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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|

Hundreds of Researchers From Harvard, Yale and Stanford Were Published in Fake Academic Journals

Source: motherboard.vice.com
Author: Daniel Oberhaus

In the so-called “post-truth era,” science seems like one of the last bastions of objective knowledge, but what if science itself were to succumb to fake news? Over the past year, German journalist Svea Eckert and a small team of journalists went undercover to investigate a massive underground network of fake science journals and conferences.

In the course of the investigation, which was chronicled in the documentary “Inside the Fake Science Factory,” the team analyzed over 175,000 articles published in predatory journals and found hundreds of papers from academics at leading institutions, as well as substantial amounts of research pushed by pharmaceutical corporations, tobacco companies, and others. Last year, one fake science institution run by a Turkish family was estimated to have earned over $4 million in revenue through conferences and journals.

The story begins with Chris Sumner, a co-founder of the nonprofit Online Privacy Foundation, who unwittingly attended a conference organized by the World Academy of Science, Engineering and Technology (WASET) last October. At first glance, WASET seems to be a legitimate organization. Its website lists thousands of conferences around the world in pretty much every conceivable academic discipline, with dates scheduled all the way out to 2031. It has also published over ten thousand papers in an “open science, peer reviewed, interdisciplinary, monthly and fully referred [sic] international research journal” that covers everything from aerospace engineering to nutrition. To any scientist familiar with the peer review process, however, WASET’s site has a number of red flags, such as spelling errors and the sheer scope of the disciplines it publishes.

Sumner attended the WASET conference to get feedback on his research, but after attending it became obvious that the conference was a scam. After digging into WASET’s background, Sumner partnered with Eckert and her colleague Till Krause, who adopted fictitious academic personas and began submitting papers to WASET’s journal. The first paper to get accepted was titled “Highly-Available, Collaborative, Trainable Communication-a policy neutral approach,” which claims to be about a type of cryptoanalysis based on “unified scalable theory.” The paper was accepted by the WASET journal with minimal notes and praise for the authors’ contribution to this field of research.

There was just one problem: The paper was pure nonsense that had been written by a joke software program designed by some MIT students to algorithmically generate computer science papers. It was, in a word, total bullshit.

As detailed in a talk this year at Def Con, last year Eckert and Krause attended a conference organized by WASET in London to present their bullshit paper. The two journalists went in disguise as the fictitious academics Dr. Cindy Poppins and Dr. Edgar Munchhausen. When they arrived, they discovered the two-hour “conference” was actually just a half-dozen people in a room with a projector, all of whom had paid hundreds of dollars for the privilege. When Eckert and Krause approached Bora Ardil, the conference organizer, to learn more about WASET, they said he was cagey and declined to give straight answers about his affiliation with the conference. According to Eckert, he claimed he was just a doctoral student working with WASET.

After this initial foray into the world of predatory publishing, Eckert and Munchhausen partnered with Sumner to dig deeper into WASET. By analyzing 83 domain names affiliated with WASET and its conferences, Eckert and her colleagues discovered that the predatory journal network was a family con run by Cemal Ardil, his daughter Ebru and son Bora. Based on the WASET website, the Ardils have been running this con since 2007.

According to Eckert and her colleagues, WASET is just a single predatory publishing platform,but it hosts over 5,000 events around the world annually and publishes hundreds of papers in its online “journals.” WASET charges hundreds of dollars to publish in its journals and attend its conferences, which netted the Ardils an estimated $4.1 million in 2017 alone.

Yet WASET doesn’t hold a candle to OMICS Publishing Group, which is likely the largest predatory publisher in the world. In 2016, the Federal Trade Commission filed a suit against OMICS for “deceiving academics and researchers about the nature of its publications and hiding publication fees ranging from hundreds to thousands of dollars.” Last November, the FTC granted a preliminary injunction against OMICS that prohibits the company from “falsely representing that their journals engage in peer review, that their journals are included in any academic journal indexing service, or any measurement of the extent to which their journals are cited.”

By scraping the OMICS and WASET websites, Eckert and her colleagues discovered tens of thousand of abstracts for fake scientific papers. India accounted for nearly 15,000 of these abstracts alone, but researchers from the United States accounted for the second highest submission rate—approximately 10,000 American papers were submitted to OMICS journals and another 3,000 to WASET journals.

So who are the people submitting to these conferences? According to Eckert, these range from academics trying to boost their publishing profile to scientists affiliated with companies who want to boost their scientific cred by having some publications under their belt. A distressing number of these academics come from elite American universities, as well. Eckert and her colleagues discovered 162 papers submitted to WASET and OMICS journals from Stanford, 153 papers from Yale, 96 from Columbia, and 94 from Harvard in the last decade. Yet according to Krause, “this goes way beyond academia.”

“It’s one thing for professors to try to polish their publication list and get more money or reputation, but it can be used for many other purposes,” Krause said last weekend during a talk at Def Con. “We as a society have this feeling that if something is scientifically proven and published, it has value. Usually science does just that, but in the case of the predatory journals it is quite different.”

The danger of these journals is that they can be used by companies to provide scientific justification for unproven treatments. One notable example of this is the case of the company First Immune, which had published dozens of “scientific” papers in these predatory journals lauding the effectiveness of an unproven cancer treatment called GcMAF. GcMAF is a protein that was marketed First Immune starting in 2010, but came under investigation shortly thereafter for running an unlicensed medical facility. The CEO of First Immune, David Noakes, will stand trial in the UK later this year for conspiracy to manufacture a medical product without a license.

The problem is that these predatory journals gave First Immune an air of legitimacy for desperate patients with cancer. This predicament is illustrated in the autobiography of a famous German media personality Miriam Pielhau, who died of breast cancer in 2016. In Dr. Hope, Pielhau describes her battle with cancer and how she settled on GcMAF as a last resort and cited medical studies published in predatory journals as the basis of her decision.

The ease with which people can be duped into taking false medical advice was driven home by Eckert and co, who submitted a research paper to the WASET Journal of Integrative Oncology that claimed that bees wax was a more effective cancer treatment than chemotherapy. The paper was accepted and published in the journal with minimal revisions.

As detailed by Eckert and her colleagues, similar tactics are used to publish studies and host conferences funded by major corporations as well, including the tobacco company Philip Morris, the pharmaceutical company AstraZeneca, and the nuclear safety company Framatone. When the predatory journals publish these companies’ research, they can claim it is “peer reviewed” and thereby grant it an air of legitimacy.

Taken together, the predatory publishers investigated by Eckert and her colleagues only represent about 5 percent of the total research published every year. While this doesn’t pose an existential threat to science as a truth-seeking process, it does work to erode public trust in legitimate research.

Eckert, Krause, and Sumner argue that that the rise of predatory journals makes it imperative that the general public, researchers, and academics stay on their guard to combat the proliferation of bogus research. Science, like democratic politics, has been responsible for some of the greatest advances in the wellbeing of humanity, but that doesn’t mean it’s immune to being undermined by a small group of persistent bad faith actors.

August, 2018|Oral Cancer News|

How ablation destroys cancer to prolong lives

Source: The Guardian
Author: David Cox

Seven years ago, when Heather Hall was informed by her oncologist that her kidney cancer had spread to the liver, she initially assumed she had just months to live. “I’d been on chemotherapy for a while, but they’d done a CT scan and found three new tumours,” she says. “But they then said that, because the tumours were relatively small, they could try to lengthen my prognosis by removing them with ablation.”

Hall underwent a course of microwave ablation, a minimally invasive treatment where surgeons use hollow needles to deliver intense, focused doses of radiation to heat each tumour until it is destroyed. While ablation technologies – they also commonly include radiofrequency ablation and cryoablation, which destroys tumours using intense cold – are not tackling the underlying cause of the disease, their impact can be enormous as they relieve pain and often prolong survival for many years, all at a low cost.

Studies based on data gathered over the past 10 years show an increasing number of cases of terminally ill patients who have lived for well over a decade after being treated with repeated ablations. Hall’s treatment was successful, but two years later, another two tumours had appeared in her liver, in different locations. Once again they were removed with microwave ablation. Over the past seven years, she has had four separate treatments. “There’s some pain in the immediate aftermath and I’ve felt quite ill for a week afterwards,” she says. “But it seems to have slowed down the progression of the disease, and I still have full function of my liver. With surgery, they would have had to cut a section of it away.”

While there have been many breakthroughs in cancer treatment heralded by the media in recent years – most notably the advances in immunotherapy and combination therapies – the considerable advances in ablation technology and resulting impact on patient survival, have consistently slipped beneath the radar. Not so long ago, the only option for patients such as Hall would have been full or partial removal of an organ, greatly reducing quality of life. But now, with increasingly powerful and efficient devices, surgeons are able to destroy drug-resistant tumours in a growing number of diseases ranging from sarcomas to prostate cancer.

“When we were first using ablation we could only treat the simplest tumours – for example, the ones in the middle of the liver, away from the blood vessels, because the devices were less powerful and predictable,” says Matthew Callstrom, a professor of radiology at the Mayo Clinic, Minnesota. “But now, for example, with microwave ablation – which works by radiating an energy field out of the tip of the needle into the tumour, heating the water within the cancer cells until they are destroyed – you can tune the shape and diameter of that field to prescribe exactly how deep it goes into the tissue. This means we can safely go after more and more complex tumours.”

Major studies published in the past couple of years have confirmed the survival benefits. Last year, the results of the Clocc trial – a five-year study of 119 patients across 22 centres in Europe – showed that patients with colorectal cancer that had metastasised to the liver and who received ablation in addition to drug treatment lived significantly longer on average than those who received drugs alone.

“We work closely with oncologists to determine who is most likely to benefit from this and who isn’t,” says Andreas Adam, professor of interventional radiology at King’s College London. “But it can have huge benefits. For example, I had a patient with breast cancer that had spread to the liver. I ablated the tumours, destroyed them completely and every few months or years, another tumour would develop and I’d ablate again. She went on to live for almost 10 years.”

With ablation treatment allowing many patients to live for far longer, it has the potential to change the perspective on some diagnoses. Patients with metastatic disease who go on to live for another decade or more in relatively little discomfort, often come to view their condition as more like a chronic illness. “It’s a strange feeling because you are still living with an illness which is likely to be terminal sooner rather than later,” Hall says. “But it’s no longer in the forefront of your mind. I’ve even been able to return to work part-time.”

However, not every patient with metastatic disease is a suitable candidate for ablation. Surgeons typically only use the technique on patients with 10 tumours or fewer. Any more, and the only viable options are treatments such as chemotherapy or immunotherapy. “You wouldn’t dream of ablating 50 tumours, because if someone has 50 visible tumours, it’s likely that they have another 100 developing that are not yet visible, and so they need drug treatment to treat the disseminated disease,” Adam says.

But in the coming years, ablation is likely to become available to more and more patients, allowing surgeons to tackle cancers in ever more complex locations.

Among the most promising methods is a technology called irreversible electroporation, which involves electrodes being inserted through the skin into a tumour, allowing a high voltage to be generated across the cancer cell membranes, causing them to self-destruct. This is only offered by a small handful of specialised centres in the world, but is expected to become more widespread over the next decade. “It’s a non-thermal approach, so you can go into more sensitive areas such as the pancreas, or ablate tumours which are in the centre of the liver,” Callstrom says.

One day, surgeons may even be able to ablate the most difficult cancers of all – deep brain tumours. The Israeli company Insightec is developing a device that can use focused ultrasound to destroy brain lesions. Because these tiny pulses of energy can be detected on MRI scanners, surgeons can calibrate them to the exact millimetre. “Each pulse generates a single ablation the size of a grain of rice,” Callstrom says. “Because it’s so tiny this allows you to basically tattoo the tumour and so avoid the boundary to any blood vessels or neurons.”

So for the many patients who have cancer that doesn’t respond to any form of drug treatment, there is now often a way of managing and prolonging their lives, which wasn’t possible before.

“The results of these studies have completely changed the thinking regarding some cancers,” Callstrom says. “With patients with metastatic sarcomas, for instance, people used to think that if the drugs failed, that was that. But now we can monitor them. And every time new tumours pop up, we ablate them.”

August, 2018|OCF In The News|

HPV: The gender-neutral killer in need of prevention among men

Source: CNN
Author: Dominic Rech

In July 2014, Phil Rech, then 59, was diagnosed with tonsil cancer.

“I had got a lump in my neck. I had the tonsils out, and within the next few days, I was having radical neck dissection,” he said. “Then I had six weeks of intensive, targeted radiotherapy. The burning effect towards the end of the treatment became very painful.”

The therapy involved a radiotherapy mask, molded to the shape of his face, that went over his head as radiotherapy was beamed in, targeting the cancer.

The discovery of his cancer not only startled him, it startled everyone who knew him.
Phil is my dad, and to our family, he had always been healthy: He doesn’t smoke, he rarely drinks alcohol, and he generally stays fairly fit.

But that’s not how cancer works.

At the time of the diagnosis, Phil didn’t question how or what could have caused his cancer, as he focused on getting better.

Like many men in the UK and around the world, he wasn’t aware of a group of viruses that were a threat, human papillomavirus or HPV, which were eventually connected to his cancer.

“To discover it was linked to HPV was a massive shock,” he said. “There was a lot of speculation over what could have caused it. To discover it was that, was certainly a surprise. I didn’t really know it was a threat to me.”

A cancerous virus

HPV is a group of 150 related viruses that can be transmitted through any form of sexual contact, whether kissing or intercourse. In most cases, the human body will get rid of it naturally, but certain high-risk types can develop into things like genital warts and cancers, including cervical, anal and throat.

But there is a vaccine, and how it works is pretty simple. It’s a mimic of the virus particle; when administered into someone’s muscle, it creates many more antibodies than a natural infection would, according to John Doorbar, professor of viral pathogenesis at Cambridge University.

According to the US Centers for Disease Control and Prevention, “almost every person who is sexually active will get HPV at some time in their life if they don’t get the HPV vaccine.”

The vaccine needs to be given before a person is exposed to HPV. Its effectiveness in terms of preventing infections is well-known — 100% in some studies — but who gets it is a question of debate around the globe, particularly in the UK.

In the UK, girls ages 12 to 13 are routinely offered the first HPV vaccination. They can get the vaccine for free via the National Health Service from ages 12 to 18. This is encouraged to help combat cervical cancer, which a recent report suggests it has done globally.

In England, between 2010 and 2016, infections with HPV 16 and 18 (two types of the virus responsible for most cervical cancer cases) fell 86% among women 16 to 21 who were eligible for the vaccine during this period, Public Health England found.

But what about men?

Until now, some experts in the UK have argued that men would ultimately be protected against the virus through “herd immunity”: As long as girls are well-protected, the male population should be shielded, too.

But according to the Royal Society of Public Health, which supports providing the vaccine to boys, uptake of the vaccine for girls is insufficiently high to ensure herd immunity in several areas of the UK. Men are still at risk of acquiring HPV from sexual contact with women from countries without a vaccination program, the society said.

In April, NHS England and Public Health England, on recommendation from the UK’s Joint Committee on Vaccination and Immunisation, decided to introduce the vaccine to men 45 or younger who have sex with other men, often called MSM, after concluding that this group does not benefit from herd immunity.

Historically, heterosexual men and young boys have not been offered it through the NHS but can pay to receive it privately. Pharmacies including Boots, Lloyds and Superdrug in the UK charge about 150 pounds ($196) per dose, with people typically needing two or three doses.

But on July 18, the vaccination committee recommended extending the HPV immunization program to boys after it reviewed the evidence for vaccinating boys since 2013. A recommendation last year concluded it was still not cost-effective to vaccinate this group, but experts and campaigners appealed for the committee to look again — and their stance changed.

“It is clear that a programme to vaccinate adolescent males would provide those vaccinated with direct protection against HPV infection, and associated disease including anogenital warts, anal, penile and oropharyngeal cancers,” the statement says. The committee confirmed that evidence has strengthened on the association of HPV with non-cervical cancers, which affect men as well as women, and that vaccination is efficacious in preventing these other HPV-related cancers.

In response to the recommendation, the same day, the Scottish government announced that it would implement a vaccination program to boys as soon as it practically could, Public Health Minister Joe FitzPatrick said. Wales also opted to roll out the vaccine to boys.

The question remaining is whether England will follow suit.

There is some disparity over the number of other countries vaccinating boys against HPV. Shirley Cramer, chief executive of the Royal Society of Public Health, said 20 countries vaccinate boys, while the HPV Action partnership says that about 15 roll it out to boys as well as girls.

The vaccine has been approved for males in the United States for almost 10 years. Italy and Australia are also pioneering gender-neutral vaccination plans.

Lagging behind and increasing rates

In 2017, after being in remission for three years, Phil’s cancer surfaced again — this time, in the brain and the lungs.

“I started to feel some funny fluttery feelings in my chest,” he said. “It was only my oncologist, who revealed to me that I had six small lesions on my lungs. An MRI scan also showed three on my brain.

“That’s the nature of cancer. It’s a crafty disease,” he said.

A 2017 study found that one in nine American men is infected with the oral form of HPV. Nationwide, rates for oral HPV infections are 11.5% of men and 3.2% of women: 11 million men, compared with 3.2 million women, the researchers estimated.

Among HPV-related cancers, a type of head and neck cancer called oropharyngeal squamous cell carcinoma was far more likely to strike men in the US, the same study found, with its incidence surpassing cervical cancer among women. Men who have had multiple sex partners, men who reported having sex with men and men with genital HPV infections were found to have the highest rates of oral HPV.

But in the UK, the discussion around vaccinating boys has been ongoing. In less than 10 years, admissions for primary cancerous tumors of the head and neck increased by almost 10,000, according to the NHS, from 29,198 in 2008-09 to 37,417 in 2016-17.

A recent review by the nonprofit medical research group Cochrane acknowledged that HPV was not only linked to cervical cancers, it increases risk of vulval cancers, penile cancers and some head and neck cancers. But the review also said that these cancers were rarer and that ascertaining the effects of vaccination on them may require the evaluation of non-randomized, population-level evidence over many years.

Beyond the price tag

“The problem is cost-effectiveness, and that is why the government hadn’t made a decision to vaccinate boys in this country,” said Jo Morrison, co-ordinating editor for the Cochrane Gynae, Neuro and Orphan Cancer Group.

However, she added, “doctors and other informed people are looking to get their boys vaccinated.”

Giampiero Favato is one of them. “Twenty years from now, we will laugh about this discussion,” said the health economics specialist at Kingston University. “It is obvious we should vaccinate boys. HPV is a gender-neutral killer. When my son is 12, I will pay for the vaccination if necessary.”

He is skeptical of “herd immunity” and giving the vaccine only to girls: “The current models are not capable of replicating the sexual behavior and preference in the normal population. Most of the models are based on the assumption that sex is only happening between fully heterosexual couples and their partnerships.”

This of course would mean more money for the NHS, but Favato says “price is not the issue,” and the private cost of the vaccine is unlikely be anywhere near that for the NHS, which is likely to get it at a competitive rate. “In Italy, the vaccination costs about $30 to $32 per vial.”

But Helen Bedford, professor of children’s health at the UCL Great Ormond Street Institute of Child Health, added that cost-effectiveness still needs to be taken into account and that the method of calculating this is what ultimately needs to change.

“In view of the long interval between infection with HPV and development of disease, [the Joint Committee on Vaccination and Immunisation] are supportive of changing the methods for calculating cost effectiveness to consider HPV vaccine for boys,” she said. “A review of cost-effectiveness modeling is soon to be concluded, and this is one of the issues that is being considered as part of that review.”

Phil said that if he could have had the vaccine readily available when he was younger, he would have taken it.

He continues to fight his cancer today, but cases like his are increasing amid the discourse on HPV vaccination rollouts in the UK.

“I would urge all boys to be vaccinated as a matter of course,” he said. “We have long vaccinated against the likes of polio, measles, mumps and rubella. HPV is just as serious and life-threatening as any of these.”

Note from OCF: We are one of the first supporters and donors to the HPV Action Partnership that originally supported research and early perception of the concept of boys being vaccinated for herd immunization. This has been a long term endeavor and a labor of love.  Men get oral cancers more than woman do and we want to inform that the HPV Vaccine goes beyond protecting from cervical cancers; it also protects from anal, penile and oropharyngeal cancer.

 

July, 2018|OCF In The News|