Researchers report that age-related hearing loss is associated with a decrease of cholesterol in the inner ear.
Experiments published August 24 in the open access journalPLOS Biologyshow that phytosterols supplements were able to act in place of the lost cholesterol and prevent sensory dysfunction inmice.
Sensory cells in the inner ear called outer hair cells (OHCs) amplify sounds by changing their length. As we age, these cells lose their ability to stretch in response to sound, preventing sound amplification and leading to age-related hearing loss. Because cholesterol is a key player in the stretch response, and because brain cholesterol has recently been shown to decrease with age, researchers hypothesized that hearing loss might be related to loss of cholesterol in OHCs. This hypothesis was tested in mice.
First, the researchers measured the amount of CYP46A1 in inner ear OHCs because this enzyme helps break down and recycle cholesterol. As expected, they found more CYP46A1 in the inner ears of older mice than in younger mice, and consequently less cholesterol.
Next, they showed cause and effect by inducing hearing loss in young mice, as indicated by abnormal inner ear-cell output, by over-activating CYP46A1 with a drug. Finally, they tested whether increasing cholesterol in the brain could counter the drug.
Since cholesterol itself cannot actually enter the brain from the blood, the researchers used plant-based cholesterol-like compounds called phytosterols which can. The young mice who got both the CYP46A1-activating drug and three weeks of dietary phytosterols displayed improved OHC function.
As phytosterols can be found in many over-the-counter supplements, they could be a convenient way to combat age-related hearing loss. However, directly testing their effects on hearing loss in older mouse models as well as in humans will be necessary before more definite conclusions can be made.
The authors add, "In the present work we show that: 1) aging triggers cholesterol loss from sensory cells of the inner ear, 2) a retroviral treatment widely employed for HIV/AIDS patients reproduces the cholesterol loss observed in aged individuals and leads to impaired outer hair cells' function and 3) we found that these defects can be partly reversed by phytosterols supplementation."
"Our findings are very promising because they provide the first proof-of-principle supporting phytosterols supplementation as a possible approach for prevention or treatment of hearing loss."
The researchers were led by María Eugenia Gomez-Casati, the Institute of Pharmacology, School of Medicine, University of Buenos Aires-CONICET; Mauricio Martin, the Institute of Medical Research Mercedes; and Martín Ferreyra, (INIMEC-CONICET-UNC), National University of Córdoba in Argentina.
More information: Sodero AO, Castagna VC, Elorza SD, Gonzalez-Rodulfo SM, Paulazo MA, Ballestero JA, et al. Phytosterols reverse antiretroviral-induced hearing loss, with potential implications for cochlear aging. PLoS Biology (2023). DOI: 10.1371/journal.pbio.3002257
The U.S. Justice Department sued Elon Musk-owned rocket and satellite company SpaceX on Thursday for allegedly discriminating against asylum seekers and refugees in hiring.
"The lawsuit alleges that, from at least September 2018 to May 2022, SpaceX routinely discouraged asylees and refugees from applying and refused to hire or consider them, because of their citizenship status, in violation of the Immigration and Nationality Act," the Justice Department said in a statement.
In job postings and public statements over several years, SpaceX wrongly claimed that under federal regulations known as export control laws, SpaceX could hire only U.S. citizens and lawful permanent residents, sometimes referred to as "green card holders," the Justice Department said.
The Justice Department also pointed to online posts from the company's billionaire owner Musk as example of "discriminatory public statements."
The lawsuit cited a June 2020 post on X, formerly called Twitter, by CEO Musk to his then 36 million followers that said: "U.S. law requires at least a green card to be hired at SpaceX, as rockets are advanced weapons technology."
SpaceX did not immediately respond to a request for comment on the lawsuit.
"Our investigation found that SpaceX failed to fairly consider or hire asylees and refugees because of their citizenship status and imposed what amounted to a ban on their hire regardless of their qualification, in violation of federal law," said U.S. Assistant Attorney General Kristen Clarke of the Justice Department’s civil rights division.
Clarke also said SpaceX recruiters and high-level officials "actively discouraged" asylum seekers and refugees from seeking work opportunities at the company.
The United States seeks fair consideration and back pay for asylum seekers and refugees who were deterred or denied employment at SpaceX due to the alleged discrimination, the Justice Department said.
The lawsuit also seeks civil penalties in an amount to be determined by court and policy changes to ensure SpaceX complies with the federal non-discrimination mandate going forward.
Service members who received general discharges when separated from the military for their refusal to obey the vaccine mandate say their transition to civilian life has been hampered because they were not given honorable discharges.
The majority of service members kicked out over their refusal to get vaccinated received general discharges. With a general discharge, service members lose all educational benefits, reemployment rights, and civil service retirement credit.
Hayden Robichaux, donor relations coordinator for the Mighty Oaks Foundation, is one such service member. He had to build a career in the Marine Corps. He spent his initial two years serving as the military equivalent of a firefighter. But life as a Marine was interrupted by Secretary of Defense Lloyd Austin’s announcement of a COVID-19 vaccine mandate in August 2021, he told The Epoch Times.
Robichaux refused the vaccine and sought religious exemption.
“But it seemed like everybody who sought religious exemption was denied,” he said. Months later, a leaked June 2021 memo by the Pentagon watchdog revealed the department may have been violating standards in its process of denying religious exemption requests for the COVID-19 vaccine.
In addition to his religious conviction against the vaccine, he took objection to the fact that the only vaccines offered to service members at the time were labeled as authorized for emergency use, rather than having full FDA approval. This argument stems from the wording of the Pentagon’s vaccine mandate, which covers “COVID-19 vaccines that receive full licensure from the Food and Drug Administration (FDA), in accordance with FDA-approved labeling and guidance.” Robichaux and others believe that this means the mandate did not apply to any vaccines issued under emergency use authorization (EUA), such as the Pfizer-BioNTech vaccine.
They argue that the military mainly offered service members EUA Pfizer-BioNTech vaccine, rather than the FDA-approved Cominarty vaccine, and thus could not compel personnel to take them. They also argued that a Pentagon policy that says the Cominarty and EUA Pfizer-BioNTech vaccines are interchangeable was illegal.
“With each denial,” Robichaux said, “I kept putting in appeals and each was denied; they were brushed off.” As he continued to refuse the vaccine, he said his leadership became “pissed.” In October 2021, he was given 10 days to get the jab. He soon faced the threat of Article 15, a form of nonjudicial punishment that can be imposed by a commander, that would “put a stain” on his career.
“Because of this,” he said, “I almost changed my mind, telling them that I was going to get it.” Members of his immediate family have collectively served in the military for over 80 years since the Vietnam War. “And I wanted to continue the legacy that we have under our name,” he said.
In the end, Robichaux maintained his religious objection to the vaccine and did not take it. Not only did he receive an Article 15, but he was also denied a promotion to corporal. While he admits he may have disobeyed the command to take the vaccine, he said, “I don’t believe it was a lawful command, as I should have never been forced to take an EUA product.”
Robichaux was discharged from the Marine Corps in February 2022. “My commanding officer recommended me for an honorable discharge, but once it went up the chain of command, it came back as a general discharge,” he said. His discharge was characterized as being connected to the commission of a serious offense. Domestic battery, murder, rape, terrorism, and drug use are considered typical commissions of a serious offense.
Since leaving the Marine Corps, he said, “I’ve only met one person that received an honorable discharge.” This, he said, is concerning when one considers the thousands of service members who were separated from the military. One day, Robichaux would like to have his discharge upgraded.
More of the Same
The Epoch Times also spoke to Private First Class Derrick Wynne, who joined the Army in July 2020. Nearly two years later, he was discharged from service for refusing to take the COVID-19 vaccine once mandated by Defense Secretary Austin.
Wynne described himself as a “hard refusal,” as he didn't apply for an exemption. He refused because “they were offering vaccines issued under emergency use authorization,” which he considered as legally distinct from the fully FDA-approved vaccines service members were mandated to take.
In November 2021, for refusing to get the jab, he received a General Officer Memorandum of Reprimand, an administrative letter of reprimand placed on his service record. In addition, he was also told by several people in leadership and many of his peers that “they were going to make my life hell for refusing the vaccine.”
At this time, Wynne was informed that he would be discharged for refusing to take the vaccine.
“When they finally kicked me out on June 28, 2022, it began as a long, drawn-out process, but when it finally happened, I was only given a two-week notice,” Wynne said. “Many of the programs put in place to aid me in a healthy, successful transition to civilian life were pushed to the side.”
“It was a general discharge, labeled under the violation of a serious offense,” Wynne said. “To anyone who doesn’t know the whole story,” he said, “I sound like I was the one who knowingly broke the law.” But he argued that it was the military that was offering an illegal vaccine by only providing vaccines issued under EUA.
“After skimming through my chapter (administrative separation) packet four or five times before speaking with Trial Defense Services, I noticed that there was no option for an honorable discharge.” When he mentioned this to his legal counsel, he also “made a note in the packet for brigade legal to, at least, add the option for an honorable discharge.”
Brigade legal told him that once his commanding officer gave his recommendation, they would add the option for an honorable discharge before sending it up to the next level of decision. To his surprise, he said, “After my Commander gave his recommendation for an honorable discharge, once it went up the chain of command, there was no option for it.”
When he realized there was no chance for an honorable discharge, Wynne said he was not surprised due to what he described as the department's recent history of “shady coercion tactics.” He said that “at the time, the military was doing everything they could to paint us [vaccine refuses] as criminals who were knowingly disobeying ‘lawful’ orders, without even taking the time to hear out our legitimate grievances.” For Wynne, “There was a blatant heavy hand on the scale, coming from the top down.”
The Epoch Times spoke to other service members who agree with Wynne. Some of them are being processed out of the military, today, for disobeying a “lawful” order mandated nearly two years ago. Most of them are receiving general discharges. The vaccine mandate was officially rescinded in January, but this did not affect the thousands of service members who had already been discharged over the vaccine.
Demand for Congressional Action
Once he was forced to leave the Army, Wynne’s reason for separation was labeled, like Robichaux, as a “misconduct (serious offense),” making subsequent job interviews more difficult, he said.
“The lack of an honorable characterization ripples outwards and is affecting thousands of us [service members] as a whole—not just from a bureaucratic perspective, but from a moral, principled aspect as well,” he said.
“I lost the education benefits I earned through my service, which would come in handy during my new career search,” he said. Within two months of being discharged, Wynne appealed the Army’s decision to the Army Discharge Review Board.
“Nearly nine months have gone by, and I’ve heard nothing,” he said. “I know Congress has the power to put in an inquiry and help soldiers like myself.”
Over the course of the last several months, wanting to address the issue of FDA-approved vaccines versus those made available through Emergency Use Authorization, Wynne has reached out to multiple congressmen to no avail.
“I was passed around from one elected official to another for months, and no one wanted to do anything to get answers to my questions,” Wynne said. “Every time a politician refuses to help me,” he said, “I feel like I’m being told: you’re a piece of trash; you should have gotten the vaccine.”
Proposed Legislation
In April 2022, Wynne was put in contact with Sen. Ted Cruz’s (R-Tex.) office. Although he remains frustrated about the lack of action in holding the Department of Defense (DOD) to account for the vaccine mandate, Wynne became aware of the Senator’s effort to ensure that those discharged under a General discharge could be designated as Honorably discharged through the AMERICANS Act.
Sen. Cruz and 18 original cosponsors introduced the Allowing Military Exemptions, Recognizing Individual Concerns About New Shots (AMERICANS) Act of 2023 (S.29) in January. The bill would require the department to offer reinstatement to service members who were separated for refusing the COVID-19 vaccine.
For Wynne, Robichaux, and the multitude of other service members like them, it also states “any administrative discharge of a member on the sole basis of a failure to receive a COVID-19 vaccine must be categorized as an honorable discharge, and DOD is prohibited from taking any adverse action against such a member for that reason.”
A spokesperson for Cruz told The Epoch Times the senator is fighting for passage of his AMERICANS Act [to] bring justice to servicemembers terminated or otherwise punished because of their COVID-19 vaccine status.”
“He is also fighting for them legislatively, authoring the statutory language to ban the Department of Defense’s COVID-19 vaccine mandate, which became law in December 2022,” the spokesperson said.
The senator "has taken the lead in calling out the Biden administration for COVID-19 overreach and fighting to protect Texas servicemembers from vaccine mandates,” the spokesperson added.
Marine Corps and Department of the Army officials did not return requests for comment from The Epoch Times.
Graphic, violent, deviant, and harmful online pornography that can permanently affect brain development can be easily accessed by children.
And the federal government is doing little to stop it, experts and lawmakers told The Epoch Times.
Although showing pornography to children is illegal under federal law, federal rules don't require porn websites to verify the age of users.
But recently, bipartisan efforts in state legislatures have intervened to protect children in a handful of states.
It's important—and urgent—because watching violent porn damages children, therapist Jon Uhler and psychologist Amy Sousa told The Epoch Times.
"Being shown violence alongside a reward system is incredibly problematic because it is sending the body a signal that this violence is pleasurable," Ms. Sousa said.
By teaching children to associate sexual pleasure with pain, she said, pornography can rewire a viewer's brain to want pain or want to inflict pain.
This rewiring undoes the body's natural response of feeling distressed when seeing someone get hurt, she explained.
And porn-watching is more common than many might realize.
Porn gets more yearly "watch hours" than all Hollywood, Netflix, and Viacom programming combined, Ms. Sousa said.
Psychologist Amy Sousa speaks at a "Save Women's Sports event in Nashville, Tenn., on April 27, 2023. (Jackson Elliott/The Epoch Times)
Normalizing Violence, Creating Psychopaths
"Eighty-eight percent of porn videos contain violence against women, which basically translates to 5.1 billion of those visits per month," Ms. Sousa said.
"Porn represents a massive propaganda arm that is normalizing and desensitizing violence against women."
Viewing pornography teaches men to see women as objects, said Mr. Uhler, who has 15 years of counseling experience and thousands of hours of experience in treating sex offenders.
Children who admit to watching porn also admit to feeling guilty about it, he said.
Over time, repeatedly engaging in behavior that violates one's conscience can turn a person into a psychopath, he said.
"As you impact conscience, you will negatively impact remorse and empathy," he said. "Those three things are the basis of psychopathy."
And this, he said, can open the gateway to becoming a sexual predator.
In counseling thousands of sexual predators, Mr. Uhler has seen a pattern. For all of his patients, the road to sexual deviancy involved viewing porn, he said.
"A lot of good researchers have looked at the effects that pornography has on the brain," Mr. Uhler said.
"It's identical to drugs, literally in terms of the impact on the structure itself and the way it processes."
With an unprecedented number of boys watching violent porn, Mr. Uhler said, the future will likely yield a massive crop of men who have learned from childhood to defy their conscience.
"We are in uncharted territory."
Conflicting Views on Restrictions
Despite these dangers, the federal government has done little to prevent children from accessing online porn, Sousa, Uhler, and lawmakers said.
"The federal law [banning pornography access for children] is not enforced," Utah state Sen. Todd Weiler, a Republican, told The Epoch Times.
Ian Andrews, a spokesman for Pornhub, told The Epoch Times that the company supports measures to restrict children from viewing porn by verifying the age of users. But he doubts new laws requiring age verification of users will help protect minors. Pornhub is the world's 12th-most-visited website, with more than 2.5 billion visitors yearly, according to the consumer research firm Similarweb.
Mr. Andrews argued that the laws may have the opposite effect.
"We hypothesized for years that, if only certain platforms were forced to verify user age, or if a law is not regulated properly, the results would see users flocking to the platforms that do not verify age," he said.
"This is no longer hypothetical. Since we became one of the few platforms in Louisiana to comply with the law and institute mandatory age verification, we have seen an approximately 80 percent drop in our traffic in the state."
Amping Up Laws
Lawmakers in some states are determined to amend state laws to block children from viewing porn.
In May, Utah passed a law requiring pornographic websites to verify that users from that state are at least 18. Louisiana, which enacted a similar law in 2022, was the first state to demand age-verification measures to access pornographic websites, Mr. Weiler said.
"We made a few minor tweaks, but we basically copied Louisiana's" law in Utah, he said.
The Louisiana law demands that porn websites perform "reasonable age-verification methods" for Louisiana users.
For Mr. Weiler, the fight to protect children from porn websites began in 2016.
"I ran the first resolution in the country to declare pornography to be a public health crisis," he said.
While the resolution declared that child viewing of pornography was a public health crisis, resolutions don't have the force of law or any law enforcement effects.
"And since that time, about 15 other states have basically copied" the resolution, Mr. Weiler said.
Five states have joined Utah and Louisiana in going farther.
Virginia, Mississippi, Texas, Montana, and Arkansas have added age-verification laws for pornography websites.
Arizona, California, South Carolina, Minnesota, and New Jersey all have bills for age verification under consideration, according to data gathered by the Free Speech Coalition (FSC).
Support for the bills is largely bipartisan, Mr. Weiler said.
"This is not just a Republican issue," he said. "I think many Democrats agree that children shouldn't be viewing this content."
Florida, Iowa, Kansas, Kentucky, South Dakota, West Virginia, Missouri, Alabama, and Tennessee have considered bills requiring age verification for porn users, but they failed to pass, according to FSC.
Relying on Honest Answers
According to federal law, the crime of "knowingly" using computer services to display obscenity to minors is punishable with imprisonment, fines, and sex offender registration.
But the word "knowingly" provides a loophole, Mr. Uhler said.
Under federal law, if a teen lies about his or her age to access porn, porn distributors can't be blamed for believing the age verification information provided by the child, he said.
"Like a kid who wants to access porn is going to be honest," Mr. Uhler said wryly.
This system puts the responsibility on minors to be truthful, rather than on porn website operators to ascertain the truth, Mr. Weiler said.
Companies have "taken steps to make sure that 14-year-old girls in Topeka, Kansas, aren't accessing online gambling sites," he said. "They've taken steps to make sure that 14-year-old girls in Topeka, Kansas, aren't buying vaping and nicotine products online. And those companies are not directly shipping wine to 14-year-old girls."
But the porn industry hasn't received the same regulatory pressure to protect children from its products, he said.
Any company actually interested in blocking minors from accessing the porn it offers could use a third-party company to screen users before they're allowed to access the site.
"The technology's there," Mr. Weiler said. "It would take about 30 seconds" to verify a would-be user's identity and age.
Utah's laws demand that verification on porn websites require more proof than simply a user's assertion that he or she is 18 or older.
Still, there are ways tech-savvy children can get around it, Mr. Weiler said.
But even if new measures don't stop all minors from accessing porn, he said, it will at least protect the youngest and most vulnerable children from seeing graphic images that can do them permanent harm.
A Generation of Porn-Watchers
Pornhub works like YouTube, the online video-sharing platform. Anyone can upload videos, and anyone can watch them. In 2021, the company says it removed more than 53,000 videos because they contained child sex abuse, 6,000 videos that included incest, more than 1,000 videos for animal abuse, and more than 5,000 videos for other obscene content too graphic to describe.
To her horror, sexual-abuse victimVictoria Galy discovered that footage of her rape had been posted to Pornhub and viewed 8 million times.
Ms. Galy told the Canadian House of Commons ethics committee in February that Pornhub made it difficult for abuse victims to take down videos of crimes against them.
To delete some of the videos, she testified, Pornhub requested a copyright infringement notification from her.
According to Pornhub's policy, anyone asking for a video's removal must give the site his or her name, postal address, telephone number, and email address.
Teens often are the consumers viewing pornographic videos, according to a survey by Common Sense Media. Researchers found about 70 percent of teens ages 13-17 admitted to watching porn online.
The survey asked more than 1,300 participants in that age group about their experience with porn. The average teen admitted to encountering porn by the age of 12, the survey found. Some started watching as young as 10.
A majority of porn-viewing teens have watched violent porn showing rape, choking, or pain, survey results showed.
While 45 percent of teens said that porn gives "helpful information about sex," about 50 percent reported feeling ashamed about the porn they watch, the survey found.
The Food and Drug Administration is now regularly approving new drugs after just one or two clinical trials — a significant departure from the more rigorous vetting process the agency was previously known for, newly published research reveals.
Furthermore, the authors say, there’s now less information available to the public about the results of all trials.
Only four of those 37 drugs, or about 11%, reported three or more studies before approval.
“Everything is supposed to be transparent with this FDA process,” Veronica Irvin, an associate professor at Oregon State University’s College of Health, said in a news release.
The FDA is facing criticism over its decisions to fast-track the approval of certain drugs, using limited data from fewer clinical trials.REUTERS “The purpose of ClinicalTrials.gov was to have a way for the non-scientific community to access the trials and their results, in a way that people can understand,” she said.
Researchers agree that it’s critical to minimize delays in making drugs for serious diseases like cancer available to patients, but these findings highlight a need for greater transparency around how drugs get approved.
For example, many drugs have been tested in multiple clinical trials, but drug companies are only required to share the results from two of those trials, leaving questions about why they selected those two trials for submission — and what happened during the other trials.
“We’re not saying that cancer drugs need a lot more studies; just that they should show all the results or trials that are completed,” said Irvin, a co-author of the paper.
“It doesn’t mean they wouldn’t get approved, but it means we’d have a more complete picture,” she added.
Another piece of new research, published in Health Affairs Scholar, found that of the 46 new drugs approved in 2017, 19 of them (41%) were approved based on a single study — though the drugmakers conducted an average of 2.2 studies per drug, including 165 studies for the popular weight-loss drug Ozempic.
The ease with which novel drugs are approved is in part the result of the 21st Century Cures Act, passed in 2016 to speed the approval of new medicines so patients could gain access to life-saving treatments.
Some critics charge that Aduhelm was approved with limited data and an “atypical collaboration” with drugmaker Biogen.AP As part of that law, the FDA relaxed some standards to allow treatments for priority health conditions such as cancer to be approved with fewer supporting studies, and with less emphasis on randomized clinical trials.
But in the years following the passage of the 21st Century Cures Act, the FDA has faced a firestorm of criticism over the approval process for some new drugs.
Last year, a congressional investigation found that the FDA’s “atypical collaboration” with drugmaker Biogen to approve Aduhelm, a high-priced Alzheimer’s drug, was “rife with irregularities.”
And a drug for treating agitation in people with Alzheimer’s disease, brexpiprazole (Rexulti), was granted fast-track approval by the FDA in May.
But a damning report in BMJ revealed that brexpiprazole failed to provide a clinically meaningful benefit even as it increased the risk of death among patients.
Nonetheless, the FDA fast-tracked its approval, and the drug’s manufacturers (Otsuka and Lundbeck) predict $1 billion in annual sales.
“We are very disappointed that the FDA approved this additional label indication for brexpiprazole on such weak data,” Nina Zeldes, health researcher at the consumer advocacy organisation Public Citizen, told BMJ.
“The FDA has set a dangerous precedent about the data it may require for future drug approvals for this vulnerable patient group,” Zeldes added.
When the FDA states that it has reviewed drugmakers’ two submitted studies, Irvin noted, the public is missing information about how many other studies were conducted, what those studies showed and why only those specific two studies were chosen for evaluation.
“We want doctors and patients to be able to see the whole picture,” she said.
SmileDirectClub (NASDAQ: SDC), the oral care leader and creator of the first med tech platform for teeth straightening, announced its intention to appeal a decision regarding an award of $63 million to be paid to Align Technology following a dispute over the Company’s exclusive supply agreement with its former strategic partner.
Align Technology became an investor, strategic partner, and exclusive third party supplier of aligners to teledentistry pioneer SmileDirectClub, by purchasing a 19% ownership stake in the company in 2016. In March of 2019, the partnership was dissolved when an arbitrator found that Align violated the terms of its agreement with SmileDirectClub by attempting to replicate its business model by competing with SmileDirectClub through its own Invisalign retail concept. Align was ordered to close its retail locations, return its stake in SmileDirectClub, and barred from competing against the Company until August 2020.
Following this decision and after the parties’ Supply Agreement expired, Align Technology, in August 2020, filed an arbitration demand against SmileDirectClub alleging that the Company breached the Supply Agreement, and subsequently, SmileDirectClub filed counterclaims against Align. On October 27, 2022, an arbitrator issued an interim award against SmileDirectClub on certain of Align’s claims, specifically stating that it was not a final award, and that a final award would be issued after the arbitration’s second phase and subsequent proceedings on attorneys’ fees, interest, and costs. In May 2023 the arbitrator issued a Final Award, awarding Align $63 million in damages, which award was confirmed by a California trial court on August 23, 2023.
