FDA’s tobacco regulation draft proposal weakened by the White House

Author: Toni Clarke and Sharon BegleySource: huffingtonpost.com  WASHINGTON, June 25 (Reuters) - White House changes to proposed rules for tobacco products significantly weakened language detailing health risks from cigars and deleted restrictions that might have prevented online sales of e-cigarettes, published documents show. The White House's Office of Management and Budget (OMB), which analyzes the potential economic consequences of proposed regulations, deleted language in the U.S. Food and Drug Administration's recently proposed regulations describing how the rules would keep thousands of people from taking up cigar smoking and have enormous public health benefits. The OMB also weakened language detailing the FDA's concerns about the safety of e-cigarettes, according to documents published Tuesday in the Federal Register. Emily Cain, a spokeswoman for OMB, said that as with any rule, OMB's office of information and regulatory affairs conducted an interagency review process "to ensure that the regulations through which agencies implement policies are efficient, well-designed to achieve their objectives, and based upon the best available evidence." "It is routine for agencies to make changes to their draft rules during the course of OMB review," she added. "The goal is to maximize the effectiveness and benefit of the rules we complete." An FDA spokeswoman, Jennifer Haliski, said the FDA does not comment on changes to a proposal during the review process but said the period for the public to comment on the proposal is still open until Aug. 8. "All comments will be carefully considered as the final rule is being developed," she said in [...]

2014-06-25T12:26:37-07:00June, 2014|Oral Cancer News|

Scientists say that E-Cigarettes and Snuff are not harmless

Author: Eliza GraySource: time.com New research casts doubt on nicotine's safety—even if you aren't smoking New research from the American Heart Association journal Circulation shows that patients who stopped using smokeless tobacco after a heart attack had improved life expectancy—similar to that of people who quit smoking. The finding offers new information about the dangers of smokeless tobacco, the risks of which are not as well understood as cigarettes’. “That was a big surprise for us,” said Dr. Gabriel Arefalk, lead researcher and a cardiologist at Uppsala University Hospital in Uppsala, Sweden. “For smoking, it has been known for decades now that people benefit from discontinuation, especially after having suffered a heart attack, but for snus we had no idea what to expect. ”The researchers reviewed data on 2,474 heart attack survivors under 75 in Sweden who used snus (oral snuff) from 2005 to 2009. About 675 quit. During the two years of follow-up, 69 of those who continued using snus died, compared with only 14 quitters. Based on this data, researchers determined that those who quit snus had almost half the mortality risk of those who didn’t quit, which is similar to the benefit of smoking cessation, according to a release from the American Heart Association. Dr. Arefalk, who is also a clinician, said the researchers wanted to study the problem because they didn’t know what to tell patients about the risks of using snus after a heart attack. He cautioned that the study was small and far from enough to [...]

2014-06-25T11:44:46-07:00June, 2014|Oral Cancer News|

Lower radiation dose may be given to HPV-positive head and neck cancer patients

Source: Vanderbilt UniversityPublished: June 19, 2014By: Dagny Stuart  A new study suggests that lowering the dose of radiation therapy for some head and neck cancer patients may improve outcomes and cause fewer long-term side effects. The research was presented by lead author Anthony Cmelak, M.D., professor of Radiation Oncology at Vanderbilt-Ingram Cancer Center, during the 50th annual meeting of the American Society of Clinical Oncology (ASCO), held May 30 to June 3 in Chicago. The study focused on patients with newly diagnosed oropharyngeal cancers related to the human papilloma virus (HPV). More than two-thirds of new head and neck cancer patients have HPV-positive tumors and the number of these patients is on the rise. Cmelak’s prior study found that patients with HPV-positive oropharyngeal cancer have significantly longer survival rates than patients whose tumors are HPV negative. For the new study, 80 HPV-positive patients with stage III, or IVa,b squamous cell cancer of the oropharynx received induction chemotherapy, including paclitaxel, cisplatin and cetuximab. After chemotherapy, 62 of the patients showed no sign of cancer and were assigned to receive a 25 percent lower dose of intensity-modulated radiation therapy (IMRT) — an advanced technology that targets the radiation beam more accurately to treat the tumor without harming surrounding tissue. The rest of the patients received a standard IMRT dose. The drug cetuximab was also given to both groups of patients along with the IMRT treatment. Two years after treatment, the survival for the low-dose IMRT patients was 93 percent. Those who did [...]

2014-06-20T12:41:01-07:00June, 2014|Oral Cancer News|

Tony Gwynn’s untimely death, baseball contemplates issues with tobacco

Source: USA TODAYPublished: June 20, 2014By: Jorge L. Ortiz, USA TODAY Sports  OAKLAND – Tony Gwynn's multitude of accomplishments, career batting average of .338 and his pioneering use of video earned him the rapt attention of players whenever he talked baseball. Major League Baseball hopes an even more important message he's delivering posthumously sinks in as well. Gwynn, who died of mouth cancer Monday at 54, speaks out against smokeless tobacco use in a taped segment of an informational video MLB is producing and plans to release this season. The Hall of Fame outfielder believed he developed cancer because of his years-long habit of using spit tobacco, although that was never medically confirmed. Whether Gwynn's untimely death and his stance against smokeless tobacco will curtail its use among players remains an open question. Research by the Pro Baseball Athletic Trainers Society revealed the number of major leaguers who use spit tobacco has declined from about 50% to 33% in the last 20 years. However, that's still about 10 times the amount in the general population, according to the American Cancer Society, whose data from 2012 showed 3.5% of Americans 12 and older – or 9 million – use the highly addictive product. "It's definitely ingrained and something that's part of our baseball culture, but it's not exclusive to baseball,'' said Oakland Athletics first baseman Brandon Moss, a non-user. "You would hope a figure like (Gwynn), something tragic like that happening, would be a wake-up call for everyone, not just those [...]

2014-06-20T12:19:11-07:00June, 2014|Oral Cancer News|

Gwynn’s death sparks dip debate

Source: www.trentonian.com Author: Nick Peruffo The death of San Diego Padres icon Tony Gwynn due to oral cancer Monday resonated across the baseball world — including the Trenton Thunder clubhouse. In addition to being a person tragedy for the Gwynn family, the news also put a renewed focus on the use of chewing tobacco in baseball. Officially, tobacco in any form has been banned in the minor leagues since 1993. If caught with chewing tobacco on the field, players face a $300 fine, while managers are docked $1,000. Away from the field, however, it is clear that some players continue to dip. “There are so many guys that do it,” said catcher Tyson Blaser, who does not use chewing tobacco. “It’s very common in the major leagues, and even though obviously in the minor leagues you are not supposed to do it, some people don’t adhere to that. To see an icon like (Gwynn) lose his battle with cancer because of a habit a lot of people do, I assume it’d be eye opening to some people.” Gwynn, who was just 54, blamed his cancer on dipping tobacco. Despite that, manager Tony Franklin conceded that while the coaching staff does its best to dissuade players from using, what they do on their own time is ultimately their own decision. “We encourage them not to do it, but they are adults with choices to make,” Franklin said. “The choices they make could be very beneficial and save their lives, so we [...]

Long term cerebral and vascular complications after irradiation of the neck in head and neck cancer patients: a prospective cohort study: study rationale and protocol

Source: 7thspace.com Author: staff Successful treatment options for cancer result in more young long-term survivors prone for long-term complications. Carotid artery vasculopathy is a potential long-term complication after radiotherapy of the neck, resulting in cerebrovascular events and probably deficits in cognitive and motor functioning. Better insight into the underlying pathofysiology of radiotherapy induced carotid artery vasculopathy is needed for prognostic purposes and to develop preventive strategies. Methods: The current study is a prospective cohort study on the long-term cerebral and vascular complications after radiotherapy of the neck, in 103 patients treated for head and neck cancer, included in our study database between 2002 and 2008. Baseline protocol (before radiotherapy) included screening for cerebrovascular risk factors and intima media thickness measurement of carotid arteries by ultrasonography. Follow-up assessment more than 5 years after radiotherapy included screening of cerebrovascular risk factors, cerebrovascular events, neurological examination with gait and balance tests, extensive neuropsychological examination, self-report questionnaires, ultrasonography of the carotid arteries with measurement of intima media thickness and elastography, magnetic resonance imaging of the brain and magnetic resonance angiography of the carotid arteries.DiscussionThe current study adds to the understanding of the causes and consequences of long-term cerebral and vascular changes after radiotherapy of the neck. These data will be helpful to develop a protocol for diagnostic and preventive strategies for long-term neurological complications in future head and neck cancer patients with anticipated radiotherapy treatment. Authors: Joyce Wilbers, Arnoud C Kappelle, Roy PC Kessels, Stefan CA Steens, Frederick JA Meijer, Johannes H Kaanders, Roy [...]

Hall of Famer and ‘Mr. Padre’ Tony Gwynn dies at 54 from Oral Cancer

Source: abcnews.go.comAuthor: Bernie Wilson Tony Gwynn could handle a bat like few other major leaguers, whether it was driving the ball through the "5.5 hole" between third base and shortstop or hitting a home run off the facade in Yankee Stadium in the World Series. He was a craftsman at the plate, whose sweet left-handed swing made him one of baseball's greatest hitters. Gwynn loved San Diego. San Diego loved "Mr. Padre" right back. Gwynn, a Hall of Famer and one of the greatest athletes in San Diego's history, died Monday of oral cancer, a disease he attributed to years of chewing tobacco. He was 54. "Our city is a little darker today without him but immeasurably better because of him," Mayor Kevin Faulconer said in a statement. In a rarity in pro sports, Gwynn played his whole career with the Padres, choosing to stay in the city where he was a two-sport star in college, rather than leaving for bigger paychecks elsewhere. His terrific hand-eye coordination made him one of the game's greatest pure hitters. He had 3,141 hits — 18th on the all-time list — a career .338 average and won eight batting titles to tie Honus Wagner's NL record. He struck out only 434 times in 9,288 career at-bats. He played in San Diego's only two World Series — batting a combined .371 — and was a 15-time All-Star. He had a memorable home run in Game 1 of the 1998 World Series off fellow San Diegan David [...]

2014-06-17T09:46:25-07:00June, 2014|Oral Cancer News|

FDA approve Lymphoseek to evaluate head and neck cancer

Source: www.medicalnewstoday.com Author: Catharine Paddock PhD The US Food and Drug Administration have given the OK for doctors to use Lymphoseek - a radioactive diagnostic imaging agent - to evaluate the spread of squamous cell carcinoma in the body's head and neck region. Lymphoseek (technetium 99m tilmanocept) Injection was approved by the Food and Drug Administration (FDA) in 2013 to help doctors identify lymph nodes closest to primary tumors in patients with breast cancer and melanoma. The receptor-targeted lymphatic mapping agent is marketed by Navidea, a biopharma company based in Dublin, OH. Identification of lymph nodes in cancer is important because they filter fluid that drains from tissue. If this tissue is cancerous then the fluid will contain cancer cells, and testing lymph nodes - via biopsy - for presence of cancer cells helps determine if the cancer has spread. The approval of Lymphoseek for use in head and neck cancer patients means doctors will be able to use the agent to guide testing of sentinel nodes - lymph nodes closest to a primary tumor - allowing for the "option of more limited lymph node surgery in patients with sentinel nodes negative for cancer," say the FDA. In a clinical trial, researchers found that "Lymphoseek-guided sentinel lymph node biopsy accurately determined if the cancer had spread through the lymphatic system." Dr. Libero Marzella, director of the Division of Medical Imaging Products in the federal agency's Center for Drug Evaluation and Research, says: "For some patients with head and [...]

Researchers bring oral cancer-fighting patch to patients

Source: medicalxpress.com Author: staff The Ohio State University and the University of Michigan have signed an exclusive worldwide agreement with Ohio-based Venture Therapeutics, Inc, to form a new company to develop and commercialize a pharmaceutical technology targeted for the treatment of precancerous oral lesions. These lesions are currently managed by invasive surgery and approximately a third of these lesions will reoccur after surgery. Previously published data shows that about 30 percent of the higher grade precancerous oral lesions progress to oral cancer, specifically oral squamous cell carcinoma. This type of cancer is particularly devastating to patients because treatment entails removal of facial and mouth structures essential for esthetics and function. The National Cancer Institute estimates that 42,440 Americans will be diagnosed with oral cancer and over 8,390 oral cancer related deaths will occur in 2014. The pharmaceutical technology developed by researchers at The Ohio State University (OSU) College of Dentistry with secondary appointments at the OSU Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James) and the University of Michigan addresses a significant unmet need related to the prevention of oral cancer. Precancerous oral lesions can be seen and touched by patients, so this easy access to the lesion allows the use of local delivery formulations in an oral patch to directly treat the disease without causing adverse side effects. "This type of collaboration, involving multiple university partners with strong industry support, is increasingly essential to expedite the discovery, development and [...]

Grateful Dead guitarist plays concerts with tribute band to benefit the Oral Cancer Foundation

Source: truebluetribune.com Author: staff Mark Karan, former lead guitarist for the post Grateful Dead band, The Other Ones, and Joe Pulitano, drummer for the Grateful Dead tribute band, Deadbeat, who are both stage IV oral cancer survivors, recently teamed up to play three benefit concerts in the North East to raise money for the Oral Cancer Foundation and the Dana Farber Cancer Institute. Following Deadbeat’s benefit performances this spring, with Mark playing guest guitar, the two men donated $7,500 of the concert proceeds to the Oral Cancer Foundation to support the organization’s research, advocacy, and educational efforts. What’s interesting is how these two talented musicians, who did not know each other before their individual encounters with this deadly disease, came together. Like many who find themselves dealing with oral cancer, Joe had complained for 14 months to his doctor about voice change, shortness of breath when speaking, and a sore throat. He was eventually diagnosed with stage IV head and neck cancer. Years before Mark’s diagnosis with oral cancer, and after Jerry Garcia’s death, he was chosen to share his lead guitar slot with Steve Kimock in the Other Ones. Just two years ago, while laying in a hospital bed, Mark asked his wife to hand him his guitar and a piece of paper. Twenty minutes later, “Walk Through Fire” was written, a song about his personal resolve, humility, acceptance, courage and lessons learned in his brush with the life-threatening disease. “It was one of those songs you hope for, [...]

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