Not long after the world learned that President Donald Trump had lost his reelection bid, states began issuing a new round of crackdowns and emergency declarations against the surging coronavirus.
Taking action this time were Republican governors who had resisted doing so during the spring and summer. Now they face an increasingly out-of-control virus and fading hope that help will come from a lame-duck president who seems consumed with challenging the election results.
President-elect Joe Biden has promised a more unified national effort once he takes office on Jan. 20, and pressure is building on Congress to pass a new financial relief package. But with record hospitalizations and new cases, many governors have decided they can’t afford to wait.
“I don’t know any governor who’s sitting there waiting for the knight to come in on the horse,” said Lanhee Chen, a fellow at the Hoover Institution and a former senior health official in President George W. Bush’s administration. “There’s no way for these guys to just sit and wait. The virus and the crisis is getting worse hour by hour, day by day.”
As new measures trickle out across states, public health policy experts worry many don’t go far enough. For those states attempting to impose meaningful restrictions, their success depends on cooperation from a population with pandemic fatigue. And people may be reluctant to curtail their holiday gatherings.
Residents of many conservative states don’t acknowledge the depth of the health problem, especially given Trump and some of his allies have stressed the crisis is being overplayed and will end quickly.
The bottom line is that many people just aren’t sufficiently scared of the virus to do what must be done to stop the spread, said Rodney Whitlock, a health policy consultant and former adviser to Sen. Chuck Grassley (R-Iowa).
“You’re dealing with folks there who definitely put liberty over everything else because they’re not afraid enough,” Whitlock said. “Even in the face of cases, even in the face of people around them getting it. They’re just not afraid.”
Among the first governors to act was outgoing Utah Gov. Gary Herbert. The day after The Associated Press called the presidential election for Biden on Nov. 7, the Republican announced Utah’s first-ever statewide mask mandate and clamped down on social gatherings and other activities until Nov. 23.
“All of us need to work together and see if there’s a better way,” Herbert said in a news conference.
Republican and Democratic governors alike followed with measures of their own in Colorado, Iowa, Michigan, Nebraska, New York, Ohio, Oregon, Pennsylvania, Washington and other states. Strategies included partial lockdowns, limits on crowds, canceling in-person classes for schools and reducing hours and capacity for bars and restaurants.
Health policy experts largely agree that the virus’s spread, not the end of the election, is what’s driving these changes — though the end of the campaign season does take political pressure off governors inclined to issue COVID-preventive policies.
“It’s much easier to act when you don’t have attention on you than when you do, but I would hope that the action is taking place regardless of what the political circumstances are,” Chen said.
No state has yet resorted to the sort of full lockdowns enacted in the spring, which resulted in mass business closures and layoffs and sent the economy crashing.
Christopher Adolph, an associate professor at the University of Washington, and his team with the university’s COVID-19 State Policy Project have been studying states’ responses to the pandemic. Some states have made a show of taking action, without much substance behind it, he said. For example, Alaska Gov. Mike Dunleavy, a Republican, declared an emergency on Nov. 12 — but only recommended, not ordered, that people wear masks and maintain social distance.
Other governors first took small steps only to follow up with tighter restrictions. In Iowa, for example, Republican Gov. Kim Reynolds, who opposed mask mandates during the presidential campaign, initially announced that all people over age 2 would be required to wear masks at gatherings of certain sizes. On Nov. 16, she issued a simpler but stricter three-week statewide mask mandate.
North Dakota Gov. Doug Burgum, a Republican, also ordered mandatory face coverings for the first time. Hospitals there have been reporting they have more patients than capacity, and the state has been leading the country in new per capita COVID cases.
At the very least, each state should make it clear that people must not gather indoors, Adolph said. Restaurants, bars, gymnasiums and large indoor events should be closed, he said, and gatherings inside people’s homes should not happen.
An exception is Herbert, one of two governors who will leave office in January. The two-term Utah governor will turn over the reins to his current lieutenant governor, Spencer Cox, who has been a part of the state’s response to the pandemic since the beginning. Both Republicans have promised a smooth, seamless transition between administrations.
The nation’s other lame-duck governor is Montana’s Steve Bullock, a Democrat. But unlike Herbert, the term-limited Bullock will be replaced by a governor from a different party. Republican U.S. Rep. Greg Gianforte defeated Bullock’s lieutenant governor, Mike Cooney, in the Nov. 3 election. And Bullock lost his bid for the U.S. Senate.
Bullock said in a Nov. 12 news conference that he would not take additional COVID-intervention measures without a federal aid package to blunt the economic fallout. Five days later, he reversed himself to expand a previous mask requirement and limit capacity and hours in bars, restaurants and other entertainment venues.
Gianforte has not directly answered whether he would continue Bullock’s restrictions. When asked, the governor-elect has spoken instead of personal responsibility and reopening the economy while protecting the most vulnerable people. In July, he referenced the unfounded hope that the virus would be slowed by the U.S. reaching “herd immunity” by the end of the year.
Another obstacle is that a district judge essentially ruled Bullock’s mask mandate unenforceable. State health department lawyers had asked District Judge Dan Wilson to enforce the mandate against five businesses accused of flouting the measure.
“The businesses and the owners have been put on the front line of implementing a state policy that has more exceptions than directives and would be about as effective in bailing water from the leaky boat of our present health circumstances as would a colander,” the judge said in denying the request.
That leaves Bullock with the task of managing a crisis in his final weeks of office with local officials already looking past him to a new administration.
In Flathead County, where the five businesses were sued for violating the mask mandate, local leaders were already chafing from what they saw as Bullock’s heavy hand.
“He has angered a lot of people in Flathead County,” County Commissioner Randy Brodehl, a Republican, said of Bullock. “He didn’t come here, he didn’t talk to us.”
Bullock’s troubles show that even if governors take measures to stem the spread of COVID-19, they may still have a difficult time persuading people to go along with them. That’s particularly an issue in the Upper Midwest and the Rocky Mountains, libertarian-leaning COVID hot spots where the medical infrastructure is already strained.
Some Trump supporters have followed the president’s lead in downplaying the virus and others are fatigued after months of isolation and precautions, said Whitlock.
In rural and conservative areas, people protest that COVID measures come at the expense of their personal freedom and their ability to earn a living, and some feel as though they’re being talked down to by mask advocates and public health officials, Whitlock said.
It’s going to take smart and consistent messaging to change attitudes — but that means more than Biden telling people to wear masks once he takes office, Whitlock added.
“Everybody has to own it,” he said. “You have to scream at the top of your lungs at the protests, at the celebrations, at the football games, at the concerts. It has to be, ‘Stop it!’”
Americans who do choose to fly will be subject to evolving COVID safety policies that vary by airline, a result of the continuing lack of a unified federal strategy.
This article was published on Friday, November 20, 2020 in Kaiser Health News.
The holidays are approaching just as COVID-19 case rates nationwide are increasing at a record-breaking pace, leading to dire warnings from public health experts.
The Centers for Disease Control and Prevention has issued cautions and updated guidelines related to family gatherings. Dr. Anthony Fauci, a White House coronavirus adviser and director of the National Institute of Allergy and Infectious Diseases, said in interviews that his kids won’t be coming home for Thanksgiving because of coronavirus risks. “Relatives getting on a plane, being exposed in an airport,” he told CBS News. “And then walking in the door and saying ‘Happy Thanksgiving’ — that you have to be concerned about.”
Are Americans listening? Maybe not. Especially as airlines, reeling from major revenue blows since the pandemic took hold in March, tell passengers they can travel with peace of mind and sweeten the deal with special holiday fares.
The airlines argue more is now known about the virus and recent industry-sponsored studies show flying is just as safe as regular daily activities. They also tout policies such as mask mandates and enhanced cleaning to protect travelers from the coronavirus.
Time for a reality check.
Americans who do choose to fly will be subject to evolving COVID safety policies that vary by airline, a result of the continuing lack of a unified federal strategy. Under the Trump administration, government agencies such as the Federal Aviation Administration and the Centers for Disease Control and Prevention have failed to issue and enforce any national directives for air travel.
And, though President-elect Joe Biden has signaled he will take a more robust federal approach to addressing COVID-19, which may result in such actions, the Trump administration remains in charge during the upcoming holiday season.
Here’s what you need to know before you book.
Airlines Say It’s Safe to Fly During the Pandemic. Is it?
The airline industry pins its safety clearance to a study funded by its leading trade group, Airlines for America, and conducted by Harvard University researchers, as well as one headed by the Department of Defense, with assistance from United Airlines.
Both reports modeled disease transmission on a plane, assuming all individuals were masked and the airplane’s highly effective air filtration systems were working. The Harvard report concluded the risk of in-flight COVID-19 transmission was “below that of other routine activities during the pandemic, such as grocery shopping or eating out,” while the DOD study concluded an individual would need to, hypothetically, sit for 54 straight hours on an airplane to catch COVID-19 from another passenger.
But these studies’ assumptions have limitations.
Despite airlines’ ramped-up enforcement of mask-wearing, reports of noncompliance among passengers continue. Most airlines say passengers who outright refuse to wear masks will not only be refused boarding, but will also be putting their future travel privileges at risk. Recent press reports indicate Delta has placed hundreds of these passengers on a no-fly list. Some passengers may still try to skirt around the rule by removing their mask to eat or drink for an extended time on the flight, and flight attendants may or may not feel they can stop them.
And though public health experts agree that airplanes do have highly effective filtration systems spaced throughout the cabin that filter and circulate the air every couple of minutes, if someone who unknowingly has COVID-19 takes off their mask to eat or drink, there is still time for viral particles to reach others seated nearby before they get sucked up by the filter.
Public health experts said comparing time on an airplane with time at the grocery store is apples and oranges.
Even if you wear a mask in both places, said Dr. Henry Wu, director of Emory TravelWell Center and associate professor of infectious diseases at Emory University School of Medicine, the duration of contact in both locales can be very different.
“If it’s a long flight and you are in that situation for several hours, then you are accumulating exposure over time. So a one-hour flight is 1/10 the risk of a 10-hour flight,” said Wu. “Whereas most people don’t spend more than an hour in the grocery store.”
Also, both studies analyzed only one aspect of a travel itinerary — risk on board the aircraft. Neither considered the related risks involved in air travel, such as getting to the airport or waiting in security lines. And public health experts say those activities pose opportunities for COVID exposure.
“Between when you arrive in the airport and you get into a plane seat, there is a lot of interaction that happens,” said Lisa Lee, a former CDC official and associate vice president for research and innovation at Virginia Tech.
And while Wu said he agrees that an airplane cabin is likely safer than other environments, with high rates of COVID-19 in communities across the U.S., “there is no doubt people are flying when they’re sick, whether they know it or not.”
Another data point touted by the airline industry has been that out of the estimated 1.2 billion people who have flown so far in 2020, only 44 cases of COVID-19 have been associated with air travel, according to data from the International Air Transport Association, a worldwide trade group.
But this number reflects only case reports published in the academic literature and isn’t likely capturing the true picture of how many COVID cases are associated with flights, experts said.
“It’s very difficult to prove, if you get sick after a trip, where exactly you got exposed,” said Wu.
The low count could also stem from systemic contact-tracing inconsistencies after a person with COVID-19 has traveled on a flight. In a recent case, a woman infected with the coronavirus died during a flight and fellow passengers weren’t notified of their exposure.
That may be due to the decentralized public health system the U.S. has in place, said Lee, the former CDC official, since contact tracing is done through state and local health departments. The CDC will step in to help with contact tracing only if there is interstate travel, which is likely during a flight — but, during the pandemic, the agency has “been less consistently effective than in the past,” said Lee.
“Let’s say there is a case of COVID on a flight. The question is, who is supposed to deal with that? The state that [the flight] started in? That it ended in? The CDC? It’s not clear,” said Lee.
Is Now the Time to Fly?
Most airlines have implemented safety measures beyond requiring masks, such as asking passengers to fill out health questionnaires, enhancing cleaning on planes, reducing interactions between crew members and passengers, and installing plexiglass stations and touchless check-in at service desks.
But many have also stepped back from other efforts, such as pledging to block middle seats. United relaxed its social distancing policy for allowing empty middle seats between customers at the end of May, though there were complaints from customers before then about flights being full. American Airlines stopped blocking middle seats in July. Other airlines plan to fill seats after the Thanksgiving holiday, with Southwest stopping the practice of blocking middle seats starting Dec. 1, and JetBlue planning to increase capacity to 85% on Dec. 2. In January, Alaska Airlines plans to stop blocking middle seats and JetBlue will fly at full capacity. Delta announced this week that it will continue to block the middle seat until March 30.
This policy change is a result of airlines’ lack of cash on hand, said Robert Mann, an aviation analyst. It also reflects a rising demand from consumers who feel increasingly comfortable traveling again, especially as holiday gatherings beckon.
“It was easy to keep middle seats empty when there wasn’t much demand,” said Mann.
Now, they’re instead hoping that new COVID-era services will calm passengers’ fears.
American, United, Alaskan and Hawaiian, among others, offer some form of preflight COVID test for customers traveling to Hawaii or specific foreign destinations that also require a negative test or quarantine upon arrival. JetBlue recently partnered with a company to offer at-home COVID tests that give rapid results for those traveling to Aruba.
Airlines are likely to expand their preflight COVID testing options in the next couple of months. “This is the new dimension of airline competition,” said Mann.
But is it a new dimension of travel safety?
Emory’s Wu said there is certainly a risk of catching the coronavirus if you travel by plane, and travelers should have a higher threshold in making the decision to travel home for the holidays than they would in years past.
After all, COVID case rates are surging nationwide.
“I think the less folks crowding the airports, the less movement in general around the country, will help us control the epidemic,” said Wu. “We are worried things will get worse with the colder weather.”
With its choice of a new leader, the Florida Hospital Association has signaled that seeking legislative approval to expand Medicaid to nearly 850,000 uninsured adults won't be among its top priorities.
In October, Mary Mayhew became the association's CEO. Mayhew, who led the state's Medicaid agency since 2019, has been a vocal critic of the Affordable Care Act's Medicaid expansion adopted by 38 other states. She has argued that expansion puts states in a difficult position because the federal government is unlikely to keep its financial commitment to pay its share of the costs.
Had Medicaid been expanded in Florida, hospitals there would have gained thousands of paying patients. But the institutions have done little in recent years to persuade the Republican-led legislature and Gov. Ron DeSantis, also Republican, who oppose such a move.
Mayhew acknowledged in an interview with KHN that expanding Medicaid to cover more uninsured patients could help hospitals financially, especially at a time when facilities have seen demand for services decline as people avoid care for fear of contracting COVID-19.
With that in mind, she said, she is now open to the idea of expanding Medicaid. "We need to look at all options on the table," she said. "Is it doable? Yes."
Still, she was quick to point out concerns about whether Florida can afford to expand.
Under the ACA, the federal government pays 90% of the costs for newly enrolled Medicaid recipients. In the traditional Medicaid program — which covers children, people who are disabled and pregnant women — the federal government pays nearly two-thirds of Florida's Medicaid costs.
"It will be financially challenging in our state budget as revenues have dropped," Mayhew said, echoing comments of state officials. "That 10% cost has to come from somewhere."
Mayhew's hire worries advocates who have spent more than seven years lobbying lawmakers to expand Medicaid. Without strong support from the hospital industry, they fear they're unlikely to change many votes.
"It may make it harder," said Karen Woodall, executive director of Florida People's Advocacy Center, a group that lobbies for policies to help low-income citizens. Marshaling hospital support is important, she said, because of the industry's money and political clout.
In many state capitals, hospitals have led the fight for Medicaid expansion either by lobbying lawmakers or bankrolling ballot initiatives. The latest example was in Missouri, which this summer expanded Medicaid via a voter initiative. The campaign for the measure was partly funded by hospitals.
But in Florida, hospitals appear to have made a calculated decision to avoid pushing an initiative that Republican leaders have said they don't want. Among the dozen states that have not expanded Medicaid, Florida is second only to Texas in the number of residents who could gain coverage.
Aurelio Fernandez, CEO of Memorial Healthcare System in Hollywood, Florida, who was chair of the hospital association board when it hired Mayhew, said her opposition to Medicaid expansion never came up in the process. The association hired Mayhew because of the "phenomenal job" she did guiding hospitals amid the COVID pandemic, he said.
"There is no appetite at this juncture [for the legislature] to expand the Medicaid program with Obamacare," said Fernandez, despite his belief that expansion would help hospitals and patients.
Mayhew, sounding more like a state official than a hospital industry spokesperson, said the ultimate decision on expansion will be up to lawmakers, who must review spending priorities. When states face a financial crunch, lawmakers look to reduce spending in education and Medicaid, which are the biggest parts of the budget, she said.
"The last thing we want to see is the state budget balanced on the backs of hospitals with deep Medicaid reimbursement cuts," Mayhew said.
Mayhew said her previous opposition to expanding Medicaid occurred when she was responsible for balancing the state budget and managing the programs in Florida and, before that, in Maine. When she ran Maine's program, she said she opposed expanding Medicaid to allow nondisabled adults into the program while there were disabled enrollees already on waiting lists to get care.
The Florida Hospital Association, which represents more than 200 hospitals, spent years lobbying state lawmakers to expand Medicaid. But since DeSantis was elected in 2018, the group has focused on other issues because the governor and Republican lawmakers made clear they would not expand the program.
Asked what the association's current position is on Medicaid expansion, Mayhew noted she has been in her job less than a month and "we have not had that policy decision by the board for me to answer that."
Miriam Harmatz, executive director of the Florida Health Justice Project, an advocacy group, said Mayhew's hire suggests that hospitals are unlikely to get behind a fledgling effort to put the expansion question to voters in 2022.
Others advocating for Medicaid expansion agree.
"It does not look like they [Florida's hospitals] are on board with helping us expand Medicaid at the moment," said Louisa McQueeney, program director of Florida Voices for Health, a consumer group helping with the ballot initiative.
All this time, the person I've most wanted to hear from is Fauci. He's a straight shooter, with no apparent conflicts of interest — political or financial — or, at 79, career ambition. He seemingly has no interests other than yours and mine.
This article was published on Thursday, November 19, 2020 in Kaiser Health News.
As a health journalist, a physician and a former foreign correspondent who lived through SARS in Beijing, I often get questions from friends, colleagues and people I don’t even know about how to live during the pandemic. Do I think it’s safe to plan a real wedding next June? Would I send my kids to school, with appropriate precautions? When will I trust a vaccine?
To the last question, I always answer: When I see Anthony Fauci take one.
Like many Americans, I take my signals from Dr. Fauci, the country’s top infectious disease expert and a member of the White House task force on the coronavirus. When he told The Washington Post that he was not wiping down packages but just letting them sit for a couple of days, I started doing the same. In October, he remarked that he was bringing shopping bags into the house. He merely washes his hands after unpacking them. (Me too!)
Now we are in a dangerous political transition, with cases spiking in much of the country and Fauci and the original task force largely sidelined. President-elect Joe Biden has appointed his own, but it can’t do much until the General Services Administration signals that it accepts the results of the election. And Fauci told me he has not yet spoken with the Biden task force. President Donald Trump has resisted the norms on government transition, in which the old and new teams brief each other and coordinate.
The past tumultuous months have been filled with information gaps (we’re still learning about the novel coronavirus), misinformation (often from the president) and a host of “experts” — public health folks, mathematical modelers, cardiologists and emergency room doctors like me — offering opinions on TV. But all this time, the person I’ve most wanted to hear from is Fauci. He’s a straight shooter, with no apparent conflicts of interest — political or financial — or, at 79, career ambition. He seemingly has no interests other than yours and mine.
So I asked him how Americans might expect to live in the next six to nine months. How should we behave? And what should the next administration do? Some answers have been edited for clarity and brevity.
Q: Are there two or three things you think a Biden administration should do on Day One?
There were some states in some regions of the country that somehow didn’t seem to have learned the lessons that could have been learned or should have been learned when New York City and other big cities got hit. And that is to do some fundamental public health measures. I want to really be explicit about this, because whenever I talk about simple things like uniform wearing of masks, keeping physical distance, avoiding crowds (particularly indoors), doing things outdoors to the extent possible with the weather, and washing hands frequently, that doesn’t mean shutting down the country. You can still have a considerable amount of leeway for business, for economic recovery, if you just do those simple things. But what we’re seeing, unfortunately, is a very disparate response to that. And that inevitably leads to the kind of surges that we see now.
Q: Do you think we need a national policy like a national mask mandate? The current administration has left a lot of COVID-19 management to the states.
I think that there should be universal wearing of masks. If we can accomplish that with local mayors, governors, local authorities, fine. If not, we should seriously consider national. The only reason that I shy away from making a strong recommendation in that regard is that things that come from the national level down generally engender a bit of pushback from an already reluctant populace that doesn’t like to be told what to do. So you might wind up having the countereffect of people pushing back even more.
Q: What would a national mask mandate look like to you? It means different things in different states. Many states require face coverings, but not specifically masks. Many 20-somethings use only a bandanna.
I think it is unlikely that there’s a substantial difference. I mean, the typical type of a mask is the surgical mask. It’s not an N95 mask. One that has thick cloth, you know, can be equally as effective. We believe there may be some small differences between them, but the main purpose is that you prevent yourself from infecting others. Recent studies have shown that [wearing a mask] also has the good effect of partially protecting you. So it goes both ways.
Q: Many places that have mask mandates have had trouble enforcing them.
That’s really one of the reasons there’s a reticence on the part of many people, including myself [to support a national mandate]. If you have a mandate, you have to enforce it. And, hopefully, we can convince people when they see what is going on in the country. But I have to tell you, Elisabeth, I was stunned by the fact that in certain areas of the country, even though the devastation of the outbreak is clear, some people are still saying it’s fake news. That is a very difficult thing to get over: why people still insist that something that’s staring you right in the face is not real.
Q: People often think of shutdowns as binary. You’re open or you’re shut. Often, when you answer questions about how to live, you start with. ‘Well, I’m in a high-risk group. …” So I would love to hear Dr. Fauci’s hierarchy of “Safe and important to keep open with precautions” and “Things that aren’t safe under any circumstances.”
The reason I answer with some degree of trepidation is because the people who are the proprietors of these businesses start getting very, very upset with me. There are some essential businesses that you want to keep open. You want to keep grocery stores open, supermarkets open, things that people need for their subsistence. You might, if it’s done properly, keep open some nonessential businesses, you know, things like clothing stores, department stores.
Q: We’re heading into the winter months. You could social distance in a restaurant or in an indoor gathering. But would you feel OK being in there without a mask?
If we’re in the hot zone the way we are now, where there’s so many infections around, I would feel quite uncomfortable even being in a restaurant. And particularly if it was at full capacity.
Q: I see you’ve been getting your hair cut. What do you think about hair salons?
I mean, again, it depends. I used to get a haircut every five weeks. I get a haircut every 12 weeks now — with a mask on me, as well as a mask on the person who’s cutting the hair, for sure.
Q: Transportation? Trains? Planes? Metro? Where are we at the moment?
It depends on your individual circumstances. If you are someone who is in the highest risk category, as best as possible, don’t travel anywhere. Or if you go someplace, you have a car, you’re in your car by yourself, not getting on a crowded subway, not getting on a crowded bus or even flying in an airplane. If you’re a 25-year-old who has no underlying conditions, that’s much different.
Q: Bars?
Bars are really problematic. I have to tell you, if you look at some of the outbreaks that we’ve seen, it’s when people go into bars, crowded bars. You know, I used to go to a bar. I used to like to sit at a bar and grab a hamburger and a beer. But when you’re at a bar, people are leaning over your shoulder to get a drink, people next to each other like this. It’s kind of fun because it’s social, but it’s not fun when this virus is in the air. So I would think that if there’s anything you want to clamp down on, for the time being, it’s bars.
Q: Some airlines and some states are telling people you have to get a coronavirus test before you get on the plane or visit another state. Does that make sense medically?
If you’re negative when you get on the plane — except in the rare circumstance that you’re in that little incubation window before you turn positive — that’s a good thing.
Q: If you had a national plan for testing, what would it be?
Surveillance testing. Literally flooding the system with tests. Getting a home test that you could do yourself, that’s highly sensitive and highly specific. And you know why that would be terrific? Because if you decided that you wanted to have a small gathering with your mother-in-law and father-in-law and a couple of children, and you had a test right there. It isn’t 100%. Don’t let the perfect be the enemy of the good. But the risk that you have — if everyone is tested before you get together to sit down for dinner — dramatically decreases. It might not ever be zero but, you know, we don’t live in a completely risk-free society.
Q: There are a number of vaccine candidates that are promising. But there’s also a lot of skepticism because we’ve seen the FDA come under both commercial and, increasingly, political pressure. When will we know it’s OK to take a vaccine? And which?
It’s pretty easy when you have vaccines that are 95% effective. Can’t get much better than that. I think what people need to appreciate — and that’s why I have said it like maybe 100 times in the last week or two — is the process by which a decision is made. The company looks at the data. I look at the data. Then the company puts the data to the FDA. The FDA will make the decision to do an emergency use authorization or a license application approval. And they have career scientists who are really independent. They’re not beholden to anybody. Then there’s another independent group, the Vaccines and Related Biological Products Advisory Committee. The FDA commissioner has vowed publicly that he will go according to the opinion of the career scientists and the advisory board.
Q: You feel the career scientists will have the final say?
Yes, yes.
Q: And will the decisions that are being made in this transition period — like the vaccine distribution plan — in any way limit the options of a new administration?
No, I don’t think so. I think a new administration will have the choice of doing what they feel. But I can tell you what’s going to happen, regardless of the transition or not, is that we have people totally committed to doing it right that are going to be involved in this. So I have confidence in that.
Q: When do you think we’ll all be able to throw our masks away?
I think that we’re going to have some degree of public health measures together with the vaccine for a considerable period of time. But we’ll start approaching normal — if the overwhelming majority of people take the vaccine — as we get into the third or fourth quarter [of 2021].
Q: Thank you so much. And have a nice Thanksgiving.
Take care, and you too.
[Editor’s note: Dr. Fauci has said his family is forgoing the usual family Thanksgiving gathering this year because his adult children would have to fly home and that travel would expose him to risk.]
You can listen to the full interview on KHN’s “What the Health?” podcast.
The drug price provisions, which would not begin until 2022, were a surprise because they were not included in the original proposed rule issued in 2019.
This article was published on Thursday, November 19, 2020 in Kaiser Health News.
Health insurance companies will have to give their customers estimated out-of-pocket costs for prescription drugs and disclose to the public the negotiated prices they pay for drugs, under an unexpected new Trump administration rule.
The administration said those requirements, part of a broader rule issued Oct. 29 forcing health plans to disclose costs and payments for most health care services, will promote competition and empower consumers to make better medical decisions.
The new rule does not, however, apply to Medicare or Medicaid.
The drug price provisions, which would not begin until 2022, were a surprise because they were not included in the original proposed rule issued in 2019.
It’s the departing Trump administration’s most ambitious effort to illuminate the complex, secret and lucrative system of prescription drug pricing, in which health plans, drug manufacturers and pharmacy benefit management firms agree on prices. The administration and Congress have tried and failed to reform part of that system — the rebates paid by drugmakers to the pharmacy benefit managers to get their products onto insurance plan formularies. Those payments, which some call kickbacks, are widely blamed for driving up costs to patients.
Patient advocates and policy experts, while generally supportive of the administration’s transparency concept, are divided on the cost-saving value of the new rule. Many say Congress needs to take broader action to curb drug prices and cap patient costs. Groups representing drugmakers, pharmacy benefit managers and commercial health plans have denounced the initiative, saying it will damage market competition and raise drug prices.
Advocates say the new rule will help patients in private health plans, including employer-based plans, and their physicians choose less expensive medications. It may even enable health plans to buy drugs more cheaply for their members. Three in 10 Americans say they have opted not to use a prescribed drug as directed because of the high cost, according to a KFF survey last year. (KHN is an editorially independent program of KFF.)
Under the new federal rule, starting in 2024 an insurance plan member can request and receive estimates of out-of-pocket costs for prescription drugs, both online and on paper, taking into account the member’s deductible, coinsurance and copays. Insurers say most plans already offer such cost-estimator tools.
Helping patients find drugs that cost them less could boost their compliance in taking needed medicines, thus improving their health.
“You can call your insurer now and ask what your copay is,” said Wendy Netter Epstein, a health law and policy professor at DePaul University in Chicago. “Patients often don’t do that. Whether or not this has an impact depends on whether patients take the initiative to obtain this information.”
Starting in 2022 under the new rule, private plans also will have to publish the prices they negotiated with drug companies and benefit management companies online in a digital, machine-readable format. That may be particularly helpful to employers that provide health insurance to workers, enabling them to seek the lowest price the drug manufacturer is offering to other purchasers.
The rule will not require plans to disclose rebates and other discounts they negotiate with drugmakers and pharmacy benefit managers.
That’s a disappointment to employers that provide health insurance for their workers. “We’d like a much clearer idea of how much we’re paying for every drug every time it’s dispensed,” said James Gelfand, senior vice president for health policy at the ERISA Industry Committee, which represents large self-insured employers. “We want to know where every cent in rebates and discounts is going. We’ll at least begin peeling back the onion. You have to start somewhere.”
But other experts argue the rule will do little to make medications more affordable. Indeed, they warn that publishing what health plans pay drug manufacturers could crimp some plans’ ability to get price concessions, raising the premiums and drug prices that plan members pay. That’s because manufacturers won’t want to give those discounts knowing other health plans and pharmacy benefit managers will see the published rates and ask for the same deals.
“Insurers and pharmacy benefit managers currently use rebates that are hidden from view to drive prices lower,” said Dr. Aaron Kesselheim, a professor of medicine at Harvard University who studies prescription drug policy. “If you make that transparent, you kind of reduce the main strategy payers have to lower drug prices.”
Patient advocates also questioned how useful the published rates will be for patients, because plans don’t have to post list prices, on which patient cost-sharing amounts are based. There also are practical limits to patients’ ability to price-shop for drugs, considering there may be only one effective drug for a given medical condition, such as many types of cancers.
Still, if the public knows more about how much health plans pay for drugs — and can estimate the size of the rebates and discounts that aren’t being passed on to patients — that could heighten pressure on federal and state elected officials to tackle the thorny issues of high prices and gaps in insurers’ drug coverage, which powerful industry groups oppose.
“If the information is presented to consumers so they realize they are paying a higher price without the benefit of the rebates, you’ll get a lot of angry consumers,” said Niall Brennan, CEO of the Health Care Cost Institute, a nonprofit group that publishes cost data.
The Biden administration is expected to keep the new price disclosure rule for health plans. In July, the Biden campaign issued a joint policy statement with Sen. Bernie Sanders (I-Vt.) favoring increased price transparency in health care.
But Kesselheim and other experts say Congress needs to consider stronger measures than price transparency to address drug affordability. These include letting the federal government negotiate prices with drugmakers, limiting the initial price of new drugs, capping price increases and establishing an impartial review process for evaluating the clinical value of drugs relative to their cost. Those are policies Biden has said he supports.
“There’s a limit to what transparency can do,” said Shawn Gremminger, health policy director at the Pacific Business Group on Health, which represents large self-insured employers. “That’s why we’re increasingly comfortable with policies that get at the underlying prices of drugs.” As an example, he cited the Trump administration’s proposal to tie what Medicare pays for drugs to lower prices in other countries.
Commercial insurers, drug manufacturers and pharmacy benefit managers are strongly opposed to the drug transparency rule. “This rule will disrupt the marketplace dynamics and undermine the highly competitive negotiations that kept net prices for brand medicines at a growth rate of just 1.7% in 2019,” said Katie Koziara, a spokesperson for the Pharmaceutical Research and Manufacturers of America. She wouldn’t say whether her group would sue to block the rule.
BOULDER, Colo. — Brady Bowman, a 19-year-old student at the University of Colorado-Boulder, and two friends strolled down 11th Street, all sporting matching neck gaiters branded with the Thomas' English Muffins logo. He had received an entire box of the promotional gaiters.
He thinks they are just more comfortable to wear than a face mask. "Especially a day like today, where it's cold out," he said, with the top of his gaiter pulled down below his chin.
More stylish? Perhaps. More comfortable? Maybe. But as effective? Not necessarily.
With states such as Colorado requiring face coverings indoors to prevent the spread of COVID-19, gaiters and bandannas have become popular accessories, particularly among college students and other young adults. Less restrictive than masks, they can easily be pulled up or down as needed — and don't convey that just-out-of-the-hospital vibe.
But tests show those hipper face coverings are not as effective as surgical or cloth face masks. Bandannas, like plastic face shields, allow the virus to escape out the bottom in aerosolized particles that can hang in the air for hours. And gaiters are often made of such thin material that they don't trap as much virus as cloth masks.
As new COVID cases, hospitalizations and deaths surge upward heading into winter, many public health experts wonder whether it's time to move beyond the anything-goes approach toward more standardization and higher-quality masks. President-elect Joe Biden reportedly is mulling a national face-covering mandate of some sort, which could not only increase mask-wearing but better define for Americans what sort of face covering would be most protective.
"Unlike seat belts, condoms or other prevention strategies, we have not yet standardized what we are recommending for the public," said Dr. Monica Gandhi, an infectious disease specialist at the University of California-San Francisco. "And that has been profoundly confusing for the American public, to have all these masks on the market."
Patchwork of Regulations
Masks have been shown to reduce the spread of respiratory droplets that contain the coronavirus. And the Centers for Disease Control and Prevention now says that masks not only help prevent people from infecting others but help protect the wearers from infection as well.
According to a recent analysis by the Institute for Health Metrics and Evaluation, implementing universal mask-wearing in late September would have saved nearly 130,000 American lives by the end of February.
Even so, many Americans still aren't wearing masks. And in some states, they haven't been required to do so.
At least 37 states and the District of Columbia have mandated face coverings but show wide variation in defining what qualifies. States such as Maryland and Rhode Island include bandannas or neck gaiters in their definitions, while South Carolina and Michigan do not, according to a KHN review of the orders. Some spell out the circumstances in which coverings must be worn or establish enforcement policies.
But according to Lawrence Gostin, a Georgetown University law professor, many states are not holding residents to those rules. Some state or local officials are choosing not to enforce them.
"We have a patchwork of inconsistent rules and laws around the country," Gostin said. "And when we are dealing with a nationwide pandemic, a patchwork just won't get the job done."
Cloth mask manufacturing was nearly nonexistent in the U.S. before the pandemic, so public health officials opted early in the year to stress the importance of wearing any face covering rather than trying to focus on one standard. As a result, Americans are wearing a hodgepodge of coverings, from home-sewn to commercial versions, with various levels of protection.
And what is worn matters. Dr. Iahn Gonsenhauser, an infectious disease specialist at the Ohio State University Wexner Medical Center, said face coverings generally fall into three categories of effectiveness. N95 masks (not those with valves), surgical masks and well-made cloth masks (constructed of tightly woven material, folded over two or three times, and properly covering the mouth and nose) are in the highly effective category.
Bandannas, neck gaiters and face shields lie at the other end of the spectrum, and most everything else falls in the middle.
"Bandannas are typically a thinner material, so if they're not doubled or tripled up, that can allow respiratory droplets, in particular, to move through the masks," he said. "But the fact that they're open along the bottom of the mouth and neck, if they're not tucked into a shirt or something like that, also allows for a lot of that exhalation droplet to escape around the mask and become airborne."
A plastic face shield can block larger droplets but won't stop aerosolized particles from flowing beyond its edges.
The evidence around neck gaiters has been mixed, in part because so many materials and designs are used. But recent testing suggests even the thin material commonly used to make gaiters is nearly as effective as a cloth mask if doubled over.
"With few exceptions, the best mask is the mask that somebody is going to use regularly and consistently," Gonsenhauser said. "It may be that the best technical mask is not going to be the mask that everybody's going to be willing to wear all the time."
Researchers at the National Institute for Occupational Safety and Health have found most of the commercially produced cloth masks block 40% to 60% of droplets, approaching the effectiveness of surgical masks.
"You can't possibly test everything, but certainly one take-home message is that anything is better than nothing," said William Lindsley, a NIOSH biomedical engineer. "We haven't tested anything that has not worked."
Call for Standardization
But Gandhi believes it's time to raise the standards for masks, ramp up the production of disposable surgical masks and encourage, if not order, Americans to wear them. Early in the pandemic, the Trump administration reportedly considered sending masks to every American but ultimately decided against it.
Taiwan, on the other hand, invested in manufacturing and distributing surgical masks, and it has one of the lowest COVID death counts in the world: fewer than 10 deaths in a country of 24 million people.
"It makes more sense to standardize masks, to mass-produce surgical masks, which are not very expensive," Gandhi said. "We're spending a lot more on everything else."
She said surgical masks might even reduce the severity of COVID-19. Gandhi and several colleagues recently wrote in a medical journal article that evidence suggests the less virus a person is exposed to, the less sick they become.
That's been backed up in tests with lab animals exposed to the coronavirus and with humansexposed to other, less dangerous respiratory viruses.
Other evidence also supports that theory. While the CDC estimates about 40% of COVID cases are asymptomatic, outbreaks in food processing plants where workers were handed surgical or N95 masks as they entered showed a much higher proportion of infected workers never developed symptoms. That could explain why many Asian countries, where mask-wearing has been a cultural norm for decades, have been able to reopen their economies without seeing death rates as high as in the United States.
"Tokyo is a good example. It's wide open, the people are walking around shoulder to shoulder, people are going to offices, people are going to school," Gandhi said. "But they're all masked and they have very low rates of severe illness."
If she's right, a national mandate calling for surgical masks could both reduce transmission and prevent serious disease.
"We can't wait," Gandhi said. "We've had enough deaths from this infection. Our case fatality rates in a country of this degree of development are just tragic."
It remains to be seen whether Americans will be more willing to wear dowdier, less comfortable but more effective masks to protect themselves and others. When Bowman, the Boulder college student, was asked if he was worried that his gaiter might not block as much of the virus as a face mask, he seemed unconcerned.
"As long as the other person is wearing a mask," he said.
The app builders had planned for pranksters, ensuring that only people with verified COVID-19 cases could trigger an alert. They'd planned for heavy criticism about privacy, in many cases making the features as bare-bones as possible. But, as more states roll out smartphone contact-tracing technology, other challenges are emerging. Namely, human nature.
The problem starts with downloads. Stefano Tessaro calls it the "chicken-and-egg" issue: The system works only if a lot of people buy into it, but people will buy into it only if they know it works.
"Accuracy of the system ends up increasing trust, but it is trust that increases adoptions, which in turn increases accuracy," Tessaro, a computer scientist at the University of Washington who was involved in creating that state's forthcoming contact-tracing app, said in a lecture last month.
In other parts of the world, people are taking that necessary leap of faith. Ireland and Switzerland, touting some of the highest uptake rates, report more than 20% of their populations use a contact-tracing app.
Americans seem not so hot on the idea. As with much of the U.S. response to the pandemic, this country hasn't had a national strategy. So it's up to states. And only about a dozen, including the recent addition of Colorado, have launched the smartphone feature, which sends users a notification if they've crossed paths with another app user who later tests positive for COVID-19.
Within those few states, enthusiasm appears dim. In Wyoming, Alabama and North Dakota, some of the few states with usage data beyond initial downloads, under 3% of the population is using the app.
The service, built by Google and Apple and adapted by individual countries, states or territories, either appears as a downloadable app or as a setting, depending on the state and the device. It uses Bluetooth to identify other phones using the app within about 6 feet for more than 15 minutes. If a user tests positive for COVID-19, they're given a verification code to input so that each contact can be notified they were potentially exposed. The person's identity is shielded, as are those of the people notified.
"The more people who add their phone to the fight against COVID, the more protection we all get. Everyone should do it," Sarah Tuneberg, who leads Colorado's test and containment effort, told reporters on Oct. 29. "The sky's the limit. Or the population is the limit, really."
But the population could prove to be quite a limit. Data from early-adopter governments suggests even those who download the app and use it might not follow directions at the most critical juncture.
According to the Virginia Health Department, from August to November, about 613 app users tested positive and received a code to alert their contacts that they may have exposed them to the virus. About 60% of them actually activated it.
In North Dakota, where the outbreak is so big that human contact tracers can't keep up, the data is even more dire. In October, about 90 people tested positive and received the codes required to alert their contacts. Only about 30% did so.
Researchers in Dublin tracking app usage in 33 regions around the world have encountered echoes of the same issue. In October, they wrote that in parts of Europe fewer people were alerting their contacts than expected, given the scale of the outbreaks and the number of active app users. Italy and Poland ranked lowest. There, they estimated, just 10% of the app users they'd expect were submitting the codes necessary to warn others.
"I'm not sure that anybody working in this field had foreseen that that could be a problem," said Lucie Abeler-Dörner, part of a team at the Big Data Institute at Oxford studying COVID-19 interventions, including digital contact tracing. "Everybody just assumed that if you sign up for a voluntary app … why would you then not push that button?"
So far, people in the field only have guesses. Abeler-Dörner wonders how much of it has to do with people going into panic mode when they find out they're positive.
Tessaro, the University of Washington computer scientist, asks if the health officials who provide the code need more training on how to provide clear instructions to users.
Elissa Redmiles, a faculty member at the Max Planck Institute for Software Systems who is studying what drives people to install contact-tracing apps, worries that people may have difficulty inputting their test results.
But Tim Brookins, a Microsoft engineer who developed North Dakota's contact-tracing app as a volunteer, has a bleaker outlook.
"There's a general belief that some people want to load the app so that they can be notified if someone else was positive, in a self-serving way," he said. "But if they're positive, they don't want to take the time."
Abeler-Dörner called the voluntary notification a design flaw and said the alerts should instead be automatically triggered.
Even with the limitations of the apps, the technology can help identify new COVID cases. In Switzerland, researchers looked at data from two studies of contact-tracing app users. They wrote in a not-yet-peer-reviewed paper that while only 13% of people with confirmed cases in Switzerland used the app to alert their contacts from July to September, that prompted about 1,700 people who had potentially been exposed to call a dedicated hotline for help. And of those, at least 41 people discovered they were, indeed, positive for COVID-19.
In the U.S., another non-peer-reviewed modeling study from Google and Oxford University looking at three Washington state counties found that even if only 15% of the population uses a contact-tracing app, it could lead to a drop in COVID-19 infections and deaths. Abeler-Dörner, a study co-author, said the findings could be applicable elsewhere, in broad strokes.
"It will avert infections," she said. "If it's 200 or 1,000 and it prevents 10 deaths, it's probably worth it."
That may be true even at low adoption rates if the app users are clustered in certain communities, as opposed to being scattered evenly across the state. But prioritizing privacy has required health departments to forgo the very data that would let them know if users are near one another. While an app in the United Kingdom asks users for the first few digits of their postal code, very few U.S. states can tell if users are in the same community.
Some exceptions include North Dakota, Wyoming and Arizona, which allow app users to select an affiliation with a college or university. At the University of Arizona, enough people are using the app that about 27% of people contacted by campus contact tracers said they'd already been notified of a possible exposure. Brookins of Microsoft, who created Care19 Alert, the app used in Wyoming and North Dakota, said that offering an affiliation option also allows people who've been exposed to get campus-specific instructions on where to get tested and what to do next.
"In theory, we can add businesses," he said. "It's so polarizing, no businesses have wanted to sign up, honestly."
The privacy-focused design also means researchers don't have what they need to prove the apps' usefulness and therefore encourage higher adoption.
"Here there is actually some irony because the fact that we are designing this solution with privacy in mind somehow prevents us from accurately assessing whether the system works as it should," Tessaro said.
In states including Colorado, Virginia and Nevada, the embedded privacy protections mean no one knows who has enabled the contact-tracing technology. Are they people who barely interact with anyone, or are they essential workers, interacting regularly with many people that human contact tracers would never be able to reach? Are they crossing paths and trading signals with other app users or, if they test positive, will their warning fall silently like a tree in an empty forest? Will they choose to notify people at all?
Colorado's health department said it's issuing thousands of COVID codes a day. As of Wednesday, 3,400 people have used the codes to notify their contacts, it said. An automated system issues codes for positive COVID-19 tests even if the infected people don't have the app, making it impossible to know how many users are acting on the codes.
"I have hope that the vast majority of Coloradans will take this opportunity to give this gift of exposure notification to other people," said Tuneberg. "I believe Coloradans will do it."
For years, Sharad Acharya's frequent hikes in the mountains outside Denver would leave him short of breath. But a real wake-up call came three years ago when he suddenly struggled to breathe while walking through an airport.
An electrocardiogram revealed that Acharya, a Nepali American from Broomfield, Colorado, had an irregular heartbeat on top of the high blood pressure he already knew about. He had to immediately undergo triple bypass surgery and get seven stents.
Acharya, now 54, thought of his late father and his many uncles who have had heart problems.
"It's part of my genetics, for sure," he said.
South Asian Americans — people with roots in Nepal, India, Pakistan, Sri Lanka, Bangladesh, Bhutan and the Maldives — have a disproportionately higher risk of heart disease and other cardiovascular ailments. Worldwide, South Asians account for 60% of all heart disease cases, even though — at 2 billion people — they make up only a quarter of the planet's population.
In the United States, there's increasing attention on these risks for Americans of South Asian descent, a growing population of about 5.4 million. Healthcare professionals attribute the problem to a mix of genetic, cultural and lifestyle influences — but researchers are advocating for more resources to fully understand it.
Rep.Pramila Jayapal (D-Wash.) is sponsoringlegislation that would direct $5 million over the next five years toward research into heart disease among South Asian Americans and raising awareness of the issue. The bill passed the U.S. House in September and is up for consideration in the Senate.
The issue could gain more attention after Sen. Kamala Harris (D-Calif.) becomes the nation's first vice president with South Asian lineage. Harris' mother, Shyamala Gopalan, moved from India to the U.S. in 1958 to attend graduate school. Gopalan, a breast cancer researcher, died in 2009 of colon cancer.
A 2018study for the American Heart Association found South Asian Americans are more likely to die of coronary heart disease than other Asian Americans and non-Hispanic white Americans. The study pointed to their high incidences of diabetes and prediabetes as risk factors, as well as high waist-to-hip ratios. People of South Asian descent have a higher tendency to gain visceral fat in the abdomen, which is associated with insulin resistance. They also were found to be less physically active than other ethnic groups in the U.S.
One of the nation's largest undertakings to understand these risks is the Mediators of Atherosclerosis in South Asians Living in America study, which began in 2006. The MASALA researchers, from institutions such as Northwestern University and the University of California-San Francisco, have examined more than 1,100 South Asian American men and women ages 40-79 to better understand the prevalence and outcomes of cardiovascular disease. They stress that high blood pressure and diabetes are common in the community, even for people at normal weights.
That's why, said Dr. Alka Kanaya, MASALA's principal investigator and a professor at UCSF, South Asians cannot rely on traditional body mass index metrics, because BMI numbers considered normal could provide false reassurance to those who might still be at risk.
Kanaya recommends cardiac CT scans, which she said help identify high-risk patients, those who need to make more aggressive lifestyle changes and those who may need preventive medication.
Another risk factor, this one cultural, is diet. Some South Asian Americans are vegetarians, though it's often a grain-heavy diet reliant on rice and flatbread. The AHA study found risks in such diets, which are high in refined carbohydrates and saturated fat.
"We have to understand the cultural nuances [with] an Indian vegetarian diet," said Dr. Ronesh Sinha, author of "The South Asian Health Solution" and an internal medicine physician. "That means something totally different than … a Westerner who's going to be consuming a lot of plant-based protein and tofu, eating lots of salads and things that typical South Asians don't."
But getting South Asians to change their eating habits can be challenging, because their culture expresses hospitality and love through food, according to Arnab Mukherjea, an associate professor of health sciences at California State University-East Bay. "One of the things South Asians tend to take a lot of pride in is transmitting cultural values and norms knowledge to the next generation," Mukherjea said.
The intergenerational transmission goes both ways, according to MASALA researchers. Adult, second-generation South Asian Americans might be the key to helping those in the first generation who are resistant to change adopt healthier habits, according to Kanaya.
In the San Francisco Bay Area, El Camino Hospital's South Asian Heart Center is one of the nation's leading centers for educating the community. Its three locations are not far from Silicon Valley tech giants, which employ many South Asian Americans.
The center's medical director, Dr. César Molina, said the center treats many relatively young patients of South Asian descent without typical risk factors for cardiovascular disease.
"It was like the typical 44-year-old engineer with a spouse and two kids showing up with a heart attack," he said.
The South Asian Health Center helps patients make lifestyle changes through meditation, exercise, diet and sleep. The nearby Palo Alto Medical Foundation's Prevention and Awareness for South Asians program and the Stanford South Asian Translational Heart Initiative provide medical support for the community. Even patients in the later stages of heart disease can be helped by lifestyle changes, Sinha said.
Dr. Kevin Shah, a University of Utah cardiologist who co-authored the AHA study, said people with diabetes, hypertension and obesity are also at higher risk of COVID-19 complications so should now especially work to improve their cardiovascular health and fitness.
In Colorado, Acharya's health is still an issue. He said he had to get four more stents this year, and the surgeries have put pressure on his family. But he's breathing well, watching what he eats — and once more exploring his beloved mountains.
"Nowadays, I feel very, very good," he said. "I'm hiking a lot."
When he started researching a troublesome childhood infection nearly four decades ago, virologist Dr. Barney Graham, then at Vanderbilt University, had no inkling his federally funded work might be key to deliverance from a global pandemic.
Yet nearly all the vaccines advancing toward possible FDA approval this fall or winter are based on a design developed by Graham and his colleagues, a concept that emerged from a scientific quest to understand a disastrous 1966 vaccine trial.
Basic research conducted by Graham and others at the National Institutes of Health, Defense Department and federally funded academic laboratories has been the essential ingredient in the rapid development of vaccines in response to COVID-19. The government has poured an additional $10.5 billion into vaccine companies since the pandemic began to accelerate the delivery of their products.
The Moderna vaccine, whose remarkable effectiveness in a late-stage trial was announced Monday morning, emerged directly out of a partnership between Moderna and Graham's NIH laboratory.
Coronavirus vaccines are likely to be worth billions to the drug industry if they prove safe and effective. As many as 14 billion vaccines would be required to immunize everyone in the world against COVID-19. If, as many scientists anticipate, vaccine-produced immunity wanes, billions more doses could be sold as booster shots in years to come. And the technology and production laboratories seeded with the help of all this federal largesse could give rise to other profitable vaccines and drugs.
The vaccines made by Pfizer and Moderna, which are likely to be the first to win FDA approval, in particular rely heavily on two fundamental discoveries that emerged from federally funded research: the viral protein designed by Graham and his colleagues, and the concept of RNA modification, first developed by Drew Weissman and Katalin Karikó at the University of Pennsylvania. In fact, Moderna's founders in 2010 named the company after this concept: "Modified" + "RNA" = Moderna, according to co-founder Robert Langer.
"This is the people's vaccine," said corporate critic Peter Maybarduk, director of Public Citizen's Access to Medicines program. "Federal scientists helped invent it and taxpayers are funding its development. … It should belong to humanity."
Moderna, through spokesperson Ray Jordan, acknowledged its partnership with NIH throughout the COVID-19 development process and earlier. Pfizer spokesperson Jerica Pitts noted the company had not received development and manufacturing support from the U.S. government, unlike Moderna and other companies.
The idea of creating a vaccine with messenger RNA, or mRNA — the substance that converts DNA into proteins — goes back decades. Early efforts to create mRNA vaccines failed, however, because the raw RNA was destroyed before it could generate the desired response. Our innate immune systems evolved to kill RNA strands because that's what many viruses are.
Karikó came up with the idea of modifying the elements of RNA to enable it to slip past the immune system undetected. The modifications she and Weissman developed allowed RNA to become a promising delivery system for both vaccines and drugs. To be sure, their work was enhanced by scientists at Moderna, BioNTech and other laboratories over the past decade.
Another key element in the mRNA vaccine is the lipid nanoparticle — a tiny, ingeniously designed bit of fat that encloses the RNA in a sort of invisibility cloak, ferrying it safely through the blood and into cells and then dissolving, thereby allowing the RNA to do its work of coding a protein that will serve as the vaccine's main active ingredient. The idea of enclosing drugs or vaccines in lipid nanoparticles arose first in the 1960s and was developed by Langer and others at the Massachusetts Institute of Technology and various academic and industry laboratories.
Karikó began investigating RNA in 1978 in her native Hungary and wrote her first NIH grant proposal to use mRNA as a therapeutic in 1989. She and Weissman achieved successes starting in 2004, but the path to recognition was often discouraging.
"I keep writing and doing experiments, things are getting better and better, but I never get any money for the work," she recalled in an interview. "The critics said it will never be a drug. When I did these discoveries, my salary was lower than the technicians working next to me."
Eventually, the University of Pennsylvania sublicensed the patent to Cellscript, a biotech company in Wisconsin, much to the dismay of Weissman and Karikó, who had started their own company to try to commercialize the discovery. Moderna and BioNTech later would each pay $75 million to Cellscript for the RNA modification patent, Karikó said. Though unhappy with her treatment at Penn, she remained there until 2013 — partly because her daughter, Susan Francia, was making a name for herself on the school's rowing team. Francia would go on to win two Olympic gold medals in the sport. Karikó is now a senior officer at BioNTech.
In addition to RNA modification and the lipid nanoparticle, the third key contribution to the mRNA vaccines — as well as those made by Novavax, Sanofi and Johnson & Johnson —- is the bioengineered protein developed by Graham and his collaborators. It has proved in tests so far to elicit an immune response that could prevent the virus from causing infections and disease.
The protein design was based on the observation that so-called fusion proteins — the pieces of the virus that enable it to invade a cell — are shape-shifters, presenting different surfaces to the immune system after the virus fuses with and infects cells. Graham and his colleagues learned that antibodies against the post-fusion protein are far less effective at stopping an infection.
The discovery arose in part through Graham's studies of a 54-year-old tragedy — the failed 1966 trial of an NIH vaccine against respiratory syncytial virus, or RSV. In a clinical trial, not only did that vaccine fail to protect against the common childhood disease, but most of the 21 children who received it were hospitalized with acute allergic reactions, and two died.
About a decade ago, Graham, now deputy director of NIH's Vaccine Research Center, took a new stab at the RSV problem with a postdoctoral fellow, Jason McLellan. After isolating and obtaining three-dimensional models of the RSV's fusion protein, they worked with Chinese scientists to identify an appropriate neutralizing antibody against it.
"We were sitting in Xiamen, China, when Jason got the first image up on his laptop, and I was like, oh my God, it's coming together," Graham recalled. The prefusion antibodies they discovered were 16 times more potent than the post-fusion form contained in the faulty 1960s vaccine.
Two 2013 papers the team published in Science earned them a runner-up prize in the prestigious journal's Breakthrough of the Year award. Their papers, which showed it was possible to plan and create a vaccine at the microscopic structural level, set the NIH's Vaccine Research Center on a path toward creating a generalizable, rapid way to design vaccines against emerging pandemic viruses, Graham said.
In 2016, Graham, McLellan and other scientists, including Andrew Ward at the Scripps Research Institute, advanced their concept further by publishing the prefusion structure of a coronavirus that causes the common cold and a patent was filed for its design by NIH, Scripps and Dartmouth — where McLellan had set up his own lab. NIH and the University of Texas — where McLellan now works — filed an additional patent this year for a similar design change in the virus that causes COVID-19.
Graham's NIH lab, meanwhile, had started working with Moderna in 2017 to design a rapid manufacturing system for vaccines. In January, they were preparing a demonstration project, a clinical trial to test whether Graham's protein design and Moderna's mRNA platform could be used to create a vaccine against Nipah, a deadly virus spread by bats in Asia.
Their plans changed rapidly when they learned on Jan. 7 that the epidemic of respiratory disease in China was being caused by a coronavirus.
"We agreed immediately that the demonstration project would focus on this virus" instead of Nipah, Graham said. Moderna produced a vaccine within six weeks. The first patient was vaccinated in an NIH-led clinical study on March 16; early results from Moderna's 30,000-volunteer late-stage trial showed it was nearly 95% effective at preventing COVID-19.
Although other scientists have advanced proposals for what may be even more potent vaccine antigens, Graham is confident that carefully designed vaccines using nucleic acids like RNA reflect the future of new vaccines. Already, two major drug companies are doing advanced clinical trials for RSV vaccines based on the designs his lab discovered, he said.
In a larger sense, the pandemic could be the event that paves the way for better, perhaps cheaper and more plentiful vaccines.
"It's a silver lining, but I think we are definitely pushing forward the way everyone is thinking about vaccines," said Michael Farzan, chair of the department of immunology and microbiology at Scripps Research's Florida campus. "Certain techniques that have been waiting in the wings, under development but never achieving the kind of funding they needed for major tests, will finally get their chance to shine."
Under a 1980 law, the NIH will obtain no money from the coronavirus vaccine patent. How much money will eventually go to the discoverers or their institutions isn't clear. Any existing licensing agreements haven't been publicized; patent disputes among some of the companies will likely last years. HHS' big contracts with the vaccine companies are not transparent, and Freedom of Information Act requests have been slow-walked and heavily redacted, said Duke University law professor Arti Rai.
Some basic scientists involved in the enterprise seem to accept the potentially lopsided financial rewards.
"Having public-private partnerships is how things get done," Graham said. "During this crisis, everything is focused on how can we do the best we can as fast as we can for the public health. All this other stuff is going to have to be figured out later."
"It's not a good look to become extremely wealthy off a pandemic," McLellan said, noting the big stock sales by some vaccine company executives after they received hundreds of millions of dollars in government assistance. Still, "the companies should be able to make some money."
For Graham, the lesson of the coronavirus vaccine response is that a few billion dollars a year spent on additional basic research could prevent a thousand times as much loss in death, illness and economic destruction.
"Basic research informs what we do, and planning and preparedness can make such a difference in how we get ahead of these epidemics," he said.
North Dakota Gov. Doug Burgum said that healthcare workers who test positive for the coronavirus but do not display symptoms could still report to work.
This article was published on Wednesday, November 18, 2020 in Kaiser Health News.
Nurse Leslie McKamey has gotten used to the 16-hour shifts, to skipping lunch, to the nightly ritual of throwing all her clothes in the laundry and showering as soon as she walks through the door to avoid potentially infecting her children. She's even grown accustomed to triaging COVID patients, who often arrive at the emergency room so short of breath they struggle to describe their symptoms.
But despite the trauma and exhaustion of the past eight months, she was shocked when North Dakota Gov. Doug Burgum said last week that healthcare workers who test positive for the coronavirus but do not display symptoms could still report to work. The order, in line withCDC guidance for mitigating staff shortages, would allow asymptomatic health workers who test positive to work only in COVID units, and treat patients who already have the virus.
But many feel the idea endangers the workers and their colleagues. It comes as North Dakota faces one of the worst outbreaks of COVID-19 and grapples with healthcare staff shortages.
"We're worried about somebody dying, frankly, because we couldn't get to them in time," said McKamey, an emergency room registered nurse in Bismarck.
According to data from the COVID Tracking Project, more than 9,400 North Dakotans tested positive for COVID-19 last week alone. About 1 in 12 North Dakota residents have been infected with the virus; nearly 1 in 1,000 have died. In early November, the North Dakota Department of Health reportedthat there were only 12 open ICU beds in the state.
McKamey said Burgum's order goes against everything she's been taught as a nurse.
"If hospital administrators start forcing COVID-positive staff to go to work, it's going to be very scary. We're trained to do no harm, and asking COVID-positive, asymptomatic nurses to return to work is putting patients at risk. It's putting fellow staff members at risk."
Nine months into the pandemic, it's clear healthcare workers already face increased risks. Lost on the Frontline, a joint effort by The Guardian and KHN, is investigating the deaths of 1,375 healthcare workers who appear to have died of COVID-19 since the start of the pandemic. Nearly a third of those healthcare workers were nurses.
McKamey described long shifts in an emergency room that has begun taking on patients overnight because other wards of the hospital did not have the capacity to admit them. Nurses pick up extra shifts to cover for colleagues who have gotten sick and take on multiple critical patients at once.
It is a scene playing out in hospitals across the country, as the coronavirus spreads unabated. As of Monday, more than 11 million people in the United States had been infected with the virus, with health officials reporting 180,000 new infections in a single day. And the country is bracing for another milestone: It will soon surpass a quarter-million deaths from COVID-19.
Healthcare workers are overwhelmed and exhausted. According to a recent survey from the National Nurses United, more than 70% of hospital nurses said they were afraid of contracting COVID-19 and 80% feared they might infect a family member. More than half said they struggled to sleep and 62 reported feeling stressed and anxious. Nearly 80% said they were forced to reuse single-use PPE, like N95 respirators.
Inaction at the state and federal levels have left many healthcare workers feeling abandoned. When Gov. Burgum issued the order that infected but asymptomatic nurses could report to work in COVID units, North Dakota had not implemented any kind of statewide mask mandate, despite expert guidance that such a measure could significantly reduce transmission of the virus.
Tessa Johnson is a registered nurse at a Bismarck nursing home and president of the North Dakota Nurses Association, which issued a statement last week denouncing Burgum's order that infected nurses continue to work.
She said the state could have done much more to ensure patients don't become infected in the first place. "We've asked and asked and asked for a mask mandate, and that hasn't happened," she said Thursday.
On Friday night, Burgum did an about-face and issued a mask mandate, ordering individuals to cover their faces when inside businesses, indoor public settings and outdoor public settings where physical distancing may be impossible.
"Our doctors and nurses heroically working on the front lines need our help, and they need it now," he said in a press statement.
Still, Johnson said there's a disconnect between what healthcare workers are experiencing inside North Dakota's health facilities, and how the general population perceives the virus. And that even before Burgum's comments, some of her colleagues felt they had to choose between taking all precautions and limited time off. "One of my closest friends, also a healthcare worker, said to me the other day, 'There's no way I will ever get tested unless I'm very sick, because I don't want to use my paid leave.'"
McKamey, the ER nurse, said she hasn't had time to process the stress of the past several months. She's focused on staying healthy, gearing up for what she anticipates will be a difficult winter and keeping her patients alive. "We are willing to break our backs and work as hard as we physically can," McKamey said. "But then to ask us to come in as a potential infectious source is just stunning."