Cigarette ads, packages must include oral cancer warnings, says FDA

Source: http://www.healthcanal.com/ Author: Craig Palmer, ADA News staff The Food and Drug Administration will require use of a “cancerous lesion on lip” image in cigarette advertising and packaging for its potential to motivate positive behavioral change, influence youth and young adults in particular and inform the public that cigarettes cause oral cancer. Flexing its regulatory muscle on the second anniversary of the Family Smoking Prevention and Tobacco Control Act, which was signed into law June 22, 2009, the FDA unveiled nine graphic health warnings to be placed on all cigarette packs, cartons and ads no later than Sept. 22, 2012. “The nine new health warning statements and the accompanying graphic images selected by FDA convey information that is factual and uncontroversial,” the agency said in the regulatory notice. The FDA simultaneously announced a public inquiry and request for comments on the public health impact of modified risk tobacco products sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products. The FDA scheduled a public forum Aug. 25-26 to obtain information on “the scientific issues associated with assessment and ongoing review of MRTPs.” These include smokeless and other products promoted as alternatives to cigarette smoking. The Association supported the 2009 tobacco control law, and has advised the FDA on using the law to shape public tobacco policy. “Dentists are the first line of defense in the war against oral cancer and many other tobacco-related diseases,” the Association told the FDA in [...]

Glowing Cornell Dots Target Cancer

SOURCE: Journal of Clinical Investigation, June 13, 2011 (Ivanhoe Newswire)-- New medical technology is showing that Cornell dots may be a potential cancer diagnostic tool. The U.S Food and Drug Administration (FDA) has recently approved the first clinical trial in humans using Cornell Dots- brightly glowing nanoparticles that can light up cancer cells in PET-optical imaging. Cornell Dots are silica spheres less than eight nanometers in diameter that enclose several dye molecules. To make the dots stick to tumor cells, organic molecules that bind to tumor surfaces, or even specific locations within the tumors, can be attached to a polyethylene glycol shell. This shell, also referred to as PEG, prevents the body from recognizing the dots as foreign substances. When exposed to near-infrared light, the dots fluoresce much brighter than dye to serve as a beacon identifying the target cells. Researchers say this technology enables visualization during surgical treatment. Cornell Dots were first developed in 2005 by Hooisweng Ow, a coauthor of the paper on this study and once a graduate student working with Ulrich Wiesner, Cornell Professor of Materials Science and Engineering. Ow and other researchers of this technology are currently in the process of forming a new commercial entity in New York City that will help transition this research into commercial products that will benefit cancer patients. Michelle S. Bradbury, M.D, of the Memorial Sloan-Kettering Cancer Center and an assistant professor of radiology at Weill Cornell Medical College, was quoted as saying, "This is the first FDA IND approved [...]

2011-06-15T11:14:48-07:00June, 2011|Oral Cancer News|

FDA to regulate cigarette pack labeling

Source: Dr.Bicuspid May 19, 2011 -- Cigarette manufacturers have deceived consumers about the risks of their products for years, and remedial actions are needed so consumers can make informed decisions about the products they purchase, according to researchers from the Roswell Park Cancer Institute (RPCI). The researchers evaluated the messages that cigarette pack labels convey to smokers and nonsmokers, and their findings will be published in three studies in an upcoming issue of the American Journal of Preventive Medicine (June 2011, Vol. 40:6, pp. 674-698). "Tobacco companies have used attractive packaging and persuasive images to market their products for decades," said lead author Maansi Bansal-Travers, PhD, a behavioral research scientist at RPCI, in a press release. "These studies support efforts by the [U.S. Food and Drug Administration] to regulate cigarette pack labeling." Tobacco manufacturers have effectively used cigarette pack design, colors, and descriptive terms to create the illusion that filtered and so-called light/mild cigarettes are safer than unfiltered and full-flavor cigarettes, when this is not the case. Beginning in June 2010, regulations contained in the Family Smoking Prevention and Tobacco Control Act have prohibited tobacco companies from using descriptive terms such as "light," "mild," or "low" in advertising and on cigarette packaging. "While the removal of these obviously misleading terms was a good first step, we discovered that cigarette manufacturers have circumvented the regulation by using different terms such as 'gold' and 'silver' and changing the colors on packs to continue to mislead consumers about their products," Bansal-Travers said. The [...]

Physicians Say Good Riddance to ‘Worst Drug in History’

Source: Medscape Today By: Allison Gandey An estimated 10 million patients have used the pain reliever propoxyphene and were sent scrambling to doctors' offices when it was recently pulled from the market. Many physicians are still dealing with the aftermath of the product, first approved by the US Food and Drug Administration (FDA) in 1957. "Propoxyphene is the worst drug in history," Ulf Jonasson, doctor of public health, from the Nordic School in Gothenburg, Sweden, told Medscape Medical News. The researcher played a role in the decision to stop the pain reliever in the United Kingdom, Sweden, and later in the entire European Union. "No single drug has ever caused so many deaths," Dr. Jonasson said. Clinicians are now prescribing analgesic alternatives to propoxyphene. Propoxyphene was banned in the United Kingdom 5 years ago because of its risk for suicide. It was taken off the market in Europe in 2009 over concerns about fatal overdoses and now in the United States for arrhythmias. "I agree that propoxyphene is among the worst drugs in history," Eduardo Fraifeld, MD, president of the American Academy of Pain Medicine, said in an interview. "I'm surprised it stayed on the market so long. It's addictive, in my experience not very effective, and toxic." "I'd probably add Demerol to the list too," Dr. Fraifeld said. "It's toxic and sedating, and my personal opinion is it should not be used at all." Also known as pethidine, Demerol was the first synthetic opioid synthesized in 1932 as a [...]

2011-02-07T12:51:33-07:00February, 2011|Oral Cancer News|

Star Scientific – filed application with U.S. FDA for approval to market a moist-snuff product

Source: snus-news.blogspot.com Author: staff Star Scientific, Inc. filed an application yesterday, February 2nd with the U.S. Food & Administration (FDA) for approval to market a moist-snuff product, Stonewall Moist-BDL™, as a modified-risk tobacco product (MRTP). The company believes that this is the first application filed with the FDA for approval of a tobacco product in a longstanding market segment. The data submitted in the application to the Center for Tobacco Products at FDA document TSNA levels in Stonewall Moist-BDL™ that are below limits of detection, or "BDL", by current standards of measure. Recent findings in the form of test results from an independent international laboratory validate the extraordinarily low levels in recently submitted samples of Stonewall Moist-BDL™, which the company believes are the lowest found anywhere in the world. The company pointed out that this application is particularly significant in two ways. First, moist snuff product sales accounted for roughly 75% of the total smokeless tobacco market in 2009. Moist snuff sales increased from 31,500 metric tons and $3.3 billion in 2004 to 37,990 metric tons and $4.64 billion in 2009 – an average annual growth rate of roughly 4%, and a 41% overall increase in sales over the six-year period. The moist snuff market segment has been well established for many decades, and is one of the oldest tobacco product categories in the United States. Second, tobacco-specific nitrosamine (TSNA) levels among the moist snuff products with the largest sales volume in 2009 averaged over 10,000 parts per billion in [...]

2011-02-06T08:36:25-07:00February, 2011|Oral Cancer News|

R.J. Reynolds Pulls Dissolvable Smokeless Products from Test Markets; Company Must Stop Pushing Tobacco Products that Entice Kids

Source: PR Newswire It is good news for the communities involved that R.J. Reynolds has decided to stop its initial test-marketing of new, dissolvable smokeless tobacco products – called Camel Sticks, Strips and Orbs – that look, taste and are packaged like candy and are likely to entice children. According to media reports and a letter RJR sent to customers, the company is pulling the products from the test markets of Columbus, Ohio, Indianapolis and Portland, Oregon, where the products have provoked outrage among public officials and the public. Unfortunately the company told the media that these products have been pulled only for potential redesign and may be test-marketed elsewhere in the future. We call on R.J. Reynolds to permanently pull these products and to stop its insidious marketing of tobacco products in ways that appeal to kids and seek to discourage smokers from quitting and keep them hooked on nicotine. The Camel dissolvable products appeal to children in that they are easily concealed and colorfully packaged, shaped and flavored to resemble mints or gum. These products also have been marketed as an alternative to cigarettes in the growing number of places where smoking is not allowed, which discourages smokers from quitting and truly protecting their health. One ad for these products states, "Enjoy Anywhere. Anytime. Anyplace." U.S. Sens. Sherrod Brown (D-OH) and Jeff Merkley (D-OR) took swift and laudable action by including a mandate that the Food and Drug Administration review the impact of these products on public health [...]

2010-12-22T10:51:57-07:00December, 2010|Oral Cancer News|

Real Cancer Drug Breakthrough Is Astronomical Prices

Source: Robert Langreth Blog In the wake of the FDA’s decision start the process to revoke Avastin’s approval in breast cancer last week, patients are puzzled and angry over how a drug once touted as a breakthrough  now can be branded as ineffective.  The controversy illustrates just how much the much-vaunted revolution in cancer therapy is driven by hype and high prices. Selling cancer drugs has become big business, with $52 billion in sales last year, according to IMS.  Some $6 billion of it goes right to Roche’s Avastin, the biggest selling of the new drugs. No wonder companies like Merck and Pfizer are  racing to develop new cancer drugs. But even as sales reach new heights, and prices keep going up–pretty much any cancer drug now costs $50,000 a year–the results from many trials are getting less and less impressive. Tarceva from Roche extends the life of pancreatic cancer patients by two weeks. Avastin has now failed to extend the lives of breast cancer patients in three giant trials. The hype about targeted cancer drugs has reached fever pitch thanks in part to baby boomers who don’t want to acknowledge their mortality; companies who need to sell hugely expensive drugs that can cost up to $100,000 a year; and science journalists eager for a positive story about a dread disease. The truth is that nobody wants to acknowledge the unpleasant fact that progress against most cancers has been grudgingly slow. Oncologists are in the business of providing hope to [...]

2010-12-21T13:56:53-07:00December, 2010|Oral Cancer News|

Hospital Performs Area’s First Robotic Surgeries on Oral Cancers HEALTH CARE: Technique Could Reduce the Length Of Patients Hospital Stay

Source: San Diego Business Journal By: Steve Sinovic The first transoral robotic surgeries in San Diego have been performed at Sharp Chula Vista Medical Center and all three patients who underwent those procedures are recovering well, said the surgeon who is leading up the effort to help patients beat early-stage oral cancer. Advances in robotic surgery prompted the hospital to look for ways to apply that technology to treat tumors of the mouth and throat. And thanks to a local benefactor, the institution hopes to be performing more procedures on local patients. The hospital is one of fewer than a dozen in the U.S. to offer the procedure, which was launched thanks to a $1.2 million anonymous donation to Sharp Chula Vista. The donation helped fund the acquisition of Intuitive Surgical Inc.’s da Vinci Surgical System, said Dan Dredla, vice president of business development for the 343-bed hospital in south San Diego County. “We were fortunate that a donor helped us purchase the da Vinci,” said Dredla. “It’s a costly system, and it was challenging to find the capital to acquire it on our own.” The da Vinci robot, which combines enhanced 3-D views with precise incision capabilities, is already being used for various surgeries at hundreds of hospitals throughout the country and around the world. However, it was just recently that the U.S. Food and Drug Administration approved using the da Vinci for the transoral surgeries, or TORS, procedures on head and neck cancers. While Dredla didn’t have exact [...]

2010-12-17T11:39:08-07:00December, 2010|Oral Cancer News|

When the state paid, people stopped smoking: study

Source: Reuters By: Maggie Fox When Massachusetts started paying for stop-smoking treatments, people not only kicked the habit but also had fewer heart attacks, researchers reported on Tuesday in the first study to show a clear payoff from investing in smoking prevention efforts. Smoking dropped by 10 percent among clients of Medicaid, the state health insurance plan for the poor, and nearly 40 percent of Medicaid patients who smoked used benefits to get nicotine patches or drugs to help them quit, the researchers said. The study -- which suggests states can save money from investing in efforts to cut smoking -- found the yearly rate of hospital admissions for heart attacks fell by 46 percent for Medicaid clients and 49 percent fewer of them were hospitalized for clogged arteries. "The dramatic decline in heart attack hospitalizations for smokers who used the benefit is stunning and demonstrates the effectiveness of tobacco treatment coverage that includes behavioral counseling and medicines approved by the Food and Drug Administration," American Heart Association CEO Nancy Brown, who was not involved in the research, said in a statement. Thomas Land and colleagues at the Massachusetts Tobacco Cessation and Prevention Program, as well as the Harvard Medical School, looked at hospital records for the study, published in the Public Library of Science journal PLoS Medicine. In July 2006, the Massachusetts Medicaid program, called MassHealth, began paying for drugs and other treatments to help smokers quit, including nicotine patches, gum and drugs. "Over 75,000 Medicaid subscribers used the [...]

2010-12-10T12:20:36-07:00December, 2010|Oral Cancer News|

Smokeless tobacco picking up steam — Products growing in popularity as smokers turn to cheaper and less obtrusive alternatives

Source: Los Angeles Times By: Julie Wernau Ron Carroll prefers to smoke cigars and pipes. But when he can't do that he says he manages to unobtrusively get his nicotine fix by slipping a packet of tobacco, about the size of a teabag, under his upper lip. "I use it all the time — movies, planes," said the Chicagoan, who adds that he likes the fact he can remove the packet as easily as a piece of gum. There's no chewing, spitting or mess, he says. "It's discreet, and you don't look like an addict, he said. "Smoking's definitely more about the flavor; the whole experience,'' Carroll said. "With this, it's just taking the edge off." Cigarette sales by volume have plummeted 17 percent from 2005, partly the result of health warnings and bans on smoking in public places as well as taxation by local and federal governments. And the heat on cigarette smokers is expected to intensify as the federal Food and Drug Administration requires images of corpses and diseased lungs to be featured on cigarette packs in two years. Smokeless tobacco products — which come in shapes ranging from toothpicks to orbs and in flavors from cherry to peach — so far have not met with the same intense scrutiny, although there have been some changes. In June, the FDA increased the size of warning labels on smokeless products. "This product is addictive" and "This product is not a safe alternative to cigarettes,'' say the warnings. Scientists say [...]

2010-12-07T12:42:38-07:00December, 2010|Oral Cancer News|
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