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For America's Aged, Surgery At Any Price?
When doctors decide whether or not to go ahead with an expensive surgery, "age is no longer the deciding factor, even for invasive treatment such as open-heart surgery," The Philadelphia Inquirer reports. One question is "whether this never-too-old approach is an example of U.S. medical progress, or an example of why Medicare -- federal health insurance for people over 64 -- is headed for insolvency. The answer, experts say, is both. Which is why the current debate over expanding federal coverage to all uninsured Americans is an ethical and economic minefield. "Forty years ago, it was taken for granted that the elderly were not good candidates for organ transplantation, dialysis, or advanced surgical procedures. That has changed," Daniel Callahan, cofounder of the Hastings Center, a bioethics research institute in Garrison, N.Y., wrote recently. "Under the best of circumstances, age should be irrelevant in the Medicare program. But so far, the cost of care has not been considered, and it can hardly remain irrelevant in a program strapped for money.""

Four Out Of 106 Heart Replacement Valves From Pig Hearts Failed
Pig heart valves used to replace defective aortic valves in human patients failed much earlier and more often than expected, says a report from cardiac surgeons at Washington University School of Medicine in St. Louis. This is the first report to demonstrate this potential problem, the researchers say.
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Sciele Pharma Announces Availability Of Ulesfia (Benzyl Alcohol Lotion 5%), First Prescription Non-Neurotoxic Head Lice Treatment
Sciele Pharma, Inc., a Shionogi Company, announced the availability of Ulesfia (Benzyl Alcohol Lotion 5%), the first and only prescription medication that kills head lice by asphyxiation without potential neurotoxic side effects. Approved by the U.S. Food & Drug Administration (FDA), Ulesfia is indicated for the topical treatment of head lice infestation in patients 6 months of age and older. Ulesfia is available now by prescription nationwide in time for peak head lice season.
Medical Devices

Gefitinib Receives European Licence For The Treatment Of Lung Cancer For Patients With EGFR Activating Mutation Positive Tumours

AstraZeneca announced that it has received a licence by the European Medicines Agency (EMEA) for its oral targeted anti-cancer drug, gefitinib, for EGFR (epidermal growth factor receptor-tyrosine kinase) activating mutation positive patients with Non Small Cell Lung Cancer (NSCLC). NSCLC is the most common type of lung cancer and accounts for 80% of all lung cancer cases. [1] The licence means that for the first time, thousands [2] of patients undergoing first line treatment of NSCLC in the UK may benefit from a more effective, [3] oral alternative to doublet chemotherapy (UK standard of care) without many of the side effects associated with chemotherapy. [3] Gefitinib is licensed for use in adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of EGFR-TK (epidermal growth factor receptor-tyrosine kinase), in all lines of therapy. [4] Gefitinib is the only oral targeted therapy available for first line use, having demonstrated superior efficacy vs. doublet chemotherapy for patients with a specific genetic mutation of their tumours (EGFR activating mutation positive tumours) and is one of just a handful of anti cancer drugs already available to target only those patients most likely to benefit. EGFR mutation status of a patient"s tumour is a strong predictor of benefit with gefitinib. [3,5] When compared to standard chemotherapy, not only did significantly more patients with EGFR mutation positive tumours respond to treatment with gefitinib (71.2% v 47.3%, p=0.0001) but they also lived significantly longer without their cancer growing (progression free survival) (median PFS 9.5 months vs 6.3 months; HR 0.48, 95% CI 0.36 to 0.64, pAbout IPASS [3] IPASS was an open label, randomised, parallel-group study that assessed the efficacy, safety and tolerability of gefitinib versus carboplatin/paclitaxel as first-line treatment in a clinically selected population of patients from Asia. The study enrolled 1,217 patients in Asia with advanced NSCLC who had not received prior chemotherapy for advanced disease, whose tumours were of adenocarcinoma histology and who had either never smoked, or were former light smokers (ceased smoking at least 15 years ago and About INTEREST [6] The INTEREST (Iressa Non-small-cell lung cancer Trial Evaluating REsponse and Survival against Taxotere) study was a randomised, open-label, parallel-group, Phase III trial evaluating survival with gefitinib versus docetaxel in 1,466 patients with locally advanced or metastatic recurrent NSCLC who had previously received platinum-based chemotherapy. The primary endpoint of INTEREST was OS, with the objective of demonstrating that gefitinib was non-inferior to docetaxel chemotherapy. The INTEREST study met its primary objective, demonstrating equivalent overall survival (OS) and significant quality of life benefits for gefitinib compared to standard chemotherapy (docetaxel) in the pre-treated setting.[6] A retrospective analysis showed a significant improvement in PFS and ORR for gefitinib over docetaxel in patients with EGFR sensitising mutation positive tumours. [7] About gefitinib - Mode of Action: gefitinib is an EGFR-TKI (epidermal growth factor receptor-tyrosine kinase inhibitor), which targets and blocks the activity of the EGFR-TK, an enzyme that regulates intracellular signalling pathways implicated in cancer cell proliferation and survival. Growth factor signalling has been identified as a key driver of tumour growth and spread in a wide range of cancers - Gefitinib (250 mg) is a once-daily oral therapy. - Gefitinib is licensed in 36 countries for the treatment of patients with locally advanced or metastatic NSCLC who have previously received chemotherapy. About EGFR mutations - EGFR mutations are changes in the DNA sequence of the EGFR gene which codes for the EGFR protein, leading to the production of mutated EGFR, rather than wild-type (non-mutated) EGFR. Tumour cells with mutated EGFR seem to be drawn to signalling via the EGFR pathway. - The EGFR receptor has been shown to play an important role in NSCLC. Some patients will exhibit mutations within the gene of this receptor. - A mutation in the EGFR is a characteristic occurring in approximately 12.7% [8] of lung cancers in non-Asian patients. About lung cancer in the UK - Lung cancer is the second most commonly diagnosed cancer in the UK. Each year more than 38,000 people are diagnosed with lung cancer in the UK. [9] - There are several different types of lung cancer, NSCLC being the most common. 80% of lung cancer patients are diagnosed with NSCLC. [1] - The UK has one of the worst lung cancer survival rates in Europe, 8.6% survival at 5-years in England compared with a mean of 12.6% across Europe. [10] About gefitinib and NICE AstraZeneca will submit gefitinib to NICE for review in September 2009 References [1] Cancer Research UK, UK Lung Cancer incidence statistics. http://info.cancerresearchuk.org/cancerstats/types/lung/incidence/. Date accessed 19.03.09 [2] AstraZeneca Data on File (DOF) IRE/014/MAY09 [3] Mok T. Phase III, Randomised, Open-Label, First-Line Study Of Gefitinib Vs Carboplatin/Paclitaxel (C/P) Clinically Selected Patients With Advanced Non-Small-Cell Lung Cancer (IPASS), Presentation at ESMO 2008 [4] Gefitinib (IRESSA [TM]) SmPC. http://www.Medicines.Org.uk [5] Kobayashi et al. First-line gefitinib versus first-line chemotherapy by carboplatin (CBDCA) plus paclitaxel (TXL) in non-small cell lung cancer (NSCLC) patients (pts) with EGFR mutations: A phase III study (002) by North East Japan Gefitinib Study Group. Poster presented at ASCO 2009. (abs. 8016) [6] Kim, ES et al. Gefitinib versus docetaxel in previously treated non-small-cell lung cancer (INTEREST): a randomised phase III trial. Lancet 2008; 372: 1809-18 [7] Douillard, J. et al. Molecular and clinical subgroup analyses from a phase III trial comparing gefitinib with docetaxel in previously treated non-small cell lung cancer (INTEREST). Presentation at ASCO 2008. [8] AstraZeneca Data on file (DOF) IRE/013/APR09 [9] Cancer Research UK. Date accessed 17.03.09 [10] Berrino F, De Angelis R, Sant M et al. Survival for eight major cancers and all cancers combined for European adults diagnosed in 1995-1999: results of the EUROCARE-4 study Lancet Oncology 2007; 8:773-783 AstraZeneca


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