Los Angeles Times Profile picture
Mar 3 9 tweets 4 min read
Federal regulators are increasingly approving medicines before studies have shown they work, leaving patients at risk of taking prescriptions that could harm but not help them.

@MelodyPetersen reports: latimes.com/business/story…
Last year, 14 new drugs received so-called accelerated approval, in which they have not gone through the testing that the FDA regularly requires. That amounted to 28% of the 50 drugs the FDA approved. latimes.com/business/story…
The rules were created to be used in rare cases.

But with pressure from the pharmaceutical industry, patient groups & politicians to speed medicines to market, now most drugs are approved under the accelerated approval rules or through 3 similar programs. latimes.com/business/story…
The shift has alarmed some experts who worry the industry is exploiting the rules to sell medicines of questionable effectiveness and safety at high prices.

“This is causing huge amounts of real harm,” - Jerome Hoffman, UCLA professor emeritus of medicine latimes.com/business/story…
A recent Times investigation from @MelodyPetersen detailed how Covis Pharma has refused the FDA’s request to withdraw a drug for pregnant women at risk of premature birth. latimes.com/business/story…
The FDA required the company to perform a study to prove the drug’s benefits.

That trial took eight years and “unequivocally failed to demonstrate” that Makena worked, FDA scientists have said. latimes.com/business/story…
Brittany Horsey was prescribed the drug Makena during two of her pregnancies because doctors believed she was at risk of giving birth too soon.

Yet, both of her babies were born prematurely and Horsey said she suffered from Makena side effects. latimes.com/business/story… Image
“Makena is the only FDA-approved therapy to reduce the risk of preterm birth in women with a history of spontaneous preterm birth and its safety profile for the mother and baby are well established.” Covis Pharma’s statement to The Times about Makena: latimes.com/business/story…
The story of Makena shows how pharmaceutical companies can use America’s drug approval system to make hundreds of millions of dollars from a cheap, decades-old medicine with questionable effectiveness and safety.

From @MelodyPetersen: latimes.com/business/story…

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More from @latimes

Mar 3
Based on the podcast of the same name, #TheDropout tracks the rise and fall of Elizabeth Holmes and her biomedical company, Theranos. latimes.com/entertainment-…
At Theranos’ zenith, Holmes became known for her personal style, which seemed poised for mythmaking.

But no aspect of Holmes’ persona has fed into the public’s fascination more than what may be its most peculiar aspect: her deep voice. latimes.com/entertainment-…
In the new @hulu limited series, getting Holmes' voice right was crucial to actress Amanda Seyfried because “people are always talking about the voice. It’s the first thing people mentioned." latimes.com/entertainment-…
Read 4 tweets
Mar 3
New: The California Supreme Court declined to lift an enrollment cap on UC Berkeley, leaving one of the nation’s most popular campuses scrambling to cut its incoming fall class by one-third just weeks before it was set to release admission decisions.

latimes.com/california/sto…
The high court rejected the UC’s appeal to stay a lower court ruling issued last August that froze enrollment at Berkeley until the campus more thoroughly examined the impact of its burgeoning growth on housing, homelessness and noise. latimes.com/california/sto…
The court left intact a ruling by Alameda County Superior Court Judge Brad Seligman, who capped enrollment while the lawsuit filed by Save Berkeley’s Neighborhoods, proceeds.

latimes.com/california/sto…
Read 4 tweets
Mar 3
Diesel fumes hang in the air.

Dirt cakes cars and windowsills.

Residents of Drumm Avenue wonder what happened to their once-quiet Wilmington street.

Read the story from @tcurwen with photography by @Carolyn_Cole

latimes.com/california/sto…
Not long into the pandemic, a daily convoy of 18-wheelers showed up on Drumm Avenue, turning the once-quiet Wilmington street into a loud and dusty truck route from dawn to well-past dusk that has continued for nearly two years.
latimes.com/california/sto…
“How do they think this is OK for us?” said Wilmington resident Valerie Contreras. “We’ve been complaining for years. Our neighborhoods are getting whittled away, so we’re left with an industrial city that Los Angeles and the ports have created.”
latimes.com/california/sto… ImageImageImageImage
Read 4 tweets
Mar 3
As of Thursday morning, the Jim fire in Orange County has burned 553 acres and is 15% contained.

latimes.com/california/sto…
“Our firefighters were able to get out and put more boots on the ground overnight,” Nathan Judy said. “Today we’ll get more crews on the fire line, building that containment line.”

latimes.com/california/sto…
The fire encroached on the burn scar of the 2018 Holy fire, which helped slow its spread along with aerial water and retardant drops.

latimes.com/california/sto…
Read 5 tweets
Mar 3
The company that ran a Beverly Hills store that rented out safe deposit boxes has agreed to plead guilty to conspiring with customers to launder drug money.

Thread ⬇️

latimes.com/california/sto…
The company admitted that it recruited drug traffickers as customers and used the illicit proceeds to run the business.

latimes.com/california/sto…
It also acknowledged that people at the company sold cocaine, arranged drug deals at the store and instructed customers how to structure cash transactions to dodge currency reporting requirements. latimes.com/california/sto…
Read 9 tweets
Mar 3
On paper, U.S. decision to freeze Russian President Vladimir Putin’s personal assets looks like an empty gesture.

While considered one of the richest men in the world, official documents only say he has a couple of old cars, an apartment & some savings.

latimes.com/politics/story…
Nobody believes the official Russian documents present the real picture.

Most experts say Putin’s vast assets are secretly held by a circle of cronies — the so-called Russian oligarchs, their families and relatives.

latimes.com/politics/story…
Despite the zealously protected secrecy, Putin’s worth runs well into the billions of dollars.

The estimate is based on a deal Putin struck with the oligarchs in 2004, a Mafia-like offer they could not refuse: Half of all they earned would belong to him.

latimes.com/politics/story…
Read 7 tweets

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