Cell Sorter Fails to Win Approval
February 1st 1995ROCKVILLE, Md--The FDA has denied a request by CellPro, Inc. (Bothell, Wash) to approve its cell sorting device Ceprate SC, used investigationally to purify bone marrow or peripheral blood autografts by concentrating CD34+ stem cells. The FDA has asked the company to provide additional information on the device.
High-Speed Cell Sorter Isolates Pure Stem Cells For Use in Autologous Transplantation Patients
February 1st 1995NASHVILLE--An experimental high-speed clinical cell selection device has been shown to be capable of isolating a pure population of hematopoietic stem cells (HSCs), essentially free from cancer cells, and the machine's developer (SyStemix, Inc., Palo Alto, Calif) has received FDA allowance for an active IND (investigational new drug) for clinical testing of HSCs purified by cell selection in cancer patients who are undergoing transplantation.
Zeneca Expands Into Health-Care Services With Salick Purchase
February 1st 1995WILMINGTON, Del--Zeneca Group PLC, London, the parent company of Zeneca Pharmaceuticals, has entered into an agreement to purchase a 50% interest in Salick Health Care, Inc., Los Angeles, a provider of health-care services to patients with cancer and other complex illnesses. It may be the first time a pharmaceutical company has purchased a health-care provider.
Study Suggests Schedule for Gyn Exams in Women on Tamoxifen
February 1st 1995SAN ANTONIO--Gynecologic evaluation of women taking prophylactic tamoxifen (Nolvadex) should be restricted to patients with endometrial thickening that exceeds 8 mm and possibly to premenopausal women with amenorrhea, a British study suggests.
Virtual Reality Promises to Improve Bronchoscopy
February 1st 1995CHICAGO--By creating a virtual reality environment, physicians in the not-too-distant future will be able to move through, around, and into a patient's airways to search for tumors, enlarged lymph nodes, and abnormal masses in the walls of the bronchi and surrounding tissue on a computer screen, David J. Vining, MD, predicted at the annual scientific meeting of the Radiological Society of North America.
Physicians Must Comply With Fraud and Abuse Statutes
February 1st 1995The second part of this three-part series discusses the various types of fraud and abuse laws, reviews the laws on false claims, and provides suggestions for limiting a physician's exposure to fraud and abuse claims. Part 1, which appeared in the January, 1995, issue of Oncology News International (page 18), discussed the Stark statute, which prohibits self-referrals for certain services covered by Medicare and Medicaid, while the final article will review the Medicare and Medicaid anti-kickback statute.
The Management of Early Ovarian Cancer
Approximately one third of patients with epithelial ovarian cancer present with localized or early-stage disease. Prognostic features identify certain subsets of patients with good risk characteristics who do not require adjuvant
SoloPak Obtains Rights to Ganite
February 1st 1995ELK GROVE VILLAGE, Ill--SoloPak Pharmaceuticals, Inc. has signed an agreement with Sloan-Kettering Institute for Cancer Research to acquire the exclusive worldwide rights to gallium nitrate (Ganite), which was FDA approved in 1991 for the treatment of acute hypercalcemia in cancer patients and had been manufactured by Fujisawa USA (Deerfield, Ill).
MDs Fear Managed Care Equals Lower-Quality Care
January 1st 1995NEW YORK--Yogi Berra had the last word at a panel discussion on health-care reform sponsored by the Medical Society of the State of New York. Television talk show host Larry King moderated the discussion and fielded the caustic remarks of doctors, pharmacists, and medical students who packed a Waldorf-Astoria ballroom to debate whether quality medical care can be maintained under health-care reform.
Dallas Medical Center Launches Umbilical Stem Cell Project
January 1st 1995DALLAS--Two pediatricians at The University of Texas Southwestern Medical Center at Dallas have established the Umbilical Stem Cell Project to procure, test, and store human umbilical cord and placental blood for use as an alternative to bone marrow in allogeneic transplant patients who lack a related compatible marrow donor.
Assessment Tools Are Essential to Improve Management of Pain
January 1st 1995NEW YORK--Health-care professionals treating pain are hindered by the lack of an objective way to measure pain, says Johns Hopkins researcher Fannie Gaston-Johansson, DrMedSc, who has introduced a new device that may help the situation (see figure).
Undertreating Pain Costs Money in the Long Run, Physician Warns
January 1st 1995NEW YORK--Despite its aim of cost containment, health-care reform threatens to increase the economic toll of pain because it may encourage undertreatment, Daniel Carr, MD, said at a media briefing on pain, sponsored by the American Medical Association and Ortho-McNeil Pharmaceutical Corp.
After 5 Years as Head, Dr. Broder Plans to Resign His Post at NCI
January 1st 1995WASHINGTON--Samuel Broder, MD, head of the National Cancer Institute (NCI) for the past 5 years, says that he will resign his post in April of this year. He will join IVAX Corporation (Miami), a manufacturer of generic drugs and IV drug delivery devices, where he plans to work on developing new drugs.
EORTC Endometrial Ca Trial Challenges Findings From GOG
January 1st 1995LISBON, Portugal--Doxorubicin coupled with cisplatin (Platinol) confers a distinct survival edge over the anthracycline alone in women with advanced inoperable or recurrent endometrial carcinoma, according to the latest findings of the Gynaecological Cancer Cooperative Group (GCCG) of the European Organization for Research and Treatment of Cancer (EORTC).
Heterosexual AIDS Cases Up Sharply, But Numbers Remain Small
January 1st 1995BETHESDA, Md--As expected, the number of reported AIDS cases increased substantially in 1993 due to the expansion of the surveillance case definition in January of that year, but an adjusted analysis shows only a slight overall increase.
Antibiotic Regimen Leads to Lymphoma Regression
January 1st 1995LISBON, Portugal--Recent evidence linking low-grade gastric lymphoma with chronic Helicobacter pylori infection, which is said to trigger antigenic stimulation and lymphoid cell invasion of the stomach mucosa, has raised the provocative question of whether eradication of H. pylori infection can cure gastric lymphoma.
Physicians Urged to Find Ways to Determine Patients' Preferences About Cancer Treatment
January 1st 1995Physicians need to find more effective ways to determine their patients' preferences about cancer treatment, according to an editorial in the November 7, 1994 issue of the Journal of the National Cancer Institute.
Zeneca Agrees to Purchase 50% Interest in Salick Health Care, Inc.
January 1st 1995LONDON, UK--As Oncology News International (ONI) went to press, we received news that Zeneca Group PLC has agreed to buy a 50% interest in Salick Health Care, Inc (Los Angeles). The agreement is subject to shareholder approval and US regulatory review, the company said.
New UN Program Hopes to Begin Large-Scale Trials of AIDS Vaccines in 1996
January 1st 1995GENEVA, Switzerland--A newly established United Nations AIDS program based in Geneva has announced plans to initiate large-scale clinical trials of two HIV vaccines as early as mid-1996, probably in Brazil and Thailand. Dr. Peter Piot, chief of research at the World Health Organization's Global Program on AIDS, will head the new group, which will involve six UN agencies.
Canadians Wait Longer for Radiotherapy Than US Patients
January 1st 1995SAN FRANCISCO--Delays for radiation treatment are longer in Ontario than in the United States, Canadian researchers reported in a poster presentation at the annual meeting of the American Society of Therapeutic Radiology and Oncology (ASTRO).