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Fights over Tylenol, SSRIs highlight the enduring lack of pregnant women in drug trials

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Reposted by Lizzy Lawrence

Usha Lee McFarling @usha.bsky.social · 5d

My first post as head of KSJ! Our first public event. This Thursday. Cambridge. Science journalism in a time of crisis. It's going to be 🔥. Join me and @katherinejwu.com @aniloza.bsky.social @sarareardon.bsky.social @akuchment.bsky.social @jeremyfaust.bsky.social and @edenmedina.bsky.social

A flyer showing speakers and describing a panel discussion "Confronting Crisis" to be held 10.9.25 from 4:15-6:15 at 101 Rogers Street in Cambridge.

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Lizzy Lawrence @lizzylawrence.bsky.social · 10d

With last week's announcement on Tylenol, pregnancy & autism — & an FDA panel in July on SSRIs during pregnancy — I've been thinking about exclusion of pregnant women in clinical trials. Talked to some experts about how we got here, and what can change:
www.statnews.com/2025/10/02/c...

Shutting pregnant women out of clinical trials to protect them and their babies has had the opposite effect, experts say.

Unsealed court documents reveal a whistleblower suit over UnitedHealth use of an artery disease test

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Lizzy Lawrence @lizzylawrence.bsky.social · 13d

ICMYI: Unsealed court documents reveal a whistleblower suit over UnitedHealth use of an artery disease test.

Also, the maker of the artery disease test was recently bought for $1.3 billion in stock by a bitcoin treasury company backed by Vivek Ramaswamy:

www.statnews.com/2025/09/26/u...

Whistleblowers are suing UnitedHealth Group over its use of a peripheral artery disease test, called QuantaFlo, to increase Medicare payments

Reposted by Lizzy Lawrence

Michael Sinha @drsinhaesq.bsky.social · 16d

#FireproofingTheFDA
Panel 3: The Current Crisis at the FDA

(1) @lizzylawrence.bsky.social @statnews.com
(2) @rachelsachs.bsky.social @washulaw.bsky.social
(3) Nathan Cortez SMU Dedman Law
(4) Jordan Paradise @loyolachicago.bsky.social

Moderator: Avery Emery @sjquinney.bsky.social @utah.edu

Autistic moms feel shamed and stigmatized by Trump’s Tylenol warning

Reposted by Lizzy Lawrence

O. Rose Broderick @rosebroderick.bsky.social · 17d

Mothers regularly shoulder the "blame" for having a child with autism. So when autistic moms watched Trump insist — despite little scientific evidence — that Tylenol use during pregnancy causes autism, it felt like a return to a dark era. #disability #autism

www.statnews.com/2025/09/25/a...

Trump's remarks linking Tylenol to autism are a return to an era when mothers were blamed for children developing the disorder.

Lizzy Lawrence on Trump Administration Targeting of Drug Advertising

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Lizzy Lawrence @lizzylawrence.bsky.social · 22d

Very fun to talk about the FDA's crackdown on DTC drug ads on C-SPAN this morning! You can check out the segment here: www.c-span.org/program/wash...

STAT FDA Reporter Lizzy Lawrence discussed recent Trump administration actions to crackdown on direct-to-consumer drug advertising and reaction from the pharmaceutical industry.

www.c-span.org

In a chaotic meeting, RFK Jr.’s handpicked advisers begin altering the childhood vaccine schedule

Reposted by Lizzy Lawrence

elizabethcooney.bsky.social @elizabethcooney.bsky.social · 23d

Two tumultuous days. @chelseacirruzzo.bsky.social. @elaineywchen.bsky.social, ans @lizzylawrence.bsky.social report

www.statnews.com/2025/09/19/w...

Kennedy says he wants to restore trust in vaccines. His hand-picked ACIP panel raised many doubts, and outside experts were left baffled and frustrated.

Federal vaccine panel remade by RFK Jr. votes to maintain insurance coverage for Covid shots

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Lizzy Lawrence @lizzylawrence.bsky.social · 23d

The CDC's vaccine panel recommended that people 6 months and older consult with their doctor before getting the Covid vaccine - preserving insurance coverage of the shots and diverging with the FDA's more limited approval:
www.statnews.com/2025/09/19/a...

The panel's decision would preserve broad insurance coverage for Covid-19 shots, even though some panelists questioned their benefits and safety.

Fear and politics pervade Kennedy’s CDC, former leaders testify

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Lizzy Lawrence @lizzylawrence.bsky.social · 25d

The CDC is not well, @elizabethcooney.bsky.social writes, based on an account from two of its former leaders at a Senate hearing on Wednesday.
www.statnews.com/2025/09/17/m...

In a climate of fear CDC scientists are withdrawing names from papers, and local and global health agencies are losing confidence.

Device maker that helped UnitedHealth collect billions settles fraud claims with DOJ

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Lizzy Lawrence @lizzylawrence.bsky.social · 25d

Semler Scientific, a device maker that helped UnitedHealth collect billions, settles fraud claims with DOJ — and reports the loss of a "significant" customer
www.statnews.com/2025/09/17/s...

Semler Scientific will pay DOJ nearly $30 million to settle health care fraud claims related to its peripheral artery disease test QuantaFlo

FDA warning letters show how it intends to ratchet up pressure over drug ads

Lizzy Lawrence @lizzylawrence.bsky.social · 25d

NEW: The FDA released about 100 letters yesterday warning companies to take down or alter drug ads the agency found misleading. It's an unprecedented show of force - but after layoffs, does FDA have the resources to fend off potential legal challenges?
www.statnews.com/2025/09/17/f...

The FDA's crackdown on drug advertising is unprecedented, but some experts questioned whether the agency has the staff to carry it out.

In internal FDA town hall, employees raise concerns about staffing, impromptu expert meetings

Lizzy Lawrence @lizzylawrence.bsky.social · Sep 12

Worth noting that Tidmarsh & Makary expressed skepticism of adcomm meetings at a town hall in August, with Makary calling them bureaucratic and expensive and Tidmarsh questioning whether they were necessary at all. My story on those comments here: www.statnews.com/2025/08/08/f...

Exclusive: FDA employees, in a town hall after the ouster of Vinay Prasad, asked about unusual meetings and staff shortages. "We are struggling," one said.

FDA leaders moving to abandon advisory committee reviews of specific new drugs

Lizzy Lawrence @lizzylawrence.bsky.social · Sep 12

Great story from @arthurallen202.bsky.social on the FDA moving to abandon advisory committees, which critics say would shield the agency's decisions from public scrutiny: www.statnews.com/2025/09/12/f...

FDA leaders under President Donald Trump are moving to abandon a decades-old policy of asking outside experts to review drug applications

FDA pledges to crack down on DTC pharma ads

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Lizzy Lawrence @lizzylawrence.bsky.social · Sep 10

NEW: FDA pledges to crack down on DTC pharma ads
www.statnews.com/2025/09/09/t...

A new EO from President Trump directs health secretary Robert F. Kennedy Jr. to crack down on misleading direct-to-consumer drug advertisements.

When we named ourselves “STAT’’ 10 years ago, we conceded, “It takes a bit of chutzpah to name a digital-age life-sciences publication after a buzzword

Reposted by Lizzy Lawrence

STAT @statnews.com · Sep 9

STAT is 10!

Join us in reflecting on a decade of reporting from the frontiers of health and medicine.

We’re proud that since 2015 we’ve delivered urgent, authoritative, and impactful journalism.

Celebrate with us: www.statnews.com/stat-10th-an...
#STAT10 🧵

STAT 10 Year Anniversary

FDA commissioner says agency is looking into question of pediatric deaths from Covid vaccines

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Lizzy Lawrence @lizzylawrence.bsky.social · Sep 5

FDA commissioner told CNN the agency is launching "intense investigation" into whether Covid shots cause deaths in kids.

The shots have been given to billions of people, and researchers have found no evidence of major safety risks aside from myocarditis.
www.statnews.com/2025/09/05/f...

Marty Makary said the FDA will release a report within weeks on childhood deaths that he said are linked to Covid shots.

FDA says it will publish reports of adverse events tied to drugs on daily basis

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Lizzy Lawrence @lizzylawrence.bsky.social · Aug 22

NEW: FDA says it will publish reports of adverse events tied to drugs on daily basis
www.statnews.com/2025/08/22/f...

The FDA said it has begun publishing reports of adverse events concerning drugs on a daily basis, instead of quarterly, as it has in the past.

Health care CEOs harvest billions even as industry lags broader stock market

Lizzy Lawrence @lizzylawrence.bsky.social · Aug 18

Don't miss STAT's analysis of health care CEO's compensation in 2024, led by @bobjherman.bsky.social and @jaspar.bsky.social. 91 health care CEOs earned at least $10 million in 2024. BioNTech CEO Uğur Şahin took home more than $300 million.
www.statnews.com/2025/08/18/h...

STAT dug into the compensation of 275 CEOs across health care.

Inside the research machine that helps UnitedHealth protect its Medicare profits

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Lizzy Lawrence @lizzylawrence.bsky.social · Aug 11

A look inside the ways UnitedHealth is able to control research into the Medicare Advantage program, from @bobjherman.bsky.social, @caseyross.bsky.social, @tarabannow.bsky.social and me: www.statnews.com/2025/08/11/u...

A STAT Investigation: Inside the research machine that helps UnitedHealth protect its Medicare profits.

Vinay Prasad returns to the FDA, weeks after his ouster

Lizzy Lawrence @lizzylawrence.bsky.social · Aug 9

BREAKING: Vinay Prasad is returning to the FDA to resume his role overseeing vaccine, gene therapy, and blood product regulation — just two weeks after his ouster. www.statnews.com/2025/08/09/v...

HFO HFO Vinay Prasad returns to a top FDA role just weeks after his abrupt dismissal.