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Shades of Big Tobacco: How (and why) Juul bought an entire issue of a scientific journal

Source: Salon
Date: July 20th, 2021
Author: Jon Skolnik

 

Facing the imminent threat of corporate death, the embattled e-cigarette maker Juul is pulling out all the stops in its fight to convince the Food and Drug Administration that its vaping products are more beneficial than harmful.

If that sounds like a stretch, it probably is. Last month, Juul settled a $40 million lawsuit that accused the company of luring in teens to use its flavored vape products, allowing Juul to avoid the potential PR nightmare of a widely covered jury trial. Juul has also spent tens of millions in federal lobbying efforts over the past several years, presumably in an effort to block comprehensive regulations on the sale of e-cigarettes.

But the most bizarre Juul news came two weeks ago, when the New York Times reported that the company had funded an entire issue of a scientific journal, in which every article presented evidence that vaping is a beneficial harm-reduction practice that can wean smokers off tobacco cigarettes.

Last month, the American Journal of Health and Behavior (AJHB), a 44-year-old academic journal that has published many nationally recognized scholars, released a special edition specifically devoted to the question of whether e-cigarettes are harmful or helpful. The 219-page issue is unusual not just by virtue of its niche subject matter — e-cigarettes are a relatively new phenomenon in the field of health behavior — but also because its publication was bankrolled entirely by one source: Juul Labs.

This fraught episode comes at an exceptionally tumultuous time for the vape maker. In early 2019, Juul, a company founded just four years earlier, was riding a wave of explosive success, boasting $1 billion in revenue. Sales had grown by 641% from 2016 to 2017 alone. A national survey in 2019 found that nearly 30% of U.S. high school students reported using e-cigarettes in the last month, with 60% of them naming Juul as their preferred brand.

In 2018, the tobacco giant Altria — previously known as Philip Morris — took a 35% stake in Juul, believing the acquisition might help recover some of the company’s losses from an overall decline in U.S. cigarette sales over the past several decades. Only a few months later, however, disaster struck. A mysterious respiratory ailment, clearly linked to vaping, sickened more than 1,000 people in the U.S., and by the fall of 2019, 34 vape users had died from lung injuries. Facing an array of potentially devastating lawsuits and pressure from the Food and Drug Administration (FDA), Juul voluntarily pulled its products from many store shelves and canceled its youth advertising campaigns, rapidly losing more than 30% of its market share.

Now Juul remains in something like corporate limbo, awaiting FDA approval to continue selling its vape products in the U.S. The agency will likely decide this year whether the alleged health benefits of Juul products outweigh their potentially addictive qualities. It’s not entirely surprising, then, that Juul wanted to subsidize an entire edition of a medical journal: Its survival as a corporation is on the line.

But is the Juul-sponsored journal ethical? That’s a murkier question than it might appear. The special issue of AJHB makes no attempt to conceal the fact that essentially all the studies it contains were funded and facilitated by Juul. As The American Prospect notes, a cursory glance at the journal’s “Conflict of Interest” statements reveals that 18 co-authors of articles in the special issue are Juul employees.

Five other co-authors work at PinneyAssociates, a firm that “provides consulting on harm reduction exclusively to JUUL Labs,” as its senior scientific adviser, Dr. Saul Shiffman, told Salon by e-mail. “We participate in JUUL’s work to publish their scientific research to inform the public dialogue about tobacco harm reduction,” he added. An additional three co-authors are involved in the Centre for Substance Use Research, another consulting firm that has a contract with Juul. Nearly every study in the issue features the brand name in its title, and all of them effectively conclude that Juul’s products are a safe form of harm reduction.

As one paper in the journal, a study based on population modeling, puts it, “after considering both potentially beneficial and potentially harmful transitions and based on the available evidence to date — the (continued) availability of ENDS [i.e., vape products such as Juul’s] in the US is likely to have a positive impact on population mortality.”

The edition’s closing perspective, written by Dr. Karl O. Fagerström, a Swedish psychologist who specializes in smoking cessation and “tobacco harm reduction,” waxes a bit more philosophical. “Because it is unlikely that humankind will give up drugs, nicotine included,” he writes, “the findings from the studies presented in this issue suggest that ENDS, and JUUL in particular, can be an acceptable substitute for more harmful cigarette alternatives.” (It is duly noted that Fagerström has served as a paid consultant to Philip Morris International and British American Tobacco.)

Outside the world of corporate-sponsored research, the existing scientific literature is mixed, at best, on the question of whether products like Juul offer effective means of smoking cessation. One study from the University of California, San Francisco, found last year that Juul’s products deliver “more nicotine to the blood per puff than cigarettes or previous-generation e-cigarettes (e-cigs) and [impair] blood vessel function comparable to cigarette smoke.”

Another study published this year in Pediatrics, the official journal of the American Academy of Pediatrics, found that e-cigarette smokers are three times more likely to switch to tobacco cigarettes later on. Other studies have found that e-cigarettes elevate the risk of heart disease, high cholesterol and depression.

To get a better sense of how this strange edition of a previously respected journal came into being, Salon contacted dozens of people listed as associate editors or senior associate editors at AJHB — none of whom are paid for their work there. Virtually none of them knew about the Juul-sponsored edition prior to its release.

“There was certainly no email sent out to any of the editors that this was going to happen,” Dr. Richard Olmstead, a research psychologist at UCLA’s Semel Institute for Neuroscience and Human Behavior, and an associate editor of AJHB, told Salon. “I think there would have been quite a bit of pushback had there been some forewarning about it.”

Dr. Carl Fertman, a professor emeritus at the University of Pittsburgh’s School of Education and an associate editor at the journal, described the special issue as a “complete surprise.”

“There was no transparency,” he said in an interview with Salon. “I don’t want to be associated with this journal. It’s upsetting.”

“I think it’s fairly unusual that a single company would sponsor a special issue,” another associate editor told Salon, asking not to be identified by name. “I was surprised to see they called out a specific company in every article.” This person added that was “different” from anything they’d seen before in “any scientific behavioral journal.”

A number of editors, however, acknowledged that there’s nothing new about seeing corporations sponsor scientific research they believe will be favorable to their bottom line.

For decades, the tobacco industry worked diligently to steer the scientific consensus away from the conclusion — now universally accepted — that cigarette smoking causes lung cancer, emphysema and other serious or life-threatening health problems. Central to that strategy was ginning up fake controversy by pushing junk science that appeared to contradict the overwhelming weight of scientific and medical evidence. Tobacco companies poured money into shadowy front groups that supported dubious science, paid consultants to prepare “expert” testimony to Congress and regulatory bodies and suppressed internal research findings that made clear that the companies themselves understood their products were killing people.

In 1998, a torrent of secret internal documents from a number of tobacco giants was released to the public as part of the Tobacco Master Settlement Agreement. By the early 2000s, the veil was just about lifted. Ruling on a landmark Justice Department suit back in 2006, U.S. District Judge Gladys E. Kessler found that several big-name tobacco companies, including Philip Morris, had systematically defrauded the American public with a decades-long effort to launder pro-tobacco “science” through academic and government channels.

To be clear, Juul is not a tobacco company. It makes and sells e-cigarettes, aka “vapes,” which contain no tobacco and are meant to simulate the experience of smoking cigarettes. They deliver high doses of nicotine to the brain through water vapor, often flavored in various ways. Whether vaping is “safe” remains an unsettled question, but it’s not the same thing as smoking.

Still, the fact Altria holds a significant interest in Juul creates an uncomfortable parallel, even if the two companies’ products would seem to be in competition. Juul’s decision to bankroll an entire edition of a medical journal struck many people as reminiscent of the Big Tobacco playbook.

Following AJHB’s publication of the special edition, a number of editors resigned from the journal, according to New York Times reporting later confirmed by Salon. Most editors declined to comment on the scientific merit of the papers published in the special edition. But there are reasons to be dubious about how the journal’s peer-review process worked in this case.

Before studies are published in any scientific journal, they are typically subject to peer review, in which experts in the relevant field read the papers and offer comments. As AHJB states in its ethical guidelines: “To decrease bias during the editorial process, we employ the classic double-blind peer review process. … The Editor-in-Chief transmits reviewer evaluations and comments to the corresponding author, usually within 4 weeks.”

AJHB editor-in-chief Dr. Elbert Glover, however, apparently told reviewers that the issue was about e-cigarettes in general — and then offered them cash rewards to complete their reviews within a week, according the the Philadelphia Inquirer. Many editors told Salon that in itself was unusual. Only after reviewers reportedly began to ask questions about “fishy” aspects of the studies did Glover reveal that the entire issue was funded by Juul. One reviewer told the Inquirer that the design of one particular study seemed so biased that she recommended it be rejected outright. “I thought, ‘No way it wasn’t funded by Juul,'” she said.

In an email exchange with Salon, Glover acknowledged that he had been privately approached by Juul, who personally paid him $57,500 to publish the edition. (Glover is the sole owner of the publication.) He maintained, however, that the peer review process was conducted in good faith.

“Reviewers were not initially notified regarding the funder of the special issue as it has been journal policy to not identify the funder of special issues during the review process,” Glover wrote to Salon. “However, during the review process, one reviewer requested the identity of the funder. As a result of the reviewer’s response, I decided to share the identity of the funder with all the reviewers of the special issue.”

Asked whether he believed it was appropriate to publish a corporate-sponsored special issue without consulting the other listed editors, Glover responded that it had not occurred to him, saying he “was more concerned about the science and did not consider who funded this issue.”

“I should have been more perceptive to their issue,” he said. “In retrospect, it was probably an error but I still do not understand the ability to ignore science and allow negative bias to enter into the decision.

“My philosophy is to allow the scientific merit to determine publication, not personal bias. Just because the tobacco industry lied, manipulated data and currently promote a product that causes death, does not mean that I have to compromise my values.”

But it’s precisely because of the tobacco industry’s dark history of lies and manipulative spin that Glover should have come clean about Juul’s sponsorship from the beginning, say experts on the other side of the issue.

“The problem is that the tobacco industry has a decades long history of spinning science to meet its regulatory, legal and PR needs,” wrote Dr. Stanton Glantz, former director of the Center for Tobacco Control Research and Education, in a blog post responding to AJHB’s special issue.

As one meta-analysis of research data found in 1998, “the only factor associated with concluding that passive smoking is not harmful was whether an author was affiliated with the tobacco industry.”

A number of AJHB editors told Salon that any study funded by an interested party, especially a large corporation, should be met with heightened scrutiny. One said it was “a red flag when the authors are part of the organization that sponsored the research,” adding: “It doesn’t mean that one can dismiss all of the findings, but it needs to be carefully scrutinized.”

It remains unclear which way the wind is blowing for Juul. In September 2019, the FDA issued a formal warning to the company, making clear that “before marketing tobacco products for reduced risk, companies must demonstrate with scientific evidence that their specific product does in fact pose less risk or is less harmful.”

“JUUL has ignored the law,” the department added, “and very concerningly, has made some of these statements in school to our nation’s youth.”

Months later, it was reported that Juul had begun beefing up its scientific staff, hiring a number of former FDA officials and recruiting researchers in hopes of clearing potential regulatory hurdles. Last July, Juul submitted a Premarket Tobacco Product Application (PMTA) to the FDA, providing “detailed scientific data from over 110 studies totaling over 125,000 pages evaluating the product’s impact on both current users of tobacco products and nonusers, including those who are underage.”

The Juul-sponsored special issue of AJHB is one aspect one part of the company’s PMTA, a Juul spokesperson told Salon in a statement.

“The research in the special issue derives from an extensive research program designed to provide the US Food and Drug Administration’s Center for Tobacco Products with information, scientific data, and analysis to determine whether JUUL products are appropriate for the protection of public health,” the statement read. “This determination, through the submission of Premarket Tobacco Product Applications (PMTAs), is based on a rigorous, science-based process. Indeed, FDA has received not only the findings and reports reflected in the published papers, but also the subject-level data and other supporting information required through the PMTA process.”

In April of this year, six major health organizations — including the American Academy of Pediatrics, the American Cancer Society, the American Heart Association and the American Lung Association — wrote a letter to the FDA urging the agency to reject Juul’s Premarket Tobacco Product Application.

“The devastating combination of appealing flavors that appeal to youth, targeted marketing strategies, and technological innovations that deliver a powerful hit of nicotine, has caused enormous damage to public health, primarily through youth uptake,” they wrote. “Because of this, no JUUL products currently on the market can meet the public health standard, and therefore, none should be authorized by CTP or be allowed to stay on the market.”

The FDA is expected to rule on Juul’s application by Sept. 9.

How Big Pharma Finds Sick Users on Facebook

Source: The MarkUp
Date: May 6th, 2021
Author: Colin Lecher

If you’re a drug manufacturer looking for patients, one company has become a major destination in the past few years: Facebook.

The social media giant, through its power to target users based on their interests, is especially attractive to pharmaceutical companies looking to sell drugs to potential patients. The Washington Post reported last year that health and pharmaceutical companies spent almost $1 billion on just Facebook mobile ads in 2019. The draw? Unlike a traditional TV or radio ad, Facebook’s ad categories help those companies target their drug ads at users who likely suffer from a specific illness the drug treats.

And data from The Markup’s Citizen Browser project—which collects Facebook data from thousands of users—shows how precise and wide-ranging that targeting is.

Though Facebook does not offer advertisers categories that explicitly identify people’s health conditions, The Markup identified dozens of ads for prescription pharmaceuticals targeted at people with “interests” in topics like “bourbon,” “oxygen,” and “Diabetes mellitus awareness.”

Indeed, The Markup found, “awareness” of a disease is a frequent proxy for illness in targeting decisions made by advertisers.

Zejula, a drug manufactured by pharmaceutical giant GlaxoSmithKline, for example, is prescribed to treat advanced ovarian cancer. We found the drug targeted at users who Facebook determined had shown an interest in “cancer awareness.”

Piqray, another cancer treatment, manufactured by Swiss company Novartis, was shown to users with an interest in “National Breast Cancer Awareness Month.” Several drugs were targeted at either “Diabetes mellitus awareness” or “Diabetes mellitus type 2 awareness.”

“Stroke awareness?” Brilinta, from AstraZeneca. “Multiple sclerosis awareness?” Mayzent and Kesimpta, two other products from Novartis. “Chronic obstructive pulmonary disease awareness?” Trelegy, another GSK product.

We also found drugs targeted by close proxies for other health conditions.

Ads for Latuda, an antipsychotic from the company Sunovion used in the treatment of bipolar depression, were shown to users with an interest in the Depression and Bipolar Support Alliance, a nonprofit support group. We also found it targeted at users interested in therapy and the National Alliance on Mental Illness.

Anoro, a GSK drug also used to treat chronic obstructive pulmonary disease, an inflammatory lung disease caused by emphysema and chronic bronchitis, was targeted at users interested in cigarettes, or just “oxygen.”

Ads for Nurtec, a Biohaven Pharmaceuticals product used for treating migraines, were targeted at users who showed an interest in the “international classification of headache disorders,” a medical scale of headaches.

The cancer treatment Keytruda, from Merck, was targeted at an especially wide array of users, including those interested in the chemical industry, Corona beer, and bourbon.

In at least one case, we found, the interest targeted was barely even a proxy. Syprine, a Bausch Health drug used to treat a rare genetic condition called Wilson’s disease, was targeted at users who’d signaled an interest in “genetic disorder.”

It’s not clear exactly how Facebook decides that a person is interested in topics such as “oxygen” or “genetic disorder.” The company only places some very specific limits on how users can target health conditions. Advertisers can’t use “sensitive” personal health data to target their ads, meaning a pharmacy, for example, couldn’t upload a list of customers with a specific illness to market to them on Facebook.

The company has also broadly defended its health privacy practices, releasing a statement in 2019 that said that “privacy and safety are particularly important for people dealing with health conditions.”

“We do not use medical history to inform the interest categories we make available to advertisers,” Facebook spokesperson Tom Channick said in a statement to The Markup. “Instead, people are placed into interest categories based on their activity on Facebook, including the pages they like or the ads they click on.”

GSK, AstraZeneca, Bausch Health, Merck, Biohaven, and Sunovion, manufacturers of some of the drugs we saw ads for, didn’t respond to requests for comment on their Facebook advertising practices. Jamie Bennett, a spokesperson for Novartis, said the company’s “goal is to reach audiences where it matters” and that it follows all regulations, both legal and those set by services like Facebook.

The potential audience size for these ads can be massive. Facebook’s ad-buying system says the number of users who have shown an interest in cancer awareness, for example, is nearly 203 million.

Other categories are more narrow. Facebook’s system said the audience for users with an interest in the depression and bipolar support alliance was a relatively slim 250,000 users.

Kirsten Ostherr, director of the Medical Futures Lab at Rice University, said there are both practical and moral problems with advertising around such medical conditions. If a work colleague walks by your computer screen and sees a targeted ad for a lung cancer drug, for example, he or she could deduce you have the condition.

“Even if the advertiser doesn’t know exactly who you are,” Ostherr said, “if these ads are popping up on your screens everywhere, that potentially exposes information about you.”

Beyond that, targeting products by surveilling the sick inherently exploits vulnerable users’ privacy, Ostherr said.

“One of the things that is most insidious about this to me is it’s really targeting and exploiting people who are in this vulnerable state and who have found real benefit from online patient communities,” she said.

Legally, aside from providing a way for advertisers to disclose side effects, Facebook is under little obligation to shield its users’ health information. The United States’ health privacy law, the Health Insurance Portability and Accountability Act, or HIPAA, only applies to a handful of entities that directly deal with patient health information.

Ostherr said the vagueness of Facebook’s targeting could be a “legally defensive maneuver” protecting it from liability in the future by keeping them as distant from protected health data as possible.

In 2016, a lawsuit filed against Facebook claimed that the company had unlawfully invaded users’ privacy by tracking their visits to sensitive health-related websites. The suit included a now-outdated list of health targeting options on Facebook, which included options like “cardiac arrest,” “renal failure,” and “West Nile virus.” (Facebook denied the allegations, calling the suit “an attack on the way the Internet works.”)

Courts have so far sided with Facebook in the dispute, saying its users must agree to its advertising practices when they sign up for the service and that health information isn’t necessarily more private than other types of data.

But the data Facebook does have can be enormously sensitive, as some independent researchers have shown. In 2019, researchers from the University of Pennsylvania and Stony Brook University reported that they were able to predict whether a Facebook user had any of 21 health conditions through language in status updates alone.

Many patients may have looked to Facebook for community and help in the past year of pandemic-enforced isolation. When someone finds support for an illness on social media, Ostherr said, it’s unlikely that the health data they’re giving away is at the forefront of their minds.

“Their priority really is not being tracked from one website to another,” Ostherr said. “Their priority is surviving.”

Genetic changes in head and neck cancer, immunotherapy resistance identified

Source: MedicalXPress
Date: April 26th, 2021
Author: University of San Diego-California

A multi-institutional team of researchers has identified both the genetic abnormalities that drive pre-cancer cells into becoming an invasive type of head and neck cancer and patients who are least likely to respond to immunotherapy.

“Through a series of surprises, we followed clues that focused more and more tightly on specific genetic imbalances and their role in the effects of specific immune components in tumor development,” said co-principal investigator Webster Cavenee, Ph.D., Distinguished Professor Emeritus at University of California San Diego School of Medicine.

“The genetic abnormalities we identified drive changes in the immune cell composition of the tumors that, in turn, dictates responsiveness to standard of care .”

Reporting in the April 26, 2021 online issue of the Proceedings of the National Academy of Sciences, researchers describe the role of somatic copy-number alterations—abnormalities that result in the loss or gain in a copy of a gene—and the loss of chromosome 9p in the development of human papillomavirus (HPV)-negative and .

The loss of chromosome 9p and the deletion of JAK2 and PD-LI, two neighboring genes found on chromosome 9p, was associated with resistance to immune checkpoint inhibitors, a type of cancer immunotherapy that uses antibodies to make tumor cells visible to a patient’s immune system.

“Although programmed death-1 (PD-1) immune checkpoint inhibitors represent a major breakthrough in , only 15 percent of patients with HPV-negative head and neck cancer respond to treatment,” said co-principal investigator Scott M. Lippman, MD, senior associate dean, associate vice chancellor for and care and Chugai Pharmaceutical Chair in Cancer at UC San Diego School of Medicine.

“The ability to predict a patient’s response or resistance to this class of therapies, a major unmet clinical need, is a unique and novel discovery. Knowing who will not respond avoids losing several months to ineffective therapy with huge financial costs and impacts to quality of life,” said Lippman, director of UC San Diego Moores Cancer Center and medical oncologist who specializes in the treatment of patients with head and neck cancer at UC San Diego Health, San Diego’s only National Cancer Institute-designated comprehensive cancer center.

For this study, co-led by New York University Langone Health’s Teresa Davoli, Ph.D., and The University of Texas MD Anderson Cancer Center’s William N. William, MD, with co-investigator Steve Dubinett, MD, of UCLA Jonsson Comprehensive Cancer Center, researchers prospectively followed 188 patients at MD Anderson Cancer Center to study genomic and immune drivers of the transition to invasive HPV-negative head and neck cancer. They reviewed comprehensive genomic and transcriptomic data of 343 HPV-negative head and neck cancer patients from The Cancer Genome Atlas and 32 HPV-negative head and neck cancer cell lines from the Cancer Cell Line Encyclopedia project, and analyzed patient survival after immunotherapy in real-world evidence cohort data from Caris Life Sciences.

In 2021, the National Cancer Institute estimates approximately 54,000 new cases of head and neck cancers will be diagnosed in the United States, with 10,850 deaths. HPV-negative head are the most common, increasing and lethal subtype of this malignancy worldwide, said Lippman.

“The data serves as a powerful predictive marker, transforming standard of care for precision immunotherapy for patients with advanced, recurrent head and ,” said Lippman. “And, while we focused in an unprecedented extensive interrogation of the most globally lethal form of head and neck squamous cancer, accounting for more than 300,000 deaths annually, the application may be useful in a wide variety of solid tumors for which immune checkpoint inhibitors comprises standard of care.”

Dental Professionals Should Remember the HPV Vaccine Too

Source: Dentistry Today
Date: April 13th, 2021
Author: Jo-Anne Jones

We live in a viral world as we patiently await the end of the COVID-19 pandemic. Many people already have chosen to be vaccinated to protect themselves from getting the virus, or, at the very least, minimize its severity.

The harsh nature of the pandemic has led to expediency in developing the vaccine, which has not been typical, historically speaking. While the COVID-19 vaccine took less than a year to develop, the mumps vaccine took four years. The polio vaccine took 13 years. The human papillomavirus (HPV), flu, and chicken pox vaccines took 17, 27, and 28 years, respectively.

Looking back in the annals of history, we have the remarkable work of Edward Jenner to thank for his development of the first vaccine. His work involved deliberately infecting a human being with a mild dose of smallpox. His rigorous trials were controlled, repeatable, and documented in his 1798 publication, “An Inquiry Into the Causes and Effects of the Variolæ Vaccinæ.”

Jenner devoted the remainder of his life advocating for the safe and effective administration of the vaccine. In 1972, routine smallpox vaccination ended in the United States, followed by the World Health Organization declaring the disease’s elimination in 1980.

Another such vaccine victory is the polio vaccine, which was first available in the United States in 1955. Thanks to its widespread use, the United States has been polio-free since 1979.

And while the United States government has said that dentists can now administer the COVID-19 vaccine, there is another vaccine that we should bring to the attention of every adult who visits our practice: the HPV vaccine.

The Rise of Oropharyngeal Cancer

The fastest-growing segment of oropharyngeal cancers is attributed to HPV. Yet it can be prevented by the Gardasil HPV nine-valent vaccine (Gardasil 9 [9vHPV]). More than 270 million doses of the Gardasil HPV vaccine have been given worldwide, including 120 million doses in the United States.

Gardasil 9 is a non-infectious recombinant vaccine prepared from virus-like particles (VLPs) of the protein of HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58.

We accept vaccination due to perceived risk. Are your patients aware of the ubiquitous nature of this virus and the fact that merely being alive and sexually active may place them at inherent risk? Many of our patients who do not possess a history of tobacco or alcohol use do not perceive a risk of oral or oropharyngeal cancer.

But according to the Centers for Disease Control and Prevention, more than 70% of oropharyngeal cancers are related to HPV. HPV-related oropharyngeal cancer has now surpassed HPV-related cervical cancer as the leading HPV-associated cancer.

Cervical cancer used to be the leading cause of cancer death for women in the United States. But in the past 40 years, the number of cervical cancer cases and the number of cervical cancer deaths have decreased significantly. This decline is primarily the result of opportunistic screening practices and the HPV vaccine.

Most sexually active Americans will clear the virus without consequence. Many of them will not be aware of even having the virus. However, for persistent infection with a high-risk strain such as HPV-16, the risk for malignant transformation is real.

In 2020, the Food and Drug Administration approved an expanded indication for Gardasil 9 for the prevention of oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58. The vaccine is also indicated to prevent cervical, vulvar, vaginal, anal, and penile cancer.

2021 is a year defined and impacted by an overstretched healthcare system. We have longer wait times and backlogs for cancer treatments than ever before. For a cancer that is essentially preventable by a vaccine, it is frustrating beyond words to know that many of our dental patients are unaware of its existence.

HPV is responsible for a small number of oral cancers, as the vast majority are caused by lifestyle behaviors including smoking and alcohol use—once again, preventable.

We are not powerless. Our patients do not have to fall victim to the collateral damage of COVID-19. We can encourage our patients to perform a self-examination of the oral cavity between professional visits. We can educate them about the subtle symptoms that may be associated with HPV-related oropharyngeal cancer.

A North American campaign entitled Check Your Mouth was developed to educate the public about the importance of oral self-examination. It is the result of collaboration between the Oral Cancer Foundation and Holland Healthcare, developer of the Throat Scope and TelScope.

The Throat Scope is the world’s first all-in-one illuminated tongue depressor. The TelScope is a seamless oral telehealth delivery system capable of capturing real-time high-resolution images and emailing them to an oral healthcare provider via encrypted email.

Empower your patients. Share the science that we are most fortunate to have and recognize that we can proactively fight back in a viral world.

Ms. Jones is an award-winning speaker who has given over a thousand presentations across the United States, Canada, England, Ireland, and Bermuda. She also joins the Dentistry Today’s Leaders in Continuing Education for the eleventh consecutive year. With her frank and open lecture style, focus on direct knowledge translation to practice, and educational and clinical resources, she has earned many loyal followers both nationally and internationally. She may be reached at jjones@jo-annejones.com.

 

2021-04-13T12:57:09-07:00April, 2021|OCF In The News|

HPV vaccine leads to more than 80% drop in infections: What parents need to know

Source: Good Morning, America
Date: April 2nd, 2021
Author: Kathleen Kindalen

 

A new study has shown the effectiveness of the HPV vaccine, and found a dramatic decline in human papillomavirus infections in both vaccinated and unvaccinated teen girls and young women in the United States.

“This study shows that the vaccine works very well against a common virus, HPV,” Dr. Hannah Rosenblum, lead author of the study and medical epidemiologist at the Centers for Disease Control and Prevention (CDC), told “Good Morning America.”

“HPV can cause serious health problems later in life, including some cancers in both women and men,” she said. “HPV vaccination is cancer prevention — by vaccinating children at age 11 or 12, we can protect them from developing cancers later in life.”

HPV is the most common sexually transmitted infection in the United States and can cause health problems like genital warts in addition to cancer, which are most commonly cervical cancer in women and throat cancer in men, according to the CDC.

The HPV vaccine was first authorized in the U.S. for females in 2006, and for males in 2011. There has since been a more than 80% decline in HPV infections nationally, according to the CDC study.

The newly-released data from the CDC shows an 88% decrease in HPV infections among 14 to 19-year-old females and an 81% decrease among 20 to 24-year-old females.

There has also been a drop in unvaccinated females, according to Rosenblum, who warned that does not mean people should let their guard down.

“We also see an effect among unvaccinated females in these age groups due to less spread of the virus, however, unvaccinated persons are not immune and are still at risk of getting HPV,” she said. “They should talk to their doctor about getting vaccinated if they are 26-years-old or younger.”

HPV viruses are found in 80 million people in the United States, according to the CDC. There are hundreds of subtypes of HPV, and 1 in 4 people in the U.S. are infected with HPV at some point in their lives.

The CDC recommends two doses of the HPV vaccine, taken six to 12 months apart, for all girls and boys ages 11 to 12, but says the vaccine can be given to children as young as 9.

Teens and older who are not vaccinated are encouraged to do so by the age of 26. People ages 15 and older need three doses of the vaccine, according to the CDC.

The timing of the vaccine has to do with the state of children’s immune systems and also trying to vaccinate pre-teens before they are sexually active, Dr. Laura Riley, chair of obstetrics and gynecology at Weill Cornell Medicine and New York-Presbyterian in New York City, told “GMA.”

“Your immune system [at ages 11 and 12] is such that you have a robust response to this vaccine, and it lasts for a really long time,” she said. “But if you haven’t had it, still continue talking to your doctor about getting it up to age 26.”

Riley said she hopes the CDC’s new data — which stands out for being a 10-year study — combined with the safety of the HPV vaccine eases any remaining concerns parents may have about getting their children vaccinated against HPV.

“When [the HPV vaccine] first rolled out, the message wasn’t quite clear, so instead of people recognizing that you were going to prevent your kid from getting cancer, people were focused on the fact that HPV is a sexually transmitted disease,” she said. “The education has to continue so that parents can understand the real benefit of this vaccine.”

“The real benefit is to prevent your child from getting cervical cancer,” Riley said. “The fact that you can prevent [cervical cancer] with a vaccine that has been used for years and has shown to be safe, why wouldn’t you do it?”

Long-lasting infection with certain types of HPV is the main cause of cervical cancer, which has the best survival rates if detected early according to the CDC. Doctors routinely screen for cervical cancer with the Pap test and HPV DNA testing depending on age and risk factors.

“We need to make sure that the teenagers and pre-teens are getting the benefit of the HPV vaccine, because it really is an anti-cancer vaccine,” said Riley. “[Cervical cancer] is a really devastating disease.”

Globally, a woman loses her life to cervical cancer every two minutes, according to a 2019 article published in the medical journal The Lancet.

In the U.S., doctors on the frontlines like Riley said more must continue to be done to educate parents about the HPV vaccine and make sure that all children across the country have access to the vaccine. As of 2018, nearly 40% of adults ages 18 to 26 reported receiving one or more doses of the HPV vaccine, according to the CDC.

“We need to make sure that we work on access to this vaccine and make sure that all girls of all races and ethnicities have the access,” said Riley. “And we need to be sure that the message is clear so that everyone gets the two doses of the vaccine, because that’s what is associated with the best protection.”

City offers Oral Cancer Screenings; Health Officials aim to reduce cancer rates, save lives

Source: El Paso Herald Post
Date: April 1st, 2021
Author: Staff Reporter

Thursday morning, city officials announced that they will be offering referral services and health screenings to decrease the rate of oral cancer diagnoses and save lives, in recognition of April’s National Oral Cancer Awareness Month.

“Improving oral and oropharyngeal cancer awareness in our community is imperative,” said Angela Mora, Department of Public Health Director.

“Oral cancer has an incidence rate of about 7.2 per 100,000 residents in El Paso County and affects males twice as much as females in the U.S., but we as a community can work to reduce the incidence rate by participating in Oral Cancer Awareness month.”

Mora said residents can take part in Oral Cancer Awareness month by:

  • Reducing the use of tobacco products

Tobacco use and vaping significantly increases the risk of infection by the human papillomavirus (HPV) which causes oral or oropharyngeal cancer.

  • Getting Screened

Oral and oropharyngeal cancers occur most often in the tongue, soft and hard palate, tonsils, gums and back of the throat which is why regular oral and dental examinations by a health professional is important.

  • Getting the Human Papilloma Virus (HPV) Vaccine

According to the CDC, HPV is known to cause approximately 70 percent of oral and oropharyngeal cancer cases, and the HPV vaccine was developed to prevent infection by the high-risk types of HPV that cause cancers such as oral and oropharyngeal cancer.

For more information on the services and health screenings provided by the Department of Public Health visit EPHealth.com under the Services Tab Education and Promotion or call 2-1-1.

 

UB awarded $1.5 million to reprogram white blood cells in fight against oral cancer

Source: Science Magazine
Date: March 25th, 2021

BUFFALO, N.Y. – The University at Buffalo has received a $1.5 million grant from the United States Department of Defense to develop new therapies that help reduce chronic inflammation and immunosuppression in oral cancers.

Through the three-year grant, the research will center on a type of white blood cell called a macrophage that – after migrating to oral tumors – triggers uncontrolled inflammation, which suppresses the body’s immune response and lowers the effectiveness of anticancer therapies.

The researchers aim to reprogram the macrophages by targeting genes that regulate inflammation. By lowering inflammation, oral cancers will become more sensitive to new and traditional chemotherapies.

If successful, the findings could help increase survivorship of oral cancers, which claim the life of roughly half of all oral cancer patients within five years, according to Keith Kirkwood, DDS, PhD, principal investigator, Centennial Endowed Chair and professor of oral biology in the UB School of Dental Medicine.

“A change in behavior in the white blood cells within the tumor itself removes the ‘brakes’ in the system, causing more oral cancer growth,” says Kirkwood, also associate dean for innovation and technology transfer in the UB School of Dental Medicine. “We propose to reprogram the white blood cells to regain control of the brakes.”

Additional investigators from Roswell Park Comprehensive Cancer Center include Wesley Hicks Jr., MD, DDS, chair of the Department of Head and Neck/Plastic and Reconstructive Surgery; William Magner, PhD, scientist in the Department of Immunology; and Scott Abrams, PhD, professor in the Department of Immunology.

The research will focus on oral squamous cell carcinoma, the most common type of oral cancer. Found in the lips, mouth or throat, oral cancers can affect the ability to eat and speak, and may cause permanent disfigurement of the face.

Veterans are two times more likely to develop head and neck cancers than non-veterans, says Kirkwood. The increased risk may be attributed to higher rates of alcohol and tobacco use among veterans, he says. Nearly 75% of oral cancers are caused by either alcohol or tobacco use, according to outside research.

Sunstar Americas, Inc. Issues Voluntary Nationwide Recall of GUM® Hydral Dry Mouth Relief Oral Spray Due to Possible Microbial Contamination

Source: Yahoo! Finance
Date: February 18th, 2021

CHICAGO, Feb. 18, 2021 /PRNewswire/ — Sunstar Americas, Inc. (SAI) is voluntarily recalling GUM® Hydral Dry Mouth Relief Oral Spray products bearing an expiration date from 2021-11 through 2022-05 (see specific lots below) to the consumer level. This product may be contaminated with the bacteria Burkholderia cepacia.

Use of the defective product in the immunocompetent host may result in oral and, potentially, systemic infections requiring antibacterial therapy. In the most at-risk populations, the use of the defective product may result in life-threatening infections, such as pneumonia and bacteremia. To date, no adverse events have been reported to SAI related to this recall.

The oral spray, available through retail, is indicated for use for lubricating, moisturizing, soothing, and refreshing properties to help relieve and manage the symptoms of dry mouth:

  • 1800R/1800RA GUM® Hydral Dry Mouth Relief Oral Spray is distributed in 2.0 fluid ounce Polyethylene Terephthalate (PET) bottles with white polypropylene caps and a separate spray nozzle.

GUM® Hydral Dry Mouth Relief Oral Spray was distributed Nationwide to Grocery and Drug Wholesalers, Grocery and Drug chains, Web distribution and sales, and direct to consumers.

SAI is notifying its direct distributors and customers by USPS Priority mail and is arranging for return of all recalled products. Patients, pharmacies, and healthcare facilities in possession of these products should stop using and dispensing immediately.

Consumers with questions regarding this recall can contact SAI by phone at 1-800-528-8537 or email us.pcr@us.sunstar.com on Monday-Friday from 8am-5pm CST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.

Affected products and lot numbers follow below:

AFFECTED LOTS

SKU# Lot Exp
1800R 493538 2021/11
1800R 493539 2021/11
1800R 493540 2021/11
1800R 493541 2021/12
1800R 498339 2021/12
1800R 498340 2021/12
1800R 498341 2021/12
1800R 498342 2021/12
1800R 511571 2022/01
1800R 516383 2022/02
1800R 516384 2022/02
1800RA C140DD 2022-05

 

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Sunstar is committed to delivering safe, fully compliant products of the highest quality and is taking necessary steps to prevent future occurrence of this issue.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

About Sunstar Americas, Inc.

Sunstar Americas, Inc., a member of the Sunstar Group of companies, is a global organization headquartered in Switzerland that is a leader in the oral care industry and the manufacturer and distributor of the GUM and Butler Brands.

2021-02-22T11:19:16-07:00February, 2021|Oral Cancer News|

How enlisting dentists can speed up Covid-19 vaccinations

Source: Knowable Magazine
Date: February 3rd, 2021
Author: Mary E. Northridge

OPINION: Dental care providers have the skills, the facilities and the trust of patients who might otherwise miss out

 

Even as the Biden administration has upped its Covid-19 vaccine goal to 1.5 million per day, early reports say vaccination rates are lagging in hard-hit Black and Latino communities. On both fronts, America’s dentists can help.

Dental professionals — dentists, dental hygienists and dental assistants — have been responding to the pandemic from the outset, even as many practices were shut down by the emergency. At the health center where I work in Brooklyn, dental providers first donated their personal protective equipment (PPE) to the affiliated hospital. Then many of them were redeployed to perform arterial blood gas measurements and even transport deceased patients to makeshift morgues.

Today, the urgent need is to get millions of shots in arms. States should immediately authorize dental providers to administer Covid-19 vaccines. That would not only expand the trained immunization workforce, it would open up additional sites to dispense the vaccine and bolster vaccine acceptance among patients who do not routinely go to the doctor.

This is not without precedent. In 2019, Oregon became the first state to allow dentists to offer any vaccine to patients. Other states, including Illinois and Minnesota, allow dentists to administer influenza vaccines. Since late 2020, Arkansas, Massachusetts and California have permitted dentists to administer Covid-19 vaccines.

During this devastating public health emergency, this idea needs to be extended to all states.

There are more than 110,000 dentists – excluding specialists — and over 200,000 hygienists in the United States, and they already have the skills needed. Dentists routinely administer intra- and extra-oral injections to provide anesthesia, so any additional training would be minimal. In California, for instance, dentists will do four hours of online training before joining the vaccination effort.

California currently plans to utilize dentists just as extra manpower at vaccine clinics. But dental offices, too, will be valuable in vaccinating hard-to-reach populations.

Dental offices and clinics are a safe location. Despite early concerns that they might be particularly vulnerable to aerosol-borne transmission of the novel coronavirus, evidence is mounting that transmission at dental sites is rare. As in medical settings, precautions such as using PPE and increasing ventilation are effective. Nearly all dental practices and clinics have reopened to provide care. And that has been essential during the pandemic: Treating damaged teeth, tooth decay, gum disease and oral sores before they become acute prevents patients from going to emergency departments because of dental pain.

Interrupting community spread, however, is the chief imperative to prevent Covid-19 cases from overwhelming hospitals today. And that means adding vaccines to dental services.

Inoculating patients who are already in chairs for dental visits could improve vaccine acceptance. At the health center where I work, a simple workflow change for preventive tooth sealant placement nearly doubled the number of eligible children treated, from 37 percent to nearly 78 percent. Rather than schedule a separate appointment, sealants were applied during the kids’ initial or recall visits. Fewer visits meant greater acceptance of the treatment and higher rates of completion. The same could be true for vaccines.

Community dental clinics also serve hard-to-reach patients — minorities, immigrants, impoverished people — those who may be hesitant to seek out the vaccine because of historical injustices, fear of deportation or lack of health insurance. But dental providers have often earned trust through longstanding service in these communities. Ongoing quality improvement studies at our health center, for instance, document no racial/ethnic bias in treatment by dental providers. When patients are treated with respect regardless of their ability to pay for services, they may be more willing to accept a vaccine that will protect them, their families and their communities.

Many states have suspended regulations and expanded the scope of dental practices to combat the pandemic. To help ensure health equity and successfully immunize the whole US population, all states ought to enlist dental providers to administer Covid-19 vaccines as well.

This article is part of “Reset: The Science of Crisis & Recovery,” an ongoing Knowable Magazine series exploring how the world is navigating the coronavirus pandemic, its consequences and the way forward. “Reset” is supported by a grant from the Alfred P. Sloan Foundation. 

 

2021-02-08T12:25:34-07:00February, 2021|Oral Cancer News|

Deadly Spread of Some Cancers May Be Driven by a Common Mouth Microbe

Source: Scientific American
Author: Claudia Wallis
Image courtesy of Fatinha Ramos

When people hear that they might have cancer, perhaps the only thing more frightening than the C word is the M word. Metastatic disease—in which the malignancy has traveled beyond its primary site to other spots in the body—is responsible for nine out of every 10 cancer deaths.

Recently an unexpected player in this process has emerged: a common bacterium. Fusobacterium nucleatum, which normally lives harmlessly in the gums, appears to have a role in the spread of some cancers of the colon, esophagus, pancreas and—possibly—breast. Laboratory studies and evidence in patients indicate that the microbe can travel through the blood and infect tumor cells by attaching to a sugar molecule on their surface. There it provokes a range of signals and immune responses known to cause tumor cells to migrate. If further confirmed, the work with F. nucleatum could add to a growing understanding of how the microbiome influences cancer progression and may even point the way to fresh approaches to treatment.
In a healthy human mouth, F. nucleatum is a law-abiding member of the microbial community. With poor dental hygiene, uncontrolled diabetes and other conditions, however, it can go rogue and cause periodontitis, tonsillitis, appendicitis and even preterm labor. A connection to colorectal cancer was first hinted at about nine years ago, when two research groups discovered that the bacterium’s DNA was overrepresented in colon tumor tissue compared with normal tissue. Dozens of studies have since found that the infection in tumor cells is a sign of trouble: it is linked to a poorer prognosis in patients with pancreatic, esophageal or colorectal cancer; resistance to chemotherapy in the latter two groups; and metastasis in colorectal cancer, which is the world’s third most common and second most deadly malignancy.

Still, the question remained: Is this bug merely a warning sign, or is it an active participant in cancer progression? This year at least three studies of colon cancer, by separate teams, pointed to an active role. “We reached the same conclusion through different pathways,” says biochemist Daniel Slade of Virginia Tech. Slade and his colleagues found that when cultured human colon tumor cells were invaded by the bacterium, they produced two inflammatory proteins called cytokines—specifically, interleukin-8 and CXCL1—that have been shown to promote the migration of malignant cells, a step in metastasis. A second paper reported that the bacterium induces changes in gene regulation that boost metastasis to the lungs in mice. A third study determined that the abundance of F. nucleatum in human colon cancer tissue correlates with the amount of metastases and, in mice, identified additional signals by which the microbe may “orchestrate” metastasis. Slade and others have also demonstrated that the bacterium incites a kind of cytokine storm that is aimed at controlling the infection but that ultimately exacerbates the cancer. “It’s like throwing gas on an already lit fire,” Slade says.

Something similar may be going on in some breast tumors. In June a team led by microbiologist Gilad Bachrach of Hebrew University reported finding F. nucleatum DNA in 30 percent of the human breast cancer tissue examined; the bacterium was most common in cancer cells that expressed a lot of the surface sugar molecule Gal/GalNAc. Researchers also showed that the infection promotes growth of both primary tumors and metastases in mouse models of breast cancer. “The data imply that fusobacterium is not a cause of cancer, but it can accelerate progression,” Bachrach says.

How much this is happening in humans is, of course, a critical question. “The findings are intriguing, and it makes sense,” says Joan Massagué of Memorial Sloan Kettering Cancer Center, who is a leading investigator of metastasis. Inflammation is invariably part of the metastatic process, he says, so an infection that incites a dramatic inflammatory reaction in a tumor will have a consequence: “it helps cancer cells engage in mobile, invasive behavior.”

The discoveries about fusobacterium are part of a fast-moving field that is illuminating the way the microbiome both promotes and battles cancer. Many modern immunotherapy drugs, for instance, work best in the presence of beneficent microbes—as do some older chemotherapies. Some scientists envision that fusobacterium eventually could be turned into a cancer fighter. Given the microbe’s attraction to a sugar on tumor cells, they suggest, perhaps it could be deployed as a Trojan horse, bound to cancer drugs and carrying them straight to a malignant target.

2020-09-24T11:24:02-07:00September, 2020|Oral Cancer News|
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