1 in 5 Men Are Carriers of High-Risk HPV

 Findings from a meta-analysis of 65 studies conducted in 35 countries indicate that nearly a third of men older than 15 years are infected with human papillomavirus (HPV), and 1 in 5 are carriers of high-risk HPV (HR-HPV). These estimates provide further weight to arguments in favor of vaccinating boys against HPV to prevent certain types of cancer.

"Our results support that sexually active men, regardless of age, are an important reservoir of HPV genital infection," wrote the authors. "These estimates emphasize the importance of incorporating men into comprehensive HPV prevention strategies to reduce HPV-related morbidity and mortality in men and ultimately achieve elimination of cervical cancer and other HPV-related diseases."

Literature Review

HPV infection is the most common sexually transmitted viral infection worldwide. More than 200 HPV types can be transmitted sexually, and at least 12 types are oncogenic. Previous studies have shown that most sexually active men and women acquire at least one genital HPV infection during their lifetime.

Although most HPV infections are asymptomatic, they can lead to cancer. Indeed, HPV is involved in the development of cervical, vulval, and vaginal cancers, as well as oropharyngeal and anal cancers, which also affect the male population. More than 25% of cancers caused by HPV occur in men.

Despite these observations, fewer epidemiologic studies have assessed HPV infection in men than in women. To determine the prevalence of HPV infection in the male population, Laia Bruni, MD, MPH, PhD, an epidemiologist at the Catalan Institute of Oncology in Barcelona, Spain, and her colleagues collated data from 65 studies conducted in 35 countries pertaining to males older than 15 years.

In this literature review, the researchers selected studies that reported infection rates in males without HPV-related symptoms. Studies conducted exclusively in populations that were considered at increased risk for sexually transmitted infections (STIs) were excluded. Overall, the analysis included close to 45,000 men.

Prevalent HPV Genotype

Testing for HPV was conducted on samples collected from the anus and genitals. The results show a global pooled prevalence of HPV infection in males older than 15 years of 31% for any HPV and 21% for HR-HPV. One of these viruses, HPV-16, was the most prevalent HPV genotype (5% prevalence).

HPV prevalence was highest among young adults. It stabilized and decreased from age 50 years. Between ages 25 and 29 years, 35% of men are infected with HPV. It should be noted that prevalence is already high in the youngest group, reaching 28% in males between the ages of 15 and 19 years. The variations are similar for HR-HPV infections.

This age-related change is different from rates in women. Among the female population, HPV prevalence peaks soon after first sexual activity and declines with age, with a slight rebound after ages 50–55 years (ie, often after or around the time of menopause), wrote the researchers.

The results also show country- and region-based disparities. The pooled prevalence for any HPV was highest in Sub-Saharan Africa (37%), followed by Europe and Northern America (36%). The lowest prevalence was in East and Southeast Asia (15%). Here again, the trends are similar with high-risk HPV.

Preventive Measures

"Our study draws attention to the high prevalence, ranging from 20% to 30% for HR-HPV in men across most regions, and the need for strengthening HPV prevention within overall STI control efforts," wrote the authors.

"Future epidemiological studies are needed to monitor trends in prevalence in men, especially considering the roll-out of HPV vaccination in girls and young women and that many countries are beginning to vaccinate boys."

In France, the HPV vaccination program was extended in 2021 to include all boys between the ages of 11 and 14 years (two-dose schedule), with a catch-up course in males up to age 19 years (three-dose schedule). This is the same vaccine program as for girls. It is also recommended for men up to age 26 years who have sex with other men.

The 2023 return to school will see the launch of a general vaccination campaign aimed at 7th-grade students, both boys and girls, with parental consent, to increase vaccine coverage. In 2021, vaccine uptake was 43.6% in girls between the ages of 15 and 18 years and scarcely 6% in boys, according to Public Health France.

Two vaccines are in use: the bivalent Cervarix vaccine, which is effective against HPV-16 and HPV-18, and the nonavalent Gardasil 9, which is effective against types 16, 18, 31, 33, 45, 52, and 58. Both provide protection against HPV-16, the type most common in men, which is responsible for more than half of cases of cervical cancer.

https://www.medscape.com/viewarticle/996020

Alkermes Settles Patent Lawsuit with Teva Over Generic Vivitrol

 Dublin-based Alkermes has settled an ongoing lawsuit with Teva Pharmaceuticals, paving the way for the Israeli multinational pharma company to launch its own generic counterpart to Alkermes’ injectable alcohol and opioid dependence drug.

The two companies have been sparring in a New Jersey court since 2020, when Teva Pharmaceuticals claimed that a patent that could protect Vivitrol until 2029 is invalid. Teva at the time filed an abbreviated new drug application for a generic version of Vivitrol.

In Wednesday’s announcement, Alkermes said it had “granted Teva a license under U.S. Patent No. 7,919,499 to market a generic version of Vivitrol in the United States beginning January 15, 2027, or earlier under certain customary circumstances.” No further details were released and the companies still have to submit the settlement agreement to the Federal Trade Commission and the Department of Justice.

While the news marks an end to Alkermes’ monopoly, it’s not catastrophic for the pharma company, which received a nearly $250 million boost after winning a suit against Johnson & Johnson in July 2023. The suit focused on back royalties and interest for technologies Alkermes provided to J&J for use in various drugs. J&J tried to partially terminate the deal on the grounds it was no longer using the intellectual property.

Alkermes Chief Commercial Officer Todd Nichols told analysts on a company earnings call in July that even if the suit didn’t go their way, the drug will remain an important and profitable product for the company.

“We have complex manufacturing, the fulfillment channels are complex, the settings of care are complex and there's not one setting that actually dominates the market. Anyone coming into the market would have to have a deep understanding of how to commercialize,” Nichols said. “We believe we are well positioned to continue to drive Vivitrol and also defend if a competitor came into the market.”

Vivitrol sales of $102.1 million—up by 6% from the first quarter—accounted for about one-sixth of the company’s total second-quarter sales this year, keeping the drug on track to generate between $380 million and $410 million this year. The company has as-yet announced no changes to its 2023-2024 market strategy for Vivitrol.

The drug is an extended-release form of naltrexone, an opioid receptor agonist which works by inhibiting the rewarding and intoxicating effects of opioids and alcohol. 

Alkermes also has “a portfolio of proprietary commercial products focused on alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of product candidates in development for neurological disorders and cancer,” according to  the company, though it’s also considering spinning out its oncology business into an independent, publicly-traded company.

https://www.biospace.com/article/alkermes-settles-patent-lawsuit-with-teva-over-generic-vivitrol/

Bosses are tracking — and judging — your social media posts for mental health red flags

Oversharing on social media may seem like the norm, but experts warn potential employers are not enthralled by applicants’ digital trauma dumping.

Initially billed as a white-collar networking platform, LinkedIn has taken a different form in recent years, becoming a site for flirtatious direct messages and unapologetic oversharing by its young users, more akin to Facebook.

But new research urges job applicants to be more guarded with their content — future employers are scrutinizing their profiles and even screening them for mental health concerns.

According to a study published Aug. 15 in the Journal of Business and Psychology, researchers found that oversharing on social media negatively impacted employers’ perceptions of applicants’ “emotional stability” and “conscientiousness.”

Online oversharing raised questions about candidates’ emotional stability.

Getty Images/iStockphoto

“People are often encouraged to discuss their mental health struggles on social media with the goal of reducing the stigma associated with mental health challenges,” study co-author Lori Foster, a professor of psychology at North Carolina State University, said in a statement.

“We think reducing stigma around mental health is extremely important, but our study suggests that mental health posts on platforms such as LinkedIn could have unforeseen consequences for people disclosing their mental health challenges.”

The study focused primarily on LinkedIn, which touts more than 930 million members, and surveyed 409 professionals with “hiring experience” who reviewed the same job candidate’s LinkedIn profile.

For the experiment, 25% saw a candidate’s post mentioning anxiety and depression on LinkedIn, while another 25% did not.

Another quarter of participants viewed the LinkedIn page without the mental health content while also listening to an audio interview, and the final 25% saw the omitted post about mental health and heard the interview.

The study enlisted 409 professionals with hiring experience.

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Then, the study cohort was asked to evaluate the applicant’s ability to perform at the job in question.

“We found that study participants who saw the LinkedIn post about mental health challenges viewed the job candidate as being less emotionally stable and less conscientious,” said study author Jenna McChesney, an assistant professor of psychology at Meredith College.

While listening to the candidate’s interview lessened qualms about their emotional stability, it was only slight.

“Our findings don’t mean people should refrain from posting about anxiety and depression on LinkedIn,” McChesney said.

“However, people who are considering posting about these issues should be aware that doing so could change future employers’ perceptions of them.”

“However, people who are considering posting about these issues should be aware that doing so could change future employers’ perceptions of them,” said McChesney.

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But the fault doesn’t fall solely on the candidate — Foster said employers are equally responsible for performing such thorough searches.

“When hiring managers look up candidates on LinkedIn, they risk seeing information that can color their perceptions, even subconsciously,” Foster explained.

“Organizations should implement guidelines for using LinkedIn during the hiring process to encourage equitable comparisons among all candidates, including those who openly discuss mental health challenges.”

https://nypost.com/2023/08/31/bosses-are-tracking-and-judging-your-social-media-posts-for-mental-health-red-flags/

Just 12% of Americans — mostly men — are eating half of our beef supply

 Where’s the beef? In America, it’s getting scarfed up by a small minority of people.

A new study reveals that 50% of the beef consumed in any given day goes to just 12% of the US population.

And this heavy consumption of beef has significant health impacts on those Americans who are eating half of our steaks, meatballs, weiners and hamburgers.

Current US Department of Agriculture guidelines suggest eating four ounces per day of meat, poultry, and eggs for those consuming 2200 calories per day. But the study reveals some Americans are far exceeding that amount.

The USDA reports Americans overall consumed a whopping 30 billion pounds of beef in 2021, which equals almost 60 pounds per person per year.

The researchers were “surprised” such a small percentage of people consume such an outsized proportion of beef, study author Dr. Diego Rose, nutrition program director at Tulane University School of Public Health and Tropical Medicine, said in a news release.

“We focused on beef because of its impact on the environment, and because it’s high in saturated fat, which is not good for your health,” Rose said.

Americans overall consumed 30 billion pounds of beef in 2021, which equals almost 60 pounds per person per year.

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Indeed, an overwhelming number of studies find that consuming red and processed meats can contribute to heart disease, cancer, diabetes and premature death.

“The evidence is consistent across different studies,” Dr. Frank Hu, chair of the Department of Nutrition at Harvard T.H. Chan School of Public Health, told Harvard Health Publishing.

And if you’re wondering who’s eating all that beef, the answer is, disproportionately, men. People between the ages of 50 and 65 were also more likely to eat a heftier portion of beef.

“On average, teenage boys consume more meat, poultry and eggs than is recommended in the [Dietary Guidelines for Americans]. For adult men, the distance from the recommendations is even greater,” the study authors wrote.

Half of the beef consumed in the US is eaten by just 12% of the American population.

MDPI

“This may be because meat, especially red meat, is associated with masculinity, strength and power in Western culture,” they added.

“Men are more likely to subscribe to the idea that human lives are more valuable than those of animals, and are more likely to associate meat with healthiness. Whatever the reasons, men are significantly less likely than women to consider reducing their meat consumption.”

Almost a third of the beef eaten came from cuts such as steak or brisket. But six of the top 10 sources were mixes like burgers, hot dogs, burritos, tacos, meatloaf or meat sauce.

The study, published in the journal Nutrients, examined data from the National Health and Nutrition Examination Survey, which tracked the meals of more than 10,000 adults over a 24-hour period.

About two-thirds of the beef consumed in America is in the form of hamburgers, hot dogs, tacos, meatloaf or meat sauce.

Getty Images/iStockphoto

Rose said the researchers’ purpose was to help target educational programs to those eating disproportionate amounts of beef.

“On one hand, if it’s only 12% accounting for half the beef consumption, you could make some big gains if you get those 12% on board,” Rose said. “On the other hand, those 12% may be most resistant to change.” 

Experts noted that despite that resistance, changing diets may require just a simple adjustment.

“If you’re getting a burrito, you could just as easily ask for chicken instead of beef,” said Amelia Willits-Smith, lead author and post-doctoral fellow at the University of North Carolina at Chapel Hill.

“The evidence shows that people with a relatively low intake [of beef] have lower health risks,” Hu said. “A general recommendation is that people should stick to no more than two to three servings per week.”

https://nypost.com/2023/08/31/50-of-us-beef-is-eaten-by-just-12-of-americans-mostly-men-study/

Drugmakers could find sympathetic US Supreme Court in drug pricing lawsuits

 Drugmakers challenging a Biden administration program requiring them to negotiate with Medicare over the prices of selected costly drugs may not have a clear legal precedent on their side, but there are signs they could get a friendly hearing from the U.S. Supreme Court, legal experts said.

Even before the administration announced the first ten drugs for inclusion in the program on Tuesday, drug companies and industry groups had sued the U.S. Centers for Medicare and Medicaid Services (CMS) in an effort to derail it.

Eight lawsuits are pending in courts across the country, before liberal and conservative judges alike, setting up the possibility of a conflict that will push the issue to the nation's top court.

Lawrence Gostin, a professor at Georgetown Law who has written publicly in support of the program, said he believed the lawsuits had "very little merit" but could nonetheless be persuasive to the Supreme Court's conservative judges.

"The court has shown a considerable hostility to federal agency action, particularly when they are trying to do big things," he said, pointing to the court's ruling last year limiting the Environmental Protection Agency's ability to regulate carbon emissions.

CMS is expected to soon begin the negotiations for lower prices on the 10 drugs that will take effect in 2026. The program, part of the Inflation Reduction Act signed by Democratic President Joe Biden, aims to save $25 billion per year on prescription medicines by 2031.

The drugs are some of the most lucrative on the market, including Bristol Myers Squibb's blood thinner Eliquis, Novartis' heart failure treatment Entresto and AstraZeneca's diabetes drug Farxiga.

Those companies filed separate lawsuits against the administration, as have the U.S. Chamber of Commerce and the leading drug industry group Pharmaceutical Research and Manufacturers of America (PhRMA).

While the cases feature differences in the legal arguments, all claim the program gives the government power to effectively dictate the price, with drugmakers' only recourse being pay prohibitive fines or stop taking part in Medicare and other government health programs.

The drug companies say that amounts to taking their property - their exclusive right to sell their patent-protected drugs - without just compensation, a violation of the U.S. Constitution's Fifth Amendment.

Americans pay far more for prescription medicines than patients in other developed nations, where governments have long negotiated prices.

Though legal scholars said there was no exact precedent supporting either side's position, the Supreme Court in recent years has upheld a strong view of property rights when interpreting the Fifth Amendment.

In 2015, the court struck down a Depression-era federal program requiring raisin producers to set aside a portion of their harvest. And in 2021, it ruled that two California fruit companies could not be compelled by state law to allow union organizers on their property.

A key question in the drugmakers' cases will be whether the government is forcing their hand.

James Blumstein, a university distinguished professor at Vanderbilt Law School who played a key role in Republican states' successful challenge to the Affordable Care Act's requirement to expand Medicaid health insurance for low-income people, said the government can attach conditions to participating in federal programs, but with limits.

In the Affordable Care Act case, the Supreme Court found that the federal government overstepped in threatening to cut off all Medicaid funding for states that did not expand the program, effectively commandeering state governments.

'CREATIVE LAWYERING'

Drug companies might be able to argue that Medicare's power in the market was so great that requiring the negotiation as a condition was similarly coercive, Blumstein said. He acknowledged that there was no perfect precedent, but suggested the companies could make an analogy with antitrust laws that restrict private companies.

"That would have to be developed through, shall we say, creative lawyering," he said.

Others were more skeptical.

"It's not as though the government is storming into warehouses and taking the drugs," said Robin Feldman, a professor at University of California College of the Law, San Francisco, specializing in health issues. He called the illegal taking claim "a heavy lift."

The drugmakers also say the law forces them to sign contracts stating the negotiated prices are "fair." They say that violates their right to free speech under the First Amendment of the Constitution by compelling them to parrot the government's claim.

The Biden administration has said nothing in the Constitution prevents Medicare from negotiating drug prices.

The Supreme Court has upheld such compelled speech claims before, notably in a 2013 decision finding that non-governmental organizations could not be forced to adopt an anti-prostitution stance to receive federal funding to combat AIDS.

Blumstein said he believed compelled speech was the companies' strongest claim.

Feldman said it was weakened by the fact that the companies could still publicly say whatever they wish about the program.

It could be some time before any of the cases reaches the Supreme Court. Only the Chamber of Commerce has sought a preliminary order halting the negotiations. Rulings in the drugmakers' lawsuits likely will not come until next year at the earliest.

https://www.yahoo.com/news/analysis-drugmakers-could-sympathetic-us-100607583.html