
California has just approved a new blueprint for offshore wind. The massive projects will cost billions.
- July 10, 2024
The California Energy Commission this week unanimously approved a sweeping plan to develop a massive floating offshore wind industry in ocean waters — a first-of-its-kind undertaking that will require billions in public and private investments and could transform parts of the coast.
The new state plan sets the path for harnessing wind power from hundreds of giant turbines, each as tall as a 70-story building, floating in the ocean about 20 miles off Humboldt Bay and Morro Bay. The untapped energy is expected to become a major power source as California electrifies vehicles and switches to clean energy.
California’s wind farms represent a giant experiment: No other place in the world has floating wind operations in such deep waters — more than a half-mile deep — so far from shore.
The commission’s vote on Wednesday came after representatives of various industries, environmentalists, community leaders and others expressed mostly support, along with some concerns.
State and federal officials use the word “urgency” to describe the frenetic pace needed to lay the groundwork for development of five areas that the federal government has leased to offshore wind companies.
“I feel the urgency to move forward swiftly,’ said energy commissioner Patty Monahan. “The climate crisis is upon us. Offshore wind is a real opportunity for us to move forward with clean energy.”
She added, though, that the plan “is a starting point…There are a lot of uncertainties about environmental impacts. We need to be clear-eyed and engage the right scientific interests and move carefully.”
The five energy companies are now assessing sites within the 583 square miles, which is expected to take five years. That will be followed by about two years of design, construction and environmental and technical reviews.
Energy Commission Chairman David Hochschild recently called it “one of the single most complex processes I’ve been involved with.”
That complexity was reflected in the heft of the strategic plan, which includes three volumes and 500 pages of public comment. The breadth of the document — which involved coordination among nine state agencies — reflects the sheer size and scope of what’s being envisioned. State officials said offshore wind requires an unprecedented level of planning and policy development in California.
The offshore wind industry must be created almost from scratch: a new manufacturing base for the still-evolving technology; a robust and reliable supply chain; transportation networks on land and sea; specially configured ports to make, assemble and maintain the gargantuan seagoing platforms; finding and training a highly specialized workforce; building a large transmission network where none exists and beefing up those that operate now.
The Energy Commission’s plan estimates that just the work to upgrade California’s ports will cost $11-$12 billion, much of it publicly funded. The plan identifies the large ports of Humboldt, Long Beach and Los Angeles as viable for storing, staging and assembling parts needed for offshore wind operations.
By 2045, 16 large and 10 small ports will be needed along California’s coast for various aspects of development and support, according to the plan. “Funding and permitting for these projects are a critical challenge to address,” the plan says. An estimated $475 million would be set aside for port infrastructure in a climate bond measure that will be on the November ballot.
Another pressing challenge is transmission — the complex job of getting the power onshore and distributing it to users. The Humboldt area presents the biggest challenge, the report says, given the rural region’s already sparse transmission network.
Capturing wind energy from giant floating ocean platforms is considered essential to achieving California’s ambitious goal of electrifying its grid with 100% zero-carbon energy. The state’s blueprint envisions offshore wind farms producing 25 gigawatts by 2045, powering 25 million homes and providing about 13% of California’s electricity.
Powering an expansive economy free of fossil fuels by 2045 means the state must triple its power generation capacity and deploy new solar and wind energy at almost five times the pace of the past decade.
The endeavor will require coordination with multiple state and federal agencies, as well as local and tribal governments, with overlapping jurisdictions and sometimes conflicting priorities.
That heavy lift, said Adam Stern, executive director of Offshore Wind California, an industry group, made it all the more remarkable that the strategic plan was finalized.
“This is tangible progress. It’s a remarkable record of intent and determination,” he said. “None of these things was happening a year ago. The plan mobilized the ecosystem of state agencies, industry, organized labor, environmental groups and tribes. There are lots of challenges ahead, but this is a great start.”
The Energy Commission missed its March deadline included in state law to approve the plan. Then the agency postponed a scheduled vote two weeks ago to give interested parties enough time to digest the dense package of documents.
The shipping industry is concerned that the plan doesn’t “address and ensure navigational safety and efficiency” for the commercial ships that serve California’s seaports. The ports of Los Angeles and Long Beach are the nation’s busiest.
“The plan lacks any effective identification and analysis of potential impacts to the commercial shipping industry,” the Pacific Marine Shipping Association wrote in a letter to the Energy Commission. “It is frankly confounding that there is resistance to include the maritime industry in this vital Plan; to be clear, the industry is not opposed to offshore wind development in practice.”
Environmental groups scoured the documents for answers to what have been unanswerable questions about offshore wind’s potential effects on marine life, migrating whales and birds, and the onshore environment.
Even state scientists have publicly noted a “data gap” when it came to understanding the impact of platforms in the sea, electrified underwater cables, huge spinning blades and increased boat traffic.
To answer those questions, the commission’s plan calls for a broad-based science consortium and a bird and bat conservation strategy, among other topics. Recreational and commercial fishing will be affected, the report says, and that will require continued research, officials say.
Some environmental groups have come to terms with the uneasy tradeoff between the need to address climate change with cleaner energy and the potential harmful impacts that come with any energy development.
Understanding that climate change is contributing to the rapid decline of bird populations means accepting some development, said Mike Lynes, director of public policy for Audubon California. “We want these projects to be successful. But we want to avoid impacts first and mitigate where we can.”
Dan Jacobson, senior adviser to the advocacy group Environment California, said he is becoming comfortable with the unknowns. “But we can’t slow down on the science and information that we need. We have to do things quickly, inexpensively and very smartly. You usually get two out of three of those things. How do we do this so that we cause the least harm and get the most good out of it?”
Assemblymember Dawn Addis, whose district includes 200 miles of the Central Coast, said it is clear to her that her constituents don’t have enough information to understand the implications of the new industry. Her 2023 bill to fund offshore wind scientific research was folded into the budget, with $3.6 million going to the state Ocean Protection Council to organize the research effort.
“Everyone’s hungry to understand the science,” said Addis, a Democrat from San Luis Obispo. “There’s still work to do to get that science into the world. This is a tremendous opportunity to study the deep ocean.”
Addis, who chairs the Legislature’s select committee on offshore wind energy, said lawmakers will analyze the strategic plan and “uncover needs that we just don’t know about yet. Getting this right is not just a slogan for me.”
Generally, the plan acknowledges environmental impacts but says that so-called “adaptive management” — flexibility to change an approach if it proves unexpectedly damaging — can address most concerns.
The projects will industrialize sections of the California coast with an indelible footprint, and could usher employment and revitalized economies to neglected regions. Nearly a fifth of Humboldt County households live in poverty.
Community groups and tribes along the North Coast, in particular, have been participating in formulating the state’s strategic plan to make sure that wind development doesn’t follow the boom-and-bust cycle of so many extractive industries, such as mining and timber. that have come and gone from the Humboldt region.
“We need to be part of the decision-making structure, to make sure that this industry delivers local community protection and investment, through legally binding and enforceable mechanism,” said Katerina Oskarsson, the executive-in-residence at CORE Hub and the Humboldt Area Foundation, part of a coalition of community groups and tribes.
“If this industry moves forward, host communities need to benefit.This is not just about jobs and economic benefit. It’s about justice beyond jobs. This needs to be transformational in a meaningful way,” she said.
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Man suspected in crossbow killing of BBC radio commentator’s wife and daughters is arrested
- July 10, 2024
By PAN PYLAS
LONDON — British police said they found Wednesday the man suspected of killing the wife and two daughters of a well-known BBC radio commentator near London in a brutal crossbow attack.
In a statement, Hertfordshire Police said 26-year-old Kyle Clifford has been found in the Enfield area of north London, near his home, and that he is receiving medical treatment for his injuries. Police did not say how those injuries happened but said they had not fired any shots.
The BBC confirmed that the women killed were the family of John Hunt — his 61-year-old wife Carol Hunt and their daughters Louise and Hannah, aged 25 and 28 respectively.
While the manhunt was underway, the public were urged not to approach Clifford. Enfield is around 52 kilometers (17 miles) to the east from the site of the killing.
“Following extensive inquiries, the suspect has been located and nobody else is being sought in connection with the investigation at this time,” said Detective Inspector Justine Jenkins from the Bedfordshire, Cambridgeshire and Hertfordshire Major Crime Unit.
“This continues to be an incredibly difficult time for the victims’ family and we would ask that their privacy is respected as they come to terms with what has happened,” she added.
Jenkins said the investigation is moving “at pace” and that formal identification of the victims is yet to take place. She also said that the “premature” naming of the victims “caused great upset.”
Police had been scouring a park in north London, near the home of Clifford, after being alerted Tuesday about the killings in a house in Bushey, a residential area in northwestern London. Police and ambulance crews tried to save them, but they were pronounced dead at the scene.
John Hunt is the main racing commentator for BBC 5 Live, the corporation’s main news and sports radio channel. His voice is known to millions through his coverage of the world famous Grand National and The Derby.
The Daily Mail newspaper and others reported that Hunt found the bodies early Tuesday evening, after returning home from reporting at Lingfield Park racecourse south of London.
As part of a note sent to BBC staff, the broadcaster described the incident as “utterly devastating” and that it will provide Hunt “with all the support we can.”
Police did not say how or whether Clifford, who is from London, was connected to the women, but British media reported that he was an ex-boyfriend of one of the daughters. The BBC reported that Clifford left the British Army after a brief period of service in 2022.
Local council member Laurence Brass, who lives nearby, said the area is “a typical leafy British suburb.”
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“At about eight o’clock last night, I was watching the football on television, and suddenly a helicopter landed in the lawn outside my flat, which is at the top of this road, and then my phone started going, and I was told that there was a major incident here in Bushey and we should all keep away because there was somebody apparently on the run,” he told the BBC.
Britain’s new home secretary, Yvette Cooper, was kept “fully informed” about the “truly shocking” incident.
People in Britain do not need a license to own a crossbow, but it is illegal to carry one in public without a reasonable excuse.
A spokesperson for the Home Office said Cooper will “swiftly consider” the findings from a recently launched review into whether further controls on crossbows should be introduced.
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Haunted Mansion construction won’t be done when Disneyland ride reopens
- July 10, 2024
Haunted Mansion fans eager to hang out with the 999 happy haunts again after seven months of refurbishments will have to navigate a warren of construction walls to get into the haunted house as crews continue to work on the Disneyland attraction.
Construction won’t be complete when the Haunted Mansion returns in time for Halloween with work continuing on the new stand-by queue and surrounding grounds, according to Disneyland.
“Our new stand-by queue experience hasn’t quite materialized yet,” according to the Disneyland website. “Using a virtual queue allows us to welcome back foolish mortals to this eerie estate once again while we continue work on the surrounding area.”
ALSO SEE: 14,000 Disneyland employees to vote on union strike
The Haunted Mansion closed in January for an extended renovation of the outdoor queue area that will add a new accessibility elevator for wheelchair users exiting the ride and a new retail shop themed as Madame Leota’s carriage house at the attraction’s exit.
Disneyland has announced Haunted Mansion Holiday will return by Aug. 23 in time for the Halloween Time season at Anaheim theme park resort. A Virtual Queue will be used to manage crowds.
The Haunted Mansion will likely reopen in late July and well before the 55th anniversary of the dark ride on Aug. 9, according to MiceChat.
“Come hell or high water, they want the attraction to open well before that date,” according to MiceChat. “Unfortunately, the new queue and shop won’t be ready in time.”
Haunted Mansion riders will bypass the construction via entrance and exit pathways, according to MiceChat.
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Vertical construction has not yet begun on the Madame Leota-themed gift shop at the ride’s exit, according to MiceChat.
“There’s still many months worth of work to be done,” according to MiceChat.
The Haunted Mansion will be in holiday mode when the ride returns for Halloween Time.
Disneyland’s Haunted Mansion has gotten a “Nightmare Before Christmas” makeover based on the Tim Burton animated film for more than 20 years now. The New Orleans Square attraction closed in January with the holiday overlay still in place.
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Gavin Newsom for president? Tallying up his assets and liabilities
- July 10, 2024
Gov. Gavin Newsom leaves the stage after addressing attendees at his inauguration for a second term at the Plaza de California in Sacramento on Jan. 6, 2023. Photo by Rahul Lal, CalMatters
In the nearly two weeks since President Joe Biden’s catastrophic performance in a televised debate, the Democratic freakout over whether he can continue as their presumptive presidential nominee has not abated
Even as Biden insists that he is committed to finishing out the race, speculation continues among the party faithful and political observers over who might be best positioned to defeat Republican former President Donald Trump instead. Among those frequently cited is California’s own Gov. Gavin Newsom, a dedicated Biden surrogate who recently completed a tour on the president’s behalf through Michigan, Pennsylvania and New Hampshire.
While Newsom says he’s standing firmly behind Biden’s re-election and has long publicly denied any presidential ambitions, this chaotic political moment is elevating the national profile that Newsom has spent years cultivating — including through a Fox News debate last fall against Florida Gov. Ron DeSantis and a heretofore unsuccessful bid for a constitutional amendment on gun control.
CalMatters spoke with political consultants and experts — veterans of California elections, swing state organizing and national campaigns — about Newsom’s prospects as a presidential contender. They largely agreed that he was extremely unlikely to become the Democratic nominee this year even if Biden ultimately withdraws, with Vice President Kamala Harris waiting in the wings, but that Newsom could be a strong candidate in the 2028 primary because of his progressive bona fides and extensive political network.
The biggest question mark: Can a California Democrat, the liberal caricature that has been a political punching bag for decades, win a presidential election? If the last eight years have taught us anything, it’s that the conventional wisdom may no longer apply.
NEWSOM ASSETS
1. He’s a dynamic campaigner
Newsom’s classic good looks and charisma have always bolstered his political star power. (Never forget the infamous “New Kennedys” profile in Harper’s Bazaar in 2004, shortly after he became mayor of San Francisco.) But several observers said they were particularly impressed by how he has navigated a tough situation as a Biden surrogate over the past two weeks, defending the president on television immediately after the debate and then rallying Democratic crowds on the campaign trail.
“I don’t want to hurt him by saying this, but he’s a natural politician,” said Bob Shrum, director of the USC Dornsife Center for the Political Future and an adviser on numerous presidential campaigns, including Democratic nominees Al Gore in 2000 and John Kerry in 2004.
Newsom’s defense of the Democratic position — even in direct confrontation with conservative opponents and sometimes out ahead of his own party — gives him the image of a fighter, which could appeal to liberal voters looking for a new leader.
“The reason Gavin gets talked about is how dynamic he is, how polished he is in terms of talking about politics and policy,” said Roger Salazar, a Democratic communications consultant who served as a spokesperson on Gore’s 2000 campaign and is a Newsom appointee to a California commission for off-road vehicle recreation. “He’s very strong on the stump and he doesn’t back down.”
It also carries potential benefits behind the scenes, ingratiating Newsom to the Democratic establishment that could clear a path for his future plans.
“Being the loyal lieutenant and not appearing too ambitious will serve him to maybe buy some goodwill and become a legitimate heir apparent,” said Jason Cabel Roe, a longtime GOP strategist in Michigan and former deputy campaign manager for Mitt Romney’s presidential bid in 2007.
2. He has a growing national fundraising base
Newsom is a prolific fundraiser with experience building a war chest to boost himself and other Democrats nationally. It is one of his greatest strengths, rivaling any senator or governor who may be considering their own campaign for president, said Rose Kapolczynski, a longtime Democratic strategist working with Close the Gap California to elect more women legislators.
“He’s raised tens of millions of dollars for his own campaigns and ballot measures. He’s been an effective fundraising surrogate for Biden and others. And that’s given him the opportunity to build a national fundraising network,” Kapolczynski said. “He has a strong small donor network and he’s certainly well-known to major donors across the country.”
Newsom’s three federal committees, branded as the Campaign for Democracy, have raised $24 million for direct contributions to candidates, ad spending and more since launching in March last year, according to data from the Federal Elections Committee. Slightly more than half of that was transferred from his 2022 gubernatorial campaign.
Most of the cash comes from donors in California, the wealthiest state in the nation and the beating heart of its lucrative tech and entertainment industries, a CalMatters analysis found. But Newsom — who regularly travels the country to elevate Democrats in red states — has also expanded his reach from coast to coast.
For example, the Campaign for Democracy PAC, Newsom’s political action committee contributing to Democratic parties and candidates, raised more than $10 million by March, about $6 million of which came from his gubernatorial account. An analysis of itemized contributions from donors who gave $200 or more suggests that more than 40% of the remaining funds came from outside California, across 46 other states.
Establishing the network now also shrewdly lays the groundwork for a potential future presidential campaign, giving Newsom a financial reserve to run ads and curry favor with other Democrats, said Bud Jackson, a longtime Democratic strategist in Washington, D.C., who spearheaded TV advertising efforts to recruit Wesley Clark and Barack Obama for president.
“It sounds like they’ve got their (stuff) together,” Jackson said.
3. He’s appealing to Democratic base voters
If Biden sticks around, the next Democratic presidential nominee will be chosen through the 2028 primaries. Those are decided by a more liberal subset of the electorate that may be drawn to a candidate like Newsom with a history of bold progressive governance — from issuing marriage licenses to same-sex couples as mayor of San Francisco in 2004 to declaring a moratorium on executions in California not long after he entered the governor’s office in 2019.
Rather than the pocketbook appeal to the working class that propelled Bill Clinton, Democratic voters in the Trump era are searching for a leader with the proper worldview, said Mike Madrid, a Republican political consultant who worked on the anti-Trump Lincoln Project during the 2020 presidential campaign. Madrid believes Newsom is the frontrunner for the 2028 nomination because he has shown Democrats how to win with the cultural issues, such as abortion rights, that are most important to the party’s core supporters.
“He understands the Democratic base better than almost any Democrat of his generation, and that they are driven almost exclusively by cultural issues,” said Madrid, who worked on the campaign for one of Newsom’s gubernatorial rivals in 2018. “I think he’s a generational talent.”
And while candidates generally try to broaden their message during the general election, Madrid said the calculus for how to win has changed. In an increasingly divided electorate, where miniscule margins will decide the presidential race, energizing the base is just as important as winning over the ever-narrower slice of swing voters.
The constant attacks against Newsom and his “California values” by Trump, DeSantis and other Republicans actually benefit Newsom with the people who hate what those conservative politicians stand for, Madrid said.
“The average Democratic voter across the country is not that different from the average California Democratic voter,” he said. “The more that Republicans say California is a liberal hellhole, that helps him. He wants that.”
Gov. Gavin Newsom speaks to reporters in the spin room after a presidential debate between President Joe Biden and Republican presidential candidate former President Donald Trump in Atlanta on June 27, 2024. Photo by John Bazemore, AP Photo
NEWSOM LIABILITIES
1. He’s not particularly popular
The challenge for Newsom is to reach beyond that Democratic base. While only a snapshot in time, recent trends in California are not encouraging.
After surging during the pandemic and then holding a steady majority, Newsom’s approval rating among California voters has cratered over the past year. The Public Policy Institute of California found in a June survey that just 47% of likely voters in the state approved of the job the governor is doing, down from 59% a year prior.
Pollsters did not track why Newsom is underwater. He’s spent most of the year dealing with a historic budget deficit and the threat of massive cuts to important public programs.
But survey director Mark Baldassare noted that the governor’s approval has shrunk notably with independents, less a third of whom approve of him. Among independent likely voters, his approval is down to 35% from 50% a year ago. During that time, Newsom has leaned into his role as a prominent national surrogate for Democrats and come under increasing criticism from Republicans. In a breakout of survey respondents from the most competitive California congressional districts, only 42% of likely voters approved of the job Newsom is doing. That’s lower than California voters overall — a potentially bad sign for his appeal in swing states.
“Gavin Newsom has become a more politically polarized candidate in a more politically polarized time,” Baldassare said. “That’s one thing that a governor experiences when they put themselves in the national spotlight.”
2. He’s got a tough record to defend
Nearly all the experts CalMatters spoke to agreed that California’s rising crime rates, homelessness crisis and massive budget shortfall provide potent ammunition for conservatives — and even fellow Democrats — to target Newsom during a presidential campaign.
“There’s just so many things that are going wrong in the state, and he owns all of them. He is identified with all of them,” said Roe, the GOP strategist from Michigan.
Voters in California are increasingly frustrated with the state’s rising violent and property crime rates in recent years, although they remain lower than in the 1980s and 1990s, according to the Public Policy Institute of California.
The sentiment fueled support for a ballot measure this November to partially undo Proposition 47 — a decade-old state law approved by voters — by toughening penalties for retail thefts and drug offenses. Newsom and Democratic legislative leaders balked at the measure but eventually backed down amid broken negotiations and failed attempts to put a rival proposal on the ballot.
Similarly, Newsom would have to reckon with overseeing a whiplash-inducing decline from record budget surplus to multibillion dollar deficit, and with the state’s homelessness crisis, which has in many ways defined his governorship. The number of homeless Californians has been on the rise in recent years, accounting for almost half of the nation’s unhoused population.
To change the narrative, Jackson said Newsom must “sidestep” these weaknesses while pointing to other accomplishments.
“He can say, ‘The economy has been in a rough spot, inflation is very high, these are things that I can’t completely control,’” Jackson said.
In part to dampen public concerns about homelessness, Newsom championed Proposition 1 — a mental health bond measure he said would help tackle homelessness — which passed by razor-thin margins in the March primary. And in a friend-of-the-court brief, he also asked the Supreme Court to grant cities more authority to clear encampments. The court’s conservative majority last month obliged, to the outrage of the court’s liberal justices.
When it comes to crime and homelessness, Salazar said, Newsom could point to “major cities in red states” with “the exact same issues.”
3. His appeal to swing state voters is unknown
California Democrats brag about being on the political cutting edge, but their proudly progressive values also make them an object of ridicule. When Rep. Nancy Pelosi was Speaker of the House, Republicans used her San Francisco hometown as a cudgel in ads against members of her caucus. Former Gov. Jerry Brown earned the nickname “Governor Moonbeam” on the way to one of three unsuccessful presidential bids.
California’s luster appears to be dimming even further as Newsom’s star rises. A Los Angeles Times poll in February found that half of American adults believe California is in decline, and nearly half of Republicans said California was not American.
“For better or worse, that’s not something that’s going to play all too well in other parts of the country,” said Dan Schnur, who served as the national communications director for John McCain’s 2000 presidential campaign and now teaches politics courses at UC Berkeley, Pepperdine University and the University of Southern California.
“If he were the smart, personable, aggressive and mediagenic governor of Wisconsin, he’d be unstoppable.”
Jonathan Kinloch, a Michigan Democratic Party official in Detroit and a Biden delegate, said many voters outside of California perceive the state as the “socialist center” of America and Newsom would have to answer their concerns about its tax and environmental policies.
“When you talk about left, California is far left and…is willing to tax itself out of existence,” Kinloch said.
FILE – California Gov. Gavin Newsom speaks during a Clean California event in San Francisco, Nov. 9, 2023. On Sunday, Feb. 25, 2024, Nearly $200 million in grant money will go to California cities and counties to move homeless people from encampments into housing, Newsom announced Thursday, April 18, 2024, pledging increased oversight of efforts by local governments to reduce homelessness. (AP Photo/Jeff Chiu, File)
Newsom would also need to figure out a stronger message with non-white working-class voters who could carry him over the top in swing states, said Madrid, the GOP consultant. These voters care more about economic issues and have consequently been drifting away from the Democratic Party in recent elections.
“The pathway to the middle class in California is among the least attainable,” Madrid argued. “The record in California is not great. Is it fixable? It is. But he’s going to need time to get there.”
Schnur said running in a presidential primary — when Newsom can lean on liberal issues that play to his strengths, such as abortion rights and climate change — would give voters more time to get to know him and become comfortable with him.
“In a general election, the landscape is going to be much less hospitable,” Schnur said. “But in a primary, it’s easier for him to change the subject.”
But being from a blue state, Newsom lacks experience in competitive races. That could put him at a disadvantage compared to other politicians — such as Michigan Gov. Gretchen Whitmer, Pennsylvania Gov. Josh Shapiro and Kentucky Gov. Andy Beshear — who have also been floated as future presidential contenders.
“His entire career, he just kind of walks into each office,” Roe, the Michigan Republican consultant, said. “So he’s got a glass jaw.”
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Safety of generic Viagra, other drugs called into doubt after false data found by FDA
- July 10, 2024
Anna Edney | (TNS) Bloomberg News
Generic versions of erectile dysfunction drugs Viagra and Cialis, among other medications, were allowed on the U.S. market using potentially problematic data that call into question their safety and efficacy, a Bloomberg analysis found.
The U.S. Food and Drug Administration alerted brand-name and generic companies June 18 about a research company in India that had falsified the data used in key studies to gain approval of its medications. Data from the researcher, Synapse Labs Pvt. Ltd., may have been used in hundreds of drugs, which remain available for sale on pharmacy shelves and in Americans’ medicine cabinets.
European regulators last year flagged Synapse to the FDA, which later told U.S. companies that relied on Synapse for key studies to gain approval of their medications that they would have to redo the work somewhere else.
The FDA said companies that used Synapse will get a year to submit new data on the drugs. Without that information, it’s difficult to know the true outcomes of the studies and whether they’re safe. And insurers may have reason to retroactively decide not to cover the medications.
“I think it raises a lot of questions about the implications for the drugs on the market,” said Massoud Motamed, who was an FDA inspector until January 2023 and has a doctorate in biochemistry.
Motamed said his biggest concern is that the drugs Synapse was involved with may have too much or too little active ingredient. Too much can lead to dangerous toxicity issues. Drugs that don’t have enough active ingredient run the risk of not working.
‘Confidential information’
The FDA isn’t telling patients, doctors or pharmacists which drugs among thousands might be impacted because the agency said whether a drugmaker used a particular research company for hire is “confidential information,” according to the FDA alert.
“This is kind of shocking to me,” Michael Santoro, a professor at Santa Clara University who specializes in business ethics and co-wrote a book called “Ethics and the Pharmaceutical Industry,” said about the FDA keeping the drugs secret. “There’s no question in my mind that this data needs to be in front of the public.”
Cherie Duvall-Jones, a spokesperson for the agency, said “the FDA remains vigilant and will act should we identify safety issues.”
She said so far the FDA hadn’t noticed any signs in its side effect data that the drugs had serious safety concerns. The FDA has not suspended sales of the drugs as European Union regulators recommended to member states and declined to say how many drugs were approved using research done by Synapse.
U.S. regulators have done little public outreach about this issue. There’s no way for patients to know which brand-name drugs used Synapse research. But for generics, the FDA guided consumers to an obscure database with codes that indicate whether a generic is deemed to be equivalent to the brand-name drug. If a drug’s code recently changed from equivalent to not equivalent, this could indicate that Synapse was involved in its approval in the US.
“It’s like a riddle,” said Erin Fox, director of the University of Utah’s drug information service that tracks drug shortages.
In addition to safety concerns, Fox said insurers may not cover non-therapeutically equivalent drugs and could even claw back payments.
Generics database
Such switches rarely occur, and usually the FDA notifies the public. For example, last year, the FDA said it no longer considered a generic organ transplant drug from Accord Healthcare Inc. the same as the brand-name version it copied. Accord’s tacrolimus released too much of the medicine at once in the body, which could cause kidney failure or seizures, the agency determined after testing the drug following years of concern from doctors.
Bloomberg’s analysis identified a number of generic drugs that are no longer deemed the same as the brand though they were earlier this year. Among them are Viagra and Cialis generics made by India’s Umedica Laboratories Pvt. Umedica is a contract manufacturer that sells these drugs to other drugmakers to package and market, including Nivagen Pharmaceuticals Inc. in Sacramento, California, and pharmacies that stock various health-care facilities such as doctors offices and hospitals. Bloomberg used databases from the FDA and the National Institutes of Health to identify the drugs and their sellers.
Other drugs on the list include generics of the cholesterol-lowering drug Lipitor from India’s Lupin Ltd and risendronate sodium from Aurobindo Pharma Ltd. Lupin sold 25 million generic Lipitor prescriptions in the U.S. between 2020 and most of 2023, according to Symphony Health prescription data compiled by Bloomberg. Umedica’s atorvastatin and carbamazepine, an epilepsy drug, also made the list.
Umedica, Nivagen, Lupin and Aurobindo didn’t respond to requests for comment.
The FDA often protects corporate information, including what factory a drug is made in, for fear of running afoul of trade secret laws. In 2011, the FDA said it found 1,900 instances during an inspection of a Cetero Research facility where lab technicians that supposedly conducted certain tests weren’t in the office at that time. The agency didn’t share what drugs had been approved using Cetero data at the time.
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©2024 Bloomberg L.P. Visit bloomberg.com. Distributed by Tribune Content Agency, LLC.
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The Audible: On Kawhi’s Olympic exit, Bronny’s presence and the Dodgers’ shrinking rotation
- July 10, 2024
Jim Alexander: An Olympic bombshell of sorts landed this morning: Kawhi Leonard is pulling out of the Games, departing from the U.S. men’s team in a move that apparently was made by USA Basketball in conjunction with the Clippers.
And my first thought when this story was posted: What are they not telling us?
Supposedly, Kawhi was feeling fine and was enthusiastic – or as enthusiastic as Kawhi gets, anyway – about playing for his country in Paris this month. And now, suddenly, he’s out, with the sole statement thus far coming from the federation:
“Kawhi has been ramping up for the Olympics over the past several weeks and had a few strong practices in Las Vegas. He felt ready to compete. However, he respects that USA Basketball and the Clippers determined it’s in his best interest to spend the remainder of the summer preparing for the upcoming season rather than participating in the Olympic Games in Paris.”
My second thought, while digesting this story: If Kawhi is potentially this fragile that international play poses such a risk, what does that say about the new contract he just signed with the Clippers?
Mirjam, you’ve been around that organization long enough to have a pretty good sense of what’s going on. So … what’s going on?
Mirjam Swanson: I suppose the nation is getting a taste of what it is to be a Clippers fan.
The prospect of Kawhi on any team is worth including him. I’ve seen Kawhi in Terminator mode, when there’s no stopping him. When he’s just an efficient, clinical, steamrolling monster. Everyone wants to experience that again – including Kawhi. It’s pretty clear that he WANTS to play. He wanted to play in the playoffs. He wanted to play in the Olympics. But his health – about which he’s been so guarded for so long – simply precludes him from doing it more and more often.
It’s just a bummer.
And because he’s so private about his health, there’s no way for medical experts to weigh in and explain to us what he’s likely dealing with – so now we have what we had this morning, which is a ton of handwringing and second-guessing and finger-pointing in every possible direction. Who was lying about what and when and why and now what and whatnot?
But it’s probably pretty simple: He’s not healthy enough to go. I don’t think there’s a conspiracy. I don’t think the Clippers dangled it in front of him for all these weeks and then pulled it back right when camp started.
It’s just another gut punch, because the Fun Guy would rather be out there having fun hooping than rehabbing and resting and hoping his knee will cooperate. But that’s not anyone’s fault. It’s just life. It’s just sad.
I know some Clippers fans were miffed that he’d play in the Olympics after sitting out most of their first-round playoff series against the Mavericks, but I always saw it as a positive thing: That means he was hurt but he’s recovered. Now we know he’s not healthy enough for Olympic competition. That should be more concerning for Clippers fans – not that he wanted to give it a shot in the first place.
What it means for the team going forward? We’ll see how cooperative his knee is when the season begins, I guess. But by now, Clippers fans know what the rest of the nation learned today – not to hold their breath.
Jim: Meanwhile, while you were composing all of that, the email tumbled into the inbox – the James Harden signing is now official. A busy morning for the Clippers, even though the Harden signing, reported at $70 million for two years, was basically done a week ago but couldn’t be immediately announced.
And I’m beginning to think that the NBA has replaced the NFL as the closest thing America has to a 365-day (or 366, in this case) sports obsession. It’s been an organic process, but consider: Regular season, playoffs, Finals, draft, free agency, summer league, and in this case the Olympics, lather, rinse, repeat … and late August and September will provide enough gossip and speculation for ESPN’s NBA Today, the social media pundits and our friend Marc Stein’s Substack newsletter.
Which brings me to my next subject. There was a suggestion the other day on the Awful Announcing website summed up with this heading: “Is Bronny James ESPN’s new Tim Tebow, where celebrity coverage dramatically exceeds on-field impact?”
I guess it’s a natural inclination, and it shouldn’t have been surprising that Bronny’s first appearance in summer league (and his first “DNP-Injury” in Game 2 because of swelling in his knee) drew so much attention. Yes, he’s the No. 55 pick in the draft, but he’s also LeBron’s kid. Yes, he’s nowhere near ready for the NBA after one fits-and-starts season at USC, but he’s also LeBron’s kid. You get where I’m going with this.
The point: Did Rich Paul, the agent, do Bronny a disservice by manipulating things to make sure he went to the Lakers? I’m not suggesting that all of this (to date unwarranted) attention is going to hurt his development, but it’s a distraction that at this point does little more than feed the “engagement farming” industry. (And now I am to understand that was a thing even before JJ Redick mentioned it at his introductory news conference. Boy, am I out of it!)
Mirjam: “Organic” in that a certain network leveraged and pumped up interest in transactional, fantasy part of the sport to drive interest and spur debate? It’s felt for years now that the general public cares more about the drama and rumors than the basketball, which … is what it is, I guess. There’s no putting the genie back.
As for Bronny? Yes, there’s way more attention focused on this guy than is warranted for sure, but we all understand why.
Is that a disservice? I don’t know, a 6-foot-4 player who returned from a health scare to average 4.8 points, 2.8 rebounds and 2.1 assists in fewer than 20 minutes per game during his one season at USC just got a $7.9 million contract to play for the Lakers.
Is it all sorts of intriguing, the idea of one of the game’s all-time greats playing with his son? Yes. Is there going to be a ton of pressure and scrutiny? Uh-huh. Will it be weird to play with your dad? With your dad who might be the greatest player of all time? Could be. Could it be great? Could LeBron teach him things first-hand that Bronny couldn’t learn from someone else somewhere else? Possibly that too.
But do I feel bad for Bronny? No.
Is it poor Bronny? No.
Will it be hard for Bronny? Maybe, but that’s the job. If he didn’t want the gig, he could’ve become a video game developer. But he’s here, let’s see – and we’re all watching – what he’s got.
Jim: I will say this: A four-year, $7.9 million contract, with a good bit of guaranteed money for a second-round pick, blows a hole in the whole “stay in school” argument. And his attitude about the commotion seems more grounded than those of us observing from afar. He’s there to work and to learn, and the rest doesn’t matter. Good for him.
Today’s last subject? The incredible shrinking Dodgers pitching staff. When they put Tyler Glasnow on the injured list Tuesday with, um, tightness in his back, it seemed little more than a device to give him a few extra days off. But consider: After Bobby Miller was knocked around again by the Phillies on Tuesday night, the starters’ ERA since Gavin Stone’s complete-game shutout against the White Sox two weeks ago ballooned to 9.20 in 10 games, six of which the Dodgers have lost.
And as of this moment, the rotation is Stone (tonight’s pitcher in Philly), Landon Knack, James Paxton, Justin Wrobleski and … I guess Sunday’s start in Detroit, the last game before the All-Star break, is either a bullpen game or an opportunity for another Triple-A or Double-A pitcher. The Dodgers have used 30 pitchers already this season, including Kiké Hernandez in one of those let’s-get-this-over-with position player appearances. Meanwhile, Glasnow, Yoshinobu Yamamoto, Walker Buehler, Clayton Kershaw, and Dustin May are all on the injured list, and those are just the pitchers.
Look at it this way: The Dodgers’ B team still has a 7½-game lead in the division. The positive: Just imagine when all the regulars are back. The negative: Will they still have a lead in the division when Betts, Muncy, Kershaw, etc. do return, or are the Padres or Diamondbacks (or both) about to wake up and make a race out of it?
Gee, maybe they can re-acquire Tyler Anderson. I’m sure the Angels are listening to all offers for their All-Star pitcher. (Then again, USA Today baseball columnist Bob Nightengale reported the other day that the Angels likely will hang on to Anderson.)
Mirjam: All those pitchers and it appears they need more pitching. Appears they’re going to need it if they intend to get where they’re trying to go, if they’re going to do what they invested so immensely in.
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But like you point out: The hits just keep coming. And even though the B Team is doing OK, playing catchup so regularly isn’t a recipe for success long term.
Not with stretches like this recent 10-game spell, in which Dodgers starters have allowed 45 runs in 44 innings, and 51 hits and 12 home runs in that span too, as our Dodgers writer Bill Plunkett pointed out in Tuesday’s game story, chronicling the Dodgers’ sixth loss in 10 games.
How do the Dodgers’ shore up their rotation? The top options – potentially guys like, say, the Chicago White Sox’s Garrett Crochet and Erick Fedde, or the Detroit Tigers’ Jack Flaherty – will come at a steep price.
But what could be more costly? Not making a move.
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Powell: Cooling job market could signal coming rate cut
- July 10, 2024
By Paul Wiseman | The Associated Press
Federal Reserve Chair Jerome Powell on Wednesday reinforced a message that the Fed is paying growing attention to a slowing job market and not only to taming inflation, a shift that signals it’s likely to begin cutting interest rates soon.
“We’re not just an inflation-targeting central bank,’’ Powell told the House Financial Services Committee on the second of two days of semi-annual testimony to Congress. “We also have an employment mandate.”
On Tuesday, when Powell addressed the Senate Banking Committee, he suggested that the Fed had made “considerable progress” toward its goal of defeating the worst inflation spike in four decades and noted that cutting rates “too late or too little could unduly weaken economic activity and employment.”
Congress has given the Fed a dual mandate: To keep prices stable and to promote maximum employment.
“For a long time,” Powell said Wednesday, “we’ve had to focus on the inflation mandate.” As the economy roared out of the pandemic recession, inflation hit a four-decade high in mid-2022. The Fed responded by raising its benchmark rate 11 times in 2022 and 2023. Inflation has since plummeted from its 9.1% peak to 3.3%.
The U.S. economy and job market have continued to grow, defying widespread predictions that much higher borrowing costs resulting from the Fed’s rate hikes would cause a recession. Still, growth has weakened this year. From April through June, U.S. employers added an average 177,000 jobs a month, the lowest three-month hiring pace since January 2021.
Powell told the House panel on Wednesday that to avoid damaging the economy, the Fed likely wouldn’t wait until inflation reached its 2% target before it would start cutting rates.
Most economists have said they expect the Fed’s first rate cut to occur in September. Powell this week has declined to say when he envisions the first cut.
Under questioning from several Republican lawmakers, Powell said the Fed and other financial regulators will overhaul a 2023 proposal, known as the “Basel III endgame,’’ that would raise the amount of capital that banks are required to hold against potential losses.
Large banks have aggressively fought against the stricter requirements, which emerged in the aftermath of the 2007-2008 financial crisis. They have warned that the tighter rules would force them to cut lending to consumers and businesses, potentially imperiling the economy.
Powell said the three main U.S. bank regulators — the Fed, the Federal Deposit Insurance Corp. and the Office of the Comptroller of the Currency — were near agreement on a new version that would be subject to public comment.
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House GOP wants proof of citizenship to vote, boosting an election-year talking point
- July 10, 2024
By Ali Swenson and Farnoush Amiri, Associated Press
WASHINGTON (AP) — The U.S. House of Representatives on Wednesday was poised to vote on a proof-of-citizenship requirement for voter registration, a proposal Republicans have prioritized as an election-year talking point even as research shows noncitizens illegally registering and casting ballots in federal elections is exceptionally rare.
Even if it passes the GOP-controlled House, the legislation is unlikely to advance through the Democratic-led Senate. The Biden administration also said it’s strongly opposed because it says safeguards already are in place to verify voter eligibility and enforce the law against noncitizens trying to cast ballots.
Still, the House vote will give Republicans an opportunity to bring attention to two of their central issues in the 2024 race – border and election security. They also are using Democratic opposition to the bill as fuel for former President Donald Trump’s claims that Democrats have encouraged the surge of migrants so they can get them to register and vote, which would be illegal. Noncitizens are not allowed to vote in federal elections, nor is it allowed for any statewide elections.
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Republican House Speaker Mike Johnson, a key backer of the bill, said in a news conference earlier this week that the Democratic opposition means many Democrats “want illegals to participate in our federal elections; they want them to vote.”
During a speech Wednesday previewing the expected House debate, he called the vote a “generation-defining moment.”
“If just a small percentage, a fraction of a fraction of all those illegals that Joe Biden has brought in here to vote, if they do vote, it wouldn’t just change one race,” he said. “It might potentially change all of our races.”
On his Truth Social platform this week, Trump suggested that Democrats are pushing to give noncitizen migrants the right to vote and urged Republicans to pass the legislation — the Safeguard American Voter Eligibility Act — or “go home and cry yourself to sleep.”
The fixation on noncitizen voting is part of a broader and long-term Trump campaign strategy of casting doubt on the validity of an election should he lose, and he has consistently pushed that narrative during his campaign rallies this year. Last month in Las Vegas, he told supporters, “The only way they can beat us is to cheat.” It also is part of a wider Republican campaign strategy, with GOP lawmakers across the country passing state legislation and putting noncitizen voting measures on state ballots for November.
Democrats and voting rights advocates have said the legislation is unnecessary because it’s already a felony for noncitizens to register to vote in federal elections, punishable by fines, prison or deportation. Anyone registering must attest under penalty of perjury that they are a U.S. citizen. Noncitizens also are not allowed to cast ballots at the state level. A handful of municipalities allow them to vote in some local elections.
They also have pointed to surveys showing that millions of Americans don’t have easy access to up-to-date documentary proof of citizenship, such as a birth certificate, naturalization certificate or passport, and therefore the bill could inhibit U.S. citizen voters who aren’t able to further prove their status.
During a floor debate before the vote Wednesday, Rep. Joe Morelle of New York, the top Democrat on the House Administration Committee, expressed concern that the bill would disenfranchise various American citizens.
He mentioned military members stationed abroad who couldn’t show documentary proof of citizenship in person at an election office, as well as married women whose names have changed, Native Americans whose tribal IDs don’t show their place of birth and natural disaster survivors who have lost their personal documents.
Morelle said he doesn’t see the bill as an attempt to maintain voter rolls, but as part of larger GOP-led plans to question the validity of the upcoming election.
“The false claim that there is a conspiracy to register noncitizens is a pretext for trying to overturn the 2024 election, potentially leading to another tragedy on January 6th, 2025,” Morelle said on the floor.
Yet Republicans who support the bill say the recent unprecedented surge of migrants illegally crossing the U.S.-Mexico border creates too large a risk of noncitizens slipping through the cracks. They could purposely or inadvertently break the law to cast ballots that sway races amid narrow margins in November’s elections.
“Every illegal vote cancels out the vote of a legal American citizen,” Rep. Bryan Steil of Wisconsin, the Republican chair of the House Administration Committee, said during the floor debate.
If passed, the bill would require noncitizens to be removed from state voter rolls and require new applicants to provide documentary proof of U.S. citizenship. It also would require states to establish a process for applicants who can’t show proof to provide other evidence beyond their attestation of citizenship, though it’s unclear what that evidence could include.
Research and audits in several states show that there have been incidences of noncitizens who successfully registered to vote and cast ballots, although it happens rarely and is typically by mistake. States have mechanisms to check for it, although there isn’t one standard protocol they all follow.
For example, Ohio Secretary of State Frank LaRose recently found 137 suspected noncitizens on the state’s rolls — out of roughly 8 million voters — and said he was taking action to confirm and remove them.
In 2022, Georgia’s Republican secretary of state, Brad Raffensperger, conducted an audit of his state’s voter rolls specifically looking for noncitizens. His office found that 1,634 had attempted to register to vote over a period of 25 years, but election officials had caught all the applications and none had been able to register.
In North Carolina in 2016, an audit of elections found that 41 legal immigrants who had not yet become citizens cast ballots, out of 4.8 million total ballots cast. The votes didn’t make a difference in any of the state’s elections.
In a document supporting the bill, Johnson listed other examples of noncitizens who had been removed from the rolls in Boston and Virginia. The elections departments there didn’t immediately answer questions from The Associated Press to verify the claims.
Several secretaries of state, interviewed during their summer conference in Puerto Rico this week, said noncitizens attempting to register and vote is not a big problem in their state.
Kentucky Secretary of State Michael Adams, a Republican, said that his state already requires photo ID to vote and that most people use a driver’s license.
“We don’t really have a problem with this in my state,” he said in an interview.
Utah Lt. Gov. Deidre Henderson, a Republican who oversees elections, said she supports the legislation in concept but provided a cautionary tale about how aggressively culling voter rolls can sometimes result in the removal of qualified voters. A few years ago, everyone in her household received mail ballots for a municipal election, except her. She had been removed from the rolls because she had been born in the Netherlands, where her father was stationed with the U.S. Air Force.
“I was the lieutenant governor, I was overseeing elections, and I got taken off because I was born in the Netherlands,” she said, “So I think we definitely have those checks and balances in the state of Utah, maybe to an extreme.”
The House vote comes days after the Republican National Committee released its party platform, which emphasizes border security issues and takes a stand against Democrats giving “voting rights” to migrants living in the country illegally.
Republicans are expected to shine a light on their immigration and election integrity concerns at the Republican National Convention next week in Milwaukee, where Trump is scheduled to accept his third straight nomination for president.
Swenson reported from New York. Associated Press writer Christina A. Cassidy in San Juan, Puerto Rico, contributed to this report.
The Associated Press receives support from several private foundations to enhance its explanatory coverage of elections and democracy. See more about AP’s democracy initiative here. The AP is solely responsible for all content.
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