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Vol. 11, No. 2 · March 2007 · Editor: Martha L. Golar, Esq.
· THE ABIGAIL ALLIANCE QUESTION: IS ACCESS TO EXPERIMENTAL DRUGS FOR TERMINALLY ILL PATIENTS A FUNDAMENTAL RIGHT? · JALBCA’s OFFICERS FOR 2007/2008 · CALENDAR / CONTACTS NEW DEVELOPMENTS IN FERTILITY CONSERVATION FOR CANCER PATIENTS At its January 22 program, JALBCA presented the program “New Developments in Fertility Conservation for Cancer Patients”, featuring joint speakers John Zhang, M.D., Ph.D, Osamu Kato, M.D. and Masashige Kuwayama, Ph.D. The speakers focused on the effects of aging and disease on female fertility, as well as the recent advancements in fertility preservation.
Dr. Zhang began the panel by discussing his work as the Medical Director of the New Hope Fertility Center, an office practice in New York City. A pioneer in the field of Mini In- Vitro Fertilization (Mini IVF), Dr. Zhang was the first physician to bring this procedure, developed by the Kato Ladies’ Clinic in Japan, to the United States. Dr. Zhang explained that fertility treatment results in high levels of estrogen as a result of increased follicle development, which can be particularly problematic for breast cancer patients. Mini IVF reduces the daily injections associated with traditional IVF, and focuses on extracting only the most viable eggs. Dr. Zhang noted that increasing age leads to decreasing fertility, and recommended that women begin considering fertility options in their early 30s. The ideal Mini IVF candidate will have good quality egg production coupled with infertility unrelated to ovarian dysfunction. For cancer patients that desire to retrieve their eggs prior to beginning chemotherapy or radiation, Mini IFV begins with 50mg daily of Clomid, a medication that blocks estrogen receptors and stimulates follicle development. Once the follicles have developed sufficiently, the oocytes are retrieved and frozen using a technique called vitrification. Dr. Zhang explained that traditional “slow-freezing” of embryos can result in damage, and many do not survive the process. Vitrification flash freezes the embryo, which has resulted in embryo survival rates nearing 98%.With more embryos surviving the cycles of freezing and thawing associated with egg cryopreservation, patients have a greater chance of a successful implantation later down the road.
Dr. Kato continued the panel by discussing his role as the director of the Kato Ladies’ Clinic in Japan, and providing an overview of their state of the art facilities and techniques. Operating with 15 doctors, 50 embryologists, and 50 paramedical employees, the Kato Ladies’ Clinic saw over 60,000 IVF cycles in the last year. With a focus on fewer drugs, safer techniques and safer freezing, the clinic developed the vitrification process discussed by Dr. Zhang. Where future fertility and egg viability is often a topic of great concern for cancer patients, vitrification allows a patient to undergo her full treatment course without foregoing the possibility of future fertility. The Clinic has seen an embryo survival rate, post vitrification, of 95% and a pregnancy success rate of 41%, post implantation. Rounding out the panel was Dr. Kuwayama, the Scientific Director of the Kato Ladies’Clinic. Dr. Kuwayama began by discussing “Future Mother,” apparently the first ever, non-profit, oocyte self-bank. “Future Mother” was developed in 2001 as a service to aid in fertility preservation for female blood cancer patients. Serving over 92 cancer patients with a total of 370 frozen oocytes, the clinic’s efforts have helped to maintain post-treatment fertility options for these many women. While Mini IVF and vitrification technology are still in their infancy, Drs. Zhang, Kato, and Kuwayama are dedicated to developing and improving fertility conservation techniques for cancer patients. NOTE from Editor: JALBCA provides educational programs and articles for informational purposes only, and does not endorse any medical treatment discussed in such programs or in Newsletter articles. THE ABIGAIL ALLIANCE QUESTION: IS ACCESS TO EXPERIMENTAL DRUGS FOR TERMINALLY ILL PATIENTS A FUNDAMENTAL RIGHT? The Abigail Alliance for Better Access to Developmental Drugs is a nonprofit organization devoted to helping cancer patients, and other individuals with life- threatening illnesses, gain increased access to developmental drugs. Founded in 2001, the group represents those individuals who have exhausted all possible treatments for their disease, and “whose best chance of survival is to obtain access to certain drugs with a record of clinical success in pre-approval testing, but which have not yet been approved by the FDA for marketing.” The United States Food and Drug Administration (“FDA”) “is the federal agency responsible for ensuring that foods are safe, wholesome and sanitary; human and veterinary drugs, biological products, and medical devices are safe and effective; cosmetics are safe; and electronic products that emit radiation are safe. FDA also ensures that these products are honestly, accurately and informatively represented to the public.” Pursuant to the authority granted by Congress under The Federal Food Drug and Cosmetic of 1938 (“FDCA”), the FDA is responsible for approving new drugs before they are introduced into interstate commerce as well as future regulation of their use and efficacy. The FDCA prompted the agency to establish regulations governing the standards for testing investigational drugs prior to marketplace approval, so as to ensure that the drug is appropriately represented in the market and that it safely serves its medicinal purpose. As a result a three-phase process was developed as a means of assessing and verifying the quality and integrity of the drug as it progresses toward final FDA approval. Phase I includes the initial introduction of an investigational new drug into humans. These studies are designed to determine the metabolic and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness. The total number of subjects included in Phase I studies varies with the drug, but is generally in the range of twenty to eighty. Phase II includes the early controlled clinical studies conducted to obtain some preliminary data on the effectiveness of the drug for a particular indication or indications in patients with the disease or condition. This phase of testing also helps determine the common, short-term side effects and risks associated with the drug. Phase II studies are typically well-controlled, closely monitored, and conducted in a relatively small number of patients, usually involving several hundred people. Phase III studies are expanded controlled and uncontrolled trials. They are performed after preliminary evidence suggesting effectiveness of the drug has been obtained in Phase II, and are intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug. Phase III studies also provide an adequate basis for extrapolating the results to the general population and transmitting that information in the physician labeling. Phase III studies usually include several hundred to several thousand people. In January 2003, Abigail Alliance submitted a proposal to the FDA entitled “Tier 1 Initial Approval Program to Expedite the Availability of Lifesaving Drugs,” which argued for new regulations that would give terminally ill patients greater access to investigational drugs that have only completed Phase I testing. In April 2003, the FDA rejected the proposal and Abigail Alliance, along with the Washington Legal Foundation, submitted a Citizen’s Petition in June 2003, pursuant to 21 C.F.R. §10.30. The Petition sought the creation of a new FDA policy that would grant initial approval for drugs that had shown promise in the early stages of testing, and were intended to treat diseases with unmet needs. It also sought regulatory changes that would permit expanding the availability of investigational drugs that had completed Phase I testing, throughout the subsequent stages of the review process. The FDA received the Petition and failed to respond within 180 days, as was required by law, thus enabling Abigail Alliance to seek judicial review of the agency’s current policy. Abigail Alliance filed suit in the United States District Court for the District of Columbia seeking to enjoin the FDA from enforcing its prohibition against terminally patients purchasing investigational drugs after exhausting all other available treatment options. Two causes of action were alleged: “Count I: FDA’s policy prohibiting the sale of investigational drugs to willing and mentally competent patients with no other treatment option interferes with the ability of Abigail Alliance’s patient-members and other terminally ill patients to choose the appropriate treatment for terminal illnesses, in violation of rights secured to those individuals by the rights to privacy and liberty of the U.S. Constitution;” and “Count II: FDA’s policy prohibiting the sale of investigational drugs to willing and mentally competent patients with no other treatment options operates as a death sentence for those patients, including the Abigail Alliance’s patient-members, in violation of the guarantee in the Fifth Amendment of the U.S. Constitution against deprivation of life without Due Process.” The District Court dismissed the suit in August of 2004 on the ground that Abigail Alliance had failed to state a fundamental Constitutional right on which to base their claim. Finding that no Constitutional right existed whereby a terminally ill patient was entitled access to investigational treatments, the court further noted that the FDA policy was rationally related to a legitimate government interest of ensuring that drugs have been expansively tested prior to entering the marketplace.
Despite a loss in the lower court, the AbigailAlliance complaint proved to be more successful on appeal. The United States Court of Appeals for the District of Columbia found that the District Court had erred in dismissing the complaint and remanded the case to determine whether the FDA’s policy served a compelling governmental interest greater than the right of a terminally ill, mentally competent adult patient’s informed access to potentially life-saving investigational new drugs, where
there are no alternative government-approved treatment options. In June 2006, FDA attorneys, in an attempt to have the decision in Abigail Alliance
reversed, requested that the entire panel of judges on the D.C. Circuit hear the case en banc. The request was granted and all parties are now waiting for the full court to hear the case. JALBCA’s OFFICERS FOR 2007/2008 JALBCA is proud to announce that the Board of Directors approved the following slate of officers for the 2007/2008 year. All officers and newly elected members of the Board of Directors and Advisory Board will be installed at the organization’s annual dinner. President Hon. Eileen Bransten Judith Livingston, Esq. Vice Presidents Hon. Joan B. Carey Edward Kornreich, Esq. Cecelia F. Marcus, Esq. Cynthia Rubin, Esq. Hon. Ellen M. Spodek Secretary Hon. Paula J. Omansky Assistant Secretary Debra Lennon, Esq. Treasurer Hon. William C. Thompson Assistant Treasurer Marvin Moskowitz, Esq. 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 1-800-813-HOPE (4673) www.cancercare.org 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
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. |
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