7/16/2005 Washington, DC Denise Grady New York Times The government warned yesterday that painkilling skin patches could cause drug overdoses and said it was investigating reports of serious side effects and 120 deaths that might have resulted. The patches, containing the narcotic fentanyl, are marketed under the name Duragesic by Janssen, a company owned by Johnson & Johnson. A generic version was put on the market in February by Mylan Laboratories. Duragesic had sales of more than $2 billion in 2004. The patches are intended for people with moderate to severe chronic pain that requires treatment around the clock for an extended period of time and that cannot be controlled by other narcotics alone, the F.D.A. and the manufacturer say. Only those already tolerant of narcotics, as some cancer patients are, should use the patches. People recovering from surgery, or suffering from short-term pain for other reasons, should not. A spokeswoman for the Food and Drug Administration said the 120 deaths had occurred since Duragesic was first approved in 1990 and added that the investigation was still going on and that it was not known whether the product actually caused the deaths and other problems reported in users. Describing fentanyl as a "very strong narcotic," the F.D.A. issued a public health advisory stating that some patients and doctors might not be fully aware of its dangers. An overdose can cause a person to stop breathing; taking off the patch will not reverse the effects because the drug has already built [...]

7/15/2005 Bangalore, India Baby Manoj Express Pharma Pulse (www.expresspharmapulse.com) Biocon’s head and neck cancer drug molecule TheraCIM - developed in association with the Cuban firm CMAB—has entered into phase II-B clinical trials. A phase-II B clinical trial is a typically single-arm study aimed at deciding whether a new treatment is sufficiently promising, relative to a standard therapy, to include in a large-scale randomised trial ‘‘As far as our cancer molecule is concerned, the development is progressing as per our expectations; we should be able to market it as per schedule,’’ Kiran Mazumdar Shaw, Biocon chief told this correspondent. It may be recalled that this newspaper had earlier reported Biocon’s cancer drug would reach market at the end of the financial year 2005-06. However, company officials denied further details. Developing a successful cancer drug would catapult an R&D based pharmaceutical company like Biocon into the zeniths of profits. Almost all the large sized pharma companies (both allopathic and ayurvedic) in India— like their more well equipped counterparts in the developed countries—are actively pursuing research in cancer. With the increasingly changing food habits (read fast food culture), life-style and more over a rapidly changing environment by the adverse human activities can definitely be linked to cancer, experts say, making R&D in cancer, a lucrative business proposition. Globally, about nine million new cancer cases are diagnosed every year (of which over half are fatal), it is learnt. In India, half a million new cases of cancer are reported annually with nearly 250,000 deaths, [...]

7/15/2005 Chicago, IL staff reporter Medical News Today (medicalnewstoday.com) Researchers at the University of Illinois at Chicago are unraveling the biochemical mechanism by which functional foods combat cancer. "Compounds like sulforaphane in broccoli and resveratrol in wine have been shown to prevent cancer," said Andrew Mesecar, associate professor of pharmaceutical biotechnology in the UIC College of Pharmacy. "They do that by signaling our bodies to ramp up the production of proteins capable of preventing damage to our DNA. "We now have a good idea how that signal works." The findings are published in this week's Early Edition of the Proceedings of the National Academy of Sciences. Two key proteins, Keap1 and Nrf2, are involved in spurring the defense against cancer when disease-preventing foods are ingested, according to Mesecar and post-doctoral researcher Aimee Eggler. Keap1, the sensor protein, detects the presence of dietary compounds like sulforaphane when they link with its cysteine residues, one of the amino acids that make up proteins. Keap1 binds to Nrf2, the messenger that turns on the genes for the protective proteins, averting DNA damage. "Earlier studies in mice suggested that natural cancer-preventing compounds worked by severing the tie between Keap1 and Nrf2, freeing Nrf2 to take action," Mesecar said. "But the signaling doesn't happen this way in humans." The scientists found that in humans the connection between the two proteins is not broken. What's important, the researchers said, is the modification of cysteines in Keap1. They found that one particular cysteine was among the most [...]

7/15/2005 washington, DC press release RedNova.com Now, more than 90 million Americans can sigh comfortably because of new relief for their bad breath. Dental experts today revealed research highlighting a new treatment option that can eliminate halitosis or chronic bad breath at the Academy of General Dentistry's 53rd Annual Meeting in Washington, DC. "Bad breath is no laughing matter and can actually be an indication of more serious health concerns such as infections," said general and cosmetic dentist, Louis J. Malcmacher, DDS, FAGD and AGD member. The research showed that using low concentrations of carbamide peroxide, an odorless ingredient used to bleach and disinfect teeth, can effectively treat chronic bad breath. Patients seeking this treatment, which costs approximately $500.00, need to first visit their dentist to have customized trays or mouth guards made to fit tightly around their teeth. A low concentration of carbamide peroxide is then placed in the tray and into the patient's mouth, where it remains for an hour. After the first treatment, patients are able to repeat this process at home for an hour everyday. After approximately three treatments, the patient will notice a significant change in their breath. Until now, dentists could only offer treatment plans that reduced, but not treat, bad breath. In the past, using various types of mouthwash and toothpaste provided a temporary solution; however, they did not stay in the mouth long enough to significantly impact bad breath. "If you are suffering from chronic bad breath it is important to work [...]

7/15/2005Newton, PANeal BelluciPharmalive.com Drugs in Development: A wealth of options in oncology With a continued investment in innovative therapies in oncology, Merck KGaA has ongoing active development programs with additional novel therapies that may offer new hope to people with cancer. The company is best known for the first-in-class EGFR-targeted monoclonal antibody, Erbitux, comprising cetuximab, that works by blocking the epidermal growth factor receptor to inhibit tumor growth and spread. Merck KGaA focuses on four therapeutic technology platforms in oncology: EGFR-targeting monoclonal antibodies that may block tumor growth; immunocytokines that may provide local stimulation of the immune system; angiogenesis inhibitors that may starve tumors of the blood supply they need to grow and spread; and cancer vaccines that may stimulate a specific immune response against tumors. "These are exciting times in oncology," says Dr. Bernhard Ehmer, VP, oncology, Merck KGaA (merck.de). "With a better understanding of the growth and spread of tumors, we are able to develop treatments that target the cancer cells and give physicians and their patients additional options with which to fight cancer. "We are particularly excited by Erbitux not only in the treatment of colorectal cancer but also in its potential in head and neck cancer, and by BLP25 Liposome Vaccine, which is showing impressive results in the treatment of nonsmall cell lung cancer. Furthermore, our humanized EGFR-targeting monoclonal antibody matuzumab is showing potential in several types of cancer." Erbitux is a first-in-class and highly active IgG1 monoclonal antibody targeting the epidermal growth factor receptor. As [...]

7/14/2005 Atlanta, GA American Cancer Society CA Cancer J Clin 2005; 55:205-206 Vitamin E supplementation does not reduce the incidence of cancer or major cardiovascular events, according to a recent article in JAMA (2005;293:1338–1347). In fact, high doses appear to actually raise the risk of heart failure in certain people, a team of Canadian, US, and British researchers reported. The findings come from a trial known as HOPE-TOO (Heart Outcomes Prevention Evaluation–The Ongoing Outcomes). The study was a continuation of an earlier trial comparing vitamin E and ramipril in patients at high risk of cardiovascular events because of diabetes, peripheral or coronary arterial disease, or other cardiovascular disease risk factors. Participants in HOPE-TOO were randomized to take either 400 IU of vitamin E daily or a placebo. The researchers examined overall cancer cases and deaths and found no significant differences between the two groups. Then they looked at specific cancers that previous studies suggested might be prevented by vitamin E: prostate, lung, oral, colorectal, breast, and melanoma. Even for these cancers, no significant difference was seen between the groups. When the researchers examined heart disease incidence, they found no differences between the groups for heart attacks, stroke, unstable angina, and several other types of heart problems. However, people on vitamin E were more likely to develop heart failure. No other study of vitamin E has looked at heart failure; the researchers suggest reviews of previous research be done to look for similar links. The study isn’t the first to find [...]

7/12/2005 Oak Brook, IL Todd M. Blodgett, MD et al. RadioGraphics 2005;25:897-912 Part 1: Physiologic, Altered Physiologic, and Artifactual FDG Uptake Positron emission tomography (PET) with 2-[fluorine-18] fluoro-2-deoxy-D-glucose (FDG) has been effective for the diagnosis, staging, and restaging of malignancies of the head and neck region. However, lack of anatomic landmarks, variable physiologic uptake, and asymmetric FDG distribution in several altered physiologic states can confound image interpretation. In addition, many benign causes and several artifacts can simulate physiologic or pathologic FDG uptake in the head and neck. Combined PET–computed tomography (CT) is a unique imaging modality that permits anatomic and functional imaging on a single scanner with nearly perfect coregistration. Combined PET-CT provides information that cannot be obtained with PET or CT alone. In particular, PET-CT facilitates the interpretation of FDG uptake in the head and neck, an area that is characterized by dense and complex anatomic structures. An atlas of FDG uptake in this anatomic region was compiled on the basis of combined PET-CT findings in 11,000 patients. In general, patterns of FDG uptake were variable and often reflected patient activity during or immediately preceding the uptake phase. With the growing interest in PET-CT, interpreting radiologists and nuclear medicine physicians must be familiar with the patterns of FDG uptake in the head and neck to avoid misinterpretation or mis-diagnosis. Authors: Todd M. Blodgett, MD, Melanie B. Fukui, MD, Carl H. Snyderman, MD, Barton F. Branstetter, IV, MD, Barry M. McCook, MD, Dave W. Townsend, PhD and Carolyn C. Meltzer, [...]

7/12/2005 Bethesda, MD Daniel M. Cook et al. Health Affairs, Vol 24, Issue 4, 994-1004 A new medical diagnostic code for secondhand smoke exposure became available in 1994, but as of 2004 it remained an invalid entry on a common medical form. Soon after the code appeared, Philip Morris hired a Washington consultant to influence the governmental process for creating and using medical codes. Tobacco industry documents reveal that Philip Morris budgeted more than $2 million for this "ICD-9 Project." Tactics to prevent adoption of the new code included third-party lobbying, Paperwork Reduction Act challenges, and backing an alternative coding arrangement. Philip Morris’s reaction reveals the importance of policy decisions related to data collection and paperwork. Authors: Daniel M. Cook, Elisa K. Tong, Stanton A. Glantz and Lisa A. Bero

7/12/2005 Christoph Matthias, Ulrich Harreus, and Richard Strange Eur Arch Otorhinolaryngol, July 8, 2005 Alcohol consumption and cigarette smoking play a key role in the development and progression of head and neck cancer. Additionally, epidemiologic studies have given evidence that other environmental and genetic factors are relevant. We present a prospective study including 465 head and neck cancer patients. All patients were recruited between 1994 and 1998 during the initial tumor diagnosis. Three hundred twelve patients could be followed over 5 years after histologically proven curative surgical treatment. All clinical data were recorded (i.e., age, gender, TNM stage, histological grading, smoking and drinking habits) and genetic variations at loci encoding detoxifying enzymes (glutathione S-transferase and cytochrome P450); immune modulating cytokines (tumor necrosis factor) and cell cycle regulating proteins (cyclin D1) were determined. Parameters with an impact on recurrence-free survival were analyzed. A strong influence could be attributed to the tumor size at the time of presentation. Additionally, the grading of the tumor showed a strong influence (5 years recurrence free: G1: 87% and G1: 61%). Furthermore, it could be shown that the recurrence-free survival was significantly influenced by cyclin D1 genotypes ( CCND1GG: P =0.01; HR=3.72) and TNF microsatellite haplotypes ( TNFB1D5: P =0.043; HR=2.05). These findings are compatible with the view that genetic predisposition is important in determining recurrence-free survival after surgical treatment of head and neck cancer. Author's affiliation: Department of Otorhinolaryngology, Ludwig Maximilian University, Marchioninistr. 15, 83177, Munich, Germany

7/12/2005 Oak Brooks, IL Melanie B. Fukui, MD et al. RadioGraphics 2005;25:913-930 Part 2: Diagnostic Uses and Pitfalls of Oncologic Imaging Positron emission tomography (PET) with 2-[fluorine-18] fluoro-2-deoxy-D-glucose (FDG) is effective for monitoring head and neck cancer. However, lack of anatomic landmarks, variable physiologic FDG uptake, and asymmetric FDG distribution in the neck can confound image interpretation. This is particularly true in the treated neck, where distortion of normal tissue planes makes detection of early disease recurrence difficult with conventional computed tomography (CT) and magnetic resonance imaging. Combined PET-CT helps prevent the misinterpretation of FDG PET findings in patients with head and neck cancer. Superior localization of FDG uptake with this technique can improve diagnostic accuracy and help avoid interpretative pitfalls. In the future, development of tumor-specific ligands will enhance the usefulness of PET-CT in the detection of initial tumors and tumor recurrence, in the evaluation of tumors with low FDG avidity, and in treatment targeting. Furthermore, improved scanner resolution will help address the limitations of PET-CT with respect to small lesions and may make this modality more valuable in initial tumor staging. Authors: Melanie B. Fukui, MD, Todd M. Blodgett, MD, Carl H. Snyderman, MD, Jonas J. Johnson, MD, Eugene N. Myers, MD, Dave W. Townsend, PhD and Carolyn C. Meltzer, MD Authors' affiliation: From the Department of Radiology, Allegheny General Hospital, 320 E North Ave, Pittsburgh, PA 15212 (M.B.F.) and the Departments of Radiology (T.M.B., D.W.T., C.C.M.), Otolaryngology (C.H.S., J.J.J., E.N.M.), Psychiatry (C.C.M.), and Neurology (C.C.M.), University of [...]