FDA – Page 10 – Oral Cancer News

Packing a heavier warning

Source: www.washingtonpost.com Author: Ranit Mishori Coming soon to the lives of American smokers: cigarette labels that go far beyond a simple warning. Imagine gruesome color photographs showing a mouth riddled with cancer, lungs blackened, a foot rotten with gangrene. If the images sound sickening, well, that's the point. Under a law signed by President Obama on June 22 -- the Family Smoking Prevention and Tobacco Control Act -- tobacco companies will be required to cover 50 percent of the front and rear panels of cigarette packages with color graphics showing what happens when you smoke and bold, specific labels saying such things as: "WARNING: Cigarettes cause fatal lung disease." "WARNING: Tobacco smoke can harm your children." "WARNING: Smoking can kill you." The first U.S.-mandated label in 1965 tentatively suggested "Cigarette Smoking May Be Hazardous to Your Health." Although the language changed over time, critics have long dismissed U.S. labeling as anemic and ineffective. Indeed, the inspiration for the new labeling standards comes from abroad. Canada started the trend in 2000 with a label that showed a picture of mouth cancer. "It's the one that smokers remember more than anything else. Even after nine years," says David Hammond, a researcher from the Department of Health Studies at the University of Waterloo in Ontario. Since then, he says, more than two dozen countries have picked up on the idea. A sampling of how explicit the labels can be: Malaysia's cigarette packs bear a photo of a diseased lung; some in Brazil show [...]

Oral Cancer Foundation News Team - A2009-08-05T04:48:03-07:00August, 2009|Oral Cancer News|

Genmab says FDA lifts hold on zalutumumab studies

Source: www.reuters.com Author: staff Danish biotechnology firm Genmab said on Thursday: - The U.S. Food and Drug Administration lifted a partial clinical hold on zalutumumab studies being conducted under a U.S. Investigational New Drug application. - Enrolment of patients can now resume in the Phase II study in patients with head and neck cancer considered incurable with standard treatment and the Phase I/II frontline study of zalutumumab in combination with chemo-radiation. Note: 1. Reporting by Copenhagen newsroom

Oral Cancer Foundation News Team - A2009-07-16T12:08:09-07:00July, 2009|Oral Cancer News|

HPV vaccine debate shifts to boys

Source: Buffalo News Author: Henry L. Davis New questions arise as cancer tied to HPV is rising in men Parents who face the dilemma of whether to protect their young daughters with a vaccine aimed at a sexually transmitted infection that causes cervical cancer now face a new question: Should they do the same for their sons? As evidence mounts of a rising number of other cancers linked to the human papillomavirus, or HPV, a debate has intensified over whether to give the vaccine to males. Advocates say vaccinating boys and men can prevent them from passing on the virus to their sexual partners. Critics still question the long-term safety and effectiveness of Merck & Co.’s Gardasil, despite studies indicating that its risks and lasting power are within the range of other vaccines. But a newer wrinkle in the debate is the discovery in recent years that oral HPV infections — most likely acquired from oral sex with multiple partners—significantly increase the risk of head and neck cancers. The rate of oral cancers is rising so steadily, especially in men, that, if the trend continues, there may be more oral cancers in the United States caused by HPV in 10 years than by tobacco or alcohol, a major study concluded last year. “We should be investing our care and dollars in preventing HPV infection instead of treating the cancers,” said Dr. Thom Loree of Roswell Park Cancer Institute. Physicians at the cancer center have begun publicly touting the benefits of [...]

Charlotte Parker2009-07-15T13:04:17-07:00July, 2009|Oral Cancer News|

Effectiveness of VitalStim therapy for patients suffering in published study

Source: Reuters.com Author: Staff Published Study Demonstrates Effectiveness of VitalStim Therapy for Patients Suffering with Dysphagia A recent study published in the April 2008 issue of the Annals of Otology, Rhinology & Laryngology has revealed the positive clinical effect of the adjunctive use of VitalStim(R) Therapy. A leading brand within the Empi Recovery Sciences line of pain management and rehabilitation products, VitalStim is a non-invasive neuromuscular electrical stimulation (NMES) device for the treatment of dysphagia. Results of the study were also originally presented at the American Association of Speech-Language Pathology Conference in Miami, Fla. in November 2006. Dysphagia, or difficulty swallowing, is a sorely neglected medical condition which affects 15 million Americans and is generally caused by a neurological disorder or event, such as a stroke, degenerative neurological diseases and head and neck cancer. Without proper management, dysphagia can lead to aspiration, pneumonia, choking, chronic malnutrition, severe life-threatening dehydration, an increased rate of infection, longer hospital stays, long-term institutional care and even death. VitalStim Therapy is a non-invasive external electrical stimulation therapy that was cleared to market by the FDA in December 2002. VitalStim is a portable, dual-channel electrotherapy system that is used with electrodes specifically designed for application to the muscles of the throat to promote swallowing. Entitled "Adjunctive Neuromuscular Electrical Stimulation for Treatment-Refractory Dysphagia," the study details the measured clinical effect of the VitalStim program on six patients with chronic, treatment-refractive dysphagia. The study describes a prospective case series using validated outcome measures to represent different domains and [...]

Charlotte Parker2009-07-15T13:04:51-07:00July, 2009|Oral Cancer News|

U.S. scientists say Lilly Erbitux cancer drug not worth price

Source: Bloomberg Author: Lisa Rapaport Eli Lilly & Co.’s tumor-fighter Erbitux doesn’t prolong lung cancer patients’ lives enough to justify its $80,000 cost, U.S. scientists said in commentary published today. Erbitux added to other cancer drugs extends survival about 1.2 months more than chemotherapy alone, making the price too high for a “marginal benefit,” commentary in the Journal of the National Cancer Institute said. Erbitux, which Lilly markets with Bristol-Myers Squibb Co., generated $1.3 billion last year as treatment approved for other malignancies. The high price of some of the newest cancer medicines are coming under scrutiny as part of an effort by lawmakers and health officials to rein in overall medical costs. President Barack Obama has set aside $1.1 billion in the U.S. economic stimulus bill to study the comparative effectiveness of treatments for cancer and other diseases. “We must avoid the temptation to tell a patient that a new drug is available if there is little evidence that it will work better than established drugs that could be offered at a miniscule fraction of the cost,” wrote the commentators, Tito Fojo with the National Cancer Institute and Christine Grady at the National Institutes of Health. Lilly, of Indianapolis, and marketing partner Bristol- Myers, of New York, withdrew an application to extend the Erbitux’s use to lung tumors in February after the Food and Drug Administration questioned differences in American and European versions of the treatment. $10,000 a Month The authors projected that Erbitux costs $80,000 based on a typical course of treatment for lung [...]

Charlotte Parker2009-06-30T16:01:21-07:00June, 2009|Oral Cancer News|

NYC may require tobacco retailers to post warning signs

Source: NEWSDAY.COM Author: MICHAEL FRAZIER The New York Health Department is proposing city tobacco retailers post signs with graphic images such as cancer-ravaged throats and black lungs in an effort to discourage smoking, health officials said Wednesday.The signs - the first of their kind in the country - would include health risk warnings and information on how to quit, said Sarah Perl, assistant commissioner of the city's Bureau of Tobacco Control."You're going to see what a blackened lung looks like; you're going to see what mouth cancer looks like; you're going to see what it looks like when you have throat cancer," Perl said. "They're going to have to think, 'Do I really want to pay 10 bucks for mouth cancer?' "The city Board of Health will hold hearings and vote in September on the proposal. Officials expect opposition from many of the city's 12,000 tobacco retailers and the cigarette industry. Jim Calvin, president of the state Association of Convenience Stores, said a new law giving the Food and Drug Administration more tobacco control is sufficient. "I'm not sure we would be eager to give up additional wall space and advertising space for posters and signs and images," said Calvin, whose group represents 7,700 stores statewide. President Barack Obama signed a law Monday allowing the FDA to lower the amount of nicotine in tobacco products; forbid ads geared toward children; ban sweetened cigarettes that appeal to youngsters; and prohibit "light" and "low tar" labeling. The Health Department said its proposal is aimed mainly [...]

Charlotte Parker2009-06-25T10:49:05-07:00June, 2009|Oral Cancer News|

Cancer patients turning to alternative remedies: become aware of dangers

Source: msnbc Author: Associated Press 60 percent seek natural ‘cures’ despite warnings from doctors TAMPA, Fla. - With much of her lower body consumed by cancer, Leslee Flasch finally faced the truth: The herbal supplements and special diet were not working. "I want this thing cut out from me. I want it out," she told her family. But it was too late. Her rectal cancer — potentially curable earlier on — had invaded bones, tissue, muscle, skin. The 53-year-old Florida woman could barely sit, and constantly bled and soiled herself. "It was terrible," one doctor said. "The pain must have been excruciating." Flasch had sought a natural cure. Instead, a deadly disease ran its natural course. And the herb peddlers who sold her hope in a bottle? "Whatever money she had left in life, they got most of it," said a sister, Sharon Flasch. "They prey on the sick public with the belief that this stuff can help them, whether they can or can't." Some people who try unproven remedies risk only money. But people with cancer can lose their only chance of beating the disease by skipping conventional treatment or by mixing in other therapies. Even harmless-sounding vitamins and "natural" supplements can interfere with cancer medicines or affect hormones that help cancer grow. Preying on insecurities Yet they are extremely popular with cancer patients, who crave control over their disease and want to do everything they can to be healthy — emotional needs that make them vulnerable to deceptive [...]

Charlotte Parker2009-06-16T12:13:51-07:00June, 2009|Oral Cancer News|

Senate votes for F.D.A. rules on tobacco

Source: nytimes.com Author: Duff Wilson The Senate voted overwhelmingly Wednesday to impose federal regulation on cigarettes and other forms of tobacco, passing a landmark bill to empower the Food and Drug Administration to control products that eventually kill half their regular users. The Senate legislation has only minor differences from a version the House passed in April. A White House spokesman, Reid H. Cherlin, said that President Obama, who was a co-sponsor of the bill when he was in the Senate, would sign the legislation when it reached his desk. An estimated one in five people in this country smoke, and more than 400,000 of them die each year from smoking-related disease. But for decades, even after the surgeon general’s 1964 report declaring cigarettes a health hazard, Congressional efforts to regulate tobacco had met stiff opposition from lawmakers from tobacco-growing states and their political allies. And when the F.D.A. tried on its own to start regulating nicotine as a drug, the Supreme Court struck down that effort in 2000, saying the agency could not take such a step without Congressional authority. Cigarettes remained less regulated than cosmetics or pet food. But with broad bipartisan support in both the Senate and House, and a campaign pledge by Barack Obama to sign such legislation if he became president, the anti-tobacco forces came into alignment. “This long-overdue grant of authority to F.D.A. to regulate tobacco products means that the agency can finally take the actions needed to protect our people from the most [...]

Oral Cancer Foundation News Team - A2009-06-11T15:34:20-07:00June, 2009|Oral Cancer News|

Senate Passes Family Smoking Prevention and Tobacco Control Act Bill

Source: CNN.com Author: Evan Glass Senate passes bill increasing FDA power over tobacco products: WASHINGTON (CNN) -- A bill that increases the power of the federal Food and Drug Administration to regulate tobacco products cleared the Senate on Thursday. The Senate voted 79-17 for the Family Smoking and Tobacco Control Act, which is similar to a bill already passed by the House of Representatives. An aide to House Majority Leader Steny Hoyer of Maryland said the chamber will vote Friday on accepting the Senate bill, which would send the measure to President Obama for his signature. Most Senate opposition came from tobacco-producing states including Kentucky, North Carolina, South Carolina and Georgia. In a break from tradition, the two senators from Virginia -- another tobacco state -- supported the measure, indicating a moderate shift in the state's politics. The tobacco bill would allow the FDA to ban some tobacco products, limit the amount of nicotine in tobacco products and enlarge warning labels. A White House statement quoted Obama as calling the measure historic for "giving the scientists and medical experts at the FDA the power to take sensible steps that will reduce tobacco's harmful effects and prevent tobacco companies from marketing their products to children." The statement said Obama looks forward to signing the bill. The American Cancer Society, in a statement released shortly after the vote, said, "Today is an historic day for public health. "Tobacco is virtually the only consumable product not regulated in the U.S. and the tobacco industry exploits this [...]

Charlotte Parker2009-06-11T15:26:59-07:00June, 2009|Oral Cancer News|

Smoking debate has become nicotine-delivery debate

Source: www.godanriver.com Authors: David Ress & John Reid Blackwell, Media General News Service Federal regulators are cracking down on a cigarette substitute that uses technology similar to devices that Philip Morris USA researchers have focused on in recent years. Meanwhile, Virginia Commonwealth University is studying how much nicotine — the addictive compound in tobacco — the “electronic cigarettes” deliver, under a grant from the National Cancer Institute to look at nicotine products. Since the start of the year, the Food and Drug Administration has issued “Import Alerts” advising staff working alongside U.S. Immigration and Customs Enforcement officers that they can seize “electronic cigarettes” made by three Chinese companies, federal court records show. The FDA has refused to let at least 17 shipments of electronic cigarettes into the country, saying they are unapproved drug-delivery devices, spokeswoman Karen Riley said. The devices are cigarette-shaped tubes that hold a heater that vaporizes a mix of nicotine and a kind of alcohol for the smoker to inhale. The nicotine and alcohol — usually propylene glycol, used as a moisturizers in cosmetics and in antifreeze — are contained in a replaceable cartridge inserted into the device, which also contains electronic controls that allow it to deliver a puff-of-smokelike dose of nicotine. The vaporizer and control units typically cost $100, while cartridges cost about $2 to $3 each and are supposed to be equivalent to a pack or two of cigarettes. Cigarettes routinely sell for more than $4.50 a pack in Virginia. “The FDA is not [...]

Oral Cancer Foundation News Team - A2009-06-10T06:41:54-07:00June, 2009|Oral Cancer News|