A group of Senate Democrats is calling on Danco Laboratories, one of the manufacturers of the abortion pill mifepristone, to update the drug’s labeling to make it easier for patients to access the drug to help reduce complications from a miscarriage.
The Democrats, led by Sens. Mazie Hirono (Hawaii), Elizabeth Warren (Mass.) and Maggie Hassan (N.H.), urged the company to submit an application to the Food and Drug Administration (FDA) to add miscarriage management to the medication’s label, which currently only includes medication abortion.
Since the Supreme Court’s decision overturning Roe v. Wade in June, women have increasingly turned to abortion pills if they need to terminate a pregnancy. But many states have passed laws that severely restrict or outright ban medication abortion.
Mifepristone has been approved for medication abortion since 2000, but evidence has shown it can also significantly improve the management of early pregnancy loss and result in fewer complications.
The senators wrote that since miscarriage management is not included on the mifepristone label, patients experiencing early pregnancy loss who need mifepristone don’t have easy access to the drug, putting them at risk of serious injury or death.
Patients in states that have restricted access to abortion have reported being denied medications to treat their miscarriages, as pharmacists said they feared prosecution for dispensing the drugs.
“At this time, Danco does not plan to submit an application to FDA for miscarriage management,” a company spokeswoman told The Hill.
Last month, the FDA denied a petition from the American College of Obstetricians and Gynecologists that asked for a miscarriage indication to be added.
The agency said only the drug’s manufacturer can submit an application asking for such a change in the labeling. The applicant must also show that the drug is safe and effective for a new indication.
The White House on Thursday marked one year since President Biden relaunched the Cancer Moonshot initiative, announcing a series of new efforts to reduce cancer deaths and provide support to those getting treatment.
The National Cancer Institute will launch a new public-private partnership to assist families with children diagnosed with cancer, the White House said. The Childhood Cancer — Data Integration for Research, Education, Care, and Clinical Trials, or CC-DIRECT, will provide support to families to help them find ideal care for their child and participate in research initiatives like clinical trials and share data on optimal treatments.
The new program is a collaboration between the National Cancer Institute, the American Association for Cancer Research, the American Cancer Society, the Office fo the National Coordinator for Health Information Technology and several other groups.
The White House also announced that the the Health Resources and Services Administration is awarding $10 million to improve access to cancer screenings to improve early detection. The funds will go to 22 National Cancer Institute-designated cancer centers, which will conduct patient outreach in their communities to promote early detection.
The Department of Health and Human Services is also launching a public-private partnership called CancerX, an innovation initiative to accelerate the development of biotech and health tech startups focused on cancer care, especially those with equity in mind.
The initiatives announced Thursday will be led by Biden’s “Cancer Cabinet,” which is made up of medical experts and roughly 20 administration officials from the White House, the Department of Commerce, the Department of Labor and other agencies.
Biden in February 2021 relaunched the Cancer Moonshot with the goal to cut the cancer death rate in half over the next 25 years and improve the lives of caregivers and cancer survivors. Biden oversaw the original moonshot initiative during the final years of the Obama administration.
The cause of ending cancer has been personal for Biden, whose son Beau Biden died of brain cancer in 2015 at the age of 46. The president has talked about ending cancer throughout his campaign and presidency, saying it would be a priority for him. He has also framed it as a bipartisan effort, meeting with members of both parties at the White House during his first year in office to discuss the effort.
Four of the highest ranking U.S. health officials—including Dr. Anthony Fauci—met in secret to discuss whether or not naturally immune people should be exempt from getting COVID-19 vaccines, The Epoch Times can reveal.
The officials brought in four outside experts to discuss whether the protection gained after recovering from COVID-19—known as natural immunity—should count as one or more vaccine doses.
“There was interest in several people in the administration in hearing basically the opinions of four immunologists in terms of what we thought about … natural infection as contributing to protection against moderate to severe disease, and to what extent that should influence dosing,” Dr. Paul Offit, one of the experts, told The Epoch Times.
Offit and another expert took the position that the naturally immune need fewer doses. The other two experts argued natural immunity shouldn’t count as anything.
The discussion did not lead to a change in U.S. vaccination policy, which has never acknowledged post-infection protection. Fauci and the other U.S. officials who heard from the experts have repeatedly downplayed that protection, claiming that it is inferior to vaccine-bestowed immunity. Most studies on the subject indicate the opposite.
The meeting, held in October 2021, was briefly discussed before on a podcast. The Epoch Times has independently confirmed the meeting took place, identified all of the participants, and uncovered other key details.
Dr. Jay Bhattacharya, a professor of medicine at Stanford University who did not participate in the meeting, criticized how such a consequential discussion took place behind closed doors with only a few people present.
“It was a really impactful decision that they made in private with a very small number of people involved. And they reached the wrong decision,” Bhattacharya told The Epoch Times.
An email obtained by The Epoch Times shows Dr. Vivek Murthy contacting colleagues to arrange the meeting. (The Epoch Times)
The Participants
From the government:
Fauci, the head of the U.S. National Institute of Allergy and Infectious Diseases and the chief medical adviser to President Joe Biden until the end of 2022
Dr. Vivek Murthy, the U.S. surgeon general
Dr. Rochelle Walensky, the head of U.S. Centers for Disease Control and Prevention (CDC)
Dr. Francis Collins, head of the U.S. National Institutes of Health, which includes the National Institute of Allergy and Infectious Diseases, until December 2021
Dr. Bechara Choucair, the White House vaccine coordinator until November 2021
From outside the government:
Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and an adviser to the U.S. Food and Drug Administration on vaccines
Dr. Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota and a former member of Biden’s COVID-19 advisory board
Akiko Iwasaki, professor of immunobiology and molecular, cellular, and developmental biology at Yale University
Dr. Peter Hotez, co-director of Texas Children’s Hospital Center for Vaccine Development and dean of the Baylor College of Medicine’s School of Tropical Medicine
Fauci and Murthy decided to hold the meeting, according to emails The Epoch Times obtained.
“Would you be available tonight from 9-9:30 for a call with a few other scientific colleagues on infection-induced immunity? Tony and I just discussed and were hoping to do this sooner rather than later if possible,” Murthy wrote in one missive to Fauci, Walensky, and Collins.
All three quickly said they could make it.
Walensky asked who would be there.
Murthy listed the participants. “I think you know all of them right?” he said.
Walensky said she knew all but one person. “Sounds like a good crew,” she added.
From top left, clockwise: Dr. Vivek Murthy, Dr. Francis Collins, Dr. Anthony Fauci, and Dr. Rochelle Walensky. (Getty Images)
‘Clear Benefit’
During the meeting, Offit put forth his position—that natural immunity should count as two doses.
At the time, the CDC recommended three shots—a two-dose primary series and a booster—for many Americans 18 and older, soon expanding that advice to all adults, even though trials of the boosters only analyzed immunogenicity and efficacy among those without evidence of prior infection.
Osterholm sided with Offit, but thought that having recovered from COVID-19 should only count as a single dose.
“I added my voice at the meeting to count an infection as equivalent to a dose of vaccine! I’ve always believed hybrid immunity likely provides the most protection,” Osterholm told The Epoch Times via email.
Hybrid immunity refers to getting a vaccine after recovering from COVID-19.
Some papers havefound vaccination after recovery boosts antibodies, which are believed to be a correlate of protection. Other research hasshown that the naturally immune have a higher risk of side effects than those who haven’t recovered from infection. Some experts believe the risk is worth the benefit but others do not.
Hotez and Iwasaki, meanwhile, made the case that natural immunity should not count as any dose—as has been the case in virtually the entire United States since the COVID-19 vaccines were first rolled out.
Iwasaki referred to a British preprint study, soon after published in Nature, that concluded, based on survey data, that the protection from the Pfizer and AstraZeneca vaccines was heightened among people with evidence of prior infection. She also noted a study she worked on that found the naturally immune had higher antibody titers than the vaccinated, but that the vaccinated “reached comparable levels of neutralization responses to the ancestral strain after the second vaccine dose.” The researchers also discovered T cells—thought to protect against severe illness—were boosted by vaccination.
There’s a “clear benefit” to boosting regardless of prior infection, Iwasaki, who has since received more than $2 million in grants from the National Institutes of Health (NIH), told participants after the meeting in an email obtained by The Epoch Times. Hotez received $789,000 in grants from the NIH in fiscal year 2020, and has received other grants totaling millions in previous years. Offit, who co-invented the rotavirus vaccine, received $3.5 million in NIH grants from 1985 through 2004.
Hotez declined interview requests through a spokesperson. Iwasaki did not respond to requests for comment.
No participants represented experts like Bhattacharya who say that the naturally immune generally don’t need any doses at all.
In an email obtained by The Epoch Times, Akiko Iwasaki wrote to other meeting participants shortly after the meeting ended. (The Epoch Times)
Public Statements
In public, Hotez repeatedly portrayed natural immunity as worse than vaccination, including citing the widely criticized CDC paper, which drew from just two months of testing in a single state.
In one post on Twitter on Oct. 29, 2021, he referred to another CDC study, which concluded that the naturally immune were five times as likely to test positive compared to vaccinated people with no prior infection, and stated: “Still more evidence, this time from @CDCMMWR showing that vaccine-induced immunity is way better than infection and recovery, what some call weirdly ‘natural immunity’. The antivaccine and far right groups go ballistic, but it’s the reality.”
That same day, the CDC issued a “science brief” that detailed the agency’s position on natural immunity versus the protection from vaccines. The brief, which has never been updated, says that available evidence shows both the vaccinated and naturally immune “have a low risk of subsequent infection for at least 6 months” but that “the body of evidence for infection-induced immunity is more limited than that for vaccine-induced immunity.”
Evidence shows that vaccination after infection, or hybrid immunity, “significantly enhances protection and further reduces risk of reinfection” and is the foundation of the CDC’s recommendations, the agency said.
Several months later, the CDC acknowledged that natural immunity was superior to vaccination against the Delta variant, which was displaced in late 2021 by Omicron. The CDC, which has made misleading representations before on the evidence supporting vaccination of the naturally immune, did not respond to a request for comment regarding whether the agency will ever update the brief.
Iwasaki had initially been open to curbing the number of doses for the naturally immune—”I think this supports the idea of just giving one dose to people who had covid19,” she said in response to one Twitter post in early 2021, which is restricted from view—but later came to argue that each person who is infected has a different immune response, and that the natural immunity, even if strong initially, wanes over time.
Osterholm has knocked people who claim natural immunity is weak or non-existent, but has also claimed that vaccine-bestowed immunity is better. Osterholm also changed the stance he took in the meeting just several months later, saying in February 2022 that “we’ve got to make three doses the actual standard” while also “trying to understand what kind of immunity we get from a previous infection.”
Offit has been the leading critic on the Vaccines and Related Biological Products Advisory Committee, which advises U.S. regulators on vaccines, over their authorizations of COVID-19 boosters. Offit has said boosters are unnecessary for the young and healthy because they don’t add much to the primary series. He also criticized regulators for authorizing updated shots without consulting the committee and absent clinical data. Two of the top U.S. Food and Drug Administration (FDA) officials resigned over the booster push. No FDA officials were listed on invitations to the secret meeting on natural immunity.
Fauci and Walensky Downplay Natural Immunity
Fauci and Walensky, two of the most visible U.S. health officials during the pandemic, have repeatedly downplayed natural immunity.
Fauci, who said in an email in March 2020 that he assumed there would be “substantial immunity post infection,” would say later that natural immunity was real but that the durability was uncertain. He noted the studies finding higher antibody levels from hybrid immunity.
In September 2021, months after claiming that vaccinated people “can feel safe that they are not going to get infected,” Fauci said that he did not have “a really firm answer” on whether the naturally immune should get vaccinated.
“It is conceivable that you got infected, you’re protected—but you may not be protected for an indefinite period of time,” Fauci said on CNN when pressed on the issue. “So I think that is something that we need to sit down and discuss seriously.”
After the meeting, Fauci would say that natural immunity and vaccine-bestowed immunity both wane, and that people should get vaccinated regardless of prior infection to boost their protection.
Walensky, before she became CDC director, signed a document called the John Snow Memorandum in response to the Great Barrington Declaration, which Bhattacharya coauthored. The declaration called for focused protection of the elderly and otherwise infirm, stating, “The most compassionate approach that balances the risks and benefits of reaching herd immunity, is to allow those who are at minimal risk of death to live their lives normally to build up immunity to the virus through natural infection, while better protecting those who are at highest risk.”
The memorandum, in contrast, said there was “no evidence for lasting protective immunity to SARS-CoV-2 following natural infection” and supported the harsh lockdown measures that had been imposed in the United States and elsewhere.
In March 2021, after becoming director, Walensky released recommendations that the naturally immune get vaccinated, noting that there was “substantial durability” of protection six months after infection but that “rare cases of reinfection” had been reported.
Walensky hyped the CDC study on natural immunity in August 2021, and the second study in October 2021. But when the third paper came out concluding natural immunity was superior, she did not issue a statement. Walensky later told a blog that the study found natural immunity provided strong protection, “perhaps even more so than those who had been vaccinated and not yet boosted.”
But, because it came before Omicron, she said, “it’s not entirely clear how that protection works in the context of Omicron and boosting.”
Walensky, Murthy, and Collins did not respond to requests for interviews. Fauci, who stepped down from his positions in late 2022, could not be reached.
Murthy and Collins also portrayed natural immunity as inferior. “From the studies about natural immunity, we are seeing more and more data that tells us that while you get some protection from natural infection, it’s not nearly as strong as what you get from the vaccine,” Murthy said on CNN about two months before the meeting. Collins, in a series of blog posts, highlighted the studies showing higher antibody levels after vaccination and urged people to get vaccinated. He also voiced support for vaccine mandates.
The US Air Force has warned that the construction of a Chinese-owned corn mill in North Dakota poses a "significant threat to national security."
The company which owns the mill is Fufeng Group, an MSG and xantham gum manufacturer based in Shandong province, China, bought 370 acres of farmland in Grand Forks - along with the promise that the $700 million site would economically benefit the region.
According to GOP Sens. John Hoeven and Kevin Cramer, however, the Air Force says: "the proposed project presents a significant threat to national security with both near- and long-term risks of significant impacts to our operations in the area," though the military branch declined to state specific threats.
Thousands of residents have speculated that the corn mill might be used for spying, however.
In August of last year, at least 5,000 residents signed a petition aimed at preventing the mill's construction.
Mayor Brandon Bochenski, while initially supportive of the mill, came out on Tuesday saying that it should be stopped.
"The federal government has requested the city’s help in stopping the project as geo-political tensions have greatly increased since the initial announcement of the project," he said, adding that he would block construction by denying building permits and refusing to connect city infrastructure to the site, Yahoo News reports.
Fufeng USA’s Chief Operating Officer Eric Chutorash has since denied that the mill would be used to spy on or harm the U.S.
The corn mill was proposed to be built 12 miles away from the Grand Forks Air Force Base, which is home to U.S. intelligence, surveillance and reconnaissance units, including its top-secret drone technology. -Yahoo!
In a Tuesday joint press release, Cramer and Hoeven called on Grand Forks officials to "discontinue" the project, and instead "work together to find an American company to develop the agriculture project."
One of today’s biggest market movers is a little-known penny stock that hasn’t done much since its initial public offering (IPO).Innovative Eyewear (NASDAQ:LUCY) made anunimpressive trading debutin August 2022 and has spent the past six months in a race to the bottom. However, things took a dramatic turn today as LUCY stock surged in early morning trading.
The company hasn’t seen any major catalysts lately. But as it turns out, momentum for a short squeeze has been building steadily. Today, LUCY is surging and has reached impressive heights after weeks of little growth or momentum. This leads to the inevitable question whenever a short squeeze is unfolding: just how high can the stock go?
To find out, let’s dive deeper into this company and the forces driving the current squeeze.
Innovative Eyewear didn’t pick the best year to start trading. Following its August IPO, the 2022 bear market began pushing it down steadily. The stock shed more than 40% of its value during this time. However, before noon today, it surged by an astounding 183%. LUCY stock has come down a bit since then, but its gains are still high. As of this writing, it is up 123% for the day.
One person recognized LUCY’s short-squeeze potential before the internet caught on. Early this morning, an investing-centric Twitter account sounded the alarm that LUCY had the markings of a likely short squeeze. It flagged that there were currently no shares available for borrowing and that the cost to borrow remained well above 400%. The post also noted the company’s low float and market capitalization. Investing influencer and short-squeeze expert Will Meade retweeted the post, which he dubbed an “unbelievable call” and instructed traders to follow the account rather than pay attention to Discord channels.
That said, Innovative Eyewear has been receiving significant attention across social media today. According to data from ApeWisdom, mentions of the LUCY stock have risen 200% in the past 24 hours while it has received 101 upvotes, an increase of roughly 10,000%. However, shares have fallen from their midday peak, suggesting that the short squeeze may be ending.
Despite promising results in the rehabilitation field, it remains unclear whether upper limb robotic wearables, e.g., for people with physical impairments resulting from neurodegenerative disease, can be made portable and suitable for everyday use. We present a lightweight, fully portable, textile-based, soft inflatable wearable robot for shoulder elevation assistance that provides dynamic active support to the upper limbs. The technology is mechanically transparent when unpowered, can quantitatively assess free movement of the user, and adds only 150 grams of weight to each upper limb. In 10 individuals with amyotrophic lateral sclerosis (ALS) with different degrees of neuromuscular impairment, we demonstrated immediate improvement in the active range of motion and compensation for continuing physical deterioration in two individuals with ALS over 6 months. Along with improvements in movement, we show that this robotic wearable can improve functional activity without any training, restoring performance of basic activities of daily living. In addition, a reduction in shoulder muscle activity and perceived muscular exertion, coupled with increased endurance for holding objects, highlight the potential of this device to mitigate the impact of muscular fatigue for patients with ALS. These results represent a further step toward everyday use of assistive, soft, robotic wearables for the upper limbs.
The Department of Homeland Security (DHS) will allow two chief border patrol agents to testify before a Congressional hearing on the U.S. border crisis, after initially trying to “muzzle” them, according to Rep. James Comer (R-Ky.).
In a letter to DHS Secretary Alejandro Mayorkas, Comer highlighted how DHS leadership sought to prevent the chief border agents from testifying at the Feb. 7 hearing, but later reversed its stance after Comer threatened to use subpoenas.
The House Committee on Oversight and Accountability plans to hold the hearing to gather facts from U.S. Border Patrol witnesses. The hearing is titled “On the Front Lines of the Border Crisis: A Hearing with Chief Patrol Agents.”
Comer wrote that he invited the agents’ testimony on Jan. 19 and that DHS “initially sought to prevent Congress from hearing invaluable testimony from Chief Patrol Agents, believing that DHS’s internal protocols superseded Congressional oversight prerogatives.”
“I am pleased that the DHS is no longer taking such a position, and will make available as witnesses Chief Patrol Agent Gloria Chavez, Rio Grande Valley Sector and Chief Patrol Agent John Modlin, Tucson Sector,” Comer wrote (pdf). “These two law enforcement professionals also serve as Lead Field Coordinators for the border regions that collectively include Texas, New Mexico, Arizona, and California.”
In a statement, Comer described the Biden administration’s “radical open borders policies” as the cause of the “worst border crisis in American history.”
“Starting on day one in office, President [Joe] Biden and his administration rolled back deterrent-focused policies, halted the construction of the border wall, gutted interior enforcement, pushed amnesty for illegal immigrants—all of which have made it difficult for U.S. Border Patrol agents to secure the border,” Comer said in a statement.
“Next week, we will hear firsthand from the Border Patrol about this humanitarian and national security crisis,” he continued, adding the Republicans on the panel were committed to holding the Biden administration accountable.
U.S. Homeland Security Secretary Alejandro Mayorkas testifies before the House Judiciary Committee at the Rayburn House Office Building in Washington on April 28, 2022. (Kevin Dietsch/Getty Images)
Republicans Move to Impeach Mayorkas
Republicans have been critical of Mayorkas’s handling of the crisis at the southern U.S. border, with House Speaker Kevin McCarthy (R-Calif.) repeatedly calling on him to resign last year, and declaring his intention to investigate and impeach Mayorkas.
On Monday, Rep. Andy Biggs (R-Ariz.) told Fox News that he intends to file articles of impeachment against Mayorkas.
