Gardasil

Finding better ways to treat, prevent HPV

Source: www.fhcrc.or
Author: Diane Mapes – Fred Hutch News Service

Twenty-nine years ago, scientists didn’t know what caused many of the genital-tract cancers they studied, much less how to stop them.

Today, not only has human papillomavirus been pinpointed as the viral perpetrator behind nearly all genital-tract and some head and neck cancers, there’s now an incredibly effective vaccine that can prevent high-risk HPV infections from ever developing into cancer.

“You can almost say on the street, ‘I’m doing HPV research’ and ordinary people will know what that is,” said Aaro Turunen, an HPV researcher from the University of Turku in Finland. “It’s a sexy subject, especially for the media.”

While scientific advancements, public awareness and yes, media coverage, have grown exponentially in the last three decades, there is still much to learn and do – particularly with regard to getting the vaccine to the people who most need it, both here in the U.S. and around the world.

That’s where the International Papillomavirus Conference, currently in its twenty-ninth year, comes in. The HPV2014 conference, now underway at the Washington State Convention Center in Seattle, has drawn the brightest minds in HPV research, including nearly 1,300 basic scientists, public health researchers, physicians, providers and others dedicated to eliminating the suffering caused by the human papillomavirus. The goal of the conference is to share cutting-edge scientific advances in the field of HPV infection and disease and come up with new ways to collaborate to advance science and public health.

The conference officially began today but kicked off early Wednesday with two days of clinical and public health pre-conference workshops covering everything from HPV infection and disease in HIV-infected men to implementing and evaluating two-dose vaccine schedules to a peek at the next generation of HPV vaccines coming down the pike.

Conference chair Dr. Denise Galloway, who holds a joint appointment with Fred Hutch’s Human Biology and Public Health Sciences divisions, said she was thrilled the conference was taking place in the Hutch’s back yard.

“I’m excited that the HPV meeting will be here as it recognizes the strength and breadth we have in HPV research in Seattle,” she said. “Our main goal was to provide a setting where people from all over the world who study various aspects of papillomavirus biology, disease and prevention could come together to share their data and ideas.”

Galloway, who has been investigating the link between cancer and viruses since 1978, was instrumental in both discovering HPV’s association with many cancers and paving the way for a vaccine able to check cervical cancer before it starts in hundreds of thousands of women worldwide.

These days, she’s researching B cell memory in order to determine how effective the HPV vaccine is over a person’s lifetime.

“If a vaccine is going to work, it’s not just important how well this will stimulate the immune system, which you can measure within a couple of months after you get the vaccine,” she said. “You also want to know, is it going to be durable? Are you going to have a response 10 years, 20 years or 30 years from now? We’re trying to figure that out by looking at the cells that are there and available to make the responses in 10 and 15 years.”

Long-term efficacy is just one of many topics covered at the conference, which boasts an ambitious lineup of over 700 abstract presentations, nine satellite sessions, four symposia and four plenary sessions, all highlighting basic, clinical and public health science topics ranging from molecular virology to novel cancer screening and treatment strategies to global public health.

Also represented at the conference are pharmaceutical companies such as Merck, producer of the HPV vaccine Gardasil, and Roche, developer of the cobas HPV test. Also present are medical device manufacturers such as QIAGEN, which along with support from Seattle’s PATH, developed the careHPV test, a field-friendly and inexpensive test that allows women, particularly in developing countries, to gather screening samples themselves.

On Friday morning, Dr. Freddie Bray of the International Agency for Research on Cancer talked about the need for quality data and cancer registries, especially in developing countries and and Dr. Scott Ramsey of Fred Hutch’s HICOR division spoke about the value of prevention-based studies and interventions.

“There was a nice study done by the CDC a few years ago that looked at the cost effectiveness of HPV vaccination of young girls in the U.S.,” he said. “This is a slide I wish I could produce as a health economist more often. HPV vaccines in this population are among the most cost effective interventions we have in the U.S.“

Despite the efficacy and overall cost effectiveness of the vaccine, however, delivery and implementation of the vaccine remain a problem, said Galloway.

“We need to find better strategies to get girls and boys to take the vaccine,” she said. “In other countries, where they have school-based programs, they’re doing much better than in the U.S.”

Saturday’s plenary will feature talks on the natural history of HPV infection and cervical cancer, the natural history of oral HPV and its progression of oropharyngeal cancer and the “genetic arms race” between host and viral genomes, presented by Fred Hutch’s Dr. Harmit Malik. Vaccines will be covered in the Sunday plenary session with talks on Merkel cell carcinoma by Fred Hutch’s Dr. Paul Nghiem, an update on Australia’s HPV vaccination program and a presentation on vaccine dosage.

“There is a growing consensus of switching from three doses to two and it will be exciting to hear more about that,” said Galloway.

Finnish researcher Turunen, whose research focuses on the relationship between HPV and the Epstein-Barr virus, said he was amazed at how much the field – and the International Papillomavirus Conference — had grown, adding that a much smaller HPV conference took place in Seattle 20 years ago.

“Both HPV researchers were there,” he quipped.

August, 2014|Oral Cancer News|

CDC finds coverage for HPV vaccination among teens is still low

Source: medicalnewstoday.com
Author: staff
 

Although there has been a slight increase in human papillomavirus vaccination coverage among adolescents since 2012, a new report from the Centers for Disease Control and Prevention states that vaccine coverage in this population remains “unacceptably low”.

Human papillomavirus (HPV) is the most common sexually transmitted infection in the US. There are more than 150 types of HPV, 40 of which can be contracted through skin-to-skin contact during vaginal, anal or oral sex.

Low-risk HPV types, such as HPV-6 and HPV-11, can cause warts around the genitals or anus. But high-risk types, including HPV-16 and HPV-18, account for approximately 5% of all cancers worldwide.

Specifically, HPV-16 and HPV-18 account for around 70% of all cervical cancers and almost 50% of all vaginal, vulvar and penile cancers. HPV-16 is also accountable for more than 50% of throat cancers.

There are currently two vaccines available for HPV, which are administered in three shots over 6 months. Cervarix and Gardasil are used for the prevention of cervical cancer, while Gardasil can also protect against anal, vulvar andvaginal cancers and genital warts.

The Advisory Committee on Immunization Practices (ACIP) recommends that preteen girls and boys aged 11 or 12 are vaccinated against HPV. The vaccination is also recommended for teenage girls and young women up to the age of 26 who did not receive it when they were younger, and teenage boys and young men up to the age of 21.

HPV vaccination coverage increased in 2012-13, but remains too low

But despite these recommendations, a new report from the Centers for Disease Control and Prevention (CDC) – published in this week’s Morbidity and Mortality Weekly Report – estimates that in 2013, only 57% of girls and 35% of boys ages 13-17 years received one or more doses of the HPV vaccine.

The figures came from results of the CDC’s National Immunization Survey-Teen (NIS-Teen), which includes vaccine information via telephone surveys for adolescents aged 13-17 years from across the US.

The CDC investigators did, however, find that HPV vaccination coverage increased slightly among girls between 2012-13, from 53.8% to 57.3%, although only a third received the complete three doses. Teenage boys saw a greater increase in vaccination coverage, from 20.8% to 34.6%.

But still, the CDC say HPV vaccination coverage among adolescents is too low, particularly when compared with coverage to other vaccination types. For example, another report from the CDC found that almost 86% of adolescents received one dose of the Tdap vaccine last year, which protects against tetanus, diphtheria and whooping cough.

A 10-year national objective in the US – set in 2010 by Healthy People 2020 – is to reach 80% HPV vaccination coverage among adolescents. These latest statistics suggest there is a lot of work to be done. But lead author of the report, Shannon Stokley, assistant director for science at the CDC’s Immunization Services Division, says they also show the 80% vaccination coverage target is realistic:

“The data on missed vaccination opportunities tells us that it is possible. When we look at the most recent cohort of girls that turned 13, 91% of them had a health care encounter where they could have started the HPV vaccine series before their 13th birthday.

Also, 86% of 13-17 year-olds have received the Tdap vaccine. What these numbers tell us is that preteens and teens are getting to the doctor and they are getting vaccinated, but they aren’t always receiving the HPV vaccine.” 

Why is HPV vaccination coverage still low?

From NIS-Teen, the CDC investigators were also able to establish some reasons as to why HPV vaccination coverage remains low among adolescents.

They found that clinicians’ recommendations significantly influenced a parent’s decision of whether to have their children vaccinated against HPV.

Of parents whose daughters were vaccinated, 74% said they received a recommendation from their doctor, while 52% of parents who did not have their daughters vaccinated received a doctor’s recommendation. Among parents whose sons were vaccinated, 72% received a recommendation, while only 26% of parents whose sons were not vaccinated received a recommendation.

Based on these findings, Dr. Anne Schuchat, assistant surgeon general and director of CDC’s National Center for Immunization and Respiratory Diseases, believes health care professionals are key in boosting HPV vaccination coverage among adolescents in the US.

“Pediatricians and family physicians are uniquely situated to prevent missed opportunities by giving HPV vaccine during the same visit they give Tdap and meningococcal vaccines,” she adds.

Parents also revealed that concerns over the safety of the HPV vaccine deterred them from vaccinating their children. However, the CDC stress that – after analyzing national postlicensure vaccine safety data – no serious safety concerns have been linked to the HPV vaccine in the 8 years it has been available.

The investigators point out that the most commonly reported side effects of the vaccine include dizziness, fainting, nausea and headache, and injection-site reactions – including pain, redness and swelling.

When we asked Stokely what needs to be done to alleviate parents’ concerns about vaccinating their children against HPV, she replied:

“Parents need to see information in mainstream media that HPV vaccination is very effective at preventing infection with the types of HPV that cause the most cancers. Parents also need to hear that the HPV vaccine is safe and that it is recommended to be given when their children are 11 or 12 years old, before their risk of acquiring an HPV infection increases.”

In conclusion to the report, the CDC say they will continue efforts to team up with state and local immunization programs, cancer organizations, professional organizations and other stakeholders in an attempt to educate parents and health care professionals about the importance of the HPV vaccine, adding:

“Collaborative efforts remain critical to promoting HPV vaccination so that the nation’s adolescents are protected against vaccine-preventable, HPV-associated cancers.”

Earlier this year, Medical News Today reported on a study claiming that two thirds of healthy American adults areinfected with one or more of 109 strains of HPV.

 
*This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.
 
July, 2014|Oral Cancer News|

Anti-seizure medications prevent cancer

Source: guardianlv.com
Author: Lindsey Alexander

A recent report came out from the journal Cancer indicating a new finding that anti-seizure medications might prevent some forms of cancer. Drugs like valporic acid (Depakote), are one form of prescription in this classification. Though also used as a mood-stabilizer, Depakote can prevent seizures from occurring, and has been investigated for cancer prevention.

These particular anti-seizure medications have been found to inhibit genetic changes that lead to cancer of the head and neck. The study included nearly 440,000 veterans, including 27,000 who were taking valporic acid for various disorders including post-traumatic stress disorder, bipolar disorder, seizures, and migraines. The overall findings suggested that veterans who were on the prescription were 34 percent less likely to develop cancers of the head and neck, than those who were not taking the drug.

The risk decreased in those subjects who took higher doses or for longer periods of time.

Dr. Johann Brandes with Atlanta Veterans Affairs Medical Center was the team leader of this study. He claims that this 34 percent statistic means 16,000 new cases, and between 3,000 and 4,000 cancer deaths can be prevented every year. Though there is a strong association, the study did not form a direct cause-and-effect relationship between cancer prevention and anti-seizure medications.

The National Cancer Institute describes cancers of the neck and head as usually squamous cell cancers that line mucosal surfaces inside the head and neck. This can affect the mouth, the throat, and the nose. This is a carcinoma that can begin in the salivary glands, and can contain many different types of cells that can in turn also become cancerous.

Valporic acid was found not to have any impact on lung, bladder, prostate, or colon cancers.

The Mayo Clinic currently says there is no proven way to prevent throat cancer. A person can restrict the amount of alcohol consumed, avoid smoking, chose a healthy diet to stick to (which includes plentiful amounts of fruits and vegetables), and protect against the human papilloma virus (HPV). Even though the HPV vaccine is recommended by the Mayo Clinic, other sources warn against the shot.

Christina England from Vactruth claims 140 people as of 2013 were lost due to the HPV vaccine, commonly referred to as Gardasil. Statistics from the Vaccine Adverse Event Reporting System (VAERS) listed many more side-effects than deaths, however. In 2013, the VAERS recorded nearly 1,000 people physically disabled, 10,000 people made a visit to the ER, and 3,000 were hospitalized among many others severe, and sometimes life-threatening side-effects.

The American Academy of Otolaryngology mentions three people in history who suffered from either oral, head, or neck cancer.

Babe Ruth, born in 1895, played for the National Baseball League and held a record of 60 home runs in one season. He was diagnosed just before retirement with nasopharyngeal carcinoma, which metastasized and later killed him.

Ulysses S. Grant was a Civil War leader and the 18th President of the United States. He came down with a cancer of the right tonsillar pillar, which was at the base of the tongue. This was referred to as a malignant squamous epithelioma. His death was referred to a slow and painful illness.

Today, however, he could have been treated and perhaps saved with inventions such as the aspiration pump, radiotherapy, surgery, and even a tracheotomy.

Sigmund Freud was also a victim of cancer. Freud was an Austrian psychoanalytic psychologist. He suffered from multiple health disorders and smoked heavily. He had cancer in the jaw, and was diagnosed at the age of 67. Treatment continued for 16 years, and he underwent many surgeries–one of which included the merging of the nasal cavity and the mouth. He died in 1939 from heart failure, cancer, and morphine overdose.

Researchers in medicine are discovering new ways of preventing cancer, and treating cancer, ranging many disciplines. Recent findings suggest future studies are necessary to determine a more substantial link between cancer prevention and anti-seizure medications. However, people are now able to consider yet another preventative measure that might prove helpful.

March, 2014|Oral Cancer News|

President’s panel calls for more girls, boys to get HPV vaccine

Author: Government news release
Source: consumer.healthday.com

Too few American girls and boys are getting vaccinated against the cancer-causing human papillomavirus (HPV), the President’s Cancer Panel reported Monday.

HPV is linked to cervical cancer as well as penis, rectal and oral cancers. One in four adults in the United States is infected with at least one type of HPV. Increasing HPV vaccination rates could prevent a large number of cancer cases and save many lives, the panel said.

“Today, there are two safe, effective, approved vaccines that prevent infection by the two most prevalent cancer-causing types, yet vaccination rates are far too low,” Barbara Rimer, chair of the President’s Cancer Panel, said in a panel news release.

“We are confident that if HPV vaccination for girls and boys is made a public health priority, hundreds of thousands will be protected from these HPV-associated diseases and cancers over their lifetimes,” she added.

Currently, the U.S. Centers for Disease Control and Prevention is recommending that girls aged 11 and 12 receive either the Cervarix or Gardasil vaccines, and Gardasil is recommended for boys of similar age.

In 2012, only a third of girls aged 13 to 17 got all three recommended doses of HPV vaccine, CDC data shows. That’s much lower than the federal government’s goal of having 80 percent of girls aged 13 to 15 fully vaccinated against HPV by 2020, the report said.

The picture is even more disappointing for boys. Less than 7 percent of males aged 13 to 17 completed the recommended HPV vaccination series in 2012. The vaccine was recommended for boys more recently.

Boosting HPV vaccination rates to 80 percent would prevent 53,000 future cervical cancer cases among girls who are currently aged 12 or younger, according to the CDC.

The agency also estimates that increased vaccination would prevent thousands of cases of other HPV-associated cancers in both females and males, the report added.

A number of things need to be done to increase HPV vaccination rates, the panel said. These include public education and other efforts to increase teens’ and parents’ acceptance of the vaccines; encouraging doctors and other health care providers to recommend and give vaccinations; and making sure that the vaccines are available where teens receive health care.

Source: President’s Cancer Panel, news release, Feb. 10, 2014

February, 2014|Oral Cancer News|

Four Ways Katie Couric Stacked The Deck Against Gardasil

Source: Forbes
Published: Wednesday, December 4, 2013
 
 

This afternoon, Katie Couric ran a long segment on her daytime talk show, Katie, about what she called the “controversy” over the vaccines against human papilloma virus, or HPV, an infection that causes cervical, throat, penile, and anal cancers. She featured one mother who says that Gardasil, the HPV vaccine made by Merck , killed her daughter, and a young woman, seated with her mother, who said that Gardasil had caused years of illness that made her think she might die. (GlaxoSmithKline GSK +0.15% makes another HPV vaccine, Cervarix, that is less commonly used in the U.S.)

Katie Couric

Alongside those stories, Couric also featured two medical experts: Dr. Diane Harper, the chair of family and geriatric medicine at the University of Louisville, who helped test Gardasil but has since argued that the vaccine has been over-marketed and its benefits oversold; and Mallika Marshall, a Harvard Medical School doctor who is Couric’s in-house medical correspondent. Marshall defended the vaccine; strangely, only her arguments appear on the show’s Web site.

Despite the attempt at balance, I think most viewers will be left with the impression that the vaccine is dangerous and that its benefits don’t outweigh its risks – a conclusion that is not shared by the American Academy of Pediatrics, the American Academy of Family Physicians, the American College of Obstetricians and Gynecologists, or the Centers for Disease Control & Prevention.

Here’s how Couric stacked the deck against the HPV vaccine:

1. By downplaying the effectiveness of the vaccine: Harper argued that HPV vaccines offer only short-term protection, lasting just five years. This elicited a shocked reaction from Couric – understandably. Why would national guidelines recommend that 11-year-old girls and boys get a vaccine that wears off by the time they are sixteen?

But the statement isn’t true. It’s more true to say that the vaccine’s effectiveness can only be measured using the data we have so far, which at one point was only five years. A recent analysis of 4,900 women in Nordic countries, which use more robust medical records systems than the United States, found Gardasil “is effective up to 6 years following vaccination with a trend of continuing protection up to 8 years following vaccination.” A second analysis, conducted by Merck, also indicates that people still have immune responses 8 years after getting the shot.

“The antibody levels would indicate that immunity is going to be for many, many years beyond five years,” says William Schaffner, a professor of preventative medicine at Vanderbilt Medical School. “We don’t know for how long.”

It’s possible that Gardasil could offer lifetime protection; or patients may need a booster shot. HPV is also different than many other infections, because it takes decades to cause cancer, so protection over the short term may actually be enough.

2. By overplaying the power of Pap smears: Harper also argued that the combination of Pap smears and HPV DNA testing could catch all cervical cancer cases – she said they were 100% accurate. The tests are really incredibly accurate, and women should get them regardless of whether or not they have had the HPV vaccine. But nothing is perfectly effective, and some women will fail to get regular screening, so a vaccine may still help. “That’s a remarkable statement because that is incorrect,” says Schaffner. “She overstated the case enormously.”

3. By underplaying the risk of cancer: Harper dismissed other cancers caused by HPV as extremely rare, implying that they shouldn’t be part of a risk-benefit calculus about the vaccine. But that’s not fair. Between 2004 and 2008, the CDC estimates that there were 11,967 cases of cervical cancer caused by HPV each year and 11,726 cases of head and neck cancer, meaning they could be seen as equally big problems. Work by authors including Maura Gillison of Ohio State University, a pioneer in studying the HPV/throat cancer link, indicates that by 2025 HPV throat cancer will be more common than cervical cancer, thanks largely to pap smears and HPV DNA tests. The CDC estimates that HPV causes 26,000 cases of different cancers each year.

A caveat: use of HPV vaccines to prevent head and neck cancer has not been approved by the Food and Drug Administration, and it probably never will be, because the studies would be too difficult to conduct. In cervical cancer, researchers could look for precancerous lesions; these are harder to detect in the tonsils, where throat cancer starts.

4. By pulling viewers’ heartstrings: Couric told moving stories about vaccine risks using live interviews with people who said they had been harmed. Defenses of Gardasil were offered in dry platitudes. There were no interviews with people who suffered from cancer that might have been prevented by the vaccine.

I started writing about the link between HPV and throat cancer in 2009. Generally speaking, head-and-neck cancer caused by HPV is less deadly than other types of head-and-neck cancer. But the patient I spoke to for that story – an economist named Martin Duffy who had run 40 consecutive Boston marathons – was killed by his disease. “I made my living as a public speaker,” he told me before he died. “Now I sound like Daffy Duck.” Without his voice, he asked, “How do you tell the people that you love you love them?”

We can’t ignore the stories of the girls Couric reported on, either. She said that eleven cases allege that HPV vaccines have caused death, according to the National Vaccine Information Center, an anti-vaccine group. (For comparison, Merck has shipped 62 million doses of Gardasil.) Vaccine makers and the CDC should redouble their efforts to make sure that if there is a risk of death from the vaccine, we know that. I think Merck in particular should be making an effort to approach these families and find out if there is anything it can learn about its vaccine. Is there any biologically plausible way that Gardasil could be having these effects? It seems unlikely, but we can’t be careful enough.

But deaths – including deaths by seizures or unexplained causes – do occur for all sorts of reasons, without explanation, and just because a death happened 18 days after a vaccine was given, as in the example on Katie’s show, does not mean the vaccine caused it. So far, investigations trying to link Gardasil and Cervarix to serious side effects have come up empty.

A study of 997,000 girls in Nordic countries found no link to autoimmune, neurological, and venous thromboembolic adverse events from the vaccine. A CDC analysis published in the Journal of the American Medical Association in 2009 also found no link between HPV vaccines and serious side effects. Schaffner says the main side effects he sees are sore arms and fever.

So far, despite the fact that many families do opt not to get the vaccine, Gardasil is performing better than expected. In the seven year period ending in 2010, the prevalence of HPV infection in girls and women fell 56% to 5.1% of the population. Thomas Frieden, the director of the CDC, told NBC the reduction was “better than we hoped for.” Let’s hope that can continue.

 

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

 

December, 2013|Oral Cancer News|

Merck’s Experimental HPV Vaccine Shows Promise in Late Stage Trial

Source: Nasdaq
By: Peter Loftus
Published: November 3, 2013

 

An experimental Merck & Co. vaccine appeared to provide broader protection against a cancer-causing virus than the company’s Gardasil shot in clinical trials.

Merck said the study results support its plan to submit the new vaccine, code-named V503, for U.S. regulatory approval by year’s end, which could lead to market launch next year at the soonest. Merck expects health-care providers to eventually switch to V503 if the product receives marketing approval. Some analysts expect its annual sales could exceed $1 billion.

“The case for using V503 is even stronger than the case for using Gardasil, which was already strong,” said Roger Perlmutter, head of Merck’s research and development unit. Dr. Perlmutter has singled out V503 as one of the programs Merck will focus on as it overhauls its R&D unit in a bid to recover from a series of setbacks.

Gardasil, launched in 2006, was the first vaccine to protect against human papillomavirus, or HPV, a sexually transmitted virus that can cause cervical cancer in women and other less-common types of cancer in males and females. The U.S. Centers for Disease Control and Prevention recommends HPV vaccination of boys and girls ages 11 and 12, though it is approved to be given to people ages 9 to 26. GlaxoSmithKline also sells an HPV vaccine called Cervarix.

Gardasil is designed to protect against four strains of HPV, two of which are believed to be responsible for about 70% of all cervical cancer cases. The other two strains are the primary culprits in causing genital warts. But Gardasil doesn’t protect against many other strains of HPV, some of which can also cause cervical and other cancers.

To close the gap, Merck designed V503 to protect against nine HPV strains, adding five cancer-causing HPV types to the four included in Gardasil. This wider set is believed to account for nearly 90% of all cases of cervical cancer globally, said Alain Luxembourg, director of clinical research for adult vaccines in Merck’s R&D unit.

Merck ran clinical trials to test the new vaccine’s safety and efficacy, and results are being presented at an HPV- focused medical meeting in Florence, Italy, this week. One study enrolled more than 14,000 women ages 16 to 26, who received either Gardasil or V503 in three doses over six months. The goal was to demonstrate V503 was comparable to Gardasil in protecting women against the four HPV strains common to both vaccines, and superior to Gardasil in protecting against the five additional strains in V503.

For the four HPV strains common to both vaccines, the study compared immune responses as measured in blood tests, and found V503 to be comparable to Gardasil. The researchers used immune response as the key measure because the rates of disease caused by these four HPV strains were too low in both groups to provide a meaningful comparison.

For the five HPV strains not covered by Gardasil, researchers compared the rates of precancerous lesions caused by those five strains. The study found that V503 reduced the incidence of these lesions by about 97% compared with Gardasil.

Merck said it couldn’t test the efficacy of V503 in virginal adolescents because they generally haven’t yet been exposed to HPV. So researchers measured immune responses in boys and girls ages 9 to 15 and compared them to the immune responses seen in women ages 16 to 26. The study concluded the responses were comparable across the nine HPV types targeted by V503, which Merck hopes will demonstrate to health authorities that the vaccine is effective in adolescents.

The rates of adverse events among V503 recipients were generally similar to those for Gardasil, though V503 subjects had a higher incidence of injection-site problems such as pain and redness than Gardasil subjects, 90.8% versus 85.1%. Safety concerns have occasionally dogged Gardasil, particularly reports of fainting after receiving the shot. But the CDC has concluded the vaccine is safe and effective.

Analysts from Leerink Swann estimate V503 sales could reach $1.9 billion by 2018, though it would cannibalize sales of Gardasil. Merck reported $1.6 billion in Gardasil sales last year, but Leerink predicts that would fall to $525 million by 2018.

Some health experts say an HPV vaccine with broader coverage would be an important advance. “We should be able to prevent more cervical cancer if that vaccine is given,” said Jessica Kahn, professor of pediatrics in the division of adolescent medicine at Cincinnati Children’s Hospital Medical Center. She wasn’t involved in the studies of V503.

It’s unclear, however, whether an HPV vaccine with broader protection would help improve vaccination rates, which have flattened out in the U.S. Public health experts say family physicians and pediatricians aren’t recommending HPV vaccination as strongly as other vaccines given to adolescents, such as the shot for tetanus, diphtheria and pertussis.

There is little research to suggest that a vaccine protecting against additional HPV strains would significantly improve vaccination rates, said Anne Schuchat, head of immunization programs at the CDC. Still, she said she welcomed industry research on improving HPV vaccines.

 

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

 

 

November, 2013|Oral Cancer News|

HPV Vaccine Found to Help with Cancers of Throat

Source: NY Times

By: Donald G. McNeil Jr.

A vaccine that protects women against cervical cancer also appears to protect them against throat cancers caused by oral sex, and presumably would protect men as well, according to a study released Thursday.

Rates of this throat cancer have soared in the past 30 years, particularly among heterosexual middle-aged men. About 70 percent of oropharyngeal cancers are now caused by sexually transmitted viruses, up from 16 percent in the 1980s. The epidemic made headlines last month when the actor Michael Douglas told a British newspaper that his throat cancer had come from performing oral sex.

Oncologists have assumed that the human papillomavirus vaccine, which is used to prevent cervical cancer, would also prevent this other type of cancer, but this was the first study to provide evidence.

“This is a very nice paper,” said Dr. Marshall R. Posner, medical director for head and neck cancer at Mount Sinai Medical Center in New York, who was not involved in the study. “We expected this — that’s why we want everyone to vaccinate both boys and girls. But there’s been no proof.”

The study, supported by the National Cancer Institute, found that Cervarix, made by GlaxoSmithKline, provided 93 percent protection against infection with the two types of human papillomavirus that cause most of the cancers.

“We were surprised at how big the effect was,” said Dr. Rolando Herrero, head of prevention for the World Health Organization’s International Agency for Research on Cancer, and the study’s lead author. “It’s a very powerful vaccine.”

The study was done with 5,840 women in Costa Rica who were ages 18 to 25 and sexually active when it began. Four years after being vaccinated, each gave a mouthwash gargle sample that picked up cells from deep in the throat. Only one woman who had received the vaccine was infected with the viruses HPV 16 or HPV 18, the cancer-causing types; 15 women who had gotten a placebo vaccine were infected.

Dr. Herrero explained some of the study’s limitations: when it began, it was concerned only with cervical cancer, so no men were enrolled. The women were initially tested to make sure they had no cervical infections, but were not tested for throat or anal infections. They gave oral samples only once, so it was not possible to say how many had persistent infections; most people clear HPV infections on their own, so only a tiny fraction lead to cancer. Four years is not long enough to know how many cancers would develop — but finding out for sure would require waiting 20 years or more, and ethical guidelines require that all women in the trial get regular examinations and that any suspicious lesions be destroyed before they turn cancerous. Also, only Cervarix, and not Merck’s similar Gardasil vaccine, was tested.

However, Dr. Herrero said, men would “probably” get the same protection as the women did, because the vaccine produces identical antibody levels in both sexes.

Dr. Posner said the large discrepancy in infection rates between those who got the vaccine and those who got placebo suggested that the data was “very reliable” even though the infections were detected far too early to produce cancers.

“What we don’t know,” he said, “is how long-term the protection is, or if re-vaccination is necessary.”

While cancers caused by smoking or drinking usually occur in the mouth, those caused by oral sex usually occur at the base of the tongue or deep in the folds of tonsillar tissue, and are hard to detect. They are more common among heterosexual men than among women or gay men; experts believe that is because vaginal fluid contains more virus than the surface of the penis.

Dr. Eric J. Moore, a Mayo Clinic surgeon specializing in these cancers, said the study was “very encouraging.”

“But remember,” he added. “It only works if you’re vaccinated prior to contracting the infection. Once you’re 40 and have had multiple sexual partners, it’s not going to help.”

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

July, 2013|Oral Cancer News|

Celebrity confession linking sex to oral cancer raises local awareness

Source: www.vancouversun.com
Author: Pamela Fayerman

Michael Douglas is credited for raising awareness about the links between oral sex and oral cancer, but experts worry his disclosure could cause public panic and stigmatize the disease to the point of bringing shame to those afflicted. Or worse, prevent patients with symptoms from getting examined promptly.

Miriam Rosin, a BC Cancer Agency scientist, said the actor’s candid revelation that his throat cancer was caused by human papillomavirus (HPV), which he picked up from performing cunnilingus, is raising awareness of a growing problem around the world, and in B.C. “It’s created a lot of noise. I think it’s important to talk about this disease … but not in a headline-grabbing way, which may damage the cause by labelling it as a sexually transmitted disease,” said Rosin, who is also a Simon Fraser University professor.

Regardless, the public is finally getting the message that HPV, the most common sexually transmitted virus in the world – and the one that causes virtually all cases of cervical cancer – is accounting for the surge in throat cancers located at the back of the throat.

In B.C., if trends continue, HPV-caused throat cancers are expected to overtake cervical cancers in incidence. About 150 cases of cervical cancers are reported annually in this province. Of about 500 head and neck cancers, 115 are HPVcaused throat cancers, according to the BCCA.

Douglas’s interview with The Guardian newspaper last month was followed by an avalanche of sensational media reports that apparently gave the Hollywood celebrity a twinge of regret. Douglas’s publicist later claimed the 68-year-old meant only that oral sex and HPV were a potential cause of such cancers while not specifically referring to his own. The U.K. newspaper, however, stood by the story and released an audio of the interview to rebut Douglas’s backtracking. Excessive smoking and drinking alcohol are also risk factors for various forms of oral cancer, and when the actor was first diagnosed in 2010, he had previously blamed his cancer on many years of indulgence in those habits.

Up to 70 per cent of throat cancers are HPV-related. There are numerous places to get oral cancers – such as the lips, cheeks, gums, palate, tongue and tonsils – and while smokers and drinkers once fit the typical profile of an oral cancer patient, now, because of waning smoking prevalence, HPV infections have emerged as the dominant risk factor for throat tumours such as the one Douglas had.

Rosin said there was a whopping 300-per-cent increase in the age-adjusted incidence rate for throat cancers in B.C. between 1980 and 2010. It’s more commonly diagnosed in mid-life, and the ratio of males to females getting such cancers is three-to-one.

Earlier this year, the American Cancer Society issued a report showing the proportion of HPV-linked oral cancers has risen from 16 per cent of all oral cancers in the mid-1980s to 72 per cent two decades later.

Dr. John Hay, a radiation oncologist at the BC Cancer Agency and an expert in oral cancers, said HPV tumours are squamous cell clusters that surface in places where skin tissue is thin and delicate.

There are more than 100 strains of HPV. Some are benign, causing common skin warts, but high-risk strains cause cervical and oral cancers, vaginal and vulva cancers, penis and anus cancers, and genital warts. HPV infections and their links to cancer are a relatively new scientific area of study so there are many questions still to be answered, including whether the relatively new HPV vaccine will prevent future generations from getting throat cancers.

The Vancouver Sun has reviewed the latest research and developments to address expected curiosity on the subject.

How common is HPV?
Very. By age 25, a quarter of Canadian women are infected by it, and by age 50, about 85 per cent of sexually active people (males and females) have been exposed to it at one time or another. The vast majority of the time, the immune system knocks the virus out within a few years. In a minority of individuals, the virus persists, potentially leading to an HPV-linked cancer.

What is fuelling the rise in HPV over the past three or four decades?
Experts believe the advent of oral contraceptives. (The Pill) five decades ago unleashed sexual freedom and changes in sexual behaviours: more sexual partners and consequently more sexually transmitted infections, including HPV. Hay said before oral contraceptives came along, condoms were the common barrier method. “Condoms keep things in and they keep things out,” he said, referring to the fact that condoms can help prevent sexually transmitted infections while oral contraceptives do not.

Is the massive increase in throat cancers attributable to better detection methods or an increase in HPV infections?
Experts say they are seeing a true increase in the proportion of throat cancers caused by HPV. Hay said typical patients are 45 to 65 years old who may have been infected with HPV up to 20 years earlier.

Does oral sex really cause throat cancer?
The HPV virus is very common; nearly everyone who has sex will get it at one point or another. The HPV micro-organisms can reside in the cervix or other body canals (anus) and the virus can also be transmitted through skin contact and saliva. One Finnish study showed that HPV could even be detected in babies under one year, possibly through skin-to-skin contact during breastfeeding.

Men are more likely to get throat cancer and one theory is that there may be more HPV in vaginal fluid than other genital areas.

“We don’t well understand how oral HPV is transmitted except to know that oral sex is the most likely way of transmitting HPV to the mouth,” said Gypsyamber D’Souza, an epidemiologist and viral cancer expert from Johns Hopkins Bloomberg School of Public Health, at the recent annual meeting of the American Society of Clinical Oncology.

What are the risk factors for contracting HPV?
Studies have shown that men are three times more likely to get HPV-related throat cancers than women, but risk for both genders goes up in those with more sexual partners. Those who’ve had six or more oral sex partners over a lifetime are 8.6 times more likely to get HPV throat cancers, compared with those who have never had oral sex. HPV is more prevalent in sexually promiscuous individuals and those already carrying other sexually transmitted infections (STI). A B.C. study done on men attending a Vancouver STI clinic found that 70 per cent were HPVpositive.

What are some of the most common symptoms of throat and other oral cancers?
Hoarseness, chronic sore throat, pain or difficulty swallowing, a painless lump in the neck area, swollen lymph nodes in the neck, ear pain and mouth sores that don’t heal.

Who should get the HPV vaccine?
There are two HPV vaccines licensed for use in Canada: Gardasil and Cervarix. Neither will wipe out infections once individuals have been exposed, so it’s best to get the vaccine before becoming sexually active. B.C. research has shown that HPV is most prevalent in women under 20, suggesting that the risky period for getting infected is when females first start having sex.

Gardasil (which protects against multiple high-risk HPV strains as well as genital warts) is approved for women aged nine to 45 and males nine to 26. Health Canada approved the vaccine for girls in 2006 and for boys a few years ago. It’s part of school-based immunization programs, but the major focus of public funding is on Grade 6 girls in B.C. The series of three shots costs up to $500 if purchased at pharmacies by parents wishing to vaccinate boys or older children who missed getting vaccinated.

The vaccine is also licensed for males up to age 25. As with girls, experts recommend boys get vaccinated before they become sexually active. Only a few provinces are considering public coverage of the vaccine for males; B.C. is not one of them at this time.

Dr. Perry Kendall, chief medical health officer for B.C., said studies have not yet proven it would be cost effective to extend public funding for vaccination of boys. “Ninety-nine per cent of cervical cancers are caused by HPV, and 70 per cent of vaginal cancers,” he said, while noting that HPV is “attributable” to about twothirds of throat cancers. B.C. spends about $3 million a year on HPV vaccines and about 60 to 70 per cent of eligible girls (Grade 6 cohorts) have been vaccinated so far, but it could take decades for the vaccine to have a significant effect in reducing both cervical and oral cancers in the younger generations.

Is the vaccine safe and effective?
A Universit y of B. C. researcher Dr. Simon Dobson has called Gardasil an “excellent vaccine.” HPV-infection suppression rates range from 70 to 90 per cent, with the highest immunity response occurring in those who get the vaccine at the youngest age.

Minor side effects such as pain at the site of injection, swelling, dizziness, nausea and headache have been reported in about six per cent of subjects, according to Dr. Monika Naus of the B.C. Centre for Disease Control in a report in the BC Medical Journal. Rare, serious adverse effects – such as deaths, stroke, embolisms and seizures – have not been directly linked to the vaccine.

How can you get tested for HPV?
Doctors scrape cells from the cervix area, similar to the way specimens are collected during a Pap smear. The test is not covered by the public medical plan so private labs charge about $90. It is not possible to swab the back-of-throat area for HPV because of gag and vomit reflexes. Saliva tests are used to detect throat HPV infections only for research purposes so far.

In women and men, swabs can be taken of the anal cavity to detect pre-cancerous changes.

Is there a treatment for HPV?
There’s no treatment for the infection but there are for the serious cancers that may result from it, such as surgery, chemotherapy and radiation.

What’s the prognosis for someone who gets HPV oral cancer?
Even those who get advanced HPV-caused throat cancers, such as actor Michael Douglas, have a fiveyear survival rate of at least 80 per cent, whereas advanced non-HPV linked oral cancers – those caused by smoking and alcohol – have a survival rate about half that. Non-HPV cancers usually affect the front of the tongue, floor of the mouth, cheeks and gums, while HPV cancers tend to affect the back regions of the mouth: the base of the tongue and tonsil area.

Is there a screening program for HPV-related oral cancers?
There’s no way to screen for HPV-related throat cancers, but a B.C.-developed device called the VELscope is used by some dentists to detect abnormalities in the front parts of the oral cavity. The device utilizes special light to detect suspicious cells, but it has not yet been shown to find HPVtype cancers in the furthest reaches of the throat. The tonsil area has folds and crevices where HPV tumours can hide out. BC Cancer Agency scientists are trying to improve the imaging system for the hardto-reach sites at the back of the throat and tonsil area.

Does it take a long time for an HPV infection to arise or should you blame the last person you had sex with?
If you do get HPV, you can’t necessarily point the finger at the last individual you had sex with. HPV infections wax and wane over lifetimes so getting an HPV-linked cancer may be more likely caused by the “sum total of your life experiences,” according to Rosin. A 2010 study in the British Medical Journal found that in those who developed throat cancers, a third had HPV antibodies (meaning they had been exposed to the virus) up to 12 years before the onset of disease.

How can one prevent or lower the chances of getting HPV-related cancers?
Talk to your doctor about getting vaccinated against the high-risk strains of HPV, reduce intake of alcohol and tobacco, limit your number of sexual partners, get tested for HPV if you have any symptoms or concerns. Women should get Pap smear tests of their cervix, which can show abnormal cellular changes that point to a possible HPV infection.

How prevalent is the oral HPV virus in the general population?
A recent snapshot-in-time U.S. study published in the Journal of the American Medical Association found that about seven per cent of Americans aged 14 to 69 are infected by HPV. But only one per cent of the 5,500 people in the study had HPV-16, the most strongly linked strain to oral and cervical cancers. If the figure is extrapolated to the whole population, it would mean that millions have HPV, but fewer than 15,000 Americans develop HPV-linked throat cancers each year. Lead author Dr. Maura Gillison, of Ohio State University, said that should be seen as reassuring; most people with oral HPV don’t get throat cancer.

The same study found that oral HPV infection was more common in men (10 per cent) than women (four per cent). HPV infection was most common in people aged 55 to 59.

How common is oral sex?
The Canadian Youth, Sexual Health and HIV/AIDS study, along with other studies and surveys in the U.S. and Canada, have shown that oral sex is enjoyed by two-thirds of adults. Results have shown it’s increasingly popular among Canadian teenagers. In 1994, nearly half of Grade 11 students (47.5 per cent) reported having oral sex at least once. When the survey was repeated in the same age group in 2002, more than half (52.5 per cent) indicated they had done so.

Should you swear off oral sex?
Since there is a long latency period for HPV infections to inflict serious damage, it’s unlikely there’s any benefit for adults to change sexual practices and preferences, especially if they are in monogamous relationships. But Rosin and Hay agree it may be prudent for individuals to be discriminating when it comes to sexual partners. They can consider asking partners about whether they’ve had HPV, if they’ve been vaccinated against HPV, or about their health and sexual histories.

July, 2013|Oral Cancer News|

Oral cancer sneaks up

Source: well.blogs.nytimes.com
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.

Fact check: Michael Douglas on HPV and throat cancer

Source: www.huffingtonpost.com
Author: Meredith Melnick

A Michael Douglas interview in The Guardian caused waves when the publication reported that the “Behind the Candelabra” star revealed HPV, the human papilloma virus, to be the cause of his stage-4 throat cancer diagnosis in 2010.

“Without wanting to get too specific, this particular cancer is caused by HPV, which actually comes about from cunnilingus,” Douglas allegedly told The Guardian.

Douglas, through his publicist, has said that the statement was misinterpreted: He wasn’t saying that his cancer was caused by the sexually transmitted disease — merely that many cancers like his are HPV-positive. As The Daily Beast points out, there is scant research evidence to directly link the act of cunnilingus with HPV infection. But regardless of the details of his own cancer, the actor is right about one thing: A growing majority of oral cancer cases are caused by HPV.

While most strains of HPV clear up on their own, the sexually transmitted disease is responsible for an array of cancers. As Douglas describes, it’s true that oral sex is an avenue through which a person can contract HPV and especially the strains, HPV-18 and HPV-16, the latter of which is responsible for half of oral cancer cases, according to the National Cancer Institute. HPV-16, HPV-18 and some less-common strains can also cause cancers of the cervix, vagina, vulva, anus and penis.

Douglas’ experience follows trends in cancer diagnosis, according to a January report from the American Cancer Society, which found a rise in oral cancer caused by HPV in both women and men. As the report said, as of 2004, 72 percent of oral cancer tumors were HPV-positive — up from 16 percent of tumors in data collected between 1984 and 1989.

Previously, excessive drinking and tobacco use were the most common causes of the throat cancer Douglas developed, but HPV has replaced tobacco as the leading cause of throat cancers. HPV’s rise as the leading cause of oral cancer is not just the result of growing rates of the virus — it is also explained by drops in smoking, thanks to public health campaigns that describe the dangers of cigarette use.

HPV-16 and 18 are targeted by the vaccine Cervarix and are two of the four strains targeted by Gardasil, the other of the two approved vaccines against HPV. Gardasil is currently recommended for boys between the ages of 13 and 21 and both Cervarix and Gardasil are recommended for girls, aged 13 to 26, according to the Centers for Disease Control and Prevention. HPV-6 and HPV-11, both of which the Gardasil vaccine immunizes against, cause about 90 percent of genital warts cases.

Despite the growing rates of oral cancer, cases like Douglas’ are still relatively rare, with about 7,100 new cases each year, reported USA Today. But that doesn’t mean oral HPV infection is rare: According to a 2012 study of Americans, aged 14 to 69, about 10 percent of men and 3.6 percent of women currently have an oral HPV infection.

According to the CDC, there is no screening test to determine overall HPV status. While women are screened for HPV-associated cervical cancer via a Pap-smear test, other HPV-associated cancers don’t have a specific screening test. Despite the fact that there are no uniform screening techniques for oral cancer, the prognosis for the disease is good, with an 80 to 90 percent survival rate, according to The Oral Cancer Foundation.