Monthly Archives: August 2010

Decreases in adolescent tobacco use leveling off


Declines in rates of adolescent tobacco use have stagnated in the past few years, prompting the CDC to call for better prevention efforts, according to a recent report.

“Smoking continues to be the leading preventable cause of death and disability in the United States; and among adult established smokers in the United States, more than 80% began smoking before age 18 years,” CDC researchers wrote.
To evaluate behaviors and attitudes toward tobacco use during the critical period of adolescence, the researchers used National Youth Tobacco Survey (NYTS) data collected from 2000 to 2009.
The NYTS, which presents school-based survey responses from a cross-sectional, nationally representative sample of middle school and high school students, gleans information on youth tobacco use; smoking cessation; tobacco-related knowledge and attitudes; access to tobacco; media and advertising and secondhand smoke exposure. The study has been conducted every 2 years since 2000.
From the 205 participating schools, 22,679 students responded. They were polled about any use of, current use of and experimentation with certain tobacco products, including cigarettes, cigars, smokeless tobacco, pipes, bidis and kreteks. Survey questions also investigated students’ willingness to initiate tobacco use.
Results indicated that 8.2% of middle school students and 23.9% of high school students reported current tobacco use in 2009, the researchers said, with 5.2% of middle school and 17.2% of high school students reporting current cigarette use. The researchers also noted that 21.2% of middle school and 24% of high school students were willing to start smoking cigarettes.
Data from 2009 also suggested that, among middle school students, 3.9% currently used cigars; 2.6%, smokeless tobacco; 2.3%, pipes; 1.6%, bidis; and 1.2%, kreteks. A similar distribution of use of these products was noted among high school students, with 10.9% currently using cigars; 6.7%, smokeless tobacco; 3.9%, pipes; 2.4%, kreteks; and 2.4%, bidis.
From 2000 to 2009, decreases occurred among middle school students for current tobacco use, 15.1% to 8.2%; current cigarette use, 11% to 5.2%; and cigarette smoking experimentation, 29.8% to 15%. Overall rates for susceptibility to smoking, however, did not decline. Analysis also indicated that rates of decreases demonstrated no change during this time.
Among high school students, current tobacco use decreased from 34.5% to 23.9% from 2000 to 2009, according to the researchers, with current cigarette use also declining from 28% to 17.2% and rates of experimentation falling from 39.4% to 30.1%. Again, rates of decline did not change.
Prevalence of susceptibility to smoking remained steady for middle school and high school students throughout the study period.
Between 2006 and 2009, however, the willingness to start using tobacco products and current use of cigarettes, cigars, smokeless tobacco, pipes, bidis and kreteks did not change among middle school or high school students. For middle school students, the researchers only noted declines in two subpopulations, with rates of current cigarette use falling from 6.4% to 4.7% among girls and decreasing from 6.5% to 4.3% among white students.
Similarly, from 2006 to 2009, prevalence among high school students only declined in girls for current tobacco use, decreasing from 21.3% to 18.2%, and current cigarette use, with rates falling from 18.4% to 14.8%. Prevalence for current bidi use also declined among white students (2.6% to 1.7%).
“The findings in this report indicate that, from 2000 to 2009, prevalences of current tobacco and cigarette use and experimentation with smoking cigarettes declined for middle school and high school students, but no overall declines were noted for the 2006-2009 period,” the researchers wrote. “The general lack of significant change during the shorter period indicates that the current rate of decline in tobacco use is relatively slow.”
Researchers noted that prevention programs are effective, but they do not receive adequate financial support. “Comprehensive tobacco control programs should be fully funded and implemented, as recommended by the CDC,” they wrote.
The researchers also said better control of cigarette advertisements and more graphic warnings on cigarette packs may help deter adolescents from smoking by altering the general public’s attitudes toward tobacco use.
“Changes in social norms might help reduce youth susceptibility to try cigarettes and other tobacco products and accelerate the decline in tobacco use among youths,” the researchers wrote.

August, 2010|Oral Cancer News|

Can saliva-based HPV tests establish cancer risk and guide patient management?

Source: Oral and Maxillofacial Pathology doi:10.1016
Author: Mark W. Lingen, DDS, PhD Section Editor, Oral and Maxillofacial Pathology

Head and neck squamous cell carcinoma (HNSCC) is the 6th most common malignancy in the world today.1 Despite numerous advances in treatment, the 5-year survival rate has remained modest. This poor outcome is due to several factors, including delayed diagnosis. Therefore, improved early detection and effective prevention strategies are critical components for management of this malignancy. The etiology of classical HNSCC has been attributed to chronic exposure to tobacco and alcohol.2 In addition, there is now sufficient evidence to support the contention that high-risk forms of the human papillomavirus (HPV) are a major causative factor for HNSCC of the tonsil, base of tongue, and oropharynx.3-8 The increasing importance of HPV in oropharyngeal HNSCC has raised considerable concern and uncertainty among healthcare professionals and patients. For example, I am often asked to describe the clinical features of HPV-associated premalignant lesions. Unfortunately, to my knowledge, the clinical spectrum of HPV-associated premalignant disease has not been adequately described. Furthermore, because this subset of HNSCC often develops in hard to- examine locations, such as tonsillar crypts, it can be exceedingly difficult to even identify the carcinomas. In the absence of such information, how can clinicians identify patients that are at increased risk for harboring an HPV-associated premalignant lesions or HNSCC?

Recently, a large commercial diagnostic lab began offering a saliva-based test for the identification of oral HPV infections. As a result of this new offering, I have been bombarded with queries from dentists who have two recurring questions: (1) Will my patient develop HNSCC if they have a positive test? (2) What should I do for my patient if they have a positive test? The company’s website states that their test provides the dentist with information that will “establish risk for HPV-related cancer and determine appropriate referral and monitoring conditions.” Unfortunately, given what we know, or more appropriately what we don’t know, it is unclear how this test will provide answers to the real-world patient management questions that confront dentists.

The Centers for Disease Control and Prevention (CDC) estimates that 20 million Americans are currently infected with HPV and that 6 million new individuals are infected each year.9 In addition, they estimate that at least 50% of sexually active adults will be infected with HPV in their lifetime.9 Further, the CDC estimates that 33,000 men and women will develop an HPV-associated malignancy this year, and that 12,000 of these cancers will be HNSCC.9 Why is there a considerable difference between rates of HPV infection and the incidence of HPV-associated cancers? In general, the HPV DNA must become integrated into the host genome (rather than remaining episomal) to be oncogenic. Fortunately, this integration occurs at a fairly low frequency. Therefore, the mere presence of HPV in a saliva test does not necessarily establish a patient as being at higher risk place for developing cancer. The company has also suggested that repeated oral HPV testing is an effective monitoring tool because serial tests will identify patients with persistent infections, which are more likely to undergo malignant transformation. While persistence of HPV infection may increase cancer risk, what is the evidence that serial HPV tests will specifically identify only those patients with persistent oral HPV infections? The natural history of cervical HPV infections is well documented. Surprisingly, there is very little known about the natural history of oral infections. However, the available data suggests that the natural history of oral and cervical HPV infections may be very different.10 For example, we do not know the clearance rates of oral infections versus cervical infections. Given the robust lymphoid tissue present in Waldeyer’s ring, one could hypothesize that oral HPV infections may be cleared at a faster rate. Given these and other uncertainties, the clinical relevance and management implications of a positive repeat monitoring test are unclear. On the one hand, a positive test may indicate that an individual has a persistent HPV infection, thus placing them at higher risk for developing HNSCC. Alternatively, a positive repeat test may simply reflect a scenario of multiple independent infections in which each viral infection was cleared prior to the subsequent re-infection. Therefore, if we do not fully understand the natural history of oral HPV infections, how will the oral HPV test aid clinicians in establishing appropriate management protocols?

The era of molecular diagnostics is upon us, with new tests introduced daily. Some of these tests may aid clinicians in their quest to improve the diagnosis, prevention, and treatment of many different diseases. However, at this time, the current saliva-based HPV test would appear to be a “test looking for a disease,” with limited clinical utility. I would respectfully urge clinicians to consider the fact that just because we can perform a test does not mean that we should. To be of true clinical benefit, a diagnostic test should have clear scientific evidence that it will aid in the treatment decision making process. In support of this concept, I would encourage readers to review the article by Jaeschke et al.11 This seminal article provides an appropriate discussion and clinical decision making framework for clinicians when considering whether or not to perform a particular test. Mark W. Lingen, DDS, PhD Section Editor, Oral and Maxillofacial Pathology doi:10.1016/j.tripleo.2010.06.002

1. Jemal A, Siegel R, Ward D, Hao Y, Xu, J, Thun MJ. Cancer statistics, 2009. CA Cancer J Clin 2009;59:225-249.
2. Blot WJ, McLaughlin JK, Winn DM, Austin DF, Greenberg RS, Preston-Martin S, et al. Smoking and drinking in relation to oral and pharyngeal cancer. Cancer Res. 1988;48:3282-7.
3. Chaturvedi AK, Engels EA, Anderson WF, Gillison ML. Incidence trends for human papillomavirus-related and –unrelated oral squamous cell carcinomas in the United States. J Clin Oncol 2008;26(4):612-9.
4. Gillison ML, D’Souza G, Westra W, Sugar E, Xiao W, Begum S, Viscidi R. Distinct risk factor profiles for human papillomavirus type 16-positive and human papillomavirus type 16-negative head and neck cancers. J Natl Cancer Inst 2008;100:407-20.
5. Gillison ML, Koch WM, Capone RB, Spafford M, Westra WH, Wu L, et al. Evidence for a causal association between human papillomavirus and a subset of head and neck cancers. J Natl Cancer Inst 2000;92:709-20.
6. D’Souza G, Kreimer AR, Viscidi R, Pawlita M, Fakhry C, Koch WM, et al. Case-control study of human papillomavirus and oropharyngeal cancer. N Engl Med 2007;356:1944-56.
7. Fakhry C, Westra WH, Li S, Cmelak A, Ridge JA, Pinto H, et al. Improved survival of patients with human papillomavirus-positive head and neck squamous cell carcinoma in a prospective clinical trial. J Natl Cancer Inst 2008;100(4):261-9.
8. Schlecht NF. Prognostic value of human papillomavirus in the survival of head and neck cancer patients: an overview of the evidence. Oncol Rep 2005;14:1239-47.
9. Centers for Disease Control and Prevention. std/HPV/STDFact-HPV.htm#common
10. D’Souza G, Fakhry C, Sugar EA, Seaberg EC, Weber K, Minkoff HL, et al. Six-month natural history of oral versus cervical human papillomavirus infection. Int Cancer 2007; 121:143-50.
11. Jaeschke R, Guyatt GH, Sackett DL. Users’ guides to the medical literature. III. How to use an article about a diagnostic test. What are the results and will they help me in caring for my patients? The Evidence-Based Medicine Working Group. JAMA 1994; 271:703-7.

August, 2010|Oral Cancer News|

Tobacco signs still target city’s poorer areas

Author: Stephen Smith

The signs, wrought in soothing italics, beckon with promises of tobacco “pleasure!’’ at low, low prices. Across Dorchester, Mattapan, and other city neighborhoods, big signs and little signs, vertical signs and horizontal signs trumpet the availability of cigarettes at corner stores and gas stations. They are plastered on façades and propped against windows, affixed to light poles and gas pumps.

A dozen years after Massachusetts attempted to ban storefront tobacco ads within 1,000 feet of schools and playgrounds, a prohibition thwarted by a tobacco company’s legal challenge, the signs remain prolific and prominent in Boston’s lower-income neighborhoods, especially those with substantial African-American and Hispanic populations.

But now, empowered by Congress to regulate tobacco companies, the Food and Drug Administration is taking steps that could rein in the pastel-hued signs that industry foes say entice young customers to start smoking.

With cigarette advertising banished from the airwaves and largely absent from billboards, storefronts are some of the last bastions of tobacco marketing. The continued presence of the ads is a testament, researchers said, to the deep reach of cigarette makers in poorer communities, where merchants said company representatives sometimes personally attach ads to store exteriors.

“Tobacco advertising is still alive and well,’’ said Dr. Michael Siegel, a tobacco control specialist at the Boston University School of Public Health. “There’s a widespread perception that somehow the tobacco advertising has gone away, that it’s been taken care of, that we don’t have to worry about this anymore. But that’s not true.’’

On Gallivan Boulevard, there is the Hess gas station, with signs for Newport, Marlboro, and Pall Mall on light posts and more ads in the window of the convenience store and on the pumps, at least 20 in all. On Dorchester Avenue, there is the red-brick Ashmont Convenience Store, where two Newport signs and one for Maverick cigarettes (“Everyday low price, $6.70’’) dominate posters touting telephone calling cards.

Hung Tran, who was behind the cash register at the Ashmont shop, said that in a neighborhood where tough times have exacted a steep toll, the signs let potential patrons know what wares he has inside.

“It’s good for customers to see it,’’ said Tran, whose brother owns the shop.

The signs, Tran said, are provided by the maker of Newport and Maverick, Lorillard Tobacco Co., which has a contract with the store. “Every three months,’’ Tran said, “they tell me what to do.’’

Lorillard’s director of investor relations, Robert Bannon, declined to discuss the company’s marketing practices. Another major cigarette producer, R.J. Reynolds Tobacco Co., did not return phone messages.

A representative of the nation’s leading tobacco maker, Philip Morris USA, defended storefront ads, citing free speech rights under the First Amendment.

“Adult consumers have a constitutionally protected interest in receiving communications from retailers and manufacturers, just as we, Philip Morris USA, have the right as a manufacturer to communicate nonmisleading information to those consumers about our products,’’ company spokesman David Sutton said.

That position echoes a legal challenge tobacco companies are making to a New York City campaign that mandates graphic warnings at cash registers about the health perils of smoking. Massachusetts regulators proposed a similar initiative earlier this year, but put it on hold, awaiting the outcome of the New York case.

At Sandy’s Variety Store, hard by Washington and Dakota streets, tobacco marketers posted new signs a few weeks back, said Arelis Villa, who has owned the shop for nearly 14 years with her husband. Three signs stand out on the red façade: one for Newport, one for Maverick American Quality, one for USA Gold.

“It doesn’t make sense,’’ Villa said, her head slowly shaking in dismay. “The government says it doesn’t want minors to smoke, that it’s dangerous. So I don’t understand why they let the companies do a lot of advertising to convince people to smoke.’’

Researchers found in 2003 and 2004 that roughly 4 of every 10 dollars spent on tobacco marketing went to store signs, payments to retailers for prime shelf space, and displays inside shops. In some cases, shopkeepers received thousands of dollars through tobacco manufacturer incentive programs.

And the more tobacco promotions children encounter, the greater the risk they will start smoking, Massachusetts scientists reported in 2006.

It is no secret that ad dollars are disproportionately spent in poorer neighborhoods, said researchers, pointing to studies from the past 15 years. In the most recent, Harvard School of Public Health researchers found that stores selling cigarettes in Dorchester were significantly more likely to have signs — and bigger signs — than retailers in Brookline. The researchers, who canvassed storefronts from November 2007 to February 2008, also discovered that stores in Dorchester were more likely to advertise prices and that the prices were lower than in Brookline.

In the Dorchester ZIP code covered by the study, 02124, the median family income was $38,203; 18 percent of Dorchester adults smoke regularly. In Brookline, where the median income was $92,993, the smoking rate was only 6.5 percent.

“Does this marketing demonstrate a targeting of disadvantaged communities? Clearly,’’ said Greg Connolly, an author of the Harvard study that appears in the American Journal of Health Promotion. “Is there a moral and economic obligation to intervene? Yes. We’re not showing dignity and respect for low-income people in Boston.’’

Both Boston and Brookline have rules prohibiting more than 30 percent of a window from being covered by any kind of signs. Brookline goes further, with a design guideline limiting brand-specific advertising. But a planning official said that rule is rarely enforced.

Brookline was the first Massachusetts municipality to impose a ban on smoking in restaurants and bars. Health director Alan Balsam said the absence of tobacco ads is more a reflection of his town’s attitude toward smoking than a recognition of obscure zoning rules.

“It just shows sometimes you don’t have to hit people with a hammer,’’ Balsam said. “It’s a long slog to educate people who own businesses about tobacco control, but I think we’ve done a fairly good job.’’

In 1996, the FDA first asserted regulatory jurisdiction over tobacco companies, including advertising, but a court ruled that the federal agency was overstepping its authority.

Two years later, Massachusetts attempted to restrict storefront ads. Tobacco maker Lorillard sued, and the US Supreme Court sided with the company.

Last year, the FDA won the power to regulate tobacco companies under a landmark law passed by Congress. The agency, after soliciting public comments, is weighing what to do about ads on the exterior walls and grounds of retailers, a spokeswoman said.

Matthew Myers, president of the advocacy group Campaign for Tobacco-Free Kids, said he believes “there is no question the FDA will clamp down’’ on the signs. But, he said, it is less clear how.

Advertising could be banned within 1,000 feet of schools and playgrounds, as the FDA and Massachusetts proposed in the 1990s. Or the agency could shrink that to a smaller radius so that fewer retailers are affected. Or, rather than an outright prohibition, it could dictate that all tobacco ads be fashioned in a muted design, such as black and white type. The rules, Myers said, would not apply to signs in store windows.

“The question purely is what rules should be in place to govern outdoor advertising that both protect the public health and are consistent with the First Amendment,’’ Myers said.

August, 2010|Oral Cancer News|

Dermatologist discusses advantages of vaccines that prevent human papillomavirus and herpes zoster

Author: public release

Vaccines have a long history of successfully preventing disease and, in effect, improving the lives of countless Americans. Now, two serious diseases – human papillomavirus (HPV) and herpes zoster – could become a thing of the past as people better understand the safety and efficacy of vaccines to prevent these serious viral infections in specific populations.

At the American Academy of Dermatology’s Summer Academy Meeting 2010 in Chicago, dermatologist Jeffrey M. Weinberg, MD, FAAD, associate clinical professor of dermatology at Columbia University College of Physicians and Surgeons in New York City, highlighted the significant benefits associated with these two new vaccines.

HPV Vaccine Protects Girls and Boys
HPV is a group of viruses commonly linked to the sexually transmitted diseases known as genital HPV infection, which have long been associated with the development of cervical cancer, a life-threatening cancer. According to the American Cancer Society’s 2010 estimates, approximately 4,210 women will die from cervical cancer in the United States.

In 2006, a breakthrough vaccine was approved by the FDA for the prevention of HPV types 6, 11, 16 and 18. HPV types 6 and 11 are responsible for more than 90 percent of all cases of genital warts, and HPV types 16 and 18 cause 70 percent of all cervical cancers. Although the vaccine is specifically approved for use in females 9 to 26 years of age, Dr. Weinberg acknowledged that many people are still reluctant to get the vaccination due to a lack of awareness about who should be vaccinated and when – as well as unease about its association with sexual activity and a general skepticism about side effects.

“The truth is that the HPV vaccine is one of the most effective methods to protect against cervical cancer and genital warts,” said Dr. Weinberg. “The vaccine has been proven 99 percent effective to prevent cervical cancer and HPV in patients five years after follow-up and is simply good preventive medicine for the millions of young women and girls who are likely to be exposed to the virus in their lifetime.”

In October 2009, the FDA approved another use of the quadrivalent vaccine for the prevention of genital warts due to HPV types 6 and 11 in boys and men, ages 9 through 26.

The effectiveness of the vaccine was studied in a randomized trial of 4,055 males ages 16 through 26 years old. The results showed that in men who were not infected by HPV types 6 and 11 at the beginning of the study, the vaccine was nearly 90 percent effective in preventing genital warts caused by HPV types 6 and 11.

Dr. Weinberg added that another misconception about the HPV vaccine is that it could cause infection upon injection. However, the HPV vaccine is a synthetic vaccine that does not contain a live virus.

“It’s not ‘biologically possible’ to get HPV from the vaccine, which contains no live or killed virus and no virus-like particles,” said Dr. Weinberg. “Plus, the most common side effect has been minor pain at the injection site.”

Dr. Weinberg also reported that a new bivalent vaccine (one that provides immunity against two viral subtypes) was recently approved for the prevention of three life-threatening cervical diseases caused by oncogenic HPV types 16 and 18 – the two higher risk subtypes.

The primary clinical study for the bivalent HPV-16/18 included more than 18,000 women ages 15-25 in the United States and 11 other countries. Approximately 9,000 of these women received the HPV-16/18 injection and 9,000 received a licensed hepatitis A virus vaccine as a control. Dr. Weinberg added that the results showed that among women who had not already been infected by HPV types 16 and/or 18 before the start of the study, bivalent HPV-16/18 was about 93 percent effective in preventing precancerous cervical lesions caused by these HPV types.

“The clinical findings indicate that the HPV vaccine could contribute greatly to reducing worldwide rates of cervical cancer,” said Dr. Weinberg. “In my opinion, protection against the most common sexually transmitted disease and a known fatal form of cancer far outweighs any risks of receiving the vaccine.”

Herpes Zoster (Shingles) Preventive Vaccine Benefits Those 60 and Older

It is estimated that there are nearly 1 million episodes of herpes zoster (shingles) annually in the United States, and 15 percent of the population will eventually be affected by the condition. There are several known risk factors for herpes zoster, including a history of chickenpox, advancing age, and a compromised immune system from illness or medical treatments. The primary complication from shingles – associated with the older patient segment – is post-herpetic neuralgia (PHN).

Dr. Weinberg explained that patients with PHN experience severe pain resulting from nerve damage caused by the shingles virus in the outbreak area, as well as beyond the area of the shingles rash. Of the 1 million people who develop shingles, about one in five people will develop PHN, which can last for months or even years. In addition, the chance of developing PHN after having shingles increases with age.

Approved by the Food and Drug Administration (FDA) in 2006 for use in adults age 60 and older, the herpes zoster vaccine was found to be effective in preventing the occurrence of shingles in 51 percent of adults age 60 and older who participated in placebo-controlled trials in the United States. Dr. Weinberg added that this pivotal study, which followed patients for a median of 3.1 years, documented an overall 39 percent reduced risk of PHN if herpes zoster develops, and reduced severity if PHN develops – which translates into a considerably improved quality of life for older patients who are good candidates for the vaccine.

“With the herpes zoster vaccine, it’s important to understand that it represents a unique use of a vaccine since it is not intended to prevent an infection, but rather to prevent a recurrence of the infection,” explained Dr. Weinberg. “Further, the herpes zoster vaccine is specifically aimed at adults age 60 and older, so it is substantially more potent than the traditional chickenpox vaccine to compensate for the reduced immune response found in aging populations.”

In addition, Dr. Weinberg noted that another distinction of the herpes zoster vaccine is that it contains a live virus. With that in mind, he cautioned that it could cause the chickenpox infection and should not be administered to anyone who has not had the chickenpox or patients with compromised or weakened immune systems.

“Patients who are candidates for the HPV or herpes zoster vaccine should discuss their concerns or questions with their dermatologist or other physician,” said Dr. Weinberg.

Headquartered in Schaumburg, Ill., the American Academy of Dermatology (Academy), founded in 1938, is the largest, most influential, and most representative of all dermatologic associations. With a membership of more than 16,000 physicians worldwide, the Academy is committed to: advancing the diagnosis and medical, surgical and cosmetic treatment of the skin, hair and nails; advocating high standards in clinical practice, education, and research in dermatology; and supporting and enhancing patient care for a lifetime of healthier skin, hair and nails. For more information, contact the Academy at 1-888-462-DERM (3376) or

Source: American Academy of Dermatology

August, 2010|Oral Cancer News|

Radiation safety a priority at Johns Hopkins

Author: Megan Martin, Communications Manager

Recent media coverage surrounding treatment errors that have occurred in radiation therapy has only intensified discussions about the need to improve safety for patients with cancer.

Joseph Herman, MD, a radiation oncologist at The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins and a featured panelist at the upcoming NCCN 2010 Patient Safety Summit, recently spoke with NCCN about policies Hopkins has implemented to ensure the safety of their radiation therapy patients.

Radiation safety, an issue that has always received great attention at Hopkins, came to the forefront a few years ago as Hopkins was looking to develop a new program for high dose rate intraoperative radiation therapy (IORT) – delivered through brachytherapy – and discovered that there were no clear standard guidelines or quality indicators for how to develop such a program.

“Safety is of particular concern in this type of treatment because due to the high dose of radiation being emitted, clinicians cannot remain in the same room as the patient, a specific cause of anxiety for anesthesiologists,” said Dr. Herman.

Using a patient simulator, the team walked through a variety of practice scenarios, identified areas for concern, and developed strategies to address potential safety issues. For example, Hopkins now uses cameras to monitor patient vital signs in the room and also has pre-measured medications available that can be delivered via a pole from another room – basically a “long-distance” method of treatment.

Furthering their aim to identify points in the process where potential errors may arise, Hopkins constructed a map listing each person who is currently in contact the patient, from consultation to treatment to follow-up, and created nodes pinpointing where an error may occur. Each node was then assigned a score based on Failure Mode and Effect Analysis (FMEA). FMEA ranks any weak points using a calculation that is based on the frequency of the occurrence, the detectability, and the severity. Utilizing these scores, Stephanie Terezakis, MD, Eric Ford, PhD, and Peter Pronovost, MD, at Johns Hopkins Department of Radiation Oncology created a list of top-ranked failure modes and strategies to address issues within each node.

Another relatively simple, yet effective, tactic designed to eliminate giving radiation to the wrong part of a person’s body was also initiated several years ago. “Before treatment can commence, we circulate a diagram of the human body with the area receiving treatment clearly marked. This diagram must be acknowledged and signed off-on by each member of the treatment team,” Dr. Herman stated.

According to Dr. Herman, there have been no cases of the misadministration of therapy since Hopkins implemented this approach.

To reduce the risk of bringing up the incorrect treatment plan for a patient, perhaps due to the confusion of a common name, Hopkins instituted a card reading system. The system does not allow a treatment plan to be accessed until the team scans the patient’s individual barcode on his or her ID bracelet.

Although great strides have been made at Hopkins, Dr. Herman stressed that patient quality and safety is a continuous process.

For example, Dr. Herman recently conducted an informal poll of his staff to determine what they thought could be improved upon and what might have a significant impact on quality and patient safety. The overwhelming response was related to tumor contouring for radiation therapy planning. The staff felt that it was imperative that contours be as accurate as possible in order to avoid a ripple effect of erroneous decisions being made by physicists and other clinicians who use the contour as a point of reference. To address this issue, the Hopkins Radiation Oncology Department is developing formal checklists to further improve the quality of tumor contouring.

Dr. Herman emphasized the importance of forums such as the NCCN 2010 Patient Safety Summit for allowing his colleagues to gain a more in-depth understanding of the role of radiation oncologists and the complexity of the treatments.

“Sometimes there is the perception that radiation oncologists simply ‘press the button’ to deliver treatment, which certainly is not the case,” said Dr. Herman. “We often want to slow down the implementation process of treatment to ensure the safety of the treatment and utilize the best technology available. It’s vitally important that oncologists learn about radiation therapy and how to work with their colleagues to guarantee the safety of their patients.”

The NCCN 2010 Patient Safety Summit is being held on October 14, 2010 in Bethesda, MD and will address issues such as radiation safety, infection control, oral chemotherapeutics, and safety and accountability. Peter J. Pronovost, MD, PhD, ScD, will provide the keynote address.

August, 2010|Oral Cancer News|

E-cigarettes: battle continues

Author: staff

A Broward e-cigarette distributor gave up a legal fight with Oregon over the sale of its products there, as the industry waits to see if it will sell its products as a drug device or tobacco product.

A leading distributor of electronic cigarettes, Weston-based Smoking Everywhere, has agreed to halt sales in Oregon, Attorney General John Kroger announced Monday.

The Oregon official said Smoking Everywhere did not seek U.S. Food and Drug Administration approval and provides no evidence to support claims that “e-cigarettes” are a safe alternative to conventional tobacco products. He also expressed concern that the company geared its marketing toward young people.

Oregon last year became the first state to go to court to block the sale of the devices, some of which are designed to look like traditional cigarettes.

Smoking Everywhere’s electronic cigarettes have a battery-powered heating element and a replaceable plastic cartridge that contains chemicals, including liquid nicotine. The heat vaporizes the liquid for inhalation.

In settling the suit, Smoking Everywhere admitted violating Oregon’s Unlawful Trade Practices Act. Besides no longer selling its products there, the company agreed to pay more than $95,000 to the Oregon Department of Justice. Elico Taieb, the company president, will pay another $25,000 and is barred from doing any business in Oregon that involves tobacco, nicotine or electronic cigarettes.

Taieb’s attorney, Jason Weaver, said, “We believe the product is safe,” and fought with Oregon on the premise of the product being sold when it was not approved by the Food and Drug Administration.

Smoking Everywhere and Sottera, which does business as the e-cigarette brand NJOY, won a case against the FDA in January, where it was ruled that the agency doesn’t have the authority to regulate electronic cigarettes as a drug-device combination. The U.S. Court of Appeals takes up the matter next month.

“Since we are not part of the appeal, it just made sense for us to settle out with Oregon and be done with it,” Weaver told The Miami Herald. “We just didn’t have a dog in the fight.”

Ray Story, a Smoking Everywhere shareholder who is in litigation against Taieb, did not approve of the settlement. “At the end of the day, he’s made some very dumb mistakes, and he’s continuing to make those,” Story said.

E-cigarette products with nicotine have no legal classification — they are neither a medical device nor a recreational tobacco product which creates the legal issues. The FDA has clashed with e-cigarette companies on the question of whether the product helps people quit smoking. If it’s marketed as a medical device, then it needs FDA approval. If it was a tobacco product, it would follow the same laws as a regular cigarette and could not be sold online, nor would the companies be able to advertise on the radio.

Story, who stepped down as CEO earlier this year because he felt the company was “on the wrong track,” contends Smoking Everywhere is a cigarette company and needs to act as such. Story said he and Taieb have disagreed on that point.

“We did $1 million a month initially,” Story told The Miami Herald, adding that companies like Smoking Everywhere don’t want to ‘shut off the cash cow’ of Internet sales. Story has started a new e-cigarette company based in Atlanta called Wannavape, which does not sell e-cigarettes online.

Hallandale Beach-based Vapor Corp., which has 20 percent of the market share of the electronic cigarette industry, was not banned from selling in Oregon but voluntarily pulled the product from distributors in Oregon to avoid any issues, company attorney Adam Laufer told The Herald. “We’re basically waiting to see and be reactive to whatever the proper and current law is,” he said.

Vapor’s profits in 2009 were near $8 million and it sells under the brands of Fifty -One, Krave, EZ Smoker, Smoke Star and Green Puffer. Laufer said the company is preparing for the courts to decide if it should be sold as drug or tobacco product.

“It’s possible we can have two products we’re simultaneously selling,” Laufer said. One would be a drug aid to quit smoking, competing with the $3 billion a year industry of gums, patches, lozenges and inhalers, and another as a less-harmful recreational smoking product — more than a $100 billion industry.

Story said e-cigarettes are less harmful than conventional cigarettes and less intrusive to nonsmokers. He sharply criticized Kroger for keeping the product away from Oregonians. “The attorney general there really doesn’t know what he’s talking about,” he said. “A state cannot ban a product without it banning every product within that same category.”

The attorney general last year got two travel store chains to stop selling e-cigarettes in Oregon and persuaded another e-cigarette company, Sottera, to leave the state. Smoking Everywhere declined a request to restrict its Oregon sales, leading to the suit filed last year in Salem.

August, 2010|Oral Cancer News|

Medicare expands coverage of tobacco cessation

Author: Mike Lillis

The Obama administration on Wednesday expanded Medicare to cover more seniors hoping to kick their tobacco habits.

“Most Medicare beneficiaries want to quit their tobacco use,” Health and Human Services Department (HHS) Secretary Kathleen Sebelius said in a statement announcing the move. “Now, [they] can get the help they need.”

Under previous rules, Medicare covered tobacco-related counseling only for beneficiaries already suffering from a tobacco-related disease.

Under the new policy, Medicare will cover as many as two tobacco-cessation counseling tries each year, including as many as four individual sessions per attempt.

The move is the latest in a string of White House efforts to shift the nation’s healthcare system toward prevention, in lieu of simply treating diseases after they’ve developed.

If successful, the new tobacco policy could pay dividends. Of the 46 million Americans estimated to smoke, about 4.5 million are seniors older than 65, HHS says. And nearly 1 million more smokers are younger than 65, but eligible for Medicare benefits.

They aren’t cheap. Tobacco-related diseases are estimated to cost Medicare about $800 billion between 1995 and 2015.

Donald Berwick, head of the Centers for Medicare and Medicaid Services, said the expansion lends seniors valuable help “to avoid the painful — and often deadly — consequences of tobacco use.”

The change affects Medicare Parts A and B — hospital care and physician services — but not Part D, which already covers smoking-cessation drugs for all beneficiaries.

August, 2010|Oral Cancer News|

Man with short-term memory doesn’t know he’s dying

Author: Ashley Singh

A Pittsylvania County man is dying, but he doesn’t know it. Stephen Kunze suffered a brain aneurysm 14 years ago. He has no short term memory.

Stephen was recently diagnosed with tongue cancer and his wife, Martha, says they don’t know how much time he has left. The only other choice she had, was to remove his tongue, but she couldn’t do that to him. He’d wake up every morning not understanding what happened. She made the decision to enter the final chapter of their love story.

Stephen thinks everyday is November 18th, 1996. That’s the day he suffered a brain aneurysm and lost his short term memory.

His wife, Martha, says it’s so severe that her husband can watch an episode of M.A.S.H, rewind it, and watch it all over again. It’s been like this for nearly 14 years.

“His memory will last for the amount of the conversation, as soon as the conversation changes it’s gone,” she said.

Last year, Stephen was diagnosed with tongue cancer.

“It gets very hard to look at him and tell him that yes, you are going to die because you can’t because it’s like learning. Every time you say it to him it would be like learning it for the first time, all over again,” said Martha.

Martha believes not knowing he’s about to die is what’s keeping him alive.

“He should be comatose in bed at those points but he’s still up walking around,” she said.

Lisa Adkins, a nurse with Liberty Hospice, checks on Stephen every week. The love she has witnessed is one of a kind.

“It takes a unique person. Martha is so strong and courageous and not a lot of people can do that,” said Adkins.

Martha looks forward to little things, like playing their wedding song, because she says Stephen remembers it well. She’s thankful for the time she has with him, for every hug, every kiss, every dance… could be their last.

“I know part of me will probably die with him because we’ve been together for 36 years and I love him,” Martha said.

August, 2010|Oral Cancer News|

New cancer drug gets dramatic results

Source: Technology Review
Author: Emily Singer

Researchers call the experimental drug a major success for targeted cancer therapies.

An experimental drug designed to block the effects of a genetic mutation often found in patients with malignant melanoma, a deadly cancer with few existing treatments, significantly shrank tumors in about 80 percent of those who carried the mutation. The findings, published Wednesday in the New England Journal of Medicine, signal a major success for so-called targeted cancer therapies, which are designed to block the effects of genetic mutations that drive the growth of cancer cells.

“This study is a major breakthrough in cancer treatment, and for metastatic melanoma,” saysMatthew Meyerson, an oncologist and researcher at the Dana Farber Cancer Institute in Boston. Meyerson was not involved in the study. “It’s a spectacular example of how genome-targeted therapies are beginning to help cancer patients.” The drug in the current study inhibits activity of a protein called BRAF, which is overactive in 50 to 60 percent of malignant melanomas.

Advances in genetic technologies over the last decade have allowed scientists to study the genetic mutations that underlie cancer in much greater detail. The result has been a new approach to drug design. Unlike chemotherapy, which can affect both healthy and cancerous cells and often triggers serious side effects, genetically targeted drugs act selectively on cancer cells that carry the mutation.

Only a handful of such drugs have been approved by the U.S. Food and Drug Administration, and most target rare mutations. The BRAF mutation, in comparison, is common. Discovered in 2002, the mutation disrupts regulation of the BRAF protein, making it continually active. The drug in the current study is under development by pharmaceutical giant Roche and Plexxikon, a startup based in Berkeley, CA. The drug is just one of a number of BRAF inhibitors currently in clinical tests.

Melanoma can be effectively treated with surgery in the early stages, but the prognosis is grim once the cancer has spread beyond the skin. The two currently available drugs work in only about 10 to 20 percent of patients. According to the new findings, 37 of 48 patients with the mutation responded to the new experimental drug, with their tumors shrinking by more than 30 percent. Tumors completely disappeared in three of those patients. About 30 percent of patients who took the drug the longest developed a specific type of squamous cell carcinoma, a tumor that usually doesn’t spread and typically resolves on its own.

Further studies are needed before the drug can be approved by the FDA. But because scientists can use genetic testing to select the patients for whom the drug is most likely to be effective, they require much smaller trials to show the drug works. Keith Flaherty, an oncologist at Massachusetts General Hospital who led the research, says the project reflects a new streamlined approach to clinical testing of cancer drugs that’s quicker and less expensive than traditional methods.

“The study highlights the potential power and importance of this type of approach,” saysAlexis Borisy, an entrepreneur in residence at Third Rock Ventures in Boston. “In a short period of time, we’ve gone from the discovery of the mutation to the design of a drug that is selective for that mutation, and which leads to dramatic clinical effects.” Borisy is the CEO of a startup, Foundation Medicine, that’s developing genetic screening tools to match cancer patients with the most appropriate drugs.

The new drug candidate does have limitations. Many patients develop resistance anywhere from three months to two years after beginning treatment, a problem that has occurred with other targeted cancer therapies as well. Scientists hope to overcome this problem by combining the drug with other compounds, an approach that worked with Gleevec, a targeted cancer drug used to treat some kinds of leukemia.

“We know some other genetic alterations that accompany BRAF, so the strategy would be to try to target more than one,” says Flaherty. “It’s like HIV, where doctors routinely use multiple drugs.” One such study, combining a BRAF inhibitor with a second drug that targets another protein in the same molecular pathway, has already begun. Researchers also aim to find the genetic variations that lead to resistance, which could ultimately help direct the most effective combinations.

The benefits of BRAF inhibitors are likely to extend beyond melanoma; the mutation is found in approximately 7 to 8 percent of all cancers, and tests of the drug in colorectal cancer are now underway. Scientists hope that studies such as these will lead to a new way to define cancer, relying on molecular characteristics rather than the tissue of origin.

A number of other clinical studies are underway for drugs targeting other mutations involved in various types of cancers. However, most of these mutations are much less frequent than BRAF. “A fundamental question that remains in the field is how many more targets like BRAF will there be,” says Flaherty. “That’s still a matter of discovery.”

August, 2010|Oral Cancer News|

How secondhand cigarette smoke changes your genes

Source: Time Magazine
Author: Alice Park

As if the growing number of smoking bans in restaurants, airplanes and other public places isn’t sending a strong enough message, researchers now have the first biological data confirming the health hazards of secondhand smoke.

Scientists led by Dr. Ronald Crystal at Weill Cornell Medical College documented changes in genetic activity among nonsmokers triggered by exposure to secondhand cigarette smoke. Public-health bans on smoking have been fueled by strong population-based data that links exposure to secondhand cigarette smoke and a higher incidence of lung diseases such as emphysema and even lung cancer, but do not establish a biological cause for the correlation. Now, for the first time, researchers can point to one possible cause: the passive recipient’s genes are actually being affected.

Crystal’s team devised a study in which 121 volunteers — some of whom smoked and some of whom had never smoked — agreed to have samples of their airway cells studied for genetic activity. The subjects also provided urine so the researchers could measure the amount of nicotine and its metabolites, like cotinine, for an objective record of their exposure to cigarette smoke.

Airway cells that line the bronchus, from the trachea all the way to the tiny alveoli deep in the lungs, are the first cells that confront cigarette smoke, whether it is inhaled directly from a cigarette or secondhand from the environment. Crystal’s group hypothesized that any deterioration in lung function associated with cancer or chronic obstructive pulmonary disease, including emphysema and bronchitis, in which the lungs lose their ability to take in air, would begin with these cells.

And indeed, that’s what he and his team found. The researchers removed airway cells from the volunteers using a bronchoscope and tested all 25,000 identified human genes in them to determine which ones were active — either turned on or off — in response to cigarettes. They narrowed the search to 372 genes that were active among the smokers but not in the cells of the nonsmokers. Based on the level of nicotine in the urine, the scientists also divided the volunteers into three groups: smokers, who showed the highest level of the tobacco metabolites; nonsmokers, who showed none of these compounds and a low-exposure group who fell in between. Comparing the 372 genes among these three groups, they found that the low-exposure group shared 34% of the same active genes with nonsmokers and 11% of the same gene activity with smokers. The low-exposure group included both nonsmokers who have never lit up as well as those who admitted to smoking only occasionally.

The results suggest that the genetic changes among the low-exposure volunteers, some of whose exposure is exclusively secondhand, mimicked those of smokers and represent the first molecular steps toward later lung disease. The study did not follow the subjects long enough to document what effect the genetic changes may actually have on the lung tissue, but Crystal says those studies are forthcoming.

“What is interesting to me is how sensitive the lung cells are to any cigarette smoke,” he says. “It doesn’t matter if you are walking into a cocktail party where other people are smoking or if you smoke one cigarette a week. No matter what level of exposure you have, your lung cells know it and they are responding. It’s sort of like canaries in the coal mine — they are crying out and saying, ‘I’m changing here, I’m changing the genes that I turn on and off in response to this environmental stress.'”

It’s not clear how permanent these genetic changes are, but previous data suggests that, at least in smokers, some of the alterations may be irreversible. Smokers experience a decline in lung function that is accelerated compared with nonsmokers, and even if they kick the habit, they can never achieve the same level of function as those who never lit up. If the genetic results are confirmed, says Crystal, they may help doctors to identify those whose genetic makeup put them at higher risk of developing lung disease when exposed to cigarettes, and potentially steer them toward drugs that can help them suppress the dangerous effects of nicotine on their cells.

In the meantime, the latest findings should reinforce public-health messages about the dangers of cigarette smoke, even if it is secondhand, says Dr. Norman Edelman, chief medical officer of the American Lung Association. “When you look at the biology, there is no safe level of exposure to tobacco smoke,” he says. “This [study] adds an important piece of evidence that inhaling secondhand smoke is deleterious and does things to the airway that are not good.”

Read more:,8599,2012103,00.html#ixzz0xevWis1L

August, 2010|Oral Cancer News|