Scott Gottlieb, MD
@ScottGottliebMD
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Senior Fellow @AEI. Partner @NEA. Contributor @CNBC. 23rd Commissioner of the @US_FDA. Public Boards: @Pfizer @Illumina @TempusAI
Washington, DC
Joined May 2009
This is GAME CHANGER. Abbott to market, starting next week, a fast point-of-care #coronavirus test, delivering positive results in 5min and negative results in 13min. Will deliver 50K tests/day to start. Kudos to Abbott and FDA’s Jeff Shuren and team at CDRH who are in the fight.
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Two new peer-reviewed studies show a sharp drop in mortality among hospitalized Covid patients. The drop is seen in all groups, including older patients and those with underlying conditions, suggesting providers are getting better at treating the illness.
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THREAD: In U.S. we face two alternative but hard outlooks with #COVID19: that we follow a path similar to South Korea or one closer to Italy. We probably lost chance to have an outcome like South Korea. We must do everything to avert the tragic suffering being borne by Italy 1/10.
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THREAD: On #Coronavirus, we may be entering a period of accelerating cases. The country could look very different over next two weeks. We’ll get through this, but need to take steps now to limit the scope and impact of virus. There are things we can do now to help ourselves. 1/n.
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Positivity rates declining in many states as covid19 testing expands nationally.
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#COVID19 won't go away. It'll infect the southern hemisphere as they winter and will want to come back to U.S. in fall. But we'll have a massive surveillance system by then, and I believe more than one drug to both prevent and treat infection. Our tool box will be very different.
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Vaccine “hesitancy” isn't the biggest challenge but making it convenient to get vaccinated. For too many people it's too hard to sign up, show up. People who work all day or care for families. We need to set up 24/7 clinics with no appointment needed for hard to reach communities.
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This is a critical milestone. Two therapeutic antibodies are now in the clinic with more on the way. These drugs can be available in time for Fall under an EUA. We must prioritize manufacturing these at scale needed to have sufficient supply for a Fall/Winter resurgence in Covid.
#COVID19 Regeneron begins human trials of Anti-Viral Antibody Cocktail in 4 separate populations.- hospitalized patients.- non-hospitalized symptomatic pts.- uninfected people at high-risk of exposure (HCWs or first responders).- uninfected people with close exposure to a patient
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Covid Patients Testing Positive After Recovery Aren’t Infectious, Study Shows. They’re shedding only dead virus.
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South Korea is showing #COVID19 can be beat with smart, aggressive public health. Their daily new cases declined again to 76. They’ve tested 268,000 people for virus since their epidemic began and implemented aggressive containment and mitigation, closing schools, venues quickly.
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Positivity rates for covid19 testing nationally are starting to decline as testing expands sharply and we move more testing away from hospitals and into community (where overall prevalence is generally lower) and as infection declines in some areas, especially hard hit New York.
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A big win for patients and the first building block in what will be an improving toolbox for reducing death and disease from covid19. FDA's authorization allows for 5 day use in patients who aren't intubated, which will extend Gilead's supply of the drug.
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Encouraging signs #COVID19 spread may be slowing in many cities, especially northeast. Mitigation is working. New cases are nonetheless still building nationally; and southeast, New Orleans, sunbelt, southern California, Detroit, among others; remain areas of significant concern.
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In South Africa, we’re thankfully seeing a striking decoupling between new Covid cases and ICU admissions and deaths. Whether #Omicron is inherently less virulent, whether this hopeful finding is result of baseline immunity in infected, or a combination of both, is still unclear.
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New study finds Covid19 patients are no longer infectious after 11 days of getting sick even though some may still test positive. The data from Singapore adds to a growing body of evidence showing people don’t transmit the infection once they’re recovered.
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47 million doses of Covid vaccine have been "allocated" to the government, less than 7 million used. We're in a race against new Covid variants gaining foothold in U.S. There are 50 million seniors over age 65. We have the tools to protect many of them. We should give them access.
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Encouraging news today on Moderna vaccine. Technology will eventually let us greatly reduce the covid threat and reclaim normal times. Early data shows it generates robust immune reaction, and its dose dependent. Getting dose right is key. Moderna now testing a new 50mcg dose 1/x.
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We updated our data on total #coronavirus testing capacity in U.S. Remember, our figures for total capacity do not reflect the actual number of tests being performed, but the number of patients who could potentially be screened daily if every lab were testing at maximum capacity.
Updated to reflect new and increasing #coronavirus test capacity at Stanford, CUMC, Northwell, NorthShore University Healthsystem and UW Virology
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New: Study of 318 outbreaks in China found transmission occurred out-of-doors in only one, involving just 2 cases. Most occurred in home or public transport. Raises key chance for states to move services outdoors (religious, gym classes, restaurants, etc).
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We're seeing a sustained decline in #Covid19 deaths nationally, another indication that the U.S. epidemic is slowing.
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Omicron infection enhances neutralizing immunity against Delta — suggesting that Omicron will help push Delta out, as it should decrease likelihood that someone infected with Omicron will get re-infected with Delta. New preprint from Sigal Lab. @sigallab
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A grim possibility is we'll see a global Covid decoupling, where much of Europe and Asia is mostly able to keep epidemics at bay but the U.S. can't, and sees higher and persistent infection and slower GDP growth; and has a cordon sanitaire remain imposed on us from other nations.
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It’s becoming clearer that spread of #COVID19 by people who are asymptomatic or mildly symptomatic may be responsible for more transmission than previously thought; making control of the virus more difficult.
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Our plan for reopening America. This is a national epidemic. When cases peak, and we've seen sustained declines in new infections for 14 days, we can gradually re-open businesses and institutions. We must have key capacities in place, like ample screening.
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I think we’ll get a bump in people seeking vaccination as result of CDC announcement. I know many on Twitter are saying the unvaccinated will simply say they were vaxed. Some will, but many won’t want to, they’ll now view vaccination as something with more value and seek it out.
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I speak to a lot of drug makers and I don’t know anyone in the pharmaceutical industry who raised any objections over this guidance. These standards have been broadly communicated for months and they were well understood across the industry.
NEW: The White House’s decision to block stringent new Covid-19 vaccine guidelines came after it told the FDA that the pharmaceutical industry had objected to the tougher standards.
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In order to contain epidemic we need broad screening. People are much more likely to self isolate with a positive result. Asking people to presume they're positive is not sufficient. Limiting testing to inpatient settings only is indication we still don't have sufficient capacity.
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Game change. This is a great day for patients as Pfizer (where I serve on the BoD) announces final top line results from the phase 3 trial with its Covid-19 vaccine. We should now have two vaccines that could effectively end the U.S. epidemic next year if everything goes right.
BREAKING: We are proud to announce, along with @BioNTech_Group, that the Phase 3 study of our #COVID19 vaccine candidate has met all primary efficacy endpoints.
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Useful primer on the benefits of masks. A recommendation from CDC for consumers to wear cotton masks (with guidelines on how to fashion these products from household items) can improve safety and reduce spread and not strain the hospital supply chain.
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More than 40% of those over age 65 are vaccinated with at least one dose. We need to start considering that population is becoming less vulnerable to covid. Against that backdrop, we should judge mitigation and the risk of infection differently as the vulnerable become protected.
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Great day for patients. We may have two highly effective vaccines for Covid if results from the interim Pfizer and Moderna trials are confirmed by the full data sets. The acute phase of the U.S. pandemic will end in 2021. We must work together to get through the next 3 months.
Moderna’s vaccine proved 94.5% effective in preventing Covid-19 with symptoms in an early look at pivotal trial results, the latest strong performance by an experimental shot, @Loftus reports
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11/n This is a dangerous virus. We have faced worse, and prevailed. People will suffer and die. The most vulnerable are at greatest risk. We must all work together to protect them. The next few months will be hard, but we will preserve life, and eventually conquer this pathogen.
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Israel has vaccinated 11% of its population, including 41% of people over the age of 60.
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THREAD: This week tragic reality on ground will overtake events. There are multiple epicenters of U.S. spread. We'll grapple with national epidemic. April will be hard. We'll get through it. Focus must be on slowing spread nationally, support healthcare system, build back in May.
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Italy reports 3,590 new cases of #COVID19 and 368 deaths, raising total to 24,747 cases and 1,809 dead. The scope of death and disease in Italy, a nation of 60 million, will dwarf the despair in China. Urgent action needed to save lives and learn what went so wrong in that nation.
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Covid hospitalizations, a critical and objective measure of disease burden in the U.S., are starting to accelerate; reaching nearly 42,000 today. Criteria for admission has been tightened over time, making the high numbers more concerning. Deaths, which lag, are also rising.
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The travel ban on South Africa didn’t work, and didn’t even buy us time. But it reordered geopolitical cooperation when it comes to public health. Hopefully an instructive lesson for future on how we treat nations that do the right thing, identifying new pathogens, alerting world.
Omicron is now most common coronavirus variant in U.S., accounting for nearly three-quarters of COVID-19 cases, CDC says.
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National data from this past week suggest that the U.S. is starting to experience a sustained and sharper decline in new covid19 cases after a period of extended plateau.
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Irony around CDC not issuing it’s reopen guidance, whatever the reason, is a lot of business literally can’t reopen without it because CDC is a de-facto regulator in a public health crisis. CDC must publish its umbrella document to publish more detailed industry specific guidance.
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Doctors in New York City tonight shared harrowing stories with me. The City’s world class health system stands on the brink of being maxed out. And it’s still early in the #COVID19 fight. New York needs the nations support. I❤️NY
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Two years ago today: The WHO reassures the world, on behalf of Chinese authorities, that there was “no clear evidence of human-to-human transmission of the novel coronavirus” first identified in Wuhan h/t @BNODesk
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The positivity rate in South Africa has been flattening and now declined for the past two days. Hospital admissions in the epicenter of the outbreak, the #Gauteng province, are stable.
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More data suggesting that New York could be approaching a peak in new cases. Over the next 7-10 days they could peak and start slowly turning the corner. Mitigation is working in New York.
New York City Emergency Room visits continued the downward trajectory through the weekend!. I'm hoping we see a blunting of the hospitalization rate soon. We may have turned the corner on infections, though ICU admissions and deaths will not peak for 1-2 weeks.
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While vast majority of deaths from #COVID19 are age 60+ many young adults and middle aged Americans are becoming seriously ill and surviving only after prolonged hospitalizations and ICU admissions that have long term consequences. This is a dangerous virus for most age groups.
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2/n In last 10 days Italy diagnosed 95% of total cases they now report; South Korea 85%. 2 weeks ago, Italy had just 9 cases. 7 weeks ago, China reported 50 cases. The point: once the epidemics are discovered, they’ve been underway. Case counts grow quickly. Same likely true here.
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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.
Regeneron reports new results on #covid19 antibody drug, from 500 additional patients. Finds in recently diagnosed patients:. The drug reduced COVID-19 related medical visits by 57% overall, 72% in patients with one or more risk factor. The problem: only 50k doses available.
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South Korea continues to show signs that its epidemic is abating, today reporting 74 new cases. Their massive testing effort aimed at identifying and isolating infected patients was no doubt a key part of their success in combatting virus, as were their early mitigation steps.
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Of note: The 4 cases of new variant identified in Botswana were incidentally detected in well people tested before air travel, and South African Medical Association chief said - so far - symptoms seen are "mostly mild symptoms, and we haven’t seen a spike in hospital admissions."
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As a fight over the federal OSHA mandate unfolds, we should remember 80.5% of responsible adults 18+ already had at least one dose of Covid vaccine. What level do we need to get to? What will the OSHA provision accomplish? And were there less divisive ways to achieve these goals?.
Breaking News: A federal appeals court in Louisiana temporarily blocked the Biden administration’s vaccine mandate for large companies.
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Bloomberg: South Africa Hospitalization Rate Plunges in Omicron Wave - “Only 1.7% of identified Covid-19 cases were admitted to hospital in the second week of infections in the fourth wave, compared with 19% in the same week of the third delta-driven wave”
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More details from Abbott Labs
BREAKING: We’re launching a test that can detect COVID-19 in as little as 5 minutes—bringing rapid testing to the frontlines.
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It’s very likely that we’ll see additional approvals of POC diagnostics behind this one, extending testing to doctor offices across the U.S.
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Covid testing continues to expand; and the overall national positivity rate remains low.
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#Coronavirus: Stunning new numbers. Running totals - 9,171 confirmed cases worldwide vs 7,711 China cases yesterday; 213 deaths vs 130 yesterday. More than 12,000 suspected cases. 1,476 in serious or critical condition. ALL regions of China are reporting cases. h/t @V2019N.
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THREAD: Our path to safety rests on massive support for our healthcare system to care for sick, and forceful steps by local leaders to break chains of transmission and quell epidemic spread. If we’re smart and aggressive across nation, cases nationally could peak by late April.
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My @WSJ Op Ed: It's time we pursue a national mask mandate. We're dangerously behind the curve in confronting rising Covid spread across the U.S. We need to maximize steps that are less intrusive now; so we can minimize those that are more disruptive later
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The bottom line analysis from the Korean CDC demonstrating that those testing positive for SARSCoV2 after recovering from covid WERE NOT infected or contagious. The positive hit on the subsequent PCR test was dead virus and could not replicate in viral cell culture.
Korean CDC analysis of 285/447 (64%) who retested #SARSCoV2 positive post #COVID19.👉Viral cell culture (n=108): 0% pos.👉Contacts traced (n=790): only 3 ill, all w/ other exposures.👉These ppl are not re-infected or still contagious. It's old, dead virus.
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To expand Covid testing access, in addition to easier collection like using saliva; we also need fast, accurate, cheap lateral flow tests (strips) which are popular in other countries, but seldom used in U.S. because of a bias toward lab testing. We must get testing to consumers.
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Another way of looking at falling covid19 positivity rate across the country. Daily tests are rising, positive cases remaining largely flat, and the positivity rate declining. We're testing more to find same number of cases, suggesting that density of epidemic may be declining.
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Actions by White House today to sharply increase testing capacity and access, declare national emergency, implement new steps to protect vulnerable Americans, support assistance for those hardest hit by mitigation steps, all very important. Will meaningfully improve readiness.
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As reported Covid cases continue to rise around the U.S., the number of Covid hospitalizations - which is an important, objective measure of total disease burden - have stopped their decline, and may be starting to increase again.
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on the long scientific path to developing today’s mRNA vaccines; marked by years of careful work, discoveries, and major milestones. h/t @EricTopol .
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Daily positive cases of covid19 as a percent of total daily tests continues to fall nationally, a very good sign as covid testing expands. Declining positivity could be a leading indicator of an epidemic starting to decline. 10% is still high but it's coming down at a steady pace
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New Covid cases are accelerating faster than testing, and the national positivity rate is rising quickly, now at 9.5%. A surge of infection in most places risks becoming a torrent of infection in every place.
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My Op Ed in @WSJ. U.S. must quickly secure its own covid vaccine to make sure Americans have access and can provide it to low income nations. We can't rely on China or Europe to make their vaccines available to us before they satisfy their domestic needs.
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LabCorp says it's now able to perform more than 20,000 #COVID19 tests per day. The public health minded people of that company, and their CEO Adam H Schechter, should be applauded for what they accomplished in record time.
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The White House, NBA, MLB, and a select group of other institutions have implemented routine testing to identify asymptomatic cases. We need to support more widespread screening of this kind in high risk communities, job sites, and schools, in order to effectively contain spread.
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4/n Mitigation: The goal is to reduce the number of cases at the peak of the epidemic. This extends the length of the epidemic, but can push the total number of cases at any one time below the point where the healthcare system gets exhausted, improving outcomes for patients.
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New York’s vaunted medical system is going to be under catastrophic strain over the next two weeks as hospitalizations start to peak and overwhelm the city’s hospitals. America must come together to backstop our people in their hour of need. Right now, New York is in grave danger
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🧵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 👇.
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This simple, accurate saliva test could soon be first test authorized for asymptomatic screening and may be lowest cost test to hit market with ability to be pooled. It’s independent of supply chains. Runs in 2 hours. Owes to work of NBA, Yale docs, others
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From my segment today on @CNBC We face a grim and avoidable resurgence of once vanquished childhood infectious diseases if we follow down a current path now being laid in Washington.
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THREAD: On New #COVID19 Diagnosis in California Tonight: We will have community spread of #coronavirus in the U.S. It is likely that we have — right now — more cases that remain undiagnosed but will soon be revealed. We need to keep in mind several key points: 1/n.
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Covid hospitalizations continue to rise nationally, will soon eclipse prior record reached in April. However, admissions to ICUs has declined as percent of total hospital admissions; reflecting earlier diagnosis at time of admission, better treatments, less vulnerable admissions.
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8/n There will be hardship especially among the vulnerable. We need to consider financial assistance; first aid through existing programs then perhaps a bigger supplemental. Many people can’t easily absorb missed work, closed schools. We must assist them for the measures to work.
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72% of those over the age of 65 have now had at least one dose of the Covid vaccine, and 47% are fully vaccinated. A great public health achievement!! 🤗.
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More evidence COVID is being spread primarily through aerosols, underscoring the importance of wearing higher quality masks if you want to protect yourself from spread.
Our peer-reviewed research is now published in Clinical Infectious Diseases! No matter how you slice it, COVID-19 is an airborne disease. Let's call it like it is and put the appropriate measures in place.
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5/n We need a uniform and timely approach to mitigation and social distancing that local, state officials can follow and clear set of principles on when to adopt the measures. School closures, event cancellations, other aggressive steps need to be implemented now in certain areas.
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Disturbing new analysis from the modeling team at Imperial College shows initial #COVID19 epidemic lasting much longer in U.S. than other circulating models that show a peak in April/May; with a resurgence of infections when mitigation steps are lifted.
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THREAD: A transition is underway to address impact of #COVID19 in U.S. We're doing a lot of things right, and while there will be epidemic spread in America, we can still limit the scope and preserve life. There's still a lot to be done. But our current vigilance serves us well.
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Growth in total confirmed #COVID19 cases as a percent of total population by country: U.S. versus Spain and Italy. (Indexed to days since the first 100 cases were confirmed in each country). U.S. is still early, but on slower relative trajectory when compared to Italy and Spain.
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To put the emerging tragedy in New York into perspective, New York State (with 15,783 #coronavirus cases) is now the country with the 6th most #COVID19 patients in the world behind only China, Italy, Spain, Germany and Iran. But yes, New York is just one of our 50 states.
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Covid19 testing in the U.S. continues to expand, and the positivity rate decline nationally.
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3/n What should we do now? Moving quickly and aggressively to mitigate spread, reduce the scope of the epidemic here, continue to ready the healthcare system, work with cities and states to develop a uniform, systematic response; provide financial assistance to help these efforts.
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Today more than 90% of people live within 5 miles of a Covid vaccine site. 40,000 pharmacies are live with vaccines and everyone over 16 is eligible.
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New numbers out from China National Health Commission regarding total #coronavirus infections: The running total count of confirmed cases now stands at 7,711 vs about 6,000 yesterday; deaths 170 vs 132 yesterday; suspected case 12,167 and 81,000 people under observation. Tragic.
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1. It starts with aggressive screening to get people diagnosed. While testing capacity expands its not evenly distributed to places most needed, we’re far behind current caseloads. To many people still can’t get screened. So we can’t identify clusters and isolate disease 2/10.
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New study suggests saliva can be as effective as nasopharyngeal swabs for detection of #coronavirus; allowing self-collection that can reduce direct provider-patient interactions, lowering the risk to healthcare system and demand on testing supply chain.
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Studies suggests activities held outdoors as temperatures warm pose lower covid risk than those done in confined indoor spaces. As we re-open, states should look to ease rules to allow more recreational, religious, and business activities to occur outside.
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Global coronavirus death toll could be 60% higher than reported. Mortality statistics show 122,000 deaths in excess of normal levels across 14 countries analysed by the Financial Times.
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Russia was reported to be behind disinformation campaigns to sow doubts in U.S. about our Covid vaccines; and today’s news that they “approved” a vaccine on the equivalent of phase 1 data may be another effort to stoke doubts or goad U.S. into forcing early action on our vaccines.
"I wouldn't take it, certainly not outside a clinical trial right now," says @ScottGottliebMD on breaking news from Russia that the country has approved a #COVID19 vaccine. "It appears that it's only been tested in several hundred patients at most."
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7/n Simple measures still matter. Hand washing, avoiding crowded indoor spaces, cleaning surfaces, keeping people more apart where appropriate. Businesses and individuals are responding with prudent and measured action, and need to step up these efforts.
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9/n Businesses need to do their part by offering flexibility to workers in order to make these mitigation measures effective - telework, flexibility when schools are closed and parents must tend to children, avoidance of unnecessary travel especially to and from areas of spread.
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6/n We must support affected cities, states with financial assistance. The feds must strongly encourage states and cities that have outbreaks to take mitigation steps to help protect nation. But localities that take on these burdens should be compensated for hardships they incur.
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10/n We will get through this. Some of these measures at social distancing, improved hygiene techniques, could persist. The epidemic will abate but outbreaks could occur again until we have a vaccine. Ultimately technology will vanquish this disease.
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In this thread, I’m collecting some of the good threads today from experts on the potential significance and implications of the new variant. Outstanding to see so much sharing of quality science, perspective on @Twitter.
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Important finding. It suggests that herd immunity could be achieved at a lower threshold than what's typically assumed, because the most susceptible people are the ones who get infected first. Some of those who remain uninfected do so because they may be less susceptible. 1/2.
Individual variation in susceptibility or exposure to SARS-CoV-2 lowers the herd immunity threshold #medRxiv.
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Evidence of immunity in those who recovered from covid19.
Assessment of #SARSCoV2 antibody response AND cellular immunity in patients recovered from #COVID19: assays, in N=14, indicate most developed neutralizing Abs and their titers correlate w/ numbers of virus-specific T cells @ImmunityCP
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