Along with the many political and public health questions raised by President Trump’s recent and very public bout with COVID-19 is the issue of when the public might have access to the same monoclonal antibody therapy that he received from doctors last week.
Having seen the President tout the benefits of Regeneron’s experimental antibody cocktail, COVID patients have reportedly been asking physicians about participating in clinical trials of the therapy, which is only available on a “compassionate use” basis outside of ongoing studies.
On Wednesday, Regeneronannounced it had submitted a request to the US Food and Drug Administration (FDA) for an Emergency Use Authorization (EUA) for the treatment, claiming that early data from ongoing trials showed promise in moderating coronavirus symptoms.
Eli Lilly, which is developing a similar antibody therapy, also announced plans to apply for an EUA, saying its drug has shown the ability to reduce hospitalizations among those infected with the virus.
The US government has already paid Regeneron $450M to access up to 300,000 doses of the therapy, and on Friday a spokesman for the Department of Health and Human Services (HHS) said the government would acquire up to a million doses from Regeneron and Eli Lilly by the end of the year, which it will allocate to hospitals in a similar approach to the way it has distributed Gilead Science’s antiviral drug remdesivir, which the President was also given last week.
News on the availability of potentially effective therapies to mitigate the impact of COVID-19 is welcome, particularly as thetimeline for COVID vaccines appears to be lengthening.
In guidance released this week, the FDA said it would require pharmaceutical companies to submit two months’ worth of data on vaccine safety and efficacy after patients received their final dose, as part of the EUA application process. The data requirement effectively means that, despite repeated promises from the White House, none of the vaccine candidates being developed will be available before the November 3rd Presidential election.
The head of the government’s vaccine program said separately this week that he expects data on vaccines being developed by Pfizer and Moderna to be available by December. As many have predicted, it will take months beyond that for a safe and effective vaccine to be distributed and administered to a majority of Americans.
Challenges will abound: ensuring sufficient manufacturing capacity, managing a complex supply chain, setting up specialized distribution and vaccination centers, and tracking those vaccinated (especially if two shots will be required). A massive public education campaign will also be needed to overcome vaccine hesitancy and ensure widespread immunization. And all of that will take time, and money.
President Trump’s recent and unfortunate illness underscores the importance of paying equal attention to the development of therapies and treatments—which are essentially a holding maneuver to get us through the coming winter and spring, and eventually to the promise of immunity that lies beyond.
The D.C. Health Department is trying to jump-start contact tracing efforts around the White House’s coronavirus outbreak. Tracing has been inadequate so far even as cases spread deeper into the city, Axios’ Marisa Fernandez writes.
The big picture:The White House has decided not to move forward with recommended public health protocols of contact tracing and testing since President Trump tested positive for the virus.
The state of play: Tracing has been done for people who had direct contact with Trump, White House spokesman Judd Deere told the Washington Post.
On Capitol Hill, there’s also no formalized contact tracing program in place, even as lawmakers themselves test positive.
Two infected staffers in Rep. Doug Lamborn’s (R-Colo.) office were told to not disclose to roommates they may have been exposed, WSJ reports.
The bottom line:The White House’s refusal to contact trace is “a missed opportunity to prevent additional spread,” Emily Wroe, a co-leader of a contact-tracing team at Partners in Health, told Nature.
The quarantining of most of the Joint Chiefs of Staff, coming on the heels of President Trump’s COVID-19 diagnosis, is raising fears that U.S. adversaries might seek to exploit a perceived weakness.
Few expect any sort of overt military action, but there are other ways to wreak havoc on the United States.
Chief among them is disinformation. Experts have been warning ever since Trump tested positive for the coronavirus last week that disinformation is likely to kick into overdrive.
Now, with six of the seven members of the Joint Chiefs of Staff waylaid at home, warnings are being amplified about the national security implications of the growing COVID-19 outbreak among U.S. leadership.
“All these kinds of things are just a huge distraction for us where our national security apparatus is consumed with matters domestic and internal,” former Director of National Intelligence James Clapper said at a Washington Post event after news broke of the Joint Chiefs quarantining. “So this is an ideal time for adversaries, particularly in adversary intelligence services, to look for ways to further confuse us, to distract us.”
Adding that “you can bet particularly our good friends the Russians are doing this,” Clapper warned of them “further sowing seeds of disinformation.”
“They will appeal to all the various tribes and continue to capitalize on the polarization in this country,” he said. “So it is a vulnerable time, and it’s an opportunity for them while we’re not looking and not being alert to further sow seeds of disinformation, casting doubt, discord, distrust in the country.”
The quarantining of top military officers stems from the Coast Guard’s No. 2 admiral contracting COVID-19. The Coast Guard announced Tuesday that its vice commandant, Adm. Charles Ray, tested positive for the coronavirus on Monday after feeling mild symptoms over the weekend.
The test result came after Ray met with most of the Joint Chiefs of Staff at the Pentagon on Friday.
That put Joint Chiefs of Staff Chairman Gen. Mark Milley into quarantine, as well as the chiefs of the Army, Navy, Air Force, Space Force and National Guard. The vice chairman, Gen. John Hyten, was also in the meetings and is quarantining.
The only member of the Joint Chiefs who didn’t meet with Ray was Marine Corps Commandant Gen. David Berger, who was traveling.
Berger’s deputy, Gen. Gary Thomas, met with Ray instead and went into quarantine Tuesday. The Marine Corps announced Wednesday evening that he has tested positive for the virus.
Gen. Paul Nakasone, commander of U.S. Cyber Command and director of the National Security Agency, also met with Ray and went into quarantine.
It’s unclear exactly where Ray caught the virus, but his schedule within the incubation period included a visit to the White House, which is now considered the epicenter of a coronavirus outbreak that includes Trump himself.
Ray — along with Milley, Defense Secretary Mark Esper and other top defense officials — attended a White House ceremony for Gold Star families on Sept. 27.
The event happened the day after Trump announced he was nominating Amy Coney Barrett for the Supreme Court, a gathering for which several attendees have since been diagnosed with COVID-19.
Since Trump’s diagnosis, the Department of Defense has sought to allay any national security concerns.
When Trump’s positive test was first announced last week, the Pentagon insisted there has been “no change to DoD alert levels.”
After news broke Tuesday of the Joint Chiefs quarantining, chief Pentagon spokesman Jonathan Hoffman reiterated that “there is no change to the operational readiness or mission capability of the U.S. Armed Forces.”
“Senior military leaders are able to remain fully mission capable and perform their duties from an alternative work location,” Hoffman said in a statement.
The military chiefs are well-equipped to work from home, and besides Ray and Thomas, none have tested positive for the virus yet.
But the development has raised questions about whether adversaries will try to take advantage of the situation nonetheless.
After the military quarantines were revealed, House Armed Services Committee Chairman Adam Smith (D-Wash.) said “the national security implications of the president’s recklessness cannot be overstated” even though the military “can still operate while leadership is quarantined.”
“Since announcing that he tested positive for the virus, the president’s antics have been downright reckless and harmful,” Smith said in a statement. “Our adversaries are always looking for any weakness to exploit. President Trump’s pathetic attempts to exude strength aren’t fooling anyone — Americans know he is weak and so do those who wish us harm.”
Rep. Jackie Speier (D-Calif.), another senior member of the Armed Services Committee, questioned why so many senior military leaders were meeting in person in the first place, as well as attending a White House reception in which they were pictured maskless.
“What if the Joint Chiefs’ responsibilities cannot be done remotely while they are isolating?” Speier wrote in a series of questions on Twitter. “How many other senior military leaders have tested positive? Why weren’t we safeguarding the health of senior military leaders like the natural security asset that it clearly is?”
Barry Pavel, senior vice president and director of the Atlantic Council’s Scowcroft Center for Strategy and Security, stressed that there is “no degradation in operational command and control” from the Joint Chiefs quarantining.
But, he added, adversaries such as Russia and China could misperceive that the United States is distracted and decide to act. For example, he cited concerns about China moving against Taiwan or Russia trying to grab more territory.
Pavel also listed what he called Russia’s “non-kinetic war” against the United States in the cybersecurity, influence and disinformation realm.
“This is a KGB officer’s most wildest dream coming true almost on a daily basis,” he said. “And so I think it’s a big threat. Who knows what proportion of our current public divisions are sown by Russian influence and bots or are just part of our current division. I don’t know the answer to that question. But they’re certainly right now exploiting it.”
To diminish those concerns, Pavel said, the Pentagon should keep emphasizing its military readiness, as well as demonstrating it by taking actions like publicizing a previously planned exercise.
“It’s probably a good idea to keep repeating those messages,” he said, “to be reiterating those messages, sending them publicly, privately, by third parties and through various forms of military activity so adversaries have no misunderstanding about our readiness and capabilities despite the chairman being quarantined in his quarters.”
The undercurrent of the VP debate is the age and health of the two men vying for the presidency.
The two remaining presidential debates, scheduled for October 15 and 22, are in question due to President Trump’s positive COVID-19 and quarantine status, making the vice presidential debate this Wednesday at 9 p.m. even more important than VP debates of past elections.
The undercurrent in the debate consists of the ages of challenger Biden, who is 77 and turning 78 before the end of the year, and Trump, 74, who has been hospitalized for COVID-19 and was released from Walter Reed Army Medical Center on Monday afternoon. Trump has said he plans to debate Biden on October 15.
This VP debate is big, said Paul Keckley, a healthcare policy analyst and managing editor of the Keckley Report.
“The reason is not so much the two are debating,” Keckley said. “We have a 77- year-old challenger and a 74-year-old incumbent. Voters are expecting the odds are one will become disabled and the vice president is going to step in. That’s the undercurrent of this debate.”
Healthcare is an obvious dominant theme Wednesday night beyond the health of the two men seeking the presidency.
It is expected that Biden’s running mate, Kamala Harris will challenge Vice President Mike Pence on his role heading the coronavirus task force when close to 7.5 million people in this country have been infected with COVID-19 and more than 200,000 have died.
Pence will likely challenge Harris on her support for Medicare for All before she backtracked to support Biden’s public-private option for healthcare coverage.
Pence and Harris are expected to lay out the healthcare plans of their respective Republican and Democratic nominees less than four weeks before the election, in a way the lead candidates failed to get across during the first presidential debate that presented more chaos than clarity.
TRUMP AND BIDEN PLANS
Trump and Biden differ fundamentally on whether the federal government should be involved in the business of providing healthcare coverage.
Trump’s guiding principles rest on the pillar of state autonomy as opposed to a federalized healthcare system and Biden’s maxim that healthcare is a right, not a privilege.
Trump believes that private solutions are better than government solutions, according to Keckley. He is much less restrained on private equity and the Federal Trade Commission’s scrutiny of vertical integration. States become the gateway to the market as private solutions are sold to states as innovation.
Trump’s other concept is that the door to engaging consumers in healthcare is price transparency. His view is that price transparency will spawn consumer engagement.
Centers for Medicare and Medicaid Services Administrator Seema Verma, who was appointed by Trump in 2016 based largely on the recommendation of Pence, is instituting a rule, starting January 1, 2021, requiring hospitals to have price transparency for 300 shoppable services. Hospitals are being required to make their contract terms with payer accessible.
This is separate from CMS’s interoperability rule aimed at payers that also goes into effect on January 1.
Trump believes healthcare is a personal responsibility, not a public obligation. To Trump, healthcare is a marketplace where there are winners and losers, according to Keckley.
Biden has a more developed policy platform on making healthcare a universal right, starting with strengthening the Affordable Care Act that was passed while Biden was vice president during President Barack Obama’s terms.
Biden wants to increase the eligibility for tax subsidies in the ACA up to 400% of the federal poverty level, which would expand access to subsidized health insurance.
He also wants to reduce the affordability threshold for employer insurance. Currently, if employees pay more than 9.7% of their adjusted income for their workplace coverage, they can seek a plan in the ACA marketplace. Biden would lower that eligibility for ACA coverage to 8.5%, opening the door for many more consumers to be insured through the ACA, at a lower cost.
Biden would also lower the age of eligibility for Medicare from 65 to 60.
For companies such as manufacturing and transportation, in which individuals can retire after 30 years of service, this lets them into the Medicare system earlier to fill that gap between retirement and Medicare eligibility.
Biden’s public option would create insurance plans that would compete with private plans.
The other factor to watch on the Biden side, Keckley said, is his clear focus on equity and diversity in healthcare.
AFFORDABLE CARE ACT
Biden wants to strengthen Obamacare while Trump is actively pursuing a repeal of the law through the Supreme Court.
President Trump’s debate prep and the White House Rose Garden event announcing the nomination of Judge Amy Coney Barrett to replace the late Supreme Court Justice Ruth Bader Ginsburg, border on the definition of super spreader events.
The Justices, perhaps with the addition of Trump’s pick, Amy Coney Barrett, if there are enough Republican senators well enough and in attendance to vote for confirmation, are scheduled to hear oral arguments in the case brought by 18 GOP-led states on November 10, the week after the election.
Senators must be present to vote, and Republicans, who have a majority of 53 to 47 seats, need a four-vote majority. Two Republican senators – Susan Collins of Maine and Lisa Murkowski of Alaska – have said they wouldn’t vote on a nominee prior to the election. Vice President Mike Pence could cast the deciding vote in a tie.
Three Republican senators have tested positive for the coronavirus. Sens. Mike Lee of Utah and Thom Tillis of North Carolina, who sit on the Judiciary Committee, tested positive for COVID-19 days after attending the White House Rose Garden event on September 26. Republican Sen. Ron Johnson of Wisconsin is now the third to test positive, though he did not attend that event.
There was a lack of social distancing and mask wearing at both the Rose Garden nomination and at a meeting between Trump and staff for debate prep. Twelve people in Trump’s inner circle, including his wife Melania, former New Jersey governor Chris Christie and White House Press Secretary Kayleigh McEnany, have tested positive since attending.
Senate Majority Leader Mitch McConnell wrote in an email to GOP senators obtained by CNN that he needs all Republican senators back in Washington by October 19.
COVID-19
Trump announced in a tweet Monday that he would be leaving Walter Reed later in the afternoon, saying he felt “really good!” and adding, “Don’t be afraid of Covid. Don’t let it dominate your life. We have developed, under the Trump Administration, some really great drugs & knowledge. I feel better than I did 20 years ago!”
Trump has been criticized for leaving the hospital on Monday to take a drive-by ride to wave to supporters. Attending physician Dr. James Phillips called the action “insanity” and “political theater” that put the lives of Secret Service agents in the car with him at risk.
Trump has downplayed the virus in an effort to reopen the country and the economy, and has put the blame on China, where the coronavirus originated.
Trump told Biden during the debate, “We got the gowns; we got the masks; we made the ventilators. You wouldn’t have made ventilators – and now we’re weeks away from a vaccine.”
Biden puts the blame squarely on Trump for delaying action to stop the spread.
Biden said during the debate: “Look, 200,000 dead. You said over seven million infected in the United States. We in fact have 5% or 4% of the world’s population – 20% of the deaths. Forty thousand people a day are contracting COVID. In addition to that, about between 750 and 1,000 people, they’re dying. When [Trump] was presented with that number he said ‘It is what it is’ – what it is what it is – because you are who you are. That’s why it is. The president has no plan. He hasn’t laid out anything.”
Biden said that back in July he laid out a plan for providing protective gear and providing money the House passed to get people the help they need to keep their businesses open and open schools.
Under Trump’s Administration, Congress passed $175 billion in provider relief funds for hospitals, small businesses, individuals and others – $100 billion from the CARES Act and $75 billion from the Paycheck Protection Program and Healthcare Enhancement Act.
MEDICAID EXPANSION
CMS Administrator Seema Verma was healthcare advisor to Pence while he was governor of Indiana. Her consulting firm, SVC, Inc., worked closely with Pence to design Indiana’s Medicaid expansion under the Affordable Care Act. They developed a unique Medicaid expansion program called Health Indiana Plan 2.0, which mandated low income adults above the poverty level pay monthly premiums for their healthcare.
Members who did not pay faced being disenrolled for six months.
As administrator, Verma has initiated similar work requirements for Medicaid coverage nationwide.
While as governor Pence implemented Medicaid expansion, as vice president he has supported torpedoing the ACA, and has pushed the Graham-Cassidy plan for healthcare reform that would have replaced the ACA.
DRUG PRICES
Neither Trump nor Biden has taken on the pharmaceutical industry in a meaningful way, though both have voiced a strong belief that drug manufacturers are egregious to the system, according to Keckley.
“Both camps are saying, we’re really going to take them on,” he said.
During the debate, Trump said he was cutting drug prices by allowing American consumers to buy drugs from Canada and other countries under a favored nation status.
“Drug prices will be coming down, 80 or 90 percent,” Trump said during the debate, telling Biden he hadn’t done anything similar during his 47 years in government.
If Trump gets a second term, there will likely be more industry folks in his circle, following up on his first term of stacking his cabinet with business people.
Biden would be more likely to lean toward a blend of public health officials and industry executives. There would be more of a spotlight on wealth creation in healthcare and executive pay.
In the $1.1 trillion world of prescription drugs, the United States makes up 40% of the market.
“We’re the hub of the prescription drug industry,” Keckley said.
Anthony Fauci, MD, says talk about a second wave of the coronavirus is premature because the United States is still dealing with the first one.
The idea of a second wave is based on the 1918 flu pandemic, when many cases were seen in the spring, he says. The spring cases “literally disappeared” and were followed by a spike in flu cases in the fall, he told CNN’s Sanjay Gupta, MD, on Thursday in an online conversation organized by Emory University.
“Rather than say, ‘A second wave,’ why don’t we say, ‘Are we prepared for the challenge of the fall and the winter?’” said Fauci, director of the National Institute of Allergy and Infectious Diseases and a member of the White House coronavirus task force.
Flu shots are an important measure to help the U.S. get through the winter, he said.
He and other health care professionals have observed that the Southern Hemisphere has had a very light flu season, probably because measures to curb the coronavirus, such as social distancing and mask-wearing, have limited the spread of the flu.
“If we listen to the public health measures, not only would we diminish the effect of COVID-19, we might get away with a very, very light flu season if we combine that with getting the flu vaccine,” Fauci said.
In a separate interview, he said the arrival of the coronavirus vaccine will not stop the need for tried-and-true measures such as mask-wearing, hand-washing, and social distancing.
In a Facebook Live conversation with New Jersey Gov. Phil Murphy, Fauci said the coronavirus vaccine will not be 100% effective and won’t be taken by the entire population. That means the virus could still spread.
“So when a vaccine comes, we look at it as an important tool to supplement the public health measures that we do,” he said. “It will allow us to more quickly and with less stringency get back to some degree of normal. But it is not going to eliminate the need to be prudent and careful with our public health measures.”
Fauci said that vaccinating 75% to 80% of the population “would be a really good accomplishment.” He expects 700 million doses to be produced by the end of this year or early 2021.
HENRY KOTULA 