Scott Gottlieb, MD Profile picture
Senior Fellow @AEI. Partner @NEA. Contributor @CNBC. 23rd Commissioner @US_FDA 2017 to 2019. Boards: @Pfizer @Illumina @AetionInc @TempusLabs
eDo Profile picture Ross Grayson, MPH, CIH Profile picture John Saunders Profile picture m rose Profile picture Norris Battin Profile picture 85 added to My Authors
21 Sep
THREAD: My book, “Uncontrolled Spread,” debuts today. It aims to shed new light on systemic woes and mistakes that left U.S. excessively vulnerable to Covid and how we make sure this never happens again. I owe deep gratitude to many people who helped bring this book to completion
I provide new details on what went wrong at the agency level to leave the U.S. excessively vulnerable to this threat, relate newly revealed stories, and offer a roadmap for how we can reform our systems to make sure that a future pandemic strain can never hit us this hard.
I want to thank the more than 100 people I interviewed for this book; the many experts who read the manuscript; hundreds of reporters, scientists, researchers whose work I reference; and especially my former colleagues at FDA and HHS who provided key insights throughout my effort
Read 4 tweets
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.
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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
27 Aug
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.
Read 6 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
21 Mar
Covid positivity rates in parts of Brooklyn, Queens are approaching 15%, among highest in nation. NYC deserves close watching. Variants now represent more than 60% of infections, and B.1526 is majority strain and is probably being undercounted because of way we're sampling. 1/2
Vaccination represents a chance to get ahead of these trends. There are 13,000 open appointments in NYC this morning, mostly in pharmacies, as NYC makes major expansion. In meantime, we need CDC to help determine if 1526 is causing breakthrough infections.
Overall cases and hospitalizations are still declining in NYC, which is good news, but testing is also falling sharply. We need better ways to more quickly link clinical outcomes with the variants we're observing, especially B1526, a new variant that we don't understand well yet.
Read 4 tweets
17 Jan
As current epidemic surge peaks, we may see 3-4 weeks of declines in new cases but then new variant will take over. It'll double in prevalence about every week. It'll change the game and could mean we have persistent high infection through spring until we vaccinate enough people.
New variants may change everything. They'll be 1% of all cases by end of next week, with hot spots in Florida and Southern California. But doubling every week, they'll be about 30% of all cases in 5 or 6 weeks. It'll be harder to hide from them, schools will be more vulnerable.
What can we do? We're in a race against time to get as much protective immunity into population as backstop against continued spread. The vaccine is our only tool. We also need to become more vigilant about masking. Quality of mask matters more now. N95 best, or double masking.
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1 Nov 20
THREAD: Covid cases are accelerating across the U.S. and we have some hard months ahead. We are at the beginning of exponential spread in many states. We need to take steps now to preserve life, and know that things will get better, and 2021 will be a very different year. 1/n
We’ll have better technology and therapeutics to address risk and protect people. We’ll have more experience caring for the sick. We’ll see infections decline as we get through this surge and enter spring. We must take steps to preserve and elevate what’s most important to us 2/n
That must include preserving in class learning for kids and re-opening schools. There are steps we can take right now to make sure kids can be back in school as current surge subsides, or keep more kids in school where classes are open. It starts with helping protect teachers 3/n
Read 6 tweets
28 Oct 20
It is deeply unfortunate that we head into Fall without enough doses of this drug. Many of us were talking about this as early as March. Regeneron did extraordinary work to secure their own manufacturing, but we needed a concerted industrial effort to get the supply we needed.
Re-upping this July Op Ed. Some of the same opportunities we identified here are still open to us. But we need to start taking steps immediately to have enough of these drugs to use as a backstop for high risk patients; and a bridge until we get a vaccine. wsj.com/articles/antib…
Re-upping this April Op Ed. wsj.com/articles/bet-b…
Read 4 tweets
23 Oct 20
The number of Covid cases, hospitalizations, and deaths is going to continue to grow sharply as we enter the winter; until all of us on our own start taking enough collective action to slow the spread. There is no seasonal backstop, and won’t be any new national policy action.
When people wear masks, it reduces likelihood of spreading Covid if they're an asymptomatic or pre-symptomatic carrier. A new @Nature study finds if 85% of Americans wore masks, we would save 95,000 people. Greater adherence to masking will reduce spread. nature.com/articles/s4159…
Masks can also protect you from contracting Covid if you are exposed to someone who is contagious; and the quality of the mask you wear can matter. The higher the quality of the mask, the greater the protection that it can afford you.
Read 4 tweets
11 Oct 20
A good reference from CDC on SARS-CoV-2 Virus Culture and Subgenomic RNA for Respiratory Specimens. Authors investigated 68 respiratory specimens from 35 coronavirus disease patients in Hong Kong, assessing them for subgenomic RNA and virus RNA by rtPCR. wwwnc.cdc.gov/eid/article/26…
Subgenomic mRNA is a newer test being used to assess for active infection and live virus and it's generally considered a good - but not foolproof - proxy for culturable, live virus.
As always, @ashishkjha with a timely and insightful explainer and assessment here:
Read 4 tweets
14 Sep 20
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.
Read 5 tweets
22 Aug 20
THREAD: For the last 6 months, FDA’s device center worked effectively with labs to advance hundreds of tests for Covid. A new HHS policy that extricates FDA from this work - and goes further, by removing any FDA role over any lab developed test - could put this work at risk. 1/x
At issue are lab developed tests. For a time, there was debate what FDA’s role was over these LDTs. It was long settled that LDTs were medical devices, subject to FDA oversight. For the vast majority of LDTs, FDA exercised enforcement discretion, and didn’t actively regulate 2/x
This FDA authority was articulated in countless guidances, enforcement actions, testimony. It was the subject of 2006 guidance that was cleared by HHS under Bush. Bipartisan legislation now moving through Congress would further codify the contours of this general framework. 3/x
Read 13 tweets
16 Aug 20
Lessons for success from abroad: "Physical distancing in and out of the classroom is common practice... Schools in Switzerland use tape on floors to mark adequate space between desks. To further limit contact, many Swiss schools reduced class sizes by 50%" commonwealthfund.org/blog/2020/reop…
"Primary school children have returned first in Denmark, and a system is in place to keep children in small groups...The other lynchpin of the Danish approach is a huge amount of hand washing and sterilizing." bbc.com/news/education…
In Iceland, where epidemic is controlled, "the 100-person limit at public gatherings remains unchanged. At secondary schools and universities, a one-meter social distancing rule will apply, without the use of face masks" Children born after 2005 are exempt icelandmonitor.mbl.is/news/news/2020…
Read 4 tweets
8 Aug 20
THREAD: Covid caused 338,000 diagnosed infections in kids. 86 tragically died, thousands more hospitalized. To compare burden to flu, an estimated 11.3 million kids got symptomatic flu in 2018-19, 477 died. If Covid became as widespread in kids as flu, outcomes could be grim. 1/3
Our focus must be on preventing Covid from becoming epidemic in kids and safely reopening schools in communities that controlled spread. There are steps we can take to accomplish these goals; reducing risks of outbreaks in schools and keeping kids safe 2/3 wsj.com/articles/want-…
There’s lot we don’t understand about Covid in kids. We shouldn't trivialize observed or possible risks. Schools have been closed; many kids deliberately sheltered from infection. In coaxing schools to open it’s imprudent to argue Covid is harmless, or milder in kids than flu 3/3
Read 6 tweets
29 Jul 20
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.
Read 4 tweets
24 Jul 20
THREAD: To safely return kids to in-class learning, schools will need detailed guidance on reducing Covid risk. They may have to look elsewhere, to state documents as well as foreign public health authorities that issued detailed, science driven guidance. cdc.gov/coronavirus/20…
School openings across globe suggest ways to keep coronavirus at bay, and protect the safety of kids and teachers sciencemag.org/news/2020/07/s…
Denmark and Finland issued detailed plans, and took important public health measures, to improve safety of children and teachers in the classroom. Their documents offer some thoughtful, science based guidance. brookings.edu/blog/education…
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12 Jul 20
Hospitalization rates are rising across the South; with higher positivity among older Americans as an epidemic that started in younger people expands into more vulnerable cohorts. Nearly 40% of Texas’ fatalities are residents of long-term care facilities. dshs.texas.gov/coronavirus/CO…
From Texas Tribune 7/10/20: "Nearly 40% of Texas’ fatalities were residents of long-term care facilities, such as nursing homes or assisted living facilities. Other hotspots include prisons and meatpacking plants." texastribune.org/2020/07/10/tex…
Bloomberg - "Covid-19 Cases Hit Record at Florida Long-Term Care Centers" bloomberg.com/news/articles/…
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