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FDA Tries to ‘Jump Start’ Pediatric Cancer Drug Trials

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ROCKVILLE, Md-A new initiative by the Food and Drug Administration seeks to move more oncology drugs into pediatric testing and onto the market. In a letter sent to drug companies and researchers, and made public, the FDA said that such an effort “merits special consideration” and notes that the “known and potential differences in the biology of pediatric and adult tumors usually will not permit the extrapolation of clinical activity from adults to children.”

Sedation in the Imminently Dying Patient

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Sedation is a clinically important therapeutic intervention in the imminently dying patient. As the patient with an advanced, irreversible illness nears the end of life, symptoms accumulate that are progressively more difficult to

Sedation in the Imminently Dying Patient

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Over the past decade, increased attention has focused on the care of dying patients. The role of the physician in caring for these patients has been the subject of renewed interest and intense, sometimes passionate, debate. Patient groups have formed to advocate for the promotion of compassion in the care of the dying, and some of these advocacy groups have asserted a fundamental “right” to physician-assisted suicide. The US Supreme Court has ruled against a constitutional right to physician-assisted suicide but has asserted its willingness to reconsider the issue if it learned that dying patients were not receiving appropriate, high-quality end-of-life care.[1]

Rituximab/CHOP Combo Effective in Low-Grade NHL

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Among patients with low-grade non-Hodgkin’s lymphoma (NHL), combining CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) chemotherapy with rituximab (Rituxan) adds therapeutic benefit

IOM Medical Error Estimates Questioned, But Legislation Considered

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When Janet Woodcock, MD, a top FDA official, appeared before a Senate committee in early February, she tried to put the issue of medical errors in perspective by referring to a patient who dies after chemotherapy. She rhetorically asked whether

PhRMA Criticizes FDA’s Proposed Rule on Antibiotic Approvals

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Due to the growing problem of antibiotic resistance, physicians have been clamoring for new drug companies to ratchet up antibiotic research and development. Congress had the same concern when it passed the FDA Modernization Act in 1997,

Coaxial Breast Biopsy Device Provides Diagnostic Specimens

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CHICAGO-A simple coaxial breast biopsy tool that can be guided by mammography provides a larger tissue specimen than standard core needle biopsies, causes less bleeding and scarring than surgical biopsy, and carries a smaller price than stereotactically guided biopsy procedures, according to Lincoln Russin, MD, who devised the new biopsy tool. Dr. Russin is a radiologist at Noble Hospital, Westfield, Massachusetts, and associate clinical professor of radiology, Yale University.

3D Digital Camera Accurately Calculates Breast Shape, Volume

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NEW ORLEANS-A novel imaging system-consisting of a three-dimensional digital camera mounted on a tripod, an LCD display monitor, and a standard desktop computer (see Figure 1)-may be the harbinger of the future of breast surgery,

New Antibiotic Effective in Treating Gram-Positive Bacteremia

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Results from the compassionate use program for linezolid (Zyvox), an investigational new antibiotic still under development, show that the drug is effective in the treatment of patients with bacteremia associated with significant gram-positive infections,

Panel Recommends Listing 9 Substances in Carcinogen Report

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ARLINGTON, Va-A scientific panel has recommended listing nine substances as either “known” or “reasonably anticipated” to be human carcinogens. If upheld after review, the substances will be listed in the 10th “Report on

State of the Union on Youth Smoking ‘Clearly Not Good’

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WASHINGTON-The most comprehensive survey of tobacco use among young people has found that 12.8% of middle school students and 34.8% of those in high school reported using some form of tobacco product in the month prior to answering a questionnaire. Cigarettes were favored by most of the students, with cigars second.

How Doctors Break Bad News

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There is no formula for telling a patient that he or she has cancer. The diagnosis is still perceived, for the most part, as a death sentence, and a patient’s reaction is usually a combination of fear, despair, and anger. How a physician

ASCO Launches Large-Scale Study on Quality of Cancer Care

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ALEXANDRIA, Virginia-The American Society of Clinical Oncology (ASCO) has launched the first study aimed at developing a national monitoring system for cancer care in the United States. A panel of ASCO physicians and other health experts will oversee the study, which will be conducted by researchers at Harvard University and the RAND Corporation, the organization said in a news release.

Poor Literacy, Low Income May Deter Cancer Screening

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CHICAGO-Poor reading ability and low income affect many aspects of health care, including cancer screening. Preliminary analysis of data from a study of new enrollees in a Medicare managed care program showed that women with low or inadequate functional literacy were less likely than literate patients to have a Pap smear, and those with yearly incomes below $20,000 were less likely to have mammography.