Lincoln County largely was spared from outbreaks of the novel coronavirus at the beginning. But by the fall, cases began to climb in the county along with the rest of Montana.
This article was published on Monday, October 12, 2020 in Kaiser Health News.
LIBBY, Mont. — Frank Fahland has spent most days since the pandemic began at the site of his dream house, working to finish a 15-year labor of love while keeping away from town and the people closest to him.
Like thousands of people from Libby and Lincoln County in the far northwestern corner of Montana, the 61-year-old Fahland has scarred lungs after years of breathing in asbestos fibers from dust and soil contaminated by the town's now-defunct plant that produced vermiculite, a mineral used in insulation and gardening.
Fahland recently gave a visitor a tour of his partially finished log home overlooking a meadow that stretches to the foothills of the Cabinet Mountains. He struggled to climb a small hill and stopped to reach for his inhaler.
"It feels like someone is standing on your chest, or almost like someone stuffed a pillow down there in your lung," he said.
Fahland's condition makes him more vulnerable to complications from COVID-19, so he's keeping his distance from people in hopes of avoiding infection. He hasn't visited his son and granddaughter in months and he recently wrote his will.
He's not alone in taking such precautions. Lincoln County has one of the nation's highest asbestos mortality rates. At least 400 people have died from asbestos-related diseases, which can include asbestosis, mesothelioma and lung cancer. At least 1 in 10 people in Libby have an asbestos-related illness, said Miles Miller, a physician assistant at the Center for Asbestos Related Disease.
"Our patients having an underlying lung disease that would make recovery from COVID-19 more difficult," Miller said.
Lincoln County, population 20,000, largely was spared from outbreaks of the novel coronavirus at the beginning, which Miller chalked up to the community's vigilance in testing, tracking and prevention efforts.
But by the fall, cases began to climb in the county along with the rest of Montana. By early October, the number of confirmed cases in Lincoln County was 170, nearly double the count at the end of August. County health officials said in a Facebook post that cases were all over the county and "it would be irresponsible to classify any towns as safe."
The vermiculite mine closed in Libby in 1990. For decades before that, Miller said, the mine constantly spewed asbestos-laden dust throughout Libby.
"During the heyday, I don't think you could shop for groceries in this town without breathing some of the dust," he said.
The extent of the public health disaster in Libby became known only after the Seattle Post-Intelligencer published a series of stories by journalist Andrew Schneider in 1999. Lawsuits began pouring in from across the nation, and W.R. Grace filed for bankruptcy protection in 2001, putting a hold on more than 100,000 pending claims against it.
The Environmental Protection Agency added Libby and the surrounding area as a Superfund site in 2002 and declared a public health emergency in 2009. The EPA spent more than $600 million to clean up 2,600 homes and properties and removed more than 1 million cubic yards of contaminated soil, according to the agency.
The company and its executives were acquitted in 2009 of federal charges that the company had conspired to conceal the mine's health risks. Grace emerged from bankruptcy in 2014 after a legal settlement that set up trust funds to pay for current and future asbestos victims' medical costs. The company agreed to pay $250 million for the cleanup in 2008.
Asbestos victims also sued the state of Montana, saying that state officials knew the danger but failed to stop it. Settlements in 2011 and 2017 totaled $68 million.
Also, the former mine site and surrounding forest have not been cleaned, leading the EPA to classify the Superfund site as still not under control for human exposure to asbestos. Those most at risk of exposure are loggers, firefighters and trespassers, the EPA said.
The county public health officer has issued an order requiring people to wear masks in public regardless of how many cases of COVID-19 the county has — a more stringent rule than the statewide requirement to wear a mask in counties where there are four or more active cases.
Though many in the community have accepted public health guidelines to avoid the coronavirus, a strong libertarian streak runs through this remote county on the U.S.-Canada border, where residents' distrust of government is heightened by the town's history with the mine.
Doug Shaw, 69, is another resident with lungs scarred from breathing in asbestos. He blames W.R. Grace and the state government for covering up the contamination for decades and calls Libby's asbestos deaths murder.
Grace officials did not directly respond to Shaw's accusation, but instead referred to the company's financial relief fund for residents with asbestos-related illness.
Shaw said he's frustrated by the government's COVID restrictions on events and businesses.
"It's nuts. Nobody has to live like this. We need to get back to work," he said.
The area depends on summer tourism to keep its economy healthy. The county has allowed large public events such as a rodeo and an international chainsaw competition to occur, raising concerns that visitors to those events could spread COVID-19 in the community.
"We need people to come here and spend money and jolt the economy," Fahland said. "Problem is, with that rodeo, there were faces in that crowd that have different license plates that came from different places that may have had issues."
Julie Kendall, a phlebotomist at a local hospital who was diagnosed with an asbestos-related disease two months ago, echoed that concern.
"These people that come to these events from out of town are going to our gas stations and our grocery stores," she said. "They could be exposing you right there."
Kendall sat at a picnic table near a railroad track where she was exposed to asbestos as a child. The area used to be home to a community swimming pool and children would play near piles of mine waste. She said she sees a similarity between asbestos and the novel coronavirus.
"It's unseen," she said. "You can be doing the most innocent thing and it could still get you."
But Kendall also believes those parallels have given folks like her a leading edge on dealing with this pandemic.
"We're already afraid here," she said. "So it's kind of like one more shake of the dice. You can't live every day in fear. But here we do."
Pharmaceutical giants Regeneron and Gilead Sciences got the kind of publicity money can't buy this week after President Donald Trump took their experimental drugs for his coronavirus infection, left the hospital and pronounced himself fully recovered.
"It was, like, unbelievable. I felt good immediately," Trump said Wednesday in a tweeted video. "I call that a cure."
He praised Regeneron's monoclonal antibody cocktail, which mimics elements of the immune system, and mentioned a similar drug under investigation by Eli Lilly and Co. The president also took Gilead's remdesivir, an antiviral that has shortened recovery times for COVID-19 patients in early research.
There is no scientific evidence that any of these drugs contributed to the president's recovery, since many patients do fine without them. It is also not known whether the president has been "cured," since the White House has released few specifics about the course of his illness.
Yet as his campaign for reelection enters its final stretch, Trump is not feeling the love in campaign contributions. Regeneron, Gilead, Lilly and the industry as a whole are sending more money elsewhere.
Reversing a trend in which contributions from drugmakers' political committees and their employees have gone largely to Republican candidates for president and Congress, so far for 2020 the industry has tilted toward Democrats.
The shift may reflect industry expectations that Democratic presidential candidate Joe Biden will win, said Steven Billet, who teaches courses in corporate lobbying and political donations at George Washington University. Pharma companies may see campaign largesse as leverage if Biden follows through on promises to address high drug prices, he said.
In a year when complaints about high prescription drug prices have been overshadowed by the pandemic, donors with ties to pharma manufacturers have given around $976,000 to Biden, according to data from the Center for Responsive Politics. That's nearly three times the pharma contributions to Trump, who recently switched his tune from complaining about "rip-off" prescription prices to describing drug firms as "great companies."
"Traditionally the industry tends to favor Republicans," said Sarah Bryner, CRP's research director. "But this cycle, we're seeing that flipped," partly reflecting Democrats' overall greater success in fundraising, she said.
Pharmaceutical companies and their trade groups have ahistory of supporting Trumpand other Republicans indirectly through hard-to-trace "dark money" nonprofits. But those contributions may not be disclosed until long after the election, if ever.
Of $177,000 given so far to 2020 federal candidates by Regeneron's employees and political action committee, four-fifths have gone to Democrats, including $35,203 to Biden, according to CRP.
Regeneron CEO Leonard Schleifer, a billionaire who has known Trump for years and belongs to the Trump National Golf Club Westchester in New York's Westchester County, has a long history of giving to Democrats. He gave $5,400 to Hillary Clinton's 2016 presidential run and $120,000 in 2018 to a political action committee attempting to flip the Senate to Democratic control.
Schleifer has made no registered political donations since last year, when his contributions went mainly to his son, Adam Schleifer, a Democrat running for Congress who lost in a primary this summer.
North Carolina Sen. Thom Tillis, representing a state with a large biotech industry and running for reelection in a tight race, has been the biggest Republican recipient of Regeneron dollars for 2020 races, tallying $5,526 so far.
"This is a company that looks as though they've always been committed to Democrats," said Billet, a former AT&T lobbyist who teaches PAC management. "And my guess is they just have a Democratic culture in this company."
A spokesperson for Regeneron, which has applied for emergency use authorization to bypass the Food and Drug Administration approval process for its drug, declined to comment on campaign donations and said the company will continue clinical trials.
The drug is expected to cost thousands of dollars per dose. "You're going to get them for free," Trump said of the COVID-19 drugs he took. The government has agreed to make initial doses of Regeneron's antibody treatment "available to the American people at no cost," the company says.
But details of the contract, including the price, remained secret. In any event, if patients get the drug at no direct cost, "it doesn't mean they're not paying for it," said James Love, director of Knowledge Ecology International, a nonprofit that works to expand access to medical technology. "They're just paying for it through taxes."
Donors with Gilead ties also lean left, giving two-thirds of their roughly $284,000 in contributions so far this cycle to Democratic candidates for Congress and president, the CRP data shows, including about $36,000 to Biden.
At Lilly, where Health and Human Services Secretary Alex Azar once ran the U.S. division, 54% of the money has gone to Democrats and 46% to Republicans. Lilly employees have given $45,000 to Biden and $13,000 to Trump, according to CRP.
Biden does not accept donations from corporate PACs; all his Regeneron, Lilly and Gilead dollars came from their employees.
Much of this year's overall pharma shift to Democrats comes in the presidential race. KHN's Pharma Cash to Congress data tracking sitting members still shows a preference this cycle of pharma PACs targeting congressional Republicans, $6 million so far compared with $4.7 million given to Democrats.
"Joe Biden has Big Pharma — as well as Big Tech and big banks — in his pocket because he's worked for them for nearly 50 years, rather than the American people," said Samantha Zager, a spokesperson for the Trump campaign.
On the campaign trail, Biden has focused largely on improving health insurance. But he also proposes letting Medicare negotiate drug prices, tying drug-price increases to inflation and allowing patients to buy imported pharmaceuticals.
Biden "will further reduce healthcare costs while expanding coverage, end practices like surprise billing, lower premiums and stand up to abuses of power by prescription drug companies," said campaign spokesperson Rosemary Boeglin.
Before Trump took office, he said pharma companies were "getting away with murder" over the prices they charge. Despite the president's claims and promises, he has done little to lower prescription drug prices, according to experts and fact-checkers.
A Trump executive order this month would require Medicare to pay no more for drugs than other developed nations, but it starts with a test program and could take months or years to implement.
Dr. Katherine Pannel was initially thrilled to see President Donald Trump's physician is a doctor of osteopathic medicine. A practicing D.O. herself, she loved seeing another glass ceiling broken for the type of doctor representing 11% of practicing physicians in the U.S. and now 1 in 4 medical students in the country.
But then, as Dr. Sean Conley issued public updates on his treatment of Trump's COVID-19, the questions and the insults about his qualifications rolled in.
"How many times will Trump's doctor, who is actually not an MD, have to change his statements?" MSNBC's Lawrence O'Donnell tweeted.
"It all came falling down when we had people questioning why the president was being seen by someone that wasn't even a doctor," Pannel said.
The osteopathic medical field has had high-profile doctors before, good and bad. Dr. Murray Goldstein was the first D.O. to serve as a director of an institute at the National Institutes of Health, and Dr. Ronald R. Blanck was the surgeon general of the U.S. Army. Former Vice President Joe Biden, challenging Trump for the presidency, also sees a doctor who is a D.O. But another now former D.O., Larry Nassar, who was the doctor for USA Gymnastics, was convicted of serial sexual assault.
Still, with this latest example, Dr. Kevin Klauer, CEO of the American Osteopathic Association, said he's heard from many fellow osteopathic physicians outraged that Conley — and by extension, they, too — are not considered real doctors.
"You may or may not like that physician, but you don't have the right to completely disqualify an entire profession," Klauer said.
For years, doctors of osteopathic medicine have been growing in number alongside the better-known doctors of medicine, who are sometimes called allopathic doctors and use the M.D. after their names.
According to the American Osteopathic Association, the number of osteopathic doctors grew 63% in the past decade and nearly 300% over the past three decades. Still, many Americans don't know much about osteopathic doctors, if they know the term at all.
"There are probably a lot of people who have D.O.s as their primary [care doctor] and never realized it," said Brian Castrucci, president and CEO of the de Beaumont Foundation, a philanthropic group focused on community health.
So What Is the Difference?
Both types of physicians can prescribe medicine and treat patients in similar ways.
Although osteopathic doctors take a different licensing exam, the curriculum for their medical training — four years of osteopathic medical school — is converging with M.D. training as holistic and preventive medicine becomes more mainstream. And starting this year, both M.D.s and D.O.s were placed into one accreditation pool to compete for the same residency training slots.
But two major principles guiding osteopathic medical curriculum distinguish it from the more well-known medical school route: the 200-plus hours of training on the musculoskeletal system and the holistic look at medicine as a discipline that serves the mind, body and spirit.
The roots of the profession date to the 19th century and musculoskeletal manipulation. Pannel was quick to point out the common misconception that their manipulation of the musculoskeletal system makes them chiropractors. It's much more involved than that, she said. Dr. Ryan Seals, who has a D.O. degree and serves as a senior associate dean at the University of North Texas Health Science Center in Fort Worth, said that osteopathic physicians have a deeper understanding than allopathic doctors of the range of motion and what a muscle and bone feel like through touch.
That said, many osteopathic doctors don't use that part of their training at all: A 2003 Ohio study said approximately 75% of them did not or rarely practiced osteopathic manipulative treatments.
The osteopathic focus on preventive medicine also means such physicians were considering a patient's whole life and how social factors affect health outcomes long before the pandemic began, Klauer said. This may explain why 57% of osteopathic doctors pursue primary care fields, as opposed to nearly a third of those with doctorates of medicine, according to the American Medical Association.
Pannel pointed out that she's proud that 42% of actively practicing osteopathic doctors are women, as opposed to 36% of doctors overall. She chose the profession as she felt it better embraced the whole person, and emphasized the importance of care for the underserved, including rural areas. She and her husband, also a doctor of osteopathic medicine, treat rural Mississippi patients in general and child psychiatry.
Given osteopathic doctors' likelihood of practicing in rural communities and of pursuing careers in primary care, Health Affairs reported in 2017, they are on track to play an increasingly important role in ensuring access to care nationwide, including for the most vulnerable populations.
Stigma Remains
To be sure, even though the physicians end up with similar training and compete for the same residencies, some residency programs have often preferred M.D.s, Seals said.
Traditional medical schools have held more esteem than schools of osteopathic medicine because of their longevity and name recognition. Most D.O. schools have been around for only decades and often are in Midwestern and rural areas.
Seals said prospective medical students ask the most questions about which path is better, worrying they may be at a disadvantage if they choose the D.O. route.
"I've never felt that my career has been hindered in any way by the degree," Seals said, noting that he had the opportunity to attend either type of medical school, and osteopathic medicine aligned better with the philosophy, beliefs and type of doctor he wanted to be.
Many medical doctors came to the defense of Conley and their osteopathic colleagues, including Dr. John Morrison, an M.D. practicing primary care outside of Seattle. He was disturbed by the elitism on display on social media, citing the skills of the many doctors of osteopathic medicine he'd worked with over the years.
"There are plenty of things you can criticize him for, but being a D.O. isn't one of them," Morrison said.
Even with insurance, Matthew Fentress faced a medical bill of more than $10,000 after a heart operation. A cook at a senior living community in Kentucky, he figured he could never pay what he owed — until a stranger who lives 2,000 miles away stepped in to help.
“The system still failed me,” said Fentress, 31. “It was humanity that stepped up.”
Karen Fritz, a retired college professor in Las Vegas, saw part of his story on “CBS This Morning,” which partners with KHN and NPR on the crowdsourced Bill of the Month investigation. Fritz found the story online, and then she called the hospital to donate $5,000 toward Fentress’ bill.
“I’ve been a young person in college with medical bills. I just really felt convicted to help him out, to help him get beyond his financial struggles. I had no hesitation; I felt led by the Holy Spirit to do that,” said Fritz, 64, who taught business and marketing at various schools. “When you help other people, it gives you joy.”
Fentress was just 25 when doctors diagnosed him with viral cardiomyopathy, a heart disease that developed after a bout of the flu. In his six years of grappling with that chronic condition, which could lead to heart failure, he had already been sued by his hospital after missing a payment and declared bankruptcy.
Financial fears reignited this year when his cardiologist suggested he undergo an ablation procedure to restore a normal heart rhythm. He said hospital officials at Baptist Health Louisville assured him he wouldn’t be on the hook for more than $7,000, a huge stretch on his $30,000 annual salary.
Though the procedure went well, the bill filled him with dread. His portion totaled more than $10,000 for the ablation and related visits in 2019 and 2020. After an adjustment, a spokesperson for his insurer, United Healthcare, said he owed nearly $7,900. That was the same as the annual out-of-pocket maximum for in-network care under his plan, which also included a $1,500 annual deductible. Like millions of other Americans, Fentress is considered underinsured.
Fentress said he learned about Fritz’s donation when he got a call from a hospital representative. He submitted a recent pay stub to the hospital, and its financial aid program covered the rest.
Hospital officials said Fentress at one point had been under the incorrect impression that he’d have to pay big monthly payments and couldn’t apply for financial assistance because he’d gotten it before.
“Baptist Health consistently has encouraged Mr. Fentress to apply for financial assistance to provide the information we need to determine a qualifying amount,” Charles Colvin, Baptist Health’s vice president for revenue strategy, said in a statement. “We are pleased to have received the additional information needed to provide that financial assistance.”
Fentress said he’s incredibly grateful to Fritz. He plans to stay in touch with her, and he’s sending her a T-shirt he designed with a picture of a heart and the words “Be nice.”
“This is the first time ever since I was 25 that I haven’t had medical debt. It’s a wonderful feeling. It gives me a lot of peace of mind,” Fentress said. “But I feel guilty that a lot of other people are still suffering.”
Do you have an interesting medical bill you want to share with us? Tell us about it!
It took Carrie Wanamaker several days to connect the face she saw on GoFundMe with the young woman she had met a few years before.
According to the fundraising site, Adeline Fagan, a 28-year-old resident OB-GYN, had developed a debilitating case of COVID-19 and was on a ventilator in Houston.
Scrolling through her phone, Wanamaker found the picture she took of Fagan in 2018, showing the fourth-year medical student at her side in the delivery room, beaming at Wanamaker's pink, crying, minutes-old daughter. Fagan supported Wanamaker's leg through the birth because the epidural paralyzed her below the waist, and they joked and laughed since Wanamaker felt loopy from the anesthesia.
"I didn't expect my delivery to go that way," said Wanamaker, a pediatric dentist in upstate New York. "You always hear about it being the woman screaming and cursing at her husband, but it wasn't like that at all. We just had a really great time. She made it a really special experience for me."
Fagan's funeral took place Saturday.
The physician tested positive for the coronavirus in early July and died Sept. 19, after spending over two months in hospital. She had worked in a Houston emergency department, and a family member says she reused personal protective equipment day after day due to shortages.
Fagan is one of over 250 medical staff who died in Southern and Western hot spot states as the virus surged there over the summer, according to reporting by the Guardian and KHN as part of Lost on the Frontline, a project to track every U.S. healthcare worker death. In Texas, nine medical deaths in April soared to 33 in July, after Gov. Greg Abbott hastily pushed to reopen the state for business and then reversed course.
Among the deceased health workers who have so far been profiledby the Lost on the Frontline team, about a dozen nationwide, including Fagan, were under 30. The median age of death from COVID for medical staff is 57, compared with 78 in the general population. Around one-third of the deaths involved concerns over inadequate PPE. Protective equipment shortages are devastating for healthcare workers, who are at least three times more likely to become infected with the COVID virus than the general population.
"It kicked me in the gut," said Wanamaker. "This is not what was supposed to happen. She was supposed to go out there and live her dreams and finally be able to enjoy her life after all these years of studying."
Fagan worked at a hospital called HCA Houston Healthcare West, and had moved to Texas in 2019 after completing medical school in Buffalo, New York, a few hours from her hometown of LaFayette.
She was the second of four sisters, all pursuing or considering careers in the medical field. A younger sibling, Maureen, 23, said Fagan dealt with patients in uncomfortable or embarrassing situations with "grace," as she had observed when she accompanied her on two medical mission trips to Haiti. "Addie was very much, 'Do you understand? Do you have other questions? I will go over this with you a million times if need be.'"
Maureen also mentioned Fagan's comical side — she was voted by her colleagues as the 'most likely to be found skipping and singing down the hall to a delivery' and prone to rolling out hammy Scottish and English accents.
Fagan "loved delivering babies, loved being part of the happy moment when a baby comes into the world, loved working with mothers," said Dr. Dori Marshall, associate dean at the University at Buffalo medical school. But she found living by herself in Houston lonely, and in February Maureen moved down to keep her company; she could just as easily prepare for her own medical school entrance exam in Texas.
It is unclear how Fagan contracted the coronavirus, but to Maureen it seemed linked to her July rotation in the ER. HCA West is part of HCA Healthcare — the country's largest hospital chain — and in recent months a national nurses union has complained of its "willful violation" of workplace safety protocols, including pushing infected staff to continue clocking in.
Amid national shortages, Maureen said her sister faced a particular challenge with PPE. "Adeline had an N95 mask and had her name written on it," she said. "Adeline wore the same N95 for weeks and weeks, if not months and months."
The CDC recommends that an N95 mask should be reused at most five times, unless a manufacturer advises otherwise. HCA West said it would not comment specifically on Maureen's allegations, but the facility's chief medical officer, Dr. Emily Sedgwick, said the hospital's policies did not involve individuals constantly reusing the same mask.
"Our protocol, based on CDC guidance, includes colleagues turning in their N95 masks at the conclusion of each shift, and receiving another mask at the beginning of their next shift." A spokesperson for HCA West, Selena Mejia, also said that hospital staff were "heartbroken" by Fagan's death.
On July 8, Fagan arrived home with body aches, a headache and a fever, and a COVID test came back positive. For a week the sisters quarantined, and Fagan, who had asthma, used her nebulizer. But her breathing difficulties persisted, and one afternoon Maureen noticed that her sister's lips were blue, and insisted they go to the hospital.
For two weeks, the hospital attempted to supplement Fagan's failing lungs with oxygen. She grew so weak she wasn't able to hold her phone up or even keep her head upright. She was transferred to another hospital, where she agreed to be put on a ventilator.
Less than a day later, she was hooked up to an ECMO device for a highly invasive treatment of last resort, in which blood is removed from the body via surgically implanted intravenous tubes, artificially oxygenated and then returned.
She lingered in this state through August, an experience documented on a blog by her software engineer father, Brant, who arrived in Houston with her mother, Mary Jane, a retired special education teacher, even though they were not allowed to visit Fagan.
The medical team tried to wean her off the machines and the nine sedatives she was at one point receiving, but as she emerged from unconsciousness she became anxious and was put back under to stop her from pulling out the tubes snaking into her body. She was able to respond to instructions to wiggle her toes. A nurse told Brant she might be suffering from "ICU psychosis," a delirium caused by a prolonged stay in intensive care.
The family tried to speak with her daily. "The nurse told us that they have seen Adeline's eyes tear up after we have been talking to her on the phone," Brant wrote. "So it must be having some impact."
On Sept. 15, her parents were at last permitted to visit. "I do not think we were prepared for what we saw, in person, when we entered her room," he wrote. "Occasionally, Adeline would try to respond, shake her head or mouth a word or two. But her stare was glassy and you were not sure if she was in there."
It was too much for him. "Being the softy that cannot stand it when one of my girls is hurting, [I] commenced to get lightheaded and pass out."
Finally, on Sept. 17, it seemed Fagan was turning a corner. Still partly sedated, she was nevertheless able to sit up without support. She mouthed the words to a song, being unable to sing because a tracheostomy prevented air from passing over her vocal cords.
The next day, the ECMO tubes were removed. The day after that, Brant made his last post.
His daughter had suffered a massive brain hemorrhage, possibly because her vascular system had been weakened by the virus. Patients on ECMO also take high doses of blood thinners to prevent clots.
A neurosurgeon said that even on the remote chance Fagan survived surgery, she would be profoundly brain-damaged.
"We spent the remaining minutes hugging, comforting and talking to Adeline," Brant wrote.
The president's physicians would not disclose the results of the president's lung scans, invoking HIPAA to selectively provide intel on the president's health.
This article was published on Wednesday, October 7, 2020 in Kaiser Health News.
Within one day, President Donald Trump announced his COVID diagnosis and was admitted to Walter Reed National Military Medical Center for treatment. The flurry of events was stunning, confusing and triggered many questions. What was his prognosis? When was he last tested for COVID-19? What is his viral load?
The answers were elusive.
Picture the scene on Oct. 5. White House physician Dr. Sean Conley, flanked by other members of Trump's medical team, met with reporters outside the hospital. But Conley would not disclose the results of the president's lung scans and other vital information, invoking a federal law he said allows him to selectively provide intel on the president's health.
"There are HIPAA rules and regulations that restrict me in sharing certain things for his safety and his own health," he told the reporters.
The law he's referring to, HIPAA, is the Health Insurance Portability and Accountability Act of 1996, which includes privacy protections designed to shield personal health information from disclosure without a patient's consent.
Because this is likely to remain an issue, we decided to take a look. In what cases does HIPAA restrict the sharing of information — and is the president covered by it?
Experts agreed that he is, but several noted there are exceptions to its protections — stirring debate over the airwaves and on Twitter regarding what information about the president's health should be released.
Explaining the Protections
HIPAA and the rules for its implementation apply to medical providers — such as doctors, dentists, pharmacists, hospitals — and most health plans that either provide or pay for medical care.
In some cases, the law permits the sharing of medical information without specific consent, such as when needed for treatment purposes or billing. Examples include doctors or hospitals sharing information with other physicians or facilities involved in the patient's care, or information shared about tests, drugs or other medical care so bills can be sent to patients.
Other than that, without specific patient consent, the law is clear.
"The default rule under HIPAA is that healthcare providers may not disclose a patient's health information. Period," said Joy Pritts, a consultant in Washington, D.C., and a former privacy official in the Obama administration.
The experts we consulted all agreed that Trump's doctors are bound by HIPAA. Since he is their patient, they cannot share his medical information without his consent.
Patients can allow some information to be released while demanding that other bits be withheld.
That may be why the public has been given only select details about Trump's COVID-19 status, such as when Conley discussed the president's blood pressure reading but not the results of his lung scans.
Trump "can pick and choose what he wants to disclose," Pritts said.
So it is up to Trump to give his doctors the green light to report to the public on his condition.
"HIPAA does not prevent the president of the United States from authorizing the disclosure of all publicly relevant information," said Lawrence Gostin, a professor of global health law at Georgetown University. "He can share it if he wanted to and he can tell his doctors to share it."
Elizabeth Gray, a teaching assistant professor of health policy and management at George Washington University, said that because Conley shared some medically private information with the American public, there must have been a conversation between the president and his doctors about what was OK to include in their press briefings.
"He would have had to have given his authorization," said Gray. In other words, Trump OK'd the details his doctors mentioned, but when follow-up questions were asked, she said, HIPAA was "a shield" because "the president hadn't authorized the release of anything else."
Still, beyond HIPAA, other factors could lead to less-than-complete disclosure of the president's health.
For starters, Trump is the commander in chief, and his personal physician is a member of the military.
"If your commander in chief says, 'I'm giving you a command — forget about HIPAA,'" said Thomas Miller, a resident fellow with the American Enterprise Institute.
Pritts and others also said the president's physician may not be covered by HIPAA if his care is provided by the White House medical unit, which does not bill for its services or involve health insurance.
But, "whether covered by HIPAA or not, a physician has an ethical obligation to maintain patient confidentiality," Pritts said.
And Leaks?
It's also important to note that HIPAA applies only to healthcare professionals and related entities working within that sphere.
So, when Sean Spicer, former White House press secretary, tweeted on Oct. 5 that a journalist had violated HIPAA (he misspelled it as "HIPPA") by reporting that a member of the White House press shop had COVID-19, he was wrong, said the experts.
"Journalists are not bound by HIPAA," said Gostin.
Email interview withJonathan Turley, professor of public interest law, GW Law, Oct. 6, 2020
Phone interview with Charles Stevenson, adjunct lecturer of American foreign policy at Nitze School of Advanced International Studies at Johns Hopkins University, Oct. 6, 2020
Phone interview with Elizabeth Gray, teaching assistant professor of health policy and management at George Washington University, Oct. 6, 2020
Phone interview with John Barry, adjunct faculty at Tulane University School of Public Health and Tropical Medicine, Oct. 6, 2020
Phone interview with Joy Pritts, privacy consultant, Oct. 6, 2020
Phone interview with Lawrence Gostin, faculty director of the O'Neill Institute for National and Global Health Law at Georgetown University, Oct. 6, 2020
Phone interview with Sharona Hoffman, co-director of the Law-Medicine Center at Case Western Reserve University School of Law, Oct. 6, 2020
Phone interview with Thomas Miller, resident fellow at the American Enterprise Institute, Oct. 6, 2020
"Behind that door is healthcare information. Hypothetically, only doctors have access to that information, and HIPAA prevents healthcare providers from unlocking that door," she said. "But, once the info gets out of that door, then HIPAA no longer applies."
And the information is likely to come out — sooner or later, said Miller. "Leaking will take care of most reporting and disclosure" about the president's health, he said.
The Exceptions
Within HIPAA are a couple of exceptions identifying when health information can be disclosed without the authorization of the patient.
Might that apply here, given that Trump took a ride around Walter Reed in a government SUV with Secret Service agents, or returned to a White House filled with other employees?
Jonathan Turley, a professor of public interest law at George Washington University Law School, said he doesn't think the public health exemption would apply in this case.
"If a patient is contagious and noncompliant, doctors can make disclosure in the interest of public health," Turley wrote in an email. "However, the team of doctors stated that they felt that it was appropriate to send President Trump back to the White House to continue to recover."
Moreover, Turley noted that nothing was withheld that would have qualified for this exception. "The world knows that the president is COVID-positive and still likely contagious," he wrote. "It is unclear what further information would do in order to put the world on notice."
Some experts, however, expressed a different view. They argued that the details of when the president last tested positive would provide insight into who may have been exposed and how long he should be considered infectious and asked to isolate. Even so, the law's public health exemption is usually interpreted to mean such information would be shared only with state and local health officials.
There are two HIPAA exceptions that apply specifically to the president, said Gray.
"They could make that disclosure to people who need to know, to the Secret Service or the vice president, but it is essentially only to protect [the president]," said Gray. "There is also an armed forces exception, but disclosures are in regards to carrying out a military mission, which doesn't apply here."
What about national security?
Miller, at AEI, said concerns about national security could be among the reasons for more disclosure, such as questioning a president's ability to carry out duties. But HIPAA wasn't designed to address this point.
Some argue that because the president is not just an average citizen, he should waive his right to medical privacy.
"The president is not just an individual; the president is the chief executive," said Charles Stevenson, an adjunct lecturer on American foreign policy at Johns Hopkins University. "The president loses a lot of privacy because our political system, our governmental system demands it. The president always has to be available to the military and that means the state of his health is a matter of national security."
Historical precedent
Trump is one in a long line of presidents who have not been completely transparent in sharing their medical information.
"There's a pretty strong tradition of these things being obscured," said John Barry, an adjunct faculty member at the Tulane University School of Public Health and Tropical Medicine. And no federal law requires a president to provide this information.
Wilson likely caught the so-called Spanish influenza in 1919, which was kept secret. Later that year, he had a severe stroke that disabled him, the gravity of which was also hidden from the public.
President John F. Kennedy used painkillers and other medications while in office, which wasn't made publicuntil years after his death.
And when President Ronald Reagan was shot in 1981, he was much closer to death than his White House spokesperson described to the public. There were also questions about Reagan's mental acuitywhile in his final years in office. He was diagnosed with Alzheimer's disease five years after his final term.
Why would White Houses want to obscure health information of presidents?
"Every White House wants the public to think the president is healthy, strong and capable of leading the country," said Barry. "That's consistent across parties and presidencies."
Throughout the 2020 election cycle, candidates’ positions on health care have been particularly important for voters with underlying and often expensive medical needs — in short, those with preexisting conditions.
It’s no surprise, then, that protections for people who have chronic health problems like diabetes and cancer have become a focal point for candidates nationwide — among them, Matt Rosendale, the Republican contender for Montana’s only U.S. House seat.
On Sept. 22, Rosendale’s campaign hit airwaves and online streaming services with an ad featuring a Whitefish resident named Sandee, whose son was diagnosed with a life-threatening disease. Sandee told the story of how Rosendale came to her family’s aid, concluding that “Matt fights for everyone with a preexisting condition.”
As is often the case with health care policy, however, the truth is far from simple. Rosendale and many other Republican congressional candidates face the challenge of convincing voters they support these safeguards even as they oppose the Affordable Care Act, which codifies those safeguards.
Polls show broad public support for keeping the ACA’s preexisting condition protections.
We decided to investigate.
Rosendale is up against Democrat Kathleen Williams for the congressional seat now occupied by Republican Rep. Greg Gianforte, who has entered the state’s gubernatorial race. The open seat has been controlled by the GOP for the past 12 terms, but this year’s race is expected to be close. Williams, who also ran for the seat in 2018, has made health care her top campaign issue.
We contacted the Rosendale campaign to find out the basis for his ad’s claim. Campaign spokesperson Shelby DeMars listed a range of health policies backed by the candidate that would help people with preexisting conditions directly or indirectly by holding down health care costs. She specifically pointed to Rosendale’s work on the state’s reinsurance program as Montana’s state auditor and insurance commissioner, a post he was elected to in 2016.
“Matt Rosendale is a champion for those with pre-existing conditions and he has the record to prove it,” DeMars said via email. “It is because of the Reinsurance program he implemented that Montanans with pre-existing conditions can access the affordable healthcare coverage they need.”
Subsequent news accounts indicated the idea worked. In-state insurers credited the program with lowering premiums by 8% to 14% for 2020. As Montana Health Co-op CEO Richard Miltenberger told MTN News shortly after the 2019 legislative session, “It allows the insurance companies to have rate stabilization for those really big claims, the ones that are the earthquakes in health insurance.” He went on to say that this stability “brings the cost down for the consumer.” More to the point, the American Medical Association has also stated that reinsurance not only serves to subsidize high-cost patients but “protects patients with pre-existing conditions.”
But there’s a rub.
The reinsurance program that Rosendale touts wouldn’t exist without a state innovation waiver created by the ACA, which Rosendale says he’ll work to repeal. That effort will doubtless continue to fuel pitched battles in Congress, and how the U.S. Supreme Court may rule on a pending ACA challenge remains a point of speculation. One thing is clear, though: If the entire ACA is thrown out, the reinsurance program goes with it, along with Montana’s Medicaid expansion and the ban on insurers excluding people with health problems from affordable coverage.
When asked about the resulting elimination of the reinsurance program, DeMars emphasized that Rosendale’s work as auditor has created a system that will ensure protections for preexisting conditions “regardless of what happens to the ACA.” She did not elaborate or explain what protections would remain if the ACA were repealed.
The Short-Term Plan Component
In defending his stance on preexisting conditions, Rosendale continues to be haunted by another health care policy specter from his political past. During his unsuccessful challenge against Democratic U.S. Sen. Jon Tester in 2018, Rosendale faced criticism for promoting short-term, limited-duration health insurance plans. Unlike plans offered on the individual marketplace, these short-term plans are exempt from the ACA’s ban on excluding people with preexisting conditions. And, under a 2018 regulatory change pushed by the Trump administration, the length of these short-term plans has been extended from three months to 12, with the potential to renew for up to three years.
As state auditor, Rosendale included those plans in his March 2020 roundup of year-round options for immediate coverage. They often exclude coverage for a variety of higher-cost benefits. In Montana, for example, a review by KFF found that of four short-term plans available in Billings in 2018, none offered coverage for maternity care, mental health, substance abuse or prescription drug services. (KHN is an editorially independent program of KFF.)
Historically, short-term plans were designed to help individuals fill gaps in health coverage. According to Dania Palanker, an assistant research professor at Georgetown University’s Center on Health Insurance Reforms, the role short-term plans play on today’s health insurance landscape is to attract younger, healthier individuals seeking low-cost options to cover catastrophic events. That splits insurers into two pools — those who are less likely to incur medical expenses, and those who are more likely to incur them. Costs on the individual market go up as a result, leaving people with preexisting conditions no other option than to pay higher premiums. Short-term plans are, Palanker said, “actively hurting people with preexisting conditions.”
“Promoting short-term plans and stumping on supporting protections for preexisting conditions are mutually exclusive,” she continued.
Asked whether the cost-lowering effect of a reinsurance program would be enough to offset the effects of short-term plans, Palanker said the only way such an offset would be enough is if the program encompassed short-term plans. She hasn’t seen that happen anywhere.
Our Ruling
A campaign ad says Rosendale “fights for everyone with a preexisting condition.” While it is true that health insurance premiums have dropped during Rosendale’s tenure as state auditor, the choice to establish Montana’s reinsurance program ultimately fell to decision-makers in the state’s legislature and the governor’s office. Since his ad’s claim simply states that he “fights” for people with preexisting conditions, his testimony in support of that program and role in securing the state waiver do seem to fit the bill.
In the long-term, however, Rosendale’s positions begin to run counter to the claim. His support for short-term, limited-duration plans poses a considerable threat to keeping health insurance affordable for all, and absent a solid plan from Congress to ensure that state reinsurance programs survive, his stated goal of repealing the ACA would actually serve to unravel the very protection he’s built his case on.
Older adults are especially vulnerable physically during the coronavirus pandemic. But they're also notably resilient psychologically, calling upon a lifetime of experience and perspective to help them through difficult times.
New research calls attention to this little-remarked-upon resilience as well as significant challenges for older adults as the pandemic stretches on. It shows that many seniors have changed behaviors — reaching out to family and friends, pursuing hobbies, exercising, participating in faith communities — as they strive to stay safe from the coronavirus.
"There are some older adults who are doing quite well during the pandemic and have actually expanded their social networks and activities," said Brian Carpenter, a professor of psychological and brain sciences at Washington University in St. Louis. "But you don't hear about them because the pandemic narrative reinforces stereotypes of older adults as frail, disabled and dependent."
Whether those coping strategies will prove effective as the pandemic lingers, however, is an open question.
"In other circumstances — hurricanes, fires, earthquakes, terrorist attacks — older adults have been shown to have a lot of resilience to trauma," said Sarah Lowe, an assistant professor at Yale University School of Public Health who studies the mental health effects of traumatic events.
"But COVID-19 is distinctive from other disasters because of its constellation of stressors, geographic spread and protracted duration," she continued. "And older adults are now cut off from many of the social and psychological resources that enable resilience because of their heightened risk."
The most salient risk is of severe illness and death: 80% of COVID-19 deaths have occurred in people 65 and older.
Here are notable findings from a new wave of research documenting the early experiences of older adults during the pandemic:
Changing behaviors. Older adults have listened to public health authorities and taken steps to minimize the risk of being infected with COVID-19, according to a new study in The Gerontologist.
Results come from a survey of 1,272 adults age 64 and older administered online between May 4 and May 17. More than 80% of the respondents lived in New Jersey, an early pandemic hot spot. Blacks and Hispanics — as well as seniors with lower incomes and in poor health — were underrepresented.
These seniors reported spending less face-to-face time with family and friends (95%), limiting trips to the grocery store (94%), canceling plans to attend a celebration (88%), saying no to out-of-town trips (88%), not going to funerals (72%), going to public places less often (72%) and canceling doctors' appointments (69%).
Safeguarding well-being. Inanother new study published in The Gerontologist, Brenda Whitehead, an associate professor of psychology at the University of Michigan-Dearborn, addresses how older adults have adjusted to altered routines and physical distancing.
Her data comes from an online survey of 825 adults age 60 and older on March 22 and 23 — another sample weighted toward whites and people with higher incomes.
Instead of inquiring about "coping" — a term that can carry negative connotations — Whitehead asked about sources of joy and comfort during the pandemic. Most commonly reported were connecting with family and friends (31.6%), interacting on digital platforms (video chats, emails, social media, texts — 22%), engaging in hobbies (19%), being with pets (19%), spending time with spouses or partners (15%) and relying on faith (11.5%).
"In terms of how these findings relate to where we are now, I would argue these sources of joy and comfort, these coping resources, are even more important" as stress related to the pandemic persists, Whitehead said.
Maintaining meaningful connections with older adults remains crucial, she said. "Don't assume that people are OK," she advised families and friends. "Check in with them. Ask how they're doing."
Coping with stress. What are the most significant sources of stress that older adults are experiencing? In Whitehead's survey, older adults most often mentioned dealing with mandated restrictions and the resulting confinement (13%), concern for others' health and well-being (12%), feelings of loneliness and social isolation (12%), and uncertainty about the future of the pandemic and its impact (9%).
Keep in mind, older adults expressed these attitudes at the start of the pandemic. Answers might differ now. And the longer stress endures, the more likely it is to adversely affect both physical and mental health.
Managing distress. The COVID-19 Coping Study, a research effort by a team at the University of Michigan's Institute for Social Research, offers an early look at the pandemic's psychological impact.
Results come from an online survey of 6,938 adults age 55 and older in April and May. Researchers are following up with 4,211 respondents monthly to track changes in older adults' responses to the pandemic over a year.
Among the key findings published to date: 64% of older adults said they were extremely or moderately worried about the pandemic. Thirty-two percent reported symptoms of depression, while 29% reported serious anxiety.
Notably, these types of distress were about twice as common among 55- to 64-year-olds as among those 75 and older. This is consistent with research showing that people become better able to regulate their emotions and manage stress as they advance through later life.
On the positive side, older adults are responding by getting exercise, going outside, altering routines, practicing self-care, and adjusting attitudes via meditation and mindfulness, among other practices, the study found.
"It's important to focus on the things we can control and recognize that we do still have agency to change things," said Lindsay Kobayashi, a co-author of the study and assistant professor of epidemiology at the University of Michigan School of Public Health.
Addressing loneliness. The growing burden of social isolation and loneliness in the older population is dramatically evident in new results from the University of Michigan's National Poll on Healthy Aging, with 2,074 respondents from 50 to 80 years old. (It found that, in June, twice as many older adults (56%) felt isolated from other people as in October 2018 (27%).
Although most reported using social media (70%) and video chats (57%) to stay connected with family and friends during the pandemic, they indicated this didn't alleviate feelings of isolation.
"What I take from this is it's important to find ways for older adults to interact face to face with other people in safe ways," said Dr. Preeti Malani, chief health officer at the University of Michigan. "Back in March, April and May, Zoom family time was great. But you can't live in that virtual universe forever."
"A lot of well-intentioned families are staying away from their parents because they don't want to expose them to risk," Malani continued. "But we're at a point where risks can be mitigated, with careful planning. Masks help a lot. Social distancing is essential. Getting tested can be useful."
Malani practices what she preaches: Each weekend, she and her husband take their children to see her elderly in-laws or parents. Both couples live less than an hour away.
"We do it carefully — outdoors, physically distant, no hugs," Malani said. "But I make a point to visit with them because the harms of isolation are just too high."
The Affordable Care Act, facing its first test during a deep recession, is providing a refuge for some — but by no means all — people who have lost health coverage as the economy has been battered by the coronavirus pandemic.
New studies, from both federal and private research groups, generally indicate that when the country marked precipitous job losses from March to May — with more than 25 million people forced out of work — the loss of health insurance was less dramatic.
That's partly because large numbers of mostly low-income workers who lost employment during the crisis were in jobs that already did not provide health insurance. It helped that many employers chose to leave furloughed and temporarily laid-off workers on the company insurance plan.
And others who lost health benefits along with their job immediately sought alternatives, such as coverage through a spouse's or parent's job, Medicaid or plans offered on the state-based ACA marketplaces.
From June to September, however, things weren't as rosy. Even as the unemployment rate declined from 14.7% in April to 8.4% in August, many temporary job losses became permanent, some people who found a new job didn't get one that came with health insurance, and others just couldn't afford coverage.
The upshot, studies indicate, is that even with the new options and expanded safety net created by the ACA, by the end of summer a record number of people were poised to become newly uninsured.
What's more, those losses could deepen in the months ahead, and into 2021, if the economy doesn't improve and Congress offers no further assistance, health policy experts and insurers say.
"It's a very fluid situation," said Sara Collins, vice president for healthcare coverage and access at the Commonwealth Fund, a New York-based health research group. "The ACA provides an important cushion, but we don't know how much of one yet, since this is first real test of the law as a safety net in a serious recession."
Collins also noted that accurately tracking health insurance coverage and shifts is difficult in the best of times; amid an economic meltdown, it becomes even more precarious.
Coverage Was Already on the Decline
Some 20 million people gained coverage between 2010 and 2016 under the ACA's expansion of Medicaid and its insurance marketplaces for people without employer-based coverage. A gradually booming economy after the 2008-2009 recession also helped. The percentage of the population without health insurance declined from about 15% in 2010 to 8.8% in 2016.
But then, even as the economy continued to grow after 2016, coverage began to decline when the Trump administration and some Republican-led states took steps that undermined the law's main aim: to expand coverage.
In 2018, 1.9 million people joined the ranks of the uninsured, and the Census Bureau reported earlier this month that an additional 1 million Americans lost coverage in 2019.
The accelerating decline is helping fuel anxiety over the fate of the ACA in the wake of the death of Supreme Court Justice Ruth Bader Ginsburg. The high court is scheduled to hear a case in November brought by Republican state officials, and supported by the Trump administration, that seeks to nullify the entire law.
In July, researchers at the Urban Institute, a Washington, D.C., think tank, forecast that around 10 million workers and their dependents would lose employer coverage in 2020. But they estimated that two-thirds of them will have found new coverage by year's end — leaving about 3.3 million uninsured.
A more recent Urban Institute report, released Sept. 18, and using 2020 data from the Census Bureau, calculated that of the roughly 3 million people under age 65 who had lost job-based insurance between May and July, 1.4 million found coverage elsewhere — most through Medicaid — and 1.9 million became newly uninsured. Notably, 2.2 million of those who lost their coverage were between 18 and 39 years old; 1.6 million were Hispanic.
Another recent study, using different methods, reported higher numbers for the same period. The analysis released by the Economic Policy Institute last month determined that between April and July 6.2 million people lost employer coverage. The authors didn't calculate how many found alternative coverage via Medicaid or the ACA, however.
Other findings support the notion that the health insurance loss trend shifted by mid summer. KFF, for example, published an analysis Sept. 11 showing that most companies that offered coverage to begin with chose to continue insuring furloughed and temporarily laid-off workers between March and the end of June. But as the virus continued to batter the economy, employers moved to permanently shed those jobs. (KHN is an editorially independent program of KFF.)
"The issue now is that the temporary layoffs have greatly decreased and permanent job losses, including jobs that came with health coverage, are increasing," said Cynthia Cox, a KFF vice president and director for the Program on the ACA.
Many low-income workers who lose their jobs and don't have coverage through a spouse or parent turn to Medicaid, the federal-state health program for low-income people. The Centers for Medicare & Medicaid Services reported last week that enrollment in Medicaid and the Children's Health Insurance Program grew by 4 million between February and June, a nearly 6% increase since the beginning of the coronavirus crisis.
The Impact of the Marketplaces
Gains and losses of coverage in the ACA marketplace are not yet clear, experts say. The Trump administration issued a report in June indicating that 487,000 people had, between January and June, enrolled in an ACA plan via the federal website, healthcare.gov. But that report failed to say how many people dropped an ACA plan in that period — for example, because they could no longer afford the premiums.
A study by Avalere, a health research and consulting firm in Washington, D.C., has estimated that enrollment in the ACA marketplaces since March could have swelled by around 1 million. That includes new enrollees in the 13 ACA marketplaces that states, plus the District of Columbia, operate. Many of those states held a "special enrollment period" when the pandemic hit. Healthcare.gov, run by the Trump administration, did not offer a special enrollment period.
About 11 million were enrolled in an ACA plan in February. Open enrollment for coverage that would start on Jan. 1, 2021, begins Nov. 1.
Jessica Banthin, a senior health policy researcher at the Urban Institute and until 2019 deputy director for health at the Congressional Budget Office, said it's anyone's guess how many people who lost their job-based coverage this year will choose this option. She said numerous factors will influence people's health insurance decisions this fall, and into 2021.
Chief among them is gauging whether they might soon get a new job, or get back an old job, that offers insurance. That may hold some people back from enrolling in an ACA plan this fall, Banthin said. Plus, buying insurance may be too expensive, especially for families more concerned with paying for housing, food and child care while going without a paycheck.
"Health insurance may not be their immediate concern," Banthin said. "Many people's lives have been disrupted as never before. There's a lot of trauma out there."
Collins of the Commonwealth Fund said that, even before the pandemic, a growing proportion of families were vulnerable to loss of coverage and care.
In a survey of more than 4,000 adults early this year, Collins and colleagues found a "persistent vulnerability among working-age adults in their ability to afford coverage and healthcare that could worsen if the economic downturn continues."
In large part, that's because 1 in 5 respondents who had coverage were "underinsured." Underinsurance reflects the extent to which coverage leaves people at risk of high out-of-pocket costs — a situation exacerbated by widespread job loss.
"Now is absolutely not be the time for the ACA to be further undermined, let alone killed outright," said Stan Dorn, director of the National Center for Coverage Innovation at Families USA.
Scientists who study vaccine policy said such plans could backfire, confusing the public, eroding confidence in any eventual vaccine and undermining the best strategy to end the pandemic.
This story was published on Wednesday, October 7, 2020 in Kaiser Health News.
As trust in the Food and Drug Administration wavers, several states have vowed to conduct independent reviews of any COVID-19 vaccine the federal agency authorizes.
But top health experts say such vetting may be misguided, even if it reflects a well-founded lack of confidence in the Trump administration — especially now that the FDA has held firm with rules that make a risky preelection vaccine release highly unlikely.
At least six states and the District of Columbia have indicated they intend to review the scientific data for any vaccine approved to fight COVID-19, with some citing concern over political interference by President Donald Trump and his appointees. Officials in New York and California said they are convening expert panels expressly for that purpose.
"Frankly, I'm not going to trust the federal government's opinion and I wouldn't recommend [vaccines] to New Yorkers based on the federal government's opinion," New York Gov. Andrew Cuomo said last month.
"We want to make sure — despite the urge and interest in having a useful vaccine — that we do it with the utmost safety of Californians in mind," Dr. Mark Ghaly, California's health and human services secretary, said at a recent news conference.
The District of Columbia, Colorado, Michigan, Oregon and West Virginia also have said they'll review vaccine data independently.
But scientists who study vaccine policy said such plans could backfire, confusing the public, eroding confidence in any eventual vaccine and undermining the best strategy to end the pandemic, which has sickened nearly 7.5 million Americans and killed more than 210,000.
"Do you really want a situation where Texas, Alabama and Arkansas are making drastically different vaccine policies than New York, California and Massachusetts?" asked Dr. Saad Omer, an epidemiologist who leads the Yale Institute for Global Health.
Separate state vaccine reviews would be unprecedented and disruptive, and a robust regulatory process already exists, said Michael Osterholm, an epidemiologist and director of the Center for Infectious Disease Research and Policy at the University of Minnesota.
"States should stay out of the vaccine review business," Osterholm said. "I think the Food and Drug Administration is doing their job right now. Unless there's something that changes that, I do believe that they will be able to go ahead."
The administration has given reasons for states to worry. Trump has repeatedly signaled a desire for approval of a vaccine by the Nov. 3 election, arousing fears that he will steamroll the normal regulatory process.
The president wields "considerable power" over the FDA because it's part of the executive branch of government, said Lawrence Gostin, faculty director of the O'Neill Institute for National and Global Health Law. The president nominates the FDA commissioner and can replace that official at any time.
Trump has already contradicted the advice of his own scientific advisers in order to promote unproven therapies to fight COVID-19. The FDA approved two treatments — hydroxychloroquineand convalescent plasma — without strong evidence of safety and efficacy after Trump pushed for the therapies to be widely available.
Late Monday, The New York Times reported that top White House officials planned to block FDA guidelines that would bolster requirements for emergency authorization of a COVID vaccine — because the new guidelines would almost certainly delay approval until after the election.
The White House's actions undermine the agency, said Dr. Paul Offit, an infectious disease expert at Children's Hospital of Philadelphia and a member of the FDA advisory committee on vaccines.
"Trump has perverted the FDA," Offit said. "He has scared people into thinking that normal systems aren't in place there anymore."
But the FDA seems to be maintaining plans that would make it virtually impossible for a vaccine to be approved by Election Day.
Dr. Peter Marks, who heads the FDA division responsible for vaccine approval, has repeatedly said career scientists at the agency are working to ensure that political pressure isn't a factor in any decision.
FDA reviewers are determined to "keep our hands over our ears to the noise that's coming in from all sides and keep our eyes on the prize," Marks said Monday in a JAMA webinar.
On Tuesday, the FDA pushed back against White House interference bypublishing stricter guidance for vaccine developers on its website. The document instructs vaccine companies to follow patients for two months after their last shot in order to give researchers more time to detect serious side effects and ensure the vaccine works.
For now, supporters of the normal regulatory process are pinning their hopes on two advisory groups of respected scientists who will evaluate vaccines for safety and efficacy and send their recommendations to federal agencies.
The FDA's advisory group, known as VRBPAC, will review data submitted by the pharmaceutical companies and the agency for any vaccine. The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices, or ACIP, will weigh in on its use. Their recommendations aren't binding, but the federal government has rarely contravened them.
Before jumping to independent reviews, states should allow ACIP and VRBPAC to do their jobs, said Dr. Marcus Plescia, chief medical officer of the Association of State and Territorial Health Officials. That's the best defense against any political pressure, he said, and individual states likely wouldn't have access to the data — or, perhaps, the expertise — to conduct their own reviews.
ACIP Chairman Dr. José Romero, who also is the chief medical officer for the Arkansas Department of Health, said the group has been meeting regularly since spring to discuss COVID vaccines and they've been able to proceed "in an unfettered fashion."
"I have not felt pressured by the CDC, other government agencies or pharmaceutical companies to arrive at any particular recommendation," he said.
Other safeguards are in place as well. Trump cannot simply override the FDA's authority to approve drugs and vaccines, which comes from Congress.
"The president can influence the FDA, but it must be consistent with the FDA's statutory mandate," Gostin said. "The White House may not, for example, direct the agency to ignore science or use a lower scientific standard."
Congress could sue the FDA for failing to follow its own standards, and a judge could issue a temporary restraining order blocking release of a COVID vaccine, Gostin said. Courts would require the FDA commissioner or health and human services secretary to have "valid, evidence-based reasons" for any decision.
"The commissioner or secretary may not act arbitrarily or according to political preferences alone," Gostin said.
Individual states could not overrule the FDA's authorization or approval of a vaccine, but they could wield their power in other ways. States distribute vaccines through contracts with the CDC, noted Dr. Kelly Moore, associate director of immunization education for the Immunization Action Coalition. They could say, "'We will not place any orders until we're sure,'" she said.
States probably could not prevent private companies, such as pharmacy chains, from distributing vaccines that are shipped directly to them. Pharmacies would likely sue any states that try to prevent them from distributing vaccines, Gostin said.
Although federal and state agencies play a crucial role in ensuring patient safety, they're not the only entities looking out for patient interests, said Dr. Joshua Sharfstein, a former FDA deputy commissioner who is now a vice dean at the Johns Hopkins Bloomberg School of Public Health. Doctors and other medical providers won't recommend a vaccine they don't trust, he said.
"We have an entire health care system standing between politics and the patients," Sharfstein said. "I think doctors are going to be very concerned if a vaccine is rushed."
Even pharmaceutical companies that stand to profit from vaccines have a huge stake in protecting the integrity of the approval process. Nine rival vaccine makers took the unusual step last month of pledging not to release a COVID vaccine until it has been thoroughly tested for safety.
The bigger consideration, however, is how state-by-state vetting would affect consumer trust in a COVID vaccine — or any vaccine in the future, Plescia said. A recent KFF poll found 54% of Americans would not submit to a COVID vaccine authorized before Election Day.
"Are people going to mistrust the entire process?" he said. "We will get through COVID one way or another, but if we undermine confidence in public health, that would be a disaster."