Monthly Archives: September 2009

Early postoperative Taxol® may improve outcomes in high-risk head and neck cancer

Author: staff

Researchers involved in the RTOG 0024 study have reported that the administration of early adjuvant Taxol® (paclitaxel) followed by concurrent chemoradiotherapy may improve local control and improve disease-free survival in patients with high-risk head and neck carcinoma. The details of this study appeared in the Journal of Clinical Oncology early online on August 31, 2009.[1]

There have been several randomized and non-randomized clinical trials that suggest that the concomitant administration of platinum-based chemotherapy and radiotherapy (RT) is superior to RT alone for the treatment of patients with advanced head and neck cancer for local and regional control. Most, but not all, have also shown a survival advantage for combined treatment.

An intergroup trial with participation of RTOG, ECOG, and SWOG compared post-operative radiotherapy alone or with concurrent Platinol® (cisplatin) for patients with high-risk head and neck cancer. This study showed that the addition of adjuvant Platinol decreased local recurrences but had no significant impact on metastatic disease or overall survival. An EORTC trial showed that the addition of Platinol to RT improved progression-free and overall survival by 10% and improved overall survival by the same degree.

The current study (RTOG 0024) sought to improve the results of adjuvant chemoradiotherapy in high-risk head and neck cancer patients by administering Taxol postoperatively on weeks 2, 3, and 4 prior to RT. Taxol and Platinol were administered concomitantly with RT after week 4. This study was compared to the previous RTOG trial 9501, which administered Platinol alone with RT.

The current study enrolled 70 patients with high-risk head and neck carcinoma, which was defined as positive surgical margins, extracapsular nodal extension, or multiple positive lymph nodes. The median follow-up was 3.3 years. This regimen appeared to be reasonably well tolerated with a compliance rate of 75.4%. There was one death during the concurrent chemoradiotherapy part of treatment due to myocardial infarction.

The estimated two-year loco-regional relapse rate was 12.4%. New primary tumors occurred in 13.8%. The estimated two-year disease-free survival was 59.5%. The estimated two-year overall survival was 64.7%. A comparison to RTOG trial 9501 suggested an improvement in overall survival and disease-free survival. These authors suggest that this earlier treatment may represent an improvement over previous studies. They suggest that even earlier administration of chemotherapy postoperatively or prior to surgery (neoadjuvant administration) should be explored.

Comments: These data suggest that the addition of a taxane to high-risk patients treated with adjuvant Platinol and RT was of significant benefit.

1. Rosenthal DI, Harris J, Forastiere AA, et al. Early postoperative paclitaxel followed by concurrent paclitaxel and cisplatin with radiation therapy for patients with resected high-risk head and neck squamous cell carcinoma: Report of the Phase II Trial RTOG 0024. Journal of Clinical Oncology [early online publication]. August 31, 2009.

September, 2009|Oral Cancer News|

FDA Panel OKs HPV Vaccine Gardasil for Boys

Source: WebMD
Author: Miranda Hitti

Sept. 9, 2009 — An FDA advisory committee voted to recommend approval of the vaccine Gardasil for males ages 9 to 26 to prevent genital warts.

Gardasil targets four strains of human papillomavirus, commonly called HPV. Males can carry HPV and transmit it sexually to their partners.

HPV can cause genital warts and penile and anal cancer in men. Each year, about 200 out of 100,000 males are newly diagnosed with genital warts, according to background information cited by the FDA. Penile cancer and anal cancer are much rarer.

Gardasil already has FDA approval for use in females ages 9 to 26. In females, HPV can cause cervical cancer.

The FDA advisory committee ruled 7 to 0, with one abstaining vote, that Gardasil’s clinical trial data support the vaccine’s effectiveness at preventing genital warts in males ages 9 to 26. And in a 7 to 1 vote, the advisory committee ruled that the data show Gardasil to be safe for males in that age range.

The FDA advisory committeereviewed three studies of Gardasil that together included more than 5,000 males ages 9 to 26 in various countries including the U.S.

Participants got a total of three shots of Gardasil or a placebo spread over six months. They also got checkups and tests to check for HPV infection.

Gardasil was 89% effective in preventing genital warts. The vaccine was less effective in participants who had already been exposed to HPV.

No serious side effects were seen, according to information posted on the FDA’s web site.

The most commonly reported adverse events were fever and headache. Injection site reactions were more common with Gardasil than with the placebo. Most of those reactions were mild to moderate in intensity, Gardasil’s maker, the drug company Merck, states in a document posted on the FDA’s web site.

Gardasil is already licensed for use in males in many countries, and there haven’t been any red flags raised about the vaccine’s safety in the limited number of international safety reports that have been done, FDA documents state. But the FDA says that post-marketing surveillance and studies will be “essential” if Gardasil is approved for males.

There weren’t enough data to assess Gardasil for preventing other conditions, since those conditions were so rare, the FDA notes.

It’s now up to the FDA to decide whether to approve Gardasil to prevent genital warts in boys and young men. The FDA often follows the recommendations of its advisory committees, but it isn’t required to do so.

Gardasil is up for FDA consideration only as a way to prevent genital warts in boys — not to prevent cancer in males or to curb transmission of the HPV virus to women.

September, 2009|Oral Cancer News|

Vitamin D for cancer prevention: global perspective

Source: Ann Epidemiol. 2009 Jul 1;19(7):468-483,
Authors: CF Garland, ED Gorham, AR Mohr, FC Garland


Higher serum levels of the main circulating form of vitamin D, 25-hydroxyvitamin D (25(OH)D), are associated with substantially lower incidence rates of colon, breast, ovarian, renal, pancreatic, aggressive
prostate and other cancers.

Epidemiological findings combined with newly discovered mechanisms suggest a new model of cancer etiology that accounts for these actions of 25(OH)D and calcium. Its seven phases are disjunction, initiation, natural selection, overgrowth, metastasis, involution, and transition (abbreviated DINOMIT). Vitamin D metabolites prevent disjunction of cells and are beneficial in other phases.

It is projected that raising the minimum year- round serum 25(OH)D level to 40 to 60 ng/mL (100­150 nmol/L) would prevent approximately 58,000 new cases of breast cancer and 49,000 new cases of colorectal cancer each year, and three fourths of deaths from these diseases in the United States and Canada, based on observational studies combined with a randomized trial. Such intakes also are expected to reduce case-fatality rates of patients who have breast, colorectal, or prostate cancer by half. There are no unreasonable risks from intake of 2000 IU per day of vitamin D3, or from a population serum 25(OH)D level of 40 to 60 ng/mL. The time has arrived for nationally coordinated action to substantially increase intake of vitamin D and calcium.

September, 2009|Oral Cancer News|

Particle beam radiation therapy promising but unproven for treating cancer


Particle beam radiation therapy, a technology used to treat several types of cancer, is considered by some clinicians to be better than traditional radiation, but there is limited evidence about its safety compared with other types of radiation therapy, according to a new comparative effectiveness report funded by HHS’ Agency for Healthcare Research and Quality.

“As technologies develop and new clinical interventions arise, it is important to balance access to potentially beneficial new technologies with ongoing research and evaluation to determine whether the technologies deliver what they promise,” said AHRQ Director Carolyn M. Clancy, M.D. “Increased funding for comparative effectiveness research is an exciting opportunity to continue important research on medical therapies and interventions.”

Particle beam radiation therapy — also known as charged particle radiation therapy or proton beam radiation therapy — uses beams of protons or other charged particles for cancer radiation treatment. Particle beam radiation therapy is an alternative to other types of cancer radiation therapy such as external radiotherapy with ionizing photon (X- or gamma-ray) beams or brachytherapy with implanted radioactive sources.

All types of radiation therapy can harm both cancerous and healthy tissues, so clinicians strive to target the radiation to the cancer while avoiding adjacent healthy tissues. This is particularly important for tumors adjacent to critical body parts such as those in the eye, brain, head and neck. Particle beam radiation therapy can target the radiation with a high degree of precision, but its potential advantages over other radiotherapy alternatives have not been verified in long-term outcome studies, according to the new AHRQ technical brief.

Particle beam radiation therapy was introduced as an experimental treatment in the 1950s but was not cleared for widespread use by the U.S. Food and Drug Administration until 2001. The technology is very expensive — an estimated $175 million for each device — and is usually only available in large academic medical centers. Only seven centers in the United States currently provide the therapy, with an additional center currently under construction and expected to be operational by 2010. Although details have not been disclosed, several other hospitals are considering developing smaller treatment facilities based on upcoming technologies that have not yet been cleared by the Food and Drug Administration.

The technical brief did not indicate that particle beam radiation therapy is riskier than conventional radiation therapy. However, most studies about the therapy were conducted on small numbers of patients and did not compare the safety of particle beam radiation therapy against other therapies. For many cancers other than head and neck cancers, there are not enough comparative studies in the literature to base an evaluation of the clinical or cost effectiveness of particle beam radiation therapy compared with other treatments. AHRQ is currently reviewing scientific studies on radiation therapies for head and neck cancers that will evaluate the clinical effectiveness of particle beam radiation therapy for those cancers.

The report is the Agency’s first in a series of technical briefs — rapid-turnaround reports that summarize key issues regarding emerging treatments. Technical briefs highlight where more research is needed and where research may be sufficient to warrant a full systematic review. Technical briefs are produced by AHRQ’s Effective Health Care program. Future technical briefs will describe the evidence on fetal surgery, stereotactic surgery for non-brain cancers and percutaneous heart valves.

AHRQ’s new report, Technical Brief: Particle Beam Radiation Therapies for Cancer, is the newest research review from the Agency’s Effective Health Care program. That program, authorized by the Medicare Prescription Drug, Improvement and Modernization Act, represents an important federal effort to compare alternative treatments for health conditions and make the findings public. The program is intended to help patients, doctors, nurses, pharmacists and others choose the most effective treatments. Information can be found at

Agency for Healthcare Research & Quality

September, 2009|Oral Cancer News|

Review: Erythropoietin could harm some cancer patients

Author: staff

A new review of data confirms that erythropoietin might be unsafe for people with head and neck cancers who receive the drug in combination with radiation: Radiation patients who were given erythropoietin had poorer outcomes than those who undergoing radiation treatment alone.

The hormone erythropoietin is used to combat the anemia suffered by many people undergoing cancer treatment. Because severe anemia can lower the oxygen supply to tumor cells, decreased oxygen in these cells is associated with more rapid tumor progression and a poorer response to therapy. “It has therefore been thought logical that using erythropoietin to correct anemia before or during chemotherapy, radiotherapy, or both would improve the prognosis,” observed radiation oncologist Phillippe Lambin and colleagues from the MAASTRO (Maastricht Radiation Oncology) Clinic in the Netherlands. Their review was published in The Cochrane Library (July 2009, issue 3), a publication of The Cochrane Collaboration, an international organization that evaluates medical research.

Dr Lambin’s team analyzed data from 5 published clinical trials involving nearly 1400 patients. The studies focused on whether combined radiation and erythropoietin was better than standard radiation therapy alone in the treatment of head and neck cancers. The reviewers learned that compared with patients who did not receive erythropoietin, those who did take it had significantly worse overall survival and significantly shorter times before their cancers worsened.

Data included in the review suggested that the reduced survival rates in the erythropoietin patients were not due to some toxic effect of the drug itself, such as an increase in deaths due to blood clots. The investigators instead hypothesize that the drug might actually cause some types of tumors to grow, and have concluded that patients with head and neck cancers should not receive erythropoietin as an addition to radiation therapy.

From the September 2009 Issue of ONN

September, 2009|Oral Cancer News|

A dying smoker, with a British accent

Author: Jennifer B. Lee

The city’s Department of Health and Mental Hygiene — never an agency to shy away from using vivid, even grisly, images to combat what it sees as public health scourges, namely soda and cigarettes — is unveiling a new television advertisement to discourage New Yorkers from smoking.

This one focuses on the emotional toll of tobacco. It features a British man, Anthony, who is dying of lung and throat cancer, but wheezes out that he is looking forward to seeing his daughter during the holidays. The next frame reveals that Anthony died 10 days later, without having seen his daughter again.

City Room wondered how New York City viewers could end up watching a British man in an antismoking ad. After all, the other antismoking stars of late have had New York ties: Ronaldo Martinez, a one-time Bronx resident who uses a device to speak from his throat, and Marie, also of the Bronx, a woman with numerous amputations.

It turns out there are a number of central online clearinghouses for antitobacco advertising where health departments and nonprofit organizations can essentially share their outreach efforts. The two most prominent exchanges are run by the Centers for Disease Controls and Prevention and World Lung Foundation. For example, the ad featuring Mr. Martinez, which was originally developed for Massachusetts, is also being used in Australia.

“There is so much effective media being produced throughout the world,” said Elizabeth Kilgore, acting assistant commissioner of tobacco control at the health department. “We take advantage of it. I personally look very often to see if there is anything new.”

The new ad featuring Anthony, which began on Monday and will run for three weeks, was originally produced for Britain’s health department. New York City’s health department discovered it on the World Lung Foundation’s site about six months ago, Ms. Kilgore said. While the licensing fees to run these ads can vary greatly, the health department is paying less than $1,000, she said.

Local officials have sometimes had to tweak foreign ads, even if they were produced in English. For example, one ad featured people with a strong Australian lilt. “We voiced those over with an American accent,” Ms. Kilgore said.

However, the city decided not to do such a voice-over with the new British-made ad. “With Anthony, we thought his voice was so effective, because you can hear the illness in his voice,” she said. “In this case, we thought it was very effective at not dubbing it over.”

September, 2009|Oral Cancer News|

FDA Advisory Committee recommends approval for use of GARDASIL® in boys and men

Author: press release

Merck & Co., Inc. announced today that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee agreed that efficacy, immunogenicity and safety data from clinical trials in males support the use of GARDASIL¨ [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] in boys and men 9 through 26 years of age for the prevention of genital warts caused by human papillomavirus (HPV) types 6 and 11.

“Merck has been committed to pursuing the use of GARDASIL in both males and females since the vaccine was discovered over a decade ago,” said Peter S. Kim, Ph.D., executive vice president, and president of Merck Research Laboratories.  “We are pleased that the Advisory Committee agrees that the data support the use of GARDASIL in boys and men.”

The committee’s recommendation will be considered by the FDA in its review of the supplemental Biologics License Application (sBLA) that Merck submitted for GARDASIL in December 2008.  The FDA is not bound by the committee’s guidance, but takes its advice into consideration when reviewing vaccines.  Merck expects a decision from the FDA in the fourth quarter of 2009 after the agency has completed its review of Merck’s application.

“Today’s discussion with the Advisory Committee brings the public health community closer to being able to provide GARDASIL to both men and women,” said Anna R. Giuliano, Ph.D., Moffitt Cancer Center.

GARDASIL has been approved for use in the U.S. since June 2006 and is currently indicated for use in girls and young women 9 through 26 years of age for the prevention of  more cervical, vulvar and vaginal cancers caused by HPV types 16 and 18; genital warts caused by HPV types 6 and 11; and precancerous or dysplastic lesions caused by HPV types 6, 11, 16 and 18.  More than 50 million doses have been distributed worldwide through June 2009, although the number of doses administered is not known.

Data for use of GARDASIL in boys and men presented
Clinical trials presented to the Advisory Committee evaluated the efficacy, immunogenicity and safety of GARDASIL in boys and men 9 to 26 years of age.  Vaccine efficacy in males was evaluated in a randomized, double-blind, placebo-controlled trial.  A total of 4,055 men were enrolled and received at least one dose of GARDASIL or placebo.  Of these, 3,457 were heterosexual men aged 16 to 23 years and 598 were men who have sex with men aged 16 to 26 years.

The per-protocol efficacy (PPE) population was the predefined primary population for the demonstration of efficacy in 16- to 26-year-old men. As defined, this population included subjects who were not infected with HPV vaccine types at the start of the study, nor did they become infected with HPV vaccine types during the course of the vaccination series.  These subjects were seronegative and HPV DNA negative to HPV vaccine types at day one, and HPV DNA negative through the vaccination series to month seven.  This population also received the three shot series within a one-year time period and generally did not deviate from the protocol.  The cases of the primary endpoint of external genital lesions (EGL) were counted starting after month seven.

Analyses were also conducted in the Full Analysis Set (FAS) population. The FAS population included all participants who received at least one dose of vaccine or placebo and endpoint cases were counted after day one, the day after the first dose of vaccine was given. The key difference from the PPE population was that the FAS also included participants who had been previously exposed, were already infected with HPV types, or became infected before the completion of the three-dose vaccine series (not specific to 6, 11, 16 and 18). 

Per protocol efficacy
In the PPE analysis, GARDASIL was 90.4 percent efficacious (95 percent CI: 69.2, 98.1) against HPV 6, 11, 16 and 18-related EGL.  Of 34 cases of EGL, 31 were genital warts.  All cases of genital warts were positive for HPV 6 and/or 11 (three cases in the vaccine group and 28 in the placebo group).  GARDASIL was 89.3 percent efficacious (95 percent CI: 65.5, 97.9) against HPV 6/11-related external genital warts.

There were three cases of HPV 6/11/16/18-related penile/perianal/perineal intraepithelial neoplasia (PIN) in the PPE analysis and all were in the placebo group.  No cases of penile/perianal/perineal cancers were observed in the vaccine or placebo groups during the study.  Although vaccine efficacy against HPV 6/11/16/18-related PIN 1 or worse was 100 percent (95 percent CI: <0, 100), there was no statistical significance due to the small number of cases seen in the study.

Full analysis set
In the FAS analysis, GARDASIL was 65.5 percent efficacious (95 percent CI: 45.8, 78.6) against HPV 6, 11, 16 and 18 EGL.  Of 104 cases of EGL, 95 were genital warts positive for HPV 6 and/or 11 (24 cases in the vaccine group and 71 in the placebo group).  GARDASIL was 66.8 percent efficacious (95 percent CI: 46.5, 80.0) against HPV 6/11-related external genital warts in this analysis.

In immunogenicity studies, GARDASIL generated robust immune responses to HPV types 6, 11, 16 and 18 in 9- to 15-year old boys and 16- to 26-year old men.

Immunobridging studies in 9- to 15-year old boys demonstrated that boys had approximately two to three fold higher HPV type-specific antibody levels at month seven compared to 16- to 26-year old men.  These data established the non-inferiority of the peak immune response as measured at month seven for all four HPV-types in boys as compared to men.

Safety data for GARDASIL
Compared with placebo recipients, a slightly higher proportion of vaccinees reported injection site (64.1 percent GARDASIL; 53.6 percent placebo) and systemic adverse experiences

(37.2 percent GARDASIL; 32.6 percent placebo), the majority of which were reported as mild to moderate intensity. Subjects who reported a severe intensity systemic adverse experience and/or an injection-site adverse experience were comparable between the two groups (systemic adverse experiences reported: 4.3 percent in the GARDASIL group versus 3.0 percent in the placebo group; injection-site adverse experiences reported: 2.0 percent in the GARDASIL group versus 1.0 percent in the placebo group).  Overall, the safety profile observed in boys and men 9 to 26 years of age in clinical studies was consistent with the safety profile observed in clinical studies in girls and women 9 to 26 years of age.

Important information about GARDASIL
GARDASIL does not substitute for routine cervical cancer screening, and women who receive GARDASIL should continue to undergo screening.

GARDASIL has not been demonstrated to provide protection against diseases from vaccine and non-vaccine HPV types to which a woman has previously been exposed through sexual activity. GARDASIL is not intended to be used for treatment of active genital warts; cervical, vulvar, and vaginal cancers; cervical intraepithelial neoplasia (CIN), vulvar intraepithelial neoplasia (VIN) or vaginal intraepithelial neoplasia (VaIN).

GARDASIL has not been demonstrated to protect against diseases due to HPV types not contained in the vaccine.  Not all vulvar and vaginal cancers are caused by HPV, and GARDASIL protects only against those vulvar and vaginal cancers caused by HPV Types 16 and 18.

Select safety information
GARDASIL is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL.

Because vaccinees may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended.  Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following vaccination with GARDASIL. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion.

GARDASIL is not recommended for use in pregnant women.

The most common adverse reaction was headache.  Common adverse reactions that were observed among recipients of GARDASIL at a frequency of at least 1.0 percent and greater than placebo were: fever, nausea, dizziness; and injection-site pain, swelling, erythema, pruritus and bruising.

Dosage and administration for GARDASIL
GARDASIL is a ready-to-use, three-dose, intramuscular vaccine.  GARDASIL should be administered in three separate intramuscular injections in the deltoid region of the upper arm or in the higher anterolateral area of the thigh.  The following dosage schedule is recommended: first dose at elected date, second dose two months after the first dose and the third dose six months after the first dose.

About HPV
There are more than 100 types of HPV, of which about 30 to 40 types can infect the genital areas of women and men.  HPV types 6 and 11 cause approximately 90 percent of genital warts cases. About one million people (both males and females) have visible genital warts at any point in time. There are currently no routine HPV screening methods in place for men.

GARDASIL is approved in 112 countries
GARDASIL (sold in some countries as SILGARD¨) has been approved in 112 countries, and additional applications are currently under review with regulatory agencies in many more countries around the world.

About Merck
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first.  Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs.  The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them.  Merck also publishes unbiased health information as a not-for-profit service.  For more information, visit 

September, 2009|Oral Cancer News|

Fury as doctors call for ban on booze ads and sponsors

Author: Lyndsay Moss

Doctors have called for a total ban on alcohol advertising and sponsorship of sport and music events to tackle the UK’s serious drink problems. The British Medical Association (BMA) yesterday outlined a measures to “tackle the soaring cost of alcohol-related harm”. Doctors said sponsorship of sporting and music events such as T in the Park must end because of the influence such marketing has on young people, in particular. They also called for an end to promotions such as two-for-one deals and ladies’ free entry nights at clubs.

The calls sparked anger from alcohol industry chiefs, who said controls were already in place and further restrictions would have a negative impact on jobs and might even lead to increased consumption. But health campaigners backed the recommendations in a report compiled by Stirling University.

The BMA also renewed its calls for a minimum price to be set per unit of alcohol – a move being pursued in Scotland – and for alcohol to be taxed at a higher rate than inflation.

Drink firms’ sponsorship of sport and music events has become widespread in recent years. The BMA highlighted deals such as Carling, which sponsors both the Celtic and Rangers football clubs, and Johnnie Walker whisky, which is a sponsor of the Formula One McLaren Team. The Scottish music festival T in the Park is sponsored by Tennent’s lager.

The BMA study, Under The Influence, said alcohol consumption in the UK had increased rapidly in recent years. It blamed advertising and heavy discounting and 24-hour licensing laws. The report states: “The population is drinking in increasingly harmful ways and the result is a plethora of avoidable medical, psychological and social harm, damaged lives and early deaths.”

It said controls on promotion were “inadequate” as they were based on voluntary agreements with the industry and focused on content, rather than the amount of alcohol advertising.

Dr Vivienne Nathanson, head of science and ethics at the BMA, said the body was not “anti- alcohol” but doctors were right to focus on patients’ health.

“Over the centuries, alcohol has become established as the country’s favourite drug,” she said. ” “Young people are drinking more because the whole population is drinking more and our society is awash with pro-alcohol messaging and marketing.”

One of the report’s authors Gerard Hastings, professor of social marketing at Stirling University, said: “Given the industry spends £800 million a year in promoting alcohol in the UK, it is no surprise that we see it everywhere. Given that adolescents often dislike the taste of alcohol, new products like alcopops and toffee vodka are developed.

“All these promotional activities serve to normalise alcohol as an essential part of everyday life. It is no surprise that young people are drawn to alcohol.”

Advertising Association chief operating officer Rae Burdon said: “The current rules regulating alcohol advertising in the UK provide a strictly-enforced framework for companies to communicate commercial messages responsibly in a mature and competitive alcoholic beverage market.”

Wine and Spirit Trade Association chief executive Jeremy Beadles said that, in the face of the worst recession since the 1930s, the BMA was calling for measures that would “hit the pockets of millions of consumers and threaten the livelihoods of thousands of people in the media, advertising, television, not to mention the drinks industry”.

David Poley, chief executive of the Portman Group, which represents companies that produce most of the alcohol sold in the UK and regulates marketing, said doctors were dismissing the existing strict controls.

He added: “The BMA is ignoring all the evidence that advertising causes brand-switching, not harmful drinking. The University of Sheffield found (a ban] would create fiercer price competition, which could actually increase overall consumption.”

The Scottish Government has brought forward proposals for a minimum price per unit of alcohol. Yesterday public health minister Shona Robison said: “We have worked with the industry to draw up Scottish sponsorship guidelines, which state that alcohol promoters must ensure their brands are not used to sponsor teams, celebrities or events with particular appeal to under-18s.”

It could be some time before the BMA’s calls for an advertising ban have a notable impact. The association started campaigning for a ban on smoking in public places in 1981 – with the first UK legislation on this taking place in Scotland in 2006.

The advertising industry pointed out that the marketing of alcohol was already subject to restrictions.

Alcohol Facts:
• UK alcohol industry spends approximately £800 million each year on advertising.
• It is related to more than 60 medical conditions, costs the NHS millions of pounds every year.
• £2.5 billion is spent annually by Scotland’s public services dealing with alcohol-related problems.
• The cost to the NHS for treating drink-related injury and illness has been estimated to be anything up to £3bn a year in the UK.
• Household spending on alcohol increased by 81 per cent between 1992-2006.
• Alcohol was 69.4 per cent more affordable in 2007 than it was in 1980.
• Cancer research UK has published figures showing an increase of 51 per cent in oral cancer rates in the last 20 years, which they attribute to increased alcohol consumption.
• The Competition Commission have found that five leading grocery retailers sold £38.6 million worth of alcohol at below-cost during the 2006 World Cup.
• The average estimated strength of table wine increased from 11.40 per cent in 1994/95 to 11.85 per cent in 2003-04
• The average estimated strength of beer increased from 4.06 per cent in 1994-95 to 4.19 per cent in 2003-04.
• Absenteeism from work – totally 17 million working days are lost each year – costing the economy about £1.5bn annually.

French Rules Irk Vintners
Despite being the world’s largest consumer of wine, France has some of the toughest regulations governing alcohol advertising outside the Middle East.

Since 1991, advertising of alcoholic drinks has been outlawed everywhere except in the press, on billboard posters and on the radio after 10pm. Even then, adverts must contain the a warning that alcohol is harmful and should be consumed in moderation.

The law, known as the Loi Evin after a former health minister, also bans “direct or indirect” advertising on television. This means posters around sports stadiums, or logos on racing cars or footballers’ shirts – or any other televised event where references to alcohol could be picked up on TV cameras – are also illegal in France.

The law is so strictly enforced that rugby’s Heineken Cup is simply called the European Rugby Cup in France, and many of the world’s major alcohol brands block French users from their websites for fear of prosecution.

But while government insists the tight controls on advertising are crucial to public health, the drinks industry claims it is being “demonised”.

CIVC champagne producers’ body spokesman Daniel Lorson said recently: “Today in France, the sight of a bottle of wine has become as offensive as a picture of war or pornography.”

September, 2009|Oral Cancer News|

Periodontitis associated with fourfold increased risk for squamous cell carcinoma of the head and neck

Author: staff

Results of a study involving 473 participants showed that periodontitis was linked with the development of squamous cell carcinoma of the head and neck.

Researchers conducted a hospital-based case-control study between June 1999 and November 2005. The study involved 266 patients with head and neck cancer treated at the Roswell Park Cancer Center’s department of dentistry and maxillofacial prosthetics, and 207 healthy participants.

The researchers said that after adjusting for age at diagnosis, gender, race/ethnicity, marital status, smoking status, alcohol use and number of missing teeth, each millimeter of alveolar bone loss was associated with a more than fourfold increased risk of SCCHN (OR=4.36; 95% CI, 3.16-6.01). When researchers evaluated disease at specific head and neck sites, they found strength of the association was higher in the oral cavity (OR=4.52; 95% CI, 3.03-6.75) compared with the oropharynx (OR=3.64; 95% CI, 2.54-5.22) and larynx (OR=2.72; 95% CI, 1.78-4.16).

The researchers also said that there was a link between smoking and alveolar bone loss (P=.03), although the association between alveolar bone loss and SCCHN was weaker in current smokers (OR=2.85) compared with former smokers (OR=7.59) and never smokers (OR=5.96).

Alcohol use was not found to be a significant risk factor. The researchers said the association between alveolar bone loss and SCCHN was similar in drinkers and nondrinkers.

Tezal M. Cancer Epidemiol Biomarkers Prev. 2009;doi:10.1158/1055-9965.EPI-09-0334.

September, 2009|Oral Cancer News|

Clove cigars avoid ban on flavored cigarettes

Author: staff

The nation’s top distributor of clove cigarettes is offering fans a new way to get their fix after the spice-flavored cigarettes are banned at the end of this month—cigars.

The new filtered cigars—close to the size of a cigarette and flavored with clove, vanilla and cherry—allow Kretek International Inc., which imports Djarum-brand tobacco products from Indonesia, to avoid new federal laws banning flavored cigarettes other than menthol.

The ban on flavored cigarettes, which critics say appeal to teenagers, doesn’t include cigars.

The difference? Cigarettes are wrapped in thin paper, cigars in tobacco leaves. While the cigars also are made with a different kind of tobacco, the taste is similar. The cigars come 12 to a pack, rather than 20 for cigarettes, but cost nearly half as much.

The ban is one of the first visible effects of a new law signed by President Barack Obama in June that gives the Food and Drug Administration wide-ranging authority to regulate tobacco, though it can’t ban nicotine or tobacco outright.

The new law gives the FDA the power to ban other products like flavored cigars, but that hasn’t happened yet.

Whether the cigars are truly different or just an attempt to circumvent the ban by making superficial changes is in the hands of the FDA, said Matthew Myers, president of the Campaign for Tobacco-Free Kids.

“The key is the legislation gives the FDA the authority to respond to these types of frankly totally irresponsible actions,” Mr. Myers said.

Mr. Myers joined executives from the American Cancer Society, American Heart Association, American Lung Association and the Amercian Legacy Foundation late last month urging the FDA to take a closer look at the issue. Often associated with bohemians, clove cigarettes may be the best-known target of the ban. Some major cigarette makers experimented with mint- or chocolate-flavored blends earlier this decade, but many of those products are no longer made after coming under fire, accused of targeting children.

John Geoghegan, director of brand development for Moorpark, Calif.-based Kretek International, said the private company has been “puzzled about (the ban) since the very beginning” because clove cigarettes constitute less than 1% of cigarettes sold in the U.S.

“For people to say, ‘Well, clove is a starter cigarette or a trainer cigarette’ or something was just preposterous,” Mr. Geoghegan said, citing company research about when and how consumers begin smoking.

Kretek International holds a 97% U.S. market share with its line of Djarum clove cigarettes, a staple of Indonesia’s smoking culture.

The U.S. market for clove cigarettes is about $140 million annually, with about 1.25 million clove smokers. Cloves have been imported to the U.S. since the 1960s and are mostly smoked by people younger than 30.

While Mr. Geoghegan said clove cigarettes make up about 65% of Kretek International’s business, the ban is “damaging but not fatal” because of the company’s other products like lighters and pipe tobacco.

Now, clove smokers are being forced to decide whether to switch to the new cigars, or quit. Many will likely stock up or try to buy the product over the Internet.

And how the ban will work remains a point of contention for shop owners who sell clove cigarettes. But the FDA says the message is clear: Flavored cigarettes are banned, and the agency has the authority necessary to enforce the prohibition.

“So, what do we do with the stuff that’s on the shelves? Who eats that? Is it legal to sell until it’s gone or what?” asked Jim Carlson, owner of two CVille Smoke Shop stores in Charlottesville, Va., about 70 miles northwest of Richmond.

Mr. Carlson said he sells about 3,000 packs of the flavored cigarettes a year.

“You don’t make a lot of money, but still it’s income … and it brings customers into the store,” he said.

Lake Isabella, Calif., resident Terry Day, 42 years old, used to drive 240 miles round-trip to buy clove cigarettes when he lived in rural Valentine, Neb. He said he might try the cigars but was dubious about whether he would like them.

“I certainly don’t like to be forced into that choice,” said the clove smoker of 14 years. “I’m probably going to buy me enough to last until Oct. 1, then I’m just going to have to quit.”

September, 2009|Oral Cancer News|