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."
As the coronavirus pandemic broke out across the country, health care providers and scientists relied on the standard method for detecting respiratory viruses: sticking a long swab deep into the nose to get a sample. The obstacles to implementing such testing on a mass scale quickly became clear.
Among them: Many people were wary of the unpleasant procedure, called a nasopharyngeal swab. It can be performed only by trained health workers, putting them at risk of infection and adding costs. And the swabs and chemicals needed to test for the virus almost immediately were in short supply.
Some places, like Los Angeles County, moved early to self-collected oral swabs of saliva and sputum, with the process supervised at drive-thru testing sites by trained personnel swathed in protective gear. Meanwhile, researchers began investigating other cheaper, simpler alternatives to the tried-and-true approach — including dribbling saliva into a test tube.
But the transition has not been immediate. Regulators and scientists are generally cautious about new, unproven technologies and have an understandable bias toward well-established protocols.
"Saliva is not a traditional diagnostic fluid," said Yale microbiologist Anne Wyllie, part of a team whose saliva-based test, called SalivaDirect, received emergency use authorization from the Food and Drug Administration in August. "When we were hit by a virus that came out of nowhere, we had to respond with the tools that were available."
Eight months into the pandemic, the move toward saliva screening is gaining traction, with tens of thousands of people across the country undergoing such testing daily. However, saliva tests still represented only a small percentage of the more than 900,000 tests conducted daily on average at the end of September.
Yale is providing its protocol on an open-source basis and recently designated laboratories in Minnesota, Florida and New York as capable of performing the test. Besides the Yale test, the FDA has authorized emergency use of several others, including versions developed at Rutgers University, the University of Illinois at Urbana-Champaign, the University of South Carolina and SUNY Upstate Medical University. A further advance, an at-home saliva test, could be headed for FDA authorization, too.
Since the start of the pandemic, the Trump administration's approach to testing has been hampered by missteps and controversy. As a key health agency during an unprecedented emergency, the FDA's effectiveness relies on public trust in how it balances the need for speed in authorizing innovative products, like saliva tests and vaccines, with ensuring safety and effectiveness, said Ann Keller, an associate professor of health policy at the University of California-Berkeley.
"You obviously want to get new tests into the mix quickly in order to address the emergency, but you still need to uphold your standards," Keller said. The White House's public pressure on the FDA has complicated the agency's efforts by undermining its credibility and independence, she said.
Respiratory viruses colonize areas inside the nasal cavity and at the back of the throat. Besides the nasopharyngeal approach, nasal samples obtained with shorter and less invasive swabs have proven effective for the coronavirus and have become widely adopted, although they also generally require a health care worker's involvement. The millions of rapid tests that will be distributed across the country, per a recent White House announcement, rely on nasal swabs.
In the early months of the pandemic, some studies reported significant levels of the virus in oral secretions. In a Hong Kong study published in February, for example, the virus was found in the saliva of 11 of 12 patients with confirmed coronavirus infection.
Turner sees an advantage to the swabbing strategy. The self-swab procedure takes only 20 to 30 seconds, while producing enough saliva for testing can take people two to three minutes, and sometimes longer, he said. "That might not sound like much difference," Turner said, "but it is when you're trying to push 5,000 people through a test site."
Curative's three labs process tens of thousands of tests from jurisdictions across the country in addition to L.A., Turner said. A test developed at SUNY Upstate Medical University, which is expected to become available at state labs around New York, also uses an oral swab.
For the Curative test, a health care worker is supposed to oversee the sample collection —reminding people to cough to bring up fluids, for example. When investigators at the University of Illinois launched what they called a "Manhattan Project" to develop a saliva test by mid-June, they hoped to make it possible for people to visit a collection site, drool into a test tube, seal it and drop it off without the aid of a health care worker.
The university is now testing more than 10,000 people a day at its three campuses and is seeking to expand access to communities across the state and country, said chemistry professor Paul Hergenrother, who led the research team. Like the similar Yale test, it is being made freely available to other laboratories. The University of Notre Dame, in Indiana, recently adopted it.
Like tests using nasopharyngeal and other kinds of nasal swabs, these saliva tests are based on PCR technology, which amplifies small amounts of viral genetic material to facilitate detection. Both the Yale and University of Illinois tests have managed to simplify the process by eliminating a standard intermediate step: the extraction of viral RNA. Their protocols also don't require viral transport media, or VTM — the chemicals generally used to stabilize the samples after collection.
"You don't need swabs, you don't need health care workers, you don't need VTM, and you don't need RNA isolation kits," Hergenrother said.
In correspondence published in the New England Journal of Medicine, the Yale team reported detecting more viral RNA in saliva specimens than in nasopharyngeal ones, with a higher proportion of the saliva tests showing positive results for up to 10 days after initial diagnosis.
The National Basketball Association provided $500,000 in support for the Yale project, said David Weiss, the NBA's senior vice president for player matters. He said the Yale team's decision to eliminate the process of RNA extraction, which separates the genetic material from other substances that could complicate detection, involved trade-offs but did not compromise the value of the test.
"Any molecular test that has an RNA extraction step is almost by definition going to be more sensitive, but it will also be more expensive and take longer and use supplies that are in shorter supply," he said. "If we're trying to look at surveillance testing to open up schools and nursing homes, a test that's still very sensitive and a lot cheaper is an important innovation."
Prices for coronavirus tests vary widely, running upward of $100. Tests based on the Yale or University of Illinois protocols, which require only inexpensive materials, could be available for as little as $10. The Curative testing service, which includes collection and transportation of samples as well as the laboratory component, averages around $150 per test depending on volume, said Clayton Kazan, chief medical director of the L.A. County Fire Department, which uses the tests.
Despite the advances in sample collection, tests using PCR — polymerase chain reaction — technology still require laboratory processing. Researchers have been investigating other approaches, including saliva-based antigen tests, that could be self-administered at home and would provide immediate results. (While PCR can detect coronavirus genetic material, antigen tests look for viral proteins that can signify a current infection.)
At least one company has announced it is seeking emergency use authorization for a saliva antigen test, although two others have dropped plans to develop their own versions as infeasible, according to The New York Times. Meanwhile, scientists at Columbia University, the University of Wisconsin and elsewhere are investigating the use of saliva with other kinds of rapid-test technologies.
"There's tons of interest" in an at-home saliva test, noted Yvonne Maldonado, chief of pediatric infectious diseases at Stanford University School of Medicine.
"People really do want to get that pregnancy-type kit out there," she said. "You could basically send people a little packet with little strips, and you pull off a strip every day and put in under your tongue."
By Julie Appleby President Donald Trump makes no secret he would like a COVID-19 vaccine to be available before the election. But it's doubtful that will happen and, even after a vaccine wins FDA approval, there would be a long wait before it's time to declare victory over the virus.
Dozens of vaccine candidates are in various testing stages around the world, with 11 in the last stage of preapproval clinical trials — including four in the U.S. One or more may prove safe and effective and enter the market in the coming months. What then?
Here are five things to consider in making vaccine dreams come true.
1. A vaccine is vital in fighting the virus, but it won't be a quick pass back to our old lives.
Vaccines have helped rid the world of scourges like smallpox, but the process takes time and there are no guarantees. Until clinical trials have been completed on this first round of vaccine candidates, no one knows how effective they might prove to be.
The minimum requirement by the Food and Drug Administration for any COVID-19 vaccine is that it should at least prove 50% effective when compared with a placebo — that is, a neutral saline solution.
By comparison, the annual influenza vaccine ranges between 40% and 60% effective in preventing the illness, depending on the recipient and the season examined. In contrast, a full course of the measles vaccine is about 97% effective.
"It's very unlikely that a first-generation vaccine will be something like a measles vaccine," notes Dr. Amesh Adalja, a physician with expertise in infectious diseases and senior scholar at the Johns Hopkins University Center for Health Security.
2. After vaccines gain approval, the real-world evaluation ensues.
Vaccines undergo a protracted testing process involving thousands of subjects. They win FDA approval only after they demonstrate safety and meet at least the minimum standard of effectiveness. Monitoring continues after they hit the market; effectiveness and any rare side effects or safety issues become more apparent after millions of doses are given.
Hypothetically, let's say the first new COVID vaccines prove 70% effective at preventing the disease. That would mean seven of every 10 people who roll up their sleeves will be protected, but three will not.
While that's good news for those protected, questions remain about who is covered and who is still vulnerable. It's possible, Adalja said, that the vaccine would reduce the severity of disease in the remaining three people, thereby helping cut hospitalizations and severe side effects.
But it's also true that regulators are focused on whether a vaccine prevents disease. Some vaccines can keep you from getting sick without preventing infection, in which case you could still spread the virus even without exhibiting symptoms.
Mysteries remain, at least for now. Scientists don't know how long the protection will last, for instance. Will protection fade, requiring annual shots, as with influenza? Or will it last for years?
Also, the COVID vaccine candidates are being tested only in adults so far. Most vaccine makers have delayed testing among children or pregnant and breastfeeding women, for example. That could mean an initial lag in safety and efficacy data for those groups, complicating vaccination efforts for children or even front-line health care workers, many of whom are women of childbearing age.
For all those reasons — "if you are looking for a magic wand, you won't find one in vaccines," said Dr. William Schaffner, a professor of preventive medicine and infectious disease at Vanderbilt University Medical Center in Nashville, Tennessee. "That said, vaccines will play a substantial role in reducing the epidemic."
3. After a vaccine is approved, you still may need to wait awhile to get your shot.
Making vaccines is complicated. And so is distributing them. Vaccine makers say they are already producing vaccine in advance of knowing whether they will win approval. But simply having ample vaccine supply doesn't mean manufacturers will have all the needed glass bottles, syringes or injectors to ship them right away. Indeed, some experts fear that a shortage of both production-line capabilities (special facilities are needed to make vaccines under strict sterile conditions) and limited supplies could hamper distribution of an approved vaccine. Many of the vaccine candidates must be shipped and stored at super-low temperatures, adding to the complexity.
"Even if you have the vaccine, that doesn't mean you can ship it out. There are multiple, multiple steps, and all of them have to work," said Dr. Ezekiel Emanuel, a vice provost at the University of Pennsylvania who has warnedof potential shortages.
The Centers for Disease Control and Prevention and the National Academy of Sciences have issued a frameworkfor who should get priority for the initial vaccine. State and local health departments will also have a say in how supplies roll out.
Current recommendations say first in line will be health care workers and people with medical conditions that put them at highest risk if they get the virus. People living in nursing homes and other congregate settings will also be higher on the list. Further down are average healthy adults.
Pay attention, and go when it's your turn, said Schaffner.
"If they say it's time for people who are middle-aged and have chronic underlying illness such as diabetes, heart disease and lung disease, you have to know what you have and understand it's your turn," he said. "You also have to understand if it's not your turn yet. Be patient."
Finally, many of the vaccines under consideration will require two doses spaced a few weeks apart, which would add to the delay. If more than one vaccine is approved, which is likely, people will need the second dose to come from the same manufacturer as the first. That could prove a record-keeping nightmare and lead to more delays — depending on how vaccine supplies hold up.
In testimony before Congress in mid-September, CDC Director Robert Redfield said that tens of millions of doses of vaccine may start to become available by late November or December. But the logistics of vaccine distribution means the country won't be able to return to "regular life" until "late second quarter, third quarter 2021," Redfield predicted.
4. So don't throw out your masks yet.
Because any vaccine is likely to fall short of 100% effectiveness and won't be in widespread distribution for a while, the use of masks and maintaining social distance will be required well into next year, experts say.
"The vaccine will be a start, but we'll still need to do the things we've been discussing throughout — hand hygiene, wearing masks and continuing to remain specifically distant," said Dr. Krutika Kuppalli, an assistant professor of infectious disease at the Medical University of South Carolina. "Those are the arsenal of tools we will need to use."
5. What if I don't want to get vaccinated?
Polls show a good percentage of Americans either don't want a vaccine or want to wait a bit before getting one. Can they be required to get a shot?
Certain employers, such as hospitals or food production plants, could require their workers to be vaccinated, but a federal mandate is highly unlikely and probably would be unconstitutional, said professor Dorit Rubinstein Reiss, an expert on employer and vaccine law at the University of California-Hastings College of Law.
The likely approach of public health authorities is to educate people about the benefits and potential side effects of a vaccine — down to whether one might experience a sore arm.
"That's what we do for every vaccine," said Adalja of Johns Hopkins. A requirement of vaccination for the general public would create resistance and "foster conspiracy theories," he said.
Most regulation of public health falls to state and local governments and health agencies, Reiss said. States would be "more likely to have narrow or specific mandates that could survive judicial review," she said.
Schools, of course, require students to be vaccinated against a wide range of illnesses. But a school-age COVID vaccine mandate is doubtful, at least in the near term, because the vaccine hasn't been tested on school-aged children.
Generally speaking, employers, including the federal government, have the power to require vaccinations, especially if they don't have a unionized workforce with a contract that might limit their power. All employers, however, face limits set by civil rights and disability laws and may have to provide alternatives for people who can't or won't get vaccinated, Reiss said.