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Delays found in drugmakers reporting of serious adverse reactions

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Drugmakers have delayed reporting serious and unexpected “adverse events” from their drugs, including death, in nearly 10 percent of cases, a study said Monday.

US regulations require drugmakers to report such incidents to the Food and Drug Administration within 15 days, but researchers at the University of Minnesota found that they delayed doing so in about one in 10 cases.

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“Strikingly, AEs (adverse events) with patient death were more likely to be delayed,” the study’s authors said.

“It is possible that manufacturers spend additional time in verifying reports concerning deaths, but this discretion is outside the scope of the current regulatory regime.”

The study appeared in JAMA Internal Medicine, whose editor said the delays exposed other patients to serious risks.

“Such reporting delays should never occur, as they mean that more patients are exposed to potentially avoidable serious harm, including death,” wrote the journal’s editor, Rita Redberg.

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She suggested that physicians who report on their patients’ adverse reactions to drugs should do so directly to the FDA, rather than to the manufacturer.

For the study, Pinar Karaca-Mandic and her co-authors examined serious adverse event reports submitted to the FDA between January 2004 and January 2014.

They found that of 1.6 million reports, 160,383 were not received by the FDA within the 15-day time window.

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Of those, 40,464 involved deaths of patients.

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Enjoy this piece?

… then let us make a small request. Like you, we here at Raw Story believe in the power of progressive journalism — and we’re investing in investigative reporting as other publications give it the ax. Raw Story readers power David Cay Johnston’s DCReport, which we've expanded to keep watch in Washington. We’ve exposed billionaire tax evasion and uncovered White House efforts to poison our water. We’ve revealed financial scams that prey on veterans, and efforts to harm workers exploited by abusive bosses. We’ve launched a weekly podcast, “We’ve Got Issues,” focused on issues, not tweets. Unlike other news sites, we’ve decided to make our original content free. But we need your support to do what we do.

Raw Story is independent. You won’t find mainstream media bias here. We’re not part of a conglomerate, or a project of venture capital bros. From unflinching coverage of racism, to revealing efforts to erode our rights, Raw Story will continue to expose hypocrisy and harm. Unhinged from corporate overlords, we fight to ensure no one is forgotten.

We need your support to keep producing quality journalism and deepen our investigative reporting. Every reader contribution, whatever the amount, makes a tremendous difference. Invest with us in the future. Make a one-time contribution to Raw Story Investigates, or click here to become a subscriber. Thank you.



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2020 Election

Trump campaign mocked after unveiling new red hats: ‘Do you have arm bands as well?’

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President Donald Trump's 2016 "Make America Great Again" hats have been replaced with new "Keep America Great" hats.

Trump re-election campaign manager Brad Parscale modeled one of the hats on Twitter.

Here is some of what people were saying:

https://twitter.com/LazarusLeBaron/status/1165430924093165568

Here I made an arm band design for you pic.twitter.com/inTyqVi2wo

— Christopher Goodwin (@LazarusLeBaron) August 25, 2019

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‘This will not end well’: Far-right extremism expert warns of Trump’s intensifying authoritarianism

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An expert on the far-right in America warned of President Donald Trump's "genuinely dangerous levels" of authoritarianism on Saturday.

Author David Neiwert posted a long Twitter thread on the commander-in-chief's "Social Dominance Orientation" -- and warned it will not end well.

Neiwert is the author of the 2017 book Alt-America: The Rise of the Radical Right in the Age of Trump.

Here is the thread he posted:

https://twitter.com/DavidNeiwert/status/1165428067138846720

https://twitter.com/DavidNeiwert/status/1165428524808724480

https://twitter.com/DavidNeiwert/status/1165429018486702081

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2020 Election

‘The Mooch’ attended Biden fundraiser in the Hamptons — because Trump ‘has lost his mind’

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Former White House press secretary Anthony Scaramucci attended a fundraiser for former Vice President Joe Biden on Saturday.

CBS News reporter Ben Mitchell posted a photo of Scaramucci at the event, and subsequently interviewed "The Mooch."

Scaramucci said he was still a registered Republican, but added that Trump "has lost his mind."

Spotted at a Biden event in the Hamptons: Fmr. Trump WH Comms Director Anthony @Scaramucci pic.twitter.com/PWVTZ8Qm15

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