GOP Lawmakers Call CDC Attention To "Suspicious" Virus Outbreak In China

 by Eva Fu via The Epoch Times,

Top Republicans on the House Energy and Commerce Committee are calling for attention from U.S. health authorities on the "suspicious" clusters of viral infections and reports of pneumonia affecting Chinese children, warning that it would be “an abdication” of their duty for allowing the Chinese regime to “repeat its misdeeds from the COVID-19 pandemic.”

In a Nov. 29 letter addressed to Centers for Disease Control and Protection (CDC) director Mandy Cohen, who is set to testify before the committee’s oversight subcommittee on Thursday, the lawmakers underscored the Chinese regime’s repeated efforts to suppress information about the burgeoning COVID-19 crisis since it began to spread in China three years ago. Such actions by China have drawn criticism from international bodies such as the World Health Organization (WHO), which, the lawmakers noted, “has long been criticized for being overly accommodating to the Chinese Communist Party (CCP).”

The infections of children with respiratory illness and pneumonia in China have overwhelmed hospitals and alarmed the WHO, which is urging China to share data about the outbreak. Anecdotal reports have also indicated that children are transmitting the illness to other members of their family, including adults.

The Chinese authorities have responded by saying that they have detected no “unusual or novel pathogens or unusual clinical presentations,” and only a “general increase in respiratory illnesses due to multiple known pathogens,” according to a WHO statement on Nov. 23. It cited Chinese authorities as further stating that “the rise in respiratory illness has not resulted in patient loads exceeding hospital capacities.”

The three Republican lawmakers—Reps. Cathy McMorris Rodgers (R-Wash.), Brett Guthrie (R-Va.), and Morgan Griffith (R-Va.)—while expressing skepticism about WHO, are asking the CDC to step up.

“The American people should not have to rely on the unaccountable and untrustworthy WHO to communicate information about Chinese public health threats. Further, we cannot allow the CCP to block the CDC from accessing the information it needs to protect Americans and assist in appropriate public health response efforts,” they wrote in the letter.

They requested the CDC to brief the committee on a biweekly basis on the issue, and respond to a list of questions about the wave of respiratory illness in China by Dec. 13, including whether CDC has engaged with the Chinese counterparts regarding the outbreak issue, related details, and its plan of action.

“There's no question that we should be taking a hard look at it and not not counting on them to give us the real facts,” Mr. Griffith, chairman of the Subcommittee on Oversight and Investigations, told The Epoch Times’s sister media NTD.

“We need to figure out what we need to do to protect ourselves from a disease that's in China from coming here, if we can.”

From the early days of the pandemic, the CDC had tried to offer assistance to China. Letters The Epoch Times obtained showed that Dr. Robert Redfield, who was head of the CDC at the time, had attempted to arrange for a team of experts to fly to China to help identify the virus. The United States and allies made nearly 100 requests to China asking to offer assistance in the health crisis, but the regime rejected them all, according to David Asher, a former lead COVID-19 investigator at the U.S. State Department.

Now, concerns about overcrowded hospitals and long lines for seeing a doctor have led China’s top health body, the National Health Commission, to call for local clinics to increase their capacity.

Chinese People on Front Line

Chinese authorities haven’t provided any data on the current outbreak, but many schools are telling students to stay home because of the large number of sick children.

A woman from Yunnan Province in southwestern China said that her four children are all experiencing fever. One of them has had a fever for half a month, with pimples appearing on the face and their throat swelling up and festering.

“The doctor didn’t tell us much and prescribed us some drugs. We’ve been taking them, but there hasn’t been much effect,” she told The Epoch Times.

Beijing resident Ms. Lin said that her two children had become infected first, before spreading the illness to her and her husband.

At their school, parents have been asked to send digital requests for a leave of absence to a group chat monitored by teachers if their children become sick.

“Every day, we would see some children explaining why they can't come to school,” she told The Epoch Times.

A majority of sick students are coughing. And even days after their symptoms go away, some of the children would start coughing again or develop fever soon after they returned to school, she said.

https://www.zerohedge.com/medical/republican-lawmakers-call-cdc-attention-suspicious-virus-outbreak-china

House Committee Puts CDC Director in the Spotlight

 Members of a House committee seemed to go a bit easy on CDC Director Mandy Cohen, MD, MPH, when they questioned her Thursday about her agency's failures during the COVID-19 pandemic, although some Republicans still took the opportunity to criticize the agency.

"If the CDC wants its credibility back, you've got to have a mea culpa moment," Rep. Dan Crenshaw (R-Texas), a member of the House Energy & Commerce Oversight and Investigations Subcommittee, told Cohen during a hearing on the CDC's challenges in rebuilding trustopens in a new tab or window during the respiratory virus season. "You're in the perfect position to do it because you had nothing to do with their decisions at the time."

"You can blame it on hindsight, you can blame it on 'we didn't know as much as we know now' -- you can do all sorts of things, but you can tell the truth," he added. "And then the public will start trusting the CDC again."

But Cohen seemed more focused on the actions her agency was taking now and would take in the future. "There have been many ways in which we've been thinking about lessons learned, particularly whether we think about the communication space or the lab safety space and the quality space," she said. Cohen appeared to be referring to what many people consider the mixed messages that the CDC gave at the beginning of the pandemic regarding the effectiveness of masks, as well as the agency's decision to roll out COVID-19 tests that it knew were flawedopens in a new tab or window.

"Those are all lessons learned that we're already baking in to our work, and I hope you're already seeing us communicate differently, both more timely, telling folks what we know when we know it -- and also what we don't know," she said. "I think we have many new procedures related to lab quality to make sure we don't ever see the mistakes on the lab side that we saw before. And we are making sure our workforce is ready to respond."

Rep. Jeff Duncan (R-S.C.) criticized the mask mandates and school closures that Cohen oversaw earlier in the pandemic when she was the health secretary for North Carolina.

"I'm very proud of the work that we did in North Carolina," Cohen responded. "I feel like we did that in a way that was very inclusive. We listened. I had great partners on both sides of the aisle in North Carolina who did that work."

She added that, at the time -- 3 years ago -- "we had very little information, we barely had any tests. We had very little PPE [personal protective equipment]. We certainly didn't have vaccines or treatment. There were very few tools at our disposal to protect folks."

Duncan asked if she would impose similar restrictions today. "The good news is, we're in a new place," Cohen said. "But I want to make sure that we are in a place where we don't have to get into that [situation] again."

Duncan expressed concern that the agency's authority was too broad. "We in Congress have never told the CDC definitively what it's supposed to do and what it isn't supposed to do," he said. "This has led to mission creep at CDC; I see the CDC as an agency of all trades but master of none ... We in Congress need to revisit the CDC's authority to impose mask mandates and vaccine mandates."

Situation in China

Subcommittee Chair Rep. Morgan Griffith (R-Va.) said the level of CDC cooperation since Cohen became director was "a little bit disappointing."

"CDC specifically has not responded to certain letters -- instead, we've received letters signed by the HHS Assistant Secretary for Legislation," he said. "Even these responses did not respond to all of our questions or provide a single document; instead, the responses recounted publicly available information ... Will you commit to working with us?"

Cohen said she would do so.

Griffith also expressed concern about the recently reported increase in respiratory viruses among children in Chinaopens in a new tab or window. "This subcommittee sent a letter to you just yesterday regarding this mysterious uptick in cases," he said. "We are hoping that you can put some pressure in an attempt to try to get China to not mislead the world as they did with COVID-19."

"What we know as of right now [is that] in China they are having an increase in some of their respiratory illnesses," Cohen responded. "In the northern part of their country, they're seeing an uptick in their pediatric population. We do not believe this is a new or novel pathogen. We believe this is all [already] existing -- meaning COVID, flu, RSV, mycoplasma [pneumoniae], but they are seeing an upsurge."

"CDC does have an office in China, and our officials have been in touch with our counterparts to make sure they were understanding the situation there," and they were saying there isn't a novel pathogen, she added.

Response on Mask Types Criticized

Rep. Debbie Lesko (R-Ariz.), the subcommittee's vice-chair, asked Cohen which was better for COVID-19 prevention: surgical masks or cloth masks. Cohen did not respond directly, saying only that "masks work" and that surgical masks work to protect the person wearing them from circulating viruses. When Lesko pressed her for a more definitive answer, Cohen said, "Surgical masks are certainly better -- N95s are better than that. But cloth masks still provide some barrier ... When CDC makes its recommendations about what kind of mask to wear, we say, 'wear a well-fitting, appropriate mask.'"

That answer left Rep. Scott Peters (D-Calif.) very dissatisfied. "I wanted a clear answer to the question, 'do cloth masks work?'" he said. "And you gave me an answer as a lawyer, but I had a hard time understanding it, and I think it's a fair question. And I guess I wish that you just said, 'Don't use a cloth mask; use a surgical mask.' Don't we have enough information to answer the question like that?"

Cohen continued to demur. "I want to make sure that we are saying that cloth masks are a barrier, meaning that they do work," she said. "But do surgical masks work better? Absolutely. Would I wear a cloth mask? No, I wouldn't. I would wear a surgical mask."

Peters was still not happy. "That's still pretty complicated ... [If] my neighbor would say, 'Should I still wear a cloth mask?' I don't know from your answer of what I should tell them."

Malaria Response

Subcommittee Chair Rep. Kathy Castor (D-Fla.) praised Cohen for the CDC's work on a malaria outbreak in Florida, saying she was "heartened" by the agency's quick response.

Cohen called that incident a "good news" story. "When we identified those first few cases of domestically acquired malaria -- which we hadn't seen in 20 years -- the local leaders were very much on top of it, but were able to reach back to state and then to us at CDC to ask for assistance," she said. "We were able to provide technical assistance related to how to control the mosquitoes and how to think about treatment for the individuals. We gave out guidance to the local communities, as well as the healthcare providers in that agency to make sure that they were looking for additional cases. We provided some backup laboratory capability for the area, and we also made sure to look at all of the mosquitoes in the area to make sure we weren't seeing further malaria in those mosquitoes."

https://www.medpagetoday.com/publichealthpolicy/publichealth/107624

Clinician Says Her Voice Was Cloned by AI for Social Media Ad

 Los Angeles podiatrist and social media personality Dana Brems, DPM, has charged in an Instagram post

opens in a new tab or window that a company used AI to make a fake recording of her voice for an ad.

The post shows Brems reacting, mouth covered in dismay, to what she said was an advertisement that "used an AI clone of my voice to pretend I recommended their product."

Social media posts from Brems regarding the ad -- which appears to be for an ear cleaning device -- have since racked up views, with many commenters pointing to the potential harms of fake health-related recommendations tied to medical professionals.

Brems discovered the ad via Facebook Rights Manager, which picked up the video because the first few seconds are from one she actually made, she told MedPage Today in an email.

The video Brems made was of her reaction to a separate video of people sticking an object in their ear, she said, which she described as dangerous, noting "we don't recommend sticking even Q-tips in your ears."

"So what the AI did is they faked the second half of that video," Brems said, making it sound as though she said she recommends using the product in the ad.

Who made the ad, or where they are based, remains unclear. Brems said the Instagram account where she found the ad, as well as an associated website, have been deleted following her post calling attention to the issue.

Hany Farid, PhD, of the School of Information at the University of California Berkeley, told MedPage Today in an email that he had analyzed the audio Brems called out, using a model he and colleagues trained to distinguish real voices from AI-generated ones. "This model classifies the audio as AI-generated," Farid said.

This instance is not an isolated one, he noted.

"As voice cloning has improved, I've been seeing an increase in these types of fakes," said Farid, who is also a member of the Berkeley Artificial Intelligence Research Lab.

"In addition to the increasing ease with which deepfake videos can be made, it is also clear that the large social media platforms remain ill-equipped to handle content moderation as it pertains to deepfakes," he added.

Ashley Hopkins, PhD, senior research fellow in the College of Medicine and Public Health at Flinders University in Adelaide, Australia, said that the technology to clone voices or make deepfake videos is "readily available via various online tools," and that, "minimal original audio or visual content is required to create convincing deepfakes without consent."

"The creation of deepfakes without an individual's knowledge raises serious ethical issues," Hopkins told MedPage Today in an email. "There's an urgent need for robust regulatory frameworks to ensure AI developers implement strategies to prevent publicly accessible AI tools from facilitating such impersonations, whether it be of healthcare professionals or others."

For Brems, her concern also extends beyond her own experience.

"Once people catch on that they can use AI to impersonate doctors [and] other authority figures," Brems said, "it's going to be a huge problem."

https://www.medpagetoday.com/special-reports/features/107609

Biora: FDA OKs IND Application for Drug/Device Combo for Ulcerative Colitis

 BT-600 will deliver a proprietary liquid formulation of tofacitinib via the NaviCap™ device for topical delivery to the colon

Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for BT-600, a drug/device combination for the treatment of moderate to severe ulcerative colitis.

https://www.globenewswire.com/news-release/2023/11/30/2788995/0/en/Biora-Therapeutics-Announces-FDA-Clearance-of-IND-Application-for-Drug-Device-Combination-BT-600-Targeting-Treatment-of-Ulcerative-Colitis.html

Leftist Mobs Are Exploiting The Palestinian Issue As Vehicle For Cultural Revolution

 In the early years of the Cultural Revolution Mao and the hard line communists were facing an increasing decline in their influence over Chinese society as their political opponents wanted more freedom in markets and changes in the CCP power structure.  In order to reestablish his dominance, Mao exploited the naivety and impulsiveness of college age children and used propaganda to appeal to their natural rebellious inclinations to conjure a rally cry of communist renewal.  Creating an ideological fervor, fear would be Mao's ultimate weapon.

Thus began the Cultural Revolution, a war against competing values and Mao's political enemies disguised as “youthful activism.”  The mob became a roving army for the establishment, terrorizing the population as they targeted symbols of what they called the “Four Olds”:

Old cultures, old ideas, old customs, and old habits.  In other words, anything that might sideline the communist cult in the mind of the public.  No ideas were allowed other than far-left ideas.  

Museums were protested, ransacked and destroyed.  Centers of learning were shut down. Statues, art and symbols from China's history were torn down.  Business owners and property owners were harassed, beaten or killed.  Struggle sessions were held regularly as the mobs dragged accused individuals into kangaroo courts and forced them to confess to the sin of not being communist enough.  

Eventually, murder and genocide became a rationalized tactic to further the revolution.  As long as the activists were killing Mao's potential enemies and keeping the populace in check, they were not interfered with.  The Red Guard was ordered to stand down and allow the activists to do whatever they pleased.  People singled out by the mob had no hope; no one was coming to save them.  One had to virtue signal their loyalty to the red  menace and to Mao daily, and even then they still might not be safe.

 

If any of this sounds familiar, it's because the exact same tactics are being used today by the establishment and the political left in America and Europe.  We haven't quite reached the point of mass-murder in the name of “diversity, equity and inclusion,” but give it a little more time and that is likely where western civilization is headed.  

Black Lives Matter hysteria is now in steep decline, the public is growing increasingly exhausted with militant gay and trans propaganda, the Jan. 6th hype is not turning the public against conservatives the way the media hoped it would and no one cares about climate change doom mongering anymore - The political left is facing a spiral into irrelevancy as all their favorite hot button issues fade into the background.  They need a new conflict to co-opt.

Suddenly, the war between Hamas and Israel has become the defining concern of the leftists in the west.  Most of them have never traveled to the region, have no genetic or cultural ties to it, they have no education on the basic history of the divide and many of them actually believe that Muslim culture is compatible with progressive ideals.  

It's an odd thing to be sure.  Not long ago these same activists were rabidly defensive of Israel and organizations like the ADL, accusing conservative critics of “anti-semitism.”  Now, they are chanting slogans like “from the river to the sea,” a mantra calling for the erasure of Israel. 

   

Why do leftists take sides in Israel at all?  Because it is politically convenient to do so.  They don't care about the plight of Palestinians or Israelis, they only care about movements of social power and using those causes to get what they want.  For a time, the Israeli/Jewish cause was useful to them.  The ADL and similar organizations operated as an amplifier for woke activism and conservatives could be demonized as bigots for exposing ADL operations.  The two groups worked as a tag team.

Now, Israel is more valuable to the left as a monster to be slain as they covet what they see as an untapped resource among Muslim migrants who also predominantly hate the west.  The call for “decolonization” is the running theme; whether in reference to Israel, the US or Europe, the end game is deconstruction of all ideas outside of the woke ideology.  Decolonization is merely an excuse - A way to hide a declaration of war behind the righteous mask of activism.  And much like the Cultural Revolution in China, law enforcement to contain the intimidation is noticeably absent or neutered.  It is as if they have been ordered to keep intervention to a minimum.

The purpose of the this revolution is to dismantle the “Four Olds” in the west, and leftists are hoping Muslim migrants will be a source of muscle to help them finish the job.

They are attempting to consolidate a wide array of inconsistent causes into one framework that they can control and it's hard to see how exactly the organization is going to work.  Can progressives mix feminism, socialism, atheism, and LGBT indoctrination with Muslim Sharia culture which seeks to remove all of these things?  It's doubtful, but the two groups seem to see each other as mutually beneficial for now. 

After Muslims have served their purpose progressives will cast them into the deplorable pit as well, just as they have turned on their old allies in Israel.  In the meantime, you're going to continue seeing wave after wave of mob actions in the US and Europe, replete with Muslim and Hamas slogans right next to BLM, Antifa, feminist and LGBT protest signs.  It's not supposed to make logical sense, it's a cultural revolution; the point is to destroy the old culture by any means necessary and sort out the rest later. 

https://www.zerohedge.com/political/leftist-mobs-are-exploiting-palestinian-issue-vehicle-cultural-revolution

Priority Review to Merck’s Application for KEYTRUDA Plus Padcev in Urothelial Cancer

 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv), an antibody-drug conjugate, for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (la/mUC). This application is being reviewed under the FDA’s Real-Time Oncology Review (RTOR) program, which aims to improve the efficiency of the review process of applications to ensure that treatments are available to patients as early as possible. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of May 9, 2024.

https://www.businesswire.com/news/home/20231130062501/en/FDA-Grants-Priority-Review-to-Merck%E2%80%99s-Application-for-KEYTRUDA%C2%AE-pembrolizumab-Plus-Padcev%C2%AE-enfortumab-vedotin-ejfv-for-the-First-Line-Treatment-of-Patients-With-Locally-Advanced-or-Metastatic-Urothelial-Cancer

Nevro Announces Acquisition of Vyrsa™ Technologies

 Refinances with $200M Structured Debt Maturing in 2029

 Nevro Corp. (NYSE: NVRO), a global medical device company that is delivering comprehensive, life-changing solutions for the treatment of chronic pain, today announced that it has acquired Vyrsa Technologies ("Vyrsa"), a privately held medical technology company focused on a minimally invasive treatment option for patients suffering from chronic sacroiliac joint ("SI Joint") pain.

Under the terms of the transaction, which signed and closed on November 30, 2023, Nevro paid $40 million at closing and agreed to pay up to an additional $35 million in cash or stock tied to achievement of certain development and sales milestones.

The US SI joint fusion market is valued at over $2 billion and expected to grow by double digits over the next several years1. Vyrsa, established in 2021, is the only SI joint company that manufactures and supports a complete portfolio of FDA-cleared, state-of-the-art sacroiliac joint fusion devices.

Nevro CMO David Caraway, M.D., stated, "Vyrsa's comprehensive product suite allows physicians to tailor therapy to specific patient needs. Their innovative implants provide optimal stability and enhance the opportunity for the SI joint to fuse, providing relief to patients suffering from chronic SI joint pain."

The Vyrsa portfolio of SI joint devices allows physician utilization of the established SI joint fusion Category I CPT codes at all approved sites of service for SI joint fusion procedures.

Nevro CEO Kevin Thornal commented, "The acquisition of Vyrsa leverages Nevro's ability to drive long-term shareholder value by accelerating our key strategic initiatives of commercial execution, market penetration, and profit progress. Vyrsa offers differentiated implants to our current call point of physicians that will help drive growth. We are ecstatic to be able to bring long-term pain relief to the 15-30% of people suffering with chronic low back pain associated with the SI joint2."

Vyrsa is projected to be accretive to Nevro in 2024 for both revenue and AEBITDA.

Closes $200 M Term Loan Credit, Refinances Portion of 2025 Convertible Notes

Nevro also announced the closing of a 6-year, $200 million term loan credit facility, the proceeds of which will be used to repurchase the majority of its 2025 Convertible Notes and for working capital and other general corporate purposes. Interest on the term loans accrues at a per annum rate of SOFR + 5.25%. At Nevro's election, certain portions of the interest may be paid-in-kind. Nevro also issued the lender a warrant to purchase approximately 2.6 million shares of Nevro common stock at a $23.19 exercise price, representing a 40% premium to Nevro's trailing 5-day VWAP.

https://www.prnewswire.com/news-releases/nevro-announces-acquisition-of-vyrsa-technologies-302002631.html