4.9 earthquake strikes near Barstow, felt throughout Southern California

• July 29, 2024

A 4.9-magnitude earthquake shook parts of Southern California on Monday afternoon, July 29, the U.S. Geological Survey reported.

The quake, which occurred at around 1 p.m., was centered about 10 miles northeast of Barstow at a depth of roughly 7.5 miles, according to the USGS.

The quake’s epicenter was near the Calico fault, which crosses the Mojave Desert, and was about 30 miles from the San Andreas fault, according to seismologist Dr. Lucy Jones.

“It will not change the probability of a San Andreas earthquake,” Jones said in a tweet.

A 3.5-magnitude earthquake struck shortly after in the same area followed by a second aftershock of 2.7, according to the USGS.

The earthquake could be felt across the region, causing a few hard jolts in cities including Pasadena, Redlands and Temecula.

There were no immediate reports of damage or injuries.

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​ Orange County Register 

Defense attorney says ‘Alec Baldwin committed no crime; he was an actor, acting’

• July 10, 2024

By MORGAN LEE and ANDREW DALTON

SANTA FE, N.M. — A defense attorney told jurors Wednesday that the shooting death of cinematographer Halyna Hutchins was an “unspeakable tragedy” but that “ Alec Baldwin committed no crime; he was an actor, acting.”

Baldwin’s lawyer Alex Spiro emphasized in his opening statement in a Santa Fe, New Mexico, courtroom that Baldwin, who is on trial for involuntary manslaughter, did exactly what actors always do on the set of the film “Rust,” where Hutchins was killed in October, 2021.

“I don’t have to tell you any more about this, because you’ve all seen gunfights in movies,” Spiro said.

Special prosecutor Erlinda Ocampo Johnson said in her opening statement that before the shooting, Baldwin skipped safety checks and recklessly handled a revolver.

“The evidence will show that someone who played make believe with a real gun and violated the cardinal rules of firearm safety is the defendant, Alexander Baldwin,” Johnson said.

Spiro replied that “these cardinal rules, they’re not cardinal rules on a movie set.”

“On a movie set, safety has to occur before a gun is placed in an actor’s hand,” Spiro told the jury.

The first witness to take the stand was the first law enforcement officer to arrive at Bonanza Creek Ranch after the shooting. Video shown in the courtroom from the body camera of Nicholas LeFleur, then a Santa Fe county sheriff’s deputy, captured the frantic efforts to save Hutchins, who looked unconscious as several people attended to her and gave her an oxygen mask. In the courtroom, Baldwin looked at the screen somberly as it played.

Later in the video, LeFleur can be seen telling Baldwin not to speak to the other potential witnesses, but Baldwin repeatedly does.

When special prosecutor Kari Morrissey asked whether the sheriff’s deputy handled the situation ideally he responded, “Probably not. But it’s what happened.”

Spiro pressed LeFleur on why he left the word “accidental” out of his description of the shooting call during his questioning by the prosecution. LeFleur said it was not intentional.

Johnson in her opening walked the jurors through the events leading up to Hutchins death. She said on that day, Baldwin declined multiple opportunities for standard safety checks with armorer Hannah Gutierrez-Reed before the rehearsal in the small church about 20 miles (32 kilometers) from the courthouse where Hutchins, “a vibrant 42-year-old rising star,” was killed. She said Baldwin instead “did his own thing.”

“He cocks the hammer, points it straight at Miss Hutchins, and fires that gun, sending that live bullet right into Miss Hutchins body,” said Johnson, a relative newcomer to the case, appointed in late April by the Santa Fe district attorney’s office.

During the presentation, Baldwin trained his eyes downward on a notepad, away from the jury. He watched Spiro intently during his opening. His wife Hilaria Baldwin and his brother, actor Stephen Baldwin, were among the family and friends sitting behind him.

The 16 jurors — 11 women and five men — come from a region with strong currents of gun ownership and safety informed by backcountry hunting. Four of the jurors will be deemed alternates while the other 12 deliberate once they get the case.

Hutchins’ death and the wounding of director Joel Souza nearly three years ago sent shock waves through the film industry and led to one felony charge against Baldwin, 66, that could result in up to 18 months in prison.

“It killed an amazing person,” Spiro said. “It wounded another, and it changed lives forever.”

Baldwin has claimed the gun fired accidentally after he followed instructions to point it toward Hutchins, who was behind the camera. Unaware that it was loaded with a live round, he said he pulled back the hammer — not the trigger — and it fired.

“No one saw him intentionally pull the trigger,” Spiro said.

But he said even if Baldwin had pulled it and was lying, Spiro said, it still would not have been manslaughter.

“On a movie set, you’re allowed to pull that trigger,” Spiro said, adding, “that doesn’t make it a homicide.”

The lawyer emphasized that the responsibility for safety lay with the film’s armorer, Gutierrez-Reed, who has already been convicted of involuntary manslaughter, and assistant director David Halls, who pleaded no contest to negligent use of a deadly weapon in exchange for his testimony at trial.

Baldwin had been told “cold gun” before getting the revolver, not knowing there was a live round in it.

“It had been checked and double checked by those responsible for ensuring the gun was safe,” Spiro said. “He did not tamper with it he did not load it himself. He did not leave it unattended.”

Spiro has in recent years become one of the most sought-after defense attorneys in the country. His clients have included Elon Musk, New England Patriots owner Robert Kraft, and Megan Thee Stallion.

Baldwin — the star of “Beetlejuice,” “Glengarry Glen Ross” and “30 Rock” — has been a household name as an actor and public personality for more than three decades.

Spiro said in concluding his opening that witnesses will attest that “no actor in history” has “intercepted a live bullet from a prop gun.”

“No one could have imagined or expected an actor to do that,” the lawyer said.

The ‘Rust’ shooting case

Alec Baldwin shooting: ‘Rust’ gun supervisor gets 18 months in prison
Alec Baldwin pleads not guilty to involuntary manslaughter charge
Grand jury indicts Alec Baldwin in fatal shooting of cinematographer on movie set in New Mexico
Alec Baldwin’s codefendant gets 6 months probation on gun charge
Troubled Alec Baldwin movie ‘Rust’ looking near Palm Springs, Nevada border for new filming location

Prosecutors have two alternative standards for proving the charge. One is based on the negligent use of a firearm. The other is proving beyond a reasonable doubt that Baldwin acted with total disregard or indifference for the safety of others.

Testimony at trial will delve into the mechanics of the weapon and whether it could have fired without a trigger pull. Prosecutors say it couldn’t have.

“That gun the defendant had asked to be assigned worked perfectly fine as it was designed,” Johnson said.

Attorney Gloria Allred sat in the front row of the courtroom audience, a reminder of Baldwin’s other legal difficulties. Allred is representing “Rust” script supervisor Mamie Mitchell and Hutchins’ sister and parents in a civil lawsuit against Baldwin and other producers.

Allred said that from her observations in court, the jury appeared to be riveted by testimony and evidence including the police lapel camera video.

Dalton reported from Los Angeles.

​ Orange County Register 

House-rich, cash-strapped: Advice for older homeowners

• July 10, 2024

By Taylor Getler | NerdWallet

For many homeowners of retirement age, much of their net worth is tied up in their home equity, their home value minus any remaining liens. Home equity makes up 47% of the net worth of a median white homeowner age 62 or older, 81% of total net worth for older Black homeowners and 89% of total net worth for older Latino homeowners, according to the Urban Institute.

If you’re looking for ways to cover expenses after retirement, you may consider converting some of your home equity into cash. “There is no universally ‘best’ source of cash flow in retirement,” says Andy Panko, owner of Tenon Financial in Metuchen, New Jersey, and a retirement income certified professional. But those who hesitate to draw from their home’s well of equity “may be depriving themselves of a great source of cash flow during their retirement years.”

It’s important to think through what you hope to leave behind, if anything. If your goal is to leave your home as a legacy, “you should generally try to avoid having any form of mortgage against the property outstanding when you die” says Panko. However, if this isn’t your main priority, “it could make sense to ‘unlock’ the equity in your home and use it during your lifetime via some form of mortgage.”

Options include a home equity line of credit, home equity loan, reverse mortgage or home equity investment. The right loan product for you depends on your reason for needing the cash, says Anneliese Lederer, senior policy counsel for the Center for Responsible Lending in Washington, D.C.

Here’s what to consider if you’re thinking about accessing your equity.

HELOCs: for qualified borrowers who want flexibility

If you need cash to finance a multistep project — for example, making some upgrades to your home to improve accessibility — the first option to consider is a home equity line of credit, or HELOC.

A HELOC is a flexible line of credit that you can borrow from as needed, up to a certain limit. You typically have 10 years to draw from the line, during which time you’re only required to make payments on the interest.

After 10 years, you can’t draw any more, and payments will include both principal and interest. HELOC interest rates are usually variable, meaning they move up and down with a banking base rate known as the prime rate.

If you’re retired, you may be required to show alternative income documentation to lenders to qualify for a HELOC. This includes any pension income, Social Security income or disbursements from retirement accounts. Just like any applicant, you’ll have to prove that you can keep up with monthly payments.

If you can’t make your monthly payments, you risk losing your home to foreclosure.

Home equity loans: for qualified borrowers who need a lump sum

If you need to liquidate some of your equity to finance a one-off expense, such as replacing your roof, you may consider a home equity loan.

This is a fixed-rate second mortgage that delivers the money all at once.

As with a HELOC, you’ll have to document your ability to pay before a lender will consider granting you the loan, and a home equity loan can lead to foreclosure if you can’t keep up with monthly payments.

Since the home equity loan has a fixed rate, payments are more predictable than a HELOC with a variable rate.

Transferring a home with a home equity loan or HELOC

There may be implications for your heirs if you can’t pay off a HELOC or home equity loan within your lifetime.

U.S. law prevents lenders from enforcing a due-on-sale provision (in which the loan needs to be paid off in a lump sum after your death) if your inheritors are relatives or a spouse. These “protected” family members could continue making monthly payments on a remaining loan balance. If you intend to leave the home to someone who doesn’t qualify under the U.S. code, you may consider putting them on the loan when you apply to allow for a seamless transfer.

Consult an estate planner for advice specific to your needs and goals. Monique D. Hayes, founder and CEO of Estates Made Easy in Miami, Florida, points out, for instance, that putting a home into a trust may be a bad fit for someone exploring home equity options.

Reverse mortgages: for borrowers 62+ who are struggling with bills

If you need a more permanent financial change that will allow you to stay in your home, you may find that a reverse mortgage is a good fit.

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This loan, also known as a home equity conversion mortgage, or HECM, is backed by the Federal Housing Authority (FHA) and is not required to be paid back until you move or die, when payment becomes the responsibility of your heirs. If you’re expecting to use your equity to help your family build generational wealth, “that’s a big negative of reverse mortgages,” Lederer says, because your heirs will need to sell the property or pay back the loan.

You must be at least 62 years old to qualify for a reverse mortgage, and you are required to meet with a housing counselor before pursuing this option. These counselors provide advice to homeowners for free or at a low cost. You can find a counselor in your area using this portal from the Consumer Financial Protection Bureau. The counselor will look at your goals, financial shortfall and income history to clarify whether a reverse mortgage is an appropriate choice, says Lederer.

Reverse mortgages don’t have income requirements, though they do require that borrowers can pay their obligations such as property taxes and homeowners insurance. Panko says, “A reverse mortgage can be a great solution to someone who’s house-rich and otherwise income not-so-rich.”

Home equity investments: for borrowers who can’t qualify for a mainstream loan

If you can’t qualify for other options and need a solution with more flexible application requirements, you may be interested in a home equity investment or sharing agreement. Traditional lenders don’t offer these — instead, they’re a niche product primarily provided by companies that specialize in these transactions and usually have much lower credit requirements than HELOCs and home equity loans. Some major names that you may see in your research include Point, Unison and Hometap.

A home equity investment allows you to access some of your home’s equity as a lump sum in exchange for giving the company a percentage of your home’s appreciation. Unlike typical loans that require monthly payments, these have one balloon payment that comes due after 10 to 30 years (or when you decide to move), when you’ll have to either sell the home or pay the investment company’s share out of pocket. The amount of this balloon payment is a percentage of the appreciation of your home from the time that you entered the agreement, though these companies will often lower your home’s initial valuation to inflate the amount of appreciation they’re entitled to receive.

You may end up paying out much more than you received. For example, Point outlines that you could owe more than double your initial cash advance in just 10 years if your home appreciates at a relatively low rate of 1.5% per year. The more your home appreciates, the more you’ll owe in the end.

There is no one-size-fits-all approach to overcoming a financial shortfall with your home equity. Weighing your options and speaking with a housing counselor can help you determine the best course of action for your situation, and in the process, can illuminate your goals for your property during your lifetime and beyond.

Taylor Getler writes for NerdWallet. Email: [email protected].

The article House-Rich, Cash-Strapped: Advice for Older Homeowners originally appeared on NerdWallet.

​ Orange County Register 

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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​ Orange County Register 

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.

​ Orange County Register 

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.

ALSO SEE: Haunted Mansion at 50: Decades of delays and distractions nearly derailed Disneyland’s venerable dark ride

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.

​ Orange County Register 

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.

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

​ Orange County Register 

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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