FDA – Page 8 – Oral Cancer News

Why men’s health is a feminist issue

Source: www.msmagazine.com Author: Adina Nack Jorge (not his real name) feared his girlfriend would dump him. He’d been diagnosed with genital warts before meeting her, and hadn’t yet told her about his infection. Jorge was being careful—no skin-to-skin sexual contact—but the disclosure was looming. So he’d done some research and learned what caused genital warts. Armed with that knowledge, he hoped that his girlfriend wouldn’t reject him, especially since he knew she could be protected from contracting warts “because of the Gardasil vaccine.” It never occurred to Jorge that Gardasil, made by the pharmaceutical company Merck, could also have protected him. But that’s probably because it was only last October that the Food and Drug Administration approved a “male” Gardasil for preventing genital warts. And the FDA has yet to put its stamp on another promising usage of the vaccine for men: preventing cancer, especially highly prevalent oral cancers. Since Gardasil was FDA-approved in 2006, it has received a huge marketing push for preventing cervical cancer in women. It has come into frequent—if sometimes controversial—use for females 9 to 26 years old because it’s designed to guard them, before they ever have sex, against contracting a virus that has been linked to cervical cancer. That virus is HPV, human papillomavirus, which causes one-third of all sexually transmitted infections (STIs) in the U.S. Gardasil offers protection against four of the 30 to 40 types of sexually transmissible HPV. While it’s fear of cervical cancer that have motivated young women to get [...]

Oral Cancer Foundation News Team - A2010-03-09T21:48:41-07:00March, 2010|Oral Cancer News|

What’s in a cigarette? FDA will study the ingredients

Source: Yahoo Author: MICHAEL FELBERBAUM RICHMOND, Va. – The Food and Drug Administration is working to lift the smokescreen clouding the ingredients used in cigarettes and other tobacco products. In June, tobacco companies must tell the FDA their formulas for the first time, just as drugmakers have for decades. Manufacturers also will have to turn over any studies they've done on the effects of the ingredients. It's an early step for an agency just starting to flex muscles granted by a new law that took effect last June that gives it broad power to regulate tobacco far beyond the warnings now on packs, short of banning it outright. Companies have long acknowledged using cocoa, coffee, menthol and other additives to make tobacco taste better. The new information will help the FDA determine which ingredients might also make tobacco more harmful or addictive. It will also use the data to develop standards for tobacco products and could ban some ingredients or combinations. "Tobacco products today are really the only human-consumed product that we don't know what's in them," Lawrence R. Deyton, the director of the Food and Drug Administration's new Center for Tobacco Products and a physician, told The Associated Press in a recent interview. While the FDA must keep much of the data confidential under trade-secret laws, it will publish a list of harmful and potentially harmful ingredients by June 2011. Under the law, it must be listed by quantity in each brand. Some tobacco companies have voluntarily listed product ingredients online [...]

Charlotte Parker2010-01-19T18:12:08-07:00January, 2010|Oral Cancer News|

Kids may mistake new tobacco products for candy

Source: Clippertoday.com Author: Melinda Williams FARMINGTON — New tobacco products often look like candy, and their packaging may look like cell phones or other electronics. “But there’s no such thing as a safe tobacco product,” Davis County health educator Isa Kaluhikaua told Board of Health members Tuesday. Kaluhikaua brought examples of smoking alternatives to show board members, most packaged in bright colors with appealing logos. There’s Snus, a no-spit tobacco pouch meant to be placed under the upper lip, and Orbs, dissolvable breath-mint sized tobacco, with a camel imprinted on each. There’s also Strips, dissolvable strips, like breath freshening strips, containing tobacco, and dissolvable Sticks. And, there’s an electronic cigarette. The products all contain tobacco or nicotine and have not been approved by the Federal Drug Administration. Kaluhikaua said if a child ingested three Orbs, they would get ill, and 10 could result in serious illness. Yet, she said, they look much like Tic-Tacs and come in a variety of flavors that children may mistake for candy. She said the Federal Drug Administration has not approved most of the products, yet they are being put out on the market pouvez trouver. “Some are designed to fit into creative packaging,” and are marketed as a safe alternative to smoking. Not all the products are on the market in Utah yet, Kaluhikaua said. That sobering message was a portion of Kaluhikaua’s annual tobacco report to the board which indicates that during 2009, only 6 percent of adults and 8.6 percent of youth [...]

Charlotte Parker2010-01-15T12:41:31-07:00January, 2010|Oral Cancer News|

Transoral robotic surgery gets FDA approval

Source: Medgadget Author: Staff The FDA has given the go ahead for surgeons to use robotic surgery for procedures in the throat and nearby regions by going through the mouth. In effect, this is a new indication for the Da Vinci Surgical System from Intuitive Medical, as it is the only robot of its type that can be used to perform the procedures. The transoral applications of robotic surgery have been developed at the University of Pennsylvania School of Medicine, where a special center was created to study the subject. Drs. Gregory S. Weinstein and Bert W. O’Malley, Jr. of the University of Pennsylvania School of Medicine’s Department of Otorhinolaryngology: Head and Neck Surgery founded the world’s first TransOral Robotic Surgery (TORS) program at Penn Medicine in 2004, where they developed and researched the TORS approach for a variety of robotic surgical neck approaches for both malignant and benign tumors of the mouth, voice box, tonsil, tongue and other parts of the throat. Since 2005, approximately 350 Penn patients have participated in the world’s first prospective clinical trials of TORS. Head and neck tumor treatments often involve a combination of surgery, radiation therapy, and chemotherapy. In many cases, surgery offers the greatest chance of cure; yet conventional surgery may require an almost ear-to-ear incision across the throat or splitting the jaw, resulting in speech and swallowing deficits for patients. In comparison, the minimally invasive TORS approach, which accesses the surgical site through the mouth, has been shown to improve long term [...]

Charlotte Parker2010-01-15T19:49:17-07:00January, 2010|Oral Cancer News|

FDA clears transoral robotic surgery – developed at Penn –for tumors of mouth, throat and voice box

Source: www.healthcanal.com Author: staff A minimally invasive surgical approach developed by head and neck surgeons at the University of Pennsylvania School of Medicine has been cleared by the U.S. Food and Drug Administration (FDA). The da Vinci Surgical System (Intuitive Surgical, Inc., Sunnyvale, California) has been cleared for TransOral Otolaryngology surgical procedures to treat benign tumors and selected malignant tumors in adults. Drs. Gregory S. Weinstein and Bert W. O’Malley, Jr. of the University of Pennsylvania School of Medicine’s Department of Otorhinolaryngology: Head and Neck Surgery founded the world’s first TransOral Robotic Surgery (TORS) programat Penn Medicine in 2004, where they developed and researched the TORS approach for a variety of robotic surgical neck approaches for both malignant and benign tumors of the mouth, voice box, tonsil, tongue and other parts of the throat. Since 2005, approximately 350 Penn patients have participated in the world’s first prospective clinical trials of TORS. These research 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 Bert O’Malley, Jr., MD, professor and chairman of Penn Medicine’s Department of Otorhinolaryngology:Head and Neck Surgery. “It is very exciting that a concept conceived at PENN, evaluated in pre-clinical experimental models at Penn, tested in clinical trials at Penn, and then taught to key surgeons and institutions both within the U.S. and internationally has been officially [...]

Oral Cancer Foundation News Team - A2009-12-19T23:10:00-07:00December, 2009|Oral Cancer News|

Evaluation of in vitro assays for assessing the toxicity of cigarette smoke and smokeless tobacco

Source: aacrjournals Author: Staff Requests for reprints:Peter G. Shields, Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, 3800 Reservoir Road Northwest, LL (S) Level, Room 150, Washington, DC 20057-1465. Phone: 202-687-0003. E-mail: [email protected] Abstract Background: In vitro toxicology studies of tobacco and tobacco smoke have been used to understand why tobacco use causes cancer and to assess the toxicologic impact of tobacco product design changes. The need for toxicology studies has been heightened given the Food and Drug Administration's newly granted authority over tobacco products for mandating tobacco product performance standards and evaluate manufacturers' health claims about modified tobacco products. The goal of this review is to critically evaluate in vitro toxicology methods related to cancer for assessing tobacco products and to identify related research gaps. Methods: PubMed database searches were used to identify tobacco-related in vitrotoxicology studies published since 1980. Articles published before 1980 with high relevance also were identified. The data were compiled to examine (a) the goals of the study, (b) the methods for collecting test substances, (c) experimental designs, (d) toxicologic end points, and (e) relevance to cancer risk. Results: A variety of in vitro assays are available to assess tobacco smoke that address different modes of action, mostly using non–human cell models. However, smokeless tobacco products perform poorly in these assays. Although reliable as a screening tool for qualitative assessments, the available in vitro assays have been poorly validated for quantitative comparisons of different tobacco products. Assay batteries have not been developed, although they exist for nontobacco assessments. Extrapolating data from in [...]

Charlotte Parker2009-12-07T15:03:33-07:00December, 2009|Oral Cancer News|

U.S. smoking rates remain steady, but vary widely by state

Source: Medical News Author: John Gever National rates of cigarette smoking showed little change in 2008 from a year earlier, the CDC reported, though states vary widely both in rates of current smoking and exposures of nonsmokers to secondhand smoke. Some 20.6% of Americans were current smokers in 2008 (95% CI 19.9% to 21.4%), not significantly different from the 19.8% found in 2007 (95% CI 19.0% to 20.6%) according to the the government's ongoing National Health Interview Survey, detailed by Shanta R. Dube, PhD, and other CDC researchers in the Nov. 13 issue ofMorbidity and Mortality Weekly Report. But analysis of a another data set in MMWR -- the 2008 results from the Behavioral Risk Factor Surveillance System (BRFSS) -- revealed a twofold variation in rates among states. Utah had by far the lowest rate of current cigarette smoking, at 9.2%, followed by California (14.0%), New Jersey (14.8%) and Maryland (14.9%), according to Ann M. Malarcher, PhD, and CDC colleagues. West Virginia led the other end of the list at 26.6%. Other states with current smoking rates of 25% or more included Indiana, Kentucky, and Missouri. West Virginia had several other smoking distinctions. It was the only state in which the current smoking rate was higher among women than men -- 27.1% versus 26.1% -- although the difference was not statistically significant. The BRFSS data showed the Mountain State had the highest rate of home exposure to secondhand smoke among 12 states and territories for which data were available. Some 10.6% [...]

Charlotte Parker2009-11-13T13:22:58-07:00November, 2009|Oral Cancer News|

Biovex agrees to Special Protocol Assessment (SPA) with the FDA for a pivotal phase III study with Oncovexin head and neck cancer

Source: www.pressreleasepoint.com Author: press release BioVex Inc, a biotechnology company developing clinical stage treatments for cancer and the prevention of infectious disease, announced today that the U.S. Food and Drug Administration (FDA) has approved the design of a single, pivotal, Phase III clinical trial evaluating its lead product, OncoVEXGM-CSF for the first line treatment of patients with squamous cell cancer of the head and neck. The study is the second the Company has agreed with the FDA under the Special Protocol Assessment (SPA) procedure and highlights the broad potential utility of BioVex’s first-in-class cancer destroying virus technology. The first SPA was in melanoma under which BioVex is currently conducting a pivotal Phase III trial. Patients with head and neck cancer often present with locally advanced, bulky disease that is too large, or too close to vital organs, to remove surgically. These patients typically undergo combination radiation and chemotherapy treatment, with in some cases additional surgery. Patients who present with tumor containing lymph nodes are particularly difficult to treat and approximately half of these patients relapse within two years. Philip Astley-Sparke, President & CEO, for BioVex said: "The announcement of our second SPA governing a Phase III study demonstrates the breadth of the commercial opportunity with OncoVEXGM-CSF. In addition to treating metastatic disease as is the intention in our ongoing Phase 3 study in melanoma, following multiple systemic responses in Phase II, OncoVEXGM-CSFalso has considerable potential utility in treating discrete solid tumor masses across multiple indications including those that are poorly [...]

Oral Cancer Foundation News Team - A2009-11-04T12:54:36-07:00November, 2009|Oral Cancer News|

Males can get HPV vaccine Gardasil thanks, in part, to Gulfport cancer survivor

Source: St. Petersburg Times Author: John Barry David Hastings' crusade to inoculate boys against a cancer-causing virus that afflicts women — but threatened him, too — has scored a victory. But it's not quite the one he has been fighting for in the past three years. A panel of the Centers for Disease Control and Prevention last week allowed a vaccine to be given to boys and young men that is already used to protect girls and young women from human papillomavirus, HPV, which causes cervical cancer. The panel's vote followed the Food and Drug Administration's recent okay of the vaccine for boys as a protection against genital warts. The vaccine, Gardasil, was approved only for females, ages 9 to 26, in 2006. But research has since linked HPV to many oral cancers in men. Hastings, who owns the Habana Cafe in Gulfport with his wife, Josefa, testified before the CDC's Advisory Committee on Immunization Practices. He told them how HPV was found in a deadly carcinoma in his throat in 2006. It took seven weeks of simultaneous chemotherapy and radiation at the H. Lee Moffitt Cancer Center in Tampa to arrest the cancer. Ever since, he has spread the message that HPV is a threat to men. He urged the CDC panel to recommend routine vaccinations for boys, as it already does for girls. Hastings and other proponents argued that only 17 percent of girls are completing the series of three doses needed for protection. "We rely on females [...]

Charlotte Parker2009-10-30T10:58:18-07:00October, 2009|Oral Cancer News|

HPV vaccine fails to get nod for routine use in boys

Source: Medscape.com Author: Robert Lowes October 21, 2009 — Despite hearing impassioned pleas to protect both men and women from cancer, a federal advisory panel today declined to recommend that a human papillomavirus (HPV) vaccine be routinely administered to boys to prevent genital warts. Instead, the Advisory Committee on Immunization Practices (ACIP) issued a "permissive" recommendation stating that physicians have the option of vaccinating boys with the HPV vaccine Gardasil(Merck) for genital-wart protection. ACIP noted that boys should receive the vaccine "before exposure to HPV through sexual contact." In 2006, the US Food and Drug Administration (FDA) approved Gardasil for use in girls and young women to prevent cervical and other cancers as well as precancers caused by HPV types 16 and 18. Last week, the FDA also approved Gardasil for use in males aged 9 through 26 to prevent genital warts. In making its recommendation today, ACIP appeared to be swayed in part by published research questioning the cost-effectiveness of routine vaccination of boys with Gardasil. The committee's decision has far-reaching economic effects because third-party payers typically pay for vaccinations that are recommended for routine use, but not those coming with a permissive recommendation. More at Stake Than Genital Wart Prevention Proponents of routine vaccination of boys with Gardasil told the committee Wednesday during the public comment period that more was at stake than merely preventing genital warts. They underlined the need to also prevent oral, throat, penile, and anal cancers caused by HPV. David Hastings, a spokesperson for the [...]

Charlotte Parker2009-10-26T09:22:06-07:00October, 2009|OCF In The News, Oral Cancer News|