There is a small chance that Pfizer's vaccine trial will yield results by Nov. 3. But it could still take weeks for FDA review. Here's everything that has to happen and how to tell a political stunt from a real vaccine.
This article was published on September, September 26, 2020 in ProPublica.
Despite President Donald Trump’s promises of a vaccine next month and pundits’ speculation about how an “October surprise” could upend the presidential campaign, any potential vaccine would have to clear a slew of scientific and bureaucratic hurdles in record time.
In short, it would take a miracle.
We talked to companies, regulators, scientific advisers and analysts and reviewed hundreds of pages of transcripts and study protocols to understand all the steps needed for a coronavirus vaccine to be scientifically validated and cleared for public use. As you’ll see, it’s a long shot in 38 days.
There are three key milestones that must be met:
A clinical trial would need to observe enough infections to demonstrate that the vaccine is better than a placebo. Right now, Pfizer’s trial is the furthest along. Pfizer has said it expects results by the end of October, but analysts who follow the company aren’t so sure it’ll be that soon or whether the results will be conclusive.
Pfizer would have to turn its trial data into an application to the Food and Drug Administration. The company could either apply for full approval — a very high bar for proving the vaccine is safe, effective and able to be reliably manufactured by the millions of doses — or for an emergency use authorization, which is more flexible. Pfizer has said it could submit its application almost immediately.
The FDA has to review the data and decide whether the vaccine is ready to go to market. That could take several weeks to a month, said Dr. Mark McClellan, who led the FDA from 2002 to 2004.
“All of this put together makes it more likely that it’ll be a late 2020 availability,” McClellan said.
None of this is to say that Trump couldn’t suddenly call a White House press conference to try to grab headlines and declare victory. But knowing all the steps that would have to come first can help the public discern between a true, scientifically validated vaccine and a mere political stunt.
Yes, Pfizer could have trial results by the end of October.
Results from ongoing trials are closely guarded so that researchers (and investors) have no opportunity to mess with them. Under strict trial rules that vaccine makers and the FDA set up in advance, there are only a few predetermined times when a data monitoring board is scheduled to look at the data. The purpose of those check-ins (known as “interim analyses”) is to see if there’s already enough evidence to conclude that the vaccine either works or doesn’t.
According to the trial rules that Pfizer released last week, it has four of these check-ins before the final analysis. The first one occurs when 32 people in the trial get sick with COVID-19.
Yes, that is a tiny number in a study designed to enroll 30,000 participants. But it could be enough to show that the vaccine works if far more of the infections occur in people who took the placebo than in those who got the vaccine, so much so that it’s probably not random.
The vaccine “would have to be way, way better to meet an interim stopping boundary,” said Frank Harrell Jr., professor of biostatistics at Vanderbilt University.
If six or fewer of the first 32 cases are people who got the vaccine, that suggests the vaccine reduced COVID-19 cases by 76%. Under Pfizer’s trial rules, the company can then conclude that its vaccine is effective enough to submit its application to the FDA. If, on the other hand, 15 or more of the first 32 infections are people who got the vaccine, it would mean the vaccine doesn’t work and the study ends.
The better the vaccine works, the longer it would take to reach 32 cases, because fewer vaccinated people would get sick and more of the infections would have to occur in the placebo group.
So when exactly will Pfizer get to 32 cases?
Analysts at JPMorgan estimate that this first readout would occur on Oct. 31 if the vaccine is 70% effective, or on Nov. 2 if the vaccine is 80%. Their model also estimates that Pfizer is more than twice as likely to be able to file for approval at 80% effectiveness vs 70% effectiveness.
The JPMorgan analysts’ prediction is roughly in line with official public statements from Pfizer, though the company has projected even more confidence. “We have a good chance that we will know if the product works by the end of October,” CEO Albert Bourla said Sept. 13 on CBS’ “Face the Nation.”
The key thing we don’t know is how fast people in Pfizer’s trial are getting sick. The trial doesn’t intentionally expose people to the virus; it waits to see who catches it on their own. Even though the pandemic is far from under control, the coronavirus is not spreading as fast as it was a few months ago. The study started with a baseline assumption that just 1.3% of participants would be infected over the course of a year.
It’s possible that the thousands of people who signed up for Pfizer’s study could be getting sick faster or slower than that, depending on how bad the outbreak is where they are. If Pfizer’s trial infection rate is 1.5 to 2 times faster than publicly reported case counts, then Pfizer’s first readout could be Oct. 12-19 with a 70% effective vaccine, or Oct. 14-22 with 80% efficacy, according to JPMorgan’s model.
“When the trials started there were a lot more cases in the U.S. at that time,” said Dr. Vamil Divan, an analyst at the bank Mizuho. “That’s a key unknown. How many of these participants are enrolled in hotter areas versus New York or Boston?”
To protect the integrity of trials like this, the drugmakers running them aren’t supposed to know what the data is showing as it comes in. And yet, company executives have led some observers to believe they know how many people have tested positive for COVID-19.
“They’re making projections based on how rapidly they’re accruing data, and they probably know the total number of events,” said Susan Ellenberg, professor of biostatistics at the University of Pennsylvania.
“When they say things like that, first of all, it does some wonders for their stock prices,” she added.
In a statement, Pfizer said that it expects results “as early as the end of October” based on current infection rates. The trial, the company said, “was designed to evaluate the safety and efficacy of the vaccine candidate as fast as possible.”
“Having said that,” the company added, “neither Pfizer nor the FDA can move faster than the data we are generating through our clinical trial.”
It’s highly unlikely that the next front-runner, Moderna, could have results before the election. The JPMorgan analysts’ model suggests that infection rates would have to be four times the publicly reported rate for Moderna to be able to report results before Nov. 3.
Dr. Tal Zaks, Moderna’s chief medical officer, told investors on Sept. 17 that “some time in November is sort of a reasonable base case” for the first look at Moderna’s results. (ProPublica’s board chairman, Paul Sagan, is a member of Moderna’s board and a company stockholder.)
Other developers are further behind. AstraZeneca’s trial is paused in the U.S. while the company investigates what happened with a participant who had a bad reaction. Johnson & Johnson is just beginning its large-scale, end-stage trial, months behind the other three.
So Pfizer is the only company with a shot at results before the election. And if the company has results to share, it’s unlikely to let political implications get in the way. The company has an ethical obligation not to delay a product that is ready to save lives, despite the risk that a vaccine announced on the eve of a contentious election could stoke partisan perceptions.
“Once you have signs of a vaccine’s effectiveness, it’s very difficult to argue anything is ethical other than making it available to those most at risk,” Dr. Mani Foroohar, an analyst with the investment bank SVB Leerink, said. “But it’s also very difficult to make the argument that you should do anything that undermines public trust. That’s one of the problems when you introduce powerful political pressures into what is meant to be a boring, dry, unemotional process.”
Once Pfizer gets results, it’s poised to seek the FDA’s go-ahead swiftly.
As soon as Pfizer has conclusive data, it will submit an application to the FDA. The application will include data from all previous trials as well as proof that the company can consistently manufacture millions of vaccine doses.
Pfizer’s CEO has indicated that the company is ready to turn around its application in a flash, if not on the same day it has results. “We will try to be able to be ready to submit with the speed of light, once we have the results ready,” Bourla said at an investor presentation on Sept. 16.
Pfizer has two options when submitting its FDA application. It can apply for an EUA or a full approval, known as a biologics license application, or BLA. An EUA would only allow Pfizer to market its vaccine for the pandemic’s duration — during the declared “emergency” period that we are currently in. If the company receives full licensure, on the other hand, its product can remain on the market forever. In its statement, Pfizer said it plans to continue its study after a possible EUA to collect more long-term data.
The bar for an EUA is lower than for full approval. By law, an EUA can be issued so long as “the product may be effective in diagnosing, treating, or preventing” the disease and “the known and potential benefits of the product … outweigh the known and potential risks.” In contrast, the standard for a full approval requires a drugmaker to prove not only that the product is safe and effective, but also that the product is pure and can be consistently made, because vaccines are biological products made from living materials.
For the COVID-19 vaccine, the FDA has said that it is going to raise the bar for an EUA, going beyond the usual requirements. Previously, the FDA has said a vaccine should be at least 50% effective. The FDA is reportedly close to announcing new standards to include at least two months of monitoring the health of trial participants after they receive their second shot. That could end up being the biggest hurdle to authorizing a vaccine before the election. Trump said on Wednesday that he might reject the new guidelines, but companies and FDA officials might still choose to observe them.
In a statement, the FDA said that “for a vaccine for which there is adequate manufacturing information,” an EUA “may be appropriate once studies have demonstrated the safety and effectiveness of the vaccine but before the manufacturer has submitted and/or the FDA has completed its formal review of the biologics license application.”
Pfizer said in a statement that it anticipates providing the agency safety data, including the median of two months safety information after the second dose, on a rolling basis. The trial has enrolled more than 31,000 participants, and 19,000 have received the second dose so far, the company said.
“The standards FDA is reportedly considering for a covid vaccine EUA represent appropriate balance between speed and safety in a crisis,” Dr. Scott Gottlieb, who led the FDA earlier in the Trump administration and serves on Pfizer’s board, tweeted on Thursday. “Even under EUA; you want higher assurance of safety and benefit for vaccine given to healthy people vs. drug given to those already sick.”
“Any political effort to shortcut [the] process or degrade reasonable standards will be [a] Pyrrhic victory if people lack confidence in a vaccine,” Gottlieb added.
The FDA will thoroughly review the application, and that’ll take a while.
Once the FDA receives a company’s submission, the agency’s review process consists of several steps which, put together, could take weeks to complete.
The FDA is the only health regulator in the world that asks drugmakers for raw data files and does its own analysis, said Dr. Joshua Sharfstein, the FDA’s former principal deputy commissioner from 2009 to 2011. “Now would not be the moment to stop” that practice, he said, despite the urgent need for a vaccine.
Besides reviewing clinical trial data, the FDA also inspects vaccine developers’ manufacturing capabilities to ensure that every vaccine batch can be made consistently and that the process is squeaky clean, so that no impurities can make their way into a vial of product. This process involves a lot of paperwork sent from the companies to the agency and also, usually, on-site inspections at manufacturing plants. The agency declined to comment on whether it had already completed on-site inspections for Pfizer and Moderna.
After the FDA finishes its assessment of the company’s application, it typically presents the data to an external advisory committee in a public meeting. Dr. Peter Marks, director of the Center for Biologics Evaluation and Research, has said that the agency is committed to holding advisory committee meetings to review individual vaccine candidates.
Those meetings will take time to schedule, but it’s an essential step, according to experts both inside and outside the agency.
“How will [the public] know that we’re not, like, holding something in and sweeping something under the rug? Well, the way they’re going to know that is because any vaccine that we issue an emergency use authorization for will go to a public advisory committee meeting,” Marks said in a Sept. 10 webinar hosted by the Duke Margolis Center for Health Policy. “It’ll be critical for people to see what’s in the briefing packages, they’ll be able to see the discussion among an impartial group of advisers, they’ll see the committee recommendation and they’ll see the public dialogue that will take place at that committee.”
Advisory committee members vote on whether they recommend product approval. While the FDA does not have to follow the committee’s recommendations, the votes are public.
“It protects against political interference — it’s important,” Sharfstein said.
We contacted every advisory committee member and interviewed six of them about how they would evaluate an EUA application for a COVID-19 vaccine. These members (speaking for themselves, not for the FDA) indicated they would expect to see a level of evidence that could be tough to meet in the next 38 days.
One factor in their caution is that a premature EUA could make it harder to definitively evaluate an effective vaccine, because subjects in ongoing trials may drop out and new enrollments in trials with placebos would no longer be feasible.
“If an EUA came too soon where we don’t have sufficient clinical efficacy data, it would make it very hard to actually complete the study as written,” Dr. Paul Spearman, director of infectious diseases at Cincinnati Children’s Hospital, said. “You would want to have enough clinical efficacy data by the time of an EUA to be pretty darn certain.”
Another committee member is Dr. Archana Chatterjee, dean of the Chicago Medical School at Rosalind Franklin University of Science and Medicine. She also expressed caution about basing a hugely consequential decision on such a small number of cases, like the 32 in Pfizer’s first look.
“It’s hard for me to say with these small numbers will we have meaningful data to make a decision on,” Chatterjee said. “I have not made up my mind on any of this because I need to see and discuss with colleagues what the data are and what the implications might be.”
One option would be for the FDA to grant an EUA for a specific group of people, such as health care workers or the elderly, who are more vulnerable to COVID-19.
The data would have to support a specific vaccine use that aligns with a recognized unmet medical need, said Dr. Michael Kurilla, an advisory committee member and the director of the Division of Clinical Innovation at the National Center for Advancing Translational Sciences, part of the National Institutes of Health. For example, it’s possible a vaccine could work well in young people but not so well in older people. In that case, it might not be that beneficial, because older people are much more vulnerable to serious disease.
“It’s not simply a matter of saying we will EUA this product,” Kurilla said. “We have to be very careful to define what it is we’re trying to address.”
Dr. Paul Offit, director of the vaccine education center at the Children’s Hospital of Philadelphia, said he would like to see robust safety data, to make sure there are no neurological side effects, from Pfizer and Moderna. Both companies are developing so-called mRNA vaccines, a type of vaccine technology that has never been approved before. He noted that most people who get vaccines are healthy, so the bar for letting a vaccine go to market is necessarily much higher than for treatments intended for severely ill COVID-19 patients.
Finally, the FDA considers the committee’s advice and makes its final decision on whether it will greenlight the product. Normally, the FDA aims to review applications for full approval within 10 months for standard reviews and six months for priority reviews.
It’s unclear exactly how quickly an EUA review can be completed for the COVID-19 vaccine. The only other vaccine that has ever received an EUA was an anthrax vaccine, but it’s not a useful comparison because the vaccine was already in use and the 2005 authorization was granted to allow the US. Department of Defense to resume giving the shots to military personnel after the mandatory vaccination program had been suspended.
Some steps could potentially be skipped when doing a review for an EUA as compared with a full approval, according to McClellan, the former FDA commissioner. For example, any vaccines needed for this pandemic won’t need long-term storage, because they’ll all be used quickly, so companies won’t need to run tests and demonstrate to the agency that their vaccines can be stored for months on end. But to receive full approval, the agency might require that.
Still, McClellan estimated, the agency’s review process from the time it receives an application to issuing an EUA could take up to a month.
All of this is just to get to yes on a vaccine. Getting shots in millions of people’s arms is another story. The two vaccine front-runners from Pfizer and Moderna pose additional logistical challenges because they have to be kept frozen.
What could go wrong?
Having read through all these steps, you can start to see the points where the process could break down and how the public might find out about it.
If a company lowers the bar for efficacy. The first four vaccine contenders have all released their clinical trial rules (Pfizer, Moderna, AstraZeneca and Johnson & Johnson), so the public should be able to assess whether the shots have met the companies’ own standards to prove it works. If they unexpectedly change their schedules or the standards, that’s concerning.
If the FDA backtracks on its commitment to consult the independent advisory board, or if the agency’s leaders reject the committee’s advice, it would be a sign that they’re acting under political pressure without scientific support.
If FDA career scientists get overruled by political appointees, that would also be a major sign of political pressure. The decision on whether or not to authorize a vaccine will fall on Marks, head of the biologics division. FDA Commissioner Stephen Hahn, however, has authority to overrule Marks’ decision, and Secretary Alex Azar of the Department of Health and Human Services has the right to further overturn Hahn’s call.
If FDA officials quit. Marks has said he’d resign if the agency authorizes an unproven or unsafe vaccine.
Ultimately, the FDA and everyone involved in vaccine development are seeking the perfect balance between speed and caution: Faced with a deadly virus that’s taken the lives of more than 200,000 Americans and upended life, devastating the economy and tearing away the livelihoods of so many, of course there is an imperative not to waste any time and an urgent desire for a vaccine.
Yet a bad vaccine could do more harm than good, and even the perception of a vaccine that is not thoroughly vetted could be just as bad, if the public doesn’t feel confident in taking it.
“A vaccine only works if it’s safe, effective and administered,” meaning people have to be willing to take it, said Bruce Mehlman, a political adviser to companies at the lobbying firm Mehlman Castagnetti Rosen & Thomas. (He doesn’t represent any pharmaceutical clients.) “If it becomes another culture war football like masks, it will not help us get past the virus and return to normal.”
It’s unlikely we’ll see a vaccine authorized in October, but to ensure the shot is safe, effective, pure and trustworthy, waiting a little longer with the knowledge that no steps have been skipped may be well worth it.
In Los Angeles, more than 35% of households report serious problems with paying credit cards, loans or other bills, while the same percentage report having depleted all or most of their savings.
This article was published on Friday, September 25, 2020 in Kaiser Health News.
Working as a fast-food cashier in Los Angeles, Juan Quezada spends a lot of his time these days telling customers how to wear a mask.
“They cover their mouth but not their nose,” he said. “And we’re like, ‘You gotta put your mask on right.'”
Quezada didn’t expect to be enforcing mask-wearing. Six months ago, he was a restaurant manager, making $30 an hour, working full time and saving for retirement. But when Los Angeles County health officials shut down most restaurants in March because of the spreading pandemic, Quezada lost his job. The only work he could find pays a lot less and is part time.
“I only work three hours and four hours rather than eight or 10 or 12 like I used to work,” he said.
Quezada doesn’t know anyone who has gotten COVID-19, but the pandemic has affected nearly every aspect of his life. “I am just draining my savings — draining and draining and draining,” he said. “I have to sell my car. Uber is a luxury.” Mostly, he now bikes or rides the bus to his part-time job.
Quezada is one of hundreds of people who responded in a newly published poll by NPR, the Robert Wood Johnson Foundation and the Harvard T.H. Chan School of Public Health. Among other things, the poll, which surveyed people from July 1 to Aug. 3, found that a whopping 71% of Latino households in Los Angeles County have experienced serious financial problems during the pandemic, compared overall with 52% of Black households there and 37% of whites. (Latinos can be of any race or combination of races.)
Like Quezada, many are burning through their savings and are having a hard time paying for necessities such as food. Quezada estimated he has about six months of savings left.
In Los Angeles, more than 35% of households report serious problems with paying credit cards, loans or other bills, while the same percentage report having depleted all or most of their savings. Eleven percent of Angelenos polled said they didn’t have any savings at the start of the outbreak.
Nationally, the picture is similar. In results released last week, the poll found that 72% of Latino households around the country reported they’re facing serious financial problems, double the share of whites who said so. And 46% of Latino households reported they have used up all or most of their savings during the pandemic.
How Poverty Differs for Latinos
Nationally, the poll found that 63% of Latinos reported loss of household income either through reduced hours or wages, furloughs or job loss since the start of the pandemic.
But Latinos have kept working through the crisis, said David Hayes-Bautista, a professor of medicine and public health at UCLA.
“In Washington, the idea is you’re poor because you don’t work. That’s not the issue with Latinos,” he said. “Latinos work. But they’re poor. The problem is, we don’t pay them.”
Latinos have the highest rate of labor force participation of any group in California. In March, when state and local officials shut down many businesses, Latinos lost jobs like everyone else. But Latinos got back to work faster.
“In April, the Latino [labor force participation] rate bounced right back up and actually has continued to increase slowly, whereas the non-Latino rate is dropping,” Hayes-Bautista said. “The reward that Latinos have for their high work ethic is a high rate of poverty.”
That work ethic has also contributed to a much higher rate of COVID-19. Hayes-Bautista pointed out that in California, as in some other regions in the U.S., Latinos tend to hold many of the jobs that have been deemed essential, and that’s made them highly susceptible to the coronavirus. Latinos now account for 60% of COVID-19 cases in California, even though they’re about 40% of the population.
“These are workers usually in their prime years — peak earning power and everything else,” Hayes-Bautista said. “Latinos between 50 and 69, those are the ones that are being hit the hardest. That’s pretty worrying.”
Exposed — And Often Without Health Insurance
Nationally, according to the poll, 1 in 4 Latino households report serious problems affording medical care during the pandemic.
Many of the essential jobs that Latinos are more likely to perform — farmworker or nursing home aide or other contract work, for example — lack benefits. That means some Latinos are more exposed to the coronavirus and less likely to have health insurance because they don’t get coverage through an employer.
Others, such as Mariel Alvarez, lack health insurance because of citizenship restrictions. She lives with her parents and sisters in Los Angeles County’s San Fernando Valley. Alvarez lost her sales job and her employer-sponsored health insurance when the pandemic hit in March, she said. Then she got sick.
Eventually, her whole family was ill. Alvarez had to pay out-of-pocket to go to a CVS clinic near her home. But after a couple of $50 visits, it got too expensive.
“I just couldn’t afford to continue to go to the doctor,” she said. She suspected it was COVID-19 but was unable to get tested.
Now that she’s recovered, getting a job with health insurance is crucial because she doesn’t qualify for any state or federal support. Alvarez is undocumented and was brought to the U.S. by her parents as a child from Bolivia. She’s one of roughly 640,000 immigrants who has a permit allowing her to work and defer deportation under the Deferred Action for Childhood Arrivals program, or DACA.
“I don’t want to jeopardize that,” Alvarez said. “You’re not supposed to use any of the government assistance when you’re on that. You’re only supposed to work, and that’s it.”
The pandemic has created a big need for one job: contact tracers. So Alvarez completed a free certificate online in the hope it will give her an edge. She’s going through the application process; if she gets hired, she hopes to have benefits again.
In the meantime, she’ll do her best not to get sick.
Jackie Fortiér is a health reporter for KPCC and LAist.com.
This story is part of a partnership that includes KPCC, NPR and KHN.
The final plan clears the way for states to implement a program bringing medications across the border despite the strong objections of drugmakers and the Canadian government.
This article was published on Friday, September 25, 2020 in Kaiser Health News.
President Donald Trump, outlining his "America First Health Plan" Thursday, announced that his administration will allow the importation of prescription drugs from Canada.
The final plan clears the way for Florida and other states to implement a program bringing medications across the border despite the strong objections of drugmakers and the Canadian government.
Florida, the biggest swing state in the presidential election, is one of six states to pass laws seeking federal approval to import drugs. Trump's announcement came the same day counties in Florida began sending out vote-by-mail ballots.
Florida Gov. Ron DeSantis, a close ally of the president, is a strong advocate of importing drugs. His administration has already advertised for a contractor to run the state program and is expected to announce Tuesday which companies have bid for the three-year, $30 million state contract.
Congress has allowed drug importation since 2000 but only if the secretary of the Department of Health and Human Services certified it is safe. That has never occurred until Secretary Alex Azar did it Wednesday, according to a letter he wrote to congressional leaders.
Implementation under the administration's final rule "poses no additional risk to the public's health and safety and will result in a significant reduction in the cost of covered products to the American consumer," Azar said in the letter KHN obtained Thursday.
The rule noted, however, that HHS is unable to make any estimates about savings because it doesn't know which drugs will be imported.
Prices are cheaper north of the border because Canada limits how much drugmakers can charge for medicines. The United States lets free market dictate drug prices.
The pharmaceutical industry has long fought efforts on importation, arguing that it would disrupt the nation's supply chain and make it easier for unsafe or counterfeit medications to enter the market.
"We are reviewing the final rule and guidance that were released; however, we continue to have grave concerns with drug importation that exposes Americans unnecessarily to the dangers of counterfeit or adulterated drugs," said a spokesperson for the Pharmaceutical Research and Manufacturers of America, an industry trade group. "It is alarming that the administration chose to pursue a policy that threatens public health at the same time that we are fighting a global pandemic."
Drugmakers have suggested in the past that they might try to stop such a policy through a lawsuit.
Trump has dangled his drug importation plan in campaign speeches over the past year — and again on Thursday in North Carolina during a speech that provided a litany of his promises on health care.
"We will finally allow the safe and legal importation of drugs from Canada," Trump said. States "can go to Canada and buy your drugs for a fraction of the price" in the U.S.
"This will be a game changer for American seniors," Trump said. "We're doing it very, very quickly."
The administration proposed the regulation in December. The final rule says it takes effect in 60 days.
But individuals will not be allowed to import drugs on their own, Azar said in his letter. Instead, they will have to rely on programs run by states.
For decades, Americans have been buying drugs from Canada for personal use — either by driving over the border, ordering medication on the internet or using storefronts that connect them to foreign pharmacies. Though the practice is illegal, the FDA has generally permitted purchases for individual use.
About 4 million Americans import medicines for personal use each year, and about 20 million say they or someone in their household has done so because prices are much lower in other countries, according to surveys.
The practice has been especially common in retiree-rich Florida, where more than a dozen stores help consumers make the purchases and where numerous cities, counties and school districts assist employees with the transactions.
The administration envisions a system in which a Canadian-licensed wholesaler buys from a manufacturer of drugs approved for sale in Canada and exports the drugs to a U.S. wholesaler/importer under contract to a state.
Florida's legislation — approved in 2019 — would set up two importation programs. The first would focus on getting drugs for state programs such as Medicaid, the Department of Corrections and county health departments. State officials said they expect the program to save the state about $150 million annually.
The second program would be geared to the broader state population.
The HHS final rule said the government will "in the future" allow pharmacists to import drugs from Canada, a provision that matches the law approved by Florida in 2019.
But pharmacists in Florida and across the country oppose drug importation, saying they don't think it will ensure that counterfeit drugs are kept out of the U.S. market.
The Canadian government told HHS last spring that the country doesn't have enough drugs to spare and the Trump plan would only worsen shortages of medicines there.
The final rule said state importation programs will have flexibility to decide which drugs to import and in what quantities.
The rule also makes clear that drug manufacturers will have to provide to importers documentation guaranteeing the medications are the same drugs as those already sold in the United States. HHS could set up regulations that require drugmakers to comply. Importers will have to send drugs to labs to certify their authenticity.
In addition to Florida, the other states seeking federal permission to buy drugs from Canada are Colorado, Maine, New Hampshire, New Mexico and Vermont.
Update: This story was updated on Friday 8:50 a.m. ET to add more information on the issue of savings.
Matthew Fentress was just 25 when he passed out while stuffing cannolis as a cook for a senior living community six years ago. Doctors diagnosed him with viral cardiomyopathy, heart disease that developed after a bout of the flu.
Three years later, the Kentucky man’s condition had worsened, and doctors placed him in a medically induced coma and inserted a pacemaker and defibrillator. Despite having insurance, he couldn’t pay what he owed the hospital. So Baptist Health Louisville sued him and he wound up declaring bankruptcy in his 20s.
“The curse of being sick in America is a lifetime of debt, which means you live a less-than-opportune life,” said Fentress, who still works for the senior facility, providing an essential service throughout the coronavirus pandemic. “The biggest crime you can commit in America is being sick.”
Financial fears reignited this year when his cardiologist suggested he undergo an ablation procedure to restore a normal heart rhythm. He said hospital officials assured him he wouldn’t be on the hook for more than $7,000, a huge stretch on his $30,000 annual salary. But if the procedure could curb the frequent extra heartbeats that filled him with anxiety, he figured the price was worth it.
He had the outpatient procedure in late January and it went well.
Afterward, “I didn’t have the fear I’m gonna drop dead every minute,” he said. “I felt a lot better.”
Then the bill came.
Patient: Matthew Fentress is a 31-year-old cook at Atria Senior Living who lives in Taylor Mill, Kentucky. Through his job, he has UnitedHealthcare insurance with an out-of-pocket maximum of $7,900 — close to the maximum allowed by law.
Total Bill: Fentress owed a balance of $10,092.13 for cardiology, echocardiography and family medicine visits on various dates in 2019 and 2020. UnitedHealthcare had paid $28,920.52 total, including $27,561.37 for the care he received on the day of his procedure.
Service Provider: Baptist Health Louisville, part of the nonprofit system Baptist Health.
Medical Service: Fentress underwent cardiac ablation this year on Jan. 23. The outpatient procedure involved inserting catheters into an artery in his groin that were threaded into his heart. He also had related cardiology services, testing and visits to a primary care doctor and a cardiologist before and after the procedure.
What Gives: Fentress said he always made sure to take jobs with health insurance, “so I thought I’d be all right.”
But like nearly half of privately insured Americans under age 65, he has a high-deductible health plan, a type of insurance that experts say often leaves patients in the lurch. When he uses health providers within his insurer’s network, his annual deductible is $1,500 plus coinsurance. His out-of-pocket maximum is $7,900, more than a quarter of his annual salary.
Fentress owed around $5,000 after his 2017 hospitalization and set up a monthly payment plan but said he was sent to collections after missing a $150 payment. He declared bankruptcy after the same hospital sued him.
He faced another bill about a year later, when a panic attack sent him to the emergency room, he said. That time, he received financial aid from the hospital.
When he got the bill for his ablation this spring, he figured he wouldn’t qualify for financial aid a second time. So instead of applying, he tried to set up a payment plan. But hospital representatives said he’d have to pay $500 a month, he said, which was far beyond his means and made him fear another spiral into bankruptcy.
This precarious situation makes him “functionally uninsured,” said author Dave Chase, who defines this as having an insurance deductible greater than your savings. “It’s a lot more frequent than a lot of people realize,” said Chase, founder of Health Rosetta, a firm that advises large employers on health costs. “We’re the undisputed leaders in medical bankruptcy. It’s a sad state of affairs.”
Jennifer Schultz, an economics professor and co-director of the Health Care Management program at the University of Minnesota-Duluth, said Fentress faces a difficult financial road ahead. “Once you declare bankruptcy, your credit rating is destroyed,” she said. “It will be hard for a young person to come back from that.”
A recent survey by the Commonwealth Fund found that just over a quarter of adults 19 to 64 who reported medical bill problems or debt were unable to pay for basic necessities like rent or food sometime in the past two years. Three percent had declared bankruptcy. In the first half of 2020, the survey found, 43% of U.S. adults ages 19 to 64 were inadequately insured. About half of them were underinsured, with deductibles accounting for 5% or more of their household income, or out-of-pocket health costs, excluding premiums, claiming 10% or more of household income over the past year.
In Fentress’ case, the $10,092 he owed the hospital was more than a third of what his insurer paid for his care. The majority of his debt — $8,271.56 — was coinsurance, about 20% of the bill, which he must pay after meeting his deductible. Because the bill covered services spanning two years, he owed more than his annual out-of-pocket maximum. If all his care had been provided during 2019, he would have owed much less and the insurer would have been responsible for more of the bill.
The insurer’s payment for Fentress’ care that January day — around $27,600 — falls into the typical cost range, Gurav said. Fentress is being asked to pay $9,296, meaning the hospital would get more than $36,000 for the care.
Schultz, a state representative from Minnesota’s Democratic-Farmer-Labor Party, said nonprofit hospitals could potentially waive or reduce costs for needy patients.
“They definitely have a moral responsibility to provide a community benefit,” she said.
Resolution: Charles Colvin, Baptist Health’s vice president for revenue strategy, said hospital officials quoted Fentress an estimated price for the ablation that was within a few dollars of the final amount, although his bill included other services such as tests and office visits on various dates. Colvin said there appeared to be some charges that UnitedHealthcare didn’t process correctly, which could lower his bill slightly.
Maria Gordon Shydlo, communications director for UnitedHealthcare, said Fentress is responsible for 100% of health costs up to his annual, in-network deductible, then pays a percentage of health costs in “coinsurance” until he reaches his out-of-pocket maximum. So he will owe around $7,900 on his bill, she said, and any new in-network care will be fully covered for the rest of the year.
A hospital representative suggested Fentress apply for financial assistance. She followed up by sending him a form, but it went to the wrong address because Fentress was in the process of moving.
In September, he said he was finally going to fill out the form and was optimistic he’d qualify.
The Takeaway: Insurance performs two functions for those lucky enough to have it. First, you get to take advantage of insurers’ negotiated rates. Second, the insurer pays the majority of your medical bills once you’ve met your deductible. It pays nothing before then. High-deductible plans have the lowest premiums, so they are attractive or are the only plans many patients can afford. But understand you will be asked to pay for everything except preventive care until you’ve hit that number. And your deductible may be only part of the picture: “Coinsurance” is the bulk of what Fentress owes.
Out-of-pocket maximums are regulated by federal law. In 2021, the maximum will be $8,550 for single coverage. Try to plan treatment and procedures with an eye on the calendar — people with chronic conditions and this kind of insurance could save a lot of money if they have an expensive surgery in December rather than January.
As always, if you face a big medical bill, ask about payment plans, financial aid and charity care. According to the Baptist Health system’s website, the uninsured and underinsured can get discounts. Those with incomes equivalent to 200%-400% of the federal poverty level — or $25,520-$51,040 for an individual — may be eligible for assistance.
If you don’t qualify for help, negotiate with the hospital anyway. Arm yourself with information about the going rate insurers pay for the care you received by consulting websites like Healthcare Bluebook or Fair Health.
As Fentress tries to move past his latest bill, he’s now worried about something else: racking up new bills if he contracts COVID-19 down the road as an essential worker with existing health problems and the same high-deductible insurance.
“I don’t have hope for a financially stable future,” he said. “It shouldn’t be such a struggle.”
Dan Weissmann, host of “An Arm and a Leg” podcast, reported the radio interview of this story. Joe Neel of NPR produced Sacha Pfeiffer’s interview with KHN Editor-in-Chief Elisabeth Rosenthal on “All Things Considered.”
Bill of the Month is a crowdsourced investigation by KHN and NPR that dissects and explains medical bills. Do you have an interesting medical bill you want to share with us? Tell us about it!
The executive order signed by Democratic Gov. Gavin Newsom late Wednesday is a response to threats made to health officers across California during the coronavirus pandemic.
This article was published on Thursday, September 24, 2020 in Kaiser Health News.
SANTA CRUZ, Calif. — California will allow public health officials to participate in a program to keep their home addresses confidential, a protection previously reserved for victims of violence, abuse and stalking and reproductive health care workers.
The executive order signed by Democratic Gov. Gavin Newsom late Wednesday is a response to threats made to health officers across California during the coronavirus pandemic. More than a dozen public health leaders have left their jobs amid such harassment over their role in mask rules and stay-at-home orders.
A series examining how the U.S. public health front lines have been left understaffed and ill-prepared to save us from the coronavirus pandemic. The project is a collaboration between KHN and the AP.
"Our public health officers have all too often faced targeted harassment and stalking," wrote Secretary of State Alex Padilla in a statement. This "program can help provide more peace of mind to the public health officials who have been on the frontlines of California's COVID-19 response."
A community college instructor accused of stalking and threatening Santa Clara health officer Sara Cody was arrested in late August. The Santa Clara County sheriff said it believes the suspect, Alan Viarengo, has ties to the "Boogaloo" movement, a right-wing, anti-government group that promotes violence and is associated with multiple killings, including the murders of a federal security officer and a sheriff deputy in the Bay Area. Thousands of rounds of ammunition, 138 firearms and explosive materials were found in his home, the sheriff's office said.
In Santa Cruz County, two top health officials have received death threats, including one allegedly signed by a far-right extremist group.
In May, a member of the public read aloud the home address of former Orange County health officer Nichole Quick at a supervisors' meeting and called for protesters to go to her home. "You have seen firsthand how people have been forced to exercise their First Amendment. Be wise, and do not force the residents of this county into feeling they have no other choice than to exercise their Second Amendment," said another attendee. Quick later resigned.
Protesters angry over mask mandates and stay-at-home orders have gone to the homes of health officers in multiple counties, including Orange and Contra Costa.
The executive order would allow health officials to register with the Secretary of State's Safe at Home program. Those in the program are given an alternative mailing address to use for public records so that their home addresses are not revealed.
Threats of violence have added to the already immense pressure public health officials have experienced since the beginning of the year. Amid chronic underfunding and staffing shortages, they have been working to limit the spread of the coronavirus, while also deflecting political pressure from other officials and anger from the public over business closures and mask mandates.
"California's local health officers have been working tirelessly since the start of the pandemic, using science to guide policy," said Kat DeBurgh, the executive director of the Health Officers Association of California. "It is regrettable that this order was necessary — but we are grateful for it nevertheless."
Nationwide, at least 61 state or local health leaders in 27 states have resigned, retired or been fired since April, according to a review by The Associated Press and KHN, a figure that has doubled since the newsrooms first began tracking the departures in June.
Thirteen of those departures have been in California, including 11 county health officials and the state's two top public health officials.
Dr. Sonia Angell, former director of the California Department of Public Health and state public health officer, quit in early August after a series of glitches in the state's infectious disease reporting system caused weeks-long delays in reporting cases of COVID-19.
In Placer County, north of Sacramento, health officer Dr. Aimee Sisson resigned effective Sept. 25 after the county Board of Supervisors voted to end its local COVID-19 health emergency. "It is with a heavy heart that I submit this letter of resignation," she wrote in her resignation letter. "Today's action by the Placer County Board of Supervisors made it clear that I can no longer effectively serve in my role."
Organizations across the state have expressed concern over the treatment of health officials during the pandemic, including the California Medical Association.
"Basic science has become politicized in so many parts of our state, and our country," wrote California Medical Association president Dr. Peter N. Bretan Jr. in a statement after Sisson's departure. "Public health officers are public servants who seek to do what their job description states — to protect public health."
The executive order also directs the state to assess impacts of the pandemic on health care providers and health care service plans, and halts evictions for commercial renters through March 31, 2021, among other pandemic-related matters.
KHN and California Healthline correspondent Angela Hart contributed to this report.
Shielding the identities of clinicians and statisticians on the board is meant to insulate them from pressure by the company sponsoring the trial, government officials or the public.
This article was published on Thursday, September 24, 2020 in Kaiser Health News.
Most Americans have never heard of Dr. Richard Whitley, an expert in pediatric infectious diseases at the University of Alabama-Birmingham.
Yet as the coronavirus pandemic drags on and the public eagerly awaits a vaccine, he may well be among the most powerful people in the country.
Whitley leads a small, secret panel of experts tasked with reviewing crucial data on the safety and effectiveness of coronavirus vaccines that U.S. taxpayers have helped fund, including products from Moderna, AstraZeneca, Johnson & Johnson and others. The data and safety monitoring board — known as a DSMB — is supposed to make sure the medicine is safe and it works. It has the power to halt a clinical trial or fast-track it.
Shielding the identities of clinicians and statisticians on the board is meant to insulate them from pressure by the company sponsoring the trial, government officials or the public, according to multiple clinical trial experts who have served on such panels. That could be especially important in the pressure-cooker environment of COVID vaccine research, fueled by President Donald Trump's promises to deliver a vaccine before Election Day.
As pharmaceutical companies work to produce one as quickly as possible, the board's anonymity has stirred concerns that the cloak of secrecy could, paradoxically, allow undue influence. Whitley, for example, represents the specialized world these experts inhabit — a professor revered in academia who also is paid by the drug industry.
Any political pressure to rush pharmaceutical companies or lean on federal regulators to prematurely greenlight a vaccine would undermine a system put in place to ensure public safety. Calls are growing for companies and the government to be more open about who's involved in reviewing the vaccine trials and whether board members have any conflicts of interest.
"We want to know they're truly independent," said Dr. Eric Topol, director of the Scripps Research Translational Institute and a specialist in clinical trials. "The lack of transparency is exasperating."
Data and safety monitoring boards have existed for decades to vet new drugs and vaccines, acting as a backstop to help ensure unsafe products don't make their way to the public. Typically, there's one board for each product. This time, a joint DSMB with 10 to 15 experts will review unblinded data across trials for multiple coronavirus vaccines whose development the U.S. government has helped fund, according to five people involved in the Trump administration's Operation Warp Speed or other coronavirus vaccine work. It is run through the National Institute of Allergy and Infectious Diseases at the National Institutes of Health and consists of outside scientists and statistical experts, not federal employees, NIH Director Francis Collins said on a call with reporters.
"Until they are convinced that there's something there that looks promising, nothing is unblinded and sent to the FDA," Collins said. "I doubt if there have been very many vaccine trials ever that have been subjected to this size and the rigor with which it's being evaluated."
The NIH safety board oversees trials in the U.S. from Moderna, Johnson & Johnson and AstraZeneca, U.S. officials and others involved in Operation Warp Speed said, but not Pfizer, which is fully funding its clinical trial work and established its own five-member safety panel. Pfizer has attested that it can conclusively determine by late October the effectiveness of its vaccine, being jointly developed with German company BioNTech. It secured a $1.95 billion purchase agreement with the Department of Health and Human Services for the first 100 million doses produced. The agreement gives HHS the option to buy an additional 500 million doses.
Moderna, Johnson & Johnson and AstraZeneca, which have either started or are aiming to soon begin large-scale trials in the U.S. involving thousands of patients, collectively have received more than $2 billion in government funds for vaccine development; billions more have been meted out under agreements similar to the HHS contract with Pfizer to buy millions of vaccine doses. Having one safety board oversee multiple trials could allow researchers to better understand the field of products and apply consistency across evaluations, clinical trial experts said in interviews.
One big advantage "could be more standardization," said Dr. Walter Orenstein, associate director of the Emory Vaccine Center at Emory University and a former senior official at the Centers for Disease Control and Prevention. "They can look at that data and look at all the trials instead of just doing one trial."
But it also means that one board has an outsize influence to dictate which coronavirus vaccines eventually succeed or come to a halt, all while most of their identities remain secret. The NIH declined to name them, saying they were "confidential" and could be identified only once a study was complete.
One exception to the mystery is Whitley, who was appointed as chair by Dr. Anthony Fauci, the nation's top infectious disease official. Fauci said that following a "combination of input from us and from him and other colleagues, the people who had the greatest expertise in a variety of areas, including statistics, clinical trials, vaccinology, immunology, clinical work," were selected for the panel.
Whitley's role became public when his university announced it, an unusual move. He is a professor as well as a board member of Gilead Sciences, which recently signed a contractwith Pfizer to manufacture remdesivir to treat COVID-19 patients. Whitley, who's been on Gilead's board since 2008, conducted research that led to remdesivir's development.
In 2019, he was paid roughly $430,000 as a Gilead board member, according to documents filed with the Securities and Exchange Commission. That same year, he received more than $7,700 in payments from GlaxoSmithKline for consulting, food and travel, according to a federal database that tracks drug and device company payments to physicians.
GlaxoSmithKline and Sanofi are jointly developing a vaccine that's received $2 billion from the U.S. government under Operation Warp Speed; however, Whitley, through a university spokesperson, said his DSMB has not seen any GlaxoSmithKline COVID protocols. The companies have yet to begin phase 3 trials. Although he chairs a separate GSK data and safety monitoring board for a pediatric vaccine, he was vetted and cleared by the NIH conflict-of-interest committee with its knowledge of his involvement, the spokesperson said.
"When handled responsibly, it is appropriate for physicians to collaborate with external entities," said UAB spokesperson Beena Thannickal, saying the university works with physicians to ensure that industry engagement is appropriate. "It facilitates a critical exchange of knowledge and accelerates and advances clinical treatments and cures, and it fuels discovery."
Multiple experts praised his skill — Dr. Walter Straus, an associate vice president at the drug company Merck & Co., said Whitley is an "éminence grise" in pediatrics whom people trust.
"I actually trust that process, and the fact that they asked Rich to do it makes me feel reassured because he's so good," said Dr. Jeanne Marrazzo, director of the University of Alabama-Birmingham's division of infectious diseases.
Multiple scientists who have participated in data and safety monitoring boards maintain it's important to keep the board anonymous to shield them against pressure or even for their safety. For example, when trials were conducted in San Francisco for HIV/AIDS research, the board was confidential to protect members from patients desperate for treatment, said Susan Ellenberg, a professor of biostatistics, medical ethics and health policy at the University of Pennsylvania who's written extensively on the history of DSMBs.
If approached by a patient, it "would be very hard to tell you, 'Oh I can't help you.' It's an unreasonable burden," said Ellenberg, who said she was involved in coronavirus-related safety boards but would not name them.
As part of a large-scale clinical trial, the DSMB and a statistician or team that prepares data for those individuals are generally the only ones who see unblinded data about the trial, making it clear who is getting what treatment. A firewall is set up between them and executives from the sponsoring company with financial interests in the trial. The companies sponsoring COVID vaccine trials are not part of any closed sessions during which unblinded data is reviewed. Those are limited to members of the DSMB, the NIAID executive secretary and the independent unblinded statistician who is presenting the data, a NIAID spokesperson said.
DSMB members or their family members should have no professional, proprietary or financial relationship with the sponsoring companies, and the NIAID DSMB executive secretary vetted all members for potential conflicts of interest, NIAID said in response to questions from KHN. Members are paid $200 per meeting.
"It's generally done out of a sense of public service," said Dr. Larry Corey of the Fred Hutchinson Cancer Research Center, who is working with NIH officials to oversee the U.S. coronavirus vaccine clinical trials. "You're doing it because of your sense of altruism and obligation to knowing the important role it plays in clinical research and the important role it plays in preserving the scientific integrity of important trials."
Moderna, AstraZeneca, Johnson & Johnson and Pfizer have each released protocols that include details on when their DSMBs would review unblinded information about trial participants, and at what points they could recommend pausing or stopping trials. The vaccine data and safety board organized by NIAID advises a broader oversight group consisting of the drug companies sponsoring the trial and representatives from NIAID and HHS' Biomedical Advanced Research and Development Authority that reviews the DSMB recommendations. Ultimately, the drug company has final authority over whether to submit its data to the Food and Drug Administration.
Moderna and Johnson & Johnson are each aiming for their vaccines to have 60% efficacy, which means there would need to be 60% fewer COVID cases among vaccinated individuals in their trials. AstraZeneca's target is 50%. The FDA has said any coronavirus vaccine must be at least 50% effective to secure approval from regulators. While the parameters of their clinical trials have similarities, there are some differences, including when and how many times the DSMB can conduct interim reviews to assess whether each vaccine works.
Pfizer is similarly aiming for its vaccine to be 60% effective. The company allows for four interim reviews of the data starting at 32 cases — a schedule that has been criticized by some researchers who contend it makes it easier for the company to stop the trial prematurely.
Pfizer declined to name the individuals on its monitoring committee, saying only that the group consisted of four people "with extensive experience in pediatric and adult infectious diseases and vaccine safety" and one statistician with a background in vaccine clinical trials. An unblinded team supporting its data-monitoring committee — which includes a medical monitor and statistician — will review severe cases of COVID-19 as they are received and any adverse events associated with the trial at least weekly.
"There is an irresolvable tension between speed and safety," said Dr. Gregory Poland, the head of Mayo Clinic's Vaccine Research Group. "Efficacy is pretty easy to figure out. It's safety that's the issue."
California Healthline editor Arthur Allen contributed to this report.
Reopening colleges drove a coronavirus surge of about 3,000 new cases a day in the United States, according to a draft study released Tuesday.
The study, done jointly by researchers at the University of North Carolina-Greensboro, Indiana University, the University of Washington and Davidson College, tracked cellphone data and matched it to reopening schedules at 1,400 schools, along with county infection rates.
"Our study was looking to see whether we could observe increases both in movement and in case count — so case reports in counties and all over the U.S.," said Ana Bento, an infectious disease expert and assistant professor at Indiana University's School of Public Health.
"Then we tried to understand if these were different in counties where, of course, there were universities or colleges, and particularly, to see if these increases were larger in magnitude in colleges with face-to-face instruction primarily," she said.
Nearly 900 of those schools opened primarily with in-person classes, according to the draft study.
The research examines the period from July 15 to Sept. 13. It does not name specific institutions or locations, but researchers found a correlation between schools that attempted in-person instruction and greater disease transmission rates.
Just reopening a university added 1.7 new infections per day per 100,000 people in a county, and teaching classes in person was associated with a 2.4 daily case rise, the study found.
"No such increase is observed in counties with no colleges, closed colleges or those that opened primarily online," the study says.
Factoring in whether students came from places where disease incidence was high added 1.2 daily cases per 100,000 people.
Daily new case counts nationwide during the study period ranged from a high of 70,000 to a low of 30,000, according to data compiled by The New York Times.
The authors are not calling it a mistake for colleges to have opened, considering the many variables each school faced. But earlier reporting on reopening plans around the country found a welter of chaotic efforts that did not conform to a single standard, suggesting the potential for disaster when students returned.
In fact, numerous reports surfaced around the country showing frightening COVID spikes in college towns, often blamed on partying by students. Even at the University of Illinois, a school lauded for its preparations and robust testing, more than 2,000 cases have been reported on campus since students went back last month. Cases there peaked about a week after classes began and have fallen since then.
The authors are not faulting irresponsible young people, either, since they studied class instruction methods, not behavior off campus, where some students have acted extremely poorly.
"I think that it's slightly unfair, perhaps, to say, 'Oh, students are congregating and creating these bad behaviors that lead to outbreaks,'" Bento said. "I think it's more this idea of when you see a huge influx from all over the country, or from different counties, into a college town that we know had a very low burden of COVID throughout the first months, all of a sudden we have this increased probability of infection, because we have a large community of individuals that were susceptible still."
Rather than lay blame, she said, the idea of the study was to measure the problem and then use that data to better figure out how to respond, which is the subject of a future study.
"In order for you to open online, hybrid or meet face to face, there needs to be a different combination of strategies that allows you to catch [cases] early so you're able to control community spread, which is the biggest problem here," Bento said.
The researchers hope to have that work done relatively soon, well before colleges start spring semesters.
There are some unanswered questions, such as how much of the surge in cases is simply from sick students testing positive when they arrive versus catching COVID-19 after they arrive — and how much students spread the virus to the community or the other way around.
Another is how well specific types of responses mitigated the spread, and whether different local safety measures helped or hurt.
And there is an alarming caveat: The work almost certainly did not capture the full extent of the campus-linked surge.
"While this study estimates around a 3,000 increase in daily cases, we have to take into account that this is actually likely an underestimate, because we still don't see" people who are asymptomatic, Bento said.
At issue is the degree to which the virus is airborne ― capable of spreading through tiny aerosol particles lingering in the air ― or primarily transmitted through large, faster-falling droplets.
This article was published on Wednesday, September 23, 2020 in Kaiser Health News.
Front-line healthcare workers are locked in a heated dispute with many infection control specialists and hospital administrators over how the novel coronavirus is spread ― and therefore, what level of protective gear is appropriate.
At issue is the degree to which the virus is airborne ― capable of spreading through tiny aerosol particles lingering in the air ― or primarily transmitted through large, faster-falling droplets from, say, a sneeze or cough. This wonky, seemingly semantic debate has a real-world impact on what sort of protective measures healthcare companies need to take to protect their patients and workers.
The Centers for Disease Control and Prevention injected confusion into the debate Friday with guidance putting new emphasis on airborne transmission and saying the tiny aerosol particles, as well as larger droplets, are the "main way the virus spreads." By Monday that language was gone from its website, and the agency explained that it had posted a "draft version of proposed changes" in error and that experts were still working on updating "recommendations regarding airborne transmission."
KHN and The Guardian are tracking healthcare workers who died from COVID-19 and writing about their lives and what happened in their final days.
Dr. Anthony Fauci, the top U.S. infectious disease expert, addressed the debate head-on in a Sept. 10 webcast for the Harvard Medical School, pointing to scientists specializing in aerosols who argued the CDC had "really gotten it wrong over many, many years."
"Bottom line is, there's much more aerosol [transmission] than we thought," Fauci said.
The topic has been deeply divisive within hospitals, largely because the question of whether an illness spreads by droplets or aerosols drives two different sets of protective practices, touching on everything from airflow within hospital wards to patient isolation to choices of protective gear. Enhanced protections would be expensive and disruptive to a number of industries, but particularly to hospitals, which have fought to keep lower-level "droplet" protections in place.
The hospital administrators and epidemiologists who argue that the virus is mostly droplet-spread cite studies that show it spreads to a small number of people, like a cold or flu. Therefore, N95 respirators and strict patient isolation practices aren't necessary for routine care of COVID-19 patients, those officials say.
On the other side are many occupational safety experts, aerosol scientists, front-line healthcare workers and their unions, who are quick to note that the novel coronavirus is far deadlier than the flu ― and argue that the science suggests that high-quality, and costlier, N95 respirators should be required for routine COVID-19 patient care.
The highly protective respirators have been in short supply nationwide and have soared in price, from about $1 to $7 each. Meanwhile, research has shown high rates of asymptomatic virus transmission, putting N95s in high demand among front-line healthcare workers in virtually every setting.
The debate has come to a head at hospitals from coast to coast, as studies have emerged showing that live virus hangs in COVID-19 patients' hospital rooms even in the absence of "aerosol-generating" procedures (such as intubations or breathing treatments) and has contributed to outbreaks at a nursing home, shuttle bus and choir practice.
KHN and The Guardian U.S. are examining more than 1,200 healthcare worker deaths from COVID-19, including many in which their family or colleagues reported they worked with inadequate personal protective gear.
Yet some front-line workers and managers disagree about exactly how and why healthcare workers are getting sick.
The hospital infection-control and epidemiology leaders cite studies suggesting that many healthcare workers are contracting the virus outside of work and at rates that mirror what's happening in their communities.
A group of Penn Medicine epidemiologists in late July characterized research on aerosol transmission as unconvincing and cited "extensive published evidence from across the globe" showing the "overwhelming majority" of coronavirus spread is "via large respiratory droplets."
Unions, occupational health researchers and aerosol scientists, though, reference another pile of studies showing healthcare workers have been hit far harder than average people ― and a study that showedactive viral particles can drift in the air up to 15 feet from a patient in a hospital room. Such particles can hang in the air for up to three hours.
Backing their concerns, a July 6 letter signed by 239 scientists urged the medical community and World Health Organization to recognize "the potential for airborne spread of Covid-19."
The letter pointed to studies that say talking, exhaling and coughing emit tiny particles that remain suspended in the air far longer than droplets and "pose a risk of exposure."
In one ward of a Dutch nursing home with recirculated air, researchers found that 81% of the residents were diagnosed with COVID-19. Half of the workers on the ward ― who all wore surgical masks during patient care but not during breaks ― also tested positive for the virus.
Although researchers couldn't exclude transmission by another method, the "near-simultaneous detection" of the virus among nearly all the residents pointed to aerosol spread.
The idea that the virus is spread by either droplets or aerosols is an oversimplification, said Dr. Shruti Gohil, associate medical director of epidemiology and infection prevention at the University of California-Irvine School of Medicine.
Gohil said it's more of a spectrum, with the virus being transmitted by some droplets and some large aerosol particles as well.
One metric people in the hospital infection-control field focus on, though, is how many people one sick person infects. For COVID-19, research has shown that the number is about two ― similar to a cold or the flu. For an unequivocally airborne disease like measles, the number is closer to 12 to 18.
Measles is "what airborne [transmission] looks like," Gohil said. "If this was truly a primary aerosol-transmissible disease, we'd be in a world of hurt."
Hospital epidemiologists are also focused on the rate of household spread of the novel coronavirus. With the measles, the risk of an unvaccinated member of a household getting sick is 85%, said Dr. Rachael Lee, a hospital epidemiologist and assistant professor at the University of Alabama-Birmingham. For COVID-19, she said, the risk is closer to 10%.
Though the virus is believed to be spread more by droplets than aerosol particles, Lee said, staffers at UAB University Hospital wear an N95 respirator for an extra layer of protection and because the patients require so many breathing treatments or procedures considered "aerosol-generating."
Such practices are not universal. At the University of Iowa's hospital, healthcare workers use N95s and face shields for aerosol-generating procedures but otherwise use surgical masks and face shields for routine care of COVID patients, said Dr. Daniel Diekema, director of the division of infectious diseases at the university.
He said such "enhanceddroplet precautions" are working. Places where workers are correctly using regular medical masks and face shields are findingno significant spread of the disease among staffers, although one such report focused on the spread from a single patient.
Elsewhere, patients have also been safe on floors where COVID-19 patients and those without the virus have been placed in adjacent rooms ― a practice those concerned about aerosol spread do not endorse.
"It's not an airborne disease the way measles or tuberculosis is," said Dr. Shira Doron, an epidemiologist at Tufts Medical Center in Boston and an assistant professor at Tufts medical school. "We know because we don't see outbreaks that affect multiple patients on a floor."
Origin of the Debate
The CDC helped set the stage for the current debate. In March, the agency issued revised guidance essentially saying it was "acceptable" for healthcare workers to use surgical masks ― instead of N95s ― for routine care. The guidance said respiratory droplets were the most likely source of transmission and recommended N95s only for aerosol-generating procedures.
"The contribution of small respirable particles, sometimes called aerosols or droplet nuclei, to close proximity transmission is currently uncertain. However, airborne transmission from person-to-person over long distances is unlikely," according to the guidance.
The California Hospital Association sent a letter to the state's congressional delegation urging the revised guidance be made permanent.
"We need the CDC to clearly, not conditionally, move from airborne to droplet precautions for patients and healthcare workers," the letter said. Doing so would enable hospitals to preserve PPE supplies and limit the use of special isolation rooms for COVID patients.
An association spokesperson told KHN that the group wasn't weighing in on the science, merely pressing for clarity of the rules.
Christopher Friese, professor of nursing, health management and policy at the University of Michigan, is among the experts who think those rules have endangered healthcare workers.
"We lost a tremendous amount of time and, candidly, lives because the early guidance was to wear N95s only for those specific procedures," Friese said.
Family members and union leaders from Missourito Michigan to Californiahave raised concerns about nurses dying of COVID-19 after caring for virus patients without N95 respirators. In such cases, hospitals have said they followed CDC guidance.
Friese echoed some occupational safety experts who suggested stronger guidance from the CDC early on calling the disease airborne might have had an impact ― perhaps pressuring President Donald Trump to invoke the Defense Production Act to boost supplies of N95s so "we might have the supply we need everywhere we need," Friese said.
Surveys across the country show there's still a shortage of personal protective equipment at many healthcare facilities.
The CDC guidance posted Friday would have put pressure on some hospitals to bolster their protective measures, something they have reportedly resisted. It said the virus can spread when a person sings, talks or breathes.
"These particles can be inhaled into the nose, mouth, airways, and lungs and cause infection," the site said. "This is thought to be the main way the virus spreads."
By Monday morning, the website was back to saying the virus mainly spreads through droplets, noting that draft language had been posted in error.
The University of Nebraska Medical Center has been taking so-called airborne precautions from the start. There, Dr. James Lawler, a physician and director of the Global Center for Health Security at the university, said his colleagues documented that the virus can drift in the air and live on surfaces at an extensive distance from patients.
He said the hospital tests all admitted patients for the virus and keeps COVID-19 patients apart from the general population. He said they pay close attention to cleaning shared spaces and monitoring airflow within the restricted-access unit. Workers also had N95 respirators or PAPRS, which are fitted hoods with filtered air pumped in.
All of it has added up to a "very low" rate of healthcare worker infections.
Amid uncertainty about the virus, and as an unprecedented number of healthcare workers are dying, adopting the "highest possible" forms of protection seems the best course, said Betsy Marville, nurse organizer for the 1199SEIU United Healthcare Workers East union in Florida.
That would mean a departure from CDC guidelines that now say healthcare workers need an N95 respirator only for "aerosol-generating" procedures, like intubations or other breathing treatments. She said the rule has left the nurses she represents in Florida scrambling for protective gear ― or unprotected ― when patients need such treatments urgently.
"You don't leave your patient in distress and go looking for a mask," she said. "That's crazy."
If the executive branch were to overrule the FDA's scientific judgment, a vaccine of limited efficacy and, worse, unknown side effects could be rushed to market.
This article was published on Monday, September 21, 2020 inKaiser Health News.
In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.
It would reflect another attempt by a norm-breaking administration, poised to ram through a Supreme Court nominee opposed to existing abortion rights and the Affordable Care Act, to inject politics into sensitive public health decisions. Trump has repeatedly contradicted the advice of senior scientists on COVID-19 while pushing controversial treatments for the disease.
If the executive branch were to overrule the FDA’s scientific judgment, a vaccine of limited efficacy and, worse, unknown side effects could be rushed to market.
The worries intensified over the weekend, after Alex Azar, the administration’s secretary of Health and Human Services, asserted his agency’s rule-making authority over the FDA. HHS spokesperson Caitlin Oakley said Azar’s decision had no bearing on the vaccine approval process.
Vaccines are typically approved by the FDA. Alternatively, Azar — who reports directly to Trump — can issue an emergency use authorization, even before any vaccines have been shown to be safe and effective in late-stage clinical trials.
“Yes, this scenario is certainly possible legally and politically,” said Dr. Jerry Avorn, a professor of medicine at Harvard Medical School, who outlined such an event in the New England Journal of Medicine. He said it “seems frighteningly more plausible each day.”
Vaccine experts and public health officials are particularly vexed by the possibility because it could ruin the fragile public confidence in a COVID-19 vaccine. It might put scientific authorities in the position of urging people not to be vaccinated after years of coaxing hesitant parents to ignore baseless fears.
Physicians might refuse to administer a vaccine approved with inadequate data, said Dr. Preeti Malani, chief health officer and professor of medicine at the University of Michigan in Ann Arbor, in a recent webinar. “You could have a safe, effective vaccine that no one wants to take.” A recent KFF poll found that 54% of Americans would not submit to a COVID-19 vaccine authorized before Election Day.
After this story was published, an HHS official said that Azar “will defer completely to the FDA” as the agency weighs whether to approve a vaccine produced through the government’s Operation Warp Speed effort.
“The idea the Secretary would approve or authorize a vaccine over the FDA’s objections is preposterous and betrays ignorance of the transparent process that we’re following for the development of the OWS vaccines,” HHS chief of staff Brian Harrison wrote in an email.
White House spokesperson Judd Deere dismissed the scientists’ concerns, saying Trump cared only about the public’s safety and health. “This false narrative that the media and Democrats have created that politics is influencing approvals is not only false but is a danger to the American public,” he said.
Usually, the FDA approves vaccines only after companies submit years of data proving that a vaccine is safe and effective. But a 2004 law allows the FDA to issue an emergency use authorization with much less evidence, as long as the vaccine “may be effective” and its “known and potential benefits” outweigh its “known and potential risks.”
Many scientists doubt a vaccine could meet those criteria before the election. But the terms might be legally vague enough to allow the administration to take such steps.
Moncef Slaoui, chief scientific adviser to Operation Warp Speed, the government program aiming to more quickly develop COVID-19 vaccines, said it’s “extremely unlikely” that vaccine trial results will be ready before the end of October.
Trump, however, has insisted repeatedly that a vaccine to fight the pandemic that has claimed 200,000 American lives will be distributed starting next month. He reiterated that claim Saturday at a campaign rally in Fayetteville, N.C.
The vaccine will be ready “in a matter of weeks,” he said. “We will end the pandemic from China.”
Although pharmaceutical companies have launched three clinical trials in the United States, no one can say with certainty when those trials will have enough data to determine whether the vaccines are safe and effective.
Officials at Moderna, whose vaccine is being tested in 30,000 volunteers, have said their studies could produce a result by the end of the year, although the final analysis could take place next spring.
Pfizer executives, who have expanded their clinical trial to 44,000 participants, boast that they could know their vaccine works by the end of October.
AstraZeneca’s U.S. vaccine trial, which was scheduled to enroll 30,000 volunteers, is on hold pending an investigation of a possible vaccine-related illness.
Scientists have warned for months that the Trump administration could try to win the election with an “October surprise,” authorizing a vaccine that hasn’t been fully tested. “I don’t think people are crazy to be thinking about all of this,” said William Schultz, a partner in a Washington, D.C., law firm who served as a former FDA commissioner for policy and as general counsel for HHS.
“You’ve got a president saying you’ll have an approval in October. Everybody’s wondering how that could happen.”
In an opinion piece published in The Wall Street Journal, conservative former FDA commissioners Scott Gottlieb and Mark McClellan argued that presidential intrusion was unlikely because the FDA’s “thorough and transparent process doesn’t lend itself to meddling. Any deviation would quickly be apparent.”
But the administration has demonstrated a willingness to bend the agency to its will. The FDA has been criticized for issuing emergency authorizations for two COVID-19 treatments that were boosted by the president but lacked strong evidence to support them: hydroxychloroquine and convalescent plasma.
Azar has sidelined the FDA in other ways, such as by blocking the agency from regulating lab-developed tests, including tests for the novel coronavirus.
Although FDA Commissioner Stephen Hahn told the Financial Times he would be willing to approve emergency use of a vaccine before large-scale studies conclude, agency officials also have pledged to ensure the safety of any COVID-19 vaccines.
A senior FDA official who oversees vaccine approvals, Dr. Peter Marks, has said he will quit if his agency rubber-stamps an unproven COVID-19 vaccine.
“I think there would be an outcry from the public health community second to none, which is my worst nightmare — my worst nightmare — because we will so confuse the public,” said Dr. Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, in his weekly podcast.
Still, “even if a company did not want it to be done, even if the FDA did not want it to be done, he could still do that,” said Osterholm, in his podcast. “I hope that we’d never see that happen, but we have to entertain that’s a possibility.”
But Trump would have to sue a company to enforce the Defense Production Act, and the company would have a strong case in refusing, said Lawrence Gostin, director of Georgetown’s O’Neill Institute for National and Global Health Law.
Also, he noted that Trump could not invoke the Defense Production Act unless a vaccine were “scientifically justified and approved by the FDA.”
Officially, the total repayment of the loan is due this month. Otherwise, federal regulators will stop reimbursing the hospitals for Medicare patients' treatments until the loan is repaid in full.
This article was published on Tuesday, September 22, 2020 in Kaiser Health News.
Note to Readers: Sarah Jane Tribble spent more than a year and halfreporting on a small town in Kansas that lost its only hospital. This month, KHN and St. Louis Public Radio will launch "Where It Hurts," a podcast exploring the often painful cracks growing in America's health system that leave people vulnerable — and without the care they need. Season One is "No Mercy," focusing on the hospital closure in Fort Scott, Kansas — and what happens to the people left behind, surviving the best way they know how. You can listen to Episode One on Tuesday, Sept. 29.
David Usher is sitting on $1.7 million he's scared to spend.
The money lent from the federal government is meant to help hospitals and other healthcare providers weather the COVID-19 pandemic. Yet some hospital administrators have called it a payday loan program that is now, brutally, due for repayment at a time when they still need help.
Coronavirus cases have "picked up recently and it's quite worrying," said Usher, chief financial officer at the 12-bed Edwards County Medical Center in rural western Kansas. Usher said he would like to use the money to build a negative-pressure room, a common strategy to keep contagious patients apart from those in the rest of the hospital.
But he's not sure it's safe to spend that cash. Officially, the total repayment of the loan is due this month. Otherwise, according to the loan's terms, federal regulators will stop reimbursing the hospitals for Medicare patients' treatments until the loan is repaid in full.
The federal Centers for Medicare & Medicaid Services has not yet begun trying to recoup its money, with the coronavirus still affecting communities nationwide, but hospital leaders fear it may come calling for repayment any day now.
Hospital leaders across the country said there has been no communication from CMS on whether or when they will adjust the repayment deadline. A CMS spokesperson had not responded to questions by press time.
"It's great having the money," Usher said. "But if I don't know how much I get to keep, I don't get to spend the money wisely and effectively on the facility."
Usher took out the loan from Medicare's Accelerated and Advance Payments program. The program, which existed long before the pandemic, was generally used sparingly by hospitals faced with emergencies such as hurricanes or tornadoes. It was expanded for use during the coronavirus pandemic — part of billions approved in federal relief funds for healthcare providers this spring.
A full repayment of a hospital's loan is technically due 120 days after it was received. If it is not paid, Medicare will stop reimbursing claims until it recoups the money it is owed — a point spelled out in the program's rules. Medicare reimburses nearly $60 billion in payments to healthcare providers nationwide under Medicare's Part A program, which makes payments to hospitals.
More than 65% of the nation's small, rural hospitals — many of which were operating at a deficit before the pandemic — jumped at the Medicare loans when the pandemic hit because they were the first funds available, said Maggie Elehwany, former vice president of government affairs for the National Rural Health Association.
CMS halted new loan applications to the program at the end of April.
"The pandemic has simply gone on longer than anyone anticipated back in March," said Joanna Hiatt Kim, vice president of payment policy and analysis for the American Hospital Association. The trade association sent a letter to CMS in late July asking for a delay in the recoupment.
On Monday, the House Appropriations Committee included partial relief for all hospitals in a new government funding plan. The committee's proposal would extend the start of the repayment period for hospitals and the amount of time they are allowed to take to repay.
The continuing resolution that includes this language about relief for hospitals (among many, many other things) is still being hammered out, though it does face its own deadline: It must be approved by the House and the Senate within the next nine days or the federal government faces a shutdown.
Tom Nickels, executive vice president at the AHA, said his organization appreciates the House committee's effort to address the loans in the new bill, but full forgiveness of the loans is still needed.
Sen. Jeanne Shaheen (D-N.H.) has called for changes to the loan repayment period for months and said Monday "our work is far from over."
"We are still in the middle of this crisis — from both health and economic standpoints," Shaheen said.
Meanwhile, hospital administrators like Peter Wright are holding their breath, waiting to see if, in order to settle the debt, Medicare will stop making payments to hospitals, even as facilities continue to grapple with coronavirus in their communities.
"The feds, if you owe them money, they just take it," said Wright, who oversees two small hospitals for Central Maine Healthcare in Bridgton, Maine. He said his healthcare system took the money because "we had no other choice; it was a cash flow issue."
For many hospitals, Medicare payments make up 40% or more of their revenue. Not being reimbursed by Medicare would be crippling — akin to a household losing nearly half its income.
"We have no idea what we're going to do if we have to pay it back as quickly as they say," Wright said.
In rural Kentucky, hospital executive Sheila Currans said she "vacillated" for about a week or so trying to decide whether to tap the loan program for her hospital — she knew it would have to be repaid and worried that could prove difficult.
"It was a desperate time," said Currans, chief executive of Harrison Memorial Hospital in Cynthiana, Kentucky. Harrison Memorial was the first hospital in Kentucky to treat a COVID-19 patient in early March, she said.
The hospital immediately quarantined dozens of staff members and shut down elective procedures. And with COVID confirmed in the community, there was a "horrible fear," Currans said, of getting infected that kept people from seeking outpatient care as well.
"Through March and April and most of May, I was in a complete spiral," Currans said. By the end of April, Currans said, her hospital was losing millions of dollars. To cope with the pandemic, she furloughed staff and turned one wing of the hospital into a "cough clinic" to be used exclusively by patients whose symptoms suggested they might be infected with the coronavirus.
Currans said the hospital is still seeing COVID cases, but patients are beginning to return for other services, such as outpatient clinics.
In terms of the hospital's finances, "it's still not a wonderful time," Currans said. The Medicare loan "as well as all the other support from the federal government helped us at least — for now — survive it."
She's hoping the repayment demand will be pushed back to 2021 or, perhaps the loan will be forgiven.
"I know it's a pipe dream," Currans said. "But this has been a historic event."