Monthly Archives: April 2012

Tobacco Makers Must List Ingredients, Prove Safety Claims

Source: Businessweek.com

Tobacco companies will have to begin reporting the amount of unsafe chemicals in their products and prove their so-called lower-risk alternatives to smoking such as snuff are actually safer, U.S. regulators said.

The Food and Drug Administration moved today to implement pieces of a 2009 law giving the agency the authority to regulate tobacco products. The FDA released preliminary guidelines for the industry that it says can educate consumers on exactly what is in cigarettes, such as ammonia and formaldehyde, and police claims that certain tobacco products may be safer than others.

The agency will share information on chemical amounts with the public within a year, Lawrence Deyton, director of the FDA’s Center for Tobacco Products, said in a telephone call with reporters. On the issue of less-risky tobacco items, the draft guidelines set up two categories: one with a higher evidence standard that lets companies claim less harm than cigarettes; and another with a lower standard that permits companies to market products as reducing exposure to unsafe ingredients.

“We are forging new territory to ensure that tobacco companies provide accurate information and do not mislead American consumers,” FDA Commissioner Margaret Hamburg said in a statement. “We are committed to stopping such practices that may cause people to start or continue using tobacco products that could lead to preventable disease and death.”

93 Chemicals

The FDA released a list of 93 chemicals that tobacco makers would have to report the quantity of in their products. The FDA is studying how best to disseminate the information publicly.

“Most people do understand tobacco use is harmful,” Deyton said. “There are also studies that people don’t really understand why to the extent the various chemicals in tobacco are harmful.”

The agency said in the draft on reduced-risk products — which include electronic cigarettes, tobacco lozenges, snuff and snus — that it’s asking for scientific information, including research findings related to a manufacturer’s claim, and may request data comparing the product with cigarettes.

Products in the two categories will be asked to show reduced risk and a benefit to the health of tobacco and non- tobacco users before companies can market them as safer, according to the draft guidelines. The companies also could advertise the products as offering less exposure to harmful ingredients if they prove that future studies may reveal a reduction in disease and death when compared with cigarettes.

Snuff Warnings

Reynolds American Inc. (RAI) (RAI) and its American Snuff unit asked the FDA in July to change labels on smokeless products to: “WARNING: No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes.” Current labels say the product isn’t a safe alternative to cigarettes.

Altria Group Inc. (MO) (MO), which owns Philip Morris USA and brands including Copenhagen and Skoal, wrote the agency “there is overwhelming scientific, medical and public health consensus that moist smokeless tobacco products” such as snuff or snus, “are substantially less hazardous than cigarettes.”

Snuff and snus are moist powder tobacco that goes under the lip either loose or in a packet.

Shares of Richmond, Virginia-based Altria gained less than 1 percent to $30.87 at the close in New York, while Winston- Salem, North Carolina-based Reynolds increased 1.2 percent to $41.46. Star Scientific Inc. (CIGX) (CIGX) fell 2.4 percent to $3.28.

Scientific Evidence

Star Scientific filed an application with FDA in February 2011 to market its snuff product Stonewall Moist-BDL. Star, based in Glenn Allen, Virginia, said in a statement then that it was the first FDA application for approval of a tobacco product.

Smokeless tobacco can cause mouth cancer, oral health diseases and nicotine addiction, according to the Atlanta-based Centers for Disease Control and Prevention. About 3.5 percent of U.S. adults used smokeless tobacco in 2009. Skoal held 25 percent of the market share the same year, followed by Copenhagen with 24 percent, according to the CDC.

Independent third parties should be required to assess the health effects of modified-risk tobacco products before companies submit applications for review to the FDA, the Institute of Medicine in Washington, which advises the nation on health matters, recommended in a December report.

This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.

April, 2012|Oral Cancer News|

April: Oral Cancer Awareness Month

Source: Aspen Dental

April is Oral Cancer Awareness Month. According to Brian Hill, founder and executive director of the Oral Cancer Foundation, as many as 40,000 people in the United States will be told they have oral or pharyngeal cancer in 2012. Some of them may be sitting in your dental chair today. With one person dying of oral cancer every hour of every day, and more than 50% of those diagnosed not living more than 5 years, this is a reminder to screen every patient yourself, and encourage your dental hygiene staff to do the same.

The Statistics

About 100 people are diagnosed with oral cancer every day in the United States. Few people are aware that the death rate for oral cancer is higher than for many other types of cancers, which is because oral cancer often is not discovered until it has reached later stages. This is particularly true for human papilloma virus number 16 (HPV16)-related oral cancer, which occurs most frequently in the posterior areas of the mouth—at the base of the tongue, around the tonsils, and in the oropharynx—where it’s harder to spot without a very thorough exam. To further complicate things, HPV16-related cancer does not always present the tell-tale physical characteristics, including lesions, that are easily distinguished from healthy oral tissues. This is not good news, because HPV16 has reached epidemic levels in the United States: of the 37,000 incidences of oral cancer, about 20,000 (up to 60%) can be linked to HPV, according to Hill.

Oral cancer accounts for 85% of the cancers grouped under “head and neck” cancers. If the number of larynx cancer cases (for which the historic risk factors; tobacco and alcohol are the same) is added to the oral cancer category, we’re now talking 50,000 people diagnosed yearly and 13,500 deaths per year in this country. More than 640,000 new cases occur worldwide annually. These stats do not include brain cancer, which is its own category.

“Late discovery and misdiagnosis are the biggest problems,” Hill says. “I’m a very typical example of this.” Hill was misdiagnosed with an infection by a physician when a painless lump appeared on the side of his neck. When it had not resolved after a course of antibiotics, Hill, who had a background in dentistry, insisted on having a needle aspiration biopsy. Testing resulted in a diagnosis of HPV16-related squamous cell carcinoma, a very deadly cancer. Fourteen years after extensive surgery, and both radiation and chemotherapy, he has since heard from literally thousands of people that they were misdiagnosed more than once, told not to worry about it, or were merely given antibiotics. “Why are so many people diagnosed late?” Hill asks. “Because, according to one study,probably under 20% of dentists are performing oral screenings.” 1 Another problem is that public awareness about oral cancer, its early signs and symptoms, and its changing etiology, is low. Additionally, oral cancer has historically been linked to long-term tobacco use and high alcohol consumption (or a combination of both), with associated lesions usually seen in the anterior areas of the oral cavity. With the prevalence of HPV16-related oral cancer increasing at an alarming rate, and tobacco-related cancers on the decline, it is critical that dental and medical professionals re-educate the public to understand the current risk factors and the need for an annual professional screening.

The Impact of HPV16

It was reported in 2009, before the advent of HPV-related cancers, that oral cancer incidence rates were more than twice as high in men as in women, and both were on the decline.2 That was before HPV-infected individuals became the fastest growing segment of the oral cancer population. HPV16 is a human papillomavirus related to more than 150 other HPV versions, over 40 of which can be easily sexually transmitted.3 Nine of these are known to be cancer causing. HPV’s were directly linked to cervical cancer, also squamous cell carcinoma, which was the number one killer of women in 1948. “Using the cervical cancer model, once ‘opportunistic’ screening and PAP testing became routine, the cervical cancer death rate dropped 71% in 10 years,” Hill notes. “We have no ‘viruscide’. But we do have an HPV vaccine that can be administered before young people become sexually active.” This is important information to share with patients, because 50%-80% of Americans will have HPV in their lifetime according to the Center for Disease Control and Prevention (CDC). About half of all men and more than 3 out of 4 women will be diagnosed with it at some point.4

Detection vs Diagnosis

Signs and symptoms or oral cancer, if there are any, range from a sore area or lesion that bleeds easily, a lump or thickening of tissues in the mouth or neck, ear pain, indurations or hard spots in the mucosa, or a red or white patch or ulceration that does not resolve within 2 weeks. If any of these are evident, the patient should return within 7-14 days to confirm either persistence or resolution. Later symptoms include difficulty chewing, swallowing, and/or moving the tongue or jaws.2

Early stage (1 and 2) lesions, which may not be readily evident during a routine exam, usually are asymptomatic and often mimic other conditions.5 It is important for dentists to acknowledge that malignant and benign lesions are virtually indistinguishable clinically, and their biological relevance cannot be assessed based on their appearance.5 Most resources advise referring any persistent abnormalities to a specialist. “We have a highly defined referral system in dentistry,” Hill points out. “You don’t have to learn anything new; you don’t have to be the expert. You just have to refer suspect tissues up the professional chain for proper evaluation/biopsy. There are many kinds of oral lesions. You may see only 3 cancer cases in 20 years of practicing dentistry, but every time you find something, especially in stage 1 or 2, you have the opportunity to save a life. Dentists are the first line of defense.”

The American Cancer Society estimated in 2009 that almost 90% of oral cancers are squamous cell carcinomas, and more than 97% of these cancers occur in adults 35 years and older.5 People ranging in age from 25-50 who never smoked are the fastest growing group being diagnosed with HPV16-related oral cancer.6

Standard treatment usually involves radiation therapy and surgery, and often chemotherapy.2 Relative survival rates vary by stage at the time of diagnosis—in 2009, about 83% survived 1 year after diagnosis, 60% 5 years after diagnosis, and 49% after 10 years.2 However, today, the 5-year survival rate is only about 57% when you include all stages of the disease at time of discovery. This high death rate is directly tied to late discovery, when treatments are less effective.7 Studies reveal that oral and pharyngeal cancer are diagnosed at a localized stage in only one-third of patients in the United States.5 It’s time to make a difference.

The Oral Cancer Foundation

The Oral Cancer Foundation (OCF) is a national public service, non-profit organization dedicated to oral cancer prevention, education, research, advocacy, and patient support activities. Its website, www.oralcancerfoundation.org, provides vetted information about rates of occurrence, risk factors, signs and symptoms, treatments, current research, complications, nutrition, clinical trials, related news, links to other sources, and treatment institutions. A free, anonymous, 8700-member patient/survivor discussion forum is open to the public, providing insights and inspiration. OCF also has a free RSS oral cancer news feed you may subscribe to which is updated several times a week. OCF is a valuable resource for patients, students, and practicing medical and dental professionals.

Visit oralcancerfoundation.org to learn of its Oral Cancer Awareness Month initiatives (such as hosting a free screening event in April), and find information to share with your patients.

This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.

HPV Vaccine Reduces All Subtypes of HPV Disease

Source: Medscape.com

Human papillomavirus (HPV) vaccination substantially reduced the risk for subsequent HPV disease in women who already had 1 bout of HPV-related disease, according to a study published online today in BMJ.

“These are, to our knowledge, the first results in vaccinated women who have undergone treatment for HPV-related disease,” write the authors, headed by Elmar Joura, MD, from the Medical University of Vienna in Austria.

The data come from a subgroup of women who participated in trials of the quadrivalent HPV vaccine Gardasil (Merck & Co).

Women who had HPV infection at the time of vaccination and who developed cervical, vulvar, or vaginal HPV disease had a substantially reduced risk of developing subsequent HPV-related disease after the first definitive treatment.

HPV vaccination substantially reduced the risk for subsequent HPV disease — not only that caused by the 4 viral strains in the quadrivalent vaccine (HPV subtypes 6, 11, 16, and 18), but also that caused by other strains of HPV-related disease.

This study “reinforces much of what we already know about the protective properties of the quadrivalent vaccine, including cross-protection against nonvaccine HPV types and vaccine benefit despite HPV exposure,” writes Jane Kim, assistant professor of health decision science at Harvard School of Public Health, Boston, Massachusetts, in an accompanying editorial.

Subgroup of Women

The study analyzed data collected from 2 large company-sponsored placebo-controlled trials of Gardasil, known as FUTURE I and FUTURE II. Together, they involved 17,622 women 15 to 26 years of age who were randomized to receive 3 doses of the quadrivalent HPV vaccine or placebo. They were subsequently followed for approximately 4 years.

The analysis focused on a subgroup of 2054 women who participated in these trials and who were subsequently treated for cervical, vulval, or vaginal disease.

More than half of this subgroup (1350 women) underwent cervical surgery (which included any method used to treat cervical disease) — 763 from the placebo group and 587 from the vaccine group.

The researchers calculate that the incidence of any subsequent HPV-related disease in the cervix was 6.6 in the vaccine group and 12.2 in the placebo group — a reduction of 46.2% with vaccination.

When only high-grade disease of the cervix was considered, this reduction is even greater; vaccination reduced the risk for any subsequent high-grade disease of the cervix by 64.9%.

The remaining women in the subgroup (229 in the vaccine group and 475 in the placebo group) were subsequently diagnosed with either genital warts or vulvar or vaginal intraepithelial neoplasia. Here, the incidence of any subsequent HPV-related disease was 20.1 in the vaccine group and 31.0 in the placebo group — a reduction of 35.2% with vaccination.

This was primarily driven by a reduction in the incidence of genital warts (63% reduction after vaccination), the authors note.

In all cases, the reduction was for all subtypes of HPV-related disease, including strains of HPV virus that were not included in the vaccine.

New Findings Welcome

These findings are “welcome,” Dr. Kim writes.

This study “moves us closer to understanding the full scope of benefits from HPV vaccination by showing for the first time that vaccine protection against disease can endure beyond the management of HPV-related disease in women already vaccinated,” she adds.

However, Dr. Kim takes issue with some of the conclusions drawn by the authors.

This study corroborates previous findings that the benefits of vaccination are not limited to the primary target group of young sexually naïve girls, Dr. Kim explains. The findings highlight the importance of vaccinating at an early age, when exposure to HPV is minimal, to maximize protection against all HPV types targeted by the vaccine.

Most important, she adds, this study examines a unique subgroup of women who were vaccinated before their first treatment for HPV-related disease. The authors suggest that these results could be generalized to women who are considering HPV vaccination after treatment for HPV-related disease, but Dr. Kim disagrees, and suggests that more data are needed.

“Only surveillance of vaccinated populations in the real world can provide clear evidence of the effectiveness of the vaccine in women who have been treated before vaccination,” Dr. Kim writes. “As we await this information, it is important to emphasize to providers and decision makers that generalizations of study findings are premature.”

The study was funded by Merck & Co. Dr. Joura reports receiving advisory board fees from Merck; and lecture fees from Merck, Sanofi Pasteur MSD, and GlaxoSmithKline. Several coauthors are employees of Merck & Co, and several report receiving funding from Merck and GlaxoSmithKline for HPV vaccine studies, and from other pharmaceutical companies. Dr. Kim has disclosed no relevant financial relationships.

This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.

April, 2012|Oral Cancer News|