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HPV vaccine may work for people who already had the virus

Wed, Apr 22, 2015

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Source: time.com
Author: Alexandra Sifferlin

A new study underlines the effectiveness of the HPV vaccine, showing the vaccine is protective against the virus on multiple sites on the body, even for women who have been infected in the past.

TIME.com stock photos

In a randomized controlled trial—considered the gold standard of scientific research—scientists wanted to know if the HPV vaccine protected against cervical, anal and oral HPV. Daniel C. Beachler, a postdoctoral fellow in the Infections and Immunoepidemiology Branch of the National Cancer Institute (NCI), and his colleagues followed 4,186 women between the ages of 18 to 25 who were either vaccinated with a HPV16/18 vaccine or a control vaccine (a hepatitis A vaccine). Cervical samples from the women were collected at their annual visits and oral and anal samples were collected at a four-year follow-up visit.

“We were interested in the question of whether the vaccination may protect non-infected sites against HPV infection or re-infection in women who were previously exposed to HPV prior to vaccination,” says Beachler. The study was presented at the American Association for Cancer Research annual meeting.

The results showed that the efficacy for the vaccine in all three sites was 83% among the women with no evidence of prior HPV exposure and infection, 58% among women with prior HPV exposure, and a 25% among women with active cervical HPV16/18 infection (the percentage was considered nonsignificant). In total, the researchers report that the overall vaccine efficacy was 65% for all sites and 91% for protection in at least two sites.

Among the women in the trial, some had no evidence of HPV, some had an active HPV infection, and some of the women did not have an active infection but had antibodies for HPV, suggesting that they had been exposed to the virus previously. That’s not uncommon, considering the U.S. Centers for Disease Control and Prevention (CDC) estimates that nearly all sexually active men and women get HPV at some point in their lives.

The CDC says teen boys and girls who did not start or finish the HPV vaccine series when they were younger should get it, and young women can get the vaccine through age 26 and young men through age 21.

The CDC says that girls who are already sexually active can still benefit from the vaccine, but it may be less effective since it’s possible they have already been exposed to one or more HPV strains. Still, the CDC says that since young women are not necessarily infected with all types of HPV, they can still benefit from the vaccine. This new study underscores that guidance.

“[This study] is supportive that there could be some benefit at these older ages,” says Beachler. “Close to 90% of individuals are able to clear an HPV infection on their own. This is not a therapeutic vaccine but it could still help protect from acquisition of new infections.”

Dr. Miriam Lango, a head and neck cancer surgeon at Fox Chase Cancer Center, says that the new study is some of the “best kind of evidence we have,” in support of vaccinating against HPV in women of that age. “My understanding was always that you get the vaccination before you get the infection and that after you’ve been infected there’s no benefit to having the vaccination,” she says. “That’s really not what the data tells us.” Lango was not involved in the study.

Beachler noted that at the end of the study, the women in the control arm of the trial were able to get vaccinated against HPV.

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LED Dental Joins With the Oral Cancer Foundation to promote oral cancer early detection initiative

Wed, Apr 22, 2015

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Source: www.marketwatch.com
Author: press release

LED Dental Inc. has announced that the company will be serving as a strategic partner in the Oral Cancer Foundation’s “Be Part of the Change”(TM) program, seeking to promote the importance of routine comprehensive oral screenings and early detection in the fight against oral cancer.

The Oral Cancer Foundation initiated the “Be Part of the Change”(TM) campaign to help promote a shift in paradigm with regard to the screening for oral cancer, creating a movement toward earlier detection of oral disease. While regular oral screenings are a key tool in the early detection of oral cancer and pre-cancerous lesions, many patients are not receiving routine oral examinations that could potentially locate a serious oral health concern. The Oral Cancer Foundation is working to change the mindset of the oral healthcare industry, making improved oral screening protocols a priority in every dental practice.

“The best defense any patient has against oral disease and oral cancer is early detection, which is where dental practitioners can effect change,” said Brian Hill, founder and executive director of the Oral Cancer Foundation. “When oral cancer is located in earlier stages, there is higher probability for reduced treatment related morbidity and improved patient outcomes. Our goal is to get healthcare professionals to commit to performing routine comprehensive oral examinations on every patient, especially during hygiene visits and recall appointments.”

As the manufacturer of the market-leading VELscope® Vx Enhanced Oral Assessment, LED Dental has joined the Oral Cancer Foundation’s cause, providing a free VELscope® Vx system to dental and specialty practices that make a commitment to perform a minimum of three oral screenings per day over a period of three years. Practices will only pay for the consumable asepsis barriers to prevent cross contamination during screenings.

“We are proud to join with our partners at the Oral Cancer Foundation to reinforce the value of routine comprehensive oral examinations to the overall health of patients,” said Dr. David Gane, CEO of LED Dental’s parent company, LED Medical Diagnostics Inc. “By helping promote this awareness initiative of the Oral Cancer Foundation and providing the VELscope to practices making a pledge to perform screenings, we are definitely taking a step in the right direction in the fight against oral cancer.”

When used in conjunction with a traditional white-light examination, the VELscope® can aid in the location of oral mucosal abnormalities, including oral cancer and pre-cancer, among other oral health concerns. The VELscope® Vx is used by over 12,000 practices in 23 countries around the world. With over 25 million VELscope® Vx examinations to date, the system is the market-leading adjunctive screening technology.

For more information about the Oral Cancer Foundation and the “Be Part of the Change”(TM) initiative, please visit www.oralcancerfoundation.org. For more details on LED Medical Diagnostics and the VELscope® Vx, please visit www.velscope.com.

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Broccoli may prevent oral cancer as clinical tests set to start on humans

Mon, Apr 20, 2015

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Source: www.mirror.co.uk
Author: staff

The much-maligned green vegetable deserves more respect as lab tests show extracts of sulforaphane reduced tumours in mice.

brocoli

Broccoli could soon protect people from cancer of the mouth, throat, neck and head in a new treatment known as “green chemoprevention.” Cruciferous vegetables such as broccoli, cabbage and garden cress have a high concentration of sulforaphane.

Previous studies, including large-scale trials in China, have shown sulforaphane helps mitigate the effects of environmental carcinogens. Now lab tests have shown extracts made from broccoli sprout protected mice against oral cancer.

American scientists now plan to carry out clinical trial on patients at high risk of a recurrence of head and neck cancer. They will be given capsules containing broccoli seed powder to determine if they can tolerate the regimen and whether it has enough of an impact on their oral lining to prevent cancer.

Associate professor Dr Julie Bauman of the University of Pittsburgh said: “People who are cured of head and neck cancer are still at very high risk for a second cancer in their mouth or throat, and, unfortunately, these second cancers are commonly fatal.

“So we’re developing a safe, natural molecule found in cruciferous vegetables to protect the oral lining where these cancers form.”

The study involved testing sulforaphane in the laboratory when over several months mice predisposed to oral cancer were given the extract and found that it significantly reduced the incidence and number of tumours.

Professor of medicine Dr Daniel Johnson at Pitt’s School of Medicine said: “The clear benefit of sulforaphane in preventing oral cancer in mice raises hope that this well-tolerated compound also may act to prevent oral cancer in humans who face chronic exposure to environmental pollutants and carcinogens.”

The research also involved giving 10 healthy volunteers fruit juice mixed with sulforaphane-rich broccoli sprout extract. The volunteers had no ill-effects from the extract and protective changes were detectable in the lining of their mouths, meaning it was absorbed and directed to at-risk tissue.

These findings were enough to prompt a clinical trial that will recruit 40 volunteers who have been curatively treated for head and neck cancer. Depending on the results larger clinical trials could be carried out.

Prof Bauman added: “We call this ‘green chemoprevention,’ where simple seed preparations or plant extracts are used to prevent disease.

“Green chemoprevention requires less money and fewer resources than a traditional pharmaceutical study, and could be more easily disseminated in developing countries where head and neck cancer is a significant problem.”

Note: The findings were presented at the American Association for Cancer Research Annual Meeting in Philadelphia.

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HPV Shots for Boys Might Cut Cancer Costs

Tue, Apr 14, 2015

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Source: MedPageToday.com
Author: Charles Bankhead

- Canadian study suggests vaccination would save money by preventing oropharyngeal cancer.

Widespread vaccination of boys against human papillomavirus (HPV) infection proved to be a cost-saving approach to prevent subsequent head and neck cancer, according to data based on the Canadian health system.

A 70% immunization rate and 99% efficacy with the quadrivalent vaccine Gardasil might reduce costs by as much as $28 million ($22.2 million U.S.). Reducing uptake and efficacy to 50% still might save $8 million ($6.35 million U.S.), Lillian L. Siu, MD, of Princess Margaret Cancer Center in Toronto, and co-authors reported online in Cancer.

“According to the findings of this preliminary analysis, HPV vaccination for boys aged 12 years may be a cost-effective strategy in relation to the prevention of oropharyngeal cancer alone, strengthening the cost-effectiveness of a male vaccination program,” the authors concluded. “The argument for funding male HPV vaccination in North America is becoming more compelling given the benefits of reductions in genital warts and anal cancer and the potential benefits for the female population because of increased herd immunity.

“Prospective data collection for male HPV vaccination and oropharyngeal cancer may validate these findings in the future.”

The data are consistent with other studies showing cancer benefits for HPV immunization, although the Canadians are the first to suggest that vaccination saves money, U.S. sources told MedPage Today.

Background

Initial clinical studies of HPV vaccination and national vaccination programs targeted girls and young women. Only recently has the focus expanded to include immunization of adolescent boys. Moreover, proponents of HPV immunization increasingly have emphasized the potential cancer-prevention benefits of preventing HPV infection, which accounts for the majority of new cases of cervical cancer and head and neck cancer (primarily oropharyngeal) cancer, the latter being a male predominant-condition.

Although nations have begun to include boys in national immunization initiatives (including the U.S.), few studies have examined the cost-effectiveness of HPV vaccination from the perspective of disease (including cancer) prevention in boys and men. To address the issue, Liu and colleagues performed a preliminary cost-effectiveness analysis based on Canadian data.

On the basis of literature-derived data on HPV-related oropharyngeal cancer in Canadian men, investigators developed a Markov model to compare the costs and effectiveness of immunization with the quadrivalent HPV vaccine versus no immunization. The model was based on a theoretical cohort of 192,940 boys who were 12 years old in 2012.

Vaccination costs applied to use of the quadrivalent vaccine. Costs associated with oropharyngeal cancer were derived from records of patients treated at the Toronto center from 2000 to 2010 and from data on patients treated throughout Ontario during 1997 to 2007. The primary outcome was the incremental cost per quality-adjusted life year(QALY).

The model considered two principal scenarios: 70% vaccine uptake and 99% vaccine efficacy and 50% uptake and efficacy. In both scenarios, the comparator was no vaccination.

Key Findings

For the 70%/99% scenario, the model yielded a 0.05 QALY and a savings of $145 (~$115 U.S.) per individual as compared with no vaccination. For the 50%/50% scenario, the model showed a gain of 0.023 QALY and a savings of $42 (~$33 U.S.). Extrapolation of the results to the entire nation resulted in potential savings of $8 million to $28 million with the two vaccination scenarios.

Though limited to the Canadian perspective, the study suggests potentially large savings in the U.S. as well. The average cost of 1 year of care care for a patient with newly diagnosed oropharyngeal cancer is $25,697 in Canada, whereas the cost estimates for the U.S. range from $79,151 for patients with commercial insurance to $59,404 for Medicaid patients to $48,410 for patients covered by Medicare.

The authors’ model assumed a fixed cost of $400 (~$318 U.S.) for the vaccine, and they acknowledged that the cost of the vaccine has been a limiting factor in the uptake in developed nations. They also acknowledged that the model did not take into account recent increases in the proportion of oropharyngeal cancer attributable to HPV infection.

The status of immunization for boys has lagged behind that of girls throughout much of the world, primarily because of research priorities surrounding vaccine trials.

“The data for clinical trials in girls came out a couple of years ahead of the data for boys, so the vaccine wasn’t FDA approved or recommended by anyone for boys,” said Debbie Saslow, PhD, of the American Cancer Society in Atlanta, which supports immunization of boys and girls. “The manufacturer didn’t ask for an indication for boys. If you start out just vaccinating girls, then, of course, there is going to be a big lag in the data.”

U.S. Perspective

In the U.S., the situation is changing rapidly, and in some states, the HPV immunization rate for boys has increased dramatically and the gap between the sexes will likely close in the near future, she added. Worldwide, however, the U.S., Canada, and Australia are the only nations that currently support HPV immunization of boys and girls.

Speaking to the Canadian study results, Saslow said studies have consistently shown that HPV immunization is cost-effective for cancer prevention, but the cost-saving result is something new.

The Canadian study attempted to address one of the problems inherent in assessing the cancer-prevention potential of HPV immunization in women and men, said Rodney Willoughby, MD, of Children’s Hospital of Wisconsin in Milwaukee.

“This is essentially an anticancer vaccine,” said Willoughby, who also is a member of the American Academy of Pediatrics’ committee on infectious diseases. “The female cancers [associated with HPV] often have premalignant lesions, which allow you to do very nice, well-powered studies to show remarkable benefit in terms of preventing precancerous lesions in the real-world setting or, even more so, preventing the cancers themselves.

“The problem with the males is that they have a higher burden of the oropharyngeal cancers, and there is no precancerous marker that allows you to do studies in a short period of time.”

A lot of the information to support immunization of boys has come from extrapolation, he added. Impetus for the support has come from historically low uptake of the vaccine among girls and growing recognition that boys and girls have a similar risk of infection.

Although the Canadian and U.S. healthcare systems differ in many respects, the two governments regularly share and discuss healthcare data, so it’s reasonable to assume that the Canadian study is applicable to the U.S., said Willoughby.

Siu and co-authors disclosed no relevant relationships with industry

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

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Legal loopholes allow big tobacco companies to target young children with new products

Mon, Apr 13, 2015

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Source: http://www.contracostatimes.com
Author: Sen. Mark Leno & Tony Thurmond 
 

With smoking now widely known as the nation’s No. 1 preventable killer, Big Tobacco is targeting our kids with new products that give an illusion of more safety but carry the age-old motive to hook kids on tobacco at a young age.

Preventing children from picking up nicotine addiction is the best way to keep them free of tobacco-related disease for life. That’s why we’ve each introduced bills that seek to curb youth usage of smokeless (chewing) tobacco and e-cigarettes.

Last year, many were shocked when Hall of Famer Tony Gwynn, who played for the San Diego Padres, died from cancer of the salivary glands that was related to decades of smokeless tobacco usage. 

Former World Series hero Curt Schilling, who helped propel the Arizona Diamondbacks and Boston Red Sox to championships, has blamed his bout with mouth cancer on chewing tobacco. 

Use of chewing tobacco by professional athletes sends the wrong message to our kids, but nonetheless a powerful one. Researchers at the Harvard School of Public Health have found that the use of smokeless tobacco by players has a powerful “role model effect” on youths, particularly young males. 

It’s no wonder then that while overall rates of smoking have declined thanks to several decades of intense educational programs, smokeless tobacco rates have remained stubbornly high among youth. One in every 6 high school boys report regular usage.

Assembly Bill 768 bans smokeless tobacco at all ballparks in California with organized baseball, including all five major league stadiums. Not only would this prevent usage at high school and college games, but our youths would not be unduly influenced by seeing their heroes serve as de-facto smokeless tobacco advertisers.

While smokeless tobacco must at least carry a warning label, electronic cigarettes unfortunately are being marketed as both a safe alternative to regular cigarettes and a tool to help smokers quit. 

With mounting evidence demonstrating the health risks of e-cigarettes, we must close the legal loopholes that have enabled kids to be targeted with products that give a false sense of safety.

Tobacco makers are prohibited from marketing cigarettes to youths or producing various flavors, but the same is not true of e-cigarettes. 

Sales of e-cigarette devices to minors are prohibited in California, but gummy bear, cotton candy and bubble gum flavors are widely available to our young people in many communities. 

Meanwhile, the use of e-cigarettes is increasing at alarming rates among our youth. The Centers for Disease Control and Prevention found that more than a quarter of a million youths who had never smoked a traditional cigarette used e-cigarettes in 2013, and youth usage tripled between 2011 and 2013.

The availability of e-cigarettes to kids belies a growing public health concern over the products. The California Department of Public Health reported in January that e-cigarettes contain 10 chemicals that cause cancer, birth defects and other reproductive harm. 

A team of researchers at UCSF also found that e-cigarettes deliver carcinogens that have been linked to asthma, stroke, heart disease and diabetes. 

Senate Bill 140 would ensure that e-cigarettes are subject to the same state rules that prohibit smoking in certain public places as well as prevent the sale of tobacco products to minors with regulations and enforcement.

In 2014, 40,000 Californians died from tobacco-related diseases, which cost California’s health care system more than $13 billion annually, with taxpayers picking up a $3 billion bill for tobacco-regulated disease in the Medi-Cal program alone. 

These two bills are part of a five-bill effort at the California state Capitol that is supported by the Save Lives Coalition of doctors, nurses, health professionals, patients and nonprofit health organizations that seek to curb tobacco usage among Californians, particularly youths. 

Individually, these bills are good policy; together, they take a step toward protecting youths from predatory tobacco companies and the grip of nicotine addiction.

Sen. Mark Leno is a Democrat from San Francisco. Assemblyman Tony Thurmond is a Democrat from Richmond.

*This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.
 
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Breath test for detecting head and neck cancer

Sun, Apr 12, 2015

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Source: http://medicalxpress.com/
Author: provided by Ecole Polytechnique Federale de Lausanne

A portable device can detect the presence of certain types of cancer in people’s breath. Tested on patients, the new device was developed in part by EPFL researchers as part of an international collaboration.

breath_test

Inhale, then exhale. This simple act could now save lives. A technology developed in part at EPFL can quickly identify the presence of a head and neck cancer, such as of the throat or mouth by analysing people’s breath. The new device, equipped with extremely sensitive sensors, has been tested on patients and operates with a computer or even a mobile phone. It’s an innovative tool for the early diagnosis of tumours.

Very few routine exams exist to detect cancer. Yet this disease is the third leading cause of death worldwide. Most tumours are found relatively late, which makes recovery less likely.

Cancer “signals” its presence in human breath
At SAMLAB in Neuchâtel, under the direction of Nico de Rooij, a team of researchers including Frédéric Loizeau, a doctoral student at the time, developed very precise micro-sensors able to distinguish the breath of a healthy patient from that of a sick one. The scientists’ starting point was the observation that human breath contains not only air, but also hundreds of volatile organic compounds (VOCs) whose presence and concentration vary depending on the patients’ state of health. The metabolism of cancerous cells is different from that of healthy cells, and the two types of cells produce different substances in terms of both quantity and typology. As a result, they leave their “signature” in people’s breath.

The researchers managed to detect these nuances with the aid of a network of micro-sensors. The technology called MSS was initially developed jointly by EPFL researcher and the late 1986 co-laureate of the Nobel price of physics, Heinrich Rohrer. Each sensor is composed of a silicon disk 500 micrometres in diameter that is covered by a polymer and suspended by four minuscule “bridges” with integrated piezoresistors. When exposed to a gas, the polymer absorbs certain molecules and the disk changes shape. This deformation is detected by the four piezoresistive bridges, which emit an electrical signal. This phenomenon makes it possible to determine the signature of the gas and its concentration. The trick lies in using different polymers on each sensor, in order to obtain an overview of the gas composition.

“There are already methods for detecting molecules called ‘electronic noses’ on the market. But they have a hard time analysing very complex gases like human breath,” says Nico de Rooij. “Humidity in particular can disrupt the reading, leading to false positives or false negatives.” With the new sensors, the detection process becomes extremely accurate.

Clinical tests on healthy and sick patients
With the collaboration of the Swiss Nanoscience Institute of the University of Basel, the EPFL researchers were able to test their device on actual patients from the University Hospital of Lausanne (Centre hospitalier universitaire vaudois, CHUV) who were either sick or had undergone surgical treatment for head and neck cancer. The results of these tests showed that the sensors were incredibly effective. A Neuchâtel-based company has already expressed interest in marketing this technology, which has been patented.

Breathe into your smartphone
breathtest2

But the story doesn’t end there for the sensors, which have numerous applications. Recently, the NIMS/MANA research centre in Japan, another partner in the project, connected the sensors to mobile phones. This innovation earned them an award at the Nanotech 2015 event.

This technology is also of interest to biologists. At the University of Neuchâtel, tests are currently being run by the Laboratoire pour la recherche fondamentale et appliquée en écologie chimique in order to analyse the gases given off by plants when they are attacked by certain insects or mushrooms. These gases serve to attract other insects that will protect the plant. The ability to detect this phenomenon early on could allow farmers to react more quickly to an attack and, as a result, use less insecticide.

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Nova Scotia to include boys in HPV vaccination schedule

Sun, Apr 12, 2015

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Source: www.theglobeandmail.com
Author: Kelly Grant, Health Reporter

hpv_vaccine
Boys in Nova Scotia will begin receiving free vaccinations against the human papillomavirus next fall, a move that makes the Maritime province only the third in Canada to extend public funding of the cancer-thwarting shot to all children, regardless of gender.

In the budget unveiled on Thursday, Nova Scotia’s Liberal government announced it would make the HPV vaccine available to Grade 7 boys as part of the regular school-based immunization program. The expansion is expected to cost $492,000 a year.

Every province in Canada already covers the HPV vaccine for girls in an effort to prevent genital warts and cervical cancer, both of which can be caused by some strains of the virus, which is transmitted through sex and skin-to-skin contact.

But in recent years, oncologists and major health organizations – including the Canadian Cancer Society and the National Advisory Committee on Immunization – have begun calling for HPV vaccinations for boys, too. Until this week, only Prince Edward Island and Alberta had heeded that call with a publicly funded program.

HPV can lead to cancers of the penis, anus, oral cavity and throat in men, as well as genital and anal warts.

“We have a vaccine. It can prevent cancers in men and women, so we want Canadians to be vaccinated against it, because we can actually prevent cancers from starting in the first place,” said Robert Nuttall, the assistant director of cancer control policy at the Canadian Cancer Society.

Nova Scotia’s decision to fund the vaccine for boys was especially important to one recently retired member of the provincial legislature. Gordie Gosse, who until last week represented the riding of Sydney-Whitney Pier in Cape Breton, was diagnosed nearly a year ago with Stage 4 throat cancer caused by HPV. The 59-year-old former speaker of the legislature had more than 12 hours of surgery to remove the tumour and reconstruct parts of his face, followed by chemotherapy and radiation.

“If I’d had the vaccine, I wouldn’t have had the cancer,” he said in an interview on Friday.

Mr. Gosse, a member of the opposition NDP, made it his final mission as an elected official to extend public funding of the HPV vaccine to boys, which, according to a spokesman for the province’s department of health, the Liberal government was already studying as part of its annual vaccine review.

When his private members’ bill on the male vaccine program passed second reading on April 1, Mr. Gosse figured the measure would be in the budget. He announced his retirement the next day. “I was quite ecstatic,” Mr. Gosse said.

The HPV vaccine is most effective when administered before a child or teen starts having sex.

However, provincial governments are wrestling with whether it is cost-effective to vaccinate boys as well as girls.

“Right now it’s [about] money,” said Eduardo Franco, chair of the department of oncology at McGill University in Montreal.

Dr. Franco pointed to an evaluation done in Quebec two years ago that found vaccinating boys would not be cost-effective, in part because men who sleep with women would benefit from the protection the vaccine provided to their female partners. But that leaves gay men vulnerable, Dr. Franco said.

“The solution is truly universal HPV vaccination,” he said. “No questions asked. We [should] just take it for granted that it’s part of the adolescent vaccine calender.”

Alberta’s Grade 5 HPV immunization program costs $11-million a year – $4-million for boys, $4-million for girls, plus an extra $3-million a year for a limited-time “catch-up” program for Grade 9 boys that ends in 2017.

But the overall HPV immunization program is expected to save an estimated $13.4-million a year down the road by preventing some cases of HPV-caused cancer, according to Alberta Health.

Ontario is reviewing its HPV immunization program, said David Jensen, a spokesman for the Ministry of Health and Long-Term Care.

“Various factors are being considered such as scientific evidence (e.g., burden of disease and vaccine effectiveness), economic and societal factors, as well as cost effectiveness and impact on the health system,” he said by e-mail.

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FDA Advisory Committee hesitates to endorse message of safe smokeless tobacco

Sun, Apr 12, 2015

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Source: www.medpagetoday.com
Author: Shannon Firth

An FDA advisory panel were reluctant to recommend a gentler warning label for one brand of smokeless tobacco products at a committee hearing on Friday.

snus

Swedish Match North America (SMNA), the first company to be considered for a modified risk tobacco designation by the FDA, is asking to replace a current label warning, “This product is not a safe alternative to cigarettes,” with this: “Warning: No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes.”

It also wants to drop warnings required for other smokeless tobacco products about oral cancers, tooth loss, and gum disease.

In a key vote, the eight-member FDA’s Tobacco Products Scientific Advisory Committee split 4-4 on whether the claim that snus offer a “substantially lower risk” claim relative to cigarettes is justified.

Many members said the health risks were lower for certain tobacco-related illnesses, but not for all health concerns. Those who disputed the claim argued that it could not be taken as a “global statement” — as there are known risks to pregnant women and uncertain risks for adolescents.

As for the proposed label change, the whole committee agreed that the sponsor’s statements would not suffice. Gary Giovino, PhD, chair of the department of Community Health and Health Behavior at the State University of New York at Buffalo, felt the statement was “dismissive of the health risks.” The word “but” in any sentence seems to negate the first half, he said.

Snus is a finely ground smokeless tobacco powder in a filter packet that is placed under the upper lip.

In his opening remarks on Thursday, Mitch Zeller, JD, director of the FDA’s Center for Tobacco Products, said that in the past companies alone decided how to advertise their products — a practice which proved damaging to consumers’ health. “Now it’s the FDA who serves as the regulatory gatekeeper, standing between consumers and the companies seeking to make claims about their products.”

To meet the standards of a modified risk tobacco product, Zeller explained, “Applicants must not only demonstrate that the products, as actually used by consumers, will significantly reduce risks to individual users of those products; they must demonstrate that they will benefit the population as a whole – taking into account both users and non-users of tobacco products.”

In its application, Swedish Match has asked to revise the labels for 10 snus products. It would maintain its warning that smokeless tobacco is addictive.

Oral Safety Unproven
The committee was unmoved by the firm’s evidence related to gum disease and tooth loss and voted 8-0 against supporting a conclusion that snus products “do not pose a risk of gum diseases or tooth loss.”

Or as Thomas Novotny, MD, MPH, the graduate school of public health at the University of California San Diego State said, when explaining his vote, “It’s not causal relationships that we’re after, it’s perception of risk and the studies don’t rule that out.”

The committee’s vote was likely influenced by Scott Tomar, DMD, MPH, DrPH, of the department of Community Dentistry and Behavioral Science, at the University of Florida, who said that “advanced gingival recession can result in tooth loss.” One of the studies presented showed a relationship between gingival recession and snus use.

As to whether snus products also “do not pose risks of oral cancer” to consumers, the committee was split 3-3 with two abstentions.
“I think the data are tending towards no increased risk but I’m not quite ready to go there,” said Giovino, one of the abstainers.

Pebbles Fagan, PhD, MPH, associate professor and member of the Cancer Prevention and Control Program at the University of Hawaii, said that based on the absence of women in the larger cohort studies, she was not comfortable claiming that snus products posed no risk of oral cancer.

Can the ‘Swedish Experience’ Cross the Ocean?
Perhaps the most important questions the committee voted on was whether the proposed labeling change would help or harm consumers. Swedish Match threw the weight of its argument behind the “Swedish Experience,” a series of government, academic ,and industry studies showing a dramatic shift from cigarette smoking to snus in the mid-1990s. The firm argued that Swedish men reduced their risk of tobacco-related diseases.

But asked whether American tobacco users would likely follow suit — swapping cigarettes for snus — panel members were unconvinced.

Only one committee member said such a switch was likely, against six voting against and one abstention.

Richard O’Connor, PhD, associate professor of oncology at the Roswell Park Cancer Institute, in Buffalo New York, the lone panelist to agree that the experience in Sweden might translate to the U.S., said the data informed “a potential pattern in the U.S.”

Another subpopulation of obvious concern is adolescents. Timothy McAfee, PhD, MPH, director of the Office on Smoking and Health at the CDC, cited animals studies on tobacco addiction that showed “deleterious effects on adolescent brain development.”

On the plus side for Swedish Match, the majority of the committee felt it unlikely that nonusers of tobacco would pick up the snus habit, although three committee members abstained from this question because they did not believe there was enough data to support such a scenario.

Lars-Erik Rutqvist, the senior vice president of scientific affairs at Swedish Match said the company was pleased with the discussion at the hearing. “On the whole they seemed to accept the fact that there is a considerable risk reduction in our products and of course that’s very important. It’s part of the definition of a modified risk product.” Rutqvist added that he would expect to continue discussions with the FDA while awaiting their decision this summer.

“I look forward to the path forward for us.”

The FDA is not required to follow the advice of its advisory committee but it usually does.

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Curt Schilling: Letter to my younger self

Sun, Apr 12, 2015

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Source: www.theplayerstribune.com
Author: Curt Schilling

Dear 16-year-old Curt,
Tomorrow at lunch, a kid is going to dare you to take a dip of Copenhagen. If you say yes, like I did, you’ll be addicted for the rest of your life. Well, the rest of your life up to the point when you are diagnosed with cancer.

I get what you’re thinking. You’re 16 — you’re invincible, just like all your buddies. If you were to jump ahead 33 years, you couldn’t write a better dream than the one your life is going to be.

With one exception.

If you say yes tomorrow, you will become addicted to chewing tobacco and you will get mouth cancer.
schilling

I’m going to tell you a little story that I think may help guide you. (I saw this on a TV series called The West Wing — great show, you’re going to love it one day — and it very much rings true).

There was a man — we’ll call him Joe. Joe lived in the same house his entire life. One day, a huge storm came. He turned on the radio: Prepare for torrential rains and deadly flash flooding. Everyone should evacuate to safety immediately.

See, Joe was a devout Christian. He had the Lord in his life for as long as he could remember. Church every Sunday, prayed twice a day.

“My faith in God is resolute. He will save me,” Joe thought.

The rain kept coming down.

About two hours later, water began to flood his house, so he scrambled on to the roof.

After a half-hour, with the water rising rapidly, a boat sputtered up to Joe’s house, which was now partially submerged.

Boat driver: “Come on down, I will take you to safety!”

Joe sat calmly on his roof.

Joe: “No thanks! My faith in God is strong, God will save me!”

So the boat sped off.

Another hour went by, and the water had risen to the roof.

A helicopter flew over, saw Joe and swooped down, dropping down a rope.

Helicopter pilot: “Grab a hold! I will pull you up!”

Joe: “No thank you! My faith in the Lord is strong. He will save me!!”

The man looked awkwardly at what he could only guess was someone who’d lost his mind. The helicopter flew off.

About 10 minutes later the water overtook Joe’s roof, so he swam out into the strong current. It quickly pulled him below.

When Joe opened his eyes, he saw the Lord standing at the gates of Heaven.

“Joe, what on earth are you doing here??”

“I was just about to ask you that very question, Father,” Joe replied.

“Wait… what?” says God.

“Father I have had Faith in you since my first memory. I have prayed morning and night to you. I have sinned, but you know that in my heart I have asked for forgiveness and tried my hardest to do right by you.”

“Yes, Joe I know in your heart you are a good, honest and loving man.”

“Then why did you let me die?” Joe asked.

“I sent you a radio message, a boat and a helicopter! What more did you want?”

I tell you, 16-year-old me, that story for a very important reason. From tomorrow forward, you will be given the same signs that Joe was given a hundred times over. Many will be far more insightful and far more telling than the ones he received.

You will develop sores, you will lose your sense of taste and smell. You will develop lesions. You will lose your gums — they will rot. You will have problems with your teeth for the rest of your life.

You will meet men — many good, honest men — who chewed. None of them will have their entire face. They will be missing jaws, chins, cheeks, noses and more. None will live more than a year or two after you meet them. All of them were tobacco chewers.

You will meet Joe Garigiola. He will introduce you to Bill Tuttle. Bill will have no lower face. His entire lower jaw is gone. It was that, or die of mouth cancer. Well, not “that or,” because that mouth cancer would kill him inside of two years.

You will brush your teeth and your mouth will bleed. Not light blood from your gums, but darker blood from deeper inside your mouth. That’s the chew destroying your tissue. You will get message after message, but your addiction will always win, until it wins the biggest battle.

You will get message after message, but your addiction will always win, until it wins the biggest battle

If you say yes tomorrow, you will begin to kill yourself from the inside out. It’s difficult for you to understand in this current phase of your life, but by chewing tobacco, you are jeopardizing your participation in what will be some of your most important moments.

You will risk any chance of seeing your four amazing children graduate high school. You will potentially lose the opportunity to walk your daughter Gabriella (who, like her dad, will be blessed with simple yet outstanding pitching mechanics) down the aisle. You will risk not seeing Gehrig, your oldest son, pitch for four years at a New England college. You may miss your son Grant graduating high school and changing the world. And you may be absent as your youngest son Garrison — who aspires to follow in your father’s footsteps and join the army — masterfully plays goalie with a remarkable passion.

You could miss the most important and rewarding days of your life with your beautiful wife Shonda.

If cancer kills you, what are you leaving them with? What are you leaving them for?

schilling2
Your dad is going to die in five years. You know what’s going to kill him? A heart attack brought on by heart disease and lung cancer caused by tobacco use. He’ll die right in front of you. You two will be alone and together for his final minutes on earth. The night before he passes away, you two are going to sit up and talk until 4 a.m. You will chalk up the conversation as peculiar, but years later it will hit you like a ton of bricks. It will hit you like a radio message, boat or helicopter. He knew. It’s why the things he told you that night were things only a dad can tell a son. He knew.

Right now, you don’t listen to the messages God gives you. And if you don’t alter this habit, in 32 years you will be diagnosed with cancer.

Finally, consider this: How many kids will start dipping over the next 32 years because they saw you do it?

Do you want that on you? No?

Then my advice is simple. Tomorrow, at lunch, just say no.

Make the right choice,

- Curt

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The Oral Cancer Foundation Launches April Oral Cancer Awareness Month

Thu, Apr 9, 2015

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Source: Yahoo News
Author: The Oral Cancer Foundation
 

NEWPORT BEACH, Calif., April 9, 2015 /PRNewswire-USNewswire/ — April is Oral Cancer Awareness Month. 2015 marks the 16th year that The Oral Cancer Foundation has lead the effort to raise awareness of this disease and the need for an annual screening.

OCF has learned that although we accomplish a great deal as an organization, we can do so much more through the formation of strategic relationships with those who share our values and goals. OCF is grateful to the thousands of private dental offices that make time on multiple days during the month of April to offer free screenings to members of the public in their local communities across the nation. Besides the screening itself, these offices provide valuable information to the public related to risk factors and early signs and symptoms. An informed public can engage in self-discovery, which has generated early stage finds in so many other cancers.

In addition to the 1,000′s of private dental offices who will join with OCF this April, a coalition of professional organizations, private sectors companies, and educational institutions have chosen to partner with us. The professional organizations include; The American Academy of Oral Medicine (AAOM), The American Academy of Periodontology (AAP), The American Dental Hygienists Association (ADHA), The American Association of Oral and Maxillofacial Surgeons (AAOMS), The Academy of General Dentistry (AGD), The American Dental Association (ADA), The American Academy of Oral & Maxillofacial Pathology (AAOMP), and The Canadian Dental Hygiene Association (CDHA).  Our private sector corporate partners include Bristol-Myers Squibb, Henry Schein Dental, LED/VELscope, OralID and Identafi. The university partners this year are NYU, Penn Dental Medicine, and Columbia University College of Dental Medicine.

Jamie O’Day, OCF Director of Operations, expressed, “We are very proud that we have been able to assemble a powerful coalition of organizations, all with a vested interest in the oral cancer cause. OCF is thrilled to be in the company of such prestigious organizations and institutions. Coupled with thousands of private dental practitioners, this creates a formidable force to alter the late discovery paradigm that has plagued this disease for too many years.”

OCF Co-Founder Ingrid Hill, states that “There are steps as a nation that WE MUST take if we are to bring this disease down from its high ranking as a killer.

  • Since the HPV16 virus has become the fastest growing cause of oropharyngeal (back of the mouth) cancers, we must engage in a more robust effort to vaccinate our youth against this virus and allow our children and grandchildren to live in a country that has reached herd immunity against HPV related cancers, all of which are killers.
  • Create a national effort, ideally lead by dental professionals who see more than 60% of Americans at least once a year, to screen everyone opportunistically that currently visit their practices, as the vaccine only works in pre-sexual youth. Catching cancers in the current adult generation of Americans at early stages decreases treatment related morbidity, and improves long-term outcomes.
  • Create enough public awareness and knowledge that some SELF DISCOVERY of early signs and symptoms can occur, and self-referral for evaluation to medical or dental professionals takes place. Combined with professional screening, this will also yield more early stage discovery of both pre-cancers and early stage disease.”

Primary risk factors for developing an oral or oropharyngeal cancer

  • Tobacco use in all its forms
  • Excessive alcohol consumption
  • A persistent HPV16 (human papilloma virus #16) oral infection

Oral cancer signs and symptoms identifiable in a conventional visual and tactile screening

  • An ulcer or sore that does not heal within 2-3 weeks
  • A discoloration on the soft tissues of the mouth that persists. It may be white, red, or even blackish in color
  • A swelling or lump in the mouth that persists. This also applies to a tonsil that is swollen but painless
  • Any abnormality that bleeds easily when touched. (friable)
  • A lump, or hard spot in the tissue. (induration)
  • Tissue raised above that surrounding it, a growth. (exophytic)
  • A sore under a denture, which even after adjustment of the denture, still does not heal.
  • A numb feeling in the mouth or lips
  • Persistent sore throat, hoarse voice, or cough
  • A painless fixated lump felt on the outside of the neck, which has been there for at least two weeks
  • Difficult or painful swallowing, or a painless sensation that when swallowing things are becoming stuck in your throat
  • An ear ache on one side (unilateral) which persists for a protracted period of time

OCF releases its 2015 projections for oral and oropharyngeal cancers derived from the government SEER database.

45,750 Americans will be newly diagnosed with an oral or oropharyngeal cancer, and there will be approximately 8,650 associated deaths. That is a one-year jump of about 5%. Brian Hill, Executive Director and Co-Founder of OCF stated, “Big numbers are hard to digest, even abstract to individuals, and people are not sure how important this data is. In simpler terms, it means 125 Americans will be newly diagnosed every day, and one American will die from this disease every hour of the day 24/7/365.  Since the two drivers of these numbers are a preventable lifestyle choice, (tobacco use), and a virus (HPV16) for which we have a readily available vaccine, the use of which would protect our next generation, is disheartening. Worse, with the virus being the more aggressive driver of these statistics, this number is without doubt, going to increase every year during our generation, since there is no vaccine for adults already exposed. When compared to other first world countries, the U.S. is far behind in vaccination and reaching herd immunity in our young people. Speaking as someone who almost lost his life to this disease from an HPV etiology, and who talks with patients and families in crisis with routine, my personal opinion is that we as Americans are doing a poor job of controlling tobacco use, contrary to scientific evidence of its harm. Given the huge financial component to the tobacco paradigm in the U.S. and the lack of any political will to change it, I do not see this undergoing any significant change in the future. That we have no national vaccine policy to protect our youth/the next generation with something in our power to change, policies accomplished with huge success in other countries around the world, I find unconscionable.”

It’s not too late to join with the other thousands of dental offices to get involved in bringing down these numbers. Click the following link to learn more about oral cancer awareness month, and how to create your own Free Oral Cancer Screening Event if you are a professional. http://www.oralcancer.org/events/oral-cancer-awareness-month.php

Members of the public can view our online calendar of events to find a screening event near them at - http://www.oralcancer-screening.org/events/?d=2015-04-01&b=1.

Be aware. Get Screened. BE PART OF THE CHANGE.

About the Oral Cancer Foundation
The Oral Cancer Foundation, founded by oral cancer survivor Brian R. Hill, is an IRS registered non-profit 501(c)(3) public service charity that provides information, patient support, sponsorship of research, and advocacy related to this disease. Oral cancer is the largest group of those cancers that fall into the head and neck cancer category. Common names for it include such things as mouth cancer, tongue cancer, head and neck cancer, and throat cancer. OCF maintains a web site at http://www.oralcancer.org, which receives millions of hits per month. Supporting the foundation’s goals is a scientific advisory board composed of leading cancer authorities from varied medical and dental specialties, and from prominent educational, treatment, and research institutions in the United States.

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

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