FDA Proposes Rules for Disseminating Data on Off-Label Uses
July 1st 1998ROCKVILLE, Md--The Food and Drug Administration (FDA) has proposed rules that would give manufacturers greater flexibility in disseminating information about the safety, effectiveness, or benefits of "off label" uses of drugs, biologics, and medical devices. The new regulations will implement provisions of the FDA Modernization Act of 1997, enacted last year.
FDA Reviews Modernization Act, Drug Approval Acceleration
July 1st 1998WASHINGTON--The mission of the FDA has historically been to respond to public needs and to protect public health, and the 1997 Modernization Act "will not divert the agency from this agenda," Michael Friedman, MD, the FDA’s lead deputy commissioner, said at a consumer forum sponsored by the FDA’s Office of Consumer Affairs.
Program Backs PBSC Protocols in Community
July 1st 1998SAN DIEGO--Not wishing to be a self-contained island of clinical research in a region with a wealth of private cancer specialists, the Fred Hutchinson Cancer Research Center established a community outreach program to involve more oncologists in clinical trials, a program that now includes autologous transplants of peripheral blood stem cells (PBSCs), Leona Holmberg, MD, an associate in the clinical division at Hutch-inson, said at a conference sponsored by the University of California, San Diego.
Update: HIV Counseling and Testing Using Rapid Tests--U.S., 1995
July 1st 1998Approximately 25 million persons each year in the United States are tested for antibody to human immunodeficiency virus (HIV). Publicly funded counseling and testing (CT) programs conduct approximately 2.5 million of these tests each year.
New Hospital Opens at Roswell Park Cancer Institute Complex
July 1st 1998BUFFALO, NY--The cornerstone of a $241.1 million dollar major modernization project was unveiled at Roswell Park Cancer Institute. The new Diagnostic and Treatment Center and patient tower (Figure 1) feature state-of-the-art diagnostic imaging, radiotherapy, surgery, postanesthesia care, and intensive care units. The 5-year renovation of the 25-acre campus coincides with the Institute’s centennial anniversary.
Senate Fails to Bring McCain Tobacco Control Bill to a Vote
July 1st 1998WASHINGTON--National tobacco legislation may be decidedly down, but it is not definitely dead. Following the two votes in the Senate that defeated the comprehensive tobacco bill sponsored by Sen. John McCain(R-Ariz), Republicans and Democrats alike vowed to continue efforts to pass some form of legislation. But politicians throughout Congress are in such discord on details that many doubt any tobacco legislation will clear Congress and win the President’s signature in 1998.
Tattooing Before Preop Chemo Aids Surgeons
July 1st 1998ORLANDO--Preoperative chemotherapy in breast cancer patients can leave a surgeon in the dark as to the specific amount of normal tissue to remove if the chemotherapy eliminates the tumor or renders it no longer palpable. A simple tattoo outlining the original tumor site can be a great aid in helping surgeons determine the type of surgery to be performed after the therapy.
Cardiotoxicity with Combination Doxorubicin/Paclitaxel (AT) Is Reversible, Rare With 6 Cycles
July 1st 1998MILAN, Italy--The cardiotoxicity seen in preliminary studies of bolus doxorubicin (Adriamycin) plus 3-hour paclitaxel (Taxol) (AT) proved to be reversible and mostly confined to patients who received more than 6 cycles of therapy, according to follow-up data presented at the ASCO meeting.
MoAb Inhibits Stomach Cancer Growth
July 1st 1998NEW ORLEANS--A monoclonal antibody isolated from a patient with stomach cancer appeared to cause specific cell death in tumors when infused into patients with stomach cancer prior to surgery, H. Peter Vollmers, PhD, said at the American Association for Cancer Research meeting. To look for an antibody that might target stomach cancer, the researchers removed B cells from the spleen of a patient with a diffuse adenocarcino-ma of the stomach and then isolated antibodies, said Dr. Vollmers, professor of experimental pathology, University of Würzburg, Germany.
3D Structure of Tumor-Suppressor Protein Generated on the Computer
July 1st 1998Researchers at Ohio State University’s Comprehensive Cancer Center have determined the three-dimensional (3D) structure of the protein produced by the p16 tumor-suppressor gene. This protein normally prevents cells from dividing inappropriately.
SWOG Self-Exam Finds Elderly Underaccrued in Clinical Trials
July 1st 1998LOS ANGELES--The Southwest Oncology Group (SWOG) is generally doing fine at enrolling women and African-Americans into clinical trials but is not doing so well at enrolling elderly patients, SWOG investigators reported at the ASCO annual meeting. SWOG biostatistician Joseph Unger found that the elderly were under-represented in almost every type of cancer clinical trial.
Older Women Have More Chemo-Induced Neutropenia But Few Clinical Consequences
July 1st 1998BALTIMORE--Adjuvant chemotherapy regimens for breast cancer are often reduced for patients over age 65 due to concerns about toxicity. These reductions may not be necessary in most cases. Elizabeth Claire Dees, MD, and her colleagues at the Johns Hopkins Oncology Center found that although older women had more neutropenia, this seldom resulted in clinical complications.
Traveling Exhibit of Cancer Educational Material
July 1st 1998MADISON, Wisconsin--The Am-erican Association for Cancer Education (AACE) and the European Association for Cancer Education have joined with the WHO International Network for Cancer Education (INCE) to put together a traveling exhibit of cancer educational materials for display at cancer congresses around the world.
Andean Mummies Reveal H pylori Is an Ancient Enemy
July 1st 1998NEW ORLEANS--Analysis of stools of centuries-old mummies shows that some were infected with Helicobacter pylori, indicating that this bacterium, which colonizes the stomach and can cause ulcers and stomach cancer, has long plagued humans.
Curcumin Inhibits Colon Cancer Progression in Rat Model
July 1st 1998NEW ORLEANS--Curcumin and sulindac sulfone both can inhibit colon carcinogenesis in a rat model during the initiation and post-initiation stages. But a study from the American Association for Cancer Research meeting suggests that during the promotion and progression stages, only curcumin inhibits tumor development.
Disease Management Avoids Fragmented Patient Care
July 1st 1998PASADENA, California--The health care system in the United States has been developed along the lines of medical specialization, which can lead to the fragmentation of patient care. Specialties are created by artificial divisions such as organ systems (cardiology, neurology); age (pediatrics, geriatrics); sex (urology, gynecology); disease (oncology); and function (surgery, obstetrics).
National Toxicology Program Requests Data on 11 Chemicals
July 1st 1998RESEARCH TRIANGLE PARK, NC--The National Toxicology Program has requested public input on 11 chemicals recommended for absorption, toxicity, or carcinogenicity studies. It seeks information from completed or ongoing studies, and information on planned studies, as well as current production data, human exposure information, use patterns, and environmental occurrences.
Natural History and Treatment of Malignant Thymoma
July 1st 1998Cowen and colleagues provide a very good review of thymomas. Although thymomas are the most common of the anterior mediastinal tumors, these tumors as a group are relatively uncommon. The authors focus their discussion on the pathology, staging, and management of thymomas.
Performing Economic Evaluations Alongside of Cancer Clinical Trials
July 1st 1998Health care providers and financing organizations have become more aware of the resource constraints on the provision of medical services, thus increasing the importance of economic evaluations within the health care industry.[1,2] This has carried over to the evaluation of new, therapeutic strategies for cancer, which have traditionally been evaluated exclusively for safety and clinical efficacy.
Epidemiology and Pathogenesis of AIDS-Related Lymphomas
July 1st 1998Dr. Aboulafia provides an accurate overview of the relationship between immunodeficiency and malignant lymphoma, the lymphoproliferative disorders that occur following solid organ transplantation, and the epidemiology and pathogenetic mechanisms possibly involved in acquired immunodeficiency syndrome (AIDS)-related lymphomagenesis.
Epidemiology and Pathogenesis of AIDS-Related Lymphomas
July 1st 1998Acquired immunodeficiency syndrome (AIDS)-related lymphoma is a complex disease process with a range of features that are distinct from both non-Hodgkin’s lymphoma (NHL) outside of the context of immunodeficiency and the lymphoproliferative disease seen in immunodeficiency unrelated to human immunodeficiency virus-1 (HIV-1). Dr. Aboulafia lucidly summarizes the issues contributing to the unique aspects of this disease.
Breakthrough Pain in Cancer Patients: Characteristics, Prevalence, and Treatment
July 1st 1998As indicated in this review by Patt and Ellison, the literature pertaining to the association between transitory acute pains and chronic cancer-related pain is limited and plagued by nomenclatural problems. Nonetheless, the clinical relevance of these so-called breakthrough pains is apparent to those who treat cancer patients.
Breakthrough Pain in Cancer Patients: Characteristics, Prevalence, and Treatment
July 1st 1998It is striking how often medical advances occur as a result of the recognition of something that, in retrospect, is obvious. Pain has always been a feared consequence of disease, particularly cancer. Only in the past decade, however, has the widespread undertreatment of pain and its impact on the quality of life of patient and family gained the attention of mainstream medical research. Rapid, simultaneous advances in basic neurobiology and clinical investigation have dramatically improved the clinician’s ability to diagnose and treat pain.