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FDA approves expanded use of Gardasil 9 to include individuals 27 through 45 years old

The U.S. Food and Drug Administration today approved a supplemental application for Gardasil 9 (Human Papillomavirus (HPV) 9-valent Vaccine, Recombinant) expanding the approved use of the vaccine to include women and men aged 27 through 45 years. Gardasil 9 prevents certain cancers and diseases caused by the nine HPV types covered by the vaccine.

“Today’s approval represents an important opportunity to help prevent HPV-related diseases and cancers in a broader age range,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. ”The Centers for Disease Control and Prevention has stated that HPV vaccination prior to becoming infected with the HPV types covered by the vaccine has the potential to prevent more than 90 percent of these cancers, or 31,200 cases every year, from ever developing.”

According to the CDC, every year about 14 million Americans become infected with HPV; about 12,000 women are diagnosed with and about 4,000 women die from cervical cancer caused by certain HPV viruses. Additionally, HPV viruses are associated with several other forms of cancer affecting men and women.

Gardasil, a vaccine approved by the FDA in 2006 to prevent certain cancers and diseases caused by four HPV types, is no longer distributed in the U.S. In 2014, the FDA approved Gardasil 9, which covers the same four HPV types as Gardasil, as well as an additional five HPV types. Gardasil 9 was approved for use in males and females aged 9 through 26 years.

The effectiveness of Gardasil is relevant to Gardasil 9 since the vaccines are manufactured similarly and cover four of the same HPV types. In a study in approximately 3,200 women 27 through 45 years of age, followed for an average of 3.5 years, Gardasil was 88 percent effective in the prevention of a combined endpoint of persistent infection, genital warts, vulvar and vaginal precancerous lesions, cervical precancerous lesions, and cervical cancer related to HPV types covered by the vaccine. The FDA’s approval of Gardasil 9 in women 27 through 45 years of age is based on these results and new data on long term follow-up from this study.

Effectiveness of Gardasil 9 in men 27 through 45 years of age is inferred from the data described above in women 27 through 45 years of age, as well as efficacy data from Gardasil in younger men (16 through 26 years of age) and immunogenicity data from a clinical trial in which 150 men, 27 through 45 years of age, received a 3-dose regimen of Gardasil over 6 months.

The safety of Gardasil 9 was evaluated in about a total of 13,000 males and females. The most commonly reported adverse reactions were injection site pain, swelling, redness and headaches.

The FDA granted the Gardasil 9 application priority review status. This program facilitates and expedites the review of medical products that address a serious or life-threatening condition.

The FDA granted approval of this supplement to the Gardasil 9 Biologics License Application to Merck, Sharp & Dohme Corp. a subsidiary of Merck & Co., Inc.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

October, 2018|Oral Cancer News|

Vaccine, anti-PD1 drug show promise against incurable HPV-related cancers

A tumor-specific vaccine combined with an immune checkpoint inhibitor shrank tumors in one third of patients with incurable cancer related to the human papilloma virus (HPV) in a phase II clinical trial led by investigators at The University of Texas MD Anderson Cancer Center and reported in JAMA Oncology.

“That encouraging response rate is about twice the rate produced by PD1 checkpoint inhibitors in previous clinical trials, so these results will lead to larger, randomized clinical trials of this combination,” said principal investigator Bonnie Glisson, M.D., professor of Thoracic/Head and Neck Medical Oncology and Abell-Hanger Foundation Distinguished Professor at MD Anderson.

Vaccines specific to HPV antigens found on tumors had previously sparked a strong immune response, but had not, by themselves, been active against established cancers, Glisson said.

“Vaccines are revving up the immune system, but the immunosuppressive tumor microenvironment probably prevents them from working,” Glisson said. “Our thinking was that inhibition of PD-1 would address one mechanism of immunosuppression, empowering the vaccine-activated T lymphocytes to attack the cancer.”

The team combined the vaccine ISA101, which targets important peptides produced by the strongly cancer-promoting HPV16 genotype of the virus, along with nivolumab, a checkpoint inhibitor that blocks activation of PD-1 on T cells.

Of the 24 patients with recurrent HPV16-related cancers, 22 had oropharyngeal (back of the throat) cancer, one had cervical cancer and one had anal cancer.

  • Eight (33 percent) had a tumor response, two were complete. All eight had oropharyngeal cancer. Median duration of response was 10.3 months.
  • Overall median survival was 17.5 months, progression-free survival was 2.7 months and 70 percent of patients survived to 12 months.
  • Five of the eight responders remain in response.

“The median survival of 17.5 months for these patients is promising and provides further support for randomized trials testing the contribution of ISA101 to PD-1 inhibition,” Glisson said.

HPV causes nearly all cervical cancers, and most oropharyngeal, anal, penile, vulvar and vaginal cancers. HPV16 and HPV18 are the leading viral genotypes that increase cancer risk. Given the viral cause of these cancers, immunotherapy has been considered a strong potential approach. The researchers note that three previous clinical trials of PD1 inhibitors alone for recurrent HPV-related cancers yielded response rates ranging from 16 to 22 percent.

Two patients had grade 3 or 4 side effects—elevated enzyme levels—that required them to discontinue nivolumab. Glisson said the team observed side effects expected from the two treatments separately, but the researchers were encouraged to see no sign of synergistic side effects caused by the combination.

“That’s important as we develop rational combination immunotherapy,” Glisson said. This clinical trial was among the first to combine vaccination with PD1 inhibition.

Randomized clinical trials of the vaccine and anti-PD1 combination for cervical and oropharyngeal cancer are being organized.

The single-arm trial was an investigator-initiated effort originated at MD Anderson, Glisson noted.

September, 2018|Oral Cancer News|

OCF’s Tobacco Cessation Spokesperson and Bradley Cooper’s Stunt Double Rides in Pendleton

You won’t find Cody Kiser at this year’s NFR, but you will find him working as a stuntman in the 2014 blockerbuster hit “American Sniper” starring Bradley Cooper.

The biographical war drama was directed by Clint Eastwood, and told the story of U.S. Navy Seal Chris Kyle.

Kiser, who rode Saturn Rocket for a 75.5-point score Friday at the Pendleton Round-Up, stepped in for Bradley during the scene that shows Kyle riding broncs during his rodeo days before he joined the Navy.

“That was the coolest thing I have ever done,” Kiser said. “I got to hang out for a day with Clint Eastwood and Bradley Cooper. Clint told me I looked a lot like Bradley. They said they wished they had me for the whole movie.”

A friend of Kiser’s who does stunt work in California put Kiser in touch with the people from the movie.

“They needed a bareback rider who had a certain look,” he said. “They had me and a saddle bronc rider, but he couldn’t ride bareback very well, so the job was mine.”

Kiser, 27, said he was living in Texas near where Kyle was shot in 2013, and that he had a friend working at the Rough Creek Ranch-Lodge in Erath County, Texas, where Kyle was shot.

“It’s such a small world,” he said.

Kiser earned a nice paycheck for his work, but said playing Kyle, even in a stunt role, was an honor.

“To be a part of that was unreal,” he said.

September, 2018|OCF In The News|

New Book: Vaccines Have Always Had Haters

Date: 09/23/18
Source: National Public Radio
Author: Susan Brink

Vaccinations have saved millions, maybe billions, of lives, says Michael Kinch, associate vice chancellor and director of the Center for Research Innovation in Business at Washington University in St. Louis. Those routine shots every child is expected to get can fill parents with hope that they’re protecting their children from serious diseases.

But vaccines also inspire fear that something could go terribly wrong. That’s why Kinch’s new book is aptly named: Between Hope and Fear: A History of Vaccines and Human Immunity.

He wrote it, he says, to present the science behind vaccines and to highlight the fallacy of anti-vaccine movements. NPR talked with Kinch about vaccines. This interview has been edited for clarity and length.

The first attempts to control smallpox go back at least 1,000 years and didn’t involve vaccines. Can you describe those attempts?

Smallpox was probably killing a half a million people a year in Europe alone. The medical community had adopted a practice called nasal insufflation. You could take a little bit of the material from a smallpox scab, turn it into a powder and have a child snort it into the nose. Or you could intentionally scrape the skin and put material from a smallpox pustule under the skin of a healthy individual. That was called variolation. Those procedures caused smallpox, and people got sick. But far fewer of them died because most people would get a less virulent form of disease than if they were infected through exposure to a smallpox patient. Those who survived were then immune to smallpox.

How do you suppose people even thought of doing those disgusting things with scabs and pus?

You have to make assumptions. Maybe someone who was caring for a person with smallpox got a cut, and the cut got infected with pus from the patient. Then the caretaker noticed that afterward, they were immune to smallpox infection.

Variolation and nasal insufflation worked reasonably well, but they were not vaccines. What is a vaccine?

A vaccine is an intentional procedure using killed or weakened germs to trigger an immune response. The exposure to the virus or bacteria allows your body’s defenses to work, clearing the germs from the body. With the next exposure to those germs, the body is ready to fight off infection. Vaccines are generally delivered in an injection in the muscle, because the vaccine stays in place long enough for the immune system to detect and fight it.

The development of the smallpox vaccine was a breakthrough by Edward Jenner in 1796. What did science learn from the smallpox vaccine?

It took about a century for all the lessons to be learned. The smallpox vaccine made people understand that, once you identify a pathogen, you can kill or weaken it. Inoculating people with those weakened or killed forms alerts their immune systems but without causing disease, without causing harm. But first, pathogens had to be identified. A whole slew of discoveries happened from the 1880s through the early 20th century. People discovered anthrax bacteria, discovered measles, mumps, rubella viruses, discovered diphtheria, pertussis and tetanus. Then scientists could weaken or kill the germs and create vaccines.

Which vaccines does the world most need now?

The two holy grails are an AIDS vaccine and a universal influenza vaccine. AIDS has proven particularly challenging because the virus mutates very rapidly, and AIDS has found really good ways to circumvent an immune response. And the influenza virus changes constantly. It kills 30,000 to 40,000 Americans a year, and every few generations, there’s a pandemic. Exactly 100 years ago, we had the Spanish flu that wiped out tens of millions of people.

There are others. The current scourge of the world is malaria. The organism that causes it can change and thus hide from a vaccine. New pathogens always arise, and with global warming they’re working their way north, where they haven’t been seen before.

The current anti-vaccination movement fears that vaccinations are linked to autism, though the original study suggesting the link has been roundly discredited. Were there always “anti-vaxers” throughout history?

The anti-vax movement is actually older than vaccines. There was a well-established anti-variolation movement when people were using scabs and pus to try to prevent smallpox. Lady Mary Wortley Montagu was the wife of the British ambassador to the Ottoman Empire and a progressive thinker. She strong-armed the embassy physician to perform variolation on her four-year-old son in 1715, but her husband was opposed to it and she had to do it behind his back.

For virtually any vaccine you can name, there was an anti-vax movement around it. An 1802 cartoon was titled “The Wonderful Effects of the New Inoculation.” It was a spoof, reflecting widespread fear and showing people sprouting cow’s heads and horns and tails after being vaccinated against smallpox. (Note: Smallpox vaccine was made with cowpox virus, which rendered people immune to both cowpox and smallpox.)

Have there been scientifically valid reasons for people to fear vaccines?

There have been mistakes. When Dr. Jonas Salk announced his polio vaccine in 1955, bells were rung around the country to celebrate. But as people started getting immunized, Cutter Laboratories, which manufactured the vaccine in California, didn’t properly prepare the vaccine. A lot of kids were unintentionally infected with polio, and the incident created a lot of fear. (According to the National Institutes of Health, 40,000 cases of polio were caused by 200,000 vaccinations from the bad batch; 10 children died and 40 were left with varying degrees of paralysis).

Vaccines aren’t perfect. But there’s no substance in the world, including water and oxygen, that is entirely safe.

Why did you write this book now?

I saw that things were getting worse. It’s becoming more expensive to develop vaccines and less profitable. We haven’t developed a novel vaccine in decades. Pharmaceutical companies are abandoning vaccines. The anti-vax movement, I would argue, is stronger than ever. They’re highly organized, highly motivated and well-funded.

September, 2018|Oral Cancer News|

Penn-led study raises hopes for vaccine to treat head and neck cancer

Date: 09/21/18
Source: The Inquire, philly.com
Author: Marie McCullough

The patient’s head and neck cancer came roaring back, spreading to his lymph nodes and skin, which developed bleeding tumors. Yet despite a grim prognosis, that man is alive and cancer-free more than two years later.

In a study led by the University of Pennsylvania and published Friday, researchers hypothesize that his remarkable remission is due to a promising combination: an experimental cancer vaccine that activated his disease-fighting T cells, plus Opdivo, one of the revolutionary “checkpoint inhibitor” drugs that cut a brake on the immune system.

“Of course, I’m biased,” said Charu Aggarwal, the Penn oncologist who led the study. “In my career, I haven’t seen a vaccine as impactful as this.”

However, the remission may have been due to Opdivo alone; the study lacks data to rule out that possibility.

Robert Ferris, director of the University of Pittsburgh Medical Center’s Hillman Cancer Center and head of the pivotal study leading to approval of Opdivo, called the Penn-led study “an important intermediate step exploring a strategy that we hope will work.”

Conventional vaccines prevent diseases by priming the immune system to recognize the distinctive “antigens” on invading microbes. Therapeutic cancer vaccines, like the one in this study, are intended to work after cancer develops by provoking a heightened immune response.

Despite decades of research, this approach remains experimental. The only approved product, the prostate cancer vaccine Provenge, was barely effective; the maker filed for bankruptcy in 2015.

A major obstacle to treatment vaccines is the fact that cancer arises from the body’s own cells. Although cancer cells produce antigens as they mutate, using these telltale proteins as targets for the immune system has proved to be very difficult.

Even so, at least four pharmaceutical groups are developing therapeutic vaccines that target human papillomavirus, HPV, the sexually transmitted virus that causes cervical cancer, head and neck cancer, and some rare genital cancers.

These diseases can be warded off with the preventive HPV vaccine that is recommended for all adolescents, but it didn’t exist until 12 years ago. Much to the dismay of public health authorities, vaccination rates remain low. And while screening can detect and treat cervical precancers, there are no early detection methods for head and neck cancers; experts call the surging incidence of these malignancies an “epidemic.”

The vaccine in the new study, called MEDI0457, was originally developed by Inovio with technology pioneered at Penn. In 2015, MedImmune, which is part of AstraZeneca, acquired exclusive rights to the drug.

MEDI0457 contains a DNA ring called a plasmid that programs the patient’s cells to produce two HPV antigens. The vaccine is injected into the patient’s muscle and enters cells with the help of a small electrical pulse applied to the skin. When the cells make the antigens, this triggers the immune system to activate disease-fighting white blood cells, so-called “killer” T cells.

For the study, published Friday in Clinical Cancer Research, 22 patients with head and neck cancer received conventional treatment — either surgery or chemotherapy and radiation — that eliminated all signs of cancer. This was supplemented by four doses of the experimental vaccine, which caused no serious side effects.

Eighteen patients, or 80 percent, showed elevated T cell activity that lasted at least three months after the final vaccine dose. While that is an encouraging sign, the study was too preliminary to detect clinical effectiveness such as tumor shrinkage or improved survival.

In the one patient who relapsed, cancer recurred seven months after vaccine treatment and spread to his lymph nodes and skin. He was given Opdivo and, eight weeks later, the cancer was gone.

Aggarwal and her co-authors note that such remarkable remissions do occasionally occur with checkpoint inhibitors. But they speculate that the vaccine revved up the patient’s T cells, then Opdivo removed the immune brake, enabling the T cells to attack the cancer.

“The response suggests the vaccine may in some manner prime the immune system, potentially boosting the effects of subsequent [checkpoint inhibitor] therapy,” Aggarwal said.

Rajarsi Mandal, director of the head and neck cancer immunotherapy research program at Johns Hopkins University, took a more conservative view: “They demonstrated vaccine specific T cell proliferation very nicely. But there is not a lot of data to suggest the vaccine is inducing any clinical response in these patients. Overall, it’s very interesting, but future studies are needed to demonstrate definitive clinical responses to the vaccine.”

Still, the combination approach is sufficiently promising that MedImmune is now funding a Penn-led clinical trial of MEDI0457 and MedImmune’s own experimental checkpoint inhibitor.

Ferris, meanwhile, said he is part of a trial of a competing experimental vaccine for HPV-related cancers, plus the approved checkpoint inhibitor Keytruda.

“The preventive HPV vaccine works really well,” he said. “But if you’re too old to get it, there is hope that you can stimulate the immune system to fight the cancer. This [new study] suggests the next logical step.”

September, 2018|Oral Cancer News|

Why I tell Everyone I have HPV

Source: bustle.com
Author: Emma McGowen

I have HPV. Or, to be more accurate, I was diagnosed with HPV when I was 19 and found a little bump on my vulva in an area where there was no chance it could be an ingrown hair. The nurse at the health clinic at my college put acid on it, watched while it turned white, and told me it was definitely a wart. That was the one and only “outbreak” I’ve ever had, but it was enough for me to say, sure, I have HPV. And I’m not shy about telling people that.

But I wasn’t always this chill about it. When I was diagnosed, I basically lost it. I fell right down the slut-shaming hole. I told myself that was “what I get” for sleeping around, and cycled through the usual you can never have sex again/HPV doesn’t go away/your vagina is going to be covered in hideous warts/YOU’RE A TERRIBLE PERSON thoughts that so many of us go through when we get an STI diagnosis. Mid-freak out, I called a close friend. “Oh yeah, I have it, too,” she said. I got the same response from a female family member. And that’s when I calmed down and realized — HPV isn’t a big deal.

Or, at least, the type of HPV I have isn’t a big deal. What I didn’t know at the time of diagnosis — but learned with a little Googling and had reinforced since, in my training as a sex educator — is that the strains of HPV that cause warts don’t have any other negative health effects. Specifically, if you have a strain of HPV that causes warts, it won’t cause cancer. And the strains that cause cancer don’t cause warts. So while the kind that I was diagnosed with has a visible component, it’s really no more annoying than the occasional pimple. And I’ve had way more pimples since I was 19 than I’ve had warts.

The other thing I’ve realized about HPV is that it’s ridiculously common. Because HPV is a skin-to-skin STI, there’s no way to protect 100 percent against it, other than never touching another human being again. Also, most people with penises carry the virus, but don’t show any symptoms — and can still spread it. So there’s no way for them to know if they have it and no way for the people who are sleeping with them to know, either. As a result of all of these factors, the CDC estimates that anyone not vaccinated against HPV will have it at some point in their lives.

Did you catch that? I’m going to repeat it, really loudly, just in case: the CDC says that anyone who is not vaccinated against HPV will have it at some points in their lives.

And here’s another fun fact: Contrary to the popular belief that HPV “never goes away,” many people actually clear the virus. That’s especially true for young people — which is the group in which the virus shows up most frequently — who get it. It’s also why the CDC doesn’t say “everyone has HPV” but that everyone who isn’t vaccinated “will get HPV at some time in their life.” So even though I was diagnosedwith HPV when I was 19, I don’t necessarily have it now, at 31. Does that mean I for sure don’t? Nope. Does that mean I for sure don’t carry other strains of the virus, including the cancer-causing ones? Nope. And that’s why I go regularly for Pap tests, which are a great method of early detection of irregular cells caused by HPV that can morph into cervical cancer. And also another reason why I honestly DGAF about my HPV status.

So if everyone will get it at some point or another, why do we still freak out about it? The answer is simultaneously really simple and really complicated: STI stigma. STI stigma is the overblown fear and shame so many of us carry about STIs. It’s the idea that getting an STI somehow means a person is “dirty” or “immoral” or a “slut.” It’s the idea that an STI is somehow worse than any other illness that one human picks up from another human. And you know why so many of us believe that? Because our culture teaches us that sex — especially for pleasure or outside of heterosexual marriage — is wrong.

With that in mind, my challenge to you is this. Ask yourself: Do I think sex outside of heterosexual marriage is wrong? Do I think sex for pleasure is wrong? Do I think people who have that kind of sex are bad? If the answer is yes, then you will probably continue thinking that people with STIs are dirty or immoral. And while I disagree with you, that’s your choice.

But if the answer is no, then I ask you: What makes an STI so much more morally wrong than any other illness? Nothing. And when you think about it that way, STI stigma and freaking out about an STI diagnosis — the way I did when I was 19 — just doesn’t make any logical sense. I don’t beat myself up when I get a cold, so why would I beat myself up for getting HPV? In both cases, there are things I could have done to be “safer” and protect myself against the virus but, hey, life happens.

So, yeah, I tell everyone I have HPV. Because, ultimately, it’s not a big deal, and because talking about it can help to eliminate some of that stigma. I also carry many forms of the common cold virus. Want to talk about that, too?

September, 2018|Oral Cancer News|

Italy Is Living Through What Happens When Politicians Embrace Anti-Vaxxers

Source: Huffingtonpost.com
Author: Nick Robins-Early

Italy’s Five Star movement, which was founded by a man who once called HIV a hoax, campaigned against mandatory vaccinations ahead of the country’s elections in March — and won. Last month, party leaders pushed through a law that ended compulsory immunizations for children attending public school.

The new law has made Italy the darling of the global anti-vaxxer movement. But now the country is struggling to stop a measles outbreak that has already infected thousands of people, and Europe is recording its highest number of cases in a decade — an inevitable and foreseeable result of anti-vaccine policies and rhetoric, experts say.

“Europe now is a good example of what happens when coverage of vaccinations is in decline,” said Vytenis Andriukaitis, the European Commissioner for Health and Food Safety.

The efforts of Five Star and its far-right coalition partner, the League, have particularly complicated the global campaign to combat measles, an extremely contagious virus that often spreads among children and can result in severe complications, including pneumonia and encephalitis. The World Health Organization in 2012 set the goal for Europe to eliminate the disease by 2015. Instead, an estimated 41,000 people across the continent have been infected in the first six months of this year.

Even a slight dip in a population’s vaccination rate can have disastrous effects: Countries need at least a 95 percent coverage rate to be measles-free. So when fewer people get vaccinated, kids get sick.

“We’ve got this terrible self-inflicted wound where you’re reversing public health gains in Europe and the U.S.,” said Peter Hotez, dean for the National School of Tropical Medicine at Baylor College of Medicine.

Five Star and the League have sometimes framed their efforts to do away with compulsory immunizations as a way for parents to make their own health decisions, rather than limiting vaccinations in the country. And Luigi Di Maio, Five Star’s current party leader, has recently tried to tamp down on outright anti-vaccine conspiracies.

But the rhetoric and proposals of other prominent party figures and their allies are much more radical. One top Five Star official, Paola Taverna, last month backed hazardous “measles parties” where children gather to infect each other and build up immunity. League party leader Matteo Salvini described mandatory vaccinations as “useless and in many cases dangerous” in June. Some party candidates and top officials went further, falsely claiming vaccines cause autism and referring to state-funded vaccination as “free genocide.”

These politicians’ rhetoric is in line with anti-vaccine groups that couch conspiracies and opposition to vaccinations in appeals to personal choice and pseudoscience. “They use these phony terms that really have no meaning … like medical freedom and vaccine choice,” Hotez said. “What these [anti-vaccine] groups are really doing is depriving children of fundamental rights.”

In a little over three months in office, Five Star and the League have furthered the goals of a small but vocal anti-vaccine community.

Just a year ago, Italy looked like it was on a path to solving its measles outbreak. The country’s previous government passed a law that required children to receive 10 vaccinations in order to attend state-run schools.

The law received the backing from infectious disease experts from the World Health Organization and Italian doctors, but was fiercely opposed by Europe’s well-organized anti-vaccine movement.

“It’s quantitatively a very small group, but qualitatively they are noisy and very, very aggressive,” said Walter Ricciardi, president of the Italian National Institute of Health.

Anti-vaccine protesters attacked government deputies outside of the Italian parliament. They held rallies in the streets of Rome. A group of 130 families wrote to Italy’s president claiming they would seek asylum in Austria to avoid the vaccinations. At one of Health Minister Beatrice Lorenzin’s events promoting her book, activists screamed accusations that she was killing children.

Prominent international anti-vaxxer organizations, a network made up of activists and even some disgraced doctors, latched on to Italy as a symbol of resistance, and posts on anti-vaxx forums lauded the demonstrations. The League and Five Star parties capitalized on the unrest and criticized the law as government overreach.

“The law was good and it was working, then the major leaders of the two parties made unscientific comments on vaccines,” Ricciardi said.

Stopping the outbreak became less important to Five Star and the League than appealing to the anti-establishment sentiment that ushered the parties into power, critics allege.

“They wanted the votes of anti-vaxxers and people that consider the law of compulsory vaccination a violation of personal freedom,” said Stefano Zona, a doctor of infectious diseases and member of IoVaccino, an Italian nonprofit that seeks to correct misinformation around vaccines.

“They are feeding the anti-vaxxer movement,” he said.

The U.S. has also had several major measles outbreaks in recent years, in part driven by anti-vaccine activists and linked to lower vaccination rates in some communities. And American politicians aren’t much more restrained than their Italian counterparts in fueling vaccine skepticism. President Donald Trump questioned the safety of vaccines during a 2015 Republican presidential debate and spent years promoting anti-vaxxer conspiracies.

September, 2018|Oral Cancer News|

DCD: Oropharyngeal squamous cell carcinoma now and most common HPV associated with cancer

In 2015, oropharyngeal squamous cell carcinoma surpassed cervical cancer as the most common HPV-associated cancer in the U.S., with 15,479 cases among men and 3,438 cases among women, according to data from the CDC published in Morbidity and Mortality Weekly Report.

The report also showed that rates of HPV-related anal squamous cell carcinoma and vulvar cancer increased over the past 15 years, whereas rates of HPV-related cervical cancer and vaginal squamous cell carcinoma decreased.

“Although smoking is a risk factor for oropharyngeal cancers, smoking rates have been declining in the United States, and studies have indicated that the increase in oropharyngeal cancer is attributable to HPV,” Elizabeth A. Van Dyne, MD, epidemic intelligence services officer in division of cancer prevention and control at the National Center for Chronic Disease Prevention and Health Promotion of the CDC, and colleagues wrote.

“In contrast to cervical cancer, there currently is no U.S. Preventive Services Task Force recommended screening for other HPV-associated cancers,” they added.

The trends in HPV-related cancers report included data from 1999 to 2015 from cancer registries — CDC’s National Program of Cancer Registries and NCI’s SEER program — covering 97.8% of the U.S. population.

The CDC reported 30,115 new cases of HPV-associated cancers in 1999 compared with 43,371 new cases in 2015.

During the study period, researchers observed a 2.7% increase in rates of oropharyngeal squamous cell carcinoma among men and a 0.8% increase among women. Rates of anal squamous cell carcinoma increased by 2.1% among men and 2.9% among women.

Among women, researchers observed a 1.6% decrease in HPV-related cervical cancer and a 0.6% decrease in rates of HPV-related vaginal squamous cell carcinoma. Rates of vulvar squamous cell carcinoma increased by 1.3%.

Rates of penile squamous cell carcinoma remained stable from 1999 to 2015.

Overall, rates of HPV-related cancers varied by age and race/ethnicity.

Researchers observed a 4% increase in the rate of oropharyngeal squamous cell carcinoma among men aged 60 to 69 years compared with a 0.8% increase among men aged 40 to 49 years.

For anal squamous cell carcinoma, the largest increases occurred among women aged 50 to 69 years (4.6% to 4.8%) and men aged 50 to 59 years (4%).

Several factors contribute to the increased incidence of oropharyngeal and anal squamous cell carcinomas, including changes in sexual behavior.

“Unprotected oral sex and receptive anal sex are risk factors for HPV infection,” the researchers wrote. “White men have the highest number of lifetime oral sex partners and report first performing oral sex at a younger age compared with other racial/ethnic groups; these risk factors could be contributing to a higher rate of oropharyngeal squamous cell carcinoma among white men than other racial/ethnic groups.”

Cervical cancer rates remained stable among women aged 35 to 39 years; however, younger and older woman demonstrated decreases ranging from 1.2% to 4.2%.

Cervical carcinoma rates decreased across all racial/ethnic groups, although decreases appeared more prominent among Hispanics than non-Hispanics (3.4% vs. 1.5%).

“The decline in cervical cancer from 1999 to 2015 represents a continued trend since the 1950s as a result of cancer screening,” the researchers wrote. “Rates of cervical carcinoma in this report decreased more among Hispanics, American Indian/Alaska Natives and blacks than other groups; however, incidence rates were still higher among Hispanics and blacks than among whites in 2015. These persistent disparities in incidence suggest that health care delivery needs of some groups are not fully met.”

The limitations of the report included the fact that the cancer registries do not routinely determine the HPV status of cancers and that race/ethnicity data was derived from medical records.

“Further research to understand the progression from HPV infection to oropharyngeal cancer would be beneficial,” the researchers wrote. “Continued surveillance through high-quality registries is important to monitor changes in HPV-associated cancer incidence.” – by Cassie Homer

August, 2018|Oral Cancer News|

Why a patient paid a $285 copay for a $40 drug

Source: pbs.org
Author: Megan Thompson

Two years ago Gretchen Liu, 78, had a transient ischemic attack — which experts sometimes call a “mini stroke” — while on a trip to China. After she recovered and returned home to San Francisco, her doctor prescribed a generic medication called telmisartan to help manage her blood pressure.

Liu and her husband Z. Ming Ma, a retired physicist, are insured through an Anthem Medicare plan. Ma ordered the telmisartan through Express Scripts, the company that manages pharmacy benefits for Anthem and also provides a mail-order service.

The copay for a 90-day supply was $285, which seemed high to Ma.

“I couldn’t understand it — it’s a generic,” said Ma. “But it was a serious situation, so I just got it.”

A month later, Ma and his wife were about to leave on another trip, and Ma needed to stock up on her medication. Because 90 days hadn’t yet passed, Anthem wouldn’t cover it. So during a trip to his local Costco, Ma asked the pharmacist how much it would cost if he got the prescription there and paid out of pocket.

The pharmacist told him it would cost about $40.

“I was very shocked,” said Ma. “I had no idea if I asked to pay cash, they’d give me a different price.”

Ma’s experience of finding a copay higher than the cost of the drug wasn’t that unusual. Insurance copays are higher than the cost of the drug about 25 percent of the time, according to a study published in March by the University of Southern California’s Schaeffer Center for Health Policy and Economics.

USC researchers analyzed 9.5 million prescriptions filled during the first half of 2013. They compared the copay amount to what the pharmacy was reimbursed for the medication and found in the cases where the copay was higher, the overpayments averaged $7.69, totaling $135 million that year.

USC economist Karen Van Nuys, a lead author of the study, had her own story of overpayment. She discovered she could buy a one-year supply of her generic heart medication for $35 out of pocket instead of $120 using her health insurance.

Van Nuys said her experience, and media reports she had read about the practice, spurred her and her colleagues to conduct the study. She had also heard industry lobbyists refer to the practice as “outlier.”

“I wouldn’t call one in four an ‘outlier practice,’” Van Nuys said.

“You have insurance because your belief is, you’re paying premiums, so when you need care, a large fraction of that cost is going to be borne by your insurance company,” said Geoffrey Joyce, a USC economist who co-authored the study with Van Nuys. “The whole notion that you are paying more for the drug with insurance is just mind boggling, to think that they’re doing this and getting away with it.”

Joyce told PBS NewsHour Weekend the inflated copays could be explained by the role in the pharmaceutical supply chain played by pharmacy benefit managers, or PBMs. He explained that insurers outsource the management of prescription drug benefits to pharmacy benefit managers, which determine what drugs will be covered by a health insurance plan, and what the copay will be. “PBMs run the show,” said Joyce.

In the case of Express Scripts, the company manages pharmacy benefits for insurers and also provides a prescription mail-delivery service.

Express Scripts spokesperson Brian Henry confirmed to PBS NewsHour Weekend the $285 copay that Ma paid in 2016 for his wife’s telmisartan was correct, but didn’t provide an explanation as to why it was so much higher than the $40 Costco price. Henry said that big retailers like Costco sometimes offer deep discounts on drugs through low-cost generics programs.

USC’s Geoffrey Joyce said it is possible that Costco negotiated a better deal on telmisartan from the drug’s maker than Express Scripts did, and thus could sell it for cheaper. But, he said, the price difference, $285 versus $40, was too large for this to be the likely explanation.

Joyce said it is possible another set of behind-the-scenes negotiations between the pharmacy benefit managers and drug makers played a role. He explained that drug manufacturers will make payments to pharmacy benefit managers called “rebates.”

Rebates help determine where a drug will be placed on a health plan’s formulary. Formularies often have “tiers” that determine what the copay will be, with a “tier one” drug often being the cheapest, and the higher tiers more expensive.

Pharmacy benefit managers usually take a cut of the rebate and then pass them on to the insurer. Insurers say they use use the money to lower costs for patients.

Joy said a big rebate to a pharmacy benefit manager can mean placement on a low tier with a low copayment, which helps drives more patients to take that drug.

In the case of Ma’s telmisartan, Express Scripts confirmed to PBS NewsHour Weekend that the generic drug was designated a “nonpreferred brand,” which put it on the plan’s highest tier with the highest copay.

Joyce said sometimes pharmacy benefit managers try to push customers to take another medication for which it had negotiated a bigger rebate. “It’s financially in their benefit that you take the other drug,” said Joyce. “But that’s of little consolation to the person who just goes to the pharmacy with a prescription that their physician gave them.”

But Joyce said the pharmacy benefit managers also profit when collecting copays that are higher than the cost of the drug.

In recent years, the industry has taken a lot of heat from the media and elected officials over a controversial practice called “clawbacks.” This happens when a pharmacist collects a copay at the cash register that’s higher than the cost of the drug, and the pharmacy benefit manager takes most of the difference.

August, 2018|Oral Cancer News|

Study: Cetuximab, radiation inferior to standard HPV throat cancer treatment

Source: upi.com
Author: Allen Cone

Treating HPV-positive throat cancer with cetuximab and radiation had worse overall and progression-free survival results compared with the current method of treatment with radiation and cisplatin, the National Institutes of Health revealed Tuesday.

The trial, which was funded by the National Cancer Institute, was intended to test whether the combination would be less toxic than cisplatin but be just as effective for human papillomavirus-positive oropharyngeal cancer. The trial, which began in 2011, enrolled 849 patients at least 18 years old with the cancer to receive cetuximab or cisplatin with radiation. The trial is expected to finish in 2020.

Cetuximab, which is manufactured under the brand name Erbitux by Eli Lilly, and cisplatin, which as sold as Platinol by Pfizer, are used in chemotherapy.

The U.S. Food and Drug Administration had approved cetuximab with radiation for patients with head and neck cancer, including oropharyngeal cancer.

HPV, which is transmitted through intimate skin-to-skin contact, is the leading cause of oropharynx cancers, which are the throat at the back of the mouth, including the soft palate, the base of the tongue and the tonsils. Most people at risk are white, non-smoking males age 35 to 55 — including a 4-to-1 male ratio over females — according to The Oral Cancer Foundation.

The NIH released the trial results after an interim analysis showed that cetuximab with radiation wasn’t as effective.

In a median follow-up of 4.5 years, the test combination was found to be “significantly inferior” to the cisplatin method.

“Clinical trials designed to test less toxic treatment strategies for patients without compromising clinical benefit are a very important area of interest for NCI and the cancer research community,” said Dr. Shakun Malik, of NCI’s Division of Cancer Treatment and Diagnosis.

Toxic side effects were different, with adverse events of renal toxicity, hearing loss and bone marrow suppression more common in patients in the cisplatin group and body rash more frequent in the cetuximab method.

For patients who cannot tolerate cisplatin, cetuximab with radiation is an accepted standard of care.

“The goal of this trial was to find an alternative to cisplatin that would be as effective at controlling the cancer, but with fewer side effects,” lead investigator Dr. Andy Trotti, of the Moffitt Cancer Center in Tampa, Fla., said in a press release. “We were surprised by the loss of tumor control with cetuximab.”

August, 2018|Oral Cancer News|