Share this page!

Enter URL or ID to Unroll

You can paste full URL like: https://x.com/threadreaderapp/status/1644127596119195649
or just the ID like: 1644127596119195649

How to get URL link on X (Twitter) App

  1. On the Twitter thread, click on or icon on the bottom
  2. Click again on or Share Via icon
  3. Click on Copy Link to Tweet
  4. Paste it above and click "Unroll Thread"!
  5. More info at Twitter Help
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.

• • •

Missing some Tweet in this thread? You can try to force a refresh
　

Keep Current with Scott Gottlieb, MD

Scott Gottlieb, MD Profile picture

Stay in touch and get notified when new unrolls are available from this author!

Read all threads

This Thread may be Removed Anytime!

PDF

Twitter may remove this content at anytime! Save it as PDF for later use!

Try unrolling a thread yourself!

how to unroll video
  1. Follow @ThreadReaderApp to mention us!

  2. From a Twitter thread mention us with a keyword "unroll"
@threadreaderapp unroll

Practice here first or read more on our help page!

More from @ScottGottliebMD

Scott Gottlieb, MD Profile picture
Jun 28
SCOTUS decision is very significant for FDA. Courts will continue to defer to FDA on product-review decisions, where Congress gave FDA discretion to make fact-based decisions based on careful process often outlined in guidance. But we'll see material changes in other areas 1/n
When FDA's decision is purely a matter of how it interprets a statute that applies across a product area, courts will no longer give deference. Some immediately affected areas could be certain food safety rules, rule on intended use, and recent rule making related to LDTs 2/n
One unintended consequence of the new SCOTUS ruling - depending on which Administration is in charge - is that it could give some FDAs a greater incentive to do more policymaking through non-binding guidance rather than rule making, to avoid this level of judicial review. 3/n
Read 4 tweets
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

Did Thread Reader help you today?

Support us! We are indie developers!

This site is made by just two indie developers on a laptop doing marketing, support and development! Read more about the story.

Become a Premium Member ($3/month or $30/year) and get exclusive features!

Become Premium

Don't want to be a Premium member but still want to support us?

Make a small donation by buying us coffee ($5) or help with server cost ($10)

Donate via Paypal

Or Donate anonymously using crypto!

Ethereum

0xfe58350B80634f60Fa6Dc149a72b4DFbc17D341E copy

Bitcoin

3ATGMxNzCUFzxpMCHL5sWSt4DVtS8UqXpi copy

Thank you for your support!

Follow Us!

Send Email!

:(