Compendia and anticancer therapy under Medicare.
ABSTRACT In 1993, Congress directed the Medicare program to refer to 3 existing published compendia, American Medical Association Drug Evaluations (AMA-DE), United States Pharmacopoeia Drug Information for the Health Professional (USP-DI), and American Hospital Formulary Service Drug Information (AHFS-DI), to identify unlabeled but medically accepted uses of drugs and biologicals in anticancer chemotherapy regimens. Public discussion during the preceding years had centered on whether to designate unlabeled uses of anticancer treatments as experimental and thus outside the scope of Medicare benefits. American Medical Association Drug Evaluations and USP-DI subsequently ceased publication, and the Medicare program faced increasing calls to revise the list of acceptable compendia, as authorized in the statute. In 2007, the Centers for Medicare & Medicaid Services used its regulatory authority to establish a publicly transparent process to revise the list. The Centers for Medicare & Medicaid Services considered 5 requests in 2008 and added National Comprehensive Cancer Network Drugs and Biologics Compendium, DRUGDEX, and Clinical Pharmacology to the list of compendia. DrugPoints was not added, and AMA-DE was removed. Because of the potential for conflicts of interest to lead to biased judgments, the 2008 Medicare Improvements for Patients and Providers Act has a provision that explicitly prohibits inclusion of compendia that do not have a publicly transparent process for evaluating therapies and identifying potential conflicts of interest.
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ABSTRACT: Five lanostane (2, 3, 4, 6 and 8) and three ergostane-type (1, 5 and 7) triterpenes isolated from the fruiting bodies of Antrodia camphorata were evaluated for their in vitro cytotoxic data against various cancer cell types. The three zhankuic acids, 1, 5 and 7 displayed the most potent cytotoxic effect with an IC(50) value of 22.3-75.0microM. The compound 3 was selectively cytotoxic in three colon cancer cell lines (HT-29, HCT-116 and SW-480) and a breast cancer model (MDA-MB-231), whereas 8 only showed its cytotoxicity against MDA-MB-231. None of these isolates was toxic to mammary epithelial (MCF10A) and primary foreskin fibroblast (HS68) cells, two human normal cell lines. The compounds 1, 5 and 7 were also demonstrated to induce apoptosis in HT-29 and SW-480 cells, as confirmed by sub-G1 cell cycle arrest. In HT-29 cells, the expression of apoptosis-associated proteins poly-(ADP-ribose) polymerase cleavage, Bcl-2 and procaspase-3 were suppressed by compounds 1, 5 and 7. A mixture containing 4microM each of compounds 1, 5 and 7 also showed a synergistic cytotoxic effect in HT-29 cells.Cancer letters 06/2009; 285(1):73-9. DOI:10.1016/j.canlet.2009.05.002 · 5.02 Impact Factor
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ABSTRACT: Under current U.S. law, physicians may prescribe drugs and devices in situations not covered on the label approved by the Food and Drug Administration. Those supporting this system say that requiring FDA approval for off-label uses would unnecessarily impede the delivery of benefits to patients. Patients do benefit from off-label prescribing that is supported by sound scientific and medical evidence. In the absence of such evidence, however, off-label prescribing can expose patients to risky and ineffective treatments. The medical community and federal authorities should more actively promote patients' interests in receiving beneficial off-label treatments. To exercise responsible self-regulation, members of the medical community must determine whether available evidence justifies specific off-label uses and must promote information-gathering when the evidence is inadequate. Physicians should also discuss with patients the uncertainties accompanying off-label uses. Federal authorities should more closely monitor the effects of off-label prescribing and adopt other measures to reduce harm and enhance benefits produced by off-label prescribing.The Journal of Law Medicine & Ethics 02/2009; 37(3):476-86, 396. DOI:10.1111/j.1748-720X.2009.00408.x · 0.94 Impact Factor
- Annals of internal medicine 10/2009; 151(5):364-5. DOI:10.7326/0003-4819-151-5-200909010-00018 · 16.10 Impact Factor