Bowman pulls fire alarm as Dems try to delay vote on GOP stopgap spending bill

 Socialist Rep. Jamaal Bowman (D-NY) pulled the fire alarm in a House office building Saturday as Democrats tried to delay a vote on a Republican stopgap spending bill, according to the GOP-controlled Administration Committee.

The wild incident in the Cannon Building was caught on camera and confirmed by several witnesses, according to Politico.

Bowman “pulled a fire alarm in Cannon this morning,” a panel spokesperson told the outlet. “An investigation into why it was pulled is underway.” 

Staten Island GOP Rep. Nicole Malliotakis’ office told The Post they would move to have Bowman expelled from the chamber.

“NY Democrat Jamaal Bowman literally pulled a fire alarm to stall and prevent our efforts to force a vote to keep the federal government open. Pathetic. Criminal investigation needs to happen,” said upstate GOP Congressman Nick Langworthy.

The wild incident in the Cannon Building was caught on camera.

Rep. Nicole Malliotakis said they would move to have Bowman expelled from the chamber.

EPA

Creating a false fire alarm is a misdemeanor in the District of Columbia and punishable by up to six months in jail.

“This is the United States Congress, not a New York City high school. To pull the fire alarm to disrupt proceedings when we are trying to draft legislation to AVERT A SHUTDOWN is pathetic…even for members of the socialist squad,” Malliotakis wrote on X, formerly Twitter. 

https://nypost.com/2023/09/30/rep-jamaal-bowman-pulled-fire-alarm-as-shutdown-looms/

Lab Tests That Escape FDA Oversight May Come Under Agency Review

 The FDA issued its long-awaited proposal for regulating laboratory developed tests (LDTs) on Friday.

The proposed ruleopens in a new tab or window would amend FDA regulations to make explicit that in vitro diagnostic products (IVDs) are medical devices under the Federal Food, Drug, and Cosmetic Act, including when the manufacturer of the IVD is a laboratory.

The agency also wants to phase out its general enforcement discretion approach for laboratory-developed tests so IVDs manufactured by a lab would generally fall under the same approach as other IVDs.

LDTs are designed, manufactured, and used within a single clinical laboratory, which must be certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIAopens in a new tab or window) and meet requirements to perform high complexity testing. Currently, LDTs are regulated by the Centers for Medicare & Medicaid Services, which does not require the tests to show clinical validity.

LDTs, like other IVDs, can be used to measure or detectopens in a new tab or window substances, analytes, or markers like proteins, glucose, cholesterol, or DNA to help provide information about a patient's health, including diagnosing, monitoring, or determining treatments. Recent LDTs have included a blood test to assess Alzheimer'sopens in a new tab or window disease risk.

"These widely used tests are not generally coming to the FDA for review or otherwise complying with FDA requirements," FDA Commissioner Robert Califf, MD, said in a news briefing. "This leaves Americans vulnerable to making important healthcare choices based on potentially faulty or inaccurate test results. This should not continue."

"Laboratory developed tests play a central role in U.S. healthcare and many are similar to other tests that do come into the FDA for review," Califf added. "This approach no longer makes sense and puts U.S. patients at risk."

The proposed rule aims to help ensure the safety and effectiveness of LDTs, which are used in a growing number of healthcare decisions, the FDA said.

"Patients cannot be assured their tests provide accurate results," Jeff Shuren, MD, JD, director of the FDA's Center for Device and Radiological Health, said in the briefing. "The FDA currently oversees tests made by non-laboratory manufacturers but is not generally overseeing tests made by laboratories."

Modern LDTs carry greater risks than ones used decades ago, he noted. In the 1970s, LDTs were "mostly low risk, manufactured in smaller volumes, and used for the specialized needs of a local patient population," Shuren said.

However, the LDT market looks drastically different today than it did roughly 50 years ago," he pointed out. "The complexity and volume of these tests have evolved dramatically," with LDTs increasingly relying on high-tech instrumentation and software, being performed in large volumes, and being vulnerable to cyber-security risks.

The FDA expressed concernopens in a new tab or window that patients could initiate unnecessary treatment, or delay or forego proper treatment based on inaccurate LDT results. "For example, the FDA is aware of IVDs offered as LDTs that could have led to patients being over- or under-treated for heart disease; patients with cancer being exposed to inappropriate therapies or not getting effective therapies; and incorrect diagnoses of rare diseases, autism, and Alzheimer's disease," the agency said.

After the rule is finalized, the FDA would gradually phase out its previous enforcement approach, the agency said. The agency also discussed alternatives for some LDTs, including a different approach for academic medical center laboratories

The American Clinical Laboratory Association (ACLA), the national trade association representing labs like Quest Diagnostics and LabCorp, issued a statementopens in a new tab or window Friday that it "does not believe that FDA's actions are in the best interest of patients or our nation's health care system."

"ACLA has long taken the position that FDA does not have statutory authority to regulate LDTs under its medical device authority and strongly opposes unilateral action that exceeds the Agency's current authority," the group said. "LDTs are not medical devices."

But other groups expressed support for the FDA's proposal. "This rule is a critical step forward for clinical medicine," Peter Lurie, MD, MPH, president of the Center for Science in the Public Interest and former FDA associate commissioner, said in a statementopens in a new tab or window.

"It will help ensure that when a patient receives a test, they can rely on the results to make essential decisions for their health," Lurie said. "This rule will close a gaping hole in FDA's current regulatory reach."

https://www.medpagetoday.com/washington-watch/fdageneral/106575

Back story of today's news: Queens Man Charged After Allegedly Posting Explicit Child Images: Feds

 A man from Queens was charged with sexual exploitation charges after allegedly posting explicit images of children online in 2021, according to Breon Peace, United States Attorney for the Eastern District of New York.

Angel Almeida, who has a 2019 felony conviction in Florida for burglary, was arraigned at a federal court in Brooklyn after he was charged with sexual exploitation and possession after enticing a minor to produce videos, prosecutors said.

Police also found a firearm and ammunition in Almeida’s home, Peace said.

The Federal Bureau of Investigation received a tip in September and October 2021 about Almeida posting sexually explicit images of children online and possessing firearms, prosecutors said.

After reviewing Almeida’s social media accounts, where he had pictures of him posing with a gun, authorities searched Almeida’s home in November 2021, Peace said.

Police found the same 9mm Taurus handgun Almeida was posing with in the pictures, prosecutors said. Between July 2021 and December 2021, Almeida enticed a minor to produce sexually explicit videos, and between February 2020 and November 2021, Almeida enticed another minor.

Almeida was also charged with possession of child pornography found in multiple cell phones, Peace said. 

https://patch.com/new-york/queens/queens-man-charged-after-allegedly-posting-explicit-child-images-feds

[Today:]

https://www.zerohedge.com/political/satanic-pedophile-extortion-cult-uncovered-after-ny-arrest

Are Obesity Drugs for Adolescents Cost-Effective?

 Anti-obesity medications have been making major headlines in the news. From nationwide shortages

opens in a new tab or window to publicized usage by celebritiesopens in a new tab or window, there is constant buzz about how these medications can lead to weight reduction in a relatively short time frame. However, the majority of this conversation has focused on adults. With obesity currently affecting more than one in fiveopens in a new tab or window children and adolescents in the U.S., anti-obesity medications are an important treatment option for this population too.

Earlier this year, the American Academy of Pediatrics (AAP) released its first clinical practice guidelineopens in a new tab or window for the treatment of obesity among children and adolescents. They now recommend pediatricians and other healthcare providers offer anti-obesity medications as an adjunct to intensive health behavior and lifestyle treatment for adolescents 12 years and older. This announcement followed the publication of results from several clinical trials that assessed the safety and efficacy of liraglutide (Saxenda)opens in a new tab or window, phentermine/topiramate (Qsymia)opens in a new tab or window, and semaglutide (Wegovy)opens in a new tab or window for adolescent patients with obesity, and their subsequent FDAopens in a new tab or window approvalsopens in a new tab or window for treatingopens in a new tab or window obesity in adolescents.

With the release of the AAP guidelines and clinical trial data, we pursued a timely evaluation of the cost-effectiveness of anti-obesity medications for adolescents with obesity.

Cost-effectiveness analyses allow us to compare the relative costs and health outcomes of different interventions. The goal is to determine which intervention leads to health outcomes that are "worth" its associated cost. In our studyopens in a new tab or window, recently published in JAMA Network Open, we evaluated the cost-effectiveness of lifestyle counseling alone and accompanied by liraglutide, mid-dose phentermine/topiramate, top-dose phentermine/topiramate, and semaglutide for the treatment of obesity in adolescents.

We estimated health outcomes using quality-adjusted life years (QALYs), which adjusts total years lived by a patient based on the quality of their health. For example, if a patient lived 5 years in poor health they would have fewer quality-adjusted life years than that of a patient who lived 5 years in perfect health. In our analysis, quality-adjusted life years was primarily affected by changes in weight. Quality-of-life was assumed to increase with weight reduction and decrease with weight gain.

We found top-dose phentermine/topiramate to be the preferred and the only cost-effective treatment among the interventions compared in our analysis. This means within the context of the U.S. health system, top-dose phentermine/topiramate had the most health benefits at an acceptable cost. While we projected top-dose phentermine/topiramate to be the only cost-effective treatment, semaglutide resulted in the greatest gain in QALYs as it was associated with the greatest weight reduction among all strategies. However, the benefits of semaglutide over top-dose phentermine/topiramate were not substantial enough given semaglutide's much higher cost. We used an incremental cost-effectiveness ratio (ICER) to determine the cost-effectiveness of one intervention compared with another. In the U.S., an intervention is typically considered cost-effective if its ICER is below $100,000 per QALY gained. We estimated that the ICER for top-dose phentermine/topiramate was $56,876 per QALY gained when compared with lifestyle counseling alone after 5 years. In comparison, we found the ICER for semaglutide was $1.1 million per QALY gained. Therefore, semaglutide was not cost-effective by a large margin as it is much more expensive than top-dose phentermine/topiramate (monthly cost $1,295 vs $191). Additionally, semaglutide only had a slight increase in QALYs compared to that of top-dose phentermine/topiramate over 5 years (3.181 QALYs vs 3.127 QALYs). We estimated that the cost of semaglutide would need to be reduced by 85% to be considered a cost-effective treatment after 5 years.

Over a 5-year time horizon, liraglutide and mid-dose phentermine/topiramate were "strictly dominated" strategies, meaning they resulted in higher costs and fewer QALYs when compared with the other strategies we examined. Therefore, they were excluded from any further cost-effectiveness analysis as they represent an inefficient use of resources when compared to other available strategies.

While our analysis estimates that anti-obesity medications can be cost-effective for adolescents on a relatively short time horizon, our results need to be considered in the context of several limitations. There is a current lack of long-term data regarding the use of anti-obesity medications by adolescents. Clinical trials only provided follow-up data for about 1 year. Therefore, we made several assumptions in order to project outcomes to 5 years. It is unclear if weight reduction is maintained during long-term treatment and how much weight regain may occur after discontinuation of treatment in adolescents. It is also possible we may have underestimated the cost-effectiveness of anti-obesity medications as they may prevent the development of comorbidities in adulthood. To properly evaluate the efficacy and safety of anti-obesity medications in adolescents, longer term studies are needed to evaluate how early and aggressive treatment may affect future outcomes.

Overall, our analysis found that liraglutide, phentermine/topiramate, and semaglutide were all effective in terms of weight reduction. They were associated with a greater gain in QALYs compared to lifestyle counseling alone. However, despite the effectiveness of these medications, costs are a major barrier to uptake by patients. Most state Medicaid plans do not cover anti-obesity medications, and private insuranceopens in a new tab or window often require patients to meet strict criteria before approval. High out-of-pocket costs may deter patients from receiving the early, aggressive treatment the AAP now recommends. If we expect patients to begin treatment with anti-obesity medications and adhere to treatment on a long-term basis, these patients should have easy and affordable access to these drugs. Even if anti-obesity medications are effective in reducing weight among adolescents, these health outcomes are not achievable if many patients are not able to obtain the drugs.

Chin Hur, MD, MPH, is a professor of medicine and epidemiology, and director of Healthcare Innovations Research & Evaluation (HIRE) at Columbia University Irving Medical Center in New York City. Francesca Lim, MS, is a research analyst with HIRE at Columbia University Irving Medical Center.

https://www.medpagetoday.com/opinion/second-opinions/106548

Lockdowns Made Homeschooling More Diverse

 New polling from The Washington Post shows that contrary to stereotypes, homeschooling families are more diverse and less religious than ever.

The new data indicate that parents have a wide range of reasons for deciding to homeschool their children and that COVID-era school closures played a major role in inspiring many parents to pull their children out of the traditional educational system.

"Everything was up in the air," during the pandemic, one parent told the Post. "We were like, let's just try to home-school, and we've been doing it ever since."

According to the poll, which was conducted by the Post and the Schar School of Policy and Government at George Mason University, three-quarters of homeschooling parents said that they chose to homeschool due to "concern about the school environment." Around two-thirds also agreed that providing "moral instruction" as well as "dissatisfaction with academic instruction at other schools" also motivated their departure from traditional schooling

While 31 percent of parents said they chose to homeschool their child in part because COVID policies at local public schools were too strict, a similar proportion—27 percent—said part of their decision to homeschool was because local public schools' COVID policies were too lax.

According to research from the Urban Institute, homeschooling increased by 30 percent between the 2019–20 and 2021–22 school years. Nationally, over 5 percent of school-age children are now estimated to be homeschooled.

"Interviews with new home-school parents suggest many were intrigued by home schooling before the pandemic but wouldn't have tried it absent the abrupt school closures in March 2020," notes the Post. "While many parents were anxious to get their children back into school, some found they liked having their kids at home."

The uptick in homeschooling has also led to more racial diversity in the homeschooling space. Prior to the pandemic, about 70 percent of homeschoolers were white. Now, that number has decreased to just under 50 percent, driven primarily—according to the Post's poll—by a rise in Hispanic families choosing to homeschool.

Homeschool families are also less focused on religion than they were before the pandemic. In 2012, 64 percent of homeschool parents said they did so in order to provide religious instruction. By 2023, that number had dropped to just 34 percent. 

"Families," Robert Kunzman, a professor at Indiana University's School of Education and director of the International Center for Home Education Research, told the Post, "who choose home schooling less for ideological reasons and more for matters of circumstance and what meets the needs of their child in the present moment will help change our conception of what it means to be a home-schooler."

Since waves of COVID school closures in 2020 and 2021 sent parents scrambling, more and more families have realized just how poorly local schools were serving their children. Instead of putting up with the status quo, an increasing portion of them are deciding to take their children's education into their own hands.

https://reason.com/2023/09/26/the-lockdowns-made-homeschooling-more-diverse/

Specialists to arrive in Ukraine to plan air defence production - presidential aide

 Specialists will arrive in Ukraine in the near future to draw up plans to establish production of military equipment including air defences, the Ukrainian president's chief of staff told reporters on Friday.

“I think very soon specialists will arrive here who will make a plan for our own production of everything that we need. First and foremost, this relates to air defences,” Andriy Yermak said.

Yermak talked more broadly about President Volodymyr Zelenskiy's visit to the United States last week, but it was not clear whether the specialists and the systems he was referring to would be American.

The presidential aide also said Ukraine was seeking to organise an international meeting of national security advisers to discuss Kyiv's peace formula in the second half of October.

https://news.yahoo.com/specialists-arrive-ukraine-plan-air-161133201.html

Voters Will Reject Inflation Reduction Act’s Assault on Medicare

 In the last few weeks, House Subcommittees have conducted important hearings on President Joe Biden’s implausibly named “Inflation Reduction Act” and its assault on Medicare.

The law is an assault on Medicare because it violates a core promise of the program – that in exchange for paying a special payroll tax your entire working life, the program will be there for you when you are older.

The law uses so-called savings from reduced spending on prescription drugs (more on that in a moment) to help pay for $500 billion in green energy and Obamacare subsidies.

This is a promise broken because the entire point of a dedicated payroll tax is that the funds are to be used for Medicare. The only way the IRA was able to accomplish the green energy and Obamacare spending without increasing overall government spending (which you can’t do if you are trying to claim the bill will reduce inflation) is to cut spending elsewhere. Analysis of the bill clearly shows that the offset spending comes out of Medicare.

The American people understand this is a violation of the promise of Medicare. Research we conducted at America’s New Majority Project revealed that 67 percent of Americans agree that any savings found in Medicare should be kept in Medicare. Most say those savings should be used to improve benefits. In addition, 59 percent say (correctly, it turns out) it is likely that programs which allow the government to reduce Medicare spending on prescription drugs would lead to the savings being spent elsewhere.

The White House and Democrats will claim that the IRA does not actually violate the promise of Medicare because seniors will still get the care they need despite the diversion of the funds. This is a falsehood, and Americans know it.

The IRA achieves its savings from Medicare through the imposition of price controls on drugs, which the White House and Democrats refer to as “negotiation.” In truth, the negotiation is Kabuki theatre. The process disrupts the highly successful private sector negotiation that is the foundation of Medicare Part D and enables government bureaucrats to set a take it or leave it price it is willing to pay for critical drugs.

Our research also revealed Americans understand the tradeoff between increased government control and doctor-patient autonomy. Sixty-five percent of voters say it is likely that price control programs such as those found in the Inflation Reduction Act would lead to more influence for lobbyists and less control by doctors and patients. Sixty-three percent say these programs would ultimately lead to seniors not receiving the medicines their doctors recommend.

Unsurprisingly, the American people are pretty smart. Multiple analyses have shown that the IRA’s plan to allow Medicare to set prescription drug prices will deter critical investments in new drug development.  According to an analysis by Horizon Government Affairs, 24 drug companies have already announced they are cutting back on drug development due to the bill. It’s even possible that the plan could result in some currently available drugs being pulled from the market.

Clearly, there is a case to be made to the American people that the Inflation Reduction Act is bad medicine. Americans understand the principles behind the concerns about the impact of the program – and the facts are there to validate those concerns if we can make the people aware of them.

The hearings held so far are a good first step to educating the American people and exposing the IRA’s assault on Medicare. They should be reinforced by lawmakers in their communications with constituents to continue to make the case against the law – and highlight alternative solutions to make drugs more affordable for Americans that don’t endanger innovation and access.

Newt Gingrich was Speaker of the U.S. House of Representatives from 1995-1999 and a candidate for president in 2012. He is Chairman of Gingrich 360, a consulting and multimedia production firm, some of whose clients are impacted by the Inflation Reduction Act. For more commentary from Newt Gingrich, visit Gingrich360.com. For more polling on this and other issues, visit AmericasNewMajorityProject.com.

https://www.realclearhealth.com/blog/2023/09/29/voters_will_reject_inflation_reduction_acts_assault_on_medicare_983045.html