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 [...]

3/1/2005 Donna Shelley et al. Pediatrics Vol. 115 No. 3 March 2005, pp. 719-725 (doi:10.1542/peds.2004-0873) This Article Objective: The present study describes patterns of tobacco use counseling among physicians and dentists as reported by adolescents and determines the association between provider advice to quit and cessation activities among current smokers. Methods: Data were analyzed from the 2000 National Youth Tobacco Survey, an anonymous, self-administered, school-based survey. The National Youth Tobacco Survey was administered to a nationally representative sample of 35828 students in grades 6 to 12 in 324 schools. Results: Thirty-three percent of adolescents who visited a physician or a dentist in the past year reported that a physician counseled them about the dangers of tobacco use, and 20% reported that a dentist provided a similar message. Among students who smoked in the past year, 16.4% received advice to quit from a physician and 11.6% received advice to quit from a dentist. Physician or dentist advice to quit was correlated with 1 or more quit attempts in the past 12 months. Conclusion: On the basis of adolescent reports, physician and dentist practice patterns remain well below recommended guidelines. Results suggest that provider advice to quit is associated with cessation activity. Additional studies are needed to confirm whether the low prevalence of brief provider tobacco use counseling is a missed opportunity to affect adolescent smoking behavior. Authors: Donna Shelley, MD, MPH(1), Jennifer Cantrell, MPA(1), Dorothy Faulkner, PhD(2), Lyndon Haviland, DrPH(3), Cheryl Healton, DrPH(3) and Peter Messeri, PhD(1) Authors' Affiliations: (1)Sociomedical Sciences, [...]

3/1/2005 Providence, RI Karen Lee Ziner The Providence Journal (www.projo.com) Ronald Lizotte's treatment for tongue cancer put him through hell. At its worst, he was nearly drowning in mucus, raw lesions pocked his tongue and throat, and "swallowing anything was like consuming fire and glass." But Lizotte had never smoked, which made him wonder how he had acquired squamous cell carcinoma of the tongue, otherwise known as "smoker's tumor." Lizotte's doctors suspect secondhand smoke, from his father's two-to-three-pack-a-day habit. As this 56-year-old life-insurance salesman says, "This is what can happen to innocent bystanders." The Cranston resident was diagnosed with cancer in 1999 and this month celebrates his five-year anniversary of being cancer-free. He plans to testify in opposition to legislation that would create new exemptions to the smoking ban that takes effect tonight at midnight. A hearing on the bill has been postponed until later this month. "It makes me angry to know that people are not worried about lives," Lizotte says of House Bill 5020, sponsored by House Labor Chairman Joseph L. Faria, D-Central Falls. "They try to jump on the bandwagon of personal freedoms," Lizotte says. "But what about the people who don't smoke?" Why should they be subjected to smoke at their workplace, at restaurants or bars? he asks. Secondhand smoke "isn't just something a bunch of scientists dreamed up," says Lizotte in a speech he has written for his House testimony, on behalf of the American Cancer Society -- Rhode Island. "It makes people sick. It [...]

2/28/2005 David Brinn Israel21c (www.israel21c.org Most of us may suffer dry mouth from time to time. But for 80 million people in the developed world who suffer from the condition - technically known as xerostomia - it is a permanent condition caused by a lack of lubrication in the mouth Now an Israeli undertaking - under the project name Saliwell - has developed a removable device called the GenNarino that stimulate saliva production through electro-stimulation. "Our devices apply a low energy level of electricity to the right nerves that lead to a higher level of saliva secretion," explained Dr Andy Wolff, Saliwell project coordinator at Assuta Medical Centers in Israel. Xerostomia is defined as the subjective feeling of dry mouth and is frequently associated with a reduction in salivary glands function.. It's a chronic and mostly irreversible condition induced as a side effect by over 500 types of medication used to treat chronic diseases (like hypertension, depression, etc.), and by radiation therapy for head & neck cancer patients. Xerostomia also is a typical symptom of some auto-immune diseases (Sjögren?s syndrome is the most prominent) and other conditions. According to Wolff, salivary glands malfunction in the mouth for a number of reasons. These include diseases such as autoimmune diseases and diabetes, treatments like chemotherapy, radiation therapy or from the side effects of medication. Those who are afflicted have the condition for life. They endure the many unpleasant aspects of xerostomia. "It disturbs their speech, their swallowing, tasting," explains Wolff. "It wakes [...]

2/28/2005 H H Severson et al. Tobacco Control 2005;14:31-36 Objective: The use of smokeless tobacco (ST) (snuff and chewing tobacco) has long been associated with baseball in the USA. This article reviews six years of survey data from major and minor league baseball players to evaluate trends in tobacco use and quitting patterns over time in order to gain insight into the effects of past interventions and to document continued intervention needs. Method: Surveys were distributed by athletic trainers to major and minor league professional baseball players during spring training session in the six years from 1998 to 2003. The surveys were anonymous and identified only by team, level of league, and other self reported demographic data. Results: ST use among professional baseball players remains much higher than among young males in the general population, and use is most prevalent among white non-Hispanic players. There was a significant decrease in ST use among minor league players from 1998 to 2003, with seven day self reported use declining from 31.7% in 1998 to 24.8% in 2003. No significant year to year changes were observed for major league players. Major league players’ self reported past week use rates, estimated at 35.9% in 1998 and at 36% in 2003, were consistently higher than those of minor league players. Self reported prevalence of past month cigarette and cigar smoking was much lower than ST use for both major and minor league players. Conclusions: Six years of survey data confirm a continuing high use of [...]