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Science hasn’t shown these medications work. They’re being sold anyway

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Federal regulators are more and more approving medicines earlier than research have proven they work, leaving sufferers vulnerable to taking prescriptions that might hurt however not assist them.

Final yr, 14 new medicine acquired so-called accelerated approval, through which they haven’t gone by the testing that the Meals and Drug Administration frequently requires. That amounted to twenty-eight% of the 50 medicine the FDA accepted. The numbers have jumped from 2018 when simply 4, or 7%, of the 59 new medicine had been accepted underneath these guidelines.

The principles had been created for use in uncommon circumstances through which severely sick sufferers had no different remedies. However with stress from the pharmaceutical business, affected person teams and politicians to hurry medicines to market, now most medicine are accepted underneath the accelerated approval guidelines or by three comparable applications requiring much less proof and regulatory scrutiny.

The shift has alarmed some consultants who fear the business is exploiting the foundations to promote medicines of questionable effectiveness and security at sky-high costs.

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“That is inflicting big quantities of actual hurt,” stated Jerome Hoffman, UCLA professor emeritus of medication, pointing to uncomfortable side effects and medical payments sufferers merely can’t afford.

Though the FDA has the ability to take away these medicine when research later present the medicines don’t work, that transfer has been uncommon.

A current Occasions investigation detailed how Covis Pharma has refused the company’s request to withdraw a drug for pregnant girls vulnerable to untimely beginning. The FDA accepted the drug known as Makena a decade in the past with hopes it might cut back deaths and severe incapacity amongst infants born too quickly. The FDA required the corporate to carry out a research to show the drug’s advantages. That trial took eight years and “unequivocally did not show” that Makena labored, company scientists have stated.

Dozens of medicine now available on the market haven’t but been backed by research confirming their effectiveness.

There isn’t a requirement that sufferers be instructed they’ve been prescribed considered one of these medicine — a spot inflicting some medical doctors to concern that persons are being misled.

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“I feel individuals typically assume that when the FDA has accepted one thing, there’s overwhelming proof it’s secure and efficient,” stated Joseph Ross, a Yale professor of medication and public well being, who has written about how the foundations ought to be reformed.

In a press release, the company stated it was “dedicated to making sure the integrity of the accelerated approval program.”

“We consider sufferers who at present lack sufficient remedy choices for severe or life-threatening ailments are prepared to simply accept some uncertainty relating to scientific profit when a brand new remedy is developed,” the FDA stated.

“Within the overwhelming majority of accelerated approvals,” it stated, the drug’s scientific advantages had been later verified by the confirmatory research it required.

Dear medicine not but confirmed to work

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The FDA is approving extra medicine earlier than research present they work. Although their effectiveness hasn’t been confirmed, some hit the market with excessive listing costs.

Exondys 51
Duchenne muscular dystrophy
$300,000 per yr

Aduhelm
Alzheimer’s illness
$28,200 per yr

Makena
Preterm beginning
$13,000 per being pregnant

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For many years, the FDA’s approval customary had been two “sufficient and well-controlled” research exhibiting “substantial proof of effectiveness.”

In 1992, with the disaster of the AIDS epidemic, the company began its accelerated approval program. This system permits corporations to make use of what are known as “surrogate endpoints” — sure indicators in scientific trials that present a drugs could be helpful for sufferers.

Many medicine accepted underneath this system have been most cancers medicine for which trials haven’t proven they lengthen lives. As an alternative the businesses have used X-rays and different measures to indicate the drug appeared to trigger a constructive response.

Since 1992, Congress has handed legal guidelines including extra methods for medicine to get sooner approval with much less proof than the FDA had lengthy required.

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The brand new applications had been launched to assist sufferers with uncommon ailments and no different hope. Now they’re generally used.

Final yr, 74% of the 50 new medicine accepted by the FDA’s Heart for Drug Analysis and Analysis had been granted some type of expedited approval. Among the many medicines on that listing are these for coronary heart failure and lupus — circumstances for which sufferers have already got a number of medicines obtainable.

“Overlook two research, neglect well-done research, neglect randomized trials,” Hoffman stated of the FDA’s growing use of the expedited approvals. “It’s now if someone says it would work and we haven’t but confirmed it’s dangerous — let’s strive it.”

If an organization is granted an accelerated approval, the FDA requires research to verify the drug works. However the company has typically not compelled corporations to finish these research, which may halt gross sales in the event that they fail.

“Corporations drag their toes,” Ross stated. “The research don’t get performed.”

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Requested concerning the delayed trials, an company spokesperson stated, “The FDA will use each authority at our disposal to encourage the diligent initiation of well-designed confirmatory research. If there are any gaps within the FDA’s means to carry builders accountable for conducting research as rapidly because the science permits, then the company will work with Congress to shut these gaps.”

In a rising variety of circumstances, corporations proceed to promote the medicine even after these research are accomplished and present the medicine aren’t efficient. Ross and different researchers name these “dangling approvals.”

“Makena is illustrative of this complete dance that’s going down,” Ross stated.

Covis has instructed the FDA it desires to maintain promoting Makena whereas it does extra analysis to strive once more to indicate it’s efficient. The corporate disputes the outcomes of the research that failed to indicate it labored, saying it didn’t embody sufficient Black girls, who’re at highest danger of preterm beginning. Covis says the drug is secure and persevering with prescriptions gained’t hurt pregnant girls. Makena’s label lists uncomfortable side effects comparable to blood clots and hypertension. Some medical doctors fear concerning the danger of stillbirths. The proof shall be reviewed at a listening to the FDA has not but scheduled despite the fact that it’s been three years because the trial confirmed Makena didn’t work.

Two current accelerated approvals have raised extra questions of whether or not the FDA has lowered the bar too far.

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Final yr, the company stirred controversy when it overruled its committee of out of doors consultants and granted approval to a drug known as Aduhelm for Alzheimer’s illness, which impacts 6 million People and has no remedy. Three committee members stop in protest.

Within the resolution, the FDA used proof from scientific trials that confirmed the drug lowered ranges of amyloid plaque within the mind. However scientists questioned the usage of that surrogate marker, declaring that different medicines have focused the plaques with little impact on a affected person’s dementia.

Infusions of the drug could cause severe uncomfortable side effects, together with swelling within the mind.

Biogen, the drug’s maker, launched Aduhelm at a worth of $56,000 a yr. The excessive worth of the drug for a situation that impacts thousands and thousands of People brought about federal officers to suggest a rise to Medicare premiums of 14.5% to cowl the billions of {dollars} the federal government anticipated to pay for it. In December, the corporate reduce the annual worth in half to $28,200.

In January, Medicare proposed that it might cowl the price of Aduhelm just for sufferers in scientific trials. A closing resolution is pending.

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Extra issues concerning the accelerated approval program had been raised in 2016 when Janet Woodcock, a high FDA official, accepted a drug for Duchenne muscular dystrophy regardless of conclusions of company scientists that it didn’t work and its dangers weren’t but recognized.

Sarepta Therapeutics started promoting the drug Exondys 51 at a worth of $300,000 a yr. The approval sparked a dispute contained in the FDA that quickly turned public when paperwork had been launched.

“By permitting the advertising of an ineffective drug, basically a scientifically elegant placebo, 1000’s of sufferers and their households can be given false hope in change for hardship and danger,” wrote Ellis Unger, one of many FDA scientists who decried Woodcock’s resolution.

Woodcock defended her transfer. Amongst her arguments was that Sarepta “wanted to be capitalized,” she instructed an inside board reviewing the dispute. She identified that the corporate’s inventory went down when a committee of consultants voted in opposition to the drug after which went up when she later despatched a letter to Sarepta saying she anticipated to quickly grant the drug accelerated approval.

She wrote that if the drug was not accepted, Sarepta would have inadequate funding to proceed to review Exondys 51 and the opposite comparable medicine in its pipeline.

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The company spokesperson instructed The Occasions that “the FDA’s resolution on any drug product, in any illness space, relies on an evaluation of whether or not the advantages of the drug outweigh its dangers. This evaluation is knowledgeable by science, drugs, coverage and judgment, in accordance with relevant authorized and regulatory requirements.”

Sufferers depend upon medical doctors to maintain them secure from medicines which have extra dangers than advantages. But one report suggests that almost all medical doctors don’t know concerning the scant proof behind some medicine they prescribe.

In a 2016 survey, 70% of medical doctors wrongly believed that an FDA approval required research exhibiting each “a statistically important” and “clinically necessary” impact.

“The drug firm and all of the promoting says it is a nice new drug,” Hoffman stated. “What number of medical doctors are literally going to go and say, ‘Wait a second. Is that actually true?’”

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State Farm seeks major rate hikes for California homeowners and renters

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State Farm seeks major rate hikes for California homeowners and renters

State Farm General is seeking to dramatically increase residential insurance rates for millions of Californians, a move that would deepen the state’s ongoing crisis over housing coverage.

In two filings with the state’s Department of Insurance on Thursday signaling financial trouble for the insurance giant, State Farm disclosed it is seeking a 30% rate increase for homeowners; a 36% increase for condo owners; and a 52% increase for renters.

“State Farm General’s latest rate filings raise serious questions about its financial condition,” Ricardo Lara, California’s insurance commissioner, said in a statement. “This has the potential to affect millions of California consumers and the integrity of our residential property insurance market.”

State Farm did not return requests for comment.

Lara noted that nothing immediately changes for policyholders as a result of the filings. His said his department would use all of its “investigatory tools to get to the bottom of State Farm’s financial situation,” including a rate hearing if necessary, before making a decision on whether to approve the requests.

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That process could take months: The department is averaging 180 days for its reviews, and complex cases can take even longer, according to a department spokesperson.

The department has already approved recent State Farm requests for significant home insurance rate increases, including a 6.9% bump in January 2023 and a 20% hike that went into effect in March.

State Farm’s bid to sharply increase home insurance rates seeks to utilize a little-known and rarely used exception to the state’s usual insurance rate-making formula. Typically, such a move signals that an insurance provider is facing serious financial issues.

In one of the filings, State Farm General said the purpose of its request was to restore its financial condition. “If the variance is denied,” the insurer wrote, “further deterioration of surplus is anticipated.”

California is facing an insurance crisis as climate change and extreme weather contribute to catastrophic fires that have destroyed thousands of homes in recent years.

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In March, State Farm announced that it wouldn’t renew 72,000 property owner policies statewide, joining Farmers, Allstate and other companies in either not writing or limiting new policies, or tightening underwriting standards.

The companies blamed wildfires, inflation that raised reconstruction costs, higher prices for reinsurance they buy to boost their balance sheets and protect themselves from catastrophes, as well as outdated state regulations — claims disputed by some consumer advocates.

As insurers have pulled back from the homeowners market, lawmakers in Sacramento are scrambling to make coverage available and affordable for residents living in high-risk areas.

Times staff writer Laurence Darmiento contributed to this report.

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High interest rates are hurting people. Here's why it's worse for Californians

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High interest rates are hurting people. Here's why it's worse for Californians

By the numbers, the overall U.S. economy may look good, but down at the street level the view is a lot grimmer and grittier.

The surge in interest rates imposed by the Federal Reserve to slow inflation has closed like an acrid cloud over would-be homeowners, car buyers, growing families, and businesses new and old, large and small. It has meant missing opportunities, settling for less — and waiting and waiting and waiting.

It’s not that the average American is underwater. It’s that many feel that they’re struggling more than they anticipated and feel more constricted. In the American Dream, if you work hard, things are supposed to get better. Fairly or not, that may be a big part of why so many voters have expressed unhappiness with President Biden’s handling of the economy.

The cost of borrowing, whether for mortgages, credit cards or car loans, is the highest in more than two decades. And that is weighing especially hard on people in California, where housing, gas and many other things are more expensive than in most other states.

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California’s economy also relies more on interest rate-sensitive sectors such as real estate and high tech, which helps explain why the state has been lagging in job growth and its unemployment rate is the highest in the nation.

Harder to budget

When interest rates rise, savers can earn more on their deposits. But in America’s consumer society, for most people higher rates mean that a lot of things cost a little (or a lot) more. That makes it harder to stretch an individual or family budget. It may mean giving up on the nicer car you had your heart set on, or settling for a smaller house, or a shorter, less glamorous vacation.

And with every uptick in interest rates, which is almost inevitably passed on to customers, some have had to give up on a purchase entirely.

Geovanny Panchame, a creative director at an advertising agency, knows these feelings all too well: He thinks often about what could have been if he and his wife had bought the starter home they were planning for in 2020.

Back then, they had been pre-approved at an interest rate of 3.1% — right around the national average — but were outbid several times. They figured they’d wait a few years to save more money for a nicer place.

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Four years later, the couple are still renting an apartment in Culver City — and now they’re expecting their first child.

Pushing to buy a house and get settled before their son is born in December, they recently made an $885,000 offer for a three-bedroom, 1.5-bath home in Inglewood. They plan to put down 10%. At the current average mortgage interest rate of 7%, that would mean a monthly payment of about $5,300 — $1,900 more than if they had an interest rate of 3.1%.

The source of that increase is the Federal Reserve’s power to set basic interest rates, which determines the interest rates for almost everything else in the economy. The Fed’s benchmark rate went up rapidly, from near zero in early 2022 to a generational high of about 5.5%, where it has been for almost a year. The rate has been higher in the past, but after two decades in which it was mostly at rock bottom, most people had gotten used to both very low inflation and low interest rates.

“Clearly, we look back and we probably should have kept going and hopped into something,” Panchame, 39, said. “I’ve been really sacrificing a lot to get to this point to purchase a home and now I just feel like I got here but I didn’t work quick enough because interest rates have gotten the better of me.”

Add property taxes and home insurance, and it’s even more painful for home buyers because those costs have also risen sharply since the COVID-19 pandemic, along with housing prices themselves.

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A typical buyer of a mid-tier home in California, priced at about $785,000 in the spring, was looking at a total housing payment of about $5,900 a month. That’s up from $3,250 in March of 2020 and almost $4,600 in March of 2022, when the Fed began raising interest rates, according to the California Legislative Analyst’s Office.

It wasn’t supposed to work like that: Lifting interest rates as fast and as high as the Fed did, in its effort to curb inflation, should have led to falling home prices.

But that didn’t happen, mainly because relatively few homes came on the market. Most existing homeowners had locked in lower mortgage rates before the surge; selling those houses once interest rates took off would have meant paying higher prices and interest rates on other homes, or bloated rents for apartments.

For most homeowners sitting on the low rates of the past, their financial well-being was further supported by low unemployment and incomes that generally remained on par with inflation or grew a little faster. And many had cushions of savings built up in early phases of the pandemic, thanks partly to government support.

All of which has kept the U.S. economy as a whole humming along, blunting the full effects of higher interest rates.

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“Consumers are doing their job,” said Claire Li, senior analyst at Moody’s Investors Service, though she added that there are now signs of slower spending, evidenced by consumers cutting back on credit card purchases.

Unlike most home loans, credit card interest rates aren’t fixed. And today the average rate has bounced up to almost 22% from 14.6% in 2021, according to Fed data. That’s starting to squeeze more borrowers, adding to their unease.

Rising credit card debt

In California, the 30-day delinquency rate on credit cards is nearing 5% — something not seen since late 2009 around the end of the Great Recession, according to the California Policy Lab at UC Berkeley.

Lower-income and younger borrowers are more prone to falling behind on credit card, auto and other consumer loan payments than those with higher incomes. And it’s these groups that are feeling the effects of higher interest rates the most.

Christian Shorter, a self-employed tech serviceman who lives in Chino, just bought a used Volkswagen Jetta for $21,000. He put down $3,500 and financed the rest over 69 months at an annual interest rate of 24%. His monthly payment is more than $480, and by the end of the loan he will have paid about $15,000 in interest.

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Shorter, 45, said he doesn’t have good credit. He plans to take out a personal loan when interest rates drop and pay off the car debt. “Definitely, definitely, they should lower interest rates,” he said of the Fed.

Between the jump in interest rates and prices of new vehicles, some auto buyers have downgraded to cheaper models. The biggest shift, though, especially in California, has been a move by more buyers to turn to electric vehicles to save on fuel costs, says Joseph Yoon, a consumer analyst at Edmunds, the car research and information firm in Santa Monica.

In May, he said, buyers on average financed about $41,000 on a new vehicle purchase at an interest rate of 7.3% (compared with 4.1% in December 2021). Over 69 months, that translates to a monthly payment of $745.

“For a big part of the population, they’re looking at this car market and saying, ‘I got to wait for something to break,’ like interest rates or dealer incentives,” Yoon said.

For a lot of small-business owners, who drive much of the economy in Los Angeles, they don’t have the luxury of waiting it out. They need funds to survive, or to expand when things are going well.

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But many can’t qualify with traditional commercial lenders, and when they can they’re typically looking at interest rates of 9%; that’s more than double what they were before the Fed’s rate hikes, according to surveys by the National Federation of Independent Business.

One result: More and more people in Southern California are looking for help from lenders such as Brea-based Lendistry, one of the nation’s largest minority-led community development financial institutions.

From January to May, applications were up 21% and the dollar volume of loans rose 33% compared with a year earlier, said Everett Sands, Lendistry’s chief executive. Interest rates on his loans range from 7.5% to 14.5%.

“Business owners, they’re resilient, entrepreneurial, scrappy — they’ll figure out a way,” he said, adding that he sees many doing side jobs like driving for Uber or making Instacart deliveries at night.

Even so, Sands said, the higher borrowing costs inevitably mean less money spent on things like investing in new technology and software and bringing on additional staff, as well as delays in owners growing their businesses.

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“Some of them lose out in progressing forward.”

‘When you put everything on the line, you get desperate.’

— Jurni Rayne, Gritz N Wafflez

Jurni Rayne, 42, started her brunch business, Gritz N Wafflez, as a ghost kitchen in February 2022, preparing food orders for delivery services. She financed that by maxing out her credit cards and getting a merchant cash advance, which is like a payday loan with super high interest rates. Her debts reached $70,000.

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“When you put everything on the line, you get desperate,” said Rayne, a Dallas native who moved to Los Angeles a decade ago and has worked as a manager at California Pizza Kitchen and the Cheesecake Factory. “You don’t care about the interest rate, because it’s something like between passion and insanity.”

She has since paid off all the merchant loans. And her business has seen such strong growth that last year Rayne got out of the ghost kitchen and into a small spot in Pico-Union, starting with just three tables. She now has 17 tables and a staff of 14.

This fall she’ll be moving to a bigger location in Koreatown and has her sights on a second restaurant in South Los Angeles. But she frets that she could have expanded sooner if interest rates had been lower and she’d had more access to financing.

Economists call that an opportunity cost. For Rayne, it’s personal.

“Absolutely, lower interest rates would have helped me,” she said.

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For many others, the wait for lower rates continues without the balm of intermediate success.

Lynn Miller, 60, began looking to buy a home in Orange County about a year ago, hoping to upgrade from her current 1,600-square-foot apartment.

“It’s not bad, it’s just not mine — the dishwasher is crappy, the washing machine is old,” she said of her rental in Corona del Mar. “I’m obviously not going to invest in these appliances. It’s just different not owning your own home.”

It’s been a discouraging process, she said, especially when she inputs her numbers into the mortgage calculators on Zillow and Realtor.com, which churn out estimates based on current interest rates.

“If you look at those monthly payment numbers, it’s shocking,” Miller, a marketing consultant, said. “It’ll get better, but it’s just not better right now.”

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She’s continuing her house search — she’d love to buy a single-family, three-bedroom home with a backyard for a dog — but is holding off for now.

“I’m still waiting because I do think that interest rates are going to go down,” Miller said, although she knows it’s a guessing game. “I could end up waiting a long time.”

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California lawmakers advance tax on Big Tech to help fund news industry

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California lawmakers advance tax on Big Tech to help fund news industry

The California state Senate on Thursday passed legislation aimed at helping the news industry by imposing a new tax on some of the biggest tech companies in the world.

Senate Bill 1327 would tax Amazon, Meta and Google for the data they collect from users and pump the money from this “data extraction mitigation fee” into news organizations by giving them a tax credit for employing full-time journalists.

“Just as we have funded a movie industry tax credit, with no state involvement in content, the same goes for this journalism tax credit,” Sen. Steve Glazer (D-Orinda) said as he presented the bill on the Senate floor, casting it as a measure to protect democracy and a free press.

Its passage comes the same week lawmakers advanced another bill that seeks to resuscitate the local news business, which has suffered from declining revenue as technology changes the way people consume news. Assembly Bill 886 would require digital platforms to pay news outlets a fee when they sell advertising alongside news content.

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Glazer said his bill is meant as a complement to the other measure, adding that he and its author, Assemblymember Buffy Wicks (D-Oakland), plan to work with the companies that could be affected by both bills “in balancing everyone’s interest.”

The legislation passed 27 to 7, with one Republican — Sen. Scott Wilk (R-Santa Clarita) — joining Democrats in support. As a tax increase, it required support from two-thirds of the Senate and now advances to the Assembly.

A Republican who opposed the bill said technology is changing many industries, not just journalism, and that some of the innovations have led to inspiring new ways to consume news, such as through podcasts or nonprofit news outlets.

“These are all new models, and very few people under the age of 50 … even pick up a paper newspaper,” said Sen. Roger Niello (R-Fair Oaks.) “So this is an evolution of the marketplace.”

Opponents of the bill include tech company trade associations Technet, Internet Coalition and Chamber of Progress; the California Chamber of Commerce; and numerous local chambers of commerce.

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Supporters include unions representing journalists, a coalition of online and nonprofit news outlets, and the publishers of several small newspapers.

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