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US to transfer long-range rocket systems to Ukraine amid Donbas struggle: reports

The U.S. will transfer long-range rocket systems to Ukraine to help aid the country’s fight against Russia in the Donbas region, officials told multiple outlets. 

Ukrainian officials have been asking the U.S. to send the Multiple Launch Rocket System (MLRS) or the High Mobility Artillery Rocket System (HIMARS), CNN first reported, citing U.S. officials.

The weapons would be a significant improvement from Ukraine’s current artillery — an MLRS is able to fire hundreds of kilometers away and HIMARS is able to fire the same type of ammunition as an MLRS.

Defense officials did not specify to The New York Times what kind of weapons transfer would be announced. However, the outlet noted that the transfer would likely be made next week.

The Guided Multiple Launch Rocket System is the most common system that the U.S. uses.  

“Certainly we’re mindful and aware of Ukrainian asks, privately and publicly, for what is known as a multiple launch rocket system. And I won’t get ahead of decisions that haven’t been made yet,” Pentagon press secretary John Kirby said Friday.

The Defense Department told The Hill they have nothing further to add beyond Kirby’s comments. 

The officials told the Times the Biden administration has been hesitant to provide Ukraine with these types of weapons as it could be seen as provocation by Russia.

According to CNN, prominent Russian commentators decried any weapons transfer shortly after the new outlet’s report.

“The US intends to discuss the issue of supplying Ukraine with these weapons as soon as next week,” Olga Skabeeva, a prominent Russian TV host, said on her show. “At the present moment, the issue is being addressed by the US presidential administration. So now, we are not even talking about tactical weapons anymore, but about the operational-tactical weapons.”

“The US MLRS can launch shells over 500 kilometers. And if the Americans do this, they will clearly cross a red line, and we will record an attempt to provoke a very harsh response from Russia.”

The war in Ukraine has continued for more than three months, with Russian forces currently focusing their efforts on the Donbas region after they failed to take over the capital city of Kyiv.

Source: TEST FEED1

Michigan case zeroes in on the legal realities of unionization

President Biden consistently has stated a desire to be “the most pro-union president” ever, but recent events have shown that being pro-union doesn’t always translate to being pro-worker. Throughout the country, unions are enforcing policies that benefit them, but are not necessarily in the best interest of their members.

The Michigan Supreme Court is considering whether to hear the case of Technical, Professional, and Officeworkers Association of Michigan v Renner, which addresses an issue of national importance. The case focuses on a county employee, Daniel Lee Renner, who sought representation from the union, TPOAM, in a dispute with his employer. The union refused to represent him unless he paid an up-front fee of $1,290, with additional fees likely to occur as the union prosecuted his case.

The union’s reasoning? Renner had resigned his membership the year prior.

At first glance, the union’s position seems reasonable — why should a union be required to represent non-members for free? But the legal realities of unionization make this position legally indefensible and objectively unfair.

The disconnect lies in a union’s duty to act as the “exclusive representative” of all employees within a bargaining unit. When a union bargains with an employer, it negotiates the right to be the sole negotiating authority. Individual employees are not allowed to negotiate their own terms and conditions of employment. The union speaks for them, even if employees have made clear that they do not want to associate with the union.

Non-members such as Renner are left with little choice about the terms and conditions of their employment, which are established by the collective bargaining agreement negotiated by the union. Even if they want to, non-members typically can’t challenge discipline on their own.

This regime exists because unions negotiate for the right to exclusively represent employees. They voluntarily accept, and vigorously pursue, the legal obligation to represent all employees within a bargaining unit, including non-members.

But Renner found out the limits of this representation after he complained about another worker’s smoking, claiming it had an effect on his health. The county investigated, determined Renner’s claims about the other worker were false, and disciplined him. In an effort to challenge the discipline, he contacted the union for representation — because he was informed he could not act on his own behalf. The union refused to represent him, despite being the only entity allowed to do so.

The situation would be different if a union did not set the employment conditions of non-members. If employees were free to act on their own behalf, it would be reasonable for a union to charge fees to non-members seeking union representation. But that’s not the case, and many unions have strongly resisted embracing that position.

This case squarely demonstrates that division. While one union, TPOAM, has advocated for the right to charge non-members fees, the Michigan affiliates of the National Education Association, the American Federation of Teachers, the AFL-CIO, and the American Federation of State, County, and Municipal Employees (AFSCME) joined in a brief opposing that position. These unions call a “fee for service” policy “antithetical to the fundamental mission of purpose of the Amici unions.”

These unions’ national representatives have even signed a policy statement opposing attempts to modify their duty to fairly represent all employees — members and non-members alike.

The most reasonable solution is fairly straightforward — relieve unions of their duty to represent non-members, and relieve non-members of the constraints of being bound by the contract the union negotiates on behalf of its members. Under this regime, workers would be free to negotiate their own terms and conditions of employment, and they could represent themselves when challenging discipline levied by their employer.

At the same time, unions would be required to represent only paying members, thereby avoiding the issue of requiring unions to expend resources on behalf of an employee who does not financially support them. This approach also provides indirect benefits to employees in the form of increased competition. Unions would be forced to demonstrate value to employees to earn their dues, and employees dissatisfied with union representation could leave and try to get better results on their own.

This approach would allow workers to make a choice about whether the terms negotiated by the union are better than those they could negotiate on their own. If President Biden is interested in being not just pro-union but also pro-worker, he should embrace this reform.

Steve Delie is the director of labor policy and Workers for Opportunity at the Mackinac Center for Public Policy in Midland, Mich.

Source: TEST FEED1

Liberals find it can be easier to fight for causes than defend them

As the Supreme Court appears poised to overturn Roe v. Wade, liberals are left wondering what more could have been done to protect it, with some questioning whether it’s easier to get Democrats to fight for a particular constitutional right or policy change than to defend one. 

Activists are experienced at advocating for policies they believe are crucial to improving Americans’ quality of life, from universal health care to student loan relief and affordable housing. Many have pushed to advance those items with support from a vocal bloc of liberal lawmakers.

But when it comes to defending a woman’s right to choose — a court assurance that has been on the books since the early 1970s — the party has struggled to make traction before the draft majority decision leaked last month exposed a major threat.

“In general, progressives embrace aspirational policy because they come from communities with long-running inequities and disparities,” said one Democratic aide who advises left-wing members of Congress. 

“As a politician, if you defend the status quo, when the people you represent feel left behind by status quo policy, then you’re likely going to be outflanked.”

A closely watched congressional primary runoff in Texas this week was a good case study. The last standing House Democrat opposed to abortion, Rep. Henry Cuellar, declared victory by fewer than 200 votes against progressive attorney Jessica Cisneros, who hasn’t yet conceded due to outstanding ballots. 

Cuellar’s anti-abortion rights stance was not enough for Democratic voters to resoundingly reject him. Moreover, he has the full support of House leadership, with Speaker Nancy Pelosi (D-Calif.) and Majority Whip James Clyburn (D-S.C.) making calls on his behalf. 

In the end, the issue doesn’t appear to have been a massive factor in the race. 

Some behavioral scholars, however, say that the fear of having something taken away can be a driving force in people’s decision making.

“In general, psychological research suggests that human beings are prone to ‘negativity bias’ — that is, we react more strongly to negative developments than to positive developments of the same intensity,” said Christopher Federico, a psychology and political science professor at the University of Minnesota. “Even when a negative event and positive event are of the same magnitude, the negative event will affect our thoughts, feelings, and behaviors more strongly than the positive event.”

Federico said that phenomenon is evident regarding abortion.

“The threat of disliked policy changes is more politically motivating than the prospective of liked policy changes,” he said. “This would lead us to predict that the looming threat to abortion rights will eventually motivate more political involvement than the other issues where the focus is on obtaining a policy gain over and above the status quo.” 

A similar scenario played out just a few years back. When Republicans were working to overturn the Affordable Care Act (ACA), activists led the fight on keeping it intact, including activating a new base of supporters.

“Defending the ACA from being gutted was a big part of our early history as a movement,” said Emily Phelps, national press secretary at Indivisible, a grassroots organization that came of age during that time.  

Some priorities, however, are easier to champion than others. 

After back-to-back mass shootings in Buffalo, N.Y. and Uvalde, Texas, advocates and Democrats on Capitol Hill again called for measures to restrict the harm caused by firearms. But it’s unclear if anything can pass the 50-50 Senate. A pair of moderate senators remain opposed to ending the filibuster, leaving some to feel already defeated. 

In the Cuellar race, leadership supported the candidate with an “A” rating from the NRA, further muddying the issue. 

“There is a chasm between what Democrats say they will fight for and what they’ll do,” said Angelo Greco, a progressive communications operative. “Gun reform, abortion, minimum wage.”

“On the one hand you have leadership saying we must do everything possible to protect a woman’s right to choose, yet they were doing robocalls for an anti-choice, pro-NRA Democrat in Texas.”

Republicans, on the flip side, have long used their base’s enthusiasm for gun rights to notch electoral gains. 

There’s arguably no perfect parallel to an issue that inspires Democrats as strongly. They have, however, seen signs of traction on desired policy changes.

The push to partially cancel student loan debt has been a focus for many on the left who believe it can be achieved before November. They say that Biden has the authority to forgive at least some federal loans for borrowers by using his executive action authority, rather than relying on Congress. 

As recently as this week, White House officials said they are looking carefully into what can be done from the Oval Office. If some cancellation happens, progressives are expected to take a victory lap. 

And other wishful fights also inspire the party’s base.

Sen. Bernie Sanders (I-Vt.) first rose to national prominence by campaigning on a progressive platform that included Medicare for All and raising the minimum wage to $15 an hour. While neither has materialized, they remain critical to the discussion about Democrats’ direction and ideology, and progressives see them as helping move the party left. While Biden never pushed for universal health care, he ran as the Democratic presidential nominee on a $15 minimum wage, a policy that some believe helped him edge out Trump.

Democrats have also seen success on unions. Biden pledged to be staunchly “pro-union” in office, and under his administration a variety of aligned organizations such as the Democratic National Committee and the Democratic Congressional Campaign Committee have unionized. Pelosi says she supports congressional staffers’ long-stated desire to form a union. 

The fight to protect abortion has been much murkier.

“Voters are just waking up to the fact that the Republican campaign to end legal abortion was not just campaign rhetoric,” Cecile Richards, the former president of Planned Parenthood who co-chairs the Democratic firm American Bridge, told The Hill.

“Voters have their own personal feelings about abortion and don’t believe it is right for government and politicians to intervene in personal decisions about pregnancy,” she said. “That is true across geography, party and background.”

Polling suggests the leak has not dramatically changed public opinion. A majority of Americans are in favor of Democrats’ attitudes over abortion, according to a new Reuters/Ipsos poll released this week. 

But when considering how likely the issue is to move voters, especially ahead of the midterms, some Democrats are more skeptical. 

“Is it easy? In rhetoric, yes,” said Greco. “But who’s actually putting it all on the line for the policy fights?”

Source: TEST FEED1

Uvalde shooting pushes gun control to the fore in Texas governor’s race

The debate over gun control is taking center stage in the Texas governor’s race after 21 people, including 19 children and two adults, were killed in a mass shooting at an elementary school in Uvalde earlier this week. 

Democratic gubernatorial candidate Beto O’Rourke made headlines on Wednesday when he confronted Gov. Greg Abbott (R) at a press conference, telling the Republican candidate that the mass shooting is ultimately “on him.” 

The incident, as well as a mass protest also attended by O’Rourke outside the NRA’s annual event in Houston on Friday, has raised questions about whether the debate over how to deal with gun violence will be a top campaign issue in a state rocked by a slew of mass shootings in recent years. The Lone Star State has seen eight mass shootings over the past 13 years, according to data compiled by the Texas Tribune. 

According to February polling from the Texas Politics Project at the University of Texas at Austin, 43 percent of Texans said they believed gun laws should be “more strict,” while 34 percent said they should be “left as they are now.” Another 16 percent said they should be “less strict.” 

With anger, fear and frustration rising over mass shootings in Texas and across the country, O’Rourke and Texas Democrats are now working to make gun control a deciding issue going into November. 

O’Rourke and Abbott came face-to-face a day after the shooting when the Democratic gubernatorial nominee confronted the governor over his stances on guns and preventing mass shootings. Abbott had been providing information on mental health before he was interrupted by O’Rourke. 

Democrats and gun-control activists praised the move as something that needed to be done. 

“Somebody had to go to this man that is the governor of the state of Texas and call him out in front of the people of the state of Texas,” said Texas Democratic Party Chair Gilberto Hinojosa. “Nothing else appears to work with him.”

“If he doesn’t listen to the parents of the children that have died, the only thing that we can do is what Beto did,” he continued. 

Republicans were quick to accuse O’Rourke of politicizing the mass shooting a day after it took place. 

“O’Rourke’s flip-flopped his position on the Second Amendment more times than anyone can track since he launched his campaign for governor,” said Republican Governors Association spokesperson Joanna Rodruguez. “For him to pretend this is a priority for him now isn’t just posturing, it underscores just how unserious he is and why he resorts to disgusting, self-serving publicity stunts like yesterday.” 

Days later, O’Rourke appeared at the NRA protest in Houston, delivering a message in front of the crowd shortly before former President Trump was expected to take the stage inside.

“You are not our enemies,” O’Rourke said of the NRA members. “We are not yours. We extend our hand open, and unarmed, in a gesture of peace and fellowship, to welcome you to join us to make sure this no longer happens in our country.”

The Texas Democrat has long been vocal on combatting gun violence. The issue hit home for him in 2019 when a gunman killed 23 people and injured 23 others at a Walmart in O’Rourke’s hometown of El Paso. O’Rourke was running for president at the time and ignited both praise and backlash during a primary debate when he voiced support for a mandatory assault weapon buyback program. 

“Hell yes, we’re going to take your AR-15, your AK-47,” O’Rourke said. “We’re not going to allow it to be used against our fellow Americans anymore.”

The remarks drew praise from Democrats and gun control advocates and criticism from Republicans and gun rights supporters. 

“Beto has never been a cookie-cutter, follow-the-playbook guy,” said a source close to the campaign. “He’ll go with his gut and what he thinks is right and channel his anger into action.”

In February, O’Rourke said he had no “interest in taking” assault weapons from gun owners. 

“What I want to make sure that we do is defend the Second Amendment,” O’Rourke said. “I want to make sure that we protect our fellow Texans far better than we’re doing right now. And that we listen to law enforcement, which Greg Abbott refused to do.”

Democrats say O’Rourke’s approach is focused on public safety. 

“What O’Rourke is proposing, and what a lot of Democrats are proposing, are policies that are going to keep students in schools safe; they’re going to keep law officers on the streets safe,” said Christina Amestoy, deputy communications director at the Democratic Governors Association. “These are efforts to increase public safety through commonsense gun safety measures. Republicans are going to attack him on it because they don’t want to do anything.”

Republicans argue that O’Rourke’s appearance at the press conference is being used as a strategy to inject energy into his campaign ahead of what is expected to be a hard-fought campaign for the Democrat. The non-partisan Cook Political Report rates the race as “likely Republican.” 

“It’s a candidate who is clearly struggling. He’s in an uphill race and is looking for an issue to give him some momentum and juice and credibility,” said one Texas Republican strategist. “He’s a guy that thirsts for that kind of attention and adoration, which by the way is not uncommon among politicians.” 

But Abbott has also faced scrutiny in the aftermath of Tuesday’s shooting. 

The governor drew criticism on Wednesday after he confirmed that he stopped at a campaign fundraiser on Tuesday after learning of the shooting in Uvalde. Abbott said he was in Taylor County, Texas, responding to wildfires in the area and stopped off at the fundraiser in Walker County. 

“On the way back to Austin, I stopped and let people know that I could not stay, that I needed to go, and I wanted them to know what happened and get back to Austin so that I could continue my collaboration with Texas law enforcement to make sure that all the needs were being met here in the Uvalde area,” Abbott said. 

O’Rourke hit Abbott over the move in a tweet late on Wednesday, saying “he was counting dollars while they were counting bodies.”

The Texas-based GOP strategist said O’Rourke would have been better off if he had made a bigger deal over Abbott’s decision to stop at the fundraiser.  

“Abbott gave him an opening, which was attending a fundraiser a couple of hours after the shooting, that actually was Beto’s real opening and opportunity, and I don’t think he needed to necessarily pull the stunt that many found distasteful and disrespectful,” the Texas GOP strategist said. 

On top of that, Abbott and other national Republicans have had to contend with an upcoming National Rifle Association in Houston set to begin on Friday. Abbott, former President Trump, Rep. Dan Crenshaw (R-Texas) and South Dakota Gov. Kristi Noem (R) are all set to attend. 

“Your job as a governor, frankly the delegation as a whole, is first and foremost to be comforters,” the Republican strategist said. “It disturbs me on either side, frankly, to see people jump immediately into the politics.” 

“There is a time and it might be tomorrow given the NRA, it probably will be tomorrow, but they haven’t even had the opportunity to even fully grieve or even start to grieve,” they continued. 

But the tragedy has already entered the political realm, with both sides strategizing how to best approach the issue going into November. 

“It should be political,” said Mimi Swartz, executive editor of Texas Monthly. “Time and again, they’ve had opportunities to make stricter gun laws, and time and again, they’ve weakened gun laws.” 

Hinojosa predicted the issue would be huge for Democrats and other voters going into the midterms, calling it “one of the most fundamental issues facing our children and our families all over America today.” 

“We’re going to constantly remind Texans, what these men did, it’s just a total lack of responsibility,” he said. “They’ve chosen guns over children.” 

Republicans, on the other hand, are not so sure it will be a definition factor in November. 

“It’s hard to think and say this now, but do I think this will be a top-of-mind issue for voters in November? No,” the GOP strategist said. 

“At the end of the day, the news coverage reduces, people go back to focusing on trying to make sure they can take care of their own family and pay the bills and afford to drive their cars.” 

Source: TEST FEED1

Giants' Kapler refusing to take field for anthem in protest

CINCINNATI (AP) — San Francisco Giants manager Gabe Kapler said Friday he will refuse to take the field for the national anthem in a protest over the nation’s political direction following this week’s school shooting in Texas.

“I don’t plan on coming out for the anthem going forward until I feel better about the direction of our country,” Kapler said before a series opener at Cincinnati. “I don’t expect it to move the needle necessarily. It’s just something that I feel strongly enough about to take that step.”

Kapler said he needs more time to consider specific actions he might suggest be taken to prevent more tragedies of this type, such as stronger gun control laws.

Kapler said that on the day of the shooting at Robb Elementary School in Uvalde, Texas, “I knew that I was not in my best place mentally and I knew that it was in connection with some of the hypocrisies for the national anthem and how it coincided with the moment of silence and how two things didn’t synch up well for me, but I couldn’t make sense of it in real time and it took me a couple of days to pull all my thoughts together.”

Only seven Giants were on the field — two coaches in front of the dugout, four players along left-field line and an athletic trainer standing alongside them — when “The Star-Spangled Banner” was played before Kapler and Reds manager David Bell exchanged lineup cards. The game started after a 2-hour, 8-minute rain delay.

Earlier in the day, Kapler used his personal blog to discuss the deaths of the 19 children and two teachers killed in Uvalde.

In a post titled “Home of the Brave,” Kapler wrote: “We elect our politicians to represent our interests. Immediately following this shooting, we were told we needed locked doors and armed teachers. We were given thoughts and prayers. We were told it could have been worse, and we just need love.

“But we weren’t given bravery, and we aren’t free. … We aren’t free when politicians decide that the lobbyist and gun industries are more important than our children’s freedom to go to school without needing bulletproof backpacks and active shooter drills.”

Kapler went on the write: “Every time I place my hand over my heart and remove my hat, I’m participating in a self congratulatory glorification of the only country where these mass shootings take place. On Wednesday, I walked out onto the field, I listened to the announcement as we honored the victims in Uvalde. I bowed my head. I stood for the national anthem. Metallica riffed on City Connect guitars. My brain said drop to a knee; my body didn’t listen. I wanted to walk back inside; instead I froze. I felt like a coward. I didn’t want to call attention to myself. I didn’t want to take away from the victims or their families.”

“But I am not OK with the state of this country.” he added. I wish I hadn’t let my discomfort compromise my integrity. I wish that I could have demonstrated what I learned from my dad, that when you’re dissatisfied with your country, you let it be known through protest.”

Kapler has protested during the anthem in the past. In July 2020, before the start of the virus-shortened 60-game season, Kapler joined outfielder Jaylin Davis in taking a knee ahead of an exhibition game against the Oakland Athletics. Davis was making a statement about racial and social issues facing the country.

Fellow outfielders Mike Yastrzemski and Austin Slater also chose to kneel. So did first base coach Antoan Richardson, while shortstop Brandon Crawford stood between Davis and Richardson with a hand on each man’s shoulder.

Kapler’s latest comments came a day after the New York Yankees and Tampa Bay Rays used their social media accounts during the game between the teams to spread information about how gun violence affects American life.

Source: TEST FEED1

Fed unit was asked by police to wait before entering Robb Elementary: report

A Customs and Border Patrol (CPB) unit at the scene of the Uvalde, Texas, elementary school shooting was told not to enter the school and instead wait, according to a report from NBC News.

Two federal officials who spoke to the outlet said that agents who were part of BORTAC, CPB’s tactical unit arrived on the scene at Robb Elementary School around 12:15 p.m., approximately 45 minutes after the suspected shooter began his rampage.

ICE Homeland Security Investigations division was also on the scene, according NBC.

Once there, local police asked them to wait and assist pulling students out of windows. However, after 30 minutes passed, the federal agents decided to move in on the shooter and take him out.

The news comes after Director of the Texas Department of Public Safety Steven McCraw said earlier Friday during a press conference that law enforcement should have engaged the shooter earlier. McCraw explained that over the course of the incident, 19 police officers were at the scene in the school’s hallway outside of the locked adjoining rooms where the shooter was hiding.

The commanding officer on the scene did not allow the law enforcement to enter the rooms because he believed the shooter was barricaded and the children were not in danger. 

Emergency calls from students inside the room revealed later that children were begging for help. McCraw said there are different rules approaching a barricaded shooter than an active shooter, with police obligated to charge an active shooter without equipment. 

“From the benefit of hindsight where I’m sitting now, of course, it was not the right decision. It was a wrong decision. Period. There was no excuse for that,” McCraw said. 

The Washington Post reported Friday citing a CPB official with knowledge of the situation that once federal agents made it into the locked rooms, the gunman emerged from a closet firing his weapon. The agents returned fire and killed him.

“They have not told me they were frustrated,” the official said. “But they told me it was hard to discern who was in charge.”

“It wasn’t a huge team,” he continued. “It was one agent from here, two from there, and they just converged there.”

Police response to the shooting has garnered scrutiny after initial statements from law enforcement showed inconsistencies.

Texas Gov. Greg Abbott (R) said Friday he was “livid” about being given inaccurate information about the police response to the shooting.

Source: TEST FEED1

Drivers: We are facing a national emergency

This Memorial Day kicks off what could be one of the most dangerous summer travel seasons in recent history. The alarming spike in drunk driving deaths and injuries during the pandemic is a wake-up call to every one of us on America’s roads. We have to do better.

During the 2020 Memorial Day period, 41 percent of fatalities involved an alcohol-impaired driver, according to the National Safety Council. And the latest data from the National Highway Traffic Safety Administration (NHTSA) shows projected 2021 traffic fatalities were 10.5 percent higher than in 2020. The agency said an estimated 42,915 people died in motor vehicle traffic crashes last year,10,000 more than in 2011. Impaired driving, speeding and not using seatbelts continue to be contributing factors.

U.S. Transportation Secretary Pete Buttigieg recognized that these numbers demand action. “We face a crisis on America’s roadways that we must address together,” he said. We at Mothers Against Drunk Driving (MADD) completely agree.

If you’ve driven on a highway lately, you’ve probably seen what’s happening. People are speeding by, weaving in and out of the lanes as if they’re in a race car video game. If you’ve walked or ridden a bike on an urban street, you may be equally frightened.

It feels like during COVID too many people have forgotten the basic rules of safe driving. Everyone was cooped up through much of the pandemic and was eager to get back behind the wheel. But for too many drivers, enthusiasm has turned into recklessness.

Solving this crisis on our roads will require every tool and strategy that federal, state and local agencies can throw at each element of the problem. But solving this is also on us, too — you and me.

Our free society requires each of us to think. We have to think about the consequences of each choice we make. We have to think about the privilege of having a driver’s license and the responsibilities that go with it. We owe it to one another to make better choices while driving.

Every one of those 42,915 people killed on our roads last year thought they would be coming home. They thought they’d reach their destination and go to work, or get up the next morning and hug their loved ones. They walked out of their door not realizing it was their last day or night on this earth.

As MADD national president, I can give you three policy recommendations we believe will help:

●      NHTSA must strictly adhere to the regulatory timetable called for under the Infrastructure Investments and Jobs Act to ensure that new cars equipped with the state-of-the-art, lifesaving technology will start rolling off the assembly line as soon as 2026 and no later than 2027

●      Our courts should prioritize fair and equitable treatment of DUI offenders, and state and local governments should give law enforcement the resources to meet this growing traffic safety challenge.

●      Secretary Buttigieg should convene a national Call to Action meeting within 30 days to identify solutions, including the Roadway Safety Strategy, to what NHTSA Deputy Administrator Dr. Steven Cliff called an “urgent and preventable” crisis on our roads. The public and private sectors, including the auto and insurance industries, should be included and realistic goals should be set for reversing the trend of increased fatalities.

My stomach turns every time I hear about drunk drivers getting off with short sentences after they’ve killed someone or caused horrific life-changing injuries. It’s unacceptable when repeat offenders are allowed to return to driving with just a wrist slap or when comedians make jokes on TV about their own DUIs.

Every day, I’m reminded of the price so many of us pay for someone’s bad choice to get behind the wheel while impaired. When I hear a siren or see an ambulance responding to a crash, I know that the lives of all involved will never be the same.

Thanks to bipartisan language in the Infrastructure Investment and Jobs Act passed by Congress and signed into law by President Biden in November, advanced vehicle technology is coming to all new cars in a few years that will reduce or even eliminate certain safety threats. Until then, we all have to do better and have each other’s backs while we’re traveling on our streets and highways. This crisis is real and must be addressed immediately. Thousands of lives are at stake. 

Alex Otte is national president of Mothers Against Drunk Driving (MADD).

Source: TEST FEED1

Abbott: New laws will come from school shooting

Texas Gov. Greg Abbott (R) on Friday said he expects new laws to be enacted in response the shooting this week that killed 21 people at an elementary school.

“Do we expect any laws to come out of this devastating crime? The answer is yes. Absolutely yes,” Abbott said. 

When asked about calling a special session for the legislature in response to the shooting, he said “all options are on the table.”

Since the shooting, Republicans have focused their messaging on school security, while Democrats are advocating for more gun control. 

When pressed further on measures Texas could see, Abbott focused on mental health and school safety.

“You can expect robust discussion and my hope is laws passed that I will sign addressing health care in this state,” Abbott said.  “There are an array of health issues that relate to those who commit gun crimes.”

Abbott seemed more resistant to measures targeting background checks on guns and new laws around buying rifles.

Abbott pointed to other school shootings where a background check did not stop a shooter because the person who committed the act passed the check.  

“Anyone who suggests we should focus on background checks instead of mental health, I suggest to you it is mistaken,” Abbott said. 

In regards to rifles, Abbott said that “ever since Texas has been a state, an 18 year old has had the ability to buy a long gun, a rifle.”

“And since that time, it seems like it’s only been in the past decade or two we’ve had school shootings,” Abbott said. “For a century and a half, 18 year olds could buy rifles and we didn’t have school shootings but we do now. Maybe we’re focusing our attention on the wrong thing.”

The shooting in Uvalde, Texas, has sparked national outrage as more details emerge about the police waiting outside the elementary school building while the shooter was inside. 

Abbott said at the press conference he is “livid” about the initial “inaccurate” information he received about the police’s response to the shooting, as he previously said authorities handled the event with “courage.”

Source: TEST FEED1

Accelerated approval: unfulfilled promises for FDA’s expedited review program

As practicing physicians, approval by the U.S. Food and Drug Administration (FDA) reassures us that the treatments we prescribe our patients have been rigorously vetted as effective and safe. For a growing number of drugs, however, FDA approval comes with lingering uncertainty of their benefit. Under the accelerated approval pathway, FDA provisionally approves drugs based on surrogate endpoints, such as laboratory or imaging results that are proxies for disease progression, with the requirement that manufacturers conduct clinical trials following approval to confirm clinical benefit. This arrangement is intended to speed access to promising treatments, with the expectation that manufacturers will confirm that the drugs improve how patients feel, function, or survive.

But manufacturers have largely failed to hold up their end of the bargain — nearly half of drugs granted accelerated approval have not been confirmed to be clinically beneficial. Deadlines to complete postapproval trials are often generous, and the trials that are completed frequently confirm benefit using surrogate endpoints, using those same endpoints that supported the initial accelerated approval. In some cases, drugs without evidence of clinical benefit can linger on the market for years. FDA recently withdrew romidepsin’s approval for peripheral T-cell lymphoma — ten years after accelerated approval, and more than a year after its confirmatory trial failed to show benefit. By the time ineffective uses are withdrawn, drugs can be anchored in the market by other indications — leaving physicians with an unclear picture of whether these treatments offer benefit over alternatives.

In the meantime, patients can be exposed to serious risks. Duvelisib, which was granted accelerated approval for a type of lymphoma, carries multiple black-box warnings, including potentially fatal infections in nearly one-third of patients. It was approved based on the assumption that the benefits would potentially outweigh these risks; nevertheless, its manufacturer never started the required trial to confirm duvelisib’s predicted benefits in the two years before FDA withdrew it. Safety concerns are more common for drugs granted accelerated approval, and there is no efficient process for the FDA to withdraw drugs, instead relying on manufacturers to do so voluntarily. Patients and physicians trying to weigh the potential risks of new drugs may wait years for answers — if they come at all.

Accelerated approval drugs also have massive financial implications, including for Medicare and Medicaid, which together provide coverage for 135 million Americans. In our recently published study in JAMA Health Forum, we found that Medicare and Medicaid spent $68 billion through 2020 on new drugs granted accelerated approval between 2012 and 2017, three-fifths of which was on drugs with postapproval trials evaluating surrogate endpoints, for which clinical benefit was not confirmed. As Medicare and Medicaid are mandated to cover certain therapeutic classes, including cancer drugs that accounted for nearly all spending in our study sample, they are on the hook for these drugs, regardless of whether they are ultimately, or ever, proven to work.

In light of recent scrutiny of accelerated approval, catalyzed by FDA’s controversial approval of aducanumab for Alzheimer’s disease, Congress is considering reforms to the pathway, in hopes of resetting the balance for patients between timely access to treatments and timely certainty of their benefit. These reforms are being considered as part of user fee legislation that authorizes FDA to collect and use fees paid by pharmaceutical companies to support new drug reviews.
Proposed legislative reforms to accelerated approval are intended to support FDA in holding manufacturers accountable for completing their postapproval studies, by requiring that confirmatory trials are initiated by the time of accelerated approval, increasing FDA oversight of trial design, and mandating manufacturers provide routine progress reports for studies. These are good first steps, but Congress should also include previously introduced provisions that would facilitate FDA enforcement of approval standards. These include automatic expiration of accelerated approvals without proof of benefit, either one year after study completion or five years after approval, and streamlining the process for withdrawing indications. Removing the proposed additional requirements to offer manufacturers meetings with advisory committees or the FDA commissioner prior to taking action would also minimize delays in withdrawing indications that pose ongoing clinical and financial risk.

Legislation should also clarify that FDA “shall,” not “may,” require postapproval studies for all accelerated approval drugs, as well as require that drugs be evaluated by advisory committees prior to approval, reversing a recent trend towards fewer independent, expert voices in the approval of new drugs. These reforms are essential to provide patients with certainty of drugs’ benefits and prevent the use of unvalidated or clinically inconsequential outcomes in granting accelerated approval or fulfilling postapproval study requirements.

Finally, legislation should ensure real-world evidence augments, rather than replaces, clinical trials fulfilling postapproval study requirements. FDA-funded research suggests only half of studies could be conducted using sources such as electronic health records or medical claims data in place of traditional clinical trials. In another published study, we found that none of the required postapproval studies for accelerated approval drugs could be emulated using such sources of evidence. Although real-world evidence can provide new insights, especially for patients underrepresented in clinical trials, our current health systems are not yet ready to be used as the sole source of data for the rigorous and reliable evaluations necessary to confirm drugs’ benefit.

In the clinic and on the wards, we are frequently called upon to interpret the relevance of clinical trials for our patients. This essential act of translation, from abstract to individual, is made significantly more challenging by the absence of data on the outcomes most relevant to patients — on months lived, hospitalizations shortened, and adverse outcomes avoided. Strong standards for FDA approval are necessary to ensure new drugs reach market in service of these goals.

Reshma Ramachandran, MD, MPP, is a family medicine physician and fellow in the Yale National Clinician Scholars Program. She leads efforts on drug pricing and FDA policy for the national non-profit organization, Doctors for America. Besides having published in the highest-impact peer-reviewed medical journals, we have also published editorials in The New York Times, Washington Post, Bloomberg Law, Baltimore Sun, The Nation, STAT News, The Hill, and CNN Opinion. Joshua Skydel, MD, is a resident physician in internal medicine at Dartmouth-Hitchcock Medical Center and led the study described in the op-ed. Joseph S. Ross, MD, MHS, is a Professor of Medicine and Public Health at Yale University with over two decades of research experience in pharmaceutical regulation, pricing, and reimbursement policy.

Source: TEST FEED1