October Symposium The Eighth Annual Ellen P. Hermanson Memorial Symposium took place on October 2, 2003, at the Association of the Bar of the City of New York. JALBCA offered this as a free, 2-CLE credit program (with the Office of Court Administration as the CLE sponsor), in cooperation with the Post-Treatment Resource Program of Memorial Sloan-Kettering Cancer Center. Past Presidents Barbara Ryan and Mikki Golar Co-Chaired the event. This year, the Symposium focused on two topics: “The Patients’ Roadmap to Medical Privacy under NY and Federal Law” and “Scientific Evidence in the Courthouse: Can a Case be Made for Toxins Causing Cancer.”  The participating judges included Chief Judge Judith S. Kaye (moderator), Hon. Myriam Altman, Hon. Helen E. Freedman, Hon. Sondra Miller, Hon. William C. Thompson, and Hon. Shirley W. Kornreich. The panel was comprised of experts from New York and Washington, D.C.: Devra Davis, PhD (epidemiologist and author of When Smoke Ran Like Water), Larry Norton, MD (Memorial Sloan-Kettering Cancer Center), Paul Rheingold, Esq. (Rheingold Valet Rheingold & Shkolnik, PC) and Sara B. Krauss, Esq. (Proskauer Rose, LLP).At the outset, Dr. Norton addressed the audience with his annual update on advancements in cancer research. He noted that one of the effects of HIPAA will be to drive research overseas. Sara Krauss commenced by providing a broad outline of the first comprehensive Federal medical privacy law. HIPAA was passed in 1996 but with a compliance deadline of April 2003. HIPAA applies to health plans, health insurers, employer-sponsored health plans and almost all health care providers with some exceptions. The law sets a framework for privacy of patient and health plan participant information and establishes patient’s rights regarding her information, e.g., access to information, information as to who has seen the records and the patient’s right to make certain requests for records. The basic rule permits the use of such medical information without permission only for treatment, payment for the treatment and the institution’s operations. The HIPAA regulators did not agree to include research as part of the institution’s basic mission for which the medical information can be used. Ms. Krauss pointed out, however, that HIPAA provides a process (albeit burdensome) around this prohibition in situations where people’s consent cannot be obtained. Dr. Norton had already identified how HIPAA impedes patient care and research and emphasized that, to use the medical information, a researcher must eliminate all identifying information about the patient, some of which is simply needed to conduct the research. This may be information as to the patients’ prognosis, their environment, their age, and dates when the cancer recurred. He also indicated the difficulty of using archived specimens where patients had signed releases identifying the purposes to which their health information could be used, which releases would not comply with HIPAA’s requirements. Additionally, he stated that the academic community was intimidated by the civil and criminal penalties for HIPAA non-compliance. As a result, medical providers were being overcompliant. Dr. Norton expressed the belief that, while protection of patient confidentiality is admirable and while there have been past abuses of patient privacy rights, HIPAA’s restrictions on researchers are unnecessary. There was also discussion about the failure of the regulators to issue a standard release form relating to medical information, with Judges Kornreich and Freedman confirming that requests for patient information create problems when litigants seek the release of patient records. Although any form containing all the elements required by HIPAA should be accepted (e.g., an expiration date or expiration event, a stated purpose for the authorization form, etc.), health care providers often insist on using their own form for fear of HIPAA non-compliance. Ms. Krauss clarified that the requirement to provide medical information in 30 days applies to a patient’s request for his/her own records and that, under New York law, there is an even stricter requirement to satisfy a patient’s request for his/her own records in 10 days. A discussion ensued regarding the continued right to use of medical information from people who signed authorization forms before April 2003. Ms. Krauss indicated that HIPAA explicitly permits a health care provider to continue to use the information as directed by, and in compliance with, the pre-April 2003 authorization form. Therefore, if the patient previously signed a general authorization form which permitted the use of information for “all research purposes,” and if such form did not expire, then the research institution may use the information but only in compliance with the authorization form. She also responded to a question from Judge Altman concerning whether patients’ privacy rights survive death. As to this issue, Ms. Krauss stated that, as a general matter, privacy rights do not stop upon death, with some exceptions relating to research and decedents. The panel then turned to Part II of the Symposium concerning whether a scientific case can be made for toxins causing cancer. Mr. Rheingold answer in the affirmative and noted that this is a lot harder to prove with breast cancer than it was, for example, with asbestos as a cause of mesothelioma. By way of background, the seminal cases of Frye v. U.S., 293 F. 1013 (1923) and Daubert v. Merrell Dow Pharmaceuticals, Inc., 113 S.Ct. 2786 (1993), have been a dominant force in the Courts on the issue of whether to allow expert scientific testimony in a given case. In the wake of Daubert and its progeny, Rule 702 of the Federal Rules of Evidence was amended to provide a method for evaluating the admissibility of expert testimony in Federal court. Although some states have adopted the Daubert standard, others have not. Many states (New York included) rely on the longstanding guidelines for expert testimony set forth in Frye. In New York, litigants often make Frye motions in an attempt to preclude experts by challenging the methods used to form scientific conclusions—arguing that the conclusions are not generally accepted within the expert community. The relevant inquiry in the context of a Frye motion is whether the techniques used by the expert, when properly performed, produced results accepted as reliable within the general scientific community. Judge Thompson inquired about the air quality in Manhattan after September 11 in the context of then-EPA head Christie Whitman’s announcement that the air quality was good. Mr. Rheingold agreed that there would be causation problems in cases arising out of the air quality condition—for example, identifying the source of the ambient asbestos, the immunities that may attach if plaintiffs try to sue the government given that there is not the traditional product liability defendant to sue, and the fact that people were told to use respirators and did not necessarily comply. Dr. Davis noted that causation in the law is not as challenging to establish with rare diseases like mesothelioma, but that with common diseases such as breast cancer, we know there are multiple causes and evidentiary burdens. She referred to pending cases in jurisdictions where the standard is more liberal because litigants do not have to prove proximate cause but, rather, that a toxin was a substantial cause. She noted, however, that it is difficult to show substantiality—or proximate cause—when dealing with low levels of exposure to multiple pollutants.  Judge Kaye questioned Mr. Rheingold as to the status of New York law. Mr Rheingold referred to the Frye test which he regarded as more liberal than the Daubert test (requiring reliable and relevant evidence) and which, he said, enabled plaintiffs to let the expert testify and see if s/he can prove through her/his own testimony that there is general acceptance of a theory. Judge Freedman, however, noted that the Frye hearings conducted in New York serve the same gatekeeper purposes and that perhaps the concept of “general acceptance” does not make sense when very few people have studied an issue. Also, Dr. Davis disagreed that Daubert was a liberal test and expressed the opinions that it had had a chilling effect on front-line science and that we do not have public access to a lot of data which is needed by researchers. She confirmed that Daubert has had a chilling effect on epidemiologists, that HIPAA too will have such a chilling effect, and that Federal statutes further discourage employers from releasing data, citing the fact that the Toxic Substances Control Act has had the effect of causing employers to cease collecting data in a way which could be useful.Dr. Norton agreed that this was a very troubling area and that there was no question that the environment causes breast cancer, but that the mechanism of causation is not understood. Further, he noted, that in terms of biology, with a common disease like breast cancer, we need very small changes in rates of events per year to greatly magnify risk. He analogized the process to continuous burns to the skin which would result in cell reproduction for each healing process, increasing the risk each time of developing skin cancer, i.e., chronic irritants can accomplish this and some specific trigger is not needed for the skin cancer explanation. He questioned whether our concern for (legal) process is the dominant feature of our thinking and whether we are doing what is necessary to protect people.  Dr. Davis opined that what is needed is a truly independent source of science information and funding for the kind of advice that is required (which she suggested could be obtained in part through fees imposed on certain industries). Looking to the future, Dr. Norton offered that there are certain molecular signatures about the large molecules in the cell that may give us a clue as to what led to the medical problem so there is real hope that, as our understanding of molecular biology and gene-environment interactions improves, the mysteries of causation may be revealed. Judge Altman asked what could be done so that a judge confronted with a Frye issue has a methodology as to how to make the inquiry. In response, Dr. Davis noted that some efforts are underway to train the judiciary in this regard.Calendar of Events JALBCA FEBRUARY PROGRAM
MEMORIAL SLOAN-KETTERING POST-TREATMENT RESOURCE PROGRAM Call 212.717.3527 to register for the following programs: Legal Rights, Employment and Insurance Issues for Cancer Survivors
Grace and Grit: A Woman's Circle
SHARE (SELF-HELP FOR WOMEN WITH BREAST OR OVARIAN CANCER) 1501 Broadway, Suite 1720 NYC Call 212.719.0364 for further information. SHARE HOTLINE: Breast: 212.382.2111 Ovarian: 212.719.1204 Adelphi NY Statewide Breast Cancer Hotline & Support Programs For members who live on Long Island, this is a reminder that Adelphi University School of Social Work operates a Breast Cancer Hotline & Support Program. The Hotline can be reached at 800.877.8077. In addition, they offer a free support group for Latina and Spanish-speaking women, as well as a new support group for lesbian women who are coping with breast cancer and their partners. For more information about the Latina support group, please contact Angela Pala MSW, Bilingual Social Worker, at 516.877.4335. For more information about the lesbian support group, which will be led by a group leader who will be a certified social worker and a self-disclosed lesbian, please contact Sandi Kafenbaum, ACSW, Group Coordinator at 516.877.4314. Courthouse Alert The 2003 Courthouse Alert project was a great success. Our thanks go out to Susan Solomon for all her efforts in coordinating the vans for the entire project. Kay Murray also handled the outreach in Harlem, where JALBCA arranged for a van for the first time since the Courthouse Alert project was commenced, and 27 mammography appointments were scheduled for this Harlem van. In total, 10 vans were scheduled and approximately 230 mammographies were provided, excluding those from one Bronx and one Brooklyn van, for which JALBCA has not received the data. 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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