FDA approves Gardasil 9, the HPV vaccine, to prevent head-and-neck cancer

For the past decade, evidence has suggested that Gardasil, the HPV vaccine, could stem an epidemic of throat cancer. But it has also never received approval from the Food and Drug Administration for that use — and it was unclear if it ever would.

On Friday, the agency granted that approval, clearing the latest version of the vaccine, Gardasil 9, to prevent a cancer that affects 13,500 Americans annually. The decision was announced by Gardasil’s maker, Merck.

The decision doesn’t change recommendations about who should get the vaccine, which is already recommended for females and males ages 9 through 45 to prevent cervical, vulvar, vaginal, and anal cancer as well as genital warts. But cancers of the head and neck — mainly those of the tonsils and throat — have been left off the list.

It’s a striking omission, because head and neck cancer, mostly cancer of the throat, is the most common malignancy caused by HPV, the human papilloma virus, in the U.S. According to the Centers for Disease Control and Prevention, there are 35,000 cases of HPV-related cancer in the U.S. annually. On top of the 13,500 cases in the throat, 10,900 are cases of cervical cancer.

“That’s excellent news,” said Stewart Lyman, a pharmaceutical consultant whose doctors discovered a tumor in his throat in 2016. It was removed surgically, and was caused by HPV. “To have this extended to head and neck cancer is really very helpful for helping to inform the public that this serious disease, which has significant morbidity and mortality associated with it, can be prevented with the vaccine,” Lyman said.

Marshall Posner, the director of head and neck medical oncology at the Tisch Cancer Institute, said the approval is “a good thing for the FDA to do” and that he would be “thrilled” if head and neck cancer cases could be reduced through vaccination in coming decades. He said he has “every expectation” that an HPV vaccine would reduce cancer rates.

The original version of the Gardasil vaccine was approved in 2006 for girls and women between the ages of 9 and 26 based on data from clinical trials showing that the vaccine, by preventing HPV infection, could also prevent precancerous cervical lesions. But such lesions don’t exist in head and neck cancer, and it was not clear how to prove the vaccine’s efficacy.

Maura Gillison, now a professor at M.D. Anderson Cancer Center, first connected a subset of head-and-neck cancers to HPV in 1999. But then she and other epidemiologists noticed something: The number of head and neck cancers was rising rapidly, and HPV seemed to be a culprit. What’s more, these sexually transmitted cases seemed different — and somewhat easier to treat. The most common victims were middle-aged men who had contracted the virus decades before.

The FDA is granting what’s known as an accelerated approval, meaning that the decision is contingent on the production of more data and is based on what’s known as a “surrogate endpoint” — an indication that a medicine works that is not foolproof. In this case, the FDA is approving the drug based on data on preventing anogenital infection. In February, Merck began a study of  6,000 men that will test whether patients who receive the vaccine are less likely to get persistent HPV infections in their throats.

Adding another disease to the approval does impact what Merck can say to doctors and patients about HPV and head and neck cancer. “It’s something that was missing in the label,” said Alain Luxembourg, director, clinical research, Merck Research Laboratories. “It is something missing in the conversation between patients and doctors.”

Otis Brawley, an oncology and epidemiology professor at Johns Hopkins University, said that while he is usually opposed to surrogate endpoints, in this case he is comfortable with the decision. “There’s already enough reasons to vaccinate for HPV in men,” he said, adding that doing so broadly might make it possible to eradicate the virus, and the cancers it causes.

For Gillison, who spotted the emergence of HPV throat cancer, it came too late. She pushed Merck to do a study, and said that the one that started in February is coming “10 years plus after when it would have really mattered.” She also thinks that the real reason for the decision is the weight of epidemiologic evidence that she and others produced.

“The fact of the matter is that this approval probably has little whatsoever to do with the anal data per se,” Gillison wrote via text message. “It is because the FDA is made more comfortable with inference because of all the data that has been generated regarding the relationship between oral HPV infection and HPV vaccination outside of vaccine trials in the last 10 years.”

FDA approves Gardasil 9, the HPV vaccine, to prevent head-and-neck cancer

Source: www.statnews.com
Author: Matthew Herper

For the past decade, evidence has suggested that Gardasil, the HPV vaccine, could stem an epidemic of throat cancer. But it has also never received approval from the Food and Drug Administration for that use — and it was unclear if it ever would.

Charles Rex Arbogast/AP

On Friday, the agency granted that approval, clearing the latest version of the vaccine, Gardasil 9, to prevent a cancer that affects 13,500 Americans annually. The decision was announced by Gardasil’s maker, Merck.

The decision doesn’t change recommendations about who should get the vaccine, which is already recommended for females and males ages 9 through 45 to prevent cervical, vulvar, vaginal, and anal cancer as well as genital warts. But cancers of the head and neck — mainly those of the tonsils and throat — have been left off the list.

It’s a striking omission, because head and neck cancer, mostly cancer of the throat, is the most common malignancy caused by HPV, the human papilloma virus, in the U.S. According to the Centers for Disease Control and Prevention, there are 35,000 cases of HPV-related cancer in the U.S. annually. On top of the 13,500 cases in the throat, 10,900 are cases of cervical cancer.

“That’s excellent news,” said Stewart Lyman, a pharmaceutical consultant whose doctors discovered a tumor in his throat in 2016. It was removed surgically, and was caused by HPV. “To have this extended to head and neck cancer is really very helpful for helping to inform the public that this serious disease, which has significant morbidity and mortality associated with it, can be prevented with the vaccine,” Lyman said.

Marshall Posner, the director of head and neck medical oncology at the Tisch Cancer Institute, said the approval is “a good thing for the FDA to do” and that he would be “thrilled” if head and neck cancer cases could be reduced through vaccination in coming decades. He said he has “every expectation” that an HPV vaccine would reduce cancer rates.

The original version of the Gardasil vaccine was approved in 2006 for girls and women between the ages of 9 and 26 based on data from clinical trials showing that the vaccine, by preventing HPV infection, could also prevent precancerous cervical lesions. But such lesions don’t exist in head and neck cancer, and it was not clear how to prove the vaccine’s efficacy.

Maura Gillison, now a professor at M.D. Anderson Cancer Center, first connected a subset of head-and-neck cancers to HPV in 1999. But then she and other epidemiologists noticed something: The number of head and neck cancers was rising rapidly, and HPV seemed to be a culprit. What’s more, these sexually transmitted cases seemed different — and somewhat easier to treat. The most common victims were middle-aged men who had contracted the virus decades before.

The FDA is granting what’s known as an accelerated approval, meaning that the decision is contingent on the production of more data and is based on what’s known as a “surrogate endpoint” — an indication that a medicine works that is not foolproof. In this case, the FDA is approving the drug based on data on preventing anogenital infection. In February, Merck began a study of 6,000 men that will test whether patients who receive the vaccine are less likely to get persistent HPV infections in their throats.

Adding another disease to the approval does impact what Merck can say to doctors and patients about HPV and head and neck cancer. “It’s something that was missing in the label,” said Alain Luxembourg, director, clinical research, Merck Research Laboratories. “It is something missing in the conversation between patients and doctors.”

Otis Brawley, an oncology and epidemiology professor at Johns Hopkins University, said that while he is usually opposed to surrogate endpoints, in this case he is comfortable with the decision. “There’s already enough reasons to vaccinate for HPV in men,” he said, adding that doing so broadly might make it possible to eradicate the virus, and the cancers it causes.

For Gillison, who spotted the emergence of HPV throat cancer, it came too late. She pushed Merck to do a study, and said that the one that started in February is coming “10 years plus after when it would have really mattered.” She also thinks that the real reason for the decision is the weight of epidemiologic evidence that she and others produced.

“The fact of the matter is that this approval probably has little whatsoever to do with the anal data per se,” Gillison wrote via text message. “It is because the FDA is made more comfortable with inference because of all the data that has been generated regarding the relationship between oral HPV infection and HPV vaccination outside of vaccine trials in the last 10 years.”

How to encourage vaccination against HPV cancers? Drexel study suggests taking a cue from anti-vaxxers

Source: www.inquirer.com
Author: Marie McCullough

To persuade more people to get the cancer-preventing HPV vaccination, public health groups should emulate a tactic of the anti-vaccine movement, concludes a Drexel University study of Instagram posts.

The researchers aren’t suggesting that vaccine proponents spread misinformation on social media, as vaccine foes do. But the study found that emotional, personal accounts with photos of youngsters — a staple of anti-vaccine content — get way more “likes” than the dispassionate, factual messages typical of pro-vaccine posts.

“By studying what makes these messages so effective, we can improve fact-based, pro-vaccination messaging,” said senior author Philip M. Massey, a community health researcher at Drexel.

The study, which analyzed 360 Instagram posts from April to August of last year, was conducted before Facebook — the owner of Instagram — announced this spring that it would curb anti-vaccine messages. But such content still abounds, because Facebook’s crackdown is limited to recommendations and ads.

Before the crackdown, a majority of Facebook ads spreading vaccine misinformation were funded by just two groups, one led by Robert F. Kennedy Jr.’s World Mercury Project, according to a study published this month in the journal Vaccine.

Another study, in JAMA Pediatrics in September, found that 13 years after Merck’s Gardasil vaccine was hailed as a revolution in cancer prevention, most Americans still don’t know that HPV (human papillomavirus) is a family of sexually transmitted germs that can cause oral and genital cancers, and most doctors still aren’t promoting the shots.

The immunization is recommended for boys and girls at age 11 or 12, before they become sexually active, and as “catch-up” shots to age 26. But only about half of U.S. teens have been fully vaccinated, federal data show. (Adults ages 27 to 45 can opt for the immunization, although they are less likely to benefit.)

Despite low uptake, many studies show vaccination has reduced genital warts and precancerous lesions that can progress to cancer. (It will take more time to see the impact on cancer rates.)

But studies also show that while cervical cancer rates have declined over the last 20 years because of routine Pap screening, rates of mouth and throat cancers in men have risen more than 200%, and anal cancers in women have risen 150%.

Scientific groups and global health authorities who continue to monitor the vaccine assert that it is safe and does not cause chronic pain, heart arrhythmias, autoimmune diseases, life-threatening allergic reactions, stroke, neurological disorders, premature ovarian failure, miscarriages, or other health problems.

But that does not prevent vaccine foes from saying it does.

“So many sad stories on here,” a woman posted recently on the Facebook page Gardasil Class Action Australia. “Here’s mine. I had Gardasil in 2007, had a miscarriage in early 2008, and now have chronic fatigue and fibromyalgia. It’s so hard to be a good mum and give the kids what they need and the house clean when you’re sooo tired and your body aches.”

The Drexel study found that 46% of anti-vaccine posts on Instagram featured personal narratives, compared with 28% of pro-vaccine posts. Each anti-vaccine message got an average of 86 likes, compared with 24 likes per pro-vaccine post.

The paper, published in the journal Health Education and Behavior, has only a few examples of actual pro and con posts, including these:

“Your child can get protection for HPV cancers during the same visit they are protected against other serious diseases,” says the U.S Centers for Disease Control and Prevention.

“Jamie is not doing well after her first Gardasil vaccine for HPV prevention. She keeps turning yellow, wants to throw up and pass out,” says a post that shows a teenage girl folded over her knees in a chair.

Although the study does not propose potential pro-vaccine narratives, Massey said in an interview that developing and testing such messages on parents of preadolescents is the next step in his research.

He pointed to a recent Merck TV commercial as an example of a pro-vaccine message that “pulls at the heartstrings.” It portrays a young woman or young man with HPV-related cancer, voicing over a retrospective of photos and videos going back to age 11 or 12. The man speculates that his parents didn’t know about HPV or the vaccine, then his tween self asks, “Right, Mom? Dad?”

“The bottom line,” Massey said, “is that there’s a great opportunity to incorporate storytelling into our pro-vaccine messages.”

2019-11-27T06:30:20-07:00November, 2019|Oral Cancer News|

HPV vaccine expanded for people ages 27 to 45

Source: www.nytimes.com
Authors: Denise Grady and Jan Hoffman

About 14 million women and men become infected with the human papillomavirus each year in the United States, according to the Centers for Disease Control and Prevention. CreditCreditKeith Bedford/The Boston Globe, via Getty Images

The HPV vaccine, which prevents cervical cancer and other malignancies, is now approved for men and women from 27 to 45-years-old, the Food and Drug Administration said on Friday.

The vaccine is Gardasil 9, made by Merck, and had been previously approved for minors and people up to age 26.

It works against the human papillomavirus, HPV, which can also cause genital warts and cancers of the vulva, anus, penis and parts of the throat. The virus has many strains. It is sexually transmitted, and most adults encounter at least one strain at some point in their lives. The vaccine protects against nine strains, including those most likely to cause cancers and genital warts.

“Today’s approval represents an important opportunity to help prevent HPV-related diseases and cancers in a broader age range,” Dr. Peter Marks, director of the F.D.A.’s Center for Biologics Evaluation and Research, said in a statement.

The approval was based on a study in women ages 27 to 45, showing that an earlier version of the vaccine was highly effective in preventing persistent HPV infection, genital warts, vulvar and vaginal precancers, cervical precancers and cervical cancers related to the virus types covered by the vaccine.

The vaccine’s effectiveness in men ages 27 to 45 is inferred from the data in women, from its efficacy in younger men and from evidence that it created immunity in a study of men 27 to 45-years-old.

The most common side effects of the vaccine include soreness at the injection site, swelling, redness and headaches.

If a person has already been exposed to a particular strain of HPV, the vaccine will not work against that strain. For that reason, vaccination has been strongly recommended for young people before they become sexually active.

But even someone who has already been exposed to a few strains — but not to all nine in the vaccine — can still gain protection against the strains they have not encountered.

“This is great,” Dr. Lois M. Ramondetta, a professor of gynecologic oncology at MD Anderson Cancer Center in Houston, said in an interview. “It’s a prevention vaccine. The best time to get it is before you turn 13 and have any intimate activity at all. But, that said, it protects against nine types of HPV, so if you have one of the types, you still can be protected from other HPV types.”

She added: “There is a whole generation of people we were missing who didn’t know about it. Doctors weren’t good at talking about it.”

She and Dr. William Schaffner, an infectious disease expert at Vanderbilt University, said people over 26 began asking doctors about the vaccine. Some were leaving marriages or monogamous relationships, expected to begin dating and realized they might be exposed to the virus.

“They want to feel protected to some extent,” Dr. Ramondetta said. “Now they have the opportunity.”

Younger people need two shots, but the older ones will need three, spaced a few months apart.

Dr. Ramondetta noted that tumors affecting part of the throat — called oropharyngeal cancers — caused by HPV are rising, particularly in men. The vaccine is believed to help prevent them.

Dr. Schaffner said a panel that advises the Centers for Disease Control and Prevention has already been discussing the data on using the vaccine in older people, and is expected to make a recommendation about it. The recommendation could be universal, meaning that everyone in that age range should receive it, or it could be “permissive,” meaning that the decision is up to doctors and patients.

Once that group, the Advisory Committee on Immunization Practices, recommends a vaccine, insurers generally cover it.

The rise of HPV-related cancers in men

Source: www.tmc.edu
Author: Alexandra Becker

Scott Courville admired his full beard and round belly in the mirror: He was ready for the upcoming holiday season. It was November 2015 and Courville, who plays Santa Claus in Lafayette, Louisiana, was too excited about his favorite time of year to worry much about the pain developing in his jaw.

By February, though, the ache had worsened and was accompanied by new symptoms: white spots on his right tonsil, difficulty swallowing and lumps in his throat. He finally made his way to a walk-in clinic where he was diagnosed with tonsillitis and prescribed antibiotics.

“They sent me home and said, ‘In two weeks everything should clear up,’” Courville recalled.

But his symptoms only worsened. Courville made an appointment with a local ear, nose and throat (ENT) specialist who also diagnosed Courville with tonsillitis. The doctor prescribed more antibiotics and steroids, but two weeks later there were no improvements. Courville was referred to a dentist—“In case they see something we don’t”—but that, too, was a dead end.

Courville’s dentist insisted he return to his ENT, where he ultimately had a CT scan that revealed a mass in his throat. That was June 6, 2016. Two days later, Courville underwent a biopsy. When he awoke from the surgery, his doctor was standing over him.

Courville always gets choked up retelling this part of his story.

“The hardest part for me is always remembering when the doctor said, ‘I’m sorry, but you’ve got cancer.’”

Courville was referred to The University of Texas MD Anderson Cancer Center, where doctors confirmed that he had squamous cell carcinoma of the right tonsil. But there was more: Courville learned that his cancer had been caused by the human papillomavirus—HPV.

11 million men
Courville’s story is becoming increasingly common, with the annual incidence of HPV-related cancers of the throat, tonsils and the base of the tongue in men in the United States now outnumbering cases of cervical cancer in women, according to the U.S. Centers for Disease Control and Prevention (CDC). A 2017 research paper authored by scientists at Baylor College of Medicine and The University of Texas Health Science Center at Houston School of Public Health, among others, found the overall prevalence of oral HPV in men in the U.S. to be upwards of 11 million—much higher than previously believed.

“This has implications, because pretty much everyone is exposed to HPV,” said Andrew Sikora, M.D., Ph.D., one of the authors of the paper and vice chair for research and co-director of the Head and Neck Cancer Program at Baylor College of Medicine. “When we’re talking about the prevalence of oral HPV infection, we’re talking about that infection persisting inside the tonsils or on the base of the tongue of these men, and I think that’s what sets you up for cancer later in life—it may happen decades after you were exposed to HPV.”

That lag time, coupled with an absence of symptoms, is part of the reason HPV-related oropharyngeal cancers, also referred to as head and neck cancers, are increasing.

“What makes this cancer interesting is that it’s one of the only cancers in the body that we’re actually seeing more cases of year over year,” explained Ron J. Karni, M.D., who serves as chief of the division of Head and Neck Surgical Oncology at McGovern Medical School at UTHealth and Memorial Hermann-Texas Medical Center. “In the U.S., we can expect a certain number of breast cancer cases and lung cancer cases every year, but this is actually starting to look a bit like an epidemic in that we are seeing more every year. It’s alarming.”

Holy grail
HPV is the most common sexually transmitted disease in the U.S., with an estimated 79 million individuals infected. According to the CDC, HPV is so common that most people who are sexually active will get the virus at some point in their lives if they do not get the HPV vaccine.

The virus is spread through vaginal, anal and oral sexual activity, and often exhibits no signs or symptoms. In many cases, HPV is cleared by the immune system and does not cause health problems, but it can also persist and show up decades later alongside conditions such as genital warts and cancer—including cervical cancer, anal cancer and oropharyngeal cancers. For reasons not well understood, oropharyngeal cancers predominately affect men.

Currently, there is no annual screening test for men to determine whether they have the virus. Women, on the other hand, are advised to get regular pap smears.

The Papanicolaou test, commonly known as the pap smear, involves collecting cells from inside a woman’s cervix to detect pre-cancerous changes. It is performed during a woman’s annual exam and has been widely credited for detecting early signs of HPV-related cervical cancer and saving countless lives. No such screening test has been successfully developed for oropharyngeal cancer—another reason cited for its steady rise.

“We’re at a huge disadvantage,” said Sikora, who, in addition to his research, treats patients at the Michael E. DeBakey VA Medical Center in Houston. “The pap smear, in terms of global health impact, is probably one of the best, most cost-effective things ever invented in terms of just the sheer number of women who have not had cancers because of it. We have nothing like that for men.”

Sikora explained that anatomy is, in part, to blame. Whereas the cervix is easily sampled, the tonsils are full of “nooks and crannies,” he said, and scientists have yet to develop a reliable technique for obtaining a representative sample of cells inside the throat, tonsils and back of the tongue.

“It’s sort of a holy grail for researchers in the field,” Sikora said. “It would be a game-changer in terms of prevention and early detection of cancer.”

Scientists at MD Anderson, where Courville was treated, may be closing in on some answers. Researchers, including Erich M. Sturgis, M.D., MPH, the Christopher & Susan Damico Chair in Viral Associated Malignancies, are currently conducting a clinical trial for an antibody test that could be used to screen for HPV-related throat cancer.

The HOUSTON study, an acronym for “HPV-related Oropharyngeal and Uncommon Cancers Screening Trial of Men,” is looking to recruit 5,000 men ages 50 to 64 years to provide blood and saliva samples for serologic HPV testing and oral HPV testing, respectively. If a subject is found to have a positive antibody test, he will be asked to participate in a second phase of the study, which includes an intensive screening program run through MD Anderson’s oral pre-cancer clinic.

“A researcher at Arizona State University, Dr. Karen Anderson, developed a serologic test that predicts extremely well the risk for HPV-related oropharyngeal cancer,” Sturgis explained. “We have been able to show that serum antibodies to HPV early proteins, which are rare in the general population, are markers for oropharyngeal cancer. Specifically, we found that those who had antibodies to certain HPV antigens have a greater than 450-fold higher risk of oropharyngeal cancer compared with those who do not have the antibodies.”

The hope is that this study will reveal that serological HPV antibody testing is an effective screening tool for HPV-related cancer in men: the equivalent to a pap smear.

A lump in the neck
If and when HPV-related cancer does develop, men often notice a pain in their jaw or throat, trouble swallowing, change or loss of voice that lasts more than a week or two, a sore spot on the tongue and, most often, a lump in the neck.

“There’s often a very small, primary tumor, which is the tumor that is in the tongue or in the tonsil, and it travels early to the lymph nodes,” Sikora explained. “Depending on what your neck looks like, lymph nodes can get pretty big before they become noticeable. But a lump in the neck is by far the most common symptom, and unfortunately it’s often detected much later than we would like.”

Even more troubling, many individuals who have these symptoms are commonly misdiagnosed and handed antibiotics, as in Courville’s case.

“The most important message I can convey is that if you have a lump in your neck, go see an ear, nose and throat doctor,” Karni said, emphasizing the importance of an informed diagnosis and specialized care.

Treatment for oropharyngeal cancers varies depending on the case and often involves a multidisciplinary team of clinicians, as well as some form of combined modality therapy such as radiation and chemotherapy. In the future, Sturgis sees novel therapies, including immunotherapy options, changing the landscape of treatment protocols.

Karni hopes UTHealth’s dedicated HPV-related throat cancer program will carry patients through the entire arc of treatment by offering minimally invasive robotic surgery for qualifying cases, as well as annual community-wide screening clinics, rehabilitation therapists, and numerous other specialists.

“We want to think about cancer the way Target thinks about shopping or the way the best airlines think about flying,” Karni said. “We designed a program that is patient-centered. We asked, ‘What does the patient need on their fourth week of radiation? What do they need on their third month post-radiation? How can we get that into one clinic space?’ It’s a large team and it’s all centered around this one disease.”

47th in the nation
In 2006, an HPV vaccine named Gardasil hit the market. It was originally intended to prevent HPV in females and, ultimately, HPV-related cervical cancer. But as scientists learned more about HPV—first that males could be carriers and later that it causes cancer in men, as well—public health professionals and clinicians unanimously recommended the vaccine to everyone. The CDC recommends all young women through the age of 26 and all young men through age 21 receive two doses for the vaccine to be effective.

And it is. A recent report published in May by Cochrane, a global independent network of clinical researchers and health care professionals, concluded that the HPV vaccine protects against cervical cancer in young women, especially when they are vaccinated between the ages of 15 and 26.

Which begs the question: Will the vaccine protect young men against the development of oropharyngeal cancers?

“There is a lot more data on cervical cancer in women and the vaccine than there is on head and neck cancer in men and the vaccine, but what data exists suggests that it is going to be a very effective intervention,” Sikora said.

Yet despite scientific evidence that prophylactic HPV vaccination of children and young adults will drastically reduce HPV-related cancers, vaccination rates in the U.S. remain alarmingly low—and Texas ranks 47th. Even more, several generations did not have the vaccine available to them and are currently at risk for HPV-related cancer.

As Karni said, it is alarming.

“Because the median age of oropharynx cancer related to HPV is about 55 and, in some studies, 60, and because the vaccine does not seem to work in individuals who have already been exposed, the benefits of vaccination on HPV-related cancer will not be realized for several decades,” Sturgis said. “Even if we vaccinate 100 percent of our boys and girls tomorrow, we have a whole generation or two who are at risk for this cancer and cannot do anything about it.”

Courville endured six rounds of chemotherapy and 33 daily rounds of radiation to treat his cancer. He lost a year of his life, 100 pounds, his taste buds and salivary glands, and can no longer grow his full beard— but his therapy was successful. He has now made it his life’s mission to inform the public about the importance of the vaccine as well as ongoing advocacy and research surrounding HPV-related cancers.

“If you can educate the public and educate the parents, they will vaccinate their kids,” Courville said. “And if we can vaccinate this generation, we could eliminate these types of cancers.”

HPV is causing an oral cancer epidemic in men by outwitting natural defenses

Source: www.philly.com
Author: Marie McCullough, staff writer

Five years ago, when actor Michael Douglas candidly revealed that his throat cancer was linked to having oral sex, two things happened.

He made headlines that mortified his family. And he helped publicize the fact that a pervasive, sexually transmitted virus called HPV was unleashing an epidemic of oral cancer among men.

Since then, scientists have made headway in figuring out why HPV, the human papillomavirus, has this glaring gender bias. Men are four times more likely than women to be diagnosed with oral cancer, a hard-to-detect, hard-to-treat disease that has overtaken cervical cancer as the most common HPV-related malignancy in the United States.

To be sure, changes in sexual norms over the last few generations have played a role in this alarming trend. But research increasingly shows the real problem is something men have practically no control over: their immune response.

Compared with women, men are more likely to get infected with HPV — including “high-risk” cancer-causing strains. They also are less able to wipe out infection on their own, and more likely to get reinfected. The reasons are unclear.

“There is good evidence that men acquire oral infections more readily than women, even if they have similar sex practices,” said Ashish A. Deshmukh, a University of Florida HPV researcher. “And more than the acquisition, it’s the persistence of the virus. The clearance rate is not that fast in men.”

Michael Becker of Yardley has stepped up as the face of this immunological inequity. The 49-year-old former biotech executive is health-conscious, clean-living, happily married for 26 years – and battling terminal oropharyngeal cancer, the medical term for malignancies in parts of the mouth and throat.

He’s also battling the misconceptions and ignorance that keep too many parents from protecting their pubescent children — especially boys — against HPV-driven cancers. Two shots. That’s all it takes for the leading vaccine, Gardasil, to prevent most cervical cancers, less common genital malignancies, and the disease that is killing Becker.

“I can’t tell you how many emails I got from parents after the CBS segment,” he said, referring to a national television interview last month. “They said, ‘What do you mean this vaccine is for boys?’ and ‘What do you mean oral cancer incidence has eclipsed cervical cancer?’ ”

An inescapable virus
HPV is a family of more than 100 virus types that can live in the flat, thin cells on the surface of the skin, cervix, vagina, anus, vulva, penis, mouth, and throat. The virus is spread through contact with infected skin, mucous membranes, and bodily fluids. Some types can be passed during intercourse or — as Douglas pointed out — oral sex. While virtually all sexually active people will get infected at some point, the virus is usually wiped out by the immune system without so much as a symptom.

But not always.

In the cervix, persistent infection with high-risk HPV types can lead to precancerous changes that, left alone, slowly turn malignant. Fortunately, the Pap smear enables the detection and removal of abnormal cells before cancer develops. What’s more, age-related changes in cervical cells reduce the risk that HPV will take hold there as women get older.

No such screening test exists for oropharyngeal sites – the tongue, soft palate, tonsils, the throat behind the nasal cavity – and symptoms usually don’t appear until cancer is advanced. Becker, for example, had metastatic disease by the time he noticed a lump under his jaw line in late 2015.

Traditionally, smoking and heavy alcohol use are the big risk factors for oral cancer, but the non-HPV tumors linked to these bad habits have been declining in recent years. HPV-related tumors, in contrast, have increased more than 300 percent over the last 20 years. The virus is now found in 70 percent of all new oral cancers.

About 13,200 new HPV oral cancers are diagnosed in U.S. men each year, compared with 3,200 in women, according to federal data. Treatment — surgery, chemotherapy, radiation — can have disfiguring, disabling side effects. About half of late-stage patients die within five years.

Natural defenses go awry
Oral HPV infection rates are skewed by gender, just like the resulting cancers. The latest national estimates of this disparity, published in October, come from Deshmukh and his University of Florida colleagues. They used a federal health survey that collected DNA specimens to estimate that 7.3 percent of men and 1.4 percent of women have oral infections with high-risk HPV types. That translates to 7 million men and 1.4 million women.

The chance of oral infection increases for women as well as men who have simultaneous genital HPV infections or a history of many sex partners, but male infection rates still far surpass female rates.

Patti Gravitt, an HPV researcher at George Washington University, believes these estimates are a bit oversimplified because women counted as uninfected may actually have undetectably low virus levels, or HPV may be hiding in a dormant state in their cells.

Still, Gravitt said the study is in line with others that suggest “men are more susceptible to HPV viral infection than women.”

In women, an HPV infection usually sets off the body’s defense mechanisms. The immune system makes antibodies that kill off the invader, then immune cells remain on guard, ready to attack if the virus reappears.

But in men, something goes awry. The HIM study — for HPV in Men — documented this by collecting genital, anal, and oral samples from 4,100 unvaccinated men in Florida, Mexico and Brazil between 2005 and 2009. The samples were tested for the presence of two high-risk HPV types and two that cause genital warts.

Among 384 men who developed infections during a 24-month period, only 8 percent produced antibodies. But this response rate varied depending on the site of infection; none of the small number of orally infected men produced antibodies.

Rather than putting the immune system on guard and protecting men from the virus, infection sharply increased the chance of getting infected again with the exact same HPV type. And many men who got reinfected were celibate at the time.

How could this be? Anna R. Giuliano, the researcher at the Moffitt Cancer Center in Tampa, Fla., who led the HIM study, said recurring infections may be due to reactivation of dormant virus, or to auto-inoculation – the man spreads infection from one part of his body to another. Or to something else entirely.

While the scientific understanding of this puzzle is evolving, one implication is clear. “HPV vaccination is the only reliable method to ensure immune protection against new HPV infections and subsequent disease in males,” Giuliano and her co-authors declared in a recent paper.

Becker hammers that message – when he is not being hammered by chemotherapy – using his self-published memoir and his blog. This week’s blog gave a shout-out to Sunday’s first-ever International HPV Awareness Day, declared by Giuliano and other members of the International Papillomavirus Society.

Becker realizes that the novelty of the vaccine, the complexity of HPV, and its link to sex are obstacles to immunization. But he focuses on the life-saving aspect.

“Parents are being asked to vaccinate their 11-year-old child and they can’t imagine 30 or 40 years down the line, it will prevent cancer,” Becker said. “If you don’t know it’s connected to six cancers, you’re not going to care. So it really should be cast as an anti-cancer vaccine.”

Young men should be required to get the HPV vaccine. It would have saved me from cancer.

Source: www.thedailybeast.com
Author: Michael Becker

In December 2015, at the age of 47, I was diagnosed with Stage IV oral squamous cell carcinoma.

More simply, I have advanced cancer of the head and neck. While initial treatment with grueling chemo-radiation appeared successful, the cancer returned one year later in both of my lungs. My prognosis shifted from potentially curable to terminal disease. The news was shocking and devastating—not just for me, but for my wife, two teenage daughters, and the rest of our family and friends.

Suddenly, my life revolved around regular appointments for chemotherapy, radiation therapy, imaging procedures, and frequent checkups. I made seemingly endless, unscheduled hospital emergency room visits—including one trip to the intensive care unit—to address some of the more severe toxicities from treatment.

All told, I suffered from more than a dozen side effects related to treatment and/or cancer progression. Some are temporary; others permanent. These include anxiety, depression, distorted sense of taste, clots forming in my blood vessels, dry mouth, weight loss, and many more.

My cancer started with a human papillomavirus (HPV) infection, a virus that is preventable with vaccines available for adolescent girls since 2006 and boys starting in 2011. The Food and Drug Administration (FDA) has approved three vaccines to prevent HPV infection: Gardasil®, Gardasil® 9, and Cervarix®. These vaccines provide strong protection against new HPV infections for young women through age 26, and young men through age 21, but they are not effective at treating established HPV infections. It was too late for me in 2011 when the HPV vaccine was made available to young men, and I was 43 years old.

According to the Centers for Disease Control and Prevention (CDC), more than 30,000 new cancers attributable to HPV are diagnosed each year. Unlike human immunodeficiency virus (HIV), which is spread by blood and semen, HPV is spread in the fluids of the mucosal membranes that line the mouth, throat, and genital tracts, and can be passed from one person to another simply via skin-to-skin contact.

While most HPV cases clear up on their own, infection with certain high-risk strains of HPV can cause changes in the body that lead to six different types of cancer, including cancers of the penis, cervix, vulva, vagina, anus, and head and neck (the last of which is what I have). Two of these, HPV strains 16 and 18, are responsible for most HPV-caused cancers.

Researchers believe that it can take between 10 and 30 years from the time of an initial HPV infection until a tumor forms. That’s why preventing HPV in the first place is so important and the HPV vaccine is so essential.

However, only 49.5 percent of girls and 37.5 percent of boys in the United States were up to date with this potentially lifesaving vaccination series, according to a 2017 CDC report. In sharp contrast, around 80 percent of adolescents receive two other recommended vaccines—a vaccine to prevent meningococcus (PDF), which causes bloodstream infections and meningitis, and the Tdap vaccine to prevent tetanus, diphtheria, and pertussis.

Even if you don’t think your child is at risk for HPV now, they almost certainly will be. HPV is extremely common. Nearly everyone gets it at some point; in fact, the CDC estimates that more than 90 percent and 80 percent of sexually active men and women, respectively, will be infected with at least one strain of HPV at some point in their lives. Around one-half of these infections are with a high-risk HPV strain.

As a cancer patient with a terminal prognosis, I find it infuriating that the HPV vaccine is tragically underutilized more than a decade since its introduction. Two simple shots administered in early adolescence can reduce a child’s risk of receiving a cancer diagnosis much later in life.

Parents who oppose the use of vaccines cite popular misconceptions that they are unsafe, ineffective, and that immunity is short-lived. Others argue that receiving the HPV vaccine may increase sexual promiscuity. Films like Vaxxed based on research that has been discredited, and directed by a researcher who fled the United Kingdom due to the misleading uproar he created, are still quoted as science.

Regardless, the fact remains that millions of adolescents aren’t getting a vaccine to prevent a virus known to cause cancer. We must counter untrue, exposed, and discredited research that keeps some parents from having their children vaccinated and put an end to the campaign of misinformation.

Viruses that are preventable, such as HPV, should be eradicated just like previous success with polio and smallpox. Cancers that are preventable through HPV vaccination should be prevented. The safety and efficacy of these vaccines are no longer subject to serious debate (PDF). Research has shown that vaccinations work; they keep children healthy, save lives, and protect future generations of Americans—but only when they are utilized.

The lesson: Don’t wait. Talk to your pediatrician about vaccinating your 11-year-old boys and girls against HPV today to eradicate this cancer-causing virus.

I only wish my parents had that opportunity when I was young, as it could have prevented the cancer that’s killing me.

2017-12-01T12:06:13-07:00December, 2017|Oral Cancer News|

Biotech exec facing death urges: Get the vaccine that prevents his cancer

Source: www.philly.com
Author: Michael D. Becker

Like most people who pen a new book, Michael D. Becker is eager for publicity.

But he has an unusual sense of urgency.

A former oncology biotech CEO, Becker has neck cancer. He expects his 49th birthday in November to be his last, if he makes it.

What also drives him to get his message out, however, is this: Children today can get a vaccine that prevents the kind of oropharyngeal cancer that is killing him.

As he collides with his mortality, Becker wants to share his story and raise awareness about the vaccine, which protects against dangerous strains of human papillomavirus, or HPV, the extremely common, sexually transmitted virus that caused his disease. His book, A Walk With Purpose: Memoir of a Bioentrepreneur (available on Amazon.com), was produced and self-published in a creative sprint between December, when his cancer recurred just a year after initial diagnosis and treatment, and April. He also has a blog, My Cancer Journey, and has been conducting media interviews.

“I had a lot of motivation to write the book quickly,” he said wryly at his home in Yardley.

In the final pages, he urges parents “to talk to their doctor about the HPV vaccine,” which “simply didn’t exist when I was a teenager, or it could have prevented my cancer.”

The leading vaccine brand, Gardasil, was hailed as a breakthrough when it was introduced in 2006. It is approved to prevent cervical cancer and less common genital malignancies, including anal cancer, that are driven by HPV infections. The vaccine was not clinically tested to prevent head and neck cancers, so it is not officially approved for that purpose, but research shows that it works. A study of young men presented last month found that vaccination reduced oral HPV infections by 88 percent.

Still, many adolescents are not getting the shots, for various reasons.

“It just kills me,” Becker says without a trace of irony, “that it’s underutilized. There are parents debating about whether to vaccinate their children. I’ve talked to immunologists about the safety. I had to make the decision to vaccinate my own kids. I was 100 percent convinced.”

From dropout to go-getter:
Becker describes his own youth as a bit misspent. He left home and dropped out of high school in his junior year, soon after his parents divorced.

“During my teens, I had experimented with sex, drugs, and alcohol while teaching myself how to play guitar and dreaming of becoming the next Eddie van Halen,” he writes in his book. “Making it through a number of near-death and reckless experiences during that period now seemed like a minor miracle.”

In his late teens, he wised up, got his equivalency diploma, and went to work for his father’s investment firm, where he discovered a talent for computer programming. Next came a job as a stock broker in Chicago, where he met and soon married Lorie Statland, an elementary school teacher who inspired him to get a college degree. The couple had two children, Rosie, now 19, and Megan, 16.

Becker went on to have a prolific career in biotechnology, complete with the occasional setbacks (lawsuits and soured partnerships) that are part of that high-stakes world. His resume includes Wall Street securities analyst, portfolio manager, founder of his own communications firm, and top executive of three biotech companies, two of which developed oncology products. During his cancer treatment, he used a prescription medicine that he played a major role in developing while at New Jersey-based Cytogen Corp: Caphosol, an electrolyte mouthwash that treats mouth ulcers caused by radiation therapy.

His diagnosis followed his discovery of a lump under his jaw line on the day before Thanksgiving in 2015. Tests revealed cancer that had spread from a tonsil to a lymph node and surrounding tissue.

At Memorial Sloan Kettering Cancer Center in New York, he opted for chemotherapy and radiation instead of surgery. The operation, he explains, can damage speech and swallowing, and if it doesn’t get all the cancer, chemo and radiation are still necessary.

He describes the main side effects of treatment – constant dry mouth and changes in taste – as manageable. And he says he was not unhappy to lose 30 pounds.

Although he sounds almost too stoic, he is frank about “the one major issue I tried to ignore … namely, depression.”

“On more than one occasion I burst into a crying session,” he writes. “I’m not talking about the quiet episode with sniffles and a tear or two. I mean full-fledged bawling your eyes out accompanied by nasal discharge and the near inability to speak normally.”

A sensitive subject:
Conspicuously missing from his book, though, is information about head and neck cancer. Over the last 30 years, the epidemiology has changed dramatically in the United States, with a decline in cases related to smoking and alcohol use, and a steady increase in HPV-related cancers. Men are three times more likely than women to develop these malignancies. Of an estimated 63,000 new head and neck cancer diagnoses this year, 11,600 will likely be caused by HPV, according to the U.S. Centers for Disease Control and Prevention.

This surge reflects changes in sexual practices, especially oral sex, research suggests. That’s a sensitive issue, as actor Michael Douglas discovered when his candor about his throat cancer and cunnilingus turned him into fodder for tweeters and late-night comics. The thing is, genital strains of HPV are so ubiquitous that almost all sexually active people — not just promiscuous ones — will be infected at some point. It is not clear why, for a fraction of these people, the immune system fails to wipe out the infection.

Becker says he did not wade into this subject in his book because of the scientific uncertainties.

In a recent blog post, he quoted the CDC: “Only a few studies have looked at how people get oral HPV, and some show conflicting results. Some studies suggest that oral HPV may be passed on during oral sex or simply open-mouthed (“French”) kissing, others have not. More research is needed to understand exactly how people get and give oral HPV infections.”

After his cancer recurred, Becker explored his options and entered a National Cancer Institute clinical trial of an experimental immunotherapy. It seems to have slowed, but not stopped, his cancer, which has spread to his lungs.

He is philosophical about his plight.

“I get up each morning feeling fine. It’s not a bad quality of life at the moment,” he said. “And I’ve had just a fabulous life. I’ve worked very hard, but the fruits of those labors were phenomenal. Being able to travel. Being able to give my daughters what they wanted. I wanted them to have a better youth than I had. I’ve got the best wife in the world. I’ve had 25 fabulous years with her. It’s hard to look at my situation and have a lot of self-pity.”

But he does have a hope: “That by sharing this experience freely, I can help create greater awareness for the disease and its impact.”

HPV vaccine; cancer prevention

Source: www.nujournal.com
Author: staff

Human papillomavirus (HPV) is a sexually transmitted infection, of several strains, most associated with cervical cancers. The virus is so common that nearly all males and females have been infected at some time in their life. One in four is currently infected in the nation.

Signs and symptoms of HPV are variable. Most will recover from the virus within two years without ever knowing they were infected, making HPV easy to spread. Occasionally, the virus lasts much longer in the body which can cause cells to change and lead to cancer. Fortunately, we have a vaccine to prevent cancer caused by HPV.

The Food and Drug Administration (FDA) has approved three vaccines for HPV; Cervarix, Gardasil, and Gardasil 9. These vaccines are tested and proven to be safe and effective.

Prevention is important with HPV. The vaccine should be administered before exposure to the virus for stronger protection against cervical, vaginal, vulvar, penile, and some mouth or throat cancers. (Gardasil and Gardasil 9 also prevent genital warts and anal cancer.) The best age to obtain maximum potential of the vaccine is at 11 or 12 years old. At this age, the body’s immune system is the most receptive to the vaccination’s virus-like particles and the body produces higher amounts of antibodies in defense, protecting the adolescent for his or her future. Both girls and boys should get the HPV vaccine. For ages 9-14, two doses – six to twelve months apart, are recommended. For 15-26 year olds, three doses are recommended. Side effects may include brief soreness, or redness or swelling at the injection site.

The HPV vaccine does prevent cancer, limiting biopsies and invasive procedures thus cutting potential health care costs. Most private insurance companies cover preventive vaccinations, it is best to call your carrier for more information. The HPV vaccine is covered by Minnesota Health Plans. Uninsured individuals may be eligible to get the vaccine at their local public health office.

Schedule your adolescent’s annual health exam today and ask which HPV vaccine is best for the child in your life.

“Every year in the United States, HPV causes 30,700 cancers in men and women. HPV vaccination can prevent most of the cancers (about 28,000) from occurring.” (CDC, December, 2016)

Learn more at www.cdc.gov/hpv or www.cancer.gov

GlaxoSmithKline pulls Cervarix from U.S. market

Source: www.managedcaremag.com
Author: staff

In response to “a very low market demand,” GlaxoSmithKline has decided to stop selling its human papillomavirus (HPV) vaccine Cervarix in the United States, according to FiercePharma. The move gives Merck’s Gardasil unchallenged dominance of the HPV vaccine market in this country.

Last year, Cervarix earned only about $3.7 million in the U.S. out of a $107 million worldwide total. In contrast, the global total for Merck’s Gardasil franchise was $1.9 billion.

Figures from the Centers for Disease Control and Prevention (CDC) last year placed HPV vaccination rates at 42% of girls and 28% of boys ages 13 to 17 years––far short of the U.S. Department of Health and Human Services’ goal of 80% for both boys and girls by 2020.

To combat the public’s lukewarm response, the CDC and other cancer organizations are urging health care providers to promote the cancer-prevention benefits of HPV vaccines rather than stressing that they protect against sexually transmitted infections, which puts off some parents who worry the vaccine will promote promiscuity or who feel that their preteens are too young to need the shots, according to the Wall Street Journal.

HPV, which is transmitted sexually, can cause at least six types of cancer as well as genital warts. The vaccine is recommended for boy and girls at age 11 or 12 and is also given at other ages.

Experts are urging pediatricians to present the vaccine as routine, rather than different from other preteen shots. They are also stressing completion of the vaccine series by age 13.

Merck, the maker of Gardasil, is currently airing an ad on national television that puts the onus on parents to get their children vaccinated.

Sources: FiercePharma; October 21, 2016; and Wall Street Journal; October 17, 2016.

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