Scott Gottlieb, MD Profile picture
Jul 29, 2020 4 tweets 2 min read Read on X
From @AmerAcadPeds data on Covid in kids. Documents 288K total child cases, and 76 tragic deaths. CDC in its school opening guidance compares pediatric Covid deaths to pediatric flu deaths. Flu caused 11.3M documented cases of symptomatic disease in kids in 2018-19 vs Covid 288K. ImageImage
More information on CDC's data regarding influenza in children for 2018-19 can be found here: cdc.gov/flu/about/burd… Image
The upshot here is Covid has not infected nearly as many children as flu does; in part because we have deliberately sheltered kids from Covid. So the comparisons in total morbidity between Covid and flu that CDC makes in their back-to-school guidance need to be viewed cautiously.
Even if we just compare the 6.9M documented flu cases that presented to a doctor to the documented Covid cases, there is still a wide gulf between pediatric incidence; and it’s possible that cases of Covid may have been more likely to present and be diagnosed in symptomatic kids.

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More from @ScottGottliebMD

Nov 20, 2023
🧵The OIG just released their report detailing the factors that led to the Covid test failures in early 2020, providing new detail on internal design and quality control issues in CDC’s labs. 1/5

Report here:



Some notable findings 👇🏼oig.hhs.gov/oas/reports/re…
Lack of Preparation: “Although CDC had agency guidance documents related to its response structure during a public health emergency…these documents do not address the development of a test kit” and it “did not have policies and procedures in place for developing a test kit” 2/5
No Standardized Quality Control: “Because no agencywide laboratory document control system existed, the use of multiple laboratory document control systems during the development of the test kit led to different versions of quality control procedures being created and used.“ 3/5
Read 5 tweets
Apr 3, 2023
🧵Lots of interesting nuggets in the new guidance CMS released to outline how it will set drug prices under the Inflation Reduction Act

This caught my eye. CMS says all negotiation materials from CMS have to be kept secret, and then documents must be destroyed within 30 days 1/7
It says off label use of a drug will be considered when establishing the "fair price," but only if the use is listed in a CMS recognized compendia -- this probably means that for purposes of setting a price, CMS will only consider the off label uses for cancer drugs. 2/7
This language, where it discusses use of "therapeutic alternatives" as a reference price, suggests CMS could use generic drugs as a reference for setting the price of a branded drug, if they judge the generic to be a "therapeutic alternative" (no clear criteria is laid out) 3/7
Read 7 tweets
Jan 22, 2023
My Op Ed. To reform CDC, we should focus it more squarely on its mission in communicable diseases; moving many other public health mandates to agencies that already oversee broad programs in same areas, getting analytical work closer to operational agents

washingtonpost.com/opinions/2023/…
A thoughtful article documenting how CDC didn’t comply with law congress passed, and in 2010 update its information technology systems as Congress prescribed, by my @aei colleague Yuval Levin. Challenges CDC faces today were set in motion many years ago

aei.org/op-eds/bidens-…
Link to the 2010 GAO report.

gao.gov/products/gao-1…
Read 4 tweets
Jan 9, 2023
🧵In the past, I've raised concerns with Twitter related to the safety of me and others, and threats being made on the platform. This included direct as well as specific threats. Sometimes it included statements that I believed were purposely false and inflammatory 👇
The selective disclosure of my private communications with Twitter stokes the threat environment. So does actions that empower people who’ve shown little restraint when it comes to purposeful vitriol. It instigates more menacing dialogue, with potentially serious consequences 👇
If the goal of TwitterFiles is transparency, here's some of the private e-mails I had with Twitter, related to threats and safety, which weren't released; and which I repeatedly highlighted in my communications with the platform. Safety remains an existential concern for Twitter:
Read 8 tweets
Dec 13, 2022
🧵If we lose chance to create modern framework for FDA regulation of diagnostics, FDA won't walk away from issue. If VALID doesn’t pass, FDA will move ahead under existing authorities; which aren't well suited to challenge of promoting safety, innovation

raps.org/news-and-artic…
We should expect FDA to act on its own if VALID doesn't pass Congress. Easiest most efficient way? Would be to end agency's historical enforcement discretion. FDA could simply clarify that all LDTs are now subject to active regulation as medical devices fda.gov/medical-device…
FDA could amend the existing medical device regulations to confirm that these regulations apply to LDTs, which FDA considers to be a type of in vitro diagnostic device. This is the most straightforward approach: issuing a regulation that pulls LDTs into medical device framework
Read 10 tweets
Nov 27, 2022
🧵What happened in 3/22 when Omicron hit Hong Kong, illustrates challenge China faces

Hong Kong like China had low vaccination rates; especially among elderly

In face of much more contagious variant, low pre-existing immunity in HK was devastating 1/x

bloomberg.com/news/features/…
When Omicron hit Hong Kong, only 72% of residents were fully vaccinated, 30% boosted

By comparison, in China, 88% were fully vaccinated, 40% boosted; a figure that hasn't changed much

Hong Kong, unlike China, deployed vaccines that have proven more effective against Omicron 2/x
Yet over first three weeks of March, HK reported 456,305 cases and 4,103 deaths; a tragic case fatality rate. Here’s the rub: Elderly residents had disproportionately gone unvaccinated for a variety of reasons; in HK it was young people not the old who had been vaccinated 3/x Image
Read 6 tweets

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