Update FDA seeks more Erbitux data on head and neck cancer

Source: www.reuters.com Author: Ransdell Pierson U.S. regulators have declined to approve use of Erbitux as a first-line treatment for head and neck cancer until a new U.S. animal study is conducted showing how the medicine is absorbed by the body, drugmakers Eli Lilly and Bristol-Myers Squibb said on Monday. Lilly and Bristol-Myers had asked the U.S. Food and Drug Administration to approve first-line use of Erbitux based on favorable head and neck cancer data from overseas studies conducted by German drugmaker Merck KGaA. Merck sells Erbitux outside the United States. Lilly separately makes Erbitux and sells it in the United States in partnership with Bristol-Myers. The FDA wants an additional study to ascertain that both batches of Erbitux have the same pharmacokinetic profile, meaning the drug is absorbed in the bloodstream in similar fashion and amounts, said Lilly spokeswoman Judy Kay Moore. "They want an additional preclinical trial to study comparability" of Erbitux batches, Moore said. Lilly and Bristol-Myers recently withdrew their U.S. application to market Erbitux for advanced non-small cell lung cancer because of the same need to confirm comparability of batches made in different plants. "Essentially we will do one animal study and that will answer the pharmacokinetic comparability questions related to first-line treatment for both head and neck and lung cancer," Moore said. Lilly hopes to refile the lung cancer marketing application in the second half of 2009, Moore said. She said the company does not need to refile its application for first-line treatment of head and [...]

The selling of tobacco to children

               Source: Examiner.com Writer: Jan Potter  Recent news articles have complained of recent marketing trends by the tobacco marketing women and girls. The cigarettes come packaged in an attractive and enticing pink package. This is not new, but every year, it appears that tobacco companies spend more and more money trying to draw in new smokers with these attractive packages.  For years, many people were upset by candy cigarettes that were sold to children as “pretend.” These have almost disappeared in many markets, but there is a new problem though and that is the marketing of tobacco “drops” or other products that look exactly like candy. Parent may not even realize that the package contains a tobacco product because of its appearance. The marketing of this “candy” and other related products is considered very dangerous for children because of the friendly appeal of the packaging. This kind of product comes as small “candy” sized pieces, as “film” strips, or as toothpick sized sticks. Another product that has been around for several years is the tobacco “snus” (which rhymes with goose). Snus generally contain more nicotine than a cigarette but some consider them safer because they are not inhaled. They are, however, addictive. The snus is a small packet of tobacco powder meant to be put under the tongue. It is believed that they are dangerous because of the impact of the tobacco on the body. It might not mean lung cancer, but there is the [...]

2009-03-02T10:56:08-07:00March, 2009|Oral Cancer News|

Calcium intake may protect against cancer

Source: Author: Laurie Barclay, MD & Hien T. Nghiem, MD Calcium intake may protect against cancer, particularly gastrointestinal tract cancer, according to the results of a prospective study reported in the February 23 issue of the Archives of Internal Medicine. "Dairy food and calcium intakes have been hypothesized to play roles that differ among individual cancer sites, but the evidence has been limited and inconsistent," write Yikyung Park, ScD, from the National Cancer Institute in Bethesda, Maryland, and colleagues. "Moreover, their effect on cancer in total is unclear." In the National Institutes of Health-AARP (formerly known as the American Association of Retired Persons) Diet and Health Study, the investigators evaluated the association of dairy food and calcium intakes with incidence of total cancer and cancer at individual sites. A food frequency questionnaire was used to determine intakes of dairy food and calcium from foods and supplements. Linkage with state cancer registries allowed identification of incident cancer cases. Relative risks and 2-sided 95% confidence intervals (CIs) were determined with a Cox proportional hazard model. During follow-up (average, 7 years), 36,965 cancer cases were identified in men and 16,605 in women. In men, calcium intake was not associated with total cancer. However, calcium intake was nonlinearly associated with total cancer in women, with the risk decreasing up to approximately 1300 mg/day but with no further risk reduction above those levels. Dairy food and calcium intakes were inversely associated with cancers of the digestive system in both men and women. Multivariate relative risk [...]

RF ablation linked to improved liver cancer survival

Source: www.medscape.com Author: David Douglas Pooled data from a review of randomized trials of percutaneous ablation therapies in hepatocellular carcinoma indicates that a radiofrequency (RF) approach offers a survival advantage, Korean researchers report in the February issue of Hepatology. Lead investigator Dr. Yun Ku Cho told Reuters Health, "Recent studies comparing RF ablation and percutaneous ethanol injection revealed no consistent survival benefit of RF ablation over percutaneous ethanol injection for patients with hepatocellular carcinoma." However, he explained, "By performing a systematic review and meta-analysis of randomized trials, we demonstrated that RF ablation showed an improved 3-year overall survival status for patients with small hepatocellular carcinomas, compared to percutaneous ethanol injection." Dr. Cho of Seoul Veterans Hospital and colleagues analyzed data from 4 trials involving 652 patients. The pooled results showed that RF ablation was in fact significantly superior to the ethanol technique, which was associated with an odds ratio for 3-year survival of 0.477. Nevertheless, the researchers point out that in these studies the number of patients involved was insufficient to determine initial tumor response, and there was "no real consensus regarding the definition of major adverse events. Therefore, quantitative analysis could not be performed for the local tumor progression or adverse events." Source: Hepatology 2009;49:453-459.

Pharmaceuticals, patents, publicity…and philanthropy?

Source: The Lancet, Volume 373, Issue 9665, Page 693, 28 February 2009 Author: editorial staff Tensions between provision of and payment for health care are familiar. Though doctors assume principal responsibility for patients' health, those who work for pharmaceutical companies view the patented medicines they design as key components of health care. Creative ways are continually found to make such drugs available to as many patients in high-income countries as possible, the profits contributing to future investment in development and leaving national drug budgets affordable, just. Yet, a few hours' flying away, patients in developing countries usually have no access to these very same patented drugs. GlaxoSmithKline (GSK) has grown in size and influence by successful drug development, timely takeovers, and shrewd management. Andrew Witty, who ascended to the vertiginous position of chief executive at GSK in the past year, has attracted attention by a surprising presentation at Harvard Medical School on Feb 13. He promises that GSK will now not only make its medicines available much more cheaply to patients in low-income countries, but also make a bolder commitment to research into neglected diseases. As one blogger puts it, “arise Sir Andrew Witty (or is it Saint Andrew?)”. Does this announcement mark a sea change in pharma's attitude to the provision of drugs in poor countries, or could it be more reminiscent of the zany hybrid vehicles that distract attention from car manufacturers' shamelessly polluting stock in trade? Witty's words were carefully weighed to cast a rosy glow around [...]

Genetic signatures of HPV-related and unrelated oropharyngeal carcinoma and their prognostic implications

Source: Clinical Cancer Research 15, 1779, March 1, 200 Author: Jens P. Klussmann et al. Purpose: Patients with human papillomavirus (HPV)-containing oropharyngeal squamous cell carcinomas (OSCC) have a better prognosis than patients with HPV-negative OSCC. This may be attributed to different genetic pathways promoting cancer. Experimental Design: We used comparative genomic hybridization to identify critical genetic changes in 60 selected OSCC, 28 of which were associated with HPV-16 as determined by HPV-specific PCR and fluorescence in situ hybridization analysis and positive p16INK4A immunostaining. The results were correlated with HPV status and clinical data from patients. Results: Two thirds of OSCC harbored gain at 3q26.3-qter irrespective of HPV status. In HPV-negative tumors this alteration was associated with advanced tumor stage (P = 0.013). In comparison with HPV-related OSCC, the HPV-negative tumors harbored: (a) a higher number of chromosomal alterations and amplifications (P = 0.03 and 0.039, respectively); (b) significantly more losses at 3p, 5q, 9p, 15q, and 18q, and gains/amplifications at 11q13 (P = 0.002, 0.03; <0.001, 0.02, 0.004, and 0.001, respectively); and (c) less often 16q losses and Xp gains (P = 0.02 and 0.03). Survival analysis revealed a significantly better disease-free survival for HPV-related OSCC (P = 0.02), whereas chromosome amplification was an unfavorable prognostic indicator for disease-free and overall survival (P = 0.01 and 0.05, respectively). Interestingly, 16q loss, predominantly identified in HPV-related OSCC, was a strong indicator of favorable outcome (overall survival, P = 0.008; disease-free survival, P = 0.01) and none of these patients had a [...]

Experts in government, public health, public policy and science outline blueprint for reducing death and disease from tobacco in the United States

Source: Bulletin Board of Oral Pathology Author: Dorothy Hatsukami et al. To further the goal of eliminating smoking as the number one cause of preventable disease and death in the U.S., twenty six of the nation's leading tobacco control researchers and policy experts today called for regulatory control of all tobacco products. They also called for policies that encourage current tobacco users to reduce their health risks by switching from the most to the least harmful nicotine-containing products. This group of experts, who have devoted their careers to reducing tobacco use, met in a two-year process they called The Strategic Dialogue on Tobacco Harm Reduction (the Dialogue). Their vision: a world in which virtually no one uses cigarettes. Dialogue participants concluded that realizing that vision would have a profound impact on reducing death and disease from tobacco use. The Dialogue process was led by Dorothy Hatsukami, Ph.D., director of the University of Minnesota's Tobacco Use Research Center and Masonic Cancer Center's Cancer Control and Prevention Programs, and Mitchell Zeller, a former associate commissioner of the U.S. Food and Drug Administration and currently a health policy expert with Pinney Associates. The Dialogue members' recommendations appear in the online version (posted February 25) of the peer-reviewed journal Tobacco Control. Their report recommends various ways to regulate tobacco products based on public health needs. It also recommends helping tobacco users who are unable or unwilling to quit to shift to the least harmful nicotine products. Prominent among the group's recommendations are: Regulation of [...]

Chinese e-cigs gain ground amid safety concerns

Source: apnews.myway.com Author: Audra Ang With its slim white body and glowing amber tip, it can easily pass as a regular cigarette. It even emits what look like curlicues of white smoke. The Ruyan V8, which produces a nicotine-infused mist absorbed directly into the lungs, is just one of a rapidly growing array of electronic cigarettes attracting attention in China, the U.S. and elsewhere - and the scrutiny of world health officials. Marketed as a healthier alternative to smoking and a potential way to kick the habit, the smokeless smokes have been distributed in swag bags at the British film awards and hawked at an international trade show. Because no burning is involved, makers say there's no hazardous cocktail of cancer-causing chemicals and gases like those produced by a regular cigarette. There's no secondhand smoke, so they can be used in places where cigarettes are banned, the makers say. Health authorities are questioning those claims. The World Health Organization issued a statement in September warning there was no evidence to back up contentions that e-cigarettes are a safe substitute for smoking or a way to help smokers quit. It also said companies should stop marketing them that way, especially since the product may undermine smoking prevention efforts because they look like the real thing and may lure nonsmokers, including children. "There is not sufficient evidence that (they) are safe products for human consumption," Timothy O'Leary, a communications officer at the WHO's Tobacco Free Initiative in Geneva, said this week. The [...]

2009-02-28T06:32:42-07:00February, 2009|Oral Cancer News|

VELscope System Called the World’s Leading Oral Cancer Screening System

Source: LED Dental Inc Writer: John Pohl WHITE ROCK, British Columbia—February 27, 2009—LED Dental Inc. claimed today that its VELscope system is used for more oral cancer examinations than any other adjunctive technology in the world. Impressive Milestones Passed According to Dr. Ralph Green, president and CEO of LED Dental's parent, LED Medical Diagnostics, "Since our mid-2006 launch, we have sold over 4,000 VELscope systems worldwide. Based on an independent survey of VELscope users, we estimate that these devices have been used to conduct over 4 million VELscope exams to date." Dr. Green added, "What's more, we estimate that over 3 million additional VELscope exams will be conducted in 2009 alone. Based on sales information reported by our leading competitor, it is clear that their product is currently being used for a much lower number of exams." Powerful Supporting Research The tissue fluorescence visualization technology platform on which the VELscope system is based is the culmination of over $50 million in research funded by the National Institutes of Health and other respected institutions and conducted by such leading organizations as the British Columbia Cancer Agency and the University of Texas's M.D. Anderson Cancer Center. Translating this highly sophisticated, breakthrough technology for use in an efficacious device to examine the oral mucosa was the brainchild of LED Dental and the British Columbia Cancer Agency. Launched in 2006 as the first tissue fluorescence device made commercially available to the dental community, the VELscope system revolutionized the dental practitioner's ability to visualize the oral mucosal [...]

2009-02-27T20:19:09-07:00February, 2009|OCF In The News, Oral Cancer News|

Current status and perspectives of brachytherapy for head and neck cancer

Source: Int J Clin Oncol, February 1, 2009; 14(1): 2-6 Author: H Shibuya Brachytherapy delivers a high radiation dose to a limited volume while sparing surrounding normal tissues. In head and neck cancer, severe soft-tissue damage and bone damage to the mandible has decreased markedly since the introduction of computer dosimetry and the use of spacers during treatment. For the curative treatment of head and neck cancer, the selection of brachytherapy sources from among the several linear and small permanent implant sources available, not only according to the tumor site but also according to the patient's physical and mental condition is important. Following the successful treatment of early head and neck cancer by brachytherapy, two major problems and one minor problem may confront the physician. The major problems are neck node metastasis and a second primary cancer of the respiratory tract or upper digestive tract, and the minor problem is radiation-induced cancer. Author's affilation: Department of Radiology, Tokyo Medical and Dental University Hospital, 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan

2009-02-27T09:56:47-07:00February, 2009|Oral Cancer News|
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