GSK European Commission amends licence for Cervarix

By: GlaxoSmithKline Source: PharmPro GlaxoSmithKline (GSK) confirmed today that the European Commission has granted Marketing Authorisation to amend the licence for its cervical cancer vaccine, Cervarix®. The approval from the European Commission is important as it recognises the extent of cervical cancer protection demonstrated by Cervarix®, which was not highlighted by the previous indication. The licence amendment is supported by data from the largest efficacy trial of a cervical cancer vaccine conducted to date, the PATRICIA study, and acknowledges that Cervarix® has shown efficacy beyond HPV 16 and 18, the two virus types contained in the vaccine. The summary of product characteristics (SPC) for Cervarix® will be updated to include the prevention of precancerous lesions and cervical cancer causally related to certain strains of the human papillomavirus (HPV) and will reflect data showing efficacy against the two vaccine types contained in the vaccine (HPV 16 and 18) and the three next most common cancer-causing virus types (HPV 31, 33 and 45).* Together these five HPV types (16, 18, 31, 33 and 45) account for 80 percent of all cervical cancers. * Vaccine efficacy is different for each of the HPV types 16, 18, 31, 33 and 45, and varies in different cohorts and endpoints. GlaxoSmithKline Biologicals (GSK Biologicals), GlaxoSmithKline’s vaccines business, is one of the world’s leading vaccine companies and a leader in innovation. The company is active in vaccine research, development and production with over 30 vaccines approved for marketing and 20 more in development - both in the prophylactic and therapeutic fields [...]

2010-09-17T09:07:55-07:00September, 2010|Oral Cancer News|

Medicare expands coverage of tobacco cessation

By Mike Lillis Source: thehill.com The Obama administration on Wednesday expanded Medicare to cover more seniors hoping to kick their tobacco habits. "Most Medicare beneficiaries want to quit their tobacco use," Health and Human Services Department (HHS) Secretary Kathleen Sebelius said in a statement announcing the move. "Now, [they] can get the help they need." Under previous rules, Medicare covered tobacco-related counseling only for beneficiaries already suffering from a tobacco-related disease. Under the new policy, Medicare will cover as many as two tobacco-cessation counseling tries each year, including as many as four individual sessions per attempt. The move is the latest in a string of White House efforts to shift the nation's healthcare system toward prevention, in lieu of simply treating diseases after they've developed. If successful, the new tobacco policy could pay dividends. Of the 46 million Americans estimated to smoke, about 4.5 million are seniors older than 65, HHS says. And nearly 1 million more smokers are younger than 65, but eligible for Medicare benefits. They aren't cheap. Tobacco-related diseases are estimated to cost Medicare about $800 billion between 1995 and 2015. Donald Berwick, head of the Centers for Medicare and Medicaid Services, said the expansion lends seniors valuable help "to avoid the painful — and often deadly — consequences of tobacco use." The change affects Medicare Parts A and B — hospital care and physician services — but not Part D, which already covers smoking-cessation drugs for all beneficiaries.

2010-09-17T08:57:45-07:00September, 2010|Oral Cancer News|

Smokeless tobacco won’t help smokers quit

Source: www.webmd.com Author: Bill Hendrick Smokeless tobacco products -- whether chewed or used as dry or moist snuff -- may increase the risk of heart attack, fatal stroke and certain cancers, says a new policy statement published online in Circulation: Journal of the American Heart Association. "No tobacco product is safe to consume," Mariann Piano, PhD, lead writer of the policy statement and a professor in the department of behavioral health science at the University of Illinois at Chicago, says in a news release. The notion that smokeless tobacco may help reduce the rate of cigarette smoking is based in part on Swedish research, which showed a significant decline in smoking by Swedish men between 1976 and 2002 that corresponded with an increase in the use of smokeless tobacco. But in similar research in the U.S., the opposite was found to be true, the article says. There was no reduction in smoking rates among people who used smokeless tobacco products. Nicotine-Replacement Therapy Piano says that smokers trying to kick the habit might want to try nicotine-replacement therapy, by chewing nicotine gum or using a nicotine patch that can be attached to the skin, rather than using smokeless tobacco products. Piano tells WebMD that most people who use nicotine-replacement therapy do so for short periods of time, and it doesn't appear to be as addictive as smokeless tobacco "because of slower absorption, lower doses of nicotine, greater cost, lack of flavoring, sociocultural influences" or a combination of such factors. She says [...]

2010-09-14T09:06:26-07:00September, 2010|Oral Cancer News|

FDA sends e-cigarette companies a warning

Source: www.boston.com Author: staff The Food and Drug Administration is lighting a fire under the electronic cigarette industry to work with the agency to legally market the devices and is cautioning other companies that their sales and manufacturing practices violate federal law. The FDA said yesterday it sent warning letters to five companies that make e-cigarettes or components for the plastic and metal devices that heat a liquid nicotine solution in a disposable cartridge, creating vapor that the smoker inhales. In the letters, the FDA said the companies are violating the Federal Food, Drug and Cosmetic Act, including unsubstantiated claims and poor manufacturing practices. The FDA is asking the companies to let the agency know within 15 business days how it plans to correct the violations. The other companies receiving warning letters were E-CigaretteDirect LLC of Colorado, Ruyan America Inc. in Minneapolis, Gamucci America in Florida, and Johnson Creek Enterprises LLC of Wisconsin. But in a letter to the Electronic Cigarette Association, the FDA said the actions were not meant to be seen as a larger effort to ban e-cigs. It urged the industry group to work with the FDA to ensure the safety and effectiveness of the devices to help people quit smoking traditional cigarettes through usually expensive clinical trials. “We are interested in finding out whether e-cigarettes can be proven safe and effective,’’ said Michael Levy, FDA compliance lawyer.

2010-09-13T09:02:45-07:00September, 2010|Oral Cancer News|

U.S. smoking rate hasn’t changed, CDC says

Source: www.latimes.com Author: Thomas H. Maugh II One in five Americans lights up regularly. If all states had prevention programs like those in California and Utah, 5 million fewer people would be smoking, the agency says. After 40 years of continual declines, the smoking rate in the United States has stabilized for the last five years, with one in every five Americans still lighting up regularly, the Centers for Disease Control and Prevention said Tuesday. Moreover, more than half of all children are exposed to toxic, secondhand smoke and 98% of those who live with a smoker have measurable levels of toxic chemicals in their blood stream, setting them up for future harm from cancer, heart disease and a variety of other ailments. "If you smoke and have children, don't kid yourself. Your smoke is harming your children," CDC Director Dr. Thomas R. Frieden said in a news conference. Using products marketed as being less harmful is no panacea, he added. "All cigarettes kill equally, and we know that light and low-tar cigarettes are no less likely to kill you." Despite the reduction in smoking over the last four decades, Frieden said, smoking remains the No. 1 cause of preventable deaths in the United States. Every year, an estimated 446,000 Americans die from smoking-related diseases. The good news is that some states are making progress in combating smoking. Utah has the lowest smoking rate at 10%, and California is second with a rate just below 13%, according to CDC figures. [...]

2010-09-13T08:07:11-07:00September, 2010|Oral Cancer News|

‘I like my odds’ against cancer, Michael Douglas says

By Donna Freydkin Source:USA TODAY NEW YORK— They don'tmake'em like Michael Douglas anymore. In this age of crass reality upstarts and pampered starlets, he's a movie star of the old school. And even in his third week of grueling radiation treatments for Stage IV throat cancer, Douglas is a gentleman first, making sure a guest is comfortable on the green sofa in his family room and apologizing repeatedly for being a little off his game after a particularly brutal radiation session this morning. He hasn't pondered the meaning of life yet, or gone on any soul-searching journeys to faraway lands. "I like my odds. I'm not dealing with mortality issues until they tell me, 'Oops, we have to go back and do surgery' or something like that," Douglas says. "The tumor is shrinking. The odds are good." He pauses a beat, smiles, and takes a sip of the aloe-infused water he's drinking to soothe his throat. "I haven't found God yet." There's no woe-is-me self-pity as Douglas manages to poke fun at his condition. "There's never a really great time for cancer, but this is one for the books," he cracks. "Actually I was doing really good, but today has not been great." It has been a doozy of a year for Douglas, 65, full of highs and staggering lows. After little-seen turns in 2009's Ghosts of Girlfriends Past and 2007's King of California, he earned positive reviews for playing a sleazy seducer in this year's intimate drama Solitary Man. [...]

2010-09-10T21:33:53-07:00September, 2010|Oral Cancer News|

Actor’s diagnosis puts spotlight on oral cancer

By: Donna Domino, Associate Editor Source: DrBicuspid.com Actor Michael Douglas' recent revelation that he has stage IV oropharyngeal cancer has highlighted the growing incidence of oral cancer, and experts say dentists can help stem the alarming increase of the disease by checking for it during routine examinations. “Tobacco is no longer the only bad guy.” — Brian Hill, executive director, Oral Cancer Foundation The actor's cancer includes a walnut-sized tumor at the base of his tongue, and he will require radiation therapy, chemotherapy, and surgery. Douglas says his doctors told him he has an 80% survival rate if it hasn't spread to his lymph nodes. While tobacco was the prime cause of oral cancer in the past, recent studies have attributed the steady increase of the disease to the human papillomavirus (HPV). There are approximately 130 versions of HPV but only nine cause cancers, and the HPV16 version causes almost half of the oral cancers in the U.S., said Brian Hill, executive director of the Oral Cancer Foundation. "Tobacco is no longer the only bad guy," he told DrBicuspid.com. “HPV16 is increasing in incidence as the causative etiology, and if it continues on this trend line, it will replace tobacco as the primary cause of oral cancers." Dentists can play a key role in catching the disease in its early stages if they check for it during examinations, Hill pointed out. "But many dentists think it's such a rare disease that they don't bother to screen for it," he said. [...]

2017-03-29T19:08:30-07:00September, 2010|OCF In The News, Oral Cancer News|

Snus increases miscarriage risk drastically

Source: The Swedish Wire Author: Johan Nylander Women who use snuff tobacco face 60% higher miscarriage risk. A Swedish study by the Karolinska Institute and Uppsala University warned that women who uses snus are 60 percent more likely to misscarry than average. “Stillbirth is probably one of the worst things that can happen to parents who are expecting a baby. That also snus increases the risk of this underlines the importance of being complete tobacco-free when you are pregnant”, Anna-Karin Wikström at the Uppsala University Hospital Women's clinic told newspaper Upsala Nya Tidning. Snus, a moist powder tobacco product that you consume by placing it under the lip, is said to be much less dangerous than smoking. But to take up snus in order to quit smoking may be contra productive. A woman who smokes just a few cigarettes a day has 40 percent higher risk of miscarriage. "Taking the help of snus to quit smoking is a bad option to protect children", said Anna-Karin Wikström. The study, that was launched more than ten years ago, involved almost 570,000 women. The small, teabag-like pouches, also called moist snuff, are used by nearly one million Swedes. Placed under the user's lip, they quickly deliver a nicotine rush to the blood and a strong salt and herbs flavour in the mouth. While cigarette sales have tumbled by 50 percent in Sweden over the past 30 years, snus is on the up, with sales rising from some 2,500 tonnes a year in the 1970s to [...]

2010-09-07T10:08:20-07:00September, 2010|Oral Cancer News|

Organ preservation for advanced resectable cancer of the base of tongue and hypopharynx: a Southwest Oncology Group trial

Source: J Clin Oncol 23:88-95 Author: Susan G. Urba et al. Purpose: The Southwest Oncology Group designed a phase II trial for patients with base of tongue or hypopharyngeal cancer to evaluate the complete histologic response rate at the primary site after induction chemotherapy followed by chemoradiotherapy for responders. Secondary end points were the rate of organ preservation and the need for salvage surgery. Patients and Methods: Fifty-nine eligible patients were enrolled; 37 had base of tongue cancer, and 22 had hypopharynx cancer. Forty-two percent had stage III disease, and 58% had stage IV disease. Induction chemotherapy was two cycles of cisplatin 100 mg/m2 and fluorouracil 1,000 mg/m2/d for 5 days. Patients who had a greater than 50% response at the primary site were treated with radiation 72Gy and concurrent cisplatin 100 mg/m2 for three cycles. Patients with less than partial response at the primary had immediate salvage surgery. Results: Forty-five patients (76%) had a greater than 50% response at the primary after induction chemotherapy; 43 went on to receive definitive chemoradiotherapy. Thirty-two patients (54%) achieved a histologic complete response at the primary site, and an additional nine patients had a complete clinical response, but biopsy was not done. Seventy-five percent of patients did not require surgery at the primary tumor site. The 3-year overall survival was 64%. The 3-year progression-free survival with organ preservation was 52%. Conclusion: Patients with base of tongue or hypopharyngeal cancer treated with this regimen of induction chemotherapy followed by definitive chemoradiotherapy have a good [...]

2010-09-07T07:46:33-07:00September, 2010|Oral Cancer News|

More ’empowered’ patients question doctors’ orders

Source: www.usatoday.com Author: Mary Brophy Marcus In the past, most patients placed their entire trust in the hands of their physician. Your doc said you needed a certain medical test, you got it. Not so much anymore. Jeff Chappell of Montgomery, Ala., recalls a visit a couple of years ago to a Charlotte emergency room, near where the family used to live, with his wife, Jacqueline, who has adrenal failure. "I blew up loud enough for everyone in the ER to hear me explain that while we were insured, an MRI was about a $1,000 co-pay," Chappell says. The couple knew her symptoms well (primarily stomach pain), knew that an MRI was not necessary under the circumstances and knew that a cortisone shot was what she needed. "The doctor walked off in a huff," Chappell says, but later came back and "compromised" by agreeing to give his wife the shot, but not before taking an abdominal X-ray to rule out other problems first. Many physicians say an increasing number of patients are getting involved in decisions about their medical care, including medication choices, whether they need a specialist, and especially whether they need expensive diagnostic tests, which some health economists say are driving up the cost of health care. 'Shared decision model' "There have been big changes," says Patrick McManus, residency director of family and community medicine at Thomas Jefferson University in Philadelphia. "Some of my older patients are still more deferential, but more and more, we talk with patients [...]

2010-09-03T20:58:23-07:00September, 2010|Oral Cancer News|
Go to Top