FDA – Page 7 – Oral Cancer News

Experts: CT scans pose risks, need more regulation

Source: news.yahoo.com Author: Marilynn Marchione, AP Medical Writer From long-term cancer risks to radiation overdose mistakes, CT scans pose a growing danger to the American public and need more regulation to improve their safety, imaging experts write in a leading medical journal. The articles in Thursday's New England Journal of Medicine come a week after a story by The Associated Press detailed the overuse of imaging tests and how much the average American's radiation dose has grown in recent years. CT scans are super-sharp X-rays that have transformed medicine by helping doctors quickly diagnose or rule out injuries and diseases. But they use far more radiation than ordinary X-rays, and too much radiation raises the risk of cancer over time. The federal Food and Drug Administration and Congress are considering new measures to help prevent medical mistakes — relatively rare cases where some people are accidentally given radiation overdoses. However, far more people face potential long-term harm from ordinary scans that are done correctly but that are overused, repeated or simply unnecessary. Each year, 10 percent of the U.S. population gets a CT scan, and use of this imaging is growing more than 10 percent per year. "That's really the area we should focus on," said the author of one of the articles, Dr. Rebecca Smith-Bindman. She is a radiologist at the University of California at San Francisco on temporary leave to do radiation research at the National Cancer Institute. The FDA regulates scanning equipment, but lacks authority to say [...]

Oral Cancer Foundation News Team - A2010-06-27T10:30:46-07:00June, 2010|Oral Cancer News|

FDA to examine cigarette ingredients

Source: Health.com Author: Amanda Gardner MONDAY, JUNE 7 (Health.com) — If you want to know what’s in your TV dinner or Twinkies—a big if—all you need to do is look on the package. But if you smoke cigarettes and want to know what you’re inhaling, you’re out of luck. For years, tobacco companies have been lacing cigarettes with hundreds of chemicals and additives ranging from ammonia to cocoa, reportedly to heighten the kick of nicotine, improve flavor, and mask the harshness of smoke. Very little is known about the health effects of these ingredients, however, since the tobacco industry isn’t required to disclose them publicly or explain their purpose. The mystery may soon come to an end. On Tuesday, a Food and Drug Administration (FDA) advisory panel will meet to investigate what “harmful or potentially harmful” ingredients are in the more than 300 billion cigarettes smoked in the U.S. each year. After a second meeting this summer, the panel will provide a list of ingredients and recommendations to the FDA, which was granted the authority by Congress to regulate tobacco products in 2009. “Maybe with a new FDA ruling, companies will have to tell us what they put in these products and why,” says Norman Edelman, MD, the chief medical officer of the American Lung Association. “The concern is that these [ingredients] have health risks and we don’t really know what they are.” Sixty years ago cigarettes contained few additives. But as tobacco companies sought to reduce the levels of nicotine [...]

Charlotte Parker2010-06-09T12:38:21-07:00June, 2010|Oral Cancer News|

FDA tobacco regulator promises firm approach, open mind

Source: The Wall St. Journal Author: David Kesmodel WILLIAMSBURG, Va.—The top tobacco regulator at the Food and Drug Administration signaled to industry executives Monday that he would take a firm approach to overseeing the industry, but pledged to keep an open mind about new products and ideas to reduce tobacco-related illnesses. Dr. Lawrence Deyton, director of the agency's Center for Tobacco Products, said in a speech at an annual tobacco-industry conference here that his job "is to address this enormous toll of confusion, suffering and death caused by the current state of tobacco use in this country." In one of his first speeches to a large group of tobacco executives, Mr. Deyton told members of the Tobacco Merchants Association that he would place strong emphasis on reducing the number of minors who become tobacco users. He said 4,000 kids begin smoking each day, on average, and 1,000 become regular users. He reiterated his concern that new, dissolvable forms of smokeless tobacco produced by companies such as Reynolds American Inc. are candy-like in their appearance. Reynolds is complying with a review of such products by the FDA and has said its dissolvable products, which are being test-marketed in three cities, are made and marketed for adults. Mr. Deyton, a longtime public-health expert, began his job in September, a few months after the agency was given broad powers to regulate the industry under a landmark law signed by President Obama. The agency is still in the early stages of solidifying the framework under [...]

Charlotte Parker2010-05-29T11:00:45-07:00May, 2010|Oral Cancer News|

FDA tobacco chief says to industry: ‘Long way to go’

Source: Associated Press Staff: Michael Felberbaum WILLIAMSBURG, Va. — The head of the government's tobacco regulator says the Food and Drug Administration's new power to regulate tobacco is a promising tool to reduce the toll of disease and death caused by tobacco use. "This is an opportunity for me to serve my country by preventing its men, women and children from suffering and dying from tobacco-related diseases," Dr. Lawrence Deyton, director of the FDA's Center for Tobacco Products told attendees Monday at the Tobacco Merchants Association annual meeting in Williamsburg, Va. Deyton, who has held the job for about nine months, said his job is to address the "enormous toll of confusion, suffering and death caused by the current state of tobacco use in this country." "And frankly, we have a long way to go," he said. Deyton said his top priorities include stopping kids from picking up the habit, educating the public and applying standards based on science. While Deyton encouraged an open dialogue with the industry, he acknowledged that some believe regulation as a threat to the tobacco business and will "try and block FDA at every turn in implementing this law." For those who ignore the law, Deyton said, the FDA has multiple options to enforce compliance and the agency will "not hesitate to take these steps when warranted." The FDA's authority granted last June is the main area of discussion at the two-day gathering of tobacco manufacturers, growers and retailers. The agency is tasked with creating [...]

Charlotte Parker2010-05-25T13:27:43-07:00May, 2010|Oral Cancer News|

Sexually transmitted virus leads to rise in oral cancer

Source: The Boston Channel Author: Staff Boston cancer specialists are trying to learn what’s behind an “epidemic” spike in oral cancer cases that they say is caused by the human papillomavirus, commonly known as HPV. “What you're seeing here is a five-fold increase in the numbers that we would expect,” said Dr. Marshall R. Posner, of the Dana Farber Cancer Institute. “So that, to me, is an epidemic.” NewsCenter 5’s Heather Unruh reported Thursday that most adults have been exposed to HPV. Doctors say it can be sexually transmitted, even through deep kissing. What doctors don’t know yet is why in some people, such a common virus develops into cancer. “Most people who get infected with HPV naturally clear the virus,” said DFCI’s Dr. Karen Anderson. Anderson and her team of researchers are trying to isolate who’s at risk for oral cancer from HPV, and why. “Because then,” Anderson said, “we can focus on more aggressive screening approaches for people who are at higher risk and start to look at more therapeutic interventions earlier on.” Posner said that at least 20,000 cases of oropharyngeal cancer are diagnosed in the United States each year. Most patients are young. Three in four occur in men. Tony is one face among the statistics. Five days a week he psyches himself up for radiation to treat the cancer that grew at the base of his tongue, where it meets his throat. “What I say,” he said, “is, ‘It is not of me, or a [...]

Charlotte Parker2010-05-14T14:37:01-07:00May, 2010|Oral Cancer News|

FDA’s risk aversion is endangering children

Source: Forbes.com Author: Henry Miller The agency has sown confusion by asking physicians to stop administering a vaccine that even they admit is safe. By applying its now-customary excessive precaution, the FDA has painted itself into a most interesting corner. The result will likely be confusion among pediatricians and the public and parents reluctant to permit their children to get an important vaccination. And that in turn will cause unnecessary cases of rotavirus infection, debilitating diarrhea and, in a few children, death. The FDA last March asked pediatricians to stop administering GlaxoSmithKline's ( GSK - news - people ) Rotarix, a vaccine that prevents rotavirus infection, a diarrheal illness that commonly affects infants and children and that can cause severe dehydration. Their rationale was self-contradictory and unpersuasive. On one hand, the FDA seemed still to be confident about the vaccine, explaining that, "Extensive studies, including placebo-controlled, randomized clinical studies involving tens of thousands of vaccine recipients, support the safety and effectiveness of the vaccine." And the positive experience of countless infants and children vaccinated since the licensing of the vaccine two years ago further confirms its safety. So why do regulators want a "pause" in administration? Because using a new ultra-sensitive assay, small amounts of DNA from a pig virus were detected in the vaccine preparation. That might sound like a good reason for concern--except that the FDA itself confirms "that the material has been present since the early stages of product development, including during clinical studies." In other words, all of the studies that confirmed the [...]

Charlotte Parker2010-05-13T07:58:04-07:00May, 2010|Oral Cancer News|

Robotic surgery for oral cancer

Source: speech-language-pathology-audiology.advanceweb.com Author: Advance, Vol 20, Issue 2 A minimally invasive surgical approach to treat benign tumors and select malignant tumors in adults has been cleared by the U.S. Food and Drug Administration (FDA). The da Vinci Surgical System, developed by head and neck surgeons at the University of Pennsylvania School of Medicine, in Philadelphia, has been cleared for transoral otolaryngologic surgical procedures. Gregory Weinstein, MD, FACS, and Bert O'Malley, Jr., MD, founded the first TransOral Robotic Surgery (TORS) program in the world at Penn Medicine in 2004. They developed and researched the TORS approach for a variety of robotic surgical neck approaches for both malignant and benign tumors of the mouth, larynx, tonsil, tongue, and other parts of the throat. Since 2005, approximately 350 patients at Penn have participated in the first prospective clinical trials of TORS. The trials compromise the largest and most comprehensive studies of the technology on record. "TORS has dramatically improved the way we treat head and neck cancer patients, completely removing tumors while preserving speech, swallowing, and other key quality-of-life issues," said Dr. O'Malley, chair of the Department of Otorhinolaryngology-Head and Neck Surgery at Penn Medicine. "It is very exciting that a concept conceived and tested at PENN and taught to surgeons and institutions within the U.S. and internationally has been officially recognized by our federal governing agencies and peers around the world as a new and improved therapy for select neck cancers and all benign tumors." As many as 45,000 Americans and approximately [...]

Oral Cancer Foundation News Team - A2010-05-09T10:23:23-07:00May, 2010|Oral Cancer News|

FDA approves Strativa Pharmaceuticals’s Oravig(TM) buccal tablets for treatment of oropharyngeal candidiasis

Source: www.biospace.com Author: press release Strativa Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has approved Oravig (miconazole) buccal tablets for the treatment of oropharyngeal candidiasis (OPC), more commonly known as thrush, in adults and children age 16 and older. Oravig is the first and only local, oral prescription formulation of miconazole – an antifungal medication – approved for this use in the U.S. Oravig, which adheres to the gum, utilizes innovative buccal tablet technology enabling once-daily dosing that delivers miconazole directly at the local site of infection throughout the day with minimal systemic absorption. Oravig is easy-to-use and provides patients with a flavorless, odorless and convenient treatment option that does not interfere with daily activities such as eating and drinking. Oravig will be offered in a 50 mg dosage strength and is expected to be available in retail pharmacies in the third quarter of 2010. "The FDA approval of Oravig underscores Strativa's commitment to improving patients' overall treatment experience by bringing to market new products that fulfill patient needs," said John A. MacPhee, President, Strativa Pharmaceuticals. "Oravig offers patients suffering from thrush a proven effective treatment in a discreet and convenient once-daily formulation." The FDA approval was based on two pivotal Phase III clinical trials. The first study demonstrated that Oravig completely resolved signs and symptoms of OPC at rates similar to Mycelex® Troche (clotrimazole) administered five times per day in HIV-positive patients. This randomized, double-blind, double-dummy trial was conducted in 577 HIV-positive patients in 28 [...]

Oral Cancer Foundation News Team - A2010-04-18T06:51:04-07:00April, 2010|Oral Cancer News|

Study evaluating clinical performance of Cervista(R) HPV HR presented at AOGIN

Source: www.prnewswire.com Author: press release Hologic, Inc. (Hologic or the Company), a leading developer, manufacturer and supplier of premium diagnostics, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, today announced that interim data from the first large-scale independent evaluation of clinical performance of Cervista® HPV HR compared to Hybrid Capture 2 (hc2), were presented at the 4th Biennial Meeting of AOGIN (Asia-Oceanic Research Organization in Genital Infection and Neoplasia) in New Delhi, India on March 26-28, 2010. Cervista HPV HR is a diagnostic test for the detection of 14 high-risk human papillomavirus (HPV) types. The study, SHENCCAST II, is a major cervical cancer screening trial including more than 10,000 women that is being conducted in China to evaluate the performance of HPV assays, among other endpoints. A preliminary analysis of data from 5,043 patients showed the Cervista HPV HR test performed as follows: Overall HPV positivity for this cohort was 12.2 percent for the Cervista HPV HR test and 14.6 percent with the hc2 test. For histologically confirmed CIN 2 or more severe lesions, the Cervista HPV HR test showed a sensitivity of 90.7 percent and a specificity of 90.2 percent. For the hc2 test, sensitivity and specificity were 94.7 percent and 87.9 percent, respectively. While the Cervista HPV HR test demonstrated improved specificity and the hc2 test yielded higher sensitivity, a statistical analysis of overall test accuracy that plots sensitivity and specificity found the two methods were clinically equivalent (area under the ROC [...]

Oral Cancer Foundation News Team - A2010-03-29T20:21:43-07:00March, 2010|Oral Cancer News|

Busting the myth of the cervical cancer vaccine

Source: Temple University Press Editorial by: Gkramer Adina Nack, author of Damaged Goods? Women Living with Incurable Sexually Transmitted Diseases, draws on her expertise as a sexual health researcher to discuss the impact of human papillomavirus (HPV) on men and the need for gender-neutral STD vaccines. When I wrote my book, Damaged Goods? I focused on how living with contagious, stigmatizing, medically incurable (though highly treatable) infections transformed women’s lives – medically, socially and psychologically. I had included a discussion of the Gardasil vaccine, which had received FDA-approval and CDC recommendation for ‘routine’ use in girls and women (ages 9 to 26) back in 2006, and I had articulated some of my concerns about the delayed testing and approval process for ‘male’ Gardasil. A family of viruses, HPV is an ‘equal opportunity infector,’ so why have HPV vaccines not been equally accessible for men as well as women? In a recent interview on Huffington Post, several blog posts of my own, and my new feature article, “Why Men’s Health Is a Feminist Issue” (Ms. Magazine,Winter 2010), I investigate the substantial public health costs that result from HPV vaccines, such as Gardasil, not having been originally developed, tested and approved as gender-neutral vaccines. The narrow and inaccurate marketing of Gardasil as a female-only, “cervical cancer” vaccine has distracted us from public discourse about this family of sexually transmitted viruses that are not only a U.S. epidemic but also a global pandemic. In the U.S., HPV is estimated to affect 75% of adults and certain strains are known [...]

Charlotte Parker2010-03-23T22:33:02-07:00March, 2010|Oral Cancer News|