THREAD: Lack of a crisis-proof clinical trial infrastructure left US unable to quickly establish which treatments were effective against Covid and equally important, debunk myths that emerged around drugs offering no benefit or causing harm. My JAMA latest jamanetwork.com/journals/jama-…
Too much of the early research during the pandemic came from constructs that were never going to yield actionable results. We missed an opportunity early on to field the kinds of practical studies that could be completed in the setting of a crisis but still generate firm evidence
British researchers proved through RECOVERY trial the value of having more central organization around conduct of research in the setting of a public health crisis, as well as virtue of practical trial designs that are more easily enrolled and completed in an emergency setting.
I discuss in depth in my forthcoming book Uncontrolled Spread, steps to remedy these gaps. US needs a coordinated national clinical trial infrastructure in setting of public health crisis. US should empower FDA and NIH to prioritize trials more likely to yield actionable evidence
That also means we must rely on practical trial designs such as approach used in RECOVERY. US didn't participate in RECOVERY, deeming it insufficiently rigorous. Yet many of the most important clinical results came from that single trial, such as evidence on benefits of steroids
It cuts both ways. We also must establish early when something doesn't work. Many continue to hold hydroxychloroquine is effective, even after definitive studies debunked its use; because speculations were able to persist for too long. Firm evidence arrived too late in the debate

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More from @ScottGottliebMD

12 Sep
THREAD: My latest article in ⁦@TheAtlantic on the Covid endgame⁩: “How Endemic COVID Becomes a Manageable Risk” -
Businesses and schools must adapt, because the dual threat from the coronavirus and the flu will be too severe. theatlantic.com/ideas/archive/…
Covid will become endemic. I write that a big challenge will be adapting work and leisure activities to turn an omnipresent virus into a manageable risk; and seeing whether enough Americans can reach a political consensus on the practical and cultural changes that it will require
The current pandemic has become a source of political division; decisions about how to handle it have been evaluated through that prism. But the political coloring of disease-fighting precautions may fade as it becomes a forever problem, and requires a sustainable long-term plan.
Read 10 tweets
8 Sep
THREAD: Delta is highly contagious and hard to control. With more schools reopening in northeast, we must double down on efforts to prevent outbreaks. A missed opportunity is use of routine screening tests to identify outbreaks, avoid quarantines. Here's how to leverage testing:
First, the opportunity: The feds made available $10 billion from the American Rescue Plan to ramp up screening testing to help schools reopen and provided new guidance on asymptomatic screening testing in schools, workplaces, and congregate settings.
hhs.gov/about/news/202…
Most school reopen plans focus on looking for kids with Covid symptoms. Yet research shows symptom screening alone won't enable schools to contain outbreaks. 40% of cases may be asymptomatic; 50% transmission occur from asymptomatic persons. Testing is key nejm.org/doi/full/10.10…
Read 11 tweets
15 Aug
In the U.S. we have no firm idea how many kids have already been infected with COVID. We have no idea if hospitalizations in south are tip of a huge iceberg of dire infection - or a sign that COVID has become more pathogenic in children. The CDC should gather this data. It isn’t.
Britain has this data. Their REACT study evaluates population-level info to reveal where, how COVID is spreading. We have no similar effort in U.S. CDC’s cohort studies are small, narrow - monitoring specific groups like nursing homes and essential workers imperial.ac.uk/medicine/resea…
If we started a similar effort at outset, we’d now know how much vulnerability remains in specific populations - how many people remain susceptible to COVID. We’re making policy in a vacuum of information. I take up these systemic woes in my forthcoming book Uncontrolled Spread.
Read 5 tweets
24 Jul
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 Image
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 ImageImage
Read 9 tweets
11 Jul
18 months into the pandemic, and after many pleadings and prodding’s, including from Congress, CDC still doesn’t have a robust system for comprehensive, near-real-time surveillance of new variants. Data on their web site is at least 3 weeks old, even as new variants move fast.
This is a question of resources, capabilities, and mission. We don’t have the equivalent of a JSOC for public health crisis. We don’t have a heavy lift capability that can do all the tracking and deployment needed to monitor and respond to a fast moving infectious disease crisis.
What’s needed is a more operationally equipped capacity in CDC - a prospective rather than a retrospective mindset. It will require a re-thinking of the organizational structure and mission. I devote a lot of focus of my forthcoming book Uncontrolled Spread to these issues.
Read 5 tweets
6 Jul
People ask why the question of COVID's origin matters at this point, since it won't impact how we address the pandemic. We already know what we need to know about how this virus behaves. But it does matter, a lot: because it impacts how we address risks of future pandemics. 1/x
If we assess probability exists, or rate as high, likelihood it came out of a lab; we must put security of BSL3/4 labs and greater supervision of high end research (and publication of dangerous synthetic sequences) much higher on list of priorities for international governance.
We must get our clandestine agencies that operate oversees more engaged in the public health mission; conducting surveillance of dangerous research that could lead to future threats. I discuss in detail how this mission could unfold in my forthcoming book Uncontrolled Spread 3/x
Read 6 tweets

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