ClearPoint SmartFrame OR™ Stereotactic System OKd

 ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the “Company”), a global device, cell, and gene therapy-enabling company offering precise navigation to the brain and spine, today announced it has received 510(k) clearance for its SmartFrame OR™ Stereotactic System.

The SmartFrame OR Stereotactic System is composed of two main components: the SmartFrame OR, and the ClearPointer™ Optical Navigation Wand. The SmartFrame OR is intended to provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures performed in conjunction with the use of a compatible optical stereotaxic navigation system using preoperative MR and/or CT imaging. These procedures include biopsies, catheter placement and electrode introduction. The ClearPointer is intended to be used in conjunction with the SmartFrame OR and a compatible stereotactic optical navigation system for patient registration and navigation. SmartFrame OR may be used with or without available bone screw fiducials. The Company plans to commence limited market release in the first half of 2024, with a planned full market release in the second half of 2024.

https://www.globenewswire.com/news-release/2024/01/16/2809835/25687/en/ClearPoint-Neuro-Announces-FDA-Clearance-for-SmartFrame-OR-Stereotactic-System.html

Tesla Charging Stations in Chicago Lined With Dead Cars and Zero Temperatures

 Chicago area drivers stranded their Teslas at charging stations in Chicago highlighting the foolishness of owing an EV without a reliable home charger.

Bunch of Dead Robots

Please consider a Bunch of Dead Robots Out Here.

Desperate Tesla owners in and around Chicago were seen trying to charge their vehicles with no luck amid frigid temperatures that have gripped the Midwest.

“Nothing. No juice. Still on zero percent,” Tyler Beard, who had been trying to recharge his Tesla at an Oak Brook, Illinois Tesla supercharging station since Sunday afternoon, told the news outlet. “And this is like three hours being out here after being out here three hours yesterday.”

“This is crazy. It’s a disaster. Seriously,” said Tesla owner Chalis Mizelle.  Mizelle said she abandoned her car and got a ride from a friend after hers would not charge. “We got a bunch of dead robots out here,” one man said. 

Do I feel sorry for anyone in this situation? No, I don’t. Nor should anyone else.

There is an upside.

The lesson of the day is don’t buy an EV unless you have a home charger. Hopefully this news will stop other people from being silly.

And the report inspired some creative thinking. One person suggested putting a windmill on top of the car to charge the battery.

Only 6 Percent in the US want an EV for their Next Vehicle

On January 15, I noted Only 6 Percent in the US want an EV for their Next Vehicle

If enough people see the dead EV report they may think twice especially if they live where it’s cold.

Hertz Is Selling 20,000 EVs Due to Lack of Customer Demand

On January 11, I noted Hertz Is Selling 20,000 EVs Due to Lack of Customer Demand

Hertz is selling a third of its EVs globally, with 20,000 in the US and will use some of the money to buy more Internal Combustion Engine (ICE) gasoline-powered cars.

Add that to the list of inconvenient facts.

Seeking Green Utopia, the US and EU are Quietly Killing Vital Industries

Despite the inconvenient facts, the US and EU governments are hell bent on pushing everyone they can into EVs.

The sad reality is a Green utopia will never exist. Meanwhile, the US and EU are Quietly Killing Vital Industries.

Finally, in China where EVs are soaring, China is still rapidly adding coal power plants to produce the needed electricity. Hooray?

https://mishtalk.com/economics/tesla-charging-stations-in-chicago-lined-with-dead-cars-and-zero-temperatures/

Proposed Federal Rule Could Exacerbate U.S. Mental Health Crisis

 America at a crossroads in an ongoing mental health crisis, with at least 1 in 5 Americans – both adults and children – living with a mental health condition while too many find it difficult to obtain affordable mental health care or substance use treatment. Quite simply, there are not enough qualified, licensed mental health clinicians to meet the rising demand, and too few of those accept health insurance. There is an obvious need to increase access to affordable mental health care, but in doing so we must ensure mental health professionals continue to be held to a high standard.

Thankfully, the Mental Health Parity and Addiction Equity Act (MHPAEA) was enacted in 2008 to ensure better parity between treating patients with mental and physical health needs which gained bipartisan support.

But now, a new federal rule change to the MHPAEA is being considered. The change would significantly increase the cost and risk for mental health patients, yet it doesn’t address the top issue of the current mental health crisis – the shortage of qualified mental health professionals.

This proposed rule would lower the quality standards for mental health professionals to join an insurance network while also pushing more patients or their caretakers to choose a higher-level mental health professional for even more mild symptoms that could be treated by a primary care physician. Simple supply and demand principles would dictate that this will lead to higher costs and exacerbate an already dangerous shortage of mental health professionals.

While the intent was to help encourage more high-level mental health professionals to join in-network insurance plans, studies show that these providers already have a multiple month waitlist for new patients and don’t want to hassle with having to deal with reimbursements.  Because they don’t have to.

Given how rapidly the mental health crisis is growing, this change could have a devastating impact, particularly to children, substance use disorder patients and low-income Americans who already face more difficulty in finding quality support. These individuals are often the most vulnerable and by lowering care standards, it will become even more difficult to navigate which providers are quality providers.

As a nurse practitioner, I’ve worked with numerous parents over the years who struggle to find the right care for their children. It’s already overwhelming for parents to navigate existing providers, but to inundate the existing field to be filled with less qualified providers, it will become even more difficult. Children will be left bouncing from one provider to the next and their condition is likely to worsen during the search.

Put simply, this rule would actually have the opposite of its intended effect. Instead of taking shortcuts in an attempt to remedy the issue of access to care, the Biden administration should implement real solutions to address the issue.

There are better solutions that are easier to implement and less costly. First, prioritize training and collaboration for primary care physicians to better identify and treat mild symptoms. Second, increase access to telehealth support, which has been a proven way to expand care who are located in areas with limited or no mental health providers. Finally, establish long-term programs to build out the mental health workforce, we can both increase access to and improve mental and behavioral health support.

Primary care physicians are often the first resort when patients are seeking specialized care but are left without the tools needed to help. By improving training for these individuals to identify mental health conditions more easily and accurately, patients will receive more tailored support early on. This would limit the potential for patients to fall into a trial-and-error scenario while seeking care.

Telehealth is also a proven means of improving access to care across the board. While this practice may have been implemented as a response to the COVID-19 pandemic, we should continue to take advantage of the benefits. Instead of imposing impossible care standards, we should support quality providers already in the field and their efforts to care for more patients—even those across state lines. In doing so, access to care for individuals in communities without specialized support will increase significantly.

Finally, the most pressing issue facing our country is a workforce shortage, with roughly 122 million Americans living in a Health Professional Shortage Area (HPSA) for mental health. We are proudly home to some of the best care physicians in the world. Instead of lowering our standards, we should focus on long-term plans to build our mental health workforce. Whether through incentivization programs for medical students to enter the mental health field or other programs, we must address this issue head on.

The answer to addressing the mental health crisis in our country is not to implement a rule that will lower standards of care. We must take meaningful steps to build a qualified workforce and bolster support for qualified physicians already practicing.

Constance “Connie” Garner spent 17 years as Policy Director for the U.S. Senate Committee on Health, Education, Labor and Pensions (HELP) under former Senators Ted Kennedy (D-MA), Chris Dodd (D-CT) and Tom Harken (D-IA) played a pivotal role in drafting The Mental Health Parity Act of 2008. She currently serves as the Senior Policy Director at Foley Hoag, K+LLC and is the executive director of Allies for Independence, a nonprofit focused on addressing long-term support needs in within the disability and aging community.

https://www.realclearhealth.com/blog/2024/01/16/proposed_federal_rule_could_exacerbate_us_mental_health_crisis_1005154.html

Targeting drug middlemen could create more loopholes

 Congress is back in session with a long list of unfinished business. Topping the health-care agenda is legislation that aims to lower the cost of prescription drugs and make their prices more transparent. Although these proposals have rare bipartisan support, lawmakers should proceed cautiously. Some well-intentioned measures could backfire or prove ineffective.

Prescription drug prices in the US have been climbing steadily for decades. About a third of adults say they haven’t taken their medicines as prescribed because of the cost. Patients have also grown frustrated by seemingly arbitrary prices. Why, for example, is the same asthma inhaler $11.99 in one Ohio pharmacy and $1,136 at another?

For years, Congress directed much of the blame toward drugmakers — they set the prices, after all. Increasingly, though, fingers have been pointing to the middlemen at the center of a labyrinthine drug supply chain: pharmacy benefit managers.

PBMs started in the 1960s processing claims for insurance companies. Today, they help clients — namely insurers and big employers — negotiate discounts from drugmakers, known as rebates. PBMs also compile lists of drugs, called formularies, that providers of health benefits agree to cover; establish pharmacy networks that patients can access; and run their own mail-order pharmacies.

Although PBMs are supposed to help lower costs, some of their practices may well do the opposite. PBMs often keep a portion of the rebates they negotiate, which can incentivize them to favor more expensive drugs on their formularies. (A $1 million drug, for example, would fetch a bigger fee than a $100 one.) Manufacturers have been known to give the same drug vastly different prices, knowing PBMs will prefer the higher option.

Other practices appear to reduce competition. PBMs restrict network access to pharmacies that, in theory, offer the lowest prices. In so doing, they often steer patients to pharmacies they own or are affiliated with, making it difficult to determine whether patients ultimately pay less at the counter. Though clients have every right to audit their PBMs, the industry has long been criticized for its evasiveness and opacity.

Congress thus has good reason to examine PBMs’ business practices. It’s unclear, however, whether eliminating certain tactics will lower costs for patients or simply create new loopholes.

 

Consider a proposal to “de-link” rebates from a drug’s list price. If clients paid PBMs a flat fee, instead of a proportion of the discount they negotiate, the incentive to inflate prices would disappear, the thinking goes. Yet there’s little evidence to suggest that drugmakers would subsequently lower their list prices. Indeed, they could very well keep those prices steady — evading statutory penalties for raising prices faster than inflation — and recoup fatter profits. (It’s worth noting that the PBM industry has proved adept at navigating such regulations, opting to reroute payments to new intermediaries and business lines.) Or take a proposed ban on so-called spread pricing, which would prevent PBMs from charging health-plan sponsors more for drugs than what they reimburse to pharmacies. Considering the three biggest PBMs own retail or mail-order pharmacies, any such restriction would most likely shift profits without clearly benefiting patients.

The strongest case is for greater transparency, the focus of a health-care bill that passed the House in December. Plan sponsors complain that requests for more data from their PBMs are routinely denied, making it tough to determine whether they’re getting a good deal. But burdensome new public reporting requirements may not help much. The goal instead should be uncovering conflicts of interest or anticompetitive behavior — ideally informed by a Federal Trade Commission review now underway — and ensuring that PBMs’ business interests are better aligned with those of their clients.

It’s understandable that lawmakers want to reduce drug prices. Given the complexity of the market, they should take their time to get it right — lest even bigger problems crop up in their place.

https://www.arcamax.com/politics/politicalnews/s-3062118

DEI’s Attack Dog

 The movement for diversity, equity, and inclusion may have lost a prominent advocate in Harvard president Claudine Gay, but it continues to dominate America’s institutions. Worse, the Biden administration has apparently enlisted the Southern Poverty Law Center (SPLC), one of DEI’s most notorious ideological enforcers, in its crusade against “domestic terrorism.”

The Southern Poverty Law Center gained its reputation by suing Ku Klux Klan groups into bankruptcy in the 1980s but in recent years has turned its fire on critics of DEI, demonizing parental rights groups like Moms for Liberty and Parents Defending Education. Through its education arm, the SPLC runs a critical race theory program called “Learning for Justice” (formerly “Teaching Tolerance”) that encourages students to categorize people as privileged or oppressed based on their race. Learning for Justice publishes and distributes a magazine to schools across the country.

But the SPLC’s preeminent weapon of cancel culture is a “hate map” that plots mainstream conservative and Christian groups alongside chapters of the Klan. In June, the SPLC added Moms for Liberty and other CRT critics to the map, looking to intimidate its ideological opponents and get donors to pony up cash to fight the “hate.” Companies such as Amazon, Eventbrite, and Vimeo have used the SPLC’s reports to exclude conservative groups.

This organization feels right at home in the Biden administration, and proudly admits as much. In the fall of 2021, about nine months after Biden took office, SPLC president Margaret Huang enthused in a donor meeting that many federal agencies had approached the center for help in crafting a domestic terrorism strategy.

“I think there’s no question that we are unparalleled in our abilities to track and monitor the hate and extremist groups in the country, and I can tell you that we’ve had many agencies in the new Biden administration reaching out to solicit our expertise and our knowledge and information to help shape the policies that the new administration is adopting to counter the domestic terrorism threat,” Huang said at a fundraising event, captured on video and published by The Daily Signal.

Though it may seem a stretch to say that the federal government is relying on a DEI enforcer like the SPLC to sic the feds on conservatives, doing so aligns with Biden’s rhetoric that “Donald Trump and the MAGA Republicans represent an extremism that threatens the very foundations of our republic.” SPLC’s ties to the Biden administration are also a matter of public record. Biden and his team have hosted SPLC leaders and staff at the White House at least 11 times since January 20, 2021, and Biden nominated an SPLC attorney, Nancy Abudu, to a federal judgeship. Last year, the FBI’s Richmond office used the SPLC’s hate group list to target “radical-traditional Catholics” in an infamous memo.

The SPLC decided to add parental rights groups to its hate map last June, two years after the administration began targeting concerned parents. In 2021, the National School Boards Association sent Biden a letter comparing parents protesting school district policies with domestic terrorists and urging the president to use the Patriot Act against them. Documents later revealed that the White House had worked with the school board group to draft the letter. 

When the SPLC added Moms for Liberty to the hate map, it slammed the parental rights group as part of an “anti-student inclusion movement” because Moms for Liberty opposes CRT and sexualized lessons in schools—lessons that the SPLC advocates through Learning for Justice. The administration has also echoed SPLC rhetoric in condemning “book bans,” a false characterization of efforts to remove books with age-inappropriate or pornographic material from school libraries.

In allying itself with the SPLC, the Biden administration overlooks the center’s many scandals. Critics have long noted that the organization exaggerates terror threats to drive donations to its endowment—now worth more than $730 million—and uses offshore accounts in the Cayman Islands. Amid a sexual harassment and racial discrimination controversy in 2019 that saw the SPLC fire its own co-founder, a former employee came forward calling the accusations of hate a “highly profitable scam.”

Worse, the SPLC itself could plausibly be charged with having ties to domestic terrorism. After all, police arrested an SPLC lawyer last March at a Molotov cocktail riot in Atlanta, and he now domestic terrorism charges. The SPLC also defended Antifa after its members’ destructive riots in the summer of 2020.

The SPLC has no business advising any organization, much less the federal government, on domestic terrorism. Yet President Biden seems willing to ignore the SPLC’s troubling recent history to silence critics of his DEI agenda.

Tyler O’Neil, managing editor of The Daily Signal, is the author of Making Hate Pay: The Corruption of the Southern Poverty Law Center.

https://www.city-journal.org/article/deis-attack-dog

Art dealer told Congress Joe Biden called, met him while he sold Hunter paintings

 The art dealer who sold Hunter Biden’s paintings told Congress that President Joe Biden both called and met him at the White House as he was pitching Hunter's artwork and that the first son also made an unusual request to be informed about who bought his pieces, according to testimony that directly undercuts the White House narrative on the sales.

The Biden White House repeatedly told the public that Hunter Biden’s art sales were covered by an ethics agreement to ensure they were arms-length and that the first family -- Hunter included -- was blinded to the identity of buyers.

But George Berges, owner of the prestigious Berges art galleries based in New York and Berlin that sold Hunter Biden’s painting from 2020 to 2023, told congressional impeachment investigators that the first son likely knew the identity of 70% of the buyers – the largest who were Democrat donors – and that Hunter Biden’s first contract made an unusual request when the relationship started.

“I believe in the first contract, he was—he was able to know who the buyers were,” Berges told investigators for the House Oversight and Judiciary Committees in a transcribed interview last week that was reviewed by Just the News. “…I don’t know how it was phrased or—but I remember that there—that that was the difference.”

“Is that normal or unusual, or where’s that? Is it a normal kind of contract?” Berges was asked. 

“That part was different. Normally, the gallerist does not let the artist know who the collectors are,” the art dealer answered.

Berges said a subsequent art sale deal with the first son dropped the requirement for Hunter Biden to be informed. “The first one was that I was required to disclose who the buyers were. In the second one, I was required to not disclose the buyers,” he explained.

Berges was also asked how many of the 15 artists he represents now – except for Hunter Biden – wanted to know the identity of purchasers. “None,” he answered.

Berges also revealed that he no longer represents Hunter Biden for art sales, saying the commercial relationship ended last fall. “I haven't represented him for four months now, and I think that also says something,” Berges said. “And I still talk to him as a friend.” Hunter Biden is still listed on Berges' website.

Not only did Hunter Biden know many of the buyers, Joe Biden apparently knew about the gallery selling Hunter Biden’s art and had two contacts with Berges, according to the testimony.

“Have you spoken to President Biden?” a House investigator asked at one point.
“Yes,” Berges answered.

“Okay. And was that in person or on the phone or both?” the investigator pressed.
“Both,” he answered.

“Can you tell me about the in-person meeting, where that was, when that was?” the questioner inquired. “At the White House wedding during Hunter's - Hunter's daughter getting married,” the art dealer explained.

“Okay. And then on the phone?” the congressional investigator asked.

“My daughter finished camp and he called to, you know, wish her, congratulate her for finishing camp and I answered the phone,” he said.

Berges’ account mirrors that of an earlier Hunter Biden business partner, Devon Archer, who gave explosive testimony to Congress last summer revealing that Joe Biden as vice president got on about two dozen calls with his son’s foreign business associates and had at least two dinners with them. The president had denied any contact with Hunter Biden associates.

Berges’ testimony also confirmed earlier reporting by Just the News, including that:

• Hollywood superlawyer and Democrat donor Kevin Morris bought some of Hunter Biden’s art work: Berges put the total at at least $875,000;
• Democrat donor Elizbeth Naftali, who Joe Biden appointed to a federal commission, bought art work as well. Berges said she bought bought one painting before her federal appointment and one after her appointment;
• Joe Biden fundraiser Lanette Phillips made the connection between Hunter Biden and Berges that led to the art sales deal;
• Berges sold his first piece of art for the first son in December 2020, just before Joe Biden took office; and
• Berges had two art sales agreements with Hunter Biden, one in 2020 and another about a year later.

But the art dealer’s most consequential testimony for the impeachment proceeding involved Joe Biden and his White House. Berges said in addition to meeting and talking with the president while helping Hunter Biden, he had never had any contact with the White House over the supposed ethics agreement.

“When you’re seeing in the press that the White House is putting in certain safeguards regarding an ethics agreement but you’ve had no conversations with [the] White House, I mean, did you ever say to Hunter Biden, ‘Hey, where’s this coming from?’” a congressional investigator asked. “I might have. I probably did, yeah,” Berges said.

“And do you remember what he said to you?" the investigator continued. “I don’t . . . . I do remember being surprised,” Berges explained.

“Why were you surprised?” he was asked. “Because I hadn’t had any communication with the White House about an agreement,” Berges answered.

https://justthenews.com/accountability/political-ethics/tueart-dealer-told-congress-joe-biden-called-met-him-while-he-sold

Vertex-Crispr Treatment of Transfusion-Dependent Beta Thalassemia OKd

 Approximately 1,000 patients in the U.S. 12 years of age and older are now eligible for this one-time treatment

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the U.S. Food and Drug Administration (FDA) has approved CASGEVY™ (exagamglogene autotemcel [exa-cel]), a CRISPR/Cas9 gene-edited cell therapy, for the treatment of transfusion-dependent beta thalassemia (TDT) in patients 12 years and older.

“On the heels of the historic FDA approval of CASGEVY for sickle cell disease, it is exciting to now secure approval for TDT well ahead of the PDUFA date,” said Reshma Kewalramani, M.D., Chief Executive Officer and President of Vertex. “TDT patients deserve new, potentially curative treatment options, and we look forward to bringing CASGEVY to eligible patients who are waiting.”

The administration of CASGEVY requires experience in stem cell transplantation; therefore, Vertex is engaging with experienced hospitals to establish a network of independently operated, authorized treatment centers (ATCs) throughout the U.S. to offer CASGEVY to patients. All nine ATCs activated in the U.S. are able to offer CASGEVY to eligible patients with TDT and sickle cell disease (SCD). Additional ATCs will be activated in the coming weeks and a complete list of ATCs can be accessed at CASGEVY.com.

https://www.businesswire.com/news/home/20240116502203/en/