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…
@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…
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…
“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…
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…
Yet, both of her babies were born prematurely and Horsey said she suffered from Makena side effects. latimes.com/business/story…
“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…
From @MelodyPetersen: latimes.com/business/story…
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