S Korea Will Lend 500,000 Artillery Shells To Shore Up Drained US Arsenal, Help Ukraine

 In a move that could help the US government supply Ukraine with ammunition, South Korea has agreed to lend the Pentagon 500,000 155mm artillery shells, Reuters reports, citing a South Korean newspaper. 

As the Pentagon relentlessly pours weapons and ammunition into its Ukraine proxy war against Russia, the American arsenal has been rapidly depleted, to the point that the Biden administration is going around begging to buy or "borrow" ammo from other countries. 

The United States has given Ukraine more than a million 155mm shells. The Korean deal will provide some relief to US stockpiles and thus the Ukrainian supply chain, but apparently came after significant hand-wringing in Seoul. 

"We've opted to significantly increase the volume of shells but take the rental method, after exploring how to respond to the request of the blood ally in good faith while sticking to the government principle of not providing lethal weapons to Ukraine," an anonymous source told the South Korean paper DongA Ilbo.  

The loaned shells will ostensibly be used to backfill the US stockpile. However, given ammunition is rather fungible, the net effect is that South Korea will aid the Ukrainian army, something prohibited by South Korean arms export policy.   

The report of the deal comes amidst a furor in South Korea over the apparent revelation that the US government spied on Korean officials as they deliberated over the decision. That conclusion is driven by purported Department of Defense documents that are among many that have leaked over the past several weeks, causing headaches for the Biden administration.

While the The Wall Street Journal couldn't authenticate the documents, the paper said "they contain enough detail to give them credibility." If legitimate, they include detailed accounts of March 1 discussions among South Korean President Yoon Suk Yeol's most senior aides. 

The officials were wary that selling ammunition to the United States would violate South Korea's policy against sending arms to countries at war. The New York Times reported that, according to the leaked documents, Korean officials also feared provoking Russia, as Seoul is looking to Moscow for help in moderating North Korean belligerence. 

South Korea's president has previously declared his country won't provide weapons to Ukraine, but  the documents suggest that, behind closed doors, Korean officials were conspiring to circumvent that public assurance.  

Ukrainian soldiers fire a US-supplied M777 howitzer near Bakhmut on March 17 (Aris Messinis/AFP/Getty Images via Bloomberg)

The leaked materials say South Korea's then-national security advisor Kim Sung-han offered the idea of selling 330,000 shells to Poland "as getting the ammunition to Ukraine quickly was the ultimate goal of the U.S.” Under that sham-transaction concept, Poland would be agree to be designated the "end user" of the ammo, only to turn around and send it to Ukraine.  

In a statement that should invite heavy skepticism, on Tuesday, a senior South Korean presidential office official claimed that senior US and South Korean defense officials agreed that many of the documents are forgeries. The same official also said it's not possible to spy on South Korea's presidential office, given its impenetrable security, reports the Journal.  

Despite those Baghdad Bob-esque assurances, a South Korean probe is underway. “If it is true that they have spied on us, it is a very disappointing act that undermines the South Korea-U.S. alliance, which is based on mutual trust,” said Lee Jae-myung, leader of the main opposition Democratic Party. 

In September, Doug Bush, assistant secretary of the Army for acquisition, logistics and technology, told a media round-table that the Pentagon is striving to nearly triple US production of 155mm shells.  

The DOD has shipped M777 155mm howitzers to Ukraine. Highly mobile and readily transported via helicopter, it's a novel weapon to the Ukrainians, so Americans have provided training at an "undisclosed area outside of Ukraine." Here's some Radio Free Europe/Radio Liberty propaganda on the M777's role in the war: 

https://www.zerohedge.com/geopolitical/s-korea-will-lend-500000-artillery-shells-shore-drained-us-arsenal-help-ukraine

X4: Phase 3 Data to Be Presented at Clinical Immunology Society

 X4 to host virtual investor event on Tuesday, May 16

CIS oral presentation to take place on Sunday, May 21

 X4 Pharmaceuticals, Inc. (Nasdaq: XFOR), a leader in the discovery and development of novel small molecule therapeutics to benefit patients with diseases of the immune system, today announced that its submitted late-breaker abstract entitled "Results of a Phase 3 Trial of an Oral CXCR4 Antagonist, Mavorixafor, for Treatment of Patients With WHIM Syndrome" has been accepted for oral presentation at the Annual Meeting of the Clinical Immunology Society (CIS), which is taking place May 18-21, 2023, in St. Louis, MO. New data related to clinical secondary endpoints, among other assessments, are to be presented.

In addition, X4 announced that the company will host a virtual event to present and discuss new data from the 4WHIM Phase 3 clinical trial at 4:00 pm ET on Tuesday, May 16, following expected publication of conference abstracts. In November 2022, X4 announced that the 4WHIM trial had met its primary endpoint and a key secondary endpoint, and that mavorixafor was generally well tolerated in the trial, with no treatment-related serious adverse events reported and no discontinuations for safety events. New data to be presented during the event will focus on additional secondary endpoints, including the impact of oral, once-daily mavorixafor on the rate, severity, and duration of infections, among other outcomes metrics, as measured during the 52-week trial period.

Additionally, the company expects to provide an update on its U.S. regulatory activities in support of its potential New Drug Application-submission for mavorixafor for the treatment of WHIM syndrome, which is expected early in the second half of 2023.

The X4 live-event webcast will be accessible on the investor relations section of the X4 website at www.x4pharma.com. Following the completion of the event, a replay will be available on the website.

https://finance.yahoo.com/news/x4-pharmaceuticals-announces-breaking-abstract-120000042.html

Dentists issue dire warning about ‘catastrophic’ TikTok DIY dentistry trend

 It looks simple.

A beautiful influencer instructing her followers how to whiten their teeth at home and bypass those pesky medical fees.

But dentists across the country are warning of the dangers lurking behind these videos.

They say they are witnessing first hand the damage of the growing trend of Do-It-Yourself dental procedures young people are replicating.

“Life hack” videos are rife on TikTok and other social media sites, showing people whitening teeth with everything from purple shampoo, bentonite clay and even hydrogen peroxide.

And it’s not the only DIY dental procedure being discussed.

Some show the popular trend of “banding” which involves using rubber bands to get perfectly aligned teeth.

@aka.levi.nelson

3x a week, results every week #fyp #tiktok #teethwhitening #PrimeDayDreamDeals #foryoupage

♬ Rich Minion – Yeat

Others shape their teeth with everything from nail files to sandpaper.

Dr Stephen Liew, the federal president of the Australian Dental Association described the trend to news.com.au as “catastrophic, with severe long-term consequences”.

“A lot of these procedures can be difficult to reverse,” he said.

“There is no world where making a health decision based on a 30-second social media video is a good idea.

“Dentistry is a profession that often performs irreversible procedures, and if you attempt to do any of these yourselves without looking at the scientific evidence, it would be like blindly driving in a straight line without checking a map first – obviously a poor idea.”

He cited the example of influencers recommending ways to mix your own teeth bleach.

“There are cases where use of the wrong concentration of bleach has killed the tooth and when that happens you end in pain and usually require root canal therapy,” he said.

TikTok user @aka.levi.nelson posted the results of using hydrogen peroxide to whiten his teeth over a one-week period.

Tik Tok/ aka.levi.nelson

He said, while dentists might use bleach in teeth whitening, the Therapeutic Goods Association (TGA) controls the levels of bleach dentists are allowed to use for safety.

Dr Liew said he was also concerned photo and video filters had created a warped perception of how normal teeth looked, particularly when it comes to whiteness.

“The body dysmorphism is being pushed so far by social media,” he said, adding that the colour of teeth did not necessarily indicate their health.

Queensland dentist Dr Jeffrey Kho said one of the worst trends he has seen was the use of a scaler hook that can now be purchased online which allows people to clean their own gums.

“We are essentially giving untrained members of the public a sharp instrument to hack off their own teeth,” he said.
“We are seeing damage to gums, recession and sensitivity.”

Dr Kho warned the government needs to implement stricter regulations around social media and dental procedures, before the problem became even more widespread.

“This is an unregulated area, it is not governed by any health act or body,” he said. “It is essentially a free for all.”

Dentist Heath Fraser, also the founder of the dental procedure comparison website Air Smile, agreed but said the industry in the meantime needed to get on the front foot.

“We need to educate patients through social media such as TikTok about the dangers, we need to be fighting the misinformation coming from influencers”.

Dr Fraser said he received questions frequently from young people (15-30) about what they are seeing on social media regarding to DIY dental work.

But some social media influencers are raising alarm bells too.

Sydney content creator Thuy Van Nguyen who goes by the Liz Caire online or @prettyprogress23 told her followers she was offered free at home aligners by a company in exchange for videos featuring the product.

Five months into her treatment, Ms Nguyen noticed her teeth were shifting apart.

“It shifted my jaw. When I visually saw my teeth were moving apart, I went to an orthodontist to get their opinion. And of course, he said, ‘This isn’t safe for your teeth. You need to be having regular check-ups because your teeth are moving so quickly in such a short time,” she said.

The company told her it was normal but a few months later she stopped using the product. She warned her followers, “This was a silly decision on my part. Don’t do it.”

https://nypost.com/2023/04/12/tiktok-diy-dental-trend-having-catastrophic-consequences/

Megyn Kelly blasts ‘non-breasted’ Dylan Mulvaney over Nike sports bra ads

 Megyn Kelly lashed out at Dylan Mulvaney over the “non-breasted’ transgender social media influencer’s deal to pitch sports bras for Nike.

“Nike sponsoring Dylan Mulvaney now for a f–king sports bra,” Kelly said during Tuesday’s edition of “The Megyn Kelly Show” on SiriusXM.

“I’m sorry, Dylan doesn’t have breasts.”

“Dylan’s been taking some sort of a hormone that has turned Dylan into some … I don’t know what’s happening there, but those are not breasts.”

“And Dylan doesn’t need any sort of a bra — never mind a sports bra,” according to Kelly.

She said that women who “know what it’s like to wear a bra” would not “be inspired to buy one based on non-breasted Dylan Mulvaney prancing around in a Nike sports bra.”

Mulvaney has become a lightning rod for criticism after the influencer entered into marketing partnerships with the apparel giant and Bud Light’s parent company, Anheuser-Busch.

“I saw the bullying, and I saw how tough it was… before it was a thing, before it was okay, when it was still very stigmatized,” Kelly said of the trans experience.

She added: “I had nothing but compassion. I feel differently now. I feel like it’s gone too far.”

“They’re getting rid of male and female on birth certificates,” Kelly said.

“Doctors in the hospital are not allowed to ask whether you’re a man or a woman or tell their residents… it’s considered offensive. We can’t say ‘breastfeed.’ That’s offensive.”

Kelly criticized “the parodies of us [women] by people like Dylan and others.”

“These people who are all over TikTok more and more saying, ‘What’s normal is trans… cis, that’s what’s abnormal… What’s normal is the freedom of being a trans person and choosing.’ No, wrong!”

She added: “So I am less and less compassionate by the day, and it seems like that makes me even more so.”

Megyn Kelly said it “appears” Dylan Mulvaney has “an eating disorder.”

Megyn Kelly/YouTube

The Post has sought comment from Mulvaney’s representatives as well as from Anheuser-Busch and Nike.

The two brands have come under fire in recent weeks from conservative critics who decried the decision to feature Mulvaney in ad campaigns.

Mulvaney, a TikTok influencer with more than 10 million followers who transitioned from a man to a woman during the COVID pandemic, recently started promoting Nike and Bud Light products on her social media accounts.

Mulvaney has recently started promoting Nike sports bras to her millions of social media followers.

Dylan Mulvaney/Instagram

Last week, she unveiled her paid partnership with Nike by posing in a sports bra.

The posts were seen by her 2 million followers on Instagram.

“Alert the media — I’m entering my workout era,” Mulvaney wrote.

Her Bud Light partnership prompted high-profile names such as Kid Rock and Travis Tritt to vow a boycott of the beer.

Mulvaney’s partnership with Bud Light has sparked calls for a boycott of Anheuser-Busch.

Instagram

The backlash has also reportedly sparked concern from beer distributors that the controversy could hurt beer sales.

Squabbles have broken out at bars and distributors are canceling events featuring the iconic Budweiser Clydesdale horses.

The 26-year-old Mulvaney is also a pitchwoman for the Kate Spade fashion brand, which has also been criticized by conservatives.

Kelly said women would not buy a sports bra marketed by Mulvaney.

Dylan Mulvaney/Instagram

Mulvaney recently posted a TikTok clip showing her shopping at a Kate Spade retail location in New York’s Rockefeller Center.

The influencer is reported to have earned more than $1 million promoting products such as Ulta Beauty, Haus Labs, Crest, InstaCart, and CeraVe.

https://nypost.com/2023/04/12/megyn-kelly-blasts-bud-light-nike-for-dylan-mulvaney-ads/

Fed expects banking crisis to cause a recession this year, minutes show

 Fallout from the U.S. banking crisis is likely to tilt the economy into recession later this year, according to Federal Reserve documents released Wednesday.

Minutes from the March meeting of the Federal Open Market Committee included a presentation from staff members on potential repercussions from the failure of Silicon Valley Bank and other tumult in the financial sector that began in early March.

Though Vice Chair for Supervision Michael Barr said the banking sector “is sound and resilient,” staff economists said the economy will take a hit.

“Given their assessment of the potential economic effects of the recent banking-sector developments, the staff’s projection at the time of the March meeting included a mild recession starting later this year, with a recovery over the subsequent two years,” the meeting summary stated.

Projections following the meeting indicated that Fed officials expect GDP growth of just 0.4% for all of 2023. With the Atlanta Fed tracking a Q1 gain around 2.2%, that would indicate a pullback later in the year.

That crisis had caused some speculation that the Fed might hold the line on rates, but officials stressed that more needed to be done to tame inflation.

Federal Open Market Committee officials ultimately voted to increase the benchmark borrowing rate by 0.25 percentage points, the ninth increase over the past year. That brought the fed funds rate to a target range of 4.75%-5%, its highest level since late-2007.

The rate hike came less than two weeks after Silicon Valley Bank, at the time the 17th largest institution in the U.S., collapsed following a run on deposits. The failure of SVB and two others spurred the Fed to create emergency lending facilities to make sure banks could continue operations.

Since the meeting, inflation data has been mostly cooperative with the Fed’s goals. Officials said at the meeting that they see prices falling further.

“Reflecting the effects of less projected tightness in product and labor markets, core inflation was forecast to slow sharply next year,” the minutes stated.

But concern over broader economic conditions remained high, particularly in light of the banking problems. Following the collapse of SVB and two other institutions, Fed officials opened a new borrowing facility for banks and eased conditions for emergency loans at the discount window.

The minutes noted that the programs helped get the industry through its troubles, but officials said they expect lending to tighten and credit conditions to deteriorate.

“Even with the actions, participants recognized that there was significant uncertainty as to how those conditions would evolve,” the minutes said.

Several policymakers questioned whether to hold rates steady as they watched to see how the crisis unfolded. However, they relented and agreed to vote for another rate hike “because of elevated inflation, the strength of the recent economic data, and their commitment to bring inflation down to the Committee’s 2 percent longer-run goal.”

In fact, the minutes noted that some members were leaning toward a half-point rate hike prior to the banking problems. Officials said inflation is “much too high” though they stressed that incoming data and the impact of the hikes will have to be considered when formulating policy ahead.

“Several participants emphasized the need to retain flexibility and optionality in determining the appropriate stance of monetary policy given the highly uncertain economic outlook,” the minutes said.

Inflation data has been generally cooperative with the Fed’s aims.

The personal consumption expenditures price index, which is the inflation gauge policymakers watch the most, increased just 0.3% in February and was up 4.6% on an annual basis. The monthly gain was less than expected.

Earlier Wednesday, the consumer price index showed an increase of just 0.1% in March and decelerated to a 5% annual pace, the latter figure down a full percentage point from February.

However, that headline CPI reading was held back mostly by tame food and energy prices, and a boost in shelter costs drove core inflation higher by 0.4% for the month and 5.6% from a year ago, slightly above where it was in February. The Fed expects housing inflation to slow through the year.

There was some bad news on the inflation front: A monthly survey from the New York Fed showed that inflation expectations over the next year increased half a percentage point to 4.75% in March.

Markets as of Wednesday afternoon were assigning about a 72% chance of one more quarter percentage point rate hike in May before a policy pivot where the Fed cuts before the end of the year, according to CME Group data.

Though the FOMC approved an increase in March, it did alter language in the post-meeting statement. Where previous statements referred to the need for “ongoing increases,” the committee changed the phrasing to indicate that more hikes “may be appropriate.”

https://www.cnbc.com/2023/04/12/fed-expects-banking-crisis-to-cause-a-recession-this-year-minutes-show.html

Drug Development Decimation

 Price controls—with all of their associated market distortions—are coming soon to a prescription drug near you. And the Biden administration is eager to get started.

The Centers for Medicare and Medicaid Services (CMS) recently released its guidance memo to explain the first phase of what President Biden calls “negotiations” over Medicare drug prices, allowed through the so-called “Inflation Reduction Act” enacted last August.

CMS will determine the “Maximum Fair Price” for certain drugs through a Rube-Goldberg process it lays out in the memo. Companies must sign an “agreement” with the government before the price-control negotiations can begin and must remain silent about the discussions, even if the government offers to pay them $1 for their product that may have cost up to $3 billion to develop. There’s no such gag order for the government negotiators, however.

Companies the government determines raised prices more than the rate of inflation will face a “price-increase penalty,” to be determined. If a company walks away from the negotiating table, the drug will get dropped from Medicare’s formularies serving 60 million seniors.

The law does not provide any substantive means for manufacturers to appeal the selection of negotiation-eligible drugs or the price the government sets for those drugs.

The impact on patients desperately hoping for treatments and cures for rare diseases is perhaps the most tragic consequence as company executives are forced to pull promising drugs from the research table.

The government basically will freeze today’s innovation in place. The process provides no incentives for companies to continue to improve a drug and find new disease applications, the source of the majority of cancer drugs.

The sheer volume of data that will be required for the federal government to determine the “appropriate price” for a drug will require companies to deploy armies of people to gather the data—a huge amount of work that does nothing to create a single new drug.

And there are steep fines—$1 million a day per violation and more—for companies that do not comply with CMS requirements or make errors.

Judicial review of the government’s price decision is not allowed. CMS did not even go through the normal rule-making process of notification and inviting public comment to which it must respond. It simply issued its 91-page memo and declared it “as final, without a comment solicitation.”

This is “one of the most profound changes” for the industry in 40 years in oncology, Peter Thompson, Private Equity Partner at OrbiMed Advisors LLC, said during a recent BIO forum.  He said the law already is “directly hampering science.”

It’s “much more of a rate-setting approach and not a negotiation,” echoed Chris Mancill, SVP and Head of Worldwide Value Access and Payment and Health Economics and Outcomes Research at Bristol Myers Squibb Company.

What good will all of this do? The American Action Forum took a deeper dive into the impact of the measure Mr. Biden sold as “substantially reducing drug costs for a wide swath of Medicare beneficiaries.”

• The AAF study finds that fewer than 6 million beneficiaries – less than 10% of enrollees – will benefit at all.
  
  
• For those who do benefit, savings are typically modest – 69% of those with any saving will save less than $300.

And for this, the Biden administration appears willing to decimate one of the strongest industry sectors in the U.S. and erode our status as the world leader in pharmaceutical innovation.

The U.S. biopharmaceutical sector directly employs more than 900,000 workers and supports a total of nearly 4.5 million jobs in all 50 states. These are high-paying jobs with everyone from scientists to truck drivers working to create and deploy medicines that will save lives.

Congress is expected to hold hearings on the CMS price-controlling regime and surely can find a way to inject some reason into this process.

Grace-Marie Turner runs the Galen Institute to advance public policy ideas that advance patient-centered health care. @gracemarietweet. She can be reached at galen@galen.org.

https://www.realclearpolicy.com/articles/2023/04/11/drug_development_decimation_893205.html

Medical Reparations Have Arrived

 The Organ Procurement and Transplantation Network (OPTN) and the United Network for Organ Sharing (UNOS) are implementing new policies to make skin color a crucial factor in who receives life-saving kidney transplants. The shift is perhaps the most dangerous victory for wokeness in health care to date.

In the name of “equity,” UNOS and OPTN purport to be expanding black patients’ access to kidney transplants. They essentially claim that the longstanding system for such transplants is racist, pointing to how black patients make up 30 percent of the dialysis population and transplant wait list but receive a smaller fraction of kidney transplants.

Activists assert that this disparity reflects bias on the part of treating physicians, particularly when referring black patients for early kidney care. But a study from the Veteran’s Administration found that more referrals for expert care did not improve outcomes or prevent progression of advanced kidney disease to the need for kidney replacement therapy.

If racism doesn’t explain the discrepancy, what does? The list of reasons is extensive, reflecting disheartening, stubborn problems that physicians and policymakers have long tried to address. One is the advanced age and complex medical conditions of many black patients with diabetes-related kidney failure; many of these patients are also relatively satisfied with dialysis treatments and unwilling to undergo extensive evaluation for transplant suitability. Others include insufficient health literacy, concern about the surgical procedures associated with transplantation, and lack of a support system for post-operative patients—an especially important factor in transplant suitability. Black families are also less likely to supply kidney donors from relatives.

UNOS and OPTN ignore these facts to advance a race-based agenda. They are forcing transplant centers to rework the waitlist for cadaveric kidneys in such a way that favors black patients. The rationale is that the longstanding formula used to estimate kidney function, which was race-conscious and required a second calculation for black patients, was racist.

Yet this second calculation was necessary to produce an accurate value for kidney function in black patients. Without it, the measure would be highly inaccurate, dramatically underestimating kidney function. (Research shows that people of African-American descent tend to have higher levels of muscle mass compared with other population groups, which can affect the levels of creatinine, a waste product produced by muscles, in their blood. Creatinine is used as a marker to estimate kidney function in GFR equations, including the MDRD equation; however, African Americans may have higher creatinine levels even if their kidney function is normal.)

Validated in multiple studies involving hundreds of patients, the old approach was long criticized yet never shown to be inaccurate. Nonetheless, activists demanded a new formula, officially rolled out in 2021. Less accurate than the previous method, the new one lowers kidney-function assessment for black patients to the point that some who did not qualify for placement on the transplant list now meet the requirement. It is a case study in politicized manipulation of data to achieve a predetermined goal.

OPTN isn’t just using this new assessment going forward. It is retroactively applying the new formula—potentially tracing back decades—to previous assessments of kidney function in black patients. Many black patients previously regarded as ineligible for the transplantation waitlist will now be listed, and some will even be moved ahead of others already on the waiting list. How many patients waiting for years for a transplant will be forced to wait still longer? Some estimates say that roughly 70,000 black patients could potentially benefit. That’s a huge number, considering that the current kidney waiting list stands at about 90,000 patients.

OPTN is also preparing, in the name of equity, to abandon its longstanding pledge to those who selflessly donated a kidney to a loved one or even to a stranger through a matching program. Currently, these courageous donors are listed at the top of the transplant waiting list should they ever require a transplant. Donating a kidney does not increase the risk of developing kidney failure, so the need is unlikely. Yet this was the only compensation for the charitable act allowed by law. And it helped reassure donors, many understandably worried about the possibility of needing a transplant of their own.

Five times as many whites as blacks donate kidneys, which means that many more whites enjoy this benefit. Activists therefore see it as racist, and they want OPTN to change its policies. The group is considering four proposals; all would eliminate prior donors’ waitlist priority and give them a mere 10 percent–15 percent improvement on their waitlist position. That would virtually eliminate the chance that a white patient might move ahead of a black patient on the wait list, even after he or she donates a kidney. And this policy, which OPTN expects to finalize before the end of this year, risks discouraging kidney donors as a whole. White people are being punished in the name of righting nonexistent wrongs, but patients of every race will suffer from this move.

The corruption of medicine continues apace. Black patients are being pushed toward the front of the kidney-transplant waiting list on the basis of something other than need. Racial reparations have arrived in health care, and kidney transplants are just the beginning.

Stanley Goldfarb, a physician and former associate dean of curriculum at the University of Pennsylvania’s Perelman School of Medicine, is the chairman of Do No Harm.

https://www.city-journal.org/article/medical-reparations-have-arrived