The wide dispersion in models forecasting the Delta wave, released by CDC, are deeply disappointing and not actionable. The huge variance in the estimates shows CDC doesn’t know how to model this wave, and has little practical idea whether we’re at beginning, middle, or end 1/n
It’s another symptom of a more systemic bureaucratic disease. CDC has a retrospective mindset, it’s not a prospective agency resourced and poised to mount operational responses to crisis. The need for such capability is a big focus of my forthcoming book, Uncontrolled Spread 2/n
The CDC’s models on Delta wave underscore this point. For the week ending August 14, CDC estimates there will be either an average of 10K infections a day, or more than 100K. Either the infection wave will be largely subsiding, or will be raging out of control. The CDC isn’t sure
What’s needed? This isn’t CDC’s job alone. We lack an organized infrastructure to mobilize a response to public health crisis. We need a JSOC for public health response. For two years, HHS did not operationalize this kind of effort aside from Warp Speed. 4/n
For its part, CDC isn’t a prospectively-minded agency. They don’t do horizon scanning, make predictions and tie to policy recommendations, coordinate heavy lift capabilities like vaccination campaigns, engage in risk estimates, or collect intelligence on foreign areas of concern
We need such a capability. An action-oriented agency able to engage in assessing and mobilizing preparations against future risks. Able to coordinate assessment of intelligence that informs on these risks. Able to become a clearing house for intel and operational direction. 6/n
Could a reformed CDC play such a role? I outline in detail how in my book. But it’ll have to go back to its roots aimed at disease control and empower a new agency (maybe a new NIH institute) to take on many current “prevention”functions. CDC will need a national security mindset
The bottom line: CDC data has consistently been thorough, meticulous, and late. In other words, it wasn’t actionable in setting of fast moving crisis. That’s not the business CDC was in. They provide definitive answers, not partial info to inform current decisions in a crisis 7/n
In closing: we’ll need such an agency somewhere. It can be a CDC retasked with a greater focus on the national security dimension of its mission. It can be a new joint operational command. We’ll have to view these risks, the ability to horizon scan - and prepare, through new lens
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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
🧵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
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
🧵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
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
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
🧵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:
🧵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
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