Osman Moneer
@osmanmoneer
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he/him/his. Current @StanfordMed Internal Medicine Resident. Formerly @YaleMed , @Columbia .
Joined February 2020
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Pinned Tweet
We’re moving to California! So excited to match at
@StanfordDeptMed
for Internal Medicine residency!!
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How reliable is evidence from observational studies?
In our new
@bmj_latest
paper, we look at the agreement between treatment effects from RCTs and observational studies for Covid-19 drugs
@JoshuaDWallach
@jsross119
@DrPeterLurie
@SkydelJ
@KDNyhan
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20
52
Had an amazing time yesterday riding my first century for
@CTFRide
@YaleCancer
!
Couldn’t have asked for better company
@shinmeichan
@original_jz
@jrwoodbridge
@PeterNatov
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4
26
As we recently saw with the United States's initial response to Covid-19, single-sourced diagnostic tests hamper clinical practice.
For more on innovation policy for diagnostics, check out my paper with
@WNicholsonPrice
and Chaaru Deb in
@J_Law_Biosci
!
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8
21
How can FDA & CMS align policies to ensure that medical device innovation is based on strong and representative evidence?
In a new
@JAMACardio
Special Communication, we explore market authorization and coverage for Breakthrough cardiovascular🫀 devices.
1
7
21
While direct-to-consumer personal genomic tests have benefits, they also pose risks. In
@NatureMedicine
, we comment on genetic data regulation for DTC-PGTs and offer policy solutions to establish safeguards.
@jsross119
@millerbioethics
@nilaydshah1
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Check out our paper on vaccine development and regulation!
We reviewed current and potential approaches to the FDA's regulation of vaccines. To contextualize the assessment of Covid-19 vaccines, we looked at all new vaccines approved in the last 15 yrs.
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Interested in learning about the performance of FDA postmarketing studies?
In our new paper, we synthesize evidence from the academic literature and gov reports to assess the track record of postmarketing requirements and commitments.
@PORTAL_Research
0
5
16
Check out our paper on postmarketing studies for new vaccines!
We found that vaccine postmarketing studies had a lengthy time to completion, highlighting the importance of ensuring that Covid-19 vaccine PMRs/PMCs are completed in a timely fashion.
@akesselheim
@PORTAL_Research
Among postmarket commitments (PMCs) and postmarket requirements (PMRs) attached to new vaccines approved in the last 15 years, only about half were considered fulfilled in 2020 and the time to completion was a median of over 4 years.
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Check out our opinion piece in
@bmj_latest
!
We discuss the challenges of evidence generation for Covid-19 drugs and suggest a role for observational studies in pandemic decision-making.
@JoshuaDWallach
@jsross119
0
5
12
Spent this morning helping facilitate a discussion with the incoming M1 class on
@DorothyERoberts
's Fatal Invention, which deconstructs biological race. Thanks to my classmates
@ellelandegife
,
@c_ijeli
,
@nobles_autumn
, and
@maituranci
for organizing such a great session!
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And as a personal milestone, this was my first paper in medical school!
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Was exciting to hear
@DorothyERoberts
herself speak at the end of the session, and I'd highly recommend reading her book and associated scholarship.
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Great work from
@jamiesonomarr
and
@shinmeichan
quantifying the differential burnout between URIM vs non-URIM students!
In a survey, underrepresented minority medical students reported experiencing higher levels of exhaustion-related burnout compared with their peers, especially if they experienced racial discrimination during training
@DowinHugh
@shinmeichan
@jamiesonomarr
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With an excellent accompanying editorial from former Chief Medical Officer and Director of the Center for Clinical Standards and Quality at CMS
@LeeAFleisher
:
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Fortunate to have worked with such an amazing team of co-authors!!
Kudos to Vinay Rathi (
@MassEyeAndEar
),
@JLJohnstonMD
(
@BrighamMedRes
),
@jsross119
(
@Yale_CRRIT
), and Sanket Dhruva (
@UCSFCardiology
)
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Along with an editor's note from
@JAMACardio
's
@NMHheartdoc
, Patrick O'Gara, and Robert Bonow contextualizing our work:
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For similar work (and a shorter read) by Professor Roberts, check out her article "Taking race out of human genetics" in Science.
I'd especially encourage other genomic researchers to read and reflect on the problematic use of race in genetic research.
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4/5 Regulatory gaps exist surrounding oversight as most companies that make DTC-PGTs are not considered to be HIPAA-covered entities (or business associates), which allows them to avoid the mainstay of US health data regulation.
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3/5 But despite these benefits, DTC-PGTs present current and future risks for data control, agency and discrimination.
Moreover, recent high-profile mergers—such as that of Virgin Group and 23andMe— could potentially change company privacy policies and heighten these concerns.
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2/5 DTC-PGTs are exciting because they provide interesting health information (like disease susceptibility) to consumers in addition to their ancestry and genealogy offerings.
They also support the development of personalized medicines by accelerated drug discovery.
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5/5 We explore policy solutions that bring DTC-PGT companies under the umbrella of HIPAA regulations to ensure better consumer protection surrounding their use.
For more, check out the full Comment!
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