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Thursday, December 5, 2024

Take Two Puberty Blockers & Call Me In The Morning? Sotomayor Under Fire For Oral Argument

 by Jonathan Turley,

Supreme Court Justice Sonia Sotomayor is under fire today for seemingly dismissing medical concerns over the risks of puberty blockers and gender surgeries for minors with a comparison to taking Aspirin. In the oral arguments in United States v. Skrmetti, Sotomayor pointed out that there are risks to any medical procedure or drug. However, the analogy belittled the concerns of many parents and groups over the research on the dangers of these treatments.

It also highlighted how the Biden Administration and liberal justices were discarding countervailing research inconveniently at odds with their preferred legal conclusion.

The Biden administration is challenging Tennessee’s law banning gender-changing drugs and procedures for minors. That state cites studies that indicate serious complications or risks associated with the treatments for children.

While the conservative justices acknowledged studies on both sides of the debate over risks, the liberal justices seemed to dismiss studies that were inconsistent with striking down the law as a violation of the Equal Protection Clause of the 14th Amendment. That issue produced a difficult moment for Solicitor General Elizabeth Prelogar when Supreme Court Justice Samuel Alito confronted her about statements made in her filing with the Court.

Alito quoted Prelogar’s petition to the Court that claimed that there was “overwhelming evidence” supporting the use of puberty blockers and hormone treatments as safe with positive results for children.

Justice Alito, however, cited extensive countervailing research from European countries showing significant risks and potential harm. The World Health Organization has recognized these risks and lack of evidence supporting these procedures and researchers in Finland recently published a study showing that suicides among kids with gender dysphoria are extremely rare in contradiction to one of the common arguments made for adolescent treatment.

Alito also cited the United Kingdom’s Cass Review, released shortly after her filing. The Cass study found scant evidence that the benefits of transgender treatment are greater than the risks. He then delivered the haymaker: “I wonder if you would like to stand by the statement in your position or if you think it would now be appropriate to modify that and withdraw your statement.”

American Civil Liberties Union attorney Chase Strangio (who has previously argued that children as young as two years old can identify themselves as transgender) seemed to later acknowledge that very few gender-dysphoric children actually go through with suicide, but insisted that the procedures reduce suicidal inclinations.

Justice Sotomayor seemed intent on defusing the problem with the opposing scientific research in her exchange with Tennessee Solicitor General Matthew Rice. In his argument, Rice stated that “they cannot eliminate the risk of detransitioners, so it becomes a pure exercise of weighing benefits versus risk. And the question of how many minors have to have their bodies irreparably harmed for unproven benefits is one that is best left to the legislature.”

That is when Sotomayor interjected: “I’m sorry, counselor. Every medical treatment has a risk — even taking Aspirin. There is always going to be a percentage of the population under any medical treatment that is going to suffer a harm.”

According to studies, aspirin can have potential side effects that are largely quite mild. The studies cited by the state are raising far more serious risks and medical changes, including irreversible double mastesctomies, genital surgeries, sterilization and infertility. There can also be long-term effects in bone growth, bone density, and other developmental areas. Those risks have led European countries to change their policies on the treatments pending further study.

The point is not that the justices should resolve this medical debate, but that it is properly resolved elsewhere, including in the state legislative process.

Sotomayor’s aspirin analogy seemed gratuitously dismissive for many and reminiscent of the response to scientists who questioned Covid protocols and policies from the six-foot rule to mask efficacy.

Stanford Professor Dr. Jay Bhattacharya (who is now nominated to lead the National Institutes of Health) and others were vilified by the media over their dissenting views on the pandemic and efforts to show countervailing research. He and others signed the 2020 Great Barrington Declaration that called on government officials and public health authorities to rethink the mandatory lockdowns and other extreme measures in light of past pandemics.

All the signatories became targets of an orthodoxy enforced by an alliance of political, corporate, media, and academic groups. Most were blocked on social media despite being accomplished scientists with expertise in this area.

Some scientists argued that there was no need to shut down schools, which has led to a crisis in mental illness among the young and the loss of critical years of education. Others argued that the virus’s origin was likely the Chinese research lab in Wuhan. That position was denounced by the Washington Post as a “debunked” coronavirus “conspiracy theory.” The New York Times Science and Health reporter Apoorva Mandavilli called any mention of the lab theory “racist.”

Federal agencies now support the lab theory as the most likely based on the scientific evidence.

Likewise, many questioned the efficacy of those blue surgical masks and supported natural immunity to the virus — both positions were later recognized by the government.

Others questioned the six-foot rule used to shut down many businesses as unsupported by science. In congressional testimony, Dr. Anthony Fauci recently admitted that the 6-foot rule “sort of just appeared” and “wasn’t based on data.” Yet not only did the rule result in heavily enforced rules (and meltdowns) in public areas, the media further ostracized dissenting critics.

Again, Fauci and other scientists did little to stand up for these scientists or call for free speech to be protected. As I discuss in my new book, The Indispensable Right,” the result is that we never really had a national debate on many of these issues and the result of massive social and economic costs.

For scientists attacked and deplatformed for years, Sotomayor’s statements were painfully familiar. They also cited European and countervailing studies that the media dismissed as fringe views or conspiratorial viewpoints. In the same way, Justice Sotomayor’s analogy seemed to treat those raising these concerns (including parents) as akin to questioning the risks of aspirin. The import seemed to be that stopping taking aspirin based on minor concerns would be ridiculous and so too are objections to gender changing treatments and procedures.

The fact is some analogies are poorly chosen or misunderstood. However, the thrust of the comments from the justice were dismissive of the science supporting Tennessee and the 23 states with similar laws. That is roughly half of the states which want to adopt a more cautious approach.

No one was arguing against adults being able to opt for such treatment, but these states do not want children to be subject to the treatments in light of this ongoing debate.

*  *  *

Jonathan Turley is the Shapiro professor of public interest law at George Washington University and the author of “The Indispensable Right: Free Speech in an Age of Rage.”

https://www.zerohedge.com/political/take-two-puberty-blockers-call-me-morning-justice-sotomayor-under-fire-aspirin-analogy

Trump, RFK Jr. Met With Pfizer, Lilly Execs

 U.S. President-elect Donald Trump met with the chief executives of U.S. drugmakers Pfizer and Eli Lilly as well as industry lobbying group PhRMA on Wednesday night, Axios reported on Thursday.

Robert F. Kennedy Jr., Trump's pick to lead the United States' top health agency, was also present at the meeting, according to the report.

Eli Lilly, Pfizer and PhRMA did not immediately respond to Reuters' requests for comment.

Trump and the company executives discussed how the public and private sectors can collaborate on finding cures for cancer, among other topics at the meeting, which took place at Mar-a-Lago, according to the report.

Trump's incoming chief of staff, Susie Wiles, also attended the meeting, the report added.

https://www.usnews.com/news/us/articles/2024-12-05/trump-rfk-jr-met-with-pfizer-lilly-executives-axios-reports

What The Trump Nominees Have Not Done... And Will Not Do

 by Victor Davis Hanson via American Greatness,

Deflated by the resounding November defeat, the left now believes it can magically rebound by destroying Donald Trump’s cabinet nominees.

Many of Trump’s picks are well outside the usual Washington, DC/New York political, media, and corporate nexus.

But that is precisely the point - to insert reformers into a bloated, incompetent, and weaponized government who are not part of it.

Trump’s nominee for FBI director, Kash Patel, is already drawing severe criticism.

His furious enemies cannot go after his resume, since he has spent a lifetime in private, congressional, and executive billets, both in investigations and intelligence.

Instead, they claim he is too vindictive and does not reflect the ethos of the FBI.

But what will Patel not do as the new director?

He will not serially lie under oath to federal investigators as did interim FBI Director Andrew McCabe, a current Patel critic.

He will not forge an FBI court affidavit, as did convicted felon and agency lawyer Kevin Clinesmith.

He will not claim amnesia 245 times under congressional oath to evade embarrassing admissions as did former Director James Comey.

He will not partner with a foreign national to collect dirt and subvert a presidential campaign as the FBI did with Christopher Steele in 2016.

He will not use the FBI to draft social media to suppress news unfavorable to a presidential candidate on the eve of an election.

He would not have suppressed FBI knowledge that Hunter Biden’s laptop was genuine—to allow the lie to spread that it was “Russian disinformation” on the eve of the 2020 election.

He will not raid the home of an ex-president with SWAT teams, surveil Catholics, monitor parents at school board meetings, or go after pro-life peaceful protestors.

Decorated combat veteran Pete Hegseth is another controversial nominee for secretary of defense.

What will Hegseth likely not do?

Go AWOL without notifying the president of a serious medical procedure as did current Secretary Lloyd Austin?

Install race and gender criteria for promotion and mandate Diversity, Equity, and Inclusion training?

Insinuate falsely that cabals of white supremacists had infiltrated the military—only to alienate that entire demographic and thus ensure the Pentagon came up 40,000 recruits short?

Oversee the scramble from Kabul that saw $50 billion in U.S. military equipment abandoned to Taliban terrorists?

Watch passively as a Chinese spy balloon traversed the continental United States for a week?

Allow the chairman of the Joint Chiefs to promise his Chinese communist counterpart that the People’s Liberation Army would first be informed if the President of the United States was felt to issue a dangerous order?

Rotate into the Pentagon from a defense contractor boardship and then leave office to rotate back there to leverage procurement decisions?

Oversee the Pentagon’s serial flunking of fiscal audits?

Health and Human Services nominee Robert F. Kennedy, Jr. is certainly a maverick. He may earn the most Democratic hits, given his former liberal credentials.

But what will RFK also not do as HHS secretary?

Oversee his agencies circumventing U.S. law by transferring money to communist China to help it produce lethal gain-of-function viruses of the COVID-19 sort—in the manner of Dr. Fauci?

Organize scientists to go after critics of mandatory masking and defame them?

Give pharmaceutical companies near-lifetime exemptions from legal jeopardy for rushing into production mRNA vaccines not traditionally vetted and tested?

Leave office to monetize his HHS expertise and thus make millions from the pharmaceutical companies?

Trump’s nominee for Director of National Intelligence, former congressional representative and military veteran Tulsi Gabbard, will soon be defamed in congressional hearings.

But what has Gabbard not done?

Joined “51 former intelligence authorities” to lie on the eve of the 2020 election that the Hunter Biden laptop “had all the hallmarks” of a Russian information/disinformation operation”—in an effort to swing the election to incumbent Joe Biden?

Lied under congressional oath like former DNI James Clapper, who claimed he only gave the “least untruthful answer” in congressional testimony?

Encourage the FBI to monitor a presidential campaign in efforts to discredit it—in the manner of former CIA Director John Brennan, who lied not once but twice under oath?

Fail to foresee the American meltdown in Kabul, the Russian invasion of Ukraine, the Hamas terrorist attacks on Israel, or the Houthis takeover of the Red Sea?

*  *  *

We are going to hear some outrageous things in the upcoming congressional confirmation hearings.

But one thing we will not hear about are the crimes, deceptions, and utter incompetence of prior and current government grandees.

The current crew, not their proposed Trump replacements, prompted the sick and tired American people to demand different people.

Voters want novel approaches to reform a government that they not only no longer trust but also now deeply fear.

https://www.zerohedge.com/political/what-trump-nominees-have-not-done-and-will-not-do

Merck, Ridgeback Start Phase 3 in Treatment of COVID-19 in High-Risk Adults

 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the initiation of the Phase 3 MOVe-NOW clinical trial to evaluate LAGEVRIOTM (molnupiravir), an investigational oral antiviral COVID-19 medicine, for the treatment of adults with COVID-19 at high risk for disease progression. This double-blind, placebo-controlled, global study is enrolling individuals who are at least 18 years of age, tested positive for SARS-CoV-2 infection, have had COVID-19 symptoms for four days or less, and are not hospitalized. Additionally, the study will only enroll adults who cannot receive nirmatrelvir/ritonavir (NMV/r) due to drug-drug interactions, allergy, previous adverse effects, or inaccessibility.

The MOVe-NOW study will use a different formulation of LAGEVRIO that includes two smaller 400-mg tablets per dose (four daily tablets) instead of the currently available four 200-mg capsules per dose (eight daily capsules). The smaller tablets are not currently approved for use in any country. For more information on the trial, visit clinicaltrials.gov.

“COVID-19 remains a leading cause of hospitalization and death around the world, and further studying LAGEVRIO may provide important insights into how it may be used to help prevent severe outcomes in the current COVID-19 environment,” said Dr. Paula Annunziato, senior vice president, infectious diseases and vaccines, Global Clinical Development, Merck Research Laboratories. “We continue to believe LAGEVRIO may be an important option for people with risk factors like older age, multiple comorbidities, and immunocompromising conditions, who are more likely to advance to severe COVID-19, and for whom other antiviral treatments may not be appropriate because of the potential for drug-drug interactions.”

LAGEVRIO is approved or authorized for use in several countries, including Japan, Australia, and available for use in the United States under emergency use authorization, for the treatment of certain adults who have been diagnosed with COVID-19. To date, LAGEVRIO has been used by more than 8.3 million patients worldwide.

https://www.businesswire.com/news/home/20241205097781/en/

Doctors Rail Against Insurer's New Anesthesia Time Limits

 Arecent policy change by health insurer Anthem Blue Cross Blue Shield (BCBS) has led to sharp criticism from the American Society of Anesthesiologists (ASA), who warn that the decision could jeopardize patient safety and increase financial strain on both patients and providers.

The proposed new policy will no longer reimburse anesthesia services for the complete duration of certain surgical procedures, opting instead for a partial coverage model, and the head of the ASA has called it "appalling" and "egregious," creating a precarious situation for patients undergoing surgery.

Anthem BCBS said plans representing Connecticut, New York, and Missouri have unilaterally declared they will no longer pay for anesthesia care if the surgery or procedure goes beyond an arbitrary time limit, regardless of how long the surgical procedure takes, reported the ASA, who has condemned the decision and called on Anthem to reverse this proposal immediately.

The organization, which represents over 59,000 anesthesiologists nationwide, expressed concern that the change will undermine the continuity of care provided by anesthesiologists during surgery.

"With this new policy, Anthem will arbitrarily predetermine the time allowed for anesthesia care during a surgery or procedure," said ASA.

"If an anesthesiologist submits a bill where the actual time of care is longer than Anthem's limit, Anthem will deny payment for the anesthesiologist's care. With this new policy, Anthem will not pay anesthesiologists for delivering safe and effective anesthesia care to patients who may need extra attention because their surgery is difficult, unusual or because a complication arises," it added.

In a strongly worded open letter last month to Elevance Health Inc., the corporate name for Anthem, Dr. Donald E. Arnold, President of the ASA, said the proposed policy was "inappropriate and misguided."

Newsweek contacted Elevance Health Inc. and ASA on Thursday via email outside of normal working hours for comment.

"On behalf of the 58,000 members of the American Society of Anesthesiologists (ASA), I write to express our grave concern about the announced Anthem policy to disregard well-established anesthesia time billing standards in Connecticut, Missouri, and New York," Dr. Arnold wrote.

"The Anthem policy provides no justification for paying for anesthesia services for only a portion of a patient's surgery. We request an immediate meeting with the Anthem officials who have authority over, and who will hold accountability for, this proposed policy change."

Dr. Arnold concluded the letter by saying: "We question how Anthem could propose paying for only a portion of the anesthesia service needed by their customers. The policy does not contemplate that an anesthesia code may apply to vastly different surgical procedures with corresponding wide variations in surgical times.

"The policy also betrays a diminished dedication to patient agency and safety on the part of Anthem. In effect, if a patient has a surgery which lasts longer than the standards accepted by Anthem, Anthem has absolved themselves of responsibility to pay for the anesthesia that is needed for the rest of the encounter.

"Likewise, the policy does not contemplate individual patient needs which are embedded within anesthesia time, including treatment of surgical complications during the course of the procedure. Such complications are not incorporated into the allocated base units but are accounted and paid for under long-standing payment regulations which incorporate time.

"The proposed Anthem policy reflects a significant disconnect between Anthem, its patients, and their needs," Dr. Arnold added.

He said the policy creates a precarious situation for patients undergoing surgery, calling the policy "appalling" and "egregious."

"This is just the latest in a long line of appalling behavior by commercial health insurers looking to drive their profits up at the expense of patients and physicians providing essential care," he said, as reported by the ASA.

"It's a cynical money grab by Anthem, designed to take advantage of the commitment anesthesiologists make thousands of times each day to provide their patients with expert, complete and safe anesthesia care. This egregious policy breaks the trust between Anthem and its policyholders who expect their health insurer to pay physicians for the entirety of the care they need."

ASA urges people concerned about Anthem's proposal to contact their state insurance commissioner or their state legislator.

https://www.newsweek.com/doctors-rail-against-insurers-new-anesthesia-time-limits-1995875

Amgen in $1B manufacturing expansion in NC

 Amgen (NASDAQ: AMGN) today announced a $1 billion expansion to establish a second drug substance manufacturing facility in North Carolina. This brings the company's total planned investment in Holly Springs to more than $1.5 billion, building on its previously announced $550 million commitment.

"This expansion underscores our unwavering focus on bringing transformative medicines to patients around the world," said Robert A. Bradway, chairman and chief executive officer at Amgen. "North Carolina will be an important part of our global manufacturing network as we continue to meet the growing demand for our innovative therapies while generating significant local economic impact."

"North Carolina's reputation as one of the world's leading centers for biotechnology soars even higher with today's decision by Amgen," said North Carolina Governor Roy Cooper. "North Carolina offers everything an innovative biotech company needs to succeed, especially our highly trained, dedicated and diverse workforce which is fine-tuned to the needs of this critical industry." 

The $1 billion facility will incorporate cutting-edge technologies and sustainable practices, aligning with Amgen's commitment to environmental stewardship and manufacturing excellence. In tandem with the existing facility, these investments will create 370 new jobs in the region, supporting a robust biomanufacturing hub.

Amgen's choice of North Carolina reflects its position as a premier life sciences destination, with a vibrant ecosystem of innovation and a skilled workforce. This expansion enhances the company's global biomanufacturing network, leveraging decades of operational expertise and technological advancements to ensure the reliable and efficient delivery of high-quality medicines to patients worldwide.

https://www.prnewswire.com/news-releases/amgen-announces-1-billion-manufacturing-expansion-in-north-carolina-302323323.html

Nano-X Up on FDA OK

 Shares of medical imaging company Nano-X Imaging (NASDAQ: NNOX) -- commonly referred to as Nanox -- went up on Thursday after some pretty substantial news broke regarding regulatory clearance. At 10:50 a.m. ET, Nanox stock was only up 6%, but it had been up as much as 24% earlier in the morning.

Another step in the right direction

In a press release this morning, Nanox announced that the U.S. Food and Drug Administration (FDA) had expanded clearance for its flagship medical device, the Nanox.ARC. The FDA had previously cleared it for certain applications, but today that clearance expanded to include pulmonary and intra-abdominal images, among other things.


Nanox has a differentiated business model that seeks to generate recurring, per-scan revenue from its medical imaging software. It plans to get its machines out there for free or at a reduced price. But to do this, it needs to satisfy the FDA. Therefore, today's news is a step toward its long-term vision.

Still a long ways to go

Like many early-stage medical device stocks, Nanox stock can be very volatile. The slightest positive news can send shares soaring, but level-headed investors need to acknowledge that the company still has a long ways to go to become profitable. The company reported financial results for the third quarter of 2024 last month, showing revenue of just $3 million.

I don't think investors should buy Nanox stock in light of today's news unless they're comfortable with many years of volatility and are prepared for the possibility of substantial losses. I'm not necessarily saying that will happen. But there are still plenty more chapters in Nanox's story yet to be written, which makes it hard to know what will happen.

That said, today's news is positive, and Nanox shareholders are justified in their excitement.


https://finance.yahoo.com/news/heres-why-nanox-stock-went-165810522.html