Duke-Margolis: In the News

NBC Nightly News Segment "Race for a Vaccine" November 29, 2020 featuring Duke-Margolis Visiting Senior Policy Fellow, Hemi Tewarson

Deploying Big Data to Determine How Well Vaccines Work

Deploying Big Data to Determine How Well Vaccines Work

The Food and Drug Administration may approve a Covid-19 vaccine for emergency use within the next few weeks. Within days of that green light, millions of doses will start making their way to patients. The distribution and administration will be logistically complex and difficult. And the study of a vaccine’s safety and efficacy doesn’t end with FDA approval. Researchers will be gathering evidence on how well these products work in the real world.

The vaccine is likely to reduce the odds of serious or symptomatic infection. But will vaccinated patients be less likely to be infected at all? Do the vaccines confer, as preliminary evidence suggested, “mucosal immunity,” in which immune cells in the respiratory tract can help reduce the chance of spreading the virus? If so, parts of the country with low spread and high rates of vaccination may be able to ease up on mitigation measures like wearing masks and distancing.

Public-health authorities also need to monitor which patients received a particular vaccine and make sure they follow up for the second dose that most of these vaccines require to be fully effective.

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Experimental drug given to Trump to treat covid-19 wins FDA clearance

Experimental drug given to Trump to treat covid-19 wins FDA clearance

Where the antibody drugs will be administered is not clear, particularly because covid-19 patients are contagious and can’t be given the drug at established infusion clinics alongside people with compromised immune systems.

 

“You can’t send them to places where cancer patients are being treated,” said Mark McClellan, director of the Duke-Margolis Center for Health Policy and a former FDA commissioner. He said that many hospital systems have extra space they could dedicate to the antibody treatments, or could set up pop-up centers. Home-infusion providers such as CVS could administer the drug in nursing homes and people’s residences, he said.

 

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It’s Now Up to Governors to Slow the Spread

It’s Now Up to Governors to Slow the Spread

The latest U.S. Covid surge isn’t confined to certain regions like the ones in the spring and summer. It’s hitting the whole nation hard. Hospitalizations reached 70,000 this week, with more than 13,000 patients in intensive-care units. Health systems in communities like Minot, N.D., and El Paso, Texas, are overburdened, and others may be in the same position soon if governors don’t work quickly and across state lines to slow the spread.

 

In previous waves, health-care workers from less-affected areas were deployed to New York and the South. It isn’t possible to send an army of health-care personnel into hot zones when the entire country is a hot zone. Another 15% of the U.S. population could be infected by the end of January, on top of the 15% that has already been infected. The genetic epidemiologist Trevor Bedford estimates that such a course could result in about 200,000 more deaths, assuming an improved infection fatality rate of about 0.45%.

 

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Covid-19 Surge Strains Hospitals Once Again

Covid-19 Surge Strains Hospitals Once Again

In this Wall Street Journal article, a report co-authored by Brystana Kaufman and Rebecca Whitaker of Duke-Margolis Center for Health Policy is cited for its research into the high risk rural populations and the stress that it is creating on rural hospitals.

 

Read the full WSJ article here.

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How Congress Can Get Kids Back to Class

How Congress Can Get Kids Back to Class

The U.K., France and other European countries are closing businesses in another wave of lock downs, as Covid-19 cases and hospitalizations rise. But unlike in the spring, schools are open. Infections are also surging across the U.S., where in many places in-person classrooms are closed and distance learning has become the norm. But there’s growing evidence schools can open safely, with reasonable precautions and, perhaps soon, regular testing.

 

The ABC Science Collaboratives, supported by Duke University researchers, are working with school boards, superintendents, principals, teachers, health departments and the state of North Carolina to share data and best practices among more than 50 districts. The findings so far suggest that spread is limited when cases occur in North Carolina districts that are open for some in-person instruction.

 

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Unlocking the Promise of Real-World Evidence

Unlocking the Promise of Real-World Evidence

Researchers today are faced with an ever-growing wealth of real-world data. While long used for safety surveillance, recent mandates in the 21st Century Cures Act and Prescription Drug User Fee Act are accelerating the use of real-world evidence in regulatory decisions, including secondary indications for already approved drugs. Today, real-world-evidence–based insights are driving not only regulatory decisions, but also reimbursement decisions.

 

This year, the COVID-19 pandemic has further fueled real-world evidence analyses. Yet, whether these real-world-evidence–based decisions are reliable or clinically accurate remains unclear.

 

William H. Crown, PhD; Lucinda Orsini, DPM, MPH; Nirosha Mahendraratnam Lederer, PhD; Shirley Wang, PhD; and Diana Brixner, RPh, PhD shared their thoughts on the use of real-world evidence for both regulatory and assessment purposes, and discussed current challenges, future opportunities, and whether real-world evidence is truly achieving its goal—helping to ensure greater patient access to more effective treatments.

 

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Where Do I Go to Get My Covid Antibody Cocktail?

Where Do I Go to Get My Covid Antibody Cocktail?

Covid researchers are racing the clock. They’ve made enormous progress on therapies and vaccines, but they aren’t far enough along to arrest the current surge of Covid infections as winter approaches. One of the biggest challenges is making sure the new treatments reach the patients who need them most.

 

The most immediate opportunity comes from antibody drugs that can be used both as treatment and prophylaxis. President Trump and former New Jersey Gov. Chris Christie both recovered after they received antibody combinations when their symptoms were worsening. These medications are likely to be most effective when used before or soon after symptoms begin.

 

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The Trump Treatment for Covid Is Coming Soon

The Trump Treatment for Covid Is Coming Soon

President Trump has been criticized for receiving experimental Covid-19 treatments that aren’t available to ordinary Americans. But man-made antibodies like those Mr. Trump received may soon be rolled out for broader public use. Such treatments may be a bridge to a vaccine.

 

Covid vaccines are being developed at a brisk pace, but their widespread use is on track for next year. Even if the Food and Drug Administration authorizes a vaccine this winter for those at high risk of Covid complications, the immunity benefit to the population will come gradually as access is expanded and more Americans are vaccinated.

 

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7 former FDA commissioners: The Trump administration is undermining the credibility of the FDA

7 former FDA commissioners: The Trump administration is undermining the credibility of the FDA

Opinion by 7 former FDA commissioners

 

September 29, 2020 at 5:16 p.m. EDT

 

Robert Califf, Scott Gottlieb, Margaret Hamburg, Jane Henney, David Kessler, Mark McClellan and Andy von Eschenbach are all former commissioners of the Food and Drug Administration. Kessler is an adviser for the Biden campaign. Gottlieb and McClellan serve on the boards of Pfizer and Johnson & Johnson, respectively, both of which are developing covid-19 vaccines.

 

With our country having passed the grim milestone of 200,000 covid-19 deaths, losing the equivalent of the entire population of Salt Lake City, the Food and Drug Administration might soon face one of its most important decisions in our lifetimes: the authorization of a coronavirus vaccine. A vaccine is urgently needed to reduce the health impacts of the virus and help Americans return to normalcy.


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Trump Can Take Credit for Vaccine Progress but Shouldn’t Rush It

Trump Can Take Credit for Vaccine Progress but Shouldn’t Rush It

By Scott Gottlieb and Mark McClellan

 

One of the most effective aspects of the Trump administration’s response to Covid-19 has been Operation Warp Speed, the effort to move a vaccine to market. It’s all the more puzzling, then, that the administration would interrupt this good work with a statement that it may try to weaken the long-established criteria for judging the safety and effectiveness of a vaccine.

 

“We’re trying to make sure that the guidance we give” is not “a inhibitor to getting things out fast,” White House chief of staff Mark Meadows said on CBS’s...

 

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Fast, low-cost testing is essential for averting a second wave of Covid-19

Fast, low-cost testing is essential for averting a second wave of Covid-19

Since the first Covid-19 cases emerged in the U.S. in early 2020, attitudes toward coronavirus testing have evolved as we’ve learned more about the novel coronavirus and how it spreads.

 

Initially, testing was intended to be diagnostic and confirm infections in people with symptoms such as cough, fever, shortness of breath, and fatigue. At that time, there was no understanding of the risk of silent transmission within the community via infected people who had not yet developed symptoms or who never developed them.

 

Given that diagnostic focus, coronavirus testing capacity emphasized the use of highly sensitive polymerase chain reaction (PCR) tests that rely on amplifying DNA copies of the RNA in SARS-CoV-2, the virus that causes Covid-19. PCR has remained the “gold standard” for testing in the U.S. and the around world.

 

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You Can Trust the FDA’s Vaccine Process

You Can Trust the FDA’s Vaccine Process

If one or more Covid vaccines prove safe and effective in large clinical trials, the Food and Drug Administration should make them available, in a careful and limited way, to those at highest risk of contracting infection and suffering a bad outcome.

Last week we wrote on these pages how the FDA could allow a Covid vaccine to be used by specific groups of patients through an Emergency Use Authorization. This authority, created by Congress to allow the FDA to respond to a public-health emergency, lets the agency authorize the distribution of a product before a full approval.

 

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In ‘Power Grab,’ Health Secretary Azar Asserts Authority Over F.D.A.

In ‘Power Grab,’ Health Secretary Azar Asserts Authority Over F.D.A.

In a stunning declaration of authority, Alex M. Azar II, the secretary of health and human services, this week barred the nation’s health agencies, including the Food and Drug Administration, from signing any new rules regarding the nation’s foods, medicines, medical devices and other products, including vaccines.

Going forward, Mr. Azar wrote in a Sept. 15 memorandum obtained by The New York Times, such power “is reserved to the Secretary.” The bulletin was sent to heads of operating and staff divisions within H.H.S.

 

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Regulatory Focus, “Marks, Hahn confirm COVID vaccine EUA guidance coming,”

Regulatory Focus, “Marks, Hahn confirm COVID vaccine EUA guidance coming,”

The US Food and Drug Administration (FDA) will soon issue guidance on the data needed to support an emergency use authorization (EUA) for a vaccine to prevent coronavirus disease (COVID-19) according to Center for Biologics Evaluation and Research (CBER) Director Peter Marks.
 
Speaking at an event hosted by the Duke Margolis Center for Health Policy on Thursday, Marks hinted that additional guidance on EUAs for COVID-19 vaccines would be coming soon.
 
“You may want to stay tuned for that,” Marks said. 

 

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Duke Chronicle, “How will we develop a COVID-19 vaccine? Experts discuss the process in Thursday webinar,”

Duke Chronicle, “How will we develop a COVID-19 vaccine? Experts discuss the process in Thursday webinar,”

As precautionary measures taken to prevent the spread of COVID-19 continue, one question is on all of our minds: When is a safe, effective vaccine going to be developed? 

The Duke-Margolis Center for Health Policy hosted a webinar Thursday afternoon led by the Center’s Director Mark McClellan to discuss questions regarding vaccine development.

Read the full article here.

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Bloomberg, “Marks, Hahn confirm COVID vaccine EUA guidance coming,”

Bloomberg, “Marks, Hahn confirm COVID vaccine EUA guidance coming”

Drugmakers seeking an emergency authorization for a Covid-19 vaccine will have to meet a higher standard of efficacy than normally would be required for such a clearance, the head of the U.S. Food and Drug Administration’s office that handles vaccines said.

Typically, an emergency use authorization, or EUA, would require a company to show their product may be effective. Peter Marks, director of the FDA’s biologics office, said Thursday that the agency will require more robust data about how well a coronavirus vaccine works before granting an emergency waiver -- something he called “EUA plus.”

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September 8, 2020 - CNN, Inside Politics with John King, interview on timing for COIVD-19 vaccines

September 8, 2020 - Fox, Your World with Neil Cavuto, interview on vaccine safety

BioCentury, “US needs master protocol to such as UK’s RECOVERY to speed COVID-19 evidence collection”

BioCentury, “US needs master protocol to such as UK’s RECOVERY to speed COVID-19 evidence collection”

This is the fourth article in BioCentury’s 28th Annual Back to School package. In the opening piece, BioCentury called on biopharma to convert its COVID response to a new era of efficient drug development. 

COVID-19 has shown how a mammoth network of platform trials would have system-wide benefits for biotech and patients.

At least 13 master protocol platform trials have been launched for COVID-19 in the space of six months, providing an unambiguous vote of confidence in the power of these studies to expedite drug development.

Read the full article and listen to the interview here.

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Associated Press, “As virus cases drop, governors may gamble on bars – again”

Associated Press, “As virus cases drop, governors may gamble on bars – again”

AUSTIN, Texas (AP) — A guy walks into a bar, which still isn't allowed in Texas.

But Jeff Brightwell owns this bar. Two months into an indefinite shutdown, he's just checking on the place — the tables six feet apart, the “Covid 19 House Rules” sign instructing drinkers not to mingle. All the safeguards that didn't keep the doors open because Dot's Hop House & Cocktail Courtyard is a bar under Texas law. And bars, in a pandemic? “Really not good," Dr. Anthony Fauci, the nation's infectious disease expert, told Congress in June.

 

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CNBC, “Over 30 million people told Facebook if they had the coronavirus or wore masks — and now it will be used for science”

CNBC, “Over 30 million people told Facebook if they had the coronavirus or wore masks — and now it will be used for science”

When Carnegie Mellon researchers had the idea to put together a survey asking the general public about their coronavirus symptoms, the scientists knew they needed to collect millions of data points to learn anything meaningful.

So they asked Facebook, which has a public team that specializes in using analytics for humanitarian causes called “Data for Good,” for its help. 

The survey, which went live to Facebook’s billions of users about six months ago, has so far collected data from more than 30 million people around the world. The survey asks whether they tested positive for the virus, if they wear masks and practice socially distancing as well as if they’re currently experiencing symptoms. Respondents also share data about their demographics, like their age, as well as their mental health status and preexisting medical conditions.

 

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New York Times, “Backed by Federal Funds, New Virus Tests Are Hitting the Market”

New York Times, “Backed by Federal Funds, New Virus Tests Are Hitting the Market”

Backed by Federal Funds, New Virus Tests Are Hitting the Market

Six months into the pandemic and with no coherent national testing strategy, the Trump administration is encouraging private development of an array of faster and cheaper techniques.

The coronavirus pandemic remained a distant threat to many Americans on Jan. 24 when Douglas C. Bryant, the president and chief executive officer of Quidel Corporation, got a call from an official at the Food and Drug Administration.

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ProPublica, “America Doesn’t Have a Coherent Strategy for Asymptomatic Testing. It Needs One”

ProPublica, “America Doesn’t Have a Coherent Strategy for Asymptomatic Testing. It Needs One”

America Doesn’t Have a Coherent Strategy for Asymptomatic Testing. It Needs One.

While it battles a virus that can spread quickly via silent carriers, the United States has yet to execute a strategy for testing asymptomatic people. This is a problem — and ProPublica health reporter Caroline Chen explains why.

Read the full article here.

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Duke Alumni Magazine Q & A with Mark McClellan

Duke Alumni Magazine Q & A with Mark McClellan

A look at how Duke University pivoted to virtual education, how Duke researchers are developing products to help the fight against COVID-19, and more.

 

Read the full article here.

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Wall Street Journal, “CDC Softens Covid-19 Testing Guidelines, Sparking Criticism”

Wall Street Journal, “CDC Softens Covid-19 Testing Guidelines, Sparking Criticism”

The U.S. Centers for Disease Control and Prevention has dialed back its guidelines about who should get tested for Covid-19, a move that has prompted pushback from public-health and infectious-disease experts.

The agency now says close contacts of confirmed Covid-19 cases don’t necessarily need to get tested if they don’t have symptoms. Earlier, it had advised that all people exposed to an infected person get tested.

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WillTalk podcast, “How 2020 is driving us toward a more sustainable, resilient healthcare system.”

WillTalk podcast, “How 2020 is driving us toward a more sustainable, resilient healthcare system.”

Welcome to our inaugural WillTalk podcast, with Humana hosts, William Fleming, PharmD, President of Clinical & Pharmacy Solutions, and Will Shrank, MD, Chief Medical & Corporate Affairs Officer. The focus of our new series will largely be on the future of healthcare and, more specifically, how we can facilitate higher-quality, cost-efficient, accessible care that meets people “where they are” on life’s journey. How appropriate, then, that our first guest is none other than Dr. Mark McClellan, who is the Robert J. Margolis Professor of Business, Medicine and Health Policy at Duke University and the founding director of the nationally-recognized Duke-Margolis Center for Health Policy. In this podcast, we’ll touch on the COVID-19 pandemic and other significant 2020 events which have further solidified the argument for and provided additional momentum toward a more sustainable, resilient model of care for patients and providers alike. Join us for an insightful conversation with one of our nation’s top advocates for better health and a more progressive, coordinated healthcare system.

Listen to the full podcast here.

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Parade, “Many Schools Offer the Choice Between In-Person and Remote Learning: How to Decide”

Parade, “Many Schools Offer the Choice Between In-Person and Remote Learning: How to Decide”

Welcome to Parent vs. Pandemic: a Parade.com series for parents who are navigating uncharted territory during the COVID-19 pandemic. Parade.com launched Parent vs. Pandemic as a way for concerned parents to get the solutions and help they need as they navigate tough choices—from pod planning to virtual learning. For our first Parent vs. Pandemic column, we tackle the question many parents are debating right now: In-person school or remote learning?

School districts across the country have slowly started re-opening during the pandemic, with mixed learning models. Some schools offer largely in-person schooling, others are remote only, and some have a hybrid mix of the two. But one thing is consistent across most school districts: No matter the main learning method of the school, parents usually have the option to choose whether their students learn remotely or in person.

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Politico: Sick, hot American Summer

Politico: Sick, hot American Summer

AMERICAN HOLIDAY — Americans treasure their chance to trade in sweltering heat for breezy beaches every August. This year, the regular rhythms of the traditional summer are colliding headfirst into peak Covid season: About 1.9 million of the country’s 4.7 million infections occurred in the month of July, according to data from Johns Hopkins University.

Travel is down broadly this summer, the first decline in more than a decade, according to AAA. But that data point isn’t slowing the pandemic: Many Americans are still traveling, and the coronavirus has become an unfortunate part of their baggage.

Read the full article here.

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