3/12/2007 Washington, DC news release US Food & Drug Administration (www.fda.gov) The U.S. Food and Drug Administration (FDA) today issued a public health advisory outlining new safety information, including revised product labeling about erythropoiesis-stimulating agents (ESAs), widely-used drugs for the treatment of anemia. The drugs affected by the safety update are darbepoetin alfa (Aranesp) and epoetin alfa (Epogen and Procrit). (ESAs are genetically engineered forms of the naturally occurring human protein, erythropoietin. Natural erythropoietin is made by the kidney and increases the number of red blood cells). FDA and the manufacturer of these products have agreed on revised product labeling that includes updated warnings, a new boxed warning, and modifications to the dosing instructions. The new boxed warning advises physicians to monitor red blood cell levels (hemoglobin) and to adjust the ESA dose to maintain the lowest hemoglobin level needed to avoid the need for blood transfusions. Physicians and patients should carefully weigh the risks of ESAs against transfusion risks. Recently completed studies describe an increased risk of death, blood clots, strokes, and heart attacks in patients with chronic kidney failure when ESAs were given at higher than recommended doses. In other studies, more rapid tumor growth occurred in patients with head and neck cancer who received these higher doses. In studies where ESAs were given at recommended doses, an increased risk of death was reported in patients with cancer who were not receiving chemotherapy and an increased risk of blood clots was observed in patients following orthopedic surgery. "The [...]

3/12/2007 New York, NY staff AMNewYork (www.amny.com) Federal health officials issued stern new warnings Friday for doctors to more carefully prescribe widely used anemia drugs that can increase the risk of death and other serious problems in patients with cancer and kidney disease. At issue are drugs sold under the brand names Procrit, Epogen and Aranesp. These drugs are genetically engineered versions of a natural protein, erythropoietin, that increases the number of red blood cells. Anemia is common with certain forms of kidney disease, especially once a patient is on dialysis, and when cancer patients take chemotherapy. But the Food and Drug Administration pointed to recent studies that found using too much of the drugs increased the risk of death, blood clots, strokes and heart attacks in patients with chronic kidney failure. In other studies, patients with head and neck cancer had more rapid tumor growth if they used higher-than-recommended doses. Even when the anemia drugs were used at FDA-recommended doses, giving them to cancer patients not on chemotherapy increased the risk of death, the agency warned. Moreover, some doctors have begun giving the drugs to patients following orthopedic surgery, also increasing the risk of blood clots, FDA said. Friday, the agency added stern warnings to each of the drug's labels urging that: -doctors monitor patients' levels of red blood cells and use the lowest possible dose to avoid the need for blood transfusions. -doctors and patients carefully weigh the risks of using anemia drugs vs. the risk of a [...]

3/12/2007 web-based article staff eMaxHealth.com In light of a new study conducted by the American Cancer Society, the South Dakota Department of Health is reminding current tobacco users that the only certain way to avoid the health risks of tobacco products is to quit completely. "This study not only confirms what we already know—that spit tobacco is not a safe alternative to cigarettes. But it also reveals that smokers who switched to chewing tobacco had considerably worse health outcomes than those who quit entirely" said Dr. Gail Gray, division director of Health and Medical Services. The study was published in the Journal of Tobacco Control and conducted by researchers at American Cancer Society and the Centers for Disease Control's Office on Smoking and Health. It studied more than 116,000 men and found that cigarette smokers who switched to spit tobacco products had a higher risk of dying prematurely from tobacco-related diseases than former smokers who stopped using all forms of tobacco. The study is the first to compare death rates among those who quit using tobacco entirely with those who switch. Previous studies have examined morbidity and mortality among the two groups separately but have not compared them. The study's principal finding was that the men who switched from smoking cigarettes to using spit tobacco had higher death rates from lung cancer, stroke, heart disease and all causes combined than men who quit using tobacco entirely. Switchers also had more than twice the death rate from cancers of the mouth [...]

3/7/2007 web-based article staff Biocompare News (news.biocompare.com) Researchers have found a way to activate Epstein-Barr viruses inside tumors as a way to identify patients whose infection can then be manipulated to destroy their tumors. They say this strategy could offer a novel way of treating many cancers associated with Epstein-Barr, including at least four different types of lymphoma and nasopharyngeal and gastric cancers. In the March 1 issue of Clinical Cancer Research, a team of radiologists and oncologists from Johns Hopkins Medical Institutions describe how they used two agents already on the market − one of which is the multiple myeloma drug Velcade − to light up tumor viruses on a gamma camera. The technique is the first in the new field of in vivo molecular-genetic imaging that doesn't require transfecting tumors with a "reporter" gene, the scientists say. "The beauty of this is that you don't have to introduce any reporter genes into the tumor because they are already there," says radiologist Martin G. Pomper, M.D., Ph.D. "This is the only example we know of where it is possible to image activated endogenous gene expression without having to transfect cells." A variety of blood and solid cancers are more likely to occur in people who have been infected with the Epstein-Barr virus (EBV), but not everyone with these cancers has such infections. For those who do, researchers, such as Hopkins oncologist and co-author Richard F. Ambinder, M.D., Ph.D., have been working on ways to activate the reproductive, or "lytic" [...]

3/7/2007 Columbus, OH Glen Forbes The lantern (media.www.thelantern.com) Dale Stokes owns a 230-acre farm in Wilmington, Ohio, but he is also in the business of saving lives. Stokes is the main berry provider for cancer researchers at Ohio State who are attempting to prove that consumption of certain berries, particularly blackberries, black raspberries and strawberries, can stop the spread of colon, esophageal and oral cancer. "I would estimate that I've given about 15,000 pounds of berries over 20 years to this research," Stokes said. "To ensure consistency, I grow all of the black raspberries at Ohio State in the same patch of roughly three acres." Several groups of researchers based at the OSU Medical Center are studying the effects of berry consumption. Black raspberries and blackberries have proven to be particularly effective in reducing the size and spread of tumors in rats with oral and esophageal cancer, according to Dr. Gary Stoner. He has led the research regarding the positive effects of antioxidants in berries for more than 20 years. "I first heard about Dr. Stoner's work in 1987 when he was with the Ohio College of Medicine in Toledo," Stokes said. "I heard what he was trying to do and I approached him and told him I was the largest individual grower of black raspberries east of the Mississippi." In the early 1980s, Stoner and his research group began working with a compound that featured ellagic acid - a plant nutrient that is plentiful in several types of berries. [...]

3/7/2007 Cleveland, OH press release FDA Recall List (www.fda.gov/opacom) Gebauer Company, a 107-year-old medical device manufacturer and marketer, today announced a nationwide, voluntary firm initiated recall of certain lots of its Salivart Oral Moisturizer, product number 0386-0009-75. These lots may contain some units that do not meet the Company's internal specification for aerobic microorganisms and mold. The problem was discovered during routine stability testing. The problem is not uniform throughout the lots. Use of the affected units of these lots of Salivart Oral Moisturizer may cause temporary and reversible health problems such as nausea, vomiting, and diarrhea. Lot numbers and expiration dates are located on the bottom of the product can. The recalled product lots are: Lot Number Expiration Date Initial Ship Date 06AA001 06-08 09-11-06 06AA002 06-08 10-05-06 06AA003 06-08 10-26-06 06AA004 07-08 11-16-06 06AA005 07-08 12-14-06 06AA006 10-08 01-10-07 Customers who believe they are in possession of the recalled product should stop using the product and dispose of it immediately in their regular trash. "We are committed to the quality of our products and we are taking all necessary measures to remedy this production issue," said John Giltinan, President of Gebauer Company. "Salivart Oral Moisturizer has been used safely since 1990 and is supported by our history of meeting high safety and efficacy standards." Should customers require additional information, they are to contact Gebauer Company Customer Service at (800) 321-9348.

3/7/2007 Stockholm, Sweden A Roosaar et al. J Oral Pathol Med, February 1, 2007; 36(2): 78-82 Aim: To assess the natural course of screening-detected oral leukoplakia (OL) among non-consulting individuals. Methods: A cohort of 555 individuals with OL, confirmed in 1973-1974 during a population-based survey, were followed through January 2002 via record linkages with nationwide and essentially complete registers. A sample of 104 drawn from the 297 surviving cohort members who still were living in the area in 1993-1995 was invited to a re-examination. Sixty-seven of them attended. Results: At the time of re-examination OL had disappeared in 29 (43%) individuals. There was a statistically significant association between cessation of/no smoking habits in 1993-1995 and the disappearance of OL. Never/previous daily smokers were thus over-represented among individuals whose OL had disappeared compared to those with persisting OL [n = 23 (82%) vs. n = 18 (47%), P < 0.01]. Eighteen (78%) of the twenty three non-smokers with disappearing OL had quit after the initial examination. One man and two women developed oral cancer during follow-up while 0.7 and 0.07, respectively, were expected. Conclusion: Smoking cessation was associated with an increased disappearance of OL. Hence, at least one-fourth had lesions that could be classified as tobacco-related. Small observed and expected numbers prohibited firm conclusions about a possible excess risk of developing oral cancer. Authors: A Roosaar, L Yin, AL Johansson, G Sandborgh-Englund, O Nyren, and T Axell Authors' affiliation: Institute of Odontology, Karolinska Institutet, Stockholm, Sweden

3/7/2007 Vancouver, British Columbia, Canada Miriam P Rosin Ann. N.Y. Acad. Sci., March 1, 2007 The genomic era has fueled a rapid emergence of new information at the molecular level with a great potential for developing innovative approaches to detection, risk assessment and management of oral cancers and premalignant disease. As yet, however, little research has been done on complementary approaches that would use different technology in conjunction with molecular approaches to create a rapid and cost-effective strategy for patient assessment and management. In our ongoing 8-year longitudinal study, a set of innovative technologies is being validated alone and in combination to best correlate with patient outcome. The plan is to use these devices in a step-by-step sequence to guide key clinicopathological decisions on patient risk and treatment. The devices include a hand-held visualization device which makes use of tissue autofluorescence to detect and delineate abnormal lesions and fields requiring follow-up, to be used in conjunction with optical contrast agents such as toluidine blue. In addition, two semi-automated high-resolution computer microscopy systems will be used to quantitate the protein expression phenotype of cell nuclei in tissue sections and exfoliated cell brushings. Previously identified risk-associated molecular changes are being used to validate these systems as well as to establish their place in a population-based triage program that will filter out high-risk cases in the community and funnel them to dysplasia clinics where higher-cost molecular tools will guide intervention. A critical development for the translation of this technology into community settings is [...]

3/6/2007 New Rochelle, NY press release Genetic Engineering News (www.genengnews.com) Cytogen Corporation today announced the launch of Caphosol Relieves Oral Mucositis, an educational support program for patients and caregivers. The announcement comes as Cytogen establishes an expanded market presence for Caphosol, an advanced electrolyte solution indicated in the U.S. as an adjunct to standard oral care in treating oral mucositis (OM) caused by radiation or high dose chemotherapy. Caphosol, a prescription medical device, is also indicated for dryness of the mouth or throat (hyposalivation, xerostomia), regardless of the cause or whether the conditions are temporary or permanent.(1) Caphosol is available through U.S. wholesalers nationwide. CARE OM As part of its commitment to advancing the treatment and care of cancer patients, Cytogen is proud to announce the launch of CARE OM - a web-based education and support center for patients and caregivers seeking to learn more about OM and Caphosol . In addition to oral mucositis educational material and support information, visitors to CARE OM, located at http://www.caphosol.com/careom, can also download an OM brochure or request a free brochure about OM by mail. "The CARE OM program is designed to help raise awareness of oral mucositis --one of the most common and debilitating complications of cancer treatment," said Michael D. Becker, president and chief executive officer of Cytogen Corporation. "As we make Caphosol more widely available in the U.S., our goal is to improve the quality of cancer patients' lives through the effective management of oral mucositis." Oral complications including mucositis [...]

3/6/2007 Pittsburgh, PA Allison M. Heinrichs Pittsburgh Tribune-Review (www.pittsburghlive.com) Lugging a suitcase filled with 600 DNA samples from people with oral deformities sparked an idea for Dr. Alexandre Vieira that simmered for seven years. That idea has since grown into the world's first dental DNA registry -- and all people have to do to help is spit into a cup. "Anything that you can imagine related to dentistry can be examined in this way," said Vieira, a dentist and assistant professor in Pitt's Center for Craniofacial and Dental Genetics. The registry allows qualified researchers access to a person's dental records -- anonymously -- along with a sample of that person's DNA, collected from saliva. Potential research projects include everything from determining whether cavities have a genetic link, to testing whether a particular couple is prone to having a baby with an oral defect, such as a cleft palate. By having a pre-existing DNA registry, Vieira expects to save Pitt and other dental research centers almost $125,000 per genetics study because researchers won't have to collect new samples. The project began in September in one of the dental school's 20-chair Oakland clinics. Patients who indicate they are willing to participate in the study sign a waiver and spit into a special cup. When Vieira started the study, he expected about 30 percent of the patients to agree. So far, 85 percent of patients have done so, and Vieira has collected almost 250 samples. He's hoping to collect 1,000 each year, with [...]