House GOP will introduce a second transgender athlete ban next week

 House Republicans are planning to launch a second legislative effort to bar transgender women and girls from competing on female school sports teams, cementing the issue as a priority for the GOP ahead of 2024.

The proposed “Save Women’s Sports Act” would require public K-12 schools and colleges to designate sports teams — including intramural and club teams — based on sex assigned at birth, rather than gender identity. The bill’s restrictions would also apply to private schools that receive federal financial assistance, according to a draft obtained by The Hill.

A second clause states that membership of athletic teams “designated only for females shall only be open to biological females at birth.” Schools that violate the provision risk losing access to all federal funding, according to the bill, which is set to be introduced next week by Rep. Lisa McClain (R-Mich.).

The congresswoman’s proposal is modeled after an identically titled law passed in Montana in 2021. A federal judge last year ruled the law’s restrictions on transgender college athletes unconstitutional, but allowed a provision barring transgender K-12 students from competing on sports teams consistent with their gender identity to remain in effect.

Similar bans have been implemented in at least two dozen states since 2020, according to the Movement Advancement Project, which tracks LGBTQ legislation. Restrictions adopted by lawmakers in Idaho, Arizona, Utah and West Virginia, however, are temporarily blocked by court orders.

The House passed a separate bill to prevent transgender women and girls from competing on school sports teams in April.

Rep. Greg Stuebe’s (R-Fla.) “Protection of Women and Girls in Sports Act” aims to restrict the participation of transgender athletes by amending Title IX — the federal civil rights law prohibiting sex-based discrimination at federally funded schools — to recognize sex as “based solely on a person’s reproductive biology and genetics at birth.”

The measure, which passed in a party-line 219-203 vote, has not been taken up by the Senate, which is controlled by Democrats. The White House in April warned that President Biden would veto the bill if it reached his desk.

McClain’s office did not immediately respond to questions about her bill, including whether she believes the proposal goes further than Stuebe’s. The congresswoman was not one of the measure’s 93 Republican co-sponsors.

Still, McClain, who has represented Michigan’s 9th Congressional District since 2021, is one of Congress’s most outspoken critics of transgender female athletes.

During a Dec. 5 House subcommittee hearing titled “The Importance of Protecting Female Athletics and Title IX,” McClain repeatedly referred to transgender women as “men” and claimed that allowing transgender athletes to participate in girls’ sports puts other student-athletes in danger and is “fundamentally unfair.”

“We are placing our daughters in danger every time they step onto the field,” she said. “This hearing is about protecting women, period.”

McClain during the nearly 3-hour hearing also alluded to her forthcoming bill, telling a panel of witnesses that transgender people can “be who [they] want to be, but the American people don’t have to fund it.”

McClain and other House Republicans lauded the testimony of Riley Gaines, a former University of Kentucky swimmer who has traveled the country to testify in favor of legislation to bar transgender women and girls from female sports teams, restrooms and locker rooms.

Gaines, who accompanied McClain to Biden’s State of the Union address in February, tied with former University of Pennsylvania swimmer Lia Thomas — the first transgender woman to win a national Division I title — for fifth place at last year’s NCAA championships.

https://thehill.com/homenews/house/4350851-house-gop-will-introduce-a-second-transgender-athlete-ban-next-week/

Senate Kills Resolution To Withdraw Troops in Syria: "Another Regional War Without Debate"

 by Dave DeCamp via AntiWar.com,

The Senate on Thursday voted down a resolution that would have directed President Biden to withdraw all US troops from Syria, where US forces have come under frequent attack in response to President Biden’s support for Israel’s Gaza onslaught.

The bill failed in a vote of 13-84 and received support from seven Democrats, five Republicans, and one Independent, Sen. Bernie Sanders (VT). The resolution was introduced by Sen. Rand Paul (R-KY), who argued the US occupation of eastern Syria risks a major regional war.

"Keeping 900 US troops in Syria does nothing to advance American security. Rather, our intervention puts those servicemembers at grave risk by providing an enticing target for Iranian-backed militias," Paul said.

"Our continued presence risks the United States getting dragged into yet another regional war in the Middle East without debate or a vote by the people’s representatives in Congress. Congress must cease abdicating its constitutional war powers to the executive branch," he added.

Paul’s bill would have given the president 30 days to withdraw from Syria unless he was able to get authorization from Congress. The resolution received support from Robert Ford, who was the US ambassador to Syria from 2011 to 2014 when the US first threw its weight behind the regime change effort against Syrian President Bashar al-Assad.

"We owe our soldiers serving there in harm’s way a serious debate about whether their mission is, in fact, achievable. Absent a debate and authorization of such a mission, our troops should be removed. Consideration of S.J. Res. 51 is an important opportunity for the Senate to take a step towards that necessary outcome," Ford said.

The US has launched several rounds of airstrikes against Shia militias in Syria and Iraq in response to the rocket and drone attacks that have targeted US bases since October 17. The US bombings, which have killed dozens of militia members, have not deterred further attacks, and the region has turned into a powder keg.

Via Artishok Interactive/EA Worldview

The US maintains that its presence in eastern Syria is about fighting ISIS remnants, but the occupation is part of a broader campaign against Damascus and its allies, which includes Iran. The US maintains crippling economic sanctions on Syria that are designed to prevent the country’s reconstruction, and the area the US occupies is where most of Syria’s oil and gas fields are located.

https://www.zerohedge.com/geopolitical/senate-votes-down-resolution-withdraw-troops-syria-another-regional-war-without-debate

White House Delays Implementing Ban On Menthol Cigarettes Until At Least 2024

 by Stephen Katte via The Epoch Times,

White House officials are reportedly taking more time to review a sweeping plan from U.S. health regulators to ban menthol from all cigarettes.

According to a Dec. 6 updated regulatory agenda, the review process will now continue into 2024, with a current target date of March to possibly implement the ban.

The Food and Drug Administration (FDA) has been developing a rule to eliminate menthol as a characterizing cigarette flavor since 2022. The federal agency estimates a ban on the flavor additive could prevent 300,000 to 650,000 smoking deaths over several decades. They claim most of the preventable deaths would be among minority groups and Americans of African descent, who disproportionately smoke menthol cigarettes.

In the proposed rule, the federal agency said the new product standard would reduce the appeal of cigarettes, particularly to youth and young adults, and possibly decrease the likelihood of them progressing to "regular cigarette smoking.” If the rule is successfully implemented, cigarette companies will have one year to phase out menthol. It's unclear if they would face any penalties for failing to adhere to the new rule.

“In addition, the tobacco product standard would improve the health and reduce the mortality risk of current menthol cigarette smokers by decreasing cigarette consumption and increasing the likelihood of cessation,” the FDA rule reads.

According to the FDA, menthol is a flavor additive with a mint taste and aroma that aids in reducing the harshness and irritation of smoking. It says the additive also helps boost the appeal of cigarettes and makes the menthol variants interact with nicotine in the brain, enhancing the nicotine’s addictive effects.

Anti-smoking groups have been backing the FDA’s efforts since the beginning. Following the updated rule implementation date, some of the anti-smoking groups warned the delay could see the effort to phase out menthol held up indefinitely.

The FDA estimates there were 18.5 million menthol cigarette smokers aged 12 and above in the United States in 2018, and there were particularly high rates of use by youth, young adults, and Americans with African ancestry and other racial and ethnic groups.

“Any delay in finalizing the FDA’s menthol rule would be a gift to the tobacco industry at the expense of Black lives,” Yolanda Richardson, CEO of the Campaign for Tobacco-Free Kids, said in a media statement.

“We urge the administration to keep its promise and issue a final rule by the end of this year," she added.

According to the Campaign for Tobacco-Free Kids, menthol is the only cigarette flavor still allowed in the United States after a 2009 law was passed by Congress that prohibited all other cigarette flavors.

FDA officials reportedly sent their final version of the regulation to the White House’s Office of Management and Budget in October. Generally, this is the last before a rule is released. However, the White House has agreed to hold meetings with groups and corporations opposing the FDA’s rule, including civil rights advocates, business owners, and law enforcement officials, before making a decision. More than 60 meetings have been scheduled at this stage, with final discussions expected to stretch into January.

https://www.zerohedge.com/political/white-house-delays-implementing-ban-menthol-cigarettes-until-least-2024

US Mulls Military Action Against Houthis After Officials Angered At Lack Of Response

The US says it is in talks with regional allies to establish a joint naval task force to protect commercial vessels traversing the Red Sea, following several attacks on commercial ships and even the hijacking of one Israeli-linked ship.

The White House has said it's in "active conversations" with allies about setting up such escorts. "We are in talks with other countries about a maritime task force of sorts involving the ships from partner nations alongside the United States in ensuring safe passage," US national security advisor Jake Sullivan said earlier this week.

The US position is that even though Houthi rebels out of Yemen had “their finger on the trigger" - also after declaring war on Israel - it remains that the Shia Muslim group's Iranian sponsors are ultimately responsible.

By the end of the week, fresh Bloomberg reporting confirmed the following on Friday:

The US has been consulting with Gulf allies about potential military action against Yemen’s Iran-backed Houthi rebels in response to their increasingly brazen attacks on ships in the Red Sea, according to several people with knowledge of the discussions.

The talks are at a preliminary stage and both the US and partners still favor diplomacy over direct confrontation, said the people, who asked not to be identified due to the sensitivity of the matter. That said, the fact the discussions are taking place at all underscores how seriously the US takes the threat, the people added.

This follows several Pentagon officials complaining to US media outlets over the lack of response from President Biden over the increased attacks from the Houthis.

Defense leaders are said to be "frustrated" and handcuffed by US political leadership's lack of action at a moment US warships are under direct threat in the region. Politico described the growing anger and pushback from the Pentagon this week as follows: 

Senior Biden administration officials agree that striking Houthis in Yemen is the wrong course of action for now, per three U.S. officials, even though some military officers have proposed more forceful responses to the militants’ attacks in the Red Sea.

There’s high-level consensus within the administration that it does not make sense for the U.S. military to respond directly to the Houthis, the officials said. Although the missile and drone attacks on three civilian vessels on Sunday drew a U.S. Navy warship into an hours-long firefight, U.S. intelligence officials have not determined that the warship was the target.

The Biden White House has further been accused of "downplaying" the threat:

Some current and former military officials were frustrated by the administration’s initial response to the Houthis’ Sunday attacks on the ships. The Houthis launched four drone and missile attacks on three ships; the destroyer USS Carney, responding to the distress calls, shot down three drones in its vicinity. Those current and former officials say the Iran-backed group’s increasingly aggressive behavior poses a significant risk to American forces in the region, and took issue with the administration’s public statements on Monday, which they say downplayed that threat.

Via BBC

The dissenters worry that lack of meaningful response could only embolden Iran-backed forces in the region, which also includes militia groups across Syria and Iraq, where Americans have also been coming under fire.

All of this serves to highlight that positioning Americans in the region - which includes the now years long occupation of Syria to put pressure on Assad - leaves troops incredibly vulnerable. Indeed Iran might see them as 'easy targets' - and with little to no strategic advance for Washington whatsoever.

https://www.zerohedge.com/military/us-mulls-military-action-against-houthis-after-pentagon-angered-lack-response

FDA Weighs Gene-Editing Treatments’ Curative Possibilities Against Potential Risks

 The FDA today signed off on Vertex Pharmaceuticals and CRISPR Therapeutics’ exa-cel for sickle cell disease. And earlier this fall, the regulator greenlit the first U.S.-based in vivo base editing trial, run by Verve Therapeutics. These actions suggest the agency deems the investigational gene-edited therapies sufficiently safe for human use and study. But as with any new modality, experts say risks remain.

The Oct. 31 adcomm for exagamglogene autotemcel (exa-cel) focused on whether Vertex and CRISPR had conducted a sufficiently thorough analysis of the therapy’s potential off-target effects.

Exa-cel contains hematopoietic stem and progenitor cells (HSPC) edited using CRISPR-Cas9, which has the potential to produce off-target genomic alterations. During gene editing, cells can experience unintended cuts in their DNA, resulting in mutations that can lead to unwanted cell growth. So ensuring safety requires an understanding of where these accidental cuts may occur.

Sekar Kathiresan

“The biggest safety event that people are concerned about in general is editing in a place in the genome that could lead to cancer,” said Verve co-founder and CEO Sekar Kathiresan. “That’s really what I think the biggest concern is from a long-term safety perspective.” 

In briefing documents published ahead of the meeting, the FDA said the in silico methods used by the Vertex and CRISPR to spot potential unintended edits used “insufficient sequencing data.” The regulator expressed concern that the limited amount of sequencing data in the reference database “may not adequately capture variants” in the target patient population.

But Martin Steinberg, a hematologist at Boston University and a member of Vertex’s exa-cel steering committee, noted that the companies conducted a variety of tests looking throughout the genome for sequences that might be targeted by the guide RNA.

“They did . . . in silico and in vitro testing to nominate possible sites,” Steinberg told BioSpace. “They were looking for actual damage to these sites and cells, and there’s nothing that’s shown up that’s concerning in any way, at least in the short term.”

Monitoring for Long-Term Effects

Ultimately, FDA advisers recommended that Vertex and CRISPR could follow patients who received exa-cel treatment for possible off-target effects. “We want to be careful to not let the perfect be the enemy of the good,” Scot Wolfe, a professor at the Department of Molecular, Cell and Cancer Biology at UMass Chan Medical School and an adcomm member, said during the meeting.

Steinberg said the patients will be followed for two reasons: first, “to look for something that we don’t expect that might be caused by off-target effects,” and second, for persistence of efficacy.

Kathiresan said he believes the risk is “extremely low. Based on the work that [Vertex and CRISPR Therapeutics] have done . . . they don’t find any concerning off-targets or any cancer-causing genes.” He noted, however, that the chemotherapy drugs given to patients as part of a conditioning treatment prior to infusion of the edited cells can potentially contribute to cancer.

Eric Kmiec, founder and executive director of the ChristianaCare Gene Editing Institute, said the risk-benefit ratio is also a consideration. “If you are trying to treat . . . mid-stage to late-stage cancer patients, the off-target stuff is not as important there as it would be to a child with sickle cell disease . . . [who] now has 40 years to find out whether or not something we couldn’t detect by our current technology has now caused a long-term tumor,” he said.

Base Editing: A Safer Option?

One modality that could limit the potential for off-target effects is base editing. CRISPR-Cas9 is “kind of like genetic scissors” that can be programmed to cut precise locations within the DNA strand, Kathiresan said. In contrast, base editing chemically modifies one of the nucleotide bases, commonly abbreviated as A, T, C and G, that make up the DNA. In other words, the “scissors feature [has] been replaced with an enzyme that actually changes one letter to another letter,” Kathiresan explained. Therefore, he said, base editing approaches, such as that used by his company, avoid the mutations that come with cutting the DNA.

Steven Dowdy

“It reduces even further the number of potential off-target edits,” agreed Steven Dowdy, a professor of cellular and molecular medicine at the University of California, San Diego. With a base editor, “not only do you have to target the gene but you have to have a target cytidine or adenosine within reach of the base editor fused to Cas9.”

Cambridge, Mass.–based Verve has a “laser-like focus” on preventing heart attacks through the long-term control of low-density lipoprotein (LDL) cholesterol, Kathiresan said. The company’s base-editing approach aims to capitalize on the discovery that some people without a working copy of the PCSK9 gene have very low LDL throughout their lifetimes and that those people are “remarkably protected from heart attack,” he added. Verve makes a “single spelling change” in one spot in the genome to turn off the PCSK9 gene.

As Verve is going after a very common condition, “we wanted every inch of potential safety advantage,” Kathiresan said. Still, he acknowledged base editing isn’t without its own risks: “You’re making that single spelling change in one place [in the genome] . . . and you have to look to see, are you making it anywhere else? And even if you’re making it somewhere else, is that a problem?”

The company recently reported its first clinical data from a Phase Ib study conducted outside the U.S. The data showed that treatment with the investigational therapy, VERVE-101, led to clinically meaningful LDL cholesterol reductions after six months of follow-up, Kathiresan said.

There were, however, two heart attacks among patients in the trial. In the first instance, a patient with cardiomyopathy suffered a fatal cardiac arrest five weeks after infusion of VERVE-101. The second patient had a heart attack one day after infusion. While the second case was labeled as “potentially related” to the treatment due to its proximity to dosing, in both cases, investigators concluded the events stemmed from the patient’s underlying conditions. “We treated patients who had severe advanced heart disease because that’s what we were guided to by the FDA,” Kathiresan said.

The independent data and safety monitoring board had recommended continued dosing, and the FDA had reviewed the entire data package, including the clinical data with these safety events, Kathiresan said, before giving Verve the green light to begin the study.

“This is sort of the first time we’ve had to worry [about] a tool specifically designed to change the genetic code and make sure that it works predominantly at its site, and I’ve always thought about it as ‘to do no harm,” Kmiec said.

Ultimately, Dowdy said the specificity of genetic medicines makes them safer than small molecule drugs. With small molecules it is impossible to predict what unintended proteins it may bind to, he said. “With these genetic medicines, we can actually see what the off-targets are and improve. Without a doubt, it’s a brave new world of medicine, and once the delivery problem is solved, you may never take a small molecule drug the rest of your life.” 

https://www.biospace.com/article/fda-weighs-gene-editing-treatments-curative-possibilities-against-potential-risks-/

Jazz Updated Phase 2a Data at SABCS 2023 in HER2+/HR+ Metastatic Breast Cancer

 First presentation of progression-free survival (PFS) primary endpoint data show zanidatamab plus palbociclib and fulvestrant demonstrated a PFS of 67% at 6 months and a median PFS of 12 months in patients with heavily pre-treated HER2+/HR+ metastatic breast cancer (mBC)

Efficacy and safety results support further investigation of this targeted combination therapy as a potential chemotherapy-free option for patients with HER2+/HR+ mBC

https://www.prnewswire.com/news-releases/jazz-pharmaceuticals-presents-updated-phase-2a-data-at-sabcs-2023-showcasing-potential-of-zanidatamab-in-her2hr-metastatic-breast-cancer-302010341.html

Vertex/CRISPR price sickle cell disease gene therapy at $2.2 mln

  Vertex Pharmaceuticals and its partner CRISPR Therapeutics said on Friday their sickle cell disease gene therapy Casgevy would be available at a list price of $2.2 million in the United States.

Bluebird bio said it has set a list price of $3.1 million for its treatment, Lyfgenia, for the condition.

Both the therapies were approved by the U.S. health regulator earlier on Friday.

https://finance.yahoo.com/news/vertex-crispr-price-sickle-cell-181618940.html