Monthly Archives: June 2013

SSRI Prevents Depression in Head, Neck Cancer

Source: MedPage Today
By Salynn Boyles, Contributing Writer
Published: June 21, 2013


Prophylactic escitalopram cut the incidence of depression in head and neck cancer patients by more than 50% and improved quality of life, a clinical trial showed.

Significantly fewer patients taking the antidepressant developed depression, when compared with those on placebo (10% vs 24.6%; stratified log-rank test, P=.04), according to a study in the June 20 issue of JAMA Otolaryngology Head and Neck Surgery.

“Depression is very common among patients with this disease, but it is not easy to predict who will become depressed at the beginning of treatment,” University of Nebraska Medical Center professor of head and neck oncology William Lydiatt, MD, told MedPage Today. “That’s why the prevention paradigm may offer considerable benefit at an acceptable risk.”

As many as half of head and neck cancer patients develop clinical depression within months of their diagnosis and suicide rates are among the highest in patients with a medical illness, Lydiatt noted.

“The burden of treatment is extensive and frequently includes dysphagia, disfigurement, voice alterations, mucositis, need for tracheostomy and feeding tubes, fatigue and depression,” the researchers wrote.

They chose the generic version of the popular SSRI Lexapro for the trial to give patients an affordable treatment option that’s well tolerated in the elderly.

The randomized, double-blind trial included 148 newly diagnosed head and neck cancer patients entering treatment who did not yet have a diagnosis of depression. The patients were stratified by sex, site of disease, stage, and primary modality of treatment (surgery versus radiation).

Half were treated with escitalopram at a dosage of 10 mg/d for the first week (one tablet) followed by 20 mg/d (two tablets) until week 16, followed by an additional week of 10 mg/d. During the acute phase of the study, dosage was reduced to 10 mg/d when adverse events occurred. Patients not treated with the antidepressant received matching placebo pills.

Among the study’s major findings:

  • Patients undergoing radiation as their initial therapy were significantly more likely than those who had surgery to develop depression (hazard ratio, 3.6; 95% CI ,1.38-9.40; P=.009).
  • A Cox progression hazards regression model comparing the two groups, after controlling for age, smoking status, and other variables, demonstrated an advantage for escitalopram (hazard ratio, 0.37; 95% CI, 0.14-0.96: P=.04).
  • Patients who took escitalopram and who completed the study without developing depression rated their overall quality of life as significantly better than those in the placebo group for 3 consecutive months after ending treatment with the antidepressant (overall quality of life, good or outstanding at weeks 20, 24 and 28 – escitalopram group = 96%, 100%, 96%, respectively; placebo group = 77%, 86%, 85%).


Lydiatt said the finding that radiotherapy patients had a higher risk for depression than surgery patients is a big surprise with important potential clinical implications.

“The higher incidence of depression in the cohort receiving radiation suggests that radiation represents a greater and longer duration stress event than surgery,” the researchers wrote. “Radiation may also generate greater inflammatory cytokines during treatment, which could contribute to the higher rate (of depression).”

Although overall treatment success and survival were not study endpoints, Lydiatt said he hopes to conduct further research with these outcomes in mind.

“I would not be surprised to see a survival advantage associated with this approach,” he said. “Depression is associated with so many negative manifestations in these patients. Depressed patients don’t comply with their treatments to the same degree as patients who aren’t depressed and they don’t take care of themselves as well. They often lose their spark to live.

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


June, 2013|Oral Cancer News|

Teen HPV Rates Were Cut In Half After The Vaccine Went Public

By Annie-Rose Strasser 
Published Jun 19, 2013 at 2:35 pm


Following the 2006 introduction of a vaccine against cancer-causing human papillomavirus, rates of HPV in teen girls have plummeted to nearly half, a new study found on Wednesday.

The Journal of Infectious Diseases reports that HPV infection in girls ages 14 to 19 dropped from 11.5 percent for the years 2003-2006 to 5.1 percent for 2007-2010. Since HPV can lead to cervical cancer, the results also could herald a drop in cancer rates for girls in this age range, too.

The study illustrates a great advancement in public health, but it also underlines the consequences for those huge numbers of women and girls who are still not getting their vaccinations; in 2011, only 35 percent of girls ages 13-17 received all three shots in the vaccination series, and only 30 percent of women ages 19-26 had received the vaccine.

Fear-mongering and conspiracy theories over the side effects of the HPV vaccine are a major reason that inoculation rates are so low. While the Centers for Disease control have deemed the shots safe, and especially effective for young girls, 16 percent of parents report not letting their children get the shots for fear of side effects. In fact, incidents of cancer from HPV are rising in the U.S., and the CDC says rates of inoculation are “unacceptably low.”

These dangerous theories are fueled by conservatives like Rep. Michele Bachmann (R-MN), who campaigned on her insistence that HPV vaccines cause “mental retardation.” Bachmann also got her fellow presidential contender Texas Gov. Rick Perry (R) to backpeddal his support for his state’s legislation that required Texan girls to get the vaccine. Another Republican Governor, South Carolina’s Gov. Nikki Haley, vetoed a bill that would have made HPV vaccines free of cost to girls in her state.


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

June, 2013|Oral Cancer News|

Vaccine is credited with steep fall of HPV in teenagers.

Source The New York Times
Published: June 19, 2013 342 Comments


The prevalence of dangerous strains of the human papillomavirus — the most common sexually transmitted infection in the United States and a principal cause of cervical cancer — has dropped by half among teenage girls in recent years, a striking measure of success for a vaccine against the virus that was introduced only in 2006, federal health officials said on Wednesday.

Dr. Judith L. Schaechter gives an HPV
vaccination to a 13-year-old girl in her
office at the University of Miami Leonard
M. Miller School of Medicine.



The sharp decline in the infection rate comes at a time of deepening worry among doctors and public health officials about the limited use of the HPV vaccine in the United States. Health departments across the country are scrambling for ways to increase vaccination rates, while nonprofit groups are using postcard reminders and social media campaigns and pediatricians are being encouraged to convince families of the vaccine’s benefits.

There are some signs that resistance to the vaccine may be growing. A study published in the journal Pediatrics in March found that 44 percent of parents in 2010 said they did not intend to vaccinate their daughters, up from 40 percent in 2008. Because it prevents a sexually transmitted infection, the vaccine comes with a stigma. Some parents worry it promotes promiscuity. And it has been controversial. During the Republican primary in 2011, Representative Michele Bachmann, Republican of Minnesota, said the vaccine could have “dangerous side effects,” a concern that health officials say is unfounded.

The magnitude of the decline in HPV infections surprised public health experts because only about a third of teenage girls in the United States have been vaccinated with the full course of three doses. By comparison, vaccination rates in countries like Denmark and Britain are above 80 percent. Even Rwanda, in East Africa, has reached 80 percent.

Yet even with relatively low vaccination rates in the United States, infection with the viral strains that cause cancer dropped to 3.6 percent among girls ages 14 to 19 in 2010, from 7.2 percent in 2006, the officials said.

“These are striking results,” said Dr. Thomas R. Frieden, director of the Centers for Disease Control and Prevention. “They should be a wake-up call that we need to increase vaccination rates. The bottom line is this: It is possible to protect the next generation from cancer, and we need to do it.”

The findings, published online Wednesday in The Journal of Infectious Diseases, covered the years 2003 to 2010 and were based on a national survey that is conducted every two years and is considered the gold standard on health indicators. Government health workers interviewed more than 8,000 girls and women ages 14 to 59 and collected vaginal swabs that were evaluated by the C.D.C.

The infection rate for girls fell even further when the two strains of the virus that cause genital warts were included, with a 56 percent drop over the period of the study. The rate was flat in the years before the vaccine was introduced, giving researchers even more assurance that the vaccine was driving the decline. Health officials began monitoring HPV prevalence in boys only this year. The first data will be available in 2015.

There are about 12,000 cases of cervical cancer and 4,000 deaths a year in the United States. At current vaccination rates, the vaccine would prevent 45,000 cases of cervical cancer and 14,000 deaths among girls now age 13 and younger over the course of their lifetimes, according to C.D.C. estimates. Increasing the rate to 80 percent could prevent an additional 53,000 cancers and nearly 17,000 deaths.

Federal officials on Wednesday sought to dispel fears about the vaccine, and emphasized its role in preventing cervical cancer.

“This is an anticancer vaccine,” Dr. Frieden said.

About 79 million Americans, most in their late teens and early 20s, are infected with HPV, or about a quarter of the American population. Each year, about 14 million people become infected. The virus causes about 19,000 cancers in women every year, and 8,000 in men, according to the C.D.C. Cervical cancer is the most common among women; among men, throat cancer is most common.

Health officials offered several possible explanations for why the drop was so sharp even though most girls in the United States are still not fully vaccinated.

One possible reason is a phenomenon known as herd immunity, in which people who are vaccinated reduce the overall prevalence of the virus in society, decreasing the chances that unvaccinated people would be exposed to someone who is infected. Another is the unexpected effectiveness of a partial dosage of the HPV vaccine, said Dr. Lauri E. Markowitz, a medical epidemiologist at the C.D.C. and the lead author of the study. About half of teenage girls in the United States have received at least one dose of the vaccine.

Because girls and women who got vaccinated tended to be more sexually active, compared with those who were not vaccinated, researchers suggest that those who had been contributing most to the prevalence of the infection were no longer infecting others.

There are two HPV vaccines, one made by Merck for boys and girls, and one by GlaxoSmithKline, for girls. Experts recommended in 2007 that all girls get vaccinated, and extended that guidance to boys in 2011.

Earlier data from the C.D.C. showed that Hispanic girls were more likely to be vaccinated than white girls, even though they were less likely to come from families with health insurance or to get regular medical care. That is partly because a federal program that covers vaccines for the poor and underserved gave the H.P.V. vaccine to clinics, while many patients with private insurance had high co-pays or had to pay the full price, generally up to $500 for a complete cycle of the vaccine.

But cost will be less of an issue after the full implementation of President Obama’s health care law, which Dr. Frieden said requires providers to cover the vaccine at no cost to patients.

Another obstacle to higher vaccination rates are doctors, who Dr. Frieden said are “not consistently giving strong recommendations for the vaccines, particularly for younger teens.”

Dr. Amanda F. Dempsey, an associate professor of pediatrics at the University of Colorado Denver, says most providers believe in the vaccine, but have met considerable resistance from parents, and feel that the brief time during visits may be better used on topics to which parents are more receptive.

“You want to make the biggest impact,” said Dr. Dempsey, who recommends the vaccine to patients, but still gets a lot of refusals. Many parents do not believe their child is at risk because they are not sexually active, but she said that she explains that vaccination should happen long before exposure.

She added, “For a lot of people there’s still a vague sense that there’s some controversy about the vaccine.”

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

June, 2013|Oral Cancer News|

Reasons for Not Vaccinating Adolescents: National Immunization Survey of Teens, 2008–2010

Source: Pediatrics
Authors: Paul M. Darden, MD, David M. Thompson, PhD, James R. Roberts, MD, MPH, Jessica J. Hale, MSa, Charlene Pope, PhD, MPH, RN, Monique Naifeh, MD, MPHa, and Robert M. Jacobson, MD
Published Online: March 18, 2013



OBJECTIVE: To determine the reasons adolescents are not vaccinated for specific vaccines and how these reasons have changed over time.

METHODS: We analyzed the 2008–2010 National Immunization Survey of Teens examining reasons parents do not have their teens immunized. Parents whose teens were not up to date (Not-UTD) for Tdap/Td and MCV4 were asked the main reason they were not vaccinated. Parents of female teens Not-UTD for human papillomavirus vaccine (HPV) were asked their intent to give HPV, and those unlikely to get HPV were asked the main reason why not.

RESULTS: The most frequent reasons for not vaccinating were the same for Tdap/Td and MCV4, including “Not recommended” and “Not needed or not necessary.” For HPV, the most frequent reasons included those for the other vaccines as well as 4 others, including “Not sexually active” and “Safety concerns/Side effects.” “Safety concerns/Side effects” increased from 4.5% in 2008 to 7.7% in 2009 to 16.4% in 2010 and, in 2010, approaching the most common reason “Not Needed or Not Necessary” at 17.4% (95% CI: 15.7–19.1). Although parents report that health care professionals increasingly recommend all vaccines, including HPV, the intent to not vaccinate for HPV increased from 39.8% in 2008 to 43.9% in 2010 (OR for trend 1.08, 95% CI: 1.04–1.13).

CONCLUSIONS: Despite doctors increasingly recommending adolescent vaccines, parents increasingly intend not to vaccinate female teens with HPV. The concern about safety of HPV grew with each year. Addressing specific and growing parental concerns about HPV will require different considerations than those for the other vaccines.


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


June, 2013|Oral Cancer News|

NIH scientists find promising biomarker for predicting HPV-related oropharynx cancer

Source: National Cancer Institute
Published: 6-17-13


Researchers have found that antibodies against the human papillomavirus (HPV) may help identify individuals who are at greatly increased risk of HPV-related cancer of the oropharynx, which is a portion of the throat that contains the tonsils.

In their study, at least 1 in 3 individuals with oropharyngeal cancer had antibodies to HPV, compared to fewer than 1 in 100 individuals without cancer.  When present, these antibodies were detectable many years before the onset of disease. These findings raise the possibility that a blood test might one day be used to identify patients with this type of cancer.



Genomic structure of HPV




The results of this study, carried out by scientists at the National Cancer Institute (NCI), part of the National Institutes of Health, in collaboration with the International Agency for Research on Cancer (IARC), were published online June 17,  2013, in the Journal of Clinical Oncology.

Historically, the majority of oropharyngeal cancers could be explained by tobacco use and alcohol consumption rather than HPV infection. However, incidence of this malignancy is increasing in many parts of the world, especially in the United States and Europe, because of increased infection with HPV type 16 (HPV16). In the United States it is estimated that more than 60 percent of current cases of oropharyngeal cancer are due to HPV16.  Persistent infection with HPV16 induces cellular changes that lead to cancer.

HPV E6 is one of the viral genes that contribute to tumor formation. Previous studies of patients with HPV-related oropharynx cancer found antibodies to E6 in their blood.

“Our study shows not only that the E6 antibodies are present prior to diagnosis—but that in many cases, the antibodies are there more than a decade before the cancer was clinically detectable, an important feature of a successful screening biomarker,” said Aimee R. Kreimer, Ph.D., the lead Investigator from the Division of Cancer Epidemiology and Genetics, NCI.

Kreimer and her colleagues tested samples from participants in the European Prospective Investigation into Cancer and Nutrition Study, a long-term study of more than 500,000 healthy adults in 10 European countries. Participants gave a blood sample at the start of the study and have been followed since their initial contribution.

The researchers analyzed blood from 135 individuals who developed oropharyngeal cancer between one and 13 years later, and nearly 1,600 control individuals who did not develop cancer. The study found antibodies against the HPV16 E6 protein in 35 percent of the individuals with cancer, compared to less than 1 percent of the samples from the cancer-free individuals. The blood samples had been collected on average, six years before diagnosis, but the relationship was independent of the time between blood collection and diagnosis. Antibodies to HPV16 E6 protein were even found in blood samples collected more than 10 years before diagnosis.

The scientists also report that HPV16 E6 antibodies may be a biomarker for improved survival, consistent with previous reports. Patients in the study with oropharyngeal cancer who tested positive for HPV16 E6 antibodies prior to diagnosis were 70 percent more likely to be alive at the end of follow-up, compared to patients who tested negative.

“Although promising, these findings should be considered preliminary,” said Paul Brennan, Ph.D., the lead investigator from IARC. “If the predictive capability of the HPV16 E6 antibody holds up in other studies, we may want to consider developing a screening tool based on this result.”


OCF NOTE: OCF is privileged to have a member of the National Cancer Institute, who has a strong background in Oral Cancer and HPV, as a member of our Science Advisory Board. 

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


June, 2013|Oral Cancer News|

Sexual Activity–Related Outcomes After Human Papillomavirus Vaccination of 11- to 12-Year-Olds

Source: Pediatrics
Published Online: October 15, 2012
By: Robert A. Bednarczyk, PhD, Robert Davis, MD, MPH, Kevin Ault, MD, Walter Orenstein, MD, and Saad B. Omer, MBBS, PhD, MPH 


OBJECTIVE: Previous surveys on hypothesized sexual activity changes after human papillomavirus (HPV) vaccination may be subject to self-response biases. To date, no studies measured clinical markers of sexual activity after HPV vaccination. This study evaluated sexual activity–related clinical outcomes after adolescent vaccination.

METHODS: We conducted a retrospective cohort study utilizing longitudinal electronic data from a large managed care organization. Girls enrolled in the managed care organization, aged 11 through 12 years between July 2006 and December 2007, were classified by adolescent vaccine (HPV; tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis, adsorbed; quadrivalent meningococcal conjugate) receipt. Outcomes (pregnancy/sexually transmitted infection testing or diagnosis; contraceptive counseling) were assessed through December 31, 2010, providing up to 3 years of follow-up. Incidence rate ratios comparing vaccination categories were estimated with multivariate Poisson regression, adjusting for health care–seeking behavior and demographic characteristics.

RESULTS: The cohort included 1398 girls (493 HPV vaccine–exposed; 905 HPV vaccine–unexposed). Risk of the composite outcome (any pregnancy/sexually transmitted infection testing or diagnosis or contraceptive counseling) was not significantly elevated in HPV vaccine–exposed girls relative to HPV vaccine–unexposed girls (adjusted incidence rate ratio: 1.29, 95% confidence interval [CI]: 0.92 to1.80; incidence rate difference: 1.6/100 person-years; 95% CI: −0.03 to 3.24). Incidence rate difference for Chlamydia infection (0.06/100 person-years [95% CI: −0.30 to 0.18]) and pregnancy diagnoses (0.07/100 person-years [95% CI: −0.20 to 0.35]), indicating little clinically meaningful absolute risk differences.

CONCLUSIONS: HPV vaccination in the recommended ages was not associated with increased sexual activity–related outcome rates.


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


June, 2013|Oral Cancer News|

E-Cigarettes Are in Vogue and at a Crossroads

Published: June 12, 2013
Source: NY Times

PARIS — On a recent day in the shadow of the Arc de Triomphe, a line of 20 people spilled onto the sidewalk of a trendy new boutique, eager to get a taste of its latest gourmet offerings.

Olivia Foiret, the manager of ClopiNette, demonstrates filling an e-cigarette for a client.

A sign in the window promoted piña colada as the store’s flavor of the month. A woman wearing a Chanel jacket said she wanted to try peach.

But this was no temple of gastronomy. It was one of scores of electronic cigarette shops that have been springing up by the week in Paris as well as in numerous cities across Europe and the United States. Inside the ClopiNette boutique, shoppers can choose from among more than 60 flavors of nicotine liquid — including Marlboro and Lucky Strike flavors — all in varying strengths and arranged in color-coded rows. (ClopiNette is a play on “clope,” French slang for a cigarette.)

“It’s like visiting a Nespresso store,” said Anne Stephan, a lawyer specializing in health issues at a nearby law firm.

What’s driving her into the store is a desire shared by many: they want to give up smoking tobacco but don’t want to kick the smoking habit. After smoking 20 cigarettes daily for 25 years and failing to quit, Ms. Stephan said she had cut down to one a day in the three months since she began puffing on a so-called e-cig. Using technology that turns nicotine-infused propylene glycol into an inhalable vapor, e-cigarettes smoke almost like the real thing, without the ashtray odor.

While e-cigarettes are still a fraction of the $80 billion-a-year market for smoking products in the United States, the growing popularity of vaping, as the practice is known, has touched off a clash in Europe between retailers and regulators. On Wednesday, the British government announced it would begin treating e-cigarettes as medicines, “so that people using these products have the confidence they are safe, are of the right quality and work.”

E-cigarettes and other nicotine products will be licensed in Britain starting in 2016, giving manufacturers time to ensure that their products comply with all standards for medicines. The British regulator says e-cigarettes aren’t recommended for use until then, but it won’t ban them entirely. Government officials in France this month announced they might ban the e-cigarettes in public spaces. Italy is considering banning them from schools.

In the United States, the Food and Drug Administration tried to block the sale of e-cigarettes, claiming that they were unapproved “drug/device combinations.” Manufacturers successfully challenged the agency’s position, but in a 2010 ruling, a federal appeals court held that e-cigarettes could be regulated by the agency as tobacco products.

An agency spokeswoman, Stephanie Yao, said the agency was preparing to release for public comment a proposed rule to regulate additional categories of tobacco products.

Currently, the F.D.A.’s tobacco regulations apply to cigarettes, tobacco and smokeless tobacco.

“Further research is needed to assess the potential public health benefits and risks of electronic cigarettes and other novel tobacco products,” Ms. Yao said in a statement.

Health officials say their safety has not been medically proved and the devices could encourage children to take up smoking. Some antismoking advocates, who are simply annoyed to see the gadgets glowing in restaurants and bars, call for a ban on their use in public places, the same ban in force for tobacco products.

The allure is unmistakable. The actor Leonardo DiCaprio was spotted puffing on an e-cig at Chateau Marmont in West Hollywood earlier this year, while the French actress Catherine Deneuve, a longtime heavy smoker, now puffs the electronic version in Parisian restaurants and even during news conferences.

Global sales jumped 30 percent in each of the previous three years to around $2 billion in 2011, with the European market around $650 million, according to a recent analysis by Euromonitor International. Retail sales of e-cigs in the United States reached $500 million last year. Although that is only about 0.5 percent of the overall tobacco market, analysts expect those figures to double this year and continue climbing.

“E-cigarette consumption could surpass traditional cigarettes in the next decade,” said Katherine Devlin, president of the London-based Electronic Cigarette Industry Trade Association. “Growth is exponential and there are no signs it’s slowing down. So there is a huge amount at stake.”

Currently, e-cigs are distributed by more than 100 small and medium-size firms like NJOY and White Cloud. Most are manufactured by a Chinese company, Ruyan, which invented the gadget that heats the nicotine solution into a smokelike vapor. The device, which also can have an LED light to mimic the glow of a burning ash, has been registered for patents in more than 50 countries.

But now, the makers of Marlboro and other big tobacco brands are rushing to get a piece of the action — especially to make up for lost sales as tobacco smoking declines in Western countries. Last year, Lorillard bought the e-cigarette maker Blu for $135 million. British American Tobacco, RJ Reynolds and Japan Tobacco International have also taken stakes in the new industry. In April, as cigarette sales fell 5.2 percent in the first quarter from a year ago, Altria announced it would soon unveil its own electronic cigarette. Earlier this month, Reynolds American said it would introduce a revamped e-cig with an ad campaign including television commercials, which are off-limits for tobacco cigarettes.

Certainly signs of growth are there. In 2011, the latest year for which data were available, more than 20 percent of adult smokers said they had tried e-cigarettes, double the rate in 2010, according to the Centers for Disease Control and Prevention. Electronic cigarettes could account for nearly 5 percent of the value of all tobacco products in the next two decades, according to Euromonitor International. Analysts say such trends would also challenge the pharmaceutical industry, where stop-smoking products like nicotine patches and gums pulled in about $2.4 billion in 2011, not including prescription treatments.

“It’s tres à la mode,” said Olivia Foiret, the manager of the ClopiNette store on the Avenue de la Grande Armée, as customers crowded around the counter. “People want to stop smoking; they try one of these and they’re hooked.”

As an alternative to smoking tobacco, the devices have become such an attractive investment option that Sean Parker, co-founder of the now defunct music-sharing site Napster, is buying a stake in NJOY, one of the companies that makes e-cigarettes.

Mr. Parker has long donated to cancer research but is said to view the electronic devices as a safe alternative.

In December, European Union officials proposed regulating e-cigarettes and most nicotine liquids across the European Union as medical products. That would limit the nicotine content sold over the counter to 4 milligrams per milliliter — lighter than the lightest cigarette — or force manufacturers to put them through clinical trials.

The new rules could also radically affect how much money governments could take in through new taxes, a not insignificant consideration when declining tobacco sales are leaving sizable holes in national treasuries. In the first two months of 2013 alone, the Italian government, for example, reported a 132 million euro revenue shortfall from sliding cigarette sales. Nicotine liquid refills are not taxed in most European Union countries, and legislators think they could help make up some of the difference.

E-cigarette supporters say European officials are having a knee-jerk reaction that fails to recognize the devices as a “safer” alternative to smoking. They point to declarations from authorities like the Royal College of Physicians in Britain, which has said the devices can lure people away from traditional cigarettes and urged that they be made widely available. A separate 2011 study in The American Journal of Preventive Medicine said e-cigarettes “may hold promise as a smoking-cessation method.”

Retailers also protest that because they don’t market e-cigarettes to help smokers quit, e-cigarettes should not be treated as a pharmaceutical. “No one is claiming it’s medicine,” Ms. Devlin said. “It allows you to keep smoking.” They added that clinical trial requirements would make liquid nicotine commercially unviable, and are pressing for the European Union not to adopt new regulations.

European regulators cite a paucity of studies on the safety of routinely inhaling propylene glycol, a viscous chemical found in everything from asthma inhalers to antifreeze. It is deemed harmless by the Food and Drug Administration, but critics say it has not been adequately tested for chain smokers who might use the e-cigarettes during most of their waking hours.

Tonio Borg, the European commissioner for health and consumer policy, has expressed concerns that e-cigarettes, with their tasty flavors and colorful tips, could be a gateway to smoking for the young. In France, where tobacco sales fell last year to their lowest levels in a decade, a recent survey among Paris school children between the ages of 12 and 17 found that 8.1 percent of more than 3,400 surveyed had experimented with e-cigarettes.

Pascal Somosierra, 50, a dapper floral artist who decorates Parisian gems like Fouquet’s restaurant on the Champs-Élysées, said that since he bought a sleek black “Ego-C” model last month, he had been using it in his office, inside cafes and even on the Metro. “Some people look at me strangely,” said Mr. Somosierra, who said he instantly stopped his 30-year-old two-pack-a-day habit. “But I’m seen more favorably with this than when I’m smoking a regular cigarette.”

But he admits, “For a young person who doesn’t smoke, it can be tempting; there are all the flavors, and it looks cool.” He keeps his e-cigs out of reach of his children. “Think about it,” he said. “If even the company that makes Marlboro is jumping into the game, it’s a way for them to get nicotine into new smokers.”


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

June, 2013|Oral Cancer News|

Oral cancer sneaks up

Author: Donald G. McNeail Jr. and Anahad O’Connor

The actor Michael Douglas has done for throat cancer what Rock Hudson did for AIDS and Angelina Jolie did for prophylactic mastectomy. By asserting last week that his cancer was caused by a virus transmitted during oral sex, Mr. Douglas pushed the disease onto the front pages and made millions of Americans worry about it for the first time.

In this case, it was a subset of Americans who normally worry more about being killed by cholesterol than by an S.T.D. The typical victim is a middle-aged, middle-class, married heterosexual white man who has had about six oral sex partners in his lifetime.

The virus, human papillomavirus Type 16, also causes cervical cancer. So is there any early oral screening that a man can have — an equivalent to the Pap smear, which has nearly eliminated cervical cancer as a death threat in this country?

The answer, according to cancer experts and a recent opinion from the United States Preventive Services Task Force, is no. And for surprising reasons.

The Pap test — invented in 1928 by Dr. George N. Papanicolaou — involves scraping a few cells from the cervix and checking them under a microscope for precancerous changes. Precancerous cells have a “halo” around the nucleus, while cancerous ones have larger, more colorful nuclei, said Dr. Paul D. Blumenthal, a professor of gynecology at Stanford University Medical School.

In theory, it should be similarly easy to scrape and examine throat cells. But in fact, cancer specialists said, doing so would be useless.

Virtually all cancers on the mouth, tongue, gums, hard palate or anywhere in front of the uvula (the “punching bag” dangling from the soft palate) are caused by tobacco and alcohol.

The kind of chronic HPV 16 infection that leads to oral cancer occurs much farther down, near the base of the tongue. Adding to the difficulty, the infection is often “deep down in the crypts of the tonsils,” said Dr. Eric J. Moore, a Mayo Clinic surgeon specializing in such cancers.

The tonsils, an expanse of lymphoid tissue that includes much more than the two back-of-the-throat bumps removed in tonsillectomies, have deep folds and crevices.

“If you spread them out, they’re 2 feet by 2 feet, said Dr. Marshall R. Posner, medical director for head and neck cancer at Mount Sinai Medical Center. “You can’t swab them. It’s just not possible.” By contrast, the end of the cervix swabbed during a Pap test is only about two square inches and easily reached with a speculum. It is impossible even to see deep tonsillar tissue without a scope that goes through the nose. Probing this area would set off gag and vomit reflexes so strong that patients might have to be anesthetized.

A saliva test can detect an oral HPV infection. But that’s not useful, since 85 percent of the population catches at least one of the 100 different human papillomaviruses that circulate. Most infections are beaten by the immune system in a year or two. Even among those who get an oral HPV 16 infection, less than 1 percent will go on to develop throat cancer.

“If I tell you that you have HPV in your mouth, it’s not going to help you if I don’t have anything to offer you, and you’re going to live with the anxiety and fear that you might get cancer,” said Dr. Robert I. Haddad, chief of head and neck cancer at the Dana-Farber Cancer Institute in Boston. “But if I tell a woman that she has an abnormal Pap smear, there’s something she can do about it.”

Someone with chronic HPV 16 year after year would be at the highest risk for throat cancer — but even then it is not clear what to do. Probing through all the tonsillar tissue under anesthesia looking for something worrisome to biopsy would be difficult and expensive and could set off bleeding near the entrance to the lungs.

Even when surgeons find large, cancerous lymph nodes, the primary tumor that seeded them sometimes turns out to be a speck only a sixteenth of an inch wide buried by healthy tissue, Dr. Moore said.

Although throat cancer caused by HPV is increasing, it is relatively rare. About 25,000 cases a year are diagnosed in the United States, compared with 226,000 lung cancers. But it is growing in importance as smoking-related oral cancers decline.

Oral sex has become more common since the sexual revolution of the 1960s, but not astonishingly so. According to Debby Herbenick, a director of Indiana University’s Center for Sexual Health Promotion, the mean number of lifetime oral sex partners reported by American men 35 to 54 is six. Men 55 to 64 report five, and men 25 to 34 report four. Men over 65 and under 25 report three.

However, such “fairly modest changes” in sexual habits do not explain why the cancer risk has doubled or tripled over the years, said Gypsyamber D’Souza, a viral cancer specialist at Johns Hopkins Bloomberg School of Public Health. It has risen the most in white men 45 and up. The older age is explained by the fact that, like cervical cancer, it can take decades to develop.

Men are twice as likely as women to get it, according to Dr. D’Souza, and it is more common among whites than blacks, perhaps because whites are more likely, by 90 percent to 69 percent, to have ever performed oral sex.

And straight men are more likely to get the cancer than gay men. One theory is that there may be more HPV in vaginal fluid than on the penis, said Dr. Lori J. Wirth, a head and neck cancer specialist at Massachusetts General Hospital.

The lack of a screening test means that a doctor should be seen as soon as symptoms appear: a lump in the neck, a sore throat or ear pain that persists for two weeks, or what Dr. Posner called “the hot potato voice: the way you talk when something is burning the back of your throat.”

Though no studies proving it have been done, Gardasil and Cervarix, the vaccines to prevent cervical cancer from HPV Types 16 and 18, should also prevent this oral cancer and should be offered to boys and young men, several doctors said.

Advaxis requests orphan drug designation for treatment of HPV-associated head and neck cancer with ADXS-HPV

Author: press release

Advaxis, Inc., a leader in developing the next generation of immunotherapies for cancer and infectious diseases, announced that it has submitted an Application for Orphan Drug Designation with the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD) for ADXS-HPV, its lead drug candidate, for the treatment of human papillomavirus (HPV)-associated head and neck cancer. There are about 50,000 new cases of head and neck cancer annually, with about 15,000 deaths. HPV infection is estimated to account for 20-50% of current incidence.

Orphan Drug Designation is granted to drug therapies intended to treat diseases or conditions that affect fewer than 200,000 people in the United States. Orphan Drug Designation entitles the sponsor to clinical protocol assistance with the FDA, as well as federal grants, tax credits, and a seven year market exclusivity period.

“HPV-associated head and neck cancer is growing at an epidemic rate in the United States and other regions throughout the world. According to the U.S. Centers for Disease Control and Prevention (CDC), over 80% of new cases occur in men, who are not typically part of HPV vaccination programs,” commented Dr. Robert Petit, Chief Scientific Officer of Advaxis. “Data from our Phase 2 study in recurrent cervical cancer show that ADXS-HPV is an active treatment in this HPV-associated cancer. We believe that ADXS-HPV immunotherapy will show similar activity in HPV-associated head and neck cancer, given the shared causality of the cancers. We have one ongoing Phase 1/2 study in HPV-positive head and neck cancer in the United Kingdom and plan to initiate another in the United States in 2013. We believe ADXS-HPV could become an important new non-cytotoxic treatment for patients with HPV-associated head and neck cancer.”

“If granted, Orphan Drug Designation (ODD) for our lead drug candidate, ADXS-HPV, could expedite our ability to help the over 10,000 Americans that the American Cancer Society estimates will be newly diagnosed with HPV-associated head and neck cancer in 2013. ODD would also provide seven years of market exclusivity for ADXS-HPV if it is approved by the FDA, tax credits on U.S. clinical trials, eligibility for orphan drug grants, and a waiver of the $1.9 million regulatory application filing fee,” commented Thomas A. Moore, Chairman and CEO of Advaxis. “It is believed that the number of new HPV-caused head and neck cancers in the United States now approaches the number of new cervical cancer cases. This indication, with these incentives, if achieved, could substantially increase the potential value of the ADXS-HPV franchise.”

About Orphan Drug Designation
Under the Orphan Drug Act (ODA), the FDA may grant orphan designation to a drug or biological product intended to treat a rare disease or condition, which is generally a disease or condition that affects fewer than 200,000 individuals in the United States, or more than 200,000 individuals in the United States and for which there is no reasonable expectation that the cost of developing and making a drug or biological product available in the United States for this type of disease or condition will be recovered from sales of the product. The benefits of orphan drug designation can be substantial and include federal grants, tax credits, and a seven year market exclusivity period once the product is approved, provided that the product is first to market.

In order for a sponsor to obtain orphan designation for a drug or biological product, an application must be submitted to OOPD, and the designation approved. The approval of an application for orphan designation is based upon the information submitted by the sponsor. A drug that has obtained orphan designation is said to have “orphan status.” Each designation request must stand on its own merit. Sponsors requesting designation of the same drug for the same indication as a previously designated product must submit their own data in support of their designation request. The approval of an orphan designation request does not alter the standard regulatory requirements and process for obtaining marketing approval. Safety and efficacy of a compound must be established through adequate and well-controlled studies.

Why HPV vaccination makes a difference against cancer

Author: Michelle Castillo

Michael Douglas’ frank discussion about the human papillomavirus (HPV) and oral cancer has put a spotlight on the dangers of the sexually transmitted virus. While using a condom may reduce risk for HPV, doctors are reminding people that the best way to protect oneself from the disease that can potentially lead to cancer is to get vaccinated at an early age and, if possible, go for routine screenings.


HPV is a group of more than 100 very common viruses, about 40 of which can be transmitted sexually, according to the U.S. Department of Health and Human Services Office on Women’s Health. Approximately 79 million Americans are currently infected with an HPV strain, the Centers for Disease Control and Prevention reports, and nearly all sexually active men and women will get one type of sexually transmitted HPV in their lifetime.

Specifically, 20 million people in the U.S. between the ages of 15 to 49 are infected with a genital HPV at any given time, and about half of men and women can expect to be infected with genital HPV in their lifetime.

“HPV is ubiquitous in our population,” Dr. Lori Wirth, medical director of the Center for Head and Neck Cancers center at Massachusetts General Hospital in Boston, explained to “Anyone who has led a normal sex life will get HPV, and develop antibodies to the virus. But, a minority of people who have contact with the virus who don’t effectively clear the virus from their system will develop other diseases.”

For the most part, once a person is infected with HPV, their body builds natural immunities against it and fights it off. But, some strains can lead to cancers of the oropharynx (back of the throat, including the base of the tongue and tonsils), cervix, vulva, vagina, penis and anus. Two strains of HPV are connected to 70 percent of cervical cancer cases, while two others cause 90 percent of genital warts. Doctors still don’t know why some people who get HPV go on to develop other diseases, while others don’t.

Screening for HPV
To look for genital HPV, women can get an HPV test during a Pap smear, which among other things will reveal if she currently is infected with the cancer-causing strains of HPV. While it does not necessarily mean she will get cervical cancer, it shows that she is at high risk for the disease. Doctors can go ahead and do more exploratory procedures for suspicious polyps or growths and continue screening to see if her HPV persists.

Women are recommended to get Pap smears once a year if they have new sexual partners. If they have no new sexual partners, they can extended that time period to every three years, granted they get a clean bill of health.

What is harder to diagnose is anal, penile and oropharyngeal cancer. Currently, there is no way to even screen for genital HPV in men, although there are some initial studies on anal Pap smears, Dr. Sharon Orrange, assistant professor of clinical medicine at Keck Medical Center of USC Downtown in Los Angeles, told However, there is no current test for HPV strains that lead to penile and anal cancer, though rates for these diseases are so low that it currently is not cost-effective to develop them, Wirth pointed out.

Not having a vaccine to protect against oropharyngeal cancer is especially concerning because this type of cancer has one of the fastest growing rates: It’s increased 225 percent from the mid 1980s to the mid 2000s, according to Wirth.

“HPV-related oropharyngeal cancer rates will outnumber cervical cancer cases by 2020,” Wirth said. “The epidemiological phenomenon is just fascinating.”

Currently, a new test allows doctors to test of the presence of HPV DNA in an oral gargle and rinse test, Wirth explained. About 10 percent of men and 3.5 percent of women test positive for strains that lead to oropharyngeal cancer under this procedure.

But, this only identifies people who are high-risk, Wirth pointed out. Part of the problem with oropharyngeal cancer is that it occurs deep in a patient’s mouth where doctors can’t even see, and the gag reflex makes it hard to take a closer look. Even without these problems, the mucosal surfaces are very repetitive and fold over each other, creating hidden pockets that easily hide pre-cancerous lesions.

Why vaccination matters
Currently, two vaccines exist that can provide protection from some of the most dangerous strains of HPV. Gardasil, which is Food and Drug Administration-approved for people between the ages of nine to 26, provides protection from HPV types 6, 11, 16, and 18. Strains 16 and 18 are behind the leading causes of cervical and other cancers, and 6 and 11 cause genital warts. Cervarix only provides protection for strains 16 and 18, and is only approved for women between 10 and 25.

“The vaccines that are available right now are one of our only protections against HPV,” Dr. Nieca Goldberg, director of the Joan H. Tisch Center for Women’s Health at NYU Langone Medical Center, told

While some might say that women may benefit more from getting the vaccines because of cervical cancer risk, it’s important to note that both men and women can get genital warts. In addition, men can transmit the dangerous strains of HPV, and if they are immunized against it, overall transmission rates could decrease.

Orrange points out that having the vaccine can also prevent having the awkward conversation with a partner when you have to tell them that you have a sexually transmitted disease.

“My patients who have HPV never know how much to disclose to an new partner,” Orrange explained. “When they disclose it, everyone runs for the hills.”

There are some limitations with the vaccine. First, it is shown to be most effective in patients who have not been infected with the HPV strains so it can help them develop immunity for future infections. For this reason, it is recommended that it is given at 11 or 12, before any sexual activity takes place. Some fear that giving the HPV vaccine may lead to sexual promiscuity at an earlier age, but studies have shown that there is no link between the two actions.

Since the vaccine was developed for an adolescent population, there isn’t much research out there on whether on not giving the vaccine even earlier would be beneficial to the patient. It’s still relatively new, so there’s not much information if the protections wear off over time.

The vaccines are recommended until the patient reaches the age of 26 in the U.S. After that age, it is assumed that the patient would have already come in contact with the virus, rendering the vaccine useless.

Still, Orrange said she’s had many patients in their 30s who have come up HPV negative following a Pap smear and pay out of pocket for the vaccine, just in case they haven’t come in contact with the disease-causing strains. In fact, Canadian labeling of the same product extends the appropriate age from 9 to 45.

“It’s not going to hurt you at all (if you’ve already contracted HPV),” Orrange said. “It just hasn’t been shown to be effective to you in any way.”

The vaccine is delivered in a series of three shots, and it is very important that the patient receives the full dose. Wirth pointed out that slightly less than a third of all girls will have the three doses by the recommended age.

“It’s a much smaller percent of young kids who get vaccinated with all three doses,” Wirth said. “We don’t know how it will work with people who only get the dose one or two times.”

Another reason preventing people from getting the vaccine is the fear of side effects. A March study in Pediatrics showed that 44 percent of parents did not want their children to get the HPV vaccine, and the main reason was because they were afraid the vaccine wasn’t safe. Wirth assures people though that because it is not a live viral vaccine — meaning you cannot get HPV from the shot – and it doesn’t contain eggs like the flu vaccine, the risk of side effects are low.

Observed reactions have been pain, redness or swelling at the injection site, mild dizziness, nausea and headache and fainting — the later of which is a side effect for any shot. There was also a risk of blood clots of the lungs compared to other women around the same age who had received vaccines, but 90 percent of the people who got the HPV vaccine had another risk factor for blood clots, including taking oral contraceptives.

“We give people vaccines for other things like polio, mumps, measles and rubella,” Goldberg said. “This is just another thing to protect ourselves.”