3/9/2005 Jon Saraceno USA Today Curt Schilling is addicted. His drug of choice ... Smokeless tobacco. It is legal, but it certainly is not harmless. And someone you know — maybe even your own child — craves the stuff at this very moment. Many would like to shake the disgusting habit, but they can't seem to conquer the highly addictive properties of nicotine. They don't feel as alert when they're not using. They become edgy and irritable without the pinch of snuff between cheek and gum. According to the Centers for Disease Control and Prevention more young athletes are trying the nasty stuff — even girls. Many are like Schilling, who first dipped at 16 in his Arizona high school. "I tried it at lunch, liked it and have been doing it ever since." Schilling, 38, wants to quit, but that New Year's resolution seems like years ago now. His family is after him, too, particularly his 7-year-old daughter, Gabriella. Tuesday, the big, tough right-hander sounded scared — almost as afraid as the time when a lesion was discovered in his mouth several years ago. He went cold turkey for a year and a half, until someone handed him the strong stuff at a golf tournament. "I took one dip, and I was full-blown back in it," he says despondently. "It's an addiction that covers so many things physically and mentally." He stopped during spring training this year. For all of two days. "I've never had any experience with something [...]

3/9/2005 JoinTogether (jointogether.org) Testing saliva rather than urine or blood for evidence of drug use and disease may be the next big trend in drug testing, Newsday reported March 8. David Wong, a researcher at UCLA's School of Dentistry, told colleagues attending the annual meeting of the American Association for the Advancement of Science that saliva testing can detect a wide range of compounds in the body. "Saliva is really a reflection of our body and circulation and blood," he said. Dental researchers have used saliva to accurately predict the formation of cavities, and the federal government recently granted $57 million for research into saliva testing. Researchers have identified 310 proteins in saliva that can be measured to screen people for diseases like oral cancer or other problems. Low levels of any substance found in the blood or urine also shows up in saliva, and police in Europe and Australia are already using roadside saliva tests to detect drug-impaired drivers. More U.S. businesses also are using saliva tests like the Intercept screening tools from OraSure Technologies. "This is certainly a more dignified approach to drug testing," said OraSure CFO Ron Spair The detection window for saliva testing is one to two days, and researchers say that they have found no masking agents that are effective in distorting saliva-test results. Addiction Research and Treatment Corp. of Brooklyn, N.Y., uses the Intercept saliva tests to detect HIV and drug use among treatment clients. Beny Primm, the executive director of the program, says [...]

3/9/2005 Phoenix, AR Business Wire (businesswire.com) Zila, Inc. today announced that it has received preliminary comments from the Food and Drug Administration (FDA) on proposed amendments to the clinical program for its OraTest(R) product. The comments that were received were technical in nature and centered on the need to provide clarifications to previously submitted materials, particularly within the statistical metrics that would be used to evaluate the data gathered during the clinical trial. A significant component of the proposed clinical program is the identification of severe dysplasia as a primary endpoint. This and certain other elements of the proposed program would permit a reduction in the total number of patients and the number of visits per patient, which would reduce the cost and duration of the program. Douglas D. Burkett, Ph.D., chairman, chief executive officer and president of Zila, Inc. stated, "Although the FDA's comments are preliminary, we are encouraged by their initial response to our clinical program amendments. Zila will continue to communicate with the FDA, focusing on addressing their technical comments. Although the FDA may have additional comments, we have concluded, in consultation with our regulatory, clinical and medical advisors, that we now have adequate information to enable us to proceed with certain of the preliminary processes necessary to conduct the amended Phase III clinical program. These tasks will include the submission of our clinical protocols to the independent review boards (IRBs) at our investigative sites in the U.S., Europe and Asia, and the completion of required contractual [...]

3/6/2005 Miguel Sanchez A a common chemotherapy drug may cause a serious bone disease called "osteonecrosis of the jaw" (ONJ), according to doctors at Long Island Jewish (LIJ) Medical Center. The discovery, published in the Journal of Oral and Maxillofacial Surgeons, prompted both the US Food and Drug Administration (FDA) and Novartis, the manufacturer of bisphosphonates used in cancer chemotherapy, to issue warnings earlier this fall to physicians and dentists about the risk for this potential adverse effect. ONJ is a condition in which the bone tissue in the jaw fails to heal after minor trauma, such as a tooth extraction, causing the bone to be exposed. The exposure eventually can lead to infection and fracture, and may require long-term antibiotic therapy or surgery to remove the dying bone tissue. Prolonged Use of Bisphosphonates Causes ONJ The chief of the Division of Oral and Maxillofacial Surgery at LIJ, Salvatore Ruggiero, DMD, MD, and his staff reported that they were struck by the appearance of a cluster of cancer patients with necrotic lesions in the jaw, a condition they previously saw only rarely -- in one to two patients a year. When they launched a study of patients’ charts, they found that 63 patients diagnosed with this condition over a three-year period shared only one common clinical feature: They had all received long-term bisphosphonate therapy. Bisphosphonates commonly are used in tablet form to prevent and treat osteoporosis in post-menopausal women. Stronger forms are used widely in the management of advanced cancers [...]

3/5/2005 FDA Advisory Committee (www.fdaadvisorycommittee.com) Advanced Magnetics’ Combidex safety and efficacy data are insufficient for approval of a broad indication in metastatic lymph node detection, FDA’s Oncologic Drugs Advisory Committee concluded. The committee voted 15 to 4 that the data presented by Advance Magnetics do not support approval of the proposed Combidex indication. Advanced Magnetics is seeking an indication for Combidex (ferumoxtran-10) in the “differentiation of metastatic and non-metastatic lymph nodes in patients with confirmed primary cancer who are at risk for lymph node metastases.” “I really wanted to vote for this drug today,” committee member Otis Brawley (Emory University) said, but the safety and efficacy of Combidex is “not proven.” Committee member Michael Perry (University of Missouri) agreed, saying that he is “not yet convinced that it is effective.” The committee’s major concerns involved design and analysis of the pivotal Combidex trials. Committee member Gregory Reaman (Children’s National Medical Center) said that Combidex is one of the “most exciting agents we have had the opportunity to review”; however, the “data are some of the least satisfactory in study design.” In theory, lymph node imaging could obviate the need for biopsies. However, FDA pointed out in its briefing materials for the meeting that the agent’s near 20% false negative rate means that Combidex-enhanced magnetic resonance imaging cannot be used to replace biopsy. The size of the studies and the number of lymph nodes included in the primary efficacy analysis for Combidex were too small to support approval of the broad [...]

3/4/2005 Fort Myers, FL Jeff Horrigan Boston Herald (bostonherald.com) At first glance, the change of appearance that Terry Francona has undergone this spring seems subtle. Those who pass the Red Sox manager during his second preseason in charge of the defending World Series champions might be inclined to do a double-take as they try to figure out the difference. His weight basically remains the same, he still dons a ubiquitous nylon jacket and he frankly doesn't have enough active follicles to change his hairstyle. Even though the change may have to be pointed out, the alteration in Francona's appearance is huge and, potentially, the most important one he could ever make. When the 45-year-old pulled on his uniform for the first time last month, he did so without an enormous wad of chewing tobacco planted in his cheek. After years of receiving disgusted glares and belittling letters, Francona finally heeded the advice of doctors and trainers, and acquiesced to the pleas of his family and is making an all-out effort to quit the habit. "My children hate it when I chew," he said. "They've asked me a lot of times not to do it and that's probably one of the biggest reasons I'm doing it, out of respect for them." Francona said that he rarely chewed tobacco during his playing career but he began doing so with regularity when he began managing in the minor leagues in 1992. The practice was popular throughout baseball for nearly a century but revelations [...]

3/3/2005 New Delhi, India Tribune de Genève (Geneva Tribune) India, which accounts for one-sixth of tobacco illnesses worldwide, faces an uphill battle to crack down on the use of the product as a global anti-smoking treaty takes effect, officials say. India, one of the early ratifiers of the tobacco control measure that came into operation last weekend, has already passed a law to tackle tobacco use in the country where 2,200 people die daily from tobacco-related diseases. But the government has found it tough going to implement the legislation that includes measures banning smoking in public places. "Only a holistic approach can work. The campaign should combine coercive methods with education," said Sajeela Maini, president of the Tobacco Control Foundation of India. At the moment people in the country of over one billion flout the law, smoking nearly everywhere they please. Shopowners have also paid little heed to the law forbidding them from selling tobacco products near schools. Authorities have been relying on an overstretched police force to enforce the anti-tobacco legislation which contains fines of 200 rupees (4.50 dollars) for smoking in public places, a sizeable sum in a country where up to 400 million people live on less than a dollar a day. But with corruption rampant and major crimes to tackle, cracking down on tobacco miscreants has been low on the police's priorities. So for the moment, the main thrust is educational. "Our plan is to focus on information, education and communication with the help of social [...]

3/2/2005 Ivanhoe Newswire (www.ivanhoe.com) A new report in this week’s issue of The Lancet offers more evidence that the tobacco industry tried to influence research on the effects of secondhand tobacco smoke. According to the authors, cigarette companies teamed up in the late 1980s to support the establishment of a new organization called the International Society of the Built Environment. One of the chief purposes of the new organization was to publish a journal, Indoor and Built Environment, aimed at investigating indoor air quality. Over the years, the organization’s executive officers and the journal’s editorial board have been dominated by paid consultants to the tobacco industry. A study of 484 papers published in the journal from January 1992 through February 2004 reveals 40 out of the 66 articles that dealt with the issue of environmental tobacco smoke reached conclusions considered favorable to the tobacco industry. Among this group, 90 percent were authored by at least one scientist with a history of ties to cigarette companies. The authors conclude, “On the basis of the evidence presented in this paper, there is a serious concern the tobacco industry may have been unduly influential on the content of the journal.” Failing to declare these ties to the industry, continue the investigators, constitutes a clear breach of the International Committee of Medical Journal Editors guidelines. Source: The Lancet, 2005;365:804-809

3/2/2005 New York, NY Dr. Jana Rieger Arch Otolaryngol Head Neck Surg 2005;131:140-145 A technique of transferring the submandibular gland, known as the Seikaly-Jha procedure (SJP), improves the xerostomia that occurs after radiation therapy for head and neck cancer, according to Canadian researchers. Moreover, the surgery promotes more efficient swallowing. "This efficiency has implications for the overall well-being and nutritional status of patients with head and neck cancer," lead author Dr. Jana Rieger, from Misericordia Community Hospital in Edmonton, and colleagues note in February issue of the Archives of Otolaryngology: Head and Neck Surgery. The findings are based on a study of 24 patients who were treated with surgery and radiotherapy for oropharyngeal cancer. Of these subjects, 13 underwent SJP and had one submandibular gland preserved, whereas the remainder had none preserved.The SJP group had higher baseline and stimulated salivary flow rates than did the control group, the authors note. In addition, SJP-treated patients moved a test bolus through the oral cavity into the pharynx faster than control patients and swallowed less often per bolus. In addition, the complete swallowing sequence took about twice as long in controls.Thus, the authors conclude, the results suggest that SJP is a useful method of preventing xerostomia in patients treated for head and neck cancer, producing benefits in salivary flow rate as well as swallowing behaviors.

3/2/2005 R. Scott Reedy Pembroke Mariner on Townline.com Red Sox Nation can relax. Yogi Berra may be a New York Yankees legend, but "Nobody Don't Like Yogi" - the play about his life opening next week at Boston's Wilbur Theatre after a successful off-Broadway run - covers more than just the time Berra spent in the dreaded pinstripes. "The piece deals with Berra's relationship with George Steinbrenner, of course, but it is also about Yogi's relationship with his family and the deep love he feels for his wife, his children and his grandchildren," explained Ben Gazzara, who portrays the basesball legend, recently from his Manhattan home. "It's a personal portrait and it's funny, of course, but also very touching. It doesn't rely on 'Yogisms' like 'You can observe a lot by watching,' or 'Ninety percent of the game is half mental,' to fill the evening, although there are plenty of them in the script. It is really a play about the human condition" Written by Thomas Lysaght and directed by Paul Linke, "Nobody Doesn't Like Yogi" celebrates its namesake's humor, loyalty and wisdom as the most quotable athlete of our time reflects on his life and extraordinary career. Gazzara, who originated the role of Brick in "Cat on a Hot Tin Roof" on Broadway 50 years ago this month and has been a high-profile working actor ever since, plays Berra in 1999 on the occasion of the Hall of Famer's return to Yankee stadium after a 14-year self-imposed exile. Team [...]