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Scott Gottlieb, MD Profile picture
@ScottGottliebMD
Sep 14, 2020 • 5 tweets • 2 min read • Read on X
Thread: My longstanding public health perspective is a critical shortcoming of our early response was the lack of diagnostic testing to detect community spread and target early mitigation. We were situationally blind. So we over-relied on flu surveillance because it’s all we had
I first raised these concerns in writing on Jan 27, when I said "global spread appears inevitable. So too are...outbreaks in the U.S." and called for the rapid development of accessible diagnostics as a "key to enabling successful public health measures" cnbc.com/2020/01/26/op-…
There were regulatory hurdles that had to be cleared to enable academic and commercial labs to offer their own, lab developed tests that could help meet the testing demand. I outlined the "Catch-22" that was blocking these tests in a series of tweets.
At the same time, I tried to help publicly outline the contours of a regulatory path for bringing more laboratory developed tests to patients through the emergency authorization process in a series of tweets and articles.
Lots of things went wrong in Feb. We were in fog of war. And there were lots of inaccurate and incomplete messages. But I think when we look back, and plan for how to prevent a similar tragedy; having early, accurate diagnostic tests deployed is going to be a critical capability.

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More from @ScottGottliebMD

Scott Gottlieb, MD Profile picture
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
Scott Gottlieb, MD Profile picture
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
Scott Gottlieb, MD Profile picture
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
Scott Gottlieb, MD Profile picture
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
Scott Gottlieb, MD Profile picture
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
Scott Gottlieb, MD Profile picture
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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